chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Peripheral swelling
Clinical narrative: Pain in armpit; swelling in armpit; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (Pain in armpit) and PERIPHERAL SWELLING (swelling in armpit) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced AXILLARY PAIN (Pain in armpit) and PERIPHERAL SWELLING (swelling in armpit). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. At the time of the report, AXILLARY PAIN (Pain in armpit) and PERIPHERAL SWELLING (swelling in armpit) 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.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow-up information received on 12 May  2021 contain information: Reporter contact details updated.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia, Urinary tract infection
Clinical narrative: UTI; Chills; Fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (UTI), CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Fatigue) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Fatigue). On 22-Mar-2021, the patient experienced URINARY TRACT INFECTION (UTI). At the time of the report, URINARY TRACT INFECTION (UTI) outcome was unknown and CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information included antibiotics for UTI (urinary tract infection).  The patients chill, fever and fatigue was left after 8 days.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Contact details of reporter was updated.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Headache, Myalgia
Clinical narrative: myalgia; headaches; no sense of smell; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (no sense of smell), MYALGIA (myalgia) and HEADACHE (headaches) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced ANOSMIA (no sense of smell). On an unknown date, the patient experienced MYALGIA (myalgia) and HEADACHE (headaches). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, ANOSMIA (no sense of smell), MYALGIA (myalgia) and HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Non significant follow up appended
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: Caught  covid after frist dose; Cough; Sore throat; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Caught  covid after frist dose), COUGH (Cough) and OROPHARYNGEAL PAIN (Sore throat) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 048B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Mar-2021, the patient experienced COUGH (Cough) and OROPHARYNGEAL PAIN (Sore throat). On 22-Mar-2021, the patient experienced COVID-19 (Caught  covid after frist dose). On 24-Mar-2021, COUGH (Cough) and OROPHARYNGEAL PAIN (Sore throat) had resolved. At the time of the report, COVID-19 (Caught  covid after frist dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, SARS-CoV-2 test positive: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication were reported.  No treatment medication were reported.   This case was linked to MOD-2021-250630 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Significant follow up received on 07-JUL-2021. Lot number of first dose vaccine updated. Additional information about second dose and events of second dose were provided.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Pain in the arm; Tingling; Numbness in the finger; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the arm), PARAESTHESIA (Tingling) and HYPOAESTHESIA (Numbness in the finger) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in the arm), PARAESTHESIA (Tingling) and HYPOAESTHESIA (Numbness in the finger). At the time of the report, PAIN IN EXTREMITY (Pain in the arm), PARAESTHESIA (Tingling) and HYPOAESTHESIA (Numbness in the finger) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Dizziness, Tenderness, Vaccination site rash
Clinical narrative: Light headedness; Large red rash around injection site which is not itchy; Soreness of left armpit; Tenderness of left armpit; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (Soreness of left armpit), TENDERNESS (Tenderness of left armpit), DIZZINESS (Light headedness) and VACCINATION SITE RASH (Large red rash around injection site which is not itchy) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced AXILLARY PAIN (Soreness of left armpit) and TENDERNESS (Tenderness of left armpit). On 11-Mar-2021, the patient experienced VACCINATION SITE RASH (Large red rash around injection site which is not itchy). On 18-Mar-2021, the patient experienced DIZZINESS (Light headedness). The patient was treated with IBUPROFEN for Axillary pain and Tenderness, at an unspecified dose and frequency. On 18-Mar-2021, DIZZINESS (Light headedness) had resolved. At the time of the report, AXILLARY PAIN (Soreness of left armpit), TENDERNESS (Tenderness of left armpit) and VACCINATION SITE RASH (Large red rash around injection site which is not itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications taken by patient.    Reporter did not allow further contact
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Headache, Myalgia, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: headache; tested POSITIVE to COVID test; sinuses; body aches; colds; sore throat; Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested POSITIVE to COVID test), NASOPHARYNGITIS (colds), OROPHARYNGEAL PAIN (sore throat), SINUS DISORDER (sinuses) and VACCINATION SITE PAIN (Arm pain) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) 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 ASCORBIC ACID (VIT C) for an unknown indication.    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 VACCINATION SITE PAIN (Arm pain). On 24-Mar-2021, the patient experienced NASOPHARYNGITIS (colds) and OROPHARYNGEAL PAIN (sore throat). On 25-Mar-2021, the patient experienced SINUS DISORDER (sinuses) and MYALGIA (body aches). On 26-Mar-2021, the patient experienced COVID-19 (tested POSITIVE to COVID test). On 27-Mar-2021, the patient experienced HEADACHE (headache). The patient was treated with IBUPROFEN (oral) at an unspecified dose and frequency. At the time of the report, COVID-19 (tested POSITIVE to COVID test), NASOPHARYNGITIS (colds), OROPHARYNGEAL PAIN (sore throat), SINUS DISORDER (sinuses), VACCINATION SITE PAIN (Arm pain), MYALGIA (body aches) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, SARS-CoV-2 test: positive (Positive) SARS-CoV-2 test positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other relevant concomitant medications included, Centrum Multivitamins for women were reported.  .
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Sinus disorder, Vaccination site pain
Clinical narrative: headache; tested POSITIVE to COVID test; sinuses; body aches; colds; sore throat; Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested POSITIVE to COVID test), NASOPHARYNGITIS (colds), OROPHARYNGEAL PAIN (sore throat), SINUS DISORDER (sinuses) and VACCINATION SITE PAIN (Arm pain) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) 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 ASCORBIC ACID (VIT C) for an unknown indication.    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 VACCINATION SITE PAIN (Arm pain). On 24-Mar-2021, the patient experienced NASOPHARYNGITIS (colds) and OROPHARYNGEAL PAIN (sore throat). On 25-Mar-2021, the patient experienced SINUS DISORDER (sinuses) and MYALGIA (body aches). On 26-Mar-2021, the patient experienced COVID-19 (tested POSITIVE to COVID test). On 27-Mar-2021, the patient experienced HEADACHE (headache). The patient was treated with IBUPROFEN (oral) at an unspecified dose and frequency. At the time of the report, COVID-19 (tested POSITIVE to COVID test), NASOPHARYNGITIS (colds), OROPHARYNGEAL PAIN (sore throat), SINUS DISORDER (sinuses), VACCINATION SITE PAIN (Arm pain), MYALGIA (body aches) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, SARS-CoV-2 test: positive (Positive) SARS-CoV-2 test positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other relevant concomitant medications included, Centrum Multivitamins for women were reported.  .
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: itchiness; almost like hives; rash all over the body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness), URTICARIA (almost like hives) and RASH (rash all over the body) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021 at 4:00 AM, the patient experienced PRURITUS (itchiness), URTICARIA (almost like hives) and RASH (rash all over the body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 28-Mar-2021, PRURITUS (itchiness), URTICARIA (almost like hives) and RASH (rash all over the body) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Injection site warmth, Pyrexia, Vaccination complication
Clinical narrative: experiencing severe reactions unlike her experience on the first dose; diarrhea on the same evening of her shot for 3-4 hrs; area around the injection site warm to touch.; body chills; 6-7 hrs after the 2nd shot, she experienced high fever - 103.7 F yesterday; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (experiencing severe reactions unlike her experience on the first dose), DIARRHOEA (diarrhea on the same evening of her shot for 3-4 hrs), INJECTION SITE WARMTH (area around the injection site warm to touch.), CHILLS (body chills) and PYREXIA (6-7 hrs after the 2nd shot, she experienced high fever - 103.7 F yesterday) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00ZAZ1A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (experiencing severe reactions unlike her experience on the first dose), DIARRHOEA (diarrhea on the same evening of her shot for 3-4 hrs), INJECTION SITE WARMTH (area around the injection site warm to touch.), CHILLS (body chills) and PYREXIA (6-7 hrs after the 2nd shot, she experienced high fever - 103.7 F yesterday). The patient was treated with PARACETAMOL (TYLENOL) for Fever and Chills, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (experiencing severe reactions unlike her experience on the first dose), DIARRHOEA (diarrhea on the same evening of her shot for 3-4 hrs), INJECTION SITE WARMTH (area around the injection site warm to touch.), CHILLS (body chills) and PYREXIA (6-7 hrs after the 2nd shot, she experienced high fever - 103.7 F yesterday) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products included PARACETAMOL (TYLENOL).
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: feeling like pins and needles like poking all over my body; arm sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA (feeling like pins and needles like poking all over my body) and PAIN IN EXTREMITY (arm sore) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm sore). On 21-Mar-2021, the patient experienced PARAESTHESIA (feeling like pins and needles like poking all over my body). At the time of the report, PARAESTHESIA (feeling like pins and needles like poking all over my body) and PAIN IN EXTREMITY (arm sore) had not resolved.            No relevant concomitant medications were reported. The patient did not take any treatment medication. Action taken with mRNA-1273 in response to the events was not applicable. The patient went to the hospital and there was no diagnosis from the doctors about her condition.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for covid after the first dose of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for covid after the first dose of the vaccine) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included Chemical exposure in September 2011. Concurrent medical conditions included Paraplegic. Concomitant products included GABAPENTINE, CELECOXIB (CELEBREX), PANTOPRAZOLE, METFORMIN, MONTELUKAST, TIZANIDINE, TRAZODONE and ALBUTEROL;IPRATROPIUM for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced COVID-19 (Tested positive for covid after the first dose of the vaccine). At the time of the report, COVID-19 (Tested positive for covid after the first dose of the vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Mar-2021, SARS-CoV-2 test: positive (Positive) COVID-19 Positive.     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 assessment.  Concomitant medication included Stool Softener. Treatment information was not provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Catarrh, Dry throat, Fatigue, Feeling abnormal, Headache
Clinical narrative: I still have the scratchy throat; I do have some mucus in my throat; numbness; it's really pretty bad,; runny nose with clear liquid like watery; tingling on my finger; my bones in hands hurt; shot still hurts; my muscles hurt; I'm very fatigued; headache; I had a scratchy throat; This spontaneous case was reported by a consumer and describes the occurrence of DRY THROAT (I still have the scratchy throat), CATARRH (I do have some mucus in my throat), HYPOAESTHESIA (numbness), DRY THROAT (I had a scratchy throat) and FEELING ABNORMAL (it's really pretty bad,) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced DRY THROAT (I had a scratchy throat) and HEADACHE (headache). On 28-Mar-2021, the patient experienced DRY THROAT (I still have the scratchy throat), CATARRH (I do have some mucus in my throat), HYPOAESTHESIA (numbness), FEELING ABNORMAL (it's really pretty bad,), RHINORRHOEA (runny nose with clear liquid like watery), PARAESTHESIA (tingling on my finger), PAIN IN EXTREMITY (my bones in hands hurt), VACCINATION SITE PAIN (shot still hurts), MYALGIA (my muscles hurt) and FATIGUE (I'm very fatigued). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency. At the time of the report, DRY THROAT (I still have the scratchy throat) and VACCINATION SITE PAIN (shot still hurts) had not resolved and CATARRH (I do have some mucus in my throat), HYPOAESTHESIA (numbness), DRY THROAT (I had a scratchy throat), FEELING ABNORMAL (it's really pretty bad,), RHINORRHOEA (runny nose with clear liquid like watery), PARAESTHESIA (tingling on my finger), PAIN IN EXTREMITY (my bones in hands hurt), HEADACHE (headache), MYALGIA (my muscles hurt) and FATIGUE (I'm very fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. The patient stated that she would not be definitely taking the second shot.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Myalgia, Pain in extremity, Paraesthesia, Rhinorrhoea
Clinical narrative: I still have the scratchy throat; I do have some mucus in my throat; numbness; it's really pretty bad,; runny nose with clear liquid like watery; tingling on my finger; my bones in hands hurt; shot still hurts; my muscles hurt; I'm very fatigued; headache; I had a scratchy throat; This spontaneous case was reported by a consumer and describes the occurrence of DRY THROAT (I still have the scratchy throat), CATARRH (I do have some mucus in my throat), HYPOAESTHESIA (numbness), DRY THROAT (I had a scratchy throat) and FEELING ABNORMAL (it's really pretty bad,) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced DRY THROAT (I had a scratchy throat) and HEADACHE (headache). On 28-Mar-2021, the patient experienced DRY THROAT (I still have the scratchy throat), CATARRH (I do have some mucus in my throat), HYPOAESTHESIA (numbness), FEELING ABNORMAL (it's really pretty bad,), RHINORRHOEA (runny nose with clear liquid like watery), PARAESTHESIA (tingling on my finger), PAIN IN EXTREMITY (my bones in hands hurt), VACCINATION SITE PAIN (shot still hurts), MYALGIA (my muscles hurt) and FATIGUE (I'm very fatigued). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency. At the time of the report, DRY THROAT (I still have the scratchy throat) and VACCINATION SITE PAIN (shot still hurts) had not resolved and CATARRH (I do have some mucus in my throat), HYPOAESTHESIA (numbness), DRY THROAT (I had a scratchy throat), FEELING ABNORMAL (it's really pretty bad,), RHINORRHOEA (runny nose with clear liquid like watery), PARAESTHESIA (tingling on my finger), PAIN IN EXTREMITY (my bones in hands hurt), HEADACHE (headache), MYALGIA (my muscles hurt) and FATIGUE (I'm very fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. The patient stated that she would not be definitely taking the second shot.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: I still have the scratchy throat; I do have some mucus in my throat; numbness; it's really pretty bad,; runny nose with clear liquid like watery; tingling on my finger; my bones in hands hurt; shot still hurts; my muscles hurt; I'm very fatigued; headache; I had a scratchy throat; This spontaneous case was reported by a consumer and describes the occurrence of DRY THROAT (I still have the scratchy throat), CATARRH (I do have some mucus in my throat), HYPOAESTHESIA (numbness), DRY THROAT (I had a scratchy throat) and FEELING ABNORMAL (it's really pretty bad,) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced DRY THROAT (I had a scratchy throat) and HEADACHE (headache). On 28-Mar-2021, the patient experienced DRY THROAT (I still have the scratchy throat), CATARRH (I do have some mucus in my throat), HYPOAESTHESIA (numbness), FEELING ABNORMAL (it's really pretty bad,), RHINORRHOEA (runny nose with clear liquid like watery), PARAESTHESIA (tingling on my finger), PAIN IN EXTREMITY (my bones in hands hurt), VACCINATION SITE PAIN (shot still hurts), MYALGIA (my muscles hurt) and FATIGUE (I'm very fatigued). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency. At the time of the report, DRY THROAT (I still have the scratchy throat) and VACCINATION SITE PAIN (shot still hurts) had not resolved and CATARRH (I do have some mucus in my throat), HYPOAESTHESIA (numbness), DRY THROAT (I had a scratchy throat), FEELING ABNORMAL (it's really pretty bad,), RHINORRHOEA (runny nose with clear liquid like watery), PARAESTHESIA (tingling on my finger), PAIN IN EXTREMITY (my bones in hands hurt), HEADACHE (headache), MYALGIA (my muscles hurt) and FATIGUE (I'm very fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. The patient stated that she would not be definitely taking the second shot.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Tension
Clinical narrative: fatigue; feeling distress; whole body achiness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), TENSION (feeling distress) and PAIN (whole body achiness) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products includedMultivitamins   for supplemental purposes for an unknown indication.                                                   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced FATIGUE (fatigue), TENSION (feeling distress) and PAIN (whole body achiness). At the time of the report, FATIGUE (fatigue), TENSION (feeling distress) and PAIN (whole body achiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Influenza like illness, Myalgia
Clinical narrative: Felt like I was hit by a truck; Sore arm feels a little sore; Fever blister on lip; Flu like symptoms; Headache; Nausea; Muscle aches; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt like I was hit by a truck), PAIN IN EXTREMITY (Sore arm feels a little sore), ORAL HERPES (Fever blister on lip), INFLUENZA LIKE ILLNESS (Flu like symptoms) and HEADACHE (Headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced FEELING ABNORMAL (Felt like I was hit by a truck), PAIN IN EXTREMITY (Sore arm feels a little sore), ORAL HERPES (Fever blister on lip), INFLUENZA LIKE ILLNESS (Flu like symptoms), HEADACHE (Headache), NAUSEA (Nausea), MYALGIA (Muscle aches), PYREXIA (Fever) and CHILLS (Chills). On 25-Mar-2021, FEELING ABNORMAL (Felt like I was hit by a truck), ORAL HERPES (Fever blister on lip), INFLUENZA LIKE ILLNESS (Flu like symptoms), HEADACHE (Headache), NAUSEA (Nausea), MYALGIA (Muscle aches), PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm feels a little sore) 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.  Treatment information included alternating doses of paracetamol and ibuprofen.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oral herpes, Pain in extremity, Pyrexia
Clinical narrative: Felt like I was hit by a truck; Sore arm feels a little sore; Fever blister on lip; Flu like symptoms; Headache; Nausea; Muscle aches; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt like I was hit by a truck), PAIN IN EXTREMITY (Sore arm feels a little sore), ORAL HERPES (Fever blister on lip), INFLUENZA LIKE ILLNESS (Flu like symptoms) and HEADACHE (Headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced FEELING ABNORMAL (Felt like I was hit by a truck), PAIN IN EXTREMITY (Sore arm feels a little sore), ORAL HERPES (Fever blister on lip), INFLUENZA LIKE ILLNESS (Flu like symptoms), HEADACHE (Headache), NAUSEA (Nausea), MYALGIA (Muscle aches), PYREXIA (Fever) and CHILLS (Chills). On 25-Mar-2021, FEELING ABNORMAL (Felt like I was hit by a truck), ORAL HERPES (Fever blister on lip), INFLUENZA LIKE ILLNESS (Flu like symptoms), HEADACHE (Headache), NAUSEA (Nausea), MYALGIA (Muscle aches), PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm feels a little sore) 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.  Treatment information included alternating doses of paracetamol and ibuprofen.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain in right arm; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Pain in right arm) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in right arm). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain in right arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the event was unknown.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Inflammation, Vaccination site pain
Clinical narrative: Inflammation localised; feeling miserable; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Inflammation localised), FEELING ABNORMAL (feeling miserable) and VACCINATION SITE PAIN (Vaccination site pain) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0298A21A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included LOSARTAN, TRAZODONE and FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). On 18-Mar-2021, the patient experienced INFLAMMATION (Inflammation localised) and FEELING ABNORMAL (feeling miserable). At the time of the report, INFLAMMATION (Inflammation localised), FEELING ABNORMAL (feeling miserable) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication were provided. No concomitant medication were provided.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Eye pain, Feeling abnormal, Feeling hot, Mood altered
Clinical narrative: felt like she was on fire; pretty bad; fever; pain even pain eyes; everything was hurting; burning sensation; aches; body was really hot like inflammation; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (pain even pain eyes), PAIN (everything was hurting), BURNING SENSATION (burning sensation), PAIN (aches) and FEELING HOT (body was really hot like inflammation) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sciatic nerve injury and Arthritis.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced EYE PAIN (pain even pain eyes), PAIN (everything was hurting), BURNING SENSATION (burning sensation), PAIN (aches), FEELING HOT (body was really hot like inflammation), MOOD ALTERED (pretty bad) and PYREXIA (fever). On an unknown date, the patient experienced FEELING ABNORMAL (felt like she was on fire). At the time of the report, EYE PAIN (pain even pain eyes), PAIN (everything was hurting), BURNING SENSATION (burning sensation), PAIN (aches), FEELING HOT (body was really hot like inflammation), MOOD ALTERED (pretty bad) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medicines includes blood pressure medicine, stomach medicine, thyroids medicine, pain medicine,muscle relaxer for arthritis. Treatment medicines were not reported.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: felt like she was on fire; pretty bad; fever; pain even pain eyes; everything was hurting; burning sensation; aches; body was really hot like inflammation; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (pain even pain eyes), PAIN (everything was hurting), BURNING SENSATION (burning sensation), PAIN (aches) and FEELING HOT (body was really hot like inflammation) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sciatic nerve injury and Arthritis.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced EYE PAIN (pain even pain eyes), PAIN (everything was hurting), BURNING SENSATION (burning sensation), PAIN (aches), FEELING HOT (body was really hot like inflammation), MOOD ALTERED (pretty bad) and PYREXIA (fever). On an unknown date, the patient experienced FEELING ABNORMAL (felt like she was on fire). At the time of the report, EYE PAIN (pain even pain eyes), PAIN (everything was hurting), BURNING SENSATION (burning sensation), PAIN (aches), FEELING HOT (body was really hot like inflammation), MOOD ALTERED (pretty bad) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medicines includes blood pressure medicine, stomach medicine, thyroids medicine, pain medicine,muscle relaxer for arthritis. Treatment medicines were not reported.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Rash, Urticaria
Clinical narrative: running errands and she was shortness of breathe and chest heaviness.; running errands and she was shortness of breathe and chest heaviness.; also reported that she had a rash and hives on the day of vaccine; also reported that she had a rash and hives on the day of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (running errands and she was shortness of breathe and chest heaviness.), CHEST DISCOMFORT (running errands and she was shortness of breathe and chest heaviness.), URTICARIA (also reported that she had a rash and hives on the day of vaccine) and RASH (also reported that she had a rash and hives on the day of vaccine) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     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 26-Mar-2021, the patient experienced URTICARIA (also reported that she had a rash and hives on the day of vaccine) and RASH (also reported that she had a rash and hives on the day of vaccine). On 27-Mar-2021, the patient experienced DYSPNOEA (running errands and she was shortness of breathe and chest heaviness.) and CHEST DISCOMFORT (running errands and she was shortness of breathe and chest heaviness.). At the time of the report, DYSPNOEA (running errands and she was shortness of breathe and chest heaviness.), CHEST DISCOMFORT (running errands and she was shortness of breathe and chest heaviness.), URTICARIA (also reported that she had a rash and hives on the day of vaccine) and RASH (also reported that she had a rash and hives on the day of vaccine) 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: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Cheilitis, Cyanosis, Erythema, Intentional dose omission, Lip swelling
Clinical narrative: She did not receive the second shot per her doctors orders; tip of nose swollen; nausea-doesn't get sick it just passes; legs became weak and can hardly walk; lips swollen and purple; swollen under lower lip; arm itch; arm swollen with bumps; Both sides of tongue have big bumps and all red; Lower lip is completely raw; arm red/hot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (arm red/hot), PRURITUS (arm itch), PERIPHERAL SWELLING (arm swollen with bumps), CYANOSIS (lips swollen and purple) and LIP SWELLING (swollen under lower lip) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included APIXABAN (ELIQUIS) and SOTALOL for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced ERYTHEMA (arm red/hot), TONGUE DISORDER (Both sides of tongue have big bumps and all red) and CHEILITIS (Lower lip is completely raw). On 21-Mar-2021, the patient experienced PRURITUS (arm itch) and PERIPHERAL SWELLING (arm swollen with bumps). On 27-Mar-2021, the patient experienced CYANOSIS (lips swollen and purple) and LIP SWELLING (swollen under lower lip). On 28-Mar-2021, the patient experienced MUSCULAR WEAKNESS (legs became weak and can hardly walk). On 29-Mar-2021, the patient experienced SWELLING (tip of nose swollen) and NAUSEA (nausea-doesn't get sick it just passes). On 08-Apr-2021, the patient experienced INTENTIONAL DOSE OMISSION (She did not receive the second shot per her doctors orders). On 08-Apr-2021, INTENTIONAL DOSE OMISSION (She did not receive the second shot per her doctors orders) had resolved. At the time of the report, ERYTHEMA (arm red/hot), PERIPHERAL SWELLING (arm swollen with bumps), CYANOSIS (lips swollen and purple), TONGUE DISORDER (Both sides of tongue have big bumps and all red) and CHEILITIS (Lower lip is completely raw) had not resolved and PRURITUS (arm itch), LIP SWELLING (swollen under lower lip), SWELLING (tip of nose swollen), MUSCULAR WEAKNESS (legs became weak and can hardly walk) and NAUSEA (nausea-doesn't get sick it just passes) outcome was unknown.            Treatment medication included Steroid shot and Diphenhydramine. The patient also cold compressed her arm. Patient's doctor suggested her to not get the second dose.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: event added, SD and Email added
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Nausea, Peripheral swelling, Pruritus, Swelling
Clinical narrative: She did not receive the second shot per her doctors orders; tip of nose swollen; nausea-doesn't get sick it just passes; legs became weak and can hardly walk; lips swollen and purple; swollen under lower lip; arm itch; arm swollen with bumps; Both sides of tongue have big bumps and all red; Lower lip is completely raw; arm red/hot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (arm red/hot), PRURITUS (arm itch), PERIPHERAL SWELLING (arm swollen with bumps), CYANOSIS (lips swollen and purple) and LIP SWELLING (swollen under lower lip) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included APIXABAN (ELIQUIS) and SOTALOL for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced ERYTHEMA (arm red/hot), TONGUE DISORDER (Both sides of tongue have big bumps and all red) and CHEILITIS (Lower lip is completely raw). On 21-Mar-2021, the patient experienced PRURITUS (arm itch) and PERIPHERAL SWELLING (arm swollen with bumps). On 27-Mar-2021, the patient experienced CYANOSIS (lips swollen and purple) and LIP SWELLING (swollen under lower lip). On 28-Mar-2021, the patient experienced MUSCULAR WEAKNESS (legs became weak and can hardly walk). On 29-Mar-2021, the patient experienced SWELLING (tip of nose swollen) and NAUSEA (nausea-doesn't get sick it just passes). On 08-Apr-2021, the patient experienced INTENTIONAL DOSE OMISSION (She did not receive the second shot per her doctors orders). On 08-Apr-2021, INTENTIONAL DOSE OMISSION (She did not receive the second shot per her doctors orders) had resolved. At the time of the report, ERYTHEMA (arm red/hot), PERIPHERAL SWELLING (arm swollen with bumps), CYANOSIS (lips swollen and purple), TONGUE DISORDER (Both sides of tongue have big bumps and all red) and CHEILITIS (Lower lip is completely raw) had not resolved and PRURITUS (arm itch), LIP SWELLING (swollen under lower lip), SWELLING (tip of nose swollen), MUSCULAR WEAKNESS (legs became weak and can hardly walk) and NAUSEA (nausea-doesn't get sick it just passes) outcome was unknown.            Treatment medication included Steroid shot and Diphenhydramine. The patient also cold compressed her arm. Patient's doctor suggested her to not get the second dose.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: event added, SD and Email added
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Tongue disorder
Clinical narrative: She did not receive the second shot per her doctors orders; tip of nose swollen; nausea-doesn't get sick it just passes; legs became weak and can hardly walk; lips swollen and purple; swollen under lower lip; arm itch; arm swollen with bumps; Both sides of tongue have big bumps and all red; Lower lip is completely raw; arm red/hot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (arm red/hot), PRURITUS (arm itch), PERIPHERAL SWELLING (arm swollen with bumps), CYANOSIS (lips swollen and purple) and LIP SWELLING (swollen under lower lip) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included APIXABAN (ELIQUIS) and SOTALOL for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced ERYTHEMA (arm red/hot), TONGUE DISORDER (Both sides of tongue have big bumps and all red) and CHEILITIS (Lower lip is completely raw). On 21-Mar-2021, the patient experienced PRURITUS (arm itch) and PERIPHERAL SWELLING (arm swollen with bumps). On 27-Mar-2021, the patient experienced CYANOSIS (lips swollen and purple) and LIP SWELLING (swollen under lower lip). On 28-Mar-2021, the patient experienced MUSCULAR WEAKNESS (legs became weak and can hardly walk). On 29-Mar-2021, the patient experienced SWELLING (tip of nose swollen) and NAUSEA (nausea-doesn't get sick it just passes). On 08-Apr-2021, the patient experienced INTENTIONAL DOSE OMISSION (She did not receive the second shot per her doctors orders). On 08-Apr-2021, INTENTIONAL DOSE OMISSION (She did not receive the second shot per her doctors orders) had resolved. At the time of the report, ERYTHEMA (arm red/hot), PERIPHERAL SWELLING (arm swollen with bumps), CYANOSIS (lips swollen and purple), TONGUE DISORDER (Both sides of tongue have big bumps and all red) and CHEILITIS (Lower lip is completely raw) had not resolved and PRURITUS (arm itch), LIP SWELLING (swollen under lower lip), SWELLING (tip of nose swollen), MUSCULAR WEAKNESS (legs became weak and can hardly walk) and NAUSEA (nausea-doesn't get sick it just passes) outcome was unknown.            Treatment medication included Steroid shot and Diphenhydramine. The patient also cold compressed her arm. Patient's doctor suggested her to not get the second dose.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: event added, SD and Email added