chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Dose-1 (20Feb2021) and Dose-2 (29Mar2021); This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-1 (20Feb2021) and Dose-2 (29Mar2021)) and NO ADVERSE EVENT (No adverse event) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Seizure and Blood pressure. Concomitant products included COLECALCIFEROL (VITAMIN D3) for an unknown indication.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-1 (20Feb2021) and Dose-2 (29Mar2021)). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-1 (20Feb2021) and Dose-2 (29Mar2021)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant medications include unspecified seizure medication, unspecified blood pressure medication, unspecified water pill, and unspecified multivitamin for 50 plus.  No treatment information was provided.   This case was linked to MOD-2022-650836.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Chills, Headache, Pain in extremity, Rash pruritic
Clinical narrative: a lot of itching; very weird hardness, hardness is getting bigger than it was; pain in her arm; swelling in the injection site; itching is like a mosquito bite; headache; joint pain; chills; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (a lot of itching), VACCINATION SITE INDURATION (very weird hardness, hardness is getting bigger than it was), PAIN IN EXTREMITY (pain in her arm), VACCINATION SITE SWELLING (swelling in the injection site) and RASH PRURITIC (itching is like a mosquito bite) in a 65-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7162D) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient do not have any allergies.The patient had never been diagnosed with/ tested positive for COVID-19. Patient did not received any other vaccine within 1 month prior to Moderna COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: Pfizer (first 3 vaccines were Pfizer). Past adverse reactions to the above products included No adverse event with Pfizer. Concurrent medical conditions included Blood pressure high and Thyroid disorder NOS (unknown Hypo or hyper).    On 20-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In September 2022, the patient experienced VACCINATION SITE PRURITUS (a lot of itching), VACCINATION SITE INDURATION (very weird hardness, hardness is getting bigger than it was), PAIN IN EXTREMITY (pain in her arm), VACCINATION SITE SWELLING (swelling in the injection site), RASH PRURITIC (itching is like a mosquito bite), HEADACHE (headache), ARTHRALGIA (joint pain) and CHILLS (chills). At the time of the report, VACCINATION SITE PRURITUS (a lot of itching), PAIN IN EXTREMITY (pain in her arm), VACCINATION SITE SWELLING (swelling in the injection site), RASH PRURITIC (itching is like a mosquito bite), HEADACHE (headache), ARTHRALGIA (joint pain) and CHILLS (chills) outcome was unknown and VACCINATION SITE INDURATION (very weird hardness, hardness is getting bigger than it was) had not resolved.            Concomitant products included High Blood Pressure medication and Thyroid medication.  Patient received fourth dose of Moderna vaccine on 13-APR-2022.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Vaccination site induration, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: a lot of itching; very weird hardness, hardness is getting bigger than it was; pain in her arm; swelling in the injection site; itching is like a mosquito bite; headache; joint pain; chills; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (a lot of itching), VACCINATION SITE INDURATION (very weird hardness, hardness is getting bigger than it was), PAIN IN EXTREMITY (pain in her arm), VACCINATION SITE SWELLING (swelling in the injection site) and RASH PRURITIC (itching is like a mosquito bite) in a 65-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7162D) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient do not have any allergies.The patient had never been diagnosed with/ tested positive for COVID-19. Patient did not received any other vaccine within 1 month prior to Moderna COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: Pfizer (first 3 vaccines were Pfizer). Past adverse reactions to the above products included No adverse event with Pfizer. Concurrent medical conditions included Blood pressure high and Thyroid disorder NOS (unknown Hypo or hyper).    On 20-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In September 2022, the patient experienced VACCINATION SITE PRURITUS (a lot of itching), VACCINATION SITE INDURATION (very weird hardness, hardness is getting bigger than it was), PAIN IN EXTREMITY (pain in her arm), VACCINATION SITE SWELLING (swelling in the injection site), RASH PRURITIC (itching is like a mosquito bite), HEADACHE (headache), ARTHRALGIA (joint pain) and CHILLS (chills). At the time of the report, VACCINATION SITE PRURITUS (a lot of itching), PAIN IN EXTREMITY (pain in her arm), VACCINATION SITE SWELLING (swelling in the injection site), RASH PRURITIC (itching is like a mosquito bite), HEADACHE (headache), ARTHRALGIA (joint pain) and CHILLS (chills) outcome was unknown and VACCINATION SITE INDURATION (very weird hardness, hardness is getting bigger than it was) had not resolved.            Concomitant products included High Blood Pressure medication and Thyroid medication.  Patient received fourth dose of Moderna vaccine on 13-APR-2022.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Condition aggravated, Fatigue, Muscle twitching
Clinical narrative: Felt tired; Twitches and crumples in shoulder, twitches and crumples below scapula, now it's in her leg and stuff; it got worst and it's scaring me; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE TWITCHING (Twitches and crumples in shoulder, twitches and crumples below scapula, now it's in her leg and stuff), CONDITION AGGRAVATED (it got worst and it's scaring me) and FATIGUE (Felt tired) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 070H21A, 042L20A and 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Drug allergy (Erythromycin), Drug allergy (Sulfa) and Dry eye. Concomitant products included VITAMINS NOS for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2022, the patient experienced MUSCLE TWITCHING (Twitches and crumples in shoulder, twitches and crumples below scapula, now it's in her leg and stuff) and CONDITION AGGRAVATED (it got worst and it's scaring me). On an unknown date, the patient experienced FATIGUE (Felt tired). At the time of the report, MUSCLE TWITCHING (Twitches and crumples in shoulder, twitches and crumples below scapula, now it's in her leg and stuff) and CONDITION AGGRAVATED (it got worst and it's scaring me) had not resolved and FATIGUE (Felt tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: blood work all fine.         Patient have allergies to Avalak. Other concomitant medication included Eye drugs for dry eye.  Bood work all fine, no other symptoms than cramping and twitching. No treatment medication was reported.   This case was linked to MOD-2022-650931 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: possible positive Covid-19 test; This spontaneous case was reported by a patient and describes the occurrence of SUSPECTED COVID-19 (possible positive Covid-19 test) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 26-Sep-2022, the patient experienced SUSPECTED COVID-19 (possible positive Covid-19 test). At the time of the report, SUSPECTED COVID-19 (possible positive Covid-19 test) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Sep-2022, SARS-CoV-2 test: assume as a negative result.         Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Age: 4.0
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event, Product administration interrupted
Clinical narrative: No adverse event; It might be close to 10 weeks before they get their 2nd dose; It might be close to 10 weeks before they get their 2nd dose; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (It might be close to 10 weeks before they get their 2nd dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (It might be close to 10 weeks before they get their 2nd dose) and NO ADVERSE EVENT (No adverse event) in a 4-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In July 2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Sep-2022, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (It might be close to 10 weeks before they get their 2nd dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (It might be close to 10 weeks before they get their 2nd dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (It might be close to 10 weeks before they get their 2nd dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (It might be close to 10 weeks before they get their 2nd dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown. No concomitant medications were reported. Four years old patient received their 1st dose of Moderna Covid-19 vaccine at the end of July 2022. It might be closed to 10 weeks before they get their 2nd dose. They can't get it sooner, because of their schedule.  No treatment medications were reported.   Reporter did not allow further contact
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No Adverse event; While administering the bivalent boosters, the needle for one of them wasn't screwed on all the way and a couple of drops came out and the patient only received about 0.4 ml of the dose versus a 0.5; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (While administering the bivalent boosters, the needle for one of them wasn't screwed on all the way and a couple of drops came out and the patient only received about 0.4 ml of the dose versus a 0.5) and NO ADVERSE EVENT (No Adverse event) in a 66-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7163B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 24-Sep-2022, the patient experienced ACCIDENTAL UNDERDOSE (While administering the bivalent boosters, the needle for one of them wasn't screwed on all the way and a couple of drops came out and the patient only received about 0.4 ml of the dose versus a 0.5). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (While administering the bivalent boosters, the needle for one of them wasn't screwed on all the way and a couple of drops came out and the patient only received about 0.4 ml of the dose versus a 0.5) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (While administering the bivalent boosters, the needle for one of them wasn't screwed on all the way and a couple of drops came out and the patient only received about 0.4 ml of the dose versus a 0.5).    No concomitant medications were reported.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Dose administered after 30-day Use By Date or after manufacturer date of expiry; No adverse event; Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (batch no. 011B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Sep-2022, the patient received first dose of mRNA-1273  (unknown route) 1 dosage form. On 26-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry).    No concomitant medication was reported.   Printed expiration date: 25-Sep-2022     Vial did not undergo any temperature excursions.   No treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: Heart problems, eventually it went away months later; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (Heart problems, eventually it went away months later) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC DISORDER (Heart problems, eventually it went away months later). At the time of the report, CARDIAC DISORDER (Heart problems, eventually it went away months later) had resolved.     No concomitant medications were reported. No treatment details were reported. It was reported that, after all the testing, nothing was found wrong and attributed to vaccination. The event eventually went away after months later.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patients were administered the Moderna Covid 19 Monovalent booster instead of the bivalent; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patients were administered the Moderna Covid 19 Monovalent booster instead of the bivalent) and NO ADVERSE EVENT (No adverse event) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     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 WRONG PRODUCT ADMINISTERED (Patients were administered the Moderna Covid 19 Monovalent booster instead of the bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patients were administered the Moderna Covid 19 Monovalent booster instead of the bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patients were administered the Moderna Covid 19 Monovalent booster instead of the bivalent).    Concomitant medication information was not provided by the reporter.  It was stated that patient accidentally administered monovalent booster dose instead of bivalent dose.  Treatment information was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-650932, US-MODERNATX, INC.-MOD-2022-650934 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-650932:Same reporter US-MODERNATX, INC.-MOD-2022-650934:Same reporter
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; First dose was Bivalent booster; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (First dose was Bivalent booster) and NO ADVERSE EVENT (No adverse event) in a 21-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Sep-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 23-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (First dose was Bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (First dose was Bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (First dose was Bivalent booster).    Concomitant medication information was not provided by the reporter.  Patient came in to get the COVID booster. Patient did not bring the COVID card, so patient was given a Bivalent vaccine, but then the patient revealed that never received a COVID shot.  Treatment information was not provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Felt sicker; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MALAISE (Felt sicker) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Felt sicker). At the time of the report, MALAISE (Felt sicker) outcome was unknown. No concomitant medication was reported.  No treatment medication was reported.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patients were administered the Moderna Covid 19 Monovalent booster instead of the bivalent; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patients were administered the Moderna Covid 19 Monovalent booster instead of the bivalent) and NO ADVERSE EVENT (No adverse event) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     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 WRONG PRODUCT ADMINISTERED (Patients were administered the Moderna Covid 19 Monovalent booster instead of the bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patients were administered the Moderna Covid 19 Monovalent booster instead of the bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patients were administered the Moderna Covid 19 Monovalent booster instead of the bivalent). No concomitant medications were provided. HCP stated that they accidentally administered 4 patients with Monovalent booster doses instead of bivalent doses. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-650927, US-MODERNATX, INC.-MOD-2022-650934 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-650934:Same reporter US-MODERNATX, INC.-MOD-2022-650927:Same reporter
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patients were administered the Moderna Covid 19 Monovalent booster instead of the bivalent; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patients were administered the Moderna Covid 19 Monovalent booster instead of the bivalent) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     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 WRONG PRODUCT ADMINISTERED (Patients were administered the Moderna Covid 19 Monovalent booster instead of the bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patients were administered the Moderna Covid 19 Monovalent booster instead of the bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patients were administered the Moderna Covid 19 Monovalent booster instead of the bivalent).    No concomitant medications was reported. No treatment medications was reported.  The reporter would like to know if she can give patients the bivalent booster now or if she should wait. She would like to know what is the procedure in these cases.   This case was linked to US-MODERNATX, INC.-MOD-2022-650927, US-MODERNATX, INC.-MOD-2022-650932 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-650927:Same reporter US-MODERNATX, INC.-MOD-2022-650932:Same reporter
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Adverse Reactions of sore right arm for a day or two; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Adverse Reactions of sore right arm for a day or two) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 prophylaxis.     The patient's past medical history included Sleep disturbance. Previously administered products included for Product used for unknown indication: Pfizer and Pfizer. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer. Concurrent medical conditions included Depression (since the age of 5). Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 06-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Dec-2021, the patient experienced VACCINATION SITE PAIN (Adverse Reactions of sore right arm for a day or two). In December 2021, VACCINATION SITE PAIN (Adverse Reactions of sore right arm for a day or two) had resolved.            The patient received Pfizer for her Primary Series. No treatment medications were reported.   This case was linked to MOD-2022-650930, MOD-2022-650962 (Patient Link).
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Headache, Joint swelling, Lymphadenopathy
Clinical narrative: lower extremity swelling around groin; lower extremity swelling around the knees; lower extremety swelling around lymph nodes,swelling was pronounced at the lymph nodes around groin and knees; total body arthritic pain,arthritic pain was most  pronounced around my pelvis and knees; low grade fever; headache; body aches; chills; This spontaneous case was reported by a nurse and describes the occurrence of SWELLING (lower extremity swelling around groin), JOINT SWELLING (lower extremity swelling around the knees), LYMPHADENOPATHY (lower extremety swelling around lymph nodes,swelling was pronounced at the lymph nodes around groin and knees), ARTHRALGIA (total body arthritic pain,arthritic pain was most  pronounced around my pelvis and knees) and PYREXIA (low grade fever) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     It was reported that the patient had no medical issues before receiving the Moderna COVID-19 vaccine.     On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced SWELLING (lower extremity swelling around groin), JOINT SWELLING (lower extremity swelling around the knees), LYMPHADENOPATHY (lower extremety swelling around lymph nodes,swelling was pronounced at the lymph nodes around groin and knees), ARTHRALGIA (total body arthritic pain,arthritic pain was most  pronounced around my pelvis and knees), PYREXIA (low grade fever), HEADACHE (headache), MYALGIA (body aches) and CHILLS (chills). On 18-Jan-2021, PYREXIA (low grade fever), HEADACHE (headache), MYALGIA (body aches) and CHILLS (chills) had resolved. At the time of the report, SWELLING (lower extremity swelling around groin), JOINT SWELLING (lower extremity swelling around the knees), LYMPHADENOPATHY (lower extremety swelling around lymph nodes,swelling was pronounced at the lymph nodes around groin and knees) and ARTHRALGIA (total body arthritic pain,arthritic pain was most  pronounced around my pelvis and knees) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. It was reported that patient had a low grade fever, headache, body aches, chills which were most persistent for 48 hours but lasted for 5 days. Treatment medications were not provided.   This case was linked to MOD-2022-650991, MOD-2022-650998 (Patient Link).
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Pyrexia, Swelling
Clinical narrative: lower extremity swelling around groin; lower extremity swelling around the knees; lower extremety swelling around lymph nodes,swelling was pronounced at the lymph nodes around groin and knees; total body arthritic pain,arthritic pain was most  pronounced around my pelvis and knees; low grade fever; headache; body aches; chills; This spontaneous case was reported by a nurse and describes the occurrence of SWELLING (lower extremity swelling around groin), JOINT SWELLING (lower extremity swelling around the knees), LYMPHADENOPATHY (lower extremety swelling around lymph nodes,swelling was pronounced at the lymph nodes around groin and knees), ARTHRALGIA (total body arthritic pain,arthritic pain was most  pronounced around my pelvis and knees) and PYREXIA (low grade fever) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     It was reported that the patient had no medical issues before receiving the Moderna COVID-19 vaccine.     On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced SWELLING (lower extremity swelling around groin), JOINT SWELLING (lower extremity swelling around the knees), LYMPHADENOPATHY (lower extremety swelling around lymph nodes,swelling was pronounced at the lymph nodes around groin and knees), ARTHRALGIA (total body arthritic pain,arthritic pain was most  pronounced around my pelvis and knees), PYREXIA (low grade fever), HEADACHE (headache), MYALGIA (body aches) and CHILLS (chills). On 18-Jan-2021, PYREXIA (low grade fever), HEADACHE (headache), MYALGIA (body aches) and CHILLS (chills) had resolved. At the time of the report, SWELLING (lower extremity swelling around groin), JOINT SWELLING (lower extremity swelling around the knees), LYMPHADENOPATHY (lower extremety swelling around lymph nodes,swelling was pronounced at the lymph nodes around groin and knees) and ARTHRALGIA (total body arthritic pain,arthritic pain was most  pronounced around my pelvis and knees) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. It was reported that patient had a low grade fever, headache, body aches, chills which were most persistent for 48 hours but lasted for 5 days. Treatment medications were not provided.   This case was linked to MOD-2022-650991, MOD-2022-650998 (Patient Link).
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Menopausal symptoms, Menstrual disorder, Myalgia, Pyrexia, Swelling
Clinical narrative: lower extremity swelling around groin; lower extremity swelling around the knees; lower extremety swelling around lymph nodes,swelling was pronounced at the lymph nodes around groin and knees; total body arthritic pain,arthritic pain was most  pronounced around my pelvis and knees; low grade fever; headache; body aches; chills; This spontaneous case was reported by a nurse and describes the occurrence of SWELLING (lower extremity swelling around groin), JOINT SWELLING (lower extremity swelling around the knees), LYMPHADENOPATHY (lower extremety swelling around lymph nodes,swelling was pronounced at the lymph nodes around groin and knees), ARTHRALGIA (total body arthritic pain,arthritic pain was most  pronounced around my pelvis and knees) and PYREXIA (low grade fever) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     It was reported that the patient had no medical issues before receiving the Moderna COVID-19 vaccine.     On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced SWELLING (lower extremity swelling around groin), JOINT SWELLING (lower extremity swelling around the knees), LYMPHADENOPATHY (lower extremety swelling around lymph nodes,swelling was pronounced at the lymph nodes around groin and knees), ARTHRALGIA (total body arthritic pain,arthritic pain was most  pronounced around my pelvis and knees), PYREXIA (low grade fever), HEADACHE (headache), MYALGIA (body aches) and CHILLS (chills). On 18-Jan-2021, PYREXIA (low grade fever), HEADACHE (headache), MYALGIA (body aches) and CHILLS (chills) had resolved. At the time of the report, SWELLING (lower extremity swelling around groin), JOINT SWELLING (lower extremity swelling around the knees), LYMPHADENOPATHY (lower extremety swelling around lymph nodes,swelling was pronounced at the lymph nodes around groin and knees) and ARTHRALGIA (total body arthritic pain,arthritic pain was most  pronounced around my pelvis and knees) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. It was reported that patient had a low grade fever, headache, body aches, chills which were most persistent for 48 hours but lasted for 5 days. Treatment medications were not provided.   This case was linked to MOD-2022-650991, MOD-2022-650998 (Patient Link).
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: vaccine was administered to a patient from a vial that was refrigerated; No adverse event; Expired dose administered to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient), PRODUCT STORAGE ERROR (vaccine was administered to a patient from a vial that was refrigerated) and NO ADVERSE EVENT (No adverse event) in a 6-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine was administered to a patient from a vial that was refrigerated) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient), PRODUCT STORAGE ERROR (vaccine was administered to a patient from a vial that was refrigerated) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) and PRODUCT STORAGE ERROR (vaccine was administered to a patient from a vial that was refrigerated).    The vial size was 2.5 mL and was an individual vial. The vial did not undergo any temperature excursions. No concomitant medications were reported. No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive after receiving the Moderna Covid 19 vaccine Bivalent; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Tested positive after receiving the Moderna Covid 19 vaccine Bivalent) in an elderly male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     The patient does not have allergies.  Previously administered products included for Drug use for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (previous doses were from Pfizer). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE.    On 10-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Sep-2022, the patient experienced COVID-19 (Tested positive after receiving the Moderna Covid 19 vaccine Bivalent). The patient was treated with MOLNUPIRAVIR (LAGEVRIO) for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested positive after receiving the Moderna Covid 19 vaccine Bivalent) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Sep-2022, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       Patient was in his 80s. Concomitant medication: Heart Medication, statins and High Blood pressure medication.   This case was linked to MOD-2022-651005 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Patient provided image of a skin rash(reaction to covid jab); This spontaneous case was reported by a patient and describes the occurrence of RASH (Patient provided image of a skin rash(reaction to covid jab)) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Sep-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In September 2022, the patient experienced RASH (Patient provided image of a skin rash(reaction to covid jab)). At the time of the report, RASH (Patient provided image of a skin rash(reaction to covid jab)) outcome was unknown.            Patient attached photo of his arm 2 days after COVID vaccination and asking if this was normal, also his wife had it at same time. That night his wife was bad could hardly walk and very dizzy.  Both had no problems with any of the previous Covid doses. Patient received vaccination on 15-Sep-2022 Thursday. This Email was received, however country was not provided. And AE was reviewed by PV team.   This case was linked to MOD-2022-650924 (E2B Linked Report).; Sender's Comments:  MOD-2022-650924:wife case
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; adult individual was only given 0.25ml dose of the new updated booster for Covid rather than the full 0.5ml dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (adult individual was only given 0.25ml dose of the new updated booster for Covid rather than the full 0.5ml dose) and NO ADVERSE EVENT (No adverse event) in a 55-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C.) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 22-Sep-2022, the patient experienced ACCIDENTAL UNDERDOSE (adult individual was only given 0.25ml dose of the new updated booster for Covid rather than the full 0.5ml dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (adult individual was only given 0.25ml dose of the new updated booster for Covid rather than the full 0.5ml dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (adult individual was only given 0.25ml dose of the new updated booster for Covid rather than the full 0.5ml dose).    No Concomitant medication was reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-1 test
Clinical narrative: Tested positive for Covid 19 after receiving The Moderna Covid 19 bivalent vaccine; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive for Covid 19 after receiving The Moderna Covid 19 bivalent vaccine) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Previous doses were from Pfizer). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Drug allergy (Allergic to Ceclor).  On 10-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Sep-2022, the patient experienced COVID-19 (Tested positive for Covid 19 after receiving The Moderna Covid 19 bivalent vaccine). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested positive for Covid 19 after receiving The Moderna Covid 19 bivalent vaccine) outcome was unknown.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Sep-2022, SARS-CoV-1 test: (Positive) Positive.    Concomitant medication were Thyroid medication and statins. Patient stated that she had leg ache, so she decided to take a test and it became positive.   This case was linked to MOD-2022-650981 (Patient Link).
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: I had a sore left arm at the injection site.; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (I had a sore left arm at the injection site.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A, 067F21A and 037B21A) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 on 20-Apr-2020.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2021, the patient experienced VACCINATION SITE PAIN (I had a sore left arm at the injection site.). At the time of the report, VACCINATION SITE PAIN (I had a sore left arm at the injection site.) outcome was unknown.            The patient was less than 50 years old.   No concomitant medication was provided by reporter.  Patient also received first booster dose on 21Nov2021 and i had a sore left arm at the injection site.  No treatment medication was provided by reporter.   This case was linked to MOD-2022-650968, MOD-2022-651007 (Patient Link).
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: I had a sore left arm at the injection site.; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (I had a sore left arm at the injection site.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A, 067F21A and 037B21A) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 on 20-Apr-2020.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2021, the patient experienced VACCINATION SITE PAIN (I had a sore left arm at the injection site.). At the time of the report, VACCINATION SITE PAIN (I had a sore left arm at the injection site.) outcome was unknown.            The patient was less than 50 years old.   No concomitant medication was provided by reporter.  Patient also received first booster dose on 21Nov2021 and i had a sore left arm at the injection site.  No treatment medication was provided by reporter.   This case was linked to MOD-2022-650968, MOD-2022-651007 (Patient Link).
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore left arm at the injection site.; redness at the injection site.; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (sore left arm at the injection site.) and VACCINATION SITE ERYTHEMA (redness at the injection site.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 on 20-Apr-2020.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced VACCINATION SITE PAIN (sore left arm at the injection site.) and VACCINATION SITE ERYTHEMA (redness at the injection site.). At the time of the report, VACCINATION SITE PAIN (sore left arm at the injection site.) and VACCINATION SITE ERYTHEMA (redness at the injection site.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported. No treatment drugs were reported The patient was less than 50 years old.   This case was linked to MOD-2022-651006, MOD-2022-651007 (Patient Link).