chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Feels like he got dragged; Vomiting; Fever of 101.5 degrees F; Aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Feels like he got dragged), VOMITING (Vomiting), PYREXIA (Fever of 101.5 degrees F), PAIN (Aches) 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 08-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GAIT DISTURBANCE (Feels like he got dragged), VOMITING (Vomiting), PYREXIA (Fever of 101.5 degrees F), PAIN (Aches) and CHILLS (Chills). At the time of the report, GAIT DISTURBANCE (Feels like he got dragged), VOMITING (Vomiting), PYREXIA (Fever of 101.5 degrees F), PAIN (Aches) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Body temperature: 101.5 (High) Fever of 101.5 degrees F.         No concomitant medications were mentioned. No treatment details were reported.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Blood urine present, Pain in extremity, Vaccination complication
Clinical narrative: Caller reported his own AE; Soreness in his arm; Blood in his urine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Caller reported his own AE), PAIN IN EXTREMITY (Soreness in his arm) and BLOOD URINE PRESENT (Blood in his urine) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007N20A and 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced PAIN IN EXTREMITY (Soreness in his arm) and BLOOD URINE PRESENT (Blood in his urine). On an unknown date, the patient experienced VACCINATION COMPLICATION (Caller reported his own AE). At the time of the report, VACCINATION COMPLICATION (Caller reported his own AE), PAIN IN EXTREMITY (Soreness in his arm) and BLOOD URINE PRESENT (Blood in his urine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication were reported. No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: Follow up contain significant information: Events - Blood in urine a nd soreness in arm were added. Dose 2 details added. Dose 1 details updated.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm hurt a little; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt a little) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Lupus erythematosus and Immunocompromised. Concomitant products included HYDROXYCHLOROQUINE, METHOTREXATE, FOLIC ACID, OMEPRAZOLE, CALCIUM FOLINATE (LEUCOVORIN CALCIUM), DICYCLOVERINE, VITAMIN C [ASCORBIC ACID] and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt a little). At the time of the report, PAIN IN EXTREMITY (Arm hurt a little) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No Concomitant medications were reported.  No Treatment medications were reported.   This case was linked to MOD-2021-314861, MOD-2021-314862 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication, Vaccination site erythema, Vaccination site warmth
Clinical narrative: Arm is hot four fingers bellow the injection site.; Red is like four fingers bellow the injection site; Felt beaten up; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Arm is hot four fingers bellow the injection site.), VACCINATION SITE ERYTHEMA (Red is like four fingers bellow the injection site) and VACCINATION COMPLICATION (Felt beaten up) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A, 042L20A and 01A21A) for COVID-19 vaccination.     Concurrent medical conditions included Lupus-like syndrome and Immunocompromised. Concomitant products included HYDROXYCHLOROQUINE, METHOTREXATE, FOLIC ACID, OMEPRAZOLE, CALCIUM FOLINATE (LEUCOVORIN CALCIUM), DICYCLOVERINE, Vitamin C and Vitamin D for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Sep-2021, the patient experienced VACCINATION SITE WARMTH (Arm is hot four fingers bellow the injection site.), VACCINATION SITE ERYTHEMA (Red is like four fingers bellow the injection site) and VACCINATION COMPLICATION (Felt beaten up). At the time of the report, VACCINATION SITE WARMTH (Arm is hot four fingers bellow the injection site.), VACCINATION SITE ERYTHEMA (Red is like four fingers bellow the injection site) and VACCINATION COMPLICATION (Felt beaten up) outcome was unknown.            No treatment medication reported.   This case was linked to MOD-2021-314861 (Patient Link).
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: hives; itching; rashes; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives), PRURITUS (itching) and RASH (rashes) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced URTICARIA (hives), PRURITUS (itching) and RASH (rashes). At the time of the report, URTICARIA (hives), PRURITUS (itching) and RASH (rashes) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue, SARS-CoV-2 test
Clinical narrative: >35 days since first dose - has not received second dose at this time; Tested positive for COVID after first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (>35 days since first dose - has not received second dose at this time) and COVID-19 (Tested positive for COVID after first dose) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced COVID-19 (Tested positive for COVID after first dose). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (>35 days since first dose - has not received second dose at this time). At the time of the report, PRODUCT DOSE OMISSION ISSUE (>35 days since first dose - has not received second dose at this time) had resolved and COVID-19 (Tested positive for COVID after first dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) POSITIVE.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was advised not to take second dose on scheduled time due to COVID positive Concomitant medications were not provided. Treatment information was not provided
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Adverse reaction from the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Adverse reaction from the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Lymphedema (Lymphedema arm).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Adverse reaction from the vaccine). At the time of the report, VACCINATION COMPLICATION (Adverse reaction from the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were provided. The patient had lymphedema arm and wants to take booster dose. The patient had to take the booster dose in the hip just like the flu shot.   Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Follow up received included no new information.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on her abdomen and chest that went away after 24hours; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on her abdomen and chest that went away after 24hours) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 008A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced RASH (rash on her abdomen and chest that went away after 24hours). On 07-Feb-2021, RASH (rash on her abdomen and chest that went away after 24hours) had resolved.            No treatment informations were reported
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Muscle tightness, Pain, Pyrexia
Clinical narrative: right thigh muscle and bicep/ tighten up; right arm and leg are cramping/diagnosed with muscle spasms; sore/ eerie-feeling; low grade temperature/running a temp; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TIGHTNESS (right thigh muscle and bicep/ tighten up), MUSCLE SPASMS (right arm and leg are cramping/diagnosed with muscle spasms), PAIN (sore/ eerie-feeling) and PYREXIA (low grade temperature/running a temp) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939902 and 034C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCLE TIGHTNESS (right thigh muscle and bicep/ tighten up), MUSCLE SPASMS (right arm and leg are cramping/diagnosed with muscle spasms), PAIN (sore/ eerie-feeling) and PYREXIA (low grade temperature/running a temp). At the time of the report, MUSCLE TIGHTNESS (right thigh muscle and bicep/ tighten up), MUSCLE SPASMS (right arm and leg are cramping/diagnosed with muscle spasms), PAIN (sore/ eerie-feeling) and PYREXIA (low grade temperature/running a temp) outcome was unknown.            Concomitant medications were not provided.  Treatment information was not provided.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Hyperhidrosis, Malaise, Myalgia, Pyrexia
Clinical narrative: Not feeling well; Arm was sore ,body aches; Temperature; Sweats; Body was burning hot; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Arm was sore ,body aches), PYREXIA (Temperature), HYPERHIDROSIS (Sweats), BURNING SENSATION (Body was burning hot) and MALAISE (Not feeling well) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Sep-2021, the patient experienced MYALGIA (Arm was sore ,body aches), PYREXIA (Temperature), HYPERHIDROSIS (Sweats) and BURNING SENSATION (Body was burning hot). On an unknown date, the patient experienced MALAISE (Not feeling well). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) for Adverse event, at an unspecified dose and frequency. At the time of the report, MYALGIA (Arm was sore ,body aches), PYREXIA (Temperature), HYPERHIDROSIS (Sweats), BURNING SENSATION (Body was burning hot) and MALAISE (Not feeling well) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Temporal temperature on right aide was 102.2 and on left side was 102.3. No concomitant medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: about 2 weeks ago started to have facial swelling where filler was/but only on one side; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (about 2 weeks ago started to have facial swelling where filler was/but only on one side) 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 Dermal filler injection (Patient had fillers placed in cheeks about two week  ago) in 2021.    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 SWELLING FACE (about 2 weeks ago started to have facial swelling where filler was/but only on one side). At the time of the report, SWELLING FACE (about 2 weeks ago started to have facial swelling where filler was/but only on one side) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported  Treatment included steroids   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Electrolyte imbalance, Fatigue, Injection site lymphadenopathy, Injection site swelling, Pain
Clinical narrative: Before getting the third dose, they had some blood tests done and they showed low electrolytes.; Severe pain; Had red patch 4-6 inches long underneath injection site; Had a red swelling on the injection site; Lymph nodes were red under the shot; Fatigue; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Sep-2021 and was forwarded to Moderna on 09-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ELECTROLYTE IMBALANCE (Before getting the third dose, they had some blood tests done and they showed low electrolytes.), PAIN (Severe pain), RASH (Had red patch 4-6 inches long underneath injection site), INJECTION SITE SWELLING (Had a red swelling on the injection site) and INJECTION SITE LYMPHADENOPATHY (Lymph nodes were red under the shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A, 013A21A and 022C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Sep-2021, 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 experienced ELECTROLYTE IMBALANCE (Before getting the third dose, they had some blood tests done and they showed low electrolytes.), PAIN (Severe pain), RASH (Had red patch 4-6 inches long underneath injection site), INJECTION SITE SWELLING (Had a red swelling on the injection site), INJECTION SITE LYMPHADENOPATHY (Lymph nodes were red under the shot) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 2 dosage form every six hours. At the time of the report, ELECTROLYTE IMBALANCE (Before getting the third dose, they had some blood tests done and they showed low electrolytes.), PAIN (Severe pain), RASH (Had red patch 4-6 inches long underneath injection site), INJECTION SITE SWELLING (Had a red swelling on the injection site), INJECTION SITE LYMPHADENOPATHY (Lymph nodes were red under the shot) and FATIGUE (Fatigue) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2021-314896 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Before getting the third dose, they had some blood tests done and they showed low electrolytes.; Severe pain; Had red patch 4-6 inches long underneath injection site; Had a red swelling on the injection site; Lymph nodes were red under the shot; Fatigue; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Sep-2021 and was forwarded to Moderna on 09-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ELECTROLYTE IMBALANCE (Before getting the third dose, they had some blood tests done and they showed low electrolytes.), PAIN (Severe pain), RASH (Had red patch 4-6 inches long underneath injection site), INJECTION SITE SWELLING (Had a red swelling on the injection site) and INJECTION SITE LYMPHADENOPATHY (Lymph nodes were red under the shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A, 013A21A and 022C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Sep-2021, 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 experienced ELECTROLYTE IMBALANCE (Before getting the third dose, they had some blood tests done and they showed low electrolytes.), PAIN (Severe pain), RASH (Had red patch 4-6 inches long underneath injection site), INJECTION SITE SWELLING (Had a red swelling on the injection site), INJECTION SITE LYMPHADENOPATHY (Lymph nodes were red under the shot) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 2 dosage form every six hours. At the time of the report, ELECTROLYTE IMBALANCE (Before getting the third dose, they had some blood tests done and they showed low electrolytes.), PAIN (Severe pain), RASH (Had red patch 4-6 inches long underneath injection site), INJECTION SITE SWELLING (Had a red swelling on the injection site), INJECTION SITE LYMPHADENOPATHY (Lymph nodes were red under the shot) and FATIGUE (Fatigue) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2021-314896 (Patient Link).
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: I had a sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (I had a sore arm at the injection site) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (Allergy to shrimp.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE PAIN (I had a sore arm at the injection site). At the time of the report, VACCINATION SITE PAIN (I had a sore arm at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment medications reported.   This case was linked to MOD-2021-314936 (Patient Link).
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Chills, Depressed mood, Illness, Myalgia
Clinical narrative: second dose "put him down"; really sick for 2 days; couldn't get out of bed; chills; body aches; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSED MOOD (second dose "put him down"), ILLNESS (really sick for 2 days), BEDRIDDEN (couldn't get out of bed), CHILLS (chills) and MYALGIA (body aches) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 845812A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jul-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 DEPRESSED MOOD (second dose "put him down"), ILLNESS (really sick for 2 days), BEDRIDDEN (couldn't get out of bed), CHILLS (chills) and MYALGIA (body aches). At the time of the report, DEPRESSED MOOD (second dose "put him down"), ILLNESS (really sick for 2 days), BEDRIDDEN (couldn't get out of bed), CHILLS (chills) and MYALGIA (body aches) outcome was unknown.            Concomitant medications were not provided. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Nausea, Vaccination site pain
Clinical narrative: left arm pain; fatigue; nausea; mild pain in left shoulder; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (left arm pain), FATIGUE (fatigue), NAUSEA (nausea) and ARTHRALGIA (mild pain in left shoulder) 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 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (left arm pain), FATIGUE (fatigue), NAUSEA (nausea) and ARTHRALGIA (mild pain in left shoulder). At the time of the report, VACCINATION SITE PAIN (left arm pain), FATIGUE (fatigue), NAUSEA (nausea) and ARTHRALGIA (mild pain in left shoulder) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: nurse gave some injections from a vial that was pierced the day before (19 hours after first punctured); This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (nurse gave some injections from a vial that was pierced the day before (19 hours after first punctured)) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (nurse gave some injections from a vial that was pierced the day before (19 hours after first punctured)). On 10-Sep-2021, EXPIRED PRODUCT ADMINISTERED (nurse gave some injections from a vial that was pierced the day before (19 hours after first punctured)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment information was provided by the reporter.  02-Sep-2021, The vial was initially stored in the refrigerator  09-Sep-2021, The vial was first punctured at 13.30 hs and then was left in the refrigerator.   10-Sep-2021, This morning a nurse came in and administer the vaccine to 3 patients from this vial.   the vial was not undergo any temperature excursions and total amount of time the vial was exposed to room temperature range was 8° to 25°C equal to 46° to 77°F: 7 times was out of the fridge just to withdraw doses  and never sat at room temperature.   Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Follow-up include dose number added.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Patient contracts covid after 1st vaccination; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Patient contracts covid after 1st vaccination) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Patient contracts covid after 1st vaccination). At the time of the report, COVID-19 (Patient contracts covid after 1st vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided No treatment medications were provided
Sex: U
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: one side of my face feeling puffy and swollen 30mins after shot and still just as bad 3hrs after shot; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (one side of my face feeling puffy and swollen 30mins after shot and still just as bad 3hrs after shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SWELLING FACE (one side of my face feeling puffy and swollen 30mins after shot and still just as bad 3hrs after shot). At the time of the report, SWELLING FACE (one side of my face feeling puffy and swollen 30mins after shot and still just as bad 3hrs after shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were mentioned. No treatment details were reported. The face was puffy and swollen even 3 hours after shot.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: administered past the 30 day refrigeration time; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (administered past the 30 day refrigeration time) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Aug-2021, the patient experienced PRODUCT STORAGE ERROR (administered past the 30 day refrigeration time). On 26-Aug-2021, PRODUCT STORAGE ERROR (administered past the 30 day refrigeration time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Vaccine refrigerated on 20 Apr 2021 and temperature changes 42 F were noted.  No concomitant medication was provided by the reporter.  No treatment information was provided by the reporter.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Ear pain, Headache, Tinnitus
Clinical narrative: The night after receiving the vaccine, I started having tinnitus/It has been ringing in my ear; headache gets so bad it makes my ears hurt; It is disabling, I cant focus it is constant; headache gets so bad it makes my ears hurt; This spontaneous case was reported by a nurse and describes the occurrence of TINNITUS (The night after receiving the vaccine, I started having tinnitus/It has been ringing in my ear), EAR PAIN (headache gets so bad it makes my ears hurt), DISTURBANCE IN ATTENTION (It is disabling, I cant focus it is constant) and HEADACHE (headache gets so bad it makes my ears hurt) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.    On 29-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TINNITUS (The night after receiving the vaccine, I started having tinnitus/It has been ringing in my ear), EAR PAIN (headache gets so bad it makes my ears hurt), DISTURBANCE IN ATTENTION (It is disabling, I cant focus it is constant) and HEADACHE (headache gets so bad it makes my ears hurt). At the time of the report, TINNITUS (The night after receiving the vaccine, I started having tinnitus/It has been ringing in my ear), EAR PAIN (headache gets so bad it makes my ears hurt), DISTURBANCE IN ATTENTION (It is disabling, I cant focus it is constant) and HEADACHE (headache gets so bad it makes my ears hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: With the 1st dose she was very sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (With the 1st dose she was very sick) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (With the 1st dose she was very sick). At the time of the report, ILLNESS (With the 1st dose she was very sick) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  No concomitant medication information provided by the reporter. NO Treatment information provided.   This case was linked to MOD-2021-315377 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: She had very little hives and it went away by itself.; This spontaneous case was reported by a non-health professional and describes the occurrence of URTICARIA (She had very little hives and it went away by itself.) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced URTICARIA (She had very little hives and it went away by itself.). On 31-Jan-2021, URTICARIA (She had very little hives and it went away by itself.) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-315301 (Patient Link).
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: chills; small fever for about 8 hours; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and PYREXIA (small fever for about 8 hours) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cancer.   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 CHILLS (chills) and PYREXIA (small fever for about 8 hours). At the time of the report, CHILLS (chills) and PYREXIA (small fever for about 8 hours) outcome was unknown.            Patient had Chemo and an Operation.   Reporter did not allow further contact
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Itchiness at the site; It started getting red and swollen she also has itchiness at the site; It started getting red and swollen she also has itchiness at the site; She had normal pain like you would get with any injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness at the site), VACCINATION SITE PAIN (She had normal pain like you would get with any injection), VACCINATION SITE ERYTHEMA (It started getting red and swollen she also has itchiness at the site) and VACCINATION SITE SWELLING (It started getting red and swollen she also has itchiness at the site) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037S21A) for COVID-19 vaccination.     No Medical History information was reported.  On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Sep-2021, the patient experienced VACCINATION SITE PAIN (She had normal pain like you would get with any injection). On 07-Sep-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness at the site), VACCINATION SITE ERYTHEMA (It started getting red and swollen she also has itchiness at the site) and VACCINATION SITE SWELLING (It started getting red and swollen she also has itchiness at the site). At the time of the report, VACCINATION SITE PRURITUS (Itchiness at the site), VACCINATION SITE PAIN (She had normal pain like you would get with any injection), VACCINATION SITE ERYTHEMA (It started getting red and swollen she also has itchiness at the site) and VACCINATION SITE SWELLING (It started getting red and swollen she also has itchiness at the site) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medications were reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Disorientation, Headache
Clinical narrative: like being disoriented, like you are drugged or something; fuzzy 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 DISORIENTATION (like being disoriented, like you are drugged or something) and HEADACHE (fuzzy 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 DISORIENTATION (like being disoriented, like you are drugged or something) and HEADACHE (fuzzy headache). At the time of the report, DISORIENTATION (like being disoriented, like you are drugged or something) and HEADACHE (fuzzy headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure decreased, Blood pressure measurement, Dizziness, Hyperhidrosis
Clinical narrative: Ten minutes after injection patient started sweating; Felt lightheaded/dizzy; really pale; weak; Lowblood pressure; Inappropriate route of vaccination; This spontaneous case was reported by a pharmacist and describes the occurrence of HYPERHIDROSIS (Ten minutes after injection patient started sweating), DIZZINESS (Felt lightheaded/dizzy), PALLOR (really pale), ASTHENIA (weak) and BLOOD PRESSURE DECREASED (Lowblood pressure) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Implant) 1 dosage form. On 29-Jul-2021, the patient experienced HYPERHIDROSIS (Ten minutes after injection patient started sweating), DIZZINESS (Felt lightheaded/dizzy), PALLOR (really pale), ASTHENIA (weak), BLOOD PRESSURE DECREASED (Lowblood pressure) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination). On 29-Jul-2021, HYPERHIDROSIS (Ten minutes after injection patient started sweating), DIZZINESS (Felt lightheaded/dizzy), PALLOR (really pale), ASTHENIA (weak), BLOOD PRESSURE DECREASED (Lowblood pressure) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jul-2021, Blood pressure measurement: low (Low) low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Implant) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Implant), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: updated route of administration and event start date.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Pallor
Clinical narrative: Ten minutes after injection patient started sweating; Felt lightheaded/dizzy; really pale; weak; Lowblood pressure; Inappropriate route of vaccination; This spontaneous case was reported by a pharmacist and describes the occurrence of HYPERHIDROSIS (Ten minutes after injection patient started sweating), DIZZINESS (Felt lightheaded/dizzy), PALLOR (really pale), ASTHENIA (weak) and BLOOD PRESSURE DECREASED (Lowblood pressure) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Implant) 1 dosage form. On 29-Jul-2021, the patient experienced HYPERHIDROSIS (Ten minutes after injection patient started sweating), DIZZINESS (Felt lightheaded/dizzy), PALLOR (really pale), ASTHENIA (weak), BLOOD PRESSURE DECREASED (Lowblood pressure) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination). On 29-Jul-2021, HYPERHIDROSIS (Ten minutes after injection patient started sweating), DIZZINESS (Felt lightheaded/dizzy), PALLOR (really pale), ASTHENIA (weak), BLOOD PRESSURE DECREASED (Lowblood pressure) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jul-2021, Blood pressure measurement: low (Low) low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Implant) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Implant), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: updated route of administration and event start date.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Temperature changes (in F): 41; administered past the 30 day refrigeration time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) and PRODUCT STORAGE ERROR (Temperature changes (in F): 41) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Temperature changes (in F): 41). On 13-Jul-2021, EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Temperature changes (in F): 41) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter.  No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: More than 35 days passed since the first dose and patient did not get the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 35 days passed since the first dose and patient did not get the second dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-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 PRODUCT DOSE OMISSION ISSUE (More than 35 days passed since the first dose and patient did not get the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 35 days passed since the first dose and patient did not get the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications and Treatment information were not provided.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported   No treatment medication was reported
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered past the 30 day refrigeration time; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time). On 07-Sep-2021, EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The date refrigeration was reported as 20-Apr-2021 and the temperature changes (in F) was 40. Earlier this week we realized that some doses of the Moderna COVID Vaccine had been administered past the 30 day refrigeration time.  No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: Was feeling pretty good, but as the day goes on I'm feeling worse; No appetite; Weak; Diz; Sore arm; Nausea; Headache; Tired; 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 FEELING ABNORMAL (Was feeling pretty good, but as the day goes on I'm feeling worse), DECREASED APPETITE (No appetite), ASTHENIA (Weak), DIZZINESS (Diz) and MYALGIA (Sore arm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 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 FEELING ABNORMAL (Was feeling pretty good, but as the day goes on I'm feeling worse), DECREASED APPETITE (No appetite), ASTHENIA (Weak), DIZZINESS (Diz), MYALGIA (Sore arm), NAUSEA (Nausea), HEADACHE (Headache) and FATIGUE (Tired). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Was feeling pretty good, but as the day goes on I'm feeling worse), DECREASED APPETITE (No appetite), ASTHENIA (Weak), DIZZINESS (Diz) and FATIGUE (Tired) outcome was unknown and MYALGIA (Sore arm), NAUSEA (Nausea) and HEADACHE (Headache) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.    Reporter did not allow further contact