chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction, Pneumonia
Clinical narrative: PNEUMONIA; TOO MANY SIDE EFFECTS; This spontaneous report received from a parent via social media a company representative concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. 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 pneumonia, and too many side effects and it was reported as "my jabbed daughter. 3 times. 2 very serious causing pneumonia too many side effects". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pneumonia and too many side effects was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000243632. This case, from the same reporter is linked to 20220750036, 20220752074, 20220750167 and 20220750301.; Sender's Comments: V0: 20220752219-covid-19 vaccine ad26.cov2.s- pneumonia. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DIED; This spontaneous report received from a consumer via social media (J&J corporate) from a company representative concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. 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 died from unknown cause of death. It was reported as "Sister in law was told she had 4 months to live, died 3 days later. It accelerates whatever you've got". It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20220749758.; Sender's Comments: V0: 20220752266 -Covid-19 vaccine ad26.cov2.s -DIED. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED COVID-19 INFECTION; CONFIRMED CLINICAL VACCINE FAILURE; This spontaneous report received from a patient via a company representative via Pfizer, Inc. concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: minocycline allergy. On an unspecified date, the patient previously vaccinated with elasomeran (Moderna vaccine) (Dose Number in Series 1) (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, vaccine administered at left arm for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with elasomeran (Dose Number in Series 1).  The patient additionally received covid-19 vaccine ad26.cov2.s (Dose Number in Series 2) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 01 total administered at left arm on 07-APR-2021 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included cannabidiol (CBD oil) for unknown indication, magnesium for unknown indication, menaquinone-7 (K2) for unknown indication, vitamin d nos for unknown indication, zinc for unknown indication and X (drug name unspecified) for unknown indication.  On an unspecified date, the patient experienced confirmed covid-19 infection. On 07-JUL-2022, the patient tested positive for coronavirus disease (COVID-19) test hence confirmed clinical vaccine failure. On the same day the patient started treatment with Paxlovid. The last dose of Paxlovid was administered on 12-JUL-2022 for the treatment of COVID-19. On 13-JUL-2022, Laboratory data included: COVID-19 virus test Negative. On 18-JUL-2022, the symptoms returned. On 19-JUL-2022, Laboratory data included: COVID-19 virus test Positive (Dose Number in Series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable and the action taken for paxlovid was drug withdrawn on 12-JUL-2022. The outcome of the confirmed clinical vaccine failure and confirmed covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000243918.; Sender's Comments: V0: 20220752325- covid-19 vaccine ad26.cov2.s- confirmed clinical vaccine failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINE FAILURE; CONFIRMED COVID 19 INFECTION; This spontaneous report received from a patient via other manufacturer Pfizer concerned a 42 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: multiple sclerosis (MS) and drug allergy (unspecified drug). The patient was not pregnant at the time of this report.  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 12-MAR-2021 to Left Arm for covid-19 prophylaxis. Age at time of vaccination 41 years old. The batch number was not reported and has been requested. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine. The patient received elasomeran (Moderna Covid-19 vaccine) (dose number in series 2) (form of admin, route of admin, batch number and expiry date were not reported) dose was not reported, administered on 09-NOV-2021 to Left Arm for covid-19 prophylaxis.  On an unspecified date in 2022, the patient experienced confirmed covid-19 infection (dose number in series 2). The patient received non-company suspect Paxlovid (Nirmatrelvir; ritonavir) (form of admin, route of admin, batch number and expiry date were not reported) therapy started on 01-JUL-2022. Therapy ended on 06-JUL-2022 administered for covid-19 treatment. Later, 5 days after treatment ended, the patient had Covid rebound and recurrence of symptoms (unspecified), and positive test which led to confirmed vaccination failure (dose series 1). Laboratory data (dates unspecified) included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable and Paxlovid was discontinued. The patient recovered from confirmed covid 19 infection on 16-JUL-2022, and the outcome of confirmed clinical vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint 90000243929.; Sender's Comments: V0: 20220752345 - Covid-19 vaccine ad26.cov2.s -CONFIRMED CLINICAL VACCINATION FAILURE. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: FELT TIRED; This spontaneous report received from a 70 year old male patient. The patient's weight, height, and medical history were not reported. The patient was previously treated with covid-19 vaccine ad26. cov2.s (Dose number in series 1) (suspension for injection, route of admin, batch number: 1808609, expiry: 04-FEB-2022) dose was not reported, administered 1 in total to the left arm on 17-MAR-2021 for covid-19 prophylaxis. Age at time of vaccination 70 years old. On 18-MAR-2021, the patient felt tired after vaccination with covid-19 vaccine ad26. cov2. s (Dose number in series 1). The patient received booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 182281 expiry: UNKNOWN) dose was not reported, administered 1 in total to the left arm on 28-OCT-2021 for covid-19 prophylaxis. Age at time of vaccination 70 years old. No concomitant medications were reported.  On 29-OCT-2021, the patient felt tired following vaccination with covid-19 vaccine ad26. cov2. s (Dose number in series 2). Patient said he had to drive 60 to 65 miles to get both the vaccine, and it could have been as a result of driving, as patient was 71 years old. Patient did not contact his physician after the shots. Patient did talk to his physician a few weeks ago about getting another booster, and his physician told him he was approved to receive another Janssen Covid-19 booster, and he thinks the CDC (Centers for Disease Control) guidelines says he can get it because he would otherwise not receive another booster since Patient wants the Janssen 2nd booster. Patient also reported that he was not in the age range of 65 to 68 for thrombosis issues, and was not concerned about another booster. Patient also mentioned that he was not in the category for blood clots as that was for ages under 60. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of felt tired was not reported. This report was non-serious. This case, involving the same patient is linked to 20220744486.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 49 year old male of an unspecified race. The patient's height, and weight were not reported. The patient's concurrent conditions included: pre-diabetes. The patient experienced drug allergy when treated with acetylsalicylic acid. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805020 and expiry: unknown) dose was not reported, dose 1, 1 total was administered on 22-MAR-2021 on left arm for covid-19 prophylaxis. Age at time of vaccination 47 years old. The patient received non-company suspect vaccine included: tozinameran (Pfizer/BioNTech) (dose number in series 2) (form of admin, route of admin were not reported, batch number: 32030BD and expiry: unknown) dose was not reported, dose 2 was administered on 02-NOV-2021 on left arm for covid-19 prophylaxis. No concomitant medications were reported. On an unspecified date, the patient had covid-19 infection (coded as confirmed covid-19 infection) (dose number in series 2). The patient received non-company suspect drug paxlovid (form of admin, route of admin were not reported, batch number: unknown and expiry: unknown) dose was not reported, administered from 12-JUL-2022 to 16-JUL-2022 for treatment of covid-19. On an 20-JUL-2022 21:00, the patient had rebound infection and symptoms and positive test approximately 5 days after the last dose (dose number in series 2). On an unspecified date, the patient experienced confirmed clinical vaccination failure (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s, tozinameran was not applicable and with paxlovid was drug discontinued. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint, and reference number requested.; Sender's Comments: V0:20220754276-COVID-19 VACCINE Ad26.COV2.S- confirmed clinical vaccination failure .The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 49 year old male of an unspecified race. The patient's height, and weight were not reported. The patient's concurrent conditions included: pre-diabetes. The patient experienced drug allergy when treated with acetylsalicylic acid. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805020 and expiry: unknown) dose was not reported, dose 1, 1 total was administered on 22-MAR-2021 on left arm for covid-19 prophylaxis. Age at time of vaccination 47 years old. The patient received non-company suspect vaccine included: tozinameran (Pfizer/BioNTech) (dose number in series 2) (form of admin, route of admin were not reported, batch number: 32030BD and expiry: unknown) dose was not reported, dose 2 was administered on 02-NOV-2021 on left arm for covid-19 prophylaxis. No concomitant medications were reported. On an unspecified date, the patient had covid-19 infection (coded as confirmed covid-19 infection) (dose number in series 2). The patient received non-company suspect drug paxlovid (form of admin, route of admin were not reported, batch number: unknown and expiry: unknown) dose was not reported, administered from 12-JUL-2022 to 16-JUL-2022 for treatment of covid-19. On an 20-JUL-2022 21:00, the patient had rebound infection and symptoms and positive test approximately 5 days after the last dose (dose number in series 2). On an unspecified date, the patient experienced confirmed clinical vaccination failure (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s, tozinameran was not applicable and with paxlovid was drug discontinued. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint, and reference number requested.; Sender's Comments: V0:20220754276-COVID-19 VACCINE Ad26.COV2.S- confirmed clinical vaccination failure .The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), on 02Nov2021 as dose 2 (booster), single (Lot number: 32030BD) at the age of 48 years, in left arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 22Mar2021 as dose 1, single (Lot number: 1805020), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Pre-diabetes" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Known allergies: aspirin, reaction(s): "Known allergies: Aspirin", notes: Known allergies: Aspirin.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Results, notes: Treatment of COVID-19; (Jul2022) positive, notes: Rebound infection. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had not received any other medication in 2 weeks. Patient took Paxlovid from 12Jul2022 to 16Jul2022 as a treatment of COVID-19. Patient had Rebound infection on 20Jul2022 09:00 PM. Symptoms and positive test approx. 5 days after last dose. The patient also had known allergies of Aspirin and other medical history was pre-diabetes. Symptoms and positive test approx. 5 days after last dose.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), on 02Nov2021 as dose 2 (booster), single (Lot number: 32030BD) at the age of 48 years, in left arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 22Mar2021 as dose 1, single (Lot number: 1805020), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Pre-diabetes" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Known allergies: aspirin, reaction(s): "Known allergies: Aspirin", notes: Known allergies: Aspirin.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Results, notes: Treatment of COVID-19; (Jul2022) positive, notes: Rebound infection. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had not received any other medication in 2 weeks. Patient took Paxlovid from 12Jul2022 to 16Jul2022 as a treatment of COVID-19. Patient had Rebound infection on 20Jul2022 09:00 PM. Symptoms and positive test approx. 5 days after last dose. The patient also had known allergies of Aspirin and other medical history was pre-diabetes. Symptoms and positive test approx. 5 days after last dose.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: COVID SYMPTOMS RELAPSE 24 HOURS AFTER LAST DOSE OF PAXLOVID (NAUSEA, FATIGUE) FOR 60 HOURS; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included: bactrim allergy, and other pre-existing medical conditions included: Patient was not pregnant at the time of vaccination. No relevant medical history and concurrent conditions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 12:30 for covid-19 prophylaxis. Age at time of vaccination 56 years old. No concomitant medications were reported. On 2022, the patient experienced covid symptoms relapse 24 hours after last dose of paxlovid (nausea, fatigue) for 60 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from covid symptoms relapse 24 hours after last dose of paxlovid (nausea, fatigue) for 60 hours. This report was non-serious.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was stored and administered beyond 30 days use by date) and PRODUCT STORAGE ERROR (Vaccine was stored and administered beyond 30 days use by date) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059M21A) for COVID-19 prophylaxis. No Medical History information was reported. On 29-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was stored and administered beyond 30 days use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored and administered beyond 30 days use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was stored and administered beyond 30 days use by date) and PRODUCT STORAGE ERROR (Vaccine was stored and administered beyond 30 days use by date) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Anatomical location for vaccination given to patient was reported as deltoid. No concomitant medication information provided. Vaccine was stored in fridge longer than 30 days prior to administration. Date the vial was initially stored in refrigerator was 27-May-2022. The vial did not undergo any temperature excursion. Upon follow-up it was stated that reporter was still investigating exactly what happened, but after talking to the pharmacist at the clinic that day it sounds like the vaccine was placed in the refrigerator on 26-May-2022. Further it was reported that reporter was still trying to determine if any patients received a dose after the 30 days, but 30-Jun-2022 is the latest it could have happened. No treatment information provided. This case was linked to US-MODERNATX, INC.-MOD-2022-613777, US-MODERNATX, INC.-MOD-2022-613606, US-MODERNATX, INC.-MOD-2022-613604, US-MODERNATX, INC.-MOD-2022-613607, US-MODERNATX, INC.-MOD-2022-613782. Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2022: Follow up contains significant information: I-narrative updated. On 11-Jul-2022: Follow-up document received includes no new information was added. On 25-Jul-2022: Significant follow-up received: Patient details added, dosage details added, event onset date updated. Narrative supplement updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-613777:Master case US-MODERNATX, INC.-MOD-2022-613606:Master case US-MODERNATX, INC.-MOD-2022-613782:Master Case US-MODERNATX, INC.-MOD-2022-613607:Master case US-MODERNATX, INC.-MOD-2022-613604:Master Case
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: 6 year old patient received her 1st dose of the Moderna COVID-19 vaccine from a 6 month - 5 year old vial presentation; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT DOSE ADMINISTERED (6 year old patient received her 1st dose of the Moderna COVID-19 vaccine from a 6 month - 5 year old vial presentation) in a 6-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jul-2022, the patient experienced INCORRECT DOSE ADMINISTERED (6 year old patient received her 1st dose of the Moderna COVID-19 vaccine from a 6 month - 5 year old vial presentation). At the time of the report, INCORRECT DOSE ADMINISTERED (6 year old patient received her 1st dose of the Moderna COVID-19 vaccine from a 6 month - 5 year old vial presentation) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. It was reported that a 6 years old patient received first dose of Moderna COVID-19 vaccine from 6 month - 5 year old vial presentation and patient did not reported any adverse reactions.  No treatment medication information was provided.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient received Moderna Covid-19 vaccine that underwent a temperature excursion; Patient received Moderna Covid-19 vaccine that underwent a temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014B22A, 005C21A and 023C21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jul-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) 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 patient received Moderna Covid-19 vaccine that underwent a temperature excursion. The temperature excursion was not known of at the time of administration of the vaccine. The temperature excursion was found out about after a review of the temperature datalogger on the refrigerator that the Moderna Covid-19 vaccine was stored in. The reporter (Nurse) had used the online Temperature excursion tool and was comfortable that the patient's dose was valid and that the affected vaccine was viable for future doses. Side effects after any doses were unknown. No treatment information was reported.   This case was linked to MOD-2022-612827 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Decreased appetite, Fatigue, Feeling abnormal
Clinical narrative: feeling bad; coughing; lower appetite/doesn't have much of an appetite; hurt; skin feels whatever; running a 100 or 101°F fever/still had a fever/fever even with Tylenol and "eating all over"; nauseas; headaches; extremely tired; aches; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (feeling bad), COUGH (coughing), DECREASED APPETITE (lower appetite/doesn't have much of an appetite), PAIN (hurt) and SKIN DISORDER (skin feels whatever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006m21a, 017e21a, 044a21a and 011a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cholesterol, Blood pressure, Thyroid disorder and Allergy to antibiotic (some antibiotics).   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jul-2022, the patient experienced FEELING ABNORMAL (feeling bad), COUGH (coughing), DECREASED APPETITE (lower appetite/doesn't have much of an appetite), PAIN (hurt), SKIN DISORDER (skin feels whatever), PYREXIA (running a 100 or 101°F fever/still had a fever/fever even with Tylenol and "eating all over"), NAUSEA (nauseas), HEADACHE (headaches), FATIGUE (extremely tired) and MYALGIA (aches). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (feeling bad), COUGH (coughing), DECREASED APPETITE (lower appetite/doesn't have much of an appetite), PAIN (hurt), SKIN DISORDER (skin feels whatever), PYREXIA (running a 100 or 101°F fever/still had a fever/fever even with Tylenol and "eating all over"), NAUSEA (nauseas), HEADACHE (headaches), FATIGUE (extremely tired) and MYALGIA (aches) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jul-2022, Body temperature: 100 or 101°F.         Concomitant products included cholesterol medication, blood pressure medication, thyroid medication. Patient still had fever even with Tylenol, eating all over and that she was perfectly fine before.  It was reported that patient symptoms improved some just a little but did not have much of an appetite. Patient was not diagnose with or tested positive for Covid-19. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. AE did not cause patient to seek medical care.The patient did not experienced a similar event in the past.   This case was linked to MOD-2022-613386 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: feeling bad; coughing; lower appetite/doesn't have much of an appetite; hurt; skin feels whatever; running a 100 or 101°F fever/still had a fever/fever even with Tylenol and "eating all over"; nauseas; headaches; extremely tired; aches; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (feeling bad), COUGH (coughing), DECREASED APPETITE (lower appetite/doesn't have much of an appetite), PAIN (hurt) and SKIN DISORDER (skin feels whatever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006m21a, 017e21a, 044a21a and 011a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cholesterol, Blood pressure, Thyroid disorder and Allergy to antibiotic (some antibiotics).   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jul-2022, the patient experienced FEELING ABNORMAL (feeling bad), COUGH (coughing), DECREASED APPETITE (lower appetite/doesn't have much of an appetite), PAIN (hurt), SKIN DISORDER (skin feels whatever), PYREXIA (running a 100 or 101°F fever/still had a fever/fever even with Tylenol and "eating all over"), NAUSEA (nauseas), HEADACHE (headaches), FATIGUE (extremely tired) and MYALGIA (aches). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (feeling bad), COUGH (coughing), DECREASED APPETITE (lower appetite/doesn't have much of an appetite), PAIN (hurt), SKIN DISORDER (skin feels whatever), PYREXIA (running a 100 or 101°F fever/still had a fever/fever even with Tylenol and "eating all over"), NAUSEA (nauseas), HEADACHE (headaches), FATIGUE (extremely tired) and MYALGIA (aches) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jul-2022, Body temperature: 100 or 101°F.         Concomitant products included cholesterol medication, blood pressure medication, thyroid medication. Patient still had fever even with Tylenol, eating all over and that she was perfectly fine before.  It was reported that patient symptoms improved some just a little but did not have much of an appetite. Patient was not diagnose with or tested positive for Covid-19. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. AE did not cause patient to seek medical care.The patient did not experienced a similar event in the past.   This case was linked to MOD-2022-613386 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Skin disorder
Clinical narrative: feeling bad; coughing; lower appetite/doesn't have much of an appetite; hurt; skin feels whatever; running a 100 or 101°F fever/still had a fever/fever even with Tylenol and "eating all over"; nauseas; headaches; extremely tired; aches; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (feeling bad), COUGH (coughing), DECREASED APPETITE (lower appetite/doesn't have much of an appetite), PAIN (hurt) and SKIN DISORDER (skin feels whatever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006m21a, 017e21a, 044a21a and 011a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cholesterol, Blood pressure, Thyroid disorder and Allergy to antibiotic (some antibiotics).   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jul-2022, the patient experienced FEELING ABNORMAL (feeling bad), COUGH (coughing), DECREASED APPETITE (lower appetite/doesn't have much of an appetite), PAIN (hurt), SKIN DISORDER (skin feels whatever), PYREXIA (running a 100 or 101°F fever/still had a fever/fever even with Tylenol and "eating all over"), NAUSEA (nauseas), HEADACHE (headaches), FATIGUE (extremely tired) and MYALGIA (aches). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (feeling bad), COUGH (coughing), DECREASED APPETITE (lower appetite/doesn't have much of an appetite), PAIN (hurt), SKIN DISORDER (skin feels whatever), PYREXIA (running a 100 or 101°F fever/still had a fever/fever even with Tylenol and "eating all over"), NAUSEA (nauseas), HEADACHE (headaches), FATIGUE (extremely tired) and MYALGIA (aches) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jul-2022, Body temperature: 100 or 101°F.         Concomitant products included cholesterol medication, blood pressure medication, thyroid medication. Patient still had fever even with Tylenol, eating all over and that she was perfectly fine before.  It was reported that patient symptoms improved some just a little but did not have much of an appetite. Patient was not diagnose with or tested positive for Covid-19. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. AE did not cause patient to seek medical care.The patient did not experienced a similar event in the past.   This case was linked to MOD-2022-613386 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clots, back of leg , tibia, and leg; This spontaneous case was reported by a patient and describes the occurrence of THROMBOSIS (blood clots, back of leg , tibia, and leg) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Patient did not have COVID+ test or diagnosis in the past. Patient had no acute or chronic illnesses at the time of vaccination. Patient was not given any vaccine within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Drug allergy (Morphine allergy).   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Jul-2022, the patient experienced THROMBOSIS (blood clots, back of leg , tibia, and leg) (seriousness criterion medically significant). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN 81) at a dose of 4 times,81mg. At the time of the report, THROMBOSIS (blood clots, back of leg , tibia, and leg) was resolving.            Patient did not seek medical care. Patient did not experience a similar event in the past. No concomitant medications were reported. Patient took 4 aspirin of 81mg.  Company comment: This spontaneous case concerns a 60 year old female with no relevant medical history, who experienced the unexpected serious (medically significant) adverse event of special interest Thrombosis which occurred 2 days after receiving the fourth dose of mRNA1273. Patient reported of blood clots on the back of the leg, tibia and leg, she did not seek medical care but took 4 aspirin of 81mg. Further details regarding the clinical course and diagnostic test done were not provided. The patient's elderly age may be considered as a risk factor for thrombosis. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-613382 (Patient Link).; Sender's Comments: This spontaneous case concerns a 60 year old female with no relevant medical history, who experienced the unexpected serious (medically significant) adverse event of special interest Thrombosis which occurred 2 days after receiving the fourth dose of mRNA1273. Patient reported of blood clots on the back of the leg, tibia and leg, she did not seek medical care but took 4 aspirin of 81mg. Further details regarding the clinical course and diagnostic test done were not provided. The patient's elderly age may be considered as a risk factor for thrombosis. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was refrigerated after 30-day use by date; Vaccine administered to patient after 30-day use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient after 30-day use by date) and PRODUCT STORAGE ERROR (Vial was refrigerated after 30-day use by date) in a 3-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1416B) for COVID-19 prophylaxis.     It was unknown if patient was diagnosed with COVID-19 in the past. Patient did not had any allergies. It was unknown if other vaccines were given within one month prior to Moderna COVID-19 vaccine.     On 21-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was refrigerated after 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient after 30-day use by date) and PRODUCT STORAGE ERROR (Vial was refrigerated after 30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information provided.  It was reported that on 21-Jul-2022 patient had administered Moderna Infant Vaccine Lot AS1416B received on 20-Jun-2022 and was expired after 30 day use by date on 20-Jul-2022. Vaccine was stored in a refrigerated state within the required temperature entirely.  It was unknown if AE caused patient to seek medical care. It was unknown if patient had experienced any similar event in the past.  No treatment information provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site rash
Clinical narrative: Rash at the injection site and a sore arm with the other 3 doses; Rash at the injection site and a sore arm with the other 3 doses; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE RASH (Rash at the injection site and a sore arm with the other 3 doses) and PAIN IN EXTREMITY (Rash at the injection site and a sore arm with the other 3 doses) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011a21a, 044a21a and 017e21a) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic, Thyroid disorder NOS, Cholesterol and Blood pressure.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-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 VACCINATION SITE RASH (Rash at the injection site and a sore arm with the other 3 doses) and PAIN IN EXTREMITY (Rash at the injection site and a sore arm with the other 3 doses). At the time of the report, VACCINATION SITE RASH (Rash at the injection site and a sore arm with the other 3 doses) and PAIN IN EXTREMITY (Rash at the injection site and a sore arm with the other 3 doses) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications included cholesterol medication, blood pressure medication and thyroid medication.  The patient never had COVID positive test or diagnosis. The patient had no other vaccines within 1 month prior to Moderna COVID-19 vaccine. There was no medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. The AE did not cause patient to seek medical care (office visit, Urgent care, ER, hospitalized). The patient did not experience a similar event in the past.  Treatment medication was not reported.   This case was linked to MOD-2022-613363 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Had low grade fever after the 3 shots but but they only lasted for a day.; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Had low grade fever after the 3 shots but but they only lasted for a day.) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 012L20A) for COVID-19 vaccination.     No allergies to medication, food and other products  The patient had never been diagnosed or tested positive for COVID-19. It was reported that the patient had chronic conditions way before getting the vaccine.  Concurrent medical conditions included Diabetes, Blood pressure high, Aneurysm of heart (watching out) and Cholesterol. Concomitant products included COLECALCIFEROL (VIT D3) for Supplementation therapy, METFORMIN, LIRAGLUTIDE (VICTOZA), INSULIN GLARGINE (LANTUS), METOPROLOL TARTRATE (LOPRESSOR), ROSUVASTATIN, LOSARTAN POTASSIUM (COZAR) and CYANOCOBALAMIN (VIT B12) 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. In 2021, the patient experienced PYREXIA (Had low grade fever after the 3 shots but but they only lasted for a day.). In 2021, PYREXIA (Had low grade fever after the 3 shots but but they only lasted for a day.) had resolved.            Patient was not ever tested or diagnosed with COVID-19.  On 11-Jan-2021, the patient experienced low grade fever after dose 1 and resolved on 12-Jan-2021.  On 08-Feb-2021, the patient experienced low grade fever after dose 2 and resolved on 09-Feb-2021. Treatment information was not provided.   This case was linked to MOD-2022-613411 (Patient Link).
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was put in the refrigerator on 15-Jun-2022 and administered on 19-Jul-2022; Administered with the vaccine that has been stored in the refrigerator for more than 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine that has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (Vaccine was put in the refrigerator on 15-Jun-2022 and administered on 19-Jul-2022) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine that has been stored in the refrigerator for more than 30 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was put in the refrigerator on 15-Jun-2022 and administered on 19-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine that has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (Vaccine was put in the refrigerator on 15-Jun-2022 and administered on 19-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was administered second booster on 19-Jul-2022. Concomitant medication list was not provided. Vaccine was put in the refrigerator on 15-Jun-2022. Treatment information was not provided.