chrisvoncsefalvay/vaers-outcomes huggingface dataset:
experienced coombs negative hemolysis; progressive hematocrit decline; This case was reported by a physician via call center representative and described the occurrence of coombs negative haemolytic anaemia in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced coombs negative haemolytic anaemia (serious criteria GSK medically significant) and hematocrit decreased. On an unknown date, the outcome of the coombs negative haemolytic anaemia and hematocrit decreased were unknown.   It was unknown if the reporter considered the coombs negative haemolytic anaemia and hematocrit decreased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The physician reported that the patient experienced coombs negative hemolysis with progressive hematocrit decline after vaccination with Shingirx. The health care professional (HCP) did not provide demographics, patient initials or date of birth, lot number or expiration date. The reporter consented to follow up.
paralysis; muscle weakness; This case was reported by a physician via call center representative and described the occurrence of paralysis in a child female patient who received Men ACWY-CRM NVS (Meningococcal ACWY Vaccine (potential Menveo)) for prophylaxis.   On an unknown date, the patient received the 1st dose of Meningococcal ACWY Vaccine (potential Menveo). On an unknown date, less than a day after receiving Meningococcal ACWY Vaccine (potential Menveo), the patient experienced paralysis (serious criteria GSK medically significant) and muscle weakness. On an unknown date, the outcome of the paralysis and muscle weakness were recovered/resolved.   It was unknown if the reporter considered the paralysis and muscle weakness to be related to Meningococcal ACWY Vaccine (potential Menveo).  Additional details were provided as follows: The age at vaccination was unknown. The patient was 18 years old at the time of reporting. The vaccine was administered by patient's pediatrician. The patient received the dose of Meningococcal ACWY vaccine (manufacturer unknown) in 2013 or 2014 and within 24 hours after the vaccination, the patient experienced muscle weakness and paralysis. The patient evaluated by neurology and told she did not have Guillain Barre Syndrome (GBS). The symptoms persisted for 1 year. The reporting allergist stated he/she had a question about any published data regarding potential/additional adverse effects of Bexsero, particularly if a patient developed adverse effect after receiving the Meningococcal A (Men ACWY per call back-manufacturer unknown) vaccine. The reporter had no further details regarding event. The reporter did not consent to follow up.
On DOS 08/09/2022 Staff gave Kinrix to a 7 year old child, Filled to follow CDC guidelines
sx started on 7DEC92 pain in joints especially lg toes & rt hand; swelling of face & hands & legs; sx progressed rt hand extreme pain & extreme swelling, unable to move fingers; pain in lg toes made it difficult to walk @ times;
Left arm 5 x 3 cm red/swollen/tender to touch.  Right arm 1 x 1 cm red/swollen/tender to touch.  Treatment with Benadryl and Tylenol.
Administration error: I administer 2nd reinforcement before completing the fourth month between your first reinforcement and the second reinforcement. We proceed to inform the patient and the Dr. In charge of the vaccination center. It was administered 1 month before the time established by the CDC guidelines.
48 hrs high fever (103), chills, joint pains, muscle aches, nausea, lathargy/fatigue
Specialist called to report a patient who has angioedema from the second dose of vaccine. She received her second dose of Pfizer vaccine on 4/5/2021. Came to ED at 0400 on 4/6/2021 for swelling of her face and it progressed to her throat. Reporter states the notes of her chart say that CPR was started on her and she is currently in the ICU, intubated.  No known allergies listed although the family stated to bedside RN that this reaction has happened before. However, it is not documented and she does not have any known allergy to ACE inhibitors, etc.
Pt reports pain during injection. That evening/next day pt had a lot of pain in arm and swelling around injection site. Pt reporst swelling stayed for 1 week. Pt reportedly could not move arm due to pain. Also, developed redness/brown area around injection site which has been there since the injection (12 days).
Transient Ischemic Attack - 2 days hospitalization,  ASA 325mg.  Resolved with no negative impact within 24 hours.
On the AM following the administration, pt experienced sensation of heart racing accompanied by some dizziness and dyspnea lasting 1 hr, then to a lesser degree intermittently. Reassurance.
I asked for a preservative free vial. Late Monday and worse on Tuesday, Wed, I had very bad back pain and very bad right knee pain and aches all over. I already have dysfunction in the above areas, but did not have a flare up until I had the shot. It was as if all my arthritis conditions came flying out much worse than ever. I could barely walk. I felt shaky as well. I was just about to go to the doctor on Thursday when the pains subsided mostly (still in back somewhat), but I am left with fatigue which isn't like me. I am cautiously optimistic that I am mostly recovered, but really scared and scared about the future.
ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY ACUTE HYPOXEMIC RESPIRATORY FAILURE  04/12/2022 - RECURRENCE OF SAME SYMPTOMS
food and seasonal allergies; food and seasonal allergies; blood blisters; This spontaneous report was received from a currently 42 years old female patient. The patient was not pregnant at the time of this report. The patient's historical vaccine included a "BTP" vaccine. The patient's concurrent conditions included Hepatitis B and Polio. The patient did not receive any concomitant therapies. On an unknown date between May and August of 1999, the patient was vaccinated with an unspecified hepatitis vaccine (hepatitis b vaccine (recombinant)) (manufacturer unknown) (lot number and expiration date were not reported) 3 doses received in the arm for Hepatitis B. On an unknown date in 2001, the patient experienced blood like blisters on her body that look like red pin dots (PT: blood blister). On an unknown date in 2009 (reported as 10 years after receiving the vaccine), the patient developed food and seasonal allergies. On an unknown date, unspecified blood work was performed, and the results were not provided. The patient received treatment for the events. There was no product quality complaint associated with this report. The outcome of the events was reported as not recovered.   The causality assessment was not provided.
9/15/21 - tested positive for COVID 9/20/21 present to ED with SOB 9/21/21 re-presents to ED with SOB and admitted. pt given remdesivir, dexamethasone, zinc and barcitinib during stay and expired 9/27/21
At 5pm, patient began to clear throat repeatedly. Water did not help. She also skipped dinner due to feeling poorly. She was given TYLENOL at 2000 because of complaints of a sore injection site. She was asleep by 8:30 and woke up at midnight with a fever of 102.4. She was complaining of "I can't breath" and speaking with chopping words. She would not lay down and was very anxious requiring a light to be on. She repeatedly stated, "I can't catch my breathe". After discussion with nurse line, we were instructed to go to ER. Cold night air improved breathing and by the time the ER was reached, she only had a dry cough and had calmed considerably. Fever continues into next day noted to be between 102 and 103 throughout the day with no further episodes of shortness of breath.
I didn't receive, I just went to my apartment and probably went to bed early. I was not having any adverse things happen but 2 days later I went through 'hell' in my dreams. People were worried because I made wild phone calls and complaints. I had even written notes and passed them out, I live in a huge apartment complex.
KIDNEY STONES; FREQUENT URINARY TRACT INFECTION WITH SKYRIZI/ URINARY TRACT INFECTION; VACCINATION MAY HAVE CAUSED RASH COVERING A FIFTH OF BODY; FEVER; This spontaneous report received from a patient concerned a 38 year old female. The patient's height, and weight were not reported. The patient's past medical history included: urinary tract infections (in her early adulthood they stopped). The patient received covid-19 vaccine ad26.cov2.s, (dose number series 1) (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, 1 total administered on 15-SEP-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: risankizumab (form of admin unknown, subcutaneous, batch number was not reported) dose and frequency were not reported from 12-JUN-2020 for moderate to severe chronic plaque psoriasis. No concomitant medications were reported. On an unspecified date, the patient was found to have two kidney stones and urinary tract infection which required two rounds of antibiotics and a month to go away. The physician did not think that the kidney stones were big enough to cause urinary tract infection. She was eleven days without Skyrizi (risankizumab). She had urinary tract infections in the past which had stopped during her early childhood, but since she started Skyrizi her condition had reemerged. She also had rash covering a fifth of body and fever which might have been because of vaccination. Treatment medications (dates unspecified) included: ondansetron (Zofran), cefalexin, meloxicam, and sulfamethoxazole/trimethoprim (Bactrim). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of risankizumab was not changed. The patient recovered from vaccination may have caused rash covering a fifth of body and fever, had not recovered from frequent urinary tract infection/urinary tract infections with Skyrizi, and the outcome of kidney stones was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20220100187-COVID-19 VACCINE AD26.COV2.S-kidney stones . This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
PASSED OUT; LIGHT HEADED; VERY SLEEPY; ARM PAIN; This spontaneous report received from a patient concerned a 58 year old male. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 043A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 07-APR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the patient was very sleepy and experienced arm pain. On 08-APR-2021, the patient passed out in shower and felt light headed, he awoke in shower with no known duration and with no injuries The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passed out, and the outcome of light headed, arm pain and very sleepy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210420738-covid-19 vaccine ad26.cov2.s -Passed out. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Stomach upset; Headache; It was like black darkness was coming over my head; Afraid; I was going to faint; I got really weak; Felt like I was going to threw up; Light-headed; I did feel like I was going to lose consciousness; This is a spontaneous report from a contactable nurse (patient). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) (Batch/Lot Number: EL9261 and Expiry Date was Unknown) via an unspecified route of administration on 28Jan2021 12:45 at single dose for covid-19 immunization. Medical history included diabetes and asthma. Concomitant medications included empagliflozin (JARDIANCE) and lisinopril. Consumer (Retired Nurse) stated, "I had my COVID Vaccine first dose yesterday 28Jan2021 at 12:45 in the afternoon and I was standing in my kitchen cooking and all of sudden I got really weak and light headed and it was like black darkness was coming over my head. I was afraid, I was going to faint. My stomach was upset. I made up to the bathroom, sat on the toilet, had a bowel movement and felt like I was going to threw up, never did threw up. I got real tired from headache and I just sat there until I thought it was safe to stand, which I did. So, I was reading in my little brochure and it said what to call this number to report any side effect so I was not dizzy but I did feel like I was going to lose consciousness." The patient assessed the events as non-serious with outcome of unknown.  Reported causality for COVID Vaccine to events for stomach upset, headache was related.
Was 5 weeks pregnant with 1st pregnancy due 10/12/21  and had a miscarriage the day after my 2nd dose. 2nd does was 2:30pm on Thursday. Had no side effects. 4:30pm the next day, Friday, began having miscarriage with no symptom warning.
Pox covering hands, feet and pen oral area and diaper area - Ax VARIVAX 12.29.10.
Body aches, lethargy, headache, fever, chills, nausea, vomiting and diarrhea. Began approx. 72 hours after receiving vaccine. Started with body aches as the days continued additional symptoms followed.  Lasted roughly 4 -6 days - I am still experiencing body aches and lethargy 10 days later. These were unrelieved by Tylenol, Ibuprofen and Ondansetron, muscle rub (Icy Hot), and heating pad
Systemic: Allergic: Anaphylaxis-Medium, Systemic: patient waited the 15 minutes in store after they left had trouble breathing. They started to go to the ER and recovered before they went in and did not go in er.-Medium, Additional Details: Patient also recived a flu shot at the same time. Patient waited the 15 minutes in store and had the reaction after they left. They drove themselves to the er but recovered so did not go inside the hospital.
vaccination was expired, no adverse reactions or events occured, provider contacted mother explained all outcomes and recomendations, reported to VFC along with a plan of action.
During first episode, patient experienced sudden-onset shortness of breath, tachycardia, and heart palpitations. Patient promptly visited the emergency room where multiple EKGs were recorded and heart rate was measured in the 150-160 range resting. Patient was given IV metoprolol to slow heart rate. Patient then followed up with primary care provider and was given a Holter monitor to wear for 48 hours and received a referral to a cardiologist. Patient then attended appointment with cardiologist who provided her with a 30 day heart monitor. Two days later, patient experienced another episode that caused her to visit the emergency room again. After being discharged, patient continued to experience episodes of tachycardia, shortness, or breath, and palpitations coupled with  dizziness, fatigue, and hypotension. Patient made another visit to her primary care provider due to more frequent episodes and constant dizziness with hypotension. Primary care provider suspects supraventricular tachycardia and orthostatic hypotension and prescribed Midodrine to patient to raise blood pressure and combat dizziness.
Resident noted to be experiencing a full body tonic/clonic seizure approximately one hour and forty-five minutes post receiving the vaccine. Supplemental oxygen via nasal cannula provided, vital sign monitoring, solu-medrol IM provided, epinephrine IM provided, clonidine tablet provided PO, stat labs ordered: CBC, BMP, depakene level, UA. Resident exhibited positive reaction to interventions. Seizure lasted approximately 5 minutes, afterwards resident presented at baseline: alert and oriented x3 and communicative. Oral intake tolerated approximately an hour and a half post seizure. Enhanced monitoring in place.
Severe neck pain; Severe ear pain; This is a spontaneous report from a contactable consumer. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 09Apr2021 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration on 19Mar2021 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. It was unknown whether the patient received any other vaccines within four weeks. On 09Apr2021 the patient experienced severe neck and ear pain. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether therapeutic measures were taken as a result of the adverse events. The clinical outcome of the events severe neck and ear pain were unknown.   No follow-up attempts are needed. No further information is expected.
05/01/2022 Vaccination 06/10/2022 I started to experience chills, sore throat, coughing, headache, temp 99.5, achy, joint pain and sinus pressure  Took a COVID test middle of the night; COVID+ *taking Paxlovid. Still waiting to retest
Fainting. Headaches. Joint pain. Dizziness. Shortness of breath. Rashes. Swollen lymph nodes, seizures. Contractures - hand, feet, fingers, toes. Causing Raynuads Phenomon --> 2011 diagnosed --> Catamenial Epilepsy --> 6-12.
Systemic: Abdominal Pain-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Visual Changes/Disturbances-Medium.
Information has been received from a physician concerning a 10 year old female who on 09-AUG-2007 was vaccinated IM with a 0.5 mL dose of Gardasil (lot #658490/0802U).  There was no concomitant medication.  On 09-AUG-2007, the patient experienced pain and soreness in her arm (unspecified).  On an unspecified date in August 2007, the patient was seen by the physician, who reported that when the patient raised her arm and activated the deltoid muscle, there was pain.  Upon examination, there was no swelling and no nodule noted.  At the time of this report, the patient was not recovered.  Additional information has been requested.
Chills, slight fever (99.2-99.6), body aches, slight headache; symptoms began at approximately 8:00 p.m. on the night that the second dose was received; symptoms resolved by 8:00 p.m. the following night (2/8/21); no adverse reactions experienced following the first dose of the vaccine.
Left thigh with 2 visible injection sites.  No purulence or tense edema.  Majority of anterior aspect is red, warm, small area medially that extends to posterior aspect at distal thigh.  Significant local reaction.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On 26-SEP-2016, the patient was vaccinated with an expired dose of VARIVAX (lot # K015992 and expiry date 23-SEP-2016) (strength, dosing details, anatomical location unknown). No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Case PHEH2016US027107 is an initial spontaneous report received from pharmacist on 18 Oct 2016. This report refers to adult female patient of unknown age. Medical history and concomitant medication was not reported. The patient was vaccinated with single dose of FLUVIRIN (batch  number: 1618701) intramuscular on an unknown date. On an unknown date, the patient did not get the entire dose (partial dose) in that some of the dose leaked out of the injection site. And pharmacist will be giving another dose of vaccine to patient. No adverse event was reported following this medication error (underdose).
This spontaneous report was received from a pharmacist and refers to a patients of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 27-APR-2016, the patient was vaccinated with the improperly stored dose of ZOSTAVAX (lot # L033311, expiration date on 01-DEC-2016; dose was not reported). Concomitant therapies were not provided. No adverse events were reported. Administered dose of vaccine experienced the temperature excursion of 39 degrees Fahrenheit for 18 hours and 19 minutes. Data logger was not involved. There was a previous temperature excursion of 22 degrees Fahrenheit for 5 hours as well as 23 degrees Fahrenheit for 35 hours. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Received flu vaccine 11/5/04 approximately 9:15a. Stated that within the hour, began experiencing severe leg pain. Call received at 10:30 AM. Pain scale to 1-10 is at an 8:11:30 am.
Mother states within 30 minutes after receiving vaccines patient's behavior became very abnormal. Mother states patient was extremely hyper, crying for no reason, twitching, biting his finger and hands and chewing on clothes.
Information has been received from a physician concerning a 75-year-old female with a history of shingles on her mid-back in 2004, who on 18-OCT-2007 was vaccinated subcutaneously with a first dose of ZOSTAVAX (lot# 658604/1088U).  On 01-NOV-2007 the patient visited the physicians office with a shingles-type rash about the size of a quarter on her chin.  The outcome was reported as not recovered.  No product quality complaint was involved.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/21/2007.  Information has been received from a physician concerning a 75-year-old female with a history of shingles on her mid-back in 2004, who on 18-OCT-2007 was vaccinated subcutaneoulsy with a first dose of ZOSTAVAX (Merck) (lot# 658604/1088U).  On 02-NOV-2007 the patient visited the physicians office with a shingles-type rash about the size of a quarter on her chin.  The outcome was reported as not recovered.  No product quality complaint was involved.  Follow-up information has been received from a physician concerning a , retired, female with sulfonamide allergy who on 18-OCT-2007 was vaccinated in the left deltoid with a dose of ZOSTAVAX (Merck) (lot# 658604/1088U, dilutent vial # "3091U").  Concomitant therapy included TOPROL XL tablets, PREVACID, DIAZEPAN, ACTONEL, hydrocodone bitartrate, nortriptyline, iron (unspecified).  "CA", "vitotuss", montelukast sodium (MSD), PRAVACHOL, EVISTA, FLOWASE, MOBIC, MUCINEX.  On 02-Oct-2007, the patient was vaccinated in the left deltoid with pneumococcal (lot# 657525/0554U (WAES# 077USA08187).  The patient was given FAMVIR 500 tid and LORTAN PRN.  The patient developed a rash that was painful  had vesicles.  There were no pictures taken.  On 01-Nov-2007, the patient's blood pressure was 120/80, pulse 80 respirations 14 and temperature 97.3.  On an unspecified date the patient recovered.  No further information is expected.
Pt. received Tdap on 3/16/07. Some arm swelling 3/18/07. Had episodes of vomiting. Since that time has difficulty eating-feeling like stuck in esophagus. Father pointed to epigastric area. Relieved by antiacids & soft diet.