chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she was in full blown pain on scale 1-10 it was a 10; she thought she was getting her period because she normally gets a little discharge and thought her period was coming.; breaking out with shingles in the vaginal area; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program.  A 34-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: FD8448; expiration date: not reported) via an unspecified route of administration, administered in left arm on 03Sep2021 (at the age of 34-years-old) at 13:30 as dose 1, single for covid-19 immunization. Medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: Chicken pox as a child, allergy to penicillin, start and stop date was unknown. Patient previously took Penicillin for cystic acne and experienced neck got red and wheezing, like boils turning up on her face, chest, and back. Had no other shots the same day or 4 weeks prior. The patient's concomitant medications were not reported.On 13Sep2021, patient experienced breaking out with shingles in the vaginal area.On 13Sep, does not know if she prolonged it or not, but she thought she was getting her period because she normally gets a little discharge and thought her period was coming. On Tuesday the 14Sep it got worse, by the 15Sep she was in full blown pain on scale 1-10 it was a 10. On Thursday the 16Sep she went to the emergency room. So everything really started on the 13th and it's completely gone now she believes because of the medication the Ob/Gyn gave her. Again, mentions she took it for 10 days and her last dose was yesterday. Patient took treatment of Valopress, 2 pills for 10 days. On 15Sep2021, patient underwent lab tests and procedures which included pain assessment resulted 10, on and unspecified date underwent lab test of sars-cov-2 test resulted positive and negative, both rechecks were negative. Therapeutic measures were taken as a result of breaking out with shingles in the vaginal area (genital herpes zoster), she was in full blown pain on scale 1-10 it was a 10 (pain). The outcome of event breaking out with shingles in the vaginal area and she thought she was getting her period because she normally gets a little discharge and thought her period was coming was recovered in Sep2021. At the time of reporting, the event she was in full blown pain on scale 1-10 it was a 10 was unknown.  No follow-up attempts are possible. No further information is expected.
Redness, tenderness, swelling L upper arm on 9/28/02. Vaccine adm 9/26/02.
Patient had rash on abdomen, back, arm, neck.  Administered Benedryl 12/5mh / 5 mL at 9:02 am.  Continued to monitor for 30 minutes, but rash continued to progress, so patient was walked to the ED at 9:22 am.  The ED observed him.
My symptoms for COVID-19 included sinus congestion, runny nose, sore throat, cough, and fatigue. I did not receive treatment from my doctor. She just told me to rest and to drink plenty of fluids. They symptoms have lessened, but I'm still experiencing some congestion and a light cough.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 76-year-old male patient who received SHINGRIX (batch number G45LN, expiry date 13th March 2021) for prophylaxis. On 25th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 27th November 2018, 2 days after receiving SHINGRIX, the patient experienced injection site erythema and injection site swelling. The patient was treated with Oral Steroids. On an unknown date, the outcome of the injection site erythema and injection site swelling were recovered/resolved. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on the left deltoid. Approximately 2 days after receiving SHINGRIX, a red band appeared around the arm and there was swelling at the injection site. The patient was seen by their doctor who prescribed oral steroids, and the events resolved within 7 days. The reporter consented to follow up.
Sore left arm after shot. Next morning whole body ached. By that afternoon was so bad I could hardly walk. Effects wore off within 36 hours.
Information has been received from a healthcare worker concerning unspecified patients of unknown demographics. Relevant medical history and drug reactions were not reported. On unspecified dates, the patients were vaccinated with improperly stored ROTATEQ (dose, not number and expiration date unspecified) orally. No adverse effect was reported. Additional information has been requested.
Information has been received from a Registered Nurse, for the Pregnancy Registry for GARDASIL, concerning a 15 year old pregnant female with a history of 0 pregnancies and 0 live births and with no other medical history who on 11-AUG-2009, 16-OCT-2009 and 11-MAR-2010 was vaccinated intramuscularly with the first, second and third doses of GARDASIL (lot# for the third dose was 662304/1013Y) respectively. Concomitant therapy included OTC prenatal vitamins (PNV) (25-MAR-2010 to present) which was used for pregnancy. The patient's LMP was approximately 22-FEB-2010 and her estimated delivery date was reported as 15-NOV-2010 by the nurse. On 30-APR-2010 HPV test showed HPV positive. On 01-MAY-2010 (11 week 3 days) ultrasound was performed for testing size and date it showed there were abnormal cranial vault, no normal cerebral, hemispheres or choroid and portion of baby "calictium" absent. Then on 11-MAY-2010 (12 week 2 days), ultrasound was performed again and showed results within normal limits. ON an unspecified date the mother experienced anemia which was treated by ferrous sulfate (since late July 2010, 325 mg daily). In August 2010, at 28 weeks of gestation, the mother experienced preterm labor (PTL) which was treated by betamethasone (from 27-AUG-2010 to 28-AUG-2010, 12 mg X2). On 27-AUG-2010 the mother experienced bacterial vaginosis which was treated by cytarabine (+) fludarabine phosphate (+) granulocyte colony stimulating factor (unspecified) (from 27-AUG-2010, duration 1 week, 500 mg twice a day). It was reported that the baby also experience intrauterine growth retardation (IUGR). On 05-NOV-2010, at 38 1/2 weeks (also reported as 38 8/7 weeks) of gestation, the mother delivered a normal, healthy male baby weighing 5 pounds, 7. Apgar score was 8/9. Baby's length was 19 and head circumference was 81.5. There were no congenital abnormalities reported. There were no complications during labor. However, the reporter thought the baby was delivered at small gestation age (SGA). Other laboratory test included: fetal fibronectin test (FFN) which was performed on 27-AUG-2010 and showed positive result, Gestational Blood Sugar (GBS) which was performed on 12-OCT-2010 and showed negative. The mother's experience has been captured in WAES 1004USA00203. Additional information has been requested.
R upper arm swelling red, tender, itchy after vaccines given 2 d ago- progressively worse 4/26/09 after pain but mostly itchy.  L arm few small slightly raised blotches beneath site of vaccine last Td 2005 no reaction.  Put on CEFTIN 250/50 2 tsp TID x 10d started on 4/25/09.
Local reaction at injection site.  Redness, swelling heat and hardness extending from injection site at left deltoid to just aboce the elbow.  Injection administered on 4/24/09 @ 1445 and symptoms presented on Saturday morning, 4/25 accompanied by intermittent fever of approximately 102 F according to patient.  Patient self treating with Acetaminophen 500mg, 2 tabs p.o q 4 hrs.
headaches; neck achy; shoulders achy; swollen hands and feet; itchy rash on back and arms; This case was reported by a consumer via call center representative and described the occurrence of headache in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immunodeficiency and lung disorder.   On 28th November 2022, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, several hours after receiving Shingrix, the patient experienced headache, neck pain, shoulder pain, peripheral swelling and itchy rash. The patient was treated with paracetamol (Tylenol) and benadryl (nos) (Benadryl). On an unknown date, the outcome of the headache was recovered/resolved and the outcome of the neck pain, shoulder pain, peripheral swelling and itchy rash were not recovered/not resolved.   It was unknown if the reporter considered the headache, neck pain, shoulder pain, peripheral swelling and itchy rash to be related to Shingrix.     Additional Information: GSK receipt date: 14 DEC 2022 Reporters comment:  The patient reported that received dose of Shingrix in the left arm.  Hours later patient experienced headaches, achy neck and shoulders and swollen hands and feet.  Patient stated the swelling has come down some, but still swollen. Patient's back and arms were itchy and noticed there was a rash on back and arms.  Patient notified her health care professional her suggested  to take Tylenol and Benadryl.  The patient also mentioned had a history of lung problems and immunodeficiency. Reporter did not consent to follow up.
This case was reported by a nurse via sales rep and described the occurrence of localized itching in a female patient who received SHINGRIX for prophylaxis. On 29th March 2019, the patient received the 1st dose of SHINGRIX. On 30th March 2019, 1 days after receiving SHINGRIX, the patient experienced localized itching and localized erythema. The patient was treated with BENADRYL. On an unknown date, the outcome of the localized itching and localized erythema were recovered/resolved. It was unknown if the reporter considered the localized itching and localized erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The case was reported by then nurse who administered SHINGRIX to the coworker. The following day, the patient developed a red, itchy area on the same arm as the injection but definitely not at the injection site. The patch of red, itchy skin (6cm X 6 cm) persisted 7 days later and was present at the time of reporting. The nurse was contacted on 8th April 2018 and she confirmed that the side effects were gone and the patient showed no additional signs of potential complications.
Attendee received first dose Pfizer vaccine at 15:08 in the left arm.  Lot# FA6780. Attendee was directed to observation area.   At 15:10 fainted in her chair x 20 seconds, her parents were by her side and she did not fall out of the chair. When she aroused she reported feeling lightheaded, dizzy, mild nausea and ring in the ears.  Attendee's skin was cool, clammy, and pale. Cot brought to the patient area. Attendee assisted to the cot to lie down, legs elevated.  Icepack applied to her neck.  15:13 HR:  88   BP:  108/58   RR:   14   O2Sat%:  97   Temp:  97.0
was OK 15 minute wait.  Driving home I felt like I was going to pass out, my throat tightened and I could not swallow then I had difficulty breathing.  Called 911 and police met us first.  Breathing returned to normal then it happened again about 5 minute later with feeling of passing out and breathing/swallowing issues.  Ambulance came and was taken to the ER.  Given predinesone and benedryl and monitored.
pt recv vax 16JUN97 & on 25JUN97 pt devel a high fever which lasted for 48hr & lethargy;then devel a papular rash on both legs;27JUN97 had a diffuse maculopapular rash up to neck;some induration & erythema mult;
This spontaneous report as received from a registered nurse refers to 3 patients of an unknown age and gender. the patients' concurrent conditions, medical history, concomitant therapies, drug reactions or allergies were not provided. On an unknown date in June 2017 (reported as "within last week"), the patients were vaccinated with PNEUMOVAX 23 lot # M043424, expiration date June 2018 (strength, dose, route and anatomical location were not provided) for prophylaxis. On an unknown date in June 2017, the patients experienced redness around the injection site and entire upper arm where injection was administered. The patients sought medical attention. The outcome of the aforementioned events was not provided. No product quality complaint was involved. The causality assessment between the events and PNEUMOVAX 23 was not provided. This is one of two reports received from the same source.; Sender's Comments: US-009507513-1707USA000399:
Syncope, R25.9 Unspecified abnormal involuntary movements. R55 Syncope and Collapse.  I don't remember how it happen just collapse, ambulance took me to the hospital.
Swelling, redness, itchiness, warmth of R upper arm at site of immunization that began evening after vaccine administered. Pt. seen on 3/5/10-R upper arm swollen, mildly erythematous-soft swelling-treated with P.O. BENADRYL, OTC anti itch lotion.
Polio vaccine given March 12 3:00 pm March 16 low grade fever, tired, March 18 broke out in hives. March 16 - 18 low grade fever March 18 bad hives complain since March 12 about leg Hurting.
Pt became shaky (hands), developed increase in heart rate and blood pressure seconds after injection (BP was 234/94 and pulse was 51 after approximately 20 min). Felt better in - 30 min, went to see MD for blood pressure.
Patient was unusually sleepy the day of and the day after the vaccinations; I noticed twitching in arms and legs, esp. hands; she moved wrists up and down and squeezed hands in and out, appeared to be involuntary; it took her a longer time to feed, although she did take a reasonable amount; cry sounded weaker; irritable; seemed to be off balance; Moro reflex noted a few times (it had disappeared two months prior).
Muscle reaction and spasms; Muscle reaction and spasms; chest pains; occasional shortness of breath; gums receeding; rapid heart beat while resting; Pains all over his body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCLE DISORDER (non-serious), MUSCLE SPASMS (non-serious), outcome "unknown" and all described as "Muscle reaction and spasms"; CHEST PAIN (non-serious), outcome "unknown", described as "chest pains"; DYSPNOEA (non-serious), outcome "unknown", described as "occasional shortness of breath"; GINGIVAL RECESSION (non-serious), outcome "unknown", described as "gums receeding"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "rapid heart beat while resting"; PAIN (non-serious), outcome "unknown", described as "Pains all over his body". Relevant laboratory tests and procedures are available in the appropriate section.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200894392 Same reporter/diff patient; Report 2 of 2;
Pfizer vaccine Difficulty breathing, delusions, hallucinations, combative, anger, sky rocketing blood pressure lack of motor control, weakness, inability to take care of herself, confusion to the extent of dementia. Non of these symptoms prior to vaccine
Pt G3P2 at 28.5 weeks with EDD of 12/22/17. Went to OB office on 10/3/17 for routine OB apt at 28.4 weeks. Pt was feeling well, feeling fetal movement, pt's fingerstick blood sugar was 138, Tdap was given per routine office policy. Later that evening, pt began to feel achy and had a low-grade fever of 99 degrees. Pt called MD at approx. 0230 on 10/4/17 to report possible spontaneous rupture of membranes. MD told her it was most likely not her water and to note if it kept coming out. Pt came to triage at hospital at approximately 0830 after feeling certain her water had broken and starting to be in some pain. AmniSure was positive and foul smell noted. Pt was 3cm at this time with no fetal heart tones found. Pt delivered fetal demise 10/4/17 at 1043 am. Baby weighed 1480g, or 3lbs. 4oz.
Stiff, Achy, fatigued, generally very uncomfortable. This started two hours after the vaccination and lasted through the night. I took 500 mg Naproxen at 2 pm and another at 9 p.m. The next morning I was no longer stiff and achy, but is was still tired and took a nap about noon. I RECEIVED A FLU SHOT EVERY YEAR FOR 20? YEARS, AND THIS IS THE FIRST TIME I HAD AN ADVERSE REACTION. THIS REACTION WAS VERY SIMILAR TO THE REACTION I GOT FROM THE SHINGLES VACCINES IN APRIL AND JUNE THIS YEAR.
pt recvd vax on 17MAY93 & noticed bilateral calf cramping & weakness on 1JUN93; weakness progressed until by 4JUN was unable to walk; had some milder upper extremity weakness too; c/o upper respiratory-like sxs;
This spontaneous report as received from a health worker (nurse) refers to unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with a dose of measles, mumps and rubella (Wistar Ra 27-3) virus vaccine, live (manufacturer unknown), lot # 1375Aa expiration date 26-AUG-2013 (dose, route not reported). It was reported that measles, mumps and rubella (Wistar Ra 27-3) virus vaccine (manufacturer unknown) underwent temperature excursion from 29-JUN-2012 to 30-JUN-2012. Measles, mumps and rubella (Wistar Ra 27-3) virus vaccine, live (manufacturer unknown) was unsupported based on stability information however it was administered after excursion. There were unspecified patients that were administered. The outcome of event was unknown. This is one of several cases reporting from same source. Additional information has been requested.
Pt had a syncopal event w/ associated dizziness. Vitals: 97/58,94,20, 100% -- > 97/58, 94, 100% Pt stable and released from vaccination site w/ mother and father
Itching all over, swelling and bruising at vaccine site, 1 day later small hives over body with itching. Call her Doctor, advised BENADRYL.
Information has been received from a health professional concerning an 18 year old female who was reported as having been vaccinated on 14-Mar-2006 with Gardasil (Lot #654389/0961F).  The patient is reported as having received her second dose of Gardasil on 04-Oct-2006.  Concomitant therapy included drospirenone (+) ethinyl estradiol (Yasmin).  On 04-Oct-2006 the patient experienced pain during administration.  The patient was given an ice pack to apply to the area.  The patient refused to come back for the third dose.  Subsequently, the patient recovered from the pain during administration on the same day.  This is one of several reports received from the same source.  Additional information has been requested.
Pt Received Pneumococcal-23 in (L) leg on 8-13-18--8-14-18 had redness and swollen to site; called PCP on 8-15-18-marked site with marker; gave BENADRYL-got bigger advised urgent care--they did nothing; high fever/vomiting/back at PCP office-admitted for (L) leg cellulitis and dehydration.
Information has been received from a Doctor of Pharmacy concerning his 17 year old daughter who on 25-APR-2007 was vaccinated with 0.5 mL second dose of Gardasil. There was no concomitant medication. Shortly after administration of the dose, the patient experienced swelling and pain at the injection site. The swelling had gone down, but there was still a nodule present at the injection site that was painful when pressure was applied to it. No form of treatment was used to help with the symptoms. At the time of this report, the patient was recovering. Additional information has been requested.
Asthma--xopenex, buedsonide, orapred, flovent, we had 4 doses of pneumo vaccine--exacerbation of RAD after each shot.
Shortly after receiving her COVID shot, began to complain of dizziness.  VSS: 97% 83 HR, BP: 150/90.  She complained of itchness, throat.  She teach art at.  She began to feel better after 30 minutes and left to go home.  Contact information was given to text if further problems and to notify of safe return home.  VS at time of discharge BP=130/80, HR 71, O2 sat=98%.
Received a KINRIX in left arm on 11/18/09. On 11/21/09 mom brought pt by the clinic. Arm with redness and swelling from top of shoulder to elbow, very warm to touch and bruised at injection site. Dr prescribed BACTRIM 1tsp bid x10 days.
This case was reported by a other health professional via call center representative and described the occurrence of chills in a 65-year-old male patient who received SHINGRIX (batch number HG4P3, expiry date 30th April 2019) for prophylaxis. On 18th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In June 2018, 3 days after receiving SHINGRIX, the patient experienced chills. On an unknown date, the patient experienced cold and feeling irritated. On an unknown date, the outcome of the chills and cold were unchanged and the outcome of the feeling irritated was unknown. The reporter considered the chills and cold to be related to SHINGRIX. It was unknown if the reporter considered the feeling irritated to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX on left deltoid. The patient experienced chills and shivering approximately three days after receiving the vaccine. On 6th June 2018, the physician conducted lab work to determine the cause of these symptoms and the results were all negative. The patient was still experiencing these symptoms and had started recently to feel cold (latency was less than a year) even though it was hot outside. The consumer was annoyed and irritated (latency was less than a year) that he was still having these symptoms. The information was transferred to MI.
fever, rash and swollen around the shot area, dizziness, fast heart beat a few minutes after receiving the second shot.
Father stated pt had H1N1 yesterday. Fever started last night up to 102 taken by tympanic. TYLENOL was given. Pt also had fever this morning. Received TYLENOL at that time. At 0300 father stated pt seemed to have a "fast heart rate" and is congested. Stated pt had no signs of congestion prior to vaccination. Father was aware it was possible for fever to occur with the vaccine according to the vaccine information sheet. Father stated he understands but in the past the fevers the pt has had from vaccines had never exceeded 101 degrees. Father was informed to bring pt in. Stated understanding. Mother called this morning 7/2/10 at approximately 0830 stating "I don't think my husband gave all of the details that happened after he got the shot". Pt had rapid heart rate lasting five hours along with deep respirations from 2300 to 0430 on the evening of June 30, 2010. Pt was monitored by mother throughout this time. Mother stated she can hear him taking the deep breaths stating, "it's like he's not getting enough air". She states he has had rapid heart rate but "not this bad".
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On an unknown date a couple of years ago the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose and route unspecified) and patient developed anaphylactic reaction due to neomycin allergy. The patient might have been hospitalized for this reaction, but it's unspecified whether she was admitted or stayed overnight. Patient sought medical attention. It was reported the event was improved. Additional information has been requested.