chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity, Pyrexia, Rash
Clinical narrative: her arm hurt for a long long time; Rash; a raised red dot at the injection site; tired; chills; fever; health care provider removed the needle during administration so she had some of the vaccine on her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (her arm hurt for a long long time), RASH (Rash), VACCINATION SITE JOINT ERYTHEMA (a raised red dot at the injection site), FATIGUE (tired) and CHILLS (chills) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Mastectomy. Concurrent medical conditions included Migraine.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-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 PAIN IN EXTREMITY (her arm hurt for a long long time), RASH (Rash), VACCINATION SITE JOINT ERYTHEMA (a raised red dot at the injection site), FATIGUE (tired), CHILLS (chills), PYREXIA (fever) and UNDERDOSE (health care provider removed the needle during administration so she had some of the vaccine on her arm). At the time of the report, PAIN IN EXTREMITY (her arm hurt for a long long time), RASH (Rash), VACCINATION SITE JOINT ERYTHEMA (a raised red dot at the injection site), FATIGUE (tired), CHILLS (chills) and PYREXIA (fever) outcome was unknown and UNDERDOSE (health care provider removed the needle during administration so she had some of the vaccine on her arm) had resolved.            Treatment information was not provided. No lab data provided by reporter. Other concomitant Excedrin that patient had taken for migraines .   This case was linked to MOD-2021-285640 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose, Vaccination site joint erythema
Clinical narrative: her arm hurt for a long long time; Rash; a raised red dot at the injection site; tired; chills; fever; health care provider removed the needle during administration so she had some of the vaccine on her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (her arm hurt for a long long time), RASH (Rash), VACCINATION SITE JOINT ERYTHEMA (a raised red dot at the injection site), FATIGUE (tired) and CHILLS (chills) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Mastectomy. Concurrent medical conditions included Migraine.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-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 PAIN IN EXTREMITY (her arm hurt for a long long time), RASH (Rash), VACCINATION SITE JOINT ERYTHEMA (a raised red dot at the injection site), FATIGUE (tired), CHILLS (chills), PYREXIA (fever) and UNDERDOSE (health care provider removed the needle during administration so she had some of the vaccine on her arm). At the time of the report, PAIN IN EXTREMITY (her arm hurt for a long long time), RASH (Rash), VACCINATION SITE JOINT ERYTHEMA (a raised red dot at the injection site), FATIGUE (tired), CHILLS (chills) and PYREXIA (fever) outcome was unknown and UNDERDOSE (health care provider removed the needle during administration so she had some of the vaccine on her arm) had resolved.            Treatment information was not provided. No lab data provided by reporter. Other concomitant Excedrin that patient had taken for migraines .   This case was linked to MOD-2021-285640 (Patient Link).
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Discomfort, Headache, Inappropriate schedule of product administration, Influenza like illness, Interchange of vaccine products
Clinical narrative: Caller got Pfizer vaccine and Moderna vaccine; kind like the flu; uncomfortable; felt nauseous; Caller got 1st moderna vaccine in june and second Moderna vaccine on 9-Aug; arm is sore/sore; headache; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Caller got 1st moderna vaccine in june and second Moderna vaccine on 9-Aug), INTERCHANGE OF VACCINE PRODUCTS (Caller got Pfizer vaccine and Moderna vaccine), INFLUENZA LIKE ILLNESS (kind like the flu), DISCOMFORT (uncomfortable) and MYALGIA (arm is sore/sore) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    The patient's past medical history included Pneumonia (had pneumonia four times and was hospitalized once), Staphylococcal infection (Staph in the left knee) and Surgery. Concurrent medical conditions included COPD, Asthma and Overweight. Concomitant products included NAPROXEN, GABAPENTIN, CARISOPRODOL (SOMA [CARISOPRODOL]), ATORVASTATIN CALCIUM (STATIN [ATORVASTATIN CALCIUM]), SALBUTAMOL (ALBUTEROL HFA) and SUMATRIPTAN for an unknown indication.   In January 2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. In February 2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Caller got 1st moderna vaccine in june and second Moderna vaccine on 9-Aug), MYALGIA (arm is sore/sore) and HEADACHE (headache). On 10-Aug-2021, the patient experienced NAUSEA (felt nauseous). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Caller got Pfizer vaccine and Moderna vaccine), INFLUENZA LIKE ILLNESS (kind like the flu) and DISCOMFORT (uncomfortable). On 09-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Caller got 1st moderna vaccine in june and second Moderna vaccine on 9-Aug) and HEADACHE (headache) had resolved. On 13-Aug-2021, NAUSEA (felt nauseous) had resolved. At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Caller got Pfizer vaccine and Moderna vaccine) had resolved, INFLUENZA LIKE ILLNESS (kind like the flu) and DISCOMFORT (uncomfortable) outcome was unknown and MYALGIA (arm is sore/sore) had not resolved.            Concomitant medication includes paxil. No treatment drugs were reported.  He took a nausea pill. Yesterday was still a little nauseous.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: Caller got Pfizer vaccine and Moderna vaccine; kind like the flu; uncomfortable; felt nauseous; Caller got 1st moderna vaccine in june and second Moderna vaccine on 9-Aug; arm is sore/sore; headache; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Caller got 1st moderna vaccine in june and second Moderna vaccine on 9-Aug), INTERCHANGE OF VACCINE PRODUCTS (Caller got Pfizer vaccine and Moderna vaccine), INFLUENZA LIKE ILLNESS (kind like the flu), DISCOMFORT (uncomfortable) and MYALGIA (arm is sore/sore) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    The patient's past medical history included Pneumonia (had pneumonia four times and was hospitalized once), Staphylococcal infection (Staph in the left knee) and Surgery. Concurrent medical conditions included COPD, Asthma and Overweight. Concomitant products included NAPROXEN, GABAPENTIN, CARISOPRODOL (SOMA [CARISOPRODOL]), ATORVASTATIN CALCIUM (STATIN [ATORVASTATIN CALCIUM]), SALBUTAMOL (ALBUTEROL HFA) and SUMATRIPTAN for an unknown indication.   In January 2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. In February 2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Caller got 1st moderna vaccine in june and second Moderna vaccine on 9-Aug), MYALGIA (arm is sore/sore) and HEADACHE (headache). On 10-Aug-2021, the patient experienced NAUSEA (felt nauseous). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Caller got Pfizer vaccine and Moderna vaccine), INFLUENZA LIKE ILLNESS (kind like the flu) and DISCOMFORT (uncomfortable). On 09-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Caller got 1st moderna vaccine in june and second Moderna vaccine on 9-Aug) and HEADACHE (headache) had resolved. On 13-Aug-2021, NAUSEA (felt nauseous) had resolved. At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Caller got Pfizer vaccine and Moderna vaccine) had resolved, INFLUENZA LIKE ILLNESS (kind like the flu) and DISCOMFORT (uncomfortable) outcome was unknown and MYALGIA (arm is sore/sore) had not resolved.            Concomitant medication includes paxil. No treatment drugs were reported.  He took a nausea pill. Yesterday was still a little nauseous.
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: updated patient information; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (updated patient information) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (updated patient information). At the time of the report, EXPIRED PRODUCT ADMINISTERED (updated patient information) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were provided.      Reporter did not allow further contact
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Ear pain, Headache, Palpitations, Vaccination site bruising
Clinical narrative: pain on the upper part of her right ear which extended to her right eye; dizziness; heart palpitations; bad bruise on her left arm where the vaccine was administered; pain on the right side of her head and the upper part of her right ear which extended to her right eye; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (pain on the upper part of her right ear which extended to her right eye), DIZZINESS (dizziness), PALPITATIONS (heart palpitations), VACCINATION SITE BRUISING (bad bruise on her left arm where the vaccine was administered) and HEADACHE (pain on the right side of her head and the upper part of her right ear which extended to her right eye) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054(?)C21A) for COVID-19 vaccination.     No medical history is provided by reporter.     On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Aug-2021, the patient experienced EAR PAIN (pain on the upper part of her right ear which extended to her right eye), DIZZINESS (dizziness), PALPITATIONS (heart palpitations), VACCINATION SITE BRUISING (bad bruise on her left arm where the vaccine was administered) and HEADACHE (pain on the right side of her head and the upper part of her right ear which extended to her right eye). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, EAR PAIN (pain on the upper part of her right ear which extended to her right eye), DIZZINESS (dizziness), PALPITATIONS (heart palpitations), VACCINATION SITE BRUISING (bad bruise on her left arm where the vaccine was administered) and HEADACHE (pain on the right side of her head and the upper part of her right ear which extended to her right eye) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant drugs were not provided
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Bowel movement irregularity, Dyspepsia, Heart rate decreased
Clinical narrative: I feel like it's inflamed; yesterday I was very uncomfortable because I had a full meal after a long time; when I eat something, it burns; when I eat something, it hurts; c-section scar was burning and hurting; I felt some cramps; I did not pass stool for a week; my heart rate dropped for a whole week after getting the shot; I've lost 12 lbs since taking shot since I can't eat much; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (I felt some cramps), BOWEL MOVEMENT IRREGULARITY (I did not pass stool for a week), DYSPEPSIA (when I eat something, it burns), ABDOMINAL PAIN UPPER (when I eat something, it hurts) and SCAR PAIN (c-section scar was burning and hurting) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included VITAMINS NOS for an unknown indication.    On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, the patient experienced MUSCLE SPASMS (I felt some cramps), BOWEL MOVEMENT IRREGULARITY (I did not pass stool for a week), WEIGHT DECREASED (I've lost 12 lbs since taking shot since I can't eat much) and HEART RATE DECREASED (my heart rate dropped for a whole week after getting the shot). On 03-Aug-2021, the patient experienced DYSPEPSIA (when I eat something, it burns), ABDOMINAL PAIN UPPER (when I eat something, it hurts) and SCAR PAIN (c-section scar was burning and hurting). On 15-Aug-2021, the patient experienced ABDOMINAL DISCOMFORT (yesterday I was very uncomfortable because I had a full meal after a long time). On an unknown date, the patient experienced SCAR INFLAMMATION (I feel like it's inflamed). The patient was treated with MACROGOL 3350 (MIRALAX) for Bowel movement irregularity, at a dose of 1 dosage form and PROBIOTICS NOS at a dose of 1 dosage form. At the time of the report, MUSCLE SPASMS (I felt some cramps), BOWEL MOVEMENT IRREGULARITY (I did not pass stool for a week), DYSPEPSIA (when I eat something, it burns), ABDOMINAL PAIN UPPER (when I eat something, it hurts), SCAR PAIN (c-section scar was burning and hurting), SCAR INFLAMMATION (I feel like it's inflamed), WEIGHT DECREASED (I've lost 12 lbs since taking shot since I can't eat much), ABDOMINAL DISCOMFORT (yesterday I was very uncomfortable because I had a full meal after a long time) and HEART RATE DECREASED (my heart rate dropped for a whole week after getting the shot) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medicine included colon cleanser for natural bowel movements.   This case was linked to US-MODERNATX, INC.-MOD-2021-287626 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-287626:same reporter
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Scar inflammation, Scar pain, Weight decreased
Clinical narrative: I feel like it's inflamed; yesterday I was very uncomfortable because I had a full meal after a long time; when I eat something, it burns; when I eat something, it hurts; c-section scar was burning and hurting; I felt some cramps; I did not pass stool for a week; my heart rate dropped for a whole week after getting the shot; I've lost 12 lbs since taking shot since I can't eat much; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (I felt some cramps), BOWEL MOVEMENT IRREGULARITY (I did not pass stool for a week), DYSPEPSIA (when I eat something, it burns), ABDOMINAL PAIN UPPER (when I eat something, it hurts) and SCAR PAIN (c-section scar was burning and hurting) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included VITAMINS NOS for an unknown indication.    On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, the patient experienced MUSCLE SPASMS (I felt some cramps), BOWEL MOVEMENT IRREGULARITY (I did not pass stool for a week), WEIGHT DECREASED (I've lost 12 lbs since taking shot since I can't eat much) and HEART RATE DECREASED (my heart rate dropped for a whole week after getting the shot). On 03-Aug-2021, the patient experienced DYSPEPSIA (when I eat something, it burns), ABDOMINAL PAIN UPPER (when I eat something, it hurts) and SCAR PAIN (c-section scar was burning and hurting). On 15-Aug-2021, the patient experienced ABDOMINAL DISCOMFORT (yesterday I was very uncomfortable because I had a full meal after a long time). On an unknown date, the patient experienced SCAR INFLAMMATION (I feel like it's inflamed). The patient was treated with MACROGOL 3350 (MIRALAX) for Bowel movement irregularity, at a dose of 1 dosage form and PROBIOTICS NOS at a dose of 1 dosage form. At the time of the report, MUSCLE SPASMS (I felt some cramps), BOWEL MOVEMENT IRREGULARITY (I did not pass stool for a week), DYSPEPSIA (when I eat something, it burns), ABDOMINAL PAIN UPPER (when I eat something, it hurts), SCAR PAIN (c-section scar was burning and hurting), SCAR INFLAMMATION (I feel like it's inflamed), WEIGHT DECREASED (I've lost 12 lbs since taking shot since I can't eat much), ABDOMINAL DISCOMFORT (yesterday I was very uncomfortable because I had a full meal after a long time) and HEART RATE DECREASED (my heart rate dropped for a whole week after getting the shot) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medicine included colon cleanser for natural bowel movements.   This case was linked to US-MODERNATX, INC.-MOD-2021-287626 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-287626:same reporter
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose received on 24Apr2021/2nd dose not received yet; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose received on 24Apr2021/2nd dose not received yet) 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 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose received on 24Apr2021/2nd dose not received yet). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose received on 24Apr2021/2nd dose not received yet) had resolved.            No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lethargy, Malaise, Pain in extremity
Clinical narrative: Lethargy; Wasn't feeling well; Sore arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargy), MALAISE (Wasn't feeling well), PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medication history was provided by the reporter.  Concomitant products included CALCIUM, MULTIVITAMINS [VITAMINS NOS], CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), CHONDROITIN SULFATE, GLUCOSAMINE (GLUCOSAMINE CHONDROITIN [CHONDROITIN SULFATE;GLUCOSAMINE]) and PARACETAMOL (TYLENOL) for an unknown indication.    On 19-Jun-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 LETHARGY (Lethargy), MALAISE (Wasn't feeling well), PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache). At the time of the report, LETHARGY (Lethargy), MALAISE (Wasn't feeling well), PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not reported.   This case was linked to MOD-2021-288138.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: on august 14th i tested positive for Covid/I recieved my first shot on 8/7/21 then tested positive  for COVID on 8/14/21; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (on august 14th i tested positive for Covid/I recieved my first shot on 8/7/21 then tested positive  for COVID on 8/14/21) 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 07-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Aug-2021, the patient experienced COVID-19 (on august 14th i tested positive for Covid/I recieved my first shot on 8/7/21 then tested positive  for COVID on 8/14/21). At the time of the report, COVID-19 (on august 14th i tested positive for Covid/I recieved my first shot on 8/7/21 then tested positive  for COVID on 8/14/21) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Aug-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment medication reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 16-Aug-2021: Follow up information received Contains No New Information.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Arm soreness; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness) and FATIGUE (Tired) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD exacerbation, Allergy to antibiotic (Azithromycin (Z pack)) and Drug allergy (Shingles medicine). Concomitant products included PREDNISONE for COPD, ETOFYLLINE, THEOPHYLLINE (DERICIP), AMLODIPINE, FUROSEMIDE, POTASSIUM, LOSARTAN, METOPROLOL, ALPRAZOLAM and MONTELUKAST for an unknown indication.   On 08-Mar-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 PAIN IN EXTREMITY (Arm soreness) and FATIGUE (Tired). At the time of the report, PAIN IN EXTREMITY (Arm soreness) and FATIGUE (Tired) had resolved.            Treatment information was not provided.  Patient was at the End of Stage life received second dose of Moderna COVID-19 vaccine.   Patient had COPD exacerbation and takes prednisone daily.   Following the vaccination patients was tired, had sore arm and events were resolved in few days.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: More than 35 days since the first shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 35 days since the first shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    In 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 since the first shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 35 days since the first shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication were provided.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: 3 large blotches on his left arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (3 large blotches on his left arm) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced RASH MACULAR (3 large blotches on his left arm). In 2021, RASH MACULAR (3 large blotches on his left arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported. No Treatment information was reported.   This case was linked to MOD-2021-290094 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: felt flu-ish" for a day and a half; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt flu-ish" for a day and a half) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS. Concomitant products included DULOXETINE HYDROCHLORIDE (DULOXETINE HCL), LAMOTRIGINE, LITHIUM CARBONATE, PANTOPRAZOLE, ROSUVASTATIN CALCIUM, LEVOTHYROXINE and CLONAZEPAM (CLOZEPAM [CLONAZEPAM]) for an unknown indication.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt flu-ish" for a day and a half). On 24-Apr-2021, INFLUENZA LIKE ILLNESS (felt flu-ish" for a day and a half) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    Seroquil were the concomitant medications.  No Treatment information  were reported   This case was linked to MOD-2021-290906 (Patient Link).
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Inappropriate schedule of product administration
Clinical narrative: Missed recommended interval between doses; Weird chest sensation; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed recommended interval between doses) and CHEST DISCOMFORT (Weird chest sensation) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed recommended interval between doses) and CHEST DISCOMFORT (Weird chest sensation). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed recommended interval between doses) had resolved and CHEST DISCOMFORT (Weird chest sensation) outcome was unknown.        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: Allergy to vaccine, Feeling hot, Rash, Tongue discomfort
Clinical narrative: A lot of allergies; Not feeling great on his tongue; Feel growing heat in the arm; Husband's arm blew up or has rashes; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (A lot of allergies), TONGUE DISCOMFORT (Not feeling great on his tongue), FEELING HOT (Feel growing heat in the arm) and RASH (Husband's arm blew up or has rashes) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, the patient experienced FEELING HOT (Feel growing heat in the arm) and RASH (Husband's arm blew up or has rashes). On 19-Aug-2021, the patient experienced TONGUE DISCOMFORT (Not feeling great on his tongue). On an unknown date, the patient experienced ALLERGY TO VACCINE (A lot of allergies). At the time of the report, ALLERGY TO VACCINE (A lot of allergies), TONGUE DISCOMFORT (Not feeling great on his tongue), FEELING HOT (Feel growing heat in the arm) and RASH (Husband's arm blew up or has rashes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant drugs were reported.  No Treatment information  were reported.
Sex: U
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: I have sold symptoms; This spontaneous case was reported by a non-health professional and describes the occurrence of NASOPHARYNGITIS (I have sold symptoms) 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 NASOPHARYNGITIS (I have sold symptoms). At the time of the report, NASOPHARYNGITIS (I have sold symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant drugs were reported.  No Treatment information  were reported.   Reporter did not allow further contact
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication, Vaccination site discolouration
Clinical narrative: did not feel great; dark cellulitis mark; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE DISCOLOURATION (dark cellulitis mark) and VACCINATION COMPLICATION (did not feel great) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030620A and 042420A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-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 an unknown date, the patient experienced VACCINATION SITE DISCOLOURATION (dark cellulitis mark) and VACCINATION COMPLICATION (did not feel great). The patient was treated with IBUPROFEN for Adverse event following immunization, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE DISCOLOURATION (dark cellulitis mark) had resolved and VACCINATION COMPLICATION (did not feel great) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant drugs were reported.
Sex: F
Vaccine: COVID19
Symptoms: Neoplasm malignant
Clinical narrative: Recently diagnosed with cancer after receiving both doses of Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of NEOPLASM MALIGNANT (Recently diagnosed with cancer after receiving both doses of Moderna vaccine) 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, 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 NEOPLASM MALIGNANT (Recently diagnosed with cancer after receiving both doses of Moderna vaccine) (seriousness criterion medically significant). At the time of the report, NEOPLASM MALIGNANT (Recently diagnosed with cancer after receiving both doses of Moderna vaccine) outcome was unknown.            The concomitant medications were not reported. The treatment information was not provided.  Company Comment :Very limited information regarding this event has been provided at this time. However, based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event has been provided at this time. However, based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Infection, Myalgia, Pain
Clinical narrative: Got sick; Infected section; Pain; Muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got sick), INFECTION (Infected section), PAIN (Pain) and MYALGIA (Muscle aches) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 ILLNESS (Got sick), INFECTION (Infected section), PAIN (Pain) and MYALGIA (Muscle aches). At the time of the report, ILLNESS (Got sick), INFECTION (Infected section), PAIN (Pain) and MYALGIA (Muscle aches) outcome was unknown.            Concomitant product use was not provided by the reporter. Patient was on antibiotics for an infected section
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Erythema, Induration, Myalgia, Peripheral swelling
Clinical narrative: I had like a ball /my shoulder where I got the shot got swollen again; my arm was a little bit swollen/the arm started to get swollen; the arm started to get swollen and very red; it was hard/had like a ball; pain in his bones; pain in his body/it hurts/my body hurts, too; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (my arm was a little bit swollen/the arm started to get swollen), ERYTHEMA (the arm started to get swollen and very red), INDURATION (it was hard/had like a ball), PERIPHERAL SWELLING (my shoulder where I got the shot got swollen again/my left armpit has been swollen) and BONE PAIN (pain in his bones) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced ERYTHEMA (the arm started to get swollen and very red), INDURATION (it was hard/had like a ball), BONE PAIN (pain in his bones) and MYALGIA (pain in his body/it hurts/my body hurts, too). On 16-Aug-2021, the patient experienced PERIPHERAL SWELLING (my arm was a little bit swollen/the arm started to get swollen). On 22-Aug-2021, the patient experienced PERIPHERAL SWELLING (my shoulder where I got the shot got swollen again/my left armpit has been swollen). At the time of the report, PERIPHERAL SWELLING (my arm was a little bit swollen/the arm started to get swollen), ERYTHEMA (the arm started to get swollen and very red), PERIPHERAL SWELLING (my shoulder where I got the shot got swollen again/my left armpit has been swollen), BONE PAIN (pain in his bones) and MYALGIA (pain in his body/it hurts/my body hurts, too) outcome was unknown and INDURATION (it was hard/had like a ball) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported No treatment medications were reported.  It was reported that patient's Second dose of vaccine was scheduled on 13-Sep-2021.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, Product temperature excursion issue
Clinical narrative: Given expired vaccine; Temperature exposure > 24 hours; Sitting in the refrigerator for 9 days/the vial was punctured on 11AUG2021and supposed to be thrown out, but it was accidently put back in fridge; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given expired vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature exposure > 24 hours) and PRODUCT STORAGE ERROR (Sitting in the refrigerator for 9 days/the vial was punctured on 11AUG2021and supposed to be thrown out, but it was accidently put back in fridge) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Aug-2021 at 8:15 AM, 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 20-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given expired vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature exposure > 24 hours) and PRODUCT STORAGE ERROR (Sitting in the refrigerator for 9 days/the vial was punctured on 11AUG2021and supposed to be thrown out, but it was accidently put back in fridge). On 20-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Given expired vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature exposure > 24 hours) and PRODUCT STORAGE ERROR (Sitting in the refrigerator for 9 days/the vial was punctured on 11AUG2021and supposed to be thrown out, but it was accidently put back in fridge) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication  was not reported.  Treatment medication was not provided.  Patient stated that she had no known drug allergies.  It was reported that the vial was punctured on 11 Aug 2021, kept in fridge for 9 days  and one dose was given to a patient.  The vial was never removed from the refrigerator after that day and wasted/disposed of.  The vial was accidently used for vaccines given on 8/20/21.   Most recent FOLLOW-UP information incorporated above includes: On 04-Sep-2021: Added Patient demographics(weight), Start date and anatomical location for second dose and new event (Expired vaccine used along with start date, stop date and outcome). Updated patient initial based on follow up On 09-Sep-2021: Follow up received on 09 Sep 2021 had  gender details(female) clarified via email communication.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: temperature exposure > 24 hours; administered expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (temperature exposure > 24 hours) and EXPIRED PRODUCT ADMINISTERED (administered expired vaccine) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History was reported.     On 20-Aug-2021 at 11:52 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (temperature exposure > 24 hours). On 20-Aug-2021, EXPIRED PRODUCT ADMINISTERED (administered expired vaccine) had resolved. At the time of the report, PRODUCT STORAGE ERROR (temperature exposure > 24 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were mentioned. reporter stated that: The vaccine vial was opened on 8/11/21 and one dose was given to a patient. The vail was never removed from the refrigerator after that day or wasted/disposed of.  The vial was accidently used for vaccines given on 08/20/2021.   Most recent FOLLOW-UP information incorporated above includes: On 04-Sep-2021: Follow-up received  added new reporter, patient demographics, date of start of suspect drug, dose number, anatomical location of vaccine administered  & event: administered expired vaccine, No side effect / adverse events. On 08-Sep-2021: Follow-up received contains additional significant followup appended. date of birth was updated.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Discomfort, Exercise tolerance decreased, Inappropriate schedule of product administration
Clinical narrative: experienced pure pain in both of her arms, pain in hand; cannot exercise; she has been hurting, painful, experienced pain; Uncomfortable; cold; pain comes down in the muscle to across her back; soreness, muscle pain, soreness is never ending, soreness goes and comes back.; pain comes down in the muscle to across her shoulder; Patient received the second dose 22 days after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (experienced pure pain in both of her arms, pain in hand), EXERCISE TOLERANCE DECREASED (cannot exercise), PAIN (she has been hurting, painful, experienced pain), DISCOMFORT (Uncomfortable) and NASOPHARYNGITIS (cold) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Eye disorder NOS. Concomitant products included LATANOPROST for Eye disorder NOS, AMLODIPINE and HYDROCHLOROTHIAZIDE for an unknown indication.   On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-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 PAIN IN EXTREMITY (experienced pure pain in both of her arms, pain in hand), EXERCISE TOLERANCE DECREASED (cannot exercise), PAIN (she has been hurting, painful, experienced pain), DISCOMFORT (Uncomfortable), NASOPHARYNGITIS (cold), BACK PAIN (pain comes down in the muscle to across her back), MYALGIA (soreness, muscle pain, soreness is never ending, soreness goes and comes back.), ARTHRALGIA (pain comes down in the muscle to across her shoulder) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose 22 days after the 1st dose). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]) for Myalgia, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (experienced pure pain in both of her arms, pain in hand) had not resolved, EXERCISE TOLERANCE DECREASED (cannot exercise), PAIN (she has been hurting, painful, experienced pain), DISCOMFORT (Uncomfortable), NASOPHARYNGITIS (cold), BACK PAIN (pain comes down in the muscle to across her back), MYALGIA (soreness, muscle pain, soreness is never ending, soreness goes and comes back.) and ARTHRALGIA (pain comes down in the muscle to across her shoulder) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose 22 days after the 1st dose) had resolved.            Treatment information was not provided for all the other events.   This case was linked to MOD-2021-296304 (Patient Link).