chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative: 7/28-COVID+; reports cough, temp, SOB, loss of taste/smell, joint pain, dizziness, and family + for COVID 8/4-symptoms improving
neuropathy of the feet and hands; headaches; chest pain; elevated heart rate; exhaustion/ am extremely fatigued following minor tasks; severe inflammation; belching; excessive sweating; cant' sleep through the night; am out of breath frequently; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received BNT162B2 dose 1 via an unspecified route of administration, administered in arm left on 17Aug2021 16:00 (Lot Number: EW0175) as single dose, at the age of 34-year-old, for COVID-19 immunisation. Medical history reported as none. There was concomitant therapy but unspecified. No other vaccine in four weeks. And there were other medications in two weeks. The patient had not contracted COVID prior vaccination and no COVID tested post vaccination. No known allergies. The patient experienced neuropathy of the feet and hands, headaches, chest pain, elevated heart rate, exhaustion/ am extremely fatigued following minor tasks, severe inflammation, belching, excessive sweating, cant' sleep through the night, am out of breath frequently, all in 2021 with outcome of not recovered. Occasionally had elevated heart rate, and still deal with the belching and sweating, all in 2021. The patient underwent lab tests and procedures which included heart rate: elevated in 2021; testing: unknown result in 2021.  Treatment received for the events that included various medications and testing. Events resulted in physician office visit.
HEADACHE; FEVER; This spontaneous report received from a patient concerned a 53 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: unknown) dose was not reported, administered on 06-APR-2021 on left Deltoid 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 06-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and fever. This report was non-serious.
Patient received Covid-19 vaccine @ 1905, 5 minutes after patient reported feeling flushed, faint, nauseas, having numbness & tingling to fingertips. Patient noted to be diaphoretic. Patient reports having syncopal episodes in the past & previous anaphylactic reaction after 4th allergy shot. Patient reports this episode does not feel like one of the previous syncopal episodes. No other symptoms noted, VSS- BP 138/69. After 45 minutes of monitoring, patient still feeling very diaphoretic, allergist on call made aware who advised to send to ED after symptoms not resolving. Patient transported to ED via wheelchair for further workup
Hypotonic-hyporesponsive episode.  Patient was fussy most of the day, did not eat well, coughed then stopped breathing, turned blue and went limp.  Father administered back blows and infant came to, event lasted 30-45 seconds.  Infant breathing normally by the time paramedics arrived.  Taken to the hospital. 3/12/08-records received-for DOS 2/8/08-Impression hypotonic hyporesponsive episode eue to vaccines, cardiac etiology, seizure, RSV, sepsis. Murmur which is likely a PPS murmur. In ED bradycardic and pale. Apenic episode at home with limpness and cyanosis. No fever.
Arm hurts a lot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Arm hurts a lot). The outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.   It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 04-Mar-2023 This case was reported by a patient via interactive digital media. The patient already got vaccinated with shingles vaccine but his/her doctor wanted a second vaccine and his/her arm hurted a lot. The follow up would not possible as no contact details were available.
patient received expired YF-VAX vaccine/ NO AE; Initial information received on 12-Feb-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves patient (unknown demographics) who received 0.5 mL YELLOW FEVER VACCINE - US [YF-VAX] (batch number: UJ090AA and expiry date: 08-Jan-2021 via an unknown at an unknown administration site) (expired product administered) on 10-Feb-2021 for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to expired vaccine used (latency: same day).  Caller would like to know if patient needs to revaccinate. The caller stated that he did not have time to provide additional adverse event details at the time of the call, as he was involved in patient care. He stated he would call back with the details. No Still using product.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
According to the nurse from the Clinic, patient fell and hit his head while sitting after the vaccination. When I saw the patient again, he was conscious and drinking water. Nurse note: fell hit head, lightheadness, ringing in ears, reported history of syncope as teen. Nurse took vitals at210pm on 5/8 HR46 BP 92/52 O2: 98% Respiration: 22 Blood glucose 2:25pm-109 EMS was called by the Clinic, patient refused to go to the hospital. Patient went home
Information has been received through the pregnancy registry, concerning a 20 year old female patient, a non smoker, with a history of one pregnancy and one live birth, who on 23-OCT-2007 and 21-DEC-2007 was vaccinated with the first and second doses of Gardasil, respectively (Lot # first dose 658560/1062U, second dose 569437/1266U). Subsequently, the patient became pregnant. It was reported that the patient's last menstrual period (LMP) was 10-JAN-2008. The estimated delivery date was 17-OCT-2008. On 10-MAR-2008 the patient experienced a spontaneous abortion, eight weeks from LMP (reported as 6 5/7 weeks). Diagnostic testing performed on 10-MAR-2008 to assess dates indicated fetal demise. No product quality complaint was involved. Upon internal review, miscarriage was considered to be an other important medical event. Additional information is not expected.
2 days after receiving the booster I had left leg pain that lasted 2 days.  Ten days after the booster the pain returned and was worse making it difficult to climb stairs or lift leg into car or bed.  Self treated with Advil and heating pad which helped some but pain was impacting sleep and quality of life.  On November 28, 2021 was seen by, PA and methylPREDNISolone 4 MG tablets and hip X-ray were ordered.  Prednisone treatment did not change the pain.  After hip results were reviewed I saw an Orthopedic doctor on 12/2/2021 who ordered a hip MRI.  I was then referred to a hip surgeon (12/16/2021) who said I was not a candidate for hip replacement and referred me to a rheumatologist.  Earliest appointment is April 2022.
itchy back and neck red and swollen face  Patient has no difficulties in breathing and able to work.  She stated she had a similar reaction from hydrocortisone shot in past. She said symptoms aren't worsen, and maybe improving.    I improved patient if its get worst.. I recommend that she see her PCP. Also, ask patient to ask PCP is it recommend to  receive the 2nd shot pfizer covid shot
patient only received Dtap/IPV component of Pentacel/No AE; Initial information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from an other health care professional.  This case involves a four and a half year old female patient who received only the dtap/ipv component of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/ IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot UI952ABA, exp dat: 30Jun2020, via intramuscular route in the left thigh (4th dose) on 30-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccinations included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR VACCIN) and INFLUENZA VACCINE (INFLUENZA VACCINE).  It was an actual medication error due to inappropriate reconstitution technique.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
I start having a light bleed 1 week prior to my actual period start time. It last 1-2 days if I continue taking my birth control pills on time. This last month (10/28) it was heavier than normal and I decided to not take my birth control. My period ended 9/4. This is very unusual. Being on birth control for 12+ years, I am normally right on track with the pill vs sugar pills
Suspected vaccination faliure; Still got the flu.; Got sick; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a child female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, less than a year after receiving Flu vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza and sickness. On an unknown date, the outcome of the vaccination failure, influenza and sickness were unknown.   The reporter considered the vaccination failure, influenza and sickness to be possibly related to Flu vaccine.     Additional Information: GSK Receipt Date: 04-Jan-2023 Reporter's Comments:  The consumer reported about the babies by posting a PSA and encouraged all of us to vaccinate our kids.  The consumer reported that the 13 year kid and had only received the flu shot once as toddlers.  The patient got sick that year and never had the flu or shot since.  As a family, decided that it would be better to opt out of the flu shot.  The consumer stated that kids rarely get sick and we tried to refrain from prescription meds as much as possible. The CDC and FDA are money makers.  These people could not be encouraging anyone to vaccinate their children.  They should be encouraging people to do what would best for their family. This case had been linked with US2023AMR001611 same reporter. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments:  US-GSK-US2023AMR001611:Same reporter
P/Receiving DTP, infant held breath 1 min, eyes rolled back, became limp & ashen color. Stimulated by RN started to breathe but made weak wimpering cry. Began to cry forcefully. Color improved but skin clammy & diaphoretic. Had loose stool.
I feel very weak and light headed; I feel very weak and light headed; Arm is Sore; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (I feel very weak and light headed), DIZZINESS (I feel very weak and light headed) and VACCINATION SITE PAIN (Arm is Sore) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced ASTHENIA (I feel very weak and light headed), DIZZINESS (I feel very weak and light headed) and VACCINATION SITE PAIN (Arm is Sore). At the time of the report, ASTHENIA (I feel very weak and light headed), DIZZINESS (I feel very weak and light headed) and VACCINATION SITE PAIN (Arm is Sore) outcome was unknown.            No concomitant was provided. No treatment information was provided.
Hives at injection site Benadryl 25 mg PO + triamcinolone cream to site.
Pt recvd 1st Engerix-B vax on 17JUL91 & onset of h/a, fever occurred approx 18JUL91;
This non-valid spontaneous report was received from an office staff representative and refers to a patient of unknown age and gender. On 19-FEB-2019, the patient was inadvertently vaccinated with an expired dose of PROQUAD (exact dose, strength, route of administration, lot#, expiration date and therapy type were not reported) for prophylaxis. There were no adverse effects reported. Follow-up information has been received from the physician on 18-MAR-2019. This case refers to a 12 years old female patient. The patient's medical history, concurrent conditions and concomitant medications were not provided. The patient received second dose of dose of PROQUAD, which was expired (lot# N021726, expiry date 06-FEB-2019, anatomical location: subcutaneously in leg). Previous doses were reported as 1. Illness at the time of vaccination and adverse event following a prior vaccination were reported as none. The vaccine was purchased with public funds. The patient was vaccinated at private doctor's office/hospital. No treatment was required for the adverse event.
Started as itching at the injection site approx 35 minutes after shot which led to generalized itching on left arm, chest, and back when another colleague examined my back and noted  hives. Became slightly short of breath and felt my heart was racing. Took 25 mg of oral Benadryl and told to go to ED.  In ED heart rate was 126 bpm and BP WAS 136/99. Monitored in the ED for a few hours with no  further interventions. Heart rate improved to 102 bpm and blood pressure to 129/82.
Information has been received from a registered pharmacist concerning a female who on approximately 12-MAR-2009 was vaccinated with a 0.65 mL dose of ZOSTAVAX (Merck), subcutaneously (lot #663881/1787X). The patient developed redness and swelling at the injection site. The patient sought medical attention through a pharmacist. The patient had not recovered. This is one of two reports from the same source. Additional information has been requested.
Experienced heavy feeling all over especially on head immediately after first dose. Hot flashes throughout the day. Extreme fatigue for the first 3 days. By the end of the month I experienced prolong chest pain that lasted 8 weeks. Imaging showed mild mitral regurgitation, mild tricuspid regurgitation, and trivial pulmonic regurgitation. It is November 11 and the chest pain comes and goes still.
Swollen injection site 1-2 cm bump, warm to touch. Local reaction to Prevnar . Use warm compress.
Information has been received from a physician concerning a 16 year old female patient who six months ago, in approximately March 2008, was vaccinated with the first dose of GARDASIL (lot # 659657/1487U). Later that same day of administration, the patient's lips began to swell and her mother gave her child oral BENADRYL and the patient recovered. Approximately 4 months ago, in approximately May 2008, was vaccinated with the second dose of GARDASIL (LOT #660391/0063X). After the second vaccination, the patient's lips began to swell, oral BENADRYL was given and the patient recovered. No other medical follow-up was necessary. When the physician heard about the incident, he decided not to vaccinate the patient with the third dose of HPV vaccine. At the time of the report the patient had recovered. The patient sought unspecified medical attention. Additional information has been requested.
Shingles diagnosed by dermatologist office- Dr.  assistant located  on on my right side of my back and around right side up under the right breast.
Patient is a 34 yo female with PMH of hypertension, diabetes type 2-- insulin dependent, mood disorder, and hypothyroidism. She lives with her sibling and his spouse, and says she was exposed to COVID this way and started having symptoms on January 15. Her main symptoms have been dry cough and difficulty breathing along with shortness of breath. In fact, it was these symptoms that prompted her to present to the ED today. She had been prescribed Azithromycin and Prednisone on 1/17/21. She denies vomiting, diarrhea, abdominal pain, difficulty or pain with urination, excessive urination, thirst, and she denies difficulty with her insulin and her blood sugars. Thus, she was surprised that after arriving to the ED she was diagnosed with DKA. She is saturating 100% on room air. She has not taken any of her medications today (including her antihypertensives), and her BP is higher than normal in the ED. She is acidotic on labs and still has an AGAP of 17 after having received 4 L of IV fluids, insulin, and the insulin drip for 2 hours. Her arterial blood gas had a pH of 7.19. She was vaccinated back in May 2021 but never received a "booster" vaccine.  PT IS CURRENTLY INPATIENT.
received the second dose of COVID vaccine Pfizer lot # ER2613(expiration date 7/30/2021) at 1306. Client reported to EMT table that he felt "cold and lightheaded". EMT and RN responded to client. @1313 Patient reported feeling cold and light headed after his first dose. Patient was sat in a zero gravity chair where an EMT applied ice packs to the posterior neck and left side. This was done after patient reported ice packs being helpful the "last time he experienced the same feelings". The last time the client experienced similar symptoms was "over two months ago" while his blood was being drawn. At this time the patient's vitals were BP: 154/100 P: 113 RR: 22. At 1321 Client reported feeling okay and vitals were BP: 144/94, P:99, RR:20. @1326 Vitals BP: 130/80, P: 94, RR: 16. Another set of vials were taken at 1331 Vitals BP: 130/90 P: 102 RR: 8 Patient was still in gravity chair and taking long and deep breaths. @1338 Vitals BP: 124/90 P: 115 RR: 10. Patient reported symptoms have resolved and is ready to leave. Pt was educated to observe for signs of allergic reactions and informed to call emergency medical services, as well as following up with his healthcare provider. No s/sx of allergic reactions were observed and patient denied EMS. Patient left site at 1341 with an observed steady gait and drove himself home.
p/third pill (fifth day) pt broke out w/red bumps;throat was scratchy also;bumps gone 3 days later c/o itching;states rash raised;
This spontaneous report was received from a healthcare worker referring to a patient of unknown age. On 24-NOV-2015 the patient was vaccinated with an improperly stored dose of GARDASIL lot # reported as K016960 (Expiration date 10-MAY-2017). No adverse effect reported. This is one of the two cases received from the same reporter. Additional information has been requested.
pt presented to ER in cardiopulmonary arrest 30JAN04; apparently occured 25-30min; prior to showing @ hosp; attempted CPR unsuccessfully; pt cold extremities, no activity on arrival to ER; final coroners report SIDS;
Pt presents to this facility 3/8/03 w/ diffuse vesicular rash over chest, back, upper arms, neck and scalp approx. one week after vaccination; onset 30 hrs prior to exam. Lesions in various stages of early vesiculation. Pt then referred to hospital for further evaluation. Pustulation of vesiculated areas were observed. Pt was discharged after areas scabbed over. Resolved.
Immediately after the vaccine his leg swelled up and he was feverish and tearful. Although he had been sleeping through the night from age 4 month, he has not slept for longer than 4 hours at a time since then. He was babbling from 3 months old but since the last vaccine, he has stopped all attempts to imitate sounds or actions, although he does still smile and laugh (which he knew how to do before).
Patient had irregular breathing with gasping after shallow breathing approx 11 hrs after vaccines given . Temp was 104. Went to ER then home and did fine.
Got shot on 2/10. On 2/11 my skin had developed swelling and redness around the injection site. Buy that afternoon the swelling was 2 inches by 2 inches firm and warm to the touch. It also hurt when it was touched but my first shot also hurt so I thought nothing of it.  By the evening of 2/12 the spot has grown to be 5 inches by 4 inches. Still warm, red and swollen. But now it?s not as firm to the touch. My dad, who is a general surgeon, has told me to put a warm compress on it 2 to 3 times a day.   I don?t have a fever or any other symptoms, but he recommend I report my side effects in case the vaccine or Administration of the vaccine was contaminated.
Pt developed face and hand swelling and back pain that prevented the pt from walking for 3 days.  No further info available
Within 10-20 minutes of receiving vaccines, patient complained of itching of both hands.  Hands became so swollen, could not close.  Vomited x2, complained of headache approximately 10 hours later.
Client was given MMRV when single antigen MMR was indicated. No adverse reaction has occurred. No treatment was needed.
This spontaneous report as received from a Registered Nurse refers to 4 patients ranging in age from 25 to 84 years old of unknown gender. The patiens' concurrent conditions, medical history and concomitant therapies were not reported. On unspecified dates between 19-APR-2017 and 01-MAY-2017, the patients received an intramuscular dose of PNEUMOVAX23 (lot: N003997; expiration date: 20-OCT-2018) to prevent pneumococcal infection (dose was not provided). On an unspecified date in 2017, within 24 hours of receiving the dose of PNEUMOVAX23, each patient developed a red, swollen, warm, sore area at the site of injection. The patients called the nurse for medical attention. No laboratories were performed.  On unknown dates, the patients recovered from the events. The relatedness of the events with PNEUMOVAX23 was not reported. This is one of several reports from same source. Additional information has been requested; Sender's Comments:  US-009507513-1705USA005378: US-009507513-1705USA001719:
COVID-19 Breakthrough--Patient admitted to hospital with generalized weakness, shortness of breath, cough for 2 days.  Feeling fatigue and weakness for 2 days PTA.  SpO2 93% on room air, Not currently requiring supplemental O2