chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Insomnia, Pyrexia
Clinical narrative: HALLUCINATIONS WHILE ASLEEP; OUT OF BODY EXPERIENCE; COULDN'T SLEEP; SO WARM; FEVER; CHILLS; This solicited report received from a patient via media concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-MAR-2021 12:30 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 10-MAR-2021 22:00, the patient experienced chills. On 11-MAR-2021, the patient experienced hallucinations while asleep. On 11-MAR-2021, the patient experienced out of body experience. On 11-MAR-2021, the patient experienced couldn't sleep. On 11-MAR-2021, the patient experienced so warm. On 11-MAR-2021 00:45, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) 102 (unit not provided). On 11-MAR-2021 01:30, Laboratory data included: Body temperature (NR: not provided) 103.1 (unit not provided). Treatment medications included: paracetamol. On 11-MAR-2021 02:30, treatment medications included: alprazolam. On 11-MAR-2021 00:45, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from so warm, and fever on 11-MAR-2021, and the outcome of chills, hallucinations while asleep, out of body experience and couldn't sleep was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and hallucinations while asleep, out of body experience, couldn't sleep, chills, so warm, and fever was related.  This report was serious (Other Medically Important Condition).  Version created to amend previously reported information on 11-MAR-2021. Upon review the following information was amended: case level seriousness and previously reported non-serious event of hallucinations was updated to serious. The company causality for all events was updated to related (previously captured as possible); Sender's Comments: Hallucinations while asleep. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are no other factors more likely to be associated with the event(s) than the drug. Therefore, this event(s) is considered related to COVID-19 vaccine ad26.cov2.s.
Sex: U
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: NEUROPATHY (NO ONE KNOWS IF SHOULDER WILL EVER GET BACK TO  NORMAL); This solicited report received from a patient via Janssen  concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on AUG-2021 for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced neuropathy (no one knows if shoulder will ever get back to normal). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from neuropathy (no one knows if shoulder will ever get back to normal). The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and neuropathy (no one knows if shoulder will ever get back to normal) was related.  This report was serious (Other Medically Important Condition).  Version created to amend previously reported information on 24-OCT-2021. Upon review the following information was amended: case level seriousness and previously reported non-serious event of neuropathy was updated to serious. Company causality was updated to related.; Sender's Comments: "No one knows if shoulder will ever get back to normal"  PT Neuropathy peripheral. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are no other factors more likely to be associated with the event(s) than the drug. Therefore, this event(s) is considered related to COVID-19 vaccine ad26.cov2.s.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Loss of personal independence in daily activities, Malaise
Clinical narrative: NOT FEELING WELL; FATIGUE/SYMPTOMS OF FATIGUE; ENERGY LEVEL LIMIT DAILY ACTIVITIES; ENERGY LEVEL LIMIT DAILY ACTIVITIES; This spontaneous report received from a patient concerned an 80 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: malignant neoplasm of prostate, and other pre-existing medical conditions included: The patient had not symptoms of hand and foot syndrome. The patient previously received first dose of non-company suspect vaccine covid-19 vaccine (dose number in series 1) (unspecified manufacturer) (form of admin, route of admin, batch number and expiry date were not reported), dose, start therapy date were not reported for prophylactic vaccination. Non-company suspect drugs included: enzalutamide (tablet, oral, batch number: EW4300 expiry: 31-MAY-2024) 160 mg, 1 time every 1 day, from JUL-2021 for malignant neoplasm of prostate. No concomitant medications were reported. On an unspecified date, the patient received second dose of covid-19 vaccine (dose number in series 2) (unspecified manufacturer) (form of admin, route of admin, batch number and expiry date were not reported), dose, start therapy date were not reported for prophylactic vaccination.  On an unspecified date, the patient experienced moderate fatigue/symptoms of fatigue (reported as level 2 out of 10) but energy level did not limit daily activities. The patient did not feel better after resting. On an unspecified date, patient rated 6 out of 10 for his fatigue, felt better after resting and energy levels did limit daily activities (loss of personal independence in daily activities and asthenia) (dose number in series 1). It was unknown if physician was aware of the events. The enzalutamide was temporarily stopped for a week and later restarted on 1 tablet daily. The patient later received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported 1 total for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  On an unspecified date, following administration with covid-19 vaccine ad26.cov2.s, the patient was not feeling well for a while (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and treatment with enzalutamide was withdrawn. The outcome of the fatigue/symptoms of fatigue, energy level limit daily activities and not feeling well was not reported. This report was non-serious.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain
Clinical narrative: STIFFNESS; PAIN; This spontaneous report received from a patient concerned a 54 year old male of unknown race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis, moderate to severe chronic plaque psoriasis, and moderate to severe ulcerative colitis, and other pre-existing medical conditions included: No known allergies and no relevant medical history. The patient previously received 2 doses of covid-19 vaccine ad26. cov2.s (dose 1 of dose number in series 1) (dose 2 of dose number in series 1) (suspension for injection, intramuscular, batch number and expiry were not reported) dose was not reported, 1 total, administered on an unspecified date for prophylactic vaccination which was an off label use and inappropriate schedule of vaccine administration (dose 2 of dose number in series 1). The patient experienced covid-19 (dose number in series 1) when treated with covid-19 vaccine ad26. cov2. s for prophylactic vaccination. The outcome of the events covid-19, inappropriate schedule of vaccine administration and off label use was unknown. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, intramuscular, batch number and expiry was not reported) dose was not reported, 1 total administered on 30-DEC-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: upadacitinib (form of admin unknown, oral, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis, moderate to severe ulcerative colitis, and moderate to severe rheumatoid arthritis. 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 unknown date in 2022, the patient experienced stiffness, and pain (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with upadacitinib was not reported. The patient recovered from stiffness, and pain. This report was non-serious. This case, involving the same patient is linked to 20220349210.
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: BEST NIGHT SLEEP IN A LONG TIME,  FEELING GREAT; This spontaneous report received from a patient concerned a 75 year old white female. The patient's height, and weight were not reported. Patient reported that she normally did not sleep well (at the time of vaccination). The patient initially received covid-19 vaccine ad26.cov2.s (Dose number in series 01) (suspension for injection, route of administration not reported, batch number: 041AQ1A, and expiry: unknown) dose was not reported, 01 total was administered on 05-APR-2021 to the left arm for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, after the primary dose of the Janssen COVID-19 vaccine, she had the best night sleep in a long time, and was feeling great and that normally doesn't sleep well (Unexpected therapeutic benefit) (Dose number in series 01). The patient received additional covid-19 vaccine ad26. cov2. s (Dose number in series 02) (suspension for injection, route of administration, batch number and expiry were not reported) dose was not reported, 01 total administered on 19-NOV-2021 for prophylactic vaccination. No adverse events/issues were observed with the Janssen booster (Dose number in series 02). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of best night sleep in a long time, feeling great was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Inappropriate schedule of product administration, Off label use
Clinical narrative: INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; OFF LABEL USE; This spontaneous report received from a patient via a company representative concerned a 69 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe chronic plaque psoriasis, moderate to severe adult crohn's disease, and moderate to severe ulcerative colitis. The patient previously received covid-19 vaccine ad26. cov2.s (dose number in series 1) (suspension for injection, intramuscular, batch number: UNKNOWN) dose, start therapy date were not reported, 1 total, administered on 20-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included adalimumab for moderate to severe chronic plaque psoriasis, moderate to severe adult crohn's disease, and moderate to severe ulcerative colitis. The patient experienced allergy, fatigue aggravated, flare up of diarrhea (diarrhea aggravated), headache with sharp pain, low blood pressure, occasional cramp flare up and sleep apnea when treated with covid-19 vaccine ad26. cov2. s (dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (second dose) (suspension for injection, intramuscular, batch number: UNKNOWN) dose, start therapy date were not reported, 1 total, administered on an unspecified date for prophylactic vaccination which was off label use and inappropriate schedule of vaccine administered (dose number in series 2). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  The patient received additional (third dose, booster) of covid-19 vaccine ad26.cov2.s (dose number in series 3) (suspension for injection, intramuscular, batch number: UNKNOWN) dose was not reported, 1 total, administered on 20-NOV-2021 for prophylactic vaccination. No adverse events were reported after third dose (dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious. This case, involving the same patient is linked to 20211021812 (dose number in series 1).
Sex: F
Vaccine: UNK
Symptoms: Drug interaction
Clinical narrative: A FLARE AND RELAPSE ALL THE PROGRESS; SUSPECTED DRUG INTERACTION; This spontaneous report received from a patient by Pfizer concerned a 45 year old female. The patient's height, and weight were not reported. The patient's past medical history included: covid, and other pre-existing medical conditions included: The patient was fine and was doing very well. The patient had no issues at all and did not relapsed. 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 NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Non-company suspect drugs included: tofacitinib citrate ( batch number: EJ9968 expiry: UNKNOWN, form of admin, route of admin were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported. On NOV-2021, the patient experienced suspected drug interaction. On an unspecified date, the patient experienced a flare and relapse all the progress. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected drug interaction and a flare and relapse all the progress was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event, Thrombosis
Clinical narrative: BLOOD CLOTS; ADVERSE REACTIONS; This spontaneous report received from a patient via a company representative via media concerned a patient of unspecified age, sex, race and ethnic origin. 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, 1 total administered 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 had adverse reactions including blood clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the adverse reactions and blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220350556-COVID-19 VACCINE AD26.COV2.S- blood clots. The event(s) has a 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: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: OUT OF SPECIFICATION PRODUCT USE; 10 VIALS UNDERWENT A SHORT TEMPERATURE EXCURSION LASTING FOR 3 MINUTES EXCEEDING IN 0.74 F THE MANUFACTURER'S UPPER RECOMMENDED LIMIT; This spontaneous report received from a pharmacist concerned a patient of unspecified age and 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 not reported, batch number: 213D21A expiry: 10-JUL-2022) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced out of specification product use, and 10 vials underwent a short temperature excursion lasting for 3 minutes exceeding in 0.74 f the manufacturer's upper recommended limit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the out of specification product use and 10 vials underwent a short temperature excursion lasting for 3 minutes exceeding in 0.74 f the manufacturer's upper recommended limit was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Acne
Clinical narrative: ACNE SECRETIONS, SMALL BUMPS ERUPTING AROUND BOTH EYES LIDS, AND LASHES, SECRETING SOMETIMES WHITE, YELLOW, AND BLACK COLOR; This spontaneous report received from a consumer concerned a 93 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 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the patient experienced acne secretions, small bumps erupting around both eyes lids, and lashes, secreting sometimes white, yellow, and black color. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from acne secretions, small bumps erupting around both eyes lids, and lashes, secreting sometimes white, yellow, and black color. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: VERY SICK AFTER THE VACCINE; 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 Cancer. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, administered on 12-APR-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 very sick after the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of very sick after the vaccine was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: GOT COVID; This spontaneous report received from a consumer concerned a male 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 and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced got covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got covid was not reported. This report was non-serious. This report was associated with product quality complaint: 90000223173 This case, from the same reporter is linked to 20220350967.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: GOT COVID; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was very exposed to close contact who have experienced covid-19. The patient's grandparent medical history included diabetes and high blood pressure. 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 got covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got covid was not reported. This report was non-serious. This case, from the same reporter is linked to 20220350895.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizzy; This spontaneous case was reported by an other health care professional and describes the occurrence of DIZZINESS (Dizzy) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizzy). At the time of the report, DIZZINESS (Dizzy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication not reported by reporter. Treatment information not reported by reporter
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Facial discomfort, Lip swelling, Lymphadenopathy, Rash, Vaccination site erythema
Clinical narrative: face was tight; lips are swollen; Rashes that looks like bug bites around her mustache area and her jaw lines (on both side)/The rashes are white circle with red edges.; Injection site red/Injection site had a 6 inches red ring around it; Armpit was swollen (like the size of a golf ball); Injection site tender; Injection site sore; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL DISCOMFORT (face was tight), LIP SWELLING (lips are swollen), VACCINATION SITE PAIN (Injection site tender), VACCINATION SITE PAIN (Injection site sore) and RASH (Rashes that looks like bug bites around her mustache area and her jaw lines (on both side)/The rashes are white circle with red edges.) in a 29-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 046L21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 18-Mar-2022, the patient experienced VACCINATION SITE PAIN (Injection site tender), VACCINATION SITE PAIN (Injection site sore), VACCINATION SITE ERYTHEMA (Injection site red/Injection site had a 6 inches red ring around it) and LYMPHADENOPATHY (Armpit was swollen (like the size of a golf ball)). On 22-Mar-2022, the patient experienced FACIAL DISCOMFORT (face was tight), LIP SWELLING (lips are swollen) and RASH (Rashes that looks like bug bites around her mustache area and her jaw lines (on both side)/The rashes are white circle with red edges.). On 21-Mar-2022, VACCINATION SITE PAIN (Injection site tender), VACCINATION SITE PAIN (Injection site sore) and VACCINATION SITE ERYTHEMA (Injection site red/Injection site had a 6 inches red ring around it) had resolved. At the time of the report, FACIAL DISCOMFORT (face was tight), LIP SWELLING (lips are swollen) and RASH (Rashes that looks like bug bites around her mustache area and her jaw lines (on both side)/The rashes are white circle with red edges.) had not resolved and LYMPHADENOPATHY (Armpit was swollen (like the size of a golf ball)) was resolving.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       Based on what she looked up online, the injection site reaction can be described as the COVID arm. The injection site reaction went away by itself yesterday morning and the swollen part of her armpit has reduced to half of the size it was when the reaction stared. There has been no changes to her diet or soap. Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: face was tight; lips are swollen; Rashes that looks like bug bites around her mustache area and her jaw lines (on both side)/The rashes are white circle with red edges.; Injection site red/Injection site had a 6 inches red ring around it; Armpit was swollen (like the size of a golf ball); Injection site tender; Injection site sore; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL DISCOMFORT (face was tight), LIP SWELLING (lips are swollen), VACCINATION SITE PAIN (Injection site tender), VACCINATION SITE PAIN (Injection site sore) and RASH (Rashes that looks like bug bites around her mustache area and her jaw lines (on both side)/The rashes are white circle with red edges.) in a 29-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 046L21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 18-Mar-2022, the patient experienced VACCINATION SITE PAIN (Injection site tender), VACCINATION SITE PAIN (Injection site sore), VACCINATION SITE ERYTHEMA (Injection site red/Injection site had a 6 inches red ring around it) and LYMPHADENOPATHY (Armpit was swollen (like the size of a golf ball)). On 22-Mar-2022, the patient experienced FACIAL DISCOMFORT (face was tight), LIP SWELLING (lips are swollen) and RASH (Rashes that looks like bug bites around her mustache area and her jaw lines (on both side)/The rashes are white circle with red edges.). On 21-Mar-2022, VACCINATION SITE PAIN (Injection site tender), VACCINATION SITE PAIN (Injection site sore) and VACCINATION SITE ERYTHEMA (Injection site red/Injection site had a 6 inches red ring around it) had resolved. At the time of the report, FACIAL DISCOMFORT (face was tight), LIP SWELLING (lips are swollen) and RASH (Rashes that looks like bug bites around her mustache area and her jaw lines (on both side)/The rashes are white circle with red edges.) had not resolved and LYMPHADENOPATHY (Armpit was swollen (like the size of a golf ball)) was resolving.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       Based on what she looked up online, the injection site reaction can be described as the COVID arm. The injection site reaction went away by itself yesterday morning and the swollen part of her armpit has reduced to half of the size it was when the reaction stared. There has been no changes to her diet or soap. Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 34.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vial was initially stored in the refrigerator on 02Feb2022, and dose administered on 22Mar2022 beyond 30-day use; We discovered that we've given Moderna Covid-19 vaccine that was beyond the 30 day use by date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We discovered that we've given Moderna Covid-19 vaccine that was beyond the 30 day use by date.) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 02Feb2022, and dose administered on 22Mar2022 beyond 30-day use) in a 34-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (We discovered that we've given Moderna Covid-19 vaccine that was beyond the 30 day use by date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 02Feb2022, and dose administered on 22Mar2022 beyond 30-day use). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We discovered that we've given Moderna Covid-19 vaccine that was beyond the 30 day use by date.) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 02Feb2022, and dose administered on 22Mar2022 beyond 30-day use) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. Date the vial was initially stored in refrigerator 02-Feb-2022 The vial did not undergo any temperature excursion. No treatment information provided.
Age: 19.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vial was initially stored in the refrigerator on 02-Feb-2022 and dose administered on 14-Mar-2022 beyond 30-day use; We discovered that we've given Moderna Covid-19 vaccine that was beyond the 30 day use by date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We discovered that we've given Moderna Covid-19 vaccine that was beyond the 30 day use by date.) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 02-Feb-2022 and dose administered on 14-Mar-2022 beyond 30-day use) in a 19-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (We discovered that we've given Moderna Covid-19 vaccine that was beyond the 30 day use by date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 02-Feb-2022 and dose administered on 14-Mar-2022 beyond 30-day use). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We discovered that we've given Moderna Covid-19 vaccine that was beyond the 30 day use by date.) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 02-Feb-2022 and dose administered on 14-Mar-2022 beyond 30-day use) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. The vial did not undergo any temperature excursion. No treatment information provided.
Age: 38.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vial was initially stored in the refrigerator on 02Feb2022, and dose administered on 07Mar2022 beyond 30-day use; vaccine administered beyond the 30 day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine administered beyond the 30 day use by date) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 02Feb2022, and dose administered on 07Mar2022 beyond 30-day use) in a 38-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022J21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine administered beyond the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 02Feb2022, and dose administered on 07Mar2022 beyond 30-day use). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine administered beyond the 30 day use by date) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 02Feb2022, and dose administered on 07Mar2022 beyond 30-day use) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug reported. The vial was initially stored in the refrigerator on 02-Feb-2022. Patient received booster 1/2 doses. No temperature excursions reported. No treatment information was provided by the reporter.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Sluggishness
Clinical narrative: Sluggish; No strength; Feeling tired; Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (Sluggish), ASTHENIA (No strength), FATIGUE (Feeling tired) and HEADACHE (Slight headache) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2022, the patient experienced SLUGGISHNESS (Sluggish), ASTHENIA (No strength), FATIGUE (Feeling tired) and HEADACHE (Slight headache). At the time of the report, SLUGGISHNESS (Sluggish), ASTHENIA (No strength), FATIGUE (Feeling tired) and HEADACHE (Slight headache) had not resolved.            No concomitant medication information was provided. Patient stated that adverse events were not that serious, just uncomfortable feeling. No treatment medications were provided.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine given after its expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given after its expiration date) in a 25-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 013h21b) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 22-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given after its expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine given after its expiration date) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medication was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Immunocompromised patient received the booster dose (half dose) after 2 primary doses; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Immunocompromised patient received the booster dose (half dose) after 2 primary doses) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Immunocompromised patient received the booster dose (half dose) after 2 primary doses). At the time of the report, ACCIDENTAL UNDERDOSE (Immunocompromised patient received the booster dose (half dose) after 2 primary doses) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that the patient received the booster dose,half dose after 2 primary doses. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Menstruation delayed
Clinical narrative: nose bled; 6 weeks did not get her period; This spontaneous case was reported by an other health care professional and describes the occurrence of EPISTAXIS (nose bled) and MENSTRUATION DELAYED (6 weeks did not get her period) in a female 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EPISTAXIS (nose bled) and MENSTRUATION DELAYED (6 weeks did not get her period). At the time of the report, EPISTAXIS (nose bled) and MENSTRUATION DELAYED (6 weeks did not get her period) 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.   Concomitant medication was not reported. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site urticaria
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (Hives around the injection site on my arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (Aspirin), Drug allergy (Ibuprofen), Anxiety, Vitamin D deficiency (Low on Vit D), Migraine and Sleep disorder (Sleep). Concomitant products included CELECOXIB (CELEXA [CELECOXIB]) and LORAZEPAM (ATIVAN) for Anxiety, SUMATRIPTAN (IMITREX [SUMATRIPTAN]) for Migraine, MIRTAZAPINE (REMERON) for Sleep disorder, VITAMIN D NOS for Vitamin D deficiency. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE URTICARIA (Hives around the injection site on my arm). On 16-Mar-2021, VACCINATION SITE URTICARIA (Hives around the injection site on my arm) had resolved. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment information includes patient took Benadryl and hives around vaccination site recovered within few hours. This case was linked to MOD-2022-452688, MOD-2022-520470 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Bone pain, Influenza like illness, Loss of personal independence in daily activities
Clinical narrative: All of a sudden felt every bone in my body hurting; Hurt to move; Painful to just get out of bed to use the restroom; Flu like symptoms; Had absolutely no energy at all; All of a sudden felt every joint in my body hurting; Entire body aches for 4 days; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (All of a sudden felt every bone in my body hurting), MOBILITY DECREASED (Hurt to move), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Painful to just get out of bed to use the restroom), INFLUENZA LIKE ILLNESS (Flu like symptoms) and ASTHENIA (Had absolutely no energy at all) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Flu-like symptoms (Patient had flu-like symptoms in her life.). Concurrent medical conditions included Allergy to NSAIDs (Allergy to Aspirin), Allergy to NSAIDs (Allergy to Ibuprofen), Anxiety, Vitamin deficiency, Migraine and Sleep disorder. Concomitant products included CELECOXIB (CELEXA [CELECOXIB]) and LORAZEPAM (ATIVAN) for Anxiety, SUMATRIPTAN (IMITREX [SUMATRIPTAN]) for Migraine, MIRTAZAPINE (REMERON) for Sleepiness, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for Vitamin D deficiency.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced BONE PAIN (All of a sudden felt every bone in my body hurting), MOBILITY DECREASED (Hurt to move), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Painful to just get out of bed to use the restroom), INFLUENZA LIKE ILLNESS (Flu like symptoms), ASTHENIA (Had absolutely no energy at all), ARTHRALGIA (All of a sudden felt every joint in my body hurting) and MYALGIA (Entire body aches for 4 days). On 17-Apr-2021, BONE PAIN (All of a sudden felt every bone in my body hurting), MOBILITY DECREASED (Hurt to move), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Painful to just get out of bed to use the restroom), INFLUENZA LIKE ILLNESS (Flu like symptoms), ASTHENIA (Had absolutely no energy at all), ARTHRALGIA (All of a sudden felt every joint in my body hurting) and MYALGIA (Entire body aches for 4 days) had resolved.            The patient never had diagnosed with or tested positive for COVID. Patient had no acute or chronic illness at the time of vaccination. It was reported that with the second vaccination patient was fine until that evening. Patient just wanted to sleep and not to move and on the fourth day all the events started getting better then all of a sudden it just went away as if nothing had ever happened. No treatment medications were reported.   This case was linked to MOD-2022-520457, MOD-2022-452688 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Myalgia
Clinical narrative: All of a sudden felt every bone in my body hurting; Hurt to move; Painful to just get out of bed to use the restroom; Flu like symptoms; Had absolutely no energy at all; All of a sudden felt every joint in my body hurting; Entire body aches for 4 days; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (All of a sudden felt every bone in my body hurting), MOBILITY DECREASED (Hurt to move), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Painful to just get out of bed to use the restroom), INFLUENZA LIKE ILLNESS (Flu like symptoms) and ASTHENIA (Had absolutely no energy at all) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Flu-like symptoms (Patient had flu-like symptoms in her life.). Concurrent medical conditions included Allergy to NSAIDs (Allergy to Aspirin), Allergy to NSAIDs (Allergy to Ibuprofen), Anxiety, Vitamin deficiency, Migraine and Sleep disorder. Concomitant products included CELECOXIB (CELEXA [CELECOXIB]) and LORAZEPAM (ATIVAN) for Anxiety, SUMATRIPTAN (IMITREX [SUMATRIPTAN]) for Migraine, MIRTAZAPINE (REMERON) for Sleepiness, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for Vitamin D deficiency.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced BONE PAIN (All of a sudden felt every bone in my body hurting), MOBILITY DECREASED (Hurt to move), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Painful to just get out of bed to use the restroom), INFLUENZA LIKE ILLNESS (Flu like symptoms), ASTHENIA (Had absolutely no energy at all), ARTHRALGIA (All of a sudden felt every joint in my body hurting) and MYALGIA (Entire body aches for 4 days). On 17-Apr-2021, BONE PAIN (All of a sudden felt every bone in my body hurting), MOBILITY DECREASED (Hurt to move), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Painful to just get out of bed to use the restroom), INFLUENZA LIKE ILLNESS (Flu like symptoms), ASTHENIA (Had absolutely no energy at all), ARTHRALGIA (All of a sudden felt every joint in my body hurting) and MYALGIA (Entire body aches for 4 days) had resolved.            The patient never had diagnosed with or tested positive for COVID. Patient had no acute or chronic illness at the time of vaccination. It was reported that with the second vaccination patient was fine until that evening. Patient just wanted to sleep and not to move and on the fourth day all the events started getting better then all of a sudden it just went away as if nothing had ever happened. No treatment medications were reported.   This case was linked to MOD-2022-520457, MOD-2022-452688 (Patient Link).
Age: 33.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The 30-day beyond use date was 18Mar2022; patients received expired doses; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients received expired doses) and PRODUCT STORAGE ERROR (The 30-day beyond use date was 18Mar2022) in a 33-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch nos. 012H21B and 068H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 21-Mar-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 21-Mar-2022,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (patients received expired doses). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The 30-day beyond use date was 18Mar2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients received expired doses) and PRODUCT STORAGE ERROR (The 30-day beyond use date was 18Mar2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  The vials were moved  from freezer to refrigerated condition on 24 Feb 2022. The vaccine vial was opened on 21 Mar 2022 at 4:00 pm.  No treatment medication was reported.   This case was linked to MOD-2022-521064 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Mar-2022: Significant follow up was received and patient demographics, suspect information were updated.