chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (her arm hurt really bad, she couldn't lift her arm after first dose), EPISTAXIS (nose bleeding), ASTHENIA (really weak), ILLNESS and DIARRHOEA in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced PAIN IN EXTREMITY (her arm hurt really bad, she couldn't lift her arm after first dose), ASTHENIA (really weak), ILLNESS, DIARRHOEA, VOMITING, CHILLS, PYREXIA (fever), MYALGIA (body aches), HEADACHE, and FATIGUE. On 15-Apr-2021, the patient experienced EPISTAXIS (nose bleedings). On 14-Apr-2021, PAIN IN EXTREMITY (her arm hurt really bad, she couldn't lift her arm after first dose), ASTHENIA (weak), ILLNESS, DIARRHOEA, VOMITING, CHILLS, PYREXIA (fever), MYALGIA (body aches), and FATIGUE outcome was unknown. At the time of the report, EPISTAXIS (nose bleedings), and HEADACHE outcome was unknown. Not Provided.          No medical history were provided and concomitant medications include birth control pills. No treatment information provided
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (her arm hurt really bad, she couldn't lift her arm after first dose), EPISTAXIS (nose bleeding), ASTHENIA (really weak), ILLNESS and DIARRHOEA in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced PAIN IN EXTREMITY (her arm hurt really bad, she couldn't lift her arm after first dose), ASTHENIA (really weak), ILLNESS, DIARRHOEA, VOMITING, CHILLS, PYREXIA (fever), MYALGIA (body aches), HEADACHE, and FATIGUE. On 15-Apr-2021, the patient experienced EPISTAXIS (nose bleedings). On 14-Apr-2021, PAIN IN EXTREMITY (her arm hurt really bad, she couldn't lift her arm after first dose), ASTHENIA (weak), ILLNESS, DIARRHOEA, VOMITING, CHILLS, PYREXIA (fever), MYALGIA (body aches), and FATIGUE outcome was unknown. At the time of the report, EPISTAXIS (nose bleedings), and HEADACHE outcome was unknown. Not Provided.          No medical history were provided and concomitant medications include birth control pills. No treatment information provided
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year old received vaccination; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received vaccination) in a 17-year-old male 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received vaccination). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received vaccination) 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.   The concomitant and treatment medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow up received on 21-MAY-2021. No new information provided
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Itchy rash on the left arm, legs, ankles, stomach, left breast; Red rash on the left arm, legs, ankles, stomach, left breast; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash on the left arm, legs, ankles, stomach, left breast) and RASH ERYTHEMATOUS (Red rash on the left arm, legs, ankles, stomach, left breast) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 011A20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history was not provided).   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form(s). On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form(s). In April 2021, the patient experienced RASH PRURITIC (Itchy rash on the left arm, legs, ankles, stomach, left breast) and RASH ERYTHEMATOUS (Red rash on the left arm, legs, ankles, stomach, left breast). At the time of the report, RASH PRURITIC (Itchy rash on the left arm, legs, ankles, stomach, left breast) and RASH ERYTHEMATOUS (Red rash on the left arm, legs, ankles, stomach, left breast) outcome was unknown. Not Provided          The biggest patch remained on her left breast and they were small red itchy patches. The patient was told by her doctor on 12-Apr-2021 to take Benadryl at bedtime, Triamcinolone acetonide 0.025% cream two times a day. The patient started the medications on 13-Apr-2021.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: red right arm; swollen right arm; sore right arm; felt sick for 12-15 hours; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (felt sick for 12-15 hours), VACCINATION SITE ERYTHEMA (red right arm), VACCINATION SITE SWELLING (swollen right arm) and VACCINATION SITE PAIN (sore right arm) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient was hospitalized for 52 days due to severe Covid-19 infection. She was discharged on 22Dec2020.) on 03-Nov-2020. Concurrent medical conditions included Acid reflux (esophageal), Hypercholesteraemia, Hypothyroidism, Rheumatoid arthritis and Drug allergy (morphine allergy). Concomitant products included POTASSIUM, PANTOPRAZOLE, LEVOTHYROXINE SODIUM (SYNTHROID), ROSUVASTATIN, AZATHIOPRINE, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), MULTIVITAMIN [VITAMINS NOS] and RITUXIMAB (RITUXAN) 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 15-Apr-2021, the patient experienced ILLNESS (felt sick for 12-15 hours). On 19-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (red right arm), VACCINATION SITE SWELLING (swollen right arm) and VACCINATION SITE PAIN (sore right arm). On 16-Apr-2021, ILLNESS (felt sick for 12-15 hours) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (red right arm), VACCINATION SITE SWELLING (swollen right arm) and VACCINATION SITE PAIN (sore right arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Dyspnoea, Myalgia, Nausea, Paraesthesia oral
Clinical narrative: throbbing pain both sides of kidneys; Difficulty breathing, feels like film on the lungs; nausea and diarrhea; tingling of the tongue; Body aches; nausea and diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of RENAL PAIN (throbbing pain both sides of kidneys), DYSPNOEA (Difficulty breathing, feels like film on the lungs), DIARRHOEA (nausea and diarrhea), PARAESTHESIA ORAL (tingling of the tongue) and MYALGIA (Body aches) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Reaction to previous exposure to any vaccine (He has always had problems with various vaccines), Diverticulitis intestinal, Cyst (Complex Cyst bleeder), Ulcer bleeding, Stroke and Inflammation (Full Body Inflamation). Concurrent medical conditions included Kidney stones (Kidneys-Chronic Stones).   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced DYSPNOEA (Difficulty breathing, feels like film on the lungs), DIARRHOEA (nausea and diarrhea), PARAESTHESIA ORAL (tingling of the tongue), MYALGIA (Body aches) and NAUSEA (nausea and diarrhea). On an unknown date, the patient experienced RENAL PAIN (throbbing pain both sides of kidneys). At the time of the report, RENAL PAIN (throbbing pain both sides of kidneys), DYSPNOEA (Difficulty breathing, feels like film on the lungs), DIARRHOEA (nausea and diarrhea), PARAESTHESIA ORAL (tingling of the tongue), MYALGIA (Body aches) and NAUSEA (nausea and diarrhea) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Follow up was received on 20 Apr 2021 included reporter details, medical history, dose details & events were updated. On 21-May-2021: Follow up was received on 21 May 2021 included medical history and event was updated.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Renal pain
Clinical narrative: throbbing pain both sides of kidneys; Difficulty breathing, feels like film on the lungs; nausea and diarrhea; tingling of the tongue; Body aches; nausea and diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of RENAL PAIN (throbbing pain both sides of kidneys), DYSPNOEA (Difficulty breathing, feels like film on the lungs), DIARRHOEA (nausea and diarrhea), PARAESTHESIA ORAL (tingling of the tongue) and MYALGIA (Body aches) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Reaction to previous exposure to any vaccine (He has always had problems with various vaccines), Diverticulitis intestinal, Cyst (Complex Cyst bleeder), Ulcer bleeding, Stroke and Inflammation (Full Body Inflamation). Concurrent medical conditions included Kidney stones (Kidneys-Chronic Stones).   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced DYSPNOEA (Difficulty breathing, feels like film on the lungs), DIARRHOEA (nausea and diarrhea), PARAESTHESIA ORAL (tingling of the tongue), MYALGIA (Body aches) and NAUSEA (nausea and diarrhea). On an unknown date, the patient experienced RENAL PAIN (throbbing pain both sides of kidneys). At the time of the report, RENAL PAIN (throbbing pain both sides of kidneys), DYSPNOEA (Difficulty breathing, feels like film on the lungs), DIARRHOEA (nausea and diarrhea), PARAESTHESIA ORAL (tingling of the tongue), MYALGIA (Body aches) and NAUSEA (nausea and diarrhea) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Follow up was received on 20 Apr 2021 included reporter details, medical history, dose details & events were updated. On 21-May-2021: Follow up was received on 21 May 2021 included medical history and event was updated.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Product dose omission issue, Urinary tract infection
Clinical narrative: urinary tract infection; cancelled her original second dose appointment since on medication and is now scheduled for second dose on 27 April.; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (urinary tract infection), PRODUCT DOSE OMISSION ISSUE (cancelled her original second dose appointment since on medication and is now scheduled for second dose on 27 April.) and PAIN IN EXTREMITY (Sore arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (COVID-positive) in November 2020.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URINARY TRACT INFECTION (urinary tract infection), PRODUCT DOSE OMISSION ISSUE (cancelled her original second dose appointment since on medication and is now scheduled for second dose on 27 April.) and PAIN IN EXTREMITY (Sore arm). The patient was treated with NITROFURANTOIN (MACROBID [NITROFURANTOIN]) for Urinary tract infection, at an unspecified dose and frequency. At the time of the report, URINARY TRACT INFECTION (urinary tract infection), PRODUCT DOSE OMISSION ISSUE (cancelled her original second dose appointment since on medication and is now scheduled for second dose on 27 April.) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing was delayed on an unknown date.       No concomitant medications were reported.   The patient cancelled her second dose vaccine appointment as she was on antibiotic therapy and was scheduled for 27-Apr-2021.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw, Paraesthesia, Pharyngeal swelling, Vaccination site reaction
Clinical narrative: pressure on right side of jaw; tingling sensation on neck and throat; swelling of the throat; Vaccination site reaction; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PAIN IN JAW (pressure on right side of jaw), PARAESTHESIA (tingling sensation on neck and throat), PHARYNGEAL SWELLING (swelling of the throat) and VACCINATION SITE REACTION (Vaccination site reaction) in a 33-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.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced PAIN IN JAW (pressure on right side of jaw), PARAESTHESIA (tingling sensation on neck and throat), PHARYNGEAL SWELLING (swelling of the throat) and VACCINATION SITE REACTION (Vaccination site reaction). At the time of the report, PAIN IN JAW (pressure on right side of jaw), PARAESTHESIA (tingling sensation on neck and throat), PHARYNGEAL SWELLING (swelling of the throat) and VACCINATION SITE REACTION (Vaccination site reaction) outcome was unknown. Not Provided      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.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Follow up information received on 20-APR-2021. Updated Events, durations, event outcome,and Event listedness
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Induration, Injection site pain, Nausea, Peripheral swelling
Clinical narrative: LEG WAS INFLAMED AND SWOLLEN; AREA ON LEG IS HARD TO TOUCH; pain at injections site; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (LEG WAS INFLAMED AND SWOLLEN), INDURATION (AREA ON LEG IS HARD TO TOUCH), INJECTION SITE PAIN (pain at injections site), HEADACHE (headache) and NAUSEA (nausea) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (LEG WAS INFLAMED AND SWOLLEN), INDURATION (AREA ON LEG IS HARD TO TOUCH), INJECTION SITE PAIN (pain at injections site), HEADACHE (headache) and NAUSEA (nausea). At the time of the report, PERIPHERAL SWELLING (LEG WAS INFLAMED AND SWOLLEN), INDURATION (AREA ON LEG IS HARD TO TOUCH), INJECTION SITE PAIN (pain at injections site), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Blood pressure measurement, Discomfort, Poor quality sleep, Tachycardia
Clinical narrative: blood pressure (125-1.30); fast heart beat, heart is pretty fast; not sleeping well; had discomfort and not able to rest; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BLOOD PRESSURE ABNORMAL (blood pressure (125-1.30)), TACHYCARDIA (fast heart beat, heart is pretty fast), POOR QUALITY SLEEP (not sleeping well) and DISCOMFORT (had discomfort and not able to rest) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced BLOOD PRESSURE ABNORMAL (blood pressure (125-1.30)), TACHYCARDIA (fast heart beat, heart is pretty fast), POOR QUALITY SLEEP (not sleeping well) and DISCOMFORT (had discomfort and not able to rest). At the time of the report, BLOOD PRESSURE ABNORMAL (blood pressure (125-1.30)), TACHYCARDIA (fast heart beat, heart is pretty fast), POOR QUALITY SLEEP (not sleeping well) and DISCOMFORT (had discomfort and not able to rest) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Apr-2021, Blood pressure measurement: 125-130 (abnormal) abnormal.         No concomitant medications reported.  No treatment medications provided by the reporter.   This case was linked to MOD-2021-078012 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Warm at injection site) and VACCINATION SITE ERYTHEMA (Red at injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Warm at injection site) and VACCINATION SITE ERYTHEMA (Red at injection site). At the time of the report, VACCINATION SITE WARMTH (Warm at injection site) and VACCINATION SITE ERYTHEMA (Red at injection site) had resolved. Patient visited a Healthcare Professional and received an unknown shot for the reaction and same resolved. Patient is alright now, the rash on her lasted for few days after vaccine. Concomitant medications included bad stomach medications. Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Significant Followup was received on 16-Jun-2021. Added patient information and treatment information. Updated outcome of events as resoleved On 08-Jul-2021: Follow-up information received on 08-jul-2021 and does not contain any new information
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Confusional state, Feeling abnormal
Clinical narrative: Still has little ache on her neck above her neck; lower back little ache; Very disconcerted; Very upsetting, she got sick; Still has little ache on her shoulder; Not feeling good; Felt as she had a flu; full blown flu like symptoms; Chills; Nausea; Pounding headache; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (full blown flu like symptoms), FEELING ABNORMAL (Not feeling good), INFLUENZA LIKE ILLNESS (Felt as she had a flu), NECK PAIN (Still has little ache on her neck above her neck) and BACK PAIN (lower back little ache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (full blown flu like symptoms), MYALGIA (Body aches), CHILLS (Chills), NAUSEA (Nausea) and HEADACHE (Pounding headache). On 18-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Felt as she had a flu). On 19-Apr-2021, the patient experienced FEELING ABNORMAL (Not feeling good), NECK PAIN (Still has little ache on her neck above her neck), BACK PAIN (lower back little ache), CONFUSIONAL STATE (Very disconcerted), ILLNESS (Very upsetting, she got sick) and ARTHRALGIA (Still has little ache on her shoulder). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 20-Apr-2021, FEELING ABNORMAL (Not feeling good), INFLUENZA LIKE ILLNESS (Felt as she had a flu), NECK PAIN (Still has little ache on her neck above her neck), BACK PAIN (lower back little ache), CONFUSIONAL STATE (Very disconcerted), ILLNESS (Very upsetting, she got sick), MYALGIA (Body aches), ARTHRALGIA (Still has little ache on her shoulder), CHILLS (Chills) and NAUSEA (Nausea) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (full blown flu like symptoms) and HEADACHE (Pounding headache) outcome was unknown.            Concomitant medications were not reported.   This case was linked to MOD-2021-081277 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: follow up received on 24-May-2021:events outcome was updated to recovered. On 25-May-2021: follow up received on 18-apr-2021: significant information was reported .
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Influenza like illness, Myalgia, Nausea
Clinical narrative: Still has little ache on her neck above her neck; lower back little ache; Very disconcerted; Very upsetting, she got sick; Still has little ache on her shoulder; Not feeling good; Felt as she had a flu; full blown flu like symptoms; Chills; Nausea; Pounding headache; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (full blown flu like symptoms), FEELING ABNORMAL (Not feeling good), INFLUENZA LIKE ILLNESS (Felt as she had a flu), NECK PAIN (Still has little ache on her neck above her neck) and BACK PAIN (lower back little ache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (full blown flu like symptoms), MYALGIA (Body aches), CHILLS (Chills), NAUSEA (Nausea) and HEADACHE (Pounding headache). On 18-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Felt as she had a flu). On 19-Apr-2021, the patient experienced FEELING ABNORMAL (Not feeling good), NECK PAIN (Still has little ache on her neck above her neck), BACK PAIN (lower back little ache), CONFUSIONAL STATE (Very disconcerted), ILLNESS (Very upsetting, she got sick) and ARTHRALGIA (Still has little ache on her shoulder). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 20-Apr-2021, FEELING ABNORMAL (Not feeling good), INFLUENZA LIKE ILLNESS (Felt as she had a flu), NECK PAIN (Still has little ache on her neck above her neck), BACK PAIN (lower back little ache), CONFUSIONAL STATE (Very disconcerted), ILLNESS (Very upsetting, she got sick), MYALGIA (Body aches), ARTHRALGIA (Still has little ache on her shoulder), CHILLS (Chills) and NAUSEA (Nausea) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (full blown flu like symptoms) and HEADACHE (Pounding headache) outcome was unknown.            Concomitant medications were not reported.   This case was linked to MOD-2021-081277 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: follow up received on 24-May-2021:events outcome was updated to recovered. On 25-May-2021: follow up received on 18-apr-2021: significant information was reported .
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: Still has little ache on her neck above her neck; lower back little ache; Very disconcerted; Very upsetting, she got sick; Still has little ache on her shoulder; Not feeling good; Felt as she had a flu; full blown flu like symptoms; Chills; Nausea; Pounding headache; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (full blown flu like symptoms), FEELING ABNORMAL (Not feeling good), INFLUENZA LIKE ILLNESS (Felt as she had a flu), NECK PAIN (Still has little ache on her neck above her neck) and BACK PAIN (lower back little ache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (full blown flu like symptoms), MYALGIA (Body aches), CHILLS (Chills), NAUSEA (Nausea) and HEADACHE (Pounding headache). On 18-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Felt as she had a flu). On 19-Apr-2021, the patient experienced FEELING ABNORMAL (Not feeling good), NECK PAIN (Still has little ache on her neck above her neck), BACK PAIN (lower back little ache), CONFUSIONAL STATE (Very disconcerted), ILLNESS (Very upsetting, she got sick) and ARTHRALGIA (Still has little ache on her shoulder). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 20-Apr-2021, FEELING ABNORMAL (Not feeling good), INFLUENZA LIKE ILLNESS (Felt as she had a flu), NECK PAIN (Still has little ache on her neck above her neck), BACK PAIN (lower back little ache), CONFUSIONAL STATE (Very disconcerted), ILLNESS (Very upsetting, she got sick), MYALGIA (Body aches), ARTHRALGIA (Still has little ache on her shoulder), CHILLS (Chills) and NAUSEA (Nausea) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (full blown flu like symptoms) and HEADACHE (Pounding headache) outcome was unknown.            Concomitant medications were not reported.   This case was linked to MOD-2021-081277 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: follow up received on 24-May-2021:events outcome was updated to recovered. On 25-May-2021: follow up received on 18-apr-2021: significant information was reported .
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Intentional product use issue
Clinical narrative: 2nd rescheduled for 43 days from the first dose; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (2nd rescheduled for 43 days from the first dose) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (2nd rescheduled for 43 days from the first dose). On 13-May-2021, INTENTIONAL PRODUCT USE ISSUE (2nd rescheduled for 43 days from the first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Significant follow-up received  - The outcome of the event was updated from unknown to recovered/resolved with the onset date and stop date of event.Consent for Follow-Up was declined by the patient.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Fall, Head injury
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold), URINARY INCONTINENCE (Lost control of bladder), ASTHENIA (weakness, very weak; when she went to bathroom she couldn't walk), FALL (fell a few times) and HEAD INJURY (fell and hit head on vanity; cut on back of head) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 pneumonia and High cholesterol. Concurrent medical conditions included Penicillin allergy, Drug allergy (Augmentin and Morphine) and Blood pressure high. Concomitant products included LOSARTAN, AMLODIPINE, FLUOXETINE HYDROCHLORIDE (PROZAC), LEVOTHYROXINE, ROPINIROLE HYDROCHLORIDE (REQUIP), FUROSEMIDE, POTASSIUM, HYDROCODONE BITARTRATE, PARACETAMOL (NORCO), GABAPENTIN and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication. 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 NASOPHARYNGITIS (Cold), URINARY INCONTINENCE (Lost control of bladder), ASTHENIA (weakness, very weak; when she went to bathroom she couldn't walk), FALL (fell a few times), HEAD INJURY (fell and hit head on vanity; cut on back of head), CHILLS (chills), PYREXIA (Low fever) and VOMITING (vomiting). At the time of the report, NASOPHARYNGITIS (Cold), URINARY INCONTINENCE (Lost control of bladder), ASTHENIA (weakness, very weak; when she went to bathroom she couldn't walk), FALL (fell a few times), HEAD INJURY (fell and hit head on vanity; cut on back of head), CHILLS (chills), PYREXIA (Low fever) and VOMITING (vomiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: fever (Low) low fever. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Ambulance showed up when she fell in bathroom; helped her to get up and took her to bedroom.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pyrexia, Urinary incontinence, Vomiting
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold), URINARY INCONTINENCE (Lost control of bladder), ASTHENIA (weakness, very weak; when she went to bathroom she couldn't walk), FALL (fell a few times) and HEAD INJURY (fell and hit head on vanity; cut on back of head) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 pneumonia and High cholesterol. Concurrent medical conditions included Penicillin allergy, Drug allergy (Augmentin and Morphine) and Blood pressure high. Concomitant products included LOSARTAN, AMLODIPINE, FLUOXETINE HYDROCHLORIDE (PROZAC), LEVOTHYROXINE, ROPINIROLE HYDROCHLORIDE (REQUIP), FUROSEMIDE, POTASSIUM, HYDROCODONE BITARTRATE, PARACETAMOL (NORCO), GABAPENTIN and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication. 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 NASOPHARYNGITIS (Cold), URINARY INCONTINENCE (Lost control of bladder), ASTHENIA (weakness, very weak; when she went to bathroom she couldn't walk), FALL (fell a few times), HEAD INJURY (fell and hit head on vanity; cut on back of head), CHILLS (chills), PYREXIA (Low fever) and VOMITING (vomiting). At the time of the report, NASOPHARYNGITIS (Cold), URINARY INCONTINENCE (Lost control of bladder), ASTHENIA (weakness, very weak; when she went to bathroom she couldn't walk), FALL (fell a few times), HEAD INJURY (fell and hit head on vanity; cut on back of head), CHILLS (chills), PYREXIA (Low fever) and VOMITING (vomiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: fever (Low) low fever. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Ambulance showed up when she fell in bathroom; helped her to get up and took her to bedroom.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Discomfort, Fatigue, Feeling abnormal, Malaise
Clinical narrative: feeling sick; racing heart; chills went back and forth all day; really uncomfortable for hours; brain fog; stayed all day in bed; Sore arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm at injection site), MALAISE (feeling sick), PALPITATIONS (racing heart), CHILLS (chills went back and forth all day) and DISCOMFORT (really uncomfortable for hours) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COPD since an unknown date. Concomitant products included FLUOXETINE and VITAMIN 15 for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore arm at injection site). On 12-Mar-2021, the patient experienced MALAISE (feeling sick), PALPITATIONS (racing heart), CHILLS (chills went back and forth all day), DISCOMFORT (really uncomfortable for hours), FEELING ABNORMAL (brain fog) and FATIGUE (stayed all day in bed). At the time of the report, VACCINATION SITE PAIN (Sore arm at injection site), MALAISE (feeling sick), PALPITATIONS (racing heart), CHILLS (chills went back and forth all day), DISCOMFORT (really uncomfortable for hours), FEELING ABNORMAL (brain fog) and FATIGUE (stayed all day in bed) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Vaccination site pain
Clinical narrative: feeling sick; racing heart; chills went back and forth all day; really uncomfortable for hours; brain fog; stayed all day in bed; Sore arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm at injection site), MALAISE (feeling sick), PALPITATIONS (racing heart), CHILLS (chills went back and forth all day) and DISCOMFORT (really uncomfortable for hours) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COPD since an unknown date. Concomitant products included FLUOXETINE and VITAMIN 15 for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore arm at injection site). On 12-Mar-2021, the patient experienced MALAISE (feeling sick), PALPITATIONS (racing heart), CHILLS (chills went back and forth all day), DISCOMFORT (really uncomfortable for hours), FEELING ABNORMAL (brain fog) and FATIGUE (stayed all day in bed). At the time of the report, VACCINATION SITE PAIN (Sore arm at injection site), MALAISE (feeling sick), PALPITATIONS (racing heart), CHILLS (chills went back and forth all day), DISCOMFORT (really uncomfortable for hours), FEELING ABNORMAL (brain fog) and FATIGUE (stayed all day in bed) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Insomnia, Pain in extremity
Clinical narrative: couldn't sleep; she can't move it; pain in that arm/arm hurts a lot from shoulder to elbow; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in that arm/arm hurts a lot from shoulder to elbow), INSOMNIA (couldn't sleep) and HYPOKINESIA (she can't move it) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced PAIN IN EXTREMITY (pain in that arm/arm hurts a lot from shoulder to elbow). On 20-Apr-2021, the patient experienced INSOMNIA (couldn't sleep) and HYPOKINESIA (she can't move it). At the time of the report, PAIN IN EXTREMITY (pain in that arm/arm hurts a lot from shoulder to elbow), INSOMNIA (couldn't sleep) and HYPOKINESIA (she can't move it) had not resolved. Not Provided          Concomitant medications reported include antidepressants.   No treatment information was provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Gait inability, Hypokinesia
Clinical narrative: couldn't get up; couldn't walk; Weak; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (couldn't get up), GAIT INABILITY (couldn't walk) and ASTHENIA (Weak) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced HYPOKINESIA (couldn't get up), GAIT INABILITY (couldn't walk) and ASTHENIA (Weak). On 26-Feb-2021, HYPOKINESIA (couldn't get up), GAIT INABILITY (couldn't walk) and ASTHENIA (Weak) had resolved.            Concomitant medications were not reported. Treatment information not provided. About 1 hour after receiving the second dose of the vaccine, he experienced a similar whole body weakness that prevented him from walking or lifting himself. On 29MAR2021 an ambulance was called and the patient was taken to the emergency room. He was admitted to the hospital for 3 days then was transferred to a rehab facility. He still currently resides in the rehab facility. He usually walks with a walker, but is not this bad. The contact is not sure of what treatments were provided to her husband. Consented to follow up by safety.  Very limited information regarding this events has been provided at this time.  Further information has been requested.Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-081291 (Patient Link).; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.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: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HEADACHE (headache) in a 68-year-old male 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) had not resolved. Not Provided          No concomitant medication were reported. Treatment information was not provided.  Reportedly, the patient has never had headaches.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia, Vaccination site erythema
Clinical narrative: Injection site that was itching and generating heat; Injection site that was itching and generating heat; Red are at the vaccination site; Body ache; Low grade fever; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site that was itching and generating heat), PAIN (Body ache), VACCINATION SITE PRURITUS (Injection site that was itching and generating heat), PYREXIA (Low grade fever) and CHILLS (Chills) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN), TRAMADOL, GABAPENTIN and PALMATINE for an unknown indication.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced PAIN (Body ache), PYREXIA (Low grade fever), CHILLS (Chills) and HEADACHE (Headache). On 20-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Injection site that was itching and generating heat), VACCINATION SITE PRURITUS (Injection site that was itching and generating heat) and VACCINATION SITE ERYTHEMA (Red are at the vaccination site). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. On 19-Apr-2021, PAIN (Body ache), PYREXIA (Low grade fever), CHILLS (Chills) and HEADACHE (Headache) had resolved. At the time of the report, VACCINATION SITE WARMTH (Injection site that was itching and generating heat), VACCINATION SITE PRURITUS (Injection site that was itching and generating heat) and VACCINATION SITE ERYTHEMA (Red are at the vaccination site) had not resolved.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Injection site that was itching and generating heat; Injection site that was itching and generating heat; Red are at the vaccination site; Body ache; Low grade fever; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site that was itching and generating heat), PAIN (Body ache), VACCINATION SITE PRURITUS (Injection site that was itching and generating heat), PYREXIA (Low grade fever) and CHILLS (Chills) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN), TRAMADOL, GABAPENTIN and PALMATINE for an unknown indication.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced PAIN (Body ache), PYREXIA (Low grade fever), CHILLS (Chills) and HEADACHE (Headache). On 20-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Injection site that was itching and generating heat), VACCINATION SITE PRURITUS (Injection site that was itching and generating heat) and VACCINATION SITE ERYTHEMA (Red are at the vaccination site). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. On 19-Apr-2021, PAIN (Body ache), PYREXIA (Low grade fever), CHILLS (Chills) and HEADACHE (Headache) had resolved. At the time of the report, VACCINATION SITE WARMTH (Injection site that was itching and generating heat), VACCINATION SITE PRURITUS (Injection site that was itching and generating heat) and VACCINATION SITE ERYTHEMA (Red are at the vaccination site) had not resolved.