chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles after vaccination; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (shingles after vaccination) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (shingles after vaccination). At the time of the report, HERPES ZOSTER (shingles after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  No concomitant medication was provided.     This case was linked to MOD-2021-020217 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: positive COVID-19 Test; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (positive COVID-19 Test) 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 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (positive COVID-19 Test). At the time of the report, SARS-COV-2 TEST POSITIVE (positive COVID-19 Test) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: The glands in her neck are swelling; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (The glands in her neck are swelling) 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 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced LYMPHADENOPATHY (The glands in her neck are swelling). At the time of the report, LYMPHADENOPATHY (The glands in her neck are swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort, Hypoacusis, Tinnitus, Vaccination site nodule, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of HYPOACUSIS (I now have a 20% loss of hearing in my right ear), EAR DISCOMFORT (I feel pressure), TINNITUS (I have this constant ringing in my ear), EAR DISCOMFORT (it felt like someone was shoving a marble in my ear) and VACCINATION SITE NODULE (a knot at the injection site) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE NODULE (a knot at the injection site) and VACCINATION SITE PAIN (soreness at injection site). On 16-Feb-2021, the patient experienced HYPOACUSIS (I now have a 20% loss of hearing in my right ear), EAR DISCOMFORT (I feel pressure), TINNITUS (I have this constant ringing in my ear) and EAR DISCOMFORT (it felt like someone was shoving a marble in my ear). At the time of the report, HYPOACUSIS (I now have a 20% loss of hearing in my right ear), EAR DISCOMFORT (I feel pressure), TINNITUS (I have this constant ringing in my ear) and EAR DISCOMFORT (it felt like someone was shoving a marble in my ear) had resolved and VACCINATION SITE NODULE (a knot at the injection site) and VACCINATION SITE PAIN (soreness at injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided.  The patient reported that he saw an ENT specialist and that he had an unrelate issue and it had since resolved. No treatment medications was reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Mar-2021: NNI On 26-Jul-2021: Updated outcome of events from unknown to resolved.
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: "little reaction"; This spontaneous case was reported by a patient and describes the occurrence of ADVERSE REACTION ("little reaction") in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 ADVERSE REACTION ("little reaction"). At the time of the report, ADVERSE REACTION ("little reaction") outcome was unknown. Not Provided          No concomitant medications reported by investigator No treatment medications provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and NAUSEA (Nausea) in a 45-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 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: arm soreness after the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm soreness after the shot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced VACCINATION SITE PAIN (arm soreness after the shot). In February 2021, VACCINATION SITE PAIN (arm soreness after the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-029361 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-029361:husband case
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria, Vaccination site pain, Vaccination site swelling
Clinical narrative: a rash or hives; arm swelled up on the injection site; a rash or hives; it also was a little sore but it went away in about 4 days; it itched; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (a rash or hives), VACCINATION SITE SWELLING (arm swelled up on the injection site), RASH (a rash or hives), VACCINATION SITE PAIN (it also was a little sore but it went away in about 4 days) and PRURITUS (it itched) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced URTICARIA (a rash or hives), VACCINATION SITE SWELLING (arm swelled up on the injection site), RASH (a rash or hives), VACCINATION SITE PAIN (it also was a little sore but it went away in about 4 days) and PRURITUS (it itched). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 28-Jan-2021, URTICARIA (a rash or hives), VACCINATION SITE SWELLING (arm swelled up on the injection site), RASH (a rash or hives), VACCINATION SITE PAIN (it also was a little sore but it went away in about 4 days) and PRURITUS (it itched) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Pain
Clinical narrative: a lump underneath his left armpit; it's painful (lump); uncomfortable pain; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (a lump underneath his left armpit), LYMPH NODE PAIN (it's painful (lump)) and PAIN (uncomfortable pain) in a 64-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided). Concomitant products included hypertension for Hypertension.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced LYMPH NODE PAIN (it's painful (lump)) and PAIN (uncomfortable pain). On an unknown date, the patient experienced LYMPHADENOPATHY (a lump underneath his left armpit). At the time of the report, LYMPHADENOPATHY (a lump underneath his left armpit), LYMPH NODE PAIN (it's painful (lump)) and PAIN (uncomfortable pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown.       Treatment: Patient took Ibuprofen on 15Feb2021
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Broke out on arms; arms were red; itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Broke out on arms), VACCINATION SITE ERYTHEMA (arms were red) and VACCINATION SITE PRURITUS (itching) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013a21a) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE RASH (Broke out on arms), VACCINATION SITE ERYTHEMA (arms were red) and VACCINATION SITE PRURITUS (itching). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE RASH (Broke out on arms), VACCINATION SITE ERYTHEMA (arms were red) and VACCINATION SITE PRURITUS (itching) outcome was unknown.            No concomitant medication was reported.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to MOD-2021-028873, MOD-2021-018253 (Patient Link).
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Headache, Hot flush, Hyperhidrosis
Clinical narrative: Sweating; Hot Flashes; Diarrhea x1 time; Dizziness; Sleepy; Body Ache; Headache; Vomiting; Little Pain Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), HOT FLUSH (Hot Flashes), DIARRHOEA (Diarrhea x1 time), DIZZINESS (Dizziness) and SOMNOLENCE (Sleepy) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE PAIN (Little Pain Injection Site). On 05-Feb-2021, the patient experienced HYPERHIDROSIS (Sweating), HOT FLUSH (Hot Flashes), DIARRHOEA (Diarrhea x1 time), DIZZINESS (Dizziness), SOMNOLENCE (Sleepy), MYALGIA (Body Ache), HEADACHE (Headache) and VOMITING (Vomiting). The patient was treated with IBUPROFEN at a dose of 1 dosage form. On 04-Feb-2021, VACCINATION SITE PAIN (Little Pain Injection Site) had resolved. At the time of the report, HYPERHIDROSIS (Sweating), HOT FLUSH (Hot Flashes), DIARRHOEA (Diarrhea x1 time), DIZZINESS (Dizziness), SOMNOLENCE (Sleepy), MYALGIA (Body Ache), HEADACHE (Headache) and VOMITING (Vomiting) outcome was unknown.            No relevant concomitant medications reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow-up received on 09-JUL-2021 and does not contain any new information.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Somnolence, Vaccination site pain, Vomiting
Clinical narrative: Sweating; Hot Flashes; Diarrhea x1 time; Dizziness; Sleepy; Body Ache; Headache; Vomiting; Little Pain Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), HOT FLUSH (Hot Flashes), DIARRHOEA (Diarrhea x1 time), DIZZINESS (Dizziness) and SOMNOLENCE (Sleepy) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE PAIN (Little Pain Injection Site). On 05-Feb-2021, the patient experienced HYPERHIDROSIS (Sweating), HOT FLUSH (Hot Flashes), DIARRHOEA (Diarrhea x1 time), DIZZINESS (Dizziness), SOMNOLENCE (Sleepy), MYALGIA (Body Ache), HEADACHE (Headache) and VOMITING (Vomiting). The patient was treated with IBUPROFEN at a dose of 1 dosage form. On 04-Feb-2021, VACCINATION SITE PAIN (Little Pain Injection Site) had resolved. At the time of the report, HYPERHIDROSIS (Sweating), HOT FLUSH (Hot Flashes), DIARRHOEA (Diarrhea x1 time), DIZZINESS (Dizziness), SOMNOLENCE (Sleepy), MYALGIA (Body Ache), HEADACHE (Headache) and VOMITING (Vomiting) outcome was unknown.            No relevant concomitant medications reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow-up received on 09-JUL-2021 and does not contain any new information.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypersensitivity, Injection site erythema, Injection site warmth, Vaccination site pain
Clinical narrative: ( whole arm) hot to the touch; whole arm was red; red spot near injection site; hypersensitivity reaction; arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (( whole arm) hot to the touch), ERYTHEMA (whole arm was red), PAIN IN EXTREMITY (arm soreness), INJECTION SITE ERYTHEMA (red spot near injection site) and HYPERSENSITIVITY (hypersensitivity reaction) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Drug allergy (Demerol- vomit and pass out), Drug allergy (Augmentin- stomach cramps), Environmental allergy (mold- wheezing), Environmental allergy (mildew- wheezing) and Crohn's disease since July 2012. Concomitant products included MESALAZINE (LIALDA) for Crohn's, ESTRADIOL (VAGIFEM) for Dryness vaginal, LANSOPRAZOLE (PREVACID) for Reflux esophagitis, LEVOTHYROXINE, METHOCARBAMOL, CENTRUM SILVER +50, CALCIUM, ASCORBIC ACID, ECHINACEA PURPUREA (ECHINACEA + VITAMINA C VITATECH) and BIOTIN for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm soreness). On 06-Feb-2021, the patient experienced HYPERSENSITIVITY (hypersensitivity reaction). On 10-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (red spot near injection site). On an unknown date, the patient experienced INJECTION SITE WARMTH (( whole arm) hot to the touch) and ERYTHEMA (whole arm was red). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) from 06-Feb-2021 to 03-Mar-2021 at an unspecified dose and frequency and BISMUTH SUBSALICYLATE (PEPTOBISMOL) 28-Feb-2021 at an unspecified dose and frequency. On 01-Feb-2021, PAIN IN EXTREMITY (arm soreness) had resolved. On 11-Feb-2021, HYPERSENSITIVITY (hypersensitivity reaction) had resolved. At the time of the report, INJECTION SITE WARMTH (( whole arm) hot to the touch), ERYTHEMA (whole arm was red) and INJECTION SITE ERYTHEMA (red spot near injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included evening primrose oil, used for unknown indication.   This case was linked to MOD-2021-192267 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Follow-up was received on 01-JUN-2021 Contains significant information. added patient demographics, current condition and allergy details in medical history tab, updated dose and indication for concomitant medication, New treatment medication and new event were added. On 30-Jun-2021: Follow-up was received on 30-JUN-2021 contains No new information.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Vaccination site discomfort
Clinical narrative: Both his ankles were swollen up a little; Discomfort on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Both his ankles were swollen up a little) and VACCINATION SITE DISCOMFORT (Discomfort on the injection site) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included HYDROXYCHLOROQUINE, FINASTERIDE and TAMSULOSIN HYDROCHLORIDE (FLOMAX RELIEF) for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE DISCOMFORT (Discomfort on the injection site). On 07-Feb-2021, the patient experienced JOINT SWELLING (Both his ankles were swollen up a little). On 06-Feb-2021, VACCINATION SITE DISCOMFORT (Discomfort on the injection site) had resolved. On 09-Feb-2021, JOINT SWELLING (Both his ankles were swollen up a little) had resolved.            Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Lymphadenopathy, Vaccination site pain
Clinical narrative: Lump underneath the collar bone; swelling of the lymph nodes; tenderness in the arm of the injection; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (Lump underneath the collar bone), LYMPHADENOPATHY (swelling of the lymph nodes) and VACCINATION SITE PAIN (tenderness in the arm of the injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-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 AXILLARY MASS (Lump underneath the collar bone), LYMPHADENOPATHY (swelling of the lymph nodes) and VACCINATION SITE PAIN (tenderness in the arm of the injection). At the time of the report, AXILLARY MASS (Lump underneath the collar bone), LYMPHADENOPATHY (swelling of the lymph nodes) and VACCINATION SITE PAIN (tenderness in the arm of the injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Non-significant follow up appended with updated reporter address.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Swelling, Vaccination site erythema, Vaccination site swelling
Clinical narrative: tremendous swelling; large rash; swelling and redness at the injection site; swelling and redness at the injection site; Itched; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (tremendous swelling), RASH (large rash), PRURITUS (Itched), VACCINATION SITE SWELLING (swelling and redness at the injection site) and VACCINATION SITE ERYTHEMA (swelling and redness at the injection site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced RASH (large rash), PRURITUS (Itched), VACCINATION SITE SWELLING (swelling and redness at the injection site) and VACCINATION SITE ERYTHEMA (swelling and redness at the injection site). On 09-Feb-2021, the patient experienced SWELLING (tremendous swelling). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, SWELLING (tremendous swelling), RASH (large rash), PRURITUS (Itched), VACCINATION SITE SWELLING (swelling and redness at the injection site) and VACCINATION SITE ERYTHEMA (swelling and redness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details also included wet rag.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Hypoaesthesia, Paraesthesia, Pruritus
Clinical narrative: Tingling; Numbness; Itched; Pain in her arm; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling), HYPOAESTHESIA (Numbness), PRURITUS (Itched) and AXILLARY PAIN (Pain in her arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On an unknown date, the patient experienced PARAESTHESIA (Tingling), HYPOAESTHESIA (Numbness), PRURITUS (Itched) and AXILLARY PAIN (Pain in her arm).   At the time of the report, PARAESTHESIA (Tingling), HYPOAESTHESIA (Numbness), PRURITUS (Itched) and AXILLARY PAIN (Pain in her arm) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic, Sensitive skin, Urticaria
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (rash progressed to hives), SENSITIVE SKIN (Skin sensitive after rash), RASH PRURITIC (Ithcing burning rash on arms,legs, stomach and back) and RASH (rash over legs, rash over abdomen, rash over arms) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 39k20A and 010u20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism and Allergy to animals (Allergic to cats). Concomitant products included THYROID (ARMOUR THYROID) for Hypothyroidism.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Jan-2021, the patient experienced URTICARIA (rash progressed to hives) and RASH (rash over legs, rash over abdomen, rash over arms). On an unknown date, the patient experienced SENSITIVE SKIN (Skin sensitive after rash) and RASH PRURITIC (Ithcing burning rash on arms,legs, stomach and back). The patient was treated with CORTISONE for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, URTICARIA (rash progressed to hives), SENSITIVE SKIN (Skin sensitive after rash) and RASH PRURITIC (Ithcing burning rash on arms,legs, stomach and back) outcome was unknown and RASH (rash over legs, rash over abdomen, rash over arms) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-075121 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Patient details updated, medical  history updated, event added, details of second vaccine  dose was added; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-075121:first dose case
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: experienced arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (experienced arm soreness) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE PAIN (experienced arm soreness). At the time of the report, VACCINATION SITE PAIN (experienced arm soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Decreased appetite, Illness, Neck pain, Pain in extremity
Clinical narrative: feel very sick (hit by truck feeling); pain in arm, leg sensation and pain; neck pain; no appetite; shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (feel very sick (hit by truck feeling)), PAIN IN EXTREMITY (pain in arm, leg sensation and pain), NECK PAIN (neck pain), DECREASED APPETITE (no appetite) and ARTHRALGIA (shoulder pain) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Graves' disease and Hyperlipidemia.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, 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 ILLNESS (feel very sick (hit by truck feeling)), PAIN IN EXTREMITY (pain in arm, leg sensation and pain), NECK PAIN (neck pain), DECREASED APPETITE (no appetite) and ARTHRALGIA (shoulder pain). At the time of the report, ILLNESS (feel very sick (hit by truck feeling)), PAIN IN EXTREMITY (pain in arm, leg sensation and pain), NECK PAIN (neck pain), DECREASED APPETITE (no appetite) and ARTHRALGIA (shoulder pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: warm to touch; rash around injection site; itchiness on left shoulder; Pink reddish circle; This spontaneous case was reported by an other and describes the occurrence of VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE RASH (rash around injection site), VACCINATION SITE PRURITUS (itchiness on left shoulder) and VACCINATION SITE ERYTHEMA (Pink reddish circle) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE RASH (rash around injection site), VACCINATION SITE PRURITUS (itchiness on left shoulder) and VACCINATION SITE ERYTHEMA (Pink reddish circle). At the time of the report, VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE RASH (rash around injection site), VACCINATION SITE PRURITUS (itchiness on left shoulder) and VACCINATION SITE ERYTHEMA (Pink reddish circle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pruritus, Vaccination site erythema
Clinical narrative: arm was itchy; arm was red; soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (arm was itchy), MYALGIA (soreness in arm) and VACCINATION SITE ERYTHEMA (arm was red) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K2) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CANDESARTAN, thyroid pill and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced MYALGIA (soreness in arm). On 09-Feb-2021, the patient experienced PRURITUS (arm was itchy) and VACCINATION SITE ERYTHEMA (arm was red). The patient was treated with CORTISONE at an unspecified dose and frequency; HYDROGEN PEROXIDE (PEROXIDE) at an unspecified dose and frequency and NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOSPORIN [NEOMYCIN SULFATE;POLYMYXIN B SULFATE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (arm was itchy), MYALGIA (soreness in arm) and VACCINATION SITE ERYTHEMA (arm was red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Nausea
Clinical narrative: got a cortisone shot a few weeks ago and now his back is killing him again; nauseous; weak; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak), BACK PAIN (got a cortisone shot a few weeks ago and now his back is killing him again) and NAUSEA (nauseous) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced ASTHENIA (weak) and NAUSEA (nauseous). On an unknown date, the patient experienced BACK PAIN (got a cortisone shot a few weeks ago and now his back is killing him again). At the time of the report, ASTHENIA (weak), BACK PAIN (got a cortisone shot a few weeks ago and now his back is killing him again) and NAUSEA (nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-029597 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-029597:Husband case
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: Light headedness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headedness) and HEADACHE (Headache) 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 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced DIZZINESS (Light headedness) and HEADACHE (Headache). On 10-Feb-2021, DIZZINESS (Light headedness) and HEADACHE (Headache) had resolved.            No concomitant medication information was provided. No treatment medication information was provided.  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.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: Updated outcome of the event Headache and Dizziness from (Unknown to Recovered/Resolved).
Sex: F
Vaccine: COVID19
Symptoms: Chills, Disturbance in attention, Headache, Influenza like illness, Pain
Clinical narrative: Flu like symptoms; Cant even concentrate; Pain all over; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), DISTURBANCE IN ATTENTION (Cant even concentrate), PAIN (Pain all over), CHILLS (Chills) and HEADACHE (Headache) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), DISTURBANCE IN ATTENTION (Cant even concentrate), PAIN (Pain all over), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), DISTURBANCE IN ATTENTION (Cant even concentrate), PAIN (Pain all over), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided. No treatment was reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: No new information was reported.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Tremor
Clinical narrative: hurting feeling throughout the body; shaking; chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PAIN (hurting feeling throughout the body) and TREMOR (shaking) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced CHILLS (chills). On an unknown date, the patient experienced PAIN (hurting feeling throughout the body) and TREMOR (shaking). At the time of the report, CHILLS (chills) had resolved and PAIN (hurting feeling throughout the body) and TREMOR (shaking) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Bed rest, Diarrhoea, Eating disorder, Feeling abnormal, Nausea
Clinical narrative: felt horrible; couldnt get out of bed; threw up once; couldent eat or drink; diarrhoea; nauseous; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), FEELING ABNORMAL (felt horrible), BED REST (couldnt get out of bed), FEELING ABNORMAL (threw up once) and EATING DISORDER (couldent eat or drink) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 13-Feb-2021, the patient experienced FEELING ABNORMAL (felt horrible), BED REST (couldnt get out of bed), FEELING ABNORMAL (threw up once), EATING DISORDER (couldent eat or drink), DIARRHOEA (diarrhoea) and NAUSEA (nauseous). On 12-Feb-2021, PAIN IN EXTREMITY (sore arm) had resolved. On 13-Feb-2021, EATING DISORDER (couldent eat or drink) had resolved. On 15-Feb-2021, FEELING ABNORMAL (felt horrible), BED REST (couldnt get out of bed), FEELING ABNORMAL (threw up once), DIARRHOEA (diarrhoea) and NAUSEA (nauseous) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication included.  No treatment medication included.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: felt horrible; couldnt get out of bed; threw up once; couldent eat or drink; diarrhoea; nauseous; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), FEELING ABNORMAL (felt horrible), BED REST (couldnt get out of bed), FEELING ABNORMAL (threw up once) and EATING DISORDER (couldent eat or drink) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 13-Feb-2021, the patient experienced FEELING ABNORMAL (felt horrible), BED REST (couldnt get out of bed), FEELING ABNORMAL (threw up once), EATING DISORDER (couldent eat or drink), DIARRHOEA (diarrhoea) and NAUSEA (nauseous). On 12-Feb-2021, PAIN IN EXTREMITY (sore arm) had resolved. On 13-Feb-2021, EATING DISORDER (couldent eat or drink) had resolved. On 15-Feb-2021, FEELING ABNORMAL (felt horrible), BED REST (couldnt get out of bed), FEELING ABNORMAL (threw up once), DIARRHOEA (diarrhoea) and NAUSEA (nauseous) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication included.  No treatment medication included.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: Fever of 102F; Injection site pain; Chills; Muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 102F), VACCINATION SITE PAIN (Injection site pain), CHILLS (Chills) and MYALGIA (Muscle ache) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced PYREXIA (Fever of 102F), VACCINATION SITE PAIN (Injection site pain), CHILLS (Chills) and MYALGIA (Muscle ache). At the time of the report, PYREXIA (Fever of 102F), VACCINATION SITE PAIN (Injection site pain), CHILLS (Chills) and MYALGIA (Muscle ache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Feb-2021, Body temperature: 102f 102F.         Concomitant medications were not provided.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Feeling abnormal, Immune system disorder
Clinical narrative: Immune system reaction; Felt poorly; was chilled; fever; fatigued; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNE SYSTEM DISORDER (Immune system reaction), FEELING ABNORMAL (Felt poorly), CHILLS (was chilled), PYREXIA (fever) and FATIGUE (fatigued) in a 54-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.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced IMMUNE SYSTEM DISORDER (Immune system reaction), FEELING ABNORMAL (Felt poorly), CHILLS (was chilled), PYREXIA (fever) and FATIGUE (fatigued). The patient was treated with IBUPROFEN at a dose of 800 mg. On 26-Jan-2021, IMMUNE SYSTEM DISORDER (Immune system reaction), FEELING ABNORMAL (Felt poorly), CHILLS (was chilled), PYREXIA (fever) and FATIGUE (fatigued) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, Body temperature: 101.5 degree (plane angle) 101.5 At 10:00AM, 102.4 degree (plane angle) 102.4 At 2:00PM and 103.4 degree (plane angle) (High) 103.4  At 4:00PM and at 5:00PM fever came down..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Immune system reaction; Felt poorly; was chilled; fever; fatigued; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNE SYSTEM DISORDER (Immune system reaction), FEELING ABNORMAL (Felt poorly), CHILLS (was chilled), PYREXIA (fever) and FATIGUE (fatigued) in a 54-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.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced IMMUNE SYSTEM DISORDER (Immune system reaction), FEELING ABNORMAL (Felt poorly), CHILLS (was chilled), PYREXIA (fever) and FATIGUE (fatigued). The patient was treated with IBUPROFEN at a dose of 800 mg. On 26-Jan-2021, IMMUNE SYSTEM DISORDER (Immune system reaction), FEELING ABNORMAL (Felt poorly), CHILLS (was chilled), PYREXIA (fever) and FATIGUE (fatigued) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, Body temperature: 101.5 degree (plane angle) 101.5 At 10:00AM, 102.4 degree (plane angle) 102.4 At 2:00PM and 103.4 degree (plane angle) (High) 103.4  At 4:00PM and at 5:00PM fever came down..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Infection, Intentional dose omission
Clinical narrative: Patient choose not to get dose 2; Infection; This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (Infection) and INTENTIONAL DOSE OMISSION (Patient choose not to get dose 2) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011LZ0A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMINS [VITAMINS NOS], BISOPROLOL, FLUOXETINE and APIXABAN (ELIQUIS) for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced INFECTION (Infection). On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (Patient choose not to get dose 2). At the time of the report, INFECTION (Infection) outcome was unknown and INTENTIONAL DOSE OMISSION (Patient choose not to get dose 2) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details included 11FEB2021 started with antibiotics and steroids started on 15FEB2021.  Patient has not had any adverse events and chose not to get 2nd shot of vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Additional information included the patient choose not to take dose 2.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Vaccination site warmth
Clinical narrative: Tiny bot from redness lil lower from the site of injection; little bit warm on her left arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Tiny bot from redness lil lower from the site of injection) and VACCINATION SITE WARMTH (little bit warm on her left arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Tiny bot from redness lil lower from the site of injection) and VACCINATION SITE WARMTH (little bit warm on her left arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Tiny bot from redness lil lower from the site of injection) and VACCINATION SITE WARMTH (little bit warm on her left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.