chrisvoncsefalvay/vaers-outcomes huggingface dataset:
injection site redness/right arm injection site is a little red; swelling/right arm injection site swelled up; itchiness/right arm injection site itched; This is a spontaneous report from a contactable consumer (patient) from medical information team. A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, in right arm, on 11Mar2021 (at the age of 53-years-old), at dose 1, single for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. After a week of vaccination on 18Mar2021, the patient experienced injection site redness/right arm injection site is a little red, swelling/right arm injection site swelled up, itchiness/right arm injection site itched; it swelled up, was a little red and it itched and clarified that it is the injection site on her right arm in the muscle area. The outcome of the events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Initial information received on 30-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to cases 2018SA331476, 2018SA331477 and 2018SA331166 (same reporter). This case involves a nine- years old patient (gender was not reported) who was vaccinated with a dose of FLUZONE HIGH DOSE (formulation Suspension for injection in pre-filled syringe) (lot number, was reported as unknown, dose, dose in series, route and site of administration was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This was a case of actual medication error due to inappropriate age at vaccine administration and overdose. It was not reported if the patient experienced any adverse events following the vaccination. 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. Documents held by sender: none.
5 days of illness post vax-hallucinations, fever, h/a, sore throat-garlic/onion taste in mouth, sore eyes, ears, mouth unusual burning in mouth, bruise for over 7 days @ inj site;
Area where vaccine was injected was  reported by grandmother to be red and swollen several hours after vaccine administered. Patient triaged to urgent care where she was prescribed Keflex and Bendryl. On 7/4/07 the area at the injection site was reported by grandmother to be "as large as a cantelope". Patient triaged to ER and prescribed Sulfamethoxazole and Cleocin. Follow-up on 7/5/07, grandmother reported child afebrile and injection site improved -less red and swollen.
Soreness and redness at injection site shortly after injection, persisting on day 3. Onset of fever/chills 8-9 hours after injection, interfered w/sleep, temp of 101 measured 8-9 hours later, responded to TYLENOL/ADVIL. Fatigue x ~24h.
chills, fever ranging from 99.2 to 100.6, extreme body aches, non stop coughing.
Information has been received from a licensed practical nurse (LPN) concerning a 29 month old male who on 23-OCT-2006 was vaccinated PO with the first dose of rotavirus reassortant vaccine live (human-bovine) (lot # 653980/0285F). It was unknown if medical attention was sought and no symptoms were noted. Additional information has been requested.
Having a lot of bone pain in the arm that I got the injection at; Having a lot of bone pain in the arm that I got the injection at; This is a spontaneous report from a contactable consumer (patient). This patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose in the arm for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient stated it was the COVID-19 Vaccine. Patient was having a lot of bone pain in the arm that patient got the injection at. It was not 'muscle' (not clarified). The outcome of events having a lot of bone pain in the arm that patient got the injection at was unknown.  Information on the Lot/Batch number has been requested.
Information has been received from a nurse referring to her 1 year old son. No concurrent or historical conditions were reported. On 17-FEB-2015, the patient was vaccinated with MMR II and his first dose of (Merck) VARIVAX (both strength, route, dose, lot# and expiration dates unknown). On an unspecified date in April 2015, patient developed 7 to 8 vesicles on his back, 2 vesicles on his chest and 2 vesicles on his belly. Medical attention was sought by visiting the office of an unspecified physician on an unspecified date. Patient was diagnosed by physician with "atypical chickenpox". No treatment was given. All vesicles resolved on an unspecified date. This is one of several reports from the same source. Additional information has been requested.
diarrea, vomiting, cant walk, dizzy, chills, fever SICK SICK SICK SICK SSICK SICK SICK SICK HOW DO YOU EXPECT A SICK PERESON TO FILL OUT THIS long form????????????????????????? I AM STILL ALIVE BUT THE CHECK MARK WON'T LETY ME CHECK SOMETHING ELSE.
pt recv vax & 7hr later pt devel gen swelling of leg into which tetramune was given;the leg was also cyanotic;pt was seen by MD 7.5hr post vax;swelling & cyanosis had resolved;MD observed a quarter sized lump w/some bruising @ the site of v
Fever 104, Arm - red splotches, warm, knot size of dime, red face and red, itching.
Patient developed rash on arm at injection site and on her leg 3 days after Zostavax injection. She also reported a dark spot on affected leg in a different spot than the rash.
Patient had severe right arm swelling with purplish discoloration of arm and cool extremity. Worsened over the 1st 24 hours. Put on prednisone and symptoms resolved in 24 hours.
Onset of Febrile Seizure with no other illness noted by ER at admission.  My daughter spiked a fever last evening that was controlled with Tylenol and today spiked fever that induced seizure.  The hospital found no evidence of any sickness other than blood work indicating a virus of some type.
Information has been received from a registered nurse concerning an approximately 17 year old female who was vaccinated intramuscularly with a first dose of 0. mL Gardasil.  Concomitant therapy included MENACTRA.  Subsequently the patient experienced white patches on back of the tongue and uvula.  The patches were not painful but could be felt by the patient.  The patient sought unspecified medical attention.  As of 27-AUG-2007 the white patches in the patient's mouth were almost gone and her mother could see her uvula.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 9/17/2007. Initial and follow up information has been received from a registered nurse concerning a 17 year old white female student who was vaccinated intramuscularly with a first dose og 0.5 mL GARDASIl. Concomitant therapy included MENACTRA. Subsequently the patient experienced white patches on back of the tongue and uvula. The patches were not painful but could be felt by the patient. As of 27-AUG-2007 the white patches in the patient's mouth were almost gone and  her mother could see her uvula. In follow up it was reported that patient had "Geographic tongue" on 20-AUG-2007. The reporter mentioned it was unclear if "geographic tongue was a true reaction to any vaccine." The patient recovered. Additional information is not recovered.
Patient had several teeth extracted under local anesthesia.     Afterward began to complain of a headache which was why she was watched a bit longer and the procedure according to her visitor.  She went to an urgent care for the headache shortly thereafter who advised she pick up some Tylenol and after they left the vaccination site she began to look around as though something was there that the visitor could not see.  She then began to laugh uncontrollably.  She subsequently fell unresponsive with generalized tonic-clonic seizure activity.  Intubated in ER.   3/3 HCT:  showed Acute hematoma in posteroinferior aspect of left temporal lobe - 3cm 3/3 Repeat HCT:  stable 3/4 MRI head:  Increase in size of Intracranial hemorrhage.  Increased vasogenic edema.
The patient started heading towards the pharmacists from the observation area stating that he felt dizzy. We grabbed a chair and had him sit down. Almost immediately he collapsed to the floor before we could grab him. He fell face first onto the floor. He moaned and shook. With the assistance of a medic and police office, he was rolled onto his back and his feet were elevated. He started to regain consciousness. EMTs were called to assess him after his head hit the floor. He was monitored by EMTs for 30 minutes. He refused to go to the hospital and was instructed to call 911 if he had additional symptoms.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: SYNCOPAL EPISODE-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: The patient experienced syncopal episode during the monitoring period after the administration of the vaccine. The mother who had accompanied her reported that the patient is on the ground. I asked my tech to call 911 and approached the patient and put her in supine position with legs in raised position. The patient was talking to me and suddenly experienced a short unresponsive state when her neck turned stiff and face turned red. She was not responding to my calls.
Symptoms - Nausea, headache, sore arm at injection site, body ache. Lasted 48 hours Treatment - ibuprofen, marijuana, sleep
no adverse effect; improperly stored PEDVAX HIB were administered/patient received one dose; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 15-APR-2019, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) injection, lot # R027320 with expiration date on 08-JUL-2021 (dose and route of administration were not reported) for prophylaxis. The vaccine underwent the temperature excursion of above 47 (55.4) degrees Fahrenheit for 10 hours 45 minutes and below 36 (34.4) degrees Fahrenheit for 20 minutes. Digital Data Logger was involved in recording of the excursion. No previous temperature excursions were reported. No adverse effects were reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-1904USA012614: US-009507513-1904USA012967: US-009507513-1904USA012968: US-009507513-1904USA012969: US-009507513-1904USA012970: US-009507513-1904USA012971: US-009507513-1904USA012972: US-009507513-1904USA012973: US-009507513-1904USA012974: US-009507513-1904USA012975: US-009507513-1904USA012976: US-009507513-1904USA012977: US-009507513-1904USA012978: US-009507513-1904USA012979: US-009507513-1904USA012981:
Local reaction to include red raised hives from injection site to approx 5 inches down arm to include a blister at end of hives.
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 63-year-old male patient received BNT162b2 (BNT162B2), on 30Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in right 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's relevant medical history included: "known allergies: Pollen" (unspecified if ongoing), notes: known allergies: Pollen. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19I tested positive again; (May2022) Negative, notes: I tested negative a few days later; (31May2022) Positive, notes: I tested positive again (31May. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: No other medications received in 2 weeks. Treatment for covid-19 started on 16May2022 and stop on 21May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Complete numbness in head, left side of face, left side of neck, left shoulder, left arm, and left hand. Numbness has been consistently present for 6 weeks now in left side but is now including the right side (right shoulder, arm, and hand namely). Has subsided slightly. Pain in neck and shoulder has increased. If arms are bent, even for a very short time, both hands instantly fall asleep with tingling feeling. Significant muscle loss has occurred in the left arm (bicep and tricep) as well. Doctor has diagnosed me with Parsonage Turner Syndrome and Cubital Tunnel Syndrome - both due to the 4th anthrax vaccine I received eight weeks ago.
Neck pain, head pain, and general body aches all day on 6/1/2016, then on 6/2/2016 he developed photophobia, and high fever, with continued head, neck pain and petechiae on right rib cage area.
No adverse effect; the patients were vaccinated with improperly stored doses; Information was received from the vaccine coordinator and refers to 4 patients of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions, drug reactions, allergies or concomitant medications.  On an unknown date in 2019, between 16-APR-2019 and 02-MAY-2019, the patients were vaccinated with improperly stored doses of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) for prophylaxis, lot number R021084 with expiration date on 14-JUN-2021 (strength, dose number, anatomical location and route of administration were not reported).  No adverse effects were reported.  The temperature was of 35.2 degrees Celsius (°C) for a timeframe of 30 minutes with a previous temperature excursion of 32.7 °C for 7 hours and 30 minutes. The temperature excursion was called because a digital data logger.  This is a non-valid case due to lack of patient identifiers.  On 03-FEB-2019, a phone call was placed to the primary reporter (physician assistant). A request was made for patient identifiers, lot and vaccine received and enquired about dates. Additional information has been requested.  On 03-FEB-2019, a returned telephone call was received from the primary reporter, who requested additional information to assist him in his research on patient information. Additional information has been requested.  Follow up information was received from the vaccine coordinator referring to an approximately 1-year-old female patient on 05-FEB-2020.  On 01-MAY-2019, the patient was vaccinated with improperly stored doses of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB).  This case was previously considered as non- valid due to lack of patient identifiers. However, on receiving the patient's initials, date of birth and gender, this case was determined as valid.  This is one of the several reports received from the same reporter.
Information has been received from a medical technologist, concerning a female patient (age not specified), who on unknown dates was vaccinated with the first and second and third doses of GARDASIL.  Subsequently, during a routine cervical cancer screen, the patient was found to be positive for both low risk and high risk human papilloma virus.  At the time of this report, the patient had not recovered.  No further information was available.  Additional information has been requested.  This is one of 2 reports from the same source.
Seizure 24 hours after vaccine from just after to 36 hrs after vaccines-fever up to 102.6 deg F, vomiting, fussiness, diarrhea 24 hrs after vaccines.
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 76 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 08-Sept-2016, the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Not reported. Batch number: WT53706. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 08-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. The patients will be contacted for revaccination.
I had a lot of skin issues, my cheeks were very red, and hot to the touch. I went to the Dermatologist, and I was diagnosed with Rosacea. I was prescribed Oxymetazoline HCL/Ivermectin/Niacinamide. It is improving but I am still dealing with this currently.
This spontaneous report was received from a nurse practitioner regarding to an unspecified patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 18-MAR-2016, the patient was inadvertently vaccinated with a dose of expired GARDASIL (lot # J009788, expiry date 17-MAR-2016) dosage regimen and route unknown and it was supported. Concomitant medications were not reported. No adverse effects were reported. Product quality complaint (PQC) was not filed. Additional information has been requested.
12/05/21 received vaccine. Sore arm, as night progressed felt warm & later some chest pressure which persisted through next 2 days & was accompanied by feeling slightly achey & teeth hurt. On 12/05/21 @ approx 4am awoke & felt dizzy & thirsty & dizziness was so severe that I almost fell. I had read to hydrate before getting the booster, so I had drank additional water prior to the shot.
The patient is a 77 y.o. female patient of a MD with history of chronic back pain, GERD, HLD, paroxysmal afib on coumadin, HTN, and peripheral neuropathy presented to the Hospital with cough and weakness.   Acute hypoxic respiratory failure d/t COVID-19 pneumonia P/w 1 week history of headache, dry cough, and weakness. Pt reporting diarrhea x 2 days, now resolved (took imodium at home). Mild wheezing on exam, improved Pt fully vaccinated plus one booster Afebrile. Pt initially hypoxic at 87%, now satting >94% on  room air ambulating CRP nl CXR: Perihilar coarsened interstitial markings and bronchial wall thickening Decadron 6mg daily for 10 days  Encourage IS use PT/OT/SW   Acute kidney injury vs CKD Initial Cr 1.1 remain at same level x 3, probably pt's baseline. GFR 50.  Likely prerenal given poor PO intake secondary to diarrhea and COVID UA and urine culture ordered   P Atrial fibrillation HTN/ HLD HDS on admission, slightly bradycardic ~ 59 Continue coumadin, flecainide, and diltiazem Pharmacy consulted for warfarin dosing, therapeutic now 3.5   Pre- DM Hba1c 5.9 BS elevated in context of steroids therapy. Diet education before discharge   Chronic back pain PRN tylenol
Moderna Covid-19 vaccine drawn up into individual syringes at about 745pm - 8pm on 3/24/2021, vaccine was administered to patient at 10:15 am  3/25/21, outside the recommended 6 hours after vial puncture. Vaccine remained in the refrigerator from the time drawn up to administration. Vaccine was inspected there was no particulate matter or discoloration prior to administration.
Technician was providing immunization.  There were 2 people with the same name getting vaccinations at the time.   The incorrect patient came in to the room and when asked if she was receiving the Moderna booster dose today, she confirmed it.  However, this was incorrect as she was signed up for a flu shot.  The patient reports "being in a haze" when the question was asked and "not hearing what was said" while she responded in the affirmative.   Patient had already received a Moderna booster dose 1 week previously so we will monitor her for any adverse events.
throat started hurting; This is a spontaneous report from a contactable consumer (patient) received via a Pfizer-sponsored program, Support. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration, on 27Jan2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that her throat started hurting on the night of 25Feb2021. The patient was wondering if she can still take second dose scheduled on 28Feb2021. The outcome of event throat started hurting was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt developed fever, chills and backache after the vax .  Pt had a tele visit w/ her PCP today 1/29/2021 - pt tested positive for COVID.  Pt will FU w/ PCP.
REDDNESS, ITCHING, PAIN AND EDEMA AT INJECTION SITE FIRST REPORTED BY PATIENT 24 HRS. POST INJECTION; PATIENT REFERRED TO ORDERING DR.
p/vax pt devel sore throat & general body pain in later afternoon;8/11/99 woke w/rash on face & during day spread over entire body;had low grade fever, glands in neck, tender & swollen;advised eval by MD;DPH for rash;
Swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (Swelling at injection site) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE SWELLING (Swelling at injection site). At the time of the report, INJECTION SITE SWELLING (Swelling at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.
About 4 days after receiving the vaccine I had pain in substernal/parasternal area. I had never had this pain before and felt it was related to the painful lympadenopathy. The pain lasted 7-10 days and improved. Only mild occasional discomfort now.