chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Patient received a 0.3mL dose of the Moderna COVID-19 vaccine BIVALENT by intramuscular injection instead of the recommended 0.5mL dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received a 0.3mL dose of the Moderna COVID-19 vaccine BIVALENT by intramuscular injection instead of the recommended 0.5mL dose) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.   In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .3 milliliter. In 2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient received a 0.3mL dose of the Moderna COVID-19 vaccine BIVALENT by intramuscular injection instead of the recommended 0.5mL dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received a 0.3mL dose of the Moderna COVID-19 vaccine BIVALENT by intramuscular injection instead of the recommended 0.5mL 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 ACCIDENTAL UNDERDOSE (Patient received a 0.3mL dose of the Moderna COVID-19 vaccine BIVALENT by intramuscular injection instead of the recommended 0.5mL dose).    Concomitant drugs were not reported.  It was reported that administrations occurred over the course of approximately 1 month. Patient had no reported symptoms, no additional doses or treatments.   This case was linked to US-MODERNATX, INC.-MOD-2022-682550, US-MODERNATX, INC.-MOD-2022-682547, US-MODERNATX, INC.-MOD-2022-682544 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-682550:same reporter US-MODERNATX, INC.-MOD-2022-682544:same reporter US-MODERNATX, INC.-MOD-2022-682547:same reporter
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: patient received a 0.3mL dose of the Moderna COVID-19 vaccine BIVALENT by intramuscular injection instead of the recommended 0.5mL dose; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (patient received a 0.3mL dose of the Moderna COVID-19 vaccine BIVALENT by intramuscular injection instead of the recommended 0.5mL dose) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 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) .3 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (patient received a 0.3mL dose of the Moderna COVID-19 vaccine BIVALENT by intramuscular injection instead of the recommended 0.5mL dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (patient received a 0.3mL dose of the Moderna COVID-19 vaccine BIVALENT by intramuscular injection instead of the recommended 0.5mL 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 ACCIDENTAL UNDERDOSE (patient received a 0.3mL dose of the Moderna COVID-19 vaccine BIVALENT by intramuscular injection instead of the recommended 0.5mL dose).    Concomitant product use was not provided by the reporter.  It was reported that administrations occurred over the course of approximately 1 month.  The patient had no reported symptoms, no additional doses.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-682550, US-MODERNATX, INC.-MOD-2022-682544, US-MODERNATX, INC.-MOD-2022-682546, US-MODERNATX, INC.-MOD-2022-682548 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-682550:same reporter US-MODERNATX, INC.-MOD-2022-682544:same reporter US-MODERNATX, INC.-MOD-2022-682546:same reporter US-MODERNATX, INC.-MOD-2022-682548:same reporter
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; patient received a 0.3mL dose of the Moderna COVID-19 vaccine BIVALENT by intramuscular injection instead of the recommended 0.5mL dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (patient received a 0.3mL dose of the Moderna COVID-19 vaccine BIVALENT by intramuscular injection instead of the recommended 0.5mL dose) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .3 milliliter. In 2022, the patient experienced ACCIDENTAL UNDERDOSE (patient received a 0.3mL dose of the Moderna COVID-19 vaccine BIVALENT by intramuscular injection instead of the recommended 0.5mL dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (patient received a 0.3mL dose of the Moderna COVID-19 vaccine BIVALENT by intramuscular injection instead of the recommended 0.5mL 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 ACCIDENTAL UNDERDOSE (patient received a 0.3mL dose of the Moderna COVID-19 vaccine BIVALENT by intramuscular injection instead of the recommended 0.5mL dose).    Concomitant drugs were not reported. It was reported that administrations occurred over the course of approximately 1 month. Patient had no reported symptoms, no additional doses or treatments.   This case was linked to US-MODERNATX, INC.-MOD-2022-682544, US-MODERNATX, INC.-MOD-2022-682546, US-MODERNATX, INC.-MOD-2022-682547, US-MODERNATX, INC.-MOD-2022-682548 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-682544:same reporter US-MODERNATX, INC.-MOD-2022-682546:same reporter US-MODERNATX, INC.-MOD-2022-682547:same reporter US-MODERNATX, INC.-MOD-2022-682548:same reporter
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; One of the facilities administered 0.25mL from the red cap Moderna Covid-19 Vaccine (monovalent) formula as a booster dose, instead of the Moderna Covid-19 Vaccine, Bivalent.; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (One of the facilities administered 0.25mL from the red cap Moderna Covid-19 Vaccine (monovalent) formula as a booster dose, instead of the Moderna Covid-19 Vaccine, Bivalent.) 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 prophylaxis.     No Medical History information was reported.    On 02-Dec-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Dec-2022, the patient experienced WRONG PRODUCT ADMINISTERED (One of the facilities administered 0.25mL from the red cap Moderna Covid-19 Vaccine (monovalent) formula as a booster dose, instead of the Moderna Covid-19 Vaccine, Bivalent.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (One of the facilities administered 0.25mL from the red cap Moderna Covid-19 Vaccine (monovalent) formula as a booster dose, instead of the Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (One of the facilities administered 0.25mL from the red cap Moderna Covid-19 Vaccine (monovalent) formula as a booster dose, instead of the Moderna Covid-19 Vaccine, Bivalent.).    The concomitant medication was not reported by reporter. The treatment medication was not reported by reporter.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Dose administered after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) in a 29-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 013B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Dec-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 01-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry).    No concomitant medication was reported.    Date the vial was initially stored in the refrigerator on 01-Dec-2022. Vial size was 5.5mL.The vial did not undergo any temperature excursions. Manufacturer date of expiration given as 22-NOV-2022.  No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: didn't do well; This spontaneous case was reported by a nurse and describes the occurrence of MALAISE (didn't do well) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (didn't do well). At the time of the report, MALAISE (didn't do well) outcome was unknown.      The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Nurse as a patient stated she only received one dose of the primary series and she did not do well and did not want to received another dose but would like to receive a bivalent dose.   No treatment medications were reported.   Reporter did not allow further contact
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Interchange of vaccine products, No adverse event
Clinical narrative: no adverse event; patient received expired Moderna Covid-19 monovalent vaccine; patient received a mixed series for his primary vaccine dose, The patient received Pfizer for for his first dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received expired Moderna Covid-19 monovalent vaccine), INTERCHANGE OF VACCINE PRODUCTS (patient received a mixed series for his primary vaccine dose, The patient received Pfizer for for his first dose) and NO ADVERSE EVENT (no adverse event) in a 36-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 051B22A) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (First dose) on 24-Jun-2022. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE.    On 02-Dec-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 02-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received expired Moderna Covid-19 monovalent vaccine) and INTERCHANGE OF VACCINE PRODUCTS (patient received a mixed series for his primary vaccine dose, The patient received Pfizer for for his first dose). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received expired Moderna Covid-19 monovalent vaccine), INTERCHANGE OF VACCINE PRODUCTS (patient received a mixed series for his primary vaccine dose, The patient received Pfizer for for his first dose) 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 (patient received expired Moderna Covid-19 monovalent vaccine) and INTERCHANGE OF VACCINE PRODUCTS (patient received a mixed series for his primary vaccine dose, The patient received Pfizer for for his first dose).    Concomitant product use was not provided by the reporter.  The patient received a mixed series for his primary vaccine dose. More than 35 days had passed in between Moderna Primary Series Covid-19 vaccines.  The patient received expired Moderna Covid-19 monovalent vaccine for his second dose of the Moderna Covid-19 vaccine primary series.  Treatment information was not provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Patient was diagnosed with covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Patient was diagnosed with covid) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A22B, 058E21A, 028L20A and 025J20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Cancer (Patient was on cancer medications from the last two dose.) since 2021. Concomitant products included ANASTROZOLE for Cancer, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN POTASSIUM/HCTZ), PRAVASTATIN SODIUM (PRAVACHOL) and ESCITALOPRAM for an unknown indication.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jun-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 experienced COVID-19 (Patient was diagnosed with covid). The patient was treated with MOLNUPIRAVIR for COVID-19, at a dose of 800 milligram every twelve hours. At the time of the report, COVID-19 (Patient was diagnosed with covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.         Concomitant medications included cancer medications.   This case was linked to MOD-2022-682627 (Patient Link).
Age: 25.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; an employee received Moderna Covid Vaccine, Bivalent, instead of Moderna Covid-19 Vaccine Monovalent for the 2nd dose of the primary series.; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (an employee received Moderna Covid Vaccine, Bivalent, instead of Moderna Covid-19 Vaccine Monovalent for the 2nd dose of the primary series.) and NO ADVERSE EVENT (No adverse event) in a 25-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. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Dec-2022, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 02-Dec-2022, the patient experienced WRONG PRODUCT ADMINISTERED (an employee received Moderna Covid Vaccine, Bivalent, instead of Moderna Covid-19 Vaccine Monovalent for the 2nd dose of the primary series.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (an employee received Moderna Covid Vaccine, Bivalent, instead of Moderna Covid-19 Vaccine Monovalent for the 2nd dose of the 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 assessment was provided for WRONG PRODUCT ADMINISTERED (an employee received Moderna Covid Vaccine, Bivalent, instead of Moderna Covid-19 Vaccine Monovalent for the 2nd dose of the primary series.).    No concomitant medications was reported. No treatment medications was reported.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no adverse event; Patient accidentally received 2 doses of bivalent booster 3 weeks apart; This spontaneous case was reported by an other health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient accidentally received 2 doses of bivalent booster 3 weeks apart) and NO ADVERSE EVENT (no adverse event) in a 60-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 016H22A and 021H22A) for COVID-19 vaccination.     The patient had no allergies. The patient had no acute and chronic illnesses at the time of vaccination.    On 10-Nov-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 01-Dec-2022, received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXTRA DOSE ADMINISTERED (Patient accidentally received 2 doses of bivalent booster 3 weeks apart). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Patient accidentally received 2 doses of bivalent booster 3 weeks apart) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (Patient accidentally received 2 doses of bivalent booster 3 weeks apart).    No concomitant medications were reported.  The patient never had COVID positive test or diagnosis. The patient did not receive any other vaccines within 1 month prior to Moderna COVID-19 vaccine. On 21-Mar-2021, the patient received the 1st dose of Moderna COVID-19 vaccine (lot number: 037A20A). On 19-Apr-2021, the patient received the 2nd dose of Moderna COVID-19 vaccine (lot number: 016B21A).  On 04-Nov-2021, the patient received the 1st booster dose of Moderna COVID-19 vaccine (lot number: 039D21A).  On 25-May-2022, the patient received the 2nd booster dose of Moderna COVID-19 vaccine (lot number: 054A22A). On 10-Nov-2022, the patient received the 1st Booster dose of Moderna COVID-19 vaccine, Bivalent. On 01-Dec-2022,  the patient received the 2nd Booster dose of Moderna COVID-19 vaccine, Bivalent.  It was unknown if any treatment was given to patient.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Mass, Nausea, Pain, Pain in extremity
Clinical narrative: Swelling; Got very sick after third covid-19 booster; Achy; Sore arm; Big lump; Fever; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling), IMMUNISATION REACTION (Got very sick after third covid-19 booster), PAIN (Achy), PAIN IN EXTREMITY (Sore arm) and MASS (Big lump) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe).   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40MG/0.4ML cf. In 2021, the patient experienced PAIN (Achy), PAIN IN EXTREMITY (Sore arm), MASS (Big lump), PYREXIA (Fever) and NAUSEA (Nauseous). On an unknown date, the patient experienced SWELLING (Swelling) and IMMUNISATION REACTION (Got very sick after third covid-19 booster). At the time of the report, SWELLING (Swelling) had not resolved and IMMUNISATION REACTION (Got very sick after third covid-19 booster), PAIN (Achy), PAIN IN EXTREMITY (Sore arm), MASS (Big lump), PYREXIA (Fever) and NAUSEA (Nauseous) outcome was unknown.            Concomitant medications were not reported.  All doses of Moderna COVID-19 vaccine were taken one in once with ID.  Humira 40mg/0.4ml solution for injection was single dose pen with citrate free (CF) daily dose.  The reporter's causality for the events of fever, achy, big lump, got very sick after third covid-19 booster, nauseous, sore arm and swelling with Humira (Adalimumab solution for injection) were not provided. AbbVie's opinion on the causality for the events of fever, achy, big lump, got very sick after third covid-19 booster, nauseous, sore arm and swelling with Humira (Adalimumab solution for injection) and Moderna COVID-19 vaccine were not provided. No treatment information was provided.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swelling
Clinical narrative: Swelling; Got very sick after third covid-19 booster; Achy; Sore arm; Big lump; Fever; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling), IMMUNISATION REACTION (Got very sick after third covid-19 booster), PAIN (Achy), PAIN IN EXTREMITY (Sore arm) and MASS (Big lump) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe).   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40MG/0.4ML cf. In 2021, the patient experienced PAIN (Achy), PAIN IN EXTREMITY (Sore arm), MASS (Big lump), PYREXIA (Fever) and NAUSEA (Nauseous). On an unknown date, the patient experienced SWELLING (Swelling) and IMMUNISATION REACTION (Got very sick after third covid-19 booster). At the time of the report, SWELLING (Swelling) had not resolved and IMMUNISATION REACTION (Got very sick after third covid-19 booster), PAIN (Achy), PAIN IN EXTREMITY (Sore arm), MASS (Big lump), PYREXIA (Fever) and NAUSEA (Nauseous) outcome was unknown.            Concomitant medications were not reported.  All doses of Moderna COVID-19 vaccine were taken one in once with ID.  Humira 40mg/0.4ml solution for injection was single dose pen with citrate free (CF) daily dose.  The reporter's causality for the events of fever, achy, big lump, got very sick after third covid-19 booster, nauseous, sore arm and swelling with Humira (Adalimumab solution for injection) were not provided. AbbVie's opinion on the causality for the events of fever, achy, big lump, got very sick after third covid-19 booster, nauseous, sore arm and swelling with Humira (Adalimumab solution for injection) and Moderna COVID-19 vaccine were not provided. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No Adverse event; Patient may have gotten the monovalent Moderna booster after the Bivalent vaccine was authorized/nurse swore that it was not the Moderna Bivalent booster at the time of administration; This spontaneous case was reported by a patient family member or friend and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient may have gotten the monovalent Moderna booster after the Bivalent vaccine was authorized/nurse swore that it was not the Moderna Bivalent booster at the time of administration) and NO ADVERSE EVENT (No Adverse event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient may have gotten the monovalent Moderna booster after the Bivalent vaccine was authorized/nurse swore that it was not the Moderna Bivalent booster at the time of administration). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient may have gotten the monovalent Moderna booster after the Bivalent vaccine was authorized/nurse swore that it was not the Moderna Bivalent booster at the time of administration) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.            No concomitant drug was reported.  Reporter stated that there was some confusion when the vaccine was given on 02-Sep-2022. Reporter had a heated discussion with the vaccination facility but they could not really tell them specifically.  Reporter stated the vaccine facility told them after 01-Sep-2022 that was all they were administering would be the Moderna Bivalent booster. The nurse who administered the vaccine at the time did not put that on the card, nurse swore that was not the Moderna Bivalent booster at the time of administration.  Reporter was speaking on behalf of his mother who might or might not received the Moderna bivalent booster dose.  Patient was told not to wait to get the Bivalent and to get whatever vaccine the facility had they had. Patient might have gotten the monovalent Moderna booster after the Bivalent vaccine was authorized. Reporter further stated that if they did not find out which vaccine their mother received they might need to give them another Bivalent booster dose (potentially receiving two Bivalent booster doses).  No treatment drug was reported.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash; This spontaneous case was reported by a nurse and describes the occurrence of RASH (rash) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 immunization.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (rash). At the time of the report, RASH (rash) outcome was unknown.      The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication not reported. Treatment medication not reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: had the Moderna vaccine, came down with Covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (had the Moderna vaccine, came down with Covid) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (had the Moderna vaccine, came down with Covid). At the time of the report, COVID-19 (had the Moderna vaccine, came down with Covid) outcome was unknown.            No concomitant medications were reported. Patient had COVID Friday night, woke up Saturday had just felt like having cold and a week later still felt like just had a cold, never got sick. Patient had the Moderna vaccine, 2 shots and 2 boosters, total of 4 doses. Patient was going to get 3rd booster, but became positive before getting 3rd booster. No treatment information was provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Experienced those issues because of the ingredients of the vaccine; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Experienced those issues because of the ingredients of the 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 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 06-Dec-2022, the patient experienced IMMUNISATION REACTION (Experienced those issues because of the ingredients of the vaccine). At the time of the report, IMMUNISATION REACTION (Experienced those issues because of the ingredients of the vaccine) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.    Patient mentioned that patient would not receive any other dose in future.   No treatment information was provided.   This case was linked to MOD-2022-648041 (Patient Link).   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose, Incorrect dose administered, No adverse event
Clinical narrative: Nurse is calling to report that 3 adult patients received Monovalent booster from a pediatric 6y-11y vial NDC 80777-0275-05 (0.5ml; Nurse is calling to report that 3 adult patients received Monovalent booster from a pediatric 6y-11y vial NDC 80777-0275-05 (0.5ml); No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of INCORRECT DOSE ADMINISTERED (Nurse is calling to report that 3 adult patients received Monovalent booster from a pediatric 6y-11y vial NDC 80777-0275-05 (0.5ml), ACCIDENTAL OVERDOSE (Nurse is calling to report that 3 adult patients received Monovalent booster from a pediatric 6y-11y vial NDC 80777-0275-05 (0.5ml)) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018C22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 05-Dec-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (Nurse is calling to report that 3 adult patients received Monovalent booster from a pediatric 6y-11y vial NDC 80777-0275-05 (0.5ml), ACCIDENTAL OVERDOSE (Nurse is calling to report that 3 adult patients received Monovalent booster from a pediatric 6y-11y vial NDC 80777-0275-05 (0.5ml)) and NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Nurse is calling to report that 3 adult patients received Monovalent booster from a pediatric 6y-11y vial NDC 80777-0275-05 (0.5ml), ACCIDENTAL OVERDOSE (Nurse is calling to report that 3 adult patients received Monovalent booster from a pediatric 6y-11y vial NDC 80777-0275-05 (0.5ml)) 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 INCORRECT DOSE ADMINISTERED (Nurse is calling to report that 3 adult patients received Monovalent booster from a pediatric 6y-11y vial NDC 80777-0275-05 (0.5ml) and ACCIDENTAL OVERDOSE (Nurse is calling to report that 3 adult patients received Monovalent booster from a pediatric 6y-11y vial NDC 80777-0275-05 (0.5ml)).    No concomitant medications were reported. The nurse told that the product was in the refrigerator less than 30 days.There was no prior temperature excursion. No treatment medications were reported.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PROBIOTICS; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22Nov2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: indication=Treatment of COVID-19; (22Nov2022) Positive, notes: Tested positive 22Nov; (28Nov2022) Negative, notes: Tested negative 28Nov; (30Nov2022) Positive, notes: Tested negative 30Nov. Therapeutic measures were taken as a result of drug ineffective, covid-19. Product COVID 19 Treatment brand was Paxlovid with treatment start date-22Nov2022 and treatment stop date-27Nov2022. Tested positive 22Nov. Took full Paxlovid course as directed. Tested negative 28Nov. Tested positive 30Nov.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I got COVID a couple days ago/ When I tested positive on Tuesday; I got COVID a couple days ago/ When I tested positive on Tuesday; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "I got COVID a couple days ago/ When I tested positive on Tuesday". The patient underwent the following laboratory tests and procedures: Body temperature: 101; SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: Caller mentioned that he already took the 5 doses of Pfizer covid 19 vaccine and now he was taking Paxlovid pill. Caller asked if the anti-bodies were still on his body. Caller stated, he got COVID a couple days ago. The symptoms were mild. He was exposed on Saturday through Sunday. He got it from his girlfriend. She came down with symptoms on Sunday. He came down with symptoms on Tuesday, which was 3 days after his first exposure. When he tested positive on Tuesday, his doctor prescribed Paxlovid. That evening he had a fever 101. He woke up Wednesday, morning but the fever was gone, no runny nose, no sore throat. Since he took Paxlovid early on in the cycle, he was trying to find out did the antibodies short circuit. Asked if the antibodies stop the antiviral process or not. The antiviral might have screwed up his antibody production. Caller asked how he will know how long to wait to receive his next booster dose. He asked should he do his COVID infection as his start date or does he use the date of his last vaccine dose.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: always get a sore arm where I get the shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), as dose 2, 0.3 ml single (Lot number: EN6203, Expiration Date: 30Jun2021), in arm for covid-19 immunisation. The patient's relevant medical history included: "hip replacement" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin for hip replacement, notes: she had to go to her dentist and had to take amoxicillin due to history of a hip replacement. Vaccination history included: Bnt162b2 (1st dose: Says Pfizer BioNTech COVID-19 vaccine 30mcg/0.3mL , Lot number: EN5318 , Expiration date: 31May2021 , NDC number: Unknown), for COVID-19 immunization, reaction(s): "always get a sore arm where I get the shot". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "always get a sore arm where I get the shot".  Additional Information: Reporter had hip replacement and usually takes 4 antibiotics. She confirmed that her 4 prior doses were all the Pfizer BioNTech COVID-19 vaccine and mentioned that she always got a sore arm where she got the shot.  Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Prehypertension" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: CHLORTHALIDONE; PANTOPRAZOLE, start date: 15Aug2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti-viral details: Product COVID 19 Treatment; Brand Paxlovid; Treatment start date was on 21Nov2022 and treatment stopped on 26Nov2022; Indication: Treatment of COVID-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 38 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: No other medication was reported in 2 weeks.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 at 14:00 as dose 5 (booster), single (Lot number: GH9693) at the age of 67 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The patient did not receive any Other medication in 2weeks. Covid -19 was treated with Anti-viral (COVID 19 Treatment - Brand Pfizer) from 19Nov2022 to 23Nov2022.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19-2
Symptoms: Peripheral coldness, Poor peripheral circulation, Pruritus, Rash, Skin discolouration
Clinical narrative: Event 1: Poor circulation in hands and feet (they turned white and cold after washing hands in mildly cold water).   Treatment and Outcome 1: This is abnormal for me, and I simply manage it by not using cold water.  Monitoring if this becomes more severe and will seek treatment if necessary.  Event 2: after 36-37 hours I developed a rash all over my body (30-40%) similar to Poison Ivy/Oak in terms of itchiness,  and focused in areas where there is higher warmth   or rubbing (e.g. elbows, arms, backs of knees, fronts of thighs, chest).  lesser degree on my back and backs of legs) Treatment and Outcome 2: Tried Calamine lotion and provided some relief, but only marginally successful.  Monitoring and will try lotion and re-application of Calamine to provide relief.  Will seek treatment if it becomes more severe.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: I mistakenly administered COVID19 Pfizer-BioNTech Bivalent Pediatric Age 5-11 0.2mL (booster only) when the patient should have received COVID19 Pfizer-BioNTech Monovalent Pediatric Age 5-11 0.2mL. This was the patient's first dose. Both vaccines look very similar in an orange and white box, with an orange cap on both vials and bivalent being in very small font. The mother did not mention that the patient had any side effects and was only concerned that her daughter was given the wrong vaccine. I informed the mother that the patient should receive one dose of COVID19 Pfizer-BioNTech Monovalent Pediatric Age 5-11 0.2mL in 3 weeks to complete the primary series. I then informed the mother the patient can receive COVID 19 Pfizer-BioNTech Bivalent Pediatric Age 5-11 0.2mL (booster only) after 2 months. The mother expressed understanding.