chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PATIENT UNDERDOSED AND RECEIVED 0.3ML; OFF LABEL USE; This spontaneous report received from a health care professional concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 2132D21A, and  expiry: UNKNOWN) .3 ml, administered on 03-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 03-DEC-2021, the patient experienced patient underdosed and received 0.3ml. On 03-DEC-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the patient underdosed and received 0.3ml and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211209999.
seen 28SEP for PE-seemed well evening 29SEP started itching rt deltoid;mom noted swollen, red plus discrete pink macular rash on abd/chest;rx DPH;
Pfizer Dose 1 1/28/21 (lot NA) Pfizer Dose 2 2/18/21 (lot NA) COVID Positive 1/28/22 COVID Positive 2/12/22  2/12/22: He is 70-year-old male with a history of traumatic brain injury, speech difficulties, cognitive issues, bilateral footdrop, attention deficit, depression and lives in a group home.  He was brought to the emergency room this morning for a swelling in the left lower back of unspecified duration.  Patient is not able to give any history but only says that the swelling is painful.  No history of a recent injury and no fever.  At the emergency room the vital signs were normal.  The laboratory test unremarkable except for mild leukocytosis of 12,000.  He had a CT scan of the chest/back with IV contrast and it demonstrates organized fluid collection within the subcutaneous tissue of the left midback.  While still at the emergency room he had aspiration of days swelling with removal of 10 mL of bloody and probably purulent fluid. Fluid sent for analysis.  2/20/22: Patient presented with upper back pain and mild SOB. He is noted to have an abscess on his back and bibasilar pneumonia. He was treated with antibiotics, and underwent incision and drainage of his abscess by the surgeon Dr. He is much improved, stable to be discharged to Private for further conditioning, but he should be continued with wound care to prevent recurrent infection.
Patient reported tingling lips, scratchy throat, and a mild headache although the headache had been off and on all day. No SOB nor difficulty breathing. Patient reported some chest tightness but felt this may be due to anxiety.  No antidote nor supportive treatment given. Symptoms resolved within 30 minutes and patient stayed an additional 15min for observation
SkinRash cellulitis / abscess signs. Narrative:  Other Relevant History:
065F21A-Lot # mRNA Active Ingredient DEC-4-2021: HYG-Moderna-COVID-19-Injection-NOV-24-Site Reaction-DEC-4-2021 which shows an EUA 'injection site reaction' that feels to me like it was probably at its height about 24 -36 hours before. As with when I bruise, it had initial, within a few days, pain and tenderness, however did not start getting itchy, scratchy, pink redness like in the picture with kind of a swollen raised effect with small raised skin pore spots (almost like it is trying to drive something out of the skin) until later ~DEC-1-2021. Moderna website info, "Injection site reactios: pain, tenderness and swelling of the lymph nodes in the same arm of the injection, swelling (hardness), See CP. Symptoms are basically like those described on Moderna website for COVID-19 injection site reactions and as depicted in picture cited. When the state where I live had similar previous COVID vaccinations, as you will likely find on a report submitted regarding me at that time in around 1980, you will likely find that I had similar symptoms and reaction then. I had been trained on the topic and was active throughout the country as counsel and a person qualified to do vaccinations which I did at various clinic and hospital locations. As at the time I was also a media content provider on the topic-COVID and vaccinations globally. When I received my vaccine at the time I had similar complications as to this Report and it had resulted in recommendations, including that future COVID vaccinations when practical be done from glass top vials with the alternatives to the rubber stoppers that are generally availabe, specifically for instance perhaps parchment-like tops. I have assumed that such a recommendation should be in my health file, and had reported to the site where I received this 2021 vaccine that I had in fact received such previous COVID vaccination around 1980-1983.
On April 8, 2021, I went to Hospital with symptoms of blood clots in my right leg.   I was diagnosed with Superficial thrombophlebitis - lower extremity
Information has been received from a health professional concerning a fifty-three year white female with no known drug allergies and no past medical history, who on 02/20/2001 was vaccinated SQ in the arm with a first dose of rubella virus vaccine (second generation0. There was no illness at the time of vaccination. Concomitant therapy included sertraline hcl, estrogens and conjugated (+) medroxyprogesterone acetate. On 03/06/2001, the patient developed joint pain of the hands, knees, wrists and great toes and a mild rash behind her knees and under her arms. Unspecified medical attention was sought. It was reported that on approximately on 03/13/2001, the symptoms started to resolve.  Follow up information has been received from a health care professional that states no medical intervention was needed, The symptoms resolved over time. The patient stated on 03/07/2001 or 0308/2001, she began to notice discomfort in her right wrist. Several days later it started in her left wrist. Within a "couple of days", the discomfort (pain when moving joint) began in her knees, toes, ankles and fingers in that order. She reported that her knees resolved the most rapidly. About a week after onset, they were much better. The other joint areas, especially her hands and fingers, remained painful for about two weeks. They finally resolved totally about two weeks after onset. The patient also reported experiencing swelling in her hands and feet that started about two weeks after the injection and persisted for three weeks. It was noted that a tuberculin skin test was performed and that a "pre-placement" rubella screen done on 02/13/2001 showed no immunity. It was also noted that the patient was considered recovered by 03/29/2001.
Patient received 1st dose Pfizer 2:15pm (Mother was present) with a minute, patient states that she can't see anything and her body was feeling fatigue.  I sat her down, she couldn't talk and answer any questions.  I quickly got my tech to call 911, they  came quickly and monitored her and took her to the hospital.
A male patient (age unknown) receiving Tice BCG developed a rash in the groin.  The reporter is not sure if the adverse event is related to the BCG therapy.
Pt received DTaP L thigh/ MMR R thigh on 7/14. Approx. 36 h later child developed L knee effusion, induration around L ant. thihg. To ER L knee with effusion, decreased ROM, WBC 8,000, ESR 12. Most likely felt extension of local reaction with reactive aronritic. Placed on Motrin 2 d later, much improved with minimal residual effusion.
Pfizer-BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization/Death. Rec'd Pfizer-BioNTech on 7/29/21 and 8/19/21.  Presented to ED 9/1/22 following same day d/c. Recently admitted and tx'd for Hypertensive urgency and acute on chronic renal failure requiring HD for volume removal. Later returned to ED with c/o SOB and difficulty ambulating. Found to be hypoxemic with O2 sats in the low 80s on RA. Imaging also revealed PNA and Covid +. Intubated on 9/4/22, pulmonary status did not improve and remained encephalopathic. Transitioned to comfort care on 9/11/22. Ex'd 9/12/22. Tx'd w/nafcillin, cefepime, and decadron.
Within 90 minutes - sore throat and cough started. This morning have chest cold that hurts!
Patient's mother stated he had swelling in all of his left arm 2 days after the shot was given she also stated she gave patient BENADRYL it helped the swelling go down office was not made aware until today 12/22/2017 he was coming in for his second dose.
pt recv vax & 25NOV96 nurse splashed vax on hand & rubbed eye w/hand;25NOV96 exp burning in eye;burning persisted @ time of report;
INCORRECT PRODUCT STORAGE; POOR QUALITY VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 4 decade old female. 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, batch number: 041A21A, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 05-MAY-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On 05-MAY-2021, the subject experienced incorrect product storage. On 05-MAY-2021, the subject experienced poor quality vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect product storage and poor quality vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210509988.
Information has been received from a registered nurse for GARDASIL, a Pregnancy Registry product, concerning a 19 year old female patient with a history of papanicolaou smear abnormal and no drug reactions or allergies who on 25-JUN-2010 was vaccinated with a first 0.5 ml dose of GARDASIL (Lot# 665547/1318Y, expiration date unknown), IM. Secondary suspect therapy included second 0.5 ml dose of VARIVAX (Lot# 665880/1299Y, expiration date unknown), SQ (MSD). Concomitant therapy included BENADRYL. The nurse reported that the patient was now pregnant. Last Menstrual Period (LMP): 26-APR-2010 Estimated Date of Delivery (EDD): 31-JAN-2011. Blood test for pregnancy were performed and showed "level was low indicating early pregnancy". The patient sought medical attention by an office visit. At the time of this report, the patient's outcome was unknown. Follow up information received from a complete questionnaire indicated that the patient was a female with seasonal allergies and amenorrhea (26-APR-2010) and a history of papanicolaou smear abnormal (leep in February 2007, 2 degrees C CIN 1) and seasonal allergies. The patient had two previous full term deliveries; in one of them the baby developed charge syndrome. The patient's Last Menstrual Period was on 26-APR-2010. On 25-JUN-2010 she was vaccinated with a first 0.5 ml dose of GARDASIL (Lot# 665547/1318Y). On the same date the patient received a 0.5 ml second dose of VARIVAX (Lot# 665880/1299Y) (MSD). The patient was not tested for varicel antibodies before vaccination with VARIVAX. On 26-JUN-2010 the patient developed localized swelling in right upper extremity. On 28-JUN-2010, the patient had a quantitative total serum human chorionic gonadotropin test (HCG) test done for amenorrhea (last menses 26-APR-2010) results were reported as "72". Based on HCG level, the patient's Estimated Date of Delivery was reported to be on 08-MAR-2011. On 12-JUL-2010 at 11 weeks from gestation, the patient had an spontaneous abortion. The products of conception were not examined. It was also reported that the patient did not experience any complications during pregnancy. Upon internal review spontaneous abortion was considered to be an other important medical event. Additional information has been requested.
I had extreme stomach pain and had to use a heating pad to help with the pain. I thought I may have gallstones like my mother had gone through. Every time I are anything, my stomach would blow up and I looked like I was pregnant. I went to an Urgent Care, and they did bloodwork and x-rays, that showed I did not have a gallstone problem. I saw my PCP who sent me to a gastrointestinal doctor, to have an upper GI in May, that came back negative. I have had a colonoscopy, they removed polyps, I am cancer free, but I do have to have a colonoscopy every six months. I normally have a very flat stomach but once I eat, I look six weeks pregnant. I have seen my gynecologist; I am completely through menopause and everything in that area is fine. I am living on a very restricted diet.
Information has been received from a health professional concerning a female pt who on 21Oct05 was vaccinated IM in the right deltoid with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy at the same site in the right deltoid included a dose of influenza virus vaccine (unspecified). On 22Oct05 the pt complained redness and soreness at the site. Unspecified medical attention was sought. The pt is recovering. Follow up information indicated that the pt has recovered. No additional information is available. Additional information is not expected.
The patient called the pharmacy about 5 days after receiving the flu shot to tell us that she called her doctor and the doctor had her come in to see him because she said her arm was a little warm and inflamed. She told us that the doctor told her she had a "mild subcutaneous infection" and the doctor gave some antibiotics. When asked the patient said that she was fine and just wanted to let us know.
Rash; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 6 days after receiving Shingrix, the patient experienced rash. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the rash was recovered/resolved.   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, but it could be 64 or 65 years. The health care professional stated that a patient experienced a rash 6 days after receiving a dose of Shingrix. The rash was not at the injection site and was not a shingles-type rash. The rash cleared up on it's own with the use of Benadryl.
Difficulty breathing, white spots in throat, swollen lymph node, high 104 degree fevers that persisted for 9 days, was put on antibiotics without any relief.
temperature excursion of negative -40f degrees or 8 hours and 25 minutes with no reported adverse events; receiving the vaccines post-temperature excursion with no adverse event; Initial information received on 01-May-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 1 years old female patient who received the HIB (PRP/T) vaccine [ACT-HIB] post temperature excursion of negative -40f degrees or 8 hours and 25 minutes with no reported adverse events.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Daptacel) for Immunisation.  On 18-Apr-2023, the patient received an unknown dose of suspect HIB (PRP/T) vaccine (lot: U026802; exp: 03-Nov-2023) via intramuscular route in left arm for prophylactic vaccination post temperature excursion of negative -40f degrees or 8 hours and 25 minutes with no reported adverse events (product storage error) (poor quality product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event temperature excursion of negative -40f degrees or 8 hours and 25 minutes with no reported adverse events and was Unknown for the event receiving the vaccines post-temperature excursion with no adverse event.  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 the 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.
pt complained off "sharp pain upon injection followed by severe pain for 3 days after injection until present"
My Tinnitus went up very next day which is 70% higher then prior taking the shot.  Also on Friday 03/19 my left arm where i got the shot show sign of red color rash and now I have pain inside my armpit which has not gone away till this day.  Tinnitus and pain is major concern at this point due to taking Moderna shot.
Patient complained of pain, left deltoid.  Pneumococcal vaccine site edematous, no redness noted.  Benadryl 25mg PO x 1.  HC cream 1% to left deltoid BID.  Warm pack to area
A few hours after the shot my arm hurt. Felt ok, otherwise, until about 20hrs after about. The right side of my face tingled and was a little numb and red; including part of my tongue, my check, and up my temple. Tingling subsided after a few hours. Then about 30 hours after the shot, a few hours after the tingle, the right side of my face got really hot, red, and slowly started to swell. It felt a little numb, including part of my tongue. I took benadryl, went to sleep, and woke up fine. I had a cousin and aunt with similar symptoms after their second moderna shot, I don't have their specific symptoms, but I do know their faces tingled, one 40 hours later the other a couple hours after the shot.
Did not realize until I was visiting with friends about the vaccine that I do have a history of seizures. They have happened since 1993 (the death of my husband and left with 5 small children to raise). They come on only if I am under stress. The last one I had was in the spring of 2012 when I was going through a stressful time. I believe I have had perhaps 10 episodes over those years. I had the vaccine (Pfizer) at 8:30 in the morning and do remember walking up on the bathroom floor sometime past midnight. I do not know for how long I was out but did hit my head pretty hard on the way down. I do remember feeling the "faint" coming on and thought I had sat down on the edge of the bathtub steps. It was actually not until a day later when I went to wash my hair that i felt the knot on my head and realized I had hit it when I when down.When I awoke I got into bed and went to sleep (probably not a very good idea, but I live alone) In the morning I stayed home all day and relaxed. There were never any more effects other than the seizer. I was not stressed about the vaccine at all so perhaps a bodily reaction.  My doctor has recently retired so I have not gone to visit and explain what happened.
This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates, reported as since December 2013, the patients were possibly administered doses of GARDASIL injection (dose, route and lot number were not reported) which were not stored properly. No adverse effects were noted. Concomitant medications were not specified. This is one of several reports received from the same reproter. Additional information has been requested.
Patient had fever within 24 hours of vaccine administration.  Patient was found unresponsive the next morning.  Patient had a history of febrile seizures. 2/17/09-records received-COD died from complications of a seizure disorder. Seizure disorder, clinical history of febrile seizures. Asthma Clinical history of mild asthma. histologic changes in large airways consistent with mild asthma.
Information has been received from a physician via a company representative referring to a 12 year old male patient. On 07-APR-2016 the patient was vaccinated with a dose of MMR II (single dose) (reported as CDC guidelines). On the same day, the patient experienced a general rash. Localization of the rash was not specialized. The patient sought medical attention by speaking with physician. The event was treated with Steroids. The outcome of the event was unknown. Causality was not reported. Additional information has been requested.
Information has been received from a nurse practitioner concerning an 11 year old female who on 16-JUL-2007 was vaccinated subcutaneously with a second single dose of varicella virus vaccine live (Oka/Merck) (Lot# 657620/0536U). Additional suspect vaccination included Gardasil vaccine (MSD). Other concomitant therapy included Menactra and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown). Within 12 hours of being vaccinated the patient developed a severe injection site reaction that continued to become "more severe." The injection site rash was about 7 inches in diameter and wrapped around the patients arm, was warm, hard to touch in the middle and was less red on the outside of the rash. On a follow-up visit to the doctor the next day (on 17-JUL-2007) the patient had a low grade fever and a general feeling of achiness. Nurse practitioner was concerned that the patient might have cellulitis. On the third day following vaccination the patient returned for another follow up visit, the rash had stabilized. It was noted that the nurse practitioner treated the patient with Benadryl. Lab studies for a white blood cell count were normal. No other information was provided. There was no product quality complaint involved. Additional information has been requested. This is one of several reports from the same source.
Information was received from a consumer via a letter. The patient was a female (age not specified). Medical history and concomitant medication use was not provided. On 26NOV2010 the patient was vaccinated with PNEUMOVAX 23, intramuscular, in the left arm. Other suspect therapies included AFLURIA. On an unknown date the patient experienced an adverse event (NOS). The outcome of adverse event is unknown. The reporter considered adverse event to be related to PNEUMOVAX 23. Additional information has been requested.
5:00am 2/21/21 thru 5:00am  02/22/21 (24 hrs) chills, fever (99.7), headache, nausea, muscle/joint pain; For reainder of 2/22/21 thru 2/2/24/21 experienced Fatigue, lack of energy and did have swelling, soreness, redness/heat Upper Right Arm where had injection.
pt recv vax 25JAN95 & 30JAN95 exp high fever,chills,weakness in legs,such that couldn't walk;lab eval revealed WBC 13,700,SMAC 22 & liver functional nl;f/u pt exp arthralgia & fever;
This case was reported by a consumer and described the occurrence of pneumonia in an adult female subject who was vaccinated with influenza virus vaccine (manufacturer unspecified) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Influenza virus vaccine (ml, unknown). At an unspecified time after vaccination with Influenza virus vaccine, the subject experienced pneumonia. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified.