chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Immune system disorder
Clinical narrative: have weird immune like they are on steroids and attack the body; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNE SYSTEM DISORDER (have weird immune like they are on steroids and attack the body) in a male 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 second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNE SYSTEM DISORDER (have weird immune like they are on steroids and attack the body). At the time of the report, IMMUNE SYSTEM DISORDER (have weird immune like they are on steroids and attack the body) outcome was unknown.            Concomitant medications were not reported.  No treatment information was provided by the reporter. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Injection site erythema, Injection site irritation, Injection site papule
Clinical narrative: Injection site itching; Injection site papule; Injection site redness; Injection site irritation; Flu like symptoms; Fatigue; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE IRRITATION (Injection site irritation), INFLUENZA LIKE ILLNESS (Flu like symptoms), INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE PAPULE (Injection site papule) and INJECTION SITE ERYTHEMA (Injection site redness) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intra-articular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intra-articular) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intra-articular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), FATIGUE (Fatigue) and NAUSEA (Nausea). On an unknown date, the patient experienced INJECTION SITE IRRITATION (Injection site irritation), INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE PAPULE (Injection site papule) and INJECTION SITE ERYTHEMA (Injection site redness). In 2021, INFLUENZA LIKE ILLNESS (Flu like symptoms), FATIGUE (Fatigue) and NAUSEA (Nausea) had resolved. At the time of the report, INJECTION SITE IRRITATION (Injection site irritation), INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE PAPULE (Injection site papule) and INJECTION SITE ERYTHEMA (Injection site redness) was resolving.            Concomitant medication was not reported.  On unknown dates, the patient experienced injection site irritated, palm size red at injection site/dime size red area, itchy at injection site and raised area at injection site. In 2021, the patient experienced fatigue, flu like symptoms and nausea. In 2021, the fatigue, flu like symptoms and nausea resolved. MODERNA COVID-19 VACCINE (elasomeran) was also considered suspect.  Treatment medication was not reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pruritus, Nausea
Clinical narrative: Injection site itching; Injection site papule; Injection site redness; Injection site irritation; Flu like symptoms; Fatigue; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE IRRITATION (Injection site irritation), INFLUENZA LIKE ILLNESS (Flu like symptoms), INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE PAPULE (Injection site papule) and INJECTION SITE ERYTHEMA (Injection site redness) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intra-articular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intra-articular) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intra-articular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), FATIGUE (Fatigue) and NAUSEA (Nausea). On an unknown date, the patient experienced INJECTION SITE IRRITATION (Injection site irritation), INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE PAPULE (Injection site papule) and INJECTION SITE ERYTHEMA (Injection site redness). In 2021, INFLUENZA LIKE ILLNESS (Flu like symptoms), FATIGUE (Fatigue) and NAUSEA (Nausea) had resolved. At the time of the report, INJECTION SITE IRRITATION (Injection site irritation), INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE PAPULE (Injection site papule) and INJECTION SITE ERYTHEMA (Injection site redness) was resolving.            Concomitant medication was not reported.  On unknown dates, the patient experienced injection site irritated, palm size red at injection site/dime size red area, itchy at injection site and raised area at injection site. In 2021, the patient experienced fatigue, flu like symptoms and nausea. In 2021, the fatigue, flu like symptoms and nausea resolved. MODERNA COVID-19 VACCINE (elasomeran) was also considered suspect.  Treatment medication was not reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza, Nasopharyngitis
Clinical narrative: Colds and Flu; Colds and Flu; Fatigue following COVID vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Colds and Flu), NASOPHARYNGITIS (Colds and Flu) and FATIGUE (Fatigue following COVID vaccine) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis and Psoriatic arthritis.    Concurrent medical conditions included Ulcerative colitis and Psoriatic arthritis.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, 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) at an unspecified dose. In 2021, the patient experienced FATIGUE (Fatigue following COVID vaccine). On an unknown date, the patient experienced INFLUENZA (Colds and Flu) and NASOPHARYNGITIS (Colds and Flu). At the time of the report, INFLUENZA (Colds and Flu), NASOPHARYNGITIS (Colds and Flu) and FATIGUE (Fatigue following COVID vaccine) outcome was unknown.            No concomitant medication provided. No treatment information mentioned.  On an unknown date patient experienced colds and flu. In 2021, patient experienced fatigue after COVID vaccine.  Reporters causality of event fatigue after COVID vaccine with Humira was no reasonable possibility  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenitis, Pyrexia
Clinical narrative: High Fever; Inflamed lymph nodes; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (High Fever) and LYMPHADENITIS (Inflamed lymph nodes) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011G21A, 013120A and 030M20A) for COVID-19 vaccination.    Co-suspect product included non-company product LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    No Medical History information was reported.   In 2004, the patient started LEVOTHYROXINE SODIUM (SYNTHROID) (Oral) 125 mcg (125 mcg,1 in 1 D). In 2005, LEVOTHYROXINE SODIUM (SYNTHROID) (Oral) dosage was changed to 112 mcg (112 mcg,1 in 1 D). On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, LEVOTHYROXINE SODIUM (SYNTHROID) (Oral) dosage was changed to 88 mcg for three days and 100 mcg for four days (88 mcg,1 in 1 D). On 23-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In January 2022, LEVOTHYROXINE SODIUM (SYNTHROID) (Oral) dosage was changed to 100 mcg (100 mcg,1 in 1 D). In December 2021, the patient experienced PYREXIA (High Fever) and LYMPHADENITIS (Inflamed lymph nodes). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. In December 2021, PYREXIA (High Fever) and LYMPHADENITIS (Inflamed lymph nodes) had resolved.            No concomitant medications were reported.  The reporter's causality for the events of high fever onset in December 2021, inflamed lymph nodes with Synthroid (levothyroxine) was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in   This case was linked to MOD-2022-621238, MOD-2022-630556 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat
Clinical narrative: Cold sweat; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (Cold sweat) 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.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe ).   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced COLD SWEAT (Cold sweat). At the time of the report, COLD SWEAT (Cold sweat) had resolved.            No relevant concomitant medications were reported. No treatment medication reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of second vaccine caused cold sweats for 2 hours with Humira was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-620607 (Patient Link).
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Inappropriate schedule of vaccine administered; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No adverse event) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 057M21A, 004F21A, 030M20A and 041L20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Allergy.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-623140 (Patient Link).
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Myalgia, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Inappropriate schedule of vaccine administered; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No adverse event) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 057M21A, 004F21A, 030M20A and 041L20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Allergy.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-623140 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Inappropriate schedule of product administration, Rash
Clinical narrative: Dizzy; First dose 8-Feb-21 and second dose 16-Mar-21; Rash after getting second dose COVID-19 dose; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), RASH (Rash after getting second dose COVID-19 dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose 8-Feb-21 and second dose 16-Mar-21) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 08-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2022, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, 1st injection (1 in 1 Once). On 13-Apr-2022, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to UNK, 2nd injection. In March 2021, the patient experienced RASH (Rash after getting second dose COVID-19 dose). On 16-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose 8-Feb-21 and second dose 16-Mar-21). In 2022, the patient experienced DIZZINESS (Dizzy). In 2022, DIZZINESS (Dizzy) had resolved. At the time of the report, RASH (Rash after getting second dose COVID-19 dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose 8-Feb-21 and second dose 16-Mar-21) outcome was unknown.      Formulation for HUMIRA was reported as Solution for injection in pre-filled pen.  It was unknown if patient was enrolled in a COVID-19 vaccine Trial.  The reporter's causality with HUMIRA for event dizziness was reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Somnolence
Clinical narrative: AFTER SECOND COVID SHOT PATIENT COULD NOT MOVE; Felt Sleepy; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (AFTER SECOND COVID SHOT PATIENT COULD NOT MOVE) and SOMNOLENCE (Felt Sleepy) in a 56-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) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (MODERATE TO SEVERE).   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced MOBILITY DECREASED (AFTER SECOND COVID SHOT PATIENT COULD NOT MOVE) and SOMNOLENCE (Felt Sleepy). At the time of the report, MOBILITY DECREASED (AFTER SECOND COVID SHOT PATIENT COULD NOT MOVE) and SOMNOLENCE (Felt Sleepy) was resolving.            No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Primary reporter did not have the lot number information, because the packaging was discarded.  The reporter's causality for the event of mobility decreased was a reasonable possibility with HUMIRA (ADALIMUMAB) and reporter's causality for the event of somnolence was not provided with HUMIRA (ADALIMUMAB).  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: contracted COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (contracted COVID-19) in a male 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. In July 2022, the patient experienced COVID-19 (contracted COVID-19). At the time of the report, COVID-19 (contracted COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant products were reported.  No further information and no additional adverse events reported.  No treatment information was reported.  Company Comment: This is a spontaneous case concerning a male patient of an unknown age with no reported medical history, who experienced the unexpected, non-serious, adverse event of special interest, COVID-19 which occurred on an unknown date and on an unknown interval (vaccination date not provided) after receiving an unspecified dose of mRNA-1273 Vaccine. No further information on risk factors, co morbidities, clinical course and management of the event was available in the report. The reported outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-648378, US-MODERNATX, INC.-MOD-2022-648379 (Linked Report).; Sender's Comments: This is a spontaneous case concerning a male patient of an unknown age with no reported medical history, who experienced the unexpected, non-serious, adverse event of special interest, COVID-19 which occurred on an unknown date and on an unknown interval (vaccination date not provided) after receiving an unspecified dose of mRNA-1273 Vaccine. No further information on risk factors, co morbidities, clinical course and management of the event was available in the report. The reported outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2022-648378:Father case US-MODERNATX, INC.-MOD-2022-648379:Mother case
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Dose administered after 30-day Use By Date/Vial was initially stored in the refrigerator on 19-AUG-2022 and vaccine was administered on 21-SEP-2022; No adverse event; receiving a dose after its beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving a dose after its beyond use date), PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date/Vial was initially stored in the refrigerator on 19-AUG-2022 and vaccine was administered on 21-SEP-2022) and NO ADVERSE EVENT (No adverse event) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057a22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving a dose after its beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date/Vial was initially stored in the refrigerator on 19-AUG-2022 and vaccine was administered on 21-SEP-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (receiving a dose after its beyond use date), PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date/Vial was initially stored in the refrigerator on 19-AUG-2022 and vaccine was administered on 21-SEP-2022) 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 (receiving a dose after its beyond use date) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date/Vial was initially stored in the refrigerator on 19-AUG-2022 and vaccine was administered on 21-SEP-2022).    No concomitant medication details was reported. Individual vials or unbroken cartons- in the open box a sealed vial. Vial size was 5.5ml vial. On 19-AUG-2022 the vial was initially stored in the refrigerator. The vial did not undergone any temperature excursions. No treatment medication details was reported.
Age: 49.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; The dose was administered after the published expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The dose was administered after the published expiration date) and NO ADVERSE EVENT (No adverse event) in a 49-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 001M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Sep-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 19-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The dose was administered after the published expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The dose was administered after the published expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (The dose was administered after the published expiration date).    It was reported that patient received monovalent first dose. It was unknown that the vial underwent any temperature excursions The patient had not reported any symptoms. No additional doses, medications, or treatments had been administered at that time.
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Monovalent vaccine given as booster; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Monovalent vaccine given as booster) and NO ADVERSE EVENT (No adverse event) 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, the patient experienced WRONG PRODUCT ADMINISTERED (Monovalent vaccine given as booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Monovalent vaccine given as booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Monovalent vaccine given as booster).    No concomitant medications were provided.  It was reported that reporter found out that they could not gave the Moderna as a booster starting 31-Aug-2022, but administered monovalent doses as boosters. She was told that booster that they received did not cover omicron, so the patients would need to be revaccinated with the bivalent later.   No treatment medications were provided.
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: monovalent vaccine given as booster; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (monovalent vaccine given as booster) and NO ADVERSE EVENT (No adverse event) in an adult male patient 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 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (monovalent vaccine given as booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (monovalent vaccine given as booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (monovalent vaccine given as booster).    No concomitant drug were reported.   It was reported that the caller was the office manager. She had a situation. She found out that they could not give the Moderna as a booster starting 31-Aug-2022, but she administered 15 monovalent doses as boosters. She called public health, who said there was no harm in it. She was also told to call VAERS. She was told that the booster that they received did not cover omicron, so they would need to be revaccinated with the bivalent later.  No treatment drug were reported.
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient received monovalent vaccine given as booster; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received monovalent vaccine given as booster) and NO ADVERSE EVENT (No adverse event) in an adult male patient 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 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received monovalent vaccine given as booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received monovalent vaccine given as booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received monovalent vaccine given as booster).    No Concomitant medications were provided. It was reported that reporter found out that they could not give the Moderna as a booster starting 31 Aug 2022, but administered 15 monovalent doses as boosters. She called public health, who said there was no harm in it. and told that booster that patients received did not cover omicron, so the patients would need to be revaccinated with the bivalent later.   No treatment medications were provided.
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: monovalent vaccine given as booster; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (monovalent vaccine given as booster) and NO ADVERSE EVENT (No adverse event) in a male 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (monovalent vaccine given as booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (monovalent vaccine given as booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (monovalent vaccine given as booster).    No concomitant medications was reported. No treatment medications was reported.  The reporter states that she has a situation. She found out that they could not give the Moderna as a booster starting 31Aug2022, but she administered 15 monovalent doses as boosters.
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient received monovalent vaccine given as booster; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of INCORRECT DOSE ADMINISTERED (Patient received monovalent vaccine given as booster) and NO ADVERSE EVENT (No adverse event) in an elderly male patient 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 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (Patient received monovalent vaccine given as booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Patient received monovalent vaccine given as booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (Patient received monovalent vaccine given as booster).    No concomitant medications were reported.  It was reported that, booster that they received did not cover omicron, so the patients would need to be revaccinated with the bivalent later.   The reporter reported that, they could not give Moderna as a booster starting 31-Aug-2022, but they administered monovalent doses as boosters.  No treatment medications were reported.
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: administered FLUZONE QIV NP after the expiration date with no reported adverse event; Initial information received on 16-Sep-2022 regarding an unsolicited valid non-serious case received from a pediatrician.  This case involves a 15-year-old male patient to whom INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] np was administered after the expiration date with no reported adverse event while receiving vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 15-Sep-2022, the patient received suspect Fluzone QIV at dose 0.5ml once via intramuscular route in the left deltoid (lot: UT7407MA, expiry date: 30-Jun-2022) for prophylactic vaccination with no reported adverse event (expired product administered) at latency same day.  Action taken: Not applicable.  At time of reporting, the outcome was Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: pushed the plunger through and half of the vaccine went in and the needle separated from the product with no adverse event; Initial information received on 16-Sep-2022 regarding an unsolicited valid non-serious case received  via pharmacist. Agency number: 01282920  This case involves a patient of unknown demographics to whom Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent] was administered with pushed the plunger through and half of the vaccine went in and the needle separated from the product with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect Fluzone High-Dose Quadrivalent half dose at (formulation, strength, lot number, route, administration site) for prophylactic vaccination as the plunger was pushed through and half of the vaccine went in and the needle separated from the product with no adverse event (incorrect dose administered) (unknown latency).  It was reported that "the caller stated as one of the employees was giving the patient the FLUZONE HIGH-DOSE, he pushed the plunger through, and half of the vaccine went in, and the needle separated from the product while the other half didn't get administered. The reported inquired should they re-administer, or would half the dose suffice? Pharmacist states it was a PFS and the employee didn't have the needle tight on the syringe."    Action taken: Not applicable.  At time of reporting, the outcome was Unknown.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: patient was injected with TDAP on 9/15 and then seeing it had expired on 9/11 with no reported adverse event; Initial information received on 19-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 12 years old female patient who was injected with DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] on 9/15 and then seeing it had expired on 9/11 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 15-Sep-2022, the patient received 0.5 mL dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (formulation and strength not reported: lot C5770AA and expiry date: 11-Sep-2022) via intramuscular route in the right arm for prophylactic immunization.  On 15-Sep-2022, (latency: same day) the patient was injected with tdap on 9/15 and then seeing it had expired on 9/11 with no reported adverse event (expired product administered) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.42
Sex: F
Vaccine: HIBV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product preparation issue
Clinical narrative: administered acthib that was reconstituted with sterile water instead of the supplied acthib diluent with no reported adverse event; administered acthib that was reconstituted with sterile water instead of the supplied acthib diluent with no reported adverse event; Initial information received on 21-Sep-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 17 months old female patient who was administered acthib that was reconstituted with sterile water instead of the supplied acthib diluent with no reported adverse event while receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) and hepatitis A vaccine (HEPATITIS A) both for Prophylactic vaccination.  On 20-Sep-2022, the patient received suspect HIB (PRP/T) VACCINE at a dose of 0.5 ml (lot UJ665AAA, expiry date: 11-Mar-2023) via intramuscular route in the left thigh for immunisation.  On 20-Sep-2022 the patient was administered acthib that was reconstituted with sterile water instead of the supplied acthib diluent with no reported adverse event (product preparation error, poor quality product administered, latency same day).  Action taken: Not applicable.  Outcome: Unknown for both the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Chills, Dizziness, Headache, Hyperhidrosis
Clinical narrative: Fever of 103 for 24 hours, chills, severe headache, severe joint pain, tachycardia, dizziness, profuse sweating, fever and redness at injection site, hard lump at injection site, severe nausea
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site mass, Nausea, Pyrexia, Tachycardia
Clinical narrative: Fever of 103 for 24 hours, chills, severe headache, severe joint pain, tachycardia, dizziness, profuse sweating, fever and redness at injection site, hard lump at injection site, severe nausea
Age: 51.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Next day, red at injection site, skin is very warm to touch, itchy, same on 2nd day. Same reaction with my 1st 3 shots. All moderna
Age: 28.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dyspnoea, Hypertension, Pyrexia, Tachycardia
Clinical narrative: Patient found by mother at 4am the next morning to have high temperature and having trouble breathing. Patient was taccycardic at 170 and was taken to the hospital where his blood pressure was extremely high.  Patient was discharged from hospital today (9/25) after staying overnight 2 nights to reduce blood pressure.  Please contact mother for more information..
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: I had received the J&J COVID vaccine when I was 13 weeks and 3 days pregnant on 09/23/2021. My baby was born at 7lbs 5oz.  My child was both with a bilateral corneal opacity. She?s been treated with the corneal disease ophthalmologist (contact information provided) since 1 month of age. This birth defect was noticed 5 minutes after birth. The ophthalmologist believes this birth defect occurred between 12-14 weeks pregnant and as stated before,  I had the J&J shot at 13 weeks. It is not certain there is a connection but I feel it is worth reporting being that the vaccine and the window that the birth defect was suspected to have occurred overlap.
Age: 47.0
Sex: F
Vaccine: COVID19-2
Symptoms: Discomfort, Injection site urticaria, Lymphadenopathy, Mass, Pain
Clinical narrative: Mild itching the night of injection but no visible irritation. Hives (raised, hot to the touch, red rash, itching) starting the following morning. hives were small at first (1/4 in in diameter) starting at injection site. Over 36 hours or so the hives increased in size and discomfort. Hard lumps in the arm near the hives were also present. Hives and lumps resolved after a total of 4 days.  Swelling, pain and lumps were visible in the left armpit beginning the day after injection. Swelling of the lymph nodes was felt. Swelling and pain increased for about1-2 days and then slowly resolved by day 4.
Age: 47.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pruritus, Rash erythematous, Skin warm, Swelling, Urticaria
Clinical narrative: Mild itching the night of injection but no visible irritation. Hives (raised, hot to the touch, red rash, itching) starting the following morning. hives were small at first (1/4 in in diameter) starting at injection site. Over 36 hours or so the hives increased in size and discomfort. Hard lumps in the arm near the hives were also present. Hives and lumps resolved after a total of 4 days.  Swelling, pain and lumps were visible in the left armpit beginning the day after injection. Swelling of the lymph nodes was felt. Swelling and pain increased for about1-2 days and then slowly resolved by day 4.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Alopecia areata, Electric shock sensation, Pain, Restless legs syndrome
Clinical narrative: The following Saturday, my right leg started exhibiting symptoms similar to restless leg syndrome.  It felt like electricity running continuously through that leg for 4 months. Now I just minor pain in there pain.  In July, my hair dresser noticed I have a patch of hair missing.  I researched it to be alopecia areata.  That has also been linked to the vaccine.  I've never had issues with my hair before the vaccine.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle atrophy, Nerve injury
Clinical narrative: Nerve damage
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Discomfort, Exercise tolerance decreased
Clinical narrative: Chest pain for over a week (right in my heart). My best guess is pericarditis. It made exercise very uncomfortable and I was always conscious of it. I took a lot of anti-inflammatory pills which helped some. After about nine days the pain went away.
Age: 36.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Chest pain, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Overwhelming swelling and redness around injection site. Diameter of affect area is more than half of forearm. Increased firmness and tenderness. Mild chest pains.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AEs reported; Consumer reports that he received his third dose of GARDASIL 9 too early. Consumer reports 1st dose: 2/24/2022, 2nd dose: 4/12/2022, and 3rd dose: 7/12/2022; This spontaneous report was received from a male patient of unknown age referring to himself. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications, or drug reactions or allergies was provided.  On 24-FEB-2022, 12-APR-2022 and 12-JUL-2022, the patient was vaccinated with the first dose, second dose and third dose of HPV rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strengths, routes of administration, vaccination scheme frequencies, anatomical locations, doses, lot numbers and expiration dates were unknown). The patient reported that he received his third dose of HPV rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) too early (inappropriate schedule of product administration). No additional adverse event reported (no adverse event).