chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (very mild burning sensation in the arm after tbe 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced BURNING SENSATION (very mild burning sensation in the arm after tbe second dose). At the time of the report, BURNING SENSATION (very mild burning sensation in the arm after tbe second dose) outcome was unknown. No concomitant medications were reported. No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: first Moderna dose on 2/18 but have not received my second dose; 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 PRODUCT DOSE OMISSION ISSUE (first Moderna dose on 2/18 but have not received my second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (first Moderna dose on 2/18 but have not received my second dose). On 18-Feb-2021, PRODUCT DOSE OMISSION ISSUE (first Moderna dose on 2/18 but have not received my second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient did not receive second dose since 12 weeks after the first dose. No treatment information, concomitant medication provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: fever; headache; 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 PYREXIA (fever) and HEADACHE (headache) 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 PYREXIA (fever) and HEADACHE (headache). At the time of the report, PYREXIA (fever) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided by the reporter  no treatment information reported by the reporter
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased
Clinical narrative: body temperature is still high at 37.8 degrees Celsius for 3days now; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE INCREASED (body temperature is still high at 37.8 degrees Celsius for 3days now) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 014C21A) for COVID-19 vaccination.     No medication history was provided.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2. On 20-May-2021, the patient experienced BODY TEMPERATURE INCREASED (body temperature is still high at 37.8 degrees Celsius for 3days now). At the time of the report, BODY TEMPERATURE INCREASED (body temperature is still high at 37.8 degrees Celsius for 3days now) outcome was unknown.            No known allergies, is not taking any concomitant medication. The patient did not informed his physician.
Sex: U
Vaccine: COVID19
Symptoms: Axillary pain
Clinical narrative: uncomfortable pain under my arm pit; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-May-2021 and was forwarded to Moderna on 23-May-2021.    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 AXILLARY PAIN (uncomfortable pain under my arm pit) 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 AXILLARY PAIN (uncomfortable pain under my arm pit). At the time of the report, AXILLARY PAIN (uncomfortable pain under my arm pit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information were not provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Not feeling too good; 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 MALAISE (Not feeling too good) 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 MALAISE (Not feeling too good). At the time of the report, MALAISE (Not feeling too good) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant Medications were reported. No Treatment Information Provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Fatigue, Headache
Clinical narrative: some diarrhea; feeling very weak; headache; tired; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHEA (some diarrhea), ASTHENIA (feeling very weak), HEADACHE (headache) and FATIGUE (tired) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 33B21A) for COVID-19 vaccination.     Concurrent medical conditions included Lymphedema and Breast cancer.    On 20-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced DIARRHEA (some diarrhea), ASTHENIA (feeling very weak), HEADACHE (headache) and FATIGUE (tired). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. At the time of the report, DIARRHEA (some diarrhea), ASTHENIA (feeling very weak), HEADACHE (headache) and FATIGUE (tired) had resolved.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Irritability, Vaccination site pain
Clinical narrative: experienced irritability; arm pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of IRRITABILITY (experienced irritability) and VACCINATION SITE PAIN (arm pain at injection site) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced IRRITABILITY (experienced irritability) and VACCINATION SITE PAIN (arm pain at injection site). On 02-May-2021, IRRITABILITY (experienced irritability) and VACCINATION SITE PAIN (arm pain at injection site) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  No treatment medications provided by the reporter.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass
Clinical narrative: Big lump with red mark came up on my left upper arm; A red mark came up on my left upper arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Big lump with red mark came up on my left upper arm) and VACCINATION SITE ERYTHEMA (A red mark came up on my left upper arm) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Asthma. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), CALCIUM and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced VACCINATION SITE MASS (Big lump with red mark came up on my left upper arm) and VACCINATION SITE ERYTHEMA (A red mark came up on my left upper arm). At the time of the report, VACCINATION SITE MASS (Big lump with red mark came up on my left upper arm) and VACCINATION SITE ERYTHEMA (A red mark came up on my left upper arm) 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.   Treatment information does not provided,   This case was linked to MOD-2021-162313 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site coldness, Vaccination site warmth
Clinical narrative: sore arm; Ice or heat on injection; Ice or heat on injection; 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 PAIN IN EXTREMITY (sore arm), VACCINATION SITE WARMTH (Ice or heat on injection) and VACCINATION SITE COLDNESS (Ice or heat on injection) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), VACCINATION SITE WARMTH (Ice or heat on injection) and VACCINATION SITE COLDNESS (Ice or heat on injection). At the time of the report, PAIN IN EXTREMITY (sore arm), VACCINATION SITE WARMTH (Ice or heat on injection) and VACCINATION SITE COLDNESS (Ice or heat on injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details were provided. No treatment medication details were provided.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: She already had her period this month and yesterday she started bleeding; This spontaneous case was reported by a patient and describes the occurrence of MENSTRUATION IRREGULAR (She already had her period this month and yesterday she started bleeding) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034B21A) for COVID-19 vaccination.     No Medical History was Provided by Reporter.     On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced MENSTRUATION IRREGULAR (She already had her period this month and yesterday she started bleeding). At the time of the report, MENSTRUATION IRREGULAR (She already had her period this month and yesterday she started bleeding) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Medicine-Birth control meds No Treatment information provided
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Immune system disorder, Mechanical urticaria, Multiple allergies, Product dose omission issue, Urticaria
Clinical narrative: did not get her 2nd dose; Dermatographia; Hives; Other allergies; Immune system hyperactive; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (Hives), MULTIPLE ALLERGIES (Other allergies), IMMUNE SYSTEM DISORDER (Immune system hyperactive), PRODUCT DOSE OMISSION ISSUE (did not get her 2nd dose) and MECHANICAL URTICARIA (Dermatographia) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (in the past allergy to and had anaphylactic reaction percocet). Concomitant products included MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced URTICARIA (Hives), MULTIPLE ALLERGIES (Other allergies) and IMMUNE SYSTEM DISORDER (Immune system hyperactive). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not get her 2nd dose) and MECHANICAL URTICARIA (Dermatographia). The patient was treated with OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) at an unspecified dose and frequency and HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives), MULTIPLE ALLERGIES (Other allergies), IMMUNE SYSTEM DISORDER (Immune system hyperactive) and PRODUCT DOSE OMISSION ISSUE (did not get her 2nd dose) 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.   patient stated that she went to allergist and result are awaiting. In the past she had allergic to and had anaphylactic reaction to Percocet. She thoughts she might be allergic to or hypersensitive to polyethylene glycol but not sure.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: VAERS ADR form
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Nausea
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (Feeling like a bad flu), SECRETION DISCHARGE (lungs filled up and was able to hack out a lot of mucus), VACCINATION SITE PAIN (Sore left arm at the injection site), HEADACHE (slight headache) and NAUSEA (Nausea) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0338214 and 007CZ4) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included DICLOFENAC DIETHYLAMINE (VOLTAREN [DICLOFENAC DIETHYLAMINE]) for Arthritis. On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (Feeling like a bad flu), VACCINATION SITE PAIN (Sore left arm at the injection site), HEADACHE (slight headache), NAUSEA (Nausea), CHILLS (Chills on and off) and FATIGUE (Extremely tired). On 18-May-2021, the patient experienced SECRETION DISCHARGE (lungs filled up and was able to hack out a lot of mucus). On 20-May-2021, SECRETION DISCHARGE (lungs filled up and was able to hack out a lot of mucus) and HEADACHE (slight headache) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Feeling like a bad flu), VACCINATION SITE PAIN (Sore left arm at the injection site), NAUSEA (Nausea), CHILLS (Chills on and off) and FATIGUE (Extremely tired) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment information were not provided. Action taken with mRNA-1273 in response to the event/s was not applicable. This case was linked to MOD-2021-162274.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Secretion discharge, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (Feeling like a bad flu), SECRETION DISCHARGE (lungs filled up and was able to hack out a lot of mucus), VACCINATION SITE PAIN (Sore left arm at the injection site), HEADACHE (slight headache) and NAUSEA (Nausea) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0338214 and 007CZ4) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included DICLOFENAC DIETHYLAMINE (VOLTAREN [DICLOFENAC DIETHYLAMINE]) for Arthritis. On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (Feeling like a bad flu), VACCINATION SITE PAIN (Sore left arm at the injection site), HEADACHE (slight headache), NAUSEA (Nausea), CHILLS (Chills on and off) and FATIGUE (Extremely tired). On 18-May-2021, the patient experienced SECRETION DISCHARGE (lungs filled up and was able to hack out a lot of mucus). On 20-May-2021, SECRETION DISCHARGE (lungs filled up and was able to hack out a lot of mucus) and HEADACHE (slight headache) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Feeling like a bad flu), VACCINATION SITE PAIN (Sore left arm at the injection site), NAUSEA (Nausea), CHILLS (Chills on and off) and FATIGUE (Extremely tired) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment information were not provided. Action taken with mRNA-1273 in response to the event/s was not applicable. This case was linked to MOD-2021-162274.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and CHILLS (Chills) 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 PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  Treatment medications were unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: How long is the redness supposed to last around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (How long is the redness supposed to last around the injection site) in a female 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 VACCINATION SITE ERYTHEMA (How long is the redness supposed to last around the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (How long is the redness supposed to last around the injection site) outcome was unknown.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Illness, Underdose
Clinical narrative: Sickness; Patient received more than half a dose initially; some leakage once needle was drawn out of patient; This spontaneous case was reported by a pharmacist and describes the occurrence of ILLNESS (Sickness), UNDERDOSE (Patient received more than half a dose initially) and DEVICE CONNECTION ISSUE (some leakage once needle was drawn out of patient) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 15-May-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, the patient experienced ILLNESS (Sickness) and DEVICE CONNECTION ISSUE (some leakage once needle was drawn out of patient). 15-May-2021, the patient experienced UNDERDOSE (Patient received more than half a dose initially). At the time of the report, ILLNESS (Sickness) and DEVICE CONNECTION ISSUE (some leakage once needle was drawn out of patient) outcome was unknown and UNDERDOSE (Patient received more than half a dose initially) had resolved.        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 concomitant medications were reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-272290 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Updated the start date of first dose of vaccine and event. On 29-Jul-2021: significant follow up appended: New events captured, Suspect products information was captured, Patient demographic details captured.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Daughter is only 15.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Daughter is only 15.) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Daughter is only 15.). On 21-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Daughter is only 15.) had resolved.            No concomitant medications were reported.   No corrective treatment was provided.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received 2nd dose of Moderna vaccine on D21st, after receiving the 1st dose of vaccine; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose of Moderna vaccine on D21st, after receiving the 1st dose of vaccine) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 21-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose of Moderna vaccine on D21st, after receiving the 1st dose of vaccine). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose of Moderna vaccine on D21st, after receiving the 1st dose of vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medications and treatment information were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-162267, US-MODERNATX, INC.-MOD-2021-162156, US-MODERNATX, INC.-MOD-2021-162328, US-MODERNATX, INC.-MOD-2021-162176, US-MODERNATX, INC.-MOD-2021-162133 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Non-significant follow up appended.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-162267: US-MODERNATX, INC.-MOD-2021-162156: US-MODERNATX, INC.-MOD-2021-162328: US-MODERNATX, INC.-MOD-2021-162176: US-MODERNATX, INC.-MOD-2021-162133:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Breast mass, Dizziness, Mammogram, Pain in extremity
Clinical narrative: Small mass on the right breast; Arm pain; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of BREAST MASS (Small mass on the right breast), PAIN IN EXTREMITY (Arm pain) and DIZZINESS (Dizziness) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (Shrimp.), Penicillin allergy, Drug allergy (Codeine), Drug allergy (Vicodin) and Drug allergy (Morphine.). Concomitant products included VITAMINS NOS for an unknown indication.    On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, the patient experienced PAIN IN EXTREMITY (Arm pain) and DIZZINESS (Dizziness). On 13-May-2021, the patient experienced BREAST MASS (Small mass on the right breast). On 09-May-2021, DIZZINESS (Dizziness) had resolved. At the time of the report, BREAST MASS (Small mass on the right breast) outcome was unknown and PAIN IN EXTREMITY (Arm pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-May-2021, Mammogram: unknown (Inconclusive) There was a small mass on the right breast..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant product use included prescribed medications. Treatment information was not provided.  The patient stated that her next mammogram and UTZ scheduled n 09 Jun 2021.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Why is my still hurting; 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 PAIN (Why is my still hurting) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical information 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 PAIN (Why is my still hurting). At the time of the report, PAIN (Why is my still hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided. No treatment medication provided.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: experienced tiredness that lasted only for that day; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (experienced tiredness that lasted only for that day) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     Concomitant products included Birth control pills and Xeralto.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced FATIGUE (experienced tiredness that lasted only for that day).        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-2021-162322 (Patient Link).   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 5 unknown patients administered 2 dose of expired vaccine/12 patients on from a expired Short-Dated Expiry Lot//11 unknown patients administered 2 dose of expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 unknown patients administered 2 dose of expired vaccine/12 patients on from a expired Short-Dated Expiry Lot//11 unknown patients administered 2 dose of expired vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History was provided by the reporter.    On 21-May-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 21-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 unknown patients administered 2 dose of expired vaccine/12 patients on from a expired Short-Dated Expiry Lot//11 unknown patients administered 2 dose of expired vaccine). On 21-May-2021, EXPIRED PRODUCT ADMINISTERED (5 unknown patients administered 2 dose of expired vaccine/12 patients on from a expired Short-Dated Expiry Lot//11 unknown patients administered 2 dose of expired vaccine) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.  It is reported that a single dose of the Moderna COVID-19 vaccine was administered to 12 patients on 21May2021 from a expired Short-Dated Expiry Lot # 028A21A, which expired on 28Apr2021. This was the second dose for all patients. The caller would like to know if they should repeat the second dose for these patients or if they are considered fully vaccinated at this time. The caller states that they have not been made aware of any symptoms this patient group have experienced as a result of receiving an expired vaccine dose.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: New event added. On 21-Jun-2021: New event added.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphagia, Oropharyngeal pain
Clinical narrative: sore throat; difficulty swallowing; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) and DYSPHAGIA (difficulty swallowing) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     No medical history provided. No concomitant medication details provided.     On 21-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat) and DYSPHAGIA (difficulty swallowing). At the time of the report, OROPHARYNGEAL PAIN (sore throat) and DYSPHAGIA (difficulty swallowing) had not resolved.            No treatment details provided.  Patient got the second dose of today Moderna Vaccine today 21May2021 around 1pm in the upper left arm (non-dominant) (Lot# 023C21A and expiration date is unknown)- started to experience sore throat and is having difficulty swallowing about 1.5 hours later after receiving Moderna vaccine but can still breath fine. Symptoms are still ongoing. Patient did not have any symptoms with the first Moderna vaccine that was giving in the upper left arm (got the 1st dose on 4/23/21, Lot # 044B21A and expiration date is unknown). Not completely sure if lot number is correct for the first Moderna vaccine due to trouble reading the hand writing. Had contacted vaccinating facility (Rite Aid) first but was directed to call Moderna. Consent to have safety team follow up via email. Consent to have Moderna contact health care provider and vaccinating facility with follow up questions.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: majority of the liquid came out while administering the vaccine due to syringe failure; majority of the liquid came out while administering the vaccine due to syringe failure; This spontaneous case was reported by a consumer and describes the occurrence of DEVICE CONNECTION ISSUE (majority of the liquid came out while administering the vaccine due to syringe failure) and UNDERDOSE (majority of the liquid came out while administering the vaccine due to syringe failure) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, the patient experienced DEVICE CONNECTION ISSUE (majority of the liquid came out while administering the vaccine due to syringe failure) and UNDERDOSE (majority of the liquid came out while administering the vaccine due to syringe failure). At the time of the report, DEVICE CONNECTION ISSUE (majority of the liquid came out while administering the vaccine due to syringe failure) and UNDERDOSE (majority of the liquid came out while administering the vaccine due to syringe failure) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that patient would like to know what she is supposed to do now. Patient had called on behalf of a vaccine administrator. Lot#022B21A (not sure if it was first or second dose)
Sex: U
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: slight sore throat; 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 OROPHARYNGEAL PAIN (slight sore throat) in a patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (slight sore throat). At the time of the report, OROPHARYNGEAL PAIN (slight sore throat) outcome was unknown.            The action taken with the drug was not applicable.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: medicine taste in back of throat; 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 TASTE DISORDER (medicine taste in back of throat) 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 TASTE DISORDER (medicine taste in back of throat). At the time of the report, TASTE DISORDER (medicine taste in back of throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION IRREGULAR (I got my first shot tuesday would it make me get my period earlier yhan usual) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. No Medical History information was reported. On 18-May-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 MENSTRUATION IRREGULAR (I got my first shot tuesday would it make me get my period earlier yhan usual). At the time of the report, MENSTRUATION IRREGULAR (I got my first shot tuesday would it make me get my period earlier yhan usual) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The patient treatment data was not provided. Reporter did not allow further contact
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: First dose admistered after vial has been stored for more than 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (First dose admistered after vial has been stored for more than 12 hours) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 immunisation.     No Medical History information was reported.    On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (First dose admistered after vial has been stored for more than 12 hours). On 21-May-2021, EXPIRED PRODUCT ADMINISTERED (First dose admistered after vial has been stored for more than 12 hours) had resolved.        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.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Rash papular, Rash pruritic
Clinical narrative: "The biggest problem I had was the rash, it was almost unbearable at times, it itched so much"; The patient reported that the rash extended from the injection site to her elbow and "lasted 4 days or so; Fever; "Nauseated at times"; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC ("The biggest problem I had was the rash, it was almost unbearable at times, it itched so much"), RASH PAPULAR (The patient reported that the rash extended from the injection site to her elbow and "lasted 4 days or so), NAUSEA ("Nauseated at times") and PYREXIA (Fever) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NAUSEA ("Nauseated at times"). On an unknown date, the patient experienced RASH PRURITIC ("The biggest problem I had was the rash, it was almost unbearable at times, it itched so much"), RASH PAPULAR (The patient reported that the rash extended from the injection site to her elbow and "lasted 4 days or so) and PYREXIA (Fever). The patient was treated with CORTISONE for Rash and Itching, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, RASH PRURITIC ("The biggest problem I had was the rash, it was almost unbearable at times, it itched so much"), RASH PAPULAR (The patient reported that the rash extended from the injection site to her elbow and "lasted 4 days or so), NAUSEA ("Nauseated at times") and PYREXIA (Fever) had resolved.            No concomitant medications were reported.   This case was linked to MOD-2021-024105 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Follow-up contains non-significant information. The contact information was updated.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm for a few days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm for a few days) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031m20a) for COVID-19 vaccination.     No Medical History was Provided by Reporter.  Concomitant products included HYDROXYZINE, METOPROLOL, SIMVASTATIN, HYDROXYCHLOROQUINE, PREDNISONE, ALPRAZOLAM (XANAX), HYDROCODONE BITARTRATE, PARACETAMOL (VICODIN) and VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL) for an unknown indication.    On 10-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 VACCINATION SITE PAIN (sore arm for a few days). At the time of the report, VACCINATION SITE PAIN (sore arm for a few days) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nausea; 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 NAUSEA (Nausea) 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 NAUSEA (Nausea). At the time of the report, NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drug was not reported. Treatment medication was not reported.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Breaking in hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Breaking in hives) 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 was provided by the reporter.  Concomitant products included RIVAROXABAN (XARELTO) for Anticoagulant therapy.    On 21-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, the patient experienced URTICARIA (Breaking in hives). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (Breaking in hives) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other concomitant medications included: Birth control pills.   This case was linked to MOD-2021-162309 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Bedridden, Myalgia, Vaccination complication
Clinical narrative: had a severe reaction to 1st dose of the Moderna Covid-19 vaccine; She was in severe pain; She had a case of severe arthritis afterward; She had to stay in the bed.; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (She had a case of severe arthritis afterward), BEDRIDDEN (She had to stay in the bed.), VACCINATION COMPLICATION (had a severe reaction to 1st dose of the Moderna Covid-19 vaccine) and MYALGIA (She was in severe pain) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis (significant).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced ARTHRITIS (She had a case of severe arthritis afterward), BEDRIDDEN (She had to stay in the bed.) and MYALGIA (She was in severe pain). On an unknown date, the patient experienced VACCINATION COMPLICATION (had a severe reaction to 1st dose of the Moderna Covid-19 vaccine). At the time of the report, ARTHRITIS (She had a case of severe arthritis afterward), BEDRIDDEN (She had to stay in the bed.), VACCINATION COMPLICATION (had a severe reaction to 1st dose of the Moderna Covid-19 vaccine) and MYALGIA (She was in severe pain) outcome was unknown.            No concomitant and treatment drugs were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-162230 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-162230:Crosslink
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of hypoesthesia (arm felt numb after the first shot) in a  patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On May 20, 2021, patient experienced hypoesthesia (arm felt numb after the first shot). At the time of the report, hypoesthesia (arm felt numb after the first shot) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information provided.
Sex: U
Vaccine: COVID19
Symptoms: Skin mass
Clinical narrative: there was a little not in my arm so I rubbed it and now there is a hard spot the size of a half dollar; 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 SKIN MASS (there was a little not in my arm so I rubbed it and now there is a hard spot the size of a half dollar) in a  patient of an unknown age and gender 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SKIN MASS (there was a little not in my arm so I rubbed it and now there is a hard spot the size of a half dollar). At the time of the report, SKIN MASS (there was a little not in my arm so I rubbed it and now there is a hard spot the size of a half dollar) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash around esrs and neck; 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 RASH (rash around esrs and neck) in a  patient of an unknown age and gender 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 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 RASH (rash around esrs and neck). At the time of the report, RASH (rash around esrs and neck) outcome was unknown.            no treatment information was provided no concomitant medication were reported