chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from an office manager, and refers to a 45 year old female patient. Concomitant therapies included ESTRACE cream for birth control. The patient had no pertinent medical history and no drug reactions or allergies. Historical drugs were not reported. On 01-JUL-2015, 05-AUG-2018 and 13-JAN-2016, the patient was vaccinated with the first, second and third doses respectively, of RECOMBIVAX HB (Thimerosal free) 5/0.5 microgram/ml Injection, intramuscular, 2 vials per vaccination (10 microgram per dose), lot # L003193, expiration date 10-NOV-2016 (also reported as 01-NOV-2016), for prophylaxis (anatomical location was not reported). The office manager informed that on 16-JAN-2018, titers were drawn in the office and were found to be negative. Other tests performed included Hepatitis C infection test, herpes infection test, Chlamydia infection test and gonorrhea infection test (results were not provided). Treatment was given for the event (not specified); the patient sought medical attention. The outcome of the event was not reported. The reporting office manager did not provide a causal relationship between the event of negative titers and vaccination with RECOMBIVAX HB.
Moderna Booster, two initial vaccines were Pfizer. I'm not on any medications. I have a change of diet. Low sodium, minimal alcohol, reduced red meat. That's really all that's changed. Monitoring blood pressure. I've never had high blood pressure before but they believe it's from being in Stage 3 kidney failure. They're doing ultrasounds to monitor the progress. May not be in relation to vaccine.
spiked a fever of 103.2, treated by wiping down with cool wash cloth and infants acetaminophen x 2 doses
just minor discomfort at the injection site; Queasy; Headache; Malaise; This is a spontaneous report from a contactable consumer (patient).   A 70-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 17Feb2021, at the age of 70-years-old, (Lot Number: EL9266) as DOSE 2, SINGLE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  Historical vaccine includes dose 1 of BNT162B2, lot number: EN5318. On 25Feb2021, the patient experienced queasy, headache, and malaise. The patient had minor discomfort at the injection site on an unspecified date. The outcome of the event minor discomfort at the injection site was unknown; while the other events was not recovered.  No follow-up attempts are possible. No further information is expected.
Redness, swelling, pain at injection site. Symptoms lessened after 6-7 days but still remain on 11/25.
Passed out and was bradycardic.  Responded to Atropine with normal heart rate. Dx Syncope
This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 08-JAN-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine underwent a temperature excursion of the lowest recorded temperature of 33 degrees Fahrenheit (0.56 degrees Celsius) for 56 hours. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
102 fever; headache; chills; restlessness; muscle and joint aches; muscle and joint aches; brain fog; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 70-years-old non pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 03Feb2021 15:15 (at the age of 70-year-old) (Batch/Lot Number: EC9265) as dose 1, single for covid-19 immunisation. Medical history included lymphoedema, hypothyroidism, atrial fibrillation, sleep apnoea syndrome and milk allergy. Concomitant medication(s) included levothyroxine (LEVOTHYROXINE); rivaroxaban (XARELTO); biotin (BIOTIN); tolnaftate (CLARUS [TOLNAFTATE]); ascorbic acid, biotin, colecalciferol, dexpanthenol, folic acid, nicotinamide, pyridoxine hydrochloride, retinol palmitate, riboflavin sodium phosphate, tocopherol, vitamin b1 nos, vitamin b12 nos (12 VITAMINS FOR INJECTION) all taken for an unspecified indication, start and stop date were not reported. The patient previously took bactrim, augmentine [amoxicillin;clavulanic acid], flagyl [metronidazole], cipro [ciprofloxacin] and experienced allergies to all. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced 102 fever, headache, chills, muscle and joint aches, brain fog, restlessness on 03Feb2021 23:30. The patient underwent lab tests and procedures which included pyrexia: 102 on 03Feb2021 23:30. No treatment received for the adverse events. The clinical outcome of the events were recovered with sequelae on an unspecified date in 2021.  No follow up attempts are possible. No further information is expected.
sore throat-chronic, fibromyalgia, epstein-Barr & cytomegalo virus, muscle twitching & spasms, short-term memory loss, spastic colon, chronic fatigue synd;
Information has been received from a physician and a 77 year old female patient with allergy to codeine and a history of heart attack in December 2007, who on 02-JUL-2008 was vaccinated with a dose of ZOSTAVAX. The physician reported that the patient was vaccinated with the shingles vaccine by another physician. There was no concomitant medication. The patient reported that on 09-JUL-2008, she developed groin pain. On 11-JUL-2008, she developed a "big rash in her groin and down the side of her leg". The physician reported that on 12-JUL-2008, the patient was seen in the office with a rash in the inguinal area x 24Hrs; rash in gluteus at perineal area - red base with clear vesicles, the diagnosed was shingles. The patient was prescribed VALTREX and ZOVIRAX. The physician reported that on 14-JUL-2008, the patient was feeling better. The physician considered shingles to be an other important medical event because it required medical intervention. No further information is available.
Found passed out on bathroom floor at school. Minimally responsive when found by fellow student. Dizzy and lightheaded prior to going to bathroom. Pt was found sleepy but arousable. Pt does not have recollection of passing out once in bathroom.
Local swelling 5 inches long inch wide, lips swelling, eyes swollen, took 3 doses of 25 mg Benadryl helped with face but not with site reaction.
Cardiac Arrest at home while in bed sleeping next to wife. Brought in to ER in Cardiac Arrest.  Coded for 20 minutes until time of death was called at 1:30am.
patient called store today to report that she still has a sore arm, injection site pain, and does not have full range of motion.  she says it feels like she just got the vaccine, but its been over 2 months since the vaccine.
Patient received covid 19 vaccine. While waiting in observation area, patient complained of dizziness, shortness of breath and high blood pressure.  Patient has a history of emphysema, diabetes and hypertension. EMS evaluated patient on scene.  EMS assessed vitals. Patient condition improved over the course of 15 minutes. Patient declined transport and signed refusal. Patient left without incident.
Patient described stiffness in his head, very painful, weren't able to move head. Began in the evening of the day he received vaccine. Weren't able to sleep for two nights due to pain in head and started getting better slowly from third day.
15 Feb2021, fiber myalgias, carpel tunnel syndrome, toes purple in ER ray notes diseases, arthritis right up BP 210/114 cat scan, BP 170/180, headaches even at Apr/May 2021. Urgent care 26 Feb for feet and toes. ER 24 Apr for BP and BP 210/114.
Gave a pediatric patient a 0.25mL dose of Moderna. No adverse effects as of now.
spontaneous chronic urticaria, appeared two weeks following the booster (third shot) Moderna vaccine. Streaks of red that widen to squares, rectangles, various shapes in different places 24/7: arms, legs, hands, feet, chest, neck, scalp, belly, shoulders, back, backside, inner thighs near groin. Redness is vivid, then fades. Streaks ("rash") appear randomly, in two to three places, then fade on its own...and reappear equally randomly. Not just one spot at a time, usually three at least, in different spots. Sometimes extremely itchy, but scratching does not remove the itch. Hives appear occasionally but not commonly; rashes are common and ongoing still. Began to appear on face as well just yesterday. Situation shows no sign of abating after 2.5 weeks.
Upon the initial vaccination day (March 23rd) there was discomfort and scoreness hours after vaccines was received, but it was minimal. The next day (24th) the area became swollen and red and was sensitive to the touch. I took Tylenol and used an ice pack for a few hours and the area started to return to its normal status, with a slight indication of a ring forming around the area of injection. I continued to take Tylenol and use an ice back moderately through the day on the 25th. By that evening the soreness was gone and well as the discomfort. Saturday the 26th everything seemed fine and I had no cause for alarm. However, on the evening of March 26th, the area of injection started to itch and was slightly pink but no visible signs of inflammation. The morning of Sunday, the 27th the injection site had flared up similar to a bee sting with significant irritation.  The prior remedy of the ice pack provided temporary relief. Wile the pack was on the inflammation went down and the itching stopped, but after the affects for the cooling wore off the Injection area flared up again and turned a bright reddish-pink. Around 10 or 11am I took a double dose of claritine to relieve the itching within 20 minutes the subsiding and the injection area began to dull in color. That same evening I took a benadryl around 4 or 5 pm. I fell asleep due to thr medicaruon and upon waking the hives were gone and the area was a light pink. Prior to goong to bed thatvnight i took another Benadryl. Upon waking up monday the 29th the inflammatiin is no existant and the area is only red at the site of injection with a slight discloration where the area had inflammed. I continued taking Zrtec during the dau, as i was out of claritin. No irritarion.
Info has been received from a licensed practical nurse concerning a pt between the age of 60 and 65 years who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot #640981/1050L). Subsequently the pt developed "severe local reactions at the injection site." Follow up info received stated that the pt's entire upper arm became red and swollen. Unspecified medical attention was sought. The pt was treated with ice/diphenhydramine hydrochloride (BENADRYL). The reporter noted that the pt recovered. The reporter also mentioned 3 other patients between the ages of 60 and 65 years that had similar experiences following vaccination with a dose of pneumococcal vaccine 23 polyvalent (Lot #640981/1050L) (WAES #0306USA02582, 0306USA02583 and 0306USA02584). Additional info is not expected.
pulled up mcir the night before didn't look at it that day ,look in the chart they need the shots but after looking at mcir noticed that they recieved the shots from the health department
Pulmonary emboli and DVT bilateral; Pulmonary emboli and DVT bilateral; This is a spontaneous report from a contactable nurse. A 75-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Lot Number: EN6204) as single dose for covid-19 immunisation. Medical history included prediabetes, hypertension (HTN), gastrooesophageal reflux disease (GERD), atherosclerotic heart disease, opthalmoplegic migraine, vitamin D deficiency. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Concomitant medications included butalbital, paracetamol (BUPAP); atorvastatin; doxepin; esomeprazole sodium (NEXIUM); minocycline; carvedilol; montelukast sodium (SINGULAIR); topiramate (TOPAMAX). The patient previously received first dose of bnt162b2 (lot number: EL9267) via intramuscular on 19Feb2021 for covid-19 immunisation. The patient experienced pulmonary emboli and deep vein thrombosis (DVT) bilateral on 19Apr2021. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was hospitalized for 1 day. And anticoagulation treatment received for the events. The events were reported as serious, serious criteria included life threatening, caused/prolonged hospitalization. The patient underwent lab tests and procedures which included nasal swab: negative on 23Apr2021. The outcome of events was recovering.; Sender's Comments: Based on current information available, the events pulmonary emboli and DVT mostly represented intercurrent condition in this patient with advanced age and relevant medical history, unrelated to Bnt162b2.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Booster; COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a sponsored program (172086). The reporter is the patient.  A 65 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Manufacturer unknown), for COVID-19 immunisation; Bnt162b2 (Dose 2, Manufacturer unknown), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10Jan2022, outcome "unknown" and all described as "COVID-19"; IMMUNISATION (medically significant), outcome "unknown", described as "Booster". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (10Jan2022) positive. Additional information: Patient had underlying health issues. Patient presented COVID-19 symptoms at time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
vaccinated 1 yr ago, Got shingles a month ago /suspected vaccination failure; shingles; little itching; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In August 2021, less than a year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pruritus. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the pruritus was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pruritus to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, got vaccinated 1 year ago, got shingles a month ago and still had a little itching. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule and laboratory confirmation of shingles were not provided.
A cyst that is located near left shoulder became enflamed, enlarged, red in color, softer mushier feel and painful.  Minor fever, chills and headache accompanied the cyst reaction.   Doctor prescribed  Doxycycline hyclate 100mg one pill 2x a day for thirty days.  The cyst is still enlarged, red and mushy although not as painful.
This case is 1 of a cluster of 2 patients' who experienced similar adverse events following vaccination with DAPTACEL and other product. The event for the second patient was captured in case number 2011-03709. Initial report received from a health care professional on 22 June 2011. A 4-year-old male patient with medical history of gastroesophageal reflux disease (GERD), asthma, seasonal allergies, and developmental delay, received a left deltoid intramuscular injection of DAPTACEL, sanofi pasteur Ltd. lot number C3473AA and a right deltoid subcutaneous injection of VARIVAX, Merck lot number 13212, on 15 June 2011 in the AM. The patient's concomitant medications included NEXIUM, ZYRTEC, FLONASE and PROAIR as needed (prn). The patient had no illness at the time of vaccination and it was unknown if he had an adverse event following prior vaccinations. On 15 June 2011 in the PM, the patient developed symptoms of the left deltoid becoming hot to touch, swollen, reddened and tender. The patient was seen by a physician and diagnosed with cellulitis. He was treated with antibiotics, prednisone and BENADRYL. The outcome was reported as recovered. Documents held by sender: None.
Patient fainted after receiving HPV & Hep A. Lasted a few seconds. Checked by Dr. Patient left the office with no complaints dizziness. Patient stated she had not eaten recently.
2 months after the vaccine, I had intense shortness of breath and pain in upper left arm. Went to ER and was admitted for acute bilateral pulmonary embolism.
Approximately 30 minutes after being vaccinated, client noted tongue felt thick and slight throat sensation of feeling thick. Color good, no difficulty breathing. Given Benadryl 50 mg while at clinic, assessed by EMS and recommended being evaluated at hospital. While at hospital symptoms did not worsen but was given IV Pepcid and Prednisone. Given prescriptions for oral Prednisone and Pepcid to take at home. Also given a prescription for an EpiPen. Sent home. Reports that 30 hours after first reaction noted return of symptoms tho not as intense as originally. After two hours was feeling normal and has had no reoccurence of symptoms.
Pt recv vax on 3/19/99; on 3/20/99 pt exp muscle soreness of right shoulder, dec motion-rotator cuff-like syndrome x 3 wk
Bicep swollen three times normal. Painful to touch. Day #2 swelling went from the bicep to the elbow area and remained swollen all day. Day #3 still some swelling in elbow area. Both areas are painful to touch.
Information has been received from a registered nurse (RN) concerning a patient who was vaccinated with a dose of Zostavax.  The RN reported that the patient subsequently developed cellulitis after vaccination.  It was unknown if medical attention was sought.  At the time of this report, the outcome was unknown.  No further information is available.
Patient reports her left upper arm was swollen, red, hot to touch w/in a day of receiving the vaccine. It was getting better then the reaction appeared to be moving down her arm. 9 days after receiving the vaccine another area became red, swollen, hot, itchy below the vaccination site.
June 15,2009 received MENACTRA vaccine to protect against meningitis-sore arm, fever, aches. June 16, 2009 feeling sick, extreme nausea, fever, skin very pale, aches, sore arm, headache. June 17, 2009 sore arm, pale, headache, feeling a little better. June 18, 2009 seems a little better. June 22, 2009 sharp abdominal pain (localized in 2 places), back pain (localized in 2 places). June 23, 2009 on and off abdominal and back pain. June 24, 2009 abdominal pain. June 25 through June 29, 2009 abdominal pain continues, chest pain, sensation of throat closing, fearful of not being able to breathe, crying, upset. June 30, 2009 doctor visit inconclusive. July 2, 2009 pain and fear continues, called doctor: discontinue swimming. July 6, 2009 still in great pain during day, subsides in evening, hurting at night (9 PM). July 7, 2009 Dr. visit: nonspecific chest/abdomen/back pain, possible gastritis, x-rays showed constipation, NEXIUM 20 mg daily x 30 days, try MIRALAX as needed for constipation. July 23 abdominal and chest pain con't through weekend. July 27 doctor visit and lab work. August still complaining of abdominal, back and chest pain. Sept. 2 Abdominal fullness, pelvic pressure, unable to participate in enjoyable activities due to discomfort. Sept. 3 called doctor, keep on MIRALAX and bulk up fiber and water intake. Sept. 8 pain and discomfort continues. Sept. 12-13 some pain and discomfort but not lasting. Sept. 15 looks pale in afternoon, falls asleep early evening about 1 hour, woke for supper. Sept. 16 severe discomfort (3 bms during day but con't to feel urge and unable). Sept. 21-23 severe sore throat, very pale, fatigued. Sept. 22 doctor visit, strep test neg., later (evening) runny nose, congestion, headache. Sept. 28 complains of urge to urinate-after having urinated still has urge, has been going on for about 1 week or longer. Sept. 29 doctor visit, urinalysis normal. Sept.-Oct. no appreciable improvement. 10/15/2009 received PCP records for multiple ov's from 6/2009 to 10/2009. Patient has multiple c/o's: fever, sore arm, pale, abdominal pain, nausea, chest pain, pelvic pain, sore throat, fever, urine frequency, sensation of throat closing. Tx : Nexium, Miralax, Bentyl with no resolutin of sx. Referred for GI consult date 10/29/2009.  1/7/2010 received Urgent care clinic records for 7/7/2009 patient with c/o's chest/abdominal/back pain
Shot administered 4/23/21 at 5:35 PM 4/24/21 - 10 AM - lethargy 4/24/21 - 12 PM  - muscle aches and headache and extreme fatigue (lasted throughout day) 4/25/21 - 9 AM - left arm pit lymph node swollen
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On approximately 13-DEC-2013 (also reported as today) the patient was vaccinated with ROTATEQ (lot number H011456, expiry date 21-NOV-2013) (dosing regimen and frequency unknown). No adverse event was reported. No product quality issue was reported. Additional information has been requested.