chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: U
Vaccine: COVID19, UNK
Symptoms: Abdominal distension, Abdominal pain upper, Diarrhoea, Flatulence, Vaccination site pain
Clinical narrative: Gas; Bloating; Loose stools; Pain stomach; Vaccination site warmth; Vaccination site swelling; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE PAIN (Vaccination site pain), FLATULENCE (Gas) and ABDOMINAL DISTENSION (Bloating) in a 68-year-old patient of an unknown gender 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 Ulcerative colitis and Panuveitis.    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 and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE PAIN (Vaccination site pain). On an unknown date, the patient experienced FLATULENCE (Gas), ABDOMINAL DISTENSION (Bloating), DIARRHOEA (Loose stools) and ABDOMINAL PAIN UPPER (Pain stomach). At the time of the report, VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE PAIN (Vaccination site pain) had resolved and FLATULENCE (Gas), ABDOMINAL DISTENSION (Bloating), DIARRHOEA (Loose stools) and ABDOMINAL PAIN UPPER (Pain stomach) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. No treatment information were provided.
Age: 68.0
Sex: U
Vaccine: COVID19, UNK
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Gas; Bloating; Loose stools; Pain stomach; Vaccination site warmth; Vaccination site swelling; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE PAIN (Vaccination site pain), FLATULENCE (Gas) and ABDOMINAL DISTENSION (Bloating) in a 68-year-old patient of an unknown gender 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 Ulcerative colitis and Panuveitis.    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 and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE PAIN (Vaccination site pain). On an unknown date, the patient experienced FLATULENCE (Gas), ABDOMINAL DISTENSION (Bloating), DIARRHOEA (Loose stools) and ABDOMINAL PAIN UPPER (Pain stomach). At the time of the report, VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE PAIN (Vaccination site pain) had resolved and FLATULENCE (Gas), ABDOMINAL DISTENSION (Bloating), DIARRHOEA (Loose stools) and ABDOMINAL PAIN UPPER (Pain stomach) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. No treatment information were provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was expired on 25-Mar-2022, stored in the refrigerator on 03-Apr-2022, and administered on 04-Apr-2022; Patient received Moderna Covid-19 vaccine that was expired.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that was expired.) and PRODUCT STORAGE ERROR (Vial was expired on 25-Mar-2022, stored in the refrigerator on 03-Apr-2022, and administered on 04-Apr-2022) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 051F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that was expired.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was expired on 25-Mar-2022, stored in the refrigerator on 03-Apr-2022, and administered on 04-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that was expired.) and PRODUCT STORAGE ERROR (Vial was expired on 25-Mar-2022, stored in the refrigerator on 03-Apr-2022, and administered on 04-Apr-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No information on concomitant and treatment medications was reported. One dose of expired vial was administered on 04-Apr-2022 and the vial did not undergo any temperature excursions.   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2022: Follow up information received includes no new information.
Sex: U
Vaccine: COVID19
Symptoms: Bedridden, Influenza
Clinical narrative: Rebound of flu symptoms; Bedridden; Flu symptom; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Rebound of flu symptoms), BEDRIDDEN (Bedridden) and INFLUENZA (Flu symptom) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021 at 12:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2022, the patient experienced INFLUENZA (Flu symptom). On 12-May-2022, the patient experienced BEDRIDDEN (Bedridden). On 12-May-2022 at 12:00 PM, the patient experienced INFLUENZA (Rebound of flu symptoms). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 04-May-2022 to 09-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. In May 2022, INFLUENZA (Flu symptom) had resolved. At the time of the report, INFLUENZA (Rebound of flu symptoms) and BEDRIDDEN (Bedridden) had not resolved.            No concomitant medication information was provided.  It was reported that rebound of flu symptoms on day 12 following the start date of 04 May 2022 for the Paxlovid. Patient had symptoms runny nose , sneezing, coughing, low fever and extreme fatigue, bedridden since 04 May 2022 with fatigue on 10 May 2022 most all symptoms were gone.
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: He got hives after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (He got hives after the vaccine) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     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 URTICARIA (He got hives after the vaccine). At the time of the report, URTICARIA (He got hives after the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication was reported. No treatment medications was reported.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Urticaria
Clinical narrative: Had a hard time breathing/difficulty breathing; Had the hives/experience the hives in his throat; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Had a hard time breathing/difficulty breathing) and URTICARIA (Had the hives/experience the hives in his throat) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     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 DYSPNOEA (Had a hard time breathing/difficulty breathing) and URTICARIA (Had the hives/experience the hives in his throat). At the time of the report, DYSPNOEA (Had a hard time breathing/difficulty breathing) and URTICARIA (Had the hives/experience the hives in his throat) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication was reported. Patient was taken to ER. Patient was administered with steroids for reaction and reported that luckily it turned out to be nothing.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Sleep disorder
Clinical narrative: Generalized asthma; when he's laying down he makes a kind of a whistling or clicking sound which interferes with his; This spontaneous case was reported by a patient and describes the occurrence of SLEEP DISORDER (when he's laying down he makes a kind of a whistling or clicking sound which interferes with his) and ASTHMA (Generalized asthma) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer Covid-19 Vaccine (2nd dose) on 27-Apr-2021 and Pfizer Covid-19 Vaccine (1st dose). Past adverse reactions to the above products included No adverse event with Pfizer Covid-19 Vaccine and Pfizer Covid-19 Vaccine. Concurrent medical conditions included Joint pain.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced SLEEP DISORDER (when he's laying down he makes a kind of a whistling or clicking sound which interferes with his). In February 2022, the patient experienced ASTHMA (Generalized asthma). The patient was treated with PREDNISONE for Asthma, at an unspecified dose and frequency and ALBUTEROL [SALBUTAMOL] for Asthma, at a dose of 2 to 3 times a day. At the time of the report, SLEEP DISORDER (when he's laying down he makes a kind of a whistling or clicking sound which interferes with his) and ASTHMA (Generalized asthma) outcome was unknown.            No relevant concomitant medications were reported.  Patient began to had asthma issues including wheezing, shortness of breath and a small amount of mucous production. It was worse at night and was when laying down ,patient would make a kind of a whistling or clicking sound which interfered with the sleep. Patient would cough, which cleared things up, and would to go back to sleep, then be awakened again after an hour or two. Furthermore, the patient took prednisone for a week that did nothing for the asthma but made previously established periodic joint pain go away.Albuterol inhaler last from 4 to 6 hours.
Age: 33.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Symptom recurrence
Clinical narrative: COVID-19; Rebound COVID symptoms 4 days after completion of the course; This spontaneous case was reported by a nurse and describes the occurrence of SYMPTOM RECURRENCE (Rebound COVID symptoms 4 days after completion of the course) and COVID-19 (COVID-19) 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 NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    The patient had no allergy.  Concurrent medical conditions included Asthma.   On 14-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) 1 dosage form. On 12-May-2022, the patient experienced SYMPTOM RECURRENCE (Rebound COVID symptoms 4 days after completion of the course). On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, SYMPTOM RECURRENCE (Rebound COVID symptoms 4 days after completion of the course) and COVID-19 (COVID-19) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. The patient was not taking any other medications within 2 weeks of starting COVID-19 treatment.  No treatment information were provided.  Company comment: This spontaneous case concerns a 33-year-old female patient with no relevant medical history who experienced the unexpected non serious AESI of COVID 19 unknown days after the administration of third dose of mRNA-1273 vaccine. Patient took NIRMATRELVIR, RITONAVIR (Paxlovid) for 5 days as treatment for COVID 19. Then patient experienced Rebound COVID symptoms 4 days after completion of the course of Paxlovid. Details regarding primary doses of vaccination, concomitant medications, other investigations are not available. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 33-year-old female patient with no relevant medical history who experienced the unexpected non serious AESI of COVID 19 unknown days after the administration of third dose of mRNA-1273 vaccine. Patient took NIRMATRELVIR, RITONAVIR (Paxlovid) for 5 days as treatment for COVID 19. Then patient experienced Rebound COVID symptoms 4 days after completion of the course of Paxlovid. Details regarding primary doses of vaccination, concomitant medications, other investigations are not available. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator on 11-Jan-2022 and administered on 13-Apr-2022; Vial was initially stored in the refrigerator on 11-Jan-2022 and administered on 13-Apr-2022/Dose administered after 30-day Use By Date; 1st dose given on 09-Feb-2021 and 2nd dose given on 10-Nov-2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vial was initially stored in the refrigerator on 11-Jan-2022 and administered on 13-Apr-2022/Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 11-Jan-2022 and administered on 13-Apr-2022) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose given on 09-Feb-2021 and 2nd dose given on 10-Nov-2021) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 035C21A and 011M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose given on 09-Feb-2021 and 2nd dose given on 10-Nov-2021). On 13-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vial was initially stored in the refrigerator on 11-Jan-2022 and administered on 13-Apr-2022/Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 11-Jan-2022 and administered on 13-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vial was initially stored in the refrigerator on 11-Jan-2022 and administered on 13-Apr-2022/Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 11-Jan-2022 and administered on 13-Apr-2022) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose given on 09-Feb-2021 and 2nd dose given on 10-Nov-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  The patient received 1st booster on 13-Apr-2022. The vial was stored initial in the refrigerator on 11-Jan-2022. The vial undergo did not any temperature excursions.  It was reported that patient did not reported adverse reaction.  Treatment information was not provided by the reporter.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 27-Apr-2022; The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 27-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 27-Apr-2022) and EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 27-Apr-2022) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 035C21A, 038B21A and 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 27-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 27-Apr-2022). At the time of the report, PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 27-Apr-2022) and EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 27-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Date the vial was initially stored in the refrigerator on 11-Jan-2022. The vial did not undergo any temperature excursions. No patient has reported adverse reaction. No treatment medications were reported.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 27-APR-2022; Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 27-APR-2022/ Dose administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 27-APR-2022/ Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 27-APR-2022) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 035C21A, 016B21A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 27-APR-2022/ Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 27-APR-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 27-APR-2022/ Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 27-APR-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Patient received first booster dose on 17-Nov-2021.  Date the vial was initially stored in the refrigerator was 11-Jan-2022. The vial did not undergo any temperature excursions. Patient received second booster dose on 27-Apr-2022. Patient did not reported any adverse reactions.  Treatment information was not provided by the reporter.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Vomiting
Clinical narrative: truly sick; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (truly sick) and VOMITING (Vomiting) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (truly sick) and VOMITING (Vomiting). At the time of the report, ILLNESS (truly sick) and VOMITING (Vomiting) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: sore right injection site arm; she was tired; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (sore right injection site arm) and FATIGUE (she was tired) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore right injection site arm) and FATIGUE (she was tired). At the time of the report, VACCINATION SITE PAIN (sore right injection site arm) and FATIGUE (she was tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications was reported. No treatment drug details was reported.   This case was linked to MOD-2022-569659, MOD-2022-569293 (Patient Link).
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was stored in the refrigerator on 11-Jan-2022, and administered on 04-May-2022; patient received expired dose more than 30 days after 11-Jan-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received expired dose more than 30 days after 11-Jan-2022) and PRODUCT STORAGE ERROR (Vial was stored in the refrigerator on 11-Jan-2022, and administered on 04-May-2022) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 035C21A, 001B21A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received expired dose more than 30 days after 11-Jan-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in the refrigerator on 11-Jan-2022, and administered on 04-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received expired dose more than 30 days after 11-Jan-2022) and PRODUCT STORAGE ERROR (Vial was stored in the refrigerator on 11-Jan-2022, and administered on 04-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medications was reported.  It was reported that reporter's team had accidentally administered expired Moderna COVID-19 vaccine to 18 patients: 9 patients on 9-May-2022 and 9 patients on 11-May-2022 (vaccine expired 5-May-2022). After further investigation it was identified that staff were not dating the boxes of vaccine when placing them in the fridge for storage. This lot number (084J21A) was received and placed in the fridge on 11-Jan-2022, which means that all doses administered more than 30 days after 11-Jan-2022 were not in accordance with the EUA. This included 84 doses administered to 82 patients (as 2 patients received 2 doses from this lot more than 30 days after it was in the fridge) administered between 16-Feb-2022 and 11-May-2022. Vial did not undergo any temperature excursion.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: tiredness; sore arm when she touched the injection site; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (tiredness) and VACCINATION SITE PAIN (sore arm when she touched the injection site) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (tiredness) and VACCINATION SITE PAIN (sore arm when she touched the injection site). At the time of the report, FATIGUE (tiredness) and VACCINATION SITE PAIN (sore arm when she touched the injection site) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 02-Mar-2022; The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 02-Mar-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 02-Mar-2022) and EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 02-Mar-2022) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 030L20A and 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 02-Mar-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 02-Mar-2022). At the time of the report, PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 02-Mar-2022) and EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 02-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Date the vial was initially stored in the refrigerator was 11-Jan-2022. The vial did not undergo any temperature excursions. No patient has reported adverse reaction. No treatment medications were reported.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vaccine was stored in the refrigerator on 11-Jan-2022/Vaccine administered on 04-May-2022; The vaccine was stored in the refrigerator on 11-Jan-2022/Vaccine administered on 04-May-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vaccine was stored in the refrigerator on 11-Jan-2022/Vaccine administered on 04-May-2022) and PRODUCT STORAGE ERROR (The vaccine was stored in the refrigerator on 11-Jan-2022/Vaccine administered on 04-May-2022) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 016M20A, 001B21A and 035C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vaccine was stored in the refrigerator on 11-Jan-2022/Vaccine administered on 04-May-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine was stored in the refrigerator on 11-Jan-2022/Vaccine administered on 04-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vaccine was stored in the refrigerator on 11-Jan-2022/Vaccine administered on 04-May-2022) and PRODUCT STORAGE ERROR (The vaccine was stored in the refrigerator on 11-Jan-2022/Vaccine administered on 04-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant a and treatment medications were reported.  The reporter wanted to know whether the patient need to be revaccinated or the dose was viable. The vial was initially stored in the refrigerator on 11-Jan-2022. The vial did not undergo any temperature excursions. The frequency was reported as times per. The patient had not reported adverse reaction. No medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 04-May-2022; Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 04-May-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 04-May-2022) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 04-May-2022) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 035C21A, 016M20A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 04-May-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 04-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 04-May-2022) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 04-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.   It was reported that the reporter had identified an additional issue that staff were not dating the boxes of vaccine when placing them in the fridge for storage. This lot number (084J21A) was received and placed in the fridge on 11-Jan-2022, which means that all doses administered more than 30 days after 11-Jan-2022 are not in accordance with the EUA.  Date the vial was initially stored in the refrigerator was 11-Jan-2022. The vial did not undergo any temperature excursions. Patient received First booster dose on 27-Oct-2021 and  second booster dose on 04-May-2022. Patient did not reported any adverse reactions.  Treatment information was not provided by the reporter.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Placed in the fridge on 11-Jan-2022 and administered on 04 May 2022; Patient administered expired moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered expired moderna vaccine) and PRODUCT STORAGE ERROR (Placed in the fridge on 11-Jan-2022 and administered on 04 May 2022) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 035C21A, 038B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered expired moderna vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Placed in the fridge on 11-Jan-2022 and administered on 04 May 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered expired moderna vaccine) and PRODUCT STORAGE ERROR (Placed in the fridge on 11-Jan-2022 and administered on 04 May 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Date the vial was initially stored in the refrigerator was on 11-Jan-2022 The vial did not undergo any temperature excursions. They identified an additional issue that staff were not dating the boxes of vaccine when placing them in the fridge for storage. No adverse event reported. No treatment drugs were reported
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial stored in refrigerator on 11-Jan-2022 and administered to the patient on 04-May-2022; Vial stored in refrigerator on 11-Jan-2022 and administered to the patient on 04-May-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vial stored in refrigerator on 11-Jan-2022 and administered to the patient on 04-May-2022) and PRODUCT STORAGE ERROR (Vial stored in refrigerator on 11-Jan-2022 and administered to the patient on 04-May-2022) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 035C21A, 007C21A and 038B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vial stored in refrigerator on 11-Jan-2022 and administered to the patient on 04-May-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial stored in refrigerator on 11-Jan-2022 and administered to the patient on 04-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vial stored in refrigerator on 11-Jan-2022 and administered to the patient on 04-May-2022) and PRODUCT STORAGE ERROR (Vial stored in refrigerator on 11-Jan-2022 and administered to the patient on 04-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was reported by pharmacist, the vaccine coordinator in their health care facility, that they inadvertently administered an expired dose of the Moderna Covid-19. Post further investigation of the issue, pharmacist identified an additional issue that staff were not dating the boxes of vaccine when placing them in the fridge for storage. This lot number 084J21A was received and placed in the fridge initially on 11-Jan-2022, which means that all doses administered more than 30 days after 11-Jan-2022 were not in accordance. The vial did not undergo any temperature excursions. The patient did not report any adverse reaction to the health care professional's knowledge.  No treatment medication was reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Disgeusa; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Disgeusa) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    The patient's past medical history included Papillary thyroid cancer. Concurrent medical conditions included Blood pressure high and Osteoporosis. Concomitant products included PREDNISONE from 06-May-2022 to 11-May-2022 for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021 at 10:00 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) 1 dosage form. On 06-May-2022, the patient experienced DYSGEUSIA (Disgeusa). On 14-May-2022, DYSGEUSIA (Disgeusa) had resolved.            No treatment information was provided by the reporter. Disgeusa Device Date reported, 15May2022.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial stored in refrigerator on 11-Jan-2022 and administered to the patient on 04-May-2022 post 30 days; Vial stored in refrigerator on 11-Jan-2022 and administered to the patient on 04-May-2022 post 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vial stored in refrigerator on 11-Jan-2022 and administered to the patient on 04-May-2022 post 30 days) and PRODUCT STORAGE ERROR (Vial stored in refrigerator on 11-Jan-2022 and administered to the patient on 04-May-2022 post 30 days) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 003F21A, 038B21A and 029A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vial stored in refrigerator on 11-Jan-2022 and administered to the patient on 04-May-2022 post 30 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial stored in refrigerator on 11-Jan-2022 and administered to the patient on 04-May-2022 post 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vial stored in refrigerator on 11-Jan-2022 and administered to the patient on 04-May-2022 post 30 days) and PRODUCT STORAGE ERROR (Vial stored in refrigerator on 11-Jan-2022 and administered to the patient on 04-May-2022 post 30 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was reported by pharmacist, the vaccine coordinator in their health care facility, that they inadvertently administered an expired dose of the Moderna Covid-19. Post further investigation of the issue, pharmacist identified an additional issue that staff were not dating the boxes of vaccine when placing them in the fridge for storage. This lot number 084J21A was received and placed in the fridge initially on 11-Jan-2022, which means that all doses administered more than 30 days after 11-Jan-2022 were not in accordance with the EUA. The vial did not undergo any temperature excursions. The patient did not report any adverse reaction to the health care professional's knowledge.  No treatment medication was reported.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 27-Apr-2022; The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 27-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 27-Apr-2022) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 27-Apr-2022) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 037F, 029A21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 27-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 27-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 27-Apr-2022) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 27-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Date the vial was initially stored in the refrigerator on 11-Jan-2022. The vial did not undergo any temperature excursions. No patient has reported adverse reaction.  No treatment medications were reported.