chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: It was reported as patient took treatment for Covid-19 with Paxlovid from 02Jan2023 to 06Jan2023. Vaccine lot was unknown as it was Misplaced/discarded. It was reported as No known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
He claimed he experienced an abdominal rash with small blisters shortly after receiving the 1st vaccination and it lasted for several weeks.  He denied any itching or pain associated with the rash but that it did leave some scarring.  Rash did not spread, no hives or SOB
Information received on 17 February 2010 from a consumer who is a health care professional. A 37 year old female patient with a history of sulfa allergies developed twitching in her fingers the evening after she received an intramuscular right deltoid dose of Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative (lot number UP013AA) on 31 October 2009. The twitching progressed to chronic generalized twitching all over her body over the next month. The patient also reported jerking movements in her legs and shoulders. The patient was seen by a neurologist, however details were not provided. Approximately four weeks prior to vaccination the patient had also received Seasonal FLUZONE (lot number not reported). Concomitant medication included birth control. Of note, the patient had "strep" one month prior to vaccination. The patient did not recover at the time of this report. List of Documents held by Sender: none.
No additional AEs reported; GARDASIL 9 was administered following a temperature excursion; This spontaneous report was received from an office manager referring to a 11-year-old female patient.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 30-SEP-2022, the patient was vaccinated with one dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe injection, administered as prophylaxis (there were five possible lot # of the vaccine administered: lot #1775811, expiration date: 07-DEC-2023; lot #1775827, expiration date: 27-JUN-2024; lot #W009829, expiration date: 19-OCT-2024; lot #U032681, expiration date: 26-OCT-2023; and lot #1780876, expiration date: 09-NOV-2023; however, it was not specified which one was received by the patient) (strength, dose, route of administration, anatomical location, and vaccination scheme were not provided). It was reported that the vaccines suffered from three temperature excursions with a total of 25 minutes (on 09-SEP-2022 for 8 minutes; on 16-SEP-2022 for 5 minutes; and on 03-JAN-2023 for 12 minutes). The excursions were not noted until it was noticed that an employee mistakenly cleaned the data logger more than once a day (product storage error). There were no additional adverse events (AEs) reported in the patient (no adverse event).  This is one of several reports received from the same reporter.
Child felt fine after shots administered. That night at 8:30 PM he started to feel sick and had fever. At 11:00 PM he had flu like symptoms. The following morning he had body aches. At 11 AM when he went to bathroom he had episode of syncope and woke up on the floor. A neighbor took him to the ER. He never had arm pain/swelling to either vaccine site. ER did EKG - mild Tachy - norm Neuro exam.
Female with patient received vaccine and waiting in post vaccine waiting room for 15 minutes.  Got to the car and started to complain of not feeling well. Called back to POD, staff went to talk with patient.  Patient stated he had low blood pressure, not feeling well, no other complaints.   Female with patient was going to take patient to seek medical attention due to the heart condition.
got covid vaccine on Friday at 5pm and developed the skin rash during the night and woke up with rashes on the chin area and was complaining about little bit of the sore throat while swallowing and Sunday morning woke up with few more rashes on the neck and chest area.Had the sore throat all day but started to complain more pain at dinner time.After dinner went to sleep at 8pm and woke up at 10pm with severe sore throat and ear pain.called the ED at 11pm and the EMS checked his vitals and told that it might be an allergic reaction for vaccine or something else and referred the over the counter children Benadryl .Gave the Benadryl around  2:30am and slept for 2 more hours.Again woke up with bad ear and throat pain at 5am. Then took him to ER and they gave Tylenol and did covid test and strep throat.Bothy came negative.please call me for further questions.
She was unable to work due to the pain; Pain in thigh, calf, hamstring of both the legs. It comes and goes away. It improves when I sleep but worsen when I sit and work. It started as thigh pain during my periods and then became calf and hamstring pain.; This is a spontaneous report from a contactable consumer. A 30-years-old female, non-pregnant, patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine via an unspecified route of administration, administered in left arm on 27Mar2021 15:00 (Batch/Lot Number: ER8730) as single dose for COVID-19 immunization. Medical history included arthritis from an unknown date and unknown if ongoing, hip pain in Jan2021, resolved by taking vitamin D3 tablets by "NatureMade" 2000IU and milk. The patient's concomitant medications were not reported. Prior to vaccination the patient was not diagnosed with COVID-19, since the vaccination the patient has not been tested for COVID-19. On 14Apr2021 13:00 the patient started experiencing pain in thigh, calf, hamstring of both the legs. It comes and goes away. It improves during sleep but worsen when the patient sits and works. It started as thigh pain during the patient's periods and then became calf and hamstring pain. The patient reported that it surely has altered something in her body. She is a software engineer and most of the time she needs to work on her laptop. She took Pfizer vaccine to save herself from COVID-19 instead this vaccine is crippling her and she was unable to work due to the pain. As a result of the event the patient scheduled an appointment with orthopedic. It was also reported that the patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, at Pharmacy or Drug Store, on 24Apr2021 at 2:30 pm (Batch/lot number: EW0170). At the time of the report the event had not resolved yet.  No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a Licensed Practical Nurse (L.P.N.) regarding a 12 month old female patient. The patient's medical history or concurrent conditions were not provided. On 12-APR-2016, the patient was vaccinated with an expired dose of PEDVAX HIB (which had lot # J006418; however dose, dosage number, route of administration and expiration date were not reported). Concomitant medications were not provided. The L.P.N. stated that there was no adverse effects to report. Additional information has been requested.
Allergic reaction (non-life threatening) where I had itchy eyes, nose, throat, and neck; Allergic reaction (non-life threatening) where the patient had itchy eyes, nose, throat, and neck; eyes were burning; felt very hot; soreness in the right arm (where the shot was given); This is a spontaneous report from a contactable other healthcare professional. A 27-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 3248) via an unspecified route of administration in the arm right on 27Apr2021 at 10:00(at the age of 27-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not take any concomitant medication. The patient's past drug included stone fruit. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  On 27Apr2021, about 2 hours after the vaccination, the patient experienced soreness in the right arm (where the shot was given) which continued for another 48 hours. On 29Apr2021 at 09:00, the patient experienced an allergic reaction (non-life threatening) where she had itchy eyes, nose, throat, and neck and her eyes were burning and felt very hot. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with BENADRYL and ALLEGRA. The clinical outcome of the events vaccination site pain, allergic reaction, burning eyes, feeling hot and itchy was resolving.  No follow-up attempts are needed. No further information is expected.
10/09/2006 Possible Urinary Tract Infection-pelvic pain. 10/17/2006 Medical doctor visit pain in feet, pelvic girdle pain, rectal pain. 10/30/2006 Neurologist loss of sensation, waist down. MR received PMH: 51 year old in excellent health.  Meds: Thyroid, Prozac, Advil PRN.  Allergic to raspberries.  She had abrupt onset of perineal pain and difficulty urinating 4 days s/p flu vax.for which she was treated with antibiotics. Subsequently developed pain, allodynia on soles of feet, perineum, axillae.  No weakness noted at this time.  Treated with 2 of 6 Apheresis treatments prior to discharge from hospital. Discharge DX:  Post-vaccinial dysimmune radiculitis
Patient notes that on 9/8 she had her first dose of Pfizer COVID vaccine. Two hours later she felt totally drained and it lasted 48 hours. She couldn't stand up for long periods because she was exhausted. Within the first 4 hours she had brief heart racing that lasted for 30 minutes off and on and then it resolved and hasn't returned. The patient states she started with SOB right after the vaccine and this has persisted. She has a history of asthma that is controlled except for seasonal changes. The SOB is sometimes at rest, but mostly with exertion. Going up stairs she feels SOB. The first week after the vaccine she was having to use her albuterol inhaler. She is not having to use the inhaler as much now. She last used the inhaler on Friday. No wheezing or coughing. She hasn't noticed any change in her allergies since before the vaccine. She also notes she has R upper arm itching and heat where she had the injection. She had a lump in her R upper arm a few days ago along with redness. She took benadryl.
One dose given > 12 hours after puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (One dose given > 12 hours after puncture) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (One dose given > 12 hours after puncture). On 31-Aug-2021, EXPIRED PRODUCT ADMINISTERED (One dose given > 12 hours after puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.  The patient received the expired dose 8 hours passed the 12-hour expiration. The vial was initially stored in the refrigerator on 24 Aug 2021 (one week ago) and was removed from refrigerator, dose drawn up at room temperature, and then administered to the patient. Total amount of time the vial was exposed to room temperature range (46° to 77° F).
expired Menactra was given on 19-feb-2020 to female nonpregnant/no AE; Initial information received on 21-Feb-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (office staff).  It was reported that 16 years old nonpregnant female patient received a 0.5 ml dose of expired MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (expired product administered) on 19-feb-2020 for prophylactic vaccination via intramuscular route at the left deltoid [lot U6015AA and expiry date 06-OCT-2019].  Medical history, concomitant therapy,medical treatment(s), vaccination(s) and family history were not provided.  It was of actual medication error case due to expired vaccine used.  At the time of reporting, no adverse event was reported.  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.
Weak, chills, fever, nausea, headache, general body ache, poor balance.
Patient fully vaccinated for COVID presented to ED on day 7 of COVID-related symptoms and was admitted.
medication error due to reconstituting with the wrong diluent and administering to a patient, with no reported adverse event; Initial information received on 15-Apr-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 16 months old female patient who experienced medication error due to reconstituting with the wrong diluent and administering to a patient, with no reported adverse event while receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].   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 (DTAP) for Prophylactic vaccination.  On 14-Apr-2022, the patient received a  dose of suspect HIB (PRP/T) VACCINE lot UJ574AAA via intramuscular route in unknown administration site for prophylactic vaccination.  On 14-APR-2022 the patient developed a non-serious medication error due to reconstituting with the wrong diluent and administering to a patient, with no reported adverse event (medication error) following the administration of HIB (PRP/T) VACCINE.  Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was not applicable.  It was not reported if the patient received a corrective treatment for the event (medication error due to reconstituting with the wrong diluent and administering to a patient, with no reported adverse event).  At time of reporting, the outcome was Unknown for the event medication error due to reconstituting with the wrong diluent and administering to a patient, with no reported 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 guidelines. 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.
2 hrs after getting GARDASIL #3 and VARIVAX #2, patient had body aches, headache.  Later that evening, had fever to 102.  Woke 4AM with nausea, vomiting x 2-3.  Nausea, malaise persisted.  Seen in office for evaluation 8/19, was afebrile, mild cervical and inguinal adenopathy.
to ED c/o SOB, cough, body aches, fever; COVID + at nursing home; TX: decadron, singulair, zinc, does not meet criteria for remdesivir, azithromycin, rocephin, no O2 required; discharged back to nursing home
Headache, Myalgia, Fever, CHILLS, EXHAUSTION Narrative:  Other Relevant History:
weak; she is not well /Got it a week ago and still having side effects /it made her feel sick; had stomach pains; chills; nauseous; She started feeling a little different; This is a spontaneous report from a contactable consumer. A 84-years-old female patient (mother) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation-solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration on 27Jan2021 as 1st dose, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. She started feeling a little different on Friday the 29Jan2021, by Saturday the 30Jan2021, she had stomach pains, chills, and was nauseous. She went to emergency room on Saturday 30Jan2021, blood work determined everything was functioning and gave her medication for nausea, but that was making her ill, don't know what the medication was. It made her feel bad. They gave her 3 doses, she took all 3, it made her feel sick as soon as she took it and she would feel a little better a little later on. I forgot to tell you she was weak. You can hear it in her voice she was not well. Today she was still the same. She got it a week ago and still having side effects. She would like to know if there is any advice for someone who is still having symptoms a week later. She stated she can do the report online. The patient underwent lab tests and procedures which included blood test: everything was functioning on 30Jan2021. The patient received treatment for nausea. The outcome of the events was unknown.  No further details provided. Information about Lot/Batch number is requested.  Follow-up attempts are completed. No further information is expected.
Patient developed fever 101-102 after immunizations. Is lethargic; slept a lot, with poor feeding. Seen in office next day, sent to ER for observation, observed and sent home.
VERY STIFF NECK. DIFFICULTY RAISING HEAD UP AND DOWN. SHOOTING PAIN TO TOP OF HEAD.  PATIENT CONTACTED DR. ABOUT ADVERSE EVENTS.
Large hives and red rash  developed one week after booster shot, have persisted for 6 weeks after becoming progressively more mild but still elicited by contact
102 FEVER, UPPER ARM CELLULITIS,   HOSPITALIZED AT :  MEDICAL CENTER ADMITTED 7/10/21; DISCHARGED 7/13/21
Patient presented to the ED and was subsequently hospitalized with acute respiratory failure with hypoxia within 6 weeks of receiving COVID vaccination.
The next morning (about 16 hours later), I got really dizzy, then freezing cold. My temperature was 103*F, and every single joint hurt so badly that I understood why people would cut body parts off from pain. I spent the day in bed, trying to listen to a book to distract me from the pain. I took Tylenol and ibuprofen alternately to try to keep the fever and pain under control. The extreme pain was gone about 12 hours after it started. I was still quite dizzy, but my temperature had dropped to 101*F the following day. I began sweating profusely, changing clothes 3-4 times a day due to the wetness of them. I was very tired, but after a week, my temperature dropped to 99.7*, and I was back to a 98.4* temperature after 2 full weeks post vaccination. The dizziness remained, however, when I bent over or tried to turn over. The sweating continued, but not when I just sat and did nothing. The slightest exertion would cause copious sweating though. The dizziness finally disappeared 6 weeks (to the day) after that second vaccine dose. The sweating, however, is still a problem 58 days later. I only have to change clothes 2-3 times a day now, but I have had to deal with the vaginal yeast infection, a fungal infection under my breasts, and now an infection between my toes that is quite painful, all because of the constant moistness of my sweaty skin.
Developed five red bumps, similar to hives in a circular pattern by my injection site.  They are approximately the size of a dime. They are hard and painful. One is slightly itchy. Noticed them on 3/6/2022 in the evening. This morning, 3/7/2022, some of the hard, red bumps are a little better, but not all. Note, I looked online at pictures of other peoples reactions where they had one large red circle. Mine is not like that. Again, mine is five distinct dime-sized circles in a circular patters around my shot. My whole shoulder hurts to the touch.
1047 Approx. 5 mins post vaccination Pt. states feeling lightheaded and dizzy. States sl. SOB and feels "like her heart is racing". c/o sl. nausea and metallic taste. States has tunnel vision. Unable to stand. Inst. to lower head between legs.  1049 Assisted to exam table to recumbent position.  BP11/66 P64. Dizziness cont. Lungs clear to auscultation.  1056 BP 102/64 p64 r18. Dizziness and tunnel vision continues .1107 BP 102/74 P60. Denies difficulty breathing. PERL. Oriented and alert. Occas. stares into space but responds to questions.  1119 Assisted to sitting over edge of exam table. Immed. became dizzy and returned to recumbent position. . B/P 112/77 p60.  1124 EHS called. Pt. informed need to send to ER. Pt. in agreement. 1135 B/P 100/58 P60.  1142 C/o L arm tingling and mid sternal pressure.  1143 EMS arrived.  1148 Ems transported pt. to ER,