chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Rash, Urticaria
Clinical narrative: Hives; rash in all over his body; Pain in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), RASH (rash in all over his body) and INJECTION SITE PAIN (Pain in the injection site) in a 39-year-old male patient who received mRNA-1273 (batch no. 014021A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-May-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced URTICARIA (Hives), RASH (rash in all over his body) and INJECTION SITE PAIN (Pain in the injection site). At the time of the report, URTICARIA (Hives), RASH (rash in all over his body) and INJECTION SITE PAIN (Pain in the injection site) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) was unknown.       No concomitant medication was reported.  Treatment drug information was not given.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: Body aches; Tired; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches) and FATIGUE (Tired) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 03-Mar-2021, the patient experienced MYALGIA (Body aches) and FATIGUE (Tired). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, MYALGIA (Body aches) and FATIGUE (Tired) outcome was unknown.            No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-132957 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Additional information include no new information.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: 2nd dose administered 21 days after 1st dose; This spontaneous case was reported by a nurse and describes the occurrence of OFF LABEL USE (2nd dose administered 21 days after 1st dose) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011j20a and 016m20a) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced OFF LABEL USE (2nd dose administered 21 days after 1st dose). On 04-Feb-2021, OFF LABEL USE (2nd dose administered 21 days after 1st dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Product dose omission issue
Clinical narrative: Maternal  exposure during pregnancy; Past the recommended dosing interval of the second dose; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal  exposure during pregnancy) and PRODUCT DOSE OMISSION ISSUE (Past the recommended dosing interval of the second dose) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 14-Feb-2021 and the estimated date of delivery was 11-Nov-2021. On 10-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Past the recommended dosing interval of the second dose). On 23-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal  exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  third week of the pregnancy.  On 10-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Past the recommended dosing interval of the second dose) had resolved. On 23-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal  exposure during pregnancy) 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.   No relevant concomitant medications were reported.  The patient received the first dose of the Moderna vaccine on 10Mar2021. Patient then saw her primary doctor on 23Mar2021, who confirmed and said it was unplanned pregnancy. Patient was worried about the vaccine because it was an unplanned pregnancy. Doctor then recommended to postpone vaccination until second trimester, due to patient concern for pregnancy complications. Also on 9Apr2021 patient had a confirmed pregnancy at the OBGYN doctor outpatient office.  No treatment information was provided.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Cough, Illness, Oropharyngeal pain
Clinical narrative: Got very sick; Flem; Coughing; Throat is hurting; Can't smell; Can't taste; Nose is running; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got very sick), PRODUCTIVE COUGH (Flem), COUGH (Coughing), OROPHARYNGEAL PAIN (Throat is hurting) and ANOSMIA (Can't smell) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced ILLNESS (Got very sick), PRODUCTIVE COUGH (Flem), COUGH (Coughing), OROPHARYNGEAL PAIN (Throat is hurting), ANOSMIA (Can't smell), AGEUSIA (Can't taste) and RHINORRHOEA (Nose is running). At the time of the report, ILLNESS (Got very sick), PRODUCTIVE COUGH (Flem), COUGH (Coughing), OROPHARYNGEAL PAIN (Throat is hurting), ANOSMIA (Can't smell), AGEUSIA (Can't taste) and RHINORRHOEA (Nose is running) 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.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Productive cough, Rhinorrhoea
Clinical narrative: Got very sick; Flem; Coughing; Throat is hurting; Can't smell; Can't taste; Nose is running; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got very sick), PRODUCTIVE COUGH (Flem), COUGH (Coughing), OROPHARYNGEAL PAIN (Throat is hurting) and ANOSMIA (Can't smell) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced ILLNESS (Got very sick), PRODUCTIVE COUGH (Flem), COUGH (Coughing), OROPHARYNGEAL PAIN (Throat is hurting), ANOSMIA (Can't smell), AGEUSIA (Can't taste) and RHINORRHOEA (Nose is running). At the time of the report, ILLNESS (Got very sick), PRODUCTIVE COUGH (Flem), COUGH (Coughing), OROPHARYNGEAL PAIN (Throat is hurting), ANOSMIA (Can't smell), AGEUSIA (Can't taste) and RHINORRHOEA (Nose is running) 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.
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Dizziness
Clinical narrative: dizziness; not clear what he was feeling; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) and CONFUSIONAL STATE (not clear what he was feeling) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced DIZZINESS (dizziness) and CONFUSIONAL STATE (not clear what he was feeling). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form; IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at a dose of UNK dosage form and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at a dose of UNK dosage form. At the time of the report, DIZZINESS (dizziness) and CONFUSIONAL STATE (not clear what he was feeling) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications reported.   Reported stated that none of the treatment medications worked.   This case was linked to MOD-2021-133057 (Patient Link).
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic, Urticaria
Clinical narrative: Itchy rash everywhere, on her back, chest.; hives all over the body; hives all over the body that were painful; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash everywhere, on her back, chest.), URTICARIA (hives all over the body) and RASH (hives all over the body that were painful) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 032B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-May-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) (Intramuscular) 1 dosage form. On 08-May-2021, the patient experienced RASH PRURITIC (Itchy rash everywhere, on her back, chest.), URTICARIA (hives all over the body) and RASH (hives all over the body that were painful). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of UNK dosage form. At the time of the report, RASH PRURITIC (Itchy rash everywhere, on her back, chest.), URTICARIA (hives all over the body) and RASH (hives all over the body that were painful) outcome was unknown.            No concomitant medications provided.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Body temperature, Fatigue, Influenza like illness, Myalgia
Clinical narrative: Arm pain; Flu like symptoms; Anxiety; Muscle aches; Fatigue; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Arm pain), INFLUENZA LIKE ILLNESS (Flu like symptoms), ANXIETY (Anxiety), MYALGIA (Muscle aches) and FATIGUE (Fatigue) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-May-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 07-May-2021, the patient experienced PAIN IN EXTREMITY (Arm pain), INFLUENZA LIKE ILLNESS (Flu like symptoms), ANXIETY (Anxiety), MYALGIA (Muscle aches) and FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (Arm pain), INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Muscle aches) and FATIGUE (Fatigue) outcome was unknown and ANXIETY (Anxiety) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-May-2021, Body temperature: increased (abnormal) 101F.         Treatment information were not provided. no concomitant was provided   This case was linked to MOD-2021-132910 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow-up received on 15-JUN-2021 contains no new information On 12-Jul-2021: Non-Significant follow up appended
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm pain; Flu like symptoms; Anxiety; Muscle aches; Fatigue; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Arm pain), INFLUENZA LIKE ILLNESS (Flu like symptoms), ANXIETY (Anxiety), MYALGIA (Muscle aches) and FATIGUE (Fatigue) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-May-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 07-May-2021, the patient experienced PAIN IN EXTREMITY (Arm pain), INFLUENZA LIKE ILLNESS (Flu like symptoms), ANXIETY (Anxiety), MYALGIA (Muscle aches) and FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (Arm pain), INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Muscle aches) and FATIGUE (Fatigue) outcome was unknown and ANXIETY (Anxiety) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-May-2021, Body temperature: increased (abnormal) 101F.         Treatment information were not provided. no concomitant was provided   This case was linked to MOD-2021-132910 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow-up received on 15-JUN-2021 contains no new information On 12-Jul-2021: Non-Significant follow up appended
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenopia, Dark circles under eyes, Myalgia
Clinical narrative: the patient had "arm mostly sore; had dark around the eyes which felt like black eye; eyes feel like I have been up for a week with no sleep,eyes feel tired; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (the patient had "arm mostly sore), DARK CIRCLES UNDER EYES (had dark around the eyes which felt like black eye) and ASTHENOPIA (eyes feel like I have been up for a week with no sleep,eyes feel tired) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     Concomitant products included BOTULINUM TOXIN TYPE A (BOTOX) from 01-May-2021 to an unknown date for Migraine.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced MYALGIA (the patient had "arm mostly sore), DARK CIRCLES UNDER EYES (had dark around the eyes which felt like black eye) and ASTHENOPIA (eyes feel like I have been up for a week with no sleep,eyes feel tired). At the time of the report, MYALGIA (the patient had "arm mostly sore) and ASTHENOPIA (eyes feel like I have been up for a week with no sleep,eyes feel tired) outcome was unknown and DARK CIRCLES UNDER EYES (had dark around the eyes which felt like black eye) had not resolved. but took nothing for it      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-132734, US-MODERNATX, INC.-MOD-2021-132945 (E2B Linked Report). This case was linked to MOD-2021-133138 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-132734: US-MODERNATX, INC.-MOD-2021-132945:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   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. The patient's last menstrual period was on 19-Feb-2021 and the estimated date of delivery was 26-Nov-2021. On 19-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 19-Feb-2021, EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved.            No relevant concomitant medications were reported.  No treatment information was provided.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Feeling abnormal
Clinical narrative: Both the anxiety and brain fog lasted for 2 weeks after each dose and disappeared one day/surging sensation through her whole body; Both the anxiety and brain fog lasted for 2 weeks after each dose and disappeared one day/surging sensation through her whole body; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Both the anxiety and brain fog lasted for 2 weeks after each dose and disappeared one day/surging sensation through her whole body) and FEELING ABNORMAL (Both the anxiety and brain fog lasted for 2 weeks after each dose and disappeared one day/surging sensation through her whole body) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy.    On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced ANXIETY (Both the anxiety and brain fog lasted for 2 weeks after each dose and disappeared one day/surging sensation through her whole body). 11-Feb-2021, the patient experienced FEELING ABNORMAL (Both the anxiety and brain fog lasted for 2 weeks after each dose and disappeared one day/surging sensation through her whole body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) for Prophylaxis, at an unspecified dose and frequency. At the time of the report, ANXIETY (Both the anxiety and brain fog lasted for 2 weeks after each dose and disappeared one day/surging sensation through her whole body) and FEELING ABNORMAL (Both the anxiety and brain fog lasted for 2 weeks after each dose and disappeared one day/surging sensation through her whole body) had resolved.            No concomitant medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-133172 (E2B Linked Report). This case was linked to MOD-2021-132767, MOD-2021-133270 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-133172:Case for patient second dose
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Patient was mistaken given the Moderna vaccine in place of a shingles shot after he has already; after he has already completed his 2 doses of Pfizer.; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient was mistaken given the Moderna vaccine in place of a shingles shot after he has already) and EXTRA DOSE ADMINISTERED (after he has already completed his 2 doses of Pfizer.) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, the patient experienced WRONG PRODUCT ADMINISTERED (Patient was mistaken given the Moderna vaccine in place of a shingles shot after he has already) and EXTRA DOSE ADMINISTERED (after he has already completed his 2 doses of Pfizer.). On 15-May-2021, WRONG PRODUCT ADMINISTERED (Patient was mistaken given the Moderna vaccine in place of a shingles shot after he has already) and EXTRA DOSE ADMINISTERED (after he has already completed his 2 doses of Pfizer.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was reported
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Myalgia, Pyrexia, Vomiting
Clinical narrative: sweating; fever; vomiting; body ache; head ache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), PYREXIA (fever), VOMITING (vomiting), MYALGIA (body ache) and HEADACHE (head ache) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced HYPERHIDROSIS (sweating), PYREXIA (fever), VOMITING (vomiting), MYALGIA (body ache) and HEADACHE (head ache). At the time of the report, HYPERHIDROSIS (sweating), PYREXIA (fever), VOMITING (vomiting), MYALGIA (body ache) and HEADACHE (head ache) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Two unknown patients >35 days from first vaccination without receiving the second dose; 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Two unknown patients >35 days from first vaccination without receiving the second dose) 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 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Two unknown patients >35 days from first vaccination without receiving the second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Two unknown patients >35 days from first vaccination without receiving the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination complication
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Mildly sore arm) and VACCINATION COMPLICATION (Non-specific report reaction to vaccine) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 031M20A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (Pantaprazole (oral) and possibly others in proton pump inhibitors (PPI) class), Hypothyroidism since 01-Sep-1990, Migraine since 01-Jul-1968, Anaphylaxis (Idiopathic anaphylaxis Improved from May 2015 when stopped Pantaprazole) since 01-Mar-2013 and Constipation. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) from 15-Mar-2013 to an unknown date and MONTELUKAST from 15-Mar-2013 to an unknown date for Anaphylaxis, DOCUSATE SODIUM (EQUATE STOOL SOFTENER) from 01-Apr-2007 to an unknown date for Constipation, LEVOTHYROXINE SODIUM (LEVOTHYROXIN) from 01-Sep-1991 to an unknown date for Hypothyroidism. On 08-Mar-2021 at 11:50 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021 at 11:50 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced VACCINATION COMPLICATION (Non-specific report reaction to vaccine). On 05-Apr-2021 at 1:00 PM, the patient experienced PAIN IN EXTREMITY (Mildly sore arm). On 18-Mar-2021, VACCINATION COMPLICATION (Non-specific report reaction to vaccine) had resolved. On 07-Apr-2021, PAIN IN EXTREMITY (Mildly sore arm) had resolved. Treatment information were not provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Eructation, Myalgia, Vaccination site pain
Clinical narrative: Constant belching feeling when raising the arm; Pain at the injection arm (left arm); The pain is more severe, while lying down towards the affected side,"the pain is persisting and its comes and goes"; This spontaneous case was reported by a consumer and describes the occurrence of ERUCTATION (Constant belching feeling when raising the arm), VACCINATION SITE PAIN (Pain at the injection arm (left arm)) and MYALGIA (The pain is more severe, while lying down towards the affected side,"the pain is persisting and its comes and goes") in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concomitant products included VALSARTAN, METFORMIN and CARVEDILOL for an unknown indication.    On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERUCTATION (Constant belching feeling when raising the arm), VACCINATION SITE PAIN (Pain at the injection arm (left arm)) and MYALGIA (The pain is more severe, while lying down towards the affected side,"the pain is persisting and its comes and goes"). At the time of the report, ERUCTATION (Constant belching feeling when raising the arm), VACCINATION SITE PAIN (Pain at the injection arm (left arm)) and MYALGIA (The pain is more severe, while lying down towards the affected side,"the pain is persisting and its comes and goes") outcome was unknown.            No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Vomiting
Clinical narrative: producing diarrhea; Producing vomits; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (producing diarrhea) and VOMITING (Producing vomits) in a male 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, the patient experienced DIARRHOEA (producing diarrhea) and VOMITING (Producing vomits). At the time of the report, DIARRHOEA (producing diarrhea) and VOMITING (Producing vomits) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Treatment of the events were not reported.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site movement impairment
Clinical narrative: Not able to bend their elbow but they can move their arm and fingers; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Not able to bend their elbow but they can move their arm and fingers) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Not able to bend their elbow but they can move their arm and fingers). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Not able to bend their elbow but they can move their arm and fingers) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Product preparation error
Clinical narrative: vaccine did not come to room temperature before administration; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT PREPARATION ERROR (vaccine did not come to room temperature before administration) 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 PRODUCT PREPARATION ERROR (vaccine did not come to room temperature before administration). At the time of the report, PRODUCT PREPARATION ERROR (vaccine did not come to room temperature before administration) 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.   No concomitant medications were reported.  No corrective treatment was provided.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Pyrexia
Clinical narrative: some diarrhea; fever; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (some diarrhea), PYREXIA (fever) and NAUSEA (nausea) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) for an unknown indication.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced DIARRHOEA (some diarrhea), PYREXIA (fever) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (some diarrhea), PYREXIA (fever) and NAUSEA (nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Chills, Crying, Feeling abnormal
Clinical narrative: Crying on and off; Headache since 3 in the morning; Body temperature was 99 to 100 in the morning; Chills; A sore arm, leg in pain; Body felt funny; Tired legs; Sweat; Feeling hot and cold; Tingly; Flu like symptoms; Back pain; Butt pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (A sore arm, leg in pain), FEELING ABNORMAL (Body felt funny), LIMB DISCOMFORT (Tired legs), HYPERHIDROSIS (Sweat) and FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine. Concomitant products included BOTULINUM TOXIN TYPE A (BOTOX) from 01-May-2021 to an unknown date for Migraine.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced PAIN IN EXTREMITY (A sore arm, leg in pain), FEELING ABNORMAL (Body felt funny), LIMB DISCOMFORT (Tired legs), HYPERHIDROSIS (Sweat), FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold), INFLUENZA LIKE ILLNESS (Flu like symptoms), BACK PAIN (Back pain), MUSCULOSKELETAL PAIN (Butt pain) and CHILLS (Chills). 14-May-2021, the patient experienced PARAESTHESIA (Tingly). On 15-May-2021, the patient experienced CRYING (Crying on and off), HEADACHE (Headache since 3 in the morning) and PYREXIA (Body temperature was 99 to 100 in the morning). The patient was treated with IBUPROFEN on 16-Apr-2021 for Adverse event, at a dose of 800 milligram. At the time of the report, PAIN IN EXTREMITY (A sore arm, leg in pain), FEELING ABNORMAL (Body felt funny), LIMB DISCOMFORT (Tired legs), HYPERHIDROSIS (Sweat), FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold), PARAESTHESIA (Tingly), INFLUENZA LIKE ILLNESS (Flu like symptoms), BACK PAIN (Back pain), MUSCULOSKELETAL PAIN (Butt pain), CRYING (Crying on and off), CHILLS (Chills), HEADACHE (Headache since 3 in the morning) and PYREXIA (Body temperature was 99 to 100 in the morning) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-May-2021, Body temperature: 99-100 Inconclusive.         This case was linked to US-MODERNATX, INC.-MOD-2021-132734, US-MODERNATX, INC.-MOD-2021-132945 (E2B Linked Report). This case was linked to MOD-2021-133031 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-132734: US-MODERNATX, INC.-MOD-2021-132945:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Headache, Hyperhidrosis, Influenza like illness, Limb discomfort
Clinical narrative: Crying on and off; Headache since 3 in the morning; Body temperature was 99 to 100 in the morning; Chills; A sore arm, leg in pain; Body felt funny; Tired legs; Sweat; Feeling hot and cold; Tingly; Flu like symptoms; Back pain; Butt pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (A sore arm, leg in pain), FEELING ABNORMAL (Body felt funny), LIMB DISCOMFORT (Tired legs), HYPERHIDROSIS (Sweat) and FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine. Concomitant products included BOTULINUM TOXIN TYPE A (BOTOX) from 01-May-2021 to an unknown date for Migraine.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced PAIN IN EXTREMITY (A sore arm, leg in pain), FEELING ABNORMAL (Body felt funny), LIMB DISCOMFORT (Tired legs), HYPERHIDROSIS (Sweat), FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold), INFLUENZA LIKE ILLNESS (Flu like symptoms), BACK PAIN (Back pain), MUSCULOSKELETAL PAIN (Butt pain) and CHILLS (Chills). 14-May-2021, the patient experienced PARAESTHESIA (Tingly). On 15-May-2021, the patient experienced CRYING (Crying on and off), HEADACHE (Headache since 3 in the morning) and PYREXIA (Body temperature was 99 to 100 in the morning). The patient was treated with IBUPROFEN on 16-Apr-2021 for Adverse event, at a dose of 800 milligram. At the time of the report, PAIN IN EXTREMITY (A sore arm, leg in pain), FEELING ABNORMAL (Body felt funny), LIMB DISCOMFORT (Tired legs), HYPERHIDROSIS (Sweat), FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold), PARAESTHESIA (Tingly), INFLUENZA LIKE ILLNESS (Flu like symptoms), BACK PAIN (Back pain), MUSCULOSKELETAL PAIN (Butt pain), CRYING (Crying on and off), CHILLS (Chills), HEADACHE (Headache since 3 in the morning) and PYREXIA (Body temperature was 99 to 100 in the morning) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-May-2021, Body temperature: 99-100 Inconclusive.         This case was linked to US-MODERNATX, INC.-MOD-2021-132734, US-MODERNATX, INC.-MOD-2021-132945 (E2B Linked Report). This case was linked to MOD-2021-133031 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-132734: US-MODERNATX, INC.-MOD-2021-132945:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal pain, Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: Crying on and off; Headache since 3 in the morning; Body temperature was 99 to 100 in the morning; Chills; A sore arm, leg in pain; Body felt funny; Tired legs; Sweat; Feeling hot and cold; Tingly; Flu like symptoms; Back pain; Butt pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (A sore arm, leg in pain), FEELING ABNORMAL (Body felt funny), LIMB DISCOMFORT (Tired legs), HYPERHIDROSIS (Sweat) and FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine. Concomitant products included BOTULINUM TOXIN TYPE A (BOTOX) from 01-May-2021 to an unknown date for Migraine.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced PAIN IN EXTREMITY (A sore arm, leg in pain), FEELING ABNORMAL (Body felt funny), LIMB DISCOMFORT (Tired legs), HYPERHIDROSIS (Sweat), FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold), INFLUENZA LIKE ILLNESS (Flu like symptoms), BACK PAIN (Back pain), MUSCULOSKELETAL PAIN (Butt pain) and CHILLS (Chills). 14-May-2021, the patient experienced PARAESTHESIA (Tingly). On 15-May-2021, the patient experienced CRYING (Crying on and off), HEADACHE (Headache since 3 in the morning) and PYREXIA (Body temperature was 99 to 100 in the morning). The patient was treated with IBUPROFEN on 16-Apr-2021 for Adverse event, at a dose of 800 milligram. At the time of the report, PAIN IN EXTREMITY (A sore arm, leg in pain), FEELING ABNORMAL (Body felt funny), LIMB DISCOMFORT (Tired legs), HYPERHIDROSIS (Sweat), FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold), PARAESTHESIA (Tingly), INFLUENZA LIKE ILLNESS (Flu like symptoms), BACK PAIN (Back pain), MUSCULOSKELETAL PAIN (Butt pain), CRYING (Crying on and off), CHILLS (Chills), HEADACHE (Headache since 3 in the morning) and PYREXIA (Body temperature was 99 to 100 in the morning) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-May-2021, Body temperature: 99-100 Inconclusive.         This case was linked to US-MODERNATX, INC.-MOD-2021-132734, US-MODERNATX, INC.-MOD-2021-132945 (E2B Linked Report). This case was linked to MOD-2021-133031 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-132734: US-MODERNATX, INC.-MOD-2021-132945:
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood glucose, Glycosylated haemoglobin, Muscular weakness, Pain
Clinical narrative: loss of strength in left arm; no energy; bad pain/ whole left side of his body in pain; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (loss of strength in left arm), ASTHENIA (no energy) and PAIN (bad pain/ whole left side of his body in pain) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included METFORMIN for an unknown indication.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-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 MUSCULAR WEAKNESS (loss of strength in left arm), ASTHENIA (no energy) and PAIN (bad pain/ whole left side of his body in pain). At the time of the report, MUSCULAR WEAKNESS (loss of strength in left arm), ASTHENIA (no energy) and PAIN (bad pain/ whole left side of his body in pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: 97-423 (High) 97-423 Patient stated his blood sugar has been erratic.. On an unknown date, Glycosylated haemoglobin: 9.9 (High) 9.9, 7 (Inconclusive) 7 and 14 (High) A1C reaching over 14, but averaging at 5-9.9..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient stated that before vaccination, A1C is about  6.3-6.5 No treatment medications provided by the reporter.      Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Additional information received on 17MAY2021, contains no significant information. On 21-Jun-2021: Follow up received on 21-JUN-2021: Updated patient initial, Added  lab data and medical history , additional  events asthenia and pain were added. On 07-Jul-2021: Follow up received on 07JUL2021, contains non significant information.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Pfizer first dose, Moderna second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Pfizer first dose, Moderna second dose) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   In April 2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage form. On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Pfizer first dose, Moderna second dose). On 14-May-2021, INTERCHANGE OF VACCINE PRODUCTS (Pfizer first dose, Moderna second dose) 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.   No concomitant medications were reported.  No treatment information was reported.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Feeling hot, Headache, Limb injury, Pain
Clinical narrative: very hot; left arm and shoulder hurt; whole body aches; little bit of cough; fever (temperature was not taken); headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (very hot), LIMB INJURY (left arm and shoulder hurt), PAIN (whole body aches), COUGH (little bit of cough) and PYREXIA (fever (temperature was not taken)) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced FEELING HOT (very hot), LIMB INJURY (left arm and shoulder hurt), PAIN (whole body aches), COUGH (little bit of cough), PYREXIA (fever (temperature was not taken)) and HEADACHE (headache). At the time of the report, FEELING HOT (very hot), LIMB INJURY (left arm and shoulder hurt), PAIN (whole body aches), COUGH (little bit of cough), PYREXIA (fever (temperature was not taken)) and HEADACHE (headache) outcome was unknown.            No concomitant medications reported by investigator.   patient drunk a lot of water, no other treatment medications provided by the reporter.   This case was linked to MOD-2021-133190 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: very hot; left arm and shoulder hurt; whole body aches; little bit of cough; fever (temperature was not taken); headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (very hot), LIMB INJURY (left arm and shoulder hurt), PAIN (whole body aches), COUGH (little bit of cough) and PYREXIA (fever (temperature was not taken)) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced FEELING HOT (very hot), LIMB INJURY (left arm and shoulder hurt), PAIN (whole body aches), COUGH (little bit of cough), PYREXIA (fever (temperature was not taken)) and HEADACHE (headache). At the time of the report, FEELING HOT (very hot), LIMB INJURY (left arm and shoulder hurt), PAIN (whole body aches), COUGH (little bit of cough), PYREXIA (fever (temperature was not taken)) and HEADACHE (headache) outcome was unknown.            No concomitant medications reported by investigator.   patient drunk a lot of water, no other treatment medications provided by the reporter.   This case was linked to MOD-2021-133190 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at the injection site) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 025C21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Drug allergy (Morphine) and Drug allergy (Erythromycin). Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) and IBUPROFEN for an unknown indication.   On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced VACCINATION SITE PAIN (pain at the injection site). At the time of the report, VACCINATION SITE PAIN (pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication not reported.   This case was linked to MOD-2021-133215 (Patient Link).