chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator on 12-Apr-2022 and was administered to a patient after 30 day use by date; Dose administered after 30-day use by date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 12-Apr-2022 and was administered to a patient after 30 day use by date) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065K21A, 006B21A, 025B21A and 034F21A) for COVID-19 vaccination.     Patient had no allergies to medications, food and other products. Patient had never diagnosed or tested positive for COVID.  Concurrent medical conditions included Nasal congestion. Concomitant products included AZITHROMYCIN (ZITHROMAX) for Nasal congestion.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (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 12-Apr-2022 and was administered to a patient after 30 day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 12-Apr-2022 and was administered to a patient after 30 day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received the booster dose on 12-May-2022 (Manufacturer expiry: 05-Jul-2022).   It was reported that patient was administered with one dose of Moderna COVID-19 Vaccine after 30-day use by date on 12-May-2022. No adverse events were reported by patient to HCP after getting the vaccine. Vial didn't undergo any temperature excursions.  No treatment information were given.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Coeliac disease
Clinical narrative: Patient has been diagnosed with Celiac disease on 02May2022; This spontaneous case was reported by a patient and describes the occurrence of COELIAC DISEASE (Patient has been diagnosed with Celiac disease on 02May2022) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A and 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hashimoto's disease (she takes levothyroxine and had this history even before the 1st dose of Moderna vaccine.). Concomitant products included LEVOTHYROXINE for Hashimoto's disease.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-May-2022, the patient experienced COELIAC DISEASE (Patient has been diagnosed with Celiac disease on 02May2022) (seriousness criterion medically significant). At the time of the report, COELIAC DISEASE (Patient has been diagnosed with Celiac disease on 02May2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Apr-2022, Biopsy: celiac disease (abnormal) On 02May2022 patient was diagnosed with celiac disease.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient's height was 5'6. Concomitant medication were given as Supplements. Patient stated that she wanted to get the 2nd booster dose on the day of reporting. No treatment medication was received.  Company Comment: This spontaneous case concerns a 68-year-old female patient with relevant medical history of Hashimoto's disease, who was diagnosed with unexpected serious (medically significant) event of Celiac disease. The event occurred 5 months 10 days after the 3rd dose of the mRNA-1273 (Spikevax). Concomitant products included levothyroxine for Hashimoto's disease. Medical history of Hashimoto's disease is known to have association with other autoimmune disorders. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 68-year-old female patient with relevant medical history of Hashimoto's disease, who was diagnosed with unexpected serious (medically significant) event of Celiac disease. The event occurred 5 months 10 days after the 3rd dose of the mRNA-1273 (Spikevax). Concomitant products included levothyroxine for Hashimoto's disease. Medical history of Hashimoto's disease is known to have association with other autoimmune disorders. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19 / Rebounded infection / Still suffering symptoms and testing positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Treatment of COVID-19 / Rebounded infection / Still suffering symptoms and testing positive) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy.    On 06-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Treatment of COVID-19 / Rebounded infection / Still suffering symptoms and testing positive). At the time of the report, COVID-19 (Treatment of COVID-19 / Rebounded infection / Still suffering symptoms and testing positive) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-May-2022, SARS-CoV-2 test: tested positive (Positive) Tested positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.  Patient took unknown drug with indication COVID-19 Treatment on 05-May-2022 and stop date 10-May-2022.  The patient was not taking other medications or products within 2 weeks of staring COVID-19 treatment. The patient previously received a unknown COVID-19 vaccine. The patient had rebounded infection after completing the 5 days, but still suffering symptoms and tested positive. The device date 19-May-2022.  Company Comment: This is a spontaneous case concerning a 72-year-old male patient with no relevant medical history, who experienced the unexpected, non-serious, adverse event of special interest, COVID-19 which occurred approximately 6 months after receiving the third dose of mRNA-1273 Vaccine. SARS-CoV-2 Test was positive, no other clinical or treatment details were given. It was reported that the outcome of the event has not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 72-year-old male patient with no relevant medical history, who experienced the unexpected, non-serious, adverse event of special interest, COVID-19 which occurred approximately 6 months after receiving the third dose of mRNA-1273 Vaccine. SARS-CoV-2 Test was positive, no other clinical or treatment details were given. It was reported that the outcome of the event has not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Post-acute COVID-19 syndrome
Clinical narrative: Within 7/8 days I came down with Covid in the worst way/it´s been a long Covid/it doesn´t go away; it´s been a long Covid/it doesn´t go away; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Within 7/8 days I came down with Covid in the worst way/it´s been a long Covid/it doesn´t go away) and POST-ACUTE COVID-19 SYNDROME (it´s been a long Covid/it doesn´t go away) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Within 7/8 days I came down with Covid in the worst way/it´s been a long Covid/it doesn´t go away) and POST-ACUTE COVID-19 SYNDROME (it´s been a long Covid/it doesn´t go away). At the time of the report, COVID-19 (Within 7/8 days I came down with Covid in the worst way/it´s been a long Covid/it doesn´t go away) and POST-ACUTE COVID-19 SYNDROME (it´s been a long Covid/it doesn´t go away) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drug was reported. Patient reported that, that was like 6 months ago, and now it´s been a long COVID, it doesn´t go away. No Treatment medications were reported. Company comment This spontaneous case was reported by a consumer and concerns a patient of an unknown age and gender, with no reported medical history, who experienced the unexpected non- serious AESIs of COVID-19 and Post-acute COVID-19 syndrome, which occurred Within 7/8 days after receiving a dose of mRNA-1273 vaccine (unknown number and schedule). Patient reported that it was 6 months ago, and it wasn't going away. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case was reported by a consumer and concerns a patient of an unknown age and gender, with no reported medical history, who experienced the unexpected non- serious AESIs of COVID-19 and Post-acute COVID-19 syndrome, which occurred Within 7/8 days after receiving a dose of mRNA-1273 vaccine (unknown number and schedule). Patient reported that it was 6 months ago, and it wasn't going away. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling, Hypersensitivity, Pruritus, Seasonal allergy
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Severe allergic reaction/allergies), SEASONAL ALLERGY (seasonal allergies), EYE SWELLING (eyes are swollen) and PRURITUS (itchy) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The patient had not had seasonal allergies before receiving the Moderna vaccine. On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced HYPERSENSITIVITY (Severe allergic reaction/allergies), SEASONAL ALLERGY (seasonal allergies), EYE SWELLING (eyes are swollen) and PRURITUS (itchy). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Allergy, at an unspecified dose and frequency; FEXOFENADINE HYDROCHLORIDE (ALLEGRA ALLERGY) for Allergy, at an unspecified dose and frequency; OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) for Allergy, at an unspecified dose and frequency and LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) for Allergy, at an unspecified dose and frequency. At the time of the report, HYPERSENSITIVITY (Severe allergic reaction/allergies), EYE SWELLING (eyes are swollen) and PRURITUS (itchy) outcome was unknown and SEASONAL ALLERGY (seasonal allergies) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication information was provided. The allergy like symptoms went away during the summer, but had came back this spring. He did not had seasonal allergies before receiving the Moderna vaccine. This case was linked to MOD-2022-571957 (Patient Link).
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Seasonal allergy
Clinical narrative: allergy like symptoms went away during the summer, but have come back this spring; body aches/muscle aches; fever; This spontaneous case was reported by a consumer and describes the occurrence of SEASONAL ALLERGY (allergy like symptoms went away during the summer, but have come back this spring), MYALGIA (body aches/muscle aches) and PYREXIA (fever) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 030B21A) for COVID-19 vaccination.     The patient had not had seasonal allergies before receiving the Moderna vaccine.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced MYALGIA (body aches/muscle aches) and PYREXIA (fever). On an unknown date, the patient experienced SEASONAL ALLERGY (allergy like symptoms went away during the summer, but have come back this spring). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, SEASONAL ALLERGY (allergy like symptoms went away during the summer, but have come back this spring), MYALGIA (body aches/muscle aches) and PYREXIA (fever) outcome was unknown.            No concomitant medications were reported.   It was reported that, the patient took Tylenol, Advil, Aleve, and unspecified pain medications for his symptoms.   This case was linked to MOD-2022-571941 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Irregular bleeding/period; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION IRREGULAR (Irregular bleeding/period) in an elderly female 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, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MENSTRUATION IRREGULAR (Irregular bleeding/period). At the time of the report, MENSTRUATION IRREGULAR (Irregular bleeding/period) outcome was unknown.            Concomitant medications was not provided by the reporter.  Patient stated she had completed the primary vaccination series and received 2 Moderna boosters. The experienced bleeding/period after getting the moderna Covid-19 vaccine.  Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Anaemia, Contusion, Headache, Injection site bruising, Vaccination site pain
Clinical narrative: ANEMIC; BRUISING ON LEFT SIDE OF STOMACH; BRUISING AT INJECTION SITE/LEFT THIGH; BRUISING AT INJECTION SITE/LEFT THIGH; VACCINE CAUSED PAIN IN INJECTION SITE; HEADACHE; This spontaneous case was reported by a consumer and describes the occurrence of ANAEMIA (ANEMIC), CONTUSION (BRUISING ON LEFT SIDE OF STOMACH), INJECTION SITE BRUISING (BRUISING AT INJECTION SITE/LEFT THIGH), CONTUSION (BRUISING AT INJECTION SITE/LEFT THIGH) and VACCINATION SITE PAIN (VACCINE CAUSED PAIN IN INJECTION SITE) in an adult 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 Ulcerative colitis.    There was no reported medical history.  Concomitant products included GABAPENTIN, LOSARTAN POTASSIUM, ATENOLOL, VITAMIN C [ASCORBIC ACID], ISOSORBIDE, MONONITRATE D'ISOSORBIDE, HYDROCHLOROTHIAZID, IDE 196 and MESALAZINE (LIALDA) for an unknown indication.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose every two weeks. On an unknown date, the patient experienced ANAEMIA (ANEMIC), CONTUSION (BRUISING ON LEFT SIDE OF STOMACH), INJECTION SITE BRUISING (BRUISING AT INJECTION SITE/LEFT THIGH), CONTUSION (BRUISING AT INJECTION SITE/LEFT THIGH), VACCINATION SITE PAIN (VACCINE CAUSED PAIN IN INJECTION SITE) and HEADACHE (HEADACHE). The patient was treated with CLOPIDOGREL at an unspecified dose and frequency. At the time of the report, ANAEMIA (ANEMIC) and VACCINATION SITE PAIN (VACCINE CAUSED PAIN IN INJECTION SITE) outcome was unknown and CONTUSION (BRUISING ON LEFT SIDE OF STOMACH), INJECTION SITE BRUISING (BRUISING AT INJECTION SITE/LEFT THIGH), CONTUSION (BRUISING AT INJECTION SITE/LEFT THIGH) and HEADACHE (HEADACHE) had resolved.            Concomitant medication Included: Probiotic (Bifidobacterium Bifidum;Bifidobacterium Lactis;Bifidobacterium Longum;Lactobacillus Acidophilus;Lactobacillus Rhamnosus)(Lactobacillus Acidophilus, Lactobacillus Rhamnosus, Bifidobacterium Lactis, Bifidobacterium Longum, Bifidobacterium Bifidum).  Humira was discontinued, dechallenge was unknown for events vaccine caused pain in injection site, anemic and rechallenge was not applicable, dechallenge was positive for events bruising on left side of stomach, bruising at injection site/left thigh and rechallenge was not done.  The reporter's causality for co-suspect Humira for the events of vaccine caused pain in injection site, anemic, bruising on left side of stomach, bruising at injection site/left thigh and headache was not provided.   Reporter did not allow further contact
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Impaired healing
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of IMPAIRED HEALING (Delayed healing of wound) and COVID-19 (COVID-19) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included ADALIMUMAB (HUMIRA) for Rheumatoid arthritis. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In December 2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced IMPAIRED HEALING (Delayed healing of wound). The patient was treated with POTASSIUM at an unspecified dose and frequency. At the time of the report, IMPAIRED HEALING (Delayed healing of wound) outcome was unknown and COVID-19 (COVID-19) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication were reported. It was reported that the daily dose of Moderna COVID-19 Vaccine given as (1 in 1 Once) and for co-suspect Humira was reported as CF PEN. It was reported that the primary reporter did not have the lot number information, because the packaging was discarded. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter causality for the events of LEG INJURY TAKING A LONG TIME TO HEAL unknown onset, COVID, NECK PROBLEMS, LEG INJURY TAKING A LONG TIME TO HEAL unknown onset and MUSCLE TIGHTNESS with HUMIRA (ADALIMUMAB) was no reasonable possibility (Not Related). Company comment: This spontaneous case concerns a 73-year-old female patient with relevant medial history of treatment with Adalimumab for Rheumatoid arthritis, who experienced the unexpected non-serious AESI Covid-19, after receiving a dose of mRNA-1273 vaccine on an unspecified date. Latency unknown as the onset date was not specified. Details of symptoms, Clinical course, investigation reports and treatment were not provided. The outcome was reported as resolved. The current pandemic situation of Covid-19 could be a confounder. Elderly age of the patient and treatment with Adalimumab could be risk factors. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns a 73-year-old female patient with relevant medial history of treatment with Adalimumab for Rheumatoid arthritis, who experienced the unexpected non-serious AESI Covid-19, after receiving a dose of mRNA-1273 vaccine on an unspecified date. Latency unknown as the onset date was not specified. Details of symptoms, Clinical course, investigation reports and treatment were not provided. The outcome was reported as resolved. The current pandemic situation of Covid-19 could be a confounder. Elderly age of the patient and treatment with Adalimumab could be risk factors. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 26-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 Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (MODERATE TO SEVERE RHEUMATOID ARTHRITIS).   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and dose of ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On 24-Apr-2022, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant). On 26-Apr-2022, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medication information provided.  The dose number of suspect Moderna vaccine was reported as COVID Booster (1 in 1 Once).  It was unknown if patient was enrolled in a COVID-19  clinical trial.  For the co-suspect Humira, action taken was reported as unknown, de-challenge reported as not applicable and reporter causality was reported as no reasonable possibility/ not related.  Company comment: This spontaneous case was received via another Manufacturer and concerns a 26-year-old female patient, with medical history of Rheumatoid arthritis in treatment with ADALIMUMAB, who experienced the unexpected serious (medically significant) AESI of RHEUMATOID ARTHRITIS, in the context of the administration of mRNA-1273 vaccine as booster dose for COVID 19 vaccination (unknown schedule). Latency cannot be assessed, as vaccination date was not reported. Rheumatoid arthritis flare up lasted for two days. The mentioned medical history remains as a confounder, and Adalimumab was reported as a co-suspect drug. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case was received via another Manufacturer and concerns a 26-year-old female patient, with medical history of Rheumatoid arthritis in treatment with ADALIMUMAB, who experienced the unexpected serious (medically significant) AESI of RHEUMATOID ARTHRITIS, in the context of the administration of mRNA-1273 vaccine as booster dose for COVID 19 vaccination (unknown schedule). Latency cannot be assessed, as vaccination date was not reported. Rheumatoid arthritis flare up lasted for two days. The mentioned medical history remains as a confounder, and Adalimumab was reported as a co-suspect drug. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: When I received the booster shot, I became sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (When I received the booster shot, I became sick) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (When I received the booster shot, I became sick). At the time of the report, ILLNESS (When I received the booster shot, I became sick) outcome was unknown.            No concomitant medications was reported. It was reported that the patient had recieved first two doses and two booster shots of Moderna vaccine.   No treatment was reported.   This case was linked to MOD-2022-572014 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vial was moved from freezer to refrigerated conditions on 28Dec2021; 5 expired vaccine doses administered after manufacturer date of expiration; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 expired vaccine doses administered after manufacturer date of expiration) and PRODUCT STORAGE ERROR (vial was moved from freezer to refrigerated conditions on 28Dec2021) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 032F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 expired vaccine doses administered after manufacturer date of expiration). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was moved from freezer to refrigerated conditions on 28Dec2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 expired vaccine doses administered after manufacturer date of expiration) and PRODUCT STORAGE ERROR (vial was moved from freezer to refrigerated conditions on 28Dec2021) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided. Vial was removed from freezer and stored in refrigerator on 28-Dec-2021. HCP reported that five Moderna COVID-19 vaccine expired doses were administered which was a mix of doses for those patients. It was confirmed that the vial had not undergone any temperature excursion issue. No treatment drug information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2022: Significant follow up appended-secondary reporter, refrigeration date and narrative updated.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Chest pain, Gait disturbance, Illness
Clinical narrative: Second booster shot, I became sick; I can hardly walk/repeats that he can't walk; He has to llive from an impairment from the vaccine; inflammation throughout my body/inflammation is so bad/ It's getting worse every day/It is systemic in my whole day; chest pain; abdominal pain; pain in my joints from the inflammation is so bad; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Second booster shot, I became sick), GAIT DISTURBANCE (I can hardly walk/repeats that he can't walk), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (He has to llive from an impairment from the vaccine), INFLAMMATION (inflammation throughout my body/inflammation is so bad/ It's getting worse every day/It is systemic in my whole day) and CHEST PAIN (chest pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Second booster shot, I became sick), GAIT DISTURBANCE (I can hardly walk/repeats that he can't walk), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (He has to llive from an impairment from the vaccine), INFLAMMATION (inflammation throughout my body/inflammation is so bad/ It's getting worse every day/It is systemic in my whole day), CHEST PAIN (chest pain), ABDOMINAL PAIN (abdominal pain) and ARTHRALGIA (pain in my joints from the inflammation is so bad). The patient was treated with MELOXICAM at a dose of 1 dosage form. At the time of the report, ILLNESS (Second booster shot, I became sick), GAIT DISTURBANCE (I can hardly walk/repeats that he can't walk), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (He has to llive from an impairment from the vaccine), CHEST PAIN (chest pain), ABDOMINAL PAIN (abdominal pain) and ARTHRALGIA (pain in my joints from the inflammation is so bad) outcome was unknown and INFLAMMATION (inflammation throughout my body/inflammation is so bad/ It's getting worse every day/It is systemic in my whole day) had not resolved.            No concomitant information were reported by the reporter. Patient reported that received the first two Moderna vaccinations and two Moderna booster shots and also reported that pain in his joints from the inflammation is so bad and it was a result of this vaccination. Other treatment medicine includes: Anti-inflammatory drugs.   This case was linked to MOD-2022-572009 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Inflammation, Loss of personal independence in daily activities
Clinical narrative: Second booster shot, I became sick; I can hardly walk/repeats that he can't walk; He has to llive from an impairment from the vaccine; inflammation throughout my body/inflammation is so bad/ It's getting worse every day/It is systemic in my whole day; chest pain; abdominal pain; pain in my joints from the inflammation is so bad; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Second booster shot, I became sick), GAIT DISTURBANCE (I can hardly walk/repeats that he can't walk), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (He has to llive from an impairment from the vaccine), INFLAMMATION (inflammation throughout my body/inflammation is so bad/ It's getting worse every day/It is systemic in my whole day) and CHEST PAIN (chest pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Second booster shot, I became sick), GAIT DISTURBANCE (I can hardly walk/repeats that he can't walk), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (He has to llive from an impairment from the vaccine), INFLAMMATION (inflammation throughout my body/inflammation is so bad/ It's getting worse every day/It is systemic in my whole day), CHEST PAIN (chest pain), ABDOMINAL PAIN (abdominal pain) and ARTHRALGIA (pain in my joints from the inflammation is so bad). The patient was treated with MELOXICAM at a dose of 1 dosage form. At the time of the report, ILLNESS (Second booster shot, I became sick), GAIT DISTURBANCE (I can hardly walk/repeats that he can't walk), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (He has to llive from an impairment from the vaccine), CHEST PAIN (chest pain), ABDOMINAL PAIN (abdominal pain) and ARTHRALGIA (pain in my joints from the inflammation is so bad) outcome was unknown and INFLAMMATION (inflammation throughout my body/inflammation is so bad/ It's getting worse every day/It is systemic in my whole day) had not resolved.            No concomitant information were reported by the reporter. Patient reported that received the first two Moderna vaccinations and two Moderna booster shots and also reported that pain in his joints from the inflammation is so bad and it was a result of this vaccination. Other treatment medicine includes: Anti-inflammatory drugs.   This case was linked to MOD-2022-572009 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: doses administered after temperature excursion events; doses administered after temperature excursion events; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after temperature excursion events) and PRODUCT STORAGE ERROR (doses administered after temperature excursion events) in a  patient of an unknown age and gender 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 PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after temperature excursion events) and PRODUCT STORAGE ERROR (doses administered after temperature excursion events). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after temperature excursion events) and PRODUCT STORAGE ERROR (doses administered after temperature excursion events) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. No Treatment medications were reported. It was reported that some vials were used during patient administration in early April and never went higher then a maximum of 4.4 degrees c.   Reporter did not allow further contact
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Depression, Fall, Head injury
Clinical narrative: After receiving the 1st shot patient fell and hit her head,; hit her head, In total patient has hit her head 9 times due to the falls; very depressed when she got the first shot; This spontaneous case was reported by a patient and describes the occurrence of FALL (After receiving the 1st shot patient fell and hit her head,), HEAD INJURY (hit her head, In total patient has hit her head 9 times due to the falls) and DEPRESSION (very depressed when she got the first shot) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03821A) for COVID-19 vaccination.     The patient's past medical history included Myelofibrosis in 1989, COVID-19 (in 202 when the pandemic started she got COVID and had to stay at home) and Immunocompromised. Concurrent medical conditions included Hypertension and Allergy NOS (Some allergies). Concomitant products included VITAMINS NOS for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FALL (After receiving the 1st shot patient fell and hit her head,), HEAD INJURY (hit her head, In total patient has hit her head 9 times due to the falls) and DEPRESSION (very depressed when she got the first shot). At the time of the report, FALL (After receiving the 1st shot patient fell and hit her head,), HEAD INJURY (hit her head, In total patient has hit her head 9 times due to the falls) and DEPRESSION (very depressed when she got the first shot) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concurrent medications included medications for high blood pressure. Treatment details was not reported by the reporter.   This case was linked to MOD-2022-572048 (Patient Link).
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Covid-19/Congestion headache and dry cough; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19/Congestion headache and dry cough) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029k2oa) for COVID-19 vaccination.     The patient was not taking any other medications or products within 2 weeks of starting COVID-19 treatment. The patient had received previously a COVID-19 vaccine.  the patient had allergic reaction on unknown drugs.     On 05-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2022, the patient experienced COVID-19 (Covid-19/Congestion headache and dry cough). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 06-May-2022 to 10-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Covid-19/Congestion headache and dry cough) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided. company comment This spontaneous case concerns a 43-year-old female patient with no relevant medical history, who experienced the unexpected non-serious adverse event of special interest COVID-19 (with a positive SARS-CoV-2 test) that occurred on an unknown date, about 2 months after receiving a dose of mRNA-1273 Vaccine. The patient was treated with paxlovid from 06-May-2022 to 10-May-2022 for 5 days for COVID-19 treatment. Four days after stopping paxlovid, on 14-May-2022, the patient experienced cough (dry cough) and headache (Congestion headache). On an unknown date, SARS-CoV-2 test was positive. Outcome of covid 19 was unknown.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a 43-year-old female patient with no relevant medical history, who experienced the unexpected non-serious adverse event of special interest COVID-19 (with a positive SARS-CoV-2 test) that occurred on an unknown date, about 2 months after receiving a dose of mRNA-1273 Vaccine. The patient was treated with paxlovid from 06-May-2022 to 10-May-2022 for 5 days for COVID-19 treatment. Four days after stopping paxlovid, on 14-May-2022, the patient experienced cough (dry cough) and headache (Congestion headache). On an unknown date, SARS-CoV-2 test was positive. Outcome of covid 19 was unknown.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Product storage error; Patient given a dose of expired Moderna COVID 19 vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient given a dose of expired Moderna COVID 19 vaccine) and PRODUCT STORAGE ERROR (Product storage error) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient given a dose of expired Moderna COVID 19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient given a dose of expired Moderna COVID 19 vaccine) and PRODUCT STORAGE ERROR (Product storage error) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Vial was initially stored in the refrigerator on 20-April-2022. Vial did not undergo any temperature excursions.  No treatment information was provided.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Paxlovid given for Treatment of COVID-19 on 06-May-2022/Rebound of symptoms 2 days after treatment with Paxlovid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Paxlovid given for Treatment of COVID-19 on 06-May-2022/Rebound of symptoms 2 days after treatment with Paxlovid) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy.    On 05-Apr-2022 at 12:00 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Paxlovid given for Treatment of COVID-19 on 06-May-2022/Rebound of symptoms 2 days after treatment with Paxlovid). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 06-May-2022 to 11-May-2022 for COVID-19 treatment, at a dose of 1 dosage form. At the time of the report, COVID-19 (Paxlovid given for Treatment of COVID-19 on 06-May-2022/Rebound of symptoms 2 days after treatment with Paxlovid) was resolving.            No Concomitant product use was reported.  It was reported that the patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient experienced rebound of symptoms on 13-May-2022 12 PM, 2 days after treatment with Paxlovid.  The device date reported as 19-May-2022.  Company Comment: This spontaneous case concerns a 68-year-old male patient with no relevant medical history, who experienced the unexpected non-serious adverse event of special interest COVID-19, that occurred on an unknown date after receiving mRNA-1273 Vaccine as fourth dose in the COVID-19 vaccination series.  Patient experienced rebound of COVID-19 symptoms 2 days after completion of COVID-19 treatment with Nirmatrelvir, Ritonavir (Paxlovid).  No information was provided on the previous 3 doses of COVID-19 vaccines received by the patient. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 68-year-old male patient with no relevant medical history, who experienced the unexpected non-serious adverse event of special interest COVID-19, that occurred on an unknown date after receiving mRNA-1273 Vaccine as fourth dose in the COVID-19 vaccination series.  Patient experienced rebound of COVID-19 symptoms 2 days after completion of COVID-19 treatment with Nirmatrelvir, Ritonavir (Paxlovid).  No information was provided on the previous 3 doses of COVID-19 vaccines received by the patient. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Hangover
Clinical narrative: Feeling like she has a hangover; This spontaneous case was reported by a patient and describes the occurrence of HANGOVER (Feeling like she has a hangover) in a 51-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product TREPROSTINIL SODIUM (REMODULIN) injection for Pulmonary arterial hypertension.    Concurrent medical conditions included Primary pulmonary hypertension. Concomitant products included TADALAFIL and AMBRISENTAN for an unknown indication.   On 11-Dec-2020, the patient TREPROSTINIL SODIUM (REMODULIN) (IV drip) dosage was changed to at an unspecified dose. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and TREPROSTINIL SODIUM (REMODULIN) (IV drip) .08 microgram/kilogram. On an unknown date, the patient experienced HANGOVER (Feeling like she has a hangover). At the time of the report, HANGOVER (Feeling like she has a hangover) outcome was unknown.            On 11-Dec-2020, the patient had begun therapy with treprostinil sodium (Remodulin) of concentration 2.5 mg/ml for primary pulmonary arterial hypertension. The current dose was reported as 0.080 µg/kg, continuous via intravenous (IV) route. The reporter causality for the event hangover with COVID-19 vaccine was considered to be possibly related. The reporter did not provide causality for the event of hangover with Remodulin.  No treatment medications were reported.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy
Clinical narrative: diagnosed with Bells Palsy; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (diagnosed with Bells Palsy) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 17-May-2022, the patient experienced BELL'S PALSY (diagnosed with Bells Palsy) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (diagnosed with Bells Palsy) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication was reported. It was reported that patient received a moderna shot on 13-May-2022 and went to ER on 17-May-2022 and was diagnosed with Bell's Palsy which is a rare side effect of moderna vax. Patient couldn't talk on phone and patient was slurring words due to the Palsy.  No treatment medications were reported.  Company Comment: This spontaneous case concerns a patient of unspecified age and gender with no reported medical history, who experienced the expected, serious (medically significant) adverse event of special interest Bell's palsy. The event was diagnosed 4 days after receiving a dose of mRNA-1273. The patient had slurring of speech and went to the emergency department for consult. Details of other presenting symptoms, course of the ER visit, diagnostic procedures conducted and medical intervention administered were not provided in the case. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of unspecified age and gender with no reported medical history, who experienced the expected, serious (medically significant) adverse event of special interest Bell's palsy. The event was diagnosed 4 days after receiving a dose of mRNA-1273. The patient had slurring of speech and went to the emergency department for consult. Details of other presenting symptoms, course of the ER visit, diagnostic procedures conducted and medical intervention administered were not provided in the case. The benefit-risk relationship of mRNA-1273 is not affected by this report.