chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site swelling
Clinical narrative: injection site was black and blue with a diameter 2.5-3 inches; little swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (injection site was black and blue with a diameter 2.5-3 inches) and VACCINATION SITE SWELLING (little swelling at the injection site) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy (Sulfa) and Osteoporosis since 03-Mar-2002. Concomitant products included DENOSUMAB (PROLIA) from 01-Jan-2012 to an unknown date and CALCIUM CITRATE, COLECALCIFEROL (CITRACAL + D [CALCIUM CITRATE;COLECALCIFEROL]) from 01-Jan-1999 to an unknown date for Osteoporosis.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced VACCINATION SITE DISCOLOURATION (injection site was black and blue with a diameter 2.5-3 inches) and VACCINATION SITE SWELLING (little swelling at the injection site). At the time of the report, VACCINATION SITE DISCOLOURATION (injection site was black and blue with a diameter 2.5-3 inches) and VACCINATION SITE SWELLING (little swelling at the injection site) outcome was unknown.            No Treatment information was provided by the reporter.   This case was linked to MOD-2021-364370 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Oct-2021: Significant: Patient demographic details added, medical history added, Concomitants added.
Sex: U
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: Received the Moderna COVID-19 vaccine and experienced atrial fibrillation; 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 ATRIAL FIBRILLATION (Received the Moderna COVID-19 vaccine and experienced atrial fibrillation) 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 ATRIAL FIBRILLATION (Received the Moderna COVID-19 vaccine and experienced atrial fibrillation) (seriousness criterion medically significant). At the time of the report, ATRIAL FIBRILLATION (Received the Moderna COVID-19 vaccine and experienced atrial fibrillation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported.  No treatment information was provided by the reporter.  Company Comment: This case concerns a patient of unknown age and gender with no reported medical history who experienced the unexpected serious event of atrial fibrillation. The event occurred on an unknown date with an unknown outcome. No further information was provided. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report   Reporter did not allow further contact; Sender's Comments: This case concerns a patient of unknown age and gender with no reported medical history who experienced the unexpected serious event of atrial fibrillation. The event occurred on an unknown date with an unknown outcome. No further information was provided. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Inappropriate schedule of product administration
Clinical narrative: He had COVID Pneumonia; he had Covid; Got the first shot on 19Jan2021 and second shot on 27Feb2021; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 PNEUMONIA (He had COVID Pneumonia) and COVID-19 (he had Covid) in a 70-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.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got the first shot on 19Jan2021 and second shot on 27Feb2021). On an unknown date, the patient experienced COVID-19 PNEUMONIA (He had COVID Pneumonia) (seriousness criteria hospitalization, disability and medically significant) and COVID-19 (he had Covid) (seriousness criterion disability). The patient was treated with OXYGEN ongoing since an unknown date at an unspecified dose and frequency. On 27-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got the first shot on 19Jan2021 and second shot on 27Feb2021) had resolved. At the time of the report, COVID-19 PNEUMONIA (He had COVID Pneumonia) and COVID-19 (he had Covid) outcome was unknown.            No concomitant medications reported by reporter. No treatment medications provided by the reporter. Patient stated that he will be on oxygen for the rest of his life.He went from a healthy person to an invalid.  reported patient's weight as 200  Company's comment: This case concerns a 70-year-old male patient, with no relevant medical history, who experienced the serious unexpected AESI of COVID 19 and COVID 19 PNEUMONIA. The events occurred on an unknown date after the second dose of the Moderna COVID-19 vaccine, which was administered in an inappropriate schedule of administration. The rechallenge is not applicable considering the nature of the events. The benefit-risk relation of Spikevax is not affected by this report.; Sender's Comments: This case concerns a 70-year-old male patient, with no relevant medical history, who experienced the serious unexpected AESI of COVID 19 and COVID 19 PNEUMONIA. The events occurred on an unknown date after the second dose of the Moderna COVID-19 vaccine, which was administered in an inappropriate schedule of administration. The rechallenge is not applicable considering the nature of the events. The benefit-risk relation of Spikevax is not affected by this report.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Pulmonary thrombosis
Clinical narrative: blood clot in his lung; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY THROMBOSIS (blood clot in his lung) in a 54-year-old male 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, the patient experienced PULMONARY THROMBOSIS (blood clot in his lung) (seriousness criterion medically significant). At the time of the report, PULMONARY THROMBOSIS (blood clot in his lung) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: blood clot in lung (abnormal) Blood clot in lung.         No concomitant medication was mentioned. No treatment medication was mentioned.  Company comment: This is a spontaneous case concerning a 54 year-old, male patient with no relevant history reported, who experienced the unexpected serious event of PULMONARY THROMBOSIS. The event occurred approximately after the 2nd dose of mRNA-1273 Moderna vaccine (date of vaccination and onset date of event were not provided). The rechallenge was not applicable (information about more new doses was not available). very limited information regarding the medical history of the patient and the event was provided. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report. Further information was requested; Sender's Comments: This is a spontaneous case concerning a 54 year-old, male patient with no relevant history reported, who experienced the unexpected serious event of PULMONARY THROMBOSIS. The event occurred approximately after the 2nd dose of mRNA-1273 Moderna vaccine (date of vaccination and onset date of event were not provided). The rechallenge was not applicable (information about more new doses was not available). very limited information regarding the medical history of the patient and the event was provided. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report. Further information was requested
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: They administered three 3rd doses for immunocompromised patients on 20Oct2021 that expired on 13Oct2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They administered three 3rd doses for immunocompromised patients on 20Oct2021 that expired on 13Oct2021) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They administered three 3rd doses for immunocompromised patients on 20Oct2021 that expired on 13Oct2021). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (They administered three 3rd doses for immunocompromised patients on 20Oct2021 that expired on 13Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.  No treatment medications were reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Rash
Clinical narrative: Rash on the soft part of both arms/Rash on the torso; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on the soft part of both arms/Rash on the torso) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, EN6203 and EM9809) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (First dose Pfizer : EM9809) on 04-Feb-2021 and Pfizer (second dose Pfizer : EN6203) on 24-Feb-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and Pfizer. Concurrent medical conditions included Thyroid disorder NOS (Thyroid). Concomitant products included LEVOTHYROXINE for Thyroid disorder NOS, ESTRADIOL (CLIMARA [ESTRADIOL]) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 27-Oct-2021, the patient experienced RASH (Rash on the soft part of both arms/Rash on the torso). On 24-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, RASH (Rash on the soft part of both arms/Rash on the torso) outcome was unknown.            No Treatment details were reported Patient stated that she experienced rash but isn't at injection site and it does not itchy. Patient stated that she took the booster dose because she's a Therapist and sees patients all day.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: they administered three 3rd doses for immunocompromised patients on 20Oct2021 that expired on 13Oct2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they administered three 3rd doses for immunocompromised patients on 20Oct2021 that expired on 13Oct2021) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (they administered three 3rd doses for immunocompromised patients on 20Oct2021 that expired on 13Oct2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (they administered three 3rd doses for immunocompromised patients on 20Oct2021 that expired on 13Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter Treatment information was not provided    This case was linked to MOD-2021-365274 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine had expired; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine had expired) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine had expired). On 23-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine had expired) 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 information were reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2021: Follow up received contains significant information, added patient demographic details and batch lot number.
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose, Off label use
Clinical narrative: "Today I received my Moderna booster. I was given a full dose by mistake; not imunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE ("Today I received my Moderna booster. I was given a full dose by mistake) and OFF LABEL USE (not imunocompromised) in a 73-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 an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE ("Today I received my Moderna booster. I was given a full dose by mistake) and OFF LABEL USE (not imunocompromised). On 26-Oct-2021, ACCIDENTAL OVERDOSE ("Today I received my Moderna booster. I was given a full dose by mistake) and OFF LABEL USE (not imunocompromised) had resolved.            No concomitant medication listed.   No treatment information provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Eye swelling, Lip swelling, Pruritus, Urticaria
Clinical narrative: itching; break out in hives; lips and eyes blew up; face broke out; her lips and eyes blew up; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), URTICARIA (break out in hives), LIP SWELLING (lips and eyes blew up), ACNE (face broke out) and EYE SWELLING (her lips and eyes blew up) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Apr-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 PRURITUS (itching), URTICARIA (break out in hives), LIP SWELLING (lips and eyes blew up), ACNE (face broke out) and EYE SWELLING (her lips and eyes blew up). At the time of the report, PRURITUS (itching), URTICARIA (break out in hives), LIP SWELLING (lips and eyes blew up), ACNE (face broke out) and EYE SWELLING (her lips and eyes blew up) outcome was unknown.            No concomitant medications reported. No treatment information was provided.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Product administered to patient of inappropriate age, Somnolence, Vaccination complication, Vaccination site pain
Clinical narrative: Patient less than 18 administered Moderna Covid-19 vaccine; drowsiness; typical reactions; pain in his left injection site arm; pain in his left injection site arm and swelling; headache; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (drowsiness), VACCINATION COMPLICATION (typical reactions), VACCINATION SITE PAIN (pain in his left injection site arm), VACCINATION SITE SWELLING (pain in his left injection site arm and swelling) and HEADACHE (headache) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced SOMNOLENCE (drowsiness), VACCINATION COMPLICATION (typical reactions), VACCINATION SITE PAIN (pain in his left injection site arm), VACCINATION SITE SWELLING (pain in his left injection site arm and swelling), HEADACHE (headache) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient less than 18 administered Moderna Covid-19 vaccine). On 18-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient less than 18 administered Moderna Covid-19 vaccine) had resolved. At the time of the report, SOMNOLENCE (drowsiness), VACCINATION COMPLICATION (typical reactions), VACCINATION SITE PAIN (pain in his left injection site arm), VACCINATION SITE SWELLING (pain in his left injection site arm and swelling) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported. No treatment drug details was reported.   This case was linked to MOD-2021-366125 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Nov-2021: Non Significant follow up - AE contact information updated
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Patient less than 18 administered Moderna Covid-19 vaccine; drowsiness; typical reactions; pain in his left injection site arm; pain in his left injection site arm and swelling; headache; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (drowsiness), VACCINATION COMPLICATION (typical reactions), VACCINATION SITE PAIN (pain in his left injection site arm), VACCINATION SITE SWELLING (pain in his left injection site arm and swelling) and HEADACHE (headache) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced SOMNOLENCE (drowsiness), VACCINATION COMPLICATION (typical reactions), VACCINATION SITE PAIN (pain in his left injection site arm), VACCINATION SITE SWELLING (pain in his left injection site arm and swelling), HEADACHE (headache) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient less than 18 administered Moderna Covid-19 vaccine). On 18-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient less than 18 administered Moderna Covid-19 vaccine) had resolved. At the time of the report, SOMNOLENCE (drowsiness), VACCINATION COMPLICATION (typical reactions), VACCINATION SITE PAIN (pain in his left injection site arm), VACCINATION SITE SWELLING (pain in his left injection site arm and swelling) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported. No treatment drug details was reported.   This case was linked to MOD-2021-366125 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Nov-2021: Non Significant follow up - AE contact information updated
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: patient was administered a 2nd dose of the Moderna vaccine at 0.25mL on accident; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (patient was administered a 2nd dose of the Moderna vaccine at 0.25mL on accident) 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 28-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 26-Oct-2021, the patient experienced ACCIDENTAL UNDERDOSE (patient was administered a 2nd dose of the Moderna vaccine at 0.25mL on accident). On 26-Oct-2021, ACCIDENTAL UNDERDOSE (patient was administered a 2nd dose of the Moderna vaccine at 0.25mL on accident) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.  Patient was administered a 2nd dose of the Moderna vaccine at 0.25mL on accident instead of 0.5mL.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Hair is falling out/hair falling out in kind of clumps/has a lot less hair now; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Hair is falling out/hair falling out in kind of clumps/has a lot less hair now) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ALOPECIA (Hair is falling out/hair falling out in kind of clumps/has a lot less hair now). At the time of the report, ALOPECIA (Hair is falling out/hair falling out in kind of clumps/has a lot less hair now) outcome was unknown.            No Concomittant medications were reported.  No treatment information was provided.  The patient stated that the hair fall started after taking the two doses of the Moderna COVID-19 vaccine. The patient also stated that she got both of the vaccine in separate arms.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Vaccination site bruising, Vaccination site pain, Vaccination site swelling
Clinical narrative: cant sleep on the left side; area is bruised; very sore/it was really hurting and it still hurts/She cant sleep on the left side/sore arm; little bit swollen in the area; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (cant sleep on the left side), VACCINATION SITE BRUISING (area is bruised), VACCINATION SITE PAIN (very sore/it was really hurting and it still hurts/She cant sleep on the left side/sore arm) and VACCINATION SITE SWELLING (little bit swollen in the area) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A, 037A21B and 048O21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: FLU VACCINE VII in September 2021. Past adverse reactions to the above products included No adverse effect with FLU VACCINE VII. Concurrent medical conditions included Blood pressure high, COPD (uses an inhaler.), Arthritis and Deaf (is deaf and uses sign language to communicate.). Concomitant products included LOSARTAN for Blood pressure high.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-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 DISCOMFORT (cant sleep on the left side), VACCINATION SITE BRUISING (area is bruised), VACCINATION SITE PAIN (very sore/it was really hurting and it still hurts/She cant sleep on the left side/sore arm) and VACCINATION SITE SWELLING (little bit swollen in the area). The patient was treated with PARACETAMOL (TYLENOL) for Vaccination site pain, at an unspecified dose and frequency. At the time of the report, DISCOMFORT (cant sleep on the left side), VACCINATION SITE BRUISING (area is bruised) and VACCINATION SITE SWELLING (little bit swollen in the area) outcome was unknown and VACCINATION SITE PAIN (very sore/it was really hurting and it still hurts/She cant sleep on the left side/sore arm) had not resolved.            Other concomitant medication included inhaler for COPD nad allergy medications.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: With the first two doses patient had fever that stayed in the 99°F range; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (With the first two doses patient had fever that stayed in the 99°F range) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 26-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 PYREXIA (With the first two doses patient had fever that stayed in the 99°F range). At the time of the report, PYREXIA (With the first two doses patient had fever that stayed in the 99°F range) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99 (High) 99°F.         No relevant concomitant medications were reported. Treatment medication was not provided by the reporter. Patient received vaccine at Pharmacy   This case was linked to MOD-2021-365802, MOD-2021-365860 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, Arthralgia, Blood test
Clinical narrative: arthritic pain in his shoulders, knees, toes, elbow, fingers and cheeks/jaw joint was aching.; "booster dose" given at full dose; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (arthritic pain in his shoulders, knees, toes, elbow, fingers and cheeks/jaw joint was aching.) and ACCIDENTAL OVERDOSE ("booster dose" given at full dose) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Aug-2021, the patient experienced ACCIDENTAL OVERDOSE ("booster dose" given at full dose). In September 2021, the patient experienced ARTHRALGIA (arthritic pain in his shoulders, knees, toes, elbow, fingers and cheeks/jaw joint was aching.). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Arthralgia, at an unspecified dose and frequency. On 26-Aug-2021, ACCIDENTAL OVERDOSE ("booster dose" given at full dose) had resolved. At the time of the report, ARTHRALGIA (arthritic pain in his shoulders, knees, toes, elbow, fingers and cheeks/jaw joint was aching.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: high (High) High Inflammation and High antibodies.         No concomitant medications were reported Symptoms: It was reported that the patient had experienced unspecified mild symptoms after the booster dose of vaccine.  Lab data: Blood tests were performed between 20-Sep-2021 to 10-Oct-2021
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site swelling
Clinical narrative: hard lump on the injection site; he was noted to have redness; swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (hard lump on the injection site), VACCINATION SITE ERYTHEMA (he was noted to have redness) and VACCINATION SITE SWELLING (swelling) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A and 010A21A) 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) (unknown route) 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 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, the patient experienced VACCINATION SITE MASS (hard lump on the injection site), VACCINATION SITE ERYTHEMA (he was noted to have redness) and VACCINATION SITE SWELLING (swelling). At the time of the report, VACCINATION SITE MASS (hard lump on the injection site), VACCINATION SITE ERYTHEMA (he was noted to have redness) and VACCINATION SITE SWELLING (swelling) outcome was unknown.            No concomitant medications were reported. No treatment details were reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered a dose from an expired vial.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered a dose from an expired vial.) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered a dose from an expired vial.). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient was administered a dose from an expired vial.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.   This case was linked to MOD-2021-366918, MOD-2021-366925 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: Urinary Tract Infection; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Urinary Tract Infection) 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 URINARY TRACT INFECTION (Urinary Tract Infection). At the time of the report, URINARY TRACT INFECTION (Urinary Tract Infection) was resolving.            No concomitant medications information was reported.  Treatment medications included antibiotics.  The patient received both doses of the Moderna COVID-19 Vaccine 5 months ago.   Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2021: Snapshot document attached
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 5 patients received an expired vaccine dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 patients received an expired vaccine dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 patients received an expired vaccine dose). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (5 patients received an expired vaccine dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported. The vial was placed in refrigerator from freezer on 9 Sep 2021 and health care profession stated that the patients will revaccinate on 29 10 2021.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Product administered to patient of inappropriate age, Somnolence, Vaccination site pain, Vomiting
Clinical narrative: Slept most of the day; Vaccination site pain; threw up; Headache; gave a shot of the Moderna first shot to a 16 year old patient; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (gave a shot of the Moderna first shot to a 16 year old patient), SOMNOLENCE (Slept most of the day), HEADACHE (Headache), VACCINATION SITE PAIN (Vaccination site pain) and VOMITING (threw up) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 11:10 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Oct-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (gave a shot of the Moderna first shot to a 16 year old patient) and HEADACHE (Headache). On 28-Oct-2021, the patient experienced SOMNOLENCE (Slept most of the day), VACCINATION SITE PAIN (Vaccination site pain) and VOMITING (threw up). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. On 27-Oct-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (gave a shot of the Moderna first shot to a 16 year old patient) had resolved. On 29-Oct-2021, SOMNOLENCE (Slept most of the day), HEADACHE (Headache), VACCINATION SITE PAIN (Vaccination site pain) and VOMITING (threw up) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered SOMNOLENCE (Slept most of the day), HEADACHE (Headache), VACCINATION SITE PAIN (Vaccination site pain) and VOMITING (threw up) to be possibly related. No further causality assessment was provided for PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (gave a shot of the Moderna first shot to a 16 year old patient).    Concomitant product use was not provided by the reporter. The patient had no allergies. The patient had never been diagnosed with COVID-19. The patient had no acute illness at the time of vaccination and up to one month before. The patient had no chronic or long-standing health conditions. No prescriptions, over-the-counter medications, dietary supplements, or herbal remedies were taken at the time of vaccination.   Most recent FOLLOW-UP information incorporated above includes: On 29-Oct-2021: Follow-up contains additional events, updated patient demographics, vaccination start time, anatomical location, action taken and treatment product.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance
Clinical narrative: in such pain she cannot walk with her left leg; severe joint pain in her left leg knee; This spontaneous case was reported by a nurse and describes the occurrence of GAIT DISTURBANCE (in such pain she cannot walk with her left leg) and ARTHRALGIA (severe joint pain in her left leg knee) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Fractured femur (excl neck) (Fractured left femur). Concurrent medical conditions included Arthritis (End stage arthritis in both knees and is going through nerve blocking things and before that she was given pain pills.) and Osteoarthritis.    On 19-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced GAIT DISTURBANCE (in such pain she cannot walk with her left leg) and ARTHRALGIA (severe joint pain in her left leg knee). At the time of the report, GAIT DISTURBANCE (in such pain she cannot walk with her left leg) and ARTHRALGIA (severe joint pain in her left leg knee) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature, Chills, Fatigue, Illness
Clinical narrative: felt bad; no energy/out of energy, no desire to go out; had a fever of 100F; aching all over; chills; swelling on the arm; got really ill; upset stomach; arm hurt a tiny bit; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt a tiny bit), PERIPHERAL SWELLING (swelling on the arm), ILLNESS (got really ill), ABDOMINAL DISCOMFORT (upset stomach) and VACCINATION COMPLICATION (felt bad) in a 66-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.     No medical history was reported.    On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (arm hurt a tiny bit). On 19-Oct-2021, the patient experienced PERIPHERAL SWELLING (swelling on the arm), ILLNESS (got really ill), ABDOMINAL DISCOMFORT (upset stomach), PYREXIA (had a fever of 100F), MYALGIA (aching all over) and CHILLS (chills). On 21-Oct-2021, the patient experienced VACCINATION COMPLICATION (felt bad) and FATIGUE (no energy/out of energy, no desire to go out). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) for Adverse event, at an unspecified dose and frequency; PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 20-Oct-2021, PERIPHERAL SWELLING (swelling on the arm), ILLNESS (got really ill), ABDOMINAL DISCOMFORT (upset stomach), PYREXIA (had a fever of 100F), MYALGIA (aching all over) and CHILLS (chills) had resolved. At the time of the report, PAIN IN EXTREMITY (arm hurt a tiny bit), VACCINATION COMPLICATION (felt bad) and FATIGUE (no energy/out of energy, no desire to go out) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Oct-2021, Body temperature: 100 (High) fever of 100F.         No concomitant medication listed.   No treatment information provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Peripheral swelling, Pyrexia, Vaccination complication
Clinical narrative: felt bad; no energy/out of energy, no desire to go out; had a fever of 100F; aching all over; chills; swelling on the arm; got really ill; upset stomach; arm hurt a tiny bit; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt a tiny bit), PERIPHERAL SWELLING (swelling on the arm), ILLNESS (got really ill), ABDOMINAL DISCOMFORT (upset stomach) and VACCINATION COMPLICATION (felt bad) in a 66-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.     No medical history was reported.    On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (arm hurt a tiny bit). On 19-Oct-2021, the patient experienced PERIPHERAL SWELLING (swelling on the arm), ILLNESS (got really ill), ABDOMINAL DISCOMFORT (upset stomach), PYREXIA (had a fever of 100F), MYALGIA (aching all over) and CHILLS (chills). On 21-Oct-2021, the patient experienced VACCINATION COMPLICATION (felt bad) and FATIGUE (no energy/out of energy, no desire to go out). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) for Adverse event, at an unspecified dose and frequency; PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 20-Oct-2021, PERIPHERAL SWELLING (swelling on the arm), ILLNESS (got really ill), ABDOMINAL DISCOMFORT (upset stomach), PYREXIA (had a fever of 100F), MYALGIA (aching all over) and CHILLS (chills) had resolved. At the time of the report, PAIN IN EXTREMITY (arm hurt a tiny bit), VACCINATION COMPLICATION (felt bad) and FATIGUE (no energy/out of energy, no desire to go out) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Oct-2021, Body temperature: 100 (High) fever of 100F.         No concomitant medication listed.   No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Vaccination complication
Clinical narrative: She says some people didn't have any problems but others had more reactions than they did with their first 2 doses.; the full dose instead of the half dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (She says some people didn't have any problems but others had more reactions than they did with their first 2 doses.) and ACCIDENTAL OVERDOSE (the full dose instead of the half dose) 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 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 22-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (the full dose instead of the half dose). On an unknown date, the patient experienced VACCINATION COMPLICATION (She says some people didn't have any problems but others had more reactions than they did with their first 2 doses.). On 22-Oct-2021, ACCIDENTAL OVERDOSE (the full dose instead of the half dose) had resolved. At the time of the report, VACCINATION COMPLICATION (She says some people didn't have any problems but others had more reactions than they did with their first 2 doses.) outcome was unknown.            Concomitant medication were not reported. No treatment details were provided.   This case was linked to MOD-2021-366021 (Patient Link).
Age: 81.0
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: did not get their second dose in time,administered greater than 42 days; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (did not get their second dose in time,administered greater than 42 days) in an 81-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 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (did not get their second dose in time,administered greater than 42 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (did not get their second dose in time,administered greater than 42 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were given by the reporter. No Treatment information were provided by the reporter.