chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Body Pain; Cold Sweats; Cough; Joint Soreness; Head Pounding; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (Body Pain), COLD SWEAT (Cold Sweats), COUGH (Cough), ARTHRALGIA (Joint Soreness) and HEADACHE (Head Pounding) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN (Body Pain), COLD SWEAT (Cold Sweats), COUGH (Cough), ARTHRALGIA (Joint Soreness) and HEADACHE (Head Pounding). The patient was treated with MORPHINE at a dose of 1 dosage form; IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN (Body Pain), COLD SWEAT (Cold Sweats), COUGH (Cough), ARTHRALGIA (Joint Soreness) and HEADACHE (Head Pounding) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information also included Nausea Tablet.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Additional information included primary reporter information and patient demographics.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on different parts of her body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on different parts of her body) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer, Blood pressure abnormal, Blood cholesterol abnormal and Thyroid disorder. Concomitant products included TAMOXIFEN for Breast cancer.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced RASH (rash on different parts of her body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) for Rash, at a dose of UNK dosage form, qd and TRIAMCINOLONE for Rash, at a dose of UNK dosage form, qd. At the time of the report, RASH (rash on different parts of her body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included that on 11Mar2021 she started taking a 9 days treatment with steroids
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Sore throat / severe sore throat; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat / severe sore throat) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat / severe sore throat). The patient was treated with PARACETAMOL (TYLENOL) for Sore throat, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Sore throat, at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (Sore throat / severe sore throat) outcome was unknown.            Concomitant medications included unspecified blood pressure medication. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection, Urinary tract pain
Clinical narrative: urinary tract infection is started and its painful; urinary tract infection is started and its painful; Urinary Tract Infection; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Urinary Tract Infection), URINARY TRACT INFECTION (urinary tract infection is started and its painful) and URINARY TRACT PAIN (urinary tract infection is started and its painful) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced URINARY TRACT INFECTION (Urinary Tract Infection). On 23-Mar-2021, the patient experienced URINARY TRACT INFECTION (urinary tract infection is started and its painful) and URINARY TRACT PAIN (urinary tract infection is started and its painful). At the time of the report, URINARY TRACT INFECTION (Urinary Tract Infection) had resolved and URINARY TRACT INFECTION (urinary tract infection is started and its painful) and URINARY TRACT PAIN (urinary tract infection is started and its painful) outcome was unknown.            The patient was on unspecified concomitant medications. No treatment information was provided.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Dyspepsia, Dyspnoea
Clinical narrative: Had a bad reaction; Felt something happening in her body; Indigestion; Hard to breathe; Dizziness; Freezing cold in evening; Weakness; Headache; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had a bad reaction), FEELING ABNORMAL (Felt something happening in her body), DYSPEPSIA (Indigestion), DYSPNOEA (Hard to breathe) and DIZZINESS (Dizziness) in an 85-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 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION COMPLICATION (Had a bad reaction), FEELING ABNORMAL (Felt something happening in her body), DYSPEPSIA (Indigestion), DYSPNOEA (Hard to breathe), DIZZINESS (Dizziness), FEELING COLD (Freezing cold in evening), ASTHENIA (Weakness), HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, VACCINATION COMPLICATION (Had a bad reaction), FEELING ABNORMAL (Felt something happening in her body), DYSPEPSIA (Indigestion), DYSPNOEA (Hard to breathe), DIZZINESS (Dizziness), ASTHENIA (Weakness), HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown and FEELING COLD (Freezing cold in evening) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included unspecified blood thinner and blood pressure medication.  No treatment information was provided   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow up received, Email updated.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Feeling cold, Headache, Vaccination complication
Clinical narrative: Had a bad reaction; Felt something happening in her body; Indigestion; Hard to breathe; Dizziness; Freezing cold in evening; Weakness; Headache; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had a bad reaction), FEELING ABNORMAL (Felt something happening in her body), DYSPEPSIA (Indigestion), DYSPNOEA (Hard to breathe) and DIZZINESS (Dizziness) in an 85-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 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION COMPLICATION (Had a bad reaction), FEELING ABNORMAL (Felt something happening in her body), DYSPEPSIA (Indigestion), DYSPNOEA (Hard to breathe), DIZZINESS (Dizziness), FEELING COLD (Freezing cold in evening), ASTHENIA (Weakness), HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, VACCINATION COMPLICATION (Had a bad reaction), FEELING ABNORMAL (Felt something happening in her body), DYSPEPSIA (Indigestion), DYSPNOEA (Hard to breathe), DIZZINESS (Dizziness), ASTHENIA (Weakness), HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown and FEELING COLD (Freezing cold in evening) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included unspecified blood thinner and blood pressure medication.  No treatment information was provided   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow up received, Email updated.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen gland under his arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LYMPHADENOPATHY (swollen gland under his arm) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (swollen gland under his arm). At the time of the report, LYMPHADENOPATHY (swollen gland under his arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.    Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow up information was received and contain no new information.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Myalgia, Pyrexia
Clinical narrative: little dizzy/ lightheaded; body aches; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (little dizzy/ lightheaded), MYALGIA (body aches), CHILLS (chills) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced DIZZINESS (little dizzy/ lightheaded), MYALGIA (body aches), CHILLS (chills) and PYREXIA (fever). At the time of the report, DIZZINESS (little dizzy/ lightheaded), MYALGIA (body aches), CHILLS (chills) and PYREXIA (fever) 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: 20.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007321A) 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 23-Mar-2021, the patient experienced COVID-19 (Tested positive for COVID). At the time of the report, COVID-19 (Tested positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, SARS-CoV-2 test: positive (Positive) positive.     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: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Ear pain, Pain, Vomiting
Clinical narrative: ear ache; achy; diarrhea; throwing up; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (ear ache), PAIN (achy), DIARRHOEA (diarrhea) and VOMITING (throwing up) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included LANSOPRAZOLE (PREVACID), LEVOTHYROXINE and TRIAMTERENE for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced EAR PAIN (ear ache), PAIN (achy), DIARRHOEA (diarrhea) and VOMITING (throwing up). The patient was treated with BISMUTH SUBSALICYLATE, CALCIUM CARBONATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE;CALCIUM CARBONATE]) at a dose of UNK dosage form and PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, EAR PAIN (ear ache), PAIN (achy), DIARRHOEA (diarrhea) and VOMITING (throwing up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 18-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 20-Mar-2021, PAIN IN EXTREMITY (Sore arm) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: negative (Negative) Tested negative..         This case was linked to MOD-2021-054238 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Non significant follow up received on 10-MAY-2021, dditional information included lab results.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Hypoaesthesia oral, Paraesthesia
Clinical narrative: itchy; numb lips; tingling face; joint pain; chills; extreme fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (itchy), HYPOAESTHESIA ORAL (numb lips), PARAESTHESIA (tingling face), ARTHRALGIA (joint pain) and CHILLS (chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced PRURITUS (itchy), HYPOAESTHESIA ORAL (numb lips), PARAESTHESIA (tingling face), ARTHRALGIA (joint pain), CHILLS (chills) and FATIGUE (extreme fatigue). At the time of the report, PRURITUS (itchy), HYPOAESTHESIA ORAL (numb lips), PARAESTHESIA (tingling face), ARTHRALGIA (joint pain), CHILLS (chills) and FATIGUE (extreme fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itchy; numb lips; tingling face; joint pain; chills; extreme fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (itchy), HYPOAESTHESIA ORAL (numb lips), PARAESTHESIA (tingling face), ARTHRALGIA (joint pain) and CHILLS (chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced PRURITUS (itchy), HYPOAESTHESIA ORAL (numb lips), PARAESTHESIA (tingling face), ARTHRALGIA (joint pain), CHILLS (chills) and FATIGUE (extreme fatigue). At the time of the report, PRURITUS (itchy), HYPOAESTHESIA ORAL (numb lips), PARAESTHESIA (tingling face), ARTHRALGIA (joint pain), CHILLS (chills) and FATIGUE (extreme fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Bone pain, Diarrhoea, Erythema, Gastrooesophageal reflux disease
Clinical narrative: Acid reflux very bad after injections; Sore throats; Stomach pain in the pit of the stomach; Stomach cramping; Achy bones; Runny nose; Loose bowels; Having pain and redness in right arm; Having pain and redness in right arm; This spontaneous case was reported by a consumer and describes the occurrence of GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux very bad after injections), OROPHARYNGEAL PAIN (Sore throats), ABDOMINAL PAIN UPPER (Stomach pain in the pit of the stomach), MUSCLE SPASMS (Stomach cramping) and BONE PAIN (Achy bones) in a 72-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 22-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 GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux very bad after injections), OROPHARYNGEAL PAIN (Sore throats), ABDOMINAL PAIN UPPER (Stomach pain in the pit of the stomach), MUSCLE SPASMS (Stomach cramping), BONE PAIN (Achy bones), RHINORRHOEA (Runny nose), DIARRHOEA (Loose bowels), PAIN (Having pain and redness in right arm) and ERYTHEMA (Having pain and redness in right arm). At the time of the report, GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux very bad after injections), OROPHARYNGEAL PAIN (Sore throats), ABDOMINAL PAIN UPPER (Stomach pain in the pit of the stomach), MUSCLE SPASMS (Stomach cramping), BONE PAIN (Achy bones), RHINORRHOEA (Runny nose), DIARRHOEA (Loose bowels), PAIN (Having pain and redness in right arm) and ERYTHEMA (Having pain and redness in right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: TCR was received Contains no new information.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Oropharyngeal pain, Pain, Rhinorrhoea
Clinical narrative: Acid reflux very bad after injections; Sore throats; Stomach pain in the pit of the stomach; Stomach cramping; Achy bones; Runny nose; Loose bowels; Having pain and redness in right arm; Having pain and redness in right arm; This spontaneous case was reported by a consumer and describes the occurrence of GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux very bad after injections), OROPHARYNGEAL PAIN (Sore throats), ABDOMINAL PAIN UPPER (Stomach pain in the pit of the stomach), MUSCLE SPASMS (Stomach cramping) and BONE PAIN (Achy bones) in a 72-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 22-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 GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux very bad after injections), OROPHARYNGEAL PAIN (Sore throats), ABDOMINAL PAIN UPPER (Stomach pain in the pit of the stomach), MUSCLE SPASMS (Stomach cramping), BONE PAIN (Achy bones), RHINORRHOEA (Runny nose), DIARRHOEA (Loose bowels), PAIN (Having pain and redness in right arm) and ERYTHEMA (Having pain and redness in right arm). At the time of the report, GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux very bad after injections), OROPHARYNGEAL PAIN (Sore throats), ABDOMINAL PAIN UPPER (Stomach pain in the pit of the stomach), MUSCLE SPASMS (Stomach cramping), BONE PAIN (Achy bones), RHINORRHOEA (Runny nose), DIARRHOEA (Loose bowels), PAIN (Having pain and redness in right arm) and ERYTHEMA (Having pain and redness in right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: TCR was received Contains no new information.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced COVID-19 (tested positive for COVID-19). At the time of the report, COVID-19 (tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     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: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Neck pain, Pain, Pain in extremity
Clinical narrative: Lower back pain; Right Hand pain; Neck pain; Knee pain; expressed excessive from her normal pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Lower back pain), PAIN IN EXTREMITY (Right Hand pain), PAIN (expressed excessive from her normal pain), NECK PAIN (Neck pain) and ARTHRALGIA (Knee pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) and OXYCODONE for Pain.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN (expressed excessive from her normal pain). On an unknown date, the patient experienced BACK PAIN (Lower back pain), PAIN IN EXTREMITY (Right Hand pain), NECK PAIN (Neck pain) and ARTHRALGIA (Knee pain). At the time of the report, BACK PAIN (Lower back pain), PAIN IN EXTREMITY (Right Hand pain), PAIN (expressed excessive from her normal pain), NECK PAIN (Neck pain) and ARTHRALGIA (Knee pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: COVID arm; Red spot at injection Site; Itching on spot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red spot at injection Site), VACCINATION SITE PRURITUS (Itching on spot) and RASH (COVID arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red spot at injection Site) and VACCINATION SITE PRURITUS (Itching on spot). On an unknown date, the patient experienced RASH (COVID arm). At the time of the report, VACCINATION SITE ERYTHEMA (Red spot at injection Site) and VACCINATION SITE PRURITUS (Itching on spot) outcome was unknown and RASH (COVID arm) had resolved.            No concomitant medication information was provided, however, it was stated that patient does take other medications.  No treatment information was provided. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable    Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: follow-up SD received on 10 may 2021 updated with new event(COVID arm) and the information about second vaccination.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Hypotension, Vaccination site urticaria
Clinical narrative: problem to breathing; blood pressure is low; has dizziness when she gets up; hot and big welt on her arm, injection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (problem to breathing), HYPOTENSION (blood pressure is low), DIZZINESS (has dizziness when she gets up) and VACCINATION SITE URTICARIA (hot and big welt on her arm, injection) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced VACCINATION SITE URTICARIA (hot and big welt on her arm, injection). On 22-Mar-2021, the patient experienced DYSPNOEA (problem to breathing), HYPOTENSION (blood pressure is low) and DIZZINESS (has dizziness when she gets up). At the time of the report, DYSPNOEA (problem to breathing), HYPOTENSION (blood pressure is low), DIZZINESS (has dizziness when she gets up) and VACCINATION SITE URTICARIA (hot and big welt on her arm, injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Patient went to health care professional (HCP) and they prescribed unspecified antibiotic to treat the infection.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Cognitive disorder, Coordination abnormal, Decreased appetite, Fatigue
Clinical narrative: elevated blood sugar; arm pain; body ache; Loss of appetite; Thirst; cognitively impaired; Coordination issues; night sweats; nausea; pounding headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (elevated blood sugar), PAIN IN EXTREMITY (arm pain), PAIN (body ache), DECREASED APPETITE (Loss of appetite) and THIRST (Thirst) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M207J and 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Type 1 diabetes mellitus. Concomitant products included INSULIN and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced BLOOD GLUCOSE INCREASED (elevated blood sugar), PAIN IN EXTREMITY (arm pain), PAIN (body ache), DECREASED APPETITE (Loss of appetite), THIRST (Thirst), COGNITIVE DISORDER (cognitively impaired), COORDINATION ABNORMAL (Coordination issues), NIGHT SWEATS (night sweats), NAUSEA (nausea), HEADACHE (pounding headache) and FATIGUE (fatigue). On 21-Mar-2021, BLOOD GLUCOSE INCREASED (elevated blood sugar), PAIN IN EXTREMITY (arm pain), PAIN (body ache), DECREASED APPETITE (Loss of appetite), THIRST (Thirst), COGNITIVE DISORDER (cognitively impaired), COORDINATION ABNORMAL (Coordination issues), NIGHT SWEATS (night sweats), NAUSEA (nausea), HEADACHE (pounding headache) and FATIGUE (fatigue) had resolved.            Action taken with mRNA-1273 in response to the event was not applicable.  No treatment information was provided
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Night sweats, Pain, Pain in extremity
Clinical narrative: elevated blood sugar; arm pain; body ache; Loss of appetite; Thirst; cognitively impaired; Coordination issues; night sweats; nausea; pounding headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (elevated blood sugar), PAIN IN EXTREMITY (arm pain), PAIN (body ache), DECREASED APPETITE (Loss of appetite) and THIRST (Thirst) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M207J and 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Type 1 diabetes mellitus. Concomitant products included INSULIN and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced BLOOD GLUCOSE INCREASED (elevated blood sugar), PAIN IN EXTREMITY (arm pain), PAIN (body ache), DECREASED APPETITE (Loss of appetite), THIRST (Thirst), COGNITIVE DISORDER (cognitively impaired), COORDINATION ABNORMAL (Coordination issues), NIGHT SWEATS (night sweats), NAUSEA (nausea), HEADACHE (pounding headache) and FATIGUE (fatigue). On 21-Mar-2021, BLOOD GLUCOSE INCREASED (elevated blood sugar), PAIN IN EXTREMITY (arm pain), PAIN (body ache), DECREASED APPETITE (Loss of appetite), THIRST (Thirst), COGNITIVE DISORDER (cognitively impaired), COORDINATION ABNORMAL (Coordination issues), NIGHT SWEATS (night sweats), NAUSEA (nausea), HEADACHE (pounding headache) and FATIGUE (fatigue) had resolved.            Action taken with mRNA-1273 in response to the event was not applicable.  No treatment information was provided
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Thirst
Clinical narrative: elevated blood sugar; arm pain; body ache; Loss of appetite; Thirst; cognitively impaired; Coordination issues; night sweats; nausea; pounding headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (elevated blood sugar), PAIN IN EXTREMITY (arm pain), PAIN (body ache), DECREASED APPETITE (Loss of appetite) and THIRST (Thirst) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M207J and 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Type 1 diabetes mellitus. Concomitant products included INSULIN and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced BLOOD GLUCOSE INCREASED (elevated blood sugar), PAIN IN EXTREMITY (arm pain), PAIN (body ache), DECREASED APPETITE (Loss of appetite), THIRST (Thirst), COGNITIVE DISORDER (cognitively impaired), COORDINATION ABNORMAL (Coordination issues), NIGHT SWEATS (night sweats), NAUSEA (nausea), HEADACHE (pounding headache) and FATIGUE (fatigue). On 21-Mar-2021, BLOOD GLUCOSE INCREASED (elevated blood sugar), PAIN IN EXTREMITY (arm pain), PAIN (body ache), DECREASED APPETITE (Loss of appetite), THIRST (Thirst), COGNITIVE DISORDER (cognitively impaired), COORDINATION ABNORMAL (Coordination issues), NIGHT SWEATS (night sweats), NAUSEA (nausea), HEADACHE (pounding headache) and FATIGUE (fatigue) had resolved.            Action taken with mRNA-1273 in response to the event was not applicable.  No treatment information was provided
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site pain
Clinical narrative: lymph node swelling on both sites of his throat and below his jaw bones; severe pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (lymph node swelling on both sites of his throat and below his jaw bones) and VACCINATION SITE PAIN (severe pain at the injection site) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included FINASTERIDE and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 18-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced VACCINATION SITE PAIN (severe pain at the injection site). On 20-Mar-2021, the patient experienced LYMPHADENOPATHY (lymph node swelling on both sites of his throat and below his jaw bones). On 22-Mar-2021, VACCINATION SITE PAIN (severe pain at the injection site) had resolved. At the time of the report, LYMPHADENOPATHY (lymph node swelling on both sites of his throat and below his jaw bones) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Headache, Illness, Nausea
Clinical narrative: she is not able to eat; extremely sick; nausea; bad headache; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (she is not able to eat), ILLNESS (extremely sick), NAUSEA (nausea) and HEADACHE (bad headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included HYDROXYCHLOROQUINE 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 22-Mar-2021, the patient experienced DECREASED APPETITE (she is not able to eat), ILLNESS (extremely sick), NAUSEA (nausea) and HEADACHE (bad headache). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of UNK dosage form. At the time of the report, DECREASED APPETITE (she is not able to eat), ILLNESS (extremely sick), NAUSEA (nausea) and HEADACHE (bad headache) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Sinus headache, Toothache
Clinical narrative: Arm hurt after second dose; Horrible headache, seems sinus headache; seems like a sinus headache because it is making her teeth hurt; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt after second dose), SINUS HEADACHE (Horrible headache, seems sinus headache), TOOTHACHE (seems like a sinus headache because it is making her teeth hurt) and CHILLS (Chills) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 002A21A) for COVID-19 vaccination.     No medical history reported.  Concomitant products included LISINOPRIL for Blood pressure management, DILTIAZEM and PANTOPRAZOLE SODIUM for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt after second dose), SINUS HEADACHE (Horrible headache, seems sinus headache), TOOTHACHE (seems like a sinus headache because it is making her teeth hurt) and CHILLS (Chills). At the time of the report, PAIN IN EXTREMITY (Arm hurt after second dose), SINUS HEADACHE (Horrible headache, seems sinus headache), TOOTHACHE (seems like a sinus headache because it is making her teeth hurt) and CHILLS (Chills) outcome was unknown.            No treatment information was provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Fatigue, Pain in extremity
Clinical narrative: Sore arm; Elevated blood sugar; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), BLOOD GLUCOSE INCREASED (Elevated blood sugar) and FATIGUE (Fatigue) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M207J and 001B21A) for COVID-19 vaccination.     Concurrent medical conditions included Type 1 diabetes mellitus. Concomitant products included INSULIN and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), BLOOD GLUCOSE INCREASED (Elevated blood sugar) and FATIGUE (Fatigue). On 20-Feb-2021, PAIN IN EXTREMITY (Sore arm), BLOOD GLUCOSE INCREASED (Elevated blood sugar) and FATIGUE (Fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: elevated (High) elevated.         No treatment information was provided  Action taken with mRNA-1273 in response to the event was not applicable.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dry throat, Fatigue, Pain in extremity, Throat clearing
Clinical narrative: arm was sore; throat was dry; Neede to clear her throat; tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore), DRY THROAT (throat was dry), FATIGUE (tired) and THROAT CLEARING (Neede to clear her throat) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and LIOTHYRONINE SODIUM (CYTOMEL) 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 20-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm was sore), DRY THROAT (throat was dry), FATIGUE (tired) and THROAT CLEARING (Neede to clear her throat). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm was sore), DRY THROAT (throat was dry), FATIGUE (tired) and THROAT CLEARING (Neede to clear her throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other treatment information was included Peppermint tea and cough drops.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abnormal sensation in eye, Dry skin, Hair texture abnormal
Clinical narrative: stomach upset; her whole system is dry"/Skin; hair; eyes; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach upset), DRY SKIN (her whole system is dry"/Skin), HAIR TEXTURE ABNORMAL (hair) and ABNORMAL SENSATION IN EYE (eyes) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 027A21A) for COVID-19 vaccination.     The patient's past medical history included Surgery (Patient had Right eye surgery.). Concurrent medical conditions included Drug allergy (Allergies include sensitivity to certain medications (unsure which).). Concomitant products included LEVOTHYROXINE SODIUM (TIROSINT) for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 06-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (stomach upset), DRY SKIN (her whole system is dry"/Skin), HAIR TEXTURE ABNORMAL (hair) and ABNORMAL SENSATION IN EYE (eyes). At the time of the report, ABDOMINAL DISCOMFORT (stomach upset), DRY SKIN (her whole system is dry"/Skin), HAIR TEXTURE ABNORMAL (hair) and ABNORMAL SENSATION IN EYE (eyes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication included drops for eyes   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow-up information received on 11 May  2021 contain information: Reporter contact details updated.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate increased
Clinical narrative: POUNDING INCREASE HEART RATE; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (POUNDING INCREASE HEART RATE) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036M21A and 016M21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEART RATE INCREASED (POUNDING INCREASE HEART RATE). At the time of the report, HEART RATE INCREASED (POUNDING INCREASE HEART RATE) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 206 (Inconclusive) 206.         No concomitant products were reported. No treatment information was provided.  Action taken with the drug in response to events was not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: tingling; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Mar-2021 and was forwarded to Moderna on 23-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     The patient's past medical history included Diabetes, Rib fracture in October 2020 and Muscle disorder in January 2020. Concomitant products included TRAMADOL for Back pain and Muscle pain, WARFARIN, ATORVASTATIN, INSULIN ASPART (NOVOLOG), INSULIN DETEMIR (LEVEMIR) and VITAMIN D3 for an unknown indication.    On 19-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced PARAESTHESIA (tingling). At the time of the report, PARAESTHESIA (tingling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Upon internal review on 24-May-2021, age was corrected to unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pain, Pain in extremity, Pruritus
Clinical narrative: she woke up with "covid arm"; she also had hives all over her body; feeling itchy; a big rash at the injection site that it's getting better; body ache; Nausea; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body ache), PAIN IN EXTREMITY (she woke up with "covid arm"), URTICARIA (she also had hives all over her body), PRURITUS (feeling itchy) and NAUSEA (Nausea) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Peanut allergy, Fruit allergy (fresh fruit.) and Allergy to nuts (tree nut.).    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN (body ache), NAUSEA (Nausea) and FATIGUE (Fatigue). On 20-Mar-2021, the patient experienced PAIN IN EXTREMITY (she woke up with "covid arm"), URTICARIA (she also had hives all over her body), PRURITUS (feeling itchy) and RASH (a big rash at the injection site that it's getting better). On 15-Mar-2021, PAIN (body ache) outcome was unknown, NAUSEA (Nausea) and FATIGUE (Fatigue) had resolved. At the time of the report, PAIN IN EXTREMITY (she woke up with "covid arm") had resolved and URTICARIA (she also had hives all over her body), PRURITUS (feeling itchy) and RASH (a big rash at the injection site that it's getting better) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment include topical Benadryl. No other medication reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-119837 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: the follow up were received on 11-MAY-2021 , the patient details were updated, relevant history was updated , event outcome updated; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-119837:First dose case