chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administration / to a / 1 year(s) 4 month(s) 20 day(s) old; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-year-old female patient who received DTPa-IPV (Kinrix) (batch number YZ97N, expiry date 26th August 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st July 2021, the patient received Kinrix (intramuscular) and Kinrix Pre-Filled Syringe Device. On 1st July 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided are as follows: The health care professional reported that, the administration of Kinrix done to the patient who was 1 year 4 months and 20 days old at the time, which led inappropriate age at vaccine administration. The reporter provided phone number for HCP reference and a warm transferred. The reporter consented to follow-up.
Age: 16.0
Sex: M
Vaccine: HEPA
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: pediatric / patient had received an adult dose; pediatric / patient had received an adult dose; This case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 16-year-old male patient who received HAV (Havrix adult) (batch number F4EL2, expiry date 11th September 2021) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th August 2021, the patient received Havrix adult and Havrix Pre-Filled Syringe Device. On 17th August 2021, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. The action taken with Havrix Pre-Filled Syringe Device was unknown. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The pharmacist reported that the pediatric patient had received an adult dose of Havrix, which led to overdose and adult product administered to the child. The reporter consented to follow up. No further details were reported at the time of the call. The case was linked with US2021174391 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021174391:Same reporter
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Carcinoid tumour
Clinical narrative: "a single carcinoid tumor that only needs surgery which doesn't require immunosuppression"; This spontaneous case was reported by a physician and describes the occurrence of CARCINOID TUMOUR ("a single carcinoid tumor that only needs surgery which doesn't require immunosuppression") in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007m20a and 012l20a) for COVID-19 vaccination.     No medical history was reported by reporter.  Concomitant products included FISH OIL and TIMOLOL for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CARCINOID TUMOUR ("a single carcinoid tumor that only needs surgery which doesn't require immunosuppression") (seriousness criterion medically significant). At the time of the report, CARCINOID TUMOUR ("a single carcinoid tumor that only needs surgery which doesn't require immunosuppression") outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication use information was not provided by reporter. Concomitant medication use information was  provided by reporter that includes supplements. Patient wants to get 3rd dose of Moderna vaccine . Patient were to have to mayor lung surgery on Aug the 19th.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Loss of consciousness, Product dose omission issue, Throat tightness
Clinical narrative: Allergic reaction / had an allergic reaction to the first dose.; The other hospitals in the area don't have Moderna; Passed out; Throat started to tighten up; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out), ALLERGY TO VACCINE (Allergic reaction / had an allergic reaction to the first dose), and THROAT TIGHTNESS (Throat started to tighten up) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criteria medically significant and life threatening) and THROAT TIGHTNESS (Throat started to tighten up) (seriousness criterion life threatening). On an unknown date, the patient experienced ALLERGY TO VACCINE (Allergic reaction / had an allergic reaction to the first dose), (seriousness criterion life threatening) and PRODUCT DOSE OMISSION ISSUE (The other hospitals in the area don't have Moderna). The patient was treated with EPINEPHRINE (EPIPEN) for Allergy to vaccine, Throat tightness and Asthma, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Asthma, Allergy to vaccine and Throat tightness, at an unspecified dose and frequency. On 15-Jan-2021, LOSS OF CONSCIOUSNESS (Passed out) and THROAT TIGHTNESS (Throat started to tighten up) had resolved. At the time of the report, ALLERGY TO VACCINE (Allergic reaction / had an allergic reaction to the first dose), and PRODUCT DOSE OMISSION ISSUE (The other hospitals in the area don't have Moderna) outcome was unknown.            Concomitant medication use information was not provided by reporter. The patient had some asthmatic symptoms at times and with the delta variant on the rise, concern regarding getting second dose.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Additional information received on 9-AUG-2021 that contains significant information that includes case seriousness as Life threatning , added events( Throat tightness, Asthamatic  ), updated Benadryl drug and Zyrtec as treatment. updated patient demographics. Treatment medication updated; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, SARS-CoV-2 antibody test
Clinical narrative: has two autoimmune diseases; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE DISORDER (has two autoimmune diseases) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced AUTOIMMUNE DISORDER (has two autoimmune diseases) (seriousness criterion medically significant). At the time of the report, AUTOIMMUNE DISORDER (has two autoimmune diseases) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: 0.02 (Low) level was 0.02, 5 months after the first dose.         The patient was tested by the physician a couple of days ago to see how effective the two doses of COVID shots were.  Concomitant products were not provided.   Treatment medication was not reported. Very limited information regarding this event has been provided at this time. Additional information required.; Sender's Comments: Very limited information regarding this event has been provided at this time. Additional information required.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebral haemorrhage, Fall, Product dose omission issue
Clinical narrative: Brain bleed; Fall; Did not receive second dose, received 1st dose on 18 Mar 2021; This spontaneous case was reported by a consumer and describes the occurrence of CEREBRAL HAEMORRHAGE (Brain bleed) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LISINOPRIL, METOPROLOL and AMIODARONE for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CEREBRAL HAEMORRHAGE (Brain bleed) (seriousness criterion medically significant), FALL (Fall) and PRODUCT DOSE OMISSION ISSUE (Did not receive second dose, received 1st dose on 18 Mar 2021). At the time of the report, CEREBRAL HAEMORRHAGE (Brain bleed) and FALL (Fall) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Did not receive second dose, received 1st dose on 18 Mar 2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided by the reporter. The brain bleed was less, only about 2 mm  Company comment: This case concerns a 73-year-old male with a serious unexpected event of cerebral haemorrhage and non-serious events of fall and product dose omission issue. Event onset a few days after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 73-year-old male with a serious unexpected event of cerebral haemorrhage and non-serious events of fall and product dose omission issue. Event onset a few days after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 test
Clinical narrative: ASYMPTOMATIC COVID-19; This spontaneous report received from a patient via a company representative concerned a female 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. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced asymptomatic covid-19. 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 patient was recovering from asymptomatic covid-19. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious
Sex: U
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 via social media 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 admin not reported, batch number: Unknown and expiry : UNKNOWN) dose was not reported, 1 total, 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 12-AUG-2021, the patient tested positive for COVID-19 (suspected clinical vaccination failure) as the patient experienced generalised aching, sore throat, fever and was sick as a dog  .  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).; Sender's Comments: V0:20210826496-COVID-19 VACCINE AD26.COV2.S-Suspected 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: M
Vaccine: COVID19
Symptoms: Influenza like illness, SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; FLU-LIKE SYMPTOMS; This spontaneous report received from a patient concerned a male of unspecified age of other race and hispanic or latino male. The patient's height, and weight were not reported. The patient's concurrent conditions included: immunocompromised, and flu-like symptoms. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 1 total, dose, on MAY-2021 for prophylactic vaccination. The batch number was not reported and it has been requested. The patient was on steroids.  On an unspecified date, the patient experienced suspected immunological vaccine failure, and flu-like symptoms with shortness of breath sometimes, body aches, and febrile but not fever. Laboratory data included: COVID-19 antibody test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu-like symptoms and suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000189781.; Sender's Comments: V0: 20210826672-covid-19 vaccine ad26.cov2.s-suspected immunological vaccine failure. This event(s) is considered not related. The event(s) has an unknown/unclear 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: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a pharmacist concerned a 62 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 21-JUN-2021) dose was not reported, frequency time 1 total was administered on left arm on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-AUG-2021, the patient was tested negative for COVID-19 antibody test and had confirmed immunological vaccine failure. 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 was associated with product quality complaint: 90000189474.; Sender's Comments: V:20210826496-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
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Illness
Clinical narrative: SICKNESS; ARTHRITIS AGGRAVATED (WORSENING IN ARTHRITIS); This spontaneous report received from a patient concerned a 46 year old female of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's past medical history included sick all the time with Risankizumab (Skyrizi) since OCT-2021, and concurrent conditions included moderate to severe chronic plaque psoriasis. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown, and expiry: unknown) dose was not reported, 1 total administered on MAR-2021 for covid-19 vaccination. Concomitant medications included Risankizumab (Skyrizi) for moderate to severe chronic plaque psoriasis. On an unspecified date, the patient experienced arthritis aggravated (worsening in arthritis). On MAR-2021, the patient experienced sickness, and was hospitalized for an unspecified days. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sickness, and had not recovered from arthritis aggravated (worsening in arthritis). This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- 20210827085-Covid-19 vaccine ad26.cov2.s-Sickness. 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: Fatigue
Clinical narrative: TIRED (VACCINE FATIGUE OR LIFE FATIGUE); 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 tired (vaccine fatigue or life fatigue). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired (vaccine fatigue or life fatigue). This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: PINCH SENSATION IN HIS ARM WHEN INJECTED, NO OTHER EFFECTS; This spontaneous report received from a patient 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 APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On APR-2021, the patient experienced pinch sensation in his arm when injected, no other effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pinch sensation in his arm when injected, no other effects was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a health care professional 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 and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced incorrect product storage, and out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect product storage and out of specification product use was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction, Body temperature, Feeling abnormal, Malaise, Pain
Clinical narrative: REALLY SEVERE BODY PAIN; VACCINE KICKED MY BUTT; ENCOUNTERED EVERY SINGLE SIDE EFFECT LISTED BY J&J; NEVER HONESTLY FELT SO SICK IN MY LIFE; 102 TEMPERATURE FEVER; 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 AUG-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 AUG-2021, the patient experienced really severe body pain. On AUG-2021, the patient experienced vaccine kicked my butt. On AUG-2021, the patient experienced encountered every single side effect listed by j&j. On AUG-2021, the patient experienced never honestly felt so sick in my life. On AUG-2021, the patient experienced 102 temperature fever. Laboratory data included: Body temperature (NR: not provided) 102. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from never honestly felt so sick in my life, 102 temperature fever, really severe body pain, vaccine kicked my butt, and encountered every single side effect listed by j&j. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: REALLY SEVERE BODY PAIN; VACCINE KICKED MY BUTT; ENCOUNTERED EVERY SINGLE SIDE EFFECT LISTED BY J&J; NEVER HONESTLY FELT SO SICK IN MY LIFE; 102 TEMPERATURE FEVER; 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 AUG-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 AUG-2021, the patient experienced really severe body pain. On AUG-2021, the patient experienced vaccine kicked my butt. On AUG-2021, the patient experienced encountered every single side effect listed by j&j. On AUG-2021, the patient experienced never honestly felt so sick in my life. On AUG-2021, the patient experienced 102 temperature fever. Laboratory data included: Body temperature (NR: not provided) 102. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from never honestly felt so sick in my life, 102 temperature fever, really severe body pain, vaccine kicked my butt, and encountered every single side effect listed by j&j. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Splenomegaly, Ultrasound spleen
Clinical narrative: SPLEEN ENLARGED FURTHER; This spontaneous report received from a consumer concerned a 19 year old male. The patient's weight was not reported and height was 71 inches. The patient's past medical history included: covid infection, mononucleosis infection, and hospitalization, and concurrent conditions included: life threatening allergy to sea food, and spleen enlarged. 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 30-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, Laboratory data included: Blood test (NR: not provided) fine, and Ultrasound spleen (NR: not provided) The spleen had enlarged further, more than was previously measured. On an unspecified date, the patient experienced spleen enlarged further. Laboratory data (dates unspecified) included: Ultrasound spleen (NR: not provided) The spleen was enlarged, but stable remaining the same size. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of spleen enlarged further 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: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Chills, Decreased appetite, Dry mouth
Clinical narrative: DRY MOUTH; DRY NOSE; DRY THROAT; BLOCKED NOSE; SLEEPINESS; DIFFICULT BOWEL MOVEMENTS; STOMACH PAIN; LOSS OF APPETITE; FEELING OF HEAVY STOMACH; NOT ABLE TO WORK; COLD CHILLS; MUSCLE ACHES IN BODY AND BACK; HIGH FEVER; This spontaneous report received from a patient concerned a 60 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: 1808982 expiry: 21-SEP-2021) dose was not reported, administered on 06-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-AUG-2021, the patient experienced dry mouth. On 06-AUG-2021, the patient experienced dry nose. On 06-AUG-2021, the patient experienced dry throat. On 06-AUG-2021, the patient experienced blocked nose. On 06-AUG-2021, the patient experienced sleepiness. On 06-AUG-2021, the patient experienced difficult bowel movements. On 06-AUG-2021, the patient experienced stomach pain. On 06-AUG-2021, the patient experienced loss of appetite. On 06-AUG-2021, the patient experienced feeling of heavy stomach. On 06-AUG-2021, the patient experienced not able to work. On 06-AUG-2021, the patient experienced cold chills. On 06-AUG-2021, the patient experienced muscle aches in body and back. On 06-AUG-2021, the patient experienced high fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from high fever, cold chills, muscle aches in body and back, dry mouth, blocked nose, sleepiness, difficult bowel movements, stomach pain, loss of appetite, feeling of heavy stomach, dry nose, dry throat, and not able to work. This report was non-serious.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Dry throat, Gastrointestinal disorder, Impaired work ability, Myalgia, Nasal dryness
Clinical narrative: DRY MOUTH; DRY NOSE; DRY THROAT; BLOCKED NOSE; SLEEPINESS; DIFFICULT BOWEL MOVEMENTS; STOMACH PAIN; LOSS OF APPETITE; FEELING OF HEAVY STOMACH; NOT ABLE TO WORK; COLD CHILLS; MUSCLE ACHES IN BODY AND BACK; HIGH FEVER; This spontaneous report received from a patient concerned a 60 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: 1808982 expiry: 21-SEP-2021) dose was not reported, administered on 06-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-AUG-2021, the patient experienced dry mouth. On 06-AUG-2021, the patient experienced dry nose. On 06-AUG-2021, the patient experienced dry throat. On 06-AUG-2021, the patient experienced blocked nose. On 06-AUG-2021, the patient experienced sleepiness. On 06-AUG-2021, the patient experienced difficult bowel movements. On 06-AUG-2021, the patient experienced stomach pain. On 06-AUG-2021, the patient experienced loss of appetite. On 06-AUG-2021, the patient experienced feeling of heavy stomach. On 06-AUG-2021, the patient experienced not able to work. On 06-AUG-2021, the patient experienced cold chills. On 06-AUG-2021, the patient experienced muscle aches in body and back. On 06-AUG-2021, the patient experienced high fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from high fever, cold chills, muscle aches in body and back, dry mouth, blocked nose, sleepiness, difficult bowel movements, stomach pain, loss of appetite, feeling of heavy stomach, dry nose, dry throat, and not able to work. This report was non-serious.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal obstruction, Pyrexia, Somnolence
Clinical narrative: DRY MOUTH; DRY NOSE; DRY THROAT; BLOCKED NOSE; SLEEPINESS; DIFFICULT BOWEL MOVEMENTS; STOMACH PAIN; LOSS OF APPETITE; FEELING OF HEAVY STOMACH; NOT ABLE TO WORK; COLD CHILLS; MUSCLE ACHES IN BODY AND BACK; HIGH FEVER; This spontaneous report received from a patient concerned a 60 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: 1808982 expiry: 21-SEP-2021) dose was not reported, administered on 06-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-AUG-2021, the patient experienced dry mouth. On 06-AUG-2021, the patient experienced dry nose. On 06-AUG-2021, the patient experienced dry throat. On 06-AUG-2021, the patient experienced blocked nose. On 06-AUG-2021, the patient experienced sleepiness. On 06-AUG-2021, the patient experienced difficult bowel movements. On 06-AUG-2021, the patient experienced stomach pain. On 06-AUG-2021, the patient experienced loss of appetite. On 06-AUG-2021, the patient experienced feeling of heavy stomach. On 06-AUG-2021, the patient experienced not able to work. On 06-AUG-2021, the patient experienced cold chills. On 06-AUG-2021, the patient experienced muscle aches in body and back. On 06-AUG-2021, the patient experienced high fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from high fever, cold chills, muscle aches in body and back, dry mouth, blocked nose, sleepiness, difficult bowel movements, stomach pain, loss of appetite, feeling of heavy stomach, dry nose, dry throat, and not able to work. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Intentional product misuse, Off label use, Therapy partial responder
Clinical narrative: INTENTIONAL PRODUCT MISUSE; OFF LABEL USE; THERAPY PARTIAL RESPONDER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-hodgkin's lymphoma (since 2013), and immune compromised. The patient was previously treated with bnt 162 for prophylactic vaccination (first dose received on 24-Feb-2021 and 2nd dose received 4 weeks later (exact date unknown). 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, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  The reporter stated that, the patient underwent antibody test on an unspecified date and resulted as negative after receiving the bnt 162 vaccine so her physician recommended to receive a dose of the Janssen covid 19 vaccine (coded as revaccination). On 09-AUG-2021, the patient had an antibody test post Janssen covid-19 vaccine and the results were 19. The patient reported her physician wanted the patient to have higher number for protection since the antibody results weren't as high as (coded as therapeutic response decreased) her physician would like to protect against the delta variant. The patient's physician prescribed a second dose/booster of Janssen covid-19 vaccine" to help her antibody levels. The patient had not yet received a second dose of Janssen covid-19 vaccine at the time of report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the therapy partial responder, intentional product misuse and off label use was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210829022 -COVID-19 VACCINE AD26.COV2.S- Therapy partial responder. 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: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Fall, Gait inability, Infection, Laboratory test
Clinical narrative: UNABLE TO WALK/COULDN'T WALK/CAN'T MOVE TOES OR LEGS; FELL DOWN; INFECTION; This spontaneous report received from a patient concerned a 64 year old male of an unspecified race and ethnic origin. The patient's weight was 310 pounds and height was 73 inches. The patient's concurrent conditions were diabetic, hypertension, depression, and painful right knee. He was regularly taking pain medications and anti-hypertensive medications. He had emergency visit for painful right knee. He stated that he was in need of knee replacement. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1803018, expiry: unknown) dose was not reported, with frequency 1 total administered in left arm on 25-MAR-2021 for prophylactic vaccination when he visited emergency room for painful right knee. No concomitant medications were reported.  On 26-MAR-2021 (in morning), the patient was unable to walk. He tried to get out of bed and fell down. He called the ambulance and they took him to hospital emergency room (ER). He was admitted to the hospital. Initially, the doctors thought his spine was the issue and discussed spinal surgery with him. However, when the tests were done found that spine was okay. Later, his bloodwork was performed results were not reported. They did some additional tests and discovered an infection. He also, scratched his back and doctors thought the scratch maybe caused the infection, but they did not know. He received anti-biotics for 16 weeks but it did not worked. At the time of this report, he was still can't move his toes or his legs and cannot walk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from unable to walk/couldn't walk/can't move toes or legs, and the outcome of fell down and infection was not reported. This report was serious (Hospitalization Caused / Prolonged, and Disability Or Permanent Damage).; Sender's Comments: V0: 20210829039 - Covid-19 vaccine ad26.cov2.s- unable to walk/couldn't walk/can't move toes or legs and fell down. 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: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Neuralgia, Pain, SARS-CoV-2 test negative
Clinical narrative: FATIGUE; NERVE PAIN AROUND MY WAIST LINE ON THE RIGHT SIDE; FULL BODY ACHES; CHILLS; This spontaneous report received from a patient concerned a 46 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: blood pressure, and thyroid, and other pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 10-AUG-2021 for prophylactic vaccination. Concomitant medications included lisinopril for blood pressure, and thiamazole for thyroid. On 11-AUG-2021, the patient experienced nerve pain around my waist line on the right side. On 11-AUG-2021, the patient experienced full body aches. On 11-AUG-2021, the patient experienced chills. On 12-AUG-2021, the patient experienced fatigue. Laboratory data (dates unspecified) included: COVID-19 virus test negative (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from full body aches, chills, and fatigue, and had not recovered from nerve pain around my waist line on the right side. This report was non-serious.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy partial responder, Weight decreased
Clinical narrative: WEIGHT LOSS; LOW ANTIBODY COUNT; This spontaneous report received from a patient concerned a 60 year old male of mixed race .The patient's weight was 158 pounds, and height was 182.88 centimeters. The patient's past medical history included: foot surgery, and hives, and concurrent conditions included: heart valve defect, impetigo, boils, food allergy, seasonal allergies, alcohol user, and non-smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 and expiry: UNKNOWN) dose was not reported, 1 total administered to left arm, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On 24-JUL-2021, the patient was tested with antibody test- IgG which showed low antibody level 36- 38 (partial responder to therapy). The patient also experienced weight loss from 165 lbs to 142 lbs. According to the patient, the vaccine increased his metabolism. The patients stated that he takes ice-cream daily at bedtime to gain weight. The patient's physician would test him for T-cell count.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the low antibody count and weight loss was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint 90000189642.; Sender's Comments: V0: 20210829077- Covid-19 vaccine ad26.cov2.s- Low antibody count. 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
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Myocardial infarction, Ultrasound scan
Clinical narrative: HEART ATTACK; This spontaneous report received from a patient concerned a 65 year old female. The patient's weight was 88 pounds, and height was 62 inches. The patient's past medical history included: stroke (at 34 age-hereditary) from that patient was healthy since, concurrent conditions included: very little smoker, abstain from alcohol, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with Plavix (clopidogrel bisulfate). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: unknown) dose was not reported, 1 total, administered on 20-MAY-2021 at left arm for prophylactic vaccination. Concomitant medications included Brilinta (ticagrelor) for unknown indication.  On 28-JUN-2021, the patient experienced heart attack, tightness in shoulder blade and could not get comfortable. On 29-JUN-2021 patient was hospitalized and discharge on 02-JUL-2021. On an unspecified date, in hospital ran a thing up to check the heart through the groin (test name unspecified) and blood test (result was unknown) was done. Treatment medications included: Coumadin (warfarin sodium), Baby aspirin (acetylsalicylic acid), atorvastatin, and metoprolol. She was on Brilinta (ticagrelor) but she was taken off on 12-AUG-2021 and put on the warfarin because she had a sonogram done which showed a blockage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart attack was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210829122-JANSSEN COVID-19 VACCINE Ad26.COV2.S -  heart attack-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: Death
Clinical narrative: This spontaneous report received from a consumer concerned a patient of an unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown expiry: unknown) with frequency 1 total administered, 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.  According to the hearsay on an unspecified date, one patient died from unknown cause of death. It was unknown if 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: 20210829146-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
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Neuropathy peripheral
Clinical narrative: MUSCLE SPASM IN THE LEG; NEUROPATHY (LEFT ARM PAIN ALONG WITH STABBING, SHOOTING, BURNING, NUMBNESS WITH DIFFICULTY IN MOVING LEFT ARM); This spontaneous report received from a consumer concerned a 58 year old  male. The patient's weight was 206 pounds and height was 76 inches. The patient was diagnosed as a teen with epilepsy (did not take medications for 5 years) and he had been seizure free. Patient was alcohol user (He consumes an occasional beer on the weekend) and non-smoker. The patient was healthy. He had no known allergies and 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: Unknown) dose was not reported, with frequency time 1 total administered on JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included Omega-3 supplements (omega-3 nos). On 10-AUG-2021, the patient experienced neuropathy along with left arm pain along with stabbing, shooting, burning, numbness and difficulty in moving left arm because it felt asleep. The patient had been able to do his daily activities such as surfing, driving, playing basketball and attending his job. It was reported that patient did not quantify the pain. On 11-AUG-2021, the patient experienced muscle spasm in the leg. The patient complained of a muscle spasm similar to the arm pain, felt in his leg. It was reported that patient came home and rolled his calf out with a muscle roller, which would make it go away. The patient complained of this in the evening, as it was exacerbated by activities such as basketball.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle spasm in the leg and neuropathy (left arm pain along with stabbing, shooting, burning, numbness with difficulty in moving left arm).  This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210829160-Covid-19 vaccine ad26.cov2.s Neuropathy. 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: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Suspected COVID-19, Thrombosis, Vaccination failure
Clinical narrative: DEATH; BLOOD CLOTS; SUSPECTED CLINICAL VACCINATION FAILURE; COVID RELATED ISSUES; This spontaneous report received from a company representative concerned a 50year old male. 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) 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. According to the hearsay, a patient died after taking the Janssen Covid 19 shot some time ago. On an unspecified date, the patient died with Covid related issues (suspected clinical vaccination failure) and he had blood clots. On an unspecified date, the patient died from unknown cause of death. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on an unspecified date, and the outcome of covid related issues, blood clots and suspected clinical vaccination failure was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0: 20210829189-COVID-19 VACCINE AD26.COV2.S-death, blood clots. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210829189-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has an unknown/unclear 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; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH