chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 07-Mar-2019 regarding an unsolicited valid non-serious case received from Other health care professional. This case is linked to case 2019SA066972, same reporter. This case involves a 15-years-old female patient who received vaccine FLUZONE QUADRIVALENT. The patients past medical history and family history were not provided. The patient did not receive any concomitant medication. On 05-Mar-2019, the patient received a 0.25ml dose of pediatric prefilled of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number, expiry date not reported via unknown route in the arm nos. It was a case of actual medication error due to vaccine underdose. It was reported that patient was administered pediatric prefilled FLUZONE QUADRIVALENT 0.25 mL in error to a 15-year-old. It was unknown whether adverse event occurred after the injection. 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. List of documents held by sender: none.
14 y/o female presented to observation after receiving covid-19 pfizer vaccine c/o of dizziness and expressing syncope after lying down for ten minutes in the vaccination station. Pt V/S as follows; at 1332; 79/49 53 12 and O2 100% RA in supine position with legs elevated. Pt continued to express dizziness. Pt reposition to seating after ten minutes. Pt V/S as follows at 1340; 86/50 57 16 and O2 100% RA. Pt provided water and chips. Pt reposition to standing after ten minutes. Pt V/S as follows at 1350; 76/45 57 16 and O2 100% RA. Pt express feeling dizzy after standing. Pt advised to reposition to sitting. Pt V/S while sitting at 1400 are as followed 85/55 53 16 and O2 100%. Pt then advised to stand and try to ambulate once ready. Pt stands and expressed they felt fine and was ready to ambulate. Pt ambulated thirty feet without assistance. Pt VS after standing and ambulating at 1209 as followed; 84/54 63 18 and O2 100% RA. Mom stated PCP reports SBP of 90 in March via phone. Pt and Pt mother advised to follow up with PCP prior to playing Baseball next day. Pt DC after displaying steady gait after ambulating, eating chips, drinking a full bottle of water  Pt stating "no longer feeling dizzy" and VS taken at 1409. Supervisor notified.
Patient received her 1st booster dose 5/4/2022 and her 2nd booster dose 7/28/2022. Her second booster was too early in the series. No reactions noted.
had fever 102.5  for almost 48 hrs   Headache, Nauseous, chills that made me shake uncontrollable, weakness, Dizziness,  the fever is gone but  still experiencing Dizziness, weakness, Headache, nauseous, confusion  at night sweats  racing hart
Immun given on 11OCT91 & pt devel fever of 100.4 the following day; 3 days of a low appetite; all pt did was sleep, & spit up p/each feeding; did not like to be picked up; 14OCT91 high pitched cry & pale;
This was Shot #2 in the Shingrex series Approximately 3 hours after shot, experienced swelling and heat in injection area. I considered this normal based on Shot #1. Approximately 12 hours after shot, fainted on kitchen floor with no history of fainting
PATIENT STATES THAT SHE NOTICED A RASH ABOUT THREE DAYS AFTER GETTING HER FLU SHOT  AND SHE HAD A APPOINTMENT WITH HER DERMATOLOGIST IN DRS OFFICE  AND SHE ORIGIANALLY THOUGHT IT MAY BE EXEMA BUT PATIENT RETURNED  TWO WEEKS LATER AND  THE RASH HAD GOTTEN WORSE  AND DOCTOR SAID ITS A RECATION FROM HER FLU SHOT  PATIENT STILL HAS RASH  AS OF 11/22/2019  AND STILL RECIVING TREATMENT .
pt started getting lesions about one week after vaccine-oozing, painful, sores mostly on torso, some on legs pt followed up with doctor conf diagnosis of herpes zoster
No additional AEs were reported; a patient received an expired VAQTA; This spontaneous report was received from a medical assistant referring a patient of a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On 23-SEP-2021, the patient received an expired hepatitis a vaccine, inactivated(VAQTA) (1 ml, lot # S034296 with expiration date 09-JAN-2021; dose and route were not reported) for prophylaxis. No additional adverse events were reported.
Information has been received from a physician concerning a female patient who was vaccinated with Gardasil.  Subsequently the patient experienced severe swelling and redness at the injection site.  Subsequently, the patient recovered.  Additional information has been requested.  03/18/2010 follow up - OEDEMA PERIPHERAL; ERYTHEMA; HYPERSENSITIVITY; SKIN WARM; PAIN IN EXTREMITY; INJECTION SITE BRUISING  This is in follow-up to report (s) previously submitted on 06/14/2007  Initial and follow-up information has been received from a physician concerning a 26 year old white female with no pertinent medical history who on 31-JAN-2007 was vaccinated with a first dose of HPV rL1 6 11 18 VLP vaccine (yeast)  (lot# 654540/1162P) Concomitant therapy included ethinyl estradiol/norgestimate (ORTHO TRI-CYCLES). On 31-Jan-2007. Immediately after the vaccination, the patient developed a severe allergic reaction with erythema. Severe swelling and warmth of the left arm and bruising at the injection site.  There was no dyspnea, wheezing or throat swelling. Ice was applied to the patient's arm. The patient recovered from severe allergic reaction with erythema, severe swelling and warmth of the left arm and bruising at the injection site.  It was reported that the patient's arm remained sore for approximately 1 week.  The second dose of HPV ILI 6 11 16 18 VLP vaccine (yeast) was not given.  No further information is available.
"heart banging against my chest"; Heart rate of 110bpm; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS ("heart banging against my chest") and HEART RATE INCREASED (Heart rate of 110bpm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PALPITATIONS ("heart banging against my chest") and HEART RATE INCREASED (Heart rate of 110bpm). On 26-Feb-2021, PALPITATIONS ("heart banging against my chest") and HEART RATE INCREASED (Heart rate of 110bpm) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Heart rate: 110 (High) 110 beats per minutes.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication provided. No concomitant medication provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up information received on 25-MAY-2021 and contains no new information.
Red blotchy rash below injection site. Skin is hard/firm and warm to the touch. Rash does not stay consistently in one spot, it migrates slowly throughout the day and appears to be a different shape/size in the evenings than it was in the morning.
From 0-24 hours post injection, I had soreness at injection site. At 18 hours post injection, I had abnormal back pain (lasted about 30 minutes). At 29 hours post injection, I had rapid onset chills (lasted 3 hours) and fever (highest measurable was 100.3, lasted about 1 hour), feeling faint (15 minutes), nausea (15 minutes).
Received Moderna booster in the afternoon on 11/5/21, that evening had an itchy petechial rash down both arms, across chest and palms as well as a large hive at the injection site. I took a benadryl and the rash subsided, hive at injection site is slowly improving with time.
Patient was given vaccines on 4/28/14 but did not start oral typhoid until 5/28/14. States he started not feeling well during taking doses, but by last dose on 6/3/14, he was very uncomfortable with abdominal pain. Did not feel like eating and also had some constipation. States he had fever 6/7-8 but by 6/9 was beginning to feel better.
first dose on 2019, didn´t received 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 91-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose with batch number A4B72, on 8th October 2019 on left deltoid).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that the patient had not yet been administered the second dose of the Shingrix vaccine, which led to incomplete course of vaccination. The reporter consented to follow up.
Narrative: COVID infection following COVID vaccine series Q05/14 Janssen, dose #1 10/23 COVID swab, result: detected 10/23 pt cc: exposure: unknown
Information has been received from a consumer, for GARDASIL, a Pregnancy Registry product, concerning her daughter in law, an 18 year old female with no drug allergy who on 02-SEP-2008 was vaccinated with the first dose of GARDASIL while few weeks pregnant.  Concomitant therapy included poliovirus vaccine (manufacturer unknown) and RECOMBIVAX HB.  The patient was now 24 weeks pregnant and was experiencing some cramping, headaches, occasional spasm in the rib cage area, yeast infections and general body aches.  She already had a yeast infection when getting GARDASIL and was prescribed and unspecified medication for it;  however the infections were coming back.  The patient performed pregnancy test and ultrasounds.  The first ultrasound came back normal.  The patient had a second ultrasound done.  At time of the report the patient was not recovered.  The patient sought medical attention.  Additional information has been requested.
Large (2 by 3 inch) swelling at injection site, warm to the touch with considerable itching.  There was no swelling or itching at the time of the injection (2/5/21) or the next 7 days. It appeared on the morning of the 8th day following the injection (2/13/21) and has persisted all day. I did not receive an automated ?health check-in? text today so I was unable to report it. The size of the swelling has not changed but there is a constant itch.
Information has been received from a licensed practical nurse (LPN) concerning a 20 year old female with no pertinent medical history or known drug allergies who on 08-JAN-2008, 11-MAR-2008 and 11-JUL-2008 was vaccinated intramuscularly with her 0.5 ml first, second and third doses of GARDASIL vaccine (yeast) (all the lot numbers are 659180/1758U). Concomitant therapy included Ibuprofen, codeine and penicillin (unspecified). After administration of her third dose of GARDASIL vaccine (yeast), the patient developed a generalized rash intermittently on different parts of her body. The patient sought medical attention via telephone. No laboratory or diagnostics tests were performed. At the time of this report, the event persisted. Additional information has been requested.
On 8/29/00 at midnight the pt had one to two minute episodes of bilateral shoulder and arm jerking. A temp of 99.9 at the time was noted, eyes were open, alert throughout episode. On 8/30/00 early morning facial and neck twitching for 30-40 seconds, was alert throughout, no postictal state, no fever. Pt was then fine.
Patient had pain and swelling of the arm (shoulder to elbow). After the swelling went down the patient experienced itching of the same area.
Patient developed sudden onset sensorineural hearing loss of right ear on 8/26/2021.
Hospitalization, admit transitional care,  tested positive in anticipation to d/c. IgG positive, presumed PCR positive as result of previous undocumented COVID.
I woke up with a sore throat and stuffy head. The next morning, on September 13, I tested myself using an at home test kit and was positive. I called my doctor and the nurse practitioner called in a prescription of PAXLOVID. She asked me to monitor blood pressure and oxygen level. I was ordered a cough syrup and told to take MUCINEX. I started the PAXLOVID that evening. I started to feel better the next day. I felt better day after day. I still had a stuffy nose and a mild cough. The stuffy nose turned into a sinus infection. I had a severe headache 2 days after stopping PAXLOVID. I was still coughing and had a lot of postnasal drip. The sinus infection cleared but my cough did not. I continued to test positive until day 17. I was having shortness of breath and a pain across my back. She did a chest X-ray which was negative, but she heard crackles in my lungs. She placed me on a different antibiotic for another 10 days. I am still having shortness of breath and pain. I saw my cardiologist on October 14, 2022, and he ordered an Echocardiogram and a stress test that I am having on Friday. I did see my asthma doctor and he sent me for a pulmonary CT on the October 28, 2022.
Shingles. Rash on right side of upper back, very swollen and painful lymph nodes under arm and right side. Feeling like i had the flu with body aches and joint pain
I started noticing swelling of my joints - my fingers, my knees and my ankles and then all of my toe joints. I was having trouble walking. I got a bunch of labs done. My labs were really off. They took a lab to see if I had had COVID and they said that I had had it at one point. I must have been Asymptomatic. I had a stiffly nose at one point and that was it. I was diagnosed with Rheumatoid Arthritis. I started on Steroids and got my booster since I am immune compromised.  Cinzia - an injection for my Rheumatoid Arthritis. I am on Prednisone - I am trying to wean off - I've been on it for two months now.  These are helping a lot with my symptoms.
This spontaneous report as received from a physician refers to several patients of unknown age. The patients were vaccinated with VARIVAX (Merck) (Lot #, dose and route not reported) instead of ZOSTAVAX for shingles. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was not known if the patients sought medical attention. Additional information has been requested.
Pt states she had a reaction to the TD shot. She states she was achy in all her joints, back, numbness in all extremities, arm was swollen and continues but not as bad, Temp of 101.4 with chills and she has never had a reaction before. Pt still doesn't feel well but is improving.
POSITIVE SIDE EFFECT (TREMORS GONE); This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's past medical history included tremors, and concurrent conditions included parkinsons.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced positive side effect (tremors gone). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of positive side effect (tremors gone) was not reported. This report was non-serious.
Raise red, warm rash around injection site.  Arm is a little sore to touch and hurts a little.
Per Dr.'s email sent out on 9/1/22-"the monovalent mRNA COVID-19 vaccines are not authorized as booster doses for individuals 12 years of age and older. Any patients that are currently scheduled to receive a booster should wait until we have the bivalent booster on hand." The patient, was seen in office on 9/2/22 and received a booster dose of the monovalent mRNA COVID-19 vaccine (pfizer) by nurse in error as patients are now only supposed to receive the bivalent booster per Dr.'s email. Pt was due for booster at the time they received it, however the bivlalent booster was not yet stocked at facility.  Possible cause of the incident is that an email was sent out regarding the discontinuation  of monovalent covid boosters until facility receives the bivalent booster doses. This was overlooked by management and staff, as previous changes to clinic processes is usually discussed in a meeting. Also ?monovalent? and ?bivalent? are new terms that have not previously been used when discussing booster vaccines.
Client had shingles vaccine, on 5/1/08 and left the clinic. Client reported to me on 5/5/08 that on 5/2/08 Friday, at the site of injection was warm to touch and slightly raised and reddened. The client stated that on 5/2/08 in the AM, she was itchy and had what looked like hives. Client took some Benadryl. On Saturday, 5/3/08 symptoms had subsided.
3/2/22 pt brought to ED from outpatient Hemodialysis Unit with episode of GI bleed; pt reports x 2 days; transferred for further evaluation; found to have a positive COVID test in ED, asymptomatic, placed in isolation; have record of first positive COVID test being 12/29/21 at Hospital; during the March hospitalization, pt experienced Atrial Fibrillation and was treated with medication; found to have a non-functioning Perm-A-Cath, replacement performed; elevated WBC, given ABX; pt coded x 3  rounds, asystole after pulse check; meds also given without success; pt passed away in the hospital
1/21 Fever 102 treat with Motrin, 103 treat with Motrin 5pm, 1/22 fever 105 seen at Hospital treated with Tylenol and Motrin and told to keep given it to him ever 4hrs Tylenol and 6hrs Motrin. Nasal congestion no sign of mucus toddler can not breathe through nose
extreme weakness beginning 3 days after shot; difficulty standing and walking; brain fog - often did not know where I was; could not understand what people were saying. This gradiually improved, but as of 4/7/21 much weakness remains. Hard to stay awake, but that is improving. Felt sicker than I ever have.
developed symptoms on 08/04/2021 and was admitted to the ICU on 08/09/2021 Patient expired on 8/24/2021
I had A Fib. I could feel that my heart was not beating correctly. I contacted my doctor about this. I was referred to a cardiologist. They did an Echocardiogram, that showed that I was in A Fib. He also put a heart monitor on me.
Within the first few hours of receiving the vaccination I had the typical reaction of a raised, hot, and painful area surrounding the injection site.  This continued for a few days.  The day after the injection I also felt tired.  All of these reactions were gone by the third day.  On day 9 the area around the injection site became red, hot, and indurated.  Over the next two days this reaction stretched down my arm, extending from my shoulder to my elbow and wrapping around my arm.   This all disappeared rather quickly by day 12.  On day  15, however, the red, hot, and indurated area returned and has again began spreading down my arm.  Having heard of "COVID arm" I was not alarmed by the first incident, but am more concerned with the fading then return of the "rash."
Started getting a fever and headache about 9-10 hours after injection.  Arm was sore the whole time even 117 hours after injection.  Fever lasted just the night but headache last into the second day of vaccine.
Pain in the armpit, red streaking ascending the left arm into the armpit and around the collar bone. Also experienceing diarrhea.
About a week after the injection I developed a red, hot-to-the-touch, itchy rash at the site of the vaccine.  The rashy area was about four inches across.  Over the course of the next week the rash slowly traveled down my arm getting closer to my elbow.  It continued to be about four inches across and red, hot-to-the-touch, and itchy.  Slowly these symptoms faded away, and I feel fine now.  To clarify on point #21, I didn't actually visit my doctor.  We communicated using MyChart.  I uploaded a picture of my rash to MyChart.
6 hours after the shot I got the chills like I have never had them Shivering, teeth chattering could not get warm. That lasted about 8 hours. This morning I have lots of body aches and a headache. sore throat and cough. Body aches the next morning ( today )
Chills, Fever, Rapid, Rapid Heart rate, severe stomach/indigestion problems, headache and chest pains.  Swelling of the eyes as well as watering of the eyes for several days.  Sensitivity to light and severe hoy flashes
Sore Arm (one day) Dizziness / Vertigo (28 April 2021)
Received vaccine 12-8-16. Throat started swelling night of 12-9-16 and lasted until morning of 12/10/16. Hard time breathing most of Friday night-Took Benadryl. Was seen in urgent care as flu like symptoms occurred - on 12/18/16 and placed on amoxicillin. As of 12-27-16 cough remains. I have taken the flu vaccine every year for many years and the throat swelling was the first bad reaction. I question whether to take the vaccine in 2017.
bilateral thigh myositis. started on 2-3 days after immunizations. lasted 3-4 days. intense pain. very stiff, did not want to move
Fever after shots. Rash began 6-15-2010. 6/17/10 was better. 6/18/2010 rash has resolved.
Patient felt Syncope / Fainting . Onsite EMS was called vitals BP 92/66 BG 80  98% O2 room air HR 68. Patient Refused Evaluation/Care, Left aginst medical advice.
A magnet and or a quarter sticks to their body at their vaccine injection site/ Magnet sticks to the injection site/ Quarter sticks to the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 29 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 12May2021 (Batch/Lot number: unknown) at the age of 29 years as dose 1, single for covid-19 immunization. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 16May2021, outcome "not recovered", described as "A magnet and or a quarter sticks to their body at their vaccine injection site/ Magnet sticks to the injection site/ Quarter sticks to the injection site".  Additional Information: Caller reported that they both received their first vaccine dose on 12May and both of them are now experiencing a side effect. Caller reports that a magnet and or a quarter stick to their body at their vaccine injection site. He reports that this is something that multiple people are experiencing as there are reports on social media about this. The patient does not go to emergency Room and physician Office.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient stated she experience "severe" body aches. She also "broke out" on her face.
Received concerns from the patients wife that after he received his COVID vaccine, it caused all of his medical problems and eventually led to his death. Patient was not positive for COVID.
pain on injection site; slight little headache; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a patient of unspecified age and gender received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration on 16Jan2021 at single dose for COVID-19 immunization. Medical history included covid, diagnosed from Aug2020 (mild symptoms). The patient's concomitant medications were not reported. The patient experienced pain on the injection site, and a slight little headache. The outcome of events was unknown.  Information on the lot/batch number has been requested.