chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: This spontaneous report received from a patient via social media through a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of admin, batch number: Unknown and expiry: unknown) dose, 1 total administered on an unspecified date for prophylactic vaccination. It was unknown whether patient had any adverse following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received additional covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (Dose number in series 2) (suspension for injection, route of administration, batch number: Unknown and expiry: unknown) dose was not reported, 1 total administered on unspecified date for prophylactic vaccination. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced Covid twice (Dose number in series 2). As per the reporter, "I have had Covid twice. I am fully vaccinated and boosted. Somebody is making big money off of this. Around election time there will be another variant to cause another pandemic. Wait and see". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of had Covid twice was not reported. This report was non-serious. This report was associated with product quality complaint: 90000216452.
Sex: M
Vaccine: COVID19
Symptoms: Death, Dyspnoea, Guillain-Barre syndrome, Haemoptysis
Clinical narrative: POSSIBLY BE GUILLIAN-BARRE; BREATHING BECAME DIFFICULT; COUGHING UP BLOOD; DIED; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. Within 2 weeks of vaccination patient was barely able to make it 20 feet from his bed to the toilet. The initial reaction from doctors and specialists was that patient would somehow hurt himself but test after test proved that theory wrong, all the while his condition was declining. By the end of JUN-2021 patient lost all ability to get himself out of the bed and walking even with assistive devices. It was also around this time that his doctors started to come around to the idea that it could quite possibly be guillian-barre, especially considering the time line. On an unspecified date in NOV-2021, breathing became difficult, patient started coughing up blood and died in the ambulance. On NOV-2021, the patient died from unknown cause of death. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on an unspecified date, and the outcome of possibly be guillian-barre, breathing became difficult and coughing up blood was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0 20220217632-  covid-19 vaccine ad26.cov2.s- Died, breathing became difficult and coughing up blood. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20220217632- Covid-19 vaccine ad26.cov2.s -possibly be Guillain-Barre Syndrome. This event(s) is labeled per RSI and is therefore considered potentially related.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Fatigue, Hypersomnia
Clinical narrative: SLEPT FOR 18 HOURS; 2 EPISODES OF CHEST PAIN UPON BREATHING; 2 EPISODES OF BACK PAIN UPON BREATHING; OVER TIRED; This spontaneous report received from a patient via social media concerned a 79 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced slept for 18 hours, 2 episodes of chest pain upon breathing, 2 episodes of back pain upon breathing, and over tired.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from over tired, and the outcome of slept for 18 hours, 2 episodes of chest pain upon breathing and 2 episodes of back pain upon breathing was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: SICK ALL THE TIME; This spontaneous report received from a patient via social media via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was never sick in the winter until took the shots. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced sick all the time. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sick all the time. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: SYMPTOMS OF COVID; EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, and batch number: 211A21A expiry: 14/DEC/2021) dose was not reported, administered on 14-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-DEC-2021, the patient experienced expired vaccine administered. On 07-FEB-2022, Laboratory data included: COVID-19 virus test (NR: not provided) negative. On an unspecified date, the patient experienced symptoms of covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the symptoms of covid and expired vaccine administered was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: CHILLS; A LITTLE BIT OF HEADACHE; This spontaneous report received from a patient concerned a 79 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: explosive gallbladder, and atrial fibrillation. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 and expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the patient experienced chills, and a little bit of headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and a little bit of headache on 20-MAR-2021. This report was non-serious. This case, involving the same patient is linked to 20220217599.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Computerised tomogram, Headache, Malaise
Clinical narrative: LOST SENSE OF SMELL; LOST SENSE OF TASTE; HEADACHE; NAUSEA; NOT FEELING WELL; This spontaneous report received from a patient concerned a 43 year old male. The patient's height, and weight were not reported. The patient's past medical history included: back surgery, and spinal fusion, and concurrent conditions included: back problems, alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient did not have any drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022, expiry: UNKNOWN) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAY-2021, the patient experienced not feeling well, and nausea. On 27-MAY-2021, the patient experienced lost sense of smell, lost sense of taste, and headache. Laboratory data (dates unspecified) included: Computerised tomogram (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from not feeling well, and nausea on 27-MAY-2021, and headache on 30-MAY-2021, and had not recovered from lost sense of smell, and lost sense of taste. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: LOST SENSE OF SMELL; LOST SENSE OF TASTE; HEADACHE; NAUSEA; NOT FEELING WELL; This spontaneous report received from a patient concerned a 43 year old male. The patient's height, and weight were not reported. The patient's past medical history included: back surgery, and spinal fusion, and concurrent conditions included: back problems, alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient did not have any drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022, expiry: UNKNOWN) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAY-2021, the patient experienced not feeling well, and nausea. On 27-MAY-2021, the patient experienced lost sense of smell, lost sense of taste, and headache. Laboratory data (dates unspecified) included: Computerised tomogram (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from not feeling well, and nausea on 27-MAY-2021, and headache on 30-MAY-2021, and had not recovered from lost sense of smell, and lost sense of taste. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal discharge, Vaginal haemorrhage
Clinical narrative: SMALL AMOUNT OF BLOOD FROM VAGINA; DISCHARGE FROM VAGINA; This spontaneous report received from a patient via social media via a company representative concerned a 61 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on AUG-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 08-FEB-2022, the patient experienced discharge from vagina. On an unspecified date, the patient experienced small amount of blood from vagina. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from small amount of blood from vagina, and the outcome of discharge from vagina was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: CURED PSORIASIS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: psoriasis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced cured psoriasis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of cured psoriasis was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: GETTING SHINGLES EVER SINCE; This spontaneous report received from a consumer via a company representative via social media concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced getting shingles ever since. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from getting shingles ever since. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: WORSE HEART PALPITATIONS; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on JAN-2021 for prophylactic vaccination. The Batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced worse heart palpitations. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of worse heart palpitations was not reported. This report was non-serious.
Age: 30.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of expired moderna vaccine that were given as booster shot to patient around 490 to 500 people; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired moderna vaccine that were given as booster shot to patient around 490 to 500 people) in a 30-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired moderna vaccine that were given as booster shot to patient around 490 to 500 people). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired moderna vaccine that were given as booster shot to patient around 490 to 500 people) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided The vaccines were stored in freezer, we took out one to two vials and placed in fridge each day as needed.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Patient hospitalized after first dose; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (Patient hospitalized after first dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Patient hospitalized after first dose) (seriousness criterion hospitalization). At the time of the report, VACCINATION COMPLICATION (Patient hospitalized after first dose) 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 did not provide any causality assessments.   Nurse had the date and lot number for the first dose but the patient can't remember where they got the vaccine. Patient who was in the hospital and about to be given his second Moderna vaccine. No concomitant product was provided. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Feb-2022: Non-significant follow up; Sender's Comments: This is a spontaneous case concerning a male patient of unknown age with no reported medical history, who experienced the serious per hospitalization criterion unexpected event of vaccination complication. The event occurred on unknown day after the first dose of mRNA-1273 vaccine administration. The event was conservatively assessed as related to the product administration as the temporal association cannot be assessed. Very limited information available at this time. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue after 2nd shot) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 009C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Fatigue after 2nd shot). On 21-May-2021, FATIGUE (Fatigue after 2nd shot) had resolved.            No concomitant product use was provided. No treatment medication was provided.   This case was linked to MOD-2022-473936, MOD-2022-473947 (Patient Link).
Age: 46.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) in a 46-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided. No treatment information was provided.  Reporter stated that the vaccines were stored in freezer and they took out one to two vials and placed in fridge each day as needed.
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The Patient received booster dose of Moderna COVID-19 Vaccine.  No treatment medications were reported. Rx number was 801035
Age: 25.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 25-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 22-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dyspepsia, Dysstasia, Feeding disorder, Feeling abnormal
Clinical narrative: digestive problems; I feel bad; i cant eat; I've been sick for 9 months; can't even stand up anymore; I can't work anymore; the tongue became numb; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (the tongue became numb), DYSPEPSIA (digestive problems), FEELING ABNORMAL (I feel bad), FEEDING DISORDER (i cant eat) and ILLNESS (I've been sick for 9 months) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced HYPOAESTHESIA ORAL (the tongue became numb). On an unknown date, the patient experienced DYSPEPSIA (digestive problems), FEELING ABNORMAL (I feel bad), FEEDING DISORDER (i cant eat), ILLNESS (I've been sick for 9 months), DYSSTASIA (can't even stand up anymore) and IMPAIRED WORK ABILITY (I can't work anymore). At the time of the report, HYPOAESTHESIA ORAL (the tongue became numb), DYSPEPSIA (digestive problems), FEELING ABNORMAL (I feel bad), FEEDING DISORDER (i cant eat), ILLNESS (I've been sick for 9 months), DYSSTASIA (can't even stand up anymore) and IMPAIRED WORK ABILITY (I can't work anymore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-May-2021, Blood pressure measurement: increased (High) increased. On 21-May-2021, Heart rate: increased (High) increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant product use was reported.  The patient took the first dose of Moderna on 21-May-2021 and after 20 minutes, the tongue became numb, the heart rate increased, and the blood pressure rose. Two months after the vaccine, the patient felt bad. The patient couldn't eat. Digestive problems.  The reporter stated that after the Moderna vaccine, the patient had been sick for 9 months. But very badly, the patient could not even stand up anymore. The patient stated they couldn't live this way anymore and couldn't work anymore.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Feb-2022: Follow-up information included no new information On 01-Feb-2022: Translation document was received on 04-Feb-2022 which contains significant information. Added new events.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate, Hypoaesthesia oral, Illness, Impaired work ability
Clinical narrative: digestive problems; I feel bad; i cant eat; I've been sick for 9 months; can't even stand up anymore; I can't work anymore; the tongue became numb; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (the tongue became numb), DYSPEPSIA (digestive problems), FEELING ABNORMAL (I feel bad), FEEDING DISORDER (i cant eat) and ILLNESS (I've been sick for 9 months) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced HYPOAESTHESIA ORAL (the tongue became numb). On an unknown date, the patient experienced DYSPEPSIA (digestive problems), FEELING ABNORMAL (I feel bad), FEEDING DISORDER (i cant eat), ILLNESS (I've been sick for 9 months), DYSSTASIA (can't even stand up anymore) and IMPAIRED WORK ABILITY (I can't work anymore). At the time of the report, HYPOAESTHESIA ORAL (the tongue became numb), DYSPEPSIA (digestive problems), FEELING ABNORMAL (I feel bad), FEEDING DISORDER (i cant eat), ILLNESS (I've been sick for 9 months), DYSSTASIA (can't even stand up anymore) and IMPAIRED WORK ABILITY (I can't work anymore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-May-2021, Blood pressure measurement: increased (High) increased. On 21-May-2021, Heart rate: increased (High) increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant product use was reported.  The patient took the first dose of Moderna on 21-May-2021 and after 20 minutes, the tongue became numb, the heart rate increased, and the blood pressure rose. Two months after the vaccine, the patient felt bad. The patient couldn't eat. Digestive problems.  The reporter stated that after the Moderna vaccine, the patient had been sick for 9 months. But very badly, the patient could not even stand up anymore. The patient stated they couldn't live this way anymore and couldn't work anymore.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Feb-2022: Follow-up information included no new information On 01-Feb-2022: Translation document was received on 04-Feb-2022 which contains significant information. Added new events.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine given after 30-day BUD; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given after 30-day BUD) 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) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given after 30-day BUD). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine given after 30-day BUD) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  No treatment medication were provided.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product administration error
Clinical narrative: four patients received vaccine on 01/24/22 less than 48 hours after the expiration date of 01/22/22 but greater than 24 hours; 0.3ml booster dose was administerd to the patient instead of 0.25ml; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (four patients received vaccine on 01/24/22 less than 48 hours after the expiration date of 01/22/22 but greater than 24 hours) and PRODUCT ADMINISTRATION ERROR (0.3ml booster dose was administerd to the patient instead of 0.25ml) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jan-2022 at 10:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .3 milliliter. On 24-Jan-2022 at 10:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (four patients received vaccine on 01/24/22 less than 48 hours after the expiration date of 01/22/22 but greater than 24 hours) and PRODUCT ADMINISTRATION ERROR (0.3ml booster dose was administerd to the patient instead of 0.25ml). On 24-Jan-2022 at 10:00 AM, EXPIRED PRODUCT ADMINISTERED (four patients received vaccine on 01/24/22 less than 48 hours after the expiration date of 01/22/22 but greater than 24 hours) and PRODUCT ADMINISTRATION ERROR (0.3ml booster dose was administerd to the patient instead of 0.25ml) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment medication information provided.  On 07 Feb 2022, case MOD-2022-460266 became valid as it was confirmed that the patient demographics was identified.  Therefore, this case was  logically processed as valid.   Most recent FOLLOW-UP information incorporated above includes: On 07-Feb-2022: Follow up received: Report type and classification updated , Patient demographics added, Suspect product -dose, anatomical location added, previously reported event verbatim updated as per followup document, newevent product administration error added.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administered 1st dose of vaccine to a 17 year old; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered 1st dose of vaccine to a 17 year old) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2022 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 20-Jan-2022 at 4:00 PM, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered 1st dose of vaccine to a 17 year old). On 20-Jan-2022 at 4:00 PM, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered 1st dose of vaccine to a 17 year old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product information was not provided.  Treatment information was not provided. I t was reported that patient did not have any reaction to the vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 07-Feb-2022: Follow up received contains significant information, patient demographics, suspect vaccine administration time and information on events were updated.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose was administered greater than 12 hours post first vial puncture.; dose was administered  greater than 24 hours at room temperature; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was administered greater than 12 hours post first vial puncture.) and PRODUCT STORAGE ERROR (dose was administered  greater than 24 hours at room temperature) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041J21A and 0331-12-1A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was administered greater than 12 hours post first vial puncture.). 24-Jan-2022, the patient experienced PRODUCT STORAGE ERROR (dose was administered  greater than 24 hours at room temperature). On 24-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Dose was administered greater than 12 hours post first vial puncture.) and PRODUCT STORAGE ERROR (dose was administered  greater than 24 hours at room temperature) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided.  Vial was first moved from freezer to refrigerator on 19-Jan-2022 and room temperature was 72F.Vial was first punctured on 23-Jan-2022 at 9:30am Date vial moved from freezer to refrigerator were 19-Jan-2022 to 25 -Jan-2022.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Lip dry, Mucosal dryness, Nasal discomfort, Nasal dryness
Clinical narrative: Dried out lips; Nose got very dry; sore on the outside and a scab would form both nostrils; anywhere with mucous membranes would be dry; Sick for a week; sore on the outside and a scab would form both nostrils; This spontaneous case was reported by a consumer and describes the occurrence of LIP DRY (Dried out lips), NASAL DRYNESS (Nose got very dry), SCAB (sore on the outside and a scab would form both nostrils), MUCOSAL DRYNESS (anywhere with mucous membranes would be dry) and ILLNESS (Sick for a week) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LISINOPRIL, ATENOLOL, OXYCODONE, TIZANIDINE, ONE A DAY WOMEN'S, VACCINIUM MACROCARPON (CRANBERRY CONCENTRATE [VACCINIUM MACROCARPON]), ACETYLSALICYLIC ACID (BABY ASPIRIN) and FISH OIL for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced LIP DRY (Dried out lips), NASAL DRYNESS (Nose got very dry), SCAB (sore on the outside and a scab would form both nostrils), MUCOSAL DRYNESS (anywhere with mucous membranes would be dry) and ILLNESS (Sick for a week). March 2021, the patient experienced NASAL DISCOMFORT (sore on the outside and a scab would form both nostrils). The patient was treated with PARAFFIN (VASELINE [PARAFFIN]) in March 2021 at an unspecified dose and frequency. In April 2021, ILLNESS (Sick for a week) had resolved. At the time of the report, LIP DRY (Dried out lips), NASAL DRYNESS (Nose got very dry), SCAB (sore on the outside and a scab would form both nostrils), MUCOSAL DRYNESS (anywhere with mucous membranes would be dry) and NASAL DISCOMFORT (sore on the outside and a scab would form both nostrils) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       About 3 days after the first dose the patient experienced adverse events which lasted for about a week. Treatment received included vaseline, lip balm, medicated lip balm.   This case was linked to MOD-2022-470487 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Scab
Clinical narrative: Dried out lips; Nose got very dry; sore on the outside and a scab would form both nostrils; anywhere with mucous membranes would be dry; Sick for a week; sore on the outside and a scab would form both nostrils; This spontaneous case was reported by a consumer and describes the occurrence of LIP DRY (Dried out lips), NASAL DRYNESS (Nose got very dry), SCAB (sore on the outside and a scab would form both nostrils), MUCOSAL DRYNESS (anywhere with mucous membranes would be dry) and ILLNESS (Sick for a week) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LISINOPRIL, ATENOLOL, OXYCODONE, TIZANIDINE, ONE A DAY WOMEN'S, VACCINIUM MACROCARPON (CRANBERRY CONCENTRATE [VACCINIUM MACROCARPON]), ACETYLSALICYLIC ACID (BABY ASPIRIN) and FISH OIL for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced LIP DRY (Dried out lips), NASAL DRYNESS (Nose got very dry), SCAB (sore on the outside and a scab would form both nostrils), MUCOSAL DRYNESS (anywhere with mucous membranes would be dry) and ILLNESS (Sick for a week). March 2021, the patient experienced NASAL DISCOMFORT (sore on the outside and a scab would form both nostrils). The patient was treated with PARAFFIN (VASELINE [PARAFFIN]) in March 2021 at an unspecified dose and frequency. In April 2021, ILLNESS (Sick for a week) had resolved. At the time of the report, LIP DRY (Dried out lips), NASAL DRYNESS (Nose got very dry), SCAB (sore on the outside and a scab would form both nostrils), MUCOSAL DRYNESS (anywhere with mucous membranes would be dry) and NASAL DISCOMFORT (sore on the outside and a scab would form both nostrils) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       About 3 days after the first dose the patient experienced adverse events which lasted for about a week. Treatment received included vaseline, lip balm, medicated lip balm.   This case was linked to MOD-2022-470487 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: They said it was anaphylactic/anaphylactic; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (They said it was anaphylactic/anaphylactic) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L21A and 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal (Blood pressure), Thyroid disorder NOS (Thyroid), Fibromyalgia and Blood cholesterol abnormal (Cholesterol).   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ANAPHYLACTIC REACTION (They said it was anaphylactic/anaphylactic) (seriousness criterion medically significant). The patient was treated with EPINEPHRINE for Adverse event, at a dose of 1 dosage form. At the time of the report, ANAPHYLACTIC REACTION (They said it was anaphylactic/anaphylactic) outcome was unknown.            The patient said that she had a severe side effect after receiving the second shot. Post vaccination for first 15 minutes patient was fine. The events started 45 minutes post vaccination. She started to not be able to breath, was clearing her throat, couldn't swallow, she was choking and realized she couldn't breath. Her throat closed up. The patient was taken to emergency in ambulance because of the events and was diagnosed as anaphylactic reaction and patient remained in the hospital for few more hours on the same day.  Concomitant medications included blood pressure medication, thyroid medication, cholesterol medication, and fibromyalgia medication. Treatment also included intravenous medication and breathing treatment.  On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route, batch 051F21A) dosage was changed to 1 dosage form. The patient stated that she didn't experience any symptoms after the booster shot.  Company comment: This is a spontaneous case concerning a 58-year-old female patient with no relevant medical history reported, who experienced the expected serious event of Anaphylactic reaction on the same day 45 minutes after the second dose of mRNA-1273 vaccine. The patient received the third dose with no adverse events reported. Negative rechallenge remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 58-year-old female patient with no relevant medical history reported, who experienced the expected serious event of Anaphylactic reaction on the same day 45 minutes after the second dose of mRNA-1273 vaccine. The patient received the third dose with no adverse events reported. Negative rechallenge remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose administered to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 077C21B) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient). On 19-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   It was reported by Health care professional  that they administered 7 doses of an expired vial of Moderna COVID-19 Vaccine to 7 patients on 19-Jan-2022.  It was further stated by the Health care professional that no adverse events were observed in the patients. Health care professional stated no treatment was given and patients were not under any concomitant or regular medication. The date of vaccination of 1st dose and 2nd dose was unknown. The expiration date of 1st dose and 2nd dose was unknown. The vial was initially stored into refrigerator on 19-Jan-2022. The vial did not undergo any temperature excursions.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose administered to 7 patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 7 patients) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 077C21B) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 7 patients). On 19-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 7 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patients were not under any concomitant or regular medication. It was reported that there were 7 doses from 1 vial. The vial was initially stored in the refrigerator on 19-Jan-2022. The vial did not undergo any temperature excursions. The reporter mentioned that no adverse events were observed in any of the patients and no treatment was given.
Sex: M
Vaccine: COVID19
Symptoms: Nerve injury
Clinical narrative: nerve damage to his arm; This spontaneous case was reported by a consumer and describes the occurrence of NERVE INJURY (nerve damage to his arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NERVE INJURY (nerve damage to his arm) (seriousness criterion hospitalization). The patient was treated with Physical therapy (Physical therapy) for Nerve injury. At the time of the report, NERVE INJURY (nerve damage to his arm) outcome was unknown.            No concomitant and treatment medications was provided by the reporter. Within a week after vaccination, the patient experienced nerve damage to his arm. He was in hospital for several days and he stated that he was going to physical therapy.  Company comment: This case concerns a male patient of an unknown age with no medical history provided, who experienced serious unexpected event of Nerve injury (reported as nerve damage to his arm) after the administration of the mRNA-1273 vaccine (as booster dose). The date of vaccination and the start date of the event were not provided, however, as per source document, it was stated that the event occurred within a week after vaccine administration. The patient was initially hospitalized for several days due to reported event and at the time of this report, the patent was going to physical therapy. No additional details regarding the clinical course of the event were disclosed. The rechallenge is not applicable as the event occurred following booster vaccination. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a male patient of an unknown age with no medical history provided, who experienced serious unexpected event of Nerve injury (reported as nerve damage to his arm) after the administration of the mRNA-1273 vaccine (as booster dose). The date of vaccination and the start date of the event were not provided, however, as per source document, it was stated that the event occurred within a week after vaccine administration. The patient was initially hospitalized for several days due to reported event and at the time of this report, the patent was going to physical therapy. No additional details regarding the clinical course of the event were disclosed. The rechallenge is not applicable as the event occurred following booster vaccination. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.