chrisvoncsefalvay/vaers-outcomes huggingface dataset:
bleeding; a new nude appeared on her husband's neck and clavicle; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), in Nov2021 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "cancer" (unspecified if ongoing), notes: her husband is a cancer patient. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary series immunization completed but manufacture unknown), for COVID-19 Immunization. The following information was reported: HAEMORRHAGE (medically significant), outcome "unknown", described as "bleeding"; NODULE (non-serious), outcome "not recovered", described as "a new nude appeared on her husband's neck and clavicle". Therapeutic measures were taken as a result of nodule.  Clinical course: Reporter stated that her husband was a cancer patient. He got a booster shot last November. She stated that she saw on the news that the booster shot had some side effects on people with cancer, specifically around the neck and experiencing numbness. After that, she noticed that a new nude appeared on her husband's neck and clavicle. For this reason, he received aggressive chemotherapy for 3 weeks, and the nodes were reduced by half. But a few weeks later they noticed that it grew back with some bleeding.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
p/vax pt devel T103.3, irritable & cranky, fever, not eating;cough, tired, lethargic, not self, not playful, fussy, no sleep, rapid heart beats, lt side of chest  larger, nose flaring, trouble breathing;to ER found heart disease;
fell on her back/fell on the back of her head; has a lot of pain from the fall; muscle pain from the fall; This spontaneous case was reported by a consumer and describes the occurrence of FALL (fell on her back/fell on the back of her head), PAIN (has a lot of pain from the fall) and MYALGIA (muscle pain from the fall) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FALL (fell on her back/fell on the back of her head), PAIN (has a lot of pain from the fall) and MYALGIA (muscle pain from the fall). At the time of the report, FALL (fell on her back/fell on the back of her head), PAIN (has a lot of pain from the fall) and MYALGIA (muscle pain from the fall) outcome was unknown.            No concomitant medications were reported No treatment medications were reported.
I got COVID-19 I had a home test and it was positive. I had sore throat, cough, congestion, mild fever, fatigue. It took 5-6 days I felt better every day and after a week I was negative.
20 minutes after receiving her moderna covid vaccine dose #1 pt began to c/o generalized itching, shortly afterwards developed nasal congestion and nausea. Her symptoms progressed to a feeling  that she wanted to vomited and c/o chest tightness.
patient filled out the consent form and was verbally confirmed to have not received any covid shot.  It was later discovered that patient had Janssen covid shot in March after insurance rejection prompted.
she had fever after getting her first covid vaccine shot; This is a spontaneous report from a contactable consumer(Patient). This female consumer of an unspecified age reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration on Mar2021 as dose 1, single for covid-19 immunisation.  Medical history included she had COVID in unspecified date in August. The patient's concomitant medications were not reported. Caller stated that she got her first Pfizer Covid shot in Mar2021 and she had fever after getting her first Covid vaccine shot. She was told not to take Tylenol for 24 hours. She wanted to know if Pfizer had any information on that. She wanted to know if she could use antipyretics after vaccination with the Pfizer- BioNTech COVID-19 vaccine or not. She was told that she could take medication after getting the vaccine. She heard people with COVID had more of severe a reaction after getting the first shot. Caller reported that she had 101 fever post vaccination. The patient underwent lab tests and procedures which included body temperature: 101 on Mar2021. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Became dizzy and left leg feeling full.  Stroke, Hospitalized in ICU, regular room, then rehab, now home health care
Migraine headache in the evening- same day as the shot  Bone & joint aches, moderate fatigue, mild muscle weakness - the day after getting the shot
Subsequent to receiving one dose of varicella virus vaccine live the pt experienced chickenpox with quite a number of lesions and a high fever. The pt sought unspecified medical treatment.
This spontaneous report was received from a physician (who is also the patient) of approximately 60 years of age. No drug reactions or allergies were reported. The patient's current condition included hypertension. Approximately on an unknown date in 2008 (reported as 5 to 6 years ago) the patient was vaccinated with a dose of ZOSTAVAX 0.65 ml, subcutaneously (lot number and expiration dates were not reported) to prevent recurring episode of a mild case of shingles that he developed in an unspecified eye a year before (approximately in 2007) as well as three years before (approximately in 2005) he received the ZOSTAVAX. The symptoms of mild case of shingles that he developed in the past were repeated pain in an unspecified eye. Concomitant therapies included candesartan (manufacturer unknown) and an unspecified beta blocker. Approximately on an unknown date in 2010 (reported as a year or two later after he received ZOSTAVAX) the patient experienced pain in his unspecified eye but it was much milder. The patient did not receive any treatment for the event. There were no lab diagnostic studies performed. The patient did not seek any medical attention. There was no product quality complaint involved. The outcome of pain in his unspecified eye was unknown. The causality of the event was not provided. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to a unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date in 2015, since 26-FEB-2015, the patients were vaccinated with improperly stored VAQTA (dose, route, lot number and expiration date were not reported). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Parent states child has four blister type rash marks.  Physician verified Chicken Pox total of 6 pox on child-no other S/S, well and dried pox 12-5-04.
The day after: fatigue, nausea, feverish, body aches, shallow breathing.
Multiple swollen and sore lymph nodes on left side of neck. Flu shot was Fluzone Intraderm 2012-13 SYR and injected in the left shoulder. Swelling and pain has continued without change since the morning following the vaccination.  Much more injection site pain than a normal flu shot. Pain lasted until 01/29/2013.
Sinus tachycardia with arrhythmia within 24 hours of vaccination.  Shortness of breath.
Injection site was in shoulder, not deltoid. Some stiffness, soreness and bruising over a week after vaccine was administered.
Patient left clinic to go downstairs to lab. 15-30 min later mom returned with patient red all over body and scratching body all over. Mom states patient reported tongue numb shortly after injections on the way to lab and itching also started then. Dr. re-examined patient (same MD for physical and ordering MD). Benadryl 1 tsp PO, Epinephrine 0.15 SC LA 95% RA, heart rate 130 per relief RN. 30 min later: HR 107, pt asleep, redness decreased, MD instructions given.
To ETC 3/23 with measles rash from vax. Confluent erythema papules on face. Small papules on back, arms and legs.
Terrile pain all over Body. Fever  Was in Bed For 3 Days. Swelling in arm  Feel Fine now
Inflammation at site of vaccination. Erythema, edema, warmth and pain in left shoulder. 9cm x 6.5cm area. Treated with cephazolin and benadryl.
case of shingles. Pt has received Shingrix vaccines/suspected vaccination failure; shingles; This case was reported by a other health professional via sales rep and described the occurrence of suspected vaccination failure in a 91-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included mepolizumab (Nucala) solution for injection for product used for unknown indication and prednisone for product used for unknown indication.   On an unknown date, the patient received Shingrix, Nucala 100 mg at an unknown frequency and prednisone at an unknown dose and frequency. On an unknown date, unknown after receiving Shingrix and Nucala, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The action taken with Nucala was unknown. The action taken with prednisone was unknown. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix. It was unknown if the reporter considered the shingles to be related to Nucala.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix vaccines and timeline of Shingrix vaccine unknown.  The patient developed case of shingles while on Nucala 100 mg and Prednisone. No updated status available for patient. The patient's history part and demographics were unknown. It was unknown if the reporter considered the shingles to be related to Prednisone. The reporter consented to follow up. This case was considered as suspected vaccination failure as details regarding the time to onset and laboratory test confirming shingles for shingles were unknown at the time of reporting. This case had been linked with US2021AMR252583 for 2nd occurrence of shingles, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR252583:same patient, 2nd outbreak
Swelling of lips and tongue began about 30 minutes after receiving vaccine. Took Benadryl; symptoms gradually improved and were gone within about 90 minutes after taking Benadryl
Information has been received from a Certified Nurse Midwife, for the Pregnancy Registry for GARDASIL, concerning a 19 year old female who in August 2008, was intramuscularly vaccinated with a dose of GARDASIL. It was reported that the patient was pregnant at the time of vaccination. The patient's LMP was 07-APR-2008 and the EDD was 12-JAN-2009. It was reported that this was the patient's first pregnancy. Pregnancy test was positive and ultrasound was performed on 10/14/2008. Follow up information was received from a certified nurse midwife who indicated the patient had positive atypical squamous cell of undetermined significance (ASCUS) HPV both in genital warts and in PAP test. The patient also had anemia during pregnancy. At 17 weeks gestation the patient performed ultrasound. On 29-JAN-2009, 41 weeks+ from her LMP, the patient delivered a health male baby weighing 9 pounds and 7 ounces. Apgar score was 7/9. The patient experienced low transverse cesarean section (LTCS) due to failure to progress (FTP). Upon internal review, low transverse cesarean section due to failure to progress was determined to be an other important medical event. No further information is available.
IPV, DTAP given right thigh on 10/1/10. Parent noted red swollen area anterior right thigh in am of 10/3/10. Took child to unknown ED. Seen 10/4/10 in office. 8x10 cm are 10/4/10
This spontaneous report as received from a pharmacist refers to a 62 years old patient. The pharmacist reported that an expired PNEUMOVAX 23 (Lot # 665708/0651Z, Exp date:15-JUN-2011, dose, route unspecified) given to the patient of 31-OCT-2012. No adverse effect reported. No treatment information was reported. The outcome was unknown. Additional information has been requested.
320PM pt recvd vax & waited 15min @ 415PM felt nauseated & vomited;drank coffee & took APAP;hives appeared on neck & arms, for about 2hr;felt fine later;
This spontaneous report as received from a male consumer of unknown age refers to himself. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot # not reported). On an unspecified date after this, he developed a "rash at the site of ZOSTAVAX injection." It was unspecified whether the patient sought for medical attention. The patient had not recovered. The relatedness for "rash at the site of ZOSTAVAX injection" was unknown for ZOSTAVAX. Legal issue was involved. Additional information is not expected.
This spontaneous report has been received from a registered nurse referring to a patient of unknown age. On 18-AUG-2014, the patient was vaccinated with the first dose of GARDASIL (dose, lot # not reported). The nurse did not know if this was GARDASIL or GARDASIL 9. On 19-OCT-2015 the patient was vaccinated with a dose of GARDASIL 9. On 21-OCT-2015, the patient was vaccinated with the second dose of GARDASIL 9 (dose and lot# not reported) (confirmed not GARDASIL). The patient received GARDASIL 9 outside of the recommended series schedule. No adverse symptoms reported. This is one of three reports from the same reporter. Additional information has been requested.
Client  presents to vaccine site requesting a Moderna Booster vaccine.  Client reports he received the 1st and 2nd Moderna COVID vaccine.  Client's vaccine card only shows documentation for 1st COVID vaccine on 01/21/2021. Client reports his 2nd dose Moderna COVID vaccine was on 02/18/2021,  not documented on vaccine card.  Client made aware of need for 2nd dose COVID vaccine documentation in order to give booster dose.  Client states he will not be able to obtain that documentation as he received it overseas, and he also states the facility is no longer offering COVID vaccines.  Client requests to have a 2nd Moderna COVID vaccine today instead of booster dose.  Medical consult sent and approved 2nd full dose of Moderna COVID vaccine today.  Client vaccinated with 2nd COVD vaccine at 3:18 pm.  No adverse symptoms reported in observation period, client leaves observation area.
local site reaction, red/swollen surrounding injection site up and down half of arm. patient has followed up with prescriber for possible antibiotics and ultrasound.
injection site red, warm to touch, swollen, and itchy Medrol Dosepak given
Patient up to date on COVID vaccinations who admitted to hospital with complications of COVID including hypoxia.  Provider d/c note:  "Stable COVID-19 infection in a fully vaccinated individual. Initially hypoxic needing O2 by nasal canula, but by discharge, hypoxia had completely resolved. Received Remdesivir x 3 doses. Will complete 10 day course of Decadron."
Routine surveillance CT scan for metastatic cancer revealed mass in left lung. Presumed to be cancer. Removed in surgery and found to be negative for cancer. Mass was a granuloma, negative for fungal infection and negative for tuberculosis type infections. Cause of granuloma is unknown.
pt recv vax & devel granuloma @ the inj site;pt was advised to apply warm packs, move the legs a lot & massage;the granuloma lasted for one to 4wk;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient received BNT162b2 (BNT162B2), on 06Oct2021 as dose 1, single (Batch/Lot number: unknown) and on 18Dec2021 as dose 2, single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history included: "known allergies: penicillin" (unspecified if ongoing), notes: known allergies: penicillin. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200996922 Same patient, drug/ different event;
I was feeling okay until Friday. On Friday I had sinus congestion and cough. I was feeling run down. My job instructed me to get a test that came back negative. I started taking CORICIDIN. I had a urgent visit today and was told take another PCR test and that came back negative. I am going to the urgent care to see if they will give me antibiotics.
1-2 hours after administration there was warmth and redness at the injection site. Later that evening the area became more inflamed and began to itch the only relief came from icing the area. As of 11/10/17 the area was better but still slightly red and itchy. As of today reaction has resolved.
she has been hospitalized (due to having Covid infection) from 12Feb2021 to 19Feb2021; she has been hospitalized (due to having Covid infection) from 12Feb2021 to 19Feb2021; Scheduled 5-6 weeks for second shot and missed appointment; Scheduled 5-6 weeks for second shot and missed appointment; This is a spontaneous report from a contactable consumer (patient) received via . A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 26Jan2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date patient was tested positive for the Sars-cov-2 antibody test and diagnosed to have COVID-19 infection. Patient was admitted to hospital from 12Feb2021 to 19Feb2021 due to having Covid infection. Technically, she also missed her second shot because it had already been more than 21 days since the first vaccine shot. The patient reported that she received the COVID shot first dose on 26Jan2021 and the paperwork that she got said second dose should be received 3 weeks apart. She was scheduled instead for 5-6 weeks and she missed her scheduled appointment for second shot. If the minimum was three weeks, patient wanted to know what the maximum was, or did she have to start over again. Patient enquired if she missed her window for the second vaccine. Patient declined to proceed with report at this time. Patient stated she had called the number the agent gave and selected option 3 and now has been waiting again. She also clarified that she spoke with a Pfizer representative already and got all the information. The initial safety information received was reporting only non-serious adverse drug reaction(s), Upon receipt of follow-up information on [15Mar2021], this case now contains serious adverse reaction(s). Information processed together.The outcome of the events were unknown.  Information on lot/ batch number has been requested.
Developed wheezing/chest tightness. No stridor or rash or injection site symptoms. Took Benadryl 50mg q4 x 3 doses, took albuterol every 2 hrs for 8 hrs. Had EpiPen nearby (a family member's, not mine), but did not use.  Felt fine the next morning, 24 hrs afterwards. Just mild headache for a few days (not unusual for me)
This spontaneous report as received from a registered pharmacist refers to a 62 years old female patient. The patient was vaccinated with ZOSTAVAX (dose, route and lot # not reported) on 07-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. On 09-AUG-2012 the patient called the pharmacy to report that she had developed a warm, hard lump at the site of injection, No treatment was prescribed. Whether sought medical attention not reported. The pharmacist suggested to the patient to call back if the symptoms persisted. Additional information has been requested.
This case was reported by a nurse and described the occurrence of vomiting in an 8 yr old female pt who received hep A vaccine inactivated (Havrix). On 28May04 the pt received the first dose of Havrix (lot VHA814A2). At an unspecified time following the admin of Havrix, on 28May04, the pt experienced vomiting. The event resolved on 30May04. The nurse considered the vomiting to possibly be related to vaccination with Havrix.
Rash on cheeks, around eyes, on abdomen, legs, under breast; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on cheeks, around eyes, on abdomen, legs, under breast) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No medical history provided by the reporter.  Concomitant products included ESOMEPRAZOLE for an unknown indication.   On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced RASH (Rash on cheeks, around eyes, on abdomen, legs, under breast). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash generalised, at an unspecified dose and frequency. At the time of the report, RASH (Rash on cheeks, around eyes, on abdomen, legs, under breast) had not resolved.            Most recent FOLLOW-UP information incorporated above includes: On 26-Jun-2021: TCR document received on 26-jun-2021 has no new information
Information has been received on 17-OCT-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age and her spouse. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about late 2016, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving the ZOSTAVAX, the patient developed a painful rash. In response to these complaints, the patient presented to a physician and was diagnosed as suffering from the shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Diagnosed with Bell's Palsy and having headache.  On Saturday went to ER, did CT scan . Saw PCP on Monday.