chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: patient only received the liquid component of Menveo; patient only received the liquid component of Menveo; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA419A, expiry date 31st August 2022) for prophylaxis.   On 19th May 2021, the patient received Menveo. On 19th May 2021, unknown after receiving Menveo, 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 reported as follows: The age at vaccination was no reported. The pharmacist reported that the patient was administered only with the liquid component of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.  The health care professional did not have patient demographics to provide. The reporter consented to follow up. The reported batch number AMXA419A was not available in sales data sheet, hence updated to AMVA419A . No further information was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose of Shingrix over a year ago / second dose/ not received till 5/18/2021 due to COVID; This case was reported by a consumer via call center representative and described the occurrence of social problem in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose intramuscularly into the left arm over a year prior to the reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: This case was reported by patient herself. The age at vaccination was not applicable for this report. The patient did not get her 2nd dose until 18th May 2021, the day before reporting due to COVID.   The reporter consented to follow up.
Sex: U
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: on 19May2021 /received an expired dose of Kinrix; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa-IPV (Kinrix) (batch number XC575, 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 19th May 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 19th May 2021, 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 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 pharmacist reported that a patient received an expired dose of Kinrix, it expired on 2nd February 2021 and was administered on the same day as reported which led to expired vaccine used. The reporter consented to follow up.
Age: 40.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: administration on May 18h 2021  of an expired dose/vaccine expired on March 2021; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 40-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA321A, expiry date 30th March 2021) for prophylaxis.   On 18th May 2021, the patient received Menveo. On 18th May 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The pharmacist called to report the administration of an expired dose of Menveo to the patient, the vaccine was expired on March 2021. No further events were reported. The reporter agreed to follow up from the safety team.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose / on 2007 and went to the facility to have his second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 40-year-old male 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.   Previously administered products included Twinrix with an associated reaction of no adverse event (1st dose received in 2007).   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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 reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination. The twinrix second dose was not given as the health care professional did not want to administer the patient because the information he read in the Twinrix PI The reporter consented to follow up. Pharmacist asked information for this case.
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Dose 1 : December 2020 / Dose 2: May 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 23-year-old male patient who received HBV (Engerix B) (batch number M4KE9, expiry date 29th April 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B (received first dose of Engerix B in December 2020, batch no.: E97CH and expiration date-19th April 2021).   In May 2021, the patient received the 2nd dose of Engerix B and Engerix B Pre-Filled Syringe Device. In May 2021, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, 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.   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 received 2nd dose of Engerix B, more than the recommended interval, which led to lenghtening of vaccination schedule. The patient wants to know when to give 3rd dose. The reported batch number 4ke9 was not found in sales data sheet, hence was updated to M4KE9. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Intercepted product prescribing error, Product administered to patient of inappropriate age
Clinical narrative: A 47 years old, male patient has a prescription to receive Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a 47-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced intercepted drug prescribing error. On an unknown date, the outcome of the intercepted drug prescribing error was unknown.  Additional details were provided as follows: The reporter stated that the 47 year old patient had a prescription to receive Shingrix which led to intercepted drug prescribing error. The patient did not receive the Shingrix vaccine till the time of reporting. The reporter consented to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Breast prosthesis removal, Contusion, Device extrusion, Ecchymosis
Clinical narrative: SKIN BREAKDOWN AND RIGHT BREAST IMPLANT EXPOSED; SURGERY TO REMOVE THE RIGHT BREAST IMPLANT; AREA OF ECCHYMOSIS OVER THE RIGHT BREAST; MULTIPLE BRUISES THROUGH OUT BODY; This spontaneous report received from a pharmacist concerned a 64 year old female. The patient's height, and weight were not reported. The patient's past medical history included right breast cancer, right breast removal, removal of TE (tissue expander) with right breast implant, TE (implant), lymphoedema, primary genetic predisposition, and secondary Lyme disease. 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, 1 total administered on an unknow date in APR-2021 (reported as about 3 weeks ago from the date of reporting) 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 (reported as sometime after receiving the Janssen COVID 19 vaccination), the patient developed multiple bruises though out her body, an area of ecchymosis over the right breast that evolved into skin breakdown and the right breast implant was exposed to this (skin breakdown). The patient was hospitalized on 11-MAY-2021, and she had to have surgery to remove the right breast implant, and the status post washout of redundant skin removal including nipple areola complex. The patient's health care profession was considering Heparin for her post operation for DVT (Deep vein thrombosis) prevention but was concerned about doing that based on the CDC (Centers for Disease Control and Prevention) information.  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the multiple bruises through out body, area of ecchymosis over the right breast, skin breakdown and right breast implant exposed and surgery to remove the right breast implant was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0.20210523197-COVID-19 VACCINE AD26.COV2.S Skin breakdown and right breast implant exposed, surgery to remove the right breast implant, area of ecchymosis over the right breast, multiple bruises through out body. 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: Arthralgia
Clinical narrative: LEFT ELBOW HURTS; This spontaneous report received from a patient 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  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced left elbow hurts. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from left elbow hurts. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINATION FAILURE; This spontaneous report received from a parent concerned a female of unspecified race, ethnic origin and age. Initial information was processed along with the additional information received on 17-MAY-2021 and 19-May-2021. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 MAY- 2021, the subject experienced confirmed immunological vaccine failure.  On MAY-2021, Laboratory data included: COVID-19 antibody test (NR: not provided) None. 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). The suspected product quality complaint has been confirmed to be not voided (meet PQC criteria). This report was associated with product quality complaint number:90000179791 The investigation has been reviewed and the root cause and disposition determinations were documented properly. the investigation is approved and closed. based on the PQC evaluation/investigation performed.; Sender's Comments: V0:20210527212-covid-19 vaccine ad26.cov2.s-Confirmed immunological vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Atrial fibrillation, Electrocardiogram, Heart rate, Heart rate variability test
Clinical narrative: ATRIAL FIBRILLATION; This spontaneous report received from a patient of unspecified age, sex, race and ethnic origin. The patient's weight and height were not reported. The patient's medical history included: On unspecified date, in JAN-2021, the patient's resting heart rate was 61 beats per minute and heart rate variability was 30 milliseconds. On 15-JAN-2021 the patient had last annual physical examination and heart was normal. On unspecified date, in FEB-2021, the patient's resting heart rate was 57 beats per minute and heart rate variability was 32 milliseconds. On unspecified date, in MAR-2021, the patient's resting heart rate was 58 beats per minute and heart rate variability was 33 milliseconds. On 04-APR-2021, the patient's heart rate variability was 25 milliseconds. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 05-APR-2021, the patient's heart rate variability was 36 milliseconds. On 06-APR-2021, the patient's heart rate variability was 40 milliseconds. On 07-APR-2021, EKG (Electrocardiogram) was performed and diagnosed with atrial fibrillation. On the same day, the patient experienced atrial fibrillation (heart rate variability increased) and heart rate variability was 203 milliseconds. On unspecified date, in APR-2021, the patient's resting heart rate was 69 beats per minute and heart rate variability was 185 milliseconds. On unspecified date, in MAY-2021, the patient's resting heart rate was 67 beats per minute and heart rate variability was 184 milliseconds. The patient reported that prior to JANSSEN COVID-19 VACCINE patient had no symptoms of heart condition and the patient's resting heart rate prior to JANSSEN COVID-19 VACCINE was usually below 60 beats per minute. Since 7-APR-2021 the patient's resting heart rate had shown large swings of 30-50 beats per minute change from the day before. The patient reported the adverse event to the Vaccine Adverse Event Reporting System (VAERS) as suggested by patient's cardiologist. The patient concerned about the risk of Blood clot, strokes, stress and other condition including death. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the atrial fibrillation was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210529871-covid-19 vaccine ad26.cov2.s-Atrial fibrillation. 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: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blood test, Contusion, Inflammation, Malaise
Clinical narrative: BACK PAIN; NECK PAIN; BUTT HURTS WHILE SITTING ON THE RASH/BRUISE; INFLAMMATION IN BLOOD; NOT BEEN NORMAL; LEGS HURT; BRUISY ON LEFT BUTTOCK; RASH LOOKING LIKE BLUE/PURPLISH DOTS ON LEFT BUTTOCK WORSENED; CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 20 year old. Initial information was processed along with the additional information received on 18-MAY-2021. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, 1 total administered to left arm on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-MAR-2021, next day after vaccination, the patient experienced bruisy rash on the left buttock. The rash looked like a little blue/purplish dots, it started coming back and worsened. If the patient does anything with impact it comes back. On 04-MAY-2021, laboratory data included: COVID-19 antibody test also called as Abbott Chemiouninesent Microparticles Immunoassay SARS COV-2 IgG test (NR: not provided) no antibodies. The patient experienced confirmed immunological vaccine failure. On an unspecified date, the patient experienced back pain, neck pain, butt hurts while sitting on it if she has rash/bruise, legs hurt, inflammation in blood and not been normal since she got it (unspecified). Laboratory data (dates unspecified) included: Blood test (NR: not provided) inflammation. The patient had been to the hospital and saw like 6 healthcare professionals and nobody knew how to help her/fix it. The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient had not recovered from bruise on left buttock, back pain, neck pain, legs hurt, butt hurts while sitting on the rash/bruise, rash looking like blue/purplish dots on left buttock worsened, and not been normal, and the outcome of confirmed immunological vaccine failure and inflammation in blood was not reported. This report was serious (Other Medically Important Condition). This case is associated with Product quality complaint number 90000179797.; Sender's Comments: V0: 20210530406--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
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal pain, Neck pain, Pain in extremity, Rash, SARS-CoV-2 antibody test
Clinical narrative: BACK PAIN; NECK PAIN; BUTT HURTS WHILE SITTING ON THE RASH/BRUISE; INFLAMMATION IN BLOOD; NOT BEEN NORMAL; LEGS HURT; BRUISY ON LEFT BUTTOCK; RASH LOOKING LIKE BLUE/PURPLISH DOTS ON LEFT BUTTOCK WORSENED; CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 20 year old. Initial information was processed along with the additional information received on 18-MAY-2021. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, 1 total administered to left arm on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-MAR-2021, next day after vaccination, the patient experienced bruisy rash on the left buttock. The rash looked like a little blue/purplish dots, it started coming back and worsened. If the patient does anything with impact it comes back. On 04-MAY-2021, laboratory data included: COVID-19 antibody test also called as Abbott Chemiouninesent Microparticles Immunoassay SARS COV-2 IgG test (NR: not provided) no antibodies. The patient experienced confirmed immunological vaccine failure. On an unspecified date, the patient experienced back pain, neck pain, butt hurts while sitting on it if she has rash/bruise, legs hurt, inflammation in blood and not been normal since she got it (unspecified). Laboratory data (dates unspecified) included: Blood test (NR: not provided) inflammation. The patient had been to the hospital and saw like 6 healthcare professionals and nobody knew how to help her/fix it. The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient had not recovered from bruise on left buttock, back pain, neck pain, legs hurt, butt hurts while sitting on the rash/bruise, rash looking like blue/purplish dots on left buttock worsened, and not been normal, and the outcome of confirmed immunological vaccine failure and inflammation in blood was not reported. This report was serious (Other Medically Important Condition). This case is associated with Product quality complaint number 90000179797.; Sender's Comments: V0: 20210530406--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
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Therapy non-responder
Clinical narrative: BACK PAIN; NECK PAIN; BUTT HURTS WHILE SITTING ON THE RASH/BRUISE; INFLAMMATION IN BLOOD; NOT BEEN NORMAL; LEGS HURT; BRUISY ON LEFT BUTTOCK; RASH LOOKING LIKE BLUE/PURPLISH DOTS ON LEFT BUTTOCK WORSENED; CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 20 year old. Initial information was processed along with the additional information received on 18-MAY-2021. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, 1 total administered to left arm on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-MAR-2021, next day after vaccination, the patient experienced bruisy rash on the left buttock. The rash looked like a little blue/purplish dots, it started coming back and worsened. If the patient does anything with impact it comes back. On 04-MAY-2021, laboratory data included: COVID-19 antibody test also called as Abbott Chemiouninesent Microparticles Immunoassay SARS COV-2 IgG test (NR: not provided) no antibodies. The patient experienced confirmed immunological vaccine failure. On an unspecified date, the patient experienced back pain, neck pain, butt hurts while sitting on it if she has rash/bruise, legs hurt, inflammation in blood and not been normal since she got it (unspecified). Laboratory data (dates unspecified) included: Blood test (NR: not provided) inflammation. The patient had been to the hospital and saw like 6 healthcare professionals and nobody knew how to help her/fix it. The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient had not recovered from bruise on left buttock, back pain, neck pain, legs hurt, butt hurts while sitting on the rash/bruise, rash looking like blue/purplish dots on left buttock worsened, and not been normal, and the outcome of confirmed immunological vaccine failure and inflammation in blood was not reported. This report was serious (Other Medically Important Condition). This case is associated with Product quality complaint number 90000179797.; Sender's Comments: V0: 20210530406--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
Age: 76.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOT; This spontaneous report received from a consumer concerned a 76 year old male. The patient's weight was 82 kilograms, and height was not reported. The patient's past medical history included angina pectoris, peptic ulcer disease, and tension headache, and concurrent conditions included asthma, atherosclerotic heart disease of native coronary artery, benign hypertension, stage 3 chronic kidney disease, chronic obstructive pulmonary disease with acute exacerbation, cirrhosis of liver, diabetes mellitus type 2, generalized osteoarthritis, morbid obesity, mixed hyperlipidemia, stenosis of bilateral carotid artery, peripheral vascular disease, malignant neoplasm large intestine, carotid artery occlusion, and hepatocellular carcinoma. 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 31-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: cabozantinib s-malate (tablet, oral, batch number was not reported) 40 mg, 4 times every 1 day, from 04-MAR-2021 for hepatocellular/liver cancer. Concomitant medications included apixaban, atorvastatin calcium, carvedilol, ergocalciferol, hydrocodone bitartrate/paracetamol, levothyroxine sodium, losartan potassium, mecobalamin, metformin hydrochloride, salbutamol sulfate, tadalafil, tamsulosin hydrochloride, and vitamin b complex.  On 03-APR-2021, the patient experienced blood clot. On an unspecified date in Apr-2021 the patient was hospitalized for one day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210530464-covid-19 vaccine ad26.cov2.s-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: CONMEDS-OTHER SUSPECT DRUGS, MEDICAL HISTORY
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Paraesthesia oral, Pyrexia, Swelling face, Swelling of eyelid
Clinical narrative: TINGLING TONGUE; FEVER; HEADACHE; SWOLLEN EYELIDS; SWOLLEN LEFT CHEEK; This spontaneous report received from a patient concerned a 36 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 203A21A) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced swollen eyelids. On MAY-2021, the subject experienced swollen left cheek. On 15-MAY-2021, the subject experienced fever. On 15-MAY-2021, the subject experienced headache. On an unspecified date, the subject experienced tingling tongue. The action taken with covid-19 vaccine was not applicable. The patient recovered from fever, and headache, and had not recovered from swollen eyelids, swollen left cheek, and tingling tongue. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: VACCINE GIVEN NEXT DAY AFTER TEMPERATURE EXCURSION FROM 46.2-46.7F; POOR QUALITY DRUG ADMINISTERED; 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  (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 expiry: 25-MAY-2021) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced vaccine given next day after temperature excursion from 46.2-46.7f. On MAY-2021, the subject experienced poor quality drug administered. The action taken with covid-19 vaccine  was not applicable. The outcome of the vaccine given next day after temperature excursion from 46.2-46.7f and poor quality drug administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210530429.
Sex: F
Vaccine: COVID19, UNK
Symptoms: SARS-CoV-2 test negative, SARS-CoV-2 test positive, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID 19 INFECTION; This spontaneous report received from a consumer via (other manufacturer- Abbvie ) concerned a 57 year old 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, intramuscular, batch number: Unknown) dose was not reported, once total administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: upadacitinib (form of admin unknown, oral, batch number was not reported) dose and frequency were not reported from an unspecified date to 2021 for moderate to severe rheumatoid arthritis. No concomitant medications were reported.  On 2021, Laboratory data included: COVID-19 virus test negative (NR: not provided) negative, and COVID-19 virus test positive (NR: not provided) positive.  On an unspecified date, the patient experienced suspected clinical vaccination failure, and suspected covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: VO 20210531141-covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Tinnitus, Vaccination complication
Clinical narrative: SERIES OF SMALL STROKES; TERRIBLE REACTIONS; SOUND IN HEAD; This spontaneous report received from a consumer via social media concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included patient was non- alcohol user, and non smoker.  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 1 total dose was administered, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced terrible reactions along with a sound in her head and a series of small strokes. She was always been healthy and now hospitalized. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the terrible reactions, sound in head and series of small strokes was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210531420-Covid-19 vaccine ad26.cov2.s-Series of small strokes, Terrible reaction, sounds in head. 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: Body temperature, Chills, Nausea, Pain, Pyrexia
Clinical narrative: BODY ACHES; NAUSEA; CHILLS; FEVER; This spontaneous report received from a patient 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 (suspension for injection, route of admin not reported, batch number: 1821286, expiry: 23/JUL/2021) dose was not reported, administered on 16-MAY-2021 11:45 for prophylactic vaccination. No concomitant medications were reported. On 16-MAY-2021 21:30, the subject experienced chills. On 16-MAY-2021 21:30, the subject experienced fever. On 17-MAY-2021, the subject experienced body aches. On 17-MAY-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 100 F. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from fever, chills, body aches, and nausea. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: UNSPECIFIED ADVERSE EVENTS; This spontaneous report received from a patient 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 (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 unspecified adverse events. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from unspecified adverse events. 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: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Facial paralysis, Pyrexia
Clinical narrative: FEVER; ANAPHYLACTIC REACTION (PASSING OUT/ COULD NOT BREATH/ SWOLLEN LIPS AND FACE); LIPS WERE DROOPING TO THE RIGHT SIDE OF FACE; This spontaneous report received from a parent concerned a 22 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma (as a child), non-alcoholic, and cigarettes smoker. The patient experienced drug allergy when treated with Tamiflu (oseltamivir phosphate).  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown, NDC number: 59676-0580-15) dose was not reported, 1 total administered on 14-MAY-2021 at 10:00 for prophylactic vaccination on left arm. The batch number was not reported and has been requested. No concomitant medications were reported.  On 14-MAY-2021, as soon as the patient got the shot (within the 15 minutes of wait at the pharmacy), he had an anaphylactic reaction. It was further reported that he could not breath, his lips and face started to swell and then he passed out. The patient was taken to ER (emergency room) and his doctor gave him EpiPen (epinephrine) shot, Medrol (methylprednisolone), Benadryl (diphenhydramine hydrochloride) and IV (intravenous) fluids. The patient's lips were drooping to the right side of his face even after taking the medications. The patient stayed at the ER for 6 or 7 hours then was sent back to home on the same day. On 15-APR-2021 (reported as Saturday), the patient had fever. On 16-MAY-2021 (reported as yesterday from the date of reporting), the patient was much better, and his drooping lips was there a little bit but not as bad. The reporter did not have patient's vaccination card (for lot number or expiration date). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from anaphylactic reaction (passing out/ could not breath/ swollen lips and face) on MAY-2021, and was recovering from fever, and lips were drooping to the right side of face. This report was serious (Other Medically Important Condition, and Life Threatening).; Sender's Comments: V0: 20210532244-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). 20210532244-COVID-19 VACCINE AD26.COV2.S-LIPS WERE DROOPING TO THE RIGHT SIDE OF FACE. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: Coagulopathy, Platelet count, Thrombocytopenia
Clinical narrative: THROMBOCYTOPENIA; COAGULOPATHY; This spontaneous report received from a consumer (wife of the patient) via Johnson and Johnson Corporate Facebook concerned a male of unspecified age, race and ethnicity unknown. Initial information was processed with additional information received on 17-MAY-2021. The patient's height, and weight were not reported. The patient's concurrent conditions included polycythemia. The patient's medical history was not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination.  The batch number was not reported.  The Company is unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported.  "In two weeks" after receiving the vaccine, the patient developed thrombocytopenia, coagulopathy, and low platelets with no underlying conditions.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the thrombocytopenia and coagulopathy was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210504574 and 20210503763.; Sender's Comments: V0: 20210532732- Covid-19 vaccine ad26.cov2.s-Thrombocytopenia and Coagulopathy. 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, UNK
Symptoms: Fatigue
Clinical narrative: FATIGUE; 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  (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported. On an unspecified date, the subject experienced fatigue. The action taken with covid-19 vaccine  was not applicable; and action taken with adalimumab was not reported. The patient recovered from fatigue. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: MILD FEVER; 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  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 17-MAY-2021 11:00 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 17-MAY-2021, the subject experienced mild fever. The action taken with covid-19 vaccine  was not applicable. The outcome of mild fever was not reported. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 65 year old female White and Not Hispanic/Latino. 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: 1805022, expiry: 25-MAY-2021) dose was not reported, administered on 09-MAR-2021, 1 in total administered on left arm for prophylactic vaccination. No concomitant medications were reported.  On 26-APR-2021, Laboratory data included: SARS-CoV-2 IgG antibody test (NR: not provided) Negative.  On an unspecified date, the patient experienced confirmed immunological vaccine failure, no antibodies present, no immunity and no protection against Covid. 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, from the same reporter is linked to 20210535317, 20210536064 and 20210536071.; Sender's Comments: V0: 20210534629-covid-19 vaccine ad26.cov2.s-confirmed immunological vaccine failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE FROZEN BEFORE GIVEN TO  PATIENT; PRODUCT STORAGE ERROR; This spontaneous report received from a pharmacist concerned an 18 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported and batch number: 1820095 expiry: 04-JUL-2021) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAY-2021, the subject experienced vaccine frozen before given to subject. On 13-MAY-2021, the subject experienced product storage error. The action taken with covid-19 vaccine  was not applicable. The outcome of the vaccine frozen before given to patient and product storage error was not reported. This report was non-serious. This case, from the same reporter is linked to 20210535717, 20210534954, 20210536001 and 20210536595.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: BODY SORENESS THE DAY OF AND DAY AFTER; CHILLS; KILLER HEADACHE; This spontaneous report received from a patient 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  (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 04-MAY-2021 11:18 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 04-MAY-2021, the subject experienced body soreness the day of and day after. On 04-MAY-2021, the subject experienced chills. On 04-MAY-2021, the subject experienced killer headache. The action taken with covid-19 vaccine  was not applicable. The outcome of the killer headache, chills and body soreness the day of and day after was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Peripheral swelling
Clinical narrative: RIGHT CALF SLIGHTLY BIGGER THAN LEFT; PAIN IN RIGHT LEG; HEADACHES ON AND OFF; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced right calf slightly bigger than left. On APR-2021, the subject experienced pain in right leg. On APR-2021, the subject experienced headaches on and off. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from pain in right leg, and headaches on and off, and the outcome of right calf slightly bigger than left was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea exertional, Feeling abnormal, Feeling drunk, Headache
Clinical narrative: COULDN'T BREATHE WHEN WENT UPSTAIRS; SEVERE BODY ACHES; FELT DRUNK; FELT LIKE GOT HIT/GOT HIT EVERYWHERE ON THE BODY/COULD FEEL IT IN BONES; FELT COMPLETELY OUT OF IT AND FELT LIKE NOT THERE; CHILLS/ CHILLS THAT SHE COULD NOT SHAKE OFF; FELT LIKE COMPLETE CRAP; HEADACHE/REALLY BAD HEADACHE AT FRONT OF THE HEAD; This spontaneous report received from a patient concerned a 25 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1808980, expiry: 20-JUN-2021) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced couldn't breathe when went upstairs. On APR-2021, the subject experienced severe body aches. On APR-2021, the subject experienced felt drunk. On APR-2021, the subject experienced felt like got hit/got hit everywhere on the body/could feel it in bones. On APR-2021, the subject experienced felt completely out of it and felt like not there. On APR-2021, the subject experienced chills/ chills that she could not shake off. On APR-2021, the subject experienced felt like complete crap. On APR-2021, the subject experienced headache/really bad headache at front of the head. The action taken with covid-19 vaccine  was not applicable. The outcome of the headache/really bad headache at front of the head, chills/ chills that she could not shake off, couldn't breathe when went upstairs, severe body aches, felt drunk, felt like got hit/got hit everywhere on the body/could feel it in bones, felt like complete crap and felt completely out of it and felt like not there 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