chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Feeding disorder, Feeling hot, Headache, Nausea, Peripheral swelling
Clinical narrative: Harsh side effects; Vision got bad; Left arm is started swollen up; Hot; Little bumps all over; Couldn't eat anything; Couldn't even stand; Constipation; Difficulty breathing; Can't concentrate; Tremendous headaches; Felt nauseated; Aches and pain in every joint; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Apr-2021 and was forwarded to Moderna on 09-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (Harsh side effects), VISUAL IMPAIRMENT (Vision got bad), PERIPHERAL SWELLING (Left arm is started swollen up), FEELING HOT (Hot) and SWELLING (Little bumps all over) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included LISINOPRIL, ERYTHROMYCIN, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A), HYDROCHLOROTHIAZIDE, HYDROCODONE and PARACETAMOL (TYLENOL) for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced ADVERSE DRUG REACTION (Harsh side effects), VISUAL IMPAIRMENT (Vision got bad), PERIPHERAL SWELLING (Left arm is started swollen up), FEELING HOT (Hot), SWELLING (Little bumps all over), FEEDING DISORDER (Couldn't eat anything), WALKING DISABILITY (Couldn't even stand), CONSTIPATION (Constipation), DYSPNOEA (Difficulty breathing), DISTURBANCE IN ATTENTION (Can't concentrate), HEADACHE (Tremendous headaches), NAUSEA (Felt nauseated) and ARTHRALGIA (Aches and pain in every joint). At the time of the report, ADVERSE DRUG REACTION (Harsh side effects), VISUAL IMPAIRMENT (Vision got bad), PERIPHERAL SWELLING (Left arm is started swollen up), FEELING HOT (Hot), SWELLING (Little bumps all over), FEEDING DISORDER (Couldn't eat anything), WALKING DISABILITY (Couldn't even stand), CONSTIPATION (Constipation), DYSPNOEA (Difficulty breathing), DISTURBANCE IN ATTENTION (Can't concentrate), HEADACHE (Tremendous headaches), NAUSEA (Felt nauseated) and ARTHRALGIA (Aches and pain in every joint) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the event included diphenhydramine (Benadryl) and paracetamol (Tylenol).
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Visual impairment, Walking disability
Clinical narrative: Harsh side effects; Vision got bad; Left arm is started swollen up; Hot; Little bumps all over; Couldn't eat anything; Couldn't even stand; Constipation; Difficulty breathing; Can't concentrate; Tremendous headaches; Felt nauseated; Aches and pain in every joint; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Apr-2021 and was forwarded to Moderna on 09-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (Harsh side effects), VISUAL IMPAIRMENT (Vision got bad), PERIPHERAL SWELLING (Left arm is started swollen up), FEELING HOT (Hot) and SWELLING (Little bumps all over) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included LISINOPRIL, ERYTHROMYCIN, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A), HYDROCHLOROTHIAZIDE, HYDROCODONE and PARACETAMOL (TYLENOL) for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced ADVERSE DRUG REACTION (Harsh side effects), VISUAL IMPAIRMENT (Vision got bad), PERIPHERAL SWELLING (Left arm is started swollen up), FEELING HOT (Hot), SWELLING (Little bumps all over), FEEDING DISORDER (Couldn't eat anything), WALKING DISABILITY (Couldn't even stand), CONSTIPATION (Constipation), DYSPNOEA (Difficulty breathing), DISTURBANCE IN ATTENTION (Can't concentrate), HEADACHE (Tremendous headaches), NAUSEA (Felt nauseated) and ARTHRALGIA (Aches and pain in every joint). At the time of the report, ADVERSE DRUG REACTION (Harsh side effects), VISUAL IMPAIRMENT (Vision got bad), PERIPHERAL SWELLING (Left arm is started swollen up), FEELING HOT (Hot), SWELLING (Little bumps all over), FEEDING DISORDER (Couldn't eat anything), WALKING DISABILITY (Couldn't even stand), CONSTIPATION (Constipation), DYSPNOEA (Difficulty breathing), DISTURBANCE IN ATTENTION (Can't concentrate), HEADACHE (Tremendous headaches), NAUSEA (Felt nauseated) and ARTHRALGIA (Aches and pain in every joint) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the event included diphenhydramine (Benadryl) and paracetamol (Tylenol).
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: This spontaneous case reported by a patient, describes the occurrence of epistaxis (patient had nosebleeds after the 1st Moderna shot) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No reported medical history. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; unspecified dose. On an unknown date, patient experienced epistaxis (patient had nosebleeds after the 1st Moderna shot). At the time of the report, epistaxis (patient had nosebleeds after the 1st Moderna shot) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Dyspnoea, Headache, Myalgia
Clinical narrative: Chills; Fever; Headache; Nausea; Muscle ache; Chest pain; Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), DYSPNOEA (Shortness of breath), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced CHEST PAIN (Chest pain) and DYSPNOEA (Shortness of breath). On an unknown date, the patient experienced CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache), NAUSEA (Nausea) and MYALGIA (Muscle ache). On 10-Mar-2021, CHEST PAIN (Chest pain) had resolved. At the time of the report, DYSPNOEA (Shortness of breath) had not resolved and CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache), NAUSEA (Nausea) and MYALGIA (Muscle ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided. After the investigation of doctors, it was ruled out everything is fine.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Chills; Fever; Headache; Nausea; Muscle ache; Chest pain; Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), DYSPNOEA (Shortness of breath), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced CHEST PAIN (Chest pain) and DYSPNOEA (Shortness of breath). On an unknown date, the patient experienced CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache), NAUSEA (Nausea) and MYALGIA (Muscle ache). On 10-Mar-2021, CHEST PAIN (Chest pain) had resolved. At the time of the report, DYSPNOEA (Shortness of breath) had not resolved and CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache), NAUSEA (Nausea) and MYALGIA (Muscle ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided. After the investigation of doctors, it was ruled out everything is fine.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A2B1) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills). At the time of the report, CHILLS (Chills) outcome was unknown.            Treatment product was not provided. concomitant product was not provided   This case was linked to MOD-2021-073336 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: TCR received on 24-MAY-2021.Received second dose. Patient declined further follow-up.; Sender's Comments:  MOD-2021-073336:Same reporter/different patient (husband case 1st dose)
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness and it could be lasting months; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness and it could be lasting months) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness and it could be lasting months). At the time of the report, DIZZINESS (dizziness and it could be lasting months) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.    This case was linked to MOD21-073350, MOD21-073378; Sender's Comments:  MOD21-073350: MOD21-073378:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Rash, Vision blurred
Clinical narrative: Blurry vision; Rash below the vaccination site; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurry vision), RASH (Rash below the vaccination site) and HEADACHE (Headache) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced VISION BLURRED (Blurry vision), RASH (Rash below the vaccination site) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at a dose of 1 dosage form. At the time of the report, VISION BLURRED (Blurry vision), RASH (Rash below the vaccination site) and HEADACHE (Headache) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.  No relevant concomitant medications were reported.    Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Additional information received on 09-Apr-2021 : Reporter contact details updated, additional events( headache, blurred vision) added
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: Loss of taste; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of taste) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced AGEUSIA (Loss of taste). At the time of the report, AGEUSIA (Loss of taste) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.    The caller is the mother of the patient. She wanted to report side effects of vaccine. She was concerned if her son is positive for COVID-19 infection.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Warm; Red or pinkish at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Warm) and INJECTION SITE ERYTHEMA (Red or pinkish at injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE WARMTH (Warm) and INJECTION SITE ERYTHEMA (Red or pinkish at injection site). At the time of the report, INJECTION SITE WARMTH (Warm) and INJECTION SITE ERYTHEMA (Red or pinkish at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Very exhausted; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Very exhausted) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 031A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported. ).   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Very exhausted). At the time of the report, FATIGUE (Very exhausted) had not resolved.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia
Clinical narrative: Fever around 102 F; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (Fever around 102 F) and CHILLS (Chills) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced HEADACHE (Headache). On 11-Apr-2021, the patient experienced PYREXIA (Fever around 102 F) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of UNK, q4h. At the time of the report, HEADACHE (Headache), PYREXIA (Fever around 102 F) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Apr-2021, Body temperature: 102 (High) Fever around 102 F and 100.6 (High) 100.6 F.         Concomitant product use was not provided by the reporter. Action taken with mRNA-1273 in response to the events were not applicable.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Fatigue
Clinical narrative: dizziness; fatigue; exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS ( dizziness ), FATIGUE (fatigue) and FATIGUE (exhaustion) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 015M20A) for COVID-19 vaccination.     Medical history not provided by the reporter.  Concomitant products included LEVOTHYROXINE and RALOXIFENE for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced DIZZINESS ( dizziness ) and FATIGUE (exhaustion). 05-Apr-2021, the patient experienced FATIGUE (fatigue). At the time of the report, DIZZINESS ( dizziness ), FATIGUE (fatigue) and FATIGUE (exhaustion) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: increased (High) INCREASED.         Treatment information was not provided.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Incontinence, Pyrexia
Clinical narrative: incontinence; fever of 102-102.4 Degrees Fahrenheit; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PYREXIA (fever of 102-102.4 Degrees Fahrenheit) and INCONTINENCE (incontinence) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 013A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included VALSARTAN, FELODIPINE (PLENDIL), METOPROLOL, ATORVASTATIN, OMEPRAZOLE, ALFUZOSIN, LEVOTHYROXINE SODIUM (SYNTHROID), FEXOFENADINE, FINASTERIDE (FENASTEN) and VITAMINS NOS 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 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced PYREXIA (fever of 102-102.4 Degrees Fahrenheit). On 09-Apr-2021, the patient experienced INCONTINENCE (incontinence). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PYREXIA (fever of 102-102.4 Degrees Fahrenheit) and INCONTINENCE (incontinence) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Other concomitant medications included Flonase and tums.  On 09-Apr-2021 patient started having a fever of 102-102.4 Degrees Fahrenheit and later it was down to 99 but right no it was at 103.8 Degrees Fahrenheit. He stated he had outpatient surgery two weeks ago where he received anesthetic. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Skin reaction
Clinical narrative: delayed reaction to vaccine; itching at the injection site; redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of SKIN REACTION (delayed reaction to vaccine), INJECTION SITE PRURITUS (itching at the injection site) and INJECTION SITE ERYTHEMA (redness at the injection site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04021A) for COVID-19 vaccination.     The patient's past medical history included Asthma.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 07-Apr-2021, the patient experienced SKIN REACTION (delayed reaction to vaccine), INJECTION SITE PRURITUS (itching at the injection site) and INJECTION SITE ERYTHEMA (redness at the injection site). The patient was treated with CORTISONE at an unspecified dose and frequency. At the time of the report, SKIN REACTION (delayed reaction to vaccine), INJECTION SITE PRURITUS (itching at the injection site) and INJECTION SITE ERYTHEMA (redness at the injection site) 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.       No concomitant medication provided.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pain, Vaccination site warmth
Clinical narrative: Like there is a knot/ like a lump at the injection site; site itself is a little burny and hot; The site itself is burny; pain at injection site/Really sore injection thing/It hurt really bad when they injected it/A bit of a bitch/ site itself is a little burny; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Like there is a knot/ like a lump at the injection site), VACCINATION SITE WARMTH (site itself is a little burny and hot), VACCINATION SITE PAIN (The site itself is burny) and VACCINATION SITE PAIN (pain at injection site/Really sore injection thing/It hurt really bad when they injected it site itself is a little burny) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included NAPROXEN SODIUM (ALEVE), APIS MELLIFICA, GELSEMIUM SEMPERVIRENS, PSEUDOGNAPHALIUM OBTUSIFOLIUM (MAGNILIFE PAIN RELIEVING FOOT CREAM), DULCAMARA and BERBERIS VULGARIS BARK (BARBERRY [BERBERIS VULGARIS BARK]) for an unknown indication.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced VACCINATION SITE MASS (Like there is a knot/ like a lump at the injection site), VACCINATION SITE WARMTH (site itself is a little burny and hot), VACCINATION SITE PAIN (The site itself is burny) and VACCINATION SITE PAIN (pain at injection site/Really sore injection thing/It hurt really bad when they injected it site itself is a little burny). At the time of the report, VACCINATION SITE MASS (Like there is a knot/ like a lump at the injection site), VACCINATION SITE WARMTH (site itself is a little burny and hot), VACCINATION SITE PAIN (The site itself is burny) and VACCINATION SITE PAIN (pain at injection site/Really sore injection thing/It hurt really bad when they injected it site itself is a little burny) 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 medication:- The patient is taking arnica and Excedrin and applied adsorbent to the site to alleviate the symptoms.  Concomitant medications: Typing error : Barberry extract( Tarberry extract ).  Follow-up received on 17 May 2021 included no new information.  Event outcome was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: This follow-up was received on 17-MAY-2021 which did not have any new information. On 17-May-2021: This follow-up was received on 18-MAY-2021 which did not have any new information.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Medication error
Clinical narrative: Received 1st dose of Moderna vaccine instead of Pfizer 2nd dose of vaccine; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of MEDICATION ERROR (Received 1st dose of Moderna vaccine instead of Pfizer 2nd dose of vaccine) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: COVID-19 VACCINE on 18-Mar-2021.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced MEDICATION ERROR (Received 1st dose of Moderna vaccine instead of Pfizer 2nd dose of vaccine). On 07-Apr-2021, MEDICATION ERROR (Received 1st dose of Moderna vaccine instead of Pfizer 2nd dose of vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Sender's Comments: This report refers to a case of Wrong product administration for mRNA-1273, lot # 032B21A with no associated AEs.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia oral
Clinical narrative: Tingling and numbness around lips, front part of tongue and around mout; Tingling and numbness around lips, front part of tongue and around mout; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (Tingling and numbness around lips, front part of tongue and around mout) and HYPOAESTHESIA (Tingling and numbness around lips, front part of tongue and around mout) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ATORVASTATIN CALCIUM (STATIN [ATORVASTATIN CALCIUM]) for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA ORAL (Tingling and numbness around lips, front part of tongue and around mout) and HYPOAESTHESIA (Tingling and numbness around lips, front part of tongue and around mout). At the time of the report, PARAESTHESIA ORAL (Tingling and numbness around lips, front part of tongue and around mout) and HYPOAESTHESIA (Tingling and numbness around lips, front part of tongue and around mout) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for COVID after getting both shots.; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Apr-2021. The most recent information was received on 09-Apr-2021 and was forwarded to Moderna on an unknown date.    This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID after getting both shots.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (tested positive for COVID after getting both shots.). At the time of the report, COVID-19 (tested positive for COVID after getting both shots.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: positive (Positive) positive.         No concomitant medication reported.  No treatment medication reported.  Based on the information provided, the natural history of COVID-19, and the established profile of mRNA-1273, a causal association between the event of COVID-19  and mRNA-1273 use is assessed as not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Upon internal review on 21-Jul-2021, an event (lack of drug effect) was added. Suspect drug dosing was also updated.; Sender's Comments: Based on the information provided, the natural history of COVID-19, and the established profile of mRNA-1273, a causal association between the event of COVID-19  and mRNA-1273 use is assessed as not applicable.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Heart rate increased, Pain in extremity, Panic attack
Clinical narrative: Rapids hear rate; Trouble breathing; Shaking like a panic attack; Shaking like a panic attack; Soreness in her arm; A little bit weak; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Soreness in her arm), ASTHENIA (A little bit weak), HEART RATE INCREASED (Rapids hear rate), DYSPNOEA (Trouble breathing) and TREMOR (Shaking like a panic attack) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Panic attack.    On 13-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 PAIN IN EXTREMITY (Soreness in her arm) and ASTHENIA (A little bit weak). On 07-Apr-2021, the patient experienced HEART RATE INCREASED (Rapids hear rate), DYSPNOEA (Trouble breathing), TREMOR (Shaking like a panic attack) and PANIC ATTACK (Shaking like a panic attack). At the time of the report, PAIN IN EXTREMITY (Soreness in her arm), ASTHENIA (A little bit weak), HEART RATE INCREASED (Rapids hear rate), DYSPNOEA (Trouble breathing), TREMOR (Shaking like a panic attack) and PANIC ATTACK (Shaking like a panic attack) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use include Over the counter pain. Treatment information was not provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Rapids hear rate; Trouble breathing; Shaking like a panic attack; Shaking like a panic attack; Soreness in her arm; A little bit weak; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Soreness in her arm), ASTHENIA (A little bit weak), HEART RATE INCREASED (Rapids hear rate), DYSPNOEA (Trouble breathing) and TREMOR (Shaking like a panic attack) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Panic attack.    On 13-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 PAIN IN EXTREMITY (Soreness in her arm) and ASTHENIA (A little bit weak). On 07-Apr-2021, the patient experienced HEART RATE INCREASED (Rapids hear rate), DYSPNOEA (Trouble breathing), TREMOR (Shaking like a panic attack) and PANIC ATTACK (Shaking like a panic attack). At the time of the report, PAIN IN EXTREMITY (Soreness in her arm), ASTHENIA (A little bit weak), HEART RATE INCREASED (Rapids hear rate), DYSPNOEA (Trouble breathing), TREMOR (Shaking like a panic attack) and PANIC ATTACK (Shaking like a panic attack) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use include Over the counter pain. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature increased, Fatigue, Headache, Illness
Clinical narrative: fever of 101; nausea; dry heaves; so sick; could not get out of bed; headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), FATIGUE (fatigue), PYREXIA (fever of 101), NAUSEA (nausea) and RETCHING (dry heaves) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced HEADACHE (headache) and FATIGUE (fatigue). On 07-Apr-2021, the patient experienced PYREXIA (fever of 101), NAUSEA (nausea), RETCHING (dry heaves), ILLNESS (so sick) and ASTHENIA (could not get out of bed). On 01-Apr-2021, HEADACHE (headache) and FATIGUE (fatigue) had resolved. On 08-Apr-2021, PYREXIA (fever of 101), NAUSEA (nausea), RETCHING (dry heaves), ILLNESS (so sick) and ASTHENIA (could not get out of bed) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2021, Body temperature increased: 101 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medications was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Non-significant follow up appended.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Retching
Clinical narrative: fever of 101; nausea; dry heaves; so sick; could not get out of bed; headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), FATIGUE (fatigue), PYREXIA (fever of 101), NAUSEA (nausea) and RETCHING (dry heaves) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced HEADACHE (headache) and FATIGUE (fatigue). On 07-Apr-2021, the patient experienced PYREXIA (fever of 101), NAUSEA (nausea), RETCHING (dry heaves), ILLNESS (so sick) and ASTHENIA (could not get out of bed). On 01-Apr-2021, HEADACHE (headache) and FATIGUE (fatigue) had resolved. On 08-Apr-2021, PYREXIA (fever of 101), NAUSEA (nausea), RETCHING (dry heaves), ILLNESS (so sick) and ASTHENIA (could not get out of bed) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2021, Body temperature increased: 101 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medications was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Non-significant follow up appended.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Myalgia, Vaccination site erythema
Clinical narrative: itching at injection site; Moderna arm where it was a red site and warm around area about 4 days after getting the; fatigue; Headache; muscle ache; redness at the injection site; swelling at the injection site.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching at injection site), VACCINATION SITE WARMTH (Moderna arm where it was a red site and warm around area about 4 days after getting the), FATIGUE (fatigue), HEADACHE (Headache) and MYALGIA (muscle ache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ALPRAZOLAM (XANAX) and VERAPAMIL for an unknown indication.    On 20-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itching at injection site), VACCINATION SITE WARMTH (Moderna arm where it was a red site and warm around area about 4 days after getting the), FATIGUE (fatigue), HEADACHE (Headache), MYALGIA (muscle ache), VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site.). At the time of the report, VACCINATION SITE PRURITUS (itching at injection site), VACCINATION SITE WARMTH (Moderna arm where it was a red site and warm around area about 4 days after getting the), FATIGUE (fatigue), HEADACHE (Headache), MYALGIA (muscle ache), VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 38.278 (Inconclusive) 38.278.         No treatment medication details were provided.   This case was linked to MOD21-073350, MOD21-073379 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Added reporter email address. Added concomitant medications(Xanax, xerapamil).Added patient DOB, age. Added events (ever of 100.6F, headache, muscle ache, and itching, swelling,redness at the injection site).; Sender's Comments:  MOD21-073350: MOD21-073379:
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: itching at injection site; Moderna arm where it was a red site and warm around area about 4 days after getting the; fatigue; Headache; muscle ache; redness at the injection site; swelling at the injection site.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching at injection site), VACCINATION SITE WARMTH (Moderna arm where it was a red site and warm around area about 4 days after getting the), FATIGUE (fatigue), HEADACHE (Headache) and MYALGIA (muscle ache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ALPRAZOLAM (XANAX) and VERAPAMIL for an unknown indication.    On 20-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itching at injection site), VACCINATION SITE WARMTH (Moderna arm where it was a red site and warm around area about 4 days after getting the), FATIGUE (fatigue), HEADACHE (Headache), MYALGIA (muscle ache), VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site.). At the time of the report, VACCINATION SITE PRURITUS (itching at injection site), VACCINATION SITE WARMTH (Moderna arm where it was a red site and warm around area about 4 days after getting the), FATIGUE (fatigue), HEADACHE (Headache), MYALGIA (muscle ache), VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 38.278 (Inconclusive) 38.278.         No treatment medication details were provided.   This case was linked to MOD21-073350, MOD21-073379 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Added reporter email address. Added concomitant medications(Xanax, xerapamil).Added patient DOB, age. Added events (ever of 100.6F, headache, muscle ache, and itching, swelling,redness at the injection site).; Sender's Comments:  MOD21-073350: MOD21-073379:
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 PYREXIA (Fever). At the time of the report, PYREXIA (Fever) had resolved.        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.   concurrent medication not provided. Treatment medication not provided. patient states that she received Moderna COVID-19 vaccine and had fever.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Headache, Vaccination site reaction, Vertigo
Clinical narrative: Woke up at 1am with a really bad headache / Headaches on and off since then; Dizzy/ Lightheadedness; Vertigo; Feeling off balance; COVID arm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy/ Lightheadedness), VERTIGO (Vertigo), BALANCE DISORDER (Feeling off balance), VACCINATION SITE REACTION (COVID arm) and HEADACHE (Woke up at 1am with a really bad headache / Headaches on and off since then) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     Concomitant products included SOTALOL, LEVOTHYROXINE SODIUM (SYNTHROID), ACETYLSALICYLIC ACID (ASPIRIN 81) and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced DIZZINESS (Dizzy/ Lightheadedness). 18-Mar-2021, the patient experienced VERTIGO (Vertigo). 18-Mar-2021, the patient experienced BALANCE DISORDER (Feeling off balance) and VACCINATION SITE REACTION (COVID arm). On 19-Mar-2021, the patient experienced HEADACHE (Woke up at 1am with a really bad headache / Headaches on and off since then). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency; IBUPROFEN (ADVIL [IBUPROFEN]) for Headache, at an unspecified dose and frequency and MECLOZINE HYDROCHLORIDE (MECLIZINE [MECLOZINE HYDROCHLORIDE]) (oral) at a dose of 25 mg, 1/2 tab two times. At the time of the report, DIZZINESS (Dizzy/ Lightheadedness), VERTIGO (Vertigo) and BALANCE DISORDER (Feeling off balance) outcome was unknown, VACCINATION SITE REACTION (COVID arm) had resolved and HEADACHE (Woke up at 1am with a really bad headache / Headaches on and off since then) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient states she saw her doctor and they ran tests but everything has been normal. She also states she has a CT scan but is unsure if she will get it before he second dose of vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: 2nd dose of the Moderna Covid 19 vaccine injected subcutaneously; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (2nd dose of the Moderna Covid 19 vaccine injected subcutaneously) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 05-Mar-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (2nd dose of the Moderna Covid 19 vaccine injected subcutaneously). On 05-Mar-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (2nd dose of the Moderna Covid 19 vaccine injected subcutaneously) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments.   No treatment information was provided.  No concomitant medication was provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Malaise, Pyrexia
Clinical narrative: Not feeling well; Fever of 101.6; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling well) and PYREXIA (Fever of 101.6) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Cancer (Cancer survivor). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and VITAMINS NOS for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced MALAISE (Not feeling well) and PYREXIA (Fever of 101.6). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of UNK dosage form. At the time of the report, MALAISE (Not feeling well) and PYREXIA (Fever of 101.6) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Body temperature: 101.6 (Inconclusive) 101.6 degree F.         Treatment information provided included paracetamol.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Hyperhidrosis, Influenza like illness, Pyrexia
Clinical narrative: sweating; Last night I woke up with chills; fever/This afternoon I had fever about 102degF; I'm not so good; I feel like I have flu; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I'm not so good), INFLUENZA LIKE ILLNESS (I feel like I have flu), HYPERHIDROSIS (sweating), CHILLS (Last night I woke up with chills) and PYREXIA (fever/This afternoon I had fever about 102degF) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 08-Apr-2021, the patient experienced FEELING ABNORMAL (I'm not so good), INFLUENZA LIKE ILLNESS (I feel like I have flu), CHILLS (Last night I woke up with chills) and PYREXIA (fever/This afternoon I had fever about 102degF). On 09-Apr-2021, the patient experienced HYPERHIDROSIS (sweating). On 09-Apr-2021, PYREXIA (fever/This afternoon I had fever about 102degF) had resolved. At the time of the report, FEELING ABNORMAL (I'm not so good), INFLUENZA LIKE ILLNESS (I feel like I have flu), HYPERHIDROSIS (sweating) and CHILLS (Last night I woke up with chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The  concomitant medications  were not provided.  No treatment information was provided.