chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Admission Date: 9/24/2022 Discharge Date: Sep 27, 2022 PRESENTING PROBLEM: Hepatitis [K75.9] Elevated troponin [R77.8] Allergic reaction, initial encounter [T78.40XA] Drug reaction, initial encounter [T50.905A]   HOSPITAL COURSE: Patient is 71-year-old female with past medical history of prior asbestos exposure and sinus bradycardia who is vaccinated x4 and diagnosis COVID-19 on 09/22 (symptoms started same day).  She was started on Paxlovid 9/23 and upon taking her 2nd dose 9/24 she broke out in hives diffusely, had wheezing, nausea, and abdominal pain so she presented to the emergency department.  LFTs were significantly elevated and BNP was mildly elevated. AST 1447 and ALT 948, BNP 978 on admission.  Gallbladder ultrasound negative.  Patient was given IV Solu-Medrol and then transitioned to oral prednisone 40 mg daily.  LFTs trended down and symptoms were improving but not resolved on 2nd hospital day.  That night her heart rate decreased into the 30s with EKG obtained 9/26 AM showing sinus bradycardia with HR of 36. She was feeling more lightheaded/dizzy especially with exertion.  Heart rate only increased to 50s with activity. Patient had mild electrolyte abnormalities which were corrected, TSH normal.  Cardiology consulted and recommended watching more night.  On 09/27/2022 with labs and vitals stable condition, having recovered from COVID infection, and recommendation from the electrophysiology team for ZIO patch placement the patient was discharged home with instructions to follow-up with her primary care physician as well as a Cardiology electrophysiology team.
Severe burning pain of left leg.   Upper thigh above near hurts as a severe muscle pull.  From knee cap down to ankle burning  pain with occasional deeper burn pain up and down shin .   Very uncomfortable.  Hardly able to sleep
Report faxed to CLinic: Left arm circumferential swelling, generalized erythema and paresthisias on left ring and small fingers which lasted approx 24 hrs.  Patient had pleuritic chest and SOB which lasted approx 1-2 hrs.  Residual minimal left arm swelling lasted 4 days.  Patient was treated with IV Zantac and Benadryl.
No additional AE/no PQC.; PROQUAD was administered after it experienced a supported temperature excursion; This spontaneous report was received from a Medical Assistant referring to a 4 year old male patient. The patient's medical history, concurrent conditions, and historical drugs were not reported.  On 19-SEP-2023, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) 0.5 ml, lot # X009731, expiration date on 30-SEP-2024, albumin status as rHA (strength, dose number, route, and anatomical location were not provided) for prophylaxis after temperature excursion of 12.7°F during 45 minutes, 30 seconds (product storage error), there was no previous temperature excursion. Concomitant therapies included sterile diluent (manufacturer unknown). No adverse event reported.
Approximately 20 hours after I received the second vaccine dose, I developed a fever of 102 F. This was associated with other moderate-to-severe flu-like symptoms including chills, myalgias, and headache. Within 3 hours, the fever decreased to 99-100 F and remained between 98-99 F throughout the rest of the day. The headache and myalgias persisted, but by the following day (today), nearly all symptoms had resolved. No GI symptoms were experienced.
Development began to delay, milestones were no longer met on time if at all, displaying signs of autism, began homeopathic treatment January 10th, 2014.
Patient with red cheeks, petechiae around eyes and a  rash which appeared to have pimple like look toit on the right side of his back, no breathing issues , swelling or wheezing.
Patient experienced hot flashes and sweating for 10 minutes. He was sitting down and didn't appear to be dizzy. He remained seated until the hot flashes subsided. He came back in the following day and told me about his experience
patient was on treadmill at home on 3/4/21 and became shortness of breath, collaspsed, hitting head on floor. Family started CPR, Downtime prior to ED arrival 30 minutes.  Arrived at ER at 8:48AM.  Intubated by EMS.  initially shocked 1x but otherwise was in asystole.  Eventually after about 70 minutes of CPR at ER patient had no ROSC, pupils dialted and fixed and at this point pronounced dead.
Case number PHEH2014US023398 is an initial spontaneous report received from a health care professional on 20 Nov 2014. This case refers to a 62 years old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on 13 Oct 2014. On the same day after vaccination, she experienced Guillain Barre Syndrome. The outcome, seriousness and causality of the event were not reported. Seriousness assessment of Guillain Barre Syndrome was upgraded based on the NVS-IME list and NVx key event list.
Caller who is responsible for vaccine storage reported administered dose of improperly stored PROQUAD.; This spontaneous report was received from office manager and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 21-JUN-2022, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) subcutaneous injection, lot #U017140, expiration date: 28-NOV-2022 (strength, and route of administration were not provided) administered for prophylaxis (Product storage error).  This is one of the several reports received from the same reporter (link reports # 2206USA007281, 2206USA007312, 2206USA007639).; Sender's Comments:  US-009507513-2206USA007312:Patient 02191883 US-009507513-2206USA007281:Patient 02191896 US-009507513-2206USA007639:Patient 02191897
Patient said she "passed out" in Highway during the day on Friday 10/20/2017. No injuries reported. Patient does not remember how long, but she is ok & no accident reported.
Patient had redness and swelling at injection site suggesting "Covid Arm".  Patient went to family doctor and was prescribed Medrol Dose Pack and Cephalexin.
PATIENT & MOM CAME BACK TO PHARMACY-REPORTED BUMPS ON HER ARM. SHE WENT TO SCHOOL TO PICK UP SCHEDULE AND THEN RETURNED AS SHE EXPERIENCED ITCHINESS, WORSENING OF BUMPS AND REDNESS ON FACE, ARMS AND LEGS. CALLED HER MD OFFICE AND TRIAGE NURSE HAD ME HAVE PT GO TO EMERGENCY ROOM.
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 65-year-old, elderly patient of an unspecified gender. It was reported that, the FLUCELVAX QIVc vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 17-Oct-2018, the patient was administered FLUCELVAX QIVc [[route of administration: intramuscular, anatomical location: left deltoid, batch number: 252230, expiry date: 31-May-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805459 was crossed linked to original cases 201804863 due to same reporter.
This Non valid spontaneous report was received from a registered nurse and refers to an unspecified number of unspecified patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On dates on or after 21-SEP-2017, the patients were vaccinated with improperly stored dose of PEDVAXHIB for prophylaxis, lot# N000238 with expiration date of 25-OCT-2019, lot# N003701 with expiration date of 01-NOV-2019, lot# N008079 with expiration date of 02-DEC-2019, lot# N012920 with expiration date of 07-FEB-2020 (strength, dose, route and frequency were not reported); or with improperly stored dose of RECOMBIVAX HB for prophylaxis, lot# N020613 with expiration date of 05-MAY-2020, lot# N002202 with expiration date of 04-NOV-2019, lot# N011851 with expiration date of 19-DEC-2019; or with improperly stored dose of ROTATEQ)orally, for prophylaxis, lot# N000175 with expiration date of 20-SEP-2018, lot# N005618 with expiration date of 04-OCT-2018, lot# N005078 with expiration date of 22-NOV-2018; or with improperly stored dose of VAQTA for prophylaxis, reported lot# M019924 with expiration date of 02-SEP-2018, lot# N008823 with expiration date of 26-MAY-2018. No adverse effects were reported. It was stated that the vaccines underwent a temperature excursion of 32°F (degrees Fahrenheit) to 35°F for 40 minutes; No previous temperature excursion was done. The call was because of a "data logger". This is a non-valid case due to lack of patient identifier. Follow up information was received from the registered nurse 30-APR-2018. The nurse stated the temperature excursion was stable and they had two refrigerators that held the related vaccines. The nurse was not able to provide patients' names or initials, or ages, but was able to provide number of patients, gender information, and vaccination dates. This report referred to a female patient vaccinated with improperly stored VAQTA (lot# N019924 with expiration date 02-SEP-2018) on 30-SEP-2017. Upon receipt of follow-up information it was determined that this case is now valid because patient identifier was received. This is one of several reports received form the same reporter (link reports: 1710USA004069, 1805USA001661, 1805USA004617, 1805USA004618, 1805USA004590, 1805USA004591, 1805USA004592, 1805USA004593, 1805USA004674, 1805USA004675, 1805USA004676, 1805USA004677, 1805USA004678, 1805USA004679, 1805USA004680, 1805USA004681, 1805USA004682, 1805USA004683, 1805USA004967, 1805USA004968, 1805USA004969, 1805USA004970, 1805USA004971, 1805USA004972, 1805USA004973, 1805USA004974, 1805USA004975, 1805USA004976, 1805USA004977, 1805USA004979, 1805USA004980, 1805USA004981, 1805USA004982).
Within 1 minute he felt faint. Had a small seizure for about 10 seconds. Head rolled back. Eyes open but eyes rolled back. Body rigid and arm flailed and loud gasp. Regained consciousness and felt faint  for about 4 more minutes and passed out again. Regained consciousness and after 10 minutes ready to leave.
48hr p/vax 4"x4" erythema, indurated swelling surrounding inj site;also warm to touch;no systemic sx noted;
Mom called and stated he woke with 1 1/2 inch diameter area surrounding shot injection site that is red and itches.
Patient died of natural causes in hospice within 6 weeks of receiving the OVID vaccine.
Stung on the leg and now has a 3-inch diameter of swelling; Stung on the left cheek and it "took out half my face" and the sting spread to the jaw and neck; Felt heat like any inflammation and moved down to the throat; Sick for a day and a half on the couch; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick for a day and a half on the couch), FACE OEDEMA (Stung on the left cheek and it "took out half my face" and the sting spread to the jaw and neck), FEELING HOT (Felt heat like any inflammation and moved down to the throat) and PERIPHERAL SWELLING (Stung on the leg and now has a 3-inch diameter of swelling) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025C21A and 031B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Allergic reaction to wasp sting. Concomitant products included PRAVASTATIN for Cholesterol, SERTRALINE for Depression, LEVOTHYROXINE for Thyroid disorder.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced ILLNESS (Sick for a day and a half on the couch). On 11-May-2021, the patient experienced FACE OEDEMA (Stung on the left cheek and it "took out half my face" and the sting spread to the jaw and neck) and FEELING HOT (Felt heat like any inflammation and moved down to the throat). On 16-May-2021, the patient experienced PERIPHERAL SWELLING (Stung on the leg and now has a 3-inch diameter of swelling). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. On 12-May-2021, FACE OEDEMA (Stung on the left cheek and it "took out half my face" and the sting spread to the jaw and neck) and FEELING HOT (Felt heat like any inflammation and moved down to the throat) had resolved. At the time of the report, ILLNESS (Sick for a day and a half on the couch) and PERIPHERAL SWELLING (Stung on the leg and now has a 3-inch diameter of swelling) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   After receiving second dose, patient was sick for a day and a half and was on the couch. Patient is a beekeeper and have no allergies to bees. Patient noticed an allergic reaction about 2 weeks after the vaccination. And on 11 May 2021, the patient was stung by the bee and there was a reaction and it took half patient's face, later it spread to the jaw, neck and throat. Patient also felt heat and inflammation over there. Then on 16 May 2021, patient got stung on the leg and developed a swelling of 3 inch. The patient was wondering whether her histamine response has changed after getting the vaccine.
itching; slept most of the day; swellling; redness; exhausted; pain; arm tenderness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd January 2020, the patient received Shingrix. On 3rd January 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. On 4th January 2020, the patient experienced swelling, erythema, exhaustion, pain and sleepiness. On 5th January 2020, the patient experienced pruritus. On an unknown date, the outcome of the pain in arm, swelling, erythema, exhaustion, pain, pruritus and sleepiness were recovering/resolving.   It was unknown if the reporter considered the pain in arm, swelling, erythema, exhaustion, pain, pruritus and sleepiness to be related to Shingrix.  Additional case details were reported as follows: On Saturday, the patient was exhausted and slept most of the day but she spent 2 hours at the gym and felt great. The outcome of pain in arm, swelling, erythema, exhaustion, pain and pruritus were reported as recovring/resolving in the database however in source document, it was mentioned as Fatal.
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. On 06-MAY-2013 the patient was vaccinated with ZOSTAVAX (lot # 6169AE, exp date 06-MAR-2013),  0.65 ml, subcutaneous (anatomical location unspecified). The Registered Nurse reported that patient received an expired dose of ZOSTAVAX. No adverse effects reported. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Syncopal episode with tonic-clonic movements. Episode occurred approximately 5 minutes after vaccines given and lasted less than a minute.
Rash under right breast , treatment benedryll and cortisone cream  better after 2 days but still sensitive
Major rash, swelling and hot to the touch on the leg that the shot was given in. Was diagnosed with cellulitis.
bleeding in the injection site at the left arm; sore and got a bruise that developed yesterday on the left arm; puffy  for day, kind of a lump there; she was sore normally; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE HAEMORRHAGE (non-serious), outcome "unknown", described as "bleeding in the injection site at the left arm"; VACCINATION SITE BRUISING (non-serious), outcome "unknown", described as "sore and got a bruise that developed yesterday on the left arm"; VACCINATION SITE MASS (non-serious), outcome "unknown", described as "puffy  for day, kind of a lump there"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "she was sore normally".  Additional Information: The caller is concerned about the symptoms she experienced after getting a dose of the Pfizer COVID-19 vaccine. She had bleeding on the site, and bruising after the injection. The caller declined to provide any information about if this was her first or second dose, no dates were provided. The agent already provided the number to Pfizer. The caller is wanting to know the research for the blood clotting disorder after administration of the vaccine. She added that she knows someone that experienced blood clotting after the administration of the COVID-19 vaccine but she doesn't know what type of COVID-19 vaccine that person took. The caller is asking for the data. Upon transfer, the caller declines to complete a report stating she has questions about the drug and she doesn't want to be involved. All she wants to know is more information about side effects and about the blood clotting disorder. She just has a bruise and wants to know if its normal. She doesn't want to make an official report or anything. Patient details: Declined to provide any details. Reporter details: Declined to provide any details. However, right after she was injected with the COVID-19 vaccine, she experienced a lot of bleeding. She is not on blood thinners and the person who administered the vaccine asked if she was and she informed him she was not. The bleeding did stop. She was sore normally, which was expected, but she got a bruise as well. She read if she was injected incorrectly, a blood clotting disorder can form. She doesn't know if it was injected incorrectly or intramuscularly, she didn't watch the person.   No follow up attempts are possible; information about lot/batch number cannot be obtained.
when checking out, pt passed out & hit head on counter;afterwards exp short term memory loss stayed & observed & 1hr vital signs stable, no rash, no resp diff
Information has been received from a licensed practical nurse concerning a 6 year old female with leukemia and an allergy to Sulfa, who on an unknown date was vaccinated with a dose of hepatitis A virus vaccine inactivated (manufacturer unknown)(Lot # not given).  Subsequently, the patient had a negative titer for Hepatitis A.  The reporter also indicated that the patient had been vaccinated at another facility and that there were no immunization records available.  It was further reported that the patient had similar experiences with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (WAES # 0206USA01324) and hepatitis B vaccine recombinant (yeast) (manufacturer unknown) (WAES # 0208USA02265).  Additional information is not expected.
pain & swelling of vax site, lt distal triceps & elbow w/induration w/in 12 hr; tx Dicloxacillin
Patient received the Pfizer Vaccine at around 3:00 PM.  Patient  proceeded to sit at the observation area for15 min. for monitoring with no s/s of adverse effects. Patient proceeded to go back to work at the factory. Nurse was flagged down by staff stating patient came back because complaint of dizziness and headache.  Patient was offered to lay down. Ice pack was placed on the back of patients neck. Nurse encouraged fluids. VS were taken and noted to be stable. Patient was monitored for 30 mins before departure. Nurse instructed patient and patient mother on  signs, Symptoms of Severe Adverse Reactions to report to health care provider or to go to the emergency room. Patient/Family verbalized understanding.
Initial report was received on 21 April 2009 by another manufacturer that received the report from a healthcare professional on 13 April 2009. A male service member (age not reported) was vaccinated with ACAM2000, SP Biologics, lot number VV04-003A) on 26 February 2009. Approximately one month later, after his deployment, he developed bleeding and bruising from the nose and mouth. While traveling, he received Yellow Fever vaccine (manufacturer and lot number unknown) and Mefloquine (malaria prophylaxis). He was deployed to a foreign country where he was diagnosed with idiopathic thrombocytopenia purpura (ITP). The report also states an allergic reaction occurred in February 2009. No additional information was provided. Documents held by sender: None
Severe headache started the day after the first shot and continued daily. At week 3, the neurologist prescribed a steroid and the headache stopped. I got the second shot about 8 days later. I got a headache driving home on Tuesday.  No headache Wednesday or Thursday, and then Friday the headache was worse than after the first shot. Two weeks later, my PCP gave me the same steroid and scheduled me for an antibody test several weeks later. The steroid took the edge off the headache, but the pain did not go away.  I was taking IBU800 and tylenol 3 daily. I started acupuncture in July to finally get relief from the headaches.
Information has been received from a nurse concerning a 16 year old female who on unspecified dates was vaccinated with the first and second doses of GARDASIL.  The first and second doses did not cause symptoms.  On 16-JUL-2008 the patient was vaccinated with the third dose of GARDASIL.  Concomitant therapy included VAQTA (manufacturer unknown).  The patient experienced "seizure-like symptoms within 30 seconds of her third dose".  The symptoms were falling on a table, mild shaking including her legs, hand stiffening and urinating on herself.  On an unspecified date the patient was recovered.  The patient saw the doctor and sought unspecified medical attention.  Upon internal review seizure-like symptoms were considered to be other important medical event.  Additional information has been requested.
pt recv vax 15AUG96 & 5 to 6 days later pt exp flu-like sx, including fever, nausea, vomiting & gen malaise;WAES 96081699 through 96081702);
Patient presents with new onset a fib with RVR. Controlled initially on Diltiazem in ER and now rate is controlled with oral metoprolol. Treated and discharged. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
I had a chest CT scan and the results showed abnormalities. I do not want to go further in details.
beyond 36 days for second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION IN ERROR (beyond 36 days for second dose) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION IN ERROR (beyond 36 days for second dose). At the time of the report, PRODUCT DOSE OMISSION IN ERROR (beyond 36 days for second dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.