chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: COVID-19; FATIGUE INCREASED; NAUSEA INCREASED; HEADACHE INCREASED; MUSCLE ACHE INCREASED; This spontaneous report received from a patient concerned a 38 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: depression, and anxiety, and other pre-existing medical conditions included: The patient was not pregnant and was not allergic to any drug at the time of this report. The patient is an other health professional. 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-MAR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 37 years old. Concomitant medications included bupropion, and escitalopram. On 13-JUL-2022 at 15:00, the patient experienced fatigue increased, nausea increased, headache increased, and muscle ache increased after treatment. On an unspecified date, the patient experienced covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue increased, nausea increased, headache increased, and muscle ache increased and the outcome of covid-19 was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via other company (Pfizer Inc.) concerned a 42 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy (No drug was reported), and other pre-existing medical conditions included: The patient was not pregnant at the time of vaccination. The patient received dose 1 with covid-19 vaccine ad26.cov2.s (Dose number in series 1), (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. The patient received dose 2 with non-company suspect vaccine Moderna covid-19 vaccine (elasomeran), (Dose number in series 2), (form of admin, route of admin, batch number and expiry date were not reported) dose was not reported, administered on 11-OCT-2021 for covid-19 prophylaxis. On an unspecified date, the patient experienced Covid-19 with mild symptoms. On an unspecified date, the patient experienced confirmed covid-19 infection with mild symptoms (Dose number in series 2) and had confirmed clinical vaccination failure (Dose number in series 1). The patient received non-company co-suspect drug Paxlovid (form of administration, route of administration, batch number, and expiry were not reported) dose was not reported, administered from 05-JUN-2022 to 09-JUN-2022 for treatment of COVID-19.  On 09-JUL-2022, Laboratory data included: COVID-19 virus test Negative (day 5 from Paxlovid treatment). On 10-JUL-2022, Laboratory data included: COVID-19 virus test Negative. On 11-JUL-2022, Laboratory data included: COVID-19 virus test Negative. On 12-JUL-2022, Laboratory data included: COVID-19 virus test Negative (tested for three days and continued be negative). On 14-JUL-2022, Laboratory data included: COVID-19 virus test positive (04 days later from Paxlovid withdrawal on 14-JUL-2022 the patient wake up with rebound infection with symptoms of sore throat). The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable and treatment with Paxlovid was withdrawn on 09-JUN-2022. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000243173.; Sender's Comments: V0:20220740244-covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Confusional state, Decreased appetite, Dizziness
Clinical narrative: This spontaneous report received from a patient concerned a 34 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: fibromyalgia, penicillin allergy, and autoimmune disorder (Human leukocyte antigen B27 (HLAB-27)), and other pre-existing medical conditions included: The patient was not pregnant at the time of reporting. The patient was O negative. The patient experienced drug allergy when treated with amoxicillin. 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 11-AUG-2021 13:00 for Covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 33 years old. Concomitant medications included levofloxacin, prednisone, and salbutamol. On 03-JUL-2022 20:00, the patient experienced suspected Covid-19 infection, blurred vision, confusion, itchy, extreme abdominal pain, loss of appetite, dizziness, joint pain, and nausea. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected Covid-19 infection, joint pain, blurred vision, confusion, itchy, extreme abdominal pain, loss of appetite, nausea, and dizziness. This report was non-serious.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pruritus, Suspected COVID-19, Vision blurred
Clinical narrative: This spontaneous report received from a patient concerned a 34 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: fibromyalgia, penicillin allergy, and autoimmune disorder (Human leukocyte antigen B27 (HLAB-27)), and other pre-existing medical conditions included: The patient was not pregnant at the time of reporting. The patient was O negative. The patient experienced drug allergy when treated with amoxicillin. 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 11-AUG-2021 13:00 for Covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 33 years old. Concomitant medications included levofloxacin, prednisone, and salbutamol. On 03-JUL-2022 20:00, the patient experienced suspected Covid-19 infection, blurred vision, confusion, itchy, extreme abdominal pain, loss of appetite, dizziness, joint pain, and nausea. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected Covid-19 infection, joint pain, blurred vision, confusion, itchy, extreme abdominal pain, loss of appetite, nausea, and dizziness. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: SICK; This spontaneous report received from a consumer concerned multiple patients. 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 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 sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sick was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Chest discomfort, Confusional state, Electrocardiogram
Clinical narrative: HEART POUNDING; TIGHTNESS IN CHEST; BACK PAIN; SWEATING; SLIGHT CONFUSION; FEVER; This spontaneous report received from a parent concerned an 18 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-alcohol user, non-smoker, environmental allergy (pollen and grass), and dust allergy, and other pre-existing medical conditions included: The patient had no history of drug abuse or illicit drug usage. The patient is athletic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855835 expiry: unknown) dose was not reported, 1 in total was administered on 13-JUL-2022 to right arm for covid-19 prophylaxis. No concomitant medications were reported.  On 13-JUL-2022, at 12:30 in the morning, patient called his mother and informed that he had tightness in his chest and his heart was pounding and his resting heart rate was 140 beats per minute after waking from sleep. The patient also had back pain. His mother took his pulse again and the reading at that time was 130 beats per minute, after 15 minutes it went down to 120 beats per minute. The patient's body was very hot, sweating and he was slightly confused. His mother took him to the ER (emergency room), where they processed him. Had taken ibuprofen at home, was given acetaminophen on admittance, and an Electrocardiogram was done and the Electrocardiogram showed mild tachycardia. The patient had fever of 101 degree Celsius on admittance to hospital. Duration of hospitalization was 1 day. Hospitalization date and discharge date information was not provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart pounding on 21-JUL-2022, and back pain, sweating, slight confusion, and fever on 14-JUL-2022, and the outcome of tightness in chest was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20220746027 and 20220745936.; Sender's Comments: V0- 20220745839-covid-19 vaccine ad26.cov2.s - Heart ponding, back pain, sweating, slight confusion, tightness in chest.-. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable. 20220745839-covid-19 vaccine ad26.cov2.s - Fever. This event(s) is labeled per the agency and is therefore considered potentially related.
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Hyperhidrosis, Palpitations, Pyrexia
Clinical narrative: HEART POUNDING; TIGHTNESS IN CHEST; BACK PAIN; SWEATING; SLIGHT CONFUSION; FEVER; This spontaneous report received from a parent concerned an 18 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-alcohol user, non-smoker, environmental allergy (pollen and grass), and dust allergy, and other pre-existing medical conditions included: The patient had no history of drug abuse or illicit drug usage. The patient is athletic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855835 expiry: unknown) dose was not reported, 1 in total was administered on 13-JUL-2022 to right arm for covid-19 prophylaxis. No concomitant medications were reported.  On 13-JUL-2022, at 12:30 in the morning, patient called his mother and informed that he had tightness in his chest and his heart was pounding and his resting heart rate was 140 beats per minute after waking from sleep. The patient also had back pain. His mother took his pulse again and the reading at that time was 130 beats per minute, after 15 minutes it went down to 120 beats per minute. The patient's body was very hot, sweating and he was slightly confused. His mother took him to the ER (emergency room), where they processed him. Had taken ibuprofen at home, was given acetaminophen on admittance, and an Electrocardiogram was done and the Electrocardiogram showed mild tachycardia. The patient had fever of 101 degree Celsius on admittance to hospital. Duration of hospitalization was 1 day. Hospitalization date and discharge date information was not provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart pounding on 21-JUL-2022, and back pain, sweating, slight confusion, and fever on 14-JUL-2022, and the outcome of tightness in chest was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20220746027 and 20220745936.; Sender's Comments: V0- 20220745839-covid-19 vaccine ad26.cov2.s - Heart ponding, back pain, sweating, slight confusion, tightness in chest.-. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable. 20220745839-covid-19 vaccine ad26.cov2.s - Fever. This event(s) is labeled per the agency and is therefore considered potentially related.
Sex: F
Vaccine: COVID19
Symptoms: Blood iron, Blood iron decreased, Blood potassium, Blood potassium decreased, Vaccination site pain
Clinical narrative: VITAMIN B12 DECREASED/LOW B12; VITAMIN D DECREASED/LOW D; IRON LOW; POTASSIUM LOW; VACCINATION SITE PAIN/COVID19 VACCINATION HURT; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe adult crohn's disease, and non-infectious intermediate posterior and panuveitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe adult crohn's disease, and non-infectious intermediate posterior and panuveitis. No concomitant medications were reported. On an unspecified date, the patient experienced vitamin b12 decreased/low b12, vitamin d decreased/low d, iron low, potassium low, and vaccination site pain/covid19 vaccination hurt. Laboratory data (dates unspecified) included: Iron Low, Potassium Low, Vitamin B12 Low, and Vitamin D Low. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The outcome of the vitamin b12 decreased/low b12, vaccination site pain/covid19 vaccination hurt, vitamin d decreased/low d, iron low and potassium low was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Vitamin B12, Vitamin B12 decreased, Vitamin D, Vitamin D decreased
Clinical narrative: VITAMIN B12 DECREASED/LOW B12; VITAMIN D DECREASED/LOW D; IRON LOW; POTASSIUM LOW; VACCINATION SITE PAIN/COVID19 VACCINATION HURT; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe adult crohn's disease, and non-infectious intermediate posterior and panuveitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe adult crohn's disease, and non-infectious intermediate posterior and panuveitis. No concomitant medications were reported. On an unspecified date, the patient experienced vitamin b12 decreased/low b12, vitamin d decreased/low d, iron low, potassium low, and vaccination site pain/covid19 vaccination hurt. Laboratory data (dates unspecified) included: Iron Low, Potassium Low, Vitamin B12 Low, and Vitamin D Low. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The outcome of the vitamin b12 decreased/low b12, vaccination site pain/covid19 vaccination hurt, vitamin d decreased/low d, iron low and potassium low was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Laboratory test, Macrocytosis, Pain, Therapeutic response shortened
Clinical narrative: MACROCYTOSIS; WEARING OFF EFFECT; COVID-19; GENERAL BODY PAIN; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for non-infectious intermediate posterior and panuveitis, and moderate to severe rheumatoid arthritis. No concomitant medications were reported. On an unspecified date, the patient experienced macrocytosis, wearing off effect, covid-19, and general body pain. Laboratory data (dates unspecified) included: Lab test Red blood cells enlarged. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient recovered from covid-19, was recovering from wearing off effect, and general body pain, and had not recovered from macrocytosis. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site nodule
Clinical narrative: HAD PAIN ALL OVER; KNOT IN ARM WHEN TOOK COVID VACCINE; This spontaneous report received from a patient concerned a 59 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 08-MAR-2021 for covid-19 prophylaxis. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. Age at time of vaccination 59 years old. 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 MAR-2021, the patient experienced knot in arm when took covid vaccine. On an unspecified date, the patient experienced had pain all over. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient had not recovered from knot in arm when took covid vaccine, and had pain all over. This report was non-serious.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Allergy to vaccine, Joint swelling
Clinical narrative: ALLERGY TO VACCINE; JOINT SWELLING IN ANKLES AND KNEES; This spontaneous report received from a patient via other company concerned a 52 year old female of an unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1), (suspension for injection, intramuscular, batch number and expiry date 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.  The patient received non-company suspect drugs Humira (adalimumab), (form of admin unknown, subcutaneous, batch number and expiry date were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported.  On JUL-2022, the patient experienced joint swelling in ankles and knees (Dose number in series 1). On an unspecified date, the patient experienced allergy to vaccine (Dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and allergy to vaccine as not related. On an unspecified date, the patient also received booster dose of Moderna covid-19 vaccine, (Dose number in series 2), (Intramuscular, form of admin, batch number and expiry date were not reported) dose was not reported, administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination (Dose number in series 2). The outcome of the joint swelling in ankles and knees and allergy to vaccine was not reported. This report was non-serious.
Age: 65.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Skin disorder
Clinical narrative: FAINT SPOTS ON LEGS/BODY; This spontaneous report received from a patient concerned a 65 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe chronic plaque psoriasis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 01-OCT-2021 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: risankizumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. Age at time of vaccination 65 years old. No concomitant medications were reported. On OCT-2021, the patient experienced faint spots on legs/body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with risankizumab was not reported. The patient had not recovered from faint spots on legs/body. This report was non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This spontaneous report received from a patient via other company concerned a 6 decade old adult female of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe adult crohn's disease. The patient received Covid-19 vaccine ad26.cov2.s (Dose number in series 1), (suspension for injection, intramuscular, batch number and expiry date were not reported) dose was not reported, 1 total administered on 25-MAR-2021 for Covid-19 prophylaxis. The batch number was not reported. Age at time of vaccination 6 decade old. The Company is unable to perform follow-up to request batch/lot numbers. The patient received non-company suspect drugs Humira (adalimumab), (solution for injection in pre-filled pen, subcutaneous, batch number and expiry date were not reported) dose, frequency, and therapy dates were not reported for moderate to severe adult crohn's disease. No concomitant medications were reported. On an unspecified date, the patient experienced headache (Dose number in series 1). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. On 10-MAR-2022, the patient also received booster dose of Moderna Covid-19 vaccine (elasomeran), (Dose number in series 2), (Intramuscular, form of admin, batch number and expiry date were not reported) dose was not reported, administered for Covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination (Dose number in series 2). The outcome of headache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: CHILLS; This spontaneous report received from a patient via Social media  via a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. On an unspecified date, The patient previously received 3 doses of  covid-19 vaccine (Unspecified manufacturer) (dose number in series: 1) (form of admin, route of admin, batch number and expiry were not reported for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following covid-19 vaccine (Unspecified manufacturer) (dose number in series: 1). The patient received fourth dose of covid-19 vaccine ad26.cov2.s (dose number in series: 2) (suspension for injection, route of admin, and batch number, expiry were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced chills and it was reported as ""I took the 4th dose of the vaccine against Covid-19, this time it was Janssen's" (dose number in series: 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of chills was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Heart rate, Heart rate increased, Hyperhidrosis
Clinical narrative: CHILLS; NOT FEELING WELL/ FEELING ABNORMAL; SWEATING; DRY COUGH; FEELING LETHARGIC; ELEVATED PULSE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: bladder cancer, neuropathy in r leg, abstains from alcohol, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies, no drug abuse or illicit drug usage. The patient previously received with covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin was not reported, batch number:1805018, expiry: unknown) dose was not reported, 1 total administered on 02-APR-2021 for covid-19 prophylaxis. The patient was previously treated with metoprolol tartrate and ketorolac tromethamine used for unknown indication.  It was unknown whether the patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855835 expiry: unknown) dose was not reported, 1 total administered to left arm on 15-DEC-2021 for covid-19 prophylaxis. No concomitant medications were reported.  On 01-JUN-2022, the patient experienced chills, not feeling well, feeling abnormal, sweating, dry cough, feeling lethargic, and elevated pulse (Dose number in series 2). Laboratory data included: Pulse rate Elevated (188). The consumer claimed that the consumer feels symptoms throughout the day.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sweating, dry cough, feeling lethargic, not feeling well, feeling abnormal, elevated pulse, and chills. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Malaise
Clinical narrative: CHILLS; NOT FEELING WELL/ FEELING ABNORMAL; SWEATING; DRY COUGH; FEELING LETHARGIC; ELEVATED PULSE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: bladder cancer, neuropathy in r leg, abstains from alcohol, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies, no drug abuse or illicit drug usage. The patient previously received with covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin was not reported, batch number:1805018, expiry: unknown) dose was not reported, 1 total administered on 02-APR-2021 for covid-19 prophylaxis. The patient was previously treated with metoprolol tartrate and ketorolac tromethamine used for unknown indication.  It was unknown whether the patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855835 expiry: unknown) dose was not reported, 1 total administered to left arm on 15-DEC-2021 for covid-19 prophylaxis. No concomitant medications were reported.  On 01-JUN-2022, the patient experienced chills, not feeling well, feeling abnormal, sweating, dry cough, feeling lethargic, and elevated pulse (Dose number in series 2). Laboratory data included: Pulse rate Elevated (188). The consumer claimed that the consumer feels symptoms throughout the day.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sweating, dry cough, feeling lethargic, not feeling well, feeling abnormal, elevated pulse, and chills. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer via social media, a company representative concerned a 55-year old female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number, expiry were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, after taking vaccine the patient died from an unknown cause of death and it was reported as " their vaccine killed mg 55 year old friend. Its listed her cause of death on death certificate...yeah they are a great company alright. Great at causing death look at their lawsuit history, and for what. And you took the jab lol". And it was unknown if an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20220749895-COVID-19 VACCINE AD26.COV2.S- Death. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: CONTRACT A MILD FORM OF PROBABLE OMICRON; This spontaneous report received from a patient via a company representative concerned a 6 decade old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient was previously received covid-19 vaccine ad26.cov2.s (dose number in series1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date in 2021 for covid-19 prophylaxis. It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total, administered on DEC-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in MAR-2022, the patient did contract a mild form of probable omicron (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of contract a mild form of probable omicron was not reported. This report was non-serious. This report was associated with product quality complaint: 90000243637.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: did not receive 3rd primary series dose; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (did not receive 3rd primary series dose) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Immunocompromised.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (did not receive 3rd primary series dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (did not receive 3rd primary series dose) outcome was unknown.            No concomitant medication reported. No treatment information was provided.  Patient reported that he was immunocompromised. Patient reported he had received two Moderna primary series doses and two Moderna booster doses. The patient stated his last booster dose was 4 or 5 months ago. The exact dates of administration and lot numbers were not provided.   This case was linked to MOD-2022-607774 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vial was initially stored in the refrigerator on 29-May-2022, administration of vaccine was on 5-Jul-2022; Booster dose administered after 30 day use-by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster dose administered after 30 day use-by date) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 29-May-2022, administration of vaccine was on 5-Jul-2022) in an elderly patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster dose administered after 30 day use-by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 29-May-2022, administration of vaccine was on 5-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Booster dose administered after 30 day use-by date) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 29-May-2022, administration of vaccine was on 5-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. It was reported that vial did not undergo any temperature excursions. It was reported that one dose was administered. No treatment drug was reported.
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator on 10-Jun-2022 and adminsitered on 12-Jul-2022; Dose administered after 30 day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 day Use By Date) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10-Jun-2022 and adminsitered on 12-Jul-2022) in a 93-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 12-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10-Jun-2022 and adminsitered on 12-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 day Use By Date) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10-Jun-2022 and adminsitered on 12-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patients weight was given as 175.   Concomitant medication list was not provided.  The vial was initially stored in the refrigerator on 10-Jun-2022. The vial had not undergone any temperature excursions. The patient had not experienced any adverse reactions. Treatment information was not provided.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was stored in refrigerator on 10-Jun-2022 and was administered to the patient on 12-Jul-2022; Vaccine was administered to the patient after 30 day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to the patient after 30 day use by date) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 10-Jun-2022 and was administered to the patient on 12-Jul-2022) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 12-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to the patient after 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 10-Jun-2022 and was administered to the patient on 12-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to the patient after 30 day use by date) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 10-Jun-2022 and was administered to the patient on 12-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Weight of the patient was reported as 118.6  No concomitant medications information was not reported.  Vial did not undergo any temperature excursions.  Patient did not experience any adverse events.  No treatment medications were provided.   This case was linked to MOD-2022-607720 (E2B Linked Report).; Sender's Comments:  MOD-2022-607720:Master case
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator on 10-Jun-2022 but vaccine was administered on 12-Jul-2022; Dose administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10-Jun-2022 but vaccine was administered on 12-Jul-2022) in a 95-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 12-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10-Jun-2022 but vaccine was administered on 12-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10-Jun-2022 but vaccine was administered on 12-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient weight was reported as 152.2.  No concomitant medications were reported.  It was reported that, the pharmacy had sent Moderna COVID-19 vaccines on 10-Jun-2022 and on the same day the vials were initially stored in refrigerator. The vaccine was administered to the patient after the 30 days use by date. The vials did not undergo any temperature excursions. No adverse reactions were reported for the patient.  No treatment medications were reported.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator on 10-Jun-2022 and adminsitered on 12-Jul-2022; Dose administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10-Jun-2022 and adminsitered on 12-Jul-2022) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 12-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10-Jun-2022 and adminsitered on 12-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10-Jun-2022 and adminsitered on 12-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient weight was reported as 175.  Concomitant medication was not provided.  15 patients were vaccinated after the 30 day beyond use date. Number of doses per vials were 15 doses.  The vial was initially stored in the refrigerator on 10-Jun-2022. The vial did not undergo any temperature excursions.   Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Headache, SARS-CoV-2 test
Clinical narrative: does not remember when his sister first caught Covid-19 but he does know that it was after her first Primary Moderna Covid-19 vaccine; headache; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (does not remember when his sister first caught Covid-19 but he does know that it was after her first Primary Moderna Covid-19 vaccine) and HEADACHE (headache) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 2021, the patient experienced COVID-19 (does not remember when his sister first caught Covid-19 but he does know that it was after her first Primary Moderna Covid-19 vaccine) and HEADACHE (headache). At the time of the report, COVID-19 (does not remember when his sister first caught Covid-19 but he does know that it was after her first Primary Moderna Covid-19 vaccine) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: first caught Covid-19 after her first Primary Moderna Covid-19 vaccine.     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.   No concomitant product was provided by the reporter.  The Patient has caught Covid-19 twice since receiving her Moderna Primary Series of vaccine. The caller did not remember when his sister first caught Covid-19 but he did know that it was after her first Primary Moderna Covid-19 vaccine. The caller said that his sister caught her second case of Covid-19 about 6 weeks ago.  No treatment medication was provided.  Company Comment: This is a Spontaneous case reported by a physician concerning an elderly female patient, with no medical history reported, who experienced the unexpected and non-serious AESI of COVID-19, which occurred within the following 11 months after the first dose of mRNA-1273 vaccine. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-610656 (Patient Link).; Sender's Comments: This is a Spontaneous case reported by a physician concerning an elderly female patient, with no medical history reported, who experienced the unexpected and non-serious AESI of COVID-19, which occurred within the following 11 months after the first dose of mRNA-1273 vaccine. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Molluscum contagiosum
Clinical narrative: developed rashes 2 days after/ The rashes worsened over time/ diagnosed him with molluscum; This spontaneous case was reported by an other caregiver and describes the occurrence of MOLLUSCUM CONTAGIOSUM (developed rashes 2 days after/ The rashes worsened over time/ diagnosed him with molluscum) in a 3-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-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 MOLLUSCUM CONTAGIOSUM (developed rashes 2 days after/ The rashes worsened over time/ diagnosed him with molluscum). At the time of the report, MOLLUSCUM CONTAGIOSUM (developed rashes 2 days after/ The rashes worsened over time/ diagnosed him with molluscum) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2022: Follow-up document received includes reporter details, additional reporter and patient's demographics.