chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Myalgia, Paraesthesia
Clinical narrative: CHOKED ON FOOD; BONES HURT; HEART GOES REALLY FAST/ IRREGULAR HEARTBEAT; SWALLOWING DIFFICULTY; DIFFICULTY BREATHING AND FORGETS TO  BREATHE; SHE COULD NOT GET OUT OF BED (LITERALLY THE DAY AFTER SHE COULD NOT MOVE)/ COULD NOT LIFT HER PHONE; TINGLING IN FEET; MUSCLES HURT; This spontaneous report received from a patient concerned a 4 decade old female with unspecified race and ethnicity. The patient's weight was 100 pounds, and height was not reported. The patient's pre-existing medical conditions included: The patient used to be very active but currently not. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, 1 total, administered on 29-MAR-2021 for covid-19 prophylaxis. Age at time of vaccination 30 years old. No concomitant medications were reported.  On an unspecified date (since the vaccination), the patient experienced swallowing difficulty, that patient chokes on food, had difficulty breathing and forgets how to breathe, had tingling in feet and had lots of issues. The patient had been recording these issues with doctor. The patient thought she had Guillain Barre Syndrome. The patient cannot function properly and it was annoying. The patient also reported that after receiving the vaccine she could not get out of bed (literally the day after she could not move) and was not able to lift her phone. The patient had gone to doctor and doctor had kept a list. The patient had muscles and bones hurt. The patient also had to stand up because her heart goes really fast/ irregular heartbeat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscles hurt, bones hurt, heart goes really fast/ irregular heartbeat, swallowing difficulty, difficulty breathing and forgets to breathe, tingling in feet, choked on food and she could not get out of bed (literally the day after she could not move)/ could not lift her phone was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20230119928.; Sender's Comments: V0: 20230118624-CHOKED ON FOOD. The event 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. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Ultrasound Doppler
Clinical narrative: DEEP VEIN THROMBOSIS (DVT); This spontaneous report received from a patient concerned a 41 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: hashimoto thyroid, alcohol user (twice a week), and non smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient had no drug abuse or illicit drug usage. The patient was on birth control. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, 1 total, administered on 11-MAR-2021 for covid-19 prophylaxis. Age at time of vaccination 39 years old. Concomitant medications included ethinylestradiol/ferrous fumarate/norethisterone acetate for birth control, and levothyroxine sodium (Synthroid 125 mcg once daily) for hashimoto thyroid.  On 24-DEC-2022, the patient, got out of the car and her right leg hurted. From then pain continued until last Thursday (05-JAN-2023), so she went to primary care doctor. The doctor ordered a doppler venous ultrasound and DVT (deep vein thrombosis) was confirmed on Thursday (05-JAN-2023) night. On Friday, 06-JAN-2023, the patient started Xarelto starter pack twice daily (15 and 20 mg). No more tests were done besides the doppler. The patient had no other side effects from vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of deep vein thrombosis (DVT) was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20230119687.; Sender's Comments: V0: 20230119179- deep vein thrombosis (DVT). The event shows an incompatible temporal relationship. Therefore, this event is considered inconsistent with vaccine administration.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: STROKE; This spontaneous report received from a consumer via a company representative concerned a male 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 were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis.  The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced stroke, and was hospitalized (date unspecified). The patient was treated at hospital. The number of days hospitalized was not reported.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20230120898 and 20230120818.; Sender's Comments: V0: 20230120832-Stroke. The event 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. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Eye contusion, Face injury, Loss of consciousness, Skin abrasion
Clinical narrative: STROKE; PASSED OUT; DAMAGE TO FACE; BLACK EYE; CUT; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age 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 not reported batch number: unknown, expiry: UNKNOWN) dose was not reported, 1 total administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient had stroke and had to be resuscitated, also had frontal lobe damage due to stroke. Patient was passed out and had damage to face, black eye and cut and patient was hospitalized for unspecified days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stroke, passed out, damage to face, black eye and cut was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20230120832 and 20230120818.; Sender's Comments: V0-20230120898- Stroke, passed out, damage to face, black eye and cut- The event 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. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chest pain, Dyspnoea, Fatigue, Headache
Clinical narrative: BLOOD CLOT IN LEFT ELBOW; SUICIDAL ATTEMPT; LEGS AND ARMS SWELLING; LEG AND ARM CRAMPS; SHORTNESS OF BREATH; PAIN; CHEST PAINS; STOMACH CRAMPS; HEADACHES; TIREDNESS; This spontaneous legal report received from a patient via a company representative concerned a male 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 were not reported, expiry: unknown) dose was not reported, 1 total, administered on 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. No concomitant medications were reported.  On an unspecified date, shortly after the administration of vaccine, he developed symptoms of leg and arm swelling, leg and arm cramps, stomach cramps, pain, headaches, chest pains, shortness of breath, tiredness, loss of energy, loss of sleep and loss of focus and concentration. Later he found an clot on his left elbow and for months he was refused examination for his illness. On NOV-2021, the physician later thought blood clot to be an cyst and performed an surgical procedure cutting into his left elbow with only blood streaming out and no cystic matter found.  On DEC-2021, later physician diagnosed it as a blood clot and prescribed a steroid injection. On JAN-2022, same physician again performed a second surgical procedure with only blood streaming out and no cystic matter found after a second surgery. This prescribed steroid injection was then administered in or around the end of FEB or early MAR of 2022 eliminating the blood clot and illness. The patient reported that he would possibly die after finding about his blood clots for which he suffered emotionally and psychologically of depression, anxiety, feelings of hopelessness, helplessness, suicidal thoughts and attempts caused by the defendants conduct, negligence, medical malpractice, injection of toxic waste (steroid injection), infliction of physical, psychological and emotional pain, suffering, injuries and risk of death making all of them liable. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain, headaches, chest pains, tiredness, blood clot in left elbow, stomach cramps, suicidal attempt, legs and arms swelling, leg and arm cramps and shortness of breath was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20230122135.; Sender's Comments: V0: Medical Assessment comment not required as per standard operating procedure for legal case.
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Pain, Peripheral swelling, Suicide attempt, Surgery
Clinical narrative: BLOOD CLOT IN LEFT ELBOW; SUICIDAL ATTEMPT; LEGS AND ARMS SWELLING; LEG AND ARM CRAMPS; SHORTNESS OF BREATH; PAIN; CHEST PAINS; STOMACH CRAMPS; HEADACHES; TIREDNESS; This spontaneous legal report received from a patient via a company representative concerned a male 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 were not reported, expiry: unknown) dose was not reported, 1 total, administered on 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. No concomitant medications were reported.  On an unspecified date, shortly after the administration of vaccine, he developed symptoms of leg and arm swelling, leg and arm cramps, stomach cramps, pain, headaches, chest pains, shortness of breath, tiredness, loss of energy, loss of sleep and loss of focus and concentration. Later he found an clot on his left elbow and for months he was refused examination for his illness. On NOV-2021, the physician later thought blood clot to be an cyst and performed an surgical procedure cutting into his left elbow with only blood streaming out and no cystic matter found.  On DEC-2021, later physician diagnosed it as a blood clot and prescribed a steroid injection. On JAN-2022, same physician again performed a second surgical procedure with only blood streaming out and no cystic matter found after a second surgery. This prescribed steroid injection was then administered in or around the end of FEB or early MAR of 2022 eliminating the blood clot and illness. The patient reported that he would possibly die after finding about his blood clots for which he suffered emotionally and psychologically of depression, anxiety, feelings of hopelessness, helplessness, suicidal thoughts and attempts caused by the defendants conduct, negligence, medical malpractice, injection of toxic waste (steroid injection), infliction of physical, psychological and emotional pain, suffering, injuries and risk of death making all of them liable. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain, headaches, chest pains, tiredness, blood clot in left elbow, stomach cramps, suicidal attempt, legs and arms swelling, leg and arm cramps and shortness of breath was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20230122135.; Sender's Comments: V0: Medical Assessment comment not required as per standard operating procedure for legal case.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOT IN LEFT ELBOW; SUICIDAL ATTEMPT; LEGS AND ARMS SWELLING; LEG AND ARM CRAMPS; SHORTNESS OF BREATH; PAIN; CHEST PAINS; STOMACH CRAMPS; HEADACHES; TIREDNESS; This spontaneous legal report received from a patient via a company representative concerned a male 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 were not reported, expiry: unknown) dose was not reported, 1 total, administered on 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. No concomitant medications were reported.  On an unspecified date, shortly after the administration of vaccine, he developed symptoms of leg and arm swelling, leg and arm cramps, stomach cramps, pain, headaches, chest pains, shortness of breath, tiredness, loss of energy, loss of sleep and loss of focus and concentration. Later he found an clot on his left elbow and for months he was refused examination for his illness. On NOV-2021, the physician later thought blood clot to be an cyst and performed an surgical procedure cutting into his left elbow with only blood streaming out and no cystic matter found.  On DEC-2021, later physician diagnosed it as a blood clot and prescribed a steroid injection. On JAN-2022, same physician again performed a second surgical procedure with only blood streaming out and no cystic matter found after a second surgery. This prescribed steroid injection was then administered in or around the end of FEB or early MAR of 2022 eliminating the blood clot and illness. The patient reported that he would possibly die after finding about his blood clots for which he suffered emotionally and psychologically of depression, anxiety, feelings of hopelessness, helplessness, suicidal thoughts and attempts caused by the defendants conduct, negligence, medical malpractice, injection of toxic waste (steroid injection), infliction of physical, psychological and emotional pain, suffering, injuries and risk of death making all of them liable. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain, headaches, chest pains, tiredness, blood clot in left elbow, stomach cramps, suicidal attempt, legs and arms swelling, leg and arm cramps and shortness of breath was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20230122135.; Sender's Comments: V0: Medical Assessment comment not required as per standard operating procedure for legal case.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: PERICARDITIS; This spontaneous report received from a health care professional (parent) concerned a 19 year old white female (daughter) of an unspecified ethnicity. The patient's height, and weight were not reported. The patient had minor allergies and nothing major. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered at left arm on 29-APR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 19 years old. No concomitant medications were reported.  On an unspecified date, on MAY-2021 (after 3 to 5 days of vaccination), the patient experienced pericarditis with deep chest pain. The patient saw the cardiologist (physician office) and found it was pericarditis. The deep chest pain now got resolved probably after 5 months. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pericarditis on an unspecified date in 2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230122084- pericarditis. The event has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.
Sex: U
Vaccine: COVID19
Symptoms: Death, Dyspnoea, Illness, Swelling, Thrombosis
Clinical narrative: DEATH; BLOOD CLOTS; ILLNESS; SHORTNESS OF BREATH; SWELLING; This spontaneous report received from a consumer via a company representative concerned multiple patients. The patient's weight, height, and medical histories were not reported. The multiple patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch numbers were not reported and have been requested. No concomitant medications were reported.  On an unspecified date, multiple patients suffered blood clots, shortness of breath, and swelling and were sent immediately to an outside hospital for diagnosis and adequate treatment regardless of conviction and/or confinement. It was reported that, all other inmates who received the Johnson and Johnson vaccination and suffered blood clots, shortness of breath and/or swelling were sent immediately to an outside hospital for diagnosis and adequate treatment regardless of conviction and/or confinement, the plaintiff however was out right refused by these defendants out of personal dislike and retaliation soley. And also stated that Johnson and Johnson was fully aware of these illnesses, potential for and death due to the (Janssen) one shot COVID-19 vaccination and death and illness as the vaccination administration was temporarily discontinued the same day plaintiff received it, due to another inmates death the same day and moments after him. On an unspecified date, the patients (another inmates) died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcomes for the multiple patients with blood clots, illness, shortness of breath and swelling was not reported. This report was serious (Death, and Other Medically Important Condition). This case, from the same reporter is linked to 20230122068.; Sender's Comments: V0- 20230122135- Death, Blood clots- Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: This spontaneous report received from a health care professional via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: disabled, and other pre-existing medical conditions included: The patient was a Registered Nurse by profession. 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 covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced allergic to the covid vaccine. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of allergic to the covid vaccine was not reported. This report was non-serious.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Dyspnoea, Electrocardiogram, Loss of personal independence in daily activities
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (dyspnoea/labored breathing/lack of air), VISION BLURRED (his sight was blurred), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (He had to stop going to work), DYSPNOEA (experienced chest pain, lack of air, very quick heart palpitations. This lasted 5 or 10 minutes and then it went away) and PALPITATIONS (palpitations/very quick heart palpitations) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A, 077A21B, 034F21A and 056M21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.        No concomitant medications were provided. There was no diagnosis of Myocarditis/Pericarditis. It was reported that the patient did not experience any symptoms like that before receiving the Moderna COVID-19 vaccine. After receiving his 4th dose (2nd booster), a week later, something strange occurred: patient stated he experienced chest pain, lack of air, very quick heart palpitations. This lasted 5 or 10 minutes and then it went away. But then came back. He never related this to the vaccine, until today, because he received his 5th dose and received some papers that stated that those could be common side effects of the vaccines and the Covid-19. He received some treatments: medicines that worked but then the symptoms started again. Treatment drugs were Clopidogrel and Amlodipino but the patient did not take it.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial necrosis marker, Palpitations, Vaccination site pain, Vision blurred
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (dyspnoea/labored breathing/lack of air), VISION BLURRED (his sight was blurred), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (He had to stop going to work), DYSPNOEA (experienced chest pain, lack of air, very quick heart palpitations. This lasted 5 or 10 minutes and then it went away) and PALPITATIONS (palpitations/very quick heart palpitations) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A, 077A21B, 034F21A and 056M21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.        No concomitant medications were provided. There was no diagnosis of Myocarditis/Pericarditis. It was reported that the patient did not experience any symptoms like that before receiving the Moderna COVID-19 vaccine. After receiving his 4th dose (2nd booster), a week later, something strange occurred: patient stated he experienced chest pain, lack of air, very quick heart palpitations. This lasted 5 or 10 minutes and then it went away. But then came back. He never related this to the vaccine, until today, because he received his 5th dose and received some papers that stated that those could be common side effects of the vaccines and the Covid-19. He received some treatments: medicines that worked but then the symptoms started again. Treatment drugs were Clopidogrel and Amlodipino but the patient did not take it.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Papilloedema
Clinical narrative: it had gradually getting worse./ In both eye, left was worse; My granddaughter has 'ptseubotatill' (edema of optic nerve)./ Her eye problems started; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAPILLOEDEMA (My granddaughter has 'ptseubotatill' (edema of optic nerve)./ Her eye problems started) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. ASKU and ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In August 2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2022, the patient experienced PAPILLOEDEMA (My granddaughter has 'ptseubotatill' (edema of optic nerve)./ Her eye problems started) (seriousness criterion medically significant). On an unknown date, the patient experienced CONDITION AGGRAVATED (it had gradually getting worse./ In both eye, left was worse). At the time of the report, PAPILLOEDEMA (My granddaughter has 'ptseubotatill' (edema of optic nerve)./ Her eye problems started) and CONDITION AGGRAVATED (it had gradually getting worse./ In both eye, left was worse) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Patient 1st dose was in August 2022, the 2nd in September 2022. Her eye problems started in October 2022. Patient went to the eye Dr (Optometrist) & he found it. Physician gave some medicine, but it didn't help. Since then it had gradually worsened. No treatment medication was reported.  Company Comment: This is a spontaneous case concerning a female patient of unknown age with no medical history reported who experienced the unexpected and serious (medically significant) event of papilloedema approximately 1 month after a second dose of mRNA-1273 vaccine was administered. It was reported that patient had edema of optic nerve in both eyes, left was worse. She was seen by the eye Dr (Optometrist) and he gave patient some medicine, but it didn't help. Since then, it has gradually got worse. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted
Clinical narrative: This spontaneous case was reported by a patient family member or friend and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (son received a single dose of the vaccine last year, but never received a second dose) and NO ADVERSE EVENT (no adverse event) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.       Concomitant product use was not provided by the reporter.   No treatment information was provided.
Sex: U
Vaccine: COVID19-2
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Transcription medication error
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of NO ADVERSE EVENT (The patients have not reported any adverse reactions), TRANSCRIPTION MEDICATION ERROR (Cards reflects the wrong lot numbers and we can not figure out which patient's records are wrong.) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7170B) for COVID-19 prophylaxis.     No Medical History information was reported.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (The patients have not reported any adverse reactions) to be not related. No further causality assessments were provided for TRANSCRIPTION MEDICATION ERROR (Cards reflects the wrong lot numbers and we can not figure out which patient's records are wrong.) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error).    No relevant concomitant medications were reported.  The patients have not reported any adverse reactions. No treatment information was provided.
Age: 27.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient accidently received a booster instead of a first dose 0.5ml dose of the bivalent Moderna COVID19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 27-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043h22a) for COVID-19 prophylaxis.     No Medical History information was reported.       No concomitant medication was provided by reporter. No treatment medication was provided by reporter.
Age: 49.0
Sex: M
Vaccine: COVID19-2, FLUX
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by another health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered >12hours post puncture/ >24 RT and administered.), PRODUCT STORAGE ERROR (Dose administered >12(hours post puncture/ >24 RT and administered.) and NO ADVERSE EVENT (No adverse event) in a 49-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 010H22A) for COVID-19 prophylaxis.       On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On 11-Jan-2023 at 9:26 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture/ >24 RT and administered.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered >12hours post puncture/ >24 RT and administered.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture/ >24 RT and administered.), PRODUCT STORAGE ERROR (Dose administered >12 hours post puncture/ >24 RT and administered.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.         The vial was stored at room temperature post puncture. The vial did not undergo any temperature excursions. No treatment medications were reported.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: The pharmacist told the patient that her 20-something year old niece also got pericarditis; This spontaneous case was reported by a consumer and describes the occurrence of PERICARDITIS (The pharmacist told the patient that her 20-something year old niece also got pericarditis) in a 3-decade-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERICARDITIS (The pharmacist told the patient that her 20-something year old niece also got pericarditis) (seriousness criterion medically significant). At the time of the report, PERICARDITIS (The pharmacist told the patient that her 20-something year old niece also got pericarditis) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 20-something year. Concomitant medications were not reported. It was unknown if the patient had any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Reporter stated that the pharmacist told reporter that her 20-something year old niece also got pericarditis. The pharmacist also told to the reporter that their family will not be getting the booster because of all the issues. No treatment medication information was provided by the reporter.  Company Comment: This is a spontaneous case concerning a 3er decade, female patient with no reported medical history, who experienced the serious (due to medically significant) expected, AESI of pericarditis, which occurred after the mRNA-1273.222 (Original/Omicron BA.4/5) vaccine, received as part of COVID-19 vaccination schedule, dose number not provided. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination date. The outcome was not reported. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-592491.   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-592491:Reporters case
Sex: U
Vaccine: COVID19-2
Symptoms: Milia
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence (Left and right breast center of nipple has developed melia cysts.) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced  (Left and right breast center of nipple has developed cysts.). At the time of the report,  (Left and right breast center of nipple has developed  cysts.) had resolved.          Treatment medication information was not reported.
Age: 48.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; HCP stated they accidentally administered 1 dose of Moderna COVID-19 Vaccine Bivalent instead of the 1st dose of the primary series on 11Jan2023; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (HCP stated they accidentally administered 1 dose of Moderna COVID-19 Vaccine Bivalent instead of the 1st dose of the primary series on 11Jan2023) and NO ADVERSE EVENT (No adverse event) in a 48-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 013H22A) for COVID-19 prophylaxis.     No Medical History information was reported.     Patient had no relevant medical history. Patient had not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant medications were not reported.  No treatment information was provided
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Vertigo
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), FATIGUE (chronic fatigue), VERTIGO (vertigo) and FEELING ABNORMAL (brain fog) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031LZ0A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine on 23-Jan-2021. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine.    On 20-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced HEADACHE (headache), FATIGUE (chronic fatigue) and VERTIGO (vertigo). On an unknown date, the patient experienced FEELING ABNORMAL (brain fog). At the time of the report, HEADACHE (headache), FATIGUE (chronic fatigue) and VERTIGO (vertigo) had not resolved and FEELING ABNORMAL (brain fog) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient stated he had several symptoms such as brain fog, headache, chronic fatigue, and vertigo. They started immediately after the second dose.  No concomitant medication were reported. No treatment medication were reported.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received a monovalent doses instead of a bivalent dose) and NO ADVERSE EVENT (No adverse event) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057A22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Blood pressure high and Cholesterol high.    On 09-Jan-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 09-Jan-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (Patient received a monovalent doses instead of a bivalent dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received a monovalent doses instead of a bivalent dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received a monovalent doses instead of a bivalent dose).    Patient had no allergies.  No concomitant medications were reported. No treatment medications were reported.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Product administration interrupted
Clinical narrative: they decided not to get the 2nd primary dose. Today, 11JAN2023, Five months after the first primary dose; The next day the baby tested positive for COVID; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (The next day the baby tested positive for COVID) and PRODUCT ADMINISTRATION INTERRUPTED (they decided not to get the 2nd primary dose. Today, 11JAN2023, Five months after the first primary dose) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jul-2022, the patient experienced COVID-19 (The next day the baby tested positive for COVID). On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (they decided not to get the 2nd primary dose. Today, 11JAN2023, Five months after the first primary dose). At the time of the report, COVID-19 (The next day the baby tested positive for COVID) had resolved and PRODUCT ADMINISTRATION INTERRUPTED (they decided not to get the 2nd primary dose. Today, 11JAN2023, Five months after the first primary dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PRODUCT ADMINISTRATION INTERRUPTED (they decided not to get the 2nd primary dose. Today, 11JAN2023, Five months after the first primary dose) to be not related. No further causality assessment was provided for COVID-19 (The next day the baby tested positive for COVID).    No concomitant medication was provided by reporter.  A 3-year-old patient received 1 primary dose of Moderna COVID-19 vaccine in 06JUL2022 from a blue cap magenta border vial. The next day the baby tested positive for COVID (not confirmed), so they decided not to get the 2nd primary dose. Today, 11-Jan-2023, Five months after the first primary dose.  No treatment medication was provided by reporter.
Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute kidney injury
Clinical narrative: AKI hospitalization 7 day in October 2022
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute myocardial infarction, Brain natriuretic peptide increased, Cardiac imaging procedure, Catheterisation cardiac normal, Chest pain
Clinical narrative: 24 hours after vaccine - fever, body aches & pain. 96 hours after vaccine - extreme fatigue, exhaustion. Six days after vaccine - chest pain, vomiting, nausea, cold sweats, fatigue. Went to DR who thought just heartburn, prescribed heartburn pills which didn?t work. Three weeks continual on/off chest pain, vomiting, nausea, cold sweats, fatigue. Went to emergency after another episode & was checked in to hospital for non-ST elevated myocardial infarction due to possible myocarditis. Prescribed three months of Colchicine.
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cold sweat, Echocardiogram normal, Electrocardiogram normal, Fatigue, Nausea
Clinical narrative: 24 hours after vaccine - fever, body aches & pain. 96 hours after vaccine - extreme fatigue, exhaustion. Six days after vaccine - chest pain, vomiting, nausea, cold sweats, fatigue. Went to DR who thought just heartburn, prescribed heartburn pills which didn?t work. Three weeks continual on/off chest pain, vomiting, nausea, cold sweats, fatigue. Went to emergency after another episode & was checked in to hospital for non-ST elevated myocardial infarction due to possible myocarditis. Prescribed three months of Colchicine.
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain, Pyrexia, Scan with contrast, Troponin increased, Vomiting
Clinical narrative: 24 hours after vaccine - fever, body aches & pain. 96 hours after vaccine - extreme fatigue, exhaustion. Six days after vaccine - chest pain, vomiting, nausea, cold sweats, fatigue. Went to DR who thought just heartburn, prescribed heartburn pills which didn?t work. Three weeks continual on/off chest pain, vomiting, nausea, cold sweats, fatigue. Went to emergency after another episode & was checked in to hospital for non-ST elevated myocardial infarction due to possible myocarditis. Prescribed three months of Colchicine.
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood test, Electrocardiogram, Fibrin D dimer, Laboratory test, Transient ischaemic attack
Clinical narrative: Vaccine booster 10/6/22. Adverse event  May be totally unrelated. Transient cerebral ischemic attack, unspecified onboard ship in middle of Atlantic Ocean
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Troponin
Clinical narrative: Vaccine booster 10/6/22. Adverse event  May be totally unrelated. Transient cerebral ischemic attack, unspecified onboard ship in middle of Atlantic Ocean
Age: 57.0
Sex: F
Vaccine: COVID19-2
Symptoms: Administration site pain, Bursitis, Immunisation reaction, Ultrasound scan, X-ray limb abnormal
Clinical narrative: Vaccine recipient w pain x 2.5 months in shoulder where vaccine was administered, starting on day of vaccination. Recipient was eventually diagnosed with vaccine-induced bursitis requiring treatment with steroid injection.
Age: 64.0
Sex: F
Vaccine: COVID19-2, FLUR4
Symptoms: COVID-19, Nasal congestion, Pyrexia, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: I had a clear running and stuffy nose. By Tuesday I was sneezing. The next day I had a low-grade fever of 99. I tested positive COVID-19. My doctor prescribed me PAXLOVID. By the second day of me taking PAXLOVID I started feeling better.
Age: 64.0
Sex: F
Vaccine: COVID19-2, FLUR4
Symptoms: Sneezing
Clinical narrative: I had a clear running and stuffy nose. By Tuesday I was sneezing. The next day I had a low-grade fever of 99. I tested positive COVID-19. My doctor prescribed me PAXLOVID. By the second day of me taking PAXLOVID I started feeling better.
Age: 27.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient received vaccine at 11:55am and reported hives and itching at 12:00pm. Had Benadryl 50mg IM administered at 12:10pm and symptoms improved after administration.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Moderna Bivalent Booster was given 0.25mcg, patient was to receive 0.5mcg. Wrong dose given.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation, Computerised tomogram, Immediate post-injection reaction, Injection site reaction, Ischaemic stroke
Clinical narrative: Developed silver dollar- sized "burn" lesion at injection site.  Immediately developed atrial fibrillation. Was sick for 3 weeks. After 2nd vaccination, developed a noticeable decline in mental awareness.  Had ischemic stroke in 2023.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Malaise, Mental impairment, Skin lesion
Clinical narrative: Developed silver dollar- sized "burn" lesion at injection site.  Immediately developed atrial fibrillation. Was sick for 3 weeks. After 2nd vaccination, developed a noticeable decline in mental awareness.  Had ischemic stroke in 2023.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Moderna Bivalent Booster 0.25mcg was given to patient, patient was to receive 0.5mcg. Patient received wrong dose.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Contusion, Incision site haemorrhage, Platelet count decreased
Clinical narrative: Drop in platelet count to 3,000, multiple bruises and bleeding from prior incision
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Anticoagulant therapy, Atrial fibrillation, Cardiac monitoring abnormal
Clinical narrative: I received the Pfizer Bivalent COVID-19 booster on 10/13/2022. On 11/7/2022, I arrived at an outpatient surgical hospital to undergo hip replacement surgery. When I was hooked up to the heart monitor prior to getting an IV, the monitor indicated that I had atrial fibrillation. I had never had this problem before or any other cardiac issues. The surgery was immediately canceled, and I was told to go to an emergency room. When I got to the ER, another reading was done of my heart. I was still experiencing atrial fibrillation 12 hours after it was first detected. The ER doctor prescribed me a blood thinner, Eliquis, to prevent a stroke. I was then discharged and advised to see a cardiologist within a couple of days. Unfortunately, I was unable to see a cardiologist right away. On or about 11/10/2022, I saw my PCP, and he did not detect atrial fibrillation at that point. He did tell me, though, that I should see a cardiologist for further diagnosis. I saw a cardiologist on or about 11/16/2022. When the cardiologist examined me, I was in atrial fibrillation. I was diagnosed with periodic atrial fibrillation. It is intermittent, and since I have learned to detected it with a smart watch, I monitored my situation daily. The longest I have experienced atrial fibrillation since learning to monitor the condition has been 30 hours; the shortest duration was 21 hours. I can then go for up to a week with normal cardiac rhythm. At the time of this writing, I have gone for 2 full weeks at normal rhythm.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Neurological symptom
Clinical narrative: Balance issues, Neuro decline, in bed for 3 weeks after shot.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Burning sensation, Dizziness, Headache, Malaise, Rash
Clinical narrative: I had 100 degree temperature for two days.  But a month later I started to have rashes on my upper armes n my legs. N they went away. N again about month later a few bumps came up n this time I felt dizzy for a few days. N they went away. N this month which about a month later a few bumps appeared and  not feeling well. I dealt with headache with bumps. Bumps are usually itchy n burning feeling, even I don't scratch them. They are red or pink. N scars won't go away.