chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Mobility decreased
Clinical narrative: I can only manage about 15 pounds; first dose >35 days from second dose; This spontaneous case was reported by a patient and describes the occurrence of MOBILITY DECREASED (I can only manage about 15 pounds) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose >35 days from second dose) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 01C21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose >35 days from second dose). On an unknown date, the patient experienced MOBILITY DECREASED (I can only manage about 15 pounds). At the time of the report, MOBILITY DECREASED (I can only manage about 15 pounds) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose >35 days from second dose) outcome was unknown.            No concomitant medications were reported. Prior to the first moderna vaccine patient was able to pick up 130 pounds in terms of pressing weight and patient hobby was weight lifting. After the vaccine patient could not pick up anything for close to 6 months. Patient states that the vaccine was on bicep on left arm, patient works out and was very fit. Patient had Electromyogram(EMG): Unknown result It was reported that there was some residual effects and the symptoms was improved but not 100 percent. Patient had not experienced similar events in past. As a treatment patient was taking acupuncture and aquatic therapy.   This case was linked to MOD-2022-644399 (Patient Link).
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: Patients received 0.25 ml of the bivalent vaccine; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patients received 0.25 ml of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a 78-year-old male patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patients received 0.25 ml of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patients received 0.25 ml of the bivalent vaccine) 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 ACCIDENTAL UNDERDOSE (Patients received 0.25 ml of the bivalent vaccine).    Concomitant product use was not provided by the reporter.  Patient was administered with Booster dose.  The patient did not experienced any side effect. Pharmacist does not know if the patient were taking other medication. HCP was not aware of incident.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-644253 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-644253:Patient - Wife Case
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: Slightly sore arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Slightly sore arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. U51PZ1A, 028A21A and 025A21A) for COVID-19 vaccination.     Concurrent medical conditions included Immune thrombocytopenic purpura (ITP, low platelet disorder for 9 years. Treatment with IVIG every 6 weeks).   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-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 VACCINATION SITE PAIN (Slightly sore arm). At the time of the report, VACCINATION SITE PAIN (Slightly sore arm) had resolved.            No concomitant medications were reported. It was reported that the patient had previous full doses of primary vaccination with Moderna. Patient did not seek medical care. Patient had experienced similar events in the past from primary vaccinations. It was reported that the symptoms were improved.   This case was linked to MOD-2022-644465 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Burning sensation, Musculoskeletal stiffness, Pain in extremity, Vaccination site discolouration
Clinical narrative: Slightly sore arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Slightly sore arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. U51PZ1A, 028A21A and 025A21A) for COVID-19 vaccination.     Concurrent medical conditions included Immune thrombocytopenic purpura (ITP, low platelet disorder for 9 years. Treatment with IVIG every 6 weeks).   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-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 VACCINATION SITE PAIN (Slightly sore arm). At the time of the report, VACCINATION SITE PAIN (Slightly sore arm) had resolved.            No concomitant medications were reported. It was reported that the patient had previous full doses of primary vaccination with Moderna. Patient did not seek medical care. Patient had experienced similar events in the past from primary vaccinations. It was reported that the symptoms were improved.   This case was linked to MOD-2022-644465 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site nerve damage, Vaccination site pain
Clinical narrative: Slightly sore arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Slightly sore arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. U51PZ1A, 028A21A and 025A21A) for COVID-19 vaccination.     Concurrent medical conditions included Immune thrombocytopenic purpura (ITP, low platelet disorder for 9 years. Treatment with IVIG every 6 weeks).   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-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 VACCINATION SITE PAIN (Slightly sore arm). At the time of the report, VACCINATION SITE PAIN (Slightly sore arm) had resolved.            No concomitant medications were reported. It was reported that the patient had previous full doses of primary vaccination with Moderna. Patient did not seek medical care. Patient had experienced similar events in the past from primary vaccinations. It was reported that the symptoms were improved.   This case was linked to MOD-2022-644465 (Patient Link).
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No Adverse event; administration error of the Moderna Covid-19 vaccine on an unauthorized age of a 10-year-old pediatric patient received his 1st dose authorized for the 12 and over age group on 19AUG2022; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administration error of the Moderna Covid-19 vaccine on an unauthorized age of a 10-year-old pediatric patient received his 1st dose authorized for the 12 and over age group on 19AUG2022) and NO ADVERSE EVENT (No Adverse event) in a 10-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 19-Aug-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administration error of the Moderna Covid-19 vaccine on an unauthorized age of a 10-year-old pediatric patient received his 1st dose authorized for the 12 and over age group on 19AUG2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administration error of the Moderna Covid-19 vaccine on an unauthorized age of a 10-year-old pediatric patient received his 1st dose authorized for the 12 and over age group on 19AUG2022) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administration error of the Moderna Covid-19 vaccine on an unauthorized age of a 10-year-old pediatric patient received his 1st dose authorized for the 12 and over age group on 19AUG2022).    Concomitant medications details were not reported by the reporter.  Treatment details were not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2022: Follow-up document contains updated patient demographics, product indication and dosing details updated accordingly, narrative updated.
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo; This spontaneous case was reported by a patient and describes the occurrence of VERTIGO (Vertigo) 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 dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced VERTIGO (Vertigo). At the time of the report, VERTIGO (Vertigo) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication was reported. Patient went to the hospital in May for Vertigo. Patient wanted to know,an increase of people reporting vertigo as a side effect after receiving the vaccine. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-644588 (E2B Linked Report). This case was linked to MOD-2021-053248 (Patient Link).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-644588:MOD-2022-644586 ( Case For Female Patient)
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: all gotten covid after receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (all gotten covid after receiving the vaccine) in a  patient of an unknown age and gender 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 COVID-19 (all gotten covid after receiving the vaccine). At the time of the report, COVID-19 (all gotten covid after receiving the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant and treatment medications were reported.  Caller stated she was preparing for the second booster dose, and she had spoken with 4 or 5 people who had COVID-19 after receiving the vaccine and even with unspecified number of people who had  vertigo after receiving the vaccine. Reporter went to the hospital in May for Vertigo and She wanted to know is there increase of people reporting vertigo as a side effect after receiving the vaccine.  Company comment: This is a spontaneous case concerning a patient of unknown age and gender with no reported medical history, who experienced the non-serious AESI COVID-19, on an unknown lapse of time after an unspecified dose of mRNA-1273. Clinical findings, course, diagnostic tests and treatment details were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-644586 (E2B Linked Report).; Sender's Comments: Company comment: This is a spontaneous case concerning a patient of unknown age and gender with no reported medical history, who experienced the non-serious AESI COVID-19, on an unknown lapse of time after an unspecified dose of mRNA-1273. Clinical findings, course, diagnostic tests and treatment details were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. US-MODERNATX, INC.-MOD-2022-644586:MOD-2022-644586 ( Case For Female Patient)
Sex: F
Vaccine: COVID19
Symptoms: Osteoarthritis, Vaccination site pain
Clinical narrative: OSTEOARTHRITIS/INCREASED OSTEOARTHRITIC; COVID VACCINE ISSUE/SORE ARM; This spontaneous case was reported by a patient and describes the occurrence of OSTEOARTHRITIS (OSTEOARTHRITIS/INCREASED OSTEOARTHRITIC) and VACCINATION SITE PAIN (COVID VACCINE ISSUE/SORE ARM) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced OSTEOARTHRITIS (OSTEOARTHRITIS/INCREASED OSTEOARTHRITIC) and VACCINATION SITE PAIN (COVID VACCINE ISSUE/SORE ARM). At the time of the report, OSTEOARTHRITIS (OSTEOARTHRITIS/INCREASED OSTEOARTHRITIC) and VACCINATION SITE PAIN (COVID VACCINE ISSUE/SORE ARM) outcome was unknown.            No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medications were reported.  The reporter's causality for the event(s) of osteoarthritis/increased osteoarthritic and COVID vaccine issue/sore arm with Rinvoq (upadacitinib) was not provided, while assessed COVID vaccine issue/sore arm as possibly related with Moderna COVID-19 vaccine.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis, Vaccination complication
Clinical narrative: REACTION/MODERNA BOOSTER VACCINE CAUSED PLAQUES TO GET WORSE; PLAQUE PSORIASIS FLARE UP ON FEET, HANDS AND SCALP; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (REACTION/MODERNA BOOSTER VACCINE CAUSED PLAQUES TO GET WORSE) and PSORIASIS (PLAQUE PSORIASIS FLARE UP ON FEET, HANDS AND SCALP) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis (Moderate to severe).   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2022, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2022, the patient experienced VACCINATION COMPLICATION (REACTION/MODERNA BOOSTER VACCINE CAUSED PLAQUES TO GET WORSE) and PSORIASIS (PLAQUE PSORIASIS FLARE UP ON FEET, HANDS AND SCALP). At the time of the report, VACCINATION COMPLICATION (REACTION/MODERNA BOOSTER VACCINE CAUSED PLAQUES TO GET WORSE) and PSORIASIS (PLAQUE PSORIASIS FLARE UP ON FEET, HANDS AND SCALP) had not resolved.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant product use was reported.   The patient had moderna booster vaccine and which caused plaques to get worse.  No treatment information was provided.  The reporter's causality for the event of reaction/moderna booster vaccine caused plaques to get worse with Skyrizi (Risankizumab) was no reasonable possibility.   The reporter's causality for the event of plaque psoriasis flare up on feet, hands and scalp with Skyrizi (Risankizumab) was a reasonable possibility.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: Patient was administered 0.25mL of Moderna Covid-19 Vaccine, Bivalent, instead of 0.5mL.; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered 0.25mL of Moderna Covid-19 Vaccine, Bivalent, instead of 0.5mL.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7144B) for COVID-19 prophylaxis.     No Medical History information was reported.    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) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered 0.25mL of Moderna Covid-19 Vaccine, Bivalent, instead of 0.5mL.) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered 0.25mL of Moderna Covid-19 Vaccine, Bivalent, instead of 0.5mL.) 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 ACCIDENTAL UNDERDOSE (Patient was administered 0.25mL of Moderna Covid-19 Vaccine, Bivalent, instead of 0.5mL.).    No concomitant medications were reported. No treatment details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-644874 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-644874:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Headache, Nasal congestion, SARS-CoV-2 test
Clinical narrative: slight cough; severe nasal congestion; headache; diagnosed with COVID in mid JUL2022; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (diagnosed with COVID in mid JUL2022), COUGH (slight cough), NASAL CONGESTION (severe nasal congestion) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2022, the patient experienced COVID-19 (diagnosed with COVID in mid JUL2022). On an unknown date, the patient experienced COUGH (slight cough), NASAL CONGESTION (severe nasal congestion) and HEADACHE (headache). At the time of the report, COVID-19 (diagnosed with COVID in mid JUL2022) outcome was unknown and COUGH (slight cough), NASAL CONGESTION (severe nasal congestion) and HEADACHE (headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.         The patient was a senior citizen, in the 62-75 age group. No concomitant drug was reported. The patient had received the Moderna COVID-19 vaccine primary series as well as one booster shot.  No treatment drug was reported. it was reported that headache and cough lasted for 5 days but the nasal congestion lasted beyond 2 weeks.  Company comment: This is a spontaneous case regarding a female patient of an unknown age who received 3 doses of mRNA-1273 vaccine and experienced non serious event of COVID-19 (AESI). Vaccination dates were not provided, latency cannot be assessed. She had a headache, slight cough, and severe nasal congestion. The headache and cough lasted for 5 days but the nasal congestion lasted beyond 2 weeks. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case regarding a female patient of an unknown age who received 3 doses of mRNA-1273 vaccine and experienced non serious event of COVID-19 (AESI). Vaccination dates were not provided, latency cannot be assessed. She had a headache, slight cough, and severe nasal congestion. The headache and cough lasted for 5 days but the nasal congestion lasted beyond 2 weeks. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: Patient was administered 0.25mL of Moderna COVID-19 Vaccine, Bivalent, instead of 0.5mL; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered 0.25mL of Moderna COVID-19 Vaccine, Bivalent, instead of 0.5mL) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7144B) for COVID-19 prophylaxis.     No Medical History information was reported.    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) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered 0.25mL of Moderna COVID-19 Vaccine, Bivalent, instead of 0.5mL) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered 0.25mL of Moderna COVID-19 Vaccine, Bivalent, instead of 0.5mL) 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 ACCIDENTAL UNDERDOSE (Patient was administered 0.25mL of Moderna COVID-19 Vaccine, Bivalent, instead of 0.5mL).    No concomitant medications were reported.  No treatment medications were reported.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Cough, Pain in extremity, Pyrexia, SARS-CoV-2 test
Clinical narrative: developed a slight cough; 99.6 degree Fahrenheit fever; sore arm for 2 days; This spontaneous case was reported by a patient and describes the occurrence of COUGH (developed a slight cough), PYREXIA (99.6 degree Fahrenheit fever) and PAIN IN EXTREMITY (sore arm for 2 days) in a 76-year-old male patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7144B) for COVID-19 prophylaxis.     Patient had no allergies Patient never had COVID positive test or diagnosis Patient had no medical history relating to mentioned adverse event and both Acute and Chronic illnesses at the time of vaccination.     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 08-Sep-2022, the patient experienced PAIN IN EXTREMITY (sore arm for 2 days). On 13-Sep-2022,  after starting mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced COUGH (developed a slight cough) and PYREXIA (99.6 degree Fahrenheit fever). On 09-Sep-2022, PAIN IN EXTREMITY (sore arm for 2 days) had resolved. At the time of the report, COUGH (developed a slight cough) and PYREXIA (99.6 degree Fahrenheit fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Sep-2022, Body temperature: 99.6 degree Fahrenheit. In September 2022, SARS-CoV-2 test: (Negative) Negative and (Negative) Negative.         No concomitant drug was reported. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. On an unknow date patient received first dose of Moderna vaccine. On an unknow date patient received second dose of Moderna vaccine. On an unknown date patient received first booster dose of Moderna vaccine. On 31-Mar-2022 patient received second booster dose of Moderna vaccine (batch number: 046L21A).  It was reported that patient had no side effects for the other Moderna vaccines. The adverse event did not cause patient to seek medical care. It was reported that new symptoms appeared and adverse event outcome was reported as ongoing. No treatment drug was reported.
Age: 72.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19
Clinical narrative: Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) in a 72-year-old female patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (unknown route) Citrate Free. In July 2022, the patient experienced COVID-19 (Covid-19). In 2022, COVID-19 (Covid-19) had resolved. The reporter's causality for the event of COVID with humira was not provided. No relevant concomitant medications were reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: received full monovalent dose 0.50 ml instead of the bivalent booster dose; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT PRODUCT FORMULATION ADMINISTERED (received full monovalent dose 0.50 ml instead of the bivalent booster dose) 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 an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On an unknown date, the patient experienced INCORRECT PRODUCT FORMULATION ADMINISTERED (received full monovalent dose 0.50 ml instead of the bivalent booster dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT PRODUCT FORMULATION ADMINISTERED (received full monovalent dose 0.50 ml instead of the bivalent booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT PRODUCT FORMULATION ADMINISTERED (received full monovalent dose 0.50 ml instead of the bivalent booster dose).    No concomitant medication was provided.  It was reported that patient had received previous doses were primary doses and one booster dose.   Treatment medication was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-644893 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-644893:Same reporter
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Received full monovalent dose 0.50 ml instead of the bivalent booster dose; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT DOSE ADMINISTERED (Received full monovalent dose 0.50 ml instead of the bivalent booster dose) 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 an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (Received full monovalent dose 0.50 ml instead of the bivalent booster dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Received full monovalent dose 0.50 ml instead of the bivalent booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (Received full monovalent dose 0.50 ml instead of the bivalent booster dose).    No concomitant medication was reported.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-644888 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-644888:Same reporter
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; The patient received an unauthorized dosage of the Moderna COVID-19 vaccine on 12-Sep-2022 instead of new Moderna COVID-19 bivalent vaccine; This spontaneous case was reported by a patient and describes the occurrence of WRONG PRODUCT ADMINISTERED (The patient received an unauthorized dosage of the Moderna COVID-19 vaccine on 12-Sep-2022 instead of new Moderna COVID-19 bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer COVID-19 vaccine and Pfizer COVID-19 vaccine (All previous vaccinations were Pfizer COVID-19 vaccine). Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 vaccine and Pfizer COVID-19 vaccine.    On 12-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (The patient received an unauthorized dosage of the Moderna COVID-19 vaccine on 12-Sep-2022 instead of new Moderna COVID-19 bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (The patient received an unauthorized dosage of the Moderna COVID-19 vaccine on 12-Sep-2022 instead of new Moderna COVID-19 bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications was reported.  The patient received an unauthorized dosage of the Moderna COVID-19 vaccine on 12-Sep-2022 and supposed to receive the new Moderna COVID-19 bivalent vaccine, but ended up receiving the 6 to 11 year dose that can be used as a booster dose for 18 years and older. The patient had not experienced any adverse reactions so far. The patient did not had vaccination records available at this time.  No treatment medications was reported.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; The patient received 0.25 ml of bivalent booster dose/ Half dose; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (The patient received 0.25 ml of bivalent booster dose/ Half dose) and NO ADVERSE EVENT (No adverse event) in a 58-year-old male patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No medical history was reported.     On 13-Sep-2022, the patient received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 13-Sep-2022, the patient experienced UNDERDOSE (The patient received 0.25 ml of bivalent booster dose/ Half dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (The patient received 0.25 ml of bivalent booster dose/ Half dose) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (The patient received 0.25 ml of bivalent booster dose/ Half dose).    No concomitant and treatment medication was reported. The patient had no symptoms. They have not reported experiencing any symptoms. No additional doses, medications, or treatments have been given at this time.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted
Clinical narrative: No adverse event; The patient received her first primary series of the Moderna Covid-19 monovalent vaccine 10 months ago. The patient has not yet received their second Moderna Covid-19 vaccine primary series dose; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (The patient received her first primary series of the Moderna Covid-19 monovalent vaccine 10 months ago. The patient has not yet received their second Moderna Covid-19 vaccine primary series dose) and NO ADVERSE EVENT (No adverse event) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In November 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (The patient received her first primary series of the Moderna Covid-19 monovalent vaccine 10 months ago. The patient has not yet received their second Moderna Covid-19 vaccine primary series dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (The patient received her first primary series of the Moderna Covid-19 monovalent vaccine 10 months ago. The patient has not yet received their second Moderna Covid-19 vaccine primary series dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (The patient received her first primary series of the Moderna Covid-19 monovalent vaccine 10 months ago. The patient has not yet received their second Moderna Covid-19 vaccine primary series dose).    Concomitant drugs were not reported. It was reported that the patient has not yet received their second Moderna Covid-19 vaccine primary series dose. Treatment medications were not provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Gait inability, Musculoskeletal pain, Pain in extremity, Spinal column injury
Clinical narrative: vertebra bones in their lower back is worn from damage; extreme pain; cannot walk; symptoms felt on the left buttocks; symptoms felt on the left leg; This spontaneous case was reported by a patient and describes the occurrence of SPINAL COLUMN INJURY (vertebra bones in their lower back is worn from damage), BACK PAIN (extreme pain), GAIT INABILITY (cannot walk), MUSCULOSKELETAL PAIN (symptoms felt on the left buttocks) and PAIN IN EXTREMITY (symptoms felt on the left leg) 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.    In November 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced SPINAL COLUMN INJURY (vertebra bones in their lower back is worn from damage), BACK PAIN (extreme pain), GAIT INABILITY (cannot walk), MUSCULOSKELETAL PAIN (symptoms felt on the left buttocks) and PAIN IN EXTREMITY (symptoms felt on the left leg). The patient was treated with CORTISONE at an unspecified dose and frequency. At the time of the report, SPINAL COLUMN INJURY (vertebra bones in their lower back is worn from damage), BACK PAIN (extreme pain), GAIT INABILITY (cannot walk), MUSCULOSKELETAL PAIN (symptoms felt on the left buttocks) and PAIN IN EXTREMITY (symptoms felt on the left leg) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  Reportedly, patient had Cortisone injection in the back as the vertebra bones in patient's lower back was worn from  damage that caused extreme pain and patient could not walk. The patient did not have the back condition until May-2022.   Reporter did not allow further contact
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: felt tired; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (felt tired) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 prophylaxis.     The patient never had COVID positive test or diagnosis. The patient did not receive any other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 1, Lot number: EW0150) on 03-Apr-2021, PFIZER BIONTECH COVID-19 VACCINE (Dose 2, Lot number:EW0169) on 24-Apr-2021, Novavax vaccine (Dose 1 experimental vaccine received in early 2021) in 2021 and Novavax vaccine (Dose 2 experimental vaccine received in early 2021) in 2021. Past adverse reactions to the above products included No adverse event with Novavax vaccine, Novavax vaccine, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Penicillin allergy, Allergic to cats, Reactive airways disease and Asthma (After receiving the vaccine his breathing felt a little like depressed. But he went to sleep and woke up okay.). Concomitant products included EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATE (TRUVADA) for Prophylaxis against AIDS.    On 09-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Dec-2021, the patient experienced FATIGUE (felt tired). At the time of the report, FATIGUE (felt tired) had not resolved.            After receiving the first Moderna Booster dose the patient felt tired and was in bed for a day or two. This adverse event did not cause patient to seek medical care. The patient did not experience similar events in the past.  No treatment details were reported.   This case was linked to MOD-2022-644995 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Rheumatic disorder
Clinical narrative: My ENT doctor had a rheumatological incidence after the Moderna booster; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATIC DISORDER (My ENT doctor had a rheumatological incidence after the Moderna booster) 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 an unknown date, the patient received dose of mRNA-1273(ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced RHEUMATIC DISORDER (My ENT doctor had a rheumatological incidence after the Moderna booster). At the time of the report, RHEUMATIC DISORDER (My ENT doctor had a rheumatological incidence after the Moderna booster) outcome was unknown.            The concomitant medication was not reported by reporter. The treatment medication was not reported by reporter.  Company comment: This is a spontaneous case reported by a consumer. A patient of an unknown age and gender received a dose of mRNA-1273  and experienced non serious event of rheumatic disorder. Vaccination date and onset date of the event were not provided, latency cannot be assessed. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273  vaccine is not affected by this report.      Reporter did not allow further contact; Sender's Comments: This is a spontaneous case reported by a consumer. A patient of an unknown age and gender received a dose of mRNA-1273  and experienced non serious event of rheumatic disorder  Vaccination date and onset date of the event were not provided, latency cannot be assessed. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed.
Sex: F
Vaccine: COVID19-2
Symptoms: Device connection issue, Extra dose administered, No adverse event
Clinical narrative: This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEVICE CONNECTION ISSUE (Syringe leaked upon administration), EXTRA DOSE ADMINISTERED (Administered an additional dose of the Bivalent moderna covid-19 vaccine from the same lot number and expiration date/ This was her 5th dose of the vaccine) and NO ADVERSE EVENT (No adverse event) 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)) (batch nos. AS7143C and AS7143C) for COVID-19 prophylaxis. No Medical History information was reported. On 13-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 13-Sep-2022, received sixth dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) dosage was changed to 1 dosage form. On 13-Sep-2022, the patient experienced DEVICE CONNECTION ISSUE (Syringe leaked upon administration) and EXTRA DOSE ADMINISTERED (Administered an additional dose of the Bivalent moderna covid-19 vaccine from the same lot number and expiration date/ This was her 5th dose of the vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, DEVICE CONNECTION ISSUE (Syringe leaked upon administration), EXTRA DOSE ADMINISTERED (Administered an additional dose of the Bivalent moderna covid-19 vaccine from the same lot number and expiration date/ This was her 5th dose of the vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.  No concomitant medications were provided. Patient received her dose of the Moderna COVID-19 bivalent vaccine by intramuscular injection as the syringe leaked upon administration. This was give on 13-SEP-2022. This was her 5th dose of the vaccine. During the call the pharmacist administered an additional dose of the Bivalent moderna covid-19 vaccine from the same lot number and expiration date. Patient has not experienced any symptoms. No treatment medications were reported.
Age: 0.42
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event; Infant received their first dose 10 days earlier than 6 months; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Infant received their first dose 10 days earlier than 6 months) and NO ADVERSE EVENT (No adverse event) in a 5-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jul-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Infant received their first dose 10 days earlier than 6 months). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Infant received their first dose 10 days earlier than 6 months) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Infant received their first dose 10 days earlier than 6 months).    No Concomitant medication were reported. Vaccines were stored in freezer. Reporter stated that seeking guidance if the Moderna vaccine (6months-5yrs) was administered earlier than 6 months of age. It was stated that a 5 months and 20 days infant received their first dose 10 days earlier than 6 months and had no reactions. Reporter stated that the doctor said the child should be fine, but wanted to confirm with the infant's mother how the patient was.     No treatment drug were reported.   This case was linked to MOD-2022-644921 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Sep-2022: Live follow-up received on 14-Sep-2022. patient information (initial and date of birth) and date of vaccination were added.