chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Whole body felt like it was breaking including her skeleton; Some weakness; Bones felt like they were breaking; Chills; Headaches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL PAIN (Whole body felt like it was breaking including her skeleton), ASTHENIA (Some weakness), BONE PAIN (Bones felt like they were breaking), CHILLS (Chills) and HEADACHE (Headaches) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005M21A, 008B21A, 047B21A and 058E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient had No allergies and Patient had no Covid diagnosis and Covid Test.  Concurrent medical conditions included Hypertension. Concomitant products included METOPROLOL for Hypertension.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2022 at 1:00 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2022, the patient experienced MUSCULOSKELETAL PAIN (Whole body felt like it was breaking including her skeleton), ASTHENIA (Some weakness), BONE PAIN (Bones felt like they were breaking), CHILLS (Chills), HEADACHE (Headaches) and PYREXIA (Fever). At the time of the report, MUSCULOSKELETAL PAIN (Whole body felt like it was breaking including her skeleton), ASTHENIA (Some weakness), BONE PAIN (Bones felt like they were breaking), CHILLS (Chills), HEADACHE (Headaches) and PYREXIA (Fever) outcome was unknown.            The patient had the 2nd booster dose and stated that she never had side effects but with this one, she had all the side effects listed on the paper except that she did not lose breathing. When asked to clarify the side effects, the patient mentioned having chills, fever, bones felt like they were breaking, whole body felt like it was breaking including her skeleton, some weakness and headaches.  The patient stated that she got the shot at 1pm in the afternoon and at night she got these side effects. In the morning, the patient stated that she did not feel worse, so she weathered it out according to her.  No treatment was received by the patient.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Tested positive for Covid-19; Lack of drug effect; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Tested positive for Covid-19) and DRUG INEFFECTIVE (Lack of drug effect) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 012L20A) for COVID-19 vaccination.     Patient did not have acute illness at time of vaccination and up to one month before. Patient did not had any allergy.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Feb-2021 at 10:20 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 16-Sep-2021, the patient experienced COVID-19 (Tested positive for Covid-19) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (Tested positive for Covid-19) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment information was provided.  Company comment: This spontaneous case concerns a 22-year-old, female patient, with no relevant medical history reported, who experienced the unexpected, non serious events of Covid 19 Infection (Tested positive for Covid-19) and drug ineffective (Lack of drug effect) about 07 months after receiving the 2 dose of mRNA-1273 vaccine in the covid 19 vaccination series. The patient received the first dose of Moderna COVID-19 Vaccine 28 days prior to the second dose. Details of symptoms, clinical course, risk factors, co-morbidities, labs, diagnostic tests, concomitant medications and treatment details were not provided. It was reported that patient did not have any acute illness at time of vaccination and up to one month before.  The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed per Regulatory Authority reporting.   This case was linked to MOD-2022-503745 (Patient Link).; Sender's Comments: This spontaneous case concerns a 22-year-old, female patient, with no relevant medical history reported, who experienced the unexpected, non serious events of Covid 19 Infection (Tested positive for Covid-19) and drug ineffective (Lack of drug effect) about 07 months after receiving the 2 dose of mRNA-1273 vaccine in the covid 19 vaccination series. The patient received the first dose of Moderna COVID-19 Vaccine 28 days prior to the second dose. Details of symptoms, clinical course, risk factors, co-morbidities, labs, diagnostic tests, concomitant medications and treatment details were not provided. It was reported that patient did not have any acute illness at time of vaccination and up to one month before.  The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed per Regulatory Authority reporting.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Vaccination site rash
Clinical narrative: Rash in left arm, where received vaccine; rash that expand to elbow and fingers/ gotten worse; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash in left arm, where received vaccine) and RASH (rash that expand to elbow and fingers/ gotten worse) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2022, the patient experienced VACCINATION SITE RASH (Rash in left arm, where received vaccine) and RASH (rash that expand to elbow and fingers/ gotten worse). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE RASH (Rash in left arm, where received vaccine) and RASH (rash that expand to elbow and fingers/ gotten worse) had not resolved.            No concomitant medication information provided.  Patient  received all previous doses from Moderna. Patient developed a rash in the left arm arm, where he received the vaccine and now it was progressing and had expanded to his elbow and was now expanding to his fingers.  The symptoms had not subsisted and had gotten worse.
Age: 117.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Feeling abnormal, Memory impairment, Parosmia, Taste disorder
Clinical narrative: buzzer sound in both ears or water filled/left ear is worse than the right/left ear is worse than the right/States the left ear is worse which was the same side; smell and taste is terrible; smell and taste is terrible; balance issue; cloudy memory; brain fog; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (buzzer sound in both ears or water filled/left ear is worse than the right/left ear is worse than the right/States the left ear is worse which was the same side), PAROSMIA (smell and taste is terrible), TASTE DISORDER (smell and taste is terrible), BALANCE DISORDER (balance issue) and MEMORY IMPAIRMENT (cloudy memory) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient was not diagnosed or tested positive for COVID-19. It was reported no any other vaccines was given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Thyroid disorder (no change in status) and Allergic reaction to drug excipient (had water blisters all over body(no change in status)). Concomitant products included VITAMINS NOS for Thyroid disorder.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TINNITUS (buzzer sound in both ears or water filled/left ear is worse than the right/left ear is worse than the right/States the left ear is worse which was the same side), PAROSMIA (smell and taste is terrible), TASTE DISORDER (smell and taste is terrible), BALANCE DISORDER (balance issue), MEMORY IMPAIRMENT (cloudy memory) and FEELING ABNORMAL (brain fog). At the time of the report, TINNITUS (buzzer sound in both ears or water filled/left ear is worse than the right/left ear is worse than the right/States the left ear is worse which was the same side), PAROSMIA (smell and taste is terrible), TASTE DISORDER (smell and taste is terrible), BALANCE DISORDER (balance issue), MEMORY IMPAIRMENT (cloudy memory) and FEELING ABNORMAL (brain fog) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       It was reported all the doses which patient had received was of moderna. It was reported that the patient received vaccine in left arm No treatment information was reported.
Age: 117.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: buzzer sound in both ears or water filled/left ear is worse than the right/left ear is worse than the right/States the left ear is worse which was the same side; smell and taste is terrible; smell and taste is terrible; balance issue; cloudy memory; brain fog; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (buzzer sound in both ears or water filled/left ear is worse than the right/left ear is worse than the right/States the left ear is worse which was the same side), PAROSMIA (smell and taste is terrible), TASTE DISORDER (smell and taste is terrible), BALANCE DISORDER (balance issue) and MEMORY IMPAIRMENT (cloudy memory) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient was not diagnosed or tested positive for COVID-19. It was reported no any other vaccines was given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Thyroid disorder (no change in status) and Allergic reaction to drug excipient (had water blisters all over body(no change in status)). Concomitant products included VITAMINS NOS for Thyroid disorder.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TINNITUS (buzzer sound in both ears or water filled/left ear is worse than the right/left ear is worse than the right/States the left ear is worse which was the same side), PAROSMIA (smell and taste is terrible), TASTE DISORDER (smell and taste is terrible), BALANCE DISORDER (balance issue), MEMORY IMPAIRMENT (cloudy memory) and FEELING ABNORMAL (brain fog). At the time of the report, TINNITUS (buzzer sound in both ears or water filled/left ear is worse than the right/left ear is worse than the right/States the left ear is worse which was the same side), PAROSMIA (smell and taste is terrible), TASTE DISORDER (smell and taste is terrible), BALANCE DISORDER (balance issue), MEMORY IMPAIRMENT (cloudy memory) and FEELING ABNORMAL (brain fog) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       It was reported all the doses which patient had received was of moderna. It was reported that the patient received vaccine in left arm No treatment information was reported.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Headache, Oropharyngeal pain
Clinical narrative: stomach is upset; sore throat; a little tired; headache; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach is upset), OROPHARYNGEAL PAIN (sore throat), FATIGUE (a little tired) and HEADACHE (headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 057M21A, 939906, 010M20A and 012L20A) for COVID-19 vaccination.     The patient's past medical history included Back injury (pain meds were taken). Concomitant products included LOSARTAN POTASSIUM (COZAAR) for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (stomach is upset), OROPHARYNGEAL PAIN (sore throat), FATIGUE (a little tired) and HEADACHE (headache). The patient was treated with SIMETHICONE at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (stomach is upset), OROPHARYNGEAL PAIN (sore throat), FATIGUE (a little tired) and HEADACHE (headache) outcome was unknown.            Patient reported he had also taken antacids as well as pain meds when he needs them for back injury
Sex: U
Vaccine: COVID19
Symptoms: Immunodeficiency, Neoplasm malignant
Clinical narrative: diagnosed with cancer following receiving the booster dose; now immunocompromised and doctor wants them to get 0.5 mL dose; This spontaneous case was reported by a pharmacist and describes the occurrence of NEOPLASM MALIGNANT (diagnosed with cancer following receiving the booster dose) and IMMUNODEFICIENCY (now immunocompromised and doctor wants them to get 0.5 mL dose) 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 October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-May-2022, the patient experienced IMMUNODEFICIENCY (now immunocompromised and doctor wants them to get 0.5 mL dose) (seriousness criterion medically significant). On an unknown date, the patient experienced NEOPLASM MALIGNANT (diagnosed with cancer following receiving the booster dose) (seriousness criterion medically significant). At the time of the report, NEOPLASM MALIGNANT (diagnosed with cancer following receiving the booster dose) and IMMUNODEFICIENCY (now immunocompromised and doctor wants them to get 0.5 mL dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment medication reported.   Pharmacist had a question regarding booster of the Moderna COVID-19 vaccine. Patient was not immunocompromised at the time; now immunocompromised and doctor wanted them to get a full dose (0.5 mL). Previously was not immunocompromised but diagnosed with cancer following receiving the booster dose. Received booster dose of 0.25 mL in Oct-2021.  Company comment: This spontaneous case concerns a patient of unknown age and gender, with no reported medical history, who experienced the unexpected serious (important medical event) events of Neoplasm malignant and Immunodeficiency, unspecified days after receiving the booster dose (dose 3) of COVID -19 vaccination with mRNA-1273 vaccine. No further information on clinical course and management of the events was available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender, with no reported medical history, who experienced the unexpected serious (important medical event) events of Neoplasm malignant and Immunodeficiency, unspecified days after receiving the booster dose (dose 3) of COVID -19 vaccination with mRNA-1273 vaccine. No further information on clinical course and management of the events was available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Booster dose on 17Nov2021 and Patient had COVID from 18Jan22; Patient previously vaccinated had a very mild case of COVID/ Patient had COVID from 18Jan22 until the end of Jan; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INEFFECTIVE (Booster dose on 17Nov2021 and Patient had COVID from 18Jan22) and COVID-19 (Patient previously vaccinated had a very mild case of COVID/ Patient had COVID from 18Jan22 until the end of Jan) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 039K20A and 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Sulfa drugs) and Thyroid disorder NOS (medication for thyroid).   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jan-2022, the patient experienced DRUG INEFFECTIVE (Booster dose on 17Nov2021 and Patient had COVID from 18Jan22) and COVID-19 (Patient previously vaccinated had a very mild case of COVID/ Patient had COVID from 18Jan22 until the end of Jan). In January 2022, COVID-19 (Patient previously vaccinated had a very mild case of COVID/ Patient had COVID from 18Jan22 until the end of Jan) had resolved. At the time of the report, DRUG INEFFECTIVE (Booster dose on 17Nov2021 and Patient had COVID from 18Jan22) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, Blood cholesterol: result not reported Result not reported, talking medication for cholesterol.         It was reported that patient's concomitant medication due to cholesterol and thyroid problem.  No treatment medications were provided.  Company comment- This spontaneous case concerns a 78-year-old female patient with no relevant medical history reported, who experienced the unexpecte COVID-19 approximately 62 days after a booster dose of mRNA-1273 vaccine was administered. Additionally, drug ineffective was also reported. No further details were provided. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.  Patient asking for 2nd booster dose.   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2022: Follow-up information received contains no new information.; Sender's Comments: This spontaneous case concerns a 78-year-old female patient with no relevant medical history reported, who experienced the unexpected COVID-19 approximately 62 days after a booster dose of mRNA-1273 vaccine was administered. Additionally, drug ineffective was also reported. No further details were provided. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Age: 61.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Cough, Fatigue, Nasal congestion, Rhinorrhoea, Sinus pain
Clinical narrative: nasal congestion; runny nose; sinus pain; cough; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (nasal congestion), RHINORRHOEA (runny nose), SINUS PAIN (sinus pain), COUGH (cough) and FATIGUE (fatigue) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 030A21A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    The patient's past medical history included Nasal congestion, Runny nose, Sinus pain, Fatigue and Cough. Concurrent medical conditions included Drug allergy (Narcotics), Food allergy (Capsaicin) and Systemic mastocytosis (Systemic mast cell disease).   On 06-May-2021 at 1:30 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2022 at 1:00 PM, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 29-Apr-2022, the patient experienced NASAL CONGESTION (nasal congestion), RHINORRHOEA (runny nose), SINUS PAIN (sinus pain), COUGH (cough) and FATIGUE (fatigue). At the time of the report, NASAL CONGESTION (nasal congestion), RHINORRHOEA (runny nose), SINUS PAIN (sinus pain), COUGH (cough) and FATIGUE (fatigue) was resolving.            No relevant concomitant medications were reported.   Four days after completing a round of Paxlovid patient had a reccurence of some of the original Covid symptoms she experienced. Specifically severe nasal congestion, runny nose, sinus pain, fatigue and cough. She was feeling pretty good after she finished the Paxlovid with most of her symptoms having either stopped or at least diminished. So this rebound response completely caught her off guard. But, no doubt what she was experiencing was Covid related.  No treatment information was provided.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, SARS-CoV-1 test
Clinical narrative: Patient received first dose of 1 ml; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Patient received first dose of 1 ml) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026LZ0A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL from 07-Jul-2012 to 01-May-2021 for Hypotension.    On 17-Jan-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 milliliter. On 17-Jan-2021, the patient experienced ACCIDENTAL OVERDOSE (Patient received first dose of 1 ml). At the time of the report, ACCIDENTAL OVERDOSE (Patient received first dose of 1 ml) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-1 test: negative (Negative) Negative.         No relevant concomitant medications were reported.  No Known Allergies. No treatment information was provided   This case was linked to MOD-2022-535508 (Patient Link).
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial exposed to room temperature for >24 hours/ approximately 30 hours; Patient receive a vaccine outside of the 12 hours from first puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient receive a vaccine outside of the 12 hours from first puncture) and PRODUCT STORAGE ERROR (The vial exposed to room temperature for >24 hours/ approximately 30 hours) in a 33-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 004M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-May-2022 at 7:45 PM, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 02-May-2022 at 7:45 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient receive a vaccine outside of the 12 hours from first puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial exposed to room temperature for >24 hours/ approximately 30 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient receive a vaccine outside of the 12 hours from first puncture) and PRODUCT STORAGE ERROR (The vial exposed to room temperature for >24 hours/ approximately 30 hours) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Date vial was initially stored in refrigerator on 29April2022. Date and time vial was first punctured was on 01MAY2022 at 11:25 AM. Vial stored post puncture was on room temperature. The vial did not undergone any temperature excursions. HCP reported that  this was the patient's first dose and has not called to report any side effects. No treatment medications were reported.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired doses administered to 13 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered to 13 patients) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered to 13 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired doses administered to 13 patients) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided.  Date the vial was initially stored in the refrigerator was unknown. The vial did not undergo any temperature excursions. It was unknown if the patient experienced any symptoms.  No treatment medication information provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose administered after 30-day Use By Date or after manufacturer date of expiry; Expired doses administered to 13 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered to 13 patients) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered to 13 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired doses administered to 13 patients) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Vial did not undergo any temperature excursions.  No relevant concomitant medications were reported.  No treatment information was provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose administered to patient / Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient / Dose administered after 30-day Use By Date or after manufacturer date of expiry) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient / Dose administered after 30-day Use By Date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient / Dose administered after 30-day Use By Date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The reporter stated that the patient was vaccinated on 02-May-2022 with expired doses of Moderna COVID-19 Vaccine. The dose was administered after 30-day Use by Date or after manufacturer date of expiry. The date when the vial was initially stored in the refrigerator was unknown. Reportedly, the vial didn't undergo any temperature excursions. It was unknown if the patient had experienced any symptoms.  No treatment information was provided.
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccinated with expired dose of Moderna COVID-19 Vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccinated with expired dose of Moderna COVID-19 Vaccine) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccinated with expired dose of Moderna COVID-19 Vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccinated with expired dose of Moderna COVID-19 Vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.     Patient was administered with 0.25 ml of vaccine on 03-May-2022 (Expiry: 29-Apr-2022). It was unknown if the patient experienced any symptoms. The vial didn't undergo any temperature excursions. Date the vial was initially stored in the refrigerator was unknown.  No treatment information was reported.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial did not undergo any temperature excursions. No treatment medications were reported.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received vaccine expired on 29-Apr-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine expired on 29-Apr-2022) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine expired on 29-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine expired on 29-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that the vial did not undergo any temperature excursions.  No treatment medications were reported.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patients where vaccinated on 2May2022 and 3May2022 with expired doses of Moderna COVID-19 Vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients where vaccinated on 2May2022 and 3May2022 with expired doses of Moderna COVID-19 Vaccine) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients where vaccinated on 2May2022 and 3May2022 with expired doses of Moderna COVID-19 Vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients where vaccinated on 2May2022 and 3May2022 with expired doses of Moderna COVID-19 Vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. It was reported that 13 patients were vaccinated on 2-May-2022 and 3-May-2022 with expired doses of Moderna COVID-19 Vaccine. The vial did not undergo any temperature excursions It is unknown if any of the patients experienced any symptoms. No treatment drug was reported.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Date the vial was initially stored in the refrigerator was unknown. The vial did not undergo any temperature excursions. It was unknown if the patient experienced any symptoms.  No treatment medications was reported.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired doses administered to 13 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered to 13 patients) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered to 13 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired doses administered to 13 patients) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided.  Date the vial was initially stored in the refrigerator was unknown. The vial did not undergo any temperature excursions. It was unknown if the patient experienced any symptoms.  No treatment medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an expired vaccine which got expired on 29-Apr-2021; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine which got expired on 29-Apr-2021) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-May-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 02-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine which got expired on 29-Apr-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine which got expired on 29-Apr-2021) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by reporter. It was patient's 2nd dose. The patient was fine, has not reported any side effects. The date in which the vial was initially stored in the refrigerator was reported as it came directly from freezer on 02-May-2022. The vial did not undergo any temperature excursions. No treatment medications were provided by reporter.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Patient had COVID on 25Jan2022; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient had COVID on 25Jan2022) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019A21A and 038A21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu shot (Give within one month prior to modernaCovid-19 Vaccine). Past adverse reactions to the above products included No adverse event with Flu shot.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Patient had COVID on 25Jan2022). At the time of the report, COVID-19 (Patient had COVID on 25Jan2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medication reported. No treatment medications were provided by reporter.  Company comment: This spontaneous case concerns 55-years-old, female patient with no reported medical history, who experienced the unexpected nonserious  event of COVID-19 which occurred 3 months 24 days after the third dose of mRNA-1273 vaccine.  SARS-CoV-2 test was positive as on 25-Jan-2021. No medical assessment or treatment has been informed. Ongoing pandemic remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-557009 (Patient Link).; Sender's Comments: This spontaneous case concerns 55-years-old, female patient with no reported medical history, who experienced the unexpected nonserious event of COVID-19 which occurred 3 months 24 days after the third dose of mRNA-1273 vaccine.  SARS-CoV-2 test was positive as on 25-Jan-2021. No medical assessment or treatment has been informed. Ongoing pandemic remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: went to get the second booster, and got .05ml instead of .25ml, because there were negligence when they were processing the syringes; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (went to get the second booster, and got .05ml instead of .25ml, because there were negligence when they were processing the syringes) 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 14-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .05 milliliter. On 14-Apr-2022, the patient experienced ACCIDENTAL UNDERDOSE (went to get the second booster, and got .05ml instead of .25ml, because there were negligence when they were processing the syringes). At the time of the report, ACCIDENTAL UNDERDOSE (went to get the second booster, and got .05ml instead of .25ml, because there were negligence when they were processing the syringes) outcome was unknown.     No concomitant drug was reported. The patient received second booster dose. The reporter stated that 45 minutes later she was ask to go back to the clinic and get a 0.2 ml doses to complete their dosages of a booster. The patient did not have side effects. No treatment drug was reported.   This case was linked to MOD-2022-557647 (Patient Link).   Reporter did not allow further contact
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Chills, Fatigue, Influenza like illness
Clinical narrative: Weakness; Flu like reactions; Chills; Exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), INFLUENZA LIKE ILLNESS (Flu like reactions), CHILLS (Chills) and FATIGUE (Exhaustion) in an elderly male patient who received mRNA-1273 (ModernCOVID-19 Vaccine) (batch nos. 021L20A and 013L20A) for COVID-19 vaccination. a     The patient's past medical history included Bypass surgery. Concurrent medical conditions included Immunocompromised.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced ASTHENIA (Weakness), INFLUENZA LIKE ILLNESS (Flu like reactions), CHILLS (Chills) and FATIGUE (Exhaustion). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ASTHENIA (Weakness), INFLUENZA LIKE ILLNESS (Flu like reactions), CHILLS (Chills) and FATIGUE (Exhaustion) outcome was unknown.            Concomitant product information was not provided.   This case was linked to MOD-2022-557646, MOD-2022-557547 (Patient Link).
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Chills, Fatigue, Inappropriate schedule of product administration, Influenza like illness
Clinical narrative: Weakness; Flu like reactions; Chills; Exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), INFLUENZA LIKE ILLNESS (Flu like reactions), CHILLS (Chills) and FATIGUE (Exhaustion) in an elderly male patient who received mRNA-1273 (ModernCOVID-19 Vaccine) (batch nos. 021L20A and 013L20A) for COVID-19 vaccination. a     The patient's past medical history included Bypass surgery. Concurrent medical conditions included Immunocompromised.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced ASTHENIA (Weakness), INFLUENZA LIKE ILLNESS (Flu like reactions), CHILLS (Chills) and FATIGUE (Exhaustion). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ASTHENIA (Weakness), INFLUENZA LIKE ILLNESS (Flu like reactions), CHILLS (Chills) and FATIGUE (Exhaustion) outcome was unknown.            Concomitant product information was not provided.   This case was linked to MOD-2022-557646, MOD-2022-557547 (Patient Link).