chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Product dose omission issue
Clinical narrative: 2nd Moderna Vaccine past 42 days; 2nd Moderna Vaccine past 42 days; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd Moderna Vaccine past 42 days) and PRODUCT DOSE OMISSION ISSUE (2nd Moderna Vaccine past 42 days) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Inappropriate schedule of vaccine administered on 05-Apr-2021, Drug allergy (Thiopental sodium) and Inappropriate schedule of vaccine administered on 05-Apr-2021.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 16-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd Moderna Vaccine past 42 days). On 05-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd Moderna Vaccine past 42 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (2nd Moderna Vaccine past 42 days) outcome was unknown. Not Provided.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd Moderna Vaccine past 42 days) and PRODUCT DOSE OMISSION ISSUE (2nd Moderna Vaccine past 42 days) to be possibly related.    The concomitant medications was not reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Covid arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm) 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 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE REACTION (Covid arm). At the time of the report, VACCINATION SITE REACTION (Covid arm) outcome was unknown.            No relevant concomitant medications reported.  No treatment information was provided.   This case was linked to MODERNATX, INC.-MOD-2021-067589 (E2B Linked Report).; Sender's Comments: MODERNATX, INC.-MOD-2021-067589:
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives are mainly on her torso and thighs; This spontaneous case was reported by a pharmacist and describes the occurrence of URTICARIA in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hives. Concomitant products included BENADRYL for an unknown indication.   On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced URTICARIA. The patient was treated with Manual therapy (Oatmeal baths) for Urticaria. At the time of the report, URTICARIA outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to events was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Adverse event; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of ADVERSE EVENT (Adverse event) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Adverse event). At the time of the report, ADVERSE EVENT (Adverse event) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment drug information provided. No concomitant drug information provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Diarrhoea, Headache, Myalgia
Clinical narrative: Diarrhea (6 times per day); Weakness; Muscle ache; Headache; Chills; Nausea; Vomiting; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (Diarrhea (6 times per day)), ASTHENIA (Weakness), MYALGIA (Muscle ache), HEADACHE (Headache) and CHILLS (Chills) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included PAROXETINE HYDROCHLORIDE (PAXIL [PAROXETINE HYDROCHLORIDE]), ATENOLOL and HYDROCHLOROTHIAZIDE for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced DIARRHOEA (Diarrhea (6 times per day)), ASTHENIA (Weakness), MYALGIA (Muscle ache), HEADACHE (Headache), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, DIARRHOEA (Diarrhea (6 times per day)) had resolved and ASTHENIA (Weakness), MYALGIA (Muscle ache), HEADACHE (Headache), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication were not reported
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Diarrhea (6 times per day); Weakness; Muscle ache; Headache; Chills; Nausea; Vomiting; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (Diarrhea (6 times per day)), ASTHENIA (Weakness), MYALGIA (Muscle ache), HEADACHE (Headache) and CHILLS (Chills) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included PAROXETINE HYDROCHLORIDE (PAXIL [PAROXETINE HYDROCHLORIDE]), ATENOLOL and HYDROCHLOROTHIAZIDE for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced DIARRHOEA (Diarrhea (6 times per day)), ASTHENIA (Weakness), MYALGIA (Muscle ache), HEADACHE (Headache), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, DIARRHOEA (Diarrhea (6 times per day)) had resolved and ASTHENIA (Weakness), MYALGIA (Muscle ache), HEADACHE (Headache), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication were not reported
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test negative
Clinical narrative: Tested negative for antibodies after receiving both doses of vaccine; This spontaneous case was reported by a physician and describes the occurrence of SARS-COV-2 ANTIBODY TEST NEGATIVE (Tested negative for antibodies after receiving both doses of vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Kidney transplant.    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, the patient experienced SARS-COV-2 ANTIBODY TEST NEGATIVE (Tested negative for antibodies after receiving both doses of vaccine). At the time of the report, SARS-COV-2 ANTIBODY TEST NEGATIVE (Tested negative for antibodies after receiving both doses of vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received both doses of Moderna Covid-19 vaccine.  The patient was tested for antibodies and the result came out negative.  It was reported that  the test would be repeated. Action taken with M-RNA-1273 (Moderna Covid-19 Vaccine) in response to the event was not applicable.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash macular
Clinical narrative: red blotches and streaks on left inner thigh; Streaks on left inner thigh; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (red blotches and streaks on left inner thigh) and RASH (Streaks on left inner thigh) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Apr-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced RASH MACULAR (red blotches and streaks on left inner thigh) and RASH (Streaks on left inner thigh). At the time of the report, RASH MACULAR (red blotches and streaks on left inner thigh) and RASH (Streaks on left inner thigh) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment medications were provided
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pre-existing condition improved, Vaccination site induration, Vaccination site pain, Vaccination site pruritus
Clinical narrative: redness was going down; red; itchy; hard; sore; This spontaneous case was reported by a consumer and describes the occurrence of PRE-EXISTING CONDITION IMPROVED (redness was going down), ERYTHEMA (red), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE INDURATION (hard) and VACCINATION SITE PAIN (sore) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS. Concomitant products included VITAMINS NOS for an unknown indication.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced PRE-EXISTING CONDITION IMPROVED (redness was going down), ERYTHEMA (red), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE INDURATION (hard) and VACCINATION SITE PAIN (sore). At the time of the report, PRE-EXISTING CONDITION IMPROVED (redness was going down), ERYTHEMA (red), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE INDURATION (hard) and VACCINATION SITE PAIN (sore) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient took thyroid medication on regular basis. Patient used cortisone cream to treat her symptoms
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Nausea, Pyrexia
Clinical narrative: low grade fever; heart rate was elevated; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low grade fever), HEART RATE INCREASED (heart rate was elevated) and NAUSEA (nauseous) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020A21A and 025B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in January 2021.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced PYREXIA (low grade fever), HEART RATE INCREASED (heart rate was elevated) and NAUSEA (nauseous). At the time of the report, PYREXIA (low grade fever), HEART RATE INCREASED (heart rate was elevated) and NAUSEA (nauseous) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Apr-2021, Heart rate: 90 (High) heart rate elevated at 90+bpm. and 83 (High) HR is currently 83bpm.. On 05-Apr-2021, Pyrexia: 99.1-100.4 (High) a low grade fever be 99.1 F and 100.4 F.         No concomitant medication was reported. The treatment medication was Tylenol. Action taken with mRNA-1273 in response to the events were not applicable.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Limb injury
Clinical narrative: wound on the bottom of his foot; This spontaneous case was reported by a consumer and describes the occurrence of LIMB INJURY (wound on the bottom of his foot) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     The patient's past medical history included Peripheral arterial disease (chronic circulation problems in his legs). Concurrent medical conditions included Wound (wound on the bottom of foot).    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIMB INJURY (wound on the bottom of his foot). At the time of the report, LIMB INJURY (wound on the bottom of his foot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications are provided. Patient had no changes in his foot conditions due to vaccine.  Treatment medication includes; Amoxycillin, Doxycycline and Levofloxacin Patients print out for these pharmaceuticals told him not to take any Viral Vaccine along with treatment medications. Second dose of vaccine is due on 14APR2021
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm where he got the injection for 2-3 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm where he got the injection for 2-3 days) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) 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 26-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore arm where he got the injection for 2-3 days). At the time of the report, VACCINATION SITE PAIN (Sore arm where he got the injection for 2-3 days) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Nausea, Pain in extremity, Vomiting
Clinical narrative: arm soreness; Diarrhea; headache; Nausea; Vomitting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness), DIARRHOEA (Diarrhea), HEADACHE (headache), NAUSEA (Nausea) and VOMITING (Vomitting) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     The patient's past medical history included Fragile X syndrome.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm soreness), DIARRHOEA (Diarrhea), HEADACHE (headache), NAUSEA (Nausea) and VOMITING (Vomitting). On 28-Mar-2021, PAIN IN EXTREMITY (arm soreness) and HEADACHE (headache) had resolved. At the time of the report, DIARRHOEA (Diarrhea), NAUSEA (Nausea) and VOMITING (Vomitting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: NNI: mailing address provided On 16-Jul-2021: Reporter's address updated.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Tenderness, Thermal burn, Vaccination site discolouration, Vaccination site erythema
Clinical narrative: Injection site swelling; Injection site redness; Large knot at injection site; Injection site discolouration; Tender to touch; 2nd degree burn; Received 2nd dose subcutaneously left arm; Huge knot at injection site; pain at the injection site 2nd dose felt like stab wounds; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Received 2nd dose subcutaneously left arm), VACCINATION SITE SWELLING (Injection site swelling), VACCINATION SITE ERYTHEMA (Injection site redness), VACCINATION SITE INDURATION (Large knot at injection site) and VACCINATION SITE DISCOLOURATION (Injection site discolouration) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Codeine).   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Received 2nd dose subcutaneously left arm). On an unknown date, the patient experienced VACCINATION SITE SWELLING (Injection site swelling), VACCINATION SITE ERYTHEMA (Injection site redness), VACCINATION SITE INDURATION (Large knot at injection site), VACCINATION SITE DISCOLOURATION (Injection site discolouration) and TENDERNESS (Tender to touch). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 28-Mar-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Received 2nd dose subcutaneously left arm) had resolved. At the time of the report, VACCINATION SITE SWELLING (Injection site swelling), VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE INDURATION (Large knot at injection site) outcome was unknown and VACCINATION SITE DISCOLOURATION (Injection site discolouration) and TENDERNESS (Tender to touch) had not resolved.            No concomitant medications were reported.    This case was linked to MOD-2021-067614 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: VAERS: Out come of the event and New events added. Allergy to Codeine added.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site mass, Vaccination site pain, Vaccination site swelling
Clinical narrative: Injection site swelling; Injection site redness; Large knot at injection site; Injection site discolouration; Tender to touch; 2nd degree burn; Received 2nd dose subcutaneously left arm; Huge knot at injection site; pain at the injection site 2nd dose felt like stab wounds; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Received 2nd dose subcutaneously left arm), VACCINATION SITE SWELLING (Injection site swelling), VACCINATION SITE ERYTHEMA (Injection site redness), VACCINATION SITE INDURATION (Large knot at injection site) and VACCINATION SITE DISCOLOURATION (Injection site discolouration) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Codeine).   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Received 2nd dose subcutaneously left arm). On an unknown date, the patient experienced VACCINATION SITE SWELLING (Injection site swelling), VACCINATION SITE ERYTHEMA (Injection site redness), VACCINATION SITE INDURATION (Large knot at injection site), VACCINATION SITE DISCOLOURATION (Injection site discolouration) and TENDERNESS (Tender to touch). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 28-Mar-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Received 2nd dose subcutaneously left arm) had resolved. At the time of the report, VACCINATION SITE SWELLING (Injection site swelling), VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE INDURATION (Large knot at injection site) outcome was unknown and VACCINATION SITE DISCOLOURATION (Injection site discolouration) and TENDERNESS (Tender to touch) had not resolved.            No concomitant medications were reported.    This case was linked to MOD-2021-067614 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: VAERS: Out come of the event and New events added. Allergy to Codeine added.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Generalized aching; Nausea; Low grade fever; Chills; Headache; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (Generalized aching), NAUSEA (Nausea), PYREXIA (Low grade fever), CHILLS (Chills) and HEADACHE (Headache) in an adult 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 included ADALIMUMAB (HUMIRA) and SODIUM CITRATE (CITRATE).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Generalized aching), NAUSEA (Nausea), PYREXIA (Low grade fever), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, PAIN (Generalized aching), NAUSEA (Nausea), PYREXIA (Low grade fever), CHILLS (Chills) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: Low.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medications include  HUMIRA and  CITRATE  Treatment details were not reported.   Reporter did not allow further contact
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Haematuria, Headache, Influenza like illness
Clinical narrative: Blood in urine; Severe flu like symptoms; Severe stomach pain; Headache; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of HAEMATURIA (Blood in urine), INFLUENZA LIKE ILLNESS (Severe flu like symptoms), ABDOMINAL PAIN UPPER (Severe stomach pain) and HEADACHE (Headache) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) 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 INFLUENZA LIKE ILLNESS (Severe flu like symptoms), ABDOMINAL PAIN UPPER (Severe stomach pain) and HEADACHE (Headache). On 04-Apr-2021, the patient experienced HAEMATURIA (Blood in urine). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. On 04-Apr-2021, INFLUENZA LIKE ILLNESS (Severe flu like symptoms), ABDOMINAL PAIN UPPER (Severe stomach pain) and HEADACHE (Headache) had resolved. At the time of the report, HAEMATURIA (Blood in urine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: F/U: Outcome of event
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Dizziness, Pain, Pain in extremity
Clinical narrative: sore arm; dizziness; stinging,/pain to the point of tears; burning; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (stinging,/pain to the point of tears), PAIN IN EXTREMITY (sore arm), BURNING SENSATION (burning) and DIZZINESS (dizziness) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis and Celiac disease.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced PAIN (stinging,/pain to the point of tears) and BURNING SENSATION (burning). On 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and DIZZINESS (dizziness). At the time of the report, PAIN (stinging,/pain to the point of tears), PAIN IN EXTREMITY (sore arm), BURNING SENSATION (burning) and DIZZINESS (dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Patient took expired Dramamine for her dizziness and it was helpful.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: pain at injection site 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (pain at injection site 1st dose) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced INJECTION SITE PAIN (pain at injection site 1st dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. On 27-Feb-2021, INJECTION SITE PAIN (pain at injection site 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   This case was linked to MOD-2021-067610 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Caught COVID in between first and second dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Caught COVID in between first and second dose) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007821A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Caught COVID in between first and second dose). At the time of the report, COVID-19 (Caught COVID in between first and second dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No corrective treatment was provided. Patient second dose was scheduled on 15-Apr-2021. Patient wanted to know if she should take the second dose or she could delay.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Headache, Pyrexia, Rhinorrhoea
Clinical narrative: runny nose; cough; head ache; Fever of 101.5 degrees Farenheight; Joints in my fingers all hurt; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA, HEADACHE, COUGH, PYREXIA, and ARTHRALGIA in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced RHINORRHOEA, HEADACHE, COUGH, PYREXIA, and ARTHRALGIA. At the time of the report, HEADACHE, COUGH, PYREXIA, and ARTHRALGIA outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Seventeen year old received Moderna Covid-19 vaccine; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Seventeen year old received Moderna Covid-19 vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018b21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Seventeen year old received Moderna Covid-19 vaccine). On 05-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Seventeen year old received Moderna Covid-19 vaccine) had resolved. Not Provided      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.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Insomnia, Pyrexia, Vaccination complication
Clinical narrative: head hurts so bad this morning and it feels bad.; slept only 5 hours; fever; throbbing and dull headache (pain)that felt like someone was hitting her with a hammer; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (slept only 5 hours), VACCINATION COMPLICATION (head hurts so bad this morning and it feels bad.), PYREXIA (fever) and HEADACHE (throbbing and dull headache (pain)that felt like someone was hitting her with a hammer) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 010A21A) for COVID-19 vaccination.     The patient's past medical history included Cough variant asthma (History of asthma cough since 2 years of age. Has Asthma cough every morning.) since 1968.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced PYREXIA (fever) and HEADACHE (throbbing and dull headache (pain)that felt like someone was hitting her with a hammer). On 03-Apr-2021, the patient experienced INSOMNIA (slept only 5 hours). On 04-Apr-2021, the patient experienced VACCINATION COMPLICATION (head hurts so bad this morning and it feels bad.). At the time of the report, INSOMNIA (slept only 5 hours), VACCINATION COMPLICATION (head hurts so bad this morning and it feels bad.), PYREXIA (fever) and HEADACHE (throbbing and dull headache (pain)that felt like someone was hitting her with a hammer) outcome was unknown.            Patient was taking asthma medication on the phone due to the cough but did not specify the medication. Patient tried icepack for 4 hours
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Pain, Pyrexia, Vomiting
Clinical narrative: pain in the intestines; fever; colic in her intestines; fever; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (colic in her intestines), PAIN (pain in the intestines), the first episode of PYREXIA (fever), VOMITING (vomiting) and the second episode of PYREXIA (fever) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B4A and 023M20A) for an unknown indication.     The patient's past medical history included No adverse event.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 05-Mar-2021, the patient experienced ABDOMINAL PAIN (colic in her intestines), the first episode of PYREXIA (fever) and VOMITING (vomiting). On 02-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN (pain in the intestines) and the second episode of PYREXIA (fever). At the time of the report, ABDOMINAL PAIN (colic in her intestines) and VOMITING (vomiting) had resolved and PAIN (pain in the intestines) and the last episode of PYREXIA (fever) had not resolved.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Product administered to patient of inappropriate age
Clinical narrative: vaccine administered at 17 years age/under 18; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administered at 17 years age/under 18) and HEADACHE (Headaches) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administered at 17 years age/under 18) and HEADACHE (Headaches). On 05-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administered at 17 years age/under 18) had resolved. At the time of the report, HEADACHE (Headaches) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  The patient did not take any treatment medication for the headache.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Decreased appetite, Gait disturbance
Clinical narrative: just trying to walk or go to the bathroom was difficult; muscle aches; arthralgia (in fingers and knees); high feverof 102°F; blinding headache; Arm was swollen and hurting; go to the bathroom was difficult and felt miserable; Serious chills; very week and tired; didnt feel like eating; Glands are still swollen / Had swollen glands behind the earlobes; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (very week and tired), DECREASED APPETITE (didnt feel like eating), GAIT DISTURBANCE (just trying to walk or go to the bathroom was difficult), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (go to the bathroom was difficult and felt miserable) and CHILLS (Serious chills) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced ASTHENIA (very week and tired), DECREASED APPETITE (didnt feel like eating), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (go to the bathroom was difficult and felt miserable), CHILLS (Serious chills), ARTHRALGIA (arthralgia (in fingers and knees)), PYREXIA (high feverof 102°F), HEADACHE (blinding headache) and VACCINATION SITE SWELLING (Arm was swollen and hurting). In April 2021, the patient experienced LYMPHADENOPATHY (Glands are still swollen / Had swollen glands behind the earlobes). On an unknown date, the patient experienced GAIT DISTURBANCE (just trying to walk or go to the bathroom was difficult) and MYALGIA (muscle aches). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. On 04-Apr-2021, ARTHRALGIA (arthralgia (in fingers and knees)) and HEADACHE (blinding headache) had resolved. At the time of the report, ASTHENIA (very week and tired), DECREASED APPETITE (didnt feel like eating), GAIT DISTURBANCE (just trying to walk or go to the bathroom was difficult), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (go to the bathroom was difficult and felt miserable), CHILLS (Serious chills), MYALGIA (muscle aches), PYREXIA (high feverof 102°F), VACCINATION SITE SWELLING (Arm was swollen and hurting) and LYMPHADENOPATHY (Glands are still swollen / Had swollen glands behind the earlobes) had resolved.            Concomitant product information was not provided.  It was also reported that patient feels fine now and has no additional things going on.   This case was linked to MOD-2021-239045 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow-up information received captured reporter details, patient demographics, product details, treatment and events.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Loss of personal independence in daily activities, Lymphadenopathy, Myalgia, Pyrexia
Clinical narrative: just trying to walk or go to the bathroom was difficult; muscle aches; arthralgia (in fingers and knees); high feverof 102°F; blinding headache; Arm was swollen and hurting; go to the bathroom was difficult and felt miserable; Serious chills; very week and tired; didnt feel like eating; Glands are still swollen / Had swollen glands behind the earlobes; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (very week and tired), DECREASED APPETITE (didnt feel like eating), GAIT DISTURBANCE (just trying to walk or go to the bathroom was difficult), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (go to the bathroom was difficult and felt miserable) and CHILLS (Serious chills) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced ASTHENIA (very week and tired), DECREASED APPETITE (didnt feel like eating), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (go to the bathroom was difficult and felt miserable), CHILLS (Serious chills), ARTHRALGIA (arthralgia (in fingers and knees)), PYREXIA (high feverof 102°F), HEADACHE (blinding headache) and VACCINATION SITE SWELLING (Arm was swollen and hurting). In April 2021, the patient experienced LYMPHADENOPATHY (Glands are still swollen / Had swollen glands behind the earlobes). On an unknown date, the patient experienced GAIT DISTURBANCE (just trying to walk or go to the bathroom was difficult) and MYALGIA (muscle aches). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. On 04-Apr-2021, ARTHRALGIA (arthralgia (in fingers and knees)) and HEADACHE (blinding headache) had resolved. At the time of the report, ASTHENIA (very week and tired), DECREASED APPETITE (didnt feel like eating), GAIT DISTURBANCE (just trying to walk or go to the bathroom was difficult), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (go to the bathroom was difficult and felt miserable), CHILLS (Serious chills), MYALGIA (muscle aches), PYREXIA (high feverof 102°F), VACCINATION SITE SWELLING (Arm was swollen and hurting) and LYMPHADENOPATHY (Glands are still swollen / Had swollen glands behind the earlobes) had resolved.            Concomitant product information was not provided.  It was also reported that patient feels fine now and has no additional things going on.   This case was linked to MOD-2021-239045 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow-up information received captured reporter details, patient demographics, product details, treatment and events.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: just trying to walk or go to the bathroom was difficult; muscle aches; arthralgia (in fingers and knees); high feverof 102°F; blinding headache; Arm was swollen and hurting; go to the bathroom was difficult and felt miserable; Serious chills; very week and tired; didnt feel like eating; Glands are still swollen / Had swollen glands behind the earlobes; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (very week and tired), DECREASED APPETITE (didnt feel like eating), GAIT DISTURBANCE (just trying to walk or go to the bathroom was difficult), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (go to the bathroom was difficult and felt miserable) and CHILLS (Serious chills) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced ASTHENIA (very week and tired), DECREASED APPETITE (didnt feel like eating), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (go to the bathroom was difficult and felt miserable), CHILLS (Serious chills), ARTHRALGIA (arthralgia (in fingers and knees)), PYREXIA (high feverof 102°F), HEADACHE (blinding headache) and VACCINATION SITE SWELLING (Arm was swollen and hurting). In April 2021, the patient experienced LYMPHADENOPATHY (Glands are still swollen / Had swollen glands behind the earlobes). On an unknown date, the patient experienced GAIT DISTURBANCE (just trying to walk or go to the bathroom was difficult) and MYALGIA (muscle aches). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. On 04-Apr-2021, ARTHRALGIA (arthralgia (in fingers and knees)) and HEADACHE (blinding headache) had resolved. At the time of the report, ASTHENIA (very week and tired), DECREASED APPETITE (didnt feel like eating), GAIT DISTURBANCE (just trying to walk or go to the bathroom was difficult), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (go to the bathroom was difficult and felt miserable), CHILLS (Serious chills), MYALGIA (muscle aches), PYREXIA (high feverof 102°F), VACCINATION SITE SWELLING (Arm was swollen and hurting) and LYMPHADENOPATHY (Glands are still swollen / Had swollen glands behind the earlobes) had resolved.            Concomitant product information was not provided.  It was also reported that patient feels fine now and has no additional things going on.   This case was linked to MOD-2021-239045 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow-up information received captured reporter details, patient demographics, product details, treatment and events.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Feeling jittery, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Puffy arms; Jittering in chest; Warm and pink Cheeks; Pain in arms; arms itching inside of arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Puffy arms), FEELING JITTERY (Jittering in chest), FEELING HOT (Warm and pink Cheeks), PAIN IN EXTREMITY (Pain in arms) and PRURITUS (arms itching inside of arm) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PERIPHERAL SWELLING (Puffy arms), FEELING JITTERY (Jittering in chest), FEELING HOT (Warm and pink Cheeks), PAIN IN EXTREMITY (Pain in arms) and PRURITUS (arms itching inside of arm). At the time of the report, PERIPHERAL SWELLING (Puffy arms), FEELING JITTERY (Jittering in chest), FEELING HOT (Warm and pink Cheeks), PAIN IN EXTREMITY (Pain in arms) and PRURITUS (arms itching inside of arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported that she is taking concomitant medication (unspecified) and will follow up with her healthcare professional.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Vaccine hot; The spot where she received the vaccine is still red; Vaccine swollen; Vaccine itchy; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE ERYTHEMA (The spot where she received the vaccine is still red), VACCINATION SITE WARMTH (Vaccine hot), VACCINATION SITE SWELLING (Vaccine swollen) and VACCINATION SITE PRURITUS (Vaccine itchy) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-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 VACCINATION SITE ERYTHEMA (The spot where she received the vaccine is still red), VACCINATION SITE WARMTH (Vaccine hot), VACCINATION SITE SWELLING (Vaccine swollen) and VACCINATION SITE PRURITUS (Vaccine itchy). At the time of the report, VACCINATION SITE ERYTHEMA (The spot where she received the vaccine is still red), VACCINATION SITE WARMTH (Vaccine hot), VACCINATION SITE SWELLING (Vaccine swollen) and VACCINATION SITE PRURITUS (Vaccine itchy) outcome was unknown. Not Provided      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 medications were not reported.  No treatment information provided by the reporter.  Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow-up information received on 02-JUL-2021 contains no new information.