chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site erythema
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (she was quite fatigued) and VACCINATION SITE ERYTHEMA (Redness at the injection site that does not hurt but is quite large) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. No Medical History information was reported. On 12-Mar-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 13-Mar-2021, the patient experienced FATIGUE (she was quite fatigued) and VACCINATION SITE ERYTHEMA (Redness at the injection site that does not hurt but is quite large). At the time of the report, FATIGUE (she was quite fatigued) and VACCINATION SITE ERYTHEMA (Redness at the injection site that does not hurt but is quite large) outcome was unknown. No concomitant and treatment medications were reported. For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Diplopia, Eye swelling, Face oedema, Salivary gland enlargement
Clinical narrative: Swollen Eyes; Double Vision; Swollen Salivary Glands; Swollen Face; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Swollen Eyes), DIPLOPIA (Double Vision), SALIVARY GLAND ENLARGEMENT (Swollen Salivary Glands) and FACE OEDEMA (Swollen Face) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) 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) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced EYE SWELLING (Swollen Eyes), DIPLOPIA (Double Vision), SALIVARY GLAND ENLARGEMENT (Swollen Salivary Glands) and FACE OEDEMA (Swollen Face). On 15-Mar-2021, EYE SWELLING (Swollen Eyes) had resolved. At the time of the report, DIPLOPIA (Double Vision), SALIVARY GLAND ENLARGEMENT (Swollen Salivary Glands) and FACE OEDEMA (Swollen Face) outcome was unknown.            Action taken for suspect drug MRNA-1273 Moderna COVID-19 vaccination was not applicable. No concomitant medications reported by investigator No treatment medications provided by the reporter.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Daydreaming, Disorientation, Dizziness, Feeling abnormal
Clinical narrative: cough; I was in outer space; I was out of it; disoriented; When trying to get out of bed, legs collapsed; dizziness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DISORIENTATION (disoriented), GAIT DISTURBANCE (When trying to get out of bed, legs collapsed), DIZZINESS (dizziness), COUGH (cough) and DAYDREAMING (I was in outer space) in a 69-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 13-Mar-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 13-Mar-2021, the patient experienced DISORIENTATION (disoriented), GAIT DISTURBANCE (When trying to get out of bed, legs collapsed), DIZZINESS (dizziness), DAYDREAMING (I was in outer space) and FEELING ABNORMAL (I was out of it). On an unknown date, the patient experienced COUGH (cough). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. On 15-Mar-2021, DISORIENTATION (disoriented), GAIT DISTURBANCE (When trying to get out of bed, legs collapsed), DIZZINESS (dizziness), DAYDREAMING (I was in outer space) and FEELING ABNORMAL (I was out of it) had resolved. At the time of the report, COUGH (cough) had resolved.            No concomitant medications were reported
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance
Clinical narrative: cough; I was in outer space; I was out of it; disoriented; When trying to get out of bed, legs collapsed; dizziness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DISORIENTATION (disoriented), GAIT DISTURBANCE (When trying to get out of bed, legs collapsed), DIZZINESS (dizziness), COUGH (cough) and DAYDREAMING (I was in outer space) in a 69-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 13-Mar-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 13-Mar-2021, the patient experienced DISORIENTATION (disoriented), GAIT DISTURBANCE (When trying to get out of bed, legs collapsed), DIZZINESS (dizziness), DAYDREAMING (I was in outer space) and FEELING ABNORMAL (I was out of it). On an unknown date, the patient experienced COUGH (cough). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. On 15-Mar-2021, DISORIENTATION (disoriented), GAIT DISTURBANCE (When trying to get out of bed, legs collapsed), DIZZINESS (dizziness), DAYDREAMING (I was in outer space) and FEELING ABNORMAL (I was out of it) had resolved. At the time of the report, COUGH (cough) had resolved.            No concomitant medications were reported
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for an unknown indication.     Concurrent medical conditions included Hypertension.   On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced RASH (Rash). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, RASH (Rash) had resolved.            Concomitant medication include antihypertensive drug. . Treatment include antihistamine and hydrocortisone cream.  Action taken with mRNA-123 is not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-046350 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-046350:2nd Dose
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Eye pruritus, Rash
Clinical narrative: Itchiness in the eyes; Arms were red; Arms were patchy; This spontaneous case was reported by a consumer and describes the occurrence of EYE PRURITUS (Itchiness in the eyes), ERYTHEMA (Arms were red) and RASH (Arms were patchy) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced EYE PRURITUS (Itchiness in the eyes), ERYTHEMA (Arms were red) and RASH (Arms were patchy). At the time of the report, EYE PRURITUS (Itchiness in the eyes), ERYTHEMA (Arms were red) and RASH (Arms were patchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: R arm from the upper arm to hand could not bend it; This spontaneous case was reported by a patient and describes the occurrence of LIMB DISCOMFORT (R arm from the upper arm to hand could not bend it) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No medical history was reported.     On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced LIMB DISCOMFORT (R arm from the upper arm to hand could not bend it). On 12-Mar-2021, LIMB DISCOMFORT (R arm from the upper arm to hand could not bend it) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot/warm at the injection site), VACCINATION SITE PRURITUS (Itchy at the injection site), VACCINATION SITE SWELLING (Swollen arm at the injection site) and VACCINATION SITE ERYTHEMA (Red at the injection site) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. No Medical History information was reported. On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Hot/warm at the injection site), VACCINATION SITE PRURITUS (Itchy at the injection site), VACCINATION SITE SWELLING (Swollen arm at the injection site) and VACCINATION SITE ERYTHEMA (Red at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Hot/warm at the injection site), VACCINATION SITE PRURITUS (Itchy at the injection site), VACCINATION SITE SWELLING (Swollen arm at the injection site) and VACCINATION SITE ERYTHEMA (Red at the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Headache, Hyperhidrosis
Clinical narrative: Inj site: right arm - sore; Nausea; Headache; Felt weak; Body aches; Chills; Fever of 99.6°F; Sweating; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), ASTHENIA (Felt weak), PAIN (Body aches), CHILLS (Chills) and PYREXIA (Fever of 99.6°F) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced HYPERHIDROSIS (Sweating), PAIN (Body aches), CHILLS (Chills) and PYREXIA (Fever of 99.6°F). On 14-Mar-2021, the patient experienced ASTHENIA (Felt weak), NAUSEA (Nausea) and HEADACHE (Headache). On an unknown date, the patient experienced VACCINATION SITE PAIN (Inj site: right arm - sore). At the time of the report, HYPERHIDROSIS (Sweating), ASTHENIA (Felt weak), PAIN (Body aches), CHILLS (Chills), PYREXIA (Fever of 99.6°F), NAUSEA (Nausea), HEADACHE (Headache) and VACCINATION SITE PAIN (Inj site: right arm - sore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Body temperature: 99.6 f High.         Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Inj site: right arm - sore; Nausea; Headache; Felt weak; Body aches; Chills; Fever of 99.6°F; Sweating; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), ASTHENIA (Felt weak), PAIN (Body aches), CHILLS (Chills) and PYREXIA (Fever of 99.6°F) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced HYPERHIDROSIS (Sweating), PAIN (Body aches), CHILLS (Chills) and PYREXIA (Fever of 99.6°F). On 14-Mar-2021, the patient experienced ASTHENIA (Felt weak), NAUSEA (Nausea) and HEADACHE (Headache). On an unknown date, the patient experienced VACCINATION SITE PAIN (Inj site: right arm - sore). At the time of the report, HYPERHIDROSIS (Sweating), ASTHENIA (Felt weak), PAIN (Body aches), CHILLS (Chills), PYREXIA (Fever of 99.6°F), NAUSEA (Nausea), HEADACHE (Headache) and VACCINATION SITE PAIN (Inj site: right arm - sore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Body temperature: 99.6 f High.         Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Fatigue, Headache
Clinical narrative: headache; feeling tired; hard to breathe; cough; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (hard to breathe), COUGH (cough), HEADACHE (headache) and FATIGUE (feeling tired) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Fibromyalgia and Rheumatoid arthritis.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form(s). On an unknown date, the patient experienced DYSPNOEA (hard to breathe), COUGH (cough), HEADACHE (headache) and FATIGUE (feeling tired). At the time of the report, DYSPNOEA (hard to breathe), COUGH (cough), HEADACHE (headache) and FATIGUE (feeling tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication provided by the reporter.  concomitant medication includes: inhaler.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Balance disorder, Constipation, Diarrhoea, Fatigue
Clinical narrative: She experienced diarrhea; She became constipated; She felt a cramp and pain in the stomach; She was sleepy; She was very tired; She experienced off balance feeling; She experienced soreness of arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (She experienced soreness of arm), BALANCE DISORDER (She experienced off balance feeling), SOMNOLENCE (She was sleepy), ABDOMINAL PAIN UPPER (She felt a cramp and pain in the stomach) and CONSTIPATION (She became constipated) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (She experienced soreness of arm). On 27-Feb-2021, the patient experienced BALANCE DISORDER (She experienced off balance feeling). On 03-Mar-2021, the patient experienced SOMNOLENCE (She was sleepy) and FATIGUE (She was very tired). On 04-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (She felt a cramp and pain in the stomach). On 08-Mar-2021, the patient experienced CONSTIPATION (She became constipated). On an unknown date, the patient experienced DIARRHOEA (She experienced diarrhea). At the time of the report, PAIN IN EXTREMITY (She experienced soreness of arm), BALANCE DISORDER (She experienced off balance feeling), SOMNOLENCE (She was sleepy), ABDOMINAL PAIN UPPER (She felt a cramp and pain in the stomach), CONSTIPATION (She became constipated) and DIARRHOEA (She experienced diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  Treatment information included ice and anti diarrhea medication for the diarrhea.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Somnolence
Clinical narrative: She experienced diarrhea; She became constipated; She felt a cramp and pain in the stomach; She was sleepy; She was very tired; She experienced off balance feeling; She experienced soreness of arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (She experienced soreness of arm), BALANCE DISORDER (She experienced off balance feeling), SOMNOLENCE (She was sleepy), ABDOMINAL PAIN UPPER (She felt a cramp and pain in the stomach) and CONSTIPATION (She became constipated) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (She experienced soreness of arm). On 27-Feb-2021, the patient experienced BALANCE DISORDER (She experienced off balance feeling). On 03-Mar-2021, the patient experienced SOMNOLENCE (She was sleepy) and FATIGUE (She was very tired). On 04-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (She felt a cramp and pain in the stomach). On 08-Mar-2021, the patient experienced CONSTIPATION (She became constipated). On an unknown date, the patient experienced DIARRHOEA (She experienced diarrhea). At the time of the report, PAIN IN EXTREMITY (She experienced soreness of arm), BALANCE DISORDER (She experienced off balance feeling), SOMNOLENCE (She was sleepy), ABDOMINAL PAIN UPPER (She felt a cramp and pain in the stomach), CONSTIPATION (She became constipated) and DIARRHOEA (She experienced diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  Treatment information included ice and anti diarrhea medication for the diarrhea.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: vaccination site swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (vaccination site swelling) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.   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) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE SWELLING (vaccination site swelling). At the time of the report, VACCINATION SITE SWELLING (vaccination site swelling) outcome was unknown.            Concomitant medication under use was said to be Antihypertensive. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.    This case was linked to US-MODERNATX, INC.-MOD-2021-046323 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-046323:1st Dose
Sex: F
Vaccine: COVID19
Symptoms: Aura, Chills, Fatigue, Hangover, Headache
Clinical narrative: sweating; head felt like the worst hangover; pulsating aura around periphery; Couldn't move; keeps lifting to the right-hand side; Hearing and vision affected; Hearing and vision affected; Fatigued; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), HANGOVER (head felt like the worst hangover), AURA (pulsating aura around periphery), HYPOKINESIA (Couldn't move) and LIMB DISCOMFORT (keeps lifting to the right-hand side) in a female patient of an unknown age 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 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 HYPERHIDROSIS (sweating), HANGOVER (head felt like the worst hangover), AURA (pulsating aura around periphery), HYPOKINESIA (Couldn't move), LIMB DISCOMFORT (keeps lifting to the right-hand side), HYPOACUSIS (Hearing and vision affected), VISUAL IMPAIRMENT (Hearing and vision affected), FATIGUE (Fatigued), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, HYPERHIDROSIS (sweating), HANGOVER (head felt like the worst hangover), AURA (pulsating aura around periphery), HYPOKINESIA (Couldn't move), LIMB DISCOMFORT (keeps lifting to the right-hand side), HYPOACUSIS (Hearing and vision affected), VISUAL IMPAIRMENT (Hearing and vision affected), FATIGUE (Fatigued), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant products were not reported by the reporter. No treatment information was provided by reporter.
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypoacusis, Hypokinesia, Limb discomfort, Visual impairment
Clinical narrative: sweating; head felt like the worst hangover; pulsating aura around periphery; Couldn't move; keeps lifting to the right-hand side; Hearing and vision affected; Hearing and vision affected; Fatigued; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), HANGOVER (head felt like the worst hangover), AURA (pulsating aura around periphery), HYPOKINESIA (Couldn't move) and LIMB DISCOMFORT (keeps lifting to the right-hand side) in a female patient of an unknown age 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 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 HYPERHIDROSIS (sweating), HANGOVER (head felt like the worst hangover), AURA (pulsating aura around periphery), HYPOKINESIA (Couldn't move), LIMB DISCOMFORT (keeps lifting to the right-hand side), HYPOACUSIS (Hearing and vision affected), VISUAL IMPAIRMENT (Hearing and vision affected), FATIGUE (Fatigued), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, HYPERHIDROSIS (sweating), HANGOVER (head felt like the worst hangover), AURA (pulsating aura around periphery), HYPOKINESIA (Couldn't move), LIMB DISCOMFORT (keeps lifting to the right-hand side), HYPOACUSIS (Hearing and vision affected), VISUAL IMPAIRMENT (Hearing and vision affected), FATIGUE (Fatigued), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant products were not reported by the reporter. No treatment information was provided by reporter.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling hot
Clinical narrative: Hot on the outside; Fatigue; Chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Mar-2021 and was forwarded to Moderna on 16-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Hot on the outside), FATIGUE (Fatigue) and CHILLS (Chills) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced FEELING HOT (Hot on the outside), FATIGUE (Fatigue) and CHILLS (Chills). On 09-Feb-2021, FEELING HOT (Hot on the outside), FATIGUE (Fatigue) and CHILLS (Chills) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No relevant concomitant medications were provided.  No treatment information was provided.   This case was linked to MOD-2021-046408.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Injection site pruritus, Injection site warmth
Clinical narrative: large lump at injection site; injection site is warm to the touch; injection site is itchy; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Mar-2021 and was forwarded to Moderna on 16-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (large lump at injection site), INJECTION SITE WARMTH (injection site is warm to the touch) and INJECTION SITE PRURITUS (injection site is itchy) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced INJECTION SITE MASS (large lump at injection site), INJECTION SITE WARMTH (injection site is warm to the touch) and INJECTION SITE PRURITUS (injection site is itchy). At the time of the report, INJECTION SITE MASS (large lump at injection site), INJECTION SITE WARMTH (injection site is warm to the touch) and INJECTION SITE PRURITUS (injection site is itchy) outcome was unknown.            No concomitant medications were reported. Action taken with mRNA-1273 in response to the drug was not applicable.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches), CHILLS (chills), PYREXIA (low grade temp) and MYALGIA (body aches) 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 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced HEADACHE (headaches), CHILLS (chills), PYREXIA (low grade temp) and MYALGIA (body aches). At the time of the report, HEADACHE (headaches), CHILLS (chills), PYREXIA (low grade temp) and MYALGIA (body aches) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment medications were reported.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Amniocentesis, Exposure during pregnancy, Ultrasound scan
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011MZ0A) for COVID-19 vaccination.     Family history included Congenital heart disease NOS ((sister)) since an unknown date. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 29-Sep-2020 and the estimated date of delivery was 06-Jul-2021. On 05-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-second week of the pregnancy. The vaginal delivery occurred on 24-Jun-2021, which was reported as Full-term. For neonate 1, the birth weight was 3024 grams (6lbs 11oz) with an APGAR score of 9 and 9 at (1, 5 minutes). The outcome was reported as Unknown. No problems during delivery and no fetal/infant abnormalities at delivery or at one month post-partum. On 05-Mar-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, Amniocentesis: normal (normal) normal. On 26-Feb-2021, Ultrasound scan: normal (normal) Normal.     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.   Patient underwent Microarry test results were normal.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Additional information added - Reporter details added. Concomitant medication added, patient details and details related to pregnancy added. Lab data added.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Swelling face
Clinical narrative: swelling of the face and throat; extremely dizzy; weakness; chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Mar-2021 and was forwarded to Moderna on 16-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (swelling of the face and throat), DIZZINESS (extremely dizzy), ASTHENIA (weakness) and CHILLS (chills) 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 16-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 SWELLING FACE (swelling of the face and throat), DIZZINESS (extremely dizzy), ASTHENIA (weakness) and CHILLS (chills). At the time of the report, SWELLING FACE (swelling of the face and throat), DIZZINESS (extremely dizzy), ASTHENIA (weakness) and CHILLS (chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Headache, Pyrexia, Rash
Clinical narrative: headache; full fever; 101.4 fever; red marks by his ankles, like sunburn; weird rash on his palms, like big dots; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (red marks by his ankles, like sunburn), RASH (weird rash on his palms, like big dots), HEADACHE (headache), PYREXIA (full fever) and PYREXIA (101.4 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) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced ERYTHEMA (red marks by his ankles, like sunburn) and RASH (weird rash on his palms, like big dots). On 16-Mar-2021, the patient experienced PYREXIA (full fever) and PYREXIA (101.4 fever). On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, ERYTHEMA (red marks by his ankles, like sunburn), RASH (weird rash on his palms, like big dots), HEADACHE (headache), PYREXIA (full fever) and PYREXIA (101.4 fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Chills, Decreased appetite, Fatigue
Clinical narrative: had lost her appetite, could not eat; felt anxiety; tired; had chills; feels very very weak/the strength is not coming back/extremely weak; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (had lost her appetite, could not eat), ASTHENIA (feels very very weak/the strength is not coming back/extremely weak), ANXIETY (felt anxiety), FATIGUE (tired) and CHILLS (had chills) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 virus test positive on 31-Dec-2020. Concurrent medical conditions included Blood pressure high, Cholesterol, Thyroid disorder and Allergy.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced ASTHENIA (feels very very weak/the strength is not coming back/extremely weak), FATIGUE (tired) and CHILLS (had chills). On an unknown date, the patient experienced DECREASED APPETITE (had lost her appetite, could not eat) and ANXIETY (felt anxiety). At the time of the report, DECREASED APPETITE (had lost her appetite, could not eat), ASTHENIA (feels very very weak/the strength is not coming back/extremely weak), ANXIETY (felt anxiety) and CHILLS (had chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included blood pressure medication, Cholesterol medication, allergy medication, thyroid medication.     Treatment details included Tylenol and anxiety medication.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Headache, Pain, Peripheral swelling, Pyrexia
Clinical narrative: achy all over; swollen arm with hot spot; severe headache; red rash all over the injection site; Fever 100.1F; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achy all over), PERIPHERAL SWELLING (swollen arm with hot spot), PYREXIA (Fever 100.1F), HEADACHE (severe headache) and VACCINATION SITE RASH (red rash all over the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     Concomitant products included GABAPENTIN, METOPROLOL, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) and RIVAROXABAN (XARELTO) for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced PAIN (achy all over), PERIPHERAL SWELLING (swollen arm with hot spot), PYREXIA (Fever 100.1F), HEADACHE (severe headache) and VACCINATION SITE RASH (red rash all over the injection site). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, PAIN (achy all over), PERIPHERAL SWELLING (swollen arm with hot spot), HEADACHE (severe headache) and VACCINATION SITE RASH (red rash all over the injection site) outcome was unknown and PYREXIA (Fever 100.1F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature increased: 100.1 f (High) increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Email was updated
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: achy all over; swollen arm with hot spot; severe headache; red rash all over the injection site; Fever 100.1F; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achy all over), PERIPHERAL SWELLING (swollen arm with hot spot), PYREXIA (Fever 100.1F), HEADACHE (severe headache) and VACCINATION SITE RASH (red rash all over the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     Concomitant products included GABAPENTIN, METOPROLOL, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) and RIVAROXABAN (XARELTO) for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced PAIN (achy all over), PERIPHERAL SWELLING (swollen arm with hot spot), PYREXIA (Fever 100.1F), HEADACHE (severe headache) and VACCINATION SITE RASH (red rash all over the injection site). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, PAIN (achy all over), PERIPHERAL SWELLING (swollen arm with hot spot), HEADACHE (severe headache) and VACCINATION SITE RASH (red rash all over the injection site) outcome was unknown and PYREXIA (Fever 100.1F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature increased: 100.1 f (High) increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Email was updated
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Tinnitus, Vomiting
Clinical narrative: Ear Ringing; Vomiting; fatigue; Lightheadedness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Lightheadedness), TINNITUS (Ear Ringing), VOMITING (Vomiting) and FATIGUE (fatigue) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL and METOPROLOL for Blood pressure, ATORVASTATIN and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 11-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 DIZZINESS (Lightheadedness), VOMITING (Vomiting) and FATIGUE (fatigue). On 13-Mar-2021, the patient experienced TINNITUS (Ear Ringing). On 12-Mar-2021, DIZZINESS (Lightheadedness) and VOMITING (Vomiting) had resolved. On 13-Mar-2021, FATIGUE (fatigue) had resolved. At the time of the report, TINNITUS (Ear Ringing) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Fatigue
Clinical narrative: In bed for two days after first dose; Feeling very tired; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (In bed for two days after first dose) and FATIGUE (Feeling very tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Mononucleosis.    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 BEDRIDDEN (In bed for two days after first dose) and FATIGUE (Feeling very tired). At the time of the report, BEDRIDDEN (In bed for two days after first dose) and FATIGUE (Feeling very tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported No treatment information was provided
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Skin indentation
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SKIN INDENTATION (he noticed right side of face, cheek, have a dimple, not been there before,) and ERYTHEMA (all cheeks red today) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No relevant medical history reported. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), VITAMINS NOS, LYSINE and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication. On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced SKIN INDENTATION (he noticed right side of face, cheek, have a dimple, not been there before,) and ERYTHEMA (all cheeks red today). At the time of the report, SKIN INDENTATION (he noticed right side of face, cheek, have a dimple, not been there before,) and ERYTHEMA (all cheeks red today) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information was not provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Skin lesion
Clinical narrative: itchy all over body; pea sized lesions all over body/lesions under toenails/lesions on 80% of legs/lesions all over arms/lesions all over back/lesions all over chest/some lesions on neck/one lesion on head/a bunch of lesions in mouth; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy all over body) and SKIN LESION (pea sized lesions all over body/lesions under toenails/lesions on 80% of legs/lesions all over arms/lesions all over back/lesions all over chest/some lesions on neck/one lesion on head/a bunch of lesions in mouth) 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 effect. Concomitant products included OLMESARTAN, TESTOSTERONE and PREDNISONE for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 03-Mar-2021, the patient experienced SKIN LESION (pea sized lesions all over body/lesions under toenails/lesions on 80% of legs/lesions all over arms/lesions all over back/lesions all over chest/some lesions on neck/one lesion on head/a bunch of lesions in mouth). On 13-Mar-2021, the patient experienced PRURITUS (itchy all over body). At the time of the report, PRURITUS (itchy all over body) and SKIN LESION (pea sized lesions all over body/lesions under toenails/lesions on 80% of legs/lesions all over arms/lesions all over back/lesions all over chest/some lesions on neck/one lesion on head/a bunch of lesions in mouth) outcome was unknown.            Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 16-Mar-2021: No specific follow-up information recorded. On 16-Mar-2021: No specific follow-up information recorded.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dyspepsia, Fatigue, Product dose omission issue
Clinical narrative: It has been 5 months since first vaccine; Stomach cramping; Burning stomach; really tired and down; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach cramping), DYSPEPSIA (Burning stomach), PRODUCT DOSE OMISSION ISSUE (It has been 5 months since first vaccine) and FATIGUE (really tired and down) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Mar-2021 at 1:40 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021 at 2:00 AM, the patient experienced ABDOMINAL PAIN UPPER (Stomach cramping). 11-Mar-2021 at 2:00 AM, the patient experienced DYSPEPSIA (Burning stomach). In March 2021, the patient experienced FATIGUE (really tired and down). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (It has been 5 months since first vaccine). At the time of the report, ABDOMINAL PAIN UPPER (Stomach cramping) and DYSPEPSIA (Burning stomach) had not resolved and PRODUCT DOSE OMISSION ISSUE (It has been 5 months since first vaccine) and FATIGUE (really tired and down) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported included some unspecified herbs.  Symptoms continued through 11 Mar 2021 and 12 Mar 2021. Symptoms lessened on 13 Mar 2021 and returned on 14 Mar 2021 continuing until 16 Mar 2021. recent antibody test shows that they are lower  Treatment information provided included famotidine which did not relieve symptoms   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Significant follow up appended (Adverse event updated)
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Vomiting, White blood cell count
Clinical narrative: fatigue; Nausea; Vomiting; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (fatigue), NAUSEA (Nausea) and VOMITING (Vomiting) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigue), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, FATIGUE (fatigue), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, White blood cell count: high (High) increased White blood count.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information was not provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and PYREXIA (Fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) 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 15-Mar-2021, the patient experienced HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.  Patient was allowed to take Tylenol as treatment.