chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose / on October2020 / second dose has not been administered; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in October 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follows:  The age at vaccination was not applicable for this report. The age group was not reported but was captured as adult as per vaccine indication. The pharmacist reported that , till the time of reporting the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The VAERS details for 1st dose were reported. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose in October and the last was May 1st (5/1), patient was late by 10 days; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in October 2020).   On 1st May 2021, the patient received the 2nd dose of Shingrix. On 1st May 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional information was provided as follows:  The age at vaccination was not reported. The patient received 2nd dose of Shingrix, more than the recommended interval, which led to lengthening of vaccination schedule. The nurse asked if patient received 2nd dose 10 days late, then was there a need to take the 3rd shot. The reporter declined to provide any patient or vaccine details. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Intercepted product prescribing error
Clinical narrative: a / 44 year old was prescribed with the first dose of the Shingrix / by her doctor /hasn't yet received it / is immunocompromised; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted product prescribing error in a 44-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included arthritis (early onset) and immunocompromised.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced intercepted product prescribing error. On an unknown date, the outcome of the intercepted product prescribing error was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter thought that the patient was possibly taking a biologic for arthritis. The reporter stated that the 44 year old patient was prescribed with the first dose of the Shingrix vaccine by her doctor and the patient had not received it till the time of reporting, which led to intercepted product prescribing error. No further events were reported.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose / on January 27, 2021 /second dose / administered on February 26, 2021.; 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 59-year-old male patient who received Herpes zoster (Shingrix) (batch number 3K743, expiry date 7th November 2022) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 26th February 2021, the patient received the 2nd dose of Shingrix. On 26th February 2021, 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 information was provided as follows:  The age at vaccination was not reported. The patient received 1st dose on 27 January 2021( batch number BA5GK, expiry date 4 November 2022). The medical assistant reported that  the patient received 2nd dose of Shingrix, less than the recommended interval, which led to shortening of vaccination schedule.  The patient received 2nd dose 30 days after 1st dose. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Only received the first dose on 2019; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follows:  The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. No adverse events were was reported. No patient identifiers were provided. No lot number, expiration date and no vaccination date were provided. The reporter did not consent to follow up.
Sex: F
Vaccine: MEN
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination
Clinical narrative: meningitis B vaccine only received one dose, and never received a second.; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The case was reported by patient's father. The age at vaccination was not applicable for this report. The patient was a teenage female. Till the time of reporting, the patient did not receive the 2nd dose of the Meningococcal B vaccine, which led to incomplete course of vaccination. The confirmation reagrding that a GSK vaccine was given could not be determined. The reporter consent to follow up.
Age: 1.0
Sex: F
Vaccine: DTAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Infanrix on 09/14/2020 (3 months prior to dosing schedule); This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 1-year-old female patient who received DTPa (Infanrix) (batch number 49TM3, expiry date 28th May 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Pediarix (1st dose received on an unknown date), Pediarix (2nd dose received on an unknown date) and Pediarix (received 3rd dose on 12th June 2020 from batch 2KD4D with expiry date 8th May 2022).   On 14th September 2020, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 14th September 2020, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, 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.   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 registered nurse reported administration of Infanrix following 3 doses of Pediarix. As per FDA, infanrix can be used to complete DTaP vaccination series initiated with pediarix. The patient received Infanrix vaccine 3 months prior to dosing schedule, which led to drug dose administration interval too short. The reporter consented to follow up. The batch number for Infanrix vaccine was reported as 49PM3 however it was updated as 49TM3 as per sales data sheet. The batch number for Pediarix vaccine was reported as 2K94D however it was updated as 2KD4D as per sales data sheet.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: May 3rd 2021/first dose was given by error/vaccine had expired on 4/13/2021; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number EY93J, expiry date 13th April 2021) for prophylaxis.   On 3rd May 2021, the patient received the 1st dose of Shingrix. On 3rd May 2021, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional information was provided as follows:  On 3rd May 2021, the patient received 1st dose of Shingrix which was already expired on 13th April 2021. The reporter asked for side effect to report. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Completed the Shingrix series yes still got Shingles/ Suspected vaccination failure; Completed the Shingrix series yes still got Shingles; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The case was reported by the sister of the patient. The age at vaccination was not reported. The reporter stated that the patient completed the Shingrix series yes and still got shingles. The reporter had the minimal information. The reporter did not consent to follow up. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and time to onset were unknown.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First dose / about 3 years ago and did not receive second dose due to other issues and then COVID happened; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received about 3 year ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable to this report. The case was reported by the consumer. The patient  inquired about getting a second dose of Shingrix. He stated that received first dose of Shingrix about 3 years ago and did not receive second dose due to other issues and then COVID happened, which led to incomplete course of vaccination. The patient's doctor said to go ahead and get the second dose as soon as possible, but his pharmacist said he need to restart the series.  The patient wanted to clarify whether restarting the vaccine series was necessary.  The reporter gave a consent to follow up with HCP but did not have HCP's email address or a fax number.  The reporter did not have a personal fax number. No further information was reported.
Age: 74.0
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient never got 3rd dose; Dose 1 04/26 2018, Dose 2 09/13/2019.; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 74-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAB (Twinrix) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received on 26th April 2018).   On 13th September 2019, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 13th September 2019, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device and not applicable after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the drug dose administration interval too long and incomplete course of vaccination 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 age at vaccination was not applicable for 3rd dose of vaccine. The registered pharmacist reported that patient received Twinrix at a different facility and both the first and second doses were off schedule. The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule. Till the time of reporting patient did not receive 3rd dose of Twinrix, which led to incomplete course of vaccination. No information of the vaccine was available. The reporter asked whether there was need to repeat series or patient can receive only 3rd dose. The reporter consented to follow up.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, RV1
Symptoms: Product storage error
Clinical narrative: Pediarix and Rotarix / Below temperature exursion; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 4-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number 5BC7N, expiry date 11th July 2022) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis, DTPa-HBV-IPV (Pediarix) (batch number T4Y35, expiry date 28th November 2022) for prophylaxis and dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th May 2021, the patient received Rotarix lyophilized formulation (oral), Rotarix Oral Applicator Device, Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Rotarix lyophilized formulation, Rotarix Oral Applicator Device, Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 as follows: The nurse reported about Pediarix and Rotarix administration to patient after the vaccines suffered a below temperature excursion, which led to incorrect storage of drug. No further events were reported.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling face
Clinical narrative: Swollen on left side of the face; This case was reported by a pharmacist via call center representative and described the occurrence of facial swelling in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number J75L9, expiry date 10th October 2022) for prophylaxis.   Concomitant products included COVID-19 MRNA-1273 VACCINE (COVID 19 VACCINE MODERNA).   On 29th April 2021, the patient received the 1st dose of Shingrix. On 30th April 2021, 1 days after receiving Shingrix, the patient experienced facial swelling. On an unknown date, the outcome of the facial swelling was unknown.   It was unknown if the reporter considered the facial swelling to be related to Shingrix.  Additional details were reported as follows: On 14th April 2021, the patient received the 2nd dose of Moderna vaccine. The pharmacist reported that the next day of the vaccination with Shingrix, the patient showed swelling on left side of the face.  The reporter did not know if symptoms still persisted. The reporter consented to follow up.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia, Tremor
Clinical narrative: Headache; Fever; Shaking; Chills; This case was reported by a consumer via call center representative and described the occurrence of headache in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles.   On 5th May 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 6th May 2021, 1 days after receiving Shingrix, the patient experienced headache, fever, tremor and chills. On an unknown date, the outcome of the headache, fever, tremor and chills were not recovered/not resolved.   The reporter considered the headache, fever, tremor and chills to be related to Shingrix.  Additional details were reported as follows: The case was reported by patient for himself. The patient received Shingrix in the right arm and had fever, chills, shaking, and headache after vaccination. The reporter did not consent to follow up. All information was not available.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a physician concerned a 54 year old of male white and  Hispanic or Latino . The patients 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 was not reported, administered on 05-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. physician called in to report that his patient received the vaccine on 05-MAR-2021 and done antibody testing done on two separate occasions on 05-APR-2021, Laboratory data included: SARS-CoV-2 IgG antibody test (NR: not provided) Negative. On 27-APR-2021, Laboratory data included: Antibody test (NR: not provided) Less than 1 no immunity. On an unspecified date, the patient experienced 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).; Sender's Comments: V0 20210460431-COVID-19 VACCINE AD26.COV2.S -Confirmed Immunological Vaccine 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: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILUR; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported batch number: UNKNOWN expiry: UNKNOWN) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On 29-APR-2021, Laboratory data included: COVID-19 antibody test (NR: not provided) negative.  On an unspecified date, the subject experienced suspected immunological vaccine failure. 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 associated with product quality complaint: 90000178328 This report was serious (Other Medically Important Condition).; Sender's Comments: vo  20210461045 -COVID-19 VACCINE AD26.COV2.S--suspected immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19
Symptoms: Blood fibrinogen, C-reactive protein, C-reactive protein increased, Computerised tomogram, Echocardiogram
Clinical narrative: RENAL ARTERY THROMBOSIS; KIDNEY INFARCTION; LEFT FLANK PAIN; RED CELLS IN URINE; ELEVATED SEDIMENTATION RATE AND C-REACTIVE PROTEINS; FLU LIKE SYMPTOMS; FEVER; This spontaneous report received from a physician concerned a 38 year old male. The patient's height and weight were not reported. The patient's pre-existing medical conditions included patient had no trauma, no illegal drug use, no predisposing medical conditions with no evidence of infection. 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 05-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 05-MAR-2021, the patient experienced fever and flu like symptoms. On 24-APR-2021, the patient experienced elevated sedimentation rate and C-reactive protein, acute onset of steady left flank pain. He went to emergency room (ER) and discovered red cells in urine. In ER did a Computerized tomography (CT) scan and ruled out kidney stones. Found infarctions of the lower half of the left kidney and thrombosis of the ventral inferior distal renal artery branch that supplied the lower pole of the left kidney. Echocardiogram was normal. On 28-APR-2021, Laboratory data showed C-reactive protein was 172 mg/L, sedimentation rate was 110 mm/h and Fibrinogen (NR: not provided) 677 mg/dL.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms, and fever on 08-MAR-2021, was recovering from left flank pain, and had not recovered from renal artery thrombosis, kidney infarction, red cells in urine, and elevated sedimentation rate and c-reactive proteins. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210500068-COVID-19 VACCINE AD26.COV2.S-1.RENAL ARTERY THROMBOSIS,KIDNEY INFARCTION,LEFT FLANK PAIN , RED CELLS IN URINE, ELEVATED SEDIMENTATION RATE AND C-REACTIVE PROTEINS- 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.
Sex: M
Vaccine: COVID19
Symptoms: Flank pain, Influenza like illness, Pyrexia, Red blood cell sedimentation rate, Red blood cells urine positive
Clinical narrative: RENAL ARTERY THROMBOSIS; KIDNEY INFARCTION; LEFT FLANK PAIN; RED CELLS IN URINE; ELEVATED SEDIMENTATION RATE AND C-REACTIVE PROTEINS; FLU LIKE SYMPTOMS; FEVER; This spontaneous report received from a physician concerned a 38 year old male. The patient's height and weight were not reported. The patient's pre-existing medical conditions included patient had no trauma, no illegal drug use, no predisposing medical conditions with no evidence of infection. 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 05-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 05-MAR-2021, the patient experienced fever and flu like symptoms. On 24-APR-2021, the patient experienced elevated sedimentation rate and C-reactive protein, acute onset of steady left flank pain. He went to emergency room (ER) and discovered red cells in urine. In ER did a Computerized tomography (CT) scan and ruled out kidney stones. Found infarctions of the lower half of the left kidney and thrombosis of the ventral inferior distal renal artery branch that supplied the lower pole of the left kidney. Echocardiogram was normal. On 28-APR-2021, Laboratory data showed C-reactive protein was 172 mg/L, sedimentation rate was 110 mm/h and Fibrinogen (NR: not provided) 677 mg/dL.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms, and fever on 08-MAR-2021, was recovering from left flank pain, and had not recovered from renal artery thrombosis, kidney infarction, red cells in urine, and elevated sedimentation rate and c-reactive proteins. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210500068-COVID-19 VACCINE AD26.COV2.S-1.RENAL ARTERY THROMBOSIS,KIDNEY INFARCTION,LEFT FLANK PAIN , RED CELLS IN URINE, ELEVATED SEDIMENTATION RATE AND C-REACTIVE PROTEINS- 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.
Sex: M
Vaccine: COVID19
Symptoms: Renal artery thrombosis, Renal infarct
Clinical narrative: RENAL ARTERY THROMBOSIS; KIDNEY INFARCTION; LEFT FLANK PAIN; RED CELLS IN URINE; ELEVATED SEDIMENTATION RATE AND C-REACTIVE PROTEINS; FLU LIKE SYMPTOMS; FEVER; This spontaneous report received from a physician concerned a 38 year old male. The patient's height and weight were not reported. The patient's pre-existing medical conditions included patient had no trauma, no illegal drug use, no predisposing medical conditions with no evidence of infection. 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 05-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 05-MAR-2021, the patient experienced fever and flu like symptoms. On 24-APR-2021, the patient experienced elevated sedimentation rate and C-reactive protein, acute onset of steady left flank pain. He went to emergency room (ER) and discovered red cells in urine. In ER did a Computerized tomography (CT) scan and ruled out kidney stones. Found infarctions of the lower half of the left kidney and thrombosis of the ventral inferior distal renal artery branch that supplied the lower pole of the left kidney. Echocardiogram was normal. On 28-APR-2021, Laboratory data showed C-reactive protein was 172 mg/L, sedimentation rate was 110 mm/h and Fibrinogen (NR: not provided) 677 mg/dL.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms, and fever on 08-MAR-2021, was recovering from left flank pain, and had not recovered from renal artery thrombosis, kidney infarction, red cells in urine, and elevated sedimentation rate and c-reactive proteins. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210500068-COVID-19 VACCINE AD26.COV2.S-1.RENAL ARTERY THROMBOSIS,KIDNEY INFARCTION,LEFT FLANK PAIN , RED CELLS IN URINE, ELEVATED SEDIMENTATION RATE AND C-REACTIVE PROTEINS- 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.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Thrombosis, Ultrasound scan, Varicose vein
Clinical narrative: VARICOSE VEIN RED AND HARD; UPPER RIGHT THIGH PAIN; SUPERFICIAL CLOTS; This spontaneous report received from a patient concerned an adult female. 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) dose was not reported, 1 total administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On 09-APR-2021, the patient experienced varicose vein red and hard, and was hospitalized. She sought care at the medical facility, as she says she had been treated there in the past.  On 09-APR-2021, the patient experienced upper right thigh pain. On Apr-2021, the patient experienced superficial clots, and was hospitalized. Laboratory data  included: Diagnostic ultrasound (NR: not provided) confirmed Superficial clots. Treatment medications included Motrin and Heating pad for Varicose veins. She was told to return in 2 weeks for a follow up ultra sound.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the superficial clots, varicose vein red and hard and upper right thigh pain was not reported. This report was serious (Hospitalization Caused / Prolonged, Other Medically important condition). This case, from the same reporter is linked to 20210501531.; Sender's Comments: V0 : 20210500162 - Covid-19 vaccine ad26.cov2.s - Superficial clots and Varicose vein red and hard . 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: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral venous disease
Clinical narrative: VENOUS CLAMP ON LOWER LEFT CALF; This spontaneous report received from a patient concerned a 27 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to cats, alcoholic, and non-smoker, and other pre-existing medical conditions included patient has no previous medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-MAY-2021, the subject experienced venous clamp on lower left calf. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from venous clamp on lower left calf. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 34 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to sulfa, rash, and fever. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 30-APR-2021, the patient had confirmed immunological vaccine failure. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) Negative, which was done after 5 weeks of vaccination. 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 case is associated with PQC number 90000178455.; Sender's Comments: V0:20210503229-COVID-19 VACCINE AD26.COV2.S-Confirmed immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Headache, Oedema peripheral, Palpitations
Clinical narrative: ASTHMA EXACERBATION; HEART PALPITATIONS; YELLOWISH FLUID WAS DRAWN FROM SWOLLEN LEFT LEG; HEADACHE; 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 chronic obstructive pulmonary disease(copd), asthma, penicillin allergy, and unspecified food allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced asthma exacerbation, heart palpitations, yellowish fluid was drawn from swollen left leg, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from asthma exacerbation, heart palpitations, and yellowish fluid was drawn from swollen left leg, and had not recovered from headache. 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: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Erythema, Euphoric mood, Fatigue, Heart rate
Clinical narrative: RUSH SENSATION; SWELLING IN RIGHT SIDE AND LEFT SIDE BUT RGHT SIDE HAD MORE SWELLING/ SWELLING IN LOWER ANKLES; INCREASED HEART RATE; REDNESS ALL OVER THE BODY; FATIGUE/TIRED/WIPED OUT; This spontaneous report received from a patient concerned a 56 year 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: 202A21A,expiry: 01-JUN-2021) dose was not reported, administered on 01-MAY-2021 11:00 for prophylactic vaccination. No concomitant medications were reported.  On 01-MAY-2021, the subject experienced rush sensation. On 01-MAY-2021, the subject experienced swelling in right side and left side but rght side had more swelling/ swelling in lower ankles. On 01-MAY-2021, the subject experienced increased heart rate. On 01-MAY-2021, the subject experienced redness all over the body. On 01-MAY-2021, the subject experienced fatigue/tired/wiped out. Laboratory data included: Electrocardiogram (NR: not provided) normal, Heart rate (NR: not provided) 70-75 BPMS, 90's BPM, USUAL 60-65 BPM, 132 BPMS, and Laboratory test (NR: not provided) normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rush sensation, and redness all over the body, swelling in right side and left side but right side had more swelling/ swelling in lower ankles, and increased heart rate on 01-MAY-2021, and fatigue/tired/wiped out on 02-MAY-2021. This report was non-serious. This case, from the same reporter is linked to 20210504154 and 20210505260.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Laboratory test, Oedema peripheral
Clinical narrative: RUSH SENSATION; SWELLING IN RIGHT SIDE AND LEFT SIDE BUT RGHT SIDE HAD MORE SWELLING/ SWELLING IN LOWER ANKLES; INCREASED HEART RATE; REDNESS ALL OVER THE BODY; FATIGUE/TIRED/WIPED OUT; This spontaneous report received from a patient concerned a 56 year 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: 202A21A,expiry: 01-JUN-2021) dose was not reported, administered on 01-MAY-2021 11:00 for prophylactic vaccination. No concomitant medications were reported.  On 01-MAY-2021, the subject experienced rush sensation. On 01-MAY-2021, the subject experienced swelling in right side and left side but rght side had more swelling/ swelling in lower ankles. On 01-MAY-2021, the subject experienced increased heart rate. On 01-MAY-2021, the subject experienced redness all over the body. On 01-MAY-2021, the subject experienced fatigue/tired/wiped out. Laboratory data included: Electrocardiogram (NR: not provided) normal, Heart rate (NR: not provided) 70-75 BPMS, 90's BPM, USUAL 60-65 BPM, 132 BPMS, and Laboratory test (NR: not provided) normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rush sensation, and redness all over the body, swelling in right side and left side but right side had more swelling/ swelling in lower ankles, and increased heart rate on 01-MAY-2021, and fatigue/tired/wiped out on 02-MAY-2021. This report was non-serious. This case, from the same reporter is linked to 20210504154 and 20210505260.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Cerebral thrombosis
Clinical narrative: BRAIN BLOOD CLOTS; This spontaneous report received via social media from a consumer via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company does not perform follow-up in this scenario to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced brain blood clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of brain blood clots was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210504075.; Sender's Comments: V0. 20210505140-COVID-19 VACCINE AD26.COV2.S-Brain blood clot. 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).
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a company representative concerned a 49 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2. s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, frequency 1 total, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 27-APR-2021, the patient died from unknown cause of death after 4 weeks of Johnson and Johnson vaccination. An autopsy was performed on an unspecified date and there was no sign of high blood pressure, heart disease, or diabetes to patient as per report.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0. 20210505962-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; Autopsy-determined Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 42 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known drug allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 02-MAY-2021, the patient tested positive for Covid-19 (coded as confirmed covid-19 infection and confirmed clinical vaccination failure). Laboratory data included: SARS-CoV-2 RT-PCR test (NR: not provided) POSITIVE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case is associated with product quality complaint (PQC) number 90000178477.; Sender's Comments: V0: 20210506427-covid-19 vaccine ad26.cov2.s-confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: International normalised ratio, International normalised ratio decreased
Clinical narrative: LOW INTERNATIONAL NORMALISED RATIO (INR); This spontaneous report received from a patient concerned a 72 year old male. The patient's weight was 240 pounds, and height was 72 inches.  The patient's past medical history included strokes at 42 and 44 years of age, and grande mal seizure at age 44 with stroke, and concurrent conditions included primary antiphospholipid antibody syndrome, blood thinners for 30 years, non-smoker, social alcohol drinker, artificial aortic valve after first stroke at age 42, and pacemaker, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. the patient's father and brother had primary antiphospholipid antibody syndrome (pps) both was deceased and his nephew recently discovered that he also have had primary antiphospholipid antibody syndrome (pps). the patient's father died at age 60 and his brother died at age 73 from primary antiphospholipid antibody syndrome (pps).  The patient experienced drug allergy when treated with phenytoin.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. Concomitant medications included warfarin sodium.  On 2021, the subject experienced low international normalised ratio (inr). Laboratory data included: INR (NR: not provided) 3.4, 2.0. On 03-MAY-2021, Laboratory data included: INR (NR: not provided) 2.5. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from low international normalised ratio (inr). This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per the standard procedure as the case is assessed as non-serious.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOT IN LEG; This spontaneous report received from a patient via a company representative concerned an adult male. The patient's weight, height, and medical history were not reported. The patient received ibrutinib (tablet, oral, batch number was not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN) dose, start therapy date were not reported, 1 in total 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 blood clot in leg, and was hospitalized (date unspecified) for two days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with ibrutinib was not reported. The outcome of blood clot in leg was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0. 20210507935-covid-19 vaccine ad26.cov2.s -blood clot in leg. 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).