chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Pyrexia, Vaccination site erythema, Vaccination site pain, White blood cell count
Clinical narrative: Left arm was sore; Left arm was red; Fever; chills; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Left arm was sore), VACCINATION SITE ERYTHEMA (Left arm was red), PYREXIA (Fever) and CHILLS (chills) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 028A21A and 025A21A) for COVID-19 prophylaxis.     The patient's past medical history included Heart block (80 percent blockage of the heart). Concurrent medical conditions included Emphysema (had a medical history significant for Emphysema, COPD), COPD (had a medical history significant for Emphysema, COPD) and White blood cell count high (Chronic high white blood cell count). Concomitant products included CLOPIDOGREL, BUDESONIDE, IPRATROPIUM, LEVOSALBUTAMOL HYDROCHLORIDE (LEVALBUTEROL [LEVOSALBUTAMOL HYDROCHLORIDE]) and AZITHROMYCIN for an unknown indication.   On 01-Mar-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 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced VACCINATION SITE PAIN (Left arm was sore), VACCINATION SITE ERYTHEMA (Left arm was red), PYREXIA (Fever) and CHILLS (chills). In April 2021, VACCINATION SITE PAIN (Left arm was sore), VACCINATION SITE ERYTHEMA (Left arm was red), PYREXIA (Fever) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: high.         On 30-Oct-2021, the patient received first booster dose of Moderna COVID-19 vaccine.  After receiving both the second dose and first booster dose of Moderna Covid-19 vaccine, the patient experienced redness and soreness in left arm, fever and chills, that lasted for 2 to 3 days.  The patient was receiving budesonide, ipratropium and levalbuterol nebulizers.  No treatment medications were reported.   This case was linked to MOD-2022-657268, MOD-2022-657182 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Atrioventricular block, Chills, Pyrexia, Vaccination site erythema, Vaccination site pain
Clinical narrative: Left arm was sore; Left arm was red; Fever; chills; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Left arm was sore), VACCINATION SITE ERYTHEMA (Left arm was red), PYREXIA (Fever) and CHILLS (chills) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 028A21A and 025A21A) for COVID-19 prophylaxis.     The patient's past medical history included Heart block (80 percent blockage of the heart). Concurrent medical conditions included Emphysema (had a medical history significant for Emphysema, COPD), COPD (had a medical history significant for Emphysema, COPD) and White blood cell count high (Chronic high white blood cell count). Concomitant products included CLOPIDOGREL, BUDESONIDE, IPRATROPIUM, LEVOSALBUTAMOL HYDROCHLORIDE (LEVALBUTEROL [LEVOSALBUTAMOL HYDROCHLORIDE]) and AZITHROMYCIN for an unknown indication.   On 01-Mar-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 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced VACCINATION SITE PAIN (Left arm was sore), VACCINATION SITE ERYTHEMA (Left arm was red), PYREXIA (Fever) and CHILLS (chills). In April 2021, VACCINATION SITE PAIN (Left arm was sore), VACCINATION SITE ERYTHEMA (Left arm was red), PYREXIA (Fever) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: high.         On 30-Oct-2021, the patient received first booster dose of Moderna COVID-19 vaccine.  After receiving both the second dose and first booster dose of Moderna Covid-19 vaccine, the patient experienced redness and soreness in left arm, fever and chills, that lasted for 2 to 3 days.  The patient was receiving budesonide, ipratropium and levalbuterol nebulizers.  No treatment medications were reported.   This case was linked to MOD-2022-657268, MOD-2022-657182 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: White blood cell count
Clinical narrative: Left arm was sore; Left arm was red; Fever; chills; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Left arm was sore), VACCINATION SITE ERYTHEMA (Left arm was red), PYREXIA (Fever) and CHILLS (chills) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 028A21A and 025A21A) for COVID-19 prophylaxis.     The patient's past medical history included Heart block (80 percent blockage of the heart). Concurrent medical conditions included Emphysema (had a medical history significant for Emphysema, COPD), COPD (had a medical history significant for Emphysema, COPD) and White blood cell count high (Chronic high white blood cell count). Concomitant products included CLOPIDOGREL, BUDESONIDE, IPRATROPIUM, LEVOSALBUTAMOL HYDROCHLORIDE (LEVALBUTEROL [LEVOSALBUTAMOL HYDROCHLORIDE]) and AZITHROMYCIN for an unknown indication.   On 01-Mar-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 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced VACCINATION SITE PAIN (Left arm was sore), VACCINATION SITE ERYTHEMA (Left arm was red), PYREXIA (Fever) and CHILLS (chills). In April 2021, VACCINATION SITE PAIN (Left arm was sore), VACCINATION SITE ERYTHEMA (Left arm was red), PYREXIA (Fever) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: high.         On 30-Oct-2021, the patient received first booster dose of Moderna COVID-19 vaccine.  After receiving both the second dose and first booster dose of Moderna Covid-19 vaccine, the patient experienced redness and soreness in left arm, fever and chills, that lasted for 2 to 3 days.  The patient was receiving budesonide, ipratropium and levalbuterol nebulizers.  No treatment medications were reported.   This case was linked to MOD-2022-657268, MOD-2022-657182 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia, Vaccination site pain, Vaccination site swelling, White blood cell count
Clinical narrative: Left arm was sore; Left arm was red; Fever; chills; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Left arm was sore), VACCINATION SITE ERYTHEMA (Left arm was red), PYREXIA (Fever) and CHILLS (chills) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 028A21A and 025A21A) for COVID-19 prophylaxis.     The patient's past medical history included Heart block (80 percent blockage of the heart). Concurrent medical conditions included Emphysema (had a medical history significant for Emphysema, COPD), COPD (had a medical history significant for Emphysema, COPD) and White blood cell count high (Chronic high white blood cell count). Concomitant products included CLOPIDOGREL, BUDESONIDE, IPRATROPIUM, LEVOSALBUTAMOL HYDROCHLORIDE (LEVALBUTEROL [LEVOSALBUTAMOL HYDROCHLORIDE]) and AZITHROMYCIN for an unknown indication.   On 01-Mar-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 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced VACCINATION SITE PAIN (Left arm was sore), VACCINATION SITE ERYTHEMA (Left arm was red), PYREXIA (Fever) and CHILLS (chills). In April 2021, VACCINATION SITE PAIN (Left arm was sore), VACCINATION SITE ERYTHEMA (Left arm was red), PYREXIA (Fever) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: high.         On 30-Oct-2021, the patient received first booster dose of Moderna COVID-19 vaccine.  After receiving both the second dose and first booster dose of Moderna Covid-19 vaccine, the patient experienced redness and soreness in left arm, fever and chills, that lasted for 2 to 3 days.  The patient was receiving budesonide, ipratropium and levalbuterol nebulizers.  No treatment medications were reported.   This case was linked to MOD-2022-657268, MOD-2022-657182 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Pyrexia, Vaccination site erythema, Vaccination site pain, White blood cell count
Clinical narrative: Left arm was sore; Left arm was swollen; Patient had a fever; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Left arm was sore), VACCINATION SITE SWELLING (Left arm was swollen) and PYREXIA (Patient had a fever) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Emphysema and COPD. Concomitant products included CLOPIDOGREL, BUDESONIDE, IPRATROPIUM, LEVALBUTEROL [LEVOSALBUTAMOL] and AZITHROMYCIN for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced VACCINATION SITE PAIN (Left arm was sore), VACCINATION SITE SWELLING (Left arm was swollen) and PYREXIA (Patient had a fever). At the time of the report, VACCINATION SITE PAIN (Left arm was sore), VACCINATION SITE SWELLING (Left arm was swollen) and PYREXIA (Patient had a fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: Chronic high white blood cell count.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient did not want to provide height or weight.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-657251, MOD-2022-657268 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Atrioventricular block, Chills, Pyrexia, Vaccination site erythema, Vaccination site pain
Clinical narrative: Left arm was sore; Left arm was swollen; Patient had a fever; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Left arm was sore), VACCINATION SITE SWELLING (Left arm was swollen) and PYREXIA (Patient had a fever) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Emphysema and COPD. Concomitant products included CLOPIDOGREL, BUDESONIDE, IPRATROPIUM, LEVALBUTEROL [LEVOSALBUTAMOL] and AZITHROMYCIN for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced VACCINATION SITE PAIN (Left arm was sore), VACCINATION SITE SWELLING (Left arm was swollen) and PYREXIA (Patient had a fever). At the time of the report, VACCINATION SITE PAIN (Left arm was sore), VACCINATION SITE SWELLING (Left arm was swollen) and PYREXIA (Patient had a fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: Chronic high white blood cell count.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient did not want to provide height or weight.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-657251, MOD-2022-657268 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: White blood cell count
Clinical narrative: Left arm was sore; Left arm was swollen; Patient had a fever; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Left arm was sore), VACCINATION SITE SWELLING (Left arm was swollen) and PYREXIA (Patient had a fever) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Emphysema and COPD. Concomitant products included CLOPIDOGREL, BUDESONIDE, IPRATROPIUM, LEVALBUTEROL [LEVOSALBUTAMOL] and AZITHROMYCIN for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced VACCINATION SITE PAIN (Left arm was sore), VACCINATION SITE SWELLING (Left arm was swollen) and PYREXIA (Patient had a fever). At the time of the report, VACCINATION SITE PAIN (Left arm was sore), VACCINATION SITE SWELLING (Left arm was swollen) and PYREXIA (Patient had a fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: Chronic high white blood cell count.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient did not want to provide height or weight.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-657251, MOD-2022-657268 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia, Vaccination site pain, Vaccination site swelling, White blood cell count
Clinical narrative: Left arm was sore; Left arm was swollen; Patient had a fever; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Left arm was sore), VACCINATION SITE SWELLING (Left arm was swollen) and PYREXIA (Patient had a fever) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Emphysema and COPD. Concomitant products included CLOPIDOGREL, BUDESONIDE, IPRATROPIUM, LEVALBUTEROL [LEVOSALBUTAMOL] and AZITHROMYCIN for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced VACCINATION SITE PAIN (Left arm was sore), VACCINATION SITE SWELLING (Left arm was swollen) and PYREXIA (Patient had a fever). At the time of the report, VACCINATION SITE PAIN (Left arm was sore), VACCINATION SITE SWELLING (Left arm was swollen) and PYREXIA (Patient had a fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: Chronic high white blood cell count.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient did not want to provide height or weight.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-657251, MOD-2022-657268 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (tested positive for COVID-19) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine)     Patient had no acute illnesses at the time of vaccination and up to one month before. Patient had no chronic or long-standing health condition. It was unknown that patient had prescriptions, over the counter medications, dietary supplements, or herbal remedies  which was being taken at time of vaccination and/ or at the time of the adverse event.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 04-Feb-2021 at 8:59 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 25-Jan-2022, the patient experienced COVID-19 (tested positive for COVID-19). At the time of the report, COVID-19 (tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2022, SARS-CoV-2 test: (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.      Most recent FOLLOW-UP information incorporated above includes: On 11-Oct-2022: Live follow-up received included no significant information.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient inadvertently administered bivalent vaccine as first dose instead of the monovalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient inadvertently administered bivalent vaccine as first dose instead of the monovalent vaccine) and NO ADVERSE EVENT (No adverse event) in a 23-year-old male 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 10-Oct-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 10-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient inadvertently administered bivalent vaccine as first dose instead of the monovalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient inadvertently administered bivalent vaccine as first dose instead of the monovalent vaccine) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient inadvertently administered bivalent vaccine as first dose instead of the monovalent vaccine).    No concomitant medications were reported.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: gave 0.3ml of the bivalent booster dose; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (gave 0.3ml of the bivalent booster dose) and NO ADVERSE EVENT (No adverse event) 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 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) .3 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (gave 0.3ml of the bivalent booster dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (gave 0.3ml of the bivalent booster 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 (gave 0.3ml of the bivalent booster dose).    No concomitant medications was reported. No treatment medications was reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy, Pain in extremity
Clinical narrative: sore arm; chills; swollen in my armpit/also had swelling in the lymph nodes; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm), CHILLS (chills) and LYMPHADENOPATHY (swollen in my armpit/also had swelling in the lymph nodes) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939904, 012A21A and 028L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In October 2021, the patient experienced PAIN IN EXTREMITY (sore arm), CHILLS (chills) and LYMPHADENOPATHY (swollen in my armpit/also had swelling in the lymph nodes). In October 2021, PAIN IN EXTREMITY (sore arm), CHILLS (chills) and LYMPHADENOPATHY (swollen in my armpit/also had swelling in the lymph nodes) had resolved.            No concomitant medication details was reported. No treatment medication details was reported.
Age: 71.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; monovalent vaccine for 6-11 years old administered instead of bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (monovalent vaccine for 6-11 years old administered instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 08-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 08-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (monovalent vaccine for 6-11 years old administered instead of bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (monovalent vaccine for 6-11 years old administered instead of bivalent vaccine) 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 (monovalent vaccine for 6-11 years old administered instead of bivalent vaccine).    Concomitant medications details were not reported by the reporter.  Reportedly, patient received 0.5ml of the dark blue cap vaccine for 6-11 years old instead of the new Bivalent vaccine.  Treatment details were not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-657525 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 11-Oct-2022: Follow-up document contains updated patient demographics.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-657525:Master case (Crosslink case with same reporter)
Sex: F
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Accidentally received a pediatric dose instead of the Moderna Covid19 bivalent booster; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of WRONG PRODUCT ADMINISTERED (Accidentally received a pediatic dose instead of the Moderna Covid19 bivalent booster) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Accidentally received a pediatric dose instead of the Moderna Covid19 bivalent booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Accidentally received a pediatric dose instead of the Moderna Covid19 bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.          No concomitant medications were provided. The patient went to receive Moderna Covid 19 bivalent vaccine dose but she accidentally received a pediatric shot. The next day, patient was contacted  by the local health department and they informed  her that she should be re vaccinated and they need to administer her with the correct Moderna Covid 19 bivalent vaccine.  No treatment information was provided.   This case was linked to MOD-2022-657514 (Patient Link).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immunisation reaction
Clinical narrative: Accidentally received a pediatric dose instead of the Moderna Covid19 bivalent booster; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of WRONG PRODUCT ADMINISTERED (Accidentally received a pediatic dose instead of the Moderna Covid19 bivalent booster) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Accidentally received a pediatric dose instead of the Moderna Covid19 bivalent booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Accidentally received a pediatric dose instead of the Moderna Covid19 bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.          No concomitant medications were provided. The patient went to receive Moderna Covid 19 bivalent vaccine dose but she accidentally received a pediatric shot. The next day, patient was contacted  by the local health department and they informed  her that she should be re vaccinated and they need to administer her with the correct Moderna Covid 19 bivalent vaccine.  No treatment information was provided.   This case was linked to MOD-2022-657514 (Patient Link).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Experienced intense reactions with all her previous Moderna Doses; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Experienced intense reactions with all her previous Moderna Doses) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Experienced intense reactions with all her previous Moderna Doses). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, IMMUNISATION REACTION (Experienced intense reactions with all her previous Moderna Doses) outcome was unknown. Concomitant medications details were not reported by the reporter.  All the doses that the patient received were manufactured by Moderna.   This case was linked to MOD-2022-657510 (Patient Link).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immunisation reaction
Clinical narrative: Experienced intense reactions with all her previous Moderna Doses; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Experienced intense reactions with all her previous Moderna Doses) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Experienced intense reactions with all her previous Moderna Doses). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, IMMUNISATION REACTION (Experienced intense reactions with all her previous Moderna Doses) outcome was unknown. Concomitant medications details were not reported by the reporter.  All the doses that the patient received were manufactured by Moderna.   This case was linked to MOD-2022-657510 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, No adverse event
Clinical narrative: No adverse event; Administration error: patient administered with the full vial of bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Administration error: patient administered with the full vial of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an elderly male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Oct-2022, the patient experienced ACCIDENTAL OVERDOSE (Administration error: patient administered with the full vial of bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL OVERDOSE (Administration error: patient administered with the full vial of bivalent vaccine) 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 OVERDOSE (Administration error: patient administered with the full vial of bivalent vaccine).    The reporter was not aware of any concomitant or regular medication for the patient. Patient had received first and second dose of COVID-19 Vaccine on an unknown date. It was reported that no adverse events had been reported until the time of report. Treatment information was not provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site inflammation
Clinical narrative: it is sore; Her right shoulder is very inflamed, the glands under the right arm and side of her body and under the arm are inflamed. This is massive and large; This spontaneous case was reported by a patient and describes the occurrence of PAIN (it is sore) and VACCINATION SITE INFLAMMATION (Her right shoulder is very inflamed, the glands under the right arm and side of her body and under the arm are inflamed. This is massive and large) in a 56-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 060F22A) for COVID-19 prophylaxis.     It was reported that patient do not had any allergies (medications, food and other products). Patient had COVID + test or diagnosis in Apr-2022. Patient did not had acute and chronic illnesses at the time of vaccination.  .  Concurrent medical conditions included Blood pressure high. Concomitant products included ATENOLOL for Blood pressure high, VENLAFAXINE HYDROCHLORIDE (EFFEXOR) and VALACICLOVIR HYDROCHLORIDE (VALTREX) for an unknown indication.    On 09-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 10-Oct-2022, the patient experienced PAIN (it is sore) and VACCINATION SITE INFLAMMATION (Her right shoulder is very inflamed, the glands under the right arm and side of her body and under the arm are inflamed. This is massive and large). At the time of the report, PAIN (it is sore) and VACCINATION SITE INFLAMMATION (Her right shoulder is very inflamed, the glands under the right arm and side of her body and under the arm are inflamed. This is massive and large) had not resolved.            It was reported that patient had received the flu shot the same day on the other shoulder.   Dose Number: 1, Date administered: 08-Jul-2021, Lot number: 045B21A.  Dose Number: 2, Date administered: 17-Sep-2021, Lot number: 046C21A.  Dose Number: 3, Date administered: 14-May-2022, Lot number: 056A22A.  AE did not caused patient to seek medical care (office visit, Urgent care, ER, hospitalized).  Patient had never experienced a similar event in the past.  It was reported that patient symptoms were ongoing.  No treatment information provided.   This case was linked to MOD-2022-657528 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19 after being vaccinated with 2 doses of the Moderna vaccine; The second dose was administered more than 36 days after the first one; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive for COVID-19 after being vaccinated with 2 doses of the Moderna vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The second dose was administered more than 36 days after the first one) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 045B21A) for COVID-19 prophylaxis.     It was reported that patient had no allergies.  Concurrent medical conditions included Blood pressure high. Concomitant products included ATENOLOL for Blood pressure high, VENLAFAXINE HYDROCHLORIDE (EFFEXOR) and VALACICLOVIR HYDROCHLORIDE (VALTREX) for an unknown indication.   On 08-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The second dose was administered more than 36 days after the first one). In April 2022, the patient experienced COVID-19 (tested positive for COVID-19 after being vaccinated with 2 doses of the Moderna vaccine). At the time of the report, COVID-19 (tested positive for COVID-19 after being vaccinated with 2 doses of the Moderna vaccine) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The second dose was administered more than 36 days after the first one) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2022, SARS-CoV-2 test: (Positive) Positive.         It was reported that patient did not seek any medical care and never experienced similar events in the past. It was also reported that the symptoms were ongoing. Patient received flu shot on the shoulder. Treatment medication was not provided.   This case was linked to MOD-2022-657519 (Patient Link).
Age: 25.0
Sex: M
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration, No adverse event, Wrong product administered
Clinical narrative: No adverse event; Received Bivalent instead of  Monovalent 2nd primary dose; Wrongful 2nd primary dose was administered more that 6 months from the first primary dose; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received Bivalent instead of  Monovalent 2nd primary dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Wrongful 2nd primary dose was administered more that 6 months from the first primary dose) and NO ADVERSE EVENT (No adverse event) in a 25-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 053D22A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2022, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Received Bivalent instead of  Monovalent 2nd primary dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Wrongful 2nd primary dose was administered more that 6 months from the first primary dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received Bivalent instead of  Monovalent 2nd primary dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Wrongful 2nd primary dose was administered more that 6 months from the first primary 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 assessments were provided for WRONG PRODUCT ADMINISTERED (Received Bivalent instead of  Monovalent 2nd primary dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Wrongful 2nd primary dose was administered more that 6 months from the first primary dose).    No concomitant medications were reported. In 2021, Patient received first dose of Monovalent Moderna COVID-19 vaccine. Lot number and expiry date of vaccine was unknown. No treatment information was reported.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adeverse event; Patient received the bivalent booster without receiving any other COVID19 vaccine in the past; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received the bivalent booster without receiving any other COVID19 vaccine in the past) and NO ADVERSE EVENT (No adeverse event) in a 31-year-old female patient 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 07-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 07-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received the bivalent booster without receiving any other COVID19 vaccine in the past). On an unknown date, the patient experienced NO ADVERSE EVENT (No adeverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received the bivalent booster without receiving any other COVID19 vaccine in the past) and NO ADVERSE EVENT (No adeverse 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 adeverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received the bivalent booster without receiving any other COVID19 vaccine in the past).    No concomitant medication information was provided.  No treatment medication was provided.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature, Muscle twitching, Palpitations, Pyrexia, Tinnitus
Clinical narrative: still got the awful twitching; ringing in her ears got worse; heart racing lasted for weeks; fever stayed at 100 F after getting the booster shots; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE TWITCHING (still got the awful twitching), TINNITUS (ringing in her ears got worse), PALPITATIONS (heart racing lasted for weeks) and PYREXIA (fever stayed at 100 F after getting the booster shots) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient had no allergies. The patient had never been tested positive or diagnosed with COVID-19.  Previously administered products included for Drug use for unknown indication: Tylenol; for Product used for unknown indication: pneumococcal vaccine, FLU VACCINE VII (flu vaccine) and Shingles vaccine (Shingles vaccine). Past adverse reactions to the above products included No adverse event with FLU VACCINE VII, Shingles vaccine, Tylenol and pneumococcal vaccine. Concurrent medical conditions included Bronchiectasis.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE TWITCHING (still got the awful twitching), TINNITUS (ringing in her ears got worse), PALPITATIONS (heart racing lasted for weeks) and PYREXIA (fever stayed at 100 F after getting the booster shots). At the time of the report, MUSCLE TWITCHING (still got the awful twitching) and TINNITUS (ringing in her ears got worse) had not resolved, PALPITATIONS (heart racing lasted for weeks) had resolved and PYREXIA (fever stayed at 100 F after getting the booster shots) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 100 degree Fahrenheit.         No concomitant medications were reported.  On 15-Apr-2022, the patient received second booster dose of Moderna COVID-19 vaccine but the patient could not recall the date of administration of the first booster dose of Moderna COVID-19 vaccine.  The patient was afraid and had to decide whether the patient would get the bivalent booster dose or not, as the patient had experienced symptoms after the first 4 doses.  No treatment medications were reported.   This case was linked to MOD-2022-657512, MOD-2022-657532 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bronchiectasis, Feeling abnormal, Headache, Rash, Tinnitus
Clinical narrative: still got the awful twitching; ringing in her ears got worse; heart racing lasted for weeks; fever stayed at 100 F after getting the booster shots; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE TWITCHING (still got the awful twitching), TINNITUS (ringing in her ears got worse), PALPITATIONS (heart racing lasted for weeks) and PYREXIA (fever stayed at 100 F after getting the booster shots) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient had no allergies. The patient had never been tested positive or diagnosed with COVID-19.  Previously administered products included for Drug use for unknown indication: Tylenol; for Product used for unknown indication: pneumococcal vaccine, FLU VACCINE VII (flu vaccine) and Shingles vaccine (Shingles vaccine). Past adverse reactions to the above products included No adverse event with FLU VACCINE VII, Shingles vaccine, Tylenol and pneumococcal vaccine. Concurrent medical conditions included Bronchiectasis.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE TWITCHING (still got the awful twitching), TINNITUS (ringing in her ears got worse), PALPITATIONS (heart racing lasted for weeks) and PYREXIA (fever stayed at 100 F after getting the booster shots). At the time of the report, MUSCLE TWITCHING (still got the awful twitching) and TINNITUS (ringing in her ears got worse) had not resolved, PALPITATIONS (heart racing lasted for weeks) had resolved and PYREXIA (fever stayed at 100 F after getting the booster shots) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 100 degree Fahrenheit.         No concomitant medications were reported.  On 15-Apr-2022, the patient received second booster dose of Moderna COVID-19 vaccine but the patient could not recall the date of administration of the first booster dose of Moderna COVID-19 vaccine.  The patient was afraid and had to decide whether the patient would get the bivalent booster dose or not, as the patient had experienced symptoms after the first 4 doses.  No treatment medications were reported.   This case was linked to MOD-2022-657512, MOD-2022-657532 (Patient Link).