chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; total of 47 patients that received the vaccines after the use-by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (total of 47 patients that received the vaccines after the use-by date) 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)) (batch no. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Jul-2023, 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 06-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (total of 47 patients that received the vaccines after the use-by date). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (total of 47 patients that received the vaccines after the use-by date) 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 EXPIRED PRODUCT ADMINISTERED (total of 47 patients that received the vaccines after the use-by date).    Patient was over 18 years of age.  No relevant concomitant medications were reported. Staff gave patients vaccines past the use date of 18Jul2023. On 6Jul2023, 6 doses were administered at administration site 2.  No treatment medication reported.   The case corresponds to 42nd out of 47 patients as reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-732752 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Follow up received, updated vaccination date and I narrative.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732752:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.) 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)) (batch no. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Jun-2023, 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 27-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      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 EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.).    No relevant concomitant medications were reported. Staff gave patients vaccines past the use date of 18 Jun 2023. On 27 Jun 2023, 3 doses were administered at administration site 2. No treatment medication reported.   This case was for the 39th patient out of 47 reported.    This case was linked to US-MODERNATX, INC.-MOD-2023-732752 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Vaccine information reported and narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732752:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date) 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)) (batch no. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Jul-2023, 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 06-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date) 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 EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date).    Concomitant medication was not reported. Staff gave patients vaccines past the use dates. The use-by date of vaccine was 18-Jun-2023. Patient received vaccine at administration site 2. Treatment medication was not reported.  This case was for the 43rd patient out of 47 adult patients reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-732752 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Vaccine administration date was added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732752:Master Case (Patient 1)
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.) 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)) (batch no. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Jul-2023, 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 06-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.) 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 EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.).    Patient was over 18 years of age. No relevant concomitant medications were reported. Staff gave patients vaccines past the use date of 18 Jun 2023. On 06 July 2023, 6 patients were administered at administration site 2. No treatment medication reported.   This case was for the 44th patient out of 47 reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-732752 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Live Follow-up received contains Vaccine information reported and narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732752:Master case (Patient 1)
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.) 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)) (batch no. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Jul-2023, 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 06-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.) 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 EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.).    Patient was of over 18 years of age. No relevant concomitant medications were reported. Staff gave patients vaccines past the use date of 18 Jun 2023. On 06 Jul 2023, 6 doses were administered at administration site 2. No treatment medication reported.   This case was for the 45th patient out of 47 reported.    This case was linked to US-MODERNATX, INC.-MOD-2023-732752 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Vaccine information reported and narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732752:Master case (Patient 1)
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.) 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)) (batch no. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Jun-2023, 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 28-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      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 EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.).    No concomitant medications were reported. Patient was over 18 years of age. Staff gave patients vaccines past the use date of 18 Jun 2023. On 28-Jun-2023, 5 doses were administered at administration site 2. Treatment medications were not reported.  This case is for 41st patient out of 47 patients reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-732752 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Live significant follow up received: Vaccine administration date was updated; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732752:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date) 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)) (batch no. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.  On 06-Jul-2023, 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 06-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided    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 EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date).    Concomitant product use was not provided by the reporter.  Staff gave patients vaccines past the use date of 18-Jun-2023.  On 06-Jul-2023, 6 doses were administered at administration site 2.   Treatment information was not provided.  This case contains information for the 46th patient out of 47 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-732752 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Live Follow-up received suspect vaccine details added, iNarrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732752:Master case (Patient 1)
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; 47 patients received the vaccines after the use-by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (47 patients received the vaccines after the use-by date) 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)) (batch no. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Jul-2023, 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 06-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (47 patients received the vaccines after the use-by date). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (47 patients received the vaccines after the use-by date) 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 EXPIRED PRODUCT ADMINISTERED (47 patients received the vaccines after the use-by date).    Patient was over 18 years of age.  No relevant concomitant medications were reported. Staff gave patients vaccines past the use date of 18 Jun 2023. On 06 Jul 2023, 6 doses were administered at administration site 2. No treatment medication reported.   The case corresponds to 47th out of 47 adult patients as reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-732752 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Follow-up received, vaccine administration date information was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732752:Master Case(Patient 1)
Sex: M
Vaccine: COVID19-2
Symptoms: Vaccination site pain
Clinical narrative: The Physician reports that the pain in his injection site from the Moderna Covid-19 vaccines is more intense than any other vaccine; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (The Physician reports that the pain in his injection site from the Moderna Covid-19 vaccines is more intense than any other vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concomitant products included INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.   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. On an unknown date, the patient experienced VACCINATION SITE PAIN (The Physician reports that the pain in his injection site from the Moderna Covid-19 vaccines is more intense than any other vaccine). At the time of the report, VACCINATION SITE PAIN (The Physician reports that the pain in his injection site from the Moderna Covid-19 vaccines is more intense than any other vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The physician says pain was much more sore than flu shot. The Physician has had 3 monovalent Moderna vaccines and 1 bivalent Moderna Covid-19 vaccines. The Physician did not wish to provide any additional information about his previous Moderna Covid-19 vaccine. Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-730373 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730373:Same patient, Bivalent product
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; HCP advised that her office administer 3 vaccinations with expired vaccines; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP advised that her office administer 3 vaccinations with expired vaccines) and NO ADVERSE EVENT (No adverse event) in an infant patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) for COVID-19 prophylaxis.     Relevant medical history or conditions, allergy, concomitant diseases and risk factor were unknown.     On 12-Jul-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Jul-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP advised that her office administer 3 vaccinations with expired vaccines). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP advised that her office administer 3 vaccinations with expired vaccines) 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 EXPIRED PRODUCT ADMINISTERED (HCP advised that her office administer 3 vaccinations with expired vaccines).    Patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine were unknown. Concomitant medication details not reported by the reporter. Dosage text was reported as unknown. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-733038, US-MODERNATX, INC.-MOD-2023-733100 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-733038:Same reporter US-MODERNATX, INC.-MOD-2023-733100:Same reporter
Age: 10.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; A dose was then administered more than 24 hours after sitting at room temperature; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A dose was then administered more than 24 hours after sitting at room temperature) and NO ADVERSE EVENT (No adverse event) in a 10-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7645B) for COVID-19 prophylaxis.     The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 13-Jul-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 13-Jul-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (A dose was then administered more than 24 hours after sitting at room temperature). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A dose was then administered more than 24 hours after sitting at room temperature) 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 EXPIRED PRODUCT ADMINISTERED (A dose was then administered more than 24 hours after sitting at room temperature).    No concomitant medication was reported. The vaccine was removed from fridge at on 12-JUL-2023. There were no reported symptoms. No treatment medication was reported.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: moderna bivalent blue cap which was administered 23 hours after it was punctured; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (moderna bivalent blue cap which was administered 23 hours after it was punctured) 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 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 EXPIRED PRODUCT ADMINISTERED (moderna bivalent blue cap which was administered 23 hours after it was punctured) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (moderna bivalent blue cap which was administered 23 hours after it was punctured) 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 EXPIRED PRODUCT ADMINISTERED (moderna bivalent blue cap which was administered 23 hours after it was punctured).    Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Age: 93.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine was given "Beyond Use Date" of 6/19/23. Not expired. Healthcare provider informed. Moderna contacted and assessed vaccine to be viable. No known health complication for patient.
Age: 13.0
Sex: F
Vaccine: HPV9, MENB, MNQ, TDAP
Symptoms: Circumstance or information capable of leading to medication error, Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: Staff nurse review consent and no record .  Mom documented wrong dob on consent . I got vaccine ready that were marked (Tdap, MCV, HPV and MenB ) . Mom denied any allergies, no medical condition, no previous reaction to previous vaccines. After vaccination instructed mom, they had to wait 15 min post injection. no complaints only was sore from left arm . I advice  to move arms , recommend she can put icepack wrapped in towel and can take tylenol or any analgesic of her choice  She asked me to write vaccine on copy she had of vaccine printed record Public Health Office and noticed dob from that record and form mom filled out was different and inquired from mom, she stated she had documented the wrong dob, she had documented her son dob instead of daughter. so, notify parent we administered vaccine not on schedule.  Vaccine would probably not count and at age  16 she would need to get re vaccinated, she voiced understanding.
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Anxiety, Balance disorder, Consciousness fluctuating, Dizziness, Dyspnoea
Clinical narrative: I took two regular aspirin before bed the night of getting the shot in anticipation of the usual flu-like side effects of all of the Covid shots I've had previously the day after vaccination. For a couple of weeks prior, I had been experiencing bouts of tachycardia and shortness of breath after exertion. The morning after the shot, I got out of bed feeling fine and went to the bathroom. Upon standing up from the toilet, my heart began to pound, my legs were weak, and I felt like I was going to faint. I managed to get to the sink to wash my hands, but was feeling very anxious. I got back to the bed just in time to collapse on it. For the rest of the day, I was in and out of consciousness or asleep (not sure which). Each time I tried to stand and walk, my heart would race, I could hear it pounding, and I had to sit down or brace myself on a counter before collapsing again. Bending over increased these symptoms significantly. By the next morning, there was some improvement and I was able to carefully take a shower and get dressed (I have a shower bench and used it) but spent the rest of that day sitting because I still felt I might collapse and I still had tachycardia upon any change in position. Since then my balance has improved, but still get tachycardia and shortness of breath.
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dyspnoea exertional, Muscular weakness, Palpitations, Syncope, Tachycardia
Clinical narrative: I took two regular aspirin before bed the night of getting the shot in anticipation of the usual flu-like side effects of all of the Covid shots I've had previously the day after vaccination. For a couple of weeks prior, I had been experiencing bouts of tachycardia and shortness of breath after exertion. The morning after the shot, I got out of bed feeling fine and went to the bathroom. Upon standing up from the toilet, my heart began to pound, my legs were weak, and I felt like I was going to faint. I managed to get to the sink to wash my hands, but was feeling very anxious. I got back to the bed just in time to collapse on it. For the rest of the day, I was in and out of consciousness or asleep (not sure which). Each time I tried to stand and walk, my heart would race, I could hear it pounding, and I had to sit down or brace myself on a counter before collapsing again. Bending over increased these symptoms significantly. By the next morning, there was some improvement and I was able to carefully take a shower and get dressed (I have a shower bench and used it) but spent the rest of that day sitting because I still felt I might collapse and I still had tachycardia upon any change in position. Since then my balance has improved, but still get tachycardia and shortness of breath.
Age: 0.75
Sex: M
Vaccine: DTAP, IPV
Symptoms: Extra dose administered
Clinical narrative: Patient received 4th doses of Dtap and IPV vaccine at 9 months. Nurse miscount number of Dtap and IPV vaccines patient already had. Pediatrician was informed and patient's mother was contacted to inform patient received extra dose of Dtap and IPV.
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine was given "Beyond Use Date" of 6/19/23. Not expired. Healthcare provider informed. Moderna contacted and assessed vaccine to be viable. No known health complication for patient.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine was given "Beyond Use Date" of 6/19/23. Not expired. Healthcare provider informed. Moderna contacted and assessed vaccine to be viable. No known health complication for patient.
Age: 96.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient came to pharmacy 07/18/2023 and I routinely chech immunization history especially for elderly and noticed no pneumococcal immunization or shingrix. I told patient's daughter felt more comfortable only administering one of the vaccines Prevnar 20 and I automatically scheduled her first Shingrix 2 weeks out. I also called patient's MD  to make sure she had not gotten either vaccines. I called and spoke to office manager who then transferred me to voice mail wher I left message. The patient routinely gets all her vaccinations st our pharmacy and ones in the area . I did not hear back from doctor office until after I administered the Prevnar 20 vaccine. She stated that the patient had already gotten the prevnar 20 vaccine but not the shingrix. She talked to me in an accusatory tone at which point I stated I followed due diligence, did not see any record of pneumoccocal or shingrix vaccinations and proceeded with prevnar 20 .
Age: 78.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine was given "Beyond Use Date" of 6/19/23. Not expired. Healthcare provider informed. Moderna contacted and assessed vaccine to be viable. No known health complication for patient.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC13, DTPPVHBHPB, PNC13
Symptoms: Breath holding, Crying, Cyanosis, Pallor
Clinical narrative: Gave patient Prevnar 13 vaccination in left thigh and then immediately gave vaxelis in right thigh and patient went cyanotic and experienced a breath-holding spell and then shortly after took a breath, recovered and then continued crying, then 5-7 minutes later patient became pale.  Continuous oxygen saturations were monitored and stayed above 97%. Patient's color returned to normal within 30 minutes after episode. After discussion with doctor it has been decided that future vaccinations will be given individually at different times for this patient
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was given "Beyond Use Date" of 6/19/23. Not expired. Healthcare provider informed. Moderna contacted and assessed vaccine to be viable. No known health complication for patient.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine was given "Beyond Use Date" of 6/19/23. Not expired. Healthcare provider informed. Moderna contacted and assessed vaccine to be viable. No known health complication for patient.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Bursitis, Fatigue, Injected limb mobility decreased, Injection site joint pain, Injection site pain
Clinical narrative: Marked fatigue started in arm 2 days post vaccination.  Could barely brush my teeth or complete writing a sentence without having to rest my arm.  Eventually my shoulder began to hurt with certain movements and kept getting worse over the course of the next few months.  I noticed my shoulder was rounding forward and no amount of exercise or consciously pulling it back would keep it in place.  I started several months of physical therapy starting on January 2023 and ending at the end of April 2023  but my arm and shoulder continued to get fatigued easily along with a pain deep in my shoulder joint that kept getting worse.  On April 20th 2023 my right shoulder and arm got significantly worse and started with a stabbing pain in my bicep along with a deep burning in the front and side of my shoulder.  I was given a steroid shot and an MRI.  The steroid shot provided no relief.  I am now unable to use my right arm for much more than eating as it hurts 24/7 and any use aggravates it.  I have been unable to work since 6/17/23.  I have tried Celebrex and Meloxicam but both ended due to harsh side effects.  I have also been given Lyrica and gabapentin to see if it is nerve pain.  Lyrica was discontinued due to side effects but I start the gabapentin tonight.   Three weeks ago my new physical therapist tried using KTape to provide some relief and it has been the most relief I've had yet but it does not allow me to work or use my arm much.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Loss of personal independence in daily activities, Magnetic resonance imaging abnormal, Pain, Tendon disorder
Clinical narrative: Marked fatigue started in arm 2 days post vaccination.  Could barely brush my teeth or complete writing a sentence without having to rest my arm.  Eventually my shoulder began to hurt with certain movements and kept getting worse over the course of the next few months.  I noticed my shoulder was rounding forward and no amount of exercise or consciously pulling it back would keep it in place.  I started several months of physical therapy starting on January 2023 and ending at the end of April 2023  but my arm and shoulder continued to get fatigued easily along with a pain deep in my shoulder joint that kept getting worse.  On April 20th 2023 my right shoulder and arm got significantly worse and started with a stabbing pain in my bicep along with a deep burning in the front and side of my shoulder.  I was given a steroid shot and an MRI.  The steroid shot provided no relief.  I am now unable to use my right arm for much more than eating as it hurts 24/7 and any use aggravates it.  I have been unable to work since 6/17/23.  I have tried Celebrex and Meloxicam but both ended due to harsh side effects.  I have also been given Lyrica and gabapentin to see if it is nerve pain.  Lyrica was discontinued due to side effects but I start the gabapentin tonight.   Three weeks ago my new physical therapist tried using KTape to provide some relief and it has been the most relief I've had yet but it does not allow me to work or use my arm much.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine was given "Beyond Use Date" of 6/19/23. Not expired. Healthcare provider informed. Moderna contacted and assessed vaccine to be viable. No known health complication for patient.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Shot given one day after the beyond use date. Patient denied any adverse effects.
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine was given "Beyond Use Date" of 6/19/23. Not expired. Healthcare provider informed. Moderna contacted and assessed vaccine to be viable. No known health complication for patient.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine was given "Beyond Use Date" of 6/19/23. Not expired. Healthcare provider informed. Moderna contacted and assessed vaccine to be viable. No known health complication for patient.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: Sore arm at injection site, headache, feverish feeling, overall achiness.
Age: 80.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine was given "Beyond Use Date" of 6/19/23. Not expired. Healthcare provider informed. Moderna contacted and assessed vaccine to be viable. No known health complication for patient.
Age: 20.0
Sex: F
Vaccine: COVID19-2
Symptoms: Angiogram pulmonary normal, Anion gap, Basophil count decreased, Basophil percentage decreased, Blood chloride normal
Clinical narrative: pt had COVID booster on 7/13 and was seen in ER on 7/14 due to nausea, dyspnea, dizziness, wobbling gait, fever to 102.3 degrees.  Symptoms are improving but not resolved.  No longer fever, breathing is better, but she still feels a bit warm.  She recalls reactions to prior covid vaccines as well. She has history of prior COVID infection and subsequent PE during that illness.  She has had COVID 3-4 times.  She reports she also gets symptomatic from flu vaccinations with intense headaches and nausea. At the ER on 7/14 she had workup including labs which showed mildly elevated WBC of 12.3 with elevated neutrophils and otherwise not significant.  CTA of chest was negative for PE.
Age: 20.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood creatinine normal, Blood glucose normal, Blood potassium normal, Blood sodium decreased, Blood urea normal
Clinical narrative: pt had COVID booster on 7/13 and was seen in ER on 7/14 due to nausea, dyspnea, dizziness, wobbling gait, fever to 102.3 degrees.  Symptoms are improving but not resolved.  No longer fever, breathing is better, but she still feels a bit warm.  She recalls reactions to prior covid vaccines as well. She has history of prior COVID infection and subsequent PE during that illness.  She has had COVID 3-4 times.  She reports she also gets symptomatic from flu vaccinations with intense headaches and nausea. At the ER on 7/14 she had workup including labs which showed mildly elevated WBC of 12.3 with elevated neutrophils and otherwise not significant.  CTA of chest was negative for PE.
Age: 20.0
Sex: F
Vaccine: COVID19-2
Symptoms: Carbon dioxide normal, Dizziness, Dyspnoea, Electrocardiogram abnormal, Eosinophil count normal
Clinical narrative: pt had COVID booster on 7/13 and was seen in ER on 7/14 due to nausea, dyspnea, dizziness, wobbling gait, fever to 102.3 degrees.  Symptoms are improving but not resolved.  No longer fever, breathing is better, but she still feels a bit warm.  She recalls reactions to prior covid vaccines as well. She has history of prior COVID infection and subsequent PE during that illness.  She has had COVID 3-4 times.  She reports she also gets symptomatic from flu vaccinations with intense headaches and nausea. At the ER on 7/14 she had workup including labs which showed mildly elevated WBC of 12.3 with elevated neutrophils and otherwise not significant.  CTA of chest was negative for PE.
Age: 20.0
Sex: F
Vaccine: COVID19-2
Symptoms: Eosinophil percentage decreased, Feeling hot, Gait disturbance, Glomerular filtration rate normal, Granulocyte percentage
Clinical narrative: pt had COVID booster on 7/13 and was seen in ER on 7/14 due to nausea, dyspnea, dizziness, wobbling gait, fever to 102.3 degrees.  Symptoms are improving but not resolved.  No longer fever, breathing is better, but she still feels a bit warm.  She recalls reactions to prior covid vaccines as well. She has history of prior COVID infection and subsequent PE during that illness.  She has had COVID 3-4 times.  She reports she also gets symptomatic from flu vaccinations with intense headaches and nausea. At the ER on 7/14 she had workup including labs which showed mildly elevated WBC of 12.3 with elevated neutrophils and otherwise not significant.  CTA of chest was negative for PE.
Age: 20.0
Sex: F
Vaccine: COVID19-2
Symptoms: Haematocrit normal, Haemoglobin normal, Immature granulocyte count, Lymphocyte count decreased, Lymphocyte count normal
Clinical narrative: pt had COVID booster on 7/13 and was seen in ER on 7/14 due to nausea, dyspnea, dizziness, wobbling gait, fever to 102.3 degrees.  Symptoms are improving but not resolved.  No longer fever, breathing is better, but she still feels a bit warm.  She recalls reactions to prior covid vaccines as well. She has history of prior COVID infection and subsequent PE during that illness.  She has had COVID 3-4 times.  She reports she also gets symptomatic from flu vaccinations with intense headaches and nausea. At the ER on 7/14 she had workup including labs which showed mildly elevated WBC of 12.3 with elevated neutrophils and otherwise not significant.  CTA of chest was negative for PE.
Age: 20.0
Sex: F
Vaccine: COVID19-2
Symptoms: Mean cell volume decreased, Monocyte count normal, Monocyte percentage, Nausea, Neutrophil count increased
Clinical narrative: pt had COVID booster on 7/13 and was seen in ER on 7/14 due to nausea, dyspnea, dizziness, wobbling gait, fever to 102.3 degrees.  Symptoms are improving but not resolved.  No longer fever, breathing is better, but she still feels a bit warm.  She recalls reactions to prior covid vaccines as well. She has history of prior COVID infection and subsequent PE during that illness.  She has had COVID 3-4 times.  She reports she also gets symptomatic from flu vaccinations with intense headaches and nausea. At the ER on 7/14 she had workup including labs which showed mildly elevated WBC of 12.3 with elevated neutrophils and otherwise not significant.  CTA of chest was negative for PE.
Age: 20.0
Sex: F
Vaccine: COVID19-2
Symptoms: Neutrophil percentage increased, Platelet count normal, Pyrexia, Red blood cell count normal, Red blood cell nucleated morphology
Clinical narrative: pt had COVID booster on 7/13 and was seen in ER on 7/14 due to nausea, dyspnea, dizziness, wobbling gait, fever to 102.3 degrees.  Symptoms are improving but not resolved.  No longer fever, breathing is better, but she still feels a bit warm.  She recalls reactions to prior covid vaccines as well. She has history of prior COVID infection and subsequent PE during that illness.  She has had COVID 3-4 times.  She reports she also gets symptomatic from flu vaccinations with intense headaches and nausea. At the ER on 7/14 she had workup including labs which showed mildly elevated WBC of 12.3 with elevated neutrophils and otherwise not significant.  CTA of chest was negative for PE.
Age: 20.0
Sex: F
Vaccine: COVID19-2
Symptoms: Red cell distribution width increased, Scan with contrast normal, Sinus tachycardia, Troponin I, White blood cell count increased
Clinical narrative: pt had COVID booster on 7/13 and was seen in ER on 7/14 due to nausea, dyspnea, dizziness, wobbling gait, fever to 102.3 degrees.  Symptoms are improving but not resolved.  No longer fever, breathing is better, but she still feels a bit warm.  She recalls reactions to prior covid vaccines as well. She has history of prior COVID infection and subsequent PE during that illness.  She has had COVID 3-4 times.  She reports she also gets symptomatic from flu vaccinations with intense headaches and nausea. At the ER on 7/14 she had workup including labs which showed mildly elevated WBC of 12.3 with elevated neutrophils and otherwise not significant.  CTA of chest was negative for PE.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Medication error, No adverse event
Clinical narrative: Patient received doubled dose of vaccination in error. No adverse reaction has occurred. Manufacturer and disease control did not recommend any further action unless adverse reaction should occur.
Age: 85.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cardiac disorder, Expired product administered, Fatigue, General physical health deterioration, Pneumonia
Clinical narrative: Patient received shot one day after the beyond use date. Patient says after this his health has gone down. He reports heart problems, hospitalization due to pneumonia, and fatigue.
Age: 8.0
Sex: F
Vaccine: DTAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: DTAP inadvertently given at the age of 8 instead of Tdap. No known reaction occurred.
Age: 88.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, Fatigue
Clinical narrative: Patient received the moderna shot one day after the beyond use date. Patient reports ongoing fatigue since this time.
Age: 71.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: patient had already received prevnar 13 based on guidelines they should have been given pnemovax 23. we recieived a prescription from the dr for prevnar 20 and after givng the vaccine and checking records we discovered the patient had been given prevnar 13 5 years prior
Age: 88.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient was given vaccine 4 days after the beyond use date. Pharmacist is attempting to contact patient. Patient phone number is no longer active.
Age: 12.0
Sex: M
Vaccine: HPV9, TDAP
Symptoms: Wrong product administered
Clinical narrative: Pt was due for Meningococcal-MCV4. I made the mistake and gave pt VAXNEUVANCE instead. I notified vaccine supervisor, clinic manager and Clinic Dr. I am trying to contact mom and let her know of the mistake and to bring pt back to administer the correct vaccine.
Age: 41.0
Sex: F
Vaccine: PNC20
Symptoms: CD4 lymphocytes, Exposure during pregnancy, Platelet count normal, Thrombocytopenia
Clinical narrative: 15 days after vaccine was administered at the clinic, patient presented for appointment and the physician that saw the patient was informed by patient that she was pregnant. As of 7/7/2023, patient's EDD is 10/1/2023, and the only known complications currently are well-controlled HIV and thrombocytopenia [suspect gestational thrombocytopenia]. PCP: no PCP
Age: 40.0
Sex: F
Vaccine: DTAP
Symptoms: Anisocoria, Crying, Dizziness, Eye pruritus, Musculoskeletal stiffness
Clinical narrative: Neck got incredibly stiff, got extremely dizzy and had a severe nausea.   They observed me for over an hour, prescribed Zofran, and told me to go home and rest. My eyes started getting itchy that afternoon. Over the next few days I tried ice packs and warm compress. By Tuesday it was so bad I went to the er. They numbed them and sent me home with a referral to an optometrist if it got worse. I woke up in so much pain I called them crying on Wednesday.  They referred me to my normal optometrist, whom I had seen early March and he diagnosed me with two ulcers in my left corena.