chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Dizziness, Head discomfort, Headache, Hypoaesthesia
Clinical narrative: felt like the top of my head was vibrating; nausea; headache; numbness / stroke-like symptom (numbness); term transient dizziness / dizziness; migraine; This spontaneous case was reported by a pharmacist and describes the occurrence of HEAD DISCOMFORT (felt like the top of my head was vibrating), DIZZINESS (term transient dizziness / dizziness), NAUSEA (nausea), HYPOAESTHESIA (numbness / stroke-like symptom (numbness)) and HEADACHE (headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 029C20A.) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History reported by reporter.  Concomitant products included VITAMIN B COMPLEX (B COMPLEX [VITAMIN B COMPLEX]) and VITAMINS NOS for an unknown indication.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Jan-2021, the patient experienced DIZZINESS (term transient dizziness / dizziness) and MIGRAINE (migraine). On 19-Apr-2021, the patient experienced HYPOAESTHESIA (numbness / stroke-like symptom (numbness)). On an unknown date, the patient experienced HEAD DISCOMFORT (felt like the top of my head was vibrating), NAUSEA (nausea) and HEADACHE (headache). The patient was treated with PREDNISONE at a dose of 1 dosage form. On 05-Jan-2021, DIZZINESS (term transient dizziness / dizziness) and MIGRAINE (migraine) had resolved. On 19-Apr-2021, HYPOAESTHESIA (numbness / stroke-like symptom (numbness)) had resolved. At the time of the report, HEAD DISCOMFORT (felt like the top of my head was vibrating), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: No Indication of Stroke.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 with the events was considered as not applicable   This case was linked to MOD-2021-116510 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: No specific follow-up information recorded.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea
Clinical narrative: felt like the top of my head was vibrating; nausea; headache; numbness / stroke-like symptom (numbness); term transient dizziness / dizziness; migraine; This spontaneous case was reported by a pharmacist and describes the occurrence of HEAD DISCOMFORT (felt like the top of my head was vibrating), DIZZINESS (term transient dizziness / dizziness), NAUSEA (nausea), HYPOAESTHESIA (numbness / stroke-like symptom (numbness)) and HEADACHE (headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 029C20A.) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History reported by reporter.  Concomitant products included VITAMIN B COMPLEX (B COMPLEX [VITAMIN B COMPLEX]) and VITAMINS NOS for an unknown indication.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Jan-2021, the patient experienced DIZZINESS (term transient dizziness / dizziness) and MIGRAINE (migraine). On 19-Apr-2021, the patient experienced HYPOAESTHESIA (numbness / stroke-like symptom (numbness)). On an unknown date, the patient experienced HEAD DISCOMFORT (felt like the top of my head was vibrating), NAUSEA (nausea) and HEADACHE (headache). The patient was treated with PREDNISONE at a dose of 1 dosage form. On 05-Jan-2021, DIZZINESS (term transient dizziness / dizziness) and MIGRAINE (migraine) had resolved. On 19-Apr-2021, HYPOAESTHESIA (numbness / stroke-like symptom (numbness)) had resolved. At the time of the report, HEAD DISCOMFORT (felt like the top of my head was vibrating), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: No Indication of Stroke.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 with the events was considered as not applicable   This case was linked to MOD-2021-116510 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: No specific follow-up information recorded.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Eye discharge, Eye pain, Insomnia, Ocular hyperaemia, Peripheral swelling
Clinical narrative: Redness in their eyes; Having a lot of discharge from eyes; Eyes are hurting a lot; Couldn't sleep; Arm was swollen; Fever; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR HYPERAEMIA (Redness in their eyes), EYE DISCHARGE (Having a lot of discharge from eyes), EYE PAIN (Eyes are hurting a lot), INSOMNIA (Couldn't sleep) and PERIPHERAL SWELLING (Arm was swollen) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension and Cholesterolosis NOS (Cholesterol). Concomitant products included LISINOPRIL for Hypertension and Cholesterolosis NOS.    On 25-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, the patient experienced OCULAR HYPERAEMIA (Redness in their eyes), EYE DISCHARGE (Having a lot of discharge from eyes), EYE PAIN (Eyes are hurting a lot), INSOMNIA (Couldn't sleep), PERIPHERAL SWELLING (Arm was swollen) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) for Fever and Swollen arm, at a dose of 325 mg. At the time of the report, OCULAR HYPERAEMIA (Redness in their eyes), EYE DISCHARGE (Having a lot of discharge from eyes), EYE PAIN (Eyes are hurting a lot), INSOMNIA (Couldn't sleep), PERIPHERAL SWELLING (Arm was swollen) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included eye wash.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Redness in their eyes; Having a lot of discharge from eyes; Eyes are hurting a lot; Couldn't sleep; Arm was swollen; Fever; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR HYPERAEMIA (Redness in their eyes), EYE DISCHARGE (Having a lot of discharge from eyes), EYE PAIN (Eyes are hurting a lot), INSOMNIA (Couldn't sleep) and PERIPHERAL SWELLING (Arm was swollen) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension and Cholesterolosis NOS (Cholesterol). Concomitant products included LISINOPRIL for Hypertension and Cholesterolosis NOS.    On 25-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, the patient experienced OCULAR HYPERAEMIA (Redness in their eyes), EYE DISCHARGE (Having a lot of discharge from eyes), EYE PAIN (Eyes are hurting a lot), INSOMNIA (Couldn't sleep), PERIPHERAL SWELLING (Arm was swollen) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) for Fever and Swollen arm, at a dose of 325 mg. At the time of the report, OCULAR HYPERAEMIA (Redness in their eyes), EYE DISCHARGE (Having a lot of discharge from eyes), EYE PAIN (Eyes are hurting a lot), INSOMNIA (Couldn't sleep), PERIPHERAL SWELLING (Arm was swollen) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included eye wash.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Nausea
Clinical narrative: Chills; naseaus; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and NAUSEA (naseaus) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills) and NAUSEA (naseaus).        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: Itching; Swollen fingers; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching) and PERIPHERAL SWELLING (Swollen fingers) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itching) and PERIPHERAL SWELLING (Swollen fingers). At the time of the report, PRURITUS (Itching) and PERIPHERAL SWELLING (Swollen fingers) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was mentioned. No treatment medication was mentioned.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jun-2021, the patient experienced DYSPNOEA (shortness of breath). At the time of the report, DYSPNOEA (shortness of breath) outcome was unknown.            No treatment was reported. No concomitant medication was reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: significantly high fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (significantly high fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 024MZOA) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Allergy. Concomitant products included VITAMINS NOS for an unknown indication.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced PYREXIA (significantly high fever). On 15-Mar-2021, PYREXIA (significantly high fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment was reported. Concomitant medication included allergy pills (unspecified) over the counter   This case was linked to MOD-2021-237395 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow-up information received on 09-Jul-2021 contains no new information
Sex: U
Vaccine: COVID19
Symptoms: Limb discomfort, Myalgia
Clinical narrative: My arms is getting heavy and pain; I feel pain,my arms is getting heavy and pain; 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 LIMB DISCOMFORT (My arms is getting heavy and pain) and MYALGIA (I feel pain,my arms is getting heavy and pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (My arms is getting heavy and pain) and MYALGIA (I feel pain,my arms is getting heavy and pain). At the time of the report, LIMB DISCOMFORT (My arms is getting heavy and pain) and MYALGIA (I feel pain,my arms is getting heavy and pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was not reported.   Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow-up received and event outcome updated.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of Expired Vaccine; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine). On 15-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-237427 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: 24 hr after 2nd dose im having severe back pain os that normal; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (24 hr after 2nd dose im having severe back pain os that normal) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BACK PAIN (24 hr after 2nd dose im having severe back pain os that normal). At the time of the report, BACK PAIN (24 hr after 2nd dose im having severe back pain os that normal) outcome was unknown.            No relevant Concomitant medications were reported. No Treatment information Provided.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Inappropriate schedule of product administration
Clinical narrative: she found out that she was pregnant through a home pregnancy test; 1st dose given on 28Apr2021 (more than 36 days ago); This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (she found out that she was pregnant through a home pregnancy test) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose given on 28Apr2021 (more than 36 days ago)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006LUA) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose given on 28Apr2021 (more than 36 days ago)). On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (she found out that she was pregnant through a home pregnancy test). At the time of the report, EXPOSURE DURING PREGNANCY (she found out that she was pregnant through a home pregnancy test) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose given on 28Apr2021 (more than 36 days ago)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: Skin mass
Clinical narrative: Big bump after second dose; This spontaneous case was reported by a consumer and describes the occurrence of SKIN MASS (Big bump after second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SKIN MASS (Big bump after second dose). At the time of the report, SKIN MASS (Big bump after second dose) outcome was unknown.            No concomitant medications were reported by the reporter.  Treatment medication was not provided by the reporter.   Reporter did not allow further contact
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of Expired Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine). On 08-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine) had resolved.        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.   This case was linked to MOD-2021-237427 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness, Feeling abnormal, Inappropriate schedule of product administration, Pyrexia
Clinical narrative: caller received the 1st dose on 04Mar2021 and the 2nd dose on 24Jun2021; stomachache; felt a little weird/felt much less funny than 1st dose, for 1h30; minimal dizziness; she had a slight fever last night; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (caller received the 1st dose on 04Mar2021 and the 2nd dose on 24Jun2021), ABDOMINAL PAIN UPPER (stomachache), FEELING ABNORMAL (felt a little weird/felt much less funny than 1st dose, for 1h30), DIZZINESS (minimal dizziness) and PYREXIA (she had a slight fever last night) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048C21A and 023M20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE, ATORVASTATIN and OMEPRAZOLE for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (caller received the 1st dose on 04Mar2021 and the 2nd dose on 24Jun2021), ABDOMINAL PAIN UPPER (stomachache), FEELING ABNORMAL (felt a little weird/felt much less funny than 1st dose, for 1h30), DIZZINESS (minimal dizziness) and PYREXIA (she had a slight fever last night). On 24-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (caller received the 1st dose on 04Mar2021 and the 2nd dose on 24Jun2021), ABDOMINAL PAIN UPPER (stomachache), FEELING ABNORMAL (felt a little weird/felt much less funny than 1st dose, for 1h30), DIZZINESS (minimal dizziness) and PYREXIA (she had a slight fever last night) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.   This case was linked to MOD-2021-237397 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: I'm think I'm having side effects from the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I'm think I'm having side effects from the shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (I'm think I'm having side effects from the shot). At the time of the report, VACCINATION COMPLICATION (I'm think I'm having side effects from the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment details were reported.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered from expired vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered from expired vial) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered from expired vial). On 27-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered from expired vial) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were not reported. No treatment medications were not provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: I have a rash on my face; This spontaneous case was reported by a consumer and describes the occurrence of RASH (I have a rash on my face) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (I have a rash on my face). At the time of the report, RASH (I have a rash on my face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Bed rest, Illness
Clinical narrative: felt sicker than dogs; in bed for 3 weeks; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (felt sicker than dogs) and BED REST (in bed for 3 weeks) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017Z21A and 031BZ1A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included GABAPENTIN and CLONAZEPAM for an unknown indication.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced ILLNESS (felt sicker than dogs) and BED REST (in bed for 3 weeks). In May 2021, ILLNESS (felt sicker than dogs) and BED REST (in bed for 3 weeks) had resolved.            Patient reported unspecified pain pills as treatment medication to treat adverse effects of the vaccine. Follow up received on 27-Jul-2021 included no new information.  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.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Non-significant follow-up appended On 02-Aug-2021: Follow up received on 02 AUG 2021 contains no new information.; 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: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of Expired Vaccine; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jun-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 15-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine). On 15-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported   This case was linked to MOD-2021-237307, MOD-2021-237412, MOD-2021-237346, MOD-2021-237347, MOD-2021-237474, MOD-2021-237480, MOD-2021-237697, MOD-2021-237470, MOD-2021-237417, MOD-2021-237428, MOD-2021-237440, MOD-2021-237445, MOD-2021-237451 (Patient Link).
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of Expired Vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine). On 08-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported.   This case was linked to MOD-2021-237427 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Aug-2021: Follow-up information include Non-Significant Information
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Palpitations
Clinical narrative: Heart palpitations; Dizziness; Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart palpitations), DIZZINESS (Dizziness) and DYSPNOEA (Shortness of breath) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Heart palpitations), DIZZINESS (Dizziness) and DYSPNOEA (Shortness of breath). At the time of the report, PALPITATIONS (Heart palpitations), DIZZINESS (Dizziness) and DYSPNOEA (Shortness of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. It was reported that the patient was in the emergency room with heart palpitations, dizziness, and shortness of breath after receiving the Moderna COVID-19 vaccination. Treatment information was unknown.; 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: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Vaccination site discolouration
Clinical narrative: At the injection site it is still pink.; It has been almost 3 months since she received her last dose and her arm is getting sore and more sore each day; She states her whole shoulder hurts in that area.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (At the injection site it is still pink.), PAIN IN EXTREMITY (It has been almost 3 months since she received her last dose and her arm is getting sore and more sore each day) and ARTHRALGIA (She states her whole shoulder hurts in that area.) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included METOPROLOL from 07-Jan-2010 to an unknown date, HYDRALAZINE from 07-Jan-2020 to an unknown date, HYDROCHLOROTHIAZIDE (HYDROCHLOROTH) from 07-Jan-2010 to an unknown date and VALSARTAN from 07-Jan-2010 to an unknown date for Blood pressure management, ATORVASTATIN from 07-Jan-2018 to an unknown date for Hypercholesteremia.   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) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced VACCINATION SITE DISCOLOURATION (At the injection site it is still pink.), PAIN IN EXTREMITY (It has been almost 3 months since she received her last dose and her arm is getting sore and more sore each day) and ARTHRALGIA (She states her whole shoulder hurts in that area.). The patient was treated with MENTHOL (BENGAY PAIN RELIEVING) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE DISCOLOURATION (At the injection site it is still pink.) was resolving and PAIN IN EXTREMITY (It has been almost 3 months since she received her last dose and her arm is getting sore and more sore each day) and ARTHRALGIA (She states her whole shoulder hurts in that area.) had not resolved.            Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Patient demographics, race and ethnicity were updated. Concomitant medication were added. Events outcome was updated.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medication history was provided.     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 VACCINATION COMPLICATION (side effects). At the time of the report, VACCINATION COMPLICATION (side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was unknown Treatment information was unknown   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Exact same issue (joint pain); 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 ARTHRALGIA (Exact same issue (joint pain)) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Exact same issue (joint pain)). At the time of the report, ARTHRALGIA (Exact same issue (joint pain)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not reported . Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects). At the time of the report, VACCINATION COMPLICATION (side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported. No specific verbatim terms were discussed.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema, Rash
Clinical narrative: eczema- like symptoms in her: ear / eyes / mouth / nose.; She experienced a rash; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Jun-2021 and was forwarded to Moderna on 27-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (eczema- like symptoms in her: ear / eyes / mouth / nose.) and RASH (She experienced a rash) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hyperthyroidism (She does not have any medications but does have hyperthyroidism at baseline).    On 18-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jun-2021, the patient experienced ECZEMA (eczema- like symptoms in her: ear / eyes / mouth / nose.) and RASH (She experienced a rash). At the time of the report, ECZEMA (eczema- like symptoms in her: ear / eyes / mouth / nose.) and RASH (She experienced a rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of Expired Vaccine; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine). On 08-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-237427 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Dyspepsia
Clinical narrative: I am experiencing severe burning in my heart, It feels like a heart attack; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (I am experiencing severe burning in my heart, It feels like a heart attack) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPEPSIA (I am experiencing severe burning in my heart, It feels like a heart attack). At the time of the report, DYSPEPSIA (I am experiencing severe burning in my heart, It feels like a heart attack) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment details were reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: the 2nd dose of Moderna vaccine was given beyond the scheduled appointment; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (the 2nd dose of Moderna vaccine was given beyond the scheduled appointment) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (the 2nd dose of Moderna vaccine was given beyond the scheduled appointment). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (the 2nd dose of Moderna vaccine was given beyond the scheduled appointment) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment details were provided.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of Expired Vaccine; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine). On 08-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No Concomitant medication were provided. No Treatment medication were provided.   This case was linked to MOD-2021-237427 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-AUG-2021: TCR received: NNI: Follow-up information included no new information
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of Expired Vaccine; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No medical history information was provided.    On 08-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine). On 15-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter.  No treatment information was provided by the reporter.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of Expired Vaccine; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine). On 08-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported No treatment medication were provided   This case was linked to MOD21-115609  (Patient Link).
Age: 95.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Tremor
Clinical narrative: uncontrolled shaking of hands and arms; Chills; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (uncontrolled shaking of hands and arms) and CHILLS (Chills) in a 95-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, the patient experienced TREMOR (uncontrolled shaking of hands and arms) and CHILLS (Chills). At the time of the report, TREMOR (uncontrolled shaking of hands and arms) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product administration error
Clinical narrative: 26May2021 and got the first dose of the Moderna vaccine,second dose of the Moderna vaccine on 23Jun2021,first dose of the Pfizer vaccine on 22Apr2021; Patient got 2 doses of Moderna vaccine and one dose of Pfizer vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of OFF LABEL USE (26May2021 and got the first dose of the Moderna vaccine,second dose of the Moderna vaccine on 23Jun2021,first dose of the Pfizer vaccine on 22Apr2021) and PRODUCT ADMINISTRATION ERROR (Patient got 2 doses of Moderna vaccine and one dose of Pfizer vaccine) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017Z21A and 017Z21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jun-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 OFF LABEL USE (26May2021 and got the first dose of the Moderna vaccine,second dose of the Moderna vaccine on 23Jun2021,first dose of the Pfizer vaccine on 22Apr2021) and PRODUCT ADMINISTRATION ERROR (Patient got 2 doses of Moderna vaccine and one dose of Pfizer vaccine). At the time of the report, OFF LABEL USE (26May2021 and got the first dose of the Moderna vaccine,second dose of the Moderna vaccine on 23Jun2021,first dose of the Pfizer vaccine on 22Apr2021) and PRODUCT ADMINISTRATION ERROR (Patient got 2 doses of Moderna vaccine and one dose of Pfizer vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was reported. No concomitant medication was reported.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a physician, describes the occurrence of administered expired product (administration of expired vaccine) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 006C21A) for COVID-19 immunization. No medical history reported. On Jun 15, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jun 15, 2021, patient administered expired product (administration of expired vaccine). On Jun 15, 2021, administered expired product (administration of expired vaccine) resolved. The reporter did not provide any causality assessments, concomitant medication information and treatment information.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Skin swelling, Urticaria
Clinical narrative: Developed hives on her skin; big red bumps on her skin; big red bumps on her skin; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Developed hives on her skin), SKIN SWELLING (big red bumps on her skin) and ERYTHEMA (big red bumps on her skin) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In May 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Developed hives on her skin), SKIN SWELLING (big red bumps on her skin) and ERYTHEMA (big red bumps on her skin). The patient was treated with LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) at an unspecified dose and frequency. At the time of the report, URTICARIA (Developed hives on her skin), SKIN SWELLING (big red bumps on her skin) and ERYTHEMA (big red bumps on her skin) had not resolved.        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 medication not provided.  Treatment information not provided.