chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Choking; Tired/worn out all a week; sluggish; coughing; in a fog/starts laughing and it feels like something went down the wrong pipe; throat feels strange/feels like its closing but she knows its not; hoarse; can't think; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration, administered in the left arm on 12Jul2021 (Lot Number: EW0181; Expiration Date: 30Aug2021) as dose 1, single for COVID-19 immunization.  Medical history included heart murmur which was diagnosed at birth on 07Apr1962 and laryngitis from an unknown date. The patient also had unspecified reactions to medicines. There were no concomitant medications.  The patient had nothing with the first dose, she was just tired and sluggish and worn out all week in Jul2021. The patient had to go see the throat doctor. The doctor ordered the tube to go down her throat because she has been choking since she had the first dose but its not as bad. The patient choked on chicken noodle soup. The patient stated that she starts coughing really bad and starts laughing and it feels like something went down the wrong pipe in Jul2021. The patient's throat feels strange. It feels like its closing but she knows its not. The patient added that by 17:00 (unknown date in 2021) she will be totally hoarse. The patient was in a fog and can't think on an unknown date in Jul2021. The outcome of the event choking was not recovered. The outcome of the events tired/worn out all a week and sluggish was recovering while the outcome of the other events was unknown.
I started feeling chest pain around 9:00pm on Friday, 09/10. I could not sleep through the night, and was in extreme pain (8 out of 10). I went to an urgent care after speaking with the pharmacy that administered the second dose of the Moderna vaccine on 09/09 at 5:00pm. The Urgent Care did an EKG that came back slightly abnormal but stated it not uncommon for my age (24). They recommended I go to the ER to get blood work done. After speaking with family members, I decided to go to the ER. I was seen immediately and many tests were done. I stayed over night (arrived Sat, 09/11 at 12:30pm and stayed until Sunday, 09/12 at 11am).
This spontaneous report as received from a female consumer of unknown age refers to herself. Information regarding the patient's medical history, concurrent condition or medical history was not reported. On an unknown date, the patient was vaccinated with an unidentified Merck HPV vaccine (dose, route, lot # and expiry date were not reported) "in the butt", which was other-than-indicated in the prescribing information. The patient was not sure whether she received the first dose of GARDASIL or GARDASIL 9. There were no adverse effects reported. Additional information has been requested.
1/22 received 1st dose Moderna.  On 1/25 started feeling pain similar to rotator cuff pain in both shoulders.  Pain worsened over the next several days and then she also developed pain in her hip joints.   2/1/2021 - 1st appt with doctor, suspected polymyalgia.  Prednisone 20mg BID  x1 wk prescribed. 2/10/2021 - 2nd appt doctor,   pain in both shoulders, possibly related to vaccine, Meloxicam 15 mg daily and labs ordered.   2/11/2021 - Labs drawn     2/15/2021 3rd appt with doctor,   Multisystem polymyalgia rheumatica (HCC) .  Labs reviewed.  Continue Meloxicam 15mg and restart Prednisone 20 mg daily and referred to Rheumatologist. 2/19/2021  1st appt with Rheumatologist, Additional Prednisone 10 mg in the evening, and continue Prednisone 20 in the morning.   She has increased her evening dose to 20 mg on her own as 10 mg was not controlling her pain.   She plans to contact Rheumatologist about the change in her dose.    Repeat labs order to be done in 3 weeks and a f/u appt arranged.
Headache ~ moderate Nausea ~ mild Fatigue/tiredness ~ moderate  *Nothing severe ~ just reporting side effects of first vaccine dose*
Redness, swelling, and itching at the injection site three days after administration of Varicella immunization. Did not self-medicate or seek medical attention.
extreme fatigue, profuse sweating, red spots on body that look like psoriasis, constant nausea
Event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date/Expired vaccine administration; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date/Expired vaccine administration) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 070H21A, 032B21A and 044A21A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer in 2001. Concurrent medical conditions included Hyperparathyroidism, Osteopenia and Tear film insufficiency, unspecified.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 24-Jan-2022 at 10:38 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 24-Jan-2022 at 10:38 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date/Expired vaccine administration). On 24-Jan-2022 at 10:38 AM, EXPIRED PRODUCT ADMINISTERED (Event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date/Expired vaccine administration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date/Expired vaccine administration) to be not related.    No concomitant and treatment products were reported. It was reported as per Moderna, the vaccine will maintain the necessary effectiveness against COVID-19. The reporter confirmed  that there were no other adverse events associated with this event. In addition Moderna COVID-19 vaccine 4 days beyond the recommended expiration date.
Pt felt sweaty, seeing black spots in vision. Pt lied down in room. BP stable, orthostatic BP's normal. Symptoms lasted 10 mins. Was not having vision difficulties while supine only when standing.
I?ve developed chronic urticaria, it?s lasted since September 4th and it comes and goes all over my body in the form of itchy lacy hives. Initially it was treated by my doctor with a steroid shot, that didn?t work. Then I was given 6 days of prednisone and steroid cream by the walk in clinic. That didn?t work. They are all over my body and it?s making daily life very tough with the terrible itching. It will show up in one place, then disappear and show up somewhere else. Everywhere from my face, arms, neck, back, legs, hands, etc it?s miserable.
Upper right arm still very sore. Hard to lift heavy things - worse when my arm is higher in the air or out farther in front of me. Can no longer sleep on my right side with arm up under head. Hurts to just raise arm up.
Pt is having infrequent but continued mild chronic pain at site of GARDASIL vaccine that was given on 11/14/07. No treatment.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Nov2021 as dose 1, single (Batch/Lot number: unknown) at the age of 46 years for covid-19 immunisation; coviD-19 vaccine janssen (COVID-19 VACCINE JANSSEN), on 15Mar2022 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Mild intermittent asthma" (unspecified if ongoing), notes: Mild intermittent asthma; "history of stage 1 ovarian cancer (in remission)" (unspecified if ongoing), notes: history of stage 1 ovarian cancer (in remission); "obesity (BMI 35)" (unspecified if ongoing), notes: obesity (BMI 35),; "ADHD" (unspecified if ongoing), notes: ADHD. Concomitant medication(s) included: ESTRADIOL oral; HYDROXYZINE; VENTOLIN HFA.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: Body mass index: (unspecified date) 35, notes: Obesity(BMI 35); SARS-CoV-2 test: (07Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: On 07Jun2022 the oral Paxlovid was taken as Treatment medication for COVID-19 upto 11Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Symptoms started as numbness and weakness in her feet which progressed to her hands, and eventually whole body.   Diagnosis is Guillain-Barre syndrome.  Remains hospitalized and receiving IVIG.
This case was reported by a pharmacist via sales rep and described the occurrence of adverse reaction in a female patient who received Influenza vaccine Quadrivalent. On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to Influenza vaccine Quadrivalent. Additional details were reported as follows: The patient had a reaction to last year's flu shot. The patient's allergist wanted to know the components of last year's vaccine and this year's vaccine so they can avoid a reaction for this year. The reporter wanted to know if the patient was able to be vaccinate this year.
This spontaneous case was reported by a patient and describes the occurrence of MIGRAINE (Migraine), INTERMENSTRUAL BLEEDING (Spotting) and PYREXIA (Very mild fever) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination. No Medical History information was reported. On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced MIGRAINE (Migraine). On 30-Apr-2021, the patient experienced INTERMENSTRUAL BLEEDING (Spotting) and PYREXIA (Very mild fever). On 30-Apr-2021, MIGRAINE (Migraine) outcome was unknown. On 01-May-2021, INTERMENSTRUAL BLEEDING (Spotting) and PYREXIA (Very mild fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was provided. Treatment provided was Aspirin and Motrin. The patient took first shot on 28Apr2021 and second shot on 28May2021. A day after the shot had migraine for a day. Very mild fever and spotting for 2 days. A day after the second shot had 104F fever and spotting for two and a half days. Also had aches and chills for two days. Lot# 049C21A (second shot)
patient inadvertently received a dose of PENTACEL after having already received a dose of Pediarix, with no reported adverse event; Initial information received on 20-Aug-2021 regarding an unsolicited valid  non-serious case from an other health professional and consumer/ non healthcare professional via Media information (under reference 00733710).  This case involves a 6 months old female patient who inadvertently received a dose of DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL [VERO]) after having already received a dose of  DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) [extra dose administered].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) not produced by Sanofi Pasteur (lot number and expiration date not reported) via unknown route in an unknown administration for prophylactic vaccination.  On 04-Aug-2021, the patient received a dose of suspect PEDIARIX not produced by Sanofi Pasteur (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On 20-Aug-2021, the patient received a 0.5 ml dose of suspect PENTACEL (lot UJ458AA and expiration date: 21-May-2022) via intramuscular route in the left thigh for prophylactic vaccination.  It was an actual medication error due to extra dose administered (same day  latency).  It was reported "Caller states that a patient inadvertently received a dose of PENTACEL on 20-Aug-2021 after having already received a dose of Pediarix on 04-Aug-2021. Caller asked if the patient was at risk for any adverse events because of the close proximity of the two doses and stated that she realized that today's dose would not count as a valid dose in the series".  At time of reporting, it was unknown if the patient experienced any adverse event and the outcome was unknown for the reported 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.
10/16/2019 at 12:30 PM--hives noted on left thigh, quickly spread to right leg and arms.  By 1:30 PM, child covered in hives on arms, legs, and trunk.  Taken to doctor's office at 2:30 PM and assessed by ARNP.  Benadryl initiated at approximately 3:00 PM.  Minimal relief from itching and hives.  Benadryl administered every 6 hours through the night.   10/17/2019--oral steroid initiated at 9:00 AM (was prescribed at doctor appointment 10/16), receives total of three doses of Prednisolone 15mg/5mL given over course of day.  Hydrocortisone cream applied topically to hives twice.  Hives reduce in number, but are constantly present and intensely itchy.  Benadryl continued.  Child misses school due to hives, itching, and drowsiness from Benadryl.  Taken to doctor's office at 5:30 PM and assessed by MD; instructed to continue Benadryl and oral steroids as prescribed, referral to be made to pediatric allergy doctor.  Child has difficulty sleeping due to increase in hives after shower, intense itching, and no relief from Benadryl nor hydrocortisone cream and is awake until 2:30 AM.  Ice packs placed around child, dressed in light pajamas (tank top and shorts, two fans circulating air in room, and window open, in an effort to keep cool and reduce hives--does not help. 10/18/2019--Hives continue, reduced in number, and are not as itchy this day.  Receives two doses of Prednisolone this date, Benadryl continued.  Aveno oatmeal bath given. 10/19/2019--No hives noted this day.  Receives two doses of Prednisolone this date. 10/20/2019--No hives.  Received Prednisolone once.
Left axillary lymphadenopathy and pain, large palpable axillary lymph nodes (at least 2). Onset slightly greater than 24 hrs following 3rd dose of Pfizer COVID-19 vaccine. Problem ongoing still 4 days following.
bloody (moderate amount of blood) diarrhea; vomiting; she developed a virus but her medical team could not determine what type of virus it was; sore throat; feels weak; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 10Mar2021 (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that on 25Mar2021, she developed a virus but her medical team could not determine what type of virus it was. She experienced bloody (moderate amount of blood) diarrhea, vomiting and was in the hospital from Mar2021 for treatment. She also states that she has a sore throat and feels weak on an unspecified date in Mar2021. She is due for her second Pfizer Covid vaccine dose 01Apr2021 and wants to know if it is safe to do so. The reporter feels that her symptoms are not related to the vaccine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available the reported events are considered not related to suspect drug.
Patient is 33 weeks pregnant and received BOOSTRIX on 06/21/16. Today she reports that baby has not been moving as much as he was prior to vaccination. Patient was advised to contact her Physician immediately. She was instructed by Physician to come in immediately to be seen.
I was feeling very tired in the evening.  When I went to bed, I felt exhaused, but was unable to fall asleep.  I started feeling hot then cold then hot all night long.  When I was able to sleep, I kept having to wake up because my dreams were what I have always considered "Fever dreams" - ones that made no sense and were not comforting at all, but felt dangerous.  My body started aching during the night, feeling like I had been run over by a truck. I also had a headache.  I was supposed to go golfing in the morning, but with the body temperature being out of whack, having had bad dreams, and my body aching, and absolutely no energy,  I told my husband I could not play. After sleeping a couple more hours, I got up but the shivering off and on continued during the day and evening until around 8:30 PM.  I had taken a Tylenol when I got out of bed which relieved the headache for the most part.  But I was listless, had no evergy and was unable to concentrate during the day, even took an hour's nap.It wasn't until about 9:30 PM when I stopped having any reactions.  Just as a note I had had no adverse reactions when I received the first Shingrix vaccine shot.
Fever (temperature 3 degrees above my normal temperature) Soreness and stiffness at site of injection and eventually extending to all muscles and joints Mild nausea, loss of appetite Discoloration (non-itchy rash?) from injection site extending up arm and down chest and across half of my left breast. (It looked like one of those magenta birth marks.) Swollen, tender, bluish lump in left armpit and lumpiness in left breast in left third of breast closest to injection site.
Fever 100.4 for 2 days on and off started same day of vac. Tired - slept for 2 days - red and tender at site,  day #3 started to feel better.
18JUN92 crying for 3hrs + started 4PM (high pitched @ times); t104.4 R started between 5 & 6PM ; t102 R x 3 days; swelling in leg where shot was given; pt wouldnt walk on it until 19JUN92;
PATIENT REFERS NUMBNESS OF RIGHT ARM DURING THE 15 MINUTES OF OBSERVATION PERIOD FOLLOWING VACCINATION. NORMAL MOVEMENT, NO OTHER COMPLAINTS.
Infection at injection site nine days after vaccine. Redness, heat, swelling, pain, and itching.
pt recvd vax & had fever of 103.5; was vomiting; shaky; eyes rolled back in head; screaming; unable to keep anything down; lethargic & pale; referred to Md;
Very tired the evening of the vaccine (3/1/21) Flu-like symptoms on 3/2/21: tired, headache, body ache, No fever though  Better after noon on 3/3/21
Complaints of general back and joint pain within 2 weeks of vaccination. Approximately 4 weeks after vaccination, complaints of severe tiredness, some weakness, and intermittent vomiting (on 24- to 61-hour periodicity). Approximately 5 weeks after vaccination, hospitalized with loss of coordination; inability to walk without assistance (falling); severe jaw, joint, and back pain. CT of head, chest X-ray, blood analyses, lumbar puncture, MRI of brain and spine; diagnosed with Guillain-Barre' Syndrome.  Immediately initiated plasmapheresis (5 treatments), followed by intravenous immunoglobulin treatment (5 treatments beginning after 3rd plasmapheresis treatment). Outcome pending; complete recovery not yet realized. GBS recovery expected to be prolonged; residual paralysis remains; permanent/permanence of damage unknown at this time.
MD reports that 4 pts who recvd 3 doses of Engerix-B did not sero-convert;
Pt recv vax on 7/23/98; 7/24/98 pt passed out w/ out feeling on right side & trouble breathing;tx=aspirin prn.
Shingles developed on abdomen.; This is a spontaneous report received from a contactable consumer (patient). A 42-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0179, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 09May2021 15:45 (at the age of 42-year-old) as 2nd dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient had no allergies. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: ER8737, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 18Apr2021 03:45 PM as 1st dose, single for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 17May2021, the patient experienced shingles developed on abdomen. The patient visited emergency room and physician office for the event. The patient received Valacyclovir as treatment for the event. The outcome of the event was reported as not recovered.
MODERNA COVID VACCINE #3 GIVEN 1/3/22, LOT #069H21A; pt had a positive COVID test on 1/6/22 at a local health care facility; in hospital for COVID pneumonia and respiratory failure; dc'd to rehabilitation facility; transferred from rehab facility to a Healthcare Hospital for further treatment; having increase in O2 requirements; DNR; admitted to ICU with high-flow O2; given ABX, steroids without improvement; DVT left arm, treated with heparin; began to have mental status changes; pt eventually weaned to O2 via NC; head CT was negative; pt passed away in the hospital
Pt experienced a red area about 2 inches below the shot that is warm to the touch.
numbness of face/lips Narrative:  Seen by PA - unknown treatment  Other Relevant History:
Patient received   PFIZER covid-19 vaccine for 12 and older as the 2nd vaccine . Mother is aware of the administration  and given information on possible adverse reactions to monitor for . While under observation in our office patient did not experienced any side effects or adverse reaction to the vaccine but since the wrong vaccine was administered based on patient's age we are reporting to VAERS incase patient  experiences  any side effects or adverse reaction.