chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event; received a 0.25 ml Moderna booster dose from  the 6m-4y vial; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT DOSE ADMINISTERED (received a 0.25 ml Moderna booster dose from  the 6m-4y vial) and NO ADVERSE EVENT (No adverse event) in a 7-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (received two Pfizer doses more than 5 months ago). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE.   On 06-Sep-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Sep-2022, the patient experienced INCORRECT DOSE ADMINISTERED (received a 0.25 ml Moderna booster dose from  the 6m-4y vial). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (received a 0.25 ml Moderna booster dose from  the 6m-4y vial) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (received a 0.25 ml Moderna booster dose from  the 6m-4y vial).    No relevant concomitant medications were reported.   Patient received two Pfizer doses more than 5 months ago. The patient was 7 years old. She was coming for the booster and received a 0.25 ml Moderna dose (from the 6m-4y vial) instead of the Pfizer on 06-Sep-2022.  No treatment information was provided.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Adult patient received the 6 month to 5 year old formulation of the Moderna Covid-19 vaccine; 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 (Adult patient received the 6 month to 5 year old formulation of the Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1416B) 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Adult patient received the 6 month to 5 year old formulation of the Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Adult patient received the 6 month to 5 year old formulation of the 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Adult patient received the 6 month to 5 year old formulation of the Moderna Covid-19 vaccine).    No Concomitant medications were provided.  It was reported that patient wanted to receive the Moderna Bivalent vaccine but the patient received the 6 month to 5 year old dosage. No adverse reaction were observed for patient.  Reporter also reported that patient received the Moderna Covid-19 vaccine for primary series and booster doses however, does not have any information on these vaccinations.  No adverse reactions are known of from these vaccinations  No treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: the patient definitely did not receive a full dose; the patient definitely did not receive a full dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (the patient definitely did not receive a full dose) and NO ADVERSE EVENT (the patient definitely did not receive a full dose) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No medical history was reported.     On 08-Sep-2022, the patient received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 08-Sep-2022, the patient experienced ACCIDENTAL UNDERDOSE (the patient definitely did not receive a full dose). On an unknown date, the patient experienced NO ADVERSE EVENT (the patient definitely did not receive a full dose). At the time of the report, ACCIDENTAL UNDERDOSE (the patient definitely did not receive a full dose) and NO ADVERSE EVENT (the patient definitely did not receive a full dose) outcome was unknown.        For mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (the patient definitely did not receive a full dose) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (the patient definitely did not receive a full dose).    No concomitant and treatment medication information was reported.   Reporter did not allow further contact
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Fatigue, Tinnitus
Clinical narrative: After receiving the vaccine, she was tired; Buzz in the left ear/Ringing in her ears; This spontaneous case was reported by a patient and describes the occurrence of TINNITUS (Buzz in the left ear/Ringing in her ears) and FATIGUE (After receiving the vaccine, she was tired) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 023M20A and 032L20A) for COVID-19 vaccination.     Patient had no acute and chronic illnesses at the time of vaccination.  Concurrent medical conditions included Drug allergy (Sulfa allergy) and Penicillin allergy. Concomitant products included LEVOTHYROXINE for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, the patient experienced TINNITUS (Buzz in the left ear/Ringing in her ears). On an unknown date, the patient experienced FATIGUE (After receiving the vaccine, she was tired). At the time of the report, TINNITUS (Buzz in the left ear/Ringing in her ears) and FATIGUE (After receiving the vaccine, she was tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Acoustic stimulation tests: left ear was worst.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the patient was taking other medication.  The patient did not have COVID positive test or diagnosis. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  Patient went to doctor and thought that the ringing in ear was due to wax. However, she was told that it was not the issue. Patient was asked to stop doing some stuff like drinking coffee. Patient was wary about getting the new booster and she does not want to get another booster shot and it get worst. Patient was scheduled to take another hearing test at a different location on 12 Sep 2021 to see if it was till bad. Patient ear specialist was aware of the side effects and wanted to perform brain scan. Patient stated that it all started after the booster shot.  Patient had put oil in the left ear. The one she had the buzz.   This case was linked to US-MODERNATX, INC.-MOD-2022-643486 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-643486:MOD22-023007(Daughter's Case)
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: A vial of Moderna Covid-19 monovalent vaccine got mixed into the Moderna Covid-19 bivalent vaccine and the monovalent vaccine was administered; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (A vial of Moderna Covid-19 monovalent vaccine got mixed into the Moderna Covid-19 bivalent vaccine and the monovalent vaccine was administered) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (A vial of Moderna Covid-19 monovalent vaccine got mixed into the Moderna Covid-19 bivalent vaccine and the monovalent vaccine was administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (A vial of Moderna Covid-19 monovalent vaccine got mixed into the Moderna Covid-19 bivalent vaccine and the monovalent vaccine was administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (A vial of Moderna Covid-19 monovalent vaccine got mixed into the Moderna Covid-19 bivalent vaccine and the monovalent vaccine was administered).    No concomitant medications were reported. Vial of Moderna COVID-19 monovalent vaccine got mixed into where the vials of the Moderna COVID-19 bivalent vaccine were stored and a dose of the monovalent vaccine was administered to the patient for the bivalent vaccine. No treatment information was provided.
Age: 1.83
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient received the second dose on day 23; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose on day 23) and NO ADVERSE EVENT (No adverse event) in a 22-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS1412B and AS1412B) for COVID-19 vaccination.     No Medical History information was reported.   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) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose on day 23) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose on day 23) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose on day 23).    No concomitant medications was reported. It was reported that first and second dose had the same LOT numbers. No treatment drug details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-643391 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-643391.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was opened on 10Aug2022, but a dose of that was administered 09Sep2022; No Adverse event; Dose given from a vial punctured more than 12 hours ago; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose given from a vial punctured more than 12 hours ago), PRODUCT STORAGE ERROR (The vial was opened on 10Aug2022, but a dose of that was administered 09Sep2022) and NO ADVERSE EVENT (No Adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 09-Sep-2022 at 10:00 AM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Sep-2022 at 10:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose given from a vial punctured more than 12 hours ago). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was opened on 10Aug2022, but a dose of that was administered 09Sep2022) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose given from a vial punctured more than 12 hours ago), PRODUCT STORAGE ERROR (The vial was opened on 10Aug2022, but a dose of that was administered 09Sep2022) 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 (Dose given from a vial punctured more than 12 hours ago) and PRODUCT STORAGE ERROR (The vial was opened on 10Aug2022, but a dose of that was administered 09Sep2022).    Concomitant product use was not provided by the reporter.  The vial was opened on 10-Aug-2022 and was first punctured at 09 AM and administered dose on 09-Sep-2022 at 10 AM. The vial was stored in fridge post puncture. The vial did not undergo any temperature excursions. The vial was exposed to room temperature range (8° to 25°C - 46° to 77°F) for 30 minutes.  Pharmacist does know that more than 12 hours elapsed and after that time at least one patient received the Moderna Monovalent Covid-19 vaccine more than 12 hours post puncture.  The patient received the dose from a vial punctured more than 12 hours ago.  Treatment information was not provided.
Age: 89.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Bone pain, COVID-19 immunisation, Interchange of vaccine products
Clinical narrative: interchange of vaccine products; Revaccination with different COVID-19 vaccine; I started having pain in my shoulder & it goes down my arm; It's like pain in my bone; This spontaneous case was reported by a patient and describes the occurrence of BONE PAIN (It's like pain in my bone), INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and ARTHRALGIA (I started having pain in my shoulder & it goes down my arm) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 prophylaxis.    No Medical History information was reported.   In September 2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. In November 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2022, the patient experienced BONE PAIN (It's like pain in my bone) and ARTHRALGIA (I started having pain in my shoulder & it goes down my arm). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine). At the time of the report, BONE PAIN (It's like pain in my bone) and ARTHRALGIA (I started having pain in my shoulder & it goes down my arm) had not resolved and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) outcome was unknown.            Past medical history and allergies (medications, food and other products) were unknown. It was unknown if patient ever had COVID positive test or diagnosis. Hx relating to mentioned AE and both acute and chronic illnesses at the time of vaccination were unknown.   No concomitant medication information was provided.  Patient started having pain in my shoulder & it went down the arm. It was like pain in the bone.Patient was afraid it might go into the back.  It was reported that symptoms were worsened.  No treatment medication was provided.  It was unknown if the AE caused patient to seek medical care (office visit, Urgent care, ER, hospitalized).It was unknown if the patient experienced a similar event in the past.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient received the second dose on day 23; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose on day 23) and NO ADVERSE EVENT (No adverse event) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS1412B and AS1412B) for COVID-19 vaccination.     No Medical History information was reported.   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) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose on day 23) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose on day 23) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose on day 23).    Concomitant drugs were not reported. It was reported that first and second dose had the same Lot numbers. Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-643385 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-643385:(Case For WB Patient)
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: little bit achiness; little bit sore arm; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (little bit achiness) and PAIN IN EXTREMITY (little bit sore arm) in a female patient of an unknown age who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Sep-2022, the patient received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (little bit achiness) and PAIN IN EXTREMITY (little bit sore arm). At the time of the report, PAIN (little bit achiness) and PAIN IN EXTREMITY (little bit sore arm) outcome was unknown.        For mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reporter. The patient received the Moderna Bivalent Booster dose last evening. On an unknown date in Sep-2022, the patient had a little bit sore arm and a little bit achiness. No treatment medications was reporter.
Sex: F
Vaccine: COVID19
Symptoms: Product administered at inappropriate site, Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site urticaria
Clinical narrative: the pharmacist who administered the vaccine injected it in the middle of her arm and not on the shoulder; Hot injection site; Itches; Welt on the injection site, a dollar size which progressed to like an apple size; Hard injection site; Red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (welt on the injection site, a dollar size which progressed to like an apple size), VACCINATION SITE INDURATION (hard injection site), VACCINATION SITE WARMTH (hot injection site), VACCINATION SITE PRURITUS (itches) and VACCINATION SITE ERYTHEMA (red) in a female patient of an unknown age who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Sep-2022, the patient received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2022, the patient experienced VACCINATION SITE URTICARIA (welt on the injection site, a dollar size which progressed to like an apple size), VACCINATION SITE INDURATION (hard injection site), VACCINATION SITE WARMTH (hot injection site), VACCINATION SITE PRURITUS (itches) and VACCINATION SITE ERYTHEMA (red). On 06-Sep-2022, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (the pharmacist who administered the vaccine injected it in the middle of her arm and not on the shoulder). At the time of the report, VACCINATION SITE URTICARIA (welt on the injection site, a dollar size which progressed to like an apple size), VACCINATION SITE INDURATION (hard injection site), VACCINATION SITE WARMTH (hot injection site) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (the pharmacist who administered the vaccine injected it in the middle of her arm and not on the shoulder) outcome was unknown and VACCINATION SITE PRURITUS (itches) and VACCINATION SITE ERYTHEMA (red) had not resolved.            No concomitant medication information provided. It was reported that patient had bivalent booster dose. No treatment information provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: the pharmacist who administered the vaccine injected it in the middle of her arm and not on the shoulder; Hot injection site; Itches; Welt on the injection site, a dollar size which progressed to like an apple size; Hard injection site; Red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (welt on the injection site, a dollar size which progressed to like an apple size), VACCINATION SITE INDURATION (hard injection site), VACCINATION SITE WARMTH (hot injection site), VACCINATION SITE PRURITUS (itches) and VACCINATION SITE ERYTHEMA (red) in a female patient of an unknown age who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Sep-2022, the patient received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2022, the patient experienced VACCINATION SITE URTICARIA (welt on the injection site, a dollar size which progressed to like an apple size), VACCINATION SITE INDURATION (hard injection site), VACCINATION SITE WARMTH (hot injection site), VACCINATION SITE PRURITUS (itches) and VACCINATION SITE ERYTHEMA (red). On 06-Sep-2022, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (the pharmacist who administered the vaccine injected it in the middle of her arm and not on the shoulder). At the time of the report, VACCINATION SITE URTICARIA (welt on the injection site, a dollar size which progressed to like an apple size), VACCINATION SITE INDURATION (hard injection site), VACCINATION SITE WARMTH (hot injection site) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (the pharmacist who administered the vaccine injected it in the middle of her arm and not on the shoulder) outcome was unknown and VACCINATION SITE PRURITUS (itches) and VACCINATION SITE ERYTHEMA (red) had not resolved.            No concomitant medication information provided. It was reported that patient had bivalent booster dose. No treatment information provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Muscle discomfort, Vaccination site pain
Clinical narrative: just a little woozy or weary.; irritation in the muscle; just a little woozy or weary.; On site achiness; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (just a little woozy or weary.), MUSCLE DISCOMFORT (irritation in the muscle), FATIGUE (just a little woozy or weary.) and VACCINATION SITE PAIN (On site achiness) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included Sensitization (to things put in the system).    On an unknown date, the patient received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (just a little woozy or weary.), MUSCLE DISCOMFORT (irritation in the muscle), FATIGUE (just a little woozy or weary.) and VACCINATION SITE PAIN (On site achiness). At the time of the report, DIZZINESS (just a little woozy or weary.) and FATIGUE (just a little woozy or weary.) outcome was unknown and MUSCLE DISCOMFORT (irritation in the muscle) and VACCINATION SITE PAIN (On site achiness) had resolved.            No concomitant medication was provided by reporter.  Patient got the Moderna booster 3 times. Patient didn't have too much ill effect. Patient was trying to schedule medical appointments after and want it to be effective. Patient was an older person. Patient was highly sensitive to things put in the system.  No treatment medication was provided by reporter.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: No adverse event; A dose of the Moderna Covid-19 vaccine was given with a shorter than recommended needle.; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (A dose of the Moderna Covid-19 vaccine was given with a shorter than recommended needle.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Sep-2022, the patient received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Sep-2022, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (A dose of the Moderna Covid-19 vaccine was given with a shorter than recommended needle.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (A dose of the Moderna Covid-19 vaccine was given with a shorter than recommended needle.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (A dose of the Moderna Covid-19 vaccine was given with a shorter than recommended needle.).    No concomitant medications were reported.   No treatment details were reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Headache, Immunisation reaction
Clinical narrative: very bad reaction; very bad headache; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (very bad reaction) and HEADACHE (very bad headache) in an elderly female patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Sep-2022, the patient received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (very bad reaction) and HEADACHE (very bad headache). At the time of the report, IMMUNISATION REACTION (very bad reaction) outcome was unknown and HEADACHE (very bad headache) had not resolved.            No concomitant medication was reported.  It was reported that the patient got omicron. On an unknown date in Sep-2022, the patient had a very bad reaction and had a very bad headache that won't go away with the migraine medicine (unspecified).   This case was linked to MOD-2022-643411 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: She had no problem with the COVID19 vaccines other than a sore injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (She had no problem with the COVID19 vaccines other than a sore injection site) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (She had no problem with the COVID19 vaccines other than a sore injection site). At the time of the report, VACCINATION SITE PAIN (She had no problem with the COVID19 vaccines other than a sore injection site) outcome was unknown.            No concomitant product use was provided. No treatment medication was provided.   This case was linked to MOD-2022-643408 (Patient Link).   Reporter did not allow further contact
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: vaccine was given after the 30 day beyond use date; No adverse event; vaccine was given after the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine was given after the 30 day beyond use date), PRODUCT STORAGE ERROR (vaccine was given after the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) in a 33-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 052B22A and 059A22A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Aug-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 07-Sep-2022, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 07-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine was given after the 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine was given after the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine was given after the 30 day beyond use date), PRODUCT STORAGE ERROR (vaccine was given after the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (vaccine was given after the 30 day beyond use date) and PRODUCT STORAGE ERROR (vaccine was given after the 30 day beyond use date).    No Concomitant medications were provided.  It was reported that the second dose of the vaccine was given after the 30 day beyond use date. That patient had not reported any symptoms. No additional doses were administered in response at that time. Patient received Monovalent product from Individual vial with vial size of 5.5 mL. Vial was initially stored in the refrigerator on 6 Aug 2022 and did not undergo temperature excursions.  No treatment medications were provided.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test, Streptococcus test
Clinical narrative: sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 58-year-old male patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. No acute illness at the time of vaccination.  The patient's past medical history included COVID-19 (felt really bad, achy, had a headache and dry cough. Tested positive in last days of Jun-2022) from June 2022 to 2022 and Streptococcal infection in 2022. Concurrent medical conditions included Allergy to antibiotic (Macrolide antibiotic) and Blood pressure abnormal. Concomitant products included LOSARTAN POTASSIUM for Blood pressure abnormal.    On 08-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2022, SARS-CoV-2 test: (Positive) Tested positive in last days of Jun-2022. In 2022, Streptococcus test: (Positive) Positive.         It was reported that the patient tested positive for COVID-19 and Streptococcus after receiving some of the Moderna COVID-19 vaccines.  It was reported that patient received 5 doses of the Moderna COVID-19 Vaccine, the primary series 2 and 3 boosters.  The patient felt really bad, achy, had a headache and dry cough and then tested positive for COVID-19 and Streptococcus. The patient was diagnosed with COVID-19 on the last days of Jun-2022.The major symptoms lasted a few days, then the patient just had a dry cough.  Sore arm had not caused the patient to seek medical care and patient had not experienced a similar event in the past. The patient had not experienced a similar event in the past. Patient experienced sore arm in sep-2022 and resolved in sep-2022. Patient took antivirals and antibiotics as treatment.   This case was linked to MOD-2022-643462 (Patient Link).
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Mechanical urticaria
Clinical narrative: diagnosed with a skin condition dermatographia; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MECHANICAL URTICARIA (diagnosed with a skin condition dermatographia) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MECHANICAL URTICARIA (diagnosed with a skin condition dermatographia). At the time of the report, MECHANICAL URTICARIA (diagnosed with a skin condition dermatographia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not reported by the reporter.  She got a skin condition that came all down her neck after receiving the vaccine.  Patient was prescribed an antihistamine, to help with the skin condition.   This case was linked to US-MODERNATX, INC.-MOD-2022-643383 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-643383:MOD22-023007(Mother's Case)
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for COVID; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (tested positive for COVID) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Aug-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 22-Aug-2022, the patient experienced COVID-19 (tested positive for COVID). At the time of the report, COVID-19 (tested positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Aug-2022, SARS-CoV-2 test: (Positive) positive at-home test.         Patient did not have any allergic condition. Concomitant medication details were not reported by the reporter. On 17-AUG-2022, patient received second booster dose of Moderna COVID-19 vaccine. After that, he was having cough and nasal congestion (symptoms of COVID-19). Patient did not received other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Treatment details was not reported by the reporter.  Company comment: This spontaneous case concerns a 65-year-old male patient with no medical history reported, who experienced the unexpected non serious AESI of COVID-19, which occurred 5 days after fourth dose (reported as secondary booster) of mRNA-1273 vaccine. SARS-CoV-2 test was positive 5 days after fourth dose (reported as secondary booster) of mRNA-1273 vaccine. Patient experienced cough and nasal congestion. No further information on clinical course and treatment received was available in the report. The outcome of the events is unknown. Ongoing pandemic of Covid-19 remains as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a 65-year-old male patient with no medical history reported, who experienced the unexpected non serious AESI of COVID-19, which occurred 5 days after fourth dose (reported as secondary booster) of mRNA-1273 vaccine. SARS-CoV-2 test was positive 5 days after fourth dose (reported as secondary booster) of mRNA-1273 vaccine. Patient experienced cough and nasal congestion. No further information on clinical course and treatment received was available in the report. The outcome of the events is unknown. Ongoing pandemic of Covid-19 remains as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Sneezing
Clinical narrative: Tested positive for Covid-19/Mild Covid-19 symptoms; "only experienced sneezes" while being positive; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive for Covid-19/Mild Covid-19 symptoms) and SNEEZING ("only experienced sneezes" while being positive) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced COVID-19 (Tested positive for Covid-19/Mild Covid-19 symptoms) and SNEEZING ("only experienced sneezes" while being positive). At the time of the report, COVID-19 (Tested positive for Covid-19/Mild Covid-19 symptoms) and SNEEZING ("only experienced sneezes" while being positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: (Positive) Positive.         The concomitant medication was not reported by reporter. Patient received Moderna 2nd booster Covid-19 vaccine in Apr-2022. Patient explained that 6 weeks later, patient tested positive for Covid-19 vaccine and had mild symptoms and only experienced sneezes while being positive. Patient called because in Oct-2022 was 6 months since 2nd booster and patient asked if patient could get a 3rd booster dose. The treatment medication was not reported by reporter.  Company Comment: This is a spontaneous case concerning a 75 year-old, male patient with no reported medical history, who experienced the non-serious unexpected, AESI of COVID-19, approximately 6 weeks after the second booster dose of mRNA-1273 vaccine. It was reported the patient tested positive for COVID-19 (without other details) and had mild COVID-19 symptoms such as sneezing. The outcome was reported as unknown. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: Company Comment: This is a spontaneous case concerning a 75 year-old, male patient with no reported medical history, who experienced the non-serious unexpected, AESI of COVID-19, approximately 6 weeks after the second booster dose of mRNA-1273 vaccine. It was reported the patient tested positive for COVID-19 (without other details) and had mild COVID-19 symptoms such as sneezing. The outcome was reported as unknown. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Vaccination site pain
Clinical narrative: pain; tenderness at the injection site; general fatigue; This spontaneous case was reported by a patient and describes the occurrence of PAIN (pain), VACCINATION SITE PAIN (tenderness at the injection site) and FATIGUE (general fatigue) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017S21A, 036B21A and 007B21A) for COVID-19 vaccination.     The patient has not ever tested or diagnosed with COVID.  Medical history relating to mentioned event and both acute and chronic illnesses at the time of vaccination were none.  Patient did not take other vaccines within 1 month prior to moderna COVID-19 vaccine.  Concurrent medical conditions included Penicillin allergy and Allergy to antibiotic (Ceftin).   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (pain), VACCINATION SITE PAIN (tenderness at the injection site) and FATIGUE (general fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (pain), VACCINATION SITE PAIN (tenderness at the injection site) and FATIGUE (general fatigue) had resolved.            No concomitant medication was provided.  patient did not seek medical care  It was reported that the patient experienced similar event in past ( last vaccination).   It was reported that the symptoms were improved.   This case was linked to MOD-2022-643547 (Patient Link).
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Little pain on the side of the injection; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (Little pain on the side of the injection) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Sep-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Little pain on the side of the injection). At the time of the report, VACCINATION SITE PAIN (Little pain on the side of the injection) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the booster dose administered by patient was not a bivalent vaccine and was no longer authorized for this indication. No concomitant medications were reported. No treatment details were reported.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Myalgia, Rhinorrhoea
Clinical narrative: had body aches all day off; Had Runny nose and has been coughing; Had Runny nose and has been coughing; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (had body aches all day off), COUGH (Had Runny nose and has been coughing) and RHINORRHOEA (Had Runny nose and has been coughing) in an 81-year-old male patient who received mRNA-1273 (MODERNA COVID-19 VACCINE, (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 vaccination.     No Medical History information was reported.        No concomitant medication were reported.  It was reported that patient was still considered taking another dose of treatment medication.