chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous case was reported by a physician assistant and describes the occurrence of UNDERDOSE (lower-than-authorized dose administered) and NO ADVERSE EVENT (No adverse event) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (lower-than-authorized dose administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (lower-than-authorized dose administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (lower-than-authorized dose administered). No concomitant product use was reported. HCP administered a Moderna Covid-19 vaccine 0.25 ml dose to a patient instead of a 0.5 ml for booster dose. HCP explained that the dose was pulled up from Moderna's purple top vial. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: Delayed lip swelling; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Delayed lip swelling) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIP SWELLING (Delayed lip swelling). At the time of the report, LIP SWELLING (Delayed lip swelling) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported.  It was reported that patient stated that she had a they delayed lip swelling after receiving a COVID-19 vaccine and did not had Botox. The reporter was unsure if it was Moderna COVID-19  Vaccine.  No treatment medications were reported.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Dysgeusia, Inappropriate schedule of product administration, Tongue discomfort
Clinical narrative: Dose 2  administered on 29Apr2021 and 1st booster administered on 6Jul2021; 3 days after the vaccine she had a burning tongue/progressing to constant burning; Patient also had dry mouth and bitter taste in the mouth.; Patient also had dry mouth and bitter taste in the mouth.; This spontaneous case was reported by a patient family member or friend and describes the occurrence of TONGUE DISCOMFORT (3 days after the vaccine she had a burning tongue/progressing to constant burning), DRY MOUTH (Patient also had dry mouth and bitter taste in the mouth.), DYSGEUSIA (Patient also had dry mouth and bitter taste in the mouth.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 2  administered on 29Apr2021 and 1st booster administered on 6Jul2021) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B12A, 012C21A and 020B21A) for COVID-19 vaccination.     It was reported that the patient did not have any allergies to medications, food, and other products. patient did not have acute and chronic illness at the time of vaccination. The patient had never been diagnosed with/ tested positive for COVID-19. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jul-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced TONGUE DISCOMFORT (3 days after the vaccine she had a burning tongue/progressing to constant burning), DRY MOUTH (Patient also had dry mouth and bitter taste in the mouth.) and DYSGEUSIA (Patient also had dry mouth and bitter taste in the mouth.). On 06-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 2  administered on 29Apr2021 and 1st booster administered on 6Jul2021). At the time of the report, TONGUE DISCOMFORT (3 days after the vaccine she had a burning tongue/progressing to constant burning) had not resolved and DRY MOUTH (Patient also had dry mouth and bitter taste in the mouth.), DYSGEUSIA (Patient also had dry mouth and bitter taste in the mouth.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 2  administered on 29Apr2021 and 1st booster administered on 6Jul2021) outcome was unknown.      Patient was born in July.  The patient was not taking other/concomitant medication.  It was reported that her tongue was burning 24 hours a day. Health care provider  was aware of the side effects.  No treatment information was provided.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was first punctured on 04-AUG-2022 at 8:15 AM and administerd on 25-AUG-2022 at at 8:30 AM; No adverse event; 3 pediatric patients received doses >12 hour post puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 pediatric patients received doses >12 hour post puncture), PRODUCT STORAGE ERROR (The vial was first punctured on 04-AUG-2022 at 8:15 AM and administerd on 25-AUG-2022 at at 8:30 AM) and NO ADVERSE EVENT (No adverse event) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9237B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Aug-2022 at 8:30 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (3 pediatric patients received doses >12 hour post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was first punctured on 04-AUG-2022 at 8:15 AM and administerd on 25-AUG-2022 at at 8:30 AM) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (3 pediatric patients received doses >12 hour post puncture), PRODUCT STORAGE ERROR (The vial was first punctured on 04-AUG-2022 at 8:15 AM and administerd on 25-AUG-2022 at at 8:30 AM) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (3 pediatric patients received doses >12 hour post puncture) and PRODUCT STORAGE ERROR (The vial was first punctured on 04-AUG-2022 at 8:15 AM and administerd on 25-AUG-2022 at at 8:30 AM).    No concomitant medication was reported. The vial was stored in the fridge for 2 weeks after puncture, was reported. It was reported that the vial was initially stored in the refrigerator on 03-Aug-2022. The vial was first punctured on 04-Aug-2022 at 8:15 AM. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-635840, US-MODERNATX, INC.-MOD-2022-635851 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-635840:Patient 2 US-MODERNATX, INC.-MOD-2022-635851:Patient 3
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, SARS-CoV-2 test
Clinical narrative: got very sick after both doses; This spontaneous case was reported by a physician and describes the occurrence of ILLNESS (got very sick after both doses) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     none vaccines given within 1 month prior to Moderna COVID-19 vaccine.  The patient's past medical history included COVID-19 (had all the symptoms, but COVID tests were not available at that time) on 16-Feb-2020, Eczema in 1975, Arthralgia (extremely bad) and Vertigo (had vertigo during COVID in 2020 and vertigo went away after the infection cleared) in 2020. Concurrent medical conditions included Allergy to vaccine (flu vaccine), Latex allergy, Allergy to animal (cat allergy), Penicillin allergy, Sulfonamide allergy, Allergy to plants (aloe allergy), Allergy to plants (citrus), Allergy to lanolin, Pollen allergy, Dust allergy, Allergy to molds, Allergy to chemicals (nitrile), Hypothyroidism since 2009, Asthma (Start Date maybe 1985) since 1985 and Allergy (sunlight, progressively worse) since 2002.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (got very sick after both doses). At the time of the report, ILLNESS (got very sick after both doses) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, SARS-CoV-2 test: (Negative) later and it was negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The physician was reporting on behalf of herself. Patient had allergy's to many many more. No concomitant drug was reported. The patient believed that patient had COVID in Feb-2020. Patient had all the symptoms, but did not test until four weeks later it was negative. Patient was recapitulating when patient had COVID the first year. Patient reported having extremely bad arthralgias. The patient thinks that during her initial COVID infection, the virus went to her ear on the left side because patient also had vertigo. patient thinks it's an autoimmune effect that was triggered by the vaccine.  No treatment drug was reported.   This case was linked to MOD-2022-635848 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID/Feeling sick/not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID/Feeling sick/not feeling well) and DRUG INEFFECTIVE (Drug ineffective) in a 65-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) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe rheumatoid arthritis).   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On 16-Aug-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (COVID/Feeling sick/not feeling well). On an unknown date, the patient experienced DRUG INEFFECTIVE (Drug ineffective). At the time of the report, COVID-19 (COVID/Feeling sick/not feeling well) and DRUG INEFFECTIVE (Drug ineffective) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Aug-2022, SARS-CoV-2 test: (Positive) Positive.         Concomitant product use was not provided. Treatment information was not provided.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter's causality for the events of COVID and feeling sick/not feeling well was not provided for Humira.  Company comment- This spontaneous case concerns a 65-year-old female patient with no relevant medical history, who experienced the unexpected, non-serious COVID-19 (with a positive SARS-CoV-2 test dose 2 days after) that occurred 7 months and 26 days after receiving the third dose of mRNA-1273 Vaccine.  Additionally, Drug ineffective was also reported.  The interval between the first and second doses of mRNA was noted to be 27 days. Outcome of the event was not recovered at the time of this report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 65-year-old female patient with no relevant medical history, who experienced the unexpected, non-serious COVID-19 (with a positive SARS-CoV-2 test dose 2 days after) that occurred 7 months and 26 days after receiving the third dose of mRNA-1273 Vaccine.  Additionally, Drug ineffective was also reported.  The interval between the first and second doses of mRNA was noted to be 27 days. Outcome of the event was not recovered at the time of this report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropathy, COVID-19, Sinus disorder
Clinical narrative: sinus symptoms; COVID-19; elbow problem; This spontaneous case was reported by a consumer and describes the occurrence of SINUS DISORDER (sinus symptoms), ARTHROPATHY (elbow problem) and COVID-19 (COVID-19) in a 75-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) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received third 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) pre-filled pen. In August 2022, the patient experienced ARTHROPATHY (elbow problem). On an unknown date, the patient experienced SINUS DISORDER (sinus symptoms) and COVID-19 (COVID-19). At the time of the report, SINUS DISORDER (sinus symptoms) and ARTHROPATHY (elbow problem) outcome was unknown and COVID-19 (COVID-19) was resolving.            No concomitant medications were reported.   It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter's causality for the events of sinus symptoms, elbow problem and COVID-19 was not provided. The reporter assessed events of sinus symptoms, elbow problem and COVID-19 as possibly related to Moderna COVID-19 vaccine.  No treatment details were reported.  Company Comment: This is a spontaneous case concerning a 75-year-old female patient with no relevant medical history, who experienced the unexpected, non-serious, adverse event of special interest, COVID-19 which occurred on an unknown date after receiving a dose of the mRNA-1273 vaccine and the co-suspect product Adalimumab, no further information on risk factors, co morbidities, clinical course and management of the events was available in the report. It was reported that the outcome of the event was resolving. The current COVID-19 pandemic of remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 75-year-old female patient with no relevant medical history, who experienced the unexpected, non-serious, adverse event of special interest, COVID-19 which occurred on an unknown date after receiving a dose of the mRNA-1273 vaccine and the co-suspect product Adalimumab, no further information on risk factors, co morbidities, clinical course and management of the events was available in the report. It was reported that the outcome of the event was resolving. The current COVID-19 pandemic of remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: had Covid-19 twice after receiving the vaccines; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (had Covid-19 twice after receiving the vaccines) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received 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 COVID-19 (had Covid-19 twice after receiving the vaccines). At the time of the report, COVID-19 (had Covid-19 twice after receiving the vaccines) outcome was unknown.            No concomitant medications were reported.  It was reported that the patient received primary series doses and a Booster dose of the Moderna COVID-19 Vaccine and had COVID-19 twice.  No Treatment details were provided.  Company comment: This spontaneous case concerns a female patient of unknown age with no medical history reported, who experienced the adverse event of special interest of CCOVID-19 an unknown time after the booster dose of mRNA-1273. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was reported as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient of unknown age with no medical history reported, who experienced the adverse event of special interest of CCOVID-19 an unknown time after the booster dose of mRNA-1273. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was reported as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chest discomfort, Chest pain, Dyspnoea, Electrocardiogram
Clinical narrative: some grogginess; felt a little out of it; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (some grogginess) and FEELING ABNORMAL (felt a little out of it) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040E21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (allergy to Acetaminophen) and Drug allergy (allergy to NSAIDs). Concomitant products included BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE (SUBOXONE) and ALPRAZOLAM for an unknown indication.    On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Jul-2021, the patient experienced SOMNOLENCE (some grogginess) and FEELING ABNORMAL (felt a little out of it). At the time of the report, SOMNOLENCE (some grogginess) and FEELING ABNORMAL (felt a little out of it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that patient never tested positive for Covid 19. It was reported that no history of Myocarditis/pericarditis. No treatment medications were reported.   This case was linked to MOD-2022-635970 (Patient Link).
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Hypertension, Insomnia, Localised infection, Mobility decreased
Clinical narrative: some grogginess; felt a little out of it; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (some grogginess) and FEELING ABNORMAL (felt a little out of it) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040E21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (allergy to Acetaminophen) and Drug allergy (allergy to NSAIDs). Concomitant products included BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE (SUBOXONE) and ALPRAZOLAM for an unknown indication.    On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Jul-2021, the patient experienced SOMNOLENCE (some grogginess) and FEELING ABNORMAL (felt a little out of it). At the time of the report, SOMNOLENCE (some grogginess) and FEELING ABNORMAL (felt a little out of it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that patient never tested positive for Covid 19. It was reported that no history of Myocarditis/pericarditis. No treatment medications were reported.   This case was linked to MOD-2022-635970 (Patient Link).
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myositis, Palpitations, X-ray
Clinical narrative: some grogginess; felt a little out of it; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (some grogginess) and FEELING ABNORMAL (felt a little out of it) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040E21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (allergy to Acetaminophen) and Drug allergy (allergy to NSAIDs). Concomitant products included BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE (SUBOXONE) and ALPRAZOLAM for an unknown indication.    On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Jul-2021, the patient experienced SOMNOLENCE (some grogginess) and FEELING ABNORMAL (felt a little out of it). At the time of the report, SOMNOLENCE (some grogginess) and FEELING ABNORMAL (felt a little out of it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that patient never tested positive for Covid 19. It was reported that no history of Myocarditis/pericarditis. No treatment medications were reported.   This case was linked to MOD-2022-635970 (Patient Link).
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Somnolence
Clinical narrative: some grogginess; felt a little out of it; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (some grogginess) and FEELING ABNORMAL (felt a little out of it) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040E21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (allergy to Acetaminophen) and Drug allergy (allergy to NSAIDs). Concomitant products included BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE (SUBOXONE) and ALPRAZOLAM for an unknown indication.    On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Jul-2021, the patient experienced SOMNOLENCE (some grogginess) and FEELING ABNORMAL (felt a little out of it). At the time of the report, SOMNOLENCE (some grogginess) and FEELING ABNORMAL (felt a little out of it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that patient never tested positive for Covid 19. It was reported that no history of Myocarditis/pericarditis. No treatment medications were reported.   This case was linked to MOD-2022-635970 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Psoriasis
Clinical narrative: PPSORIASIS FLARE UPS/PATCHES ON FACE, STOMACH AND ARMS; First Dose was adminstered on 31-Aug-2021 and Second Dose on 21-Sep-2021; This spontaneous case was reported by a patient and describes the occurrence of PSORIASIS (PPSORIASIS FLARE UPS/PATCHES ON FACE, STOMACH AND ARMS) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Dose was adminstered on 31-Aug-2021 and Second Dose on 21-Sep-2021) in a 68-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 Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On 21-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Dose was adminstered on 31-Aug-2021 and Second Dose on 21-Sep-2021). On an unknown date, the patient experienced PSORIASIS (PPSORIASIS FLARE UPS/PATCHES ON FACE, STOMACH AND ARMS). At the time of the report, PSORIASIS (PPSORIASIS FLARE UPS/PATCHES ON FACE, STOMACH AND ARMS) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Dose was adminstered on 31-Aug-2021 and Second Dose on 21-Sep-2021) outcome was unknown. Not Provided    No relevant concomitant medications were reported.   The reporter's causality for the event of psoriasis flare ups/patches on face, stomach and arms with humira was not provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Primary reporter contact for lot number information was unsuccessful.  No treatment information was provided.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: accidently gave the 6 year old child .25 of the red top vial; no adverse event; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT DOSE ADMINISTERED (accidently gave the 6 year old child .25 of the red top vial) and NO ADVERSE EVENT (no adverse event) in a 6-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (accidently gave the 6 year old child .25 of the red top vial) and NO ADVERSE EVENT (no adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (accidently gave the 6 year old child .25 of the red top vial) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (accidently gave the 6 year old child .25 of the red top vial).    No concomitant information was reported. It was reported that a family came in and the nurse doing the vaccine accidently gave the 6-year-old child .25 of the red top vial Moderna with the blue label instead of from the pediatric dose vial.  No treatment information was provided.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event, Underdose
Clinical narrative: should have had 3 full doses for the primary series and 2 halfdose boosters according to the recommendation; immunocompromised patient should have received a full dose, but received half dose; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (should have had 3 full doses for the primary series and 2 halfdose boosters according to the recommendation), UNDERDOSE (immunocompromised patient should have received a full dose, but received half dose) and NO ADVERSE EVENT (No adverse event) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised. Concomitant products included NATALIZUMAB (TYSABRI) for Immunomodulatory therapy.   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, 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (should have had 3 full doses for the primary series and 2 halfdose boosters according to the recommendation), UNDERDOSE (immunocompromised patient should have received a full dose, but received half dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (should have had 3 full doses for the primary series and 2 halfdose boosters according to the recommendation), UNDERDOSE (immunocompromised patient should have received a full dose, but received half dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (should have had 3 full doses for the primary series and 2 halfdose boosters according to the recommendation) and UNDERDOSE (immunocompromised patient should have received a full dose, but received half dose).    The patient received 4 doses of Moderna COVID-19 vaccine, 2 full doses and 2 boosters. Patient received 4th dose as a second booster.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-635832 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 29-Aug-2022: Additional information received and included reporter details were updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-635832:
Age: 67.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Inappropriate schedule of product administration, Weight
Clinical narrative: Severe shoulder pain; Dose 2 administered on 28-Aug-2021 and dose 3 administered on 21-Jan-2022; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Severe shoulder pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 2 administered on 28-Aug-2021 and dose 3 administered on 21-Jan-2022) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe).   On 01-Jul-2021, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 02-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jan-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 2 administered on 28-Aug-2021 and dose 3 administered on 21-Jan-2022). On an unknown date, the patient experienced ARTHRALGIA (Severe shoulder pain). At the time of the report, ARTHRALGIA (Severe shoulder pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 2 administered on 28-Aug-2021 and dose 3 administered on 21-Jan-2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: 160 lost weight went from 160 pounds to 143 pounds and 143 lost weight went from 160 pounds to 143 pounds.   Concomitant medication was not provided. Treatment information was not provided. Reporters causality for Rinvoq with respect to weight loss and shoulder pain was reported as not related.   This case was linked to MOD-2022-600445 (Patient Link).
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: got positive COVID-19 test; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (got positive COVID-19 test) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received 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. In 2022, the patient experienced COVID-19 (got positive COVID-19 test). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) in 2022 for COVID-19, at an unspecified dose and frequency. In 2022, COVID-19 (got positive COVID-19 test) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: (Positive) Positive (3 weeks prior) and (Negative) Negative after 7 days treatment with paxlovid.         No concomitant medication was reported. It was reported that, the patient received 2 booster doses months ago and tested positive for COVID-19 three weeks prior to this report. The patient was treated with Paxlovid approximately 2 days after symptoms and was tested negative on day 7 of treatment. Approximately for 5-7 days the patient was week . The patient was fine at the time of this report. Company Comment:    This is an spontaneous case concerning a 70-years-old male patient with no medical history  Reported who experienced the unexpected AESI of COVID-19, unknown days after the 4th. dose of mRNA-1273 vaccine. In 2022, SARS-CoV-2 test Negative after 7 days treatment with paxlovid and was Positive 3 weeks before it. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.  Events seriousness was assessed based on medical judgement   This case was linked to US-MODERNATX, INC.-MOD-2022-636282 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments: Company Comment:    This is an spontaneous case concerning a 70-years-old male patient with no medical history  Reported who experienced the unexpected AESI of COVID-19, unknown days after the 4th. dose of mRNA-1273 vaccine. In 2022, SARS-CoV-2 test Negative after 7 days treatment with paxlovid and was Positive 3 weeks before it. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.  Events seriousness was assessed based on medical judgement US-MODERNATX, INC.-MOD-2022-636282:Reporters wifes case
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: got pos COVID; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (got pos COVID) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received 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. In August 2022, the patient experienced COVID-19 (got pos COVID). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) in August 2022 at a dose of Approx 5-7 days. At the time of the report, COVID-19 (got pos COVID) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2022, SARS-CoV-2 test: (Positive) Positive, three weeks ago and (Negative) Negative, day 5.         No concomitant medication was reported.  Company comment.  This spontaneous case concerns a 56  year  old, female patient, with no medical history reported, who received a booster dose of mRNA-1273 vaccine (considered as fourth dose of patient´s COVID  19 vaccination schedule) and experienced the non  serious unexpected AESI of COVID-19. Vaccination date and exact onset date of the event were not reported; hence latency and temporal association cannot be properly assessed. The patient received treatment with Paxlovid (Nirmatrelvir, Ritonavir) and tested negative for COVID  19 on day 5. No further clinical information was available for medical reviewing. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 56  year  old, female patient, with no medical history reported, who received a booster dose of mRNA-1273 vaccine (considered as fourth dose of patient´s COVID  19 vaccination schedule) and experienced the non  serious unexpected AESI of COVID-19. Vaccination date and exact onset date of the event were not reported; hence latency and temporal association cannot be properly assessed. The patient received treatment with Paxlovid (Nirmatrelvir, Ritonavir) and tested negative for COVID  19 on day 5. No further clinical information was available for medical reviewing. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Interchange of vaccine products, No adverse event
Clinical narrative: 1st Dose as Moderna and Second Dose as Pfizer Vaccine.; 1st Dose as Moderna and Second Dose as Pfizer Vaccine.; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (1st Dose as Moderna and Second Dose as Pfizer Vaccine.), COVID-19 IMMUNISATION (1st Dose as Moderna and Second Dose as Pfizer Vaccine.) and NO ADVERSE EVENT (No adverse event) in a 5-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (COMIRNATY) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and second dose of TOZINAMERAN (COMIRNATY) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (1st Dose as Moderna and Second Dose as Pfizer Vaccine.), COVID-19 IMMUNISATION (1st Dose as Moderna and Second Dose as Pfizer Vaccine.) and NO ADVERSE EVENT (No adverse event). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (1st Dose as Moderna and Second Dose as Pfizer Vaccine.), COVID-19 IMMUNISATION (1st Dose as Moderna and Second Dose as Pfizer Vaccine.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INTERCHANGE OF VACCINE PRODUCTS (1st Dose as Moderna and Second Dose as Pfizer Vaccine.) and COVID-19 IMMUNISATION (1st Dose as Moderna and Second Dose as Pfizer Vaccine.).    It was reported that a 5-year old received her 1st dose from Moderna before patient turned 5 years old and received the Pfizer-Biontech Covid vaccine for her 2nd dose when patient turned 5 years old. No concomitant product reported. No treatment medication reported.   Reporter did not allow further contact
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was initially stored in refrigerator on 21Jul2022 and administered on 22Aug2022; No adverse event; Received expired first booster dose after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired first booster dose after 30-day Use By Date), PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 21Jul2022 and administered on 22Aug2022) and NO ADVERSE EVENT (No adverse event) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Aug-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired first booster dose after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 21Jul2022 and administered on 22Aug2022) and NO ADVERSE EVENT (No adverse event). On 25-Aug-2022, EXPIRED PRODUCT ADMINISTERED (Received expired first booster dose after 30-day Use By Date) outcome was unknown. At the time of the report, PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 21Jul2022 and administered on 22Aug2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received expired first booster dose after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 21Jul2022 and administered on 22Aug2022).    No concomitant medications were reported. The vial was initially stored in refrigerator on 21-Jul-2022. The vial did not undergo any temperature excursions. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-636313 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-636313:Case for Patient 1
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in refrigerator on 21-Jul-2022 and was administerd on 25-Aug-2022; No adverse event; Received expired first booster dose after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired first booster dose after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 21-Jul-2022 and was administerd on 25-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Aug-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired first booster dose after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 21-Jul-2022 and was administerd on 25-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired first booster dose after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 21-Jul-2022 and was administerd on 25-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received expired first booster dose after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 21-Jul-2022 and was administerd on 25-Aug-2022).    No concomitant medications were reported. The vial was initially stored in refrigerator on 21-Jul-2022. The manufacturer expiration date was given as 18-Nov-2022. The vial did not undergo any temperature excursions. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-636312 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-636312:Case for Patient 1
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; 2nd Dose Administration date on 14Apr2021 and 1st Booster dose Administration date on 31Jul2021; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd Dose Administration date on 14Apr2021 and 1st Booster dose Administration date on 31Jul2021) and NO ADVERSE EVENT (No adverse event) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0588H21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to allopathic drugs (Ciclosporin), Allergy to antibiotic (ciprofloxacin) and Drug tolerance (Tolerance to Enzyme Inhibitors).   On 12-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 31-Jul-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd Dose Administration date on 14Apr2021 and 1st Booster dose Administration date on 31Jul2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd Dose Administration date on 14Apr2021 and 1st Booster dose Administration date on 31Jul2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd Dose Administration date on 14Apr2021 and 1st Booster dose Administration date on 31Jul2021).    Patient was taking concomitant medication, HCP did not specify what type of medications was used by patient. Patient height was mentioned as 6 foot. The patient never tested positive for Covid. No treatment drug details was reported.   This case was linked to MOD-2022-635175 (Patient Link).