chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose on 10Sep2020 and 2nd dose on 06Oct2020.; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 6th October 2020, the patient received the 2nd dose of Shingrix. On 6th October 2020, unknown after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The patient received 1st dose of Shingrix on 10th September 2020. The health care professional stated that, the patient received 2nd dose of Shingrix early than the recommended time interval, which led to shortening of vaccination schedule. The reporter did not have lot number and expiration date information at the time of the call. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Shingrix vaccines were frozen; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The health care provided wanted to know how to proceed with some Shingrix vaccines being frozen, which led to incorrect storage of drug. The health care professional's demographic details were provided for a callback. Health care professional could not be contacted in order to collect further details of the event. Only information provided was that some Shingrix vaccines were frozen.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Paraesthesia, Scar
Clinical narrative: Shingles; nerve tingling; scarring; This case was reported by a consumer via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix. In June 2021, between 1 and 2 years after receiving Shingrix, the patient experienced shingles, tingling and scar. On an unknown date, the outcome of the shingles, tingling and scar were not recovered/not resolved.   It was unknown if the reporter considered the shingles, tingling and scar to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient for herself. The age at vaccination was not reported. The patient reported that she received Shingrix vaccine. The patient experienced shingles and was still experiencing nerve tingling and scarring. The reporter consented to follow-up For tolerance refer linked case US2021AMR203662, same reporter for the second dose.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR203662:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Skin lesion
Clinical narrative: raised lesions on her lower back; This case was reported by a consumer via call center representative and described the occurrence of skin lesion in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced skin lesion. On an unknown date, the outcome of the skin lesion was not recovered/not resolved.   It was unknown if the reporter considered the skin lesion to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient for herself. The age at vaccination was not reported. The patient reported that she took her first dose  of Shingrix vaccine series. The patient stated that after vaccination she developed some raised lesions on her lower back. The patient's health care professional ruled out shingles and bed bugs. The patient reported that she would see her dermatologist. The patient declined to provide any other information. The patient did not consented to follow-up.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Syringe issue, Underdose
Clinical narrative: did not receive a full dose; liquid leaked out of the patient's arm; Inadvertent exposure to vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 69-year-old male patient who received Herpes zoster (Shingrix) (batch number AE2J4, expiry date 30th March 2023) for prophylaxis.   On 22nd September 2021, the patient received the 1st dose of Shingrix. On 22nd September 2021, unknown after receiving Shingrix, the patient experienced accidental underdose, exposure via skin contact and inadvertent exposure to vaccine. On an unknown date, the outcome of the accidental underdose, exposure via skin contact and inadvertent exposure to vaccine were unknown.  Additional details were reported as follows: The pharmacist reported that patient who did not receive a full dose of Shingrix because while administering it, most of the liquid leaked out of the patient's arm, which led to accidental underdose, exposure via skin contact and inadvertent exposure to vaccine. The pharmacist does not know how much of the vaccine the patient received. The reporter consented to follow up.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site hyperaesthesia, Vaccination site pain, Vaccination site swelling
Clinical narrative: very warm; it became very sensitive; I had a fever for 2 days; my arm swelled up/it was the size of a golf ball; it was very red; it was painful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (very warm), VACCINATION SITE HYPERAESTHESIA (it became very sensitive), PYREXIA (I had a fever for 2 days), VACCINATION SITE SWELLING (my arm swelled up/it was the size of a golf ball) and VACCINATION SITE ERYTHEMA (it was very red) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A, 013M20A and 037F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Renal disease and Heart disease, unspecified. Concomitant products included ATENOLOL, FELODIPINE, ESCITALOPRAM OXALATE (LEXAPRO), FISH OIL and DOXAZOSIN for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Sep-2021, the patient experienced VACCINATION SITE WARMTH (very warm), VACCINATION SITE HYPERAESTHESIA (it became very sensitive), PYREXIA (I had a fever for 2 days), VACCINATION SITE SWELLING (my arm swelled up/it was the size of a golf ball), VACCINATION SITE ERYTHEMA (it was very red) and VACCINATION SITE PAIN (it was painful). On 13-Sep-2021, PYREXIA (I had a fever for 2 days) had resolved. On 18-Sep-2021, VACCINATION SITE WARMTH (very warm), VACCINATION SITE HYPERAESTHESIA (it became very sensitive), VACCINATION SITE SWELLING (my arm swelled up/it was the size of a golf ball), VACCINATION SITE ERYTHEMA (it was very red) and VACCINATION SITE PAIN (it was painful) had resolved.            The treatment medication was unknown.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: very warm; it became very sensitive; I had a fever for 2 days; my arm swelled up/it was the size of a golf ball; it was very red; it was painful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (very warm), VACCINATION SITE HYPERAESTHESIA (it became very sensitive), PYREXIA (I had a fever for 2 days), VACCINATION SITE SWELLING (my arm swelled up/it was the size of a golf ball) and VACCINATION SITE ERYTHEMA (it was very red) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A, 013M20A and 037F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Renal disease and Heart disease, unspecified. Concomitant products included ATENOLOL, FELODIPINE, ESCITALOPRAM OXALATE (LEXAPRO), FISH OIL and DOXAZOSIN for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Sep-2021, the patient experienced VACCINATION SITE WARMTH (very warm), VACCINATION SITE HYPERAESTHESIA (it became very sensitive), PYREXIA (I had a fever for 2 days), VACCINATION SITE SWELLING (my arm swelled up/it was the size of a golf ball), VACCINATION SITE ERYTHEMA (it was very red) and VACCINATION SITE PAIN (it was painful). On 13-Sep-2021, PYREXIA (I had a fever for 2 days) had resolved. On 18-Sep-2021, VACCINATION SITE WARMTH (very warm), VACCINATION SITE HYPERAESTHESIA (it became very sensitive), VACCINATION SITE SWELLING (my arm swelled up/it was the size of a golf ball), VACCINATION SITE ERYTHEMA (it was very red) and VACCINATION SITE PAIN (it was painful) had resolved.            The treatment medication was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Neuropathy peripheral
Clinical narrative: NEUROPATHY PERIPHERAL; CONDITION AGGRAVATED; This spontaneous report received from a patient via a Regulatory Authority (ID: 1471293) concerned a 72-year-old female of unknown race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: sulfonamide allergy, high blood pressure, and peripheral neuropathy. The patient experienced drug allergy when treated with codeine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) frequency 1 total, dose was not reported, administered on 11-Apr-2021 for prophylactic vaccination. All required follow-up attempts have been made. The Batch number for COVID-19 Vaccine Janssen AD26.COV.2.S has not been provided. Concomitant medications included lisinopril, and nifedipine.  On 11-Apr-2021, the patient stated that most intense bout of peripheral neuropathy in both legs and feet (condition aggravated) which patient frequently gets from degenerative disks and pinched nerves, from which patient had been suffering for years. The patient mentioned usually had one sided stabbing at night after patient lays down which lasts all night. The patient stated that the event lasted all night long but the intensity was hard to deal with. The patient mentioned that it stopped the next day but was really shocked. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from neuropathy peripheral, and condition aggravated on 12-Apr-2021. This report was serious (Other Medically Important Condition).  Additional information was received on 28-Sep-2021.The following information was updated and incorporated into the case narrative: All required follow-up attempts have been made. The Batch number for COVID-19 Vaccine Janssen AD26.COV.2.S has not been provided.; Sender's Comments: V1: The follow up information in this version updates: All required follow-up attempts have been made. The Batch number for COVID-19 Vaccine Janssen AD26.COV.2.S has not been provided. This updated information does not alter the causality of previously reported event.  20210750560-COVID-19 VACCINE Ad26.COV2.S-Neuropathy Peripheral-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: MEDICAL HISTORY, UNDERLYING DISEASE
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Arterial occlusive disease, Cardiac disorder, Catheterisation cardiac, Chest discomfort, Chest pain
Clinical narrative: ANGIOGRAM ABNORMAL; CATHETERISATION CARDIAC; ELECTROCARDIOGRAM ABNORMAL; STENT PLACEMENT; CARDIAC DISORDER; ARTERIAL OCCLUSIVE DISEASE; CHEST DISCOMFORT; CHEST PAIN; This spontaneous report received from a patient via Regulatory Authority Agency; concerned a 60 year old male. The patient's height, and weight were not reported. The patient had no known allergies, no current illness and history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 07-APR-2021 in right arm for prophylactic vaccination. All required follow up attempts have been made. The batch number for covid-19 vaccine ad26.cov2.s has not been provided. Concomitant medications included curcuma longa anti-inflammatory, multiple vitamins, naproxen sodium pain reliver and additional vitamins.  On 03-MAY-2021, A few weeks receiving the vaccination, patient started having chest pressure and pain (chest discomfort, chest pain). He was hospitalized (date unspecified) for 1 day. On 02-JUN-2021, he had severe pressure and pain in his chest. He went to the emergency room. An electrocardiogram indicated an abnormal heart problem (cardiac disorder). Angiogram revealed an artery blockage (arterial occlusive disease). A stent was inserted into the artery to resume blood flow (stent placement). Laboratory data included: Angiogram (NR: not provided) Artery blockage (Abnormal), Catheterizations cardiac (NR: not provided) Unknown, Electrocardiogram (NR: not provided) Abnormal heart problem, and Stent placement (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2. s was not applicable. The patient recovered from cardiac disorder, arterial occlusive disease, chest discomfort, chest pain, angiogram abnormal, catheterization cardiac, electrocardiogram abnormal, and stent placement. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).  Additional information was received on 28-SEP-2021. All required follow up attempts have been made. The batch number for covid-19 vaccine ad26.cov2.s has not been provided.; Sender's Comments: V1: Additional information in this version updates: All required follow up attempts have been made. The batch number for covid-19 vaccine ad26.cov2.s has not been provided. This updated information does not alter the causality of previously reported events. 20210751650-COVID-19 VACCINE AD26.COV2.S-Cardiac disorder, arterial occlusive disease, chest discomfort, chest pain, angiogram abnormal, catheterisation cardiac, electrocardiogram abnormal, stent placement. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Stent placement
Clinical narrative: ANGIOGRAM ABNORMAL; CATHETERISATION CARDIAC; ELECTROCARDIOGRAM ABNORMAL; STENT PLACEMENT; CARDIAC DISORDER; ARTERIAL OCCLUSIVE DISEASE; CHEST DISCOMFORT; CHEST PAIN; This spontaneous report received from a patient via Regulatory Authority Agency; concerned a 60 year old male. The patient's height, and weight were not reported. The patient had no known allergies, no current illness and history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 07-APR-2021 in right arm for prophylactic vaccination. All required follow up attempts have been made. The batch number for covid-19 vaccine ad26.cov2.s has not been provided. Concomitant medications included curcuma longa anti-inflammatory, multiple vitamins, naproxen sodium pain reliver and additional vitamins.  On 03-MAY-2021, A few weeks receiving the vaccination, patient started having chest pressure and pain (chest discomfort, chest pain). He was hospitalized (date unspecified) for 1 day. On 02-JUN-2021, he had severe pressure and pain in his chest. He went to the emergency room. An electrocardiogram indicated an abnormal heart problem (cardiac disorder). Angiogram revealed an artery blockage (arterial occlusive disease). A stent was inserted into the artery to resume blood flow (stent placement). Laboratory data included: Angiogram (NR: not provided) Artery blockage (Abnormal), Catheterizations cardiac (NR: not provided) Unknown, Electrocardiogram (NR: not provided) Abnormal heart problem, and Stent placement (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2. s was not applicable. The patient recovered from cardiac disorder, arterial occlusive disease, chest discomfort, chest pain, angiogram abnormal, catheterization cardiac, electrocardiogram abnormal, and stent placement. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).  Additional information was received on 28-SEP-2021. All required follow up attempts have been made. The batch number for covid-19 vaccine ad26.cov2.s has not been provided.; Sender's Comments: V1: Additional information in this version updates: All required follow up attempts have been made. The batch number for covid-19 vaccine ad26.cov2.s has not been provided. This updated information does not alter the causality of previously reported events. 20210751650-COVID-19 VACCINE AD26.COV2.S-Cardiac disorder, arterial occlusive disease, chest discomfort, chest pain, angiogram abnormal, catheterisation cardiac, electrocardiogram abnormal, stent placement. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate increased, Influenza like illness, Palpitations, Pyrexia
Clinical narrative: DIZZINESS IS DEBILITATING; FEELING FLUEY; INCREASED HEART RATE; FEVER; RINGING IN EARS; HEAR HER HEART IN EARS LIKE STRONG PULSE; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's past medical history included: runny nose, and concurrent conditions included: hashimoto's disease, and unspecified allergy, and other pre-existing medical conditions included: The patient reports no symptoms prior to vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the patient experienced hear her heart in ears like strong pulse. On 08-APR-2021, the patient experienced ringing in ears. On 09-APR-2021, the patient experienced increased heart rate. On 09-APR-2021, the patient experienced fever. Laboratory data included: Heart rate (NR: not provided) increased. On MAY-2021, the patient experienced feeling fluey. On an unspecified date, the patient experienced dizziness is debilitating. Laboratory data (dates unspecified) included: Blood test (NR: not provided) No signs of infection, and COVID-19 virus test (NR: not provided) Negative, Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from increased heart rate, and fever on 10-APR-2021, hear her heart in ears like strong pulse, and ringing in ears on 03-JUN-2021, had not recovered from dizziness is debilitating, and the outcome of feeling fluey was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: DIZZINESS IS DEBILITATING; FEELING FLUEY; INCREASED HEART RATE; FEVER; RINGING IN EARS; HEAR HER HEART IN EARS LIKE STRONG PULSE; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's past medical history included: runny nose, and concurrent conditions included: hashimoto's disease, and unspecified allergy, and other pre-existing medical conditions included: The patient reports no symptoms prior to vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the patient experienced hear her heart in ears like strong pulse. On 08-APR-2021, the patient experienced ringing in ears. On 09-APR-2021, the patient experienced increased heart rate. On 09-APR-2021, the patient experienced fever. Laboratory data included: Heart rate (NR: not provided) increased. On MAY-2021, the patient experienced feeling fluey. On an unspecified date, the patient experienced dizziness is debilitating. Laboratory data (dates unspecified) included: Blood test (NR: not provided) No signs of infection, and COVID-19 virus test (NR: not provided) Negative, Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from increased heart rate, and fever on 10-APR-2021, hear her heart in ears like strong pulse, and ringing in ears on 03-JUN-2021, had not recovered from dizziness is debilitating, and the outcome of feeling fluey was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Rectal discharge
Clinical narrative: THICK, BLACKISH-GREEN DISCHARGE FROM ANUS, COULD NOT PASS FLATULENCE WITHOUT SPEWING OUT FROM ANUS; This spontaneous report received from a consumer 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, and batch number were not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced thick, blackish-green discharge from anus, could not pass flatulence without spewing out from anus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of thick, blackish-green discharge from anus, could not pass flatulence without spewing out from anus was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: OFF LABEL USE; This spontaneous report received from a patient 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. Per procedure, no follow-up will be requested for this case. Concomitant medications included covid-19 vaccine for prophylactic vaccination.  On an unspecified date, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of off label use was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Thrombocytopenia, Thrombosis
Clinical narrative: VACCINE INDUCED IMMUNE THROMBOTIC THROMBOCYTOPENIA (VITT) SYMPTOMS; THROMBOCYTOPENIA; This spontaneous report received from a pharmacist concerned a 44 year old female of unknown race and ethnicity. The patient's height, and weight were not reported. The patient was not pregnant at the time of reporting. 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 10-MAY-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 vaccine induced immune thrombotic thrombocytopenia (VITT) symptoms, and thrombocytopenia, and was hospitalized (date unspecified). The duration of hospitalization was unspecified. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine induced immune thrombotic thrombocytopenia (VITT) symptoms and thrombocytopenia was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210946732-covid-19 vaccine ad26.cov2.s-vaccine induced immune thrombotic thrombocytopenia (VITT) symptoms and thrombocytopenia. This event(s) is labeled per RA and is therefore considered potentially related.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer concerned a patient of unspecified age, sex, 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 not reported, batch number: Unknown, expiry: unknown) 1 total, 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 covid-19, and suspected clinical vaccination failure. On an unspecified date, the patient died from covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure was not reported. This report was serious (Death, and Other Medically Important Condition). This case, from the same reporter is linked to 20210950686, 20210950658 and 20210950539.; Sender's Comments: V0: 20210950479- COVID-19 VACCINE AD26.COV2.S-  covid-19 - 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). 20210950479-covid-19 vaccine ad26.cov2.s- suspected clinical vaccination failure. 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; Reported Cause(s) of Death: COVID-19
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, SARS-CoV-2 test, Unevaluable event
Clinical narrative: COULD NOT BREATHE; CAME OUT LOOKING LIKE AN 80 YEAR OLD MAN; This spontaneous report received from a consumer via a company representative through social media concerned a male of unspecified age, 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 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced could not breathe and was hospitalized for over two weeks, he was on oxygen. He came out looking like an 80 year old man. Hospital discharge information not reported. SARS-CoV-2 test was performed and result was negative.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the could not breathe, came out looking like an 80 year old man and ended up in the hospital for over two weeks an oxygen was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210951067.; Sender's Comments: V0: 20210950516-Covid-19 vaccine ad26.cov2.s -Could not breathe. 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: U
Vaccine: COVID19
Symptoms: Antibody test, Antibody test abnormal, Fatigue
Clinical narrative: ANTIBODY LEVELS ABNORMAL; TIRED; This spontaneous report received from a patient 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: Unk) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On MAR-2021, the patient experienced tired. On SEP-2021, the patient experienced antibody levels abnormal. Laboratory data included: Antibody test (NR: 1 - 10) Low (1.2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the antibody levels abnormal and tired was not reported. This report was non-serious.; Sender's Comments: V0 :  Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Age: 61.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Anxiety, Headache, Insomnia, Root canal infection, Stress
Clinical narrative: TOOTHACHE; STRESS; INFECTION IN JAW AFTER ROOT CANAL; ANXIETY; DIFFICULTY IN SLEEPING; HEADACHE; This spontaneous report received from a patient concerned a 61 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: waldenstrom's macroglobulinemia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  Non-company suspect drugs included: ibrutinib (tablet, oral, batch number: 1137534 expiry: -MAY-2023) 420 mg, 1 time every 1 day, from 01-FEB-2017 for waldenstrom's macroglobulinemia. No concomitant medications were reported. On an unspecified date, the patient experienced toothache, stress, infection in jaw after root canal, anxiety, difficulty in sleeping, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from infection in jaw after root canal, and headache, and had not recovered from toothache, stress, anxiety, and difficulty in sleeping. This case, involving the same patient is linked to 20210943562.
Age: 61.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Toothache
Clinical narrative: TOOTHACHE; STRESS; INFECTION IN JAW AFTER ROOT CANAL; ANXIETY; DIFFICULTY IN SLEEPING; HEADACHE; This spontaneous report received from a patient concerned a 61 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: waldenstrom's macroglobulinemia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  Non-company suspect drugs included: ibrutinib (tablet, oral, batch number: 1137534 expiry: -MAY-2023) 420 mg, 1 time every 1 day, from 01-FEB-2017 for waldenstrom's macroglobulinemia. No concomitant medications were reported. On an unspecified date, the patient experienced toothache, stress, infection in jaw after root canal, anxiety, difficulty in sleeping, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from infection in jaw after root canal, and headache, and had not recovered from toothache, stress, anxiety, and difficulty in sleeping. This case, involving the same patient is linked to 20210943562.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 41 year old male of unknown ethnicity. The patient's weight was 210 pounds, and height was 70 inches. The patient's concurrent conditions included: allergic to bee stings, social alcohol drinker, and non-smoker. The patient did not have any 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: 206A21A, expiry: unknown) dose was not reported, 1 total administered on 02-JUN-2021 for prophylactic vaccination. Concomitant medications included guaifenesin. On 20-SEP-2021, patient experienced cough and runny nose that started Monday at night. His last interaction with other employees was at his last visit to a work site which was this past Monday. On 21-SEP-2021 night, he had a fever with chills. On 22-SEP-2021, patient reported having a rapid test for covid-19 and the results came out to be positive (suspected covid-19 and suspected clinical vaccination failure). He did not took any prescription medications. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000194921.; Sender's Comments: V0;20210952710-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. 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: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance, Inappropriate schedule of product administration, Insomnia, Joint stiffness
Clinical narrative: RESIDUAL DISCOMFORT IN RIGHT HIP; LETHARGY; MUSCLE SORENESS; STIFFNESS IN RIGHT HIP; COULD NOT WALK WELL; COULD NOT SLEEP; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; DISCOMFORT WITH RIGHT LEG; A UNIQUE HIP PAIN/ WHOLE LOT OF PAIN AND FELT LIKE A PRONOUNCED, EXAGGERATED WHEN HIP GETS TIGHT; This spontaneous report received from a patient concerned a 57 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: chronic pain, and other pre-existing medical conditions included: Patient took muscle relaxer and NSAID for pain relief. 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 25-SEP-2021, and dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 25-SEP-2021, the patient experienced stiffness in right hip. On 25-SEP-2021, the patient experienced could not walk well. On 25-SEP-2021, the patient experienced could not sleep. On 25-SEP-2021, the patient experienced discomfort with right leg. On 25-SEP-2021, the patient experienced a unique hip pain/ whole lot of pain and felt like a pronounced, exaggerated when hip gets tight. On 25-SEP-2021, the patient experienced inappropriate schedule of vaccine administered. On 26-SEP-2021, the patient experienced lethargy. On 26-SEP-2021, the patient experienced muscle soreness. On 27-SEP-2021, the patient experienced residual discomfort in right hip. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from stiffness in right hip, had not recovered from muscle soreness, lethargy, and residual discomfort in right hip, and the outcome of could not sleep, a unique hip pain/ whole lot of pain and felt like a pronounced, exaggerated when hip gets tight, could not walk well, inappropriate schedule of vaccine administered and discomfort with right leg was not reported. This report was non-serious.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Limb discomfort, Musculoskeletal discomfort, Myalgia
Clinical narrative: RESIDUAL DISCOMFORT IN RIGHT HIP; LETHARGY; MUSCLE SORENESS; STIFFNESS IN RIGHT HIP; COULD NOT WALK WELL; COULD NOT SLEEP; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; DISCOMFORT WITH RIGHT LEG; A UNIQUE HIP PAIN/ WHOLE LOT OF PAIN AND FELT LIKE A PRONOUNCED, EXAGGERATED WHEN HIP GETS TIGHT; This spontaneous report received from a patient concerned a 57 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: chronic pain, and other pre-existing medical conditions included: Patient took muscle relaxer and NSAID for pain relief. 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 25-SEP-2021, and dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 25-SEP-2021, the patient experienced stiffness in right hip. On 25-SEP-2021, the patient experienced could not walk well. On 25-SEP-2021, the patient experienced could not sleep. On 25-SEP-2021, the patient experienced discomfort with right leg. On 25-SEP-2021, the patient experienced a unique hip pain/ whole lot of pain and felt like a pronounced, exaggerated when hip gets tight. On 25-SEP-2021, the patient experienced inappropriate schedule of vaccine administered. On 26-SEP-2021, the patient experienced lethargy. On 26-SEP-2021, the patient experienced muscle soreness. On 27-SEP-2021, the patient experienced residual discomfort in right hip. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from stiffness in right hip, had not recovered from muscle soreness, lethargy, and residual discomfort in right hip, and the outcome of could not sleep, a unique hip pain/ whole lot of pain and felt like a pronounced, exaggerated when hip gets tight, could not walk well, inappropriate schedule of vaccine administered and discomfort with right leg was not reported. This report was non-serious.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective
Clinical narrative: LACK OF EFFECT; TESTED POSITIVE FOR COVID; This spontaneous report received from a patient concerned a 35 year old male unspecified 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 admin not reported, batch number: 1808960 expiry: UNKNOWN) dose was not reported,1 total administered to right deltoid on JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient tested positive for covid (lack of effect). Laboratory data (dates unspecified) 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 the tested positive for covid and lack of effect was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210952834- JANSSEN COVID-19 VACCINE Ad26.COV2.S- Lack of effect. 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: M
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a male of unspecified age, 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 admin not reported, batch number: Unknown) dose was not reported, 1 total administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. In late AUG-2021, the patient caught Covid (suspected covid-19 infection, suspected clinical vaccination failure) but was not hospitalized. The patient mentioned he was listed as a moderate case although it didn't felt moderate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210953291. This report was associated with a product quality complaint.; Sender's Comments: 20210952846-covid-19 vaccine ad26.cov2.s- suspected clinical vaccination failure. 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
Sex: F
Vaccine: COVID19
Symptoms: Cerebral thrombosis, Cerebrovascular accident
Clinical narrative: STROKE/ LEFT SIDE IMPAIRED; BLOOD CLOT ON BRAIN; This spontaneous report received from a consumer concerned a female of unspecified age, 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 admin not reported, batch number: Unknown) dose was not reported, 1 total administered on 21-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 22-SEP-2021, the patient was admitted to the hospital with a blood clot on brain causing a stroke which left patients' left side impaired. The number of days hospitalized was unknown.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stroke/ left side impaired and blood clot on brain was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210952881-COVID-19 VACCINE AD26.COV2.S-stroke/ left side impaired and 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).
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a male of unspecified age, 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 admin not reported, batch number: 1808609 expiry: 07-SEP-2021) dose was not reported, 1 total, administered on 11-APR-2021 15:00 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient had an antibody test specific for IgG antibodies for Covid-19 under direction from family doctor. The patient was notified that the result was negative (suspected immunological vaccine failure). Laboratory data (dates unspecified) included: SARS-CoV-2 IgG antibody test (NR: not provided) Negative.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).  This report was associated with product quality complaint: 90000194929.; Sender's Comments: V0.20210952901-covid-19 vaccine ad26.cov2.s-Suspected immunological vaccination failure. 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