chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Resident was admitted to the facility on 5/3/2021 from Medical Center. Resident is alert and verbally responsive and cognitively intact. Is able to recall and communicate medical history and events. Resident denied receiving the Covid-19 vaccination and did not have a vaccination card. Review of the discharging  hospital documentation including PRI, Notes and discharge summary did not indicate Covid-19 vaccine was given. The system was checked on 5/5/2021 and the resident was not listed as receiving the Covid-19 vaccine. The resident requested and consented for the Covid-19 vaccine.  On 5/7/2021 the resident received the 1st dose of the Pfizer vaccine and tolerated well. No adverse reaction was noted.  On Friday 5/21/2021 the resident's son informed the facility the resident may have received the Moderna vaccine in a previous Nursing home. The facility contacted agency which confirmed the resident did receive the 1st dose of Moderna vaccine on 4/23/2021. The resident has remained stable. No signs and symptoms of adverse reaction noted
Moderate stomach cramps, diarrhea, mild soreness at injection site, mild aching joints
Patient began feeling numbness/tingling in left hand.  Began to feel nauseated, dizzy, flushed, and light headed.  Symptoms would come in waves.  Felt shaky.  A few nurses and pharmacist on duty came to assess her.  Heart rate was 110, SpO2 was 99.  Assisted her into a wheelchair and brought her to a separate room so she could lay flat and elevate legs  Checked blood pressure, 122/58. 10 minutes after reactioni started heart rate had lowered to 87.  Once she was laying down she did not experience any additional dizziness, flushing, or nausea. After she sat up for a couple minutes, ambulated in the hall with nurse she was released at 6:20pm and a friend drove her home.
Patient reported sweating and anxious. Observation done. Water offered. Symptoms improved. Patient discharged to home.
On morning after vaccination, patient woke up with deep pain at site of vaccination (left deltoid) and difficulty raising arm. Level of pain worsened over the next 3 days, then plateaued and has continued since then (3 1/2 weeks now). Patient reported that it seemed a little better today, but is still hurting and unable to lift arm. Has been taking ALEVE and TYLENOL alternately. Advised to follow up with primary care provider.
Event occurred after 2nd vaccine. First vaccine was on 3/9/21 and the second one on 4/6/21.Pt tested positive for COVID-19 on  11/16/21.
sick with fever; sinus pain; red hot circle blotches on her arm; sinus infection; dizziness; sick with fever; chills; body aches; nausea; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick with fever), SINUS PAIN (sinus pain), RASH MACULAR (red hot circle blotches on her arm), SINUSITIS (sinus infection) and DIZZINESS (dizziness) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-May-2021, the patient experienced ILLNESS (sick with fever), SINUS PAIN (sinus pain), RASH MACULAR (red hot circle blotches on her arm), SINUSITIS (sinus infection), DIZZINESS (dizziness), PYREXIA (sick with fever), CHILLS (chills), MYALGIA (body aches) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Sinus infection, at an unspecified dose and frequency. In May 2021, ILLNESS (sick with fever), SINUS PAIN (sinus pain), RASH MACULAR (red hot circle blotches on her arm), SINUSITIS (sinus infection), DIZZINESS (dizziness), PYREXIA (sick with fever), CHILLS (chills), MYALGIA (body aches) and NAUSEA (nausea) had resolved.     No concomitant medications were reported. other treatment includes something for sinuses, Cold compress on her arm and all the symptoms was resolved after about 4-5 days.
Patient made the Health Department aware today (08/22/2022) that they had soreness of arm that TDAP vaccine was given in that went down to hand. Reports bruising/redness at site after vaccine was given but has since resolved. Advised patient go to urgent care to have arm evaluated.
This spontaneous report as received from a registered nurse refers to a male patient of unknown age. A patient who received first 0.5 mL dose of an unspecified hepatitis B vaccine on 04-AUG-2009, and received his second dose of an unspecified hepatitis B vaccine on 04-NOV-2009, would receive his third dose of RECOMBIVAX HB on 22-OCT-2012. No adverse effect reported. No other information was available. Additional information has been requested.
This spontaneous report as received from a nurse practitioner, refers to a 7-year-old patient of unknown gender. No information on the patient's concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On an unknown date, the patient was vaccinated subcutaneously with a dose of PROQUAD injection (albumin status: recombinant human albumin (rHA), lot # M021729, expiration date: 29-OCT-2017; dose not reported), which was reconstituted with a dose of MENACTRA (dose, lot # and expiration date were not reported) in error. There were no concomitant therapies reported. The nurse practitioner stated that the error may had occurred because both the vial of the MENACTRA and the vial of sterile diluent had a white label and their flip-caps looked similar. According to the nurse practitioner, the MENACTRA vial had a white flip-cap and the sterile diluent vial had a grey flip-cap. The patient did not experience an adverse effect. There was no product quality complaint involved. Additional information has been requested.
Breakthrough case admission after 3 vaccines Pfizer 1/8/21 Lot# El0140;  Pfizer 1/29/21 Lot# EL9261;  Pfizer 11/2/21 Lot# EW0186;
This case was reported by a nurse and described the occurrence of limb swelling in a 5-year old male who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix) for prophylaxis. On 08 July 2003, the patient received the fifth dose of Infanrix. Within 24 hours post-immunization on 09 July 2003, the patient experienced a "more than usual reaction" characterized by a "large amount" of swelling extending from shoulder to elbow, redness, and warmth. The patient was seen by the physician. The events resolved after an unspecified period of time. The nurse considered the events to be possibly related to vaccination with Infanrix.
Noticed a rash on left arm about 3 inches lower than injection site 2 days after injection. Arm was very sore in that area.  Woke up on 3rd day after injection and my arm was extremely sore and rash was much worse.  Pain, redness, warm to touch.
On April 23, 2021 my right eye started acting erratically. On Saturday, April 24 2021 I went to the hospital. The hospital could not do anything. On Monday I went to a specialist who said I had onset floaters in my eye. I had a macular tear and ultimately in doing the analysis with pictures also showed a macular hole. I had a hole in my retina. In July 2021 I had surgery to fill the hole at a HCF. They injected a gas in my eye and then I had to lay face down with limiting the amount of times I raised my head. I had to do this for 5 days. The surgery was successful. There were a lot of tears that they had to laser during surgery. I had another procedure to fix more tears in the retina in December 2021. I can see out of my eye but have been left with a cataract. I have not had surgery yet to fix the cataract.
50% loss of vision; Tingling on one side of body; Experienced Transient Ischemic Attack 1 week after vaccine 2nd dose (April 27, 2021).; Strong pressure in head; loss of ability to support body in RL; Slurred  speech; Difficulty in breathing; Cognitive difficulties; Extreme headache; This is a spontaneous report from a contactable consumer (patient) reported for himself that a 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number: EL7533) via an unspecified route of administration, administered in Arm Left on 20Apr2021 14:00 as 2nd dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 (Lot number EL8727) in the Left arm on 29Mar2021 16:00 at the age of 40 years for covid-19 immunisation. No known allergies. No vaccines were received within 4 weeks prior to the COVID vaccine. Healthy and no prior adverse event history.  The patient experienced transient ischemic attack 1 week after vaccine 2nd dose, strong pressure in head, loss of ability to support body in RL, slurred speech, difficulty breathing, cognitive difficulties, extreme headache on 27Apr2021 16:30; visited emergency department.  2nd incident 02May2021- 50% loss of vision, tingling on one side of body, slurred speech, cognitive difficulties, extreme headache. The adverse events resulted in emergency room and healthcare professional office visit. Patient was treated with headache medications. It was reported that patient was recovered from events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovered in 2021.   Information on Lot/Batch number was available. Additional information has been requested.
Saw the medical personnel, not Dr. - on vacation. I have not felt right since I had this vaccine. I was very sick with pain-body aches, soreness, throughout body, rash on arms, back of hands, top of fingers, rash around mouth and on front of neck and at waist on both sides of belly button. Body felt raw inside, mouth and tongue very dry, lips pale; and some chapping, itchy, stinging, sensation over body. Hot flushes would go over my body and go off at a feeling of sensation. I felt like my body was not mine, legs and arms felt heavy, log like sometimes, felt out of body. Swelling in knees and thighs. After almost 2 months, NP prescribed BENADRYL. After taking some, I just now begin to feel better, however I still feel tired, lack of energy and settle unwell feeling throughout my body. I have never experienced this type of long lasting pain, body aches, soreness, itchy all over my body - it was very scary.
pt right arm red and swollen at the injection site and under the arm, told patient to contact md
Information has been received from a physician concerning a 5 yr old male who on 24Aug01 was vaccinated SC with a 0.5mL dose of varicella virus vaccine live (lot 05006). On 06Jun05 the pt presented with a painful linear rash that looked like zoster. It was reported that the rash on the pt's chest, went around to his back and stopped at the midline. The rash started as vesicles which scabbed over, but new vesicles were forming at the time of the report. Unspecified medical attention was sought. The pt was prescribed acyclovir and pain medication. At the time of the report the pt was had not yet recovered. There was no product quality complaint involved. Additional information has been requested.
a fib; Cholesterol high; This is a spontaneous report from a contactable Nurse via Pfizer sales representative. This non- contactable Nurse reported that a 69-year-old male patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported.  It was reported that the patient experienced Cholesterol high and a fib on an unspecified date. Events took place after use of product. Outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information currently available, Cholesterol high and fib represent intercurrent medical condition representing common cardiovascular occurrences in the patient with 69 years of age.  No known biological plausibility and close time association speak for the relatedness of the events with the vaccination.  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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Started with pain in left breast a couple days after vaccine given, then developed the Shingles rash a week after vaccine was given.
Initial unsolicited report received from other Healthcare Professional on 01-Oct-2018. This case involves an unknown demographic patient who was vaccinated with a dose of less than 0.5 ml of FLUZONE HIGH DOSE (batch number, expiration date were not reported) via Intramuscular in left deltoid on an unknown date. The patient's medical history, medication and treatment were not reported. It is an actual medication error due to vaccine underdose and exposure via skin contact as it was reported the needle loosed and quite a bit of the vaccine leaked out on the patient's arm. The immunization leaked out of where the needle attached to the syringe. Less than 0.5 mL, was injected IM in the left deltoid. It is also a case of syringe issue. 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. List of documents held by sender: none.
Chills, diaphoresis, rash over both arms, achy. Possibly a fever last PM. Skin was sun sensitive. This morning achy and diaphoretic.
felt pretty awful; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A 39-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: Not reported), for COVID-19 Immunization. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "felt pretty awful".  Additional information: Patient dread the possible side effects. patient felt pretty awful for 24 hours after my second dose of the original [Pfizer] vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient Received the Moderna Vaccine, 2nd Dose at 1845. At 1900 she started to experience a hot feeling around her neck area which was red. Her fingers were swollen as well. Her blood pressure was 148/72 HR 81 and her SpO2 was 94%. She did not have any hives, SOB, able to converse without any issues. Bp taken again at 1908 Bp 129/72 HR 77, 94%. The flushing had dissipated, her finger swelling had improved and her rings were now able to be removed. She felt like her baseline and was released with her husband.
On May 13, doctor vistit for cough, sore throat, ear pain, itchy red eyes. Diagnosed with OM. Treated with amoxicillin. On May 27, presented to health center with rash and diagnosed with chicken pox. Resolved on June 2.
Case number PHEH2014US025073, is an initial spontaneous report received from a nurse on 09 Dec 2014. This report refers to a 74 year old female patient. Medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 13 Nov 2014. Nurse reported that patient received FLUVIRIN that was at 49 degree F 12 times over a period of 34 days. The temperature excursions began around 16 Oct 14. 12 separate temperature excursion lasting 30 minutes each in which the temperature was 46-49 degree F during each of those excursions. No adverse event was reported following this maladministration. No further information was provided.
1 Week later site of injection, Arm swollen, Red,  Hot, Hard bump to touch, Itchy
pt began rash on stomach, perineal area on 20OCT;pt was very warm according to mom but no temp was taken since they had no thermometer;22OCT rash all over the pt;pt eating very few solids but drinking alot of water;cries alot & restless
Information has been received from a patient's mother via Internet concerning her daughter who was vaccinated the past year, in 2008, with a dose of GARDASIL. The patient had no adverse reaction besides the injection site being red for a day. No further information is available.
Patient received her 2nd Pfizer Covid-19 Vaccine on 2-1-21. She was exposed to Cvoid-19 through her husband who she lives with on 2-9-21 when he tested positive. She was tested through her place of  work on 2-11-21 & 2-17-21 and was negative. She tested on 2-22-21 and returned positive results on both a rapid and PCR test. She has been placed on in-home quarantine and has no had any singificant effects at this time.
Pt received second Moderna Vaccination on 2/21/21 at 1:00 pm at Pharmacy.  Pt present on 2/22/21 to ER via ambulance at 1940.  Upon presentation C/C hypotension Post COVID vaccine.  Nurse notes states that Home Health nurse sent patient to ER secondary to hypotension and hyperglycemia.  Pt states back ached and was holding his head.  Nurse noted pt had random petechiae over body and bruising to abdomen following injections received during recent hospitalization. (unknown hospitalization).  Patient was treated with IVF bolus in addition to initiating Dopamine for hypotension, patient became agonal and daughter at bedside presented Adv. Directive, pt was DNR.  Pt pronounced time of death was 2110pm.  (Pt only reported a sore shoulder secondary to vaccine).
5 hours after shot I was standing in kitchen felt light-headed and heart racing. Sat down for few minutes. Felt better. Took blood pressure 130/86 heart rate 119. Sat down again. After 5 min. Took bp again 117/78 heart rate 91.  Fine since that day.
That evening he developed a rash up his back and neck. The following day he didn?t want to go on a fun outing. He wanted to sleep instead. He never naps. He fell asleep at 3pm the following day and wouldn?t wake up during the night when we tried to take him to the bathroom. He slept until 8am the next day. I had to wake him up. He didn?t feel well. I took him to the dr to have them check his TB bubble which was fine and to let them know about his rash and how he was acting not himself. The dr was not in so the nurse took notes and looked at rash.  Rash went away Thursday and everyday for 16 days he would wake up violently screaming and would be up for hours in a daze and not talk to us. His preschool told us they even noticed a huge change in his behavior for the worse.  My husband took him to the dr to be checked out for his symptoms they said he now has an ear infection and that the vaccine lowered his immune system.  We are now on week 7 of him no longer sleeping through the night, he is constantly cranky/moody and he has been very aggressive which is not like him.  He is having trouble staying focused and we are trying anything to help him.
Following the booster, I had Covid like symptoms with fever, chills and sinus/chest pressure. I had a Covid exposure everyday between 12/13/21-12/19/21. Once those symptoms subsided I had a few hours of feeling better then by the next night I woke up covered in hives. They were very large and had traveled to my entire body. My eyes even swelled shut from how bad they spread. The doctor gave me a tapering prednisone to use but it did not seem to help. Since this I have had an issue of continuously breaking out in hives but if I take fexofenadine then it helps hold the hives off but they still come up. I am still suffering from this issue today.
Dry mouth, tooth decaying and soreness. Fragile and brittle and breaking off at gum. Rot from inside out of teeth. Turning black, grey and yellow of color.
Had pain in the arm/pain when touching it; Hardness; Redness at the injection site; A 2 inches bulge; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Had pain in the arm/pain when touching it), INJECTION SITE INDURATION (Hardness), INJECTION SITE ERYTHEMA (Redness at the injection site) and INJECTION SITE SWELLING (A 2 inches bulge) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Had pain in the arm/pain when touching it), INJECTION SITE INDURATION (Hardness), INJECTION SITE ERYTHEMA (Redness at the injection site) and INJECTION SITE SWELLING (A 2 inches bulge). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Had pain in the arm/pain when touching it), INJECTION SITE INDURATION (Hardness), INJECTION SITE ERYTHEMA (Redness at the injection site) and INJECTION SITE SWELLING (A 2 inches bulge) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Other treatment medication included application of ice.
Within 1 hour of the injection I was feeling ill, headache, very sore arm & body aches. By that evening I had a fever of 101.4 and the next morning a fever of 102.4. Severe body aches, severe arm pain, unable to sleep more than an hour over night. Dehydration & fatigue to the point of not being able to walk more than 20 to 30 steps before needing to stop.  Tightness in my chest & difficulty breathing. My entire torso from breastbone to waist, front and back are red, inflamed and sore. I have a high tolerance to pain and rarely use the term severe.  The pain, body aches and fever began to subside by Friday evening.  By Saturday I was better but not back to normal. By Sunday my torso redness is beginning to fade.
Light rash on face, neck and back. Itching at site of rash, orthopnea. Treated with Benadryl, 25 mg and Advair, 250/50 mcg.
This spontaneous report as received from a physician refers to his medical assistant a female patient of unknown age with asthma. Drug reactions and allergies were unspecified by the reporter. On an unknown date, the patient received twice doses of (Merck) VARIVAX "nonresponder". On an unknown date, the patient performed viral titer and the results showed titer negative each time (date unspecified). The outcome of the patient received (Merck) VARIVAX twice on unspecified dates and titer were negative each time and patient was a VARIVAX "nonresponder" was unknown. Additional information has been requested.