chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 3 year old given Moderna as 1st booster; Monovalent vaccine given as a booster dose; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (3 year old given Moderna as 1st booster), WRONG PRODUCT ADMINISTERED (Monovalent vaccine given as a booster dose) and NO ADVERSE EVENT (No adverse event) in a 3-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer vaccines (1st dose, lot number FT9142) on 07-Jul-2022, Pfizer vaccines (2nd dose and lot number FT9142) on 21-Jul-2022. Past adverse reactions to the above products included No adverse event with Pfizer vaccines and Pfizer vaccines.    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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (3 year old given Moderna as 1st booster), WRONG PRODUCT ADMINISTERED (Monovalent vaccine given as a booster dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (3 year old given Moderna as 1st booster), WRONG PRODUCT ADMINISTERED (Monovalent vaccine given as a booster 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 assessments were provided for PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (3 year old given Moderna as 1st booster) and WRONG PRODUCT ADMINISTERED (Monovalent vaccine given as a booster dose).    The concomitant medication was not reported by reporter. It was reported that a staff at a pediatric clinic called to report that they inadvertently administered the Moderna Covid-19 vaccine (blue cap with pink border) to a 3 year old for their 1st booster dose. They wanted to know how to proceed and if they had to watch out for any adverse reactions on this patient.  No adverse reactions had been reported. The treatment medication was not reported by reporter.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Hair loss after receiving the Moderna vaccine; This spontaneous case was reported by a patient and describes the occurrence of ALOPECIA (Hair loss after receiving the Moderna vaccine) 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 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)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ALOPECIA (Hair loss after receiving the Moderna vaccine). At the time of the report, ALOPECIA (Hair loss after receiving the Moderna vaccine) outcome was unknown. The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) was unknown. No concomitant medications were reported. No treatment medications were reported.  This case was linked to US-MODERNATX, INC.-MOD-2022-670176, US-MODERNATX, INC.-MOD-2022-670184 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-670176:Female case 1 US-MODERNATX, INC.-MOD-2022-670184:cross link case MOD22-028969 (2 female patient)
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Received Moderna Covid-19 vaccine monovalent instead of the bivalent dose for their booster dose.; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received Moderna Covid-19 vaccine monovalent instead of the bivalent dose for their booster dose.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) 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 (Received Moderna Covid-19 vaccine monovalent instead of the bivalent dose for their booster dose.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received Moderna Covid-19 vaccine monovalent instead of the bivalent dose for their booster 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 WRONG PRODUCT ADMINISTERED (Received Moderna Covid-19 vaccine monovalent instead of the bivalent dose for their booster dose.).    Concomitant Medication use information was not provided by reporter. During a Moderna Covid-19 vaccine clinic Patient received Moderna Covid-19 vaccine monovalent instead of the bivalent dose for their booster dose. The Nurse stated that this was happened because the monovalent vaccine with the purple border was labeled booster doses. Treatment Medication use information was not provided by reporter.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; staff gave vaccine to a patient that was out of the 12 hour window; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (staff gave vaccine to a patient that was out of the 12 hour window) and NO ADVERSE EVENT (No adverse event) in a 55-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 014H22A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Nov-2022 at 2:40 AM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 03-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (staff gave vaccine to a patient that was out of the 12 hour window). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (staff gave vaccine to a patient that was out of the 12 hour window) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (staff gave vaccine to a patient that was out of the 12 hour window).    No concomitant medication was reported.  Date the vial was initially stored in the refrigerator on 01-Nov-2022. Date and time vial was first punctured on 02-Nov-2022 around 10:00 AM. The vial did not undergo any temperature excursions. No treatment information was reported.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event, Wrong product administered
Clinical narrative: No adverse event; Bivalent dose administered before 2nd dose of primary series; Bivalent dose administered before 2nd dose of primary series; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Bivalent dose administered before 2nd dose of primary series), WRONG PRODUCT ADMINISTERED (Bivalent dose administered before 2nd dose of primary series) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 010H22A) for COVID-19 vaccination.     No other vaccines were given within 1 month prior to Moderna COVID-19 Vaccine.     On 04-Nov-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 04-Nov-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Bivalent dose administered before 2nd dose of primary series) and WRONG PRODUCT ADMINISTERED (Bivalent dose administered before 2nd dose of primary series). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Bivalent dose administered before 2nd dose of primary series), WRONG PRODUCT ADMINISTERED (Bivalent dose administered before 2nd dose of primary series) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Bivalent dose administered before 2nd dose of primary series) and WRONG PRODUCT ADMINISTERED (Bivalent dose administered before 2nd dose of primary series).    The reported stated that the patient was not under any concomitant or regular medication.  Patient had only received a first dose from primary series of Moderna COVID-19 vaccination on 19-Jul-2021. Patient then received Moderna bivalent booster dose before receiving second dose.  No adverse events were reported  No treatment details was reported.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: achy injection site left arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (achy injection site left arm) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced VACCINATION SITE PAIN (achy injection site left arm). At the time of the report, VACCINATION SITE PAIN (achy injection site left arm) outcome was unknown.            No concomitant medications was reported.  On 23-Mar-2021, the patient complains of a sore left arm, achy injection site left arm after the First vaccination and again on 20-Apr-2021 patient complains of a sore left arm, achy injection site left arm after the second vaccination.  No treatment medications was reported.   This case was linked to MOD-2022-670196 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: received the Moderna Monovalent Booster instead of the bivalent Booster; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (received the Moderna Monovalent Booster instead of the bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) 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 (received the Moderna Monovalent Booster instead of the bivalent Booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (received the Moderna Monovalent Booster 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 (received the Moderna Monovalent Booster instead of the bivalent Booster).    No concomitant information was reported. Reporter stated this happened because the monovalent vaccine with the purple border was labled "booster doses". No adverse effects noted No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: 1 patient received Moderna Covid-19 vaccine that had undergone a temperature excursion and was administered prior to knowing the viability of the vaccine.; Patient received moderna vaccine that underwent a temperature excursion; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (1 patient received Moderna Covid-19 vaccine that had undergone a temperature excursion and was administered prior to knowing the viability of the vaccine.), POOR QUALITY PRODUCT ADMINISTERED (Patient received moderna vaccine that underwent a temperature excursion) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (1 patient received Moderna Covid-19 vaccine that had undergone a temperature excursion and was administered prior to knowing the viability of the vaccine.), POOR QUALITY PRODUCT ADMINISTERED (Patient received moderna vaccine that underwent a temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (1 patient received Moderna Covid-19 vaccine that had undergone a temperature excursion and was administered prior to knowing the viability of the vaccine.), POOR QUALITY PRODUCT ADMINISTERED (Patient received moderna vaccine that underwent a temperature excursion) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (1 patient received Moderna Covid-19 vaccine that had undergone a temperature excursion and was administered prior to knowing the viability of the vaccine.) and POOR QUALITY PRODUCT ADMINISTERED (Patient received moderna vaccine that underwent a temperature excursion).    Concomitant product use was not provided by the reporter.  No information available about the patient's primary series of Moderna COVID-19 vaccine.  The patient received Moderna COVID-19 vaccine that underwent a temperature excursion and was administered prior to knowing the viability of the vaccine.  Vaccine expiration date was not known. Patient did not remember which arm they received the vaccine in. This dose was a booster dose.   No other adverse events were reported.  Treatment information was not provided.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was first punctured on 04-Nov-2022 and was administered on 06-Nov-2022; No adverse event; given vaccine from vial punctured for more than 12 hours; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (given vaccine from vial punctured for more than 12 hours), PRODUCT STORAGE ERROR (Vial was first punctured on 04-Nov-2022 and was administered on 06-Nov-2022) and NO ADVERSE EVENT (No adverse event) in a 45-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 immunisation.     No Medical History information was reported.    On 06-Nov-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 06-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (given vaccine from vial punctured for more than 12 hours). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was first punctured on 04-Nov-2022 and was administered on 06-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (given vaccine from vial punctured for more than 12 hours), PRODUCT STORAGE ERROR (Vial was first punctured on 04-Nov-2022 and was administered on 06-Nov-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (given vaccine from vial punctured for more than 12 hours) and PRODUCT STORAGE ERROR (Vial was first punctured on 04-Nov-2022 and was administered on 06-Nov-2022).    Concomitant product use was not provided by the reporter.  Nurse practitioner reported that they inadvertently administered the bivalent booster dose from a vial which has been punctured for more than 12 hours. It was reported that patient received vaccine from vial with size of 2.5 ml.  There was no information provided when vial was initially stored in the refrigerator. Vial was first punctured on 04-Nov-2022 and was administered on 06-Nov-2022. Vial was stored post puncture in the fridge.  Treatment information was not provided.
Age: 6.0
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Half volume dose administered instead of full volume dose of monovalent Moderna COVID-19 Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Half volume dose administered instead of full volume dose of monovalent Moderna COVID-19 Vaccine) and NO ADVERSE EVENT (No adverse event) in a 6-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Nov-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 25 microgram. On 07-Nov-2022, the patient experienced ACCIDENTAL UNDERDOSE (Half volume dose administered instead of full volume dose of monovalent Moderna COVID-19 Vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Half volume dose administered instead of full volume dose of monovalent Moderna COVID-19 Vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Half volume dose administered instead of full volume dose of monovalent Moderna COVID-19 Vaccine).    No concomitant medications were reported. It was stated that, on 7Nov2022 a 6 year old patient received half of a dose (25 mcg) instead of full dose (50 mcg) of the monovalent Moderna COVID-19 Vaccine. Caller informed that patient did not report any adverse event so far. No treatment medications were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Received the Moderna Monovalent Booster instead of the bivalent vaccine; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received the Moderna Monovalent Booster instead of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) 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 (Received the Moderna Monovalent Booster instead of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received the Moderna Monovalent Booster instead of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Received the Moderna Monovalent Booster instead of the bivalent vaccine). No concomitant products reported. It was reported that during a Moderna Covid-19 clinic patient received Moderna Covid-19 vaccine monovalent instead of the bivalent dose for the booster dose. The nurse stated that happened because the monovalent vaccine with the purple border was labelled as booster dose.  No treatment products reported.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diplopia, Dizziness
Clinical narrative: Double vision within 15 minutes after first primary dose; Dizziness within 15 minutes after first primary dose; This spontaneous case was reported by a patient and describes the occurrence of DIPLOPIA (Double vision within 15 minutes after first primary dose) and DIZZINESS (Dizziness within 15 minutes after first primary dose) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (Hypertension for the past 30 years controlled with medication Zestril 5mg once a day.) and Diabetes (for the past 2 years and it was being controlled with diet & exercise.). Concomitant products included LISINOPRIL (ZESTRIL) for Blood pressure high.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, the patient experienced DIPLOPIA (Double vision within 15 minutes after first primary dose) and DIZZINESS (Dizziness within 15 minutes after first primary dose). The patient was treated with GLUCOSE on 04-May-2021 for Double vision and Dizziness, at an unspecified dose and frequency. On 04-May-2021, DIPLOPIA (Double vision within 15 minutes after first primary dose) and DIZZINESS (Dizziness within 15 minutes after first primary dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient experienced double vision and dizziness within 15 minutes after vaccination. The pharmacist gave glucose tablets for the events and it went away within 1 hour.   This case was linked to MOD-2022-670217, MOD-2022-670221 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Influenza like illness, Pyrexia
Clinical narrative: Double vision within 15 minutes after first primary dose; Dizziness within 15 minutes after first primary dose; This spontaneous case was reported by a patient and describes the occurrence of DIPLOPIA (Double vision within 15 minutes after first primary dose) and DIZZINESS (Dizziness within 15 minutes after first primary dose) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (Hypertension for the past 30 years controlled with medication Zestril 5mg once a day.) and Diabetes (for the past 2 years and it was being controlled with diet & exercise.). Concomitant products included LISINOPRIL (ZESTRIL) for Blood pressure high.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, the patient experienced DIPLOPIA (Double vision within 15 minutes after first primary dose) and DIZZINESS (Dizziness within 15 minutes after first primary dose). The patient was treated with GLUCOSE on 04-May-2021 for Double vision and Dizziness, at an unspecified dose and frequency. On 04-May-2021, DIPLOPIA (Double vision within 15 minutes after first primary dose) and DIZZINESS (Dizziness within 15 minutes after first primary dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient experienced double vision and dizziness within 15 minutes after vaccination. The pharmacist gave glucose tablets for the events and it went away within 1 hour.   This case was linked to MOD-2022-670217, MOD-2022-670221 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diplopia, Dizziness
Clinical narrative: Flu Like symptoms 1-2 days after the 2nd primary shot; High Fever 103F 1-2 days after the 2nd primary shot; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu Like symptoms 1-2 days after the 2nd primary shot) and PYREXIA (High Fever 103F 1-2 days after the 2nd primary shot) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. P13H21B or 013H21B, 049C21A and 003C21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes (For the past 2 years and it was being controlled with diet & exercise) and Hypertension (For the past 30 years controlled with medication). Concomitant products included LISINOPRIL (ZESTRIL) for Hypertension.   On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu Like symptoms 1-2 days after the 2nd primary shot) and PYREXIA (High Fever 103F 1-2 days after the 2nd primary shot). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Fever, at an unspecified dose and frequency. In January 2022, INFLUENZA LIKE ILLNESS (Flu Like symptoms 1-2 days after the 2nd primary shot) and PYREXIA (High Fever 103F 1-2 days after the 2nd primary shot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 103 F.         Patient experienced events 1-2 days after both second and first booster dose and recovered 3 days later .   This case was linked to MOD-2022-670195, MOD-2022-670221.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Influenza like illness, Pyrexia
Clinical narrative: Flu Like symptoms 1-2 days after the 2nd primary shot; High Fever 103F 1-2 days after the 2nd primary shot; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu Like symptoms 1-2 days after the 2nd primary shot) and PYREXIA (High Fever 103F 1-2 days after the 2nd primary shot) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. P13H21B or 013H21B, 049C21A and 003C21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes (For the past 2 years and it was being controlled with diet & exercise) and Hypertension (For the past 30 years controlled with medication). Concomitant products included LISINOPRIL (ZESTRIL) for Hypertension.   On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu Like symptoms 1-2 days after the 2nd primary shot) and PYREXIA (High Fever 103F 1-2 days after the 2nd primary shot). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Fever, at an unspecified dose and frequency. In January 2022, INFLUENZA LIKE ILLNESS (Flu Like symptoms 1-2 days after the 2nd primary shot) and PYREXIA (High Fever 103F 1-2 days after the 2nd primary shot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 103 F.         Patient experienced events 1-2 days after both second and first booster dose and recovered 3 days later .   This case was linked to MOD-2022-670195, MOD-2022-670221.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Pain in extremity, Vaccination site pain
Clinical narrative: Patient had a mild case of Covid-19 in July 2022; achy injection site left arm; sore left arm; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Patient had a mild case of Covid-19 in July 2022), VACCINATION SITE PAIN (achy injection site left arm) and PAIN IN EXTREMITY (sore left arm) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A, 007B21A and 048B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, the patient experienced VACCINATION SITE PAIN (achy injection site left arm) and PAIN IN EXTREMITY (sore left arm). In July 2022, the patient experienced COVID-19 (Patient had a mild case of Covid-19 in July 2022). At the time of the report, COVID-19 (Patient had a mild case of Covid-19 in July 2022), VACCINATION SITE PAIN (achy injection site left arm) and PAIN IN EXTREMITY (sore left arm) outcome was unknown.            No concomitant medications was provided. Patient had a mild case of Covid-19 in July 2022 Sore Throat and mild congestion  No treatment medications was provided.   This case was linked to MOD-2022-670187 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Received the Moderna Monovalent Booster instead of the bivalent vaccine; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received the Moderna Monovalent Booster instead of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) 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 (Received the Moderna Monovalent Booster instead of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received the Moderna Monovalent Booster instead of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Received the Moderna Monovalent Booster instead of the bivalent vaccine).    Concomitant product use was not provided by the reporter.  The nurse stated that it happened because of the monovalent vaccine with the purple border was labeled booster doses.  Treatment information was not provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No Adverse Event; patient was supposed to get themonovalent vaccine, but they received the bivalent booster as their first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient was supposed to get themonovalent vaccine, but they received the bivalent booster as their first dose) and NO ADVERSE EVENT (No Adverse Event) in a 59-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Oct-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 28-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (patient was supposed to get themonovalent vaccine, but they received the bivalent booster as their first dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient was supposed to get themonovalent vaccine, but they received the bivalent booster as their first dose) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (patient was supposed to get themonovalent vaccine, but they received the bivalent booster as their first dose).    No concomitant medications were reported. Patient was supposed to get monovalent vaccine but received bivalent vaccine as the First dose. It was reported that patient had no known allergies or past medical conditions at the time of vaccination. Patient didn't receive other vaccine 1 month prior to Moderna COVID-19 vaccine. Patient was not taking other medications and patient's HCP was not aware of this incident. Patient not had symptoms associated with COVID-19. Not had a COVID-19 test. No treatment information was reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted
Clinical narrative: Patient never received the second primary dose; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Patient never received the second primary dose) and NO ADVERSE EVENT (No adverse event) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Patient never received the second primary dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Patient never received the second primary dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (Patient never received the second primary dose).    HCP was unaware if patient was taking other medication.  Pharmacist stated the patient had received her first Moderna dose about 2 years ago. Now patient wanted to get the second dose. Patient's HCP  was aware that patient did not receive the second dose.  No treatment medications were reported.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was intially stored on 08-Sep-2022 and given on 37 days; No adverse event; Patients received dosage after BUD,Dose administered after 30-day Use By Date (37 days); This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received dosage after BUD,Dose administered after 30-day Use By Date (37 days)), PRODUCT STORAGE ERROR (Vial was intially stored on 08-Sep-2022 and given on 37 days) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 057A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Nov-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 06-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received dosage after BUD,Dose administered after 30-day Use By Date (37 days)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was intially stored on 08-Sep-2022 and given on 37 days) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received dosage after BUD,Dose administered after 30-day Use By Date (37 days)), PRODUCT STORAGE ERROR (Vial was intially stored on 08-Sep-2022 and given on 37 days) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patients received dosage after BUD,Dose administered after 30-day Use By Date (37 days)) and PRODUCT STORAGE ERROR (Vial was intially stored on 08-Sep-2022 and given on 37 days).    No concomitant medication was reported.   The vial was initially stored in the refrigerator on 08-Sep-2022. The vial size was 5.5 ml. The vial did not undergo any temperature excursions.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-670209 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-670209:Bivalent Invalid female case (4 female) same reporter
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient received a regular Moderna instead of the bivalent booster; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received a regular Moderna instead of the bivalent booster) and NO ADVERSE EVENT (No adverse event) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In December 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (Patient received a regular Moderna 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 (Patient received a regular Moderna 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 (Patient received a regular Moderna instead of the bivalent booster).    No concomitant medication information was provided.  Pharmacist wants information to see when the patient can get the bivalent booster (lot number 052B22A).  No treatment medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: 11 Adult patients received Bivalent booster from vials that experienced excursion in the refrigerator on 03OCT2022; no adverse event; Adult patient received Bivalent booster from vial that experienced excursion in the refrigerator on 03OCT2022; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Adult patient received Bivalent booster from vial that experienced excursion in the refrigerator on 03OCT2022), PRODUCT TEMPERATURE EXCURSION ISSUE (11 Adult patients received Bivalent booster from vials that experienced excursion in the refrigerator on 03OCT2022) 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 vaccination.     No Medical History information was reported.    In October 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. In October 2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Adult patient received Bivalent booster from vial that experienced excursion in the refrigerator on 03OCT2022). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (11 Adult patients received Bivalent booster from vials that experienced excursion in the refrigerator on 03OCT2022) and NO ADVERSE EVENT (no adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Adult patient received Bivalent booster from vial that experienced excursion in the refrigerator on 03OCT2022), PRODUCT TEMPERATURE EXCURSION ISSUE (11 Adult patients received Bivalent booster from vials that experienced excursion in the refrigerator on 03OCT2022) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Adult patient received Bivalent booster from vial that experienced excursion in the refrigerator on 03OCT2022) and PRODUCT TEMPERATURE EXCURSION ISSUE (11 Adult patients received Bivalent booster from vials that experienced excursion in the refrigerator on 03OCT2022).    Concomitant medications details were not reported by the reporter.  It was reported that excursion occurred in refrigerator on 03-Oct-2022 with minimum temperature of 1.76 Celsius and maximum of 1.97 Celsius for 1 hour 40 minutes. It was the first time the excursion occurred. It was reported that some of the vials were used and some were discarded.Treatment details was not reported by the reporter. This case was reported for patient 2nd of 11 adult patients.
Age: 57.0
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No Adverse event; gave the patient 0.3mL of Moderna Covid-19 Vaccine, Bivalent, instead of 0.5mL.; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (gave the patient 0.3mL of Moderna Covid-19 Vaccine, Bivalent, instead of 0.5mL.) and NO ADVERSE EVENT (No Adverse event) in a 57-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 013H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .3 milliliter. On 02-Nov-2022, the patient experienced ACCIDENTAL UNDERDOSE (gave the patient 0.3mL of Moderna Covid-19 Vaccine, Bivalent, instead of 0.5mL.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (gave the patient 0.3mL of Moderna Covid-19 Vaccine, Bivalent, instead of 0.5mL.) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (gave the patient 0.3mL of Moderna Covid-19 Vaccine, Bivalent, instead of 0.5mL.).    No concomitant medication details was reported. It was reported that HCP travelled and used to giving the Pfizer, which was 0.3mL. No treatment medication details was reported.   This case was linked to MOD-2022-668652.   Reporter did not allow further contact