chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event; 7 year old received Moderna booster that is not authorized yet; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (7 year old received Moderna booster that is not authorized yet) and NO ADVERSE EVENT (No adverse event) in a 7-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Pfizer (Dose 1) on 09-Nov-2021 and Pfizer (Dose 2) on 30-Nov-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 06-Aug-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Aug-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (7 year old received Moderna booster that is not authorized yet). 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 (7 year old received Moderna booster that is not authorized yet) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medication information provided. No medical history information was provided.  No treatment medication information provided.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Illness, Pyrexia
Clinical narrative: Sick; chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick), CHILLS (chills) and PYREXIA (Fever) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On 01-Jul-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick), CHILLS (chills) and PYREXIA (Fever). At the time of the report, ILLNESS (Sick), CHILLS (chills) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.5 degree Celsius.   The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   No concomitant medication information was provided. No treatment medication were provided.
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: patient got Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (patient got Covid) in an 8-decade-old patient of an unknown 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 (patient got Covid). At the time of the report, COVID-19 (patient got Covid) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported. No treatment drugs were reported.  Company Comment:  This is a spontaneous case, reported by a consumer, concerning an elderly (8th decade of life) patient of an unknown gender with no medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19, in the context of a dose of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date nor event onset date were provided. No further details about the clinical course, diagnostic procedures and treatments were provided. Outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case, reported by a consumer, concerning an elderly (8th decade of life) patient of an unknown gender with no medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19, in the context of a dose of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date nor event onset date were provided. No further details about the clinical course, diagnostic procedures and treatments were provided. Outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Glaucoma
Clinical narrative: Glaucoma; This spontaneous case was reported by a consumer and describes the occurrence of GLAUCOMA (Glaucoma) in an elderly 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.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form, third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced GLAUCOMA (Glaucoma) (seriousness criterion medically significant). At the time of the report, GLAUCOMA (Glaucoma) outcome was unknown.            No concomitant medications were reported.  Patient had wore mask and had hard time seeing, She was older and could not see as well, clouds were floating in front of her eyeballs and was diagnosed with Glaucoma. She had two Covid Moderna shots and two Moderna Covid Boosters.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of GLAUCOMA with SKYRIZI(RISANKIZUMAB) was no reasonable possibility.  No treatment medications were reported.  Company Comment:  This is a spontaneous case concerning a elderly female patient of unknown age under treatment with RISANKIZUMAB for unknown reason, with no other medical history reported, who experienced the unexpected serious (medically significant) event of glaucoma. Patient received 4 doses of mRNA-1273 vaccine. It is unknown after which dose the event was diagnosed.  RISANKIZUMAB was also reported as a suspect drug. Patient range of age is a risk factor for the event. No further information was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a elderly female patient of unknown age under treatment with RISANKIZUMAB for unknown reason, with no other medical history reported, who experienced the unexpected serious (medically significant) event of glaucoma. Patient received 4 doses of mRNA-1273 vaccine. It is unknown after which dose the event was diagnosed.  RISANKIZUMAB was also reported as a suspect drug. Patient range of age is a risk factor for the event. No further information was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products, Suspected COVID-19
Clinical narrative: interchange of vaccine products; suspected covid-19 infection; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (suspected covid-19 infection) and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 prophylaxis.    No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. In June 2022, the patient experienced SUSPECTED COVID-19 (suspected covid-19 infection). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products). At the time of the report, SUSPECTED COVID-19 (suspected covid-19 infection) and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products) outcome was unknown.            No concomitant medication information was provided. On Jun-2022 patient experienced suspected COVID-19 infection (dose number in series 2) with symptoms of scratchy throat, joint pain, slight nasal congestion (head colds were worsen then this ) loss of taste and smell. IT was reported that the whole family had it in early june. No treatment medication were provided. This is an spontaneous case concerning an unknown years-old patient with no medical history reported who experienced the unexpected AESI of COVID-19, unknown days after the 2nd. dose of mRNA-1273 vaccine. Also, as patient received Jannsen covid-19 vaccine,  interchange of vaccine products event was noted in the case The outcome was reported as unknown.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.  Event´s seriousness assessed as reported.; Sender's Comments: This is an spontaneous case concerning an unknown years-old patient with no medical history reported who experienced the unexpected AESI of COVID-19, unknown days after the 2nd. dose of mRNA-1273 vaccine. Also, as patient received Jannsen covid-19 vaccine,  interchange of vaccine products event was noted in the case The outcome was reported as unknown.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.  Event´s seriousness assessed as reported.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022; No adverse event; Dose administered after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date), PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022) and NO ADVERSE EVENT (No adverse event) in a 64-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 003K21-2A, 022C21A, 053C21A and 013H21B) for COVID-19 prophylaxis.     The patient was never diagnosed with or tested positive for COVID-19.  Concurrent medical conditions included Blood pressure high. Concomitant products included AMLODIPINE BESILATE (NORVASC) for an unknown indication.   On 20-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 17-Jun-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .5 milliliter. On 18-Jan-2022, received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .25 milliliter. On 26-May-2022 at 10:26 AM, received fourth dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .25 milliliter. On 26-May-2022 at 10:26 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date), PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related and EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date) to have an unknown relationship. No further causality assessment was provided for PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022).    The vial did not undergo any temperature excursions. The vial was initially stored in the refrigerator on 21-Jan-2022. Number of vials involved was 5. The used vials were placed in the refrigerator on the same day of administration on 26 May 2022. The event did not cause the patient to seek medical care. It was unknown whether there are any other potential causes for the event to occur and patient experienced any similar event in the past.   No treatment medication reported by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator on 8-Jul-2022 and was administered on 9-Aug-2022; No adverse event; Expired dose administered to patient 2 days after use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient 2 days after use by date), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 8-Jul-2022 and was administered on 9-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 006M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Aug-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient 2 days after use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 8-Jul-2022 and was administered on 9-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient 2 days after use by date), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 8-Jul-2022 and was administered on 9-Aug-2022) 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 (Expired dose administered to patient 2 days after use by date) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 8-Jul-2022 and was administered on 9-Aug-2022).    No concomitant medications were reported. The patient had not reported any adverse reactions to this dose. The vial was initially stored in the refrigerator on 8-Jul-2022. No treatment medications were reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Illness, Mobility decreased, Vomiting
Clinical narrative: Couldn't move; wiped out; got sick the next day; simultaneous diarrhea and vomiting/vomiting/diarrhea; vomiting/simultaneous diarrhea and vomiting; This spontaneous case was reported by a patient and describes the occurrence of MOBILITY DECREASED (Couldn't move), ILLNESS (got sick the next day), DIARRHOEA (simultaneous diarrhea and vomiting/vomiting/diarrhea), VOMITING (vomiting/simultaneous diarrhea and vomiting) and FATIGUE (wiped out) in a 72-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 024M20A, 047A21A and 004C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism and Kidney disorder. Concomitant products included MULTIVITAMIN [VITAMINS NOS], KRILL OIL and PROBIOTICS NOS for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2021, received third dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced ILLNESS (got sick the next day), DIARRHOEA (simultaneous diarrhea and vomiting/vomiting/diarrhea) and VOMITING (vomiting/simultaneous diarrhea and vomiting). On an unknown date, the patient experienced MOBILITY DECREASED (Couldn't move) and FATIGUE (wiped out). On 14-Feb-2021, DIARRHOEA (simultaneous diarrhea and vomiting/vomiting/diarrhea) and VOMITING (vomiting/simultaneous diarrhea and vomiting) had resolved. At the time of the report, MOBILITY DECREASED (Couldn't move), ILLNESS (got sick the next day) and FATIGUE (wiped out) outcome was unknown.            Patient's concomitant medication included CoQ10. No treatment information were provided.
Sex: M
Vaccine: COVID19, COVID19, COVID19, UNK
Symptoms: COVID-19 immunisation, Diarrhoea, Faeces hard, Interchange of vaccine products
Clinical narrative: Stools hard; Diarrhea; Interchange of vaccine products; Revaccination with different covid-19 Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of FAECES HARD (Stools hard), DIARRHOEA (Diarrhea), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different covid-19 Vaccine) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Ulcerative colitis, COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 vaccination and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    Concomitant products included POLYCARBOPHIL CALCIUM (FIBERCON) for an unknown indication.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form, dose of ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form, dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (Intramuscular) 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FAECES HARD (Stools hard), DIARRHOEA (Diarrhea), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different covid-19 Vaccine). At the time of the report, FAECES HARD (Stools hard), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different covid-19 Vaccine) outcome was unknown and DIARRHOEA (Diarrhea) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       The information was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No Treatment medication reported.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was initially stored in refrigerator on 6Jul2022 and administered on 8Aug2022; No adverse event; Dose administered after 30-day use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date), PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 6Jul2022 and administered on 8Aug2022) and NO ADVERSE EVENT (No adverse event) in a 3-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 vaccination.     It was unknown if the patient had ever tested or diagnosed with COVID-19 It was unknown whether patient Allergies to medications, food and other products.     On 08-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 6Jul2022 and administered on 8Aug2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date), PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 6Jul2022 and administered on 8Aug2022) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date) and PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 6Jul2022 and administered on 8Aug2022).    Patient was not under any concomitant or regular medication.  Reporter reported that the vaccine had expired on 5Aug2022. No adverse events were reported post vaccine administration. Vaccine was initially stored in refrigerator on 6Jul2022. It was confirmed that the product had not undergone any temperature excursion issue.  No treatment drug information was provided.
Age: 53.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Headache, Pain
Clinical narrative: Extreme Headaches; Ache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Extreme Headaches) and PAIN (Ache) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On 20-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2022, received second 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) 1 dosage form. In 2021, the patient experienced HEADACHE (Extreme Headaches) and PAIN (Ache). At the time of the report, HEADACHE (Extreme Headaches) and PAIN (Ache) had resolved.            Concomitant product use was not provided by the reporter.  The patient took two vaccines of moderna and with the first vaccine he had bad side effects of extreme headaches and aches. He had recovered since then just worried now about getting a refill from the pharmacy.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Treatment information was not provided.  The reporter's causality for the events of extreme headaches and ache with Humira was not provided.  The reporter's causality for the events of extreme headaches and ache with Moderna COVID-19 vaccine was reported as possible.   This case was linked to MOD-2022-627433 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: booster dose was much less severe; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (booster dose was much less severe) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (booster dose was much less severe). At the time of the report, VACCINATION COMPLICATION (booster dose was much less severe) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. The patient received first booster. Reporter called to report about her daughter's reaction to Moderna doses. No treatment drug was reported.   This case was linked to MOD-2021-079311, MOD-2021-079320.
Age: 1.25
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: the vial was initially stored in the refrigerator on 08Jul2022 with a BUD of 07-Aug-2022 and vaccine were given on 08Aug2022; No adverse event; We had the pediatric Moderna Covid-19 vaccine with a BUD of 07Aug2022, dose of that vaccine were given on 08Aug2022.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We had the pediatric Moderna Covid-19 vaccine with a BUD of 07Aug2022, dose of that vaccine were given on 08Aug2022.), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 08Jul2022 with a BUD of 07-Aug-2022 and vaccine were given on 08Aug2022) and NO ADVERSE EVENT (No adverse event) in a 15-month-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (We had the pediatric Moderna Covid-19 vaccine with a BUD of 07Aug2022, dose of that vaccine were given on 08Aug2022.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 08Jul2022 with a BUD of 07-Aug-2022 and vaccine were given on 08Aug2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We had the pediatric Moderna Covid-19 vaccine with a BUD of 07Aug2022, dose of that vaccine were given on 08Aug2022.), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 08Jul2022 with a BUD of 07-Aug-2022 and vaccine were given on 08Aug2022) 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 EXPIRED PRODUCT ADMINISTERED (We had the pediatric Moderna Covid-19 vaccine with a BUD of 07Aug2022, dose of that vaccine were given on 08Aug2022.) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 08Jul2022 with a BUD of 07-Aug-2022 and vaccine were given on 08Aug2022).    No concomitant medication information provided. On 08-Jul-2022, the vial was initially stored in the refrigerator. The  did not cause patient to seek medical care. The vial  had not undergone any temperature excursions. No treatment details reported.   T
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Pain in jaw
Clinical narrative: loss of appetite; jaw pain; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (loss of appetite) and PAIN IN JAW (jaw pain) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (patient was hospitalized) in January 2022.    In February 2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (loss of appetite) and PAIN IN JAW (jaw pain). At the time of the report, DECREASED APPETITE (loss of appetite) and PAIN IN JAW (jaw pain) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported. Patient had COVID-19 in January 2022 and was hospitalized. Then in February 2022 he got the first dose of the Moderna COVID-19 vaccine. He nowwas experiencing loss of appetite and jaw pain. He wondered if these were allergic reactions to the vaccine.  No treatment medications were reported.   Reporter did not allow further contact
Age: 4.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 08-Jul-2022 and vaccine were given on 08-Aug-2022 (BUD 30 days); No adverse event; We had the pediatric Moderna Covid-19 vaccine with a BUD of 07-Aug-2022, doses of that vaccine were given on 08-Aug-2022.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We had the pediatric Moderna Covid-19 vaccine with a BUD of 07-Aug-2022, doses of that vaccine were given on 08-Aug-2022.), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and vaccine were given on 08-Aug-2022 (BUD 30 days)) and NO ADVERSE EVENT (No adverse event) in a 4-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (We had the pediatric Moderna Covid-19 vaccine with a BUD of 07-Aug-2022, doses of that vaccine were given on 08-Aug-2022.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and vaccine were given on 08-Aug-2022 (BUD 30 days)) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We had the pediatric Moderna Covid-19 vaccine with a BUD of 07-Aug-2022, doses of that vaccine were given on 08-Aug-2022.), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and vaccine were given on 08-Aug-2022 (BUD 30 days)) 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 EXPIRED PRODUCT ADMINISTERED (We had the pediatric Moderna Covid-19 vaccine with a BUD of 07-Aug-2022, doses of that vaccine were given on 08-Aug-2022.) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and vaccine were given on 08-Aug-2022 (BUD 30 days)).    No concomitant medication information provided. On 08-Jul-2022  the vial was initially stored in the refrigerator. The vial  had not undergone  any temperature excursions. The AE did not cause patient to seek medical care. No treatment medication information provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort, Feeling abnormal, Muscle twitching, Pain in extremity
Clinical narrative: I was having an issue with my ears. I felt like I was under water.; I also started having twitching in my left cheek, in the cheek bone area.; I felt like I was under water.; I had a sore arm., It felt like somebody punched you in the arm, but nothing debilitating; This spontaneous case was reported by a patient and describes the occurrence of EAR DISCOMFORT (I was having an issue with my ears. I felt like I was under water.), MUSCLE TWITCHING (I also started having twitching in my left cheek, in the cheek bone area.), FEELING ABNORMAL (I felt like I was under water.) and PAIN IN EXTREMITY (I had a sore arm., It felt like somebody punched you in the arm, but nothing debilitating) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Allergic to Cipro) and Penicillin allergy.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced EAR DISCOMFORT (I was having an issue with my ears. I felt like I was under water.), MUSCLE TWITCHING (I also started having twitching in my left cheek, in the cheek bone area.), FEELING ABNORMAL (I felt like I was under water.) and PAIN IN EXTREMITY (I had a sore arm., It felt like somebody punched you in the arm, but nothing debilitating). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) in February 2021 at an unspecified dose and frequency. At the time of the report, EAR DISCOMFORT (I was having an issue with my ears. I felt like I was under water.), MUSCLE TWITCHING (I also started having twitching in my left cheek, in the cheek bone area.) and FEELING ABNORMAL (I felt like I was under water.) had not resolved and PAIN IN EXTREMITY (I had a sore arm., It felt like somebody punched you in the arm, but nothing debilitating) had resolved.            Concomitant medication details were not reported. Patient felt like patient was under water. It would sometimes be in 1 ear, sometimes both.Patient took Claritin & it clears it up. It goes away as fast as it came. Patient started having twitching in left cheek, in the cheek bone area. It comes & goes, but it's not a Bells Palsy. Patient saw PCP, stated patient's ears were fine. Patient denied that patient ever had COVID positive test or diagnosis.. Event Sore arm and Twitching facial did not cause the patient to seek medical care. Event Ear discomfort and Feeling abnormal cause patient to seek medical care. Patient had not experienced event Twitching facial in the past.
Age: 42.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Pain, Psoriasis, Pyrexia
Clinical narrative: PLAQUE PSORIASIS BAD FLARE; FEVER AFTER TAKING COVID VACCINE; PAIN AFTER TAKING COVID VACCINE; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (PAIN AFTER TAKING COVID VACCINE), PSORIASIS (PLAQUE PSORIASIS BAD FLARE) and PYREXIA (FEVER AFTER TAKING COVID VACCINE) in a 42-year-old male 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.    No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 1 dosage form. In 2021, the patient experienced PAIN (PAIN AFTER TAKING COVID VACCINE) and PYREXIA (FEVER AFTER TAKING COVID VACCINE). In June 2022, the patient experienced PSORIASIS (PLAQUE PSORIASIS BAD FLARE). At the time of the report, PAIN (PAIN AFTER TAKING COVID VACCINE) and PYREXIA (FEVER AFTER TAKING COVID VACCINE) had resolved and PSORIASIS (PLAQUE PSORIASIS BAD FLARE) outcome was unknown.            No concomitant medication were provided  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event of Plaque psoriasis bad flare because unable to get Sktrizi,Pain after taking COVID vaccine and fever after taking COVID vaccine had no reasonable possibility with Sktrizi.  No treatment details were provided
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Had a sore arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Had a sore arm) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 650-005) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Cipro) and Penicillin allergy (Penicllin).   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-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 received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE PAIN (Had a sore arm). At the time of the report, VACCINATION SITE PAIN (Had a sore arm) had resolved.            No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter. It was unknown whether vaccines was given within 1 month prior to Moderna COVID-19 vaccine.  had not caused patient to seek medical care. It was unknown patient had experienced a similar event in the past.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: adverse event; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (adverse event) 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 VACCINATION COMPLICATION (adverse event). At the time of the report, VACCINATION COMPLICATION (adverse event) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications information was reported.  No treatment medications were provided.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Vaccination site nodule, Vaccination site pain, Vaccination site swelling
Clinical narrative: swelling and nodule at the injection site; her chest wall muscle was swollen on the left side; pain (7 out of 10) in her left deltoid that radiates down left arm, which was the injection arm; swelling and nodule at the injection site; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE NODULE (swelling and nodule at the injection site), CHEST DISCOMFORT (her chest wall muscle was swollen on the left side), VACCINATION SITE PAIN (pain (7 out of 10) in her left deltoid that radiates down left arm, which was the injection arm) and VACCINATION SITE SWELLING (swelling and nodule at the injection site) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060A22A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Aug-2022, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE NODULE (swelling and nodule at the injection site), CHEST DISCOMFORT (her chest wall muscle was swollen on the left side), VACCINATION SITE PAIN (pain (7 out of 10) in her left deltoid that radiates down left arm, which was the injection arm) and VACCINATION SITE SWELLING (swelling and nodule at the injection site). At the time of the report, VACCINATION SITE NODULE (swelling and nodule at the injection site), CHEST DISCOMFORT (her chest wall muscle was swollen on the left side), VACCINATION SITE PAIN (pain (7 out of 10) in her left deltoid that radiates down left arm, which was the injection arm) and VACCINATION SITE SWELLING (swelling and nodule at the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient was visited emergency room.  No treatment medications were reported.
Age: 70.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Chest pain
Clinical narrative: Chest pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) for Waldenstrom's macroglobulinemia.    No Medical History information was reported.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-May-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 IBRUTINIB (IMBRUVICA) (Oral) at an unspecified dose. In 2021, the patient experienced CHEST PAIN (Chest pain). At the time of the report, CHEST PAIN (Chest pain) was resolving.            No concomitant medication was provided.  Treatment medication was not provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event of chest pain after third COVID vaccine with imbruvica ibrutinib was no reasonable possibility.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Foot fracture, Lymphadenopathy, Urinary tract infection, Vaccination site pruritus, Wrist fracture
Clinical narrative: Urinary tract infection; Broken wrist; broken right second toe; swollen lymph nodes; fractured left foot; covid vaccine/injection site itching; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Urinary tract infection), FOOT FRACTURE (fractured left foot), WRIST FRACTURE (Broken wrist), FOOT FRACTURE (broken right second toe) and VACCINATION SITE PRURITUS (covid vaccine/injection site itching) in a 64-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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Aug-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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced VACCINATION SITE PRURITUS (covid vaccine/injection site itching). On 01-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FOOT FRACTURE (fractured left foot). On an unknown date, the patient experienced URINARY TRACT INFECTION (Urinary tract infection), WRIST FRACTURE (Broken wrist), FOOT FRACTURE (broken right second toe) and LYMPHADENOPATHY (swollen lymph nodes). At the time of the report, URINARY TRACT INFECTION (Urinary tract infection), FOOT FRACTURE (fractured left foot), WRIST FRACTURE (Broken wrist), FOOT FRACTURE (broken right second toe) and VACCINATION SITE PRURITUS (covid vaccine/injection site itching) outcome was unknown and LYMPHADENOPATHY (swollen lymph nodes) had not resolved.            No concomitant drug information was provided.  It was unknown if the patient was enrolled in COVID-19 trial. The causality of the events with respect to SKYRIZI was not reported.  No treatment drug information was provided.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Asthenia, Vaccination site erythema
Clinical narrative: Loss of energy; Injection site redness/ red mark after thier last injection for COVID; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Loss of energy) and VACCINATION SITE ERYTHEMA (Injection site redness/ red mark after thier last injection for COVID) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced ASTHENIA (Loss of energy) and VACCINATION SITE ERYTHEMA (Injection site redness/ red mark after thier last injection for COVID). At the time of the report, ASTHENIA (Loss of energy) outcome was unknown and VACCINATION SITE ERYTHEMA (Injection site redness/ red mark after their last injection for COVID) had resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. Concomitant medications details were not reported by the reporter.  Treatment details were not reported by the reporter.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Injection site irritation, Injection site pruritus, Injection site rash, Pain in extremity
Clinical narrative: INJECTION SITE IRRITATED; INJECTION SITE ITCHY; SORE ARM; INJECTION SITE RASH; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE IRRITATION (INJECTION SITE IRRITATED), INJECTION SITE PRURITUS (INJECTION SITE ITCHY), PAIN IN EXTREMITY (SORE ARM) and INJECTION SITE RASH (INJECTION SITE RASH) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced INJECTION SITE IRRITATION (INJECTION SITE IRRITATED), INJECTION SITE PRURITUS (INJECTION SITE ITCHY), PAIN IN EXTREMITY (SORE ARM) and INJECTION SITE RASH (INJECTION SITE RASH). At the time of the report, INJECTION SITE IRRITATION (INJECTION SITE IRRITATED), INJECTION SITE PRURITUS (INJECTION SITE ITCHY), PAIN IN EXTREMITY (SORE ARM) and INJECTION SITE RASH (INJECTION SITE RASH) had resolved.            No concomitant medications were reported.  The Causality as per reporter for HUMIRA was not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medications were reported.