chrisvoncsefalvay/vaers-outcomes huggingface dataset:
101 degree fever (even with fever reducers), eyes swollen shut, rash, full-body swelling - fever-reducers and antihistamines taken.
Initial onset was dull headache behind my left eye and remained unresponsive to 1000 mg doses of Tylenol for the next few days.  The pain remained a fairly consistent dull ache, but on Friday, September 19 the pain became excruciating, and led to light headedness and vomiting.  At this point, due to the non-responsiveness of the headache to OTC pain medications, I went to the ER.
This is a spontaneous report from a contactable nurse practitioner. A 17-year-old patient of an unspecified gender received TRUMENBA in Jul2018 at single dose for immunization. Medical history included ongoing latex sensitivity (a Band Aid sensitivity, it was not anaphylactic). The patient's concomitant medications were not reported. In Jul2018, after receiving the vaccine, the patient experienced shortness of breath, heart rate increased and fever. Events were non serious. The patient still had increased heart rate and fever. Outcome of shortness of breath was unknown.
Had chest pain; This is a spontaneous report from a contactable consumer. A male patient of unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number, NDC number and Expiry date: Not provided), via an unspecified route of administration on an unspecified date as dose 1, single for Covid-19 immunisation. No medical history and concomitant medications were reported. On an unspecified date the patient had chest pain. The additional context received as, the patient doctor said that there were patients who were having problems after the first shot. There was one guy who had chest pain. For some reason these adverse events happened about a week out when they started having problems. Caller declined to complete the safety report and only wants her question addressed, unable to obtain further details at this time. Outcome of the event was unknown.  Information about lot/batch number has been requested.
received zostavax on 6/6/08.  Two weeks later developed shingles R thigh
Blood clots in the legs; Had shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DEEP VEIN THROMBOSIS (Blood clots in the legs) and DYSPNOEA (Had shortness of breath) in a 66-year-old male patient 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEEP VEIN THROMBOSIS (Blood clots in the legs) (seriousness criterion medically significant) and DYSPNOEA (Had shortness of breath) (seriousness criterion medically significant). At the time of the report, DEEP VEIN THROMBOSIS (Blood clots in the legs) and DYSPNOEA (Had shortness of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were mentioned. No treatment details were reported.  Company comment: This case concerns a 66-year-old male patient, with no medical history reported, who experienced the serious unexpected ADR of deep vein thrombosis and serious unexpected event of dyspnoea after dose of mRNA-1273. Very limited information regarding date of vaccination, date of the events, clinical evolution, complementary studies and treatment was provided at this time. The re-challenge is unknown since no information regarding dose number was provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report   This case was linked to MOD-2021-403940 (Patient Link).; Sender's Comments: This case concerns a 66-year-old male patient, with no medical history reported, who experienced the serious unexpected ADR of deep vein thrombosis and serious unexpected event of dyspnoea after dose of mRNA-1273. Very limited information regarding date of vaccination, date of the events, clinical evolution, complementary studies and treatment was provided at this time. The re-challenge is unknown since no information regarding dose number was provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Information has been received from a physician concerning a female who on an unspecified date was vaccinated with a dose of GARDASIL. Physician reported that the patient experienced fainted after receiving GARDASIL. Follow up information has been received from a Registered Nurse concerning a female patient with no known drug allergies who on 20-MAY-2008 at 2:00 pm was vaccinated intramuscularly into the right arm with the first dose of GARDASIL (Lot # 660391/0063X). Concomitant therapy given on the same day on 20-MAY-2008 at 2:00 pm intramuscularly into the left arm included the first dose of BOOSTRIX (Lot # AC52BO20AA) and a first dose given intramuscularly into the left arm of HAVRIX (Lot # AHAVB233AA). The RN reported that after receiving the 3 vaccines on 20-May-2008, at 2:00 pm the patient fainted. Blood pressure after fainting was 98/50. The patient responded well in few seconds. This is one of several reports received from the same source. Additional information is not expected.
I started having symptoms on 10/30/2022.  I woke up and had chills, but I kept going throughout the day. By night, I had a fever, chills, and body aches. This is when I started wearing a mask. On Tuesday, I developed a strong cough and decided to call my doctor and she called in a prescription. Paxlovid, Azithromycin, and Benzonatate. Since starting the medication, my fever stopped. I tested positive for COVID-19 on 11/01/2022. I still have nausea and migraines at this time.
3/7 tiredness, muscle pain, headache, shivering, nausea, skin sensitivity;  3/8 -3/10 increasing redness/swelling from injection site to mid-bicep;  3/11 increased redness/swelling from injection site to elbow (including bicep and interior or arm), tingling at tip of tongue, tingling lips -at 12:00pm used anti-itch cream - effect lasted only 20-30 minutes each time, at 9:30pm took diphenhydramine hcl 25ml tab; 3/12 took 1 diphenhydramine hcl 25mg tab - arm still itchy and red - swelling to elbow and inside of arm.  3/13took 1 diphenhydramine hcl 25mg tab arm itchy, swollen to elbow and inside of arm
Very itchy/itch all over body; Very painful on the left arm; Hard to sleep at night; Burning sensation; Redness on the left arm; swollen; Painful poking from the inside; little bumby; Rash appeared on same arm (left arm)/rash all over the body; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-May-2021 and was forwarded to Moderna on 02-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Very itchy/itch all over body), PAIN IN EXTREMITY (Very painful on the left arm), INSOMNIA (Hard to sleep at night), BURNING SENSATION (Burning sensation) and ERYTHEMA (Redness on the left arm) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: Flu shot. Concurrent medical conditions included Allergy to edible fungus (Allergy to mushroom.).    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced PRURITUS (Very itchy/itch all over body), PAIN IN EXTREMITY (Very painful on the left arm), INSOMNIA (Hard to sleep at night), BURNING SENSATION (Burning sensation), ERYTHEMA (Redness on the left arm), SWELLING (swollen), PAIN (Painful poking from the inside), URTICARIA (little bumby) and RASH (Rash appeared on same arm (left arm)/rash all over the body). The patient was treated with PREDNISONE for Adverse event, at a dose of 1 dosage form. At the time of the report, PRURITUS (Very itchy/itch all over body), PAIN IN EXTREMITY (Very painful on the left arm), INSOMNIA (Hard to sleep at night), BURNING SENSATION (Burning sensation), ERYTHEMA (Redness on the left arm), SWELLING (swollen), PAIN (Painful poking from the inside), URTICARIA (little bumby) and RASH (Rash appeared on same arm (left arm)/rash all over the body) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications also included Hydrolyzed HCL. No concomitant Products were reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Follow-up received on 09 Jun 2021, contained completed vaccine hypersensitivity/anaphylaxis follow-up form. Updates to vaccine history, events and treatment information.
Information has been received from a nurse practitioner concerning a 22 year old female who on 09-JAN-2008 was vaccinated IM with a 0.5 mL dose of GARDASIL (no lot# provided).  On 10-JAN-2008 the patient developed an itchy rash under her arm in the axilla area and rash later spread over her whole body.  Subsequently, the patient recovered from itchy rash under her arm in the axilla area and over her whole body.  The patient sought medical attention via the family physician.  No product quality complaint was involved.  Additional information has been requested. This is in follow-up to report previously submitted on 04/14/2008: Followup information has been received from the certified registered nurse practitioner (CRNP). It was reported that the 22 year old female, weighing 175 pounds, height of 65.75 inches, with no pre-existing allergies, birth defects or medical conditions, on 09-JAN-2008 (incorrectly reported as 19-Jan-2008) was vaccinated IM in the left deltoid with the first 0.5 mL dose of GARDASIL (no lot# provided). On 10-JAN-2008 (incorrectly reported as 20-Jan-2008) the patient developed a red, itchy rash under her arm which later became widespread. When the patient returned to the office for the second dose, she notified the physician of the rash she developed after receiving the first dose. It was reported that no treatment was tendered and "self-limited." The patient did not receive the second dose due to the rash she had developed after receiving the first dose. It was reported by the CRNP that she does not think the patient will finish the series due to the rash. No laboratory diagnostics tests were performed. It was also reported that the patient's 3 year old son had a virus and a rash a week prior to the patient receiving the first dose, so patient does not know if the rash she developed was due to the vaccine or the virus and rash her son had. The patient's son is not a patient of that office and they have no information on the son's medical history. It was reported that the patient recovered on an unspecified date (previously reported as 17-Jan-2008). No further information is expected.
received both doses of Shingrix and still developed Shingles / Shingles is ongoing / suspected vaccination failure; received both doses of Shingrix and still developed Shingles / Shingles is ongoing; This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a 74-year-old male patient who received Herpes zoster (Shingrix) (batch number 7RK7K, expiry date 26th November 2021) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 30th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported for 2nd dose. The patient received both doses of Shingrix and still developed Shingles. No health factors, concomitant medications or specific date when the infection began was given. The outbreak of Shingles was ongoing. This case was considered as suspected vaccination failure as details regarding laboratory test confirmation and time to onset for the event was unknown at the time of reporting. The reporter consented to follow up. As per sales data sheet reported batch number was changed from 7RK76 to 7RK7K.
Gasping respiration, diaphoretic, hives, decreased breath. Sounds upper lobes, absent lower lobes, mildly tachycardic. Remained pink throughout episode. Episode lasted 3-5 minutes, recovered spontaneously.
Severe chills on 2/12/21; overnight on 2/12/21 restless sleep; 2/13/21 - headache, stomachache, diarrhea, vomiting, chills, temperature of 95.6
About an hour after the shot, I started to feel the left side of my face (specifically the jaw area) getting numb and tingly. With the progression of the day, my entire left side of my face was numb and I was feeling pain and burning sensations in my left year. Movement in that side of my face was okay. By the evening, my lips had also gone numb and were swollen. The left side of my tongue also swell, which resulted in me biting it a couple of times. At night, the numbness and swelling got worse, but my breathing was always okay.   My lips and tongue went back to normal within 24 hours, however the numbness in my face and the pain the my ear have persisted and I still feel some of these sensations  and pain after almost 7 days since receiving the vaccine. Also, at least one time per day, but sometimes more often, I get a metallic taste in my mouth when I am not eating or drinking anything at that particular time.
Chills, fever, headache, extremely sore arm that?s hurts to even move
On 5/5/21, about 7 hours after her second Pfizer COVID vaccine, pt developed R sided visual distortion in both eyes, associated with headache.  Pt was seen on 5/7/21,  Ophtho exam was negative.  MRI brain with MRV done showed a 10 mm bright lesion in the L corpus callosum with possible swelling as well as nonspecific white matter disease.  Pt was sent to ED, left prior to evaluation and returned the next day.  Seen by Neurologist in ED who recommended inpt evaluation.  Pt did not wish admission and left. Outpatient Neurologist evaluation was unable to be scheduled in a timely matter, so pt went to another ED on 5/13/21 and had evaluation including LP.  Working ddx included MS/ischemic stroke, SLE.  Started on ASA and statin. Pt has had outpatient Neurology and Rheumatology followups, planned for Neuro-Ophthlamologist consultation. R visual distortion was improving but still present at her 5/21/21 followup with me.
Well at injection site, swollen arm around injection site, nausea, fatigue.  Resolved on 01/08/2021
1/27/21 BY 8PM HEADACHE, CHILLS, BODY ACHES, 1/28/21 6AM CHILLS BODY ACHES WENT TO WORK 8:30 NO FEVER BUT FELT EXTREMELY WARM CHECKED TEMP 98.9 BY 9:30 AM TEMP WAS 100.6 LEFT WORK CAME HOME SLEPT ALL DAY. WOKE UP AT 5PM FEVER WAS 101. BODY ACHES CHILLS WERE MUCH WORSE. TOOK ADVIL 9PM SLEPT ALL NIGHT WOKE UP 10AM 1/29/21 FEVER 99.8 BY NOON FELT MUCH BETTER. LOST TWO DAYS OF WORK.
She states that the effectiveness of the last booster that she had was only 7% effective; She is gradually getting a sore throat. At this point it is very sore.; This spontaneous case was reported by a patient and describes the occurrence of OROPHARYNGEAL PAIN (She is gradually getting a sore throat. At this point it is very sore.) and DRUG INEFFECTIVE (She states that the effectiveness of the last booster that she had was only 7% effective) in a 75-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In 2023, the patient experienced OROPHARYNGEAL PAIN (She is gradually getting a sore throat. At this point it is very sore.). On an unknown date, the patient experienced DRUG INEFFECTIVE (She states that the effectiveness of the last booster that she had was only 7% effective). At the time of the report, OROPHARYNGEAL PAIN (She is gradually getting a sore throat. At this point it is very sore.) had not resolved and DRUG INEFFECTIVE (She states that the effectiveness of the last booster that she had was only 7% effective) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.  Patient stated that the effectiveness of the last booster that she had was only 7% effective. She was calling to find out if that is correct. The last vaccine she received was on 15 Oct 2023, and she confirmed it was Spikevax. She read that information from a political email. She was gradually getting a sore throat. At this point it was very sore. She was concerned that the booster was not effective.  Company Comment This spontaneous case concerns a 75-year-old female patient with no medical history reported who experienced the unexpected events of sore throat and drug ineffective unknown days after a dose of mRNA-1273.815 vaccine. Concomitant medication details nor Treatment details were reported. She was calling to find out if that is correct, concerned that the booster was not effective.  The benefit-risk relationship of mRNA-1273.815 vaccine is not affected by this report.
This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a adult female patient who received SHIGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site pain, injection site itching and injection site erythema. On an unknown date, the outcome of the injection site pain, injection site itching and injection site erythema were unknown. It was unknown if the reporter considered the injection site pain, injection site itching and injection site erythema to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The healthcare professional (HCP) reported a patient developed an injection site reaction after the dose of SHINGRIX, including soreness, itching and a 2 inch reddened oval area. No vaccine information was available. The reporter consented to follow up.
MA went to administer vaccine on LA. Injected vaccine and plunger wouldn't plunge. Pushed x 2 Pt. cried in pain stated L shoulder hurt. Vaccine removed gotten rid of. Area examined by physician. No erythema. Ice pack applied. New flu administered on R. arm w/no complications.
Sudden onset of respiratory arrest and subsequent brain death. 07/27/2000 final autopsy report not get typed but findings are:Aucal herniation 2 degree to: 1. diffuse cerbral edema 2 degree 2. Severe micro vesicular for steotosis metabolic enephalopathy. Reye's Syndrome still susoected but apparently injection of ASA has not been verified. MD still considered it a toxic event. Typed report should be available in about 1 week.
Information has been received from a physician concerning a 15 month old white female with no medical history or allergies who on 20-OCT-2006 was vaccinated SC in the right thigh with a 0.5 mL first dose of Varivax (lot # 654525/1041F). There was no illness at the time of vaccination. Ten days after vaccination the patient experienced redness and tenderness at the injection site. She also developed three papules that were not varicella like. One was on her torso and two in the diaper area. Unspecified medical attention was sought. There was no product quality complaint involved. Follow up information from the physician described the patient's experience as on 30-OCT-2006 her right thigh was slightly erythematous without tenderness, and slightly firm with a central papule at the site of injection, the patient's diaper area had two papules that were not varicella appearing. The patient's right cheek had one papule that was not varicella appearing. The patient recovered in November 2006. No laboratory diagnostic tests were performed. The patient did not experience any adverse events following prior vaccination. Additional information is not expected.
This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patient's medical history or concurrent conditions were not reported. On an unknown dates, the patients were vaccinated with ROTATEQ orally, for prophylaxis (dosage information and lot number were not informed). Information regarding concomitant medication was not provided. The registered  nurse reported a temperature excursion that lasted 22 hours. However the reporter was unable to provide a temperature range for the excursion, was not even sure if it went beyond the (>46F to <77F) range or even out of the (36F to 46F range) because her data logger malfunctioned. It could not be ruled out if the vaccines experienced out of range temperatures or not. The nurse also stated that the temperature was in recommended storage range prior to the malfunction of the data logger. No adverse effects reported. There was no product quality complaint involved. This is one of two cases from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1702USA006715:
Myoclonic activity in right arm then moved to both arms.  Also experienced fever, dizziness, and severe migraine.
Left thumb began throbbing, sore to the touch, "arthritic pain" type of feeling. Within two days, Left arm and side (beginning under arm, radiating down) began hurting. Could not lay on her side or raise her arm, even currently (2 weeks later).
After vaccination 02-11-22 the next day in the morning severe cramping in bilateral feet ( toes ) and bilateral calves, pain in bilateral knees but more in left knee and left hip. MD- ordered ultrasound duplex  spectral analysis.  After couple of weeks pain increase and advance to my shoulders and elbows especially my left elbow very strong pain.  Im doing this report until now because symptoms getting worse.  Pain getting worse and I noticed cardiac arrhythmias .
This is a spontaneous report from a contactable consumer (patient herself). A female patient, of an unspecified age, received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection; batch/lot# not reported), via an unspecified route of administration, on Mar 18, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. On an unknown date (3 hours after the first dose), patient experienced itchiness; with outcome of unknown. No follow-up attempts possible. Information on lot/batch number cannot be obtained.