chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Little welts or hives in the site where she received vaccine; Area towards my shoulder blade began to get sore again; Site where she received vaccine was a localized pinkish raised area; Some soreness; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE URTICARIA (Little welts or hives in the site where she received vaccine), PAIN (Some soreness), ARTHRALGIA (Area towards my shoulder blade began to get sore again) and VACCINATION SITE SWELLING (Site where she received vaccine was a localized pinkish raised area) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2020, the patient experienced PAIN (Some soreness). On 10-Jan-2021, the patient experienced VACCINATION SITE URTICARIA (Little welts or hives in the site where she received vaccine), ARTHRALGIA (Area towards my shoulder blade began to get sore again) and VACCINATION SITE SWELLING (Site where she received vaccine was a localized pinkish raised area). At the time of the report, VACCINATION SITE URTICARIA (Little welts or hives in the site where she received vaccine), PAIN (Some soreness), ARTHRALGIA (Area towards my shoulder blade began to get sore again) and VACCINATION SITE SWELLING (Site where she received vaccine was a localized pinkish raised area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Patient had tried using witch hazel and cold water on the effected area without improvement.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Employee stated that she developed hives 4 to 5 days after receiving the second dose of the Pfizer COVID-19 vaccine. Stated the hives started off mild, but are now severe and all over (face, stomach, back, legs, arms, neck). Employee stated when the hives first started she would take Benadryl and the hives would go away for a couple of days then return. Now the Benadryl is not helping. Employee stated that she went to the ER Friday (6-25-2021) because the hives were so bad and she was having trouble swallowing. Stated the ER discharged her home with some steroids and Benadryl, but the medication does not appear to be helping. The employee stated that she had the flu shot 5 years ago and had the same reaction with the hives and is no longer able to receive the flu vaccine. Advised employee to follow the advise of the ER, and if symptoms do not improve or get worse to return back to the doctor. Also advised employee that she may need to see an allergist or immunologist.
severe fever and chills for 24 hours, fatigue, diarrhea, brain fog, and body aches. Treated with acetaminophen to reduce fever. Symptoms subsided within 26-30 hours of onset.
Information has been received from a registered medical assistant concerning an 8 year old male with medical history of bleeding from other vaccination sites in the past and no drug allergies who on 08-DEC-2010 was vaccinated IM in left deltoid with a 0.5 ml dose of VAQTA (lot# 668913/1088Z, expired date 25-JUL-2013). There was no concomitant medication. On 08-DEC-2010 following vaccination with VAQTA in the deltoid, blood squirted from the site of the vaccination when the needle was removed. The bleeding stopped immediately, but then continued as a small trickle. Pressure was applied and the site was bandaged. Patient was kept at the office for observation for 20 minutes then released. No lab diagnostics studies performed. Patient sought medical attention by office visit On 08-DEC-2010 patient recovered. The reporter stated that she had seen bleeding from other vaccination sites in the past. No name of products, number of occurrences, dates or other information were available about previous bleeding occurrences from other vaccination sites. Follow-up information was received from the registered medical assistant who reported that that on 08-DEC-2010 4:00 PM, the patient was vaccinated in left arm with the second 0.5 ml dose of VAQTA. The medical assistant reported that there was no adverse reaction. The question was whether there was any contraindication if vaccine was given into an artery. No further information is available.
2 hours after flu shot: hoarseness, shortness of breath, wheezing, changed in voice. Pt transferred to hospital after call 911.
Pt had immunization on the 6/01/04, on the two days later mother of pt noticed a large welt on area around where the immunization was given. Large red warm size welt was 3" long by 2.25 " wide.
CLIENT RETURNED TO CLINIC 6/1/17 AND 7/26/17 DUE TO COMPLAINT OF RIGHT ARM PAIN.
blood clot in my right leg; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clot in my right leg) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced THROMBOSIS (blood clot in my right leg) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (blood clot in my right leg) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant and treatment medications are provided by the reporter. patient stopped breast feeding on 8-sep-2021,  Company comment: This case concerns a 37-year-old, female patient with no relevant medical history reported, who experienced the unexpected event of thrombosis. The event occurred on an unknown number of days day after the first dose of mRNA-1273. The rechallenge was unknown since it is unknown the outcome of the event. The benefit-risk relationship of mRNA-1273 in not affected by this report.; Sender's Comments: This case concerns a 37-year-old, female patient with no relevant medical history reported, who experienced the unexpected event of thrombosis. The event occurred on an unknown number of days day after the first dose of mRNA-1273. The rechallenge was unknown since it is unknown the outcome of the event. The benefit-risk relationship of mRNA-1273 in not affected by this report.
Pain and soreness at injection site, muscle aches through body within 6 hours. Severe shaking chills, skin feeling hot, and incessant teeth chattering within 12 hours. All symptoms continue at least 24 hours after injection. Chills and teeth chattering come in waves.
Mom noted rash on left deltoid this AM. Nurse observed site of DTAP injection in the center of area that was red, raised and almost vesicle-like in appearance. Rash (3" long by 1 1/2" wide area of skin involved). IPV injection site looks fine. Mom was advised to take child to MD.
Received vaccine on 4/11/18 @ 6pm. Began having a headache that evening but nothing serious. On 4/12/18 around 10:00am, I began feeling very bad: Headache; Soreness at Site; Rash at Site; Ankles Hurting; Legs aching; Back hurting; Neck hurting; Shivering; Nauseous; Weakness; Temperature 101.6. Fever broke around 6pm on 4/12/18, still felt achy and weak through 4/13 (present).
I got the first dosage of the Pfizer Vaccine on 03-12-2021.  Since then I have developed side effects.  About 6.5 days afterward on 03-18-2021, I started having some tingling in my chest area, shoulders, arms, hands, and fingers.  It progressed to a feeling of low oxygen in muscles in the areas described before.  I did not have any problems with breathing, no temperature, and high levels of oxygen saturation (95% to 100%).  On the 23rd, I got the Covid-19 test.  The results were sent to me on the 24th.  The results were negative.  Since then, the low oxygen feeling continues with the addition of the lung muscles. I still have no temperature, and high levels of oxygen saturation (95% to 100%).  The lungs still seem to exchange oxygen well, no congestion.  I will be getting the second dose this Saturday, 04-03-2021.
secondary cellulitis of left deltoid injection site started on Keflex has follow up scheduled for 4 days
I did not have an adverse reaction to the vaccine. I had an irregular heartbeat, intense flushing and I almost fainted at rest in 03/2023. I contacted my doctor, and they directed me to the emergency room for observation. I went through multiply test all in normal range. At this time, I am waiting for results from another test before seeing a cardiologist.
Per employee "I received my influenza vaccine in my L upper arm on 9/30/22. A few months later I still have L upper arm pain at the site of the injection. It is a shooting pain with certain movements of my arm. It has limited my exercise and ADLs due to pain." Documented date was 09/29/22 in Employee Health records.
after Midnight on the night of the 7th, it started with body aches.  During the night I needed to go to the bathroom and could not get out of bed, needed assistance.  On the morning of the 8th, I  experienced chills and headache. Took Advil that morning and 4 hours after. Did start to feel better. Experienced Dizziness at times. Today, the 9th just chills throughout the day.
A nurse reported that a male infant received a dose of Prevnar along with DTaP, IPOL and hep B vaccines on 9/5/02 at 4 months of age.  On 9/26/02 at 5 months of age, the infant died. SIDS was the reported cause of death. No further info was available at the date of this report. This report of a serious, labeled event is being submitted in a 15-day time frame as requested. Info regarding this event has been forwarded to manufacturer of IPOL vaccine. From initial information received at manufacturer on 03/03/2003 from another manufacturer regarding an event that happened in the U.S. concerning a 4-month-old male patient who received IPOL on 02/05/2002.  The lot number and site/route for the vaccination was not reported.  The patient died on 09/26/2002 from SUDDEN INFANT DEATH SYNDROME.  From additional information received at manufacturer on 04/24/2003, it was reported that the patient also received Prevnar, DTaP and Hepatitis B Vaccine on 09/05/2002.  The manufacturer, lot number and route/site were all not reported for Hepatitis B Vaccine and DTaP.  Prevnar was given intra-muscular.  Autopsy results showed Sudden Infant Death Syndrome (LLT, SIDS) as reported cause of death.  From additional information received on 05/13/2003 from manufacturer, it was reported that their manufacturer number be added to WAES 0305USA00241.
3 days after shot given suffered an ischemic stroke on the  left pons 30 days later suffered another ischemic stroke on the right pons and 30 days after that suffered another ischemic stroke in the frontal lobe
Information has been received from a consumer concerning her 3 year old son with no allergies or medical history who in 1993, during his first two years, was vaccinated SC with a dose of MMR (lot # 619795/0994D). Concomitant therapy included a dose of hepatitis B virus vaccine (lot # 614567/0280D), a whole bunch of vaccines, and Arispidol. In 1996, at 3 years of age, the patient was diagnosed with autism. Unspecified medical attention was sought. At the time of the report, the patient was noted to be 20 years old and had not recovered. A product quality complaint was not involved. It was also noted that the patient's brother received a whole bunch of vaccines at unspecified times and was diagnosed with autism at 2 years of age. Upon internal review, autism was determined to be an other important medical event (OMIC). No further information is available.
received improperly stored vaccine; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history or concomitant medications was provided.  On an unknown date, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) one dose, lot # S003865 and expiration date: 08-AUG-2020 (exact dose, frequency and route of administration were not reported) for prophylaxis. The vaccine was stored in 32.5 Fahrenheit (F) for 8 hours. There was no previous temperature excursion. The temperature excursion was recorded by digital data logger.
The syringe malfunctioned when the needle was in the patient's arm. The plunger wouldn't move toward the needle. I filled another syrine and gave the vaccine to the patient.
MOP asked for a booster dose, but we realized after the shot the primary serie was not completed and it was not Pfizer (021 2022)
The night of vaccination I had fever, aches and body chills that lasted for 4 days. On the 6th day after the vaccine the chest pains started. I've been seen in the ER three times now.  A stabbing pain under my left breast that is continuous.
Rec'd 3 doses since Feb 2021. All 3 times got bladder/kidney infection(s). Had to take strong antibiotics 3 times & am on daily low dose antibiotic to keep infections down/cleared. Grateful for the vaccine(s) but thought needed to report the infections.
Received expired vaccine beyond 12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond 12 hours post puncture) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond 12 hours post puncture). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond 12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  On 04-NOV-2021 vial was initially stored in the refrigerator. On 17-NOV-2021 10.00 AM vial was first punctured. Post puncture vial was stored under room temperature. Vial did not undergone any temperature excursions. Vial was exposed to room temperature range 46° to 77°F from 17-NOV-2021 10:53AM until 18NOV2021 11:00AM.
headache; chills; This case was reported by a consumer via call center representative and described the occurrence of headache in a 85-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced headache and chills. On an unknown date, the outcome of the headache and chills were unknown.   It was unknown if the reporter considered the headache and chills to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had a bad reaction to the 2nd dose of Shingrix headache and chills.
This spontaneous report as received from a nurse refers to a 14 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 05-SEP-2017, the patient was vaccinated with improperly stored GARDASIL 9 (dosing details were not reported) (lot # N007931, expiry date: 17-NOV-2019) for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054.
Injection at 11:40 on 2/9/21. Had dizziness and headache during the 24hrs after the injection. Around hour 28 (3pm 2/10/21), I began feeling inebriated and then began acting as such. Like I had taken a substance or drank several alcoholic beverages. I had not and was 100% sober. Fell asleep at 7pm and slept until 6am only briefly waking a few times as I was warm & a little sweaty. Head was completely clear by 11:30pm  but dizzy when I stood up. By 6am, only remaining symptom was dull headache.
lymph node swelling both armpits; Pins and needles under both forearms; Right arm swelling; pain; Left chest wall swelling; This is a spontaneous report from a contactable consumer, the patient. A 83-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EL9264), via an unspecified route of administration, administered in the arm right on 02Feb2021 13:15 as dose 1, single (at the age of 83-years-old) for covid-19 immunization. Medical history included left mastectomy, stroke, ongoing high blood pressure, pacemaker and allergies to penicillin, simvastatin, hydrochlorothiazide and letrozole. The patient did not have thyroid. Concomitant medications included apixaban, rosuvastatin, chlorthalidone and thyroid (ARMOUR THYROID). On 04Feb2021, the patient experienced right arm swelling. Pain and lymph node swelling both armpits. Left chest wall swelling and pain. Pins and needles under both forearms. Symptoms developed and had persisted. The patient performed mammogram and ultrasound for the events. The patient visited the doctor or other healthcare professional office/clinic. The patient did not receive the any other vaccine in four weeks. The patient did not have covid prior to vaccination and did not tested for covid post vaccination. Therapeutic measures were taken for the events. The outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills). At the time of the report, CHILLS (chills) 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 provided by the reporter.
Pain at injection site immediately and continues soreness in arm Fever, chills, and body aches approximately 6 hours after dose  Increased testing heart rate to 96 bpm approximately 6 hours after dose
Fatigue, headache, joint and muscle soreness (including mild injection site pain) beginning 18 hours after 2nd dose.   Symptoms lasted two full days, 3rd day mild headache but rest of the systems have gone.
Within 12 hours of receiving the vaccination I experienced fever, rolling chills, aching joints that lasted another 12-14 hours.
Varicella - Information has been received from a registered nurse concerning a 12 month old female who is a twin.  In may 2000 the patient was vaccinated with one dose of varicella virus vaccine live (site unknown). Ten days post vaccination, the patient developed 10-15 or 50 vesicles and the next day had a full blown case of chickenpox and was broken out all over with hundreds of chickenpox indicating that the patient had already been unknowingly exposed by an active source.  Unsepecified medial attention was sought.  Also reported was the patient's twin sister who was vaccinated and developed similar events (Waes 00060099).
Minutes after receiving vaccine, as mother was checking out, she noticed bumps on pt's legs.  Pt also was crying more than she did the first time, and after being re-roomed, it was noted that pt had small erythematous papules to both legs. Was given liquid Benadryl 12.5 mg and monitored for an additional 30 min, by which time rash had completely disappeared and infant was sleeping.
This spontaneous report was received from a physician assistant via a company representative referring to a female patient of unknown age. No information about the patient's medical history, concurrent conditions or concomitant medications was provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL or GARDASIL 9 for prophylaxis (dose, frequency, route, lot number and expiration date were not provided). On an unknown date, the patient experienced ovarian dysfunction (ovarian disorder). No product quality complaint (PQC) was involved. At the time of reporting, the outcome of ovarian disorder was unknown. The primary reporter did not provide the causal relationship between GARDASIL and GARDASIL 9 and  ovarian disorder. Additional information has been requested.
Patient seen for cellulitis due to a laceration on his L forearm that occurred approx 1 week earlier on 8/2/2010. Patient's last TD was 9 years ago, therefore the ADACEL was administered in his L deltoid. Patient was also given a 2 scripts, 1) BACTROBAN to apply to the affected area TID 2) ZITHROMAX (Z-Pak) use as directed. Patient was seen 8/3 due to a c/o of low-grade fever and generalized achiness that started the evening before. Patient was taking SAVELLA for his fibromyalgia that he discontinued 2 days earlier due to GI upset. Patient temp today is 100 degrees F. Cellulitis has improved. Z-pak was discontinued. Patient is to call with status in 24hrs and go to the ED if symptoms worsen, patient voiced understanding.
Had fatigue, chills, aches and a headache that started 24 hours after 2nd dose.  No fever thought.  This generally subsided by 48 hours.  But then 8 days after the 2nd dose, same side effects occurred again but worse.  Was out of commission for two and a half days before feeling better.  Had bad headache and body aches I couldn't relieve with Advil or Tylenol.  Also my head broke out with a bunch of painful acne on the left side.  This is still slowly resolving, the body aches/ chills resolved after 72 hours.
Mom states child had dry lips, swelling, fever which was not measured, and sleeping more then usual.