chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient administered Flublock at 6:01 pm and had no initial reaction, but asked to sit in waiting room for 20 min after due to first flu immunization in over 10 years.  At 6:15 pm the wife called me over that the patient was feeling weird.  Patient was on the floor oriented but pale and mild perspiration on forehead. He did not complain of shortness of breath or pain, just dizzy and seeing spots. He said he felt unwell and lay down on the floor.  I took BP and it was 100/55 pulse 52 while supine. He was less pale at 6:20 pm BP 105/62 pulse 69. He wanted to move out of main waiting room and carefully we got him up into the treatment room where he returned to supine at 6:26 and bp 123/78 pulse 76.  He then felt like sitting up against the wall and stated he hadn't eaten all day so we got some orange juice for him to drink. At 6:33 pm BP was 125/85 pulse 78 and he was feeling much better, and a little embarrassed.  He moved to sitting in the chair with assistance and at 6:38 pm bp was 126-75 pulse 75 and he said he thought he would be ok to leave.  I checked and he did not have any shortness of breath, chest pain, or complain of any injury.  I took one final bp at 6:40 pm standing and it was 116/82 pulse 85.  He stated he would take it easy and go home to rest but he felt much better, no dizziness and would follow up with me if any other symptoms occurred.
Administration error, not adverse event. On 2/19/2021 patient reported that he had not (yet) been administered COVID-19 vaccine. This was confirmed by database lookup that revealed no COVID vaccine dose administration. Subsequent to administering the Moderna COVID-19 vaccine on 2/19/2021, it was discovered that the patient had in fact already received the first Moderna COVID-19 vaccine on 2/11/2021 at his home.  The AFH was late in entering the dose into system, and the patient did not recall getting it. Thus, the second dose was administered 20 days early. The patient displayed no symptoms or adverse reactions as a result of the early dose.
Client underwent seizure activity 10 minutes subsequent to vaccine administration. Nursing staff was available to keep client safe and to assess for airway, breathing and circulation; supplemental oxygen and rescue inhaler (provided by client's caregiver) was administered.  EMS was dispatched and client was safely transported to a local hospital emergency department.
On 1/6 at 3:30am woke up with severe migraine that made me nauseous and vomiting. Lasted until about 6pm. Spoke with my doctor who told me to take advil.  Then on morning of 1/13 work up with a welt the size of a baseball at the injection site that was red, painful, and hot to touch. Was sent to urgent care by my PCP. Welt continued to grow. They didn't know if it was an infection at the injection site or an delayed allergic reaction. They put me on antibiotics and benadryl cream.  Finally stopped growing and started to clear up by the 17th.
3.5 HOURS AFTER THE VACCINATION, PT EXPERIENCED ITCHING AND HIVES.  NO SHORTNESS OF BREATH AND NO SWELLING OF THE TONGUE OR LIPS.  THAT EVENING PT. C/O GENERALIZED MUSCLE ACHES, JOINT PAIN, NAUSEA AND DIZZINESS.
Pt complained of urticaria on arms, legs, upper thigh.  1-2 mm in diameter pustule filled weeping rash. Itchy though not painful or hot to the touch. Noticed approximately 2 weeks post vax. Rash intermittent in severity. Returns in same area on the body.
ITP - platelets of 3; severe thrombocytpenia; This is a spontaneous report from a contactable physician. A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 20Apr2021 at single dose for covid-19 immunisation at the age of 44-year-old. The patient medical history and concomitant medications were not reported. No any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Idiopathic thrombocytopenic purpura (ITP) - platelets of 3 and severe thrombocytpenia, both on 30Apr2021. The events were reported as serious with seriousness criteria of hospitalization (from an unspecified date in 2021). The events resulted in Emergency room/department or urgent care. The patient underwent lab tests and procedures which included platelet count: severe thrombocytpenia/ITP - platelets of 3 on 30Apr2021, Nasal Swab: negative on 30Apr2021. Treatment received for the events that included intravenous immunoglobulin (IVIG), IV steroids. The outcome of the events was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported Idiopathic thrombocytopenic purpura and severe thrombocytopenia and the use of BNT162B2 cannot be fully excluded.  There is limited information available, thus precluding further assessment. The case will be assessed further upon receipt of additional information. 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.
itchy eyes; I started with sneezing and drippy nose; Sore arm; I started with sneezing and drippy nose; It's just like sinus and allergy; It's just like sinus and allergy; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6198, UPC, NDC number and Expiry date: Unknown), via an unspecified route of administration on 26Feb2021 as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included allergy to pollen and asthma from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient got the first dose of the Pfizer COVID-19 vaccine on Friday morning (26Feb2021). Yesterday (27Feb2021), patient started to have adverse events like itch eyes, runny nose and drippy nose, and sneezing. The patient was fine with the sore arm. The patient said this allergic reaction maybe attributed to her allergy to pollen. The patient said other than the reactions patient mentioned, she felt fine, patient had no headache, etc. The patient mentioned her reaction got worse this morning (28Feb2021). The patient wanted to know if it was ok to take Claritin or other anti-allergy medications. The patient wanted to manage her reaction because it might flare up and the patient might have trouble because patient also has asthma. The patient had allergies anyways like with pollen going on and on now. The patient just wants to make sure because patient got up this morning and it worst. The patient does not have any other symptoms, there was no fever, and there was no pain, nothing like that. It was just like sinus and allergy. The patient just wants to make sure if it was okay patient had that. The patient did not take any Tylenol for the soreness for arm, the patient has not taken anything like that. I just want to make sure that it is okay to take maybe Zyrtec or Claritin, something like that. Outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Patient got up from the shot booth, took a few steps and started fluttering and fell into moms arms. Eyes rolled back and patient was very pale.  She sat with mom and some water, ice pack and a lollipop . Over the next few minutes she came back to her normal self, though she indicated she was tired. Mom insisted we call 911, and the paramedics checked her out with a positive outcome. Mom declined the ambulance and stated she would bring her to the hospital herself.  She walked to her car aided by mom.
Difficulty breathing. Fatigue. Intense pain all over. Fever. Extreme chills. Involuntary shaking. Headache. Dizziness. Lose of strength. Loss of appetite.
Information was received from a nurse concerning a first grade female student who on 23 JUL 1999 was vaccinated with a dose of Varicella.  In mid DEC 2004 she developed chickenpox.  It was reported that 58 other students developed chickenpox in mid DEC 2004 and according to the elementary school nurse 34 of the children had previously been vaccinated with Varicella.  Unspecified medical attention was sought.  There was no informaiton regarding the present status of the student.  No product quality complaint was involved. Additional information was requested.
Abnormal menstrual bleeding (currently have been spotting for 16 days). Petechiae on hands for first 24 hours after vaccine.
Psoriasis; COVID; COVID; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4302044-00 (Agency).  A 51 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date May2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2022, outcome "unknown" and all described as "COVID"; PSORIASIS (non-serious), outcome "recovering", described as "Psoriasis". The action taken for adalimumab was unknown.  The reporter's did not provided causality of adalimumab for the event "covid" and "psoriasis". The reporter considered events"covid" and "psoriasis" possible to bnt162b2.; Sender's Comments: Considering the nature of the reported events and product profile, a causal role of the suspect drug cannot be denied for the reported events.
pt devel an inj site rxn characterized by redness & swelling;pt had recovered @ the date of this report;
a GARDASIL 9 was administered twice at the same time/ there were two nurses when the incident happened and they both grabbed the GARDASIL 9 and gave it at the same time; one dose was meant for the patient's sibling; Therapy Start Date: May 20th 2019/ was at office to receive second dose of the series/ AE Onset Date: 08-SEP-2020; This spontaneous report was received from a registered nurse, referring to a 16-year-old male patient. The patient's pertinent medical history or current conditions were not reported. He had no concomitant medications and his previous drug reactions/allergies were amoxicillin and penicillin.  On 20-MAY-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (formulation, strength, dose, route of administration, lot number or expiration date were not reported) as prophylaxis.  On 08-SEP-2020, the patient was at the nurse's office to receive the second dose of the 3 series of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (inappropriate schedule of product administration). The nurses were giving multiple vaccines, and two nurses grabbed one vaccine each, and the patient was vaccinated twice at the same time with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 milliliter (ml), intramuscular (strength and anatomical site of vaccination were not reported; lot number S026371, expiration date reported and validated as 01-APR-2022) as prevention of human papillomavirus (HPV) (prophylaxis) (incorrect dose administered). The nurse reported that there were two doses of the vaccine in the room at that time, and one dose was meant for the patient's sibling (wrong patient received product). It was reported that the patient did not receive any treatment for the events, and no laboratories diagnostics/ studies were performed. The patient was stable at the time of the report and he did not seek medical attention. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: S026371; expirationdate: 01-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability.
Patient developed itchy, red rash all over his body that started 3 days after vaccination.  Present on his abdomen, arms, and legs. Never had a rash similar to this before
Patient received vaccine and stayed for 15min monitoring; noted was very slightly light-headed but did not think it was due to the vaccine and not enough to keep from returning to work. Patient was brought to nurses' station at 5:00pm by coworkers stating patient appeared to be "not well" and had continued light-headedness. Patient was transported to nearby ER for evaluation; supervisor noted she seemed ok before departure and that the trip was just precautionary.
This spontaneous report was received from a healthcare worker referring to multiple unspecified patients of unknown age and gender. No information regarding the patient's medical history, concurrent condition and concomitant medication was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, lot # L025737, expiration date 28-JUL-2017; lot # M003659, expiration date 20-SEP-2017 (dose and route of administration were not reported). No adverse effects were reported. Data logger was involved. The vaccine lots were exposed to a temperature of 32.7 degrees Fahrenheit (F), time frame of excursion was reported as 4 hours and 54 minutes total cumulative time. There was no previous excursions. No product quality complaint (PQC) was reported. This is one of several reports from the same reporter. Additional information has been requested.
Severe pain right knee joint with tenderness.  Pain continues today with decreased intensity due to Motrin and Hot & Cold packs during the night.
Pt developed pus inside a big welt. Was admitted to the hospital to drain welt, still in hospital as of 10/14/2005, pt is fine, right arm cellulitis per Dr office 10/14/2005. 11/1/05 Review of d/c summary confirms diagnosis of R deltoid cellulitis s/p flu & pneumococcal vaccines. Treated with Vancomycin. Per annual report-10/17/05 per telephone follow up to vaccine providers, both vaccines were administered in the R arm. The site of the cellulitis.
105 temp on 11/9/96 whimpering & vomited - 24 hr of high temp treated with tylenol
I did not seek medical care but about 3 days after the second dose of Moderna, I started experiencing intermittent, left-side, anterior chest pain (dull). It felt like pain was localized to my heart. I took OTC ibuprofen during the first week for pain, up to 800mg per day. Pain was worse (5-6 out of 10) during the first week and began to improve thereafter. The pain fully resolved by mid-March.
5:30 pm  Cold, chills, uncontrollable shaking 7:30 pm Fever of 101. Broke at 3:00am
Pyelonephritis, hypokalemia (3.0) and COVID-19(has history of intermittent asthma). Received 3 days of Remdesivir as a precaution. D-dimer 2299 (CT negative)
01/07/21 @ 03:00 A.M> Woke with Severe Headache too soon to take medications         Nausea @ 04:55 A.M. took Ondancatron 8 mg, Promethazine 25 mg, Hydrocodone 1/2 - 10-325, Tylenol 500 mg, and Benedryl 25          mg. 11:00  A.M. Hands/Ankles and Feet swollen - Rings were very tight on my fingers.        02:00 P.M Walked to work 1/4 mile - and was sent home again 1/4 mile - upon reaching home I was short of breath - NOT Normal        for me. Severe Headache all day, but nausea has subsided. Some itching of injection site earlier in day, now just sore if touched.
The day after the vaccination he complained of a sore arm at injection site (he did not have this with previous vaccinations).  Five days later on October 29th at around 6pm he complained of chills, he had rigors and said he felt lousy.  I took his temperature but he could not hold it in his mouth well due to rigors it was 100.8F.  I gave him 600 mg Motrin and he went to bed.  Saturday am around 6:30 he got up and said he felt a bit better but within 30 min he had chills and rigors.  After a few minutes he said he was having trouble breathing and was panicking and I called 911. They took him to hospital and observed him and ran test, administered IV Fluids and then he came home.  EMT told me his temp was as high as 105 but the nurse in ER stated they recorder 103+. Sunday he felt awful and continued to spike temps. And was given Tylenol and Motrin.  Monday he said he was back to normal and went about his daily activities but had night sweats and today he is still doing his usual activities but says he feels a bit off.
Within hours of the shot, I began having full body itching and have continued to have itching for several days. Allegra, Zyrtec and Benadryl have offered little relief.
This spontaneous report was received from a 89 year old female patient regarding herself. The patient has high blood pressure and kidney problems. The patient's medical history included shingles (reported as 5 years ago). On an unknown date in 2010 (reported as 2 years ago), the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiry date and route was not reported). Concomitant medications were not reported. On an unknown date, the patient stated that she fell and broke her hip, but could not be real specific about whether she broke her hip before or after getting ZOSTAVAX. The patient stated that she still had tremendous pain and scratching in her head, her left eye and forehead. Her physician diagnosed her with having PHN (post herpetic neuralgia). She had tried many forms of pain management as a treatment and nothing had worked. She also stated that gabapentin (manufacturer unspecified) did not work for her. At the time of this report the patient had not recovered from the reported events. The patient sought medical attention (was seen by HCP). Upon internal review the event of she fell and broke her hip was considered to be medically significant. Additional information is not expected.
This spontaneous report was received from a Medical Assistant refers to a patient of unknown age and gender, who on 29-MAY-2015 was vaccinated with an improperly stored dose of GARDASIL (lot # K006960) (dose and route not reported). According to the reporter the vaccine dose administered underwent only one excursion of 63 hours. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received.
Lump under skin and warm to touch at injection site of Left Deltoid since administration date 20 days ago. Per patient's mother lump seems to be getting bigger.
I first noticed having a sore throat. I took an at home COVID-19  test, and it was negative. The next day I woke up with a sore throat so I took another COVID-19 at home test ,and it was positive. I called my doctor, and she prescribed me Paxlovid.  The only symptom I had was a sore throat, and hoarseness that lasted for about 3 days.
very sick; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (very sick) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (very sick). At the time of the report, MALAISE (very sick) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided by the reporter.  No treatment medication was provided by the reporter.
Hives started under left arm pit, wrapped around left bicep and down to left wrist then across the back of both shoulders and down right arm under arm pit to right wrist. A few popped up on front and back of lower torso. Very itchy, prickly and painful red bumps/patches. Lasted from 4/10-4/20.  Used antihistamines and Tylenol to treat at home.
I have had 3rd dose fever, arm hot, hyperglycemia sick in bed for 2 days arm pain from shoulder to elbow.  fever 101; nausea; achy all over; I spoke to my doctor about it but was not given any medication.
The rash on right foot, right calf, right groin, right armpit, left thigh and left scalp; swollen/fluid-filled bumps; hives; itchy rash; red; This case was reported by a consumer via call center representative and described the occurrence of rash in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th August 2019, the patient received the 1st dose of Shingrix. On 23rd August 2019, 14 days after receiving Shingrix, the patient experienced rash, blister, hives, itchy rash and erythema. On an unknown date, the outcome of the rash was not recovered/not resolved and the outcome of the blister, hives, itchy rash and erythema were unknown.   It was unknown if the reporter considered the rash, blister, hives, itchy rash and erythema to be related to Shingrix.  Additional details were provided as follows: The caller was a patient. The patient received Shingrix and developed an itchy rash with hives and red, swollen, fluid-filled bumps. The rash was on the patient's right foot, right calf, right groin, right armpit, left thigh and left scalp. The reporter consented to follow up.
I started getting pain in my wrist, hands, shoulders, elbows, and knees. As time goes by, I am developing arthritic pain in different joints. My doctor referred to it and Polymyalgia. I was prescribed Meloxicam, Tylenol, and Gabapentin. The pain is somewhat better because of the pain relievers, but I keep finding pain in different joints.
pt recv vax 6FEB98 & on arising 7FEB98 exp severe knee & ankle pain-never occurred before-went t ER;given cortisone & was told allergic rxn to shot (MMR);
pt called  and stated that she was having heart palpitations- normal 70 and hers was 90. I suggested she try to relax if she felt bad she could call her dr or go to the er.
Metallic taste in mouth; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 29Aug2021 14:30 (Batch/Lot number: unknown) at the age of 36 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DYSGEUSIA (non-serious) with onset 29Aug2021 14:45, outcome "recovered" (2021), described as "Metallic taste in mouth". Therapeutic measures were not taken as a result of dysgeusia.  Additional information: No other vaccine in four weeks. No medications in two weeks. No covid prior vaccination.  No covid tested post vaccination.No Known allergies  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received moderna vaccine on 3/18/21, 4/16/21, and 11/2/21. Unsure of lot or site location. Presented to ER on 7/26/22 and found to be COVID positive. PMH of emphysema/COPD on 4-5 L at home. brought by EMS from home because of worsening SOB, fever- 102, cough with yellow sputum production, headache, appetite, diarrhea,Patient received albuterol, xanax, ketorolac, normal saline, potassium magnesium, patient is diagnosed and admitted as hypoxia with COVID-19 pneumonia, received Rocephin, doxycycline, Decadron and remdesivir. Discharged on 8/1/22