chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have been taking birth control for over 2 years, in that time my menstrual cycle has lessened to practically nothing.  For the past almost year during the inactive pill week I at most would spot a day or two, never enough to even get on a maxi pad, just a little blood when I go to the bathroom and wipe.  My menstrual cycle began on 11/16, earlier than normally would and it was very heavy for four days, then continued light for another 4 days, and I have continued to spot everyday since, which I have NEVER done before in my life while on birth control.
Local area of shot, sensitive to touch, swelling 3" around site. A knot beneath the skin is 1" around and still exists as of 3/6/2000. Extreme itching and soreness and "rash like" around site. Knot beneath skin still exists.
Could not lift left arm. Dr. referred him to Dr. Did X-ray, MRI, and Cat Scan x-ray date? MRI -      11/20/2017 CT Scan 11/27/2017  (See additional Page listing)
EDEMA Narrative:  Note: pt does have history of anaphylactic allergy to eggs which is relevant to him receiving the flu vaccine
hearing loss (couple of months later); bump at injection site; soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (hearing loss (couple of months later)) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Alzheimer's disease.    On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE MASS (bump at injection site) and VACCINATION SITE PAIN (soreness at injection site). On an unknown date, the patient experienced DEAFNESS (hearing loss (couple of months later)) (seriousness criterion medically significant). At the time of the report, DEAFNESS (hearing loss (couple of months later)) outcome was unknown and VACCINATION SITE MASS (bump at injection site) and VACCINATION SITE PAIN (soreness at injection site) had resolved.            Concomitant products were not provided. Patient reported that her husband received his second Moderna vaccine on 11-Mar-2021.  Initially, he had a bump and soreness at the injection site that went away. Then, a couple of months later, he developed hearing loss. Patient's husband also suffers from Alzheimer's.  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. However, regarding the event of deafness, very limited information regarding this event has been provided at this time. Further information has been requested.; 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. However, regarding the event of deafness, very limited information regarding this event has been provided at this time. Further information has been requested.
Erythema, swelling, rash at injection site, low grade fever, fatigue, neck pain and stiffness, headache, sleeping more than 12hrs a day.  Seen by MD on 8/28/13, prescribed Benadryl p.o.
shingles vaccine. Shortly after she got the shot broke out with a bad case of shingles / Suspected vaccination failure; bad case of shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The patient was reporter's sister-in-law. The age at vaccination was not reported. Shortly after the patient got the shingles shot, she broke out with a bad case of shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
L arm pain, neck pain, shoulder and L back pain. 1st episode was Sunday evening around 8 PM. Unable to lift arm very painful for 20 mins. 2nd episode Tuesday 1 or 2 AM same pain not as hard but couldn't lift arm. Called on call Dr. was told to see PCP.
patient has experienced three episodes of bloody nose and one of prolonged bleeding gum (after tooth loss) in the week since receiving the vaccine (not previously experienced these issues before)
Patient received 4 immunizations today and then on the way out of the building per the patient's mom, she passed out in the elevator and then again when she got back out of the elevator. Found patient on the floor. She was breathing, alert and oriented; color pale. Pt said she hadn't eaten anything prior to the appointment. Patient's mom not sure if she hit her head, reported no pain. Patient then wheeled back to exam room. VS - B/P 96/72, P64, given crackers and juice and examined by physician.
Pt recv vax on 3/30/99; on same day pt exp shortness of breath
Hive like rash on elbows and knees.  Began 9 days after injection on elbows.  Raised and itchy.  10th day had spread to both knees and some finger joints.
Information has been received from a physician concerning a 7 year old patient with "no unusual medical history" who on 12-NOV-2003 was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck). On 11-MAY-2007, the patient was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (Lot # 656173/1499F). On 13-MAY-2007 (two days after receiving second dose of vaccine), the patient experienced wheezing and shortness of breath. The patient was treat with epinephrine and nebulizer. It was reported that the patient "responded well," but the outcome was not reported. No further information is available.
Pt recvd 1 dose of Engerix-B about 15JUL92 & 1 wk post inject exp pain & stiffness in the arms, hands, legs & joints, worsening back problems (torn ligaments), myalgia, arthralgia & vomiting (4 times); hospitalized; unable to bear wt on leg
2-3 WEEKs after receiving vaccine...pain in right foot (rheumatoid arthritis)  sore and weak all over, tired-lethargic  on 3/19- woke up, sat at edge of bed to text daughter, got up walking to bathroom, got dizzy and collapsed = passed out.  Got up and again collapsed passed out =don't remember it happening .... Went to ER for fall and analysis as to what , why, etc.   I would be having this acute autoimmune reaction... blood work etc. you can contact the LWRM  and Dr for details.
After receiving 1st vaccine series (04-29-08) at age 3 mo x 3 day infant lethargic. Poor or no neck control, improved by 3rd days. No further problem without these signs and symptoms.
dizzy; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy) and HEADACHE (headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizzy) and HEADACHE (headache). At the time of the report, DIZZINESS (dizzy) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Client received 1st yellow fever vaccination on 5/22/08 --Vaccine had been reconstituted for greater than 1 hour.  Client was brought back in on 5/28/08 and revaccinated with Yellow Fever vaccine.
My son started throwing up the day following his immunizations on 11/17/00. He kept throwing up for 3 days so took him to ER. They couldn't do anything because he wasn't dehydrated. He threw up every day after the shots. Took him back to ER on 11/26/00. Took blood test and urine test and couldn't find anything. He kept throwing up. Took him to his MD on 12/7/00 and he prescribed Zyrtec and he kept getting worse. He was laying around and would not get out of bed all day. He wouldn't eat or drink. He still vomited. Finally took him to hospital on 12/9/00. They admitted him and have done a battery of tests on him and we are still waiting for results. They released him on 12/14/00 and he is still throwing up. One of the tests they did, showed his liver wasn't producing a protein called albumin or he was losing it somewhere in his body. Also they did a scope and his stomach was inflamed. It has been over a month now that he began vomiting and I still don't know what's causing this. When I took him to get his shots, he was a healthy 4 year old boy and why was he given 5 shots at one time? I didn't want him to have the varicella or the Prevnar at the time I took him to get his shots but while I was holding him she gave it to him anyway. (And how did that happen?) I was holding him and trying to watch my 16 month old little girl at the same time.  60 day follow-up states the pt continues to throw up.
The evening of my first dose of the Pfizer Covid Vaccine a terrible case of tinitus (ringing in both ears) ensued. It hasn't stopped since and it's been two years.
A 26 year old female was bitten by a cat (unknown if animal is rabid or not). The patient worked in a vet clinic and had received pre-exposure prophylaxis, thus fell into the category of previously immunized person and was to receive 2 doses of RabAvert IM 3 days apart. The patient received first dose on 9/13/02 and got sick 3 days later. Based on symptoms (fever of 102.8, and flank pain) and urinalysis: (cloudy urine) 1+ nitrate, 2+ leukocyte and 2+ blood), the patient was diagnosed with pyelonephritis. The patient was admitted to the hospital and subsequently treated with appropriate antibiotics. MD did not think that this is related to RabAvert. no significant medical history, and unknown concurrent meds.
O.5ml Fluzone in prefilled syringe was administered to an infant. Packaging and labeling look alike.
Initial unsolicited report received from a pharmacist on 17 Oct 2016. This case involves a female patient (age and date of birth not reported) who was vaccinated with a dose of Fluzone high dose (batch number: UI666AB, expiration date: 13 Apr 2017, route, dose not reported) and dose of Pneumovax 23 (batch number: L035686, expiration date: 16 Feb 2017, route, dose not reported) in the arm on 07 Oct 2016. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) and concomitant medications were not provided. On 07 Oct 2016, same day post vaccination; the patient experienced soreness and a red area on upper arm in the area of the injections. It was reported that the red area was increased in size (until 10 Oct 2016) and extending from the injection sites down to elbow. Lab data and corrective treatment was not reported. On an unspecified date, the patient was recovered from the event soreness. Outcome of other events was not reported. List of documents held by sender: none.
Pt returns to office 08/05/04 with erythema, swelling and warmth to right arm. Advised Benadryl as needed. 08/06/04: Re-checked, erythema, swelling resolving.
Received vaccine Fluzone 10/13/2005 at 12pm. Symptoms started at 3:30pm. Reported nasal congestion, over production of sputum, conjunctivitis, Shortness of breath.
Received the vaccine at 9:30 am. Originally felt fine with mild soreness in the arm.  Woke up around 2:15 am to use the restroom, and got extremely dizzy... started to feel weird, and felt like there was a rush all over.  My head started to feel like it was closing in and there was a static, crackling, speaker-like sound along with tinnitus in my ears making it feel like I was in a tunnel.  I sat on the floor and waited several minutes until the feeling passed and was able to get back into bed.  I waited several more minutes until I felt "normal" again. Was able to get back to sleep, and feel better this morning, with no dizziness, but will continue to monitor any additional symptoms closely.
Localized swelling, pain, sensitivity & itching at injection site starting a week post vaccine. No rash or changes in skin texture, but very itchy!
patient woke up the next day to soreness and weakness/heaviness in the arm,  swelling and redness at the injection site, intense itching all over the body and some hives
Information has been received from a physician referring to 14 anonymous patients of unknown age and gender. Patients' concurrent conditions, concomitant medication and medical history were not provided. On unknown dates between 12-APR-2015 and 30-JUN-2015, the 14 patients were vaccinated with expired GARDASIL (lot # H016238, expiry date 11-APR-2015, dose and route were not provided). The physician reported that the GARDASIL had previous temperature excursions on unknown dates and was unable to provide the excursion details at this time. No adverse symptoms were reported. The physician called back on 09-JUL-2015 and provided the names of 14 patients administered improperly stored and expired doses of GARDASIL. Physician did not specify what dose in the GARDASIL series was administered to each patient. One of the patients was administered the vaccine on 02-APR-2015 (improperly stored only) and 23-JUN-2015. This is one of several reports received from the same reporter. Additional information has been requested.
First, very strong muscle pain. 99.8 F on October 8. Fatigue and Muscle pain. Much worse than before quitting CRESTOR, especially the fatigue. Especially mornings.
2021/09/15 Time:1800 approximately(seen at medical clinic on base on 2021/09/20) -severe body aches -fatigue   2021/09/17 Time:0800 approximately(seen at medical clinic on base on 2021/09/20) -left arm numb  2021/09/19 Time:1100 approximately(seen at medical clinic on base on 2021/09/20, referred to urologist off base/appointment scheduled 2021/10/22) -painful ejaculation and hard gelatin like substances in sperm -left arm numb Time:2200 approximately  2021/09/21 Time:1630 approximately(ER visit off base, referred to cardiologist/no appointment made at this time) -fluttering heart/sharp pain felt in heart  2021/09/22 Time:0700 approximately -sharp pain felt in heart
Permanent hearing loss, severe fatigue. Went to ENT diagnosed with tinnitus 75% loss of hearing. Audiology test was done.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN (hurts under left arm pit), LYMPHADENOPATHY (swollen lymph nodes under left arm pit) and HEADACHE (headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. No medical history was reported. Concomitant products included INFLIXIMAB (REMICADE), PRAVASTATIN, PREDNISONE, COLECALCIFEROL (VIT D [COLECALCIFEROL]), AMLODIPINE, LEFLUNOMIDE, FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), LISINOPRIL, FOLIC ACID and MONTELUKAST. On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 09-Mar-2021, the patient experienced PAIN (hurts under left arm pit), LYMPHADENOPATHY (swollen lymph nodes under left arm pit) and HEADACHE (headache). At the time of the report, PAIN (hurts under left arm pit), LYMPHADENOPATHY (swollen lymph nodes under left arm pit) and HEADACHE (headache) outcome was unknown. CONCOMITANT MEICATION INCLUDES :allergy pills, latanopril. No treatment medication was reported.
On 04/09/2021 patient received her first CoViD-19 vaccine, a single dose of JANSSEN SARS-COV-2 COVID-19 VACCINE. On 11/19/2021 patient received her "booster" CoViD-19 vaccine, a single dose of MODERNA SARS-COV-2 COVID-19 VACCINE 0.5ML. Around Thanksgiving, 11/25/21, patient began feeling slightly short of breath, worse with exertion. Had done some travelling to see family, approximately 4 hour plane flight. Over the next 6 weeks, symptoms gradually worsening. Was seen at another ED (not mine) and was reportedly hypoxemic, but no chest x-ray or CT performed. Arrived to my ED on 12/18/21 with severe dyspnea, back pain, nausea, fever, found to be hypoxemic, and CTA chest showed saddle pulmonary embolism and extensive clot burden with multiple segmental and subsegmental PE bilaterally with signs of cor pulmonale.  Admitted for anticoagulation, currently on our step down unit transitioning to warfarin.
flu; Initial information was received on 14-Oct-2020 regarding an unsolicited non-valid non-serious case from a consumer/non-health care professional via social media.   This case is linked to case 2020SA293954 and 2020SA293953.  This case involves a female patient (age unspecified) who got the flu at the same time and it lasted 2 1/2 days (Influenza), while she received INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got the flu at the same time and it lasted 2 1/2 days (influenza) (unknown latency, non-serious) following the administration of INFLUENZA VACCINE.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome was recovered from flu.  There will be no information available on the lot number for this case.
No additional AE's; ROTATEQ that underwent a temperature excrusion was administered to one patient; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not provided.  On 07-APR-2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1660995, expiration date 01-MAY-2021) orally for prophylaxis (strength, dose and vaccination schedule were not provided); The reporter stated that the vaccines had a temperature excursion of 10 degree Celsius for 1 hour, which was detected by a data logger and the vaccines had no previous temperature excrusions. No additional adverse event was reported.
Client waited 15 mins in obs post vaccination and developed itching and rash to vaccinated arm (right arm), staff and MD notified, benadryl 50 mg IM given x 1 to left arm. Client felt better and signed out medical release at 11:00 AM.
Pt developed fever (99.5), sore throat, chills, cough, loss of taste and smell, headache, fatigue, shortness of breath and chest pain on 09/08/2021.
Information has been received from a physician concerning a 10 year old female with no medical history or allergies, who on 07-MAR-2008 was vaccinated with a booster dose of varicella virus vaccine live (Oka/Merck) (lot# 659430/1587U). There was no concomitant medication. On 09-MAR-2008, the patient developed a large erythematous area approximately 4X4 inches that had a vesicle in the middle. It was reported that there were no other symptoms. It was also reported that the patient went to the office. No diagnostic laboratory studies were performed. The patient's large erythematous area persisted. No product quality was involved. Additional information has been requested.
Feeling hot and Shivering  10 mins after vaccination , along with a headache. Denies SOB, CP, Dyspnea . Refused transport VS 149/86, 81 O2 sat 100% at RA
I first noticed a fever on the night of April 20th 2022. I had a positive covid home test on the morning of the 21st. I had fever, fatigue, and a slight cough. That afternoon my fever got up to 102.5. I continued to have a fever through the 22nd but not as high. I continued to experience fatigue and slept a lot but conditions were getting better. By Saturday night (72 hours later), my symptoms were basically gone. I did a televisit with my doctor on 22nd who suggested Paxlovid, but due to my pre existing health conditions we decided against it.
Patient presented to doctor's office with a red, heated area beneath the injection site on her upper left arm.  She stated that it began the day after the vaccine was administered, and she sought medical treatment 3 days after the vaccine was administered. The doctor that she visited decided to treat for potential cellulitis, and treated this with sulfamethoxazole/trimethoprim.
Patient stated she had second Pfizer on 5/28/21, and after 5 minutes her throat felt like it was tingling for a minute or two. She stated the next day she felt tired, achy and soreness at injection site. She stated she still feels tired, but not as much as on the weekend.
Had a pretty bad flare up on two places in the body (nose and groin) which resulted in an infected boil; Had a pretty bad flare up on two places in my body (nose and groin) which resulted in an infected boil; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 02Apr2021 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included gastroesophageal reflux disease (GERD) and hidradenitis suppurativa from an unknown date. Concomitant medication included vitamin D supplement (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received minocycline (MANUFACTURER UNKNOWN) on an unknown date and experienced possible mild drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient had a skin condition called hidradenitis suppurativa, which was thought to be auto-immune in nature and caused painful boils. The patient did not had a flare up in over a year before the vaccine. On 06Apr2021, in a week after the vaccine, the patient had a pretty bad flare up on two places in the body (nose and groin) which resulted in an infected boil which required oral antibiotics. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the reported events and included treatment with steroid injection (unspecified), oral antibiotics (unspecified) and topical cream (unspecified). The clinical outcome of the event had a pretty bad flare up on two places in the body (nose and groin) which resulted in an infected boil was recovering.  No follow-up attempts are needed. No further information is expected.