chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: arms are hurting; shoulders are hurting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arms are hurting) and ARTHRALGIA (shoulders are hurting) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0342250) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (arms are hurting) and ARTHRALGIA (shoulders are hurting). At the time of the report, PAIN IN EXTREMITY (arms are hurting) and ARTHRALGIA (shoulders are hurting) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash pruritic
Clinical narrative: Very itchy rash; Big redness; This spontaneous case was reported by a physician and describes the occurrence of RASH PRURITIC (Very itchy rash) and ERYTHEMA (Big redness) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 015M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included TAMOXIFEN from 05-Jan-2015 to an unknown date for Breast cancer.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced RASH PRURITIC (Very itchy rash) and ERYTHEMA (Big redness). At the time of the report, RASH PRURITIC (Very itchy rash) and ERYTHEMA (Big redness) 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.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Patient demographics, start date of concomitant drug, outcome of events were updated.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Micturition urgency, Pollakiuria
Clinical narrative: frequent urination; urgent urination; This spontaneous case was reported by a patient and describes the occurrence of POLLAKIURIA (frequent urination) and MICTURITION URGENCY (urgent urination) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concomitant products included BENAZEPRIL, AMLODIPINE BESILATE (AMLODIPIN (BESILAT) DEXCEL), CARVEDILOL, HYDROCHLOROTHIAZIDE (CARVEDIL D), DOXAZOSIN and ALOPURINOL for an unknown indication.    On 13-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced POLLAKIURIA (frequent urination) and MICTURITION URGENCY (urgent urination). On 16-Feb-2021, POLLAKIURIA (frequent urination) and MICTURITION URGENCY (urgent urination) had resolved.            No relevant concomitant medications were reported.  Treatment information was not provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: 102.1°F fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (102.1°F fever) and CHILLS (Chills) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced PYREXIA (102.1°F fever) and CHILLS (Chills). At the time of the report, PYREXIA (102.1°F fever) and CHILLS (Chills) outcome was unknown.            No concomitant medications were provided.  Treatment medications were not provided. Action taken in response to mRNA-1273 was not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Insomnia
Clinical narrative: got extremely dizzy and weak; got extremely dizzy and weak; could not sleep the night of the vaccination; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (got extremely dizzy and weak), ASTHENIA (got extremely dizzy and weak) and INSOMNIA (could not sleep the night of the vaccination) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 011J20A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL, ATORVASTATIN and LEVOTHYROXINE for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced DIZZINESS (got extremely dizzy and weak), ASTHENIA (got extremely dizzy and weak) and INSOMNIA (could not sleep the night of the vaccination). On 09-Feb-2021, DIZZINESS (got extremely dizzy and weak), ASTHENIA (got extremely dizzy and weak) and INSOMNIA (could not sleep the night of the vaccination) had resolved. Not Provided          No treatment information was provided.     Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: No specific follow-up information recorded. On 22-Apr-2021: NNI
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hypersensitivity, Nervousness, Oropharyngeal discomfort, SARS-CoV-2 antibody test negative
Clinical narrative: Throat issues; Nervous; Sinus/allergy infection; Allergy symptoms; Chills(shaking so bad she couldn't get warm); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of OROPHARYNGEAL DISCOMFORT (Throat issues), NERVOUSNESS (Nervous), SINUSITIS (Sinus/allergy infection), HYPERSENSITIVITY (Allergy symptoms) and CHILLS (Chills(shaking so bad she couldn't get warm)) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol high and Multiple allergies (multiple medication allergies, reported mycins.). Concomitant products included ESTRADIOL, ROSUVASTATIN and VITAMINS NOS for an unknown indication.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 04-Feb-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (Throat issues), NERVOUSNESS (Nervous), SINUSITIS (Sinus/allergy infection), HYPERSENSITIVITY (Allergy symptoms) and CHILLS (Chills(shaking so bad she couldn't get warm)). The patient was treated with AMOXICILLIN for Sinus infection, at a dose of 875 milligram and VITAMIN B12 NOS for Adverse event, at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL DISCOMFORT (Throat issues), NERVOUSNESS (Nervous), SINUSITIS (Sinus/allergy infection), HYPERSENSITIVITY (Allergy symptoms) and CHILLS (Chills(shaking so bad she couldn't get warm)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test negative: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment medication reported During follow up patient noticed they did not add in that a week after receiving the Moderna vaccine she had really bad chills that lasted 2 hours and it did not stop until she got into a bathtub with hot water. She stated when she went to the doctors, the PA gave her a B12 shot and she thinks it might have been a reaction to receiving the B12 shot.   This case was linked to US-MODERNATX, INC.-MOD-2021-029603 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Non-significant FU-Email updated. On 06-Jul-2021: Non-Significant Follow Up - Contact information updated; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-029603:Crosslinked case
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: Throat issues; Nervous; Sinus/allergy infection; Allergy symptoms; Chills(shaking so bad she couldn't get warm); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of OROPHARYNGEAL DISCOMFORT (Throat issues), NERVOUSNESS (Nervous), SINUSITIS (Sinus/allergy infection), HYPERSENSITIVITY (Allergy symptoms) and CHILLS (Chills(shaking so bad she couldn't get warm)) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol high and Multiple allergies (multiple medication allergies, reported mycins.). Concomitant products included ESTRADIOL, ROSUVASTATIN and VITAMINS NOS for an unknown indication.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 04-Feb-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (Throat issues), NERVOUSNESS (Nervous), SINUSITIS (Sinus/allergy infection), HYPERSENSITIVITY (Allergy symptoms) and CHILLS (Chills(shaking so bad she couldn't get warm)). The patient was treated with AMOXICILLIN for Sinus infection, at a dose of 875 milligram and VITAMIN B12 NOS for Adverse event, at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL DISCOMFORT (Throat issues), NERVOUSNESS (Nervous), SINUSITIS (Sinus/allergy infection), HYPERSENSITIVITY (Allergy symptoms) and CHILLS (Chills(shaking so bad she couldn't get warm)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test negative: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment medication reported During follow up patient noticed they did not add in that a week after receiving the Moderna vaccine she had really bad chills that lasted 2 hours and it did not stop until she got into a bathtub with hot water. She stated when she went to the doctors, the PA gave her a B12 shot and she thinks it might have been a reaction to receiving the B12 shot.   This case was linked to US-MODERNATX, INC.-MOD-2021-029603 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Non-significant FU-Email updated. On 06-Jul-2021: Non-Significant Follow Up - Contact information updated; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-029603:Crosslinked case
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pruritus, Vaccination site erythema
Clinical narrative: Redness below injection site; Itchy shoulder; Shoulder soreness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (Itchy shoulder), VACCINATION SITE ERYTHEMA (Redness below injection site) and ARTHRALGIA (Shoulder soreness) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced ARTHRALGIA (Shoulder soreness). On 03-Feb-2021, the patient experienced PRURITUS (Itchy shoulder). On 05-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness below injection site). The patient was treated with HYDROCORTISONE for Itchy, at an unspecified dose and frequency and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Itchy, at an unspecified dose and frequency. At the time of the report, PRURITUS (Itchy shoulder) had resolved and VACCINATION SITE ERYTHEMA (Redness below injection site) and ARTHRALGIA (Shoulder soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications for itchy shoulder included hydrocortisone and OTC Benadryl.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: sore throat; woke up with chills and fever; Body aches; woke up with chills and fever; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN, PYREXIA, PAIN, and CHILLS in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 09-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 OROPHARYNGEAL PAIN, PYREXIA, PAIN, and CHILLS. The patient was treated with IBUPROFEN (ADVIL 12 HOUR) for Ache, at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN, PYREXIA, PAIN, and CHILLS had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Skin discolouration
Clinical narrative: Tiny purple spot; Bruising; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION and CONTUSION in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included GABAPENTIN, PROBIOTICS, CALCIUM CARBONATE, VITAMIN D, and CALCIUM for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced SKIN DISCOLOURATION and CONTUSION. At the time of the report, SKIN DISCOLOURATION and CONTUSION outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage
Clinical narrative: Injection hit a blood vessel and had blood running down the arm; A spontaneous report  was received from a consumer concerning a 70-year-old, male patient, who experienced injection hit a blood vessel and experienced blood running down the arm/vaccination site hemorrhage.  The patient's medical history was not provided. No relevant concomitant medications were provided.  On 11 Feb 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 031L20A) for prophylaxis of COVID-19 infection.   On 11 Feb 2021, after receiving the vaccination, the patient reported that the injection hit a blood vessel and had blood running down the arm.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, injection hit a blood vessel and had blood vessel running down the arm, was not reported..; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: aching; headache; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (aching) and HEADACHE (headache) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M2017) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced MYALGIA (aching) and HEADACHE (headache). At the time of the report, MYALGIA (aching) had resolved and HEADACHE (headache) had not resolved. Not Provided          No relevant concomitant medications were reported.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Head discomfort, Illness, Malaise, Nausea
Clinical narrative: No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (have gotten really sick), HEAD DISCOMFORT (my head is not in the right place/  I can't think straight), MALAISE (I still do not feel well), ASTHENIA (weakness), NAUSEA (nausea) and THINKING ABNORMAL (can't think straight). At the time of the report, ILLNESS (have gotten really sick), HEAD DISCOMFORT (my head is not in the right place/  I can't think straight), MALAISE (I still do not feel well), ASTHENIA (weakness), NAUSEA (nausea) and THINKING ABNORMAL (can't think straight) 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.   This case was linked to US-MODERNATX, INC.-MOD-2021-012401 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-012401:
Sex: F
Vaccine: COVID19
Symptoms: Thinking abnormal
Clinical narrative: No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (have gotten really sick), HEAD DISCOMFORT (my head is not in the right place/  I can't think straight), MALAISE (I still do not feel well), ASTHENIA (weakness), NAUSEA (nausea) and THINKING ABNORMAL (can't think straight). At the time of the report, ILLNESS (have gotten really sick), HEAD DISCOMFORT (my head is not in the right place/  I can't think straight), MALAISE (I still do not feel well), ASTHENIA (weakness), NAUSEA (nausea) and THINKING ABNORMAL (can't think straight) 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.   This case was linked to US-MODERNATX, INC.-MOD-2021-012401 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-012401:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pruritus, Pyrexia, Rash, Somnolence
Clinical narrative: rash on my arm 10 days now almost down to my elbow; itches a tiny bit; rash very aggravated by warmth; sleeping more often; temp slightly raised to 98F; went away overt the weekend and came back in full force yesterday; This spontaneous case was reported by a consumer and describes the occurrence of RASH, PRURITUS, FEELING HOT, SOMNOLENCE, and PYREXIA in a 75-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.     Concomitant products included VITAMIN B 1-6-12 for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH, PRURITUS, FEELING HOT, SOMNOLENCE, PYREXIA, and SYMPTOM RECURRENCE. At the time of the report, RASH, PRURITUS, FEELING HOT, SOMNOLENCE, PYREXIA, and SYMPTOM RECURRENCE outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient used cold wash cloths as treatment.   This case was linked to MOD-2021-101140 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Symptom recurrence
Clinical narrative: rash on my arm 10 days now almost down to my elbow; itches a tiny bit; rash very aggravated by warmth; sleeping more often; temp slightly raised to 98F; went away overt the weekend and came back in full force yesterday; This spontaneous case was reported by a consumer and describes the occurrence of RASH, PRURITUS, FEELING HOT, SOMNOLENCE, and PYREXIA in a 75-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.     Concomitant products included VITAMIN B 1-6-12 for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH, PRURITUS, FEELING HOT, SOMNOLENCE, PYREXIA, and SYMPTOM RECURRENCE. At the time of the report, RASH, PRURITUS, FEELING HOT, SOMNOLENCE, PYREXIA, and SYMPTOM RECURRENCE outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient used cold wash cloths as treatment.   This case was linked to MOD-2021-101140 (Patient Link).
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE and NAUSEA in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 04-Feb-2021, the patient experienced HEADACHE and NAUSEA. At the time of the report, HEADACHE and NAUSEA outcome was unknown. Not Provided.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: Itchy rash at the injection site; Itchy rash at the injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (Itchy rash at the injection site) and VACCINATION SITE RASH (Itchy rash at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PRURITUS (Itchy rash at the injection site) and VACCINATION SITE RASH (Itchy rash at the injection site). At the time of the report, VACCINATION SITE PRURITUS (Itchy rash at the injection site) and VACCINATION SITE RASH (Itchy rash at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: The reporter's contact information was updated.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspepsia, Headache, Nausea
Clinical narrative: Indigestion; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA, HEADACHE, and NAUSEA in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concomitant products included METFORMIN, GABAPENTIN and LISINOPRIL for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced DYSPEPSIA, HEADACHE, and NAUSEA. The patient was treated with TYLENOL ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, DYSPEPSIA, HEADACHE, and NAUSEA outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Dizziness, Vertigo
Clinical narrative: mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 016M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DABIGATRAN ETEXILATE MESILATE (PRADAXA) for Blood cholesterol abnormal, LOSARTAN for Blood pressure high, DILTIAZEM HYDROCHLORIDE (MATZIM LA) for Hypertension, METFORMIN for Type 2 diabetes mellitus.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced VERTIGO (vertigo, dizziness, kind of low blood pressure sensation now and then for about three weeks after), DIZZINESS (vertigo, dizziness, kind of low blood pressure sensation now and then for about three weeks after) and BLOOD PRESSURE FLUCTUATION (vertigo, dizziness, kind of low blood pressure sensation now and then for about three weeks after). At the time of the report, VERTIGO (vertigo, dizziness, kind of low blood pressure sensation now and then for about three weeks after), DIZZINESS (vertigo, dizziness, kind of low blood pressure sensation now and then for about three weeks after) and BLOOD PRESSURE FLUCTUATION (vertigo, dizziness, kind of low blood pressure sensation now and then for about three weeks after) outcome was unknown.      Other medication include Sinteroid.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Abscess, Erythema, Nausea, Pruritus
Clinical narrative: right arm at the site of injection was pink; right arm at the site of injection was  puffy and hard; right arm at the site of injection was itchy; nausea; This spontaneous case was reported by a nurse and describes the occurrence of ERYTHEMA, PRURITUS, ABSCESS, and NAUSEA in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Abscess (Itching of the skin at the injection site) on 09-Feb-2021.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced ERYTHEMA, PRURITUS, ABSCESS, and NAUSEA. At the time of the report, ERYTHEMA, PRURITUS, ABSCESS, and NAUSEA outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  No concomitant medication was provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Musculoskeletal stiffness
Clinical narrative: Stiff neck; Headache; Upper shoulder pain; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiff neck), HEADACHE (Headache), ARTHRALGIA (Upper shoulder pain) and FATIGUE (Fatigue) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff neck), HEADACHE (Headache), ARTHRALGIA (Upper shoulder pain) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiff neck), HEADACHE (Headache), ARTHRALGIA (Upper shoulder pain) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness in the left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included INSULIN for an unknown indication.    On 05-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE PAIN. The patient was treated with ACETAMINOPHEN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient also takes unspecified blood pressure medication as concomitant medication.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Illness, Temperature regulation disorder
Clinical narrative: Problems regulating temperature; Hot sweats; Headaches; Sick; A spontaneous report was received from a consumer concerning a female patient of unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced illness, problems regulating temperature, hot sweats/hyperhidrosis, headache.  The patient's medical history was not provided. Concomitant product use was unknown by the reporter.  On an unspecified date the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) via unknown route and site for prophylaxis of COVID-19 infection. On 5 Feb 2021, approximately 8 prior to the onset of the events, the patient received their second dose of mRNA-1273 (Lot number: unknown) via unknown route and site for prophylaxis of COVID-19 infection.   On 5 Feb 2021, the patient experienced illness. On an unspecified date the patient experienced problems regulating temperature, hot sweats/hyperhidrosis, headache. Treatment information was unknown.    Action taken with mRNA-1273 in response to the events is not applicable.   The event illness were considered resolved on 6 Feb 2021. The events problems regulating temperature, hot sweats/hyperhidrosis, headache were considered not resolved during the time of this report.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling cold, Paraesthesia
Clinical narrative: Tingling; Had difficulty catching her breath, noticed she was not breathing correctly; Felt like she had a band and it was very cold right below her bra area; Felt like a Cold band again, at the top of her chest; Felt like a Cold band in her arm, tingling feeling; Felt like a cold band in her back, tingling feeling; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA (Tingling), DYSPNOEA (Had difficulty catching her breath, noticed she was not breathing correctly), FEELING COLD (Felt like she had a band and it was very cold right below her bra area), FEELING COLD (Felt like a Cold band again, at the top of her chest) and FEELING COLD (Felt like a Cold band in her arm, tingling feeling) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Psoriasis and Psoriatic arthritis.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced PARAESTHESIA, DYSPNOEA, FEELING COLD, FEELING COLD, FEELING COLD, and PARAESTHESIA. On 15-Jan-2021, PARAESTHESIA, DYSPNOEA, FEELING COLD, FEELING COLD, FEELING COLD, and PARAESTHESIA had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Slight swelling at injection site; Itching and a red ring at injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE SWELLING (Slight swelling at injection site) and VACCINATION SITE PRURITUS (Itching and a red ring at injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Slight swelling at injection site) and VACCINATION SITE PRURITUS (Itching and a red ring at injection site). The patient was treated with HYDROCORTISONE (CORTISONE [HYDROCORTISONE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE SWELLING (Slight swelling at injection site) and VACCINATION SITE PRURITUS (Itching and a red ring at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Gait disturbance, Headache, Rash, Somnolence
Clinical narrative: Experienced a rash; Red spot at injection site; Drowsiness; Experienced a Headache; Injection site was painful; I could not stand up; Felt like a walking zombie; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSSTASIA (I could not stand up), GAIT DISTURBANCE (Felt like a walking zombie), SOMNOLENCE (Drowsiness), RASH (Experienced a rash) and HEADACHE (Experienced a Headache) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included IBUPROFEN and LEVOTHYROXINE for an unknown indication.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced DYSSTASIA (I could not stand up), GAIT DISTURBANCE (Felt like a walking zombie) and VACCINATION SITE PAIN (Injection site was painful). On 08-Feb-2021, the patient experienced SOMNOLENCE (Drowsiness) and HEADACHE (Experienced a Headache). On an unknown date, the patient experienced RASH (Experienced a rash) and VACCINATION SITE ERYTHEMA (Red spot at injection site). At the time of the report, DYSSTASIA (I could not stand up), GAIT DISTURBANCE (Felt like a walking zombie), SOMNOLENCE (Drowsiness), RASH (Experienced a rash), HEADACHE (Experienced a Headache), VACCINATION SITE PAIN (Injection site was painful) and VACCINATION SITE ERYTHEMA (Red spot at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  The patient had visited the Emergency Room and was told at the Emergency Room that everything was normal.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Patient does not want further follow up.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: Experienced a rash; Red spot at injection site; Drowsiness; Experienced a Headache; Injection site was painful; I could not stand up; Felt like a walking zombie; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSSTASIA (I could not stand up), GAIT DISTURBANCE (Felt like a walking zombie), SOMNOLENCE (Drowsiness), RASH (Experienced a rash) and HEADACHE (Experienced a Headache) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included IBUPROFEN and LEVOTHYROXINE for an unknown indication.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced DYSSTASIA (I could not stand up), GAIT DISTURBANCE (Felt like a walking zombie) and VACCINATION SITE PAIN (Injection site was painful). On 08-Feb-2021, the patient experienced SOMNOLENCE (Drowsiness) and HEADACHE (Experienced a Headache). On an unknown date, the patient experienced RASH (Experienced a rash) and VACCINATION SITE ERYTHEMA (Red spot at injection site). At the time of the report, DYSSTASIA (I could not stand up), GAIT DISTURBANCE (Felt like a walking zombie), SOMNOLENCE (Drowsiness), RASH (Experienced a rash), HEADACHE (Experienced a Headache), VACCINATION SITE PAIN (Injection site was painful) and VACCINATION SITE ERYTHEMA (Red spot at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  The patient had visited the Emergency Room and was told at the Emergency Room that everything was normal.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Patient does not want further follow up.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) 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 (Medical history was not reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Headache, Hypokinesia, Malaise
Clinical narrative: Plantar fascitis; Arthritis in both feet; Stiffness; Limitations in movement; Decreased range of motion of shoulder with some discomfort.; Multiple joint pains; Malaise; Painful shoulder; Nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Malaise), PLANTAR FASCIITIS (Plantar fascitis), ARTHRITIS (Arthritis in both feet), MUSCULOSKELETAL STIFFNESS (Stiffness) and HYPOKINESIA (Limitations in movement) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 011620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: shingrix vaccine (Past history to vaccine and present and reported to Glaxo Smith Kline) on 21-Jun-2018. Past adverse reactions to the above products included Polymyalgia rheumatica with shingrix vaccine. Concomitant products included SIMVASTATIN, LEVOTHYROXINE, PREDNISONE, ACETAMINOPHEN, BUSPIRONE and CHLORTHALIDONE for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced MALAISE (Malaise), ARTHRALGIA (Painful shoulder), NAUSEA (Nausea) and HEADACHE (headache). On an unknown date, the patient experienced PLANTAR FASCIITIS (Plantar fascitis), ARTHRITIS (Arthritis in both feet), MUSCULOSKELETAL STIFFNESS (Stiffness), HYPOKINESIA (Limitations in movement), MUSCULOSKELETAL DISCOMFORT (Decreased range of motion of shoulder with some discomfort.) and ARTHRALGIA (Multiple joint pains). On 12-Feb-2021, MALAISE (Malaise), NAUSEA (Nausea) and HEADACHE (headache) had resolved. On 26-Feb-2021, ARTHRALGIA (Painful shoulder) was resolving. At the time of the report, PLANTAR FASCIITIS (Plantar fascitis), ARTHRITIS (Arthritis in both feet), MUSCULOSKELETAL STIFFNESS (Stiffness), HYPOKINESIA (Limitations in movement), MUSCULOSKELETAL DISCOMFORT (Decreased range of motion of shoulder with some discomfort.) and ARTHRALGIA (Multiple joint pains) outcome was unknown.            Polymyalgia rheumatica was severe in both hands and wrists.  Patient took cold-compress as concomitant medication.  No treatment medication was reported by reporter.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Patient demographics, concomitant medications, second dose details and new events were updated.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort, Musculoskeletal stiffness, Nausea, Plantar fasciitis
Clinical narrative: Plantar fascitis; Arthritis in both feet; Stiffness; Limitations in movement; Decreased range of motion of shoulder with some discomfort.; Multiple joint pains; Malaise; Painful shoulder; Nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Malaise), PLANTAR FASCIITIS (Plantar fascitis), ARTHRITIS (Arthritis in both feet), MUSCULOSKELETAL STIFFNESS (Stiffness) and HYPOKINESIA (Limitations in movement) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 011620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: shingrix vaccine (Past history to vaccine and present and reported to Glaxo Smith Kline) on 21-Jun-2018. Past adverse reactions to the above products included Polymyalgia rheumatica with shingrix vaccine. Concomitant products included SIMVASTATIN, LEVOTHYROXINE, PREDNISONE, ACETAMINOPHEN, BUSPIRONE and CHLORTHALIDONE for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced MALAISE (Malaise), ARTHRALGIA (Painful shoulder), NAUSEA (Nausea) and HEADACHE (headache). On an unknown date, the patient experienced PLANTAR FASCIITIS (Plantar fascitis), ARTHRITIS (Arthritis in both feet), MUSCULOSKELETAL STIFFNESS (Stiffness), HYPOKINESIA (Limitations in movement), MUSCULOSKELETAL DISCOMFORT (Decreased range of motion of shoulder with some discomfort.) and ARTHRALGIA (Multiple joint pains). On 12-Feb-2021, MALAISE (Malaise), NAUSEA (Nausea) and HEADACHE (headache) had resolved. On 26-Feb-2021, ARTHRALGIA (Painful shoulder) was resolving. At the time of the report, PLANTAR FASCIITIS (Plantar fascitis), ARTHRITIS (Arthritis in both feet), MUSCULOSKELETAL STIFFNESS (Stiffness), HYPOKINESIA (Limitations in movement), MUSCULOSKELETAL DISCOMFORT (Decreased range of motion of shoulder with some discomfort.) and ARTHRALGIA (Multiple joint pains) outcome was unknown.            Polymyalgia rheumatica was severe in both hands and wrists.  Patient took cold-compress as concomitant medication.  No treatment medication was reported by reporter.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Patient demographics, concomitant medications, second dose details and new events were updated.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Extreme fatigue) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced FATIGUE (Extreme fatigue). At the time of the report, FATIGUE (Extreme fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant information  provided. No Treatment information  provided   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: unknown
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: temperature 101.2 degrees F, 99.9 this morning; fever during the night, 101.3 degrees in the middle of the night; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever during the night, 101.3 degrees in the middle of the night) and PYREXIA (temperature 101.2 degrees F, 99.9 this morning) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     no medical history was provided by the reporter.  The patient's past medical history included No adverse event. Concomitant products included SERTRALINE, DESOGESTREL, ETHINYLESTRADIOL (ISIBLOOM) and BUPROPION HYDROCHLORIDE (BUPROPION HCL XL) for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced PYREXIA (fever during the night, 101.3 degrees in the middle of the night). On 10-Feb-2021, the patient experienced PYREXIA (temperature 101.2 degrees F, 99.9 this morning). At the time of the report, PYREXIA (fever during the night, 101.3 degrees in the middle of the night) and PYREXIA (temperature 101.2 degrees F, 99.9 this morning) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details included Advil, Tylenol.