chrisvoncsefalvay/vaers-outcomes huggingface dataset:
None--pt was given vaccine that had been stored in a conventional freezer for > 2 weeks.  Pt offered another dose.  Pt's 2nd dose was from same group that had been stored in freezer for more than 2 weeks (administered 2/28/22).
pt had 1 min lt facial seizure involving lt upper extrem & + LOC, + post-ictal;
COVID Vaccine Breakthrough Case  Pfizer Dose 1 3/18/21 (EN6208) Pfizer Dose 2 4/14/21 (EW0153) COVID Positive 11/24/21  11/24/21: History obtained from medical records, wife is not present at bedside.  History limited due to confusion.   An 83-year-old man with a history of atrial fibrillation, on anticoagulation therapy with warfarin, type 2 diabetes mellitus, dyslipidemia, sleep apnea, who was brought in by the EMS with complaints of confusion.  Patient lives with his wife, who noticed that he was incoherent and not acting like himself after dinner.  No loss of consciousness.  No history of falls.  On presentation to the emergency room, patient was noted to be febrile with temperature of 102 degrees, blood pressure was elevated to 188/95mmHg.  Laboratory workup CMP within normal limits.  CBC reveals normocytic anemia with hemoglobin of 12.1, INR is 2.5.  COVID-19 screen presented negative.  Urinalysis reveals WBC of 4 to 10 per high-power field.  Chest x-ray done, infiltrating the left upper pole of.  Patient received IV ceftriaxone and azithromycin is being admitted to the hospitalist service.  11/28/21: Patient was admitted and found to be COVID-19 positive.  Continued to have intermittent low-grade fevers however he developed no shortness of breath or cough.  Was noted to have urinary retention and Foley catheter was placed.  Blood cultures on admission were positive for Gram-positive cocci in clusters and he was started on vancomycin.  Repeat blood cultures were drawn and remained negative.  He grew 2 different species of coag-negative staph which were consistent with contamination.  Vancomycin was discontinued.  Patient will discharge home with COVID-19 at home.  He should follow-up with Urology in 1-2 weeks for voiding trial.  11/29/21: This is an 83-year-old male with history of hypertension, type 2 diabetes mellitus, atrial fibrillation on chronic anticoagulation with Coumadin who presented to the emergency department with generalized weakness and fatigue. Patient was admitted on 11/24/2021 and was discharged yesterday on 11/28/2021 for acute metabolic encephalopathy, COVID-19 infection and a Gram-positive bacteremia. He reports that he has been feeling very weak and tired and unable to stand up steadily since leaving the hospital.  Visiting nurses' services were ordered but due to some delays patient has not been seen by visiting services. He has no chest pain, shortness of breath, abdominal pain, nausea, vomiting, diarrhea or constipation.   In the emergency department, labs showed a WBC count of 3.2, hemoglobin of 12.3 and platelets of 128, INR of 2.1. Chest x-ray showed increased right perihilar opacification concerning for pneumonia. Patient was given IV fluids and a dose of IV Levaquin.  12/3/21: P.o. Levaquin course P.o. Januvia 100 mg daily  P.o. glyburide 5 mg b.i.d.  Resume home metformin  Monitor Accu-Cheks  Will hold today's Coumadin dose  Repeat INR tomorrow and resume on p.o. 5 mg daily if INR is less than 3 tomorrow.  Hemodynamically stable for discharge  Will discharge to skilled nursing facility  Follow-up with PCP in 3-5 days
This spontaneous report was received from a medical assistant 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 an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant human albumin) (RHA) lot # N019251 with an expiration date 20-DEC-2018 for prophylaxis, which was reconstituted with properly stored sterile diluent. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion from 6 to 14 degrees Fahrenheit for 24 hours. A digital data logger was involved. There was no previous temperature excursion.
Blood sugar fluctuates up and down, body temperature fluctuates up and down. Patient sweats a lot.
Information has been received from a healthcare worker (operations manager) referring to unknown number of patients. On unknown dates, the patients were administered improperly stored GARDASIL, lot # K006960, expiry date: 19-FEB-2017, (route, dose and frequency were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Soreness in place of shot. Headaches. Unable to think clearly...ie fuzzy headed. I am at one week tomarrow and feel as though I'm going thru menapause all over again. I'm moody, mean, argumentive, can't think clearly, tired, stress(anxiety)...foggy doing and saying things that are not normal.
I had a sore upper left arm at the injection area for 3 days.  On the 9th day after my 1st vaccine, my arm became itchy, red, hot and swollen at the injection area. Took Benedryl topical and oral to help with the issue. The symptoms lasted for 3 days.
had a sore arm for a few days; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 45 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 08Apr2021 10:59 (Lot number: EN6204) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (ongoing). There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "had a sore arm for a few days". No follow-up attempts are possible. No further information is expected.
Approximately 20 to 30 mins after vaccine i developed feeling of hot all in my body reminded me of broom injected worn contrast dye my heart was pounding tachycardia some chest heaviness jaw popping have self epi pen went to hospital monitored for  4 hours give ativan im  had feeling of hot flushing tachycardia chest heaviness impending doom at least 10 or more times before it went away. Slept for 16 hours nausea threw up once. Mild confusion don't remember leaving hospital coming home or talking to some people on the phone
2 wks. after innoculation - head ache, stiff neck, mild nausea, general body aches, shingles rash (non painful) down left side from arm pit to hip and across upper abdomen with tingling sensation, low grade fever, faint feeling. Symptoms cleared (except rash) 10/15/09. Rash continues to slowing fade but still visible as of 11/03/09. Saw Dr 10/19/09.
Tinnitus in both ears happened approximately on February 28, 2021.  Still present as if March 17, 2021
linear rash; This case was reported by a physician via sales rep and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. The patient experienced a linear rash after receiving Shingrix. The reporter consented to follow up.
Full-blown flu-like symptoms: fever, muscle pain, swollen lymph nodes, chills, tiredness, fatigue, sensitive skin, sensitive eyes, headache started in the evening of the vaccination date; acetaminophen caplets and liquid  NyQuill were taken, to alleviate the symptoms; the symptoms took three days to subside On the third-fourth day ?Moderna Arm? appeared: red hot fist-size area on the shoulder of injection; resolved itself in two days On the fifth day severe skin  itch all over body  (back, legs, arms, scalp); and severe itch in both eyes appeared; Benadryl and cortisone cream were used on skin, which  helped slightly;Visine was used in eyes, with no positive effect; The itch on skin and in eyes is still present at the time of filling this form
3 days ago 4 mm rash inceased, progress to groin, back, and chest. Was seen yesterday 9/13/09 and given Zyrtec, today 9/14/09 follow up with PA.
chills; myalgias; fever; progressively worsening swelling at injection site; Initial information received on 17-Aug-2021 regarding an unsolicited valid  non-serious case (under reference number : 00727839) from a physician. This case involves a 34 years old female patient who experienced chills, myalgias (myalgia), fever (pyrexia) and progressively worsening swelling at injection site (vaccination site swelling), after receiving DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 13-Aug-2021, the patient received a dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (Solution for injection, once, total, lot U6831AA and expiration date :08-Oct-2022) via intramuscular route in the left deltoid for prophylactic vaccination.  On 13-Aug-2021, the patient developed a non-serious chills, myalgias (myalgia), fever and progressively worsening swelling at injection site (vaccination site swelling), on the same day following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT.  It was reported as " Physician reported that a patient received TENIVAC on 13AUG2021. She returned to office on 17AUG2021 with complaints of progressively worsening swelling at injection site, fever, chills, and myalgias. Physician asking if there are any recommendations on how to proceed, and the ingredients of TENIVAC. Physician was unable to provide all information for AE report at time of call. Physician given case number and states he will call back when he has all information to complete AE report. Physician declined to provide email." No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for all the reported events.
Fever of 100.8 degrees, lowered to normal a day after appearing Headache, gone with fever Tightness/fatigue in chest, went away at approx. 3:00 PM on the same day Pain at injection site, persistent to the time of this report but severity has gone down dramatically
HPI 2016, he says Pneumonia vaccine may have not been valid. He got a new one for this reason on 5/8/2018. He says the next day he had redness and warmth of his shoulder. He says he was given ibuprofen and two ice packs. He says later that day, he had swelling of the arm and elbow. He returned the following day and the swelling is worse. The areas is itchy, red, and hot. Prescribed and gave Depo-Medrol injection. Vistaril given for itching.
Dizziness lasting 4 weeks (and still ongoing).  Visual tracking connected to dizziness. Lightheaded. Pain in neck (on side of injection) lasting 4 weeks past injection.
Approximately one week after vaccination, at site of vaccination, left arm became very itchy, red and somewhat swollen.  Itchiness and redness lasted 3 days and then began to dissipate.
got gout one day after first dose; got gout in left big toe one day after second dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient (reported as patient's age: 67; unit: unspecified) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GOUT (non-serious), outcome "unknown", described as "got gout one day after first dose; got gout in left big toe one day after second dose".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021332273 duplicate case
Patient was inconsolable after 2 mo. shots. Went to ER after hours of crying.
Information has been received from a medical assistant concerning a patient who on 02-OCT-2006 was inadvertently vaccinated with only half of the recommended dose (about 0.2 mL) of Vaqta (lot # 652509/0036F). The medical assistant also mentioned that the patient's muscles tensed during administration. No symptoms have been reported. There was no product quality complaint. No further information is available.
This child had paralysis of the left arm after OPV. The annual follow up states that the vaccine recipient continues to have the same symptoms from the condition previously reported-dense weakness of left arm, no change or no increase in symptoms.
This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On unknown dates, the patient were vaccinated with doses of improperly stored (ZOSTAVAX) (doses and routes were not reported) lot # L012475 expiration date 10-JUL-2016. No symptoms reported. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish further contact.
Tiredness; Headache; Muscle pain; Chills; Fever; Nausea; Diarrhea; lost my sense of taste and smell; lost my sense of taste and smell; This is a spontaneous report from a contactable consumer (patient). A 27-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left at age of 27 years on 31Jul2021 13:00 (Lot Number: EW0151) as dose 1, single for covid-19 immunisation. Medical history included Known allergies with penicillin (causes rash). No covid prior vaccination. There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. Per CDC website, the side effects of the Pfizer vaccine include: tiredness, headache, muscle pain, chills, fever, nausea. The patient experienced all of these things as described, however he additionally had diarrhea and lost his sense of taste and smell. The CDC said that no vaccine can cause loss of taste and smell, yet one week after the vaccination patient did. Patient had a fever for 3 straight days starting 6 days after the vaccination, during which he lost sense of taste and smell. Patient took a Covid-19 nasal swab test from CVS 7 days after vaccination (during the middle of 3 days straight of fever) and had it sent to a lab, and tested negative. Which means all the side effects he was experiencing were not from a live virus but the vaccine itself, including sense of smell and taste, which he deem an adverse side effect not described. As this event has just taken place, he has yet to recover from loss of taste and smell. Adverse event start date was 06Aug2021 13:00. Covid test (SARS-COV-2 RNA, QL NAAT, RTPCR/TMA (COVID-19)) on 07Aug2021 was negative. No treatment was received. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Moderna COVID?19 Vaccine EUA On 3/23 I was fatigued and slept the entire day, woke at 9 am and slept 11 am to 603 pm. Today, 3/24, the injection site has developed a rash which is itchy and hot to the touch and some mild swelling. I plan to get my second dose on 4/8
achy/breathe in I felt a sharp pain under my breast; fever real achy; bad flu like coughing; coughing; weak; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. Medical history included covid-19 from Jun2020 (for about 6 days last June). The patient's concomitant medications were not reported. it is unusual that still have anti bodies from last June but its almost May now. Patient had covid for about 6 days last June. Ever since then have been donating plasma every 6 weeks. I have been giving whole blood and plasma. Doctor told the patient could help sick people. The PA told that the patient would have natural anti bodies and the anti bodies from the inject fever real achy. When the patient would breathe in patient felt a sharp pain under breast. It was a bad flu like coughing. Patient was very weak for about 6 days just felt like laying there. haven't been sick since Then. Patient have been getting tested regularly for anti bodies in blood and it has been about a year. Patient want to know if patient should wait to take the vaccine because still have those anti bodies, do pfizer want to run test on my blood? Events outcome was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a pharmacist referring to a 41 year old female patient. The patient had no drug allergy. Pertinent medical history included Crohn's disease. On 30-SEP-2015 the patient was vaccinated with a dose of PNEUMOVAX23 lot # L08664 with expiration date of 03-NOV-2015, 0.5 ml, intramuscular) in the deltoid of the left arm. Concomitant therapies included budesonide and vedolizumab. About 2 hours later after the patient received PNEUMOVAX23, the patient's left shoulder was swollen and hot. It was hard for the patient to lift her arm. On 01-OCT-2015 the patient emailed the hospital and reported the events. On the same day, the patient was seen at the emergency room because "her left upper arm had then become red, warm, and painful". In the Emergency Room the patient had a complete blood count (CBC) performed which showed "her while blood cell count was 15,000 (unit not provided) which was elevated. An unspecified physician at the hospital diagnosed the patient with cellulitis. The patient was given ANCEF (manufacturer unspecified) as treatment while in the Emergency Room. The patient was also given a  prescription for CEFALEX (manufacturer unspecified). The patient was not admitted to the hospital and left "later in the day" on 01-OCT-2014. ON 02-OCT-2015 the patient was seen by her unspecified primary care provider ad it was reported that the redness had spread and the patient wasn't getting better. The patient was then prescribed BACTRIM (manufacturer  unspecified). The outcome of the events was unknown. IT was also unknown if the patient was taking all of the above mentioned treatments (ANCEF, CEFALEX, and BACTRIM) at the same time. Additional information has been requested.
Pt broke out in hives covering almost all of her body went to urgent care & was given prednisone course x 5 days and BENADRYL. Pt did not break out in hives until about 30 min. Pt received flu shot in 2011 with no AE.
Pt woke up at 1 am on 5/1/21 and noticed a small red bump on the inside of her arm, between her elbow and wrist.  Tuesday morning 5/4/21 patient noticed several blotchy red spots around injection site and now her whole right arm is swollen. She reports a bump at the injection site. It is very painful and warm to touch. Gabapentin 100mg tid started on 5/3/21, Cipro 500mg BID x 10 days started on 5/4/21 and Prednisone 20mg QD x 7 days started today, 5/6/21. Pt also reports having lifted a 70#box of tile that resulted in her "pulling a muscle" in her shoulder/neck area on her right side.  She has been icing  the site.
Dizziness; Allergic red rash at the injection site/the rash is not itchy and painful; Little fever; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), VACCINATION SITE RASH (Allergic red rash at the injection site/the rash is not itchy and painful) and PYREXIA (Little fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 031B21A) for COVID-19 vaccination.     Patient medical history was not reported.  Concomitant products included FISH OIL for an unknown indication.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced DIZZINESS (Dizziness), VACCINATION SITE RASH (Allergic red rash at the injection site/the rash is not itchy and painful) and PYREXIA (Little fever). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, DIZZINESS (Dizziness) and PYREXIA (Little fever) outcome was unknown and VACCINATION SITE RASH (Allergic red rash at the injection site/the rash is not itchy and painful) was resolving.            Patient reported that on the same day of the second vaccination, she developed fever and dizziness. Two to three hours after the second shot she noticed an allergic red rash at the injection site. The following day on 12-MAY-2021 she visited Urgent Care who advised to wait for two days and the rash would disappear by itself. Patient took Ibuprofen for the symptoms. The rash was persisting and the patient was quoted, "I want a clean hand. " The rash was not itchy nor painful. The concern was if the symptoms were normal adverse reactions after receiving the Moderna vaccine and what she should do since the rash was persisting.    This case was linked to MOD-2021-133429 (Patient Link).
Rash all over trunk and face and neck. Vision issues. Dizziness and headache. Extreme fatigue.
I received my annual flu shot on the above date. After receiving the flu shot, I immediately felt the medication go all over my body, I could taste it in my mouth, and also felt like my stomach was on fire. I felt an intense burning in my stomach that last several minutes. Out of fear of what was happening, I jumped to my feet, where I immediately started seeing stars and felt like I was going to pass out. Several hours later, I became nauseous and felt like my body was shaking. Within about 30 minutes of this, I started with chills. Within another 30 minutes, I began to run fever of 101.2. This continued for two days. I did go to my physician for a follow up to the incident on Thursday, November 1, and will notify her of our conversation and ask her for documentation.
9/20/16 Received Flu shot, left deltoid. Within 3-4 mins sensation periodical numbness, tingling arms - fingers. Took ZYRTEC 10 mg po 15 mins. Later palpitations and difficulty swallowing - took PEPCID 10 g po. Co-workers note rash on face and neck (hives). Return of numbness fingers, toes took DECADRON 4g PO, Albuterol 2 puffs x1, EMS called. BENADRYL 25g PO to ER and discharged. Return of numbness in fingers x15-20 mins that evening and next morning perioral numbness x 15 mins after ZYRTEC 10mg.
Patient started having pain/soreness in the right deltoid (shoulder down to elbow) within a couple of hours of receiving the shot at 4:40pm. Upon awaking the next morning, patient had worsened pain from the previous day and then noticed an area of redness a few inches below the injection site on the right arm. The reddened area was blotchy and appeared to have a larger central area that was about 3-4 inches in diameter with several smaller abnormal shaped reddened areas about the size of dimes surrounding the main reddened area. The area of redness the morning of 10/5/18 and progressed to worsen until reporting on 10/6/18 to a reddened area that wrapped all around the arm (in the area that a blood pressure cuff would be). The pain and swelling have gotten worse from 10/5 to 10/6. The area is also warm to the touch.
Symptomatic COVID infection, COVID pneumonia, hospitalized for IV antibiotics and breathing treatments.
rash on injection site, chest, and upper back with little raised bumps that were itchy and red.  Took over the counter Benadryl and Zyrtec rash and bumps still remain next day.