chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mother called stating the child had a rash all over his body, she brought the child to the LHU and there was small pin point rash scattered all over his body. Mother states he has been a little fussy and just doesn't want anyone to touch him. Mother states he has not ran a temperature, no shortness of breath. Encouraged mother to take child to PCP for evaluation. Child was down on floor playing and no acute distress.
sore arm; red circle and rash at injection site; red circle and rash at injection site; It is itching terribly; severe headache; vision not really good; feels shaky; temperature of 101; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), VACCINATION SITE ERYTHEMA (red circle and rash at injection site), VACCINATION SITE RASH (red circle and rash at injection site), VACCINATION SITE PRURITUS (It is itching terribly) and HEADACHE (severe headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), VACCINATION SITE ERYTHEMA (red circle and rash at injection site), VACCINATION SITE RASH (red circle and rash at injection site), VACCINATION SITE PRURITUS (It is itching terribly), HEADACHE (severe headache), VISUAL IMPAIRMENT (vision not really good), NERVOUSNESS (feels shaky) and PYREXIA (temperature of 101). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), VACCINATION SITE ERYTHEMA (red circle and rash at injection site), VACCINATION SITE RASH (red circle and rash at injection site), VACCINATION SITE PRURITUS (It is itching terribly), HEADACHE (severe headache), VISUAL IMPAIRMENT (vision not really good), NERVOUSNESS (feels shaky) and PYREXIA (temperature of 101) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 f.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Crying unconsolable greater than 3 hours.  Swelling at injection site with redness, hives.
Before administering vaccine discussed possible SE's & denied previous syncope or presyncope with HPV #1 vaccine. This pt provided with HPV #2 vaccine and w/in 5 seconds of injection pt had full syncopal episode with clonic like behavioral as well as loss of bowel control & a vivid dream. Pt denied post-injection or post syncopal confusion. Pt laid down with improvement, but did develop n/v.
still having side effects after 2 weeks; RASH; warm; red; itcky; got a lump near injection site; Still has lump and doctor said to get an ultrasound; if it was ok to get her second dose of the Moderna vaccine in the opposite arm as her first injection; it is still sore; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (still having side effects after 2 weeks), RASH (RASH), VACCINATION SITE WARMTH (warm), ERYTHEMA (red) and PRURITUS (itcky) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012LD0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (still having side effects after 2 weeks), RASH (RASH), VACCINATION SITE WARMTH (warm), ERYTHEMA (red), PRURITUS (itcky), INJECTION SITE MASS (got a lump near injection site), VACCINATION SITE MASS (Still has lump and doctor said to get an ultrasound), VACCINATION SITE DISCOMFORT (if it was ok to get her second dose of the Moderna vaccine in the opposite arm as her first injection) and MYALGIA (it is still sore). At the time of the report, ADVERSE EVENT (still having side effects after 2 weeks), RASH (RASH), VACCINATION SITE WARMTH (warm), ERYTHEMA (red), PRURITUS (itcky), INJECTION SITE MASS (got a lump near injection site), VACCINATION SITE MASS (Still has lump and doctor said to get an ultrasound) and VACCINATION SITE DISCOMFORT (if it was ok to get her second dose of the Moderna vaccine in the opposite arm as her first injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Have a soreness on her arm where injection occurred; Being achy, tired; Being achy, tired; This is a spontaneous report from a contactable consumer, the patient.  A female patient of unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient reported that after receiving the 2nd dose of the Covid 19 vaccine she report being achy, tired and have a soreness on her arm where injection occurred. The symptoms subsided after 24 hours. The clinical outcome of the events achy, tired and have a soreness on her arm where injection occurred was recovering.   No follow-up attempts are possible; information about lot number cannot be obtained.
Patient in observation reports feeling "pressure" in her head and reports "headache." BP=222/90 right arm, 190/80 left arm. HR=70, O2 sat=98%. EMS called, pt transported to Hospital for further assessment.
I developed a migraine the evening of Jan 20 and began to experience chills before bed around 8-9pm.  At that time, my temperature was 99.8. I took my daily PM and migraine medication as prescribed, with no relief. Approximately 2 hours later I took the second dose of my migraine medication and rechecked my temp, it read 101.2. Around 8am Jan 21 I felt fatigued, still had a migraine, and my temp was up to 101.8. I took 2 tablets of Tylenol to reduce my fever. I did not go into work. Around 12pm my fever reached 102.1 and remained there throughout the day and I took Tylenol as described on the bottle. My migraine was greatly diminished by the evening and I did not take more migraine medication. On Jan 22 I again did not go into work. At approximately 9am my fever was at 101.2 and I called my primary care's office to seek advice about a COVID test. I did not request additional care, but the nurse recorded my symptoms and advised I was able to get tested even with the slight fever. At 2pm both fever and migraine were gone. I was tested on Jan 22 at 10am at a site, my results were negative.
Initial misuse report received from a healthcare profession on 11 November 2013. On unspecified date a 68-year-old patient had received an intradermal dose of FLUZONE. Intradermal vaccines have not been established in persons less than 18 or 65 and over years of age. Thus vaccine was administered at inappropriate age. No adverse event was reported. List of documents held by sender: none.
Approx. 4 cm raised red welt with inoculation site mark in the middle. Child complained of pain down her arm, was very fussy, crying, slight fever that night (102 F). Children's Advil did not appear to relieve her symptoms. The site is still red and swollen two days later.
couldn't think straight.called for a ride home as i felt ill and strange.no luck so drove home 10 min. away and fell asleep at wheel...was able to get back on my side of road before any accident.for 4 days felt weird and couldn't think straight.chills fever.huge red lump that went from back of arm to the front.
Multiple near syncopal episodes. SVT runs and other arrhythmia. Symptoms lasted approximately 45 min- 1 hour. Tiredness and repetitive yawning lingered for another hour. Treatment: vagal maneuver, water, and apple Juice.
Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. PMH significant for nocturia, senile xeroderma, PE, Alzheimer's disease, Atrial Fibrillation, CAD, Essential Hypertension, solitary nodule of lung. Pt was 82 years of age at time of death. Deceased under the care of hospice. No notation regarding cause of death available. Pt did fall out chair on 4/17 but was not taken to ER.
No adverse event.  The patient received the Moderna vaccine at the age of 15 years.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored (in 51.3 F for 30.75 hours and in 59.4F for 4.5 hours) doses of PNEUMOVAX 23 (lot # L048264, expiration date 10-JUN-2017; dose and route of administration were not reported). No adverse effect and no previous excursion were reported. The call was made because of the data logger. This is one of several reports received from the same reporter. Additional information has been requested.
Headache, Myalgia, NauseaVomiting, chills Narrative:  Chills, headache, myalgia, nausea; tylenol; resolved.
I am about to time out and do not have time to keep doing this form....how dumb to time me out!!!
On 09/18/2000 the patient was seen in his physician's office with a sore throat, congested cough, wheezing and headache. Asthma was diagnosed the same day and the patient was referred to an allergist and pulmonologist. The patient was treated with Serevent and Intal. Subsequently, the patient recovered. Additional information is not expected.
Mild erythema and swelling on (R) deltoid. Advised ice, can try BENADRYL and ibuprofen.
shoulder got sore the next day; felt blah; This is a spontaneous report from a contactable consumer (patient's family member). This consumer reported similar events for six patients. This is the third of six reports. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter stated that the patient said her shoulder got sore the next day and felt blah but that was it. The outcome of the events was unknown.  The lot number for BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101090541 same reporter/drug, same/similar event, different /patient.
The day after the vaccine, I had a headache, chills, and fatigue. The second day after the vaccine, I woke up with a rash (looked like a mild sunburn) on my back, buttocks, around my groin, and on my left shoulder.
The first 24 hours there was a fever (102 degrees) and extreme fatigue. Ever since, I have lost my appetite. My normally large appetite has changed into not wanting to eat meals and when I do feel hungry I can only eat a little bit. Weight loss is happening. The fever and fatigue was only the first 24 hours but the lack of appetite is still happening.
No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant referring to a patient of an unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 22-MAR-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose and route of administration were not reported) (lot # R022117 and expiry date 02-AUG-2020) for prophylaxis (product storage error). Other suspect therapy included sterile diluent (strength, dose and route of administration, lot# and expiry date were not reported) for prophylaxis. There were no adverse effect reported. There was a previous temperature excursion and the time frame and temperature was unknown. No product quality complaint (PQC) was reported.
Felt " off" on Monday evening  3/1/ 21 light headache.   Tues. 3/2   4:am. Woke to severe dry heaves, chills, sweating, and headache. Dry heaves would last 5/ 7 minutes, and then severely tired. Sleep for 2 hours, then repeat all day on Tuesday. slept a total of 20 hours.  Wednesday: I could control the dry heaves, Worse headache that ibuprofen couldn't control. Drank fluids and slept another 20 hours.  Thursday:  Improvement , still had headache, sweating and chills, no dry heaves.  Slept 15  hours.  Fluids and toast. Friday to present. Still tired, but recovered
Severe hives on left wrist and hand.  Very itchy. Took two Benadryl and hives went away after 30 minutes.
Local reaction to MMR. left arm swelling erythema, pain, tenderness & rash. Ice pack applied. taking Advil. Local reaction resolved 1-14-02
Patient had no adverse events when shot was given. Came to pharmacy on 11/28/16. Said she has had numbness, tingling in the hand, and shoulder was sore. An exact time course for all these events is unknown patient said the numbness in hand was improving.  Manufacturer was contacted on 11/28/16. Patient was advised to see a physician by manufacturer, per recommendations Facts and Comparisons, and pharmacy. The manufacturer said they was going to submit a report as well.
heart block - type II AV nodal, with syncope, requiring pacemaker insertion  on 10/1/2021. Syncope resolved but arrhythmia persists under pacemaker control
Six Hours post Injection patient experienced swelling,tenderness and warm to touch at injction site, left deltoid.  Symptoms intensified for 48 hours afterwards. Treatment ordered, ice to area, Tylenol PRN.
Pt. had syncopal episode while eating with friends, passed out, tremoring of extremities, legs & arms very weak, vomited, hypotensive, and diaphoretic. B/P 87/50 in ER.  CT scan of head was normal.
I had tingling and numbness in my arm, hand and face for 10 days with twitching of my eye. I ran a fever over 101 for 8 days; I had tingling and numbness in my arm, hand and face for 10 days with twitching of my eye. I ran a fever over 101 for 8 days; I had tingling and numbness in my arm, hand and face for 10 days with twitching of my eye. I ran a fever over 101 for 8 days; I ran a fever over 101 for 8 days; I had total loss of apetite with a 7 pound weight loss over 10 days; I had total loss of apetite with a 7 pound weight loss over 10 days; I have extreme fatigue and joint pain that still persists and is debilitating; I have extreme fatigue and joint pain that still persists and is debilitating; This is a spontaneous report from a contactable other hcp. A 49-years-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL0142) via an unspecified route of administration, in arm left on 13Jan2021 18:15 as first dose, single dose for COVID-19 immunization. Medical history included thyroid cancer, hashimotos, GERD and vitamin d deficiency. Patient had known allergies of penicillin and sulfa. Concomitant medications included levothyroxine sodium (SYNTHROID), vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]), aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]), esomeprazole magnesium (ESOMEPRAZOLE MAGNESIUM) and ampicillin trihydrate (ALPRA). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had tested for COVID-19. On 15Jan2021 the patient had tingling and numbness in arm, hand and face for 10 days with twitching of my eye, ran a fever over 101 for 8 days, total loss of appetite with a 7-pound weight loss over 10 days, extreme fatigue and joint pain that still persists and is debilitating. The patient underwent lab tests and procedures on Jan2021 which included body temperature over 101 and weight: 7-pound weight loss had total loss of appetite, on 20Jan2021 and 27Jan2021 Covid test result: Negative, sars-cov-2 test: negative. The patient was received treatment currently on my second Medrol dose pack. The patient was currently on her second steroid pack with no relief in symptoms. She was advised to wait to take her second shot by her physician. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
She got her 5th vaccine, at 9:00 PM she started to feel as though she suddenly had the flu.  She felt achy, headache and bad chills.  She went to bed and felt chilled the entire night even though it was a warm night.  she had to put on extra clothing.  She has dark redness on her cheeks of her face.  By morning she felt better over all but then had a severe headache. She stayed hydrated as she has with all vaccines, and stays away from alcohol/sugar, etc.  By morning she felt what she would call woozy.  When she stood up she was dizzy, had to grab the wall to steady herself, which is not anything usual for her.  She took it easy all day Saturday and sat outside all day as she could not do anything.  She did not fully herself, and told herself that it was going to be over.  On Sunday she had bouts of when she would suddenly get vertigo if she moved her head a certain way and when she laid down to sleep.  The chills are gone, but she woke this morning with vertigo, but is colder than anybody else in her house.  Her cheeks are still dark red, and she had vertigo.  She feels that this not normal and called in case she could be helpful to anybody else.  She has also had some GI issues that are not  normal, discoloration of her stools.  She had been fatigued for the first day, but was up because of the chills and felt lethargic the 2nd day.  She did feel like she had a little brain fog, could not concentrate to do anything, could not read to do anything, if she would move her head she would have the dizziness.  She has not taken anything for her symptoms.    She has not called her doctor.    She did not have any reactions at all to any of the vaccines.  Her other vaccines were Pfizer.    She has untreated psoriasis/eczema at childhood, has not had it as an adult.  She used to always have low blood pressure generally speaking, but has not had that kind of thing in years, more than 5 years, but does not know if it is related to that.  she does not take any medications, and is not aware of any systemic reactions in her body.    The first day and first night she did have joint pain on both sides of her legs and the opposite arm of the vaccine, and felt facial tingling that first day and night, does not have it anymore.   Today she felt the headache coming back and the vertigo seems to be increasing rather than decreasing.
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant information  provided. No Treatment information  provided   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: TCR- NNI
Developed a rash 2 inches in size on left arm where PREVNAR was given. Rash felt hot and was swollen. Per patient, using cold compress and ibuprofen. Checkin in 12 hours and hotness and swelling has gone. Getting better. Stil has a rash.
Two weeks and two days after I was hospitalized for congestive heart failure. Never before diagnosed. I was treated during a hospital stay and then sent home.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 19-OCT-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB (exposed to the following temperatures and cumulative time frames colder than 36F: In September of 2015, the coldest temperature was 34F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34F for 192 hours, for a total of 1,031.3 hours (43 days)) with lot number: L010595, expiry date: 12-NOV-2016 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
PT FELT LIGHT- HEADED AND "DRUNK" ABOUT 30 MINUTES FOLLOWING VACCINE
Pt fussy with low-grade fever of 100.8 within 24 hours of immunizations.
Arm pain at administration site, throat tightening and difficulty breathing within 6 hrs of admin.
Received vaccination at 14:20 2/26/21. Was observed until discharged at 15:15. Discharged per wheel chair to lobby in alert/stable condition, to wait on bus to take him home. At 18:00 his neighbor heard him fall, could not get patient to answer phone, found him unresponsive. Neighbor called 9-1-1, ambulance personnel could not revive patient.  Coroner's office ruled his death as Natural Causes due to Hypertension, Cardiac disease, Diabetes, ESRD.  There were no indication of anaphylactic reaction noted when I questioned the coroner's office. The Coroner's office/EMS were aware the patient had received the Moderna COVID 19 vaccination that day.
tinnitus increased substantially for 2 weeks, and then lessened, but is still more than it was pre-vaccine. onset date of side effect estimated
Injection site soreness; COVID; Patient not received 2nd; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In October 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site pain, covid-19 and incomplete course of vaccination. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the covid-19 was not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the injection site pain and covid-19 to be related to Shingrix.     Additional Information: GSK Receipt Date: 14-Jul-2022. Reporter's Comments: The patient reported that received first dose of Shingrix vaccine and had not received second dose. Patient was planning on getting it soon, but patient had Covid. She also stated that after her first injection, she experienced soreness at the injection site that had resolved. The reporter did not consented to follow up. Additional Supportive Information: The patient did not receive the 2nd dose, which led to incomplete course of vaccination.