chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Mobility decreased, Pain in extremity
Clinical narrative: The redness in my arm has moved down to what seems like a vein; its hard to move my arm without severe pain; My arm hurts; from back of my shoulder all the way down it; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (The redness in my arm has moved down to what seems like a vein), MOBILITY DECREASED (its hard to move my arm without severe pain), PAIN IN EXTREMITY (My arm hurts) and ARTHRALGIA (from back of my shoulder all the way down it) 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 ERYTHEMA (The redness in my arm has moved down to what seems like a vein), MOBILITY DECREASED (its hard to move my arm without severe pain), PAIN IN EXTREMITY (My arm hurts) and ARTHRALGIA (from back of my shoulder all the way down it). At the time of the report, ERYTHEMA (The redness in my arm has moved down to what seems like a vein), MOBILITY DECREASED (its hard to move my arm without severe pain), PAIN IN EXTREMITY (My arm hurts) and ARTHRALGIA (from back of my shoulder all the way down it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided. No treatment medication was provided.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, SARS-CoV-2 test
Clinical narrative: Lost taste; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Lost taste) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AGEUSIA (Lost taste). At the time of the report, AGEUSIA (Lost taste) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not reported Treatment medication were not reported
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Actively has COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Actively has COVID) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 COVID-19 (Actively has COVID). At the time of the report, COVID-19 (Actively has COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Tested positive for COVID.         No concomitant medications were reported.  No treatment medications were reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Erythema, Fatigue, Pruritus, Swelling
Clinical narrative: Itchy on her scalp; Red ears; Hot ears; Swollen Nose; Felt tired; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Sep-2021 and was forwarded to Moderna on 07-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy on her scalp), ERYTHEMA (Red ears), EAR DISCOMFORT (Hot ears), SWELLING (Swollen Nose) and FATIGUE (Felt tired) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 023M20A) for COVID-19 vaccination.     No lab data was provided by the reporter.  Concurrent medical conditions included Immunocompromised, Rheumatoid arthritis and Cancer ((Not on Chemo now)). Concomitant products included INFLIXIMAB (REMICADE), METHOTREXATE and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced PRURITUS (Itchy on her scalp), ERYTHEMA (Red ears), EAR DISCOMFORT (Hot ears), SWELLING (Swollen Nose) and FATIGUE (Felt tired). On 19-Mar-2021, PRURITUS (Itchy on her scalp), ERYTHEMA (Red ears), EAR DISCOMFORT (Hot ears), SWELLING (Swollen Nose) and FATIGUE (Felt tired) had resolved.            No treatment medications were provided.  Reporter stated that patient  followed the doctor's instructions and took Benadryl.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Expired vaccine administered beyond 12 hours expiration for punctured vial; Expired vaccine administered beyond 12 hours expiration for punctured vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours expiration for punctured vial) and PRODUCT STORAGE ERROR (Expired vaccine administered beyond 12 hours expiration for punctured vial) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours expiration for punctured vial) and PRODUCT STORAGE ERROR (Expired vaccine administered beyond 12 hours expiration for punctured vial). On 06-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours expiration for punctured vial) and PRODUCT STORAGE ERROR (Expired vaccine administered beyond 12 hours expiration for punctured vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   Treatment information was not provided.   Pharmacist is called to report that 8 patients received expired doses of Moderna COVID-19 vaccine beyond 12 hour expiration for punctured vials.  Date the vial was initially stored in the refrigerator was 31AUG2021.  Date first punctured was on 05SEP2021 11AM Kept in Refrigerator.  Date of administration of vaccine was on 06SEP2021 4:30PM Room Temperature on 06SEP2021  then discarded the vial.  Total amount of time the vial was exposed to room temperature range 46° to 77° F.  From 06SEP2021 9:00AM and discarded vial after 4:30PM.   This case was linked to MOD-2021-311383 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Follow up information included Updated Fax Contact details.
Age: 77.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Extra dose administered, Fatigue, Myalgia, Vaccination site pain
Clinical narrative: Chills; an ache all over feeling; Fatigue; Ache all over feeling, specially in the area where I got the booster shot; Received a booster shot; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Sep-2021 and was forwarded to Moderna on 07-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), MYALGIA (an ache all over feeling), FATIGUE (Fatigue), VACCINATION SITE PAIN (Ache all over feeling, specially in the area where I got the booster shot) and EXTRA DOSE ADMINISTERED (Received a booster shot) in a 77-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Congestive heart failure.   On 04-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 04-Sep-2021, the patient experienced EXTRA DOSE ADMINISTERED (Received a booster shot). On an unknown date, the patient experienced CHILLS (Chills), MYALGIA (an ache all over feeling), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Ache all over feeling, specially in the area where I got the booster shot). On 04-Sep-2021, EXTRA DOSE ADMINISTERED (Received a booster shot) had resolved. At the time of the report, CHILLS (Chills), MYALGIA (an ache all over feeling), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Ache all over feeling, specially in the area where I got the booster shot) outcome was unknown.            No concomitant medications were not provided. No treatment information was provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Illness, Vomiting, Weight decreased
Clinical narrative: sick as a dog/still sick a month later/made me sick; lost 20 pounds/She's lost 18 pounds; can't hold anything down; can't get rid of my headache/ plagued with headaches; can't quit throwing up/throwing up water and bile; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick as a dog/still sick a month later/made me sick), WEIGHT DECREASED (lost 20 pounds/She's lost 18 pounds), ASTHENIA (can't hold anything down), HEADACHE (can't get rid of my headache/ plagued with headaches) and VOMITING (can't quit throwing up/throwing up water and bile) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006D21A and 039C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Aug-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 ILLNESS (sick as a dog/still sick a month later/made me sick), WEIGHT DECREASED (lost 20 pounds/She's lost 18 pounds), ASTHENIA (can't hold anything down), HEADACHE (can't get rid of my headache/ plagued with headaches) and VOMITING (can't quit throwing up/throwing up water and bile). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]) for Headache, at a dose of 6-8 Excedrin a day. At the time of the report, ILLNESS (sick as a dog/still sick a month later/made me sick), WEIGHT DECREASED (lost 20 pounds/She's lost 18 pounds), ASTHENIA (can't hold anything down), HEADACHE (can't get rid of my headache/ plagued with headaches) and VOMITING (can't quit throwing up/throwing up water and bile) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient has stated that she underwent MRI scan to her brain but can't found anything No concomitant medications were reported. Patient has stated that it hits her hard and felt angry and she felt plagued with headache and had headache prior to the vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2021: Updated Reporter information, Updated patient details, Updated treatment partial frequency, Added patient lab details, Added suspect start dates and lot numbers, Added events.
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: period last for more than 3 weeks and is not stopping; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (period last for more than 3 weeks and is not stopping) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Aug-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 HEAVY MENSTRUAL BLEEDING (period last for more than 3 weeks and is not stopping). At the time of the report, HEAVY MENSTRUAL BLEEDING (period last for more than 3 weeks and is not stopping) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The treatment history was not reported. The concomitant medication was not reported.   This case was linked to MOD-2021-311208 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Breast mass, Peripheral swelling
Clinical narrative: Hand swollen; Few female had lump in their breast; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Hand swollen) and BREAST MASS (Few female had lump in their breast) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Hand swollen) and BREAST MASS (Few female had lump in their breast). At the time of the report, PERIPHERAL SWELLING (Hand swollen) and BREAST MASS (Few female had lump in their breast) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided by the reporter  Treatment information was not provided
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Illness, Rhinorrhoea
Clinical narrative: I have been sick for 3 days; runny nose; Diarrhoea now; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I have been sick for 3 days), RHINORRHOEA (runny nose) and DIARRHOEA (Diarrhoea now) 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.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced ILLNESS (I have been sick for 3 days), RHINORRHOEA (runny nose) and DIARRHOEA (Diarrhoea now). At the time of the report, ILLNESS (I have been sick for 3 days) and RHINORRHOEA (runny nose) outcome was unknown and DIARRHOEA (Diarrhoea now) had not resolved.            No concomitant medication were reported. The treatment information were unknown.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Heart rate, Oxygen saturation, Oxygen saturation decreased, Pyrexia
Clinical narrative: Oxygen levels in the 80s for 6 hours the first 10 after injection with the 2nd dose; Heart rate between 120-130; A fever of 102; This spontaneous case was reported by a consumer and describes the occurrence of OXYGEN SATURATION DECREASED (Oxygen levels in the 80s for 6 hours the first 10 after injection with the 2nd dose), TACHYCARDIA (Heart rate between 120-130) and PYREXIA (A fever of 102) 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 OXYGEN SATURATION DECREASED (Oxygen levels in the 80s for 6 hours the first 10 after injection with the 2nd dose), TACHYCARDIA (Heart rate between 120-130) and PYREXIA (A fever of 102). At the time of the report, OXYGEN SATURATION DECREASED (Oxygen levels in the 80s for 6 hours the first 10 after injection with the 2nd dose), TACHYCARDIA (Heart rate between 120-130) and PYREXIA (A fever of 102) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) A fever of 102. On an unknown date, Heart rate: 120-130 (High) 120-130. On an unknown date, Oxygen saturation: low (Low) Oxygen levels in 80s for 6 hours the first 10 after injection with the 2nd dose).         No concomitant medication information was provided.  No treatment medication were provided.   This case was linked to MOD-2021-311256 (Patient Link).; Sender's Comments: Based on current available information and the temporal associations between product and the start date of the events a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Oxygen levels in the 80s for 6 hours the first 10 after injection with the 2nd dose; Heart rate between 120-130; A fever of 102; This spontaneous case was reported by a consumer and describes the occurrence of OXYGEN SATURATION DECREASED (Oxygen levels in the 80s for 6 hours the first 10 after injection with the 2nd dose), TACHYCARDIA (Heart rate between 120-130) and PYREXIA (A fever of 102) 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 OXYGEN SATURATION DECREASED (Oxygen levels in the 80s for 6 hours the first 10 after injection with the 2nd dose), TACHYCARDIA (Heart rate between 120-130) and PYREXIA (A fever of 102). At the time of the report, OXYGEN SATURATION DECREASED (Oxygen levels in the 80s for 6 hours the first 10 after injection with the 2nd dose), TACHYCARDIA (Heart rate between 120-130) and PYREXIA (A fever of 102) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) A fever of 102. On an unknown date, Heart rate: 120-130 (High) 120-130. On an unknown date, Oxygen saturation: low (Low) Oxygen levels in 80s for 6 hours the first 10 after injection with the 2nd dose).         No concomitant medication information was provided.  No treatment medication were provided.   This case was linked to MOD-2021-311256 (Patient Link).; Sender's Comments: Based on current available information and the temporal associations between product and the start date of the events a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: some aches [after first shot]; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (some aches [after first shot]) 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 MYALGIA (some aches [after first shot]). At the time of the report, MYALGIA (some aches [after first shot]) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-311030 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Had 2nd dose 6 months after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Had 2nd dose 6 months after the 1st 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, 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Had 2nd dose 6 months after the 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Had 2nd dose 6 months after the 1st dose) had resolved.            No concomitant medications were reported.  No treatment medications were reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Oropharyngeal pain
Clinical narrative: sore throat; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) and FATIGUE (fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat) and FATIGUE (fatigue). At the time of the report, OROPHARYNGEAL PAIN (sore throat) and FATIGUE (fatigue) outcome was unknown.        This case was linked to MOD-2021-311155 (Patient Link).  Concomitant medication was not reported. Treatment information was not reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nasopharyngitis
Clinical narrative: I had the chills; cold sensation; This spontaneous case was reported by a non-health professional and describes the occurrence of CHILLS (I had the chills) and NASOPHARYNGITIS (cold sensation) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-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 02-Mar-2021, the patient experienced CHILLS (I had the chills) and NASOPHARYNGITIS (cold sensation). At the time of the report, CHILLS (I had the chills) and NASOPHARYNGITIS (cold sensation) outcome was unknown.            No concomitant medications were provided by reporter. No treatment medications were provided by reporter.   This case was linked to MOD-2021-311211, MOD-2021-311061 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: experienced cold chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (experienced cold chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21A, 029A21A and 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 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 an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, the patient experienced CHILLS (experienced cold chills). At the time of the report, CHILLS (experienced cold chills) outcome was unknown.            No concomitant medications were provided by reporter.  No treatment details were provided by reporter.   This case was linked to MOD-2021-311061, MOD-2021-311210 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: I feel nauseous; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (I feel nauseous) 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 NAUSEA (I feel nauseous). At the time of the report, NAUSEA (I feel nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants medication were provided.  No treatment medication were provided.
Sex: U
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: My arm hurt; stiffness spread up over my shoulder, across my collarbone and up the side of my neck; discomfort spread up over my shoulder, across my collarbone and up the side of my neck; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (My arm hurt), MUSCULOSKELETAL STIFFNESS (stiffness spread up over my shoulder, across my collarbone and up the side of my neck) and MUSCULOSKELETAL DISCOMFORT (discomfort spread up over my shoulder, across my collarbone and up the side of my neck) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness spread up over my shoulder, across my collarbone and up the side of my neck) and MUSCULOSKELETAL DISCOMFORT (discomfort spread up over my shoulder, across my collarbone and up the side of my neck). On 05-Sep-2021, the patient experienced PAIN IN EXTREMITY (My arm hurt). At the time of the report, PAIN IN EXTREMITY (My arm hurt) and MUSCULOSKELETAL STIFFNESS (stiffness spread up over my shoulder, across my collarbone and up the side of my neck) outcome was unknown and MUSCULOSKELETAL DISCOMFORT (discomfort spread up over my shoulder, across my collarbone and up the side of my neck) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Nerve injury, Paraesthesia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (shooting tingling in her right arm/shooting tingling in her neck/shooting tingling into her shoulder blades/shooting tingling into her back/shooting tingling into her spine) and NERVE INJURY (She thought it was nerve damage) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Fibromyalgia and Arthritis. On 02-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jul-2021, the patient experienced PARAESTHESIA (shooting tingling in her right arm/shooting tingling in her neck/shooting tingling into her shoulder blades/shooting tingling into her back/shooting tingling into her spine) and NERVE INJURY (She thought it was nerve damage). At the time of the report, PARAESTHESIA (shooting tingling in her right arm/shooting tingling in her neck/shooting tingling into her shoulder blades/shooting tingling into her back/shooting tingling into her spine) and NERVE INJURY (She thought it was nerve damage) outcome was unknown. No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dizziness, Head discomfort, Ocular discomfort
Clinical narrative: had the runs (meaning stomach issues); felt dizzy; pressure to the back of his head, pressure around temple; pressure behind his eyes; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (had the runs (meaning stomach issues)), DIZZINESS (felt dizzy), HEAD DISCOMFORT (pressure to the back of his head, pressure around temple) and OCULAR DISCOMFORT (pressure behind his eyes) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Sep-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 ABDOMINAL DISCOMFORT (had the runs (meaning stomach issues)), DIZZINESS (felt dizzy), HEAD DISCOMFORT (pressure to the back of his head, pressure around temple) and OCULAR DISCOMFORT (pressure behind his eyes). At the time of the report, ABDOMINAL DISCOMFORT (had the runs (meaning stomach issues)), DIZZINESS (felt dizzy), HEAD DISCOMFORT (pressure to the back of his head, pressure around temple) and OCULAR DISCOMFORT (pressure behind his eyes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided.  No treatment medication were provided.
Sex: U
Vaccine: COVID19
Symptoms: Petechiae
Clinical narrative: arm capillaries burst in flight; 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 PETECHIAE (arm capillaries burst in flight) 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 PETECHIAE (arm capillaries burst in flight). At the time of the report, PETECHIAE (arm capillaries burst in flight) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vaccination complication, Vertigo
Clinical narrative: three days later from each time, I had horrible, horrible reaction; vertigo; so dizzy, couldn't even walk to the bathroom,She had no balance whatsoever. Her dizziness was so bad that she had to; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (three days later from each time, I had horrible, horrible reaction), DIZZINESS (so dizzy, couldn't even walk to the bathroom,She had no balance whatsoever. Her dizziness was so bad that she had to) and VERTIGO (vertigo) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced DIZZINESS (so dizzy, couldn't even walk to the bathroom,She had no balance whatsoever. Her dizziness was so bad that she had to). On an unknown date, the patient experienced VACCINATION COMPLICATION (three days later from each time, I had horrible, horrible reaction) and VERTIGO (vertigo). At the time of the report, VACCINATION COMPLICATION (three days later from each time, I had horrible, horrible reaction), DIZZINESS (so dizzy, couldn't even walk to the bathroom,She had no balance whatsoever. Her dizziness was so bad that she had to) and VERTIGO (vertigo) outcome was unknown.            No concomitant medication were provided by the reporter  No treatment medication were provided by the reporter   This case was linked to MOD-2021-311397, MOD-2021-311050, MOD-2021-311042 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects from the vaccine) 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. In January 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 VACCINATION COMPLICATION (side effects from the vaccine). At the time of the report, VACCINATION COMPLICATION (side effects from the vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications was not provided by the reporter. Treatment information was not provided. This case was linked to MOD-2021-311281.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: First dose 8 months ago; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (First dose 8 months ago) 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.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (First dose 8 months ago). In February 2021, PRODUCT DOSE OMISSION ISSUE (First dose 8 months ago) had resolved.            Concomitant medications were not reported.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product lot number issue
Clinical narrative: Wrong expiration; Incorrect lot number; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (wrong expiration) and PRODUCT LOT NUMBER ISSUE (incorrect lot number) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (wrong expiration) and PRODUCT LOT NUMBER ISSUE (incorrect lot number). On 04-Sep-2021, EXPIRED PRODUCT ADMINISTERED (wrong expiration) had resolved and PRODUCT LOT NUMBER ISSUE (incorrect lot number) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Feeling abnormal, Hyperhidrosis
Clinical narrative: Body aches; Pyrexia; Cold; Migraine; She felt like a dish rag.; She was so sick; Right arm hurt where I got the shot; Nauseated; Chills; Full body sweats; Light-headed; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Full body sweats), DIZZINESS (Light-headed), NASOPHARYNGITIS (Cold), MIGRAINE (Migraine) and FEELING ABNORMAL (She felt like a dish rag.) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20VT, 010A21A and 032L20VT) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, the patient experienced HYPERHIDROSIS (Full body sweats) and DIZZINESS (Light-headed). On 03-Sep-2021, the patient experienced NASOPHARYNGITIS (Cold), MIGRAINE (Migraine), FEELING ABNORMAL (She felt like a dish rag.), ILLNESS (She was so sick), VACCINATION SITE PAIN (Right arm hurt where I got the shot), NAUSEA (Nauseated), CHILLS (Chills) and PYREXIA (Pyrexia). On an unknown date, the patient experienced MYALGIA (Body aches). The patient was treated with PARACETAMOL (TYLENOL) on 04-Sep-2021 for Adverse event, at an unspecified dose and frequency. On 04-Sep-2021, ILLNESS (She was so sick) had resolved. At the time of the report, HYPERHIDROSIS (Full body sweats), DIZZINESS (Light-headed), NASOPHARYNGITIS (Cold), MIGRAINE (Migraine), FEELING ABNORMAL (She felt like a dish rag.), VACCINATION SITE PAIN (Right arm hurt where I got the shot), NAUSEA (Nauseated), CHILLS (Chills), MYALGIA (Body aches) and PYREXIA (Pyrexia) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Sep-2021, Body temperature: 103.5 f (High) 103.5- F :  High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Relevant concomitant medications were not reported.  It was reported that patient took two Tylenol medication at night.   This case was linked to MOD-2021-311278 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Additional information received and updated suspect product start date and event details (start date and event outcome ).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Migraine, Myalgia, Nasopharyngitis, Nausea
Clinical narrative: Body aches; Pyrexia; Cold; Migraine; She felt like a dish rag.; She was so sick; Right arm hurt where I got the shot; Nauseated; Chills; Full body sweats; Light-headed; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Full body sweats), DIZZINESS (Light-headed), NASOPHARYNGITIS (Cold), MIGRAINE (Migraine) and FEELING ABNORMAL (She felt like a dish rag.) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20VT, 010A21A and 032L20VT) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, the patient experienced HYPERHIDROSIS (Full body sweats) and DIZZINESS (Light-headed). On 03-Sep-2021, the patient experienced NASOPHARYNGITIS (Cold), MIGRAINE (Migraine), FEELING ABNORMAL (She felt like a dish rag.), ILLNESS (She was so sick), VACCINATION SITE PAIN (Right arm hurt where I got the shot), NAUSEA (Nauseated), CHILLS (Chills) and PYREXIA (Pyrexia). On an unknown date, the patient experienced MYALGIA (Body aches). The patient was treated with PARACETAMOL (TYLENOL) on 04-Sep-2021 for Adverse event, at an unspecified dose and frequency. On 04-Sep-2021, ILLNESS (She was so sick) had resolved. At the time of the report, HYPERHIDROSIS (Full body sweats), DIZZINESS (Light-headed), NASOPHARYNGITIS (Cold), MIGRAINE (Migraine), FEELING ABNORMAL (She felt like a dish rag.), VACCINATION SITE PAIN (Right arm hurt where I got the shot), NAUSEA (Nauseated), CHILLS (Chills), MYALGIA (Body aches) and PYREXIA (Pyrexia) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Sep-2021, Body temperature: 103.5 f (High) 103.5- F :  High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Relevant concomitant medications were not reported.  It was reported that patient took two Tylenol medication at night.   This case was linked to MOD-2021-311278 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Additional information received and updated suspect product start date and event details (start date and event outcome ).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Body aches; Pyrexia; Cold; Migraine; She felt like a dish rag.; She was so sick; Right arm hurt where I got the shot; Nauseated; Chills; Full body sweats; Light-headed; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Full body sweats), DIZZINESS (Light-headed), NASOPHARYNGITIS (Cold), MIGRAINE (Migraine) and FEELING ABNORMAL (She felt like a dish rag.) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20VT, 010A21A and 032L20VT) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, the patient experienced HYPERHIDROSIS (Full body sweats) and DIZZINESS (Light-headed). On 03-Sep-2021, the patient experienced NASOPHARYNGITIS (Cold), MIGRAINE (Migraine), FEELING ABNORMAL (She felt like a dish rag.), ILLNESS (She was so sick), VACCINATION SITE PAIN (Right arm hurt where I got the shot), NAUSEA (Nauseated), CHILLS (Chills) and PYREXIA (Pyrexia). On an unknown date, the patient experienced MYALGIA (Body aches). The patient was treated with PARACETAMOL (TYLENOL) on 04-Sep-2021 for Adverse event, at an unspecified dose and frequency. On 04-Sep-2021, ILLNESS (She was so sick) had resolved. At the time of the report, HYPERHIDROSIS (Full body sweats), DIZZINESS (Light-headed), NASOPHARYNGITIS (Cold), MIGRAINE (Migraine), FEELING ABNORMAL (She felt like a dish rag.), VACCINATION SITE PAIN (Right arm hurt where I got the shot), NAUSEA (Nauseated), CHILLS (Chills), MYALGIA (Body aches) and PYREXIA (Pyrexia) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Sep-2021, Body temperature: 103.5 f (High) 103.5- F :  High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Relevant concomitant medications were not reported.  It was reported that patient took two Tylenol medication at night.   This case was linked to MOD-2021-311278 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Additional information received and updated suspect product start date and event details (start date and event outcome ).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Paraesthesia
Clinical narrative: tingling in the right arm/ tingling from arm to hand; The tingling in from arm to hand and it bothering; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in the right arm/ tingling from arm to hand) and LIMB DISCOMFORT (The tingling in from arm to hand and it bothering) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Aug-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 PARAESTHESIA (tingling in the right arm/ tingling from arm to hand) and LIMB DISCOMFORT (The tingling in from arm to hand and it bothering). At the time of the report, PARAESTHESIA (tingling in the right arm/ tingling from arm to hand) and LIMB DISCOMFORT (The tingling in from arm to hand and it bothering) 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 information was not provided by the reporter.  Treatment information was not provided by the reporter.  Patient reported that she was not allergic to any ingredients of the vaccine as far as she known.  Patient tried to get some medical evaluation and treatment at local emergency room. At the local emergency room patient was not evaluated and told to reach out to her HCP.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Hypoaesthesia, Paraesthesia, Pyrexia
Clinical narrative: Tingling  right leg after second shot; Numbness right leg after second shot; High Fever (102 F) after second shot; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling  right leg after second shot), HYPOAESTHESIA (Numbness right leg after second shot) and PYREXIA (High Fever (102 F) after second shot) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 027B21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: ANTACID [CALCIUM CARBONATE] (Antacids prior to vaccination).   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (High Fever (102 F) after second shot). On 13-May-2021, the patient experienced PARAESTHESIA (Tingling  right leg after second shot) and HYPOAESTHESIA (Numbness right leg after second shot). On 09-May-2021, PYREXIA (High Fever (102 F) after second shot) had resolved. At the time of the report, PARAESTHESIA (Tingling  right leg after second shot) and HYPOAESTHESIA (Numbness right leg after second shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-May-2021, Body temperature: 102 (High) 102 Fahrenheit.         Concomitant medication was not provided Treatment information was not reported Patient has seen several doctors and has done tests that were normal.