chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within 5 hours, had muscle pain, couldn't close my hand, chills, aches and pains over entire body. multiple headaches in different areas of head thru the night. Very tired for next 4 days. After that started upper leg pain, still have it. Went to physical therapy. Didn't help. Doing more testing now. P
COVID-19 Vaccine Reaction   Vaccine administered: Pfizer dose 2/2  Patient reaction, action taken, & outcome:   1206 - 2nd Pfizer dose given 1212 - Syncopal w/ fall forward w/ abrasion/contusion injury to left orbital area while walking from vaccination area to observation area. Diaphoretic. Pale. Lightheaded. 1215 - placed on stretcher and brought to triage area. BP 92/55, RR 28, HR 86, SpO2 96. Gave OJ and water. 1220 - BP 94/64, RR 26, HR 90, SpO2 96 1223 - BP 115/73, RR 26, HR 96, SpO2 97 1226 - BP 121/71, RR 20, HR 96, SpO2 96. Sitting EOB. 1335 - BP 98/59, RR 22, HR 85, SpO2 95. Lightheaded again. Gave OJ and laid back down. No longer pale or diaphoretic now, but neck becoming sore. 1240 - BP 114/67, RR 20, HR 80, SpO2 97  1246 - BP 117/67, HR 77 Sitting EOB   MD lead at bedside directing care throughout and d/ced patient at 1300 w/ info about concussions and after ambulation.
Aching, general malaise, fever for 36 hours.  Plus soreness at injection point.  Had a pap smear 10/12/2009, uterus bleeding started 10/17/2009, miscarried baby 10/30/2009.  It's my unprofessional opinion that the sickness (especially the fever) caused by the flu shot resulted the miscarriage.  The baby had, again in my unprofessional opinion, a neural defect which we think was caused by the fever.  This was the first time she ever had a flu shot.
We did not see the patient directly, as per patient's caregiver: Patient's arm was red, swollen, injection site was raised and discolored (pink/purple) from 4 inches below deltoid to elbow.
Widespread body aches and fatigue onset ~ 24 hours post dose resolved by 48 hrs post-dose
Patient passed out roughly 5-10 minutes following vaccine while seated on a planter; witnessed by store employee. Hit his head causing a small laceration above the right eyebrow which was cleaned with alcohol and bandaged prior to EMS arrival. The patient experienced dizziness and numbness/tingling in both hands/arms. He was able to tell RPh his name, the year, and knew where he was. Paramedics were called to assess his condition. Per patient and mother, only underlying condition is anxiety and only medication is zoloft.
Patient had hypotonic hyporesponsive episode within 5 minutes of receiving the vaccine. Episode lasted for approx 5 min and patient was fine thereafter.
got his first Shingrix shot on 20 OCT 2020 and has not gotten his second shot yet; had COVID-19 disease; injected (left) arm was sore after his first Shingrix dose; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 20th October 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient received the 2nd dose of Shingrix. On 20th October 2020, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site pain. On 11th January 2021, the patient experienced covid-19. On an unknown date, the patient experienced incomplete course of vaccination. On 22nd October 2020, the outcome of the injection site pain was recovered/resolved. On 16th February 2021, the outcome of the covid-19 was recovered/resolved. On an unknown date, 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. It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient received 1st dose on left arm  through intramuscular route on  20th October 2020 batch number and expiry date was not reported and experienced pain at injection site. The patient had covid 19 disease on 11th January 2021 and recovered on 16th February 2021due to which patient did not received the second dose which led to the incomplete course of vaccination. The reporter did not consent to follow up.
Pt received DTP & OPV 4:00 pm, Pt OK until 6:30 pm next evening, pt had three shaky spells all over lasting 5-10 seconds. No fever or irritability.  Another skaky spell 29Apr90 3 times lasting a few sec. Exam normal, referred neurologist.
pt presented to hosp by mom on 21NOV97 5AM was DOA;coroner lists causes of death as renal failure, obstructive uropathy, & UTi;
Syncope; This case was reported by a physician via call center representative and described the occurrence of syncope in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th July 2019, the patient received the 1st dose of Shingrix. On 19th July 2019, 1 days after receiving Shingrix, the patient experienced syncope (serious criteria GSK medically significant). On an unknown date, the outcome of the syncope was recovered/resolved.   It was unknown if the reporter considered the syncope to be related to Shingrix.  Additional details were provided as follows: The patient had a syncopal episode 1 day after immunization.
She got her vaccine at approximately 7:10 PM , they had them wait for about 5-8  minutes near the pharmacy.  She felt the vaccine from the time of leaving the room going up the side of her neck, running down her arm and spreading feeling.  Like a burn/thickness not sure what she felt.  She tried to put her arms in the air and it was sore.  About 8 minutes later they left, she brought water with her and drank 44 oz of water which was advised.   Through the night she was getting severely tired as she was cleaning up some things.  Her fiance noticed that she was acting a little weird, felt that she was tired and went upstairs to get ready for bed.  During the night she was sleeping on her left side as it helped the pain, but then would woke up due to the pain.  Around 8:00 AM when she woke up they noticed that their arms were sore, and she felt it other places like body aches.  Then she couldn't really get up, went to the bathroom and was not able to do anything.  She messaged him today while he was at work, and she tried to take a nap but it was difficult to go to sleep.  Her body got cold and her body aches, and everything hurts, anything touching her hurts.  She took a nap and when she woke up she had a temp of 99.4, and wanted to take another nap which was around 11:00.  She got exhausted just trying to get up.  She went back to bed, and then got up and was unable to move.  Any movement hurts, she cannot lift her arm, and if she's moving she is yelling due to the pain.  She could not find anything to suggest she could not take Naproxen which did not help her, she took it around 12:00.  Her heart and inside her teeth have sharp pains, as well as her lungs having sharp pain, also down the back of her neck, down her jaw.  Her pain in the arm is severe like she got punched and radiating pain and numbness.  She feels as if she fell off a 20 story building.   Her fiance also got the vaccine at the same time, they got the same dosage and does not feel that they should have and it should be based off of her BMI.  He has not had any symptoms other than a sore arm.    She called her doctor and they told her to call her pharmacy which they were at lunch.    She is going to go to the ER due to her heart issues and her lung symptoms.
Moderna covid-19 vaccine EUA - headache, nausea, and severe chills started between 11:00-11:30pm, followed by severe body aches, joint pain, neck pain, fatigue, and fever up  to 102.8 that continued all day on 1/1/2021.  Temperature down to 99.8 on 1/2/2021 in the am.
BUMPS IN EAR PAIN NOW BAD HEADACHES DIFFICULT BREATHING CLINIC WILL NOT LISTEN 2 TOPICAL MEDS PRESCRIBED 10-05-2012 THEY JUST TELL ME TO CONTINUE MEDS
31 Y/O MALE WITHA PMHX OF GERD CONTROLLED DAILY WITH OMEPRAZOLE AND RANITIDNE, PRESENTS POST COVID VACCINE 4/12 PFIZER # 1 WITH EPIGASTRIC BURNING 10/10 CONSTANT, SEVERE SWEATING, SOAKING TSHRTS 3 AT NIGHT AND SWEATING NONSTOP DAILY, INSATIABLE HUNGER, MUSCLE CRAMPS TODAY ONLY.  HAS BEEN PRESENT SINCE WEDNESDAY BUT WORSENED TODAY/  n. Pt states he takes Omeprazole, Tums, and Pepto. Pt states Pepto relieved his symptoms temporarily. Pt states he is nausea, but denies vomiting and diarrhea. Pt rates pain 10/10. EP PAIN IS CONSTANT, DENIES FEVER ., ADMITS URINARY HESTANCY   BP 173/117 HR 113  DIAPHORETIC,  SEVERE PAIN
If i was recently diagnosed with covid19 do I need to wait for 3 months to get my booster; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (If i was recently diagnosed with covid19 do I need to wait for 3 months to get my booster) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (If i was recently diagnosed with covid19 do I need to wait for 3 months to get my booster). At the time of the report, COVID-19 (If i was recently diagnosed with covid19 do I need to wait for 3 months to get my booster) 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.   Concomitant medications was not reported.  Treatment medications was not reported.  Company Comment: This is a Spontaneous case concerning a patient of an unknown gender and age, with no medical history reported, who experienced the non-serious unexpected AESI of COVID-19. The event occurred in an unknown date under an unknown schedule of vaccination of the mRNA-1273 vaccine. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. The case was assessed as non-serious.; Sender's Comments: This is a Spontaneous case concerning a patient of an unknown gender and age, with no medical history reported, who experienced the non-serious unexpected AESI of COVID-19. The event occurred in an unknown date under an unknown schedule of vaccination of the mRNA-1273 vaccine. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. The case was assessed as non-serious.
This medically confirmed spontaneous report (initial receipt: 26-Feb-2016) concerns a 75 year-old male patient. On 29-Sep-2015, the patient received AFLURIA (batch number U55406; expiry date: 30-Jun-2016 yet reported as 12-Jun-2016) 0.5 mL via the intramuscular route. The AFLURIA vaccine was stored at 0.6 to 1.1 degrees Celsius (reported as 33-34 degrees Fahrenheit) multiple times. The last excursion was 0 degrees Celsius (reported as 32 degrees Fahrenheit) for no more than 24 hours. The outcome was reported.
This outcome happened around one to two weeks after I received the vaccination. The right side of my face went numb and I had no facial muscle control. It lasted less than a minute. I have decided to report this after my friend told me about a similar incident she read about.
Headache; is 14 weeks pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (is 14 weeks pregnant) and HEADACHE (Headache) in a 33-year-old female patient (gravida 4, para 3) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011120A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Live, full-term birth) on 25-Oct-2001, Pregnancy (Live, full-term birth) on 18-Apr-2006 and Pregnancy (Live, full-term birth) on 26-Jun-2012. Concurrent medical conditions included Arm injury and Dust allergy.    On 09-Jan-2021 at 1:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 08-Oct-2020 and the estimated date of delivery was 15-Jul-2021. On 09-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (is 14 weeks pregnant). On 12-Jan-2021, the patient experienced HEADACHE (Headache). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirteenth week of the pregnancy.  On 09-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (is 14 weeks pregnant) had resolved. On 13-Jan-2021, HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       There was no concomitant medication reported. On 25-OCT-2001, it was reported that 1st pregnancy ended with live, full-term birth. On 18-APR-2006, it was reported that 2st pregnancy ended with live, full-term birth. On 26-JUN-2012 was reported that 3t pregnancy ended with live, full-term birth. On an unknown date in Oct-2020, it was reported as the estimated date of conception. Treatment information was not provided.  Company Comment: This is a case of product exposure during pregnancy with no associated AEs for this 33-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy. Based on current available information and the temporal association between product use and the start date of Headache, a causal relationship cannot be excluded, while the event was reported not vaccine related.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jan-2021: Internal review on 20-Jul-2021 resulted in updates to the patient details, events, and narrative.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 33-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy. Based on current available information and the temporal association between product use and the start date of Headache, a causal relationship cannot be excluded, while the event was reported not vaccine related.
Patient presented with abdominal pain and shortness of breath for 2-3 days, nausea and vomiting for the past 2 weeks. Tested positive for Covid-19. Patient treated with Vitamin D and Zinc, as needed oxygen, nebulizers, imodium. Discharged home on home o2.
This spontaneous report as received from registered nurse refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (dose, route and lot # not reported). No adverse symptoms were reported. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report was received from a physician assistant via a company representative, and refers to a female patient in her "mid 60's". The patient had no medical history, concomitant medications, concurrent conditions nor drug reactions/allergies. On an unknown date in September 2017 (reported as about a month ago), the patient was vaccinated with a dose of ZOSTAVAX for prevention of shingles (dose, route, lot number and expiration date were not provided). In approximately September 2017 (reported as the patient came back into the office a few days later), the patient had developed Ramsay-Hunt syndrome. As a result, the patient was prescribed an unspecified steroid, and acyclovir, and was also referred to see an unspecified ear, nose and throat (ENT) provider. No product quality complaint (PQC) was involved. The outcome of herpes zoster oticus was unknown. However, The physician's assistant stated that he believed the patient was doing better, since the patient has not come back to the office for any follow up visits. The causal relationship between ZOSTAVAX and herpes zoster oticus was not provided. Upon internal review, the event herpes zoster oticus was determined to be a medically significant event.
A report has been received from a Study Investigator concerning a 43 year old, female subject, Height: 68.0 inches, Weight: 155.0 Pounds. A post marketing Safety study of Q/LAIV in Subjects 2 through 49 years of age. No relevant history was reported. The patient did not receive any concomitant medications.  The date of last menstrual period was 13-JUN-2013. The estimated date of conception was on 27-JUN-2013. The patient received a single dose of FLUMIST Quadrivalent on 03-OCT-2013.   The patient experienced pregnancy which started on 03-OCT-2013. The patient recovered from the event on the same day. The estimated date of delivery was 20-MAR-2014. The outcome of the pregnancy was reported to be a healthy baby born on 03-MAR-2014. The number of weeks at outcome of pregnancy at outcome was 37.3. They delivery type was vaginal. There were no problems or complications during delivery. The gender of the baby was female, the weight was 3.525 kg, the length was 49.5 cm. The Apgar Score at 1 minute was 8, at 5 minutes was 9. There were no abnormalities. The report was considered to be non-serious. The study investigator considered that there was no casual relationship between pregnancy and study therapy.
MOST ALLARMING; SWELLING, REDNESS, WARM TO THE TOUCH AND PAIN IN ONE OF PATIENT'S CALVES. POSSIBLE DVT.  PATIENT FIRST COMPLAINED OF JOINT PAIN IN ONE OR MORE JOINTS AT A TIME AND MOVING TO DIFFERENT JOINTS ON DIFFERENT DAYS BEGINNING SHORTLY AFTER ADMINISTRATION OF THE FIRST DOSE OF MODERNA COVID-19 VACCINE.
PT APPEARED FLUSHED AND SAID ARM TINGLED IMMEDIATELY AFTER INJECTION. PT NOT EXAMINED BY PHYSICIAN.
Approx two weeks after COVID booster: Heart failure, myocarditis  with ejection fraction initially 15%, improved to 50% two weeks later. ICD placement. Unsure if vaccine related but wanted to report.
rash started on 9/13/22 that included both arms and the back area, it was mildly itchy and she is self treating with hydrocortisone, patient contacted he primary care physician as well
lost 5 lbs; BP shot upwards/High blood pressure; dizzy; fatigue; Extreme weakness; he had been in bed for 3 days; The patient received an unknown Covid-19 vaccine as dose one and two.; The patient received an unknown Covid-19 vaccine as dose one and two.; This is a spontaneous report from a contactable consumer (the daughter).  A 96-years-old male patient received bnt162b2 (BNT162B2), dose 3 booster intramuscular on 04Oct2021 10:30 (Batch/Lot number was not reported) as single dose  for covid-19 immunization. Medical history included ongoing gout (15-20 years ago), cardiac disorder from 2013 and ongoing , back pain from 1960 and ongoing , skin cancer from 2019 to 2019 (2019 couple months before removed) , surgery on 2019, covid-19 from May2021 to an unknown date. Concomitant medications included apixaban (ELIQUIS) taken for gout from an unspecified start date and ongoing; diphenhydramine hydrochloride (BENYLIN [DIPHENHYDRAMINE HYDROCHLORIDE]) taken for an unspecified indication from an unspecified start date and ongoing.  The patient received an unknown Covid-19 vaccine as dose one and two. The patient experienced BP shot upwards/high blood pressure  (medically significant) on 12Oct2021 with outcome of recovered , dizzy  (medically significant) on Oct2021 with outcome of unknown , lost 5 lbs  (medically significant) on an unspecified date with outcome of unknown , extreme weakness  (medically significant) on Oct2021 with outcome of recovering , fatigue  (medically significant) on Oct2021 with outcome of recovering , he had been in bed for 3 days  (medically significant) on Oct2021 with outcome of recovered.  The patient underwent lab tests and procedures which included blood pressure measurement: 180/??   on 12Oct2021   , blood pressure measurement: 120s/??   on 12Oct2021   , weight: lost 5 lb lbs on Oct2021.  Course of the event. A few days after receiving the Pfizer vaccine (he doesn't remember when it started exactly), he became extremely weak. He had to stay in bed, could not move or eat (spoke with the reporter about this, his daughter 06Oct2021 and told her he had been in bed for 3 days). He lost 5 lb. It took 4-5 days for him to start walking a little bit. Yesterday his BP shot upwards to over 180/?? (he became very dizzy). It went down at the end of the day to 120s/?? after lying down.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up..
LLE swelling started 24 hours after receiving HIB 3+ Pediarix 3 in same. Erythema and thigh swelling dayone one. Erythema resolved-swelling extending to lower leg on day 2. No fever. No pain. S/S
Myalgia, Arthralgia, Fever, injection site pain, chills Narrative:  Employee reports injection site pain/discomfort and swelling, as well as fever (99.5 F), chills, headache, joint pain, body aches, and fatigue. Reports arm was "red, swollen, welt, warm." Reports taking Tylenol (no dose/frequency given).
I got a little dizzy while walking to my seat. I got a rush of adrenaline and my heart rate shot up. I went and sat with the paramedics and they took my BP, but it wasn't considered abnormal. They walked me outside and I felt better. I had some splotches under my throat, but that happens sometimes when I get upset. There was no swelling or anything and it resolved within 25 minutes. That night, I had a 101 temp, was really cold and just generally felt crummy. The following Thursday, I was using ammonia and couldn't smell it. My son complained of being cold that night, which isn't normal for him. We got tested the next day and we both were positive for COVID. I had an exposure on Jan 12, but didn't find out until I called my boss and she told my coworker had it. I was sick for another 10 days, but was never hospitalized. I had a Chest x-ray done on 1/31 and I had developed pneumonia.  I got my 2nd dose on Feb 19th. I experienced basic symptoms along with residual tightening in the chest and fogginess, but I think that was because I had just had COVID. About 36 hours later, I was back to normal.
dizzy; nauseas; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer COVID vaccine), lot no. EL1283, via an unspecified route of administration (vaccine location: left arm) on 27Jan2021 10:00 at a single dose for COVID-19 immunization at a public health clinic/administration facility. Medical history included Gerd and allergies to tetracycline. Concomitant medications included omeprazole, cetirizine hydrochloride (ZYRTEC), ergocalciferol (VIT D), and unspecified multivitamins. No other vaccines in four weeks. No Covid prior vaccination. On 27Jan2021 10:00 AM (as reported), within 1 minute, the patient was dizzy and nauseas. The symptoms went away in10 minutes. No treatment for the events. She has not experienced any other side effects. No Covid test post vaccination. The outcome of the events was recovered on 27Jan2021 10:10.
low temperature, chills/rigors, nausea, vomiting, myalgias, severe abdominal pain, anorexia.  started within 12 hours of vaccination, much worse by 24 hours.
rt leg red from groin to midcalf, swollen, hot to touch 3hrs p/shot;pt awakened from nap @ 145 cried nonstop for 3hrs, t102;mom used cold washcloth, ice pack & APAP
Reaction occurred 2-3 hours after shots. Right thigh, red, firm, hot - rt leg 1.5 inches larger than left - area of induration 5.5 x 4.5 inches. At least 1.2 of leg or more.