chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dizziness when sitting up; Head spinning dizziness; Headache; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8730) via an unspecified route of administration in the left arm on 23Mar2021 at 16:30 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis (as reported RA), crohn's, breast cancer, lymphoma (brought on by chemo), overweight, heart disease. The patient had allergy to latex. The patient received unspecified medications within 2 weeks of COVID vaccine. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Mar2021, the patient experienced dizziness when sitting up, head spinning dizziness and headache. Rode it out and was able to stand eventually. Events started in the evening of the shot and into second day. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of postural dizziness, vertigo and headache was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
Daughter called and said her mom was unresponsive and that fire rescue were on the way to her house.  No other details provided. Daugher was asked to keep us informed but no follow up as of yet.
QUADRACEL was administered to a 22 month old infant with no reported adverse event; Initial information received  on 03-Mar-2022 regarding an unsolicited valid non-serious case received from the health professional.  This case involves a 22 months old infant patient of unknown gender, wo was administered with diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine (Quadracel) with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient was administered with diphtheria-15/tetanus/5 hybrid AC pertussis/ipv (mrc5) vaccine (strength, formulation, dosage, route, administration site, lot number and expiry not reported) for prophylactic vaccination (Product administered to patient of inappropriate age) (latency: same day).  No adverse event reported.   Action taken was not applicable.  At time of reporting, the outcome was Unknown for the 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.
Information has been received from a physician concerning a female under the age of 25 who was vaccinated(date not reported) intramuscularly (site not reported) with the 1st and 2nd dose of GARDASIL (lot# not reported). Subsequently, post vaccination, the developed flu-like symptoms. At time of reporting, the patient's outcome was unknown. This is one of 2 reports from the same source. Additional information has been requested.
Information has been received from a physician concerning her daughter an early 20's year old female who on 28-MAY-2008 was vaccinated with her first dose of GARDASIL injection (lot # 659657/1487U) and on 12-SEP-2008 received her second dose of GARDASIL injection (lot # 660553/0070X).  One day after receiving her first dose (on 29-MAY-2008) and her second dose (on 13-SEP-2008) the patient experienced a lot of body aches, sleepiness and decreased of alertness.  The symptoms lasted for 3 days.  Subsequently, the patient recovered from body aches, sleepiness and decrease of alertness and per physician "patient is fine now".  Additional information has been requested.
Within 18 hours of the shot: whole-body muscle pain, weakness, nausea, chills, very sore at the injection site. All symptoms faded within 36 hours of the shot.
At about 1:30 in the morning I woke up bathed in sweat. At first I thought it might just be night sweats, but then I realized it was a fever and got up and checked with my digital oral thermometer. I experienced fever, chills and aches in my joints as fever rose, but then it had subsided before noon.
Continued night sweats, headache, fever, chills Continued tremors in both hands.
It started as a sharp ache of my left breast. It moved to my back and my shoulder blades. I hurt for 7 to 10 days with the pain. Then I went ER on 12/7/2021. At the ER, I had to go 4 days with clear liquids, the pain subsided. That gave me 2 bottles of the stuff they put in you ID. I had to start eating soft foods for three days. and I could not eat any fat, sugars. I was diagnosed pancreatitis. Three months earlier I had the gout and could not get rid of it. It started in June of 2021. on my 1st shot I had a rash that itched and a doctor came to see me and gave me a pill and a Benadryl. I had to wait ten minutes before I had to have my 2nd shot.
Pt came back to rx reporting of tingling sensation in her throat. Pt was administered a dose of BENADRYL and then went to the clinic. Pt was administered an EPIPEN at the clinic. Pt heart rate, BP, and breathing were monitored at the clinic until the pt felt safe to leave.
Passed out and fell face-first on a tile floor.  Teeth cut inside lip requiring many stitches.  Glasses cut across my nose.  Hit left cheek bone - bruised. Bloody nose.  Bruise and cut on right shoulder where I must have hit the counter on the way down.  Sore forehead.  Headache.
I was 40 years old and received both doses of the Pfizer vaccine and not only has my body hurt more with my fibromyalgia, but I have been in a CONSTANT flare since the shot.  I have had Interstitial Cystitis since age 23 and the only thing I did differently was to take the covid vaccine, not realizing it is gene therapy and an mRNA vaccine. I usually have no flares in the summer. Ragweed and spring allergies tend to mess me up, but summer is usually pretty good.
My toes and feet began tingling around 2100. Some tingling relieved with movement. No pain.
6 hours after dose patient noticed neuropathy. started in arms and went to feet. Lasted until following morning. patient complained of still having faint neuropathy
8/27/2020: Pt due for HPV, MCV4, Tdap, and MMR today; PMH includes seizures and syncope. This RN entered patient's room at approximately 0920 to administer due vaccines; pt was sitting upright on exam table when she verbalized feeling nervous about receiving vaccines; mother stood at pt's left side for comfort and provided a cellphone to use as a distraction. MMR was administered SC in right arm and MCV4 administered IM in right deltoid at approximately 0925. Pt appeared to tolerate injections well; shortly after administration pt verbalized feeling dizzy and was then placed in supine position on exam table. Before administering next set of vaccines, pt was given approximately 2-3 minutes to rest where she then verbalized being ready for vaccines; mother moved to pt's right side for comfort. Tdap and HPV administered IM in left deltoid. Less than 10 seconds later, pt said aloud "I am going to pass out". Immediately afterward, pt's eyes rolled back into head and her upper body began to shake for approximately 15-20 seconds; pt was unresponsive to vocal or physical stimuli during this time. Once pt's safety was ensured, this RN notified provider; provider then entered room to assess pt. O2 sat was checked and found to be 99%. Once pt was alert and responsive, she was placed in upright sitting position with back of exam table fully elevated for support; apple juice was provided and mother provided donuts for additional sugar intake. Pt verbalized feeling nauseous but did not vomit; pt then requested to go to the bathroom and was accompanied by her mother. Pt returned to room and was monitored for another 15+ minutes. At 0953, this RN re-entered exam room and pt reported feeling "better" but asked for additional time before leaving; provider was notified of same. Provider assessed pt; pt sent home w/o further incident. This RN will call mother tomorrow (8/28/2020) to check on pt's status.  8/28/2020: Called pt's mother today to f/u on pt's status r/t syncopal episode on 8/27/2020.  Pt's mother reports 1x episode of vomiting  yesterday after leaving clinic but that patient is "feeling well and is back to her normal self" today.
Shortly after the child received a vaccines in the mother with the front desk in child started to act odd  the child started vomiting was brought back into the exam room and patient continued to vomit and became lethargic we assumed the patient was having a reaction to the vaccine possibly a vasovagal and possibly a seizure since the patient seemed to be post ictal we gave the child oxygen head and monitored because of the lethargy 911 was called and EMT he has came and took the child to the emergency department I found out that on route to the hospital the child developed a rash and worsened patient was given a shot of epi and the patient began to recover apparently the child had a allergic reaction to either the chickenpox vaccine or the Prevnar vaccine I spoke to the mother while she was in the emergency department and she states that the child was doing much better.
1st dose / on 04/20/2021 / 2nd dose / on 06/02/2021; 23y/o adult - administered 1st dose of 10mcg dose; 23y/o adult - administered 1st dose of 10mcg dose; This case was reported by a pharmacist via call center representative and described the occurrence of adult use of a child product in a 23-year-old female patient who received HBV (Engerix B adult) for prophylaxis.   Co-suspect products included HBV (Engerix B pediatric) for prophylaxis and hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd June 2021, the patient received the 2nd dose of Engerix B adult 20 ug. On 20th April 2021, the patient received the 1st dose of Engerix B pediatric 10 ug and Engerix B Pre-Filled Syringe Device. On 20th April 2021, not applicable after receiving Engerix B adult and unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced adult use of a child product and underdose. On 2nd June 2021, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the adult use of a child product, underdose and drug dose administration interval too long were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The pharmacist reported that 23 years old patient administered 1st dose of Engerix B 10 mcg, which led to adult use of child product and underdose. The patient received 2nd dose of Engerix B 20 mcg more than the recommended interval, which led to lengthening of vaccine schedule. The reporter consent to follow up. This case has been linked with case US2021134489, reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021134489:same reporter
Immediately after receiving vaccine as technician was placing syringe in the sharps container, patient slowly began to slump to the side.  Patient mother was in the vaccine booth as is required for minors.  She noticed him slumping and was able to stabilize him before lowering him to the ground.  Patient was passed out for about 15-20 seconds as per the technician.  We did contact emergency services and patient is stable at this time.  Mom came back to get collect their covid-19 cards and stated he was home from the ED and likely had a vagal syncope.
Very sore arm & some swelling & redness around injection site. Morning of 7/3 - woke with unusual fatigue.  By 10:00 a.m. 7/3 began experiencing body chills & malaise which progressed to neck ache/headache/ dizziness and increasing chills requiring me to leave work. Went home, took 600 mg Advil & Zyrtec and symptoms all resolved after 3 hours except for continued very sore arm.  Arm soreness   and fatigue much improved late in day on 7/4
Body aches, Chills, Headache, Pain and swelling at injection site, Lethargy, Fatigue, Possible fever on 10/24,
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The patient received other medications. The patient also received products within 2 weeks of starting COVID-19 treatment. The patient was previously received a COVID-19 Vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
1 of 2 pts who presented w/fever & cellulitis;no culture taken;pt recvd vax 9DEC94 & 14DEC lt arm swollen & had fever of 102;15DEC MD visit-dx cellulitis;tx Keflex;recovered
holds lt arm; cool wet cloth & APAP relieves distress; swollen from elbow to shlulder & inflammed;
left arm feels "heavy", warm to touch and continued redness at injection site. No pain or tenderness voiced.Patient has antihistamine cream, advised to apply anti histamine cream to affected area.
Swelling and erythema to injection site.  Also reports headache, fever and chills.
Mom reports redness initially noted to right arm yesterday. Father drew a circle around area last night; area measured 5x3 cm last night. Denies pain. Reports area is slightly itchy, but mom has not seen child scratching. Afebrile. Denies other sick symptoms. Acting normal per mom. Patient given cephalexin suspension 250 mg/5ml, 6.5 ml, orally, every 12 hours, 10 days, for cellulitis.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years 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's relevant medical history included: "Cll" (ongoing). There were no concomitant medications. No known allergies. 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: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
her head is bothering her; pain in her arm for three days that made her shoulder hurt and even her lung; pain in lung; shoulder hurt; Mild headache; This spontaneous case was reported by a patient and describes the occurrence of SINUS HEADACHE (her head is bothering her), PAIN IN EXTREMITY (pain in her arm for three days that made her shoulder hurt and even her lung), PULMONARY PAIN (pain in lung), ARTHRALGIA (shoulder hurt) and HEADACHE (Mild headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Ear discomfort and Sinusitis.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced PAIN IN EXTREMITY (pain in her arm for three days that made her shoulder hurt and even her lung), PULMONARY PAIN (pain in lung), ARTHRALGIA (shoulder hurt) and HEADACHE (Mild headache). On 24-Feb-2021, the patient experienced SINUS HEADACHE (her head is bothering her). In February 2021, PAIN IN EXTREMITY (pain in her arm for three days that made her shoulder hurt and even her lung) had resolved. At the time of the report, SINUS HEADACHE (her head is bothering her), PULMONARY PAIN (pain in lung), ARTHRALGIA (shoulder hurt) and HEADACHE (Mild headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. On 13-FEB-2021, the patient went to the physician because her ear was bothering her and was prescribed amoxicillin antibiotic. She did not take it because the next day she had to get the vaccinated. No treatment information was provided.
Bruising, pain lasting almost 1 week at the site, Pt's pain gone on follow up on 4/27/17. Follow up with Doctor 4/29/17, Pt is doing well.
his glucose reading was at 166 mg/dl.; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BLOOD GLUCOSE INCREASED (his glucose reading was at 166 mg/dl.) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-ZA) for COVID-19 vaccination.     The patient's past medical history included Triple vessel bypass graft and Stent placement since an unknown date. Concurrent medical conditions included Diabetes (Patient reported triple bypass and has heart stents.). Concomitant products included METFORMIN for Diabetes.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced BLOOD GLUCOSE INCREASED (his glucose reading was at 166 mg/dl.). At the time of the report, BLOOD GLUCOSE INCREASED (his glucose reading was at 166 mg/dl.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, Blood glucose: 166 mg/dl (High) blood glucose normally runs about 120 mg/dl. On an unknown date, Blood glucose: 120 mg/dl (Inconclusive) blood glucose normally runs about 120 mg/dl. On an unknown date, Glycosylated haemoglobin: 5.7 Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: This case concerns a 79-year-old male with a nonserious unexpected event of blood glucose increased. Event onset 4 days after first dose mRNA-1273. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Was given BEXSERO in L arm on 09/27/16. C/O L arm pain - that got worse. Using ibuprofen and applying ice packs as reported by mom on 09/29/16. Mom reports doing better 9/30/16 - moving L arm again.
Swollen lymph nodes in neck; Soreness at injection site; Headache; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 07Apr2021 at 12:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. The medical history included sarcoidosis. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included pramipexole(MANUFACTURER UNKNOWN)  for an unknown indication from an unknown date and unknown if ongoing. On 08Apr2021 at 12:00, the patient experienced swollen lymph nodes in neck, soreness at injection site, headache and fatigue. The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen lymph nodes in neck, soreness at injection site, headache and fatigue were resolving at the time of this report. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 28Apr2021 at 12:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation.   No follow-up attempts are needed. No further information is expected.
No history of severe allergic reactions.  Observed for 15 minutes following vaccine injection.  Felt fine at that point so I was told that I could leave.  About 10-15 minutes after leaving (about 25-30 minutes after vaccine injection), I started to feel tingling in the bottom half of my face (most noticeable in the bottom lip and chin area), slight swelling on back sides of tongue, and slight swelling of area under chin at the top of the throat (right side only).  I could still breathe, drink, and talk normally.  Although symptoms did not seem to be intensifying, I decided to seek care at a nearby urgent care out of caution.  I arrived at the urgent care about 10 minutes after the onset of symptoms (about 45 minutes after vaccine injection).  Provider evaluated me, administered pepcid and a Benadryl shot, and notified me that if I went into anaphylactic shock that they would administer an epipen and call an ambulance.  Vitals were normal and remained normal throughout observation.  Symptoms began to abate about 15 minutes after Benadryl injection.  Tongue swelling abated first about 15 minutes after Benadryl injection.  Active tingling in the chin abated about 30 minutes after Benadryl injection, although light numbness remained.  Swelling under chin abated about 45 minutes after Benadryl injection.  Provider or staff checked on me every 15-20 minutes.  Provider released me from observation after about 2 hours.  At that point all symptoms had abated with the exception of slight numbness on bottom half of face, which persisted for several more hours.
Headache- 3 hours after injection. Fatigue - 12 hours after injection. Muscle aches/weakness- 12-15 hours after injection. Low Fever/chills - 15-20 hours after injection. Swelling/burning pain at injection site - 24 hours after injection. Stiffness/swelling of shoulder- 24 hours after injection.
Redness, swelling and hot. Pt given Keflex X 4 days.