chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 89.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pruritus, Scratch, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: itching; arm swollen; red arm; itchy arm; scratching the insides of her hands and wrists; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), VACCINATION SITE SWELLING (arm swollen), VACCINATION SITE ERYTHEMA (red arm), VACCINATION SITE PRURITUS (itchy arm) and SCRATCH (scratching the insides of her hands and wrists) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.    Co-suspect product included non-company product COLLAGEN for an unknown indication.    Concomitant products included OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), HYDROCODONE BITARTRATE, PARACETAMOL (VICODIN), AMLODIPINE, GABAPENTIN, amour thryoid, FLUOXETINE HYDROCHLORIDE (PROZAC), CYANOCOBALAMIN, FOLIC ACID (VITAMIN B12 & FOLIC ACID), MAGNESIUM and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started COLLAGEN (unknown route) dosage form. On 05-Apr-2021, the patient experienced PRURITUS (itching), VACCINATION SITE SWELLING (arm swollen), VACCINATION SITE ERYTHEMA (red arm), VACCINATION SITE PRURITUS (itchy arm) and SCRATCH (scratching the insides of her hands and wrists). At the time of the report, PRURITUS (itching), VACCINATION SITE SWELLING (arm swollen), VACCINATION SITE ERYTHEMA (red arm), VACCINATION SITE PRURITUS (itchy arm) and SCRATCH (scratching the insides of her hands and wrists) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included,Cortisone and Neosporin with no alleviation
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Myalgia
Clinical narrative: Not felling well; Severe body aches; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not felling well), MYALGIA (Severe body aches) and FATIGUE (Fatigue) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     Concomitant products included VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced MYALGIA (Severe body aches) and FATIGUE (Fatigue). On 07-Apr-2021, the patient experienced MALAISE (Not felling well). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form. At the time of the report, MALAISE (Not felling well), MYALGIA (Severe body aches) and FATIGUE (Fatigue) outcome was unknown.            On 06-Apr-2021, the patient received their 2nd dose of the Moderna vaccine and by midnight the patient began to experience fatigue, and severe body aches.  Reportedly, on 07-Apr-2021, the patient was not feeling well.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-069657 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Pain is worse after the vaccine than day before the vaccine shot; zero improvement in the pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Pain is worse after the vaccine than day before the vaccine shot; zero improvement in the pain) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Cortisone (Cortisone injection in her hip.) on 22-Feb-2021. Past adverse reactions to the above products included No adverse reaction with Cortisone. Concurrent medical conditions included Arthralgia.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced ARTHRALGIA (Pain is worse after the vaccine than day before the vaccine shot; zero improvement in the pain). At the time of the report, ARTHRALGIA (Pain is worse after the vaccine than day before the vaccine shot; zero improvement in the pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       On 09-Mar-2021, the patient received their first dose. On 22-Feb-2021, the patient had a Cortisone injection in their hip. On 08-Mar-2021, the patient visited the doctor who gave them the injection. At this time, the patient reported to the doctor that they had 70% improvement in their hip pain.  Reportedly, the patient told to their doctor that the patient was looking to get vaccine but was concerned about doing it after getting the Cortisone injection to which their doctor advised the patient to wait two weeks after the Cortisone injection to get the vaccine.  The patient reported that the pain was back to where it was on 09-Mar-2021 and had zero improvement in the pain and patient was still struggling with it. The patient said the pain was worse after the vaccine than day before the vaccine shot. The patient asked their doctor who gave the Cortisone injection if the vaccine could reverse the effect of the shot and the doctor said all of this is so new and no one really knows.  No Concomitant product use was reported. No treatment information was provided.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Lethargy, Product administered to patient of inappropriate age, Pyrexia, Vertigo
Clinical narrative: Vertigo; Fever; headaches; 16-years-old patient was administered Moderna's Covid-19 vaccine; Lethargy; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16-years-old patient was administered Moderna's Covid-19 vaccine), LETHARGY (Lethargy), VERTIGO (Vertigo), PYREXIA (Fever) and HEADACHE (headaches) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020.    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 (16-years-old patient was administered Moderna's Covid-19 vaccine), LETHARGY (Lethargy), PYREXIA (Fever) and HEADACHE (headaches). On 06-Apr-2021, the patient experienced VERTIGO (Vertigo). On 05-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16-years-old patient was administered Moderna's Covid-19 vaccine) had resolved. On 06-Apr-2021, VERTIGO (Vertigo) outcome was unknown. At the time of the report, LETHARGY (Lethargy), PYREXIA (Fever) and HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided. Caller does not know that their son shouldn't receive the vaccine.  This report refers to a case of Product administered to patient of inappropriate age, for mRNA-1273, lot # unknown. Based on the current available information and temporal association between the use of the product and the start date of the events, headache, pyrexia, vertigo, lethargy, a causal relationship cannot be excluded.   This case was linked to MOD21-071243, MOD21-071244 (E2B Linked Report).; Sender's Comments: This report refers to a case of Product administered to patient of inappropriate age, for mRNA-1273, lot # unknown. Based on the current available information and temporal association between the use of the product and the start date of the events, headache, pyrexia, vertigo, lethargy, a causal relationship cannot be excluded. MOD21-071243:same reporter MOD21-071244:same reporter
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    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 PAIN IN EXTREMITY (Sore Arm). At the time of the report, PAIN IN EXTREMITY (Sore Arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient received their first dose of Moderna Covid-19 vaccine and experienced a sore arm.  No Concomitant product use was reported. No treatment information was provided.   This case was linked to INC.-MOD-2021-069676 (E2B Linked Report).; Sender's Comments:   INC.-MOD-2021-069676:
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Vaccination site pain, Vaccination site swelling
Clinical narrative: Generalized body pains; swelling at the injection site; Tenderness at Injection site; fever; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Generalized body pains), VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE PAIN (Tenderness at Injection site), PYREXIA (fever) and NAUSEA (Nausea) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history was not provided).    On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced PAIN (Generalized body pains), VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE PAIN (Tenderness at Injection site), PYREXIA (fever) and NAUSEA (Nausea). At the time of the report, PAIN (Generalized body pains), VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE PAIN (Tenderness at Injection site), PYREXIA (fever) and NAUSEA (Nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment for the events included paracetamol.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: Possible incorrect administration of second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Possible incorrect administration of second dose) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020 and COVID-19 in July 2020.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Possible incorrect administration of second dose). On 07-Apr-2021, PRODUCT ADMINISTRATION ERROR (Possible incorrect administration of second dose) had resolved.            The reporter was calling on behalf of their husband who received their second dose on 07-Apr-2021. The reporter informed that during the administration of the second dose of the vaccine, it was believed that there was an administration error. The reporter believes that the patient did not receive the dose correctly.  Reportedly, instead of the injection being done straight into the deltoid muscle, the administrator pinched the skin on the deltoid and then administered the vaccine. No other side effects have been reported by the reporter with the second administration. The reporter also informed that the patient had previous COVID-19 infections in July and December of 2020.  No Concomitant product use was reported. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to INC.-MOD-2021-069658 (E2B Linked Report). This case was linked to MOD-2021-069658 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: TCR was received on 19-May-2021 and contains non-significant information.; Sender's Comments: INC.-MOD-2021-069658:First Dose of husband
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Myalgia, Pain in extremity
Clinical narrative: Malestar en el cuerpo/ discomfort in the body; Dolor en el brazo/ pain in the arm; Dolor en el cuerpo /pain in the body; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Malestar en el cuerpo/ discomfort in the body), PAIN IN EXTREMITY (Dolor en el brazo/ pain in the arm) and MYALGIA (Dolor en el cuerpo /pain in the body) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     Concomitant products included PRAVASTATIN 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 PAIN IN EXTREMITY (Dolor en el brazo/ pain in the arm) and MYALGIA (Dolor en el cuerpo /pain in the body). On 05-Apr-2021, the patient experienced DISCOMFORT (Malestar en el cuerpo/ discomfort in the body). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 04-Apr-2021, PAIN IN EXTREMITY (Dolor en el brazo/ pain in the arm) and MYALGIA (Dolor en el cuerpo /pain in the body) had resolved. At the time of the report, DISCOMFORT (Malestar en el cuerpo/ discomfort in the body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient was a Spanish speaker and received their first dose of Moderna vaccine on 01-Apr-2021. At night, the patient's daughter had symptoms and on Friday their daughter tested positive for COVID-19. On 02-Apr-2021, Friday, the patient began to have symptoms, such as pain in their body and in their arm. These symptoms continued on Saturday but on Sunday the patient felt fine. On 05-Apr-2021, the patient again experienced discomfort in their body.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swollen tongue, Tongue disorder
Clinical narrative: tongue swollen and itchy; tongue swollen and itchy; bumps on it; tongue is starting to itch more; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (tongue swollen and itchy), PRURITUS (tongue swollen and itchy), TONGUE DISORDER (bumps on it) and PRURITUS (tongue is starting to itch more) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWOLLEN TONGUE (tongue swollen and itchy), PRURITUS (tongue swollen and itchy), TONGUE DISORDER (bumps on it) and PRURITUS (tongue is starting to itch more). At the time of the report, SWOLLEN TONGUE (tongue swollen and itchy), PRURITUS (tongue swollen and itchy), TONGUE DISORDER (bumps on it) and PRURITUS (tongue is starting to itch more) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. No concomitant medication  were provided.
Sex: M
Vaccine: COVID19
Symptoms: Mouth ulceration
Clinical narrative: Mouth ulcer; This spontaneous case was reported by a consumer and describes the occurrence of MOUTH ULCERATION (Mouth ulcer) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 MOUTH ULCERATION (Mouth ulcer). At the time of the report, MOUTH ULCERATION (Mouth ulcer) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No relevant concomitant medications were reported.   This case was linked to MOD21-071427 (E2B Linked Report).; Sender's Comments:  MOD21-071427:
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Vaccination site pain
Clinical narrative: Body Aches; sore arm at the injection site; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body Aches), VACCINATION SITE PAIN (sore arm at the injection site) and FATIGUE (tiredness) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 030A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced MYALGIA (Body Aches). 03-Apr-2021, the patient experienced VACCINATION SITE PAIN (sore arm at the injection site) and FATIGUE (tiredness). At the time of the report, MYALGIA (Body Aches), VACCINATION SITE PAIN (sore arm at the injection site) and FATIGUE (tiredness) outcome was unknown. Not Provided          Concomitant Medications were not provided by the reporter. Treatment Medications were not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-069670 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-069670:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Fatigue, Headache
Clinical narrative: sore arm; a really bad rash; really bad chills; the knot on her arm is about the size of a tennis ball; headache; coughing; sneezing; and extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), RASH (a really bad rash), CHILLS (really bad chills), NODULE (the knot on her arm is about the size of a tennis ball) and HEADACHE (headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (She had Corona virus in November and was hospitalized.) in November 2020. Concurrent medical conditions included Haemoglobin low. Concomitant products included WARFARIN and PREDNISONE for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), RASH (a really bad rash), CHILLS (really bad chills), NODULE (the knot on her arm is about the size of a tennis ball), HEADACHE (headache), COUGH (coughing), SNEEZING (sneezing) and FATIGUE (and extremely tired). At the time of the report, PAIN IN EXTREMITY (sore arm), RASH (a really bad rash), CHILLS (really bad chills), NODULE (the knot on her arm is about the size of a tennis ball), HEADACHE (headache), COUGH (coughing), SNEEZING (sneezing) and FATIGUE (and extremely tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, COVID-19: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications provided were cortisone cream and warm compress.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Nodule, Pain in extremity, Rash, Sneezing
Clinical narrative: sore arm; a really bad rash; really bad chills; the knot on her arm is about the size of a tennis ball; headache; coughing; sneezing; and extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), RASH (a really bad rash), CHILLS (really bad chills), NODULE (the knot on her arm is about the size of a tennis ball) and HEADACHE (headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (She had Corona virus in November and was hospitalized.) in November 2020. Concurrent medical conditions included Haemoglobin low. Concomitant products included WARFARIN and PREDNISONE for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), RASH (a really bad rash), CHILLS (really bad chills), NODULE (the knot on her arm is about the size of a tennis ball), HEADACHE (headache), COUGH (coughing), SNEEZING (sneezing) and FATIGUE (and extremely tired). At the time of the report, PAIN IN EXTREMITY (sore arm), RASH (a really bad rash), CHILLS (really bad chills), NODULE (the knot on her arm is about the size of a tennis ball), HEADACHE (headache), COUGH (coughing), SNEEZING (sneezing) and FATIGUE (and extremely tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, COVID-19: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications provided were cortisone cream and warm compress.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Hypoglycaemia
Clinical narrative: blood sugar went down to 80 and is now normal without medications; This spontaneous case was reported by a consumer and describes the occurrence of HYPOGLYCAEMIA (blood sugar went down to 80 and is now normal without medications) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Handicap. Concomitant products included INSULIN HUMAN (NOVOLIN R) and INSULIN HUMAN INJECTION, ISOPHANE (NOVOLIN N) for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPOGLYCAEMIA (blood sugar went down to 80 and is now normal without medications). At the time of the report, HYPOGLYCAEMIA (blood sugar went down to 80 and is now normal without medications) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Blood glucose: 80.         Action taken with mRNA-1273 in response to the events was not applicable. Treatment details were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-069694 (E2B Linked Report). This case was linked to MOD-2021-069694 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Lymph node pain, Pain, Pyrexia, Swollen tongue
Clinical narrative: shingles; joint and lymph node hurt; painful; fever; swollen tongue; hives; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), SWOLLEN TONGUE (swollen tongue), URTICARIA (hives), HERPES ZOSTER (shingles) and LYMPH NODE PAIN (joint and lymph node hurt) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ATORVASTATIN, LEVOTHYROXINE SODIUM (SYNTHROID) and SPIRONOLACTONE for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On 27-Mar-2021, the patient experienced PYREXIA (fever), SWOLLEN TONGUE (swollen tongue), URTICARIA (hives), LYMPH NODE PAIN (joint and lymph node hurt) and PAIN (painful). On 07-Apr-2021, the patient experienced HERPES ZOSTER (shingles). At the time of the report, PYREXIA (fever), SWOLLEN TONGUE (swollen tongue), URTICARIA (hives), HERPES ZOSTER (shingles), LYMPH NODE PAIN (joint and lymph node hurt) and PAIN (painful) outcome was unknown. Not Provided          Treatment Medications were not Provided by the reporter.   Reporter did not allow further contact.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: shingles; joint and lymph node hurt; painful; fever; swollen tongue; hives; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), SWOLLEN TONGUE (swollen tongue), URTICARIA (hives), HERPES ZOSTER (shingles) and LYMPH NODE PAIN (joint and lymph node hurt) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ATORVASTATIN, LEVOTHYROXINE SODIUM (SYNTHROID) and SPIRONOLACTONE for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On 27-Mar-2021, the patient experienced PYREXIA (fever), SWOLLEN TONGUE (swollen tongue), URTICARIA (hives), LYMPH NODE PAIN (joint and lymph node hurt) and PAIN (painful). On 07-Apr-2021, the patient experienced HERPES ZOSTER (shingles). At the time of the report, PYREXIA (fever), SWOLLEN TONGUE (swollen tongue), URTICARIA (hives), HERPES ZOSTER (shingles), LYMPH NODE PAIN (joint and lymph node hurt) and PAIN (painful) outcome was unknown. Not Provided          Treatment Medications were not Provided by the reporter.   Reporter did not allow further contact.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Her left arm started hurting at injection site on same day; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Her left arm started hurting at injection site on same day) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.    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 VACCINATION SITE PAIN (Her left arm started hurting at injection site on same day). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date at a dose of UNK dosage form. At the time of the report, VACCINATION SITE PAIN (Her left arm started hurting at injection site on same day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications also  include  Vitamins.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site swelling, Pain, Pyrexia
Clinical narrative: Next day, she had fever; Chills; She had body ache; Swollen at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (She had body ache), INJECTION SITE SWELLING (Swollen at injection site), PYREXIA (Next day, she had fever) and CHILLS (Chills) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 immunisation.     No medical history was provided by the reporter.  Concomitant products included DOXEPIN for an unknown indication.   On 05-Apr-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) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced PAIN (She had body ache) and INJECTION SITE SWELLING (Swollen at injection site). On 06-Apr-2021, the patient experienced PYREXIA (Next day, she had fever) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form once a day. In April 2021, PAIN (She had body ache), INJECTION SITE SWELLING (Swollen at injection site), PYREXIA (Next day, she had fever) and CHILLS (Chills) had resolved.            Most recent FOLLOW-UP information incorporated above includes: On 26-Jun-2021: A follow up report received on 26-JUN-2021 included information about the outcome of the events and was updated along with stop date.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Extrasystoles, Palpitations, Vaccination site pain
Clinical narrative: Heartbeats skipped; Palpitations of the heart, heart being accelerated heart being accelerated; Little pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of EXTRASYSTOLES (Heartbeats skipped), PALPITATIONS (Palpitations of the heart, heart being accelerated heart being accelerated) and VACCINATION SITE PAIN (Little pain at the injection site) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 42L20E) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included LISINOPRIL for Blood pressure high.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced EXTRASYSTOLES (Heartbeats skipped), PALPITATIONS (Palpitations of the heart, heart being accelerated heart being accelerated) and VACCINATION SITE PAIN (Little pain at the injection site). At the time of the report, EXTRASYSTOLES (Heartbeats skipped) outcome was unknown and PALPITATIONS (Palpitations of the heart, heart being accelerated heart being accelerated) and VACCINATION SITE PAIN (Little pain at the injection site) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient took cholesterol medication. No treatment medication were reported. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable   Most recent FOLLOW-UP information incorporated above includes: On 26-Jun-2021: TCR is attached on 26-Jun-2021 Updated outcome for the events (palpitations and vaccination site pain) from unknow to recovered. On 16-Jul-2021: Follow-up received on 16-JUL-2021 contains non significant information. Verbatim of the event palpitation updated, patient initials updated.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Blood urine, Blood urine present, Chills, Dysuria, Illness
Clinical narrative: Frequent urination; Got sick; Night sweats; Blood in urine; Pain in the arm; Foul smell of urine; Frequent urination, little bit pain; Light fever; Aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of URINE OUTPUT INCREASED (Frequent urination), ILLNESS (Got sick), NIGHT SWEATS (Night sweats), BLOOD URINE PRESENT (Blood in urine) and PAIN IN EXTREMITY (Pain in the arm) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018b21a and 005c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (COVID-19 positive) in February 2021, Chills from 30-Nov-2020 to 15-Dec-2020, UTI from 30-Nov-2020 to 15-Dec-2020, Fever from 30-Nov-2020 to 15-Dec-2020 and Myalgia from 30-Nov-2020 to 15-Dec-2020. Concurrent medical conditions included Kidney stones (Patient was being treated for Kidney stones lithotropsy in November and again at the end of December) since 01-Jan-2014.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced URINE OUTPUT INCREASED (Frequent urination), ILLNESS (Got sick), NIGHT SWEATS (Night sweats), BLOOD URINE PRESENT (Blood in urine), PAIN IN EXTREMITY (Pain in the arm), URINE ODOUR ABNORMAL (Foul smell of urine), DYSURIA (Frequent urination, little bit pain), PYREXIA (Light fever), MYALGIA (Aches) and CHILLS (Chills). On 04-Apr-2021, URINE OUTPUT INCREASED (Frequent urination), ILLNESS (Got sick), NIGHT SWEATS (Night sweats), PAIN IN EXTREMITY (Pain in the arm), URINE ODOUR ABNORMAL (Foul smell of urine), DYSURIA (Frequent urination, little bit pain) and PYREXIA (Light fever) had resolved. On 05-Apr-2021, BLOOD URINE PRESENT (Blood in urine), MYALGIA (Aches) and CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, SARS-CoV-2 test: positive (Positive) antibody test by blood bank. On 02-Apr-2021, Blood urine: present (Positive) Blood in urine. On 02-Apr-2021, Urine output: increase (High) Frequent urination.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow-up information received on 18-MAY-2021 contains reporter details, patient demographics, patient medical history, lab data, dose details, vaccine facility and event stop date were updated.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Night sweats, Pain in extremity, Pyrexia, SARS-CoV-2 test
Clinical narrative: Frequent urination; Got sick; Night sweats; Blood in urine; Pain in the arm; Foul smell of urine; Frequent urination, little bit pain; Light fever; Aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of URINE OUTPUT INCREASED (Frequent urination), ILLNESS (Got sick), NIGHT SWEATS (Night sweats), BLOOD URINE PRESENT (Blood in urine) and PAIN IN EXTREMITY (Pain in the arm) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018b21a and 005c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (COVID-19 positive) in February 2021, Chills from 30-Nov-2020 to 15-Dec-2020, UTI from 30-Nov-2020 to 15-Dec-2020, Fever from 30-Nov-2020 to 15-Dec-2020 and Myalgia from 30-Nov-2020 to 15-Dec-2020. Concurrent medical conditions included Kidney stones (Patient was being treated for Kidney stones lithotropsy in November and again at the end of December) since 01-Jan-2014.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced URINE OUTPUT INCREASED (Frequent urination), ILLNESS (Got sick), NIGHT SWEATS (Night sweats), BLOOD URINE PRESENT (Blood in urine), PAIN IN EXTREMITY (Pain in the arm), URINE ODOUR ABNORMAL (Foul smell of urine), DYSURIA (Frequent urination, little bit pain), PYREXIA (Light fever), MYALGIA (Aches) and CHILLS (Chills). On 04-Apr-2021, URINE OUTPUT INCREASED (Frequent urination), ILLNESS (Got sick), NIGHT SWEATS (Night sweats), PAIN IN EXTREMITY (Pain in the arm), URINE ODOUR ABNORMAL (Foul smell of urine), DYSURIA (Frequent urination, little bit pain) and PYREXIA (Light fever) had resolved. On 05-Apr-2021, BLOOD URINE PRESENT (Blood in urine), MYALGIA (Aches) and CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, SARS-CoV-2 test: positive (Positive) antibody test by blood bank. On 02-Apr-2021, Blood urine: present (Positive) Blood in urine. On 02-Apr-2021, Urine output: increase (High) Frequent urination.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow-up information received on 18-MAY-2021 contains reporter details, patient demographics, patient medical history, lab data, dose details, vaccine facility and event stop date were updated.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Urine odour abnormal, Urine output, Urine output increased
Clinical narrative: Frequent urination; Got sick; Night sweats; Blood in urine; Pain in the arm; Foul smell of urine; Frequent urination, little bit pain; Light fever; Aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of URINE OUTPUT INCREASED (Frequent urination), ILLNESS (Got sick), NIGHT SWEATS (Night sweats), BLOOD URINE PRESENT (Blood in urine) and PAIN IN EXTREMITY (Pain in the arm) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018b21a and 005c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (COVID-19 positive) in February 2021, Chills from 30-Nov-2020 to 15-Dec-2020, UTI from 30-Nov-2020 to 15-Dec-2020, Fever from 30-Nov-2020 to 15-Dec-2020 and Myalgia from 30-Nov-2020 to 15-Dec-2020. Concurrent medical conditions included Kidney stones (Patient was being treated for Kidney stones lithotropsy in November and again at the end of December) since 01-Jan-2014.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced URINE OUTPUT INCREASED (Frequent urination), ILLNESS (Got sick), NIGHT SWEATS (Night sweats), BLOOD URINE PRESENT (Blood in urine), PAIN IN EXTREMITY (Pain in the arm), URINE ODOUR ABNORMAL (Foul smell of urine), DYSURIA (Frequent urination, little bit pain), PYREXIA (Light fever), MYALGIA (Aches) and CHILLS (Chills). On 04-Apr-2021, URINE OUTPUT INCREASED (Frequent urination), ILLNESS (Got sick), NIGHT SWEATS (Night sweats), PAIN IN EXTREMITY (Pain in the arm), URINE ODOUR ABNORMAL (Foul smell of urine), DYSURIA (Frequent urination, little bit pain) and PYREXIA (Light fever) had resolved. On 05-Apr-2021, BLOOD URINE PRESENT (Blood in urine), MYALGIA (Aches) and CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, SARS-CoV-2 test: positive (Positive) antibody test by blood bank. On 02-Apr-2021, Blood urine: present (Positive) Blood in urine. On 02-Apr-2021, Urine output: increase (High) Frequent urination.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow-up information received on 18-MAY-2021 contains reporter details, patient demographics, patient medical history, lab data, dose details, vaccine facility and event stop date were updated.
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Nausea, Vaccination complication, Vaccination site erythema
Clinical narrative: Felt cold and could not get warm; Injection site area was warm to the touch; General side effects; Huge bright red circle around injection site; Injections site area did not hurt unless it was touched; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Felt cold and could not get warm), VACCINATION SITE WARMTH (Injection site area was warm to the touch), VACCINATION COMPLICATION (General side effects), VACCINATION SITE ERYTHEMA (Huge bright red circle around injection site) and VACCINATION SITE PAIN (Injections site area did not hurt unless it was touched) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced FEELING COLD (Felt cold and could not get warm), VACCINATION SITE WARMTH (Injection site area was warm to the touch), VACCINATION COMPLICATION (General side effects), VACCINATION SITE ERYTHEMA (Huge bright red circle around injection site), VACCINATION SITE PAIN (Injections site area did not hurt unless it was touched), NAUSEA (Nausea) and HEADACHE (Headache). In April 2021, FEELING COLD (Felt cold and could not get warm), VACCINATION SITE WARMTH (Injection site area was warm to the touch), VACCINATION COMPLICATION (General side effects), VACCINATION SITE ERYTHEMA (Huge bright red circle around injection site), VACCINATION SITE PAIN (Injections site area did not hurt unless it was touched), NAUSEA (Nausea) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site warmth
Clinical narrative: Felt cold and could not get warm; Injection site area was warm to the touch; General side effects; Huge bright red circle around injection site; Injections site area did not hurt unless it was touched; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Felt cold and could not get warm), VACCINATION SITE WARMTH (Injection site area was warm to the touch), VACCINATION COMPLICATION (General side effects), VACCINATION SITE ERYTHEMA (Huge bright red circle around injection site) and VACCINATION SITE PAIN (Injections site area did not hurt unless it was touched) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced FEELING COLD (Felt cold and could not get warm), VACCINATION SITE WARMTH (Injection site area was warm to the touch), VACCINATION COMPLICATION (General side effects), VACCINATION SITE ERYTHEMA (Huge bright red circle around injection site), VACCINATION SITE PAIN (Injections site area did not hurt unless it was touched), NAUSEA (Nausea) and HEADACHE (Headache). In April 2021, FEELING COLD (Felt cold and could not get warm), VACCINATION SITE WARMTH (Injection site area was warm to the touch), VACCINATION COMPLICATION (General side effects), VACCINATION SITE ERYTHEMA (Huge bright red circle around injection site), VACCINATION SITE PAIN (Injections site area did not hurt unless it was touched), NAUSEA (Nausea) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, 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 experienced FATIGUE (Tiredness). At the time of the report, FATIGUE (Tiredness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant Medications were not provided by the reporter. Treatment Medications were not provided by the reporter.   This case was linked to MOD-2021-069692 (Patient Link).
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria, Vaccination complication
Clinical narrative: Itching/pruritus; Hives on her body and face/still experiencing hives everyday,hives are not going away/Hives started along jawline; COVID arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (Hives on her body and face/still experiencing hives everyday,hives are not going away/Hives started along jawline), VACCINATION COMPLICATION (COVID arm) and PRURITUS (Itching/pruritus) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A214) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Omnicef (cefdinir) antibiotic. The patient had hives since 2007 when she was allergic to omnicef). Concomitant products included ETHINYLESTRADIOL, FERROUS FUMARATE, NORETHISTERONE ACETATE (LO LOESTRIN FE) for Birth control.    On 26-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 URTICARIA (Hives on her body and face/still experiencing hives everyday,hives are not going away/Hives started along jawline) and VACCINATION COMPLICATION (COVID arm). On an unknown date, the patient experienced PRURITUS (Itching/pruritus). At the time of the report, URTICARIA (Hives on her body and face/still experiencing hives everyday,hives are not going away/Hives started along jawline) had not resolved and VACCINATION COMPLICATION (COVID arm) and PRURITUS (Itching/pruritus) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: Follow-up information  received on 08-Apr-2021 contains information include reporter contact details were updated, event verbatim was updated, event outcome was updated. On 18-May-2021: Follow-up information  received on  18-May-2021 contains information include relevant medical history was updated, De and re challenge details were updated, concomitant medication was updated, treatment information was added.