chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive for Covid) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2022, the patient experienced COVID-19 (Tested positive for Covid). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2022, SARS-CoV-2 test: (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had fourth booster of Pfizer COVID-19 vaccine (lot numberFJ4991.) on 19 Jul 2022.(route - intramuscular). Patient was taking more concomitant prescription medications, but nothing relevant to COVID. Patient had COVID-19 following family funeral and treated with Paxlovid (Miracle drug).   Most recent FOLLOW-UP information incorporated above includes: On 18-Oct-2022: Follow-up received include. Patient Demographics (D.O.B. ,age, height, weight) added, Product details updated, Narrative updated
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: Discomfort on the left chest around the heart area on and off after Bivalent Booster; This spontaneous case was reported by a patient and describes the occurrence of CHEST DISCOMFORT (Discomfort on the left chest around the heart area on and off after Bivalent Booster) in a 78-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 050D22A) for COVID-19 prophylaxis.     Concurrent medical conditions included COPD (10 years ago,Taking Inhalers.) and Blood pressure high (diagnosed about 25 years ago under control with HBP medicine.). Concomitant products included CHLORTALIDONE (CHLORTHALIDONE), LISINOPRIL, TERAZOSIN, BISOPROLOL, SPIRONOLACTONE, OLODATEROL HYDROCHLORIDE, TIOTROPIUM BROMIDE MONOHYDRATE (STIOLTO RESPIMAT) and CICLESONIDE (ALVESCO) for an unknown indication.   On 18-Oct-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. On 18-Oct-2022, the patient experienced CHEST DISCOMFORT (Discomfort on the left chest around the heart area on and off after Bivalent Booster). At the time of the report, CHEST DISCOMFORT (Discomfort on the left chest around the heart area on and off after Bivalent Booster) outcome was unknown.      Patient had COPD and blood pressure and it did not get any better or worse after vaccination. Patient received 5 doses of Moderna COVID-19 vaccine, 2 primary, 2 Monovalent boosters and 1 Bivalent booster. First dose on 29-Jan-2021 (batch no. 042L20A and Expiry Date: 06-Jul-2021), second dose on 01-Mar-2021 (batch no. 011A21A and Expiry Date: 16-Aug-2021), first booster dose on 17-Nov-2021 (batch no.065F21A) and second booster dose on 13-Apr-2022 (batch no.045L21A). Treatment information include doctor were reduced patient's blood pressure medications.  This case was linked to MOD-2022-660880 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore right arm ,Sore Right Arm,Sore injection site arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Sore right arm ,Sore Right Arm,Sore injection site arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025D21A, 032M20A and 014M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Sore right arm ,Sore Right Arm,Sore injection site arm). At the time of the report, VACCINATION SITE PAIN (Sore right arm ,Sore Right Arm,Sore injection site arm) outcome was unknown.     Concomitant drugs were not reported. Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-660901, US-MODERNATX, INC.-MOD-2022-660904 (Linked Report). This case was linked to MOD-2022-661014 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-660901:MOD22-027076 Husband case US-MODERNATX, INC.-MOD-2022-660904:MOD22-027076 Husband case
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Somnolence, Vaccination site pain
Clinical narrative: Sore right arm ,Sore Right Arm,Sore injection site arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Sore right arm ,Sore Right Arm,Sore injection site arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025D21A, 032M20A and 014M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Sore right arm ,Sore Right Arm,Sore injection site arm). At the time of the report, VACCINATION SITE PAIN (Sore right arm ,Sore Right Arm,Sore injection site arm) outcome was unknown.     Concomitant drugs were not reported. Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-660901, US-MODERNATX, INC.-MOD-2022-660904 (Linked Report). This case was linked to MOD-2022-661014 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-660901:MOD22-027076 Husband case US-MODERNATX, INC.-MOD-2022-660904:MOD22-027076 Husband case
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: Made patient sleepy.; Injection site soreness; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (Made patient sleepy.) and VACCINATION SITE PAIN (Injection site soreness) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046L21A, 025D21A, 032M20A and 014M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2022, the patient experienced SOMNOLENCE (Made patient sleepy.) and VACCINATION SITE PAIN (Injection site soreness). At the time of the report, SOMNOLENCE (Made patient sleepy.) and VACCINATION SITE PAIN (Injection site soreness) outcome was unknown.            No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2022-661012 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Somnolence, Vaccination site pain
Clinical narrative: Made patient sleepy.; Injection site soreness; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (Made patient sleepy.) and VACCINATION SITE PAIN (Injection site soreness) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046L21A, 025D21A, 032M20A and 014M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2022, the patient experienced SOMNOLENCE (Made patient sleepy.) and VACCINATION SITE PAIN (Injection site soreness). At the time of the report, SOMNOLENCE (Made patient sleepy.) and VACCINATION SITE PAIN (Injection site soreness) outcome was unknown.            No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2022-661012 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort
Clinical narrative: Had phone on speaker because holding the phone is hard on caller's neck; This spontaneous case was reported by a nurse and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Had phone on speaker because holding the phone is hard on caller's neck) 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 MUSCULOSKELETAL DISCOMFORT (Had phone on speaker because holding the phone is hard on caller's neck). At the time of the report, MUSCULOSKELETAL DISCOMFORT (Had phone on speaker because holding the phone is hard on caller's neck) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: It is itchy and warm  to the touch; It is itchy and warm  to the touch; Injection site is raised with approximately 3-4cm diameter; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PRURITUS (It is itchy and warm  to the touch), VACCINATION SITE WARMTH (It is itchy and warm  to the touch) and VACCINATION SITE SWELLING (Injection site is raised with approximately 3-4cm diameter) 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 prophylaxis.     No Medical History information was reported.    On 17-Oct-2022 at 8:15 AM, 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 18-Oct-2022, the patient experienced VACCINATION SITE PRURITUS (It is itchy and warm  to the touch), VACCINATION SITE WARMTH (It is itchy and warm  to the touch) and VACCINATION SITE SWELLING (Injection site is raised with approximately 3-4cm diameter). At the time of the report, VACCINATION SITE PRURITUS (It is itchy and warm  to the touch), VACCINATION SITE WARMTH (It is itchy and warm  to the touch) and VACCINATION SITE SWELLING (Injection site is raised with approximately 3-4cm diameter) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Events were reported as similar to that of an allergy shot. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: having a PE after routine hip replacement; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PULMONARY EMBOLISM (having a PE after routine hip replacement) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Hip replacement (routine hip replacement).    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 PULMONARY EMBOLISM (having a PE after routine hip replacement) (seriousness criteria medically significant and life threatening). At the time of the report, PULMONARY EMBOLISM (having a PE after routine hip replacement) outcome was unknown.            Concomitant medications were not provided.  The reporter needed to find info to either condemn or verify whether blood clots were tied to the mRNA vaccination. Patient was clinically dead except for the husband who literally saved her.  Treatment medications were not provided.  Company comment: This is a spontaneous case regarding a female patient of an unknown age, with medical history of hip replacement, who received third dose of mRNA-1273 vaccine and experienced medically significant and life-threatening event of pulmonary embolism (AESI). Vaccination date and onset date of the event were not provided, latency cannot be assessed. According to the reporter, patient experienced pulmonary embolism  after a routine hip replacement and she was convinced it was from her COVID vaccines which it has been at least 4 months since her 3rd shot. Patient was clinically dead except for her husband who literally saved her. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. Medical history of hip replacement represents a risk factor for pulmonary embolism. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-661268 (E2B Linked Report).; Sender's Comments: This is a spontaneous case regarding a female patient of an unknown age, with medical history of hip replacement, who received third dose of mRNA-1273 vaccine and experienced medically significant and life-threatening event of pulmonary embolism (AESI). Vaccination date and onset date of the event were not provided, latency cannot be assessed. According to the reporter, patient experienced pulmonary embolism  after a routine hip replacement and she was convinced it was from her COVID vaccines which it has been at least 4 months since her 3rd shot. Patient was clinically dead except for her husband who literally saved her. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. Medical history of hip replacement represents a risk factor for pulmonary embolism. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2022-661268:Reporter's case
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Adult patient received a 6 to 11 year old dose instead of the bivalent booster; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Adult patient received a 6 to 11 year old dose instead of the bivalent booster) and NO ADVERSE EVENT (No adverse event) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.   On 18-Oct-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Adult patient received a 6 to 11 year old dose instead of the bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Adult patient received a 6 to 11 year old dose instead of the bivalent booster) 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 (Adult patient received a 6 to 11 year old dose instead of the bivalent booster).    No Concomitant medications were provided. It was reported that, patient had received 3 doses prior to the administration error. No treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patients received Booster dose of Moderna COVID-19 vaccine from a Pediatric vial (6Y to 11Y) instead of Bivalent booster vial; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (patients received Booster dose of Moderna COVID-19 vaccine from a Pediatric vial (6Y to 11Y) instead of Bivalent booster vial) and NO ADVERSE EVENT (No adverse event) in an adult 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 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 received Booster dose of Moderna COVID-19 vaccine from a Pediatric vial (6Y to 11Y) instead of Bivalent booster vial) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patients received Booster dose of Moderna COVID-19 vaccine from a Pediatric vial (6Y to 11Y) instead of Bivalent booster vial) 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 received Booster dose of Moderna COVID-19 vaccine from a Pediatric vial (6Y to 11Y) instead of Bivalent booster vial).    This case pertains to the adult patient number 3.  No concomitant medication was reported.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-Oct-2022: Live follow up received. IRD of initial version updated to 17-OCT-2022. On 17-Oct-2022: Live follow up received. No new information.
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was administered monovalent vaccine instead of bivalent; No Adverse Event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient was administered monovalent vaccine instead of bivalent) and NO ADVERSE EVENT (No Adverse Event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035B22A) 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 (Patient was administered monovalent vaccine instead of bivalent) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient was administered monovalent vaccine instead of 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 (Patient was administered monovalent vaccine instead of bivalent).    No concomitant medications were reported.  The patient received 2 primary Moderna doses and 1 Moderna booster. No adverse reaction was reported.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient received Booster dose of Moderna COVID-19 vaccine from a Pediatric vial (6Y-11Y) instead of Bivalent booster vial; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient received Booster dose of Moderna COVID-19 vaccine from a Pediatric vial (6Y-11Y) instead of Bivalent booster vial) and NO ADVERSE EVENT (No adverse event) in an adult 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 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 (patient received Booster dose of Moderna COVID-19 vaccine from a Pediatric vial (6Y-11Y) instead of Bivalent booster vial) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient received Booster dose of Moderna COVID-19 vaccine from a Pediatric vial (6Y-11Y) instead of Bivalent booster vial) 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 (patient received Booster dose of Moderna COVID-19 vaccine from a Pediatric vial (6Y-11Y) instead of Bivalent booster vial).    The case pertains to patient number 5. Concomitant products were not provided. Treatment medication were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-Oct-2022: Live follow up received. Initial version updated to 17-OCT-2022. On 17-Oct-2022: Live follow-up contains no new information.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No Adverse event; Patient received 1st booster dose instead of 3rd dose; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT DOSE ADMINISTERED (Patient received 1st booster dose instead of 3rd dose) and NO ADVERSE EVENT (No Adverse event) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 52C21A, 032L20A and 027L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Aug-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Patient received 1st booster dose instead of 3rd dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Patient received 1st booster dose instead of 3rd dose) 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 INCORRECT DOSE ADMINISTERED (Patient received 1st booster dose instead of 3rd dose).    No concomitant information provided Patient was immunocompromised, & patient took 5 different immunosuppressants.  Patient received 1st dose: 24Jan2021 with Lot: 027L20A Patient received  2nd dose: 24Feb2021 with Lot: 032L20A Patient received  1st booster dose: 21Aug2021 with Lot: "52C21A" No treatment information provided   This case was linked to MOD-2022-661304 (Patient Link).
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient administered with monovalent Moderna vaccines (0.5 mL) instead of Moderna bivalent; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient administered with monovalent Moderna vaccines (0.5 mL) instead of Moderna bivalent) and NO ADVERSE EVENT (No adverse event) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient administered with monovalent Moderna vaccines (0.5 mL) instead of Moderna bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient administered with monovalent Moderna vaccines (0.5 mL) instead of Moderna 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 (Patient administered with monovalent Moderna vaccines (0.5 mL) instead of Moderna bivalent).    The concomitant and treatment medication was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Wrong product administered
Clinical narrative: No adverse event; Received Expired Monovalent Booster; Received Monovalent Booster instead of Bivalent; This spontaneous case was reported by a phlebotomist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent Booster), WRONG PRODUCT ADMINISTERED (Received Monovalent Booster instead of Bivalent) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent Booster) and WRONG PRODUCT ADMINISTERED (Received Monovalent Booster instead of Bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent Booster), WRONG PRODUCT ADMINISTERED (Received Monovalent Booster instead of 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent Booster) and WRONG PRODUCT ADMINISTERED (Received Monovalent Booster instead of Bivalent).    No Concomitant medications were provided.  No treatment medications were provided.  This case contains information for the 1st of 2 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-661317 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-661317:2nd adult patient case
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; patient administered with monovalent Moderna vaccine (0.5 mL) instead of Moderna bivalent booster; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient administered with monovalent Moderna vaccine (0.5 mL) instead of Moderna bivalent booster) and NO ADVERSE EVENT (No adverse event) in a 79-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 13-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (patient administered with monovalent Moderna vaccine (0.5 mL) instead of Moderna bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient administered with monovalent Moderna vaccine (0.5 mL) instead of Moderna bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (patient administered with monovalent Moderna vaccine (0.5 mL) instead of Moderna bivalent booster).    Concomitant medication information was not provided.  No adverse event was reported post vaccination.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-661311, US-MODERNATX, INC.-MOD-2022-661318. Sender's Comments:  US-MODERNATX, INC.-MOD-2022-661311:same reporter US-MODERNATX, INC.-MOD-2022-661318:same reporter
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Wrong product administered
Clinical narrative: No adverse event; Received Expired Monovalent Booster of Moderna COVID-19 vaccine; Received Monovalent Booster instead of Bivalent; This spontaneous case was reported by a phlebotomist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent Booster of Moderna COVID-19 vaccine), WRONG PRODUCT ADMINISTERED (Received Monovalent Booster instead of Bivalent) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent Booster of Moderna COVID-19 vaccine) and WRONG PRODUCT ADMINISTERED (Received Monovalent Booster instead of Bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent Booster of Moderna COVID-19 vaccine), WRONG PRODUCT ADMINISTERED (Received Monovalent Booster instead of 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent Booster of Moderna COVID-19 vaccine) and WRONG PRODUCT ADMINISTERED (Received Monovalent Booster instead of Bivalent).    No concomitant medications were reported.  No treatment medications were reported.  This case contains information for the 2nd of 2 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-661313 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-661313:1st adult patient case
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; 3 patients administered with monovalent Moderna vaccines (0.5 mL) instead of Moderna bivalent; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (3 patients administered with monovalent Moderna vaccines (0.5 mL) instead of Moderna bivalent) and NO ADVERSE EVENT (No adverse event) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (3 patients administered with monovalent Moderna vaccines (0.5 mL) instead of Moderna bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (3 patients administered with monovalent Moderna vaccines (0.5 mL) instead of Moderna 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 (3 patients administered with monovalent Moderna vaccines (0.5 mL) instead of Moderna bivalent).    No concomitant medication information provided. No treatment information provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Mouth swelling
Clinical narrative: swollen lip; Swelling started on the right side of her mouth.; This spontaneous case was reported by a patient and describes the occurrence of LIP SWELLING (swollen lip) and MOUTH SWELLING (Swelling started on the right side of her mouth.) in a 72-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 027822A) for COVID-19 prophylaxis.     The patient's past medical history included Fall (Patient fall in garage) on 21-Aug-2022, Shoulder dislocation on 21-Aug-2022 and Ischemic stroke (Mild) in 2014. Concurrent medical conditions included Multiple sclerosis and Lupus syndrome. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), LOSARTAN, ASPIRIN [ACETYLSALICYLIC ACID], CLONAZEPAM, PREGABALIN (LYRICA), VITAMIN B12 [VITAMIN B12 NOS], COLECALCIFEROL (VITAMIN D3), PARACETAMOL (TYLENOL), CAFFEINE, PARACETAMOL (EXCEDRIN [CAFFEINE;PARACETAMOL]) and CLONAZEPAM for an unknown indication.    On 18-Oct-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. On 19-Oct-2022, the patient experienced LIP SWELLING (swollen lip) and MOUTH SWELLING (Swelling started on the right side of her mouth.). At the time of the report, LIP SWELLING (swollen lip) and MOUTH SWELLING (Swelling started on the right side of her mouth.) outcome was unknown.            Patient took first dose of moderna on 29-JAN-2021, lot number 028L20A on left arm, 2nd dose on 01-MAR-2021, lot number 014M20A on left arm, First booster dose on 31-AUG-2021, lot number 051E21A and second booster dose on 20-MAY-2022, lot number 054A22A on left arm.  Treatment medication was not provided by the reporter.   This case was linked to MOD-2022-661321 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Joint dislocation
Clinical narrative: Patient fell in her garage; Dislocated shoulder; This spontaneous case was reported by a patient and describes the occurrence of FALL (Patient fell in her garage) and JOINT DISLOCATION (Dislocated shoulder) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054A22A, 028L20A, 014M20A and 051E21A) for COVID-19 prophylaxis.     The patient's past medical history included Ischemic stroke (mild) in 2014. Concurrent medical conditions included Multiple sclerosis and Lupus anticoagulant hypoprothrombinemia syndrome (Lupus Anticoagulant Disorder). Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), LOSARTAN, ASPIRIN [ACETYLSALICYLIC ACID], CLONAZEPAM, PREGABALIN (LYRICA), VITAMIN B12 [VITAMIN B12 NOS], COLECALCIFEROL (VITAMIN D3), PARACETAMOL (TYLENOL) and CLONAZEPAM for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Aug-2022, the patient experienced FALL (Patient fell in her garage) and JOINT DISLOCATION (Dislocated shoulder). At the time of the report, FALL (Patient fell in her garage) and JOINT DISLOCATION (Dislocated shoulder) outcome was unknown.            Other concomitant medications included Excedin as needed. No treatment information was provided.   This case was linked to MOD-2022-661319 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: extreme vertigo/mini stroke/symptoms were very similar to a mini stroke; This spontaneous case was reported by a patient and describes the occurrence of VERTIGO (extreme vertigo/mini stroke/symptoms were very similar to a mini stroke) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939909, 011a21a and 036a21a) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included SIMVASTATIN (STATIN [SIMVASTATIN]), MULTIVITAMINS [VITAMINS NOS] and MAGNESIUM for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VERTIGO (extreme vertigo/mini stroke/symptoms were very similar to a mini stroke). At the time of the report, VERTIGO (extreme vertigo/mini stroke/symptoms were very similar to a mini stroke) had resolved.            Patient was never tested positive for COVID-19. Patient did not received other vaccines within 1 month prior to Moderna COVID-19 vaccine. Following vaccination to the 1st booster patient started to experience the next morning extreme vertigo for about 30 minutes. symptoms came and went, were very similar to a mini stroke. Patient to seek medical care, in touch with doctor and follow up in the next week with neurologist, patient could not conclude if it was a mini stroke or a reaction to the shot. Treatment details was not reported by the reporter.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: inadvertently administered 2 bivalent booster doses to a patient one week apart; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of EXTRA DOSE ADMINISTERED (inadvertently administered 2 bivalent booster doses to a patient one week apart) and NO ADVERSE EVENT (No adverse event) in an 84-year-old male patient 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, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (inadvertently administered 2 bivalent booster doses to a patient one week apart) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (inadvertently administered 2 bivalent booster doses to a patient one week apart) 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 EXTRA DOSE ADMINISTERED (inadvertently administered 2 bivalent booster doses to a patient one week apart).    No concomitant medications were reported.  The reporter asked for recommendation that needed to be done in this situation.  No treatment medications were reported.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: patient complained because her leg hurt; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (patient complained because her leg hurt) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1416B) for COVID-19 vaccination.     The patient had no allergy.  The patient's past medical history included COVID-19 (Hospitalized for 3 days and was sick for almost 2 weeks) in August 2021.   On 28-Jun-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jun-2022, the patient experienced PAIN IN EXTREMITY (patient complained because her leg hurt). On 30-Jun-2022, PAIN IN EXTREMITY (patient complained because her leg hurt) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   The concomitant and treatment medication was not reported. The patient received flu shot the same day, 17-Oct-2022, with the third dose of Moderna.   This case was linked to MOD-2022-661333, MOD-2022-661338 (Patient Link).
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: patient complained because her leg hurt; 1st dose: 28-Jun-2022/2nd dose:19-Jul-2022; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (patient complained because her leg hurt) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose: 28-Jun-2022/2nd dose:19-Jul-2022) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AR9237B and AS1416B) for COVID-19 vaccination.     Patient did not have any allergies. Patient did not have any Acute and Chronic illnesses at the time of vaccination. Patient was not under any concomitant or regular medication.  The patient's past medical history included COVID-19 (she was hospitalized for 3 days and she was sick for almost 2 weeks) in August 2021.   On 28-Jun-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jul-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Jul-2022, the patient experienced PAIN IN EXTREMITY (patient complained because her leg hurt) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose: 28-Jun-2022/2nd dose:19-Jul-2022). On 21-Jul-2022, PAIN IN EXTREMITY (patient complained because her leg hurt) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose: 28-Jun-2022/2nd dose:19-Jul-2022) outcome was unknown.            No treatment medications were reported.   This case was linked to MOD-2022-661337, MOD-2022-661333 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event; received the Moderna bivalent booster vaccine for their first primary dose./patients had never received a primary series of the Moderna Covid-19 vaccine.; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (received the Moderna bivalent booster vaccine for their first primary dose./patients had never received a primary series of the Moderna Covid-19 vaccine.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender 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 18-Oct-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 18-Oct-2022, the patient experienced INCORRECT DOSE ADMINISTERED (received the Moderna bivalent booster vaccine for their first primary dose./patients had never received a primary series of the Moderna Covid-19 vaccine.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (received the Moderna bivalent booster vaccine for their first primary dose./patients had never received a primary series of the Moderna Covid-19 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 INCORRECT DOSE ADMINISTERED (received the Moderna bivalent booster vaccine for their first primary dose./patients had never received a primary series of the Moderna Covid-19 vaccine.).    No concomitant information provided Two patients walked into the Pharmacy yesterday and received the Moderna bivalent booster vaccine for their first primary dose. The patients had never received a primary series of the Moderna Covid-19 vaccine. No treatment information provided