chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MNQ
Symptoms: Incomplete course of vaccination
Clinical narrative: Patients that might have received an incomplete schedule of Menveo; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in unspecified number of patients who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, 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 for this report. The pharmacists reported that they had patients that might have received an incomplete schedule of Menveo. Till the time of reporting, the patients did not receive the dose of Menveo, which led to incomplete course of vaccination. The reporter consented to follow up via email. The healthcare professional had no data about patients or vaccines. This case had been linked with US2021094211, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021094211:Same reporter.
Sex: U
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: An expired Kinrix vaccine dose was recieved on february 4th 2021/expired on 2nd February 2021; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa-IPV (Kinrix) (batch number unknown, expiry date 2nd February 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th February 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 age at vaccination was not reported. The patient had received Kinrix vaccine dose on 4th February 2021 which had already expired on 2nd February 2021. The reporter did not have information about the patient. The reporter consented to follow-up. This case has been linked to US2021094184, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021094184:Same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient is late for the second dose of Shingrix / only received the first dose on September 2018; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose in September 2018).   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 for this report. The pharmacist stated that the patient was late for the 2nd dose of Shingrix and till the time of reporting, the patient did not receive 2nd dose, which led to incomplete course of vaccination. The reporter consented to follow up. No further information was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache
Clinical narrative: Headache; Fatigue; This case was reported by a physician via call center representative and described the occurrence of headache in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache and fatigue. On an unknown date, the outcome of the headache and fatigue were recovered/resolved.   It was unknown if the reporter considered the headache and fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving 1st doses of Shingrix, the patient experienced headache and fatigue.  Health care practitioner described the headaches and fatigue had not gotten any better or worse since they began. Health care practitioner did not have lot number or expiration date of doses of Shingrix. No additional information provided. This is one of 4 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021094723:case for husband 2nd dose US-GLAXOSMITHKLINE-US2021AMR095072:same reporter US-GLAXOSMITHKLINE-US2021094721:same reporter
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose/ in September 2019 and 2nd dose in December 2020.; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in September 2019).   In December 2020, the patient received the 2nd dose of Shingrix. In December 2020, 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 details were provided as follows: The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. The reporter consented to follow up.  No information regarding the vaccine's lot number and expiry date was available.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: administration of a expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 53HA4, expiry date 26th March 2021) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th April 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 28th April 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 patient received a dose Paediarix which had expired on 26th March 2021, which led to expired vaccine used. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: her husband received / first dose / September 2020. He has yet to receive the second; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in Spetmber 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 details were provided as follows: The reporter was patient's wife. The age at vaccination was not applicable for this report. The patient was not notified that 2nd dose was required. Till the time of reporting, patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter stated that, they referred to Food and Drug Administration, The centers for Disease Control and Prevention and Health Care Professional and provided content regarding not restarting vaccine series. No other information was provided.  The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Caller received the first vaccine April 30, 2019. / did not receive the second vaccine.; This case was reported by a consumer and described the occurrence of incomplete course of vaccination in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose intramuscularly on unknown date, batch number-2Y9R4, expiration date-28th June 2021).   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 case was reported by patient. The age at vaccination was not applicable for this report. Till the time of reporting, patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Product prescribing issue
Clinical narrative: doctor prescribe Shingrix to / patient born in 92 that is immunocompromised; This case was reported by a pharmacist and described the occurrence of product prescribing error in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immunocompromised.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product prescribing error. On an unknown date, the outcome of the product prescribing error was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that, the doctor prescribed Shingrix to the patient was younger than 50 years of age and was immunocompromised, which led to product prescribing error. The patient's identifiers was not provided. The reporter did not consent to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose of shingrix late.1st dose of shingrix was on 09/05/2019 and  2nd dose on 4/28/2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number NP33H, expiry date 8th April 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 5th September 2019).   On 28th April 2021, the patient received the 2nd dose of Shingrix. On 28th April 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 details were reported as follows: The patient received the 2nd dose of Shingrix later than the recommended interval, which led to lengthening of the vaccination schedule. The reporter enquired about revaccination. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product formulation administered
Clinical narrative: I gave adjuvant and didn't mix shingrix; I gave adjuvant and didn't mix shingrix; This case was reported by a pharmacist and described the occurrence of inappropriate preparation of medication in a adult patient who received Herpes zoster (Shingrix) (batch number ASKU, expiry date unknown) for prophylaxis.   On 29th April 2021, the patient received Shingrix. On 29th April 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient age group was not  reported however captured as adult as per vaccine indication. The age at vaccination was not reported.  The pharmacist given adjuvant to the patient without mixing, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consented to follow-up. The pharmacist abruptly discontinued webchat prior to provided an details regarding patient, Shingrix lot number and expiration date or administration date.  No additional details were available. The pharmacist was called and left a message for him to call back.; Reporter's Comments: Pharmacist reports I gave adjuvant and didn't mix shingrix. Did not consent to follow-up. Call Notes:Pharmacist abruptly discontinued webchat prior to provided an details regarding patient, Shingrix lot# and expiration date or administration date. No additional details available. Called pharmacist and left a message for him to call back
Sex: M
Vaccine: COVID19
Symptoms: Skin burning sensation
Clinical narrative: HEAD BURNING; This spontaneous report received from a consumer concerned a male 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 and has been requested.  No concomitant medications were reported. On an unspecified date, the subject experienced head burning. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of head burning was not reported. This report was non-serious. This case, from the same reporter is linked to 20210419762.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Catheterisation cardiac, Chest pain, Myocardial infarction
Clinical narrative: CHEST PAIN; TWO HEART ATTACKS; This spontaneous report received from a patient via the VAERS (Vaccine Adverse Event Reporting System; VAERS ID 1202551] concerned a 54 year old white not Hispanic or Latino male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient did not had allergies to medications, food, or other products, did not had other illnesses at the time of vaccination, up to one month prior and did not had spleen. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802070, expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 12:00 for prophylactic vaccination on right arm. Concomitant medications included lisinopril for drug used for unknown indication. On MAR-2021, the patient experienced two heart attacks, first attack was on day of vaccine and another was the day after the vaccine and was hospitalized (date unspecified). On 16-MAR-2021 04:00, the patient experienced chest pain prior to each heart attack but had never suffered chest pain before. He further reported that he was continuing to suffer from periods of chest pain at rest.  Laboratory data (dates unspecified) included: Cardiac catheterization (NR: not provided) 20 to 30 percentage blockage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from two heart attacks. This report was serious (Hospitalization Caused / Prolonged, Life Threatening, and Disability Or Permanent Damage).; Sender's Comments: V0. 20210439984-covid-19 vaccine ad26.cov2.s -Two heart attacks, Chest pain- 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: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Blood test, Chest X-ray, Computerised tomogram, Cor pulmonale acute
Clinical narrative: PULMONARY EMBOLISM; THROMBOSIS; COR PULMONALE ACUTE/ DYSPNOEA; HYPOXIA; DIZZINESS; COUGHING; This spontaneous report received from a patient via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAER reference number 1120494) concerned a 68 year old female unknown ethnicity.  The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 14:15 for prophylactic vaccination. Concomitant medications included amitriptyline for sleep, and zolmitriptan for migraine.  On 07-MAR-2021 08:30, the subject experienced pulmonary embolism, thrombosis, cor pulmonale acute/ dyspnoea, hypoxia, dizziness, coughing, and was hospitalized (date unspecified). On 12-MAR-2021, Laboratory data included: COVID-19 virus test negative (NR: not provided) Negative. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) normal, Blood test (NR: not provided) normal, CT scan (NR: not provided) Pulmonary Embolism, Chest X-ray (NR: not provided) normal, Diagnostic ultrasound (NR: not provided) No blood clots or vein thrombosis, Echocardiography (NR: not provided) Increased pressure on the right side of heart due to blood clots, and Heart rate (NR: not provided) elevated. Treatment medications (dates unspecified) included: oxygen, salbutamol, and rivaroxaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the  pulmonary embolism, thrombosis, cor pulmonale acute/ dyspnoea, hypoxia, dizziness, coughing was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition); Sender's Comments: V2:Additional version created for MAC update. This updated information does not alter the causality of previously reported events. 20210441745-Covid-19 vaccine ad26.cov2.s-Thrombosis, pulmonary embolism ,Cor pulmonale acute, Hypoxia, dizziness, cough. These events are considered unassessable. These events 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 events.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dizziness, Echocardiogram, Heart rate, Hypoxia
Clinical narrative: PULMONARY EMBOLISM; THROMBOSIS; COR PULMONALE ACUTE/ DYSPNOEA; HYPOXIA; DIZZINESS; COUGHING; This spontaneous report received from a patient via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAER reference number 1120494) concerned a 68 year old female unknown ethnicity.  The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 14:15 for prophylactic vaccination. Concomitant medications included amitriptyline for sleep, and zolmitriptan for migraine.  On 07-MAR-2021 08:30, the subject experienced pulmonary embolism, thrombosis, cor pulmonale acute/ dyspnoea, hypoxia, dizziness, coughing, and was hospitalized (date unspecified). On 12-MAR-2021, Laboratory data included: COVID-19 virus test negative (NR: not provided) Negative. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) normal, Blood test (NR: not provided) normal, CT scan (NR: not provided) Pulmonary Embolism, Chest X-ray (NR: not provided) normal, Diagnostic ultrasound (NR: not provided) No blood clots or vein thrombosis, Echocardiography (NR: not provided) Increased pressure on the right side of heart due to blood clots, and Heart rate (NR: not provided) elevated. Treatment medications (dates unspecified) included: oxygen, salbutamol, and rivaroxaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the  pulmonary embolism, thrombosis, cor pulmonale acute/ dyspnoea, hypoxia, dizziness, coughing was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition); Sender's Comments: V2:Additional version created for MAC update. This updated information does not alter the causality of previously reported events. 20210441745-Covid-19 vaccine ad26.cov2.s-Thrombosis, pulmonary embolism ,Cor pulmonale acute, Hypoxia, dizziness, cough. These events are considered unassessable. These events 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 events.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism, SARS-CoV-2 test negative, Thrombosis, Ultrasound scan
Clinical narrative: PULMONARY EMBOLISM; THROMBOSIS; COR PULMONALE ACUTE/ DYSPNOEA; HYPOXIA; DIZZINESS; COUGHING; This spontaneous report received from a patient via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAER reference number 1120494) concerned a 68 year old female unknown ethnicity.  The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 14:15 for prophylactic vaccination. Concomitant medications included amitriptyline for sleep, and zolmitriptan for migraine.  On 07-MAR-2021 08:30, the subject experienced pulmonary embolism, thrombosis, cor pulmonale acute/ dyspnoea, hypoxia, dizziness, coughing, and was hospitalized (date unspecified). On 12-MAR-2021, Laboratory data included: COVID-19 virus test negative (NR: not provided) Negative. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) normal, Blood test (NR: not provided) normal, CT scan (NR: not provided) Pulmonary Embolism, Chest X-ray (NR: not provided) normal, Diagnostic ultrasound (NR: not provided) No blood clots or vein thrombosis, Echocardiography (NR: not provided) Increased pressure on the right side of heart due to blood clots, and Heart rate (NR: not provided) elevated. Treatment medications (dates unspecified) included: oxygen, salbutamol, and rivaroxaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the  pulmonary embolism, thrombosis, cor pulmonale acute/ dyspnoea, hypoxia, dizziness, coughing was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition); Sender's Comments: V2:Additional version created for MAC update. This updated information does not alter the causality of previously reported events. 20210441745-Covid-19 vaccine ad26.cov2.s-Thrombosis, pulmonary embolism ,Cor pulmonale acute, Hypoxia, dizziness, cough. These events are considered unassessable. These events 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 events.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Migraine, Pain in extremity, Pyrexia
Clinical narrative: MIGRAINE; FEVER; HEADACHE; ARM PAIN; POTENTIAL BLOOD CLOT; This spontaneous report received from a patient concerned a 35 year old female. The patient's height, and weight were not reported. The patient's past medical history included stroke, and concurrent conditions included non-smoker, and sulfa allergy (anaphylactic). The patient experienced drug allergy when treated with nitrofurantoin. 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 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, patients arm was hurting and on the 11-APR-2021, night patient started having a headache. On 11-APR-2021, the patient had a fever of 103 and a migraine on 12-APR-2021. Patient took 2 Tylenol and rested in bed for the whole day. On 12-APR-2021, patient saw the physician due to her migraine. The physician was concerned that the patient may have a potential blood clot since the patient has had a stroke in 2016. Physician wanted her to get a MRV (Magnetic Resonance Venography) with contrast of the brain to make sure patient does not have another stroke and also prescribed baby aspirin until she can get the MRV The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from arm pain, fever, and headache, had not recovered from migraine, and the outcome of potential blood clot was not reported.. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210443400-Covid-19 vaccine ad26.cov2.s-Potential blood clot. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: MIGRAINE; FEVER; HEADACHE; ARM PAIN; POTENTIAL BLOOD CLOT; This spontaneous report received from a patient concerned a 35 year old female. The patient's height, and weight were not reported. The patient's past medical history included stroke, and concurrent conditions included non-smoker, and sulfa allergy (anaphylactic). The patient experienced drug allergy when treated with nitrofurantoin. 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 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, patients arm was hurting and on the 11-APR-2021, night patient started having a headache. On 11-APR-2021, the patient had a fever of 103 and a migraine on 12-APR-2021. Patient took 2 Tylenol and rested in bed for the whole day. On 12-APR-2021, patient saw the physician due to her migraine. The physician was concerned that the patient may have a potential blood clot since the patient has had a stroke in 2016. Physician wanted her to get a MRV (Magnetic Resonance Venography) with contrast of the brain to make sure patient does not have another stroke and also prescribed baby aspirin until she can get the MRV The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from arm pain, fever, and headache, had not recovered from migraine, and the outcome of potential blood clot was not reported.. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210443400-Covid-19 vaccine ad26.cov2.s-Potential blood clot. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient 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 not reported, batch number: Unknown) dose was not reported, 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 2021, the patient experienced suspected covid-19 infection and suspected clinical vaccination failure. Patient wanted to thank for the 1 dose vaccine which helped her symptoms to be lesser.  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 associated with product quality complaint: 90000177503. This report was serious (Other Medically Important Condition).; Sender's Comments: V0;20210451340- covid-19 vaccine ad26.cov2.s -suspected 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
Sex: U
Vaccine: COVID19
Symptoms: Autoimmune disorder, Lung infiltration
Clinical narrative: AUTOIMMUNE DISORDER; BILATERAL INFILTRATES; This spontaneous report received from a physician concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient did not have autoimmune disorder prior to receiving the Janssen covid-19 vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced autoimmune disorder and bilateral infiltrates and visited emergency room. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of the autoimmune disorder and bilateral infiltrates was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210451619-covid-19 vaccine ad26.cov2.s-autoimmune disorder. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic shock, Idiopathic intracranial hypertension
Clinical narrative: RECURRENT ANAPHYLACTIC SHOCK; IDIOPATHIC INTRACRANIAL HYPERTENSION; This spontaneous report received via company representative from a patient concerned a patient of unspecified age and sex. 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: 042A21A, expiry: UNKNOWN)dose was not reported, 1 total administered on 06-Apr-2021;11:54 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021 at 12:10pm the patient was reacting to the vaccine and was hospitalized and received treatment for extreme Anaphylactic Shock ( had 3 bounceback reactions over the course of the next 24 hours. Patient was treated with Epinephrine (iv drip), Steroids and multiple Nebulizer treatments. Patient was in the ICU for 3days and a regular room for e additional days. Hospitalized from 6Apr through 11Apr.I was home for several days and was again hospitalized 19Apr through 22Apr for a severe headache, ringing in ears, numbness in left arm, leg, an leg. Also for blurry/double vision in right eye. On 19-APR-2021, the patient was again hospitalized for a severe headache, ringing in ears, numbness in left arm, and leg, blurry/double vision in right eye. It was determined to be Idiopathic Intracranial Hypertension and still being treated for it and will be attending Occupational and Physical therapy to get vision, arm and leg to work properly again. Patient was hospitalized for 3 days. The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The patient had not recovered from idiopathic intracranial hypertension, and the outcome of recurrent anaphylactic shock was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: 20210452704-Covid-19 vaccine ad26.cov2.s-Idiopathic intracranial hypertension. 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). 20210452704-Covid-19 vaccine ad26.cov2.s-Anaphylactic reaction. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Pain in extremity, Thrombosis
Clinical narrative: ESCALATING PAIN IN THE LOWER BACK; PAIN IN LEG; BLOOD CLOT IN LEG; This spontaneous report received from a consumer (representative) concerned a 4 decade (early 30's) old adult 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 was not reported, 1 total administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up would be requested for this case. No concomitant medications were reported. On 16-APR-2021, the patient experienced escalating pain in the lower back and in leg. The patient also experienced blood clot in leg, and was hospitalized in an unknown date in APR-2021. The patient had improvement and scheduled to leave the hospital in a few days at the time of this report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blood clot in leg, escalating pain in the lower back, and pain in leg. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210452829-COVID-19 VACCINE AD26.COV2.S-BLOOD CLOT IN LEG, ESCALATING PAIN IN THE LOWER BACK. 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). 20210452829-COVID-19 VACCINE AD26.COV2.S-PAIN IN LEG . This event(s) is labeled per RSI and is therefore considered potentially related.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Migraine, Muscular weakness, SARS-CoV-2 test
Clinical narrative: SEVERE MIGRAINE; RIGHT ARM WEAKNESS; LOSS OF TASTE; LOSS OF SMELL; This spontaneous report received from a patient concerned a 49 year old female. The patient's weight was 125 pounds, and height was 160 centimeters. The patient's concurrent conditions included migraine, history of concussion, post concussion syndrome, eye convergence inefficiency due to concussion, regelan and penicillin allergy, non alcohol user, and non smoker, and other pre-existing medical conditions included the patient did not had any drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. Concomitant medications included gabapentin for severe migraine. On 17-APR-2021, the subject experienced loss of taste. On 17-APR-2021, the subject experienced loss of smell. On 22-APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 23-APR-2021, the subject experienced severe migraine. On 23-APR-2021, the subject experienced right arm weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from loss of taste, loss of smell, severe migraine, and right arm weakness. 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.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Appendicitis, Asthenia, Chest pain, Contusion, Headache
Clinical narrative: APPENDICITIS; CHEST PAIN; WEAKNESS; BODY ACHES; SKIN BLOTCHES; BRUISES; HEADACHE; This spontaneous report received from a consumer concerned a 27 year old white, hispanic or latino female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to aspirin (unknown reaction), no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no relevant medical history. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808980, expiry: 20-JUN-2021) dose was not reported, 1 total administered on 02-APR-2021 on right arm for prophylactic vaccination. No concomitant medications were reported. It was reported that, the patient experienced side effects that developed after receiving covid-19 vaccine ad26.cov2.s. On 03-APR-2021, the patient experienced headache. On 06-APR-2021, the patient experienced skin blotches and bruises. On 07-APR-2021, the patient experienced body aches. On 14-APR-2021, the patient experienced weakness. On 19-APR-2021, the patient experienced chest pain. On 27-APR-2021, the patient experienced appendicitis and had a hospitalization that resulted in surgery for appendectomy. The patient had visited emergency room/department or urgent care and doctor/healthcare professional office. The patient was hospitalized for 1 day and was discharged on 28-APR-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from skin blotches, bruises, and appendicitis, and had not recovered from headache, chest pain, body aches, and weakness. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210456304- COVID-19 VACCINE AD26.COV2.S-Appendicitis. 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: F
Vaccine: COVID19
Symptoms: Pain, Rash macular
Clinical narrative: APPENDICITIS; CHEST PAIN; WEAKNESS; BODY ACHES; SKIN BLOTCHES; BRUISES; HEADACHE; This spontaneous report received from a consumer concerned a 27 year old white, hispanic or latino female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to aspirin (unknown reaction), no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no relevant medical history. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808980, expiry: 20-JUN-2021) dose was not reported, 1 total administered on 02-APR-2021 on right arm for prophylactic vaccination. No concomitant medications were reported. It was reported that, the patient experienced side effects that developed after receiving covid-19 vaccine ad26.cov2.s. On 03-APR-2021, the patient experienced headache. On 06-APR-2021, the patient experienced skin blotches and bruises. On 07-APR-2021, the patient experienced body aches. On 14-APR-2021, the patient experienced weakness. On 19-APR-2021, the patient experienced chest pain. On 27-APR-2021, the patient experienced appendicitis and had a hospitalization that resulted in surgery for appendectomy. The patient had visited emergency room/department or urgent care and doctor/healthcare professional office. The patient was hospitalized for 1 day and was discharged on 28-APR-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from skin blotches, bruises, and appendicitis, and had not recovered from headache, chest pain, body aches, and weakness. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210456304- COVID-19 VACCINE AD26.COV2.S-Appendicitis. 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: Thrombosis
Clinical narrative: CLOTS; This spontaneous report received from a physician concerned a patient of unspecified age and sex. 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 administration not reported, batch number: Unknown) frequency one total, dose, start therapy date were not reported for prophylactic vaccination.The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient died due to clot. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died to clots on an unspecified date. This report was serious (Death). This case, from the same reporter is linked to 20210457363.; Sender's Comments: V0: 20210456400-Covid-19 vaccine ad26.cov2.s-Death. 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).; Reported Cause(s) of Death: CLOTS
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chest discomfort, Condition aggravated, Dyspnoea, Nervousness
Clinical narrative: ANXIETY; NERVOUS; SHORTNESS OF BREATH; CONDITION AGGRAVATED; CHEST TIGHTNESS; This spontaneous report received from a patient concerned a 24 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced chest tightness. On 24-APR-2021, the subject experienced shortness of breath. On 24-APR-2021, the subject experienced condition aggravated. On an unspecified date, the subject experienced anxiety, and nervous. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chest tightness, shortness of breath, anxiety, nervous and condition aggravated was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Fatigue, Wheezing
Clinical narrative: COUGH; WHEEZING; FATIGUE/ FEELING RUN DOWN; This spontaneous report received from a patient concerned a 57 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, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-MAR-2021, the subject experienced fatigue/ feeling run down. On an unspecified date, the subject experienced cough, and wheezing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue/ feeling run down, and had not recovered from cough, and wheezing. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: SORE; TIRED; 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) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced sore, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore and tired was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product container issue, Product storage error
Clinical narrative: EXPIRED VACCINE USED; VACCINE VIAL PUNCTURED; INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. 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, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced expired vaccine used, vaccine vial punctured, and incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine vial punctured, incorrect product storage and expired vaccine used was not reported. This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Cardiac stress test, Chest discomfort, Chest pain, Electrocardiogram
Clinical narrative: CHEST PAIN; CHEST PRESSURE; This spontaneous report received from a consumer concerned a 58 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-APR-2021, the subject experienced chest pain. On 19-APR-2021, the subject experienced chest pressure. Laboratory data included: Blood test (NR: not provided) Normal, and EKG (NR: not provided) Normal. Laboratory data (dates unspecified) included: Stress test (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest pain, and chest pressure. This report was non-serious.; Sender's Comments: MAC not required as per standard procedure as case was assessed as non-serious.