chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: brainf fog; The second shot the back pain was worse and traveled down to legs, hips, and calves. Also pain in neck that moved down to shoulders.  Can't turn head all the way right and left; can hardly walk , can't get out of bed, has a hard time getting off the toilet.; fatigue; chills; fever; back pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Apr-2021 and was forwarded to Moderna on 26-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (can hardly walk , can't get out of bed, has a hard time getting off the toilet.), BACK PAIN, FEELING ABNORMAL (brains fog), MYALGIA (The second shot the back pain was worse and traveled down to legs, hips, and calves. Also pain in neck that moved down to shoulders.  Can't turn head all the way right and left) and FATIGUE (fatigue) in a 76-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 was provided by the reporter.  Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), LEVOTHYROXINE SODIUM (SYNTHROID), LIOTHYRONINE SODIUM (CYTOMEL), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), Flax Seed Oil, POTASSIUM, MAGNESIUM, ESTRADIOL and PROGESTERONE for an unknown indication.    On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced BACK PAIN (back pain). On 25-Mar-2021, the patient experienced FATIGUE (fatigue), CHILLS (chills) and PYREXIA (fever). On an unknown date, the patient experienced GAIT DISTURBANCE (can hardly walk , can't get out of bed, has a hard time getting off the toilet.), FEELING ABNORMAL (brainf fog) and MYALGIA (The second shot the back pain was worse and traveled down to legs, hips, and calves. Also pain in neck that moved down to shoulders.  Can't turn head all the way right and left). The patient was treated with NAPROXEN ongoing since an unknown date at an unspecified dose and frequency. On 27-Mar-2021, FATIGUE (fatigue), CHILLS (chills) and PYREXIA (fever) had resolved. At the time of the report, GAIT DISTURBANCE (can hardly walk , can't get out of bed, has a hard time getting off the toilet.), BACK PAIN (back pain), FEELING ABNORMAL (brainf fog) and MYALGIA (The second shot the back pain was worse and traveled down to legs, hips, and calves. Also pain in neck that moved down to shoulders.  Can't turn head all the way right and left) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-090649 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Lymphadenopathy, Myalgia, Pyrexia
Clinical narrative: Aches/ body aches; Lymph node is swollen; Fever of 101.5; Chills; Headaches; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (Aches/ body aches), LYMPHADENOPATHY (Lymph node is swollen), PYREXIA (Fever of 101.5), CHILLS (Chills) and HEADACHE (Headaches) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-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 MYALGIA (Aches/ body aches), LYMPHADENOPATHY (Lymph node is swollen), PYREXIA (Fever of 101.5), CHILLS (Chills) and HEADACHE (Headaches). At the time of the report, MYALGIA (Aches/ body aches), LYMPHADENOPATHY (Lymph node is swollen), PYREXIA (Fever of 101.5), CHILLS (Chills) and HEADACHE (Headaches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was provided by the reporter.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity
Clinical narrative: Tiredness; Chills; sore arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness), CHILLS (Chills) and PAIN IN EXTREMITY (sore arm at injection site) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included No adverse reaction (no medical history reported). Concomitant products included HCTZ and METFORMIN for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced FATIGUE (Tiredness), CHILLS (Chills) and PAIN IN EXTREMITY (sore arm at injection site). On 26-Mar-2021, FATIGUE (Tiredness), CHILLS (Chills) and PAIN IN EXTREMITY (sore arm at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: swelling arm; Arm sore; Itching at vaccination site; soreness of the injection site; that it was like lyme disease and looked like a bull's-eye; fever; nausea; chills; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling arm), PAIN IN EXTREMITY (Arm sore), VACCINATION SITE PRURITUS (Itching at vaccination site), VACCINATION SITE PAIN (soreness of the injection site) and VACCINATION SITE RASH (that it was like lyme disease and looked like a bull's-eye) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032220A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis and Lyme disease.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (swelling arm), PAIN IN EXTREMITY (Arm sore), VACCINATION SITE PRURITUS (Itching at vaccination site), VACCINATION SITE PAIN (soreness of the injection site), VACCINATION SITE RASH (that it was like lyme disease and looked like a bull's-eye), PYREXIA (fever), NAUSEA (nausea) and CHILLS (chills). At the time of the report, PERIPHERAL SWELLING (swelling arm), PAIN IN EXTREMITY (Arm sore), VACCINATION SITE PRURITUS (Itching at vaccination site), VACCINATION SITE PAIN (soreness of the injection site), VACCINATION SITE RASH (that it was like lyme disease and looked like a bull's-eye), PYREXIA (fever), NAUSEA (nausea) and CHILLS (chills) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient stated that her symptoms were like Lyme disease and looked like a bull's eye. She did not take anything to treat her symptoms and she wasn't taking any other concomitant medications. patient said vaccine helped with her arthritis symptoms.   This case was linked to MOD-2021-090348 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow-up received- Contact info and medical history updated.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: swelling arm; Arm sore; Itching at vaccination site; soreness of the injection site; that it was like lyme disease and looked like a bull's-eye; fever; nausea; chills; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling arm), PAIN IN EXTREMITY (Arm sore), VACCINATION SITE PRURITUS (Itching at vaccination site), VACCINATION SITE PAIN (soreness of the injection site) and VACCINATION SITE RASH (that it was like lyme disease and looked like a bull's-eye) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032220A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis and Lyme disease.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (swelling arm), PAIN IN EXTREMITY (Arm sore), VACCINATION SITE PRURITUS (Itching at vaccination site), VACCINATION SITE PAIN (soreness of the injection site), VACCINATION SITE RASH (that it was like lyme disease and looked like a bull's-eye), PYREXIA (fever), NAUSEA (nausea) and CHILLS (chills). At the time of the report, PERIPHERAL SWELLING (swelling arm), PAIN IN EXTREMITY (Arm sore), VACCINATION SITE PRURITUS (Itching at vaccination site), VACCINATION SITE PAIN (soreness of the injection site), VACCINATION SITE RASH (that it was like lyme disease and looked like a bull's-eye), PYREXIA (fever), NAUSEA (nausea) and CHILLS (chills) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient stated that her symptoms were like Lyme disease and looked like a bull's eye. She did not take anything to treat her symptoms and she wasn't taking any other concomitant medications. patient said vaccine helped with her arthritis symptoms.   This case was linked to MOD-2021-090348 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow-up received- Contact info and medical history updated.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Diarrhoea, Fatigue, Gastroenteritis viral, Illness
Clinical narrative: Covid-19 positive; he started feeling ill; Started feeling ill as if stomach flue; Diarrhea; fatigue; body ache; This spontaneous case was reported by a consumer and describes the occurrence of GASTROENTERITIS VIRAL, DIARRHOEA, FATIGUE, MYALGIA, and COVID-19 in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced GASTROENTERITIS VIRAL, DIARRHOEA, FATIGUE, MYALGIA, and ILLNESS. On 23-Apr-2021, the patient experienced COVID-19 (Covid-19 positive). At the time of the report, GASTROENTERITIS VIRAL, DIARRHOEA, FATIGUE, MYALGIA, COVID-19 (positive), and ILLNESS outcome was unknown. Not Provided.     DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, SARS-CoV-2 test: Positive Covid Test.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.       No concomitant medication reported. No treatment medication reported.   Most recent FOLLOW-UP information incorporated above included, on 27-May-2021: Follow up report received on 27-MAY-2021 contains No New Information.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, SARS-CoV-2 test
Clinical narrative: Covid-19 positive; he started feeling ill; Started feeling ill as if stomach flue; Diarrhea; fatigue; body ache; This spontaneous case was reported by a consumer and describes the occurrence of GASTROENTERITIS VIRAL, DIARRHOEA, FATIGUE, MYALGIA, and COVID-19 in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced GASTROENTERITIS VIRAL, DIARRHOEA, FATIGUE, MYALGIA, and ILLNESS. On 23-Apr-2021, the patient experienced COVID-19 (Covid-19 positive). At the time of the report, GASTROENTERITIS VIRAL, DIARRHOEA, FATIGUE, MYALGIA, COVID-19 (positive), and ILLNESS outcome was unknown. Not Provided.     DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, SARS-CoV-2 test: Positive Covid Test.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.       No concomitant medication reported. No treatment medication reported.   Most recent FOLLOW-UP information incorporated above included, on 27-May-2021: Follow up report received on 27-MAY-2021 contains No New Information.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, Fatigue, Feeling abnormal, Illness, Pruritus
Clinical narrative: still sick; also got covid 19; COVID arm; feeling out of it; itching; fatigue / tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm), FEELING ABNORMAL (feeling out of it), PRURITUS (itching), ILLNESS (still sick) and EXPOSURE TO SARS-COV-2 (also got covid 19) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Apr-2021, the patient experienced FEELING ABNORMAL (feeling out of it), PRURITUS (itching) and FATIGUE (fatigue / tired). On 26-Apr-2021, the patient experienced VACCINATION SITE REACTION (COVID arm). On an unknown date, the patient experienced ILLNESS (still sick) and EXPOSURE TO SARS-COV-2 (also got covid 19). At the time of the report, VACCINATION SITE REACTION (COVID arm), FEELING ABNORMAL (feeling out of it), PRURITUS (itching), ILLNESS (still sick), EXPOSURE TO SARS-COV-2 (also got covid 19) and FATIGUE (fatigue / tired) had resolved.            This case was linked to MODERNATX, INC.-MOD-2021-090448 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Significant Follow up appended; Sender's Comments:  MODERNATX, INC.-MOD-2021-090448:Case of son
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: still sick; also got covid 19; COVID arm; feeling out of it; itching; fatigue / tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm), FEELING ABNORMAL (feeling out of it), PRURITUS (itching), ILLNESS (still sick) and EXPOSURE TO SARS-COV-2 (also got covid 19) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Apr-2021, the patient experienced FEELING ABNORMAL (feeling out of it), PRURITUS (itching) and FATIGUE (fatigue / tired). On 26-Apr-2021, the patient experienced VACCINATION SITE REACTION (COVID arm). On an unknown date, the patient experienced ILLNESS (still sick) and EXPOSURE TO SARS-COV-2 (also got covid 19). At the time of the report, VACCINATION SITE REACTION (COVID arm), FEELING ABNORMAL (feeling out of it), PRURITUS (itching), ILLNESS (still sick), EXPOSURE TO SARS-COV-2 (also got covid 19) and FATIGUE (fatigue / tired) had resolved.            This case was linked to MODERNATX, INC.-MOD-2021-090448 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Significant Follow up appended; Sender's Comments:  MODERNATX, INC.-MOD-2021-090448:Case of son
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site urticaria, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: itchy; Big hives at the injection site; red; swollen; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PRURITUS (itchy), INJECTION SITE URTICARIA (Big hives at the injection site), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE SWELLING (swollen) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 008B21-2A) for COVID-19 vaccination.     Concurrent medical conditions included Behcet's disease, Ankylosing spondylitis, Addison's disease and Gastroesophageal reflux disease. Concomitant products included PREDNISONE, SARILUMAB (KEVZARA), METHOTREXATE, OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC), NORTRIPTYLINE and PARACETAMOL (TYLENOL) for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (itchy), INJECTION SITE URTICARIA (Big hives at the injection site), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE SWELLING (swollen). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (itchy), INJECTION SITE URTICARIA (Big hives at the injection site), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE SWELLING (swollen) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked toMOD-2021-090191,MOD-2021-090148 (E2B Linked Report).; Sender's Comments:  MOD-2021-090191:Same reporter MOD-2021-090148:Same reporter
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Malaise, Pyrexia, Vaccination site reaction
Clinical narrative: Fever; Sick feeling; Covid arm; Lethargic; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PYREXIA (Fever), MALAISE (Sick feeling), VACCINATION SITE REACTION (Covid arm) and LETHARGY (Lethargic) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Insomnia and Drug allergy. Concomitant products included ZOLPIDEM TARTRATE (AMBIEN) from 01-Jan-2015 to an unknown date for Insomnia, VITAMINS NOS and IBUPROFEN (ADVIL [IBUPROFEN]) for an unknown indication.    On 20-Feb-2021 at 11:15 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced PYREXIA (Fever) and LETHARGY (Lethargic). 20-Feb-2021, the patient experienced MALAISE (Sick feeling) and VACCINATION SITE REACTION (Covid arm). On 25-Feb-2021, PYREXIA (Fever), MALAISE (Sick feeling), VACCINATION SITE REACTION (Covid arm) and LETHARGY (Lethargic) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Specific treatment information was not reported.   This case was linked to MOD-2021-018071 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Myalgia
Clinical narrative: upset stomach; body aches; chills; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (upset stomach), MYALGIA (body aches) and CHILLS (chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    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 ABDOMINAL DISCOMFORT (upset stomach), MYALGIA (body aches) and CHILLS (chills). At the time of the report, ABDOMINAL DISCOMFORT (upset stomach), MYALGIA (body aches) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Positive covid-19 test post 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Positive covid-19 test post 1st dose) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No historical conditions were reported.  Concomitant products included VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Positive covid-19 test post 1st dose). At the time of the report, SARS-COV-2 TEST POSITIVE (Positive covid-19 test post 1st dose) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Apr-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were provided.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Peripheral swelling
Clinical narrative: left arm became swollen; hand became numb for 6 hours; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Apr-2021 and was forwarded to Moderna on 26-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (left arm became swollen) and HYPOAESTHESIA (hand became numb for 6 hours) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 148A21A and 177A27A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included Clot blood (blood clot in left arm 3 years ago) and Factor V Leiden thrombophilia. Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced PERIPHERAL SWELLING (left arm became swollen) and HYPOAESTHESIA (hand became numb for 6 hours). On 04-Mar-2021, PERIPHERAL SWELLING (left arm became swollen) and HYPOAESTHESIA (hand became numb for 6 hours) had resolved. Not Provided          This case was linked to MOD-2021-090687 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Fever; Headache; severe chills; This spontaneous case was reported by a physician and describes the occurrence of PYREXIA (Fever), HEADACHE (Headache) and CHILLS (severe chills) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever), HEADACHE (Headache) and CHILLS (severe chills). At the time of the report, PYREXIA (Fever), HEADACHE (Headache) and CHILLS (severe chills) outcome was unknown.        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.   Concomitant medications were not reported.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Rash
Clinical narrative: pain in arm; had little rash; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm) and RASH (had little rash) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 01-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 PAIN IN EXTREMITY (pain in arm) and RASH (had little rash). The patient was treated with IBUPROFEN at an unspecified dose and frequency and CLONAZEPAM (KLONOPIN) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (pain in arm) and RASH (had little rash) outcome was unknown. Possible      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-090694 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090694:case for second dose
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received second dose on 24Apr2021, over 90 days after 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose on 24Apr2021, over 90 days after 1st dose) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose on 24Apr2021, over 90 days after 1st dose). On 24-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose on 24Apr2021, over 90 days after 1st dose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatments were provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and HEADACHE (headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever) and HEADACHE (headache). At the time of the report, PYREXIA (fever) and HEADACHE (headache) had resolved.            No concomitant medications reported. No treatment information provided. Action taken with mRNA-1273 in response to the events was  not applicable.   This case was linked to MOD-2021-018435 (Patient Link).   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site swelling
Clinical narrative: Large swollen rectangle with a lump in the middle at injection site; Large swollen rectangle with a lump in the middle at injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Large swollen rectangle with a lump in the middle at injection site) and VACCINATION SITE SWELLING (Large swollen rectangle with a lump in the middle at injection site) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (Large swollen rectangle with a lump in the middle at injection site) and VACCINATION SITE SWELLING (Large swollen rectangle with a lump in the middle at injection site). At the time of the report, VACCINATION SITE MASS (Large swollen rectangle with a lump in the middle at injection site) and VACCINATION SITE SWELLING (Large swollen rectangle with a lump in the middle at injection site) had resolved.            No treatment of events was reported.  No concomitant medications were reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Tinnitus
Clinical narrative: She had a soft patter sound in her ears that Happened when she burped and bent over; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TINNITUS (She had a soft patter sound in her ears that Happened when she burped and bent over) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. EN6200) for COVID-19 vaccination.     The patient's past medical history included Breast cancer (She was considered cancer free 5 years past her diagnosis) in 2001, Shoulder replacement in 2020 and Cardiac ablation (She had Cardiac ablation about 3 years ago) in 2018. Previously administered products included for COVID-19 vaccination: Pfizer Covid-19 Vaccine (Pfizer Lot Number: EL3427 She reported she got her first Covid vaccine in her left arm) on 05-Feb-2021. Concurrent medical conditions included AFib (She was diagnosed with AFib in either 2015 or 2016) and Osteoporosis in 2020. Concomitant products included APIXABAN (ELIQUIS) for AFib, DENOSUMAB (PROLIA) from July 2020 to an unknown date for Osteoporosis.    On 01-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced TINNITUS (She had a soft patter sound in her ears that Happened when she burped and bent over). At the time of the report, TINNITUS (She had a soft patter sound in her ears that Happened when she burped and bent over) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Mar-2021, Acoustic stimulation tests: normal (normal) Normal.         She has been on Eliquis 5mg tablet for about 3 years. On 01-Mar-2021, her second Covid vaccine was between 1:00 to 1:30PM On 15-Mar-2021, her ear doctor cleaned and waxed out both  ears, and checked her ears, nose, and throat. On 07-Apr-2021, her ear doctor dug out a skin flap in her right ear but that did not take care of the soft patter sound in her ears.   This case was linked to INC.-MOD-2021-089491, MOD-2021-185552 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: No significant information received; Sender's Comments:  INC.-MOD-2021-185552:Dose 1 INC.-MOD-2021-089491:Same reporter
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure increased, Lymphadenopathy, Myalgia, Palpitations
Clinical narrative: Palpitations; Increase in m yblood pressure; Had lymph nodes; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitations), BLOOD PRESSURE INCREASED (Increase in m yblood pressure), LYMPHADENOPATHY (Had lymph nodes) and MYALGIA (Muscle pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Palpitations), BLOOD PRESSURE INCREASED (Increase in m yblood pressure), LYMPHADENOPATHY (Had lymph nodes) and MYALGIA (Muscle pain). At the time of the report, PALPITATIONS (Palpitations), BLOOD PRESSURE INCREASED (Increase in m yblood pressure), LYMPHADENOPATHY (Had lymph nodes) and MYALGIA (Muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. No treatment information provided.
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Palpitations, Presyncope, Visual impairment
Clinical narrative: Almost blacked out; Dizziness; Anxiety attacks; Vision was not all that well; Heart palpitations; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (Almost blacked out), DIZZINESS (Dizziness), ANXIETY (Anxiety attacks), VISUAL IMPAIRMENT (Vision was not all that well) and PALPITATIONS (Heart palpitations) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PRESYNCOPE (Almost blacked out), DIZZINESS (Dizziness), ANXIETY (Anxiety attacks), VISUAL IMPAIRMENT (Vision was not all that well) and PALPITATIONS (Heart palpitations). At the time of the report, PRESYNCOPE (Almost blacked out), DIZZINESS (Dizziness), ANXIETY (Anxiety attacks), VISUAL IMPAIRMENT (Vision was not all that well) and PALPITATIONS (Heart palpitations) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medicines were not reported.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Headache, Hypoaesthesia, Incorrect route of product administration
Clinical narrative: body aches; 98 degree Fahrenheit fever for a day/fever of 99.5 degrees Fahrenheit; headache; hand was numb for 6 hours; migraine; dizzy; administered downward in her left arm; wrist felt like some one was squeezing it; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (hand was numb for 6 hours), MIGRAINE (migraine), DIZZINESS (dizzy), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (administered downward in her left arm) and ARTHRALGIA (wrist felt like some one was squeezing it) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 148A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient's past medical history included Factor V Leiden thrombophilia (blood clot in left arm 3 years ago). Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.    On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced HYPOAESTHESIA (hand was numb for 6 hours), MIGRAINE (migraine), DIZZINESS (dizzy), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (administered downward in her left arm), ARTHRALGIA (wrist felt like some one was squeezing it) and HEADACHE (headache). On 01-Apr-2021, the patient experienced MYALGIA (body aches) and PYREXIA (98 degree Fahrenheit fever for a day/fever of 99.5 degrees Fahrenheit). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. On 01-Apr-2021, HYPOAESTHESIA (hand was numb for 6 hours), MIGRAINE (migraine), DIZZINESS (dizzy), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (administered downward in her left arm), ARTHRALGIA (wrist felt like some one was squeezing it), MYALGIA (body aches), HEADACHE (headache) and PYREXIA (98 degree Fahrenheit fever for a day/fever of 99.5 degrees Fahrenheit) had resolved. Not Provided          This case was linked to US-irms-MOD21-097869 (E2B Linked Report). This case was linked to MOD-2021-090673 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow up received; adverse events and vaccination facility details were added.; Sender's Comments:  US-irms-MOD21-097869:irms
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Myalgia, Pyrexia
Clinical narrative: body aches; 98 degree Fahrenheit fever for a day/fever of 99.5 degrees Fahrenheit; headache; hand was numb for 6 hours; migraine; dizzy; administered downward in her left arm; wrist felt like some one was squeezing it; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (hand was numb for 6 hours), MIGRAINE (migraine), DIZZINESS (dizzy), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (administered downward in her left arm) and ARTHRALGIA (wrist felt like some one was squeezing it) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 148A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient's past medical history included Factor V Leiden thrombophilia (blood clot in left arm 3 years ago). Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.    On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced HYPOAESTHESIA (hand was numb for 6 hours), MIGRAINE (migraine), DIZZINESS (dizzy), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (administered downward in her left arm), ARTHRALGIA (wrist felt like some one was squeezing it) and HEADACHE (headache). On 01-Apr-2021, the patient experienced MYALGIA (body aches) and PYREXIA (98 degree Fahrenheit fever for a day/fever of 99.5 degrees Fahrenheit). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. On 01-Apr-2021, HYPOAESTHESIA (hand was numb for 6 hours), MIGRAINE (migraine), DIZZINESS (dizzy), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (administered downward in her left arm), ARTHRALGIA (wrist felt like some one was squeezing it), MYALGIA (body aches), HEADACHE (headache) and PYREXIA (98 degree Fahrenheit fever for a day/fever of 99.5 degrees Fahrenheit) had resolved. Not Provided          This case was linked to US-irms-MOD21-097869 (E2B Linked Report). This case was linked to MOD-2021-090673 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow up received; adverse events and vaccination facility details were added.; Sender's Comments:  US-irms-MOD21-097869:irms
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis
Clinical narrative: bad sweating; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (bad sweating) in a 41-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) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (bad sweating). At the time of the report, HYPERHIDROSIS (bad sweating) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Bone pain, Headache, Myalgia, Pain
Clinical narrative: fever; headache; body aches; muscle pain; tremors; weak; bone pain; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), HEADACHE (headache), PAIN (body aches), MYALGIA (muscle pain) and TREMOR (tremors) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced PYREXIA (fever), HEADACHE (headache), PAIN (body aches), MYALGIA (muscle pain), TREMOR (tremors), ASTHENIA (weak) and BONE PAIN (bone pain). On 06-Mar-2021, PYREXIA (fever), HEADACHE (headache), PAIN (body aches), MYALGIA (muscle pain), TREMOR (tremors), ASTHENIA (weak) and BONE PAIN (bone pain) had resolved. 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.   No concomitant medications taken. No treatment information provided.   This case was linked to MOD-2021-090705 (Patient Link).
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: fever; headache; body aches; muscle pain; tremors; weak; bone pain; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), HEADACHE (headache), PAIN (body aches), MYALGIA (muscle pain) and TREMOR (tremors) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced PYREXIA (fever), HEADACHE (headache), PAIN (body aches), MYALGIA (muscle pain), TREMOR (tremors), ASTHENIA (weak) and BONE PAIN (bone pain). On 06-Mar-2021, PYREXIA (fever), HEADACHE (headache), PAIN (body aches), MYALGIA (muscle pain), TREMOR (tremors), ASTHENIA (weak) and BONE PAIN (bone pain) had resolved. 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.   No concomitant medications taken. No treatment information provided.   This case was linked to MOD-2021-090705 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Dyspnoea, Fatigue, Headache
Clinical narrative: Hot-flashes; Difficulty breathing; Arm swollen like a baseball; Arm tender; Hear rate 194; Headache; Fatigue; Joint pain; Muscle pain; Fever of 101.9; Nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HOT FLUSH (Hot-flashes), DYSPNOEA (Difficulty breathing), PERIPHERAL SWELLING (Arm swollen like a baseball), TENDERNESS (Arm tender) and PALPITATIONS (Hear rate 194) in a 52-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 was provided by the reporter.  Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), MAGNESIUM and CALCIUM for an unknown indication.   On 17-Apr-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 17-Apr-2021, the patient experienced HOT FLUSH (Hot-flashes), DYSPNOEA (Difficulty breathing), PERIPHERAL SWELLING (Arm swollen like a baseball), TENDERNESS (Arm tender), PALPITATIONS (Hear rate 194), HEADACHE (Headache), FATIGUE (Fatigue), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain), PYREXIA (Fever of 101.9) and NAUSEA (Nausea). On 19-Apr-2021, DYSPNOEA (Difficulty breathing) outcome was unknown. On 22-Apr-2021, HOT FLUSH (Hot-flashes), PERIPHERAL SWELLING (Arm swollen like a baseball), PALPITATIONS (Hear rate 194), HEADACHE (Headache), FATIGUE (Fatigue), ARTHRALGIA (Joint pain), PYREXIA (Fever of 101.9) and NAUSEA (Nausea) had resolved. At the time of the report, TENDERNESS (Arm tender) and MYALGIA (Muscle pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Apr-2021, Body temperature: 101.9 f (High) outcome was recovered/resolved. On 17-Apr-2021, Heart rate: 194 (High) outcome was recovered/resolved.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Hot flush, Myalgia, Nausea, Palpitations
Clinical narrative: Hot-flashes; Difficulty breathing; Arm swollen like a baseball; Arm tender; Hear rate 194; Headache; Fatigue; Joint pain; Muscle pain; Fever of 101.9; Nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HOT FLUSH (Hot-flashes), DYSPNOEA (Difficulty breathing), PERIPHERAL SWELLING (Arm swollen like a baseball), TENDERNESS (Arm tender) and PALPITATIONS (Hear rate 194) in a 52-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 was provided by the reporter.  Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), MAGNESIUM and CALCIUM for an unknown indication.   On 17-Apr-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 17-Apr-2021, the patient experienced HOT FLUSH (Hot-flashes), DYSPNOEA (Difficulty breathing), PERIPHERAL SWELLING (Arm swollen like a baseball), TENDERNESS (Arm tender), PALPITATIONS (Hear rate 194), HEADACHE (Headache), FATIGUE (Fatigue), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain), PYREXIA (Fever of 101.9) and NAUSEA (Nausea). On 19-Apr-2021, DYSPNOEA (Difficulty breathing) outcome was unknown. On 22-Apr-2021, HOT FLUSH (Hot-flashes), PERIPHERAL SWELLING (Arm swollen like a baseball), PALPITATIONS (Hear rate 194), HEADACHE (Headache), FATIGUE (Fatigue), ARTHRALGIA (Joint pain), PYREXIA (Fever of 101.9) and NAUSEA (Nausea) had resolved. At the time of the report, TENDERNESS (Arm tender) and MYALGIA (Muscle pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Apr-2021, Body temperature: 101.9 f (High) outcome was recovered/resolved. On 17-Apr-2021, Heart rate: 194 (High) outcome was recovered/resolved.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported