chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Subject woke up to use the bathroom and passed out while on the toilet. She called my name immediately prior to the event. She fell prostrate on the floor resulting in facial bruising/cuts. Subject regained conciousness one minute later. She was able to work the next day and had chills for the next 2 days.
This spontaneous report as received from a nurse practitioner refers to a 2 months old patient of unknown gender. The patient had no drug reactions/allergies. On 24-FEB-2014, about 15 minutes ago, the patient was received with the first dose of ROTATEQ (lot# unspecified) ("suspension2" as reported) (strength, dose unspecified). The nurse reported that the patient spit out some of the dose which then dribbled out of the patient's mouth. The patient's facial skin where the ROTATEQ dribbled on then developed hives. Patient was currently still in the office. At the time of the report, the outcome of the event was not recovered. Additional information has been requested.
Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. On unspecified dates in August 2015 unspecified patients were vaccinated with 4 doses of improperly stored (Oka-Merck) PROQUAD HSA (human serum albumin) (lot # K018144, expiration date 10-APR-2016) (dosage, strength and route were not reported). There was no concomitant medication reported. No adverse symptoms was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 11Jan2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 71 years for covid-19 immunisation. The patient's relevant medical history included: "Diabetes mellitus" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID-19 treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient did not received any other medication in 2 weeks. He received treatment of Covid-19 with antiviral Paxlovid Treatment started on 03Jun2022 and stopped on 07Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
About 45 minutes after receiving vaccination, I had extreme pain in my shoulder and could not lift my arm.  This lasted for about 24 hours.  I had difficulty sleeping because of the pain.  I took ibuprofen every 4 hours for the next 24 hours.  The pain gradually subsided.  I still have pain with certain positions of my shoulder.  I believe the injection was given too high on my arm and too close to my shoulder joint.
Patient is a 57yF w/ PMHx of asthma, OSA with CPAP, CAD status post stent, and bipolar disorder presenting with acute onset SOB.  At time of my exam, patient intubated and sedated, unable to provide history.  History obtained per chart review and discussion with patient's daughter.  She reports that patient's husband called daughter whenever patient began to develop difficulty speaking due to SOB.  Daughter then instructed patient's husband to call EMS.  On 1st responder arrival patient was noted to be significantly dyspneic, lip cyanosis noted, responding in 1 to 2 word phrases only.  Reportedly AOx2 at that time.  Patient was also noted to be diaphoretic, without nausea.  EKG with NSR.  Patient was given albuterol and Atrovent via non-rebreather mask, and transported to ED. Daughter reports that patient is generally AOx4, but that she "has the mental status of a 12 year old, and won't get any older than that." Denies any diagnosis associated with this.  Patient has been vaccinated for COVID, no known positive contacts.   DISCHARGE:Admitting diagnoses:  History of asthma, COVID-19 viral infection, hypercapnic respiratory failure, respiratory acidosis, acute encephalopathy, acute kidney injury, bipolar disorder, CAD, history of coronary artery stenting, hypertension, OSA on CPAPDischarge diagnoses: History of asthma, COVID-19 viral infection, hypercapnic respiratory failure, respiratory acidosis,  acute kidney injury, bipolar disorder, CAD, history of coronary artery stenting, hypertension, OSA on CPAP Consulting physician:   Dr. from-pulmonology at a Clinic  Procedures and Diagnostics: CTA of the chest per PE protocol 02/04/2022:  IMPRESSION: NO EVIDENCE FOR PULMONARY EMBOLISM. ATHEROSCLEROSIS INCLUDING CORONARY ARTERY DISEASE. SMALL CALIBER TRACHEA AND MAINSTEM BRONCHI, SUGGESTIVE OF TRACHEOBRONCHOMALACIA.  CORRELATION FOR POTENTIALLY RELATED SYMPTOMS RECOMMENDED. MILD, CENTRAL GROUND-GLASS CHANGES IN EACH LUNG ARE NONSPECIFIC AND FAVORED TO BE SECONDARY TO LOW LUNG VOLUMES AT THE TIME OF THE EXAMINATION.  MILD BRONCHIOLITIS IS ALSO POSSIBLE. MILDLY DILATED UPPER THORACIC AND LOWER CERVICAL ESOPHAGUS WITH AN AIR-FLUID LEVEL, LIKELY GASTROESOPHAGEAL REFLUX. INCIDENTAL, NONOBSTRUCTING LEFT NEPHROLITHIASIS.  THE FINAL REPORT IS CONCORDANT WITH THE PRELIMINARY REPORT.
COVID Arm, rash formed under site of injection, approx 3in across and 2in tall. Mildly itchy, warm to the touch, not painful. Appeared on 3rd morning after receiving booster shot.
Onset began the evening of the vaccination severe chills and did not feel well. On the first week had extreme fatigue. The second week I lost my sense of smell and taste. The fatigue and lost of smell and taste  lasted up to five weeks. I gradually felt better, but it took about 8 weeks before I felt better.
had body aches.; had a 102 Fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (had body aches.) and PYREXIA (had a 102 Fever) in an 18-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Adverse event following immunisation (Experienced side effects with the original immunization shots).    On 15-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2022, the patient experienced PYREXIA (had a 102 Fever). On 17-Jan-2022, the patient experienced MYALGIA (had body aches.). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) on 15-Jan-2022 at an unspecified dose and frequency. In January 2022, PYREXIA (had a 102 Fever) had resolved. At the time of the report, MYALGIA (had body aches.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, SARS-CoV-2 test: negative (Negative) Negative. On 16-Jan-2022, Body temperature: 102 (High) 102 degree Fahrenheit.         It was reported that the patient had experienced side effects with the original immunization shots, so had preventatively taken some Advil on that evening after vaccination.  No concomitant medications were reported.
Body aches, starting the night Tdap was given.  Took Advil for 2 days. Better on 3rd.day.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with PNEUMOVAX23 that was improperly stored. Dose, route, frequency, lot number and expiration date were not reported. No adverse effects reported. This is one of two reports from the same source (other case # 1707USA012406). Additional information has been requested.
On the 15th I woke up in the middle of the night with extremely itch palms and feet. I woke up the next day in hives and lines all over my body called dermatographia. The next day I took Benadryl, but it only worked for about a few hours and the following day it was back. On 1/20/22 I went to my PCP and they said is possible that I was having a reaction and told me to take Claritin and Benadryl as needed. The doctor also recommended I go to a allergy specialist, on 01/27 I went and they switched me from Claritin to Vertex. Vertex was making me really sleepy, so I was switched to Allegra 1x a day and it's been helping.
Memory loss, severe chills, sever muscle/joint pain, tingling throughout body, intractable vomiting. Unable to walk due to pain and weakness for 24 hrs
49yo patient received pediatric formulation; 49yo patient received pediatric formulation; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 49-year-old female patient who received HBV (Engerix B pediatric) (batch number MY3RA, expiry date 21st September 2022) for prophylaxis.   On 3rd September 2022, the patient received the 1st dose of Engerix B pediatric. On 3rd September 2022, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK receipt date: 08-Sept-2022 Reporter's comment: The clinic quality manager reported that due to low titers, an adult patient received Engerix B first dose of  pediatric formulation. The reporter consented to follow-up via email. Additional supportive information: The patient received an pediatric dose of Engerix B which led to underdose and adult use a child product. Follow-up request was raised to confirm whether patient had received any series for Hepatitis B in past before the antibody test.
vaccine was expired, no temperature excursion occurred and Moderna determined the vial "maintained the activity necessary to protect against SARS C0-V2 virus at the time of administration".  Patient reported no adverse reactions.
Upon working out, my heart rate went to 195 bpm.  After workout, it slowly went down to 135 bpm and then to 110-120 bpm and remained at this for the remainder of the day.  My heart rate was measured via my smart Watch.
The pt experienced chronic permanent diarrhea, chronic "yeast infection" type rashes, change in hearing, loss of eye contact, started to walk on tip toes and spin allot.
the rash has gotten worse, it is all over her body and resembles roseola, not the measles; felt had a low grade temp/high fever; tired/tired was reported as worsened; This is a spontaneous report from a contactable consumer (parent). A 22-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6202), via an unspecified route of administration, in right arm, on 27Feb2021 17:00 (at the age of 22-years-old) at dose 1, single for covid-19 immunization. The patient had no family history and medical history. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine and no additional vaccines administered on the same day of vaccination. The patient experienced tired/tired was reported as worsened (as reported) on 28Feb2021 05:00, felt had a low grade temp on 01Mar2021, the rash has gotten worse, it is all over her body and resembles roseola, not the measles and high fever on 02Mar2021. The patient underwent lab tests and procedures which included body temperature: 102.5 Fahrenheit on Mar2021 and body temperature: low grade on 01Mar2021. The outcome of the event high fever was recovering, and all the other events were not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a medical office receptionist who saw a news report in which it was reported that a female patient who was vaccinated with Gardasil experienced a seizure. She had no further information and reported she only saw part of the news report. Upon internal review, seizure was considered an other important medical event. Additional information has been requested.
Fever that went up to 101 degrees Fahrenheit; Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 78-year-old female patient received BNT162b2 (BNT162B2), on 08Jun2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 78 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 08Jun2022, outcome "recovered" (09Jun2022), described as "Fever that went up to 101 degrees Fahrenheit"; CHILLS (non-serious) with onset Jun2022, outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: husband calling on behalf of his wife. Caller later reported FM9992 or FM4992, when probed as to what specific product he was calling about. Caller stated that last night (08Jun2022), his wife started to run a fever that went up to 101 degrees Fahrenheit. Caller stated that the fever finally abated this morning (09Jun2022).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt stated he had a rash on his body since he got the flu vaccine. He has been taking OTC benadryl ever since but the rash is still not going away. He is allergic to eggs but marked "no" to that question on the VAR form. He reported this to the pharmacy on 11/18/13. Rash on arms with redness and hives. Pt will see PCP.
Information has been received from a 38 year old female registered nurse who, on 18-DEC-2006, as part of her employees health vaccine administration, was vaccinated with Varivax (Merck). On the evening of 18-DEC-2006 the patient experienced a fever of 104', big red spots and 100 blisters on her belly area. The nurse reported that the fever lasted three days. Six days later, on approximately 23-DEC-06, the nurse reported that the blisters had dried up and she was recovered. No further information was available. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
The patient was administered with Quadracel past expiration date, no AE; Initial information was received on 14-Sep-2020 regarding an unsolicited valid non-serious case from a other health professional .  This case involves a 4 year old female patient who was administered with DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] past expiration date (expired product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot C5500CA, expiry date: 16-Aug-2020) via unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency: same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Couldn't warm up the 1st night of vaccine; Body aches; Freakin burning up, temperature went up a bit; This case was reported by a consumer via interactive digital media and described the occurrence of feeling cold in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a day after receiving Shingles vaccine, the patient experienced feeling cold, general body pain and body temperature increased. On an unknown date, the outcome of the feeling cold, general body pain and body temperature increased were unknown.   It was unknown if the reporter considered the feeling cold, general body pain and body temperature increased to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 18-APR-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The reporter self-reported the case. The patient could not warm up himself/herself the 1st night of vaccine with body aches and the next day, was freaking burning up, temperature even went up a bit.
Severe chills and fever onset approximately 8 hours after administration, accompanied by sever muscular pain in neck, legs, hips.  Nausea onset approximately 15 hours after administration.
On the night of the vaccine  my left arm was just slightly sore and I had a headache. I took 2 advil before bed and woke up the next morning fine.  The real reaction came almost a week to the day later on Monday, Feb. 8 in them morning I noticed that my shoulder joint on my left arm was very sore and all of the lymph nodes from my shoulder to my elbow on just my left arm were very achey.  This came and went off and on all that day. I did not take anything for it because I wanted to see how long it lasted.  By the next morning it was entirely gone and has remained gone and I feel just fine.
This spontaneous report was received from a registered nurse referring to an 11 year old male patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 11-OCT-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored. This is one of several reports received from the same source. Sender's Comments: US-009507513-1709USA008666.
Narrative:  COVID infection following COVID vaccine series 02/22, Pfizer, dos #1 03/15, Pfizer, dose #2 12/16 COVID swab, result: not detected 12/29 COVID swab, result: detected 12/28 pt cc: cough, fever, medication, myalgias, sore throat exposure: unknown 01/11 pt admit to ED cc: cough, ear and sinus pressure, and mild shortness of breath dx; COVID infection LOS: 1 day clinically resolved 1/11 CXR impression: No acute infiltrate.
Pt was admitted with sepsis, necrotizing fasciitis of the right upper arm, acute kidney injury and encephalopathy. On 9/29 he went to the OR for right upper extremity incision and drainage with debridement. Pt currently in ICU.
pt recv vax JUN96 & 24DEC96 pt devel 15 to 20 lesions w/one on finger & the rest on chest;
patients received a vaccine that under went a temperature excursion; No adverse event; patients received a vaccine that under went a temperature excursion; This spontaneous case was reported by a medical assistant and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patients received a vaccine that under went a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (patients received a vaccine that under went a temperature excursion) and NO ADVERSE EVENT (No adverse event) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS1412B and AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 13-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Aug-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients received a vaccine that under went a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients received a vaccine that under went a temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patients received a vaccine that under went a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (patients received a vaccine that under went a temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (patients received a vaccine that under went a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients received a vaccine that under went a temperature excursion).    The patient had a weight of 24 (unit not specified).  No concomitant medication was reported.  The patient had Moderna administration location on LQ (unspecified).  Some vaccines were stored in the freezer and other vials in the refrigerator. The excursion occurred on 7-Aug-2022 and was picked up by state review of the temperature data logger 2 weeks later after the excursion. Total 38 patients received this.  1 refrigerated vial was with lot number AS1412B and expiration date 10-Feb-2023. Maximum or minimum temperatures reached was 14 degrees Celsius for 3hr 5min. Vial was moved from refrigerator on 8-Aug-2022. Those were administered or discarded. Proposed desired used by date was 18-Aug-2022.  No treatment medication was reported.
Increased temp 100-102 x 2 days. Temp 100.9, today, 12/6/99. Given Tylenol. Swollen lymph glands L/neck. No sore throat or earache.
Fatigue - Presented 12 hours after and persistent for 2 days.  Diarrhea- Presented 12 hours after and resolved after 24 hours. Severe muscle aches- Presented 4 hours after and persisted for 2 days.  Numbness in face- Presented 12 hours after and resolved 32 hours after.  Numbness in injection arm- Presented 2 hours after and resolved after 24 hours.  Swollen lymph nodes- Presented day after and still unresolved.  Headache -Presented 12 hours after and persisted for 24 hours.  Chills- Presented 4 hours after and persisted for 24 hours.   No medical treatment by provider. At home treatment with NSAID?s and rest.
Large lump which turned red and itchy. It lasted for about 10 days. Then I got a red circle about 2" wide which went around my whole arm. I still have the bruise where the shot was given.
Anthrax 3 days prior - erythema extending beyond elbow w/swelling - possible cellulitis.
On 5/19/03 pt. reported small bumps on palms & sides of the hands- 2 on R & 2 on left.  Describe "feels like splinter in each one" itchy only after hot water- shower etc.  Thought at first they were reaction to new soap- she had used soap before but is washing hands more frequently now due to vaccination.  Over the next 2 days number increased to 5 on L.  On On lower outer palm & side of hand.  Papules some with pale centers and red outer edge.  Range in size from .5 mm to 5 mm.  Tc to CDC Clinical information line- spoke with Dr. who advised sounded like contact dermatitis vs. non specific rash.  Watch to see if progresses like vaccinia