chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Foetal exposure during pregnancy, Jaundice neonatal
Clinical narrative: JAUNDICE; FETAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a consumer concerned a male neonate with unspecified race and ethnicity. The patient was enrolled in a non-company sponsored study. The patient's weight was 3.71 kilograms, and height was 51 centimeters. The patient's pre-existing medical conditions included: The baby has been overall healthy with no birth defects; genetic or inherited disorders have been diagnosed. The patient's parent's medical history included anxiety, the mother had no relevant obstetrical history and no history of alcohol, tobacco or recreational drug use, the mother's first day of the last menstrual period (LMP) was calculated to be 12-Aug-2020.  At gestational age 34 weeks and one day, the patient's mother initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: 042A21A and expiry: Unknown) dose was not reported, 1 total, administered on 08-APR-2021 for covid-19 immunisation. The patient (baby) received it via transplacental route exposure. Maternal concomitant medications included prenatal vitamins. On 08-APR-2021, the patient experienced fetal exposure during pregnancy. At gestational age 40 weeks and two days, the mother delivered vaginally a live, full-term, male neonate. The mother spent three days in the hospital for the delivery. The neonate's birth weight was 8 pounds and 3 ounces and body length was 20 inches. On 25-May-2021, the neonate was hospitalized due to jaundice, the duration of hospitalization were not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fetal exposure during pregnancy on 21-MAY-2021, and the outcome of jaundice was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2., and jaundice was related and fetal exposure during pregnancy was not related.  This report was serious (Hospitalization Caused / Prolonged). This parent/child case is linked to 20210728807.; Sender's Comments: V0: 20211112636-COVID-19 VACCINE AD26.COV2.S- Jaundice. This event is considered related. The event 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. 20211112636-COVID-19 VACCINE AD26.COV2.S-Fetal exposure during pregnancy. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS
Age: 51.0
Sex: M
Vaccine: 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 concerned a 52 year old male. Initial information was processed along with the additional information received from regulatory authority on 08-Nov-2021. 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: 043A21A, and expiry: UNKNOWN) 1 total, dose was not reported, administered to right arm on 06-APR-2021 for prophylactic vaccination.  Concomitant medications included Pfizer booster dose (BNT 162) on 27-OCT-2021.  On 28-OCT-2021, the patient experienced symptoms of loss of taste and congestion and on 02-NOV-2021,COVID-19 virus test was positive (confirmed clinical vaccination failure).   The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000200244 The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified. based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20211107880-covid-19 vaccine ad26.cov2.s-confirmed clinical vaccination failure. This event(s) is considered not related. 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
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: breathing issues (not otherwise specified). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route unknown, batch number and expiry: Unknown) dose was not reported, 1 total, administered on an unspecified date in MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date after vaccination the patient contacted their primary physician who ordered a blood work to test for antibodies. SARS-CoV-2 antibody test confirmed no antibodies (confirmed immunological vaccine failure). The patient received the first dose of COVID-19 Moderna vaccine on 02-NOV-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report is associated with product quality complaint: 90000200479. The suspected product quality complaint has been confirmed to be not voided as the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20211110156-covid-19 vaccine ad26.cov2.s-confirmed immunological vaccine failure. This event(s) is considered not related. 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
Sex: U
Vaccine: COVID19
Symptoms: Myocardial infarction, Thrombosis
Clinical narrative: BLOOD CLOT; HEART ATTACK; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex, race and ethnic origin The patient's height, and weight were not reported. The patient's concurrent conditions included: plaque, and other pre-existing medical conditions included: Good physical condition with no cholesterol issues The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown expiry: Unknown) dose, start therapy date were not reported 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient had blood clot which led to a heart attack. Patient went to cardiologist and had to live with taking daily medications and medical bills.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot and heart attack was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20211110262-covid-19 vaccine ad26.cov2.s -blood clot. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20211110262-covid-19 vaccine ad26.cov2.s -heart attack. This event(s) is considered not related. 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: MEDICAL HISTORY
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Fatigue, Heart rate, Heart rate increased, Incorrect route of product administration
Clinical narrative: VASCULITIS; VACCINE WAS INADVERTENTLY ADMINISTERED INTRAVASCULARLY RATHER THAN INTRAMUSCULARLY; HEART RATE INCREASES TO 150-160 WHEN STANDING; INFLAMMATORY ARTHRITIS; MENTAL EXHAUSTION; PHYSICAL EXHAUSTION; SEVERE RINGING IN THE EARS; This spontaneous report received from a consumer concerned a 30 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received Covid-19 vaccine ad26. cov2. s for prophylactic vaccination on an unspecified date in JAN-2021. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intravenous, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination approximately 6 to 8 months after first vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient's vaccine was inadvertently administered intravascularly rather than intramuscularly. It was injected into a blood vessel and it has been a nightmare since. He was confined to home because he has got a heart rate issue, just upon standing his heart rate increased to 150-160. He had inflammatory arthritis, vasculitis, mental exhaustion, physical exhaustion, and severe ringing in the ears. Laboratory data (dates unspecified) included: Heart rate (NR: not provided) (increased) 150-160. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine was inadvertently administered intravascularly rather than intramuscularly, heart rate increases to 150-160 when standing, inflammatory arthritis, vasculitis, severe ringing in the ears, mental exhaustion and physical exhaustion was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Mental fatigue, Tinnitus, Vasculitis
Clinical narrative: VASCULITIS; VACCINE WAS INADVERTENTLY ADMINISTERED INTRAVASCULARLY RATHER THAN INTRAMUSCULARLY; HEART RATE INCREASES TO 150-160 WHEN STANDING; INFLAMMATORY ARTHRITIS; MENTAL EXHAUSTION; PHYSICAL EXHAUSTION; SEVERE RINGING IN THE EARS; This spontaneous report received from a consumer concerned a 30 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received Covid-19 vaccine ad26. cov2. s for prophylactic vaccination on an unspecified date in JAN-2021. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intravenous, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination approximately 6 to 8 months after first vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient's vaccine was inadvertently administered intravascularly rather than intramuscularly. It was injected into a blood vessel and it has been a nightmare since. He was confined to home because he has got a heart rate issue, just upon standing his heart rate increased to 150-160. He had inflammatory arthritis, vasculitis, mental exhaustion, physical exhaustion, and severe ringing in the ears. Laboratory data (dates unspecified) included: Heart rate (NR: not provided) (increased) 150-160. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine was inadvertently administered intravascularly rather than intramuscularly, heart rate increases to 150-160 when standing, inflammatory arthritis, vasculitis, severe ringing in the ears, mental exhaustion and physical exhaustion was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a health care professional concerned multiple patients of an unspecified age, sex, race and ethnic origin. No past medical history or concurrent conditions were reported. The patients' received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, batch number and expiry were not reported) dose, start therapy date were not reported, 01 total administered, for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch numbers. No concomitant medications were reported.    It was reported that the patients from died of unknown cause of death after taking the johnson and johnson, moderna and pfizer vaccine jabs. It was unspecified 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: 20211122133 -covid-19 vaccine ad26.cov2.s- death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000201911.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: WORST SIDE EFFECTS; This spontaneous report received from a consumer via a company representative concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced worst side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of worst side effects was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: SIDE  EFFECTS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from side effects. This report was non-serious.; Sender's Comments: V0 :Medical assessment comment is not required as per standard procedure as case was assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Blood urine present, Haemorrhage urinary tract, Myalgia, Pyrexia
Clinical narrative: FEVER; MUSCLE ACHES; BLOOD CLOTS IN URINE; BLOODY URINE; This spontaneous report received from a pharmacist concerned a 23 year old male with unspecified ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: non alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no known drug allergy, The patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855191, expiry: 11-APR-2022) dose was not reported, 1 total administered on 11-NOV-2021 17:00 to the left arm for prophylactic vaccination. No concomitant medications were reported.  On 11-NOV-2021, between 22.00 to 23.00 the patient experienced blood clots in urine and bloody urine. The patient visited physician for the same. On 12-NOV-2021, the patient experienced fever and muscle aches. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood clots in urine, and bloody urine on 12-NOV-2021, and had not recovered from fever, and muscle aches.  This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210414709.; Sender's Comments: V0: 20211130285-COVID-19 VACCINE AD26.COV2.S- blood clots in urine. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Biopsy bone marrow, Platelet count, Platelet count decreased
Clinical narrative: ANEMIA; LOW PLATELET COUNT; This spontaneous report received from a consumer concerned a 79 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: cll (Chronic lymphocytic leukaemia), and other pre-existing medical conditions included: The patient had no known allergies, and no relevant medical history reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, 1 total administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included ibrutinib for cll (Chronic lymphocytic leukaemia).  On an unspecified date, the patient experienced anemia, and low platelet count, and was hospitalized (dates and duration unspecified). Laboratory data (dates unspecified) included: Platelet count (NR: not provided) low. On 02-NOV-2021, Laboratory data included: Bone marrow biopsy (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from low platelet count, and the outcome of anemia was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, involving the same patient is linked to 20211123439.; Sender's Comments: V0: 20211130491-COVID-19 VACCINE AD26.COV2.S-low platelet count, anemia. This event(s) is considered not related. 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: CONMEDS-OTHER SUSPECT DRUGS
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: A VERY RARE REACTION; This spontaneous report received from a consumer via a company representative concerned 5 patients of unspecified sex, race and ethnicity. The patient's height, and weight were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  The reporter stated that "5 people died from a very rare reaction to the vaccine out of millions vaccinated". It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20211131451- COVID-19 VACCINE AD26.COV2.S- A very rare reaction. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: RARE REACTION
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Influenza like illness, Sensitive skin
Clinical narrative: WHOLE BODY ACHES, MUSCLE ACHES, HEADACHE, FEVER, FEELS WEAK AND FEELS LIKE THE FLU; SKIN FEELS SENSITIVE; DIARRHEA; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: seizure, and other pre-existing medical conditions included: Patient had no known drug allergies and had a history of seizures which excluded her from taking ibuprofen. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 12-NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 12-NOV-2021, the patient experienced whole body aches, muscle aches, headache, fever, feels weak and feels like the flu. On 12-NOV-2021, the patient experienced skin feels sensitive. On 12-NOV-2021, the patient experienced diarrhea. Laboratory data included: Body temperature (NR: not provided) 101 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from skin feels sensitive, and diarrhea on NOV-2021, and had not recovered from whole body aches, muscle aches, headache, fever, feels weak and feels like the flu.  This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: POSSIBLE GUILLAIN BARRE (MILD VERSION); This spontaneous report received from a patient (Physician) concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration and batch number were not reported) dose was not reported, 1 total, administered on 12-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  After 10 days of vaccination, on 22-MAY-2021, the patient experienced bilateral leg weakness and paraesthesias in the hands and feet. The patient was able to walk but felt it difficult. Patient reported that, the symptoms dissipated over a 2 week period. The patient was concerned that may have had a mild version of Guillain Barre. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from possible Guillain Barre (mild version) on an unspecified date in JUN-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20211132972 - covid-19 vaccine ad26.cov2.s  Possible Guillain-Barre syndrome(Mild version)-. This event(s) is labeled per RSI and is therefore considered potentially related.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Tinnitus
Clinical narrative: TINNITUS HAS INCREASED IN AMPLITUDE BY 3-4 TIMES, UNBEARABLE; POSSIBLY WORSENED DISC DISEASE AND BONE SPURS CONDITION SINCE VACCINATION; This spontaneous report received from a patient concerned a 57 year old male. The patient's weight was 260 pounds, and height was 77 inches. The patient's concurrent conditions included: mild tinnitus, bone spurs, medically controlled hypertension, mid range hearing loss, and neck/back pain with disc disease, and other pre-existing medical conditions included: Patient did not had any known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, expiry: 11-APR-2022) dose was not reported, administered on 05-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On NOV-2021, the patient experienced possibly worsened disc disease and bone spurs condition since vaccination. On 05-NOV-2021, the patient experienced tinnitus has increased in amplitude by 3-4 times, unbearable. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tinnitus has increased in amplitude by 3-4 times, unbearable, and the outcome of possibly worsened disc disease and bone spurs condition since vaccination was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event, Pain in extremity
Clinical narrative: DIFFERENT SYMPTOMS EACH DAY FOR A WEEK; ARM WAS SORE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced different symptoms each day for a week, and arm was sore. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm was sore and different symptoms each day for a week was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: POSITIVE COVID TEST; This spontaneous report received from a patient via a company representative concerned a 59 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 01-NOV-2021, the patient experienced positive covid test. Laboratory data (dates unspecified) included: SARS-CoV-2 test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of positive covid test was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case is assessed as non serious.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 TEST POSITIVE; This spontaneous report received from a consumer concerned an adult female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-NOV-2021, the patient experienced covid-19 test positive. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: COUGH; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch and lot numbers.  No concomitant medications were reported.  On an unspecified date, the patient experienced cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cough. This report was non-serious. This case, from the same reporter is linked to 20211133950.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: ADMINISTERED PUNCTURED VIAL STORED AT ROOM TEMPERATURE FOR 2.5 HOURS (OUTSIDE OF THE RECOMMENDED STORAGE CONDITIONS); VACCINE STORED AT ROOM TEMPERATURE FOR 2.5 HOUR (OUTSIDE OF THE RECOMMENDED STORAGE CONDITIONS); This spontaneous report received from a pharmacist concerned a 19 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809 expiry: 07-MAR-2022) dose was not reported, administered on 14-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-NOV-2021, the patient experienced administered punctured vial stored at room temperature for 2.5 hours (outside of the recommended storage conditions). On 14-NOV-2021, the patient experienced vaccine stored at room temperature for 2.5 hour (outside of the recommended storage conditions). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered punctured vial stored at room temperature for 2.5 hours (outside of the recommended storage conditions) and vaccine stored at room temperature for 2.5 hour (outside of the recommended storage conditions) was not reported. This report was non-serious.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Skin discolouration
Clinical narrative: RED MARK ON ARM; This spontaneous report received from a consumer concerned an elderly male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced red mark on arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from red mark on arm. This report was non-serious. This case, from the same reporter is linked to 20211133810.
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: RESTING HEART RATE OF 150 ABOVE GOING ON LIKE 10 DAYS; This spontaneous report received from a consumer via a company representative via social media concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry date: unknown) dose was not reported, 1 total, start therapy date not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced adverse reaction to the covid-19 vaccine ad26.cov2.s which further descried as heart rate was above 150 going on like 10 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of resting heart rate of 150 above going on like 10 days was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211133748-Covid-19 vaccine ad26.cov2.s- Resting heart rate of 150 above going on like 10 days. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: BELLS PALSEY; This spontaneous report received from a patient concerned a 46 year old male. The patient's height, and weight were not reported. Patient had no known allergies. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 23-JUN-2021) dose was not reported, frequency time 1 total was administered on 30-APR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 27-OCT-2021, the patient experienced bells palsey and went to urgent care (Emergency room). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bells palsey on 29-OCT-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211133835-covid-19 vaccine ad26.cov2.s-bells palsy .This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: Injection site hypoaesthesia
Clinical narrative: NUMBNESS IN INJECTION SITE ARM; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced numbness in injection site arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of numbness in injection site arm was not reported. This report was non-serious.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash
Clinical narrative: Rash at injection site; Reddish at injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE ERYTHEMA (Reddish at injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031a21a and 041l20a) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE ERYTHEMA (Reddish at injection site). At the time of the report, VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE ERYTHEMA (Reddish at injection site) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.   This case was linked to MOD-2021-369040, MOD-2021-010081 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Flushing, Night sweats, Pain in extremity
Clinical narrative: itching; erythema; feeling hot; arm still rashy; arm still rashy and tender; Night sweats; Face is flushed; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Night sweats), FLUSHING (Face is flushed), PRURITUS (itching), ERYTHEMA (erythema) and FEELING HOT (feeling hot) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided.  The patient's past medical history included Celiac sprue (Pain In stomach and rash on face feel sick gluten free) in 2008 and Pulmonary valve replacement in 2021. Concurrent medical conditions included Drug allergy (Swollen face ,red and hot flashes), Penicillin allergy (S Itchy back hives) since 1977, CLL since 2012, Celiac disease (Diet) since 2012 and Osteoporosis (Recasts once a yr). Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for Blood cholesterol abnormal, FUROSEMIDE (LASIX [FUROSEMIDE]) from August 2021 to an unknown date, METOPROLOL from August 2021 to an unknown date, CALCIUM ASCORBATE, TOCOPHERYL ACETATE (VITAMIN E+C [CALCIUM ASCORBATE;TOCOPHERYL ACETATE]), VITAMIN D [VITAMIN D NOS] and ZINC for an unknown indication.    On 29-Oct-2021 at 4:45 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced NIGHT SWEATS (Night sweats) and FLUSHING (Face is flushed). On an unknown date, the patient experienced PRURITUS (itching), ERYTHEMA (erythema), FEELING HOT (feeling hot), RASH (arm still rashy) and PAIN IN EXTREMITY (arm still rashy and tender). At the time of the report, NIGHT SWEATS (Night sweats), FLUSHING (Face is flushed), PRURITUS (itching), ERYTHEMA (erythema) and FEELING HOT (feeling hot) outcome was unknown and RASH (arm still rashy) and PAIN IN EXTREMITY (arm still rashy and tender) had not resolved. Not Provided          Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2021: reporter information, allergies and medical histories, concomitant medications and events added.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: itching; erythema; feeling hot; arm still rashy; arm still rashy and tender; Night sweats; Face is flushed; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Night sweats), FLUSHING (Face is flushed), PRURITUS (itching), ERYTHEMA (erythema) and FEELING HOT (feeling hot) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided.  The patient's past medical history included Celiac sprue (Pain In stomach and rash on face feel sick gluten free) in 2008 and Pulmonary valve replacement in 2021. Concurrent medical conditions included Drug allergy (Swollen face ,red and hot flashes), Penicillin allergy (S Itchy back hives) since 1977, CLL since 2012, Celiac disease (Diet) since 2012 and Osteoporosis (Recasts once a yr). Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for Blood cholesterol abnormal, FUROSEMIDE (LASIX [FUROSEMIDE]) from August 2021 to an unknown date, METOPROLOL from August 2021 to an unknown date, CALCIUM ASCORBATE, TOCOPHERYL ACETATE (VITAMIN E+C [CALCIUM ASCORBATE;TOCOPHERYL ACETATE]), VITAMIN D [VITAMIN D NOS] and ZINC for an unknown indication.    On 29-Oct-2021 at 4:45 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced NIGHT SWEATS (Night sweats) and FLUSHING (Face is flushed). On an unknown date, the patient experienced PRURITUS (itching), ERYTHEMA (erythema), FEELING HOT (feeling hot), RASH (arm still rashy) and PAIN IN EXTREMITY (arm still rashy and tender). At the time of the report, NIGHT SWEATS (Night sweats), FLUSHING (Face is flushed), PRURITUS (itching), ERYTHEMA (erythema) and FEELING HOT (feeling hot) outcome was unknown and RASH (arm still rashy) and PAIN IN EXTREMITY (arm still rashy and tender) had not resolved. Not Provided          Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2021: reporter information, allergies and medical histories, concomitant medications and events added.
Sex: U
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: 50 patients administered doses from temp excursion vials; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (50 patients administered doses from temp excursion vials) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (50 patients administered doses from temp excursion vials). On 29-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (50 patients administered doses from temp excursion vials) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It mentioned that the patients were not experienced any events.  No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Nov-2021: Follow-up was received on 4-NOV-2021 and Reporters response includes no events were experienced by patients.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Illness, Influenza like illness, Myalgia
Clinical narrative: has been really sick; had flu like symptoms; diarrhea; Fever; muscle aches; Chills; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (has been really sick), INFLUENZA LIKE ILLNESS (had flu like symptoms), DIARRHOEA (diarrhea), PYREXIA (Fever) and MYALGIA (muscle aches) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 010M20A and 012120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient experienced ILLNESS (has been really sick), INFLUENZA LIKE ILLNESS (had flu like symptoms), DIARRHOEA (diarrhea), PYREXIA (Fever), MYALGIA (muscle aches) and CHILLS (Chills). At the time of the report, ILLNESS (has been really sick), INFLUENZA LIKE ILLNESS (had flu like symptoms), DIARRHOEA (diarrhea), PYREXIA (Fever), MYALGIA (muscle aches) and CHILLS (Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: has been really sick; had flu like symptoms; diarrhea; Fever; muscle aches; Chills; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (has been really sick), INFLUENZA LIKE ILLNESS (had flu like symptoms), DIARRHOEA (diarrhea), PYREXIA (Fever) and MYALGIA (muscle aches) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 010M20A and 012120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient experienced ILLNESS (has been really sick), INFLUENZA LIKE ILLNESS (had flu like symptoms), DIARRHOEA (diarrhea), PYREXIA (Fever), MYALGIA (muscle aches) and CHILLS (Chills). At the time of the report, ILLNESS (has been really sick), INFLUENZA LIKE ILLNESS (had flu like symptoms), DIARRHOEA (diarrhea), PYREXIA (Fever), MYALGIA (muscle aches) and CHILLS (Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported.