chrisvoncsefalvay/vaers-outcomes huggingface dataset:
drooping of her face; swelling on her face; under her eyes it was sticky and hot/some areas on her face feel hot; under her eyes it was sticky and hot/some areas on her face feel hot; This is a spontaneous report from a non-contactable consumer. An 85-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8727), dose 2 via an unspecified route of administration, administered in Arm Left on 24Mar2021 14:15 (at the age of 85years) as single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 on 03Mar2021 in the left arm (unspecified route) for Covid-19 immunization. The patient's medical history was reported as none. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient had the second dose on Wednesday (24Mar2021) and four days later (as reported) (on 28Mar2021) she has swelling on her face and drooping of her face on the left side. It was further reported that it seems to be getting better today (31Mar2021); the drooping is almost all gone but some areas on her face feel hot; under her eyes it was sticky and hot. The reported asked if it was normal, or should the patient see the doctor. The patient was given Tylenol and she seems better. The outcome of events was recovering.  Follow-up attempts are completed. No further information is expected.
Initial report received on Nov 1 2005 from a health care professional. A 17 year old female patient with a medical history of chronic pain, reflex sympathetic dystrophy and seasonal allergies developed paralysis in right arm Sept 22 2005, I.E. the day after the intramuscular influenza vaccine (Fluzone SV 2005-2006) lot # U1772AA, administration. The patient had the ongoing reflex sympathetic dystrophy at the time of the vaccination. On Oct 4 2005, had an MRI for the persistent paralysis. On Oct 21 2005, the consulting neurologist diagnosed the Parsonage turner syndrome. It was reported that, on Oct 27 2005, she was hospitalized due to total body paralysis from the neck to downwards but had some movements. The patient was not recovered at the time of this report.
Although this was the first dose for my parents (aged 88 and 90) and I, our reactions were more along the line of what we have heard follows the second dose.  All three of us had fever, fatigue, headache, nausea, etc.  My mother threw up several times, and my father had diarrhea for three days, nearly becoming dehydrated.  I report this only because we suspected we had Corona Virus in January, but I wasn't able to get my parents to the clinic to be tested.  We have been told since having the vaccine that, if you had COVID-19 recently, you will react to the first shot more along the lines of what others feel after the second shot.  I don't know it this is true, but thought it is the type of data the CDC would want to track.
2 year old patient was administered quadracel with no reported adverse event; Initial information received on 09-Dec-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 2-year-old male patient who was administered diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis B Vaccine and influenza vaccine (Influenza) for prophylactic vaccination (Immunisation).  On 28-Nov-2022, the patient received dose 1 of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine at a dose of 0.5 ml once (lot C5970AA, expiry date: 02-Feb-2024) via intramuscular route in the left thigh for immunization.  On 28-Nov-2022, 2-year-old patient was administered quadracel with no reported adverse event (product administered to patient of inappropriate age, latency: same day).  Action taken: Not applicable.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient's mother called and stated that the patient had a very hot, hard and red arm on left side, between shoulder and elbow some puss coming out. Patient was going to the doctor for treatment.
Discharge Provider: MD, MPH Primary Care Provider:  MD Admission Date: 7/3/2022 Discharge Date: Jul 5, 2022  PRESENTING PROBLEM: ARF (acute renal failure)  Diarrhea, unspecified type COVID    HOSPITAL COURSE: Patient is a 81 y.o. female who presents today with fatigue and diarrhea. pmh copd,htn,pad presenting with co extreme fatigue and generalized weakness. States onset loose stools one week ago . Since that time has been having 2-3 loose not watery stools per day . Initially taking stool softer now stopped . Tested positive for covid 4 days ago and now today completed course of Paxlovid today . No co abdominal  Pain , no blood in stool or black stools . Denies fever or chills . She has continued to take medications including cozaar. Co progressive generalized weakness and fatigue. Able to stand and walk short distances . Denies focal weakness , no paraesthesias. Note mild non productive cough . Feels oral intake has declined due to decreased mobility though appetite at baseline . No loss of taste or smell. Feels breathing and her copd are at baseline . Denies dysuria.    In ed vitals stable , afebrile , bp was elevated to 240/77 . Given iv hydralazine and ativan with improvement. Per patient she is highly anxious in hospital and not uncommon for her. Labs showing sodium 125.k 3.0,creat 1.65 , nml wbc of 7.47. ua with no infectious findings, tested pos for covid 19. Given x2 liter fluid bolus,zofran , 40 meq kcl  Patient symptoms of weakness, shortness of breath are improved by day 2 of admission.  Does feel good to ambulate on her own, agreeable to the plan per home with outpatient follow-up.
Red rash at vaccine site, itching. Approx 4cm x 8cm. Itching. Presented 1/30/21 (8 days post injection)
Injection site redness, swelling, itchiness, warmth day 8 post vaccination.  immediate improvement after taking a zyrtec with near resolution 24hrs after.
Rabies vaccine #2 of possible 3 - had itching all over body w/ rash, swollen lymph node to left side of neck.
12 hours post vaccine I started with  nausea/vomiting.  A migraine headache developed which continued  along with general ill feeling.  Migraine was very strong (I have a history of migraines and the only relief was sumatriptain).  Ice packs and cold wet cloth only provided minimal relief.  In the early morning hours all my muscles started quivering similar to the chills but I didn't FEEL cold.  The quivering lasted for 2.5 hours and then stopped.  After that all my muscles hurt like I'd exercised too hard.  All symptoms lasted about 36 hours and then went away.
Starting the evening of Sat. 9/24 and continuing into late night Sun. 9/25, I had the following symptoms: fever (100.8 after taking Tylenol then ibuprofen), extreme fatigue, no appetite, headaches that wouldn?t resolve, generalized dull ache, but the worst was the nausea and vomiting. I was unable keep any food, water or medications down., I can?t say for certain whether it was strong immune response to the bivalent, or if I happened to have a virus that I wasn?t aware of at the time of the vaccine. I had no symptoms of illness when I got it. But the timing made me wonder about the bivalent. I did have a moderate reaction to Moderna dose 2 and a milder version of that with the Moderna booster. When I awoke early Monday morning 9/26, I was 100% better and able to go to work.
24  hours after receiving  vaccination patient became light headed, clammy, pale, and "felt weird". Small possible hive rash on same arm as vaccination administered. Observation and PO fluids.
This case was reported by a physician and described the occurrence of hives in an infant male subject who was vaccinated with KINRIX, (GlaxoSmithKline). On an unspecified date in July 2013 the subject received unspecified dose of KINRIX (unknown) and experienced inappropriate age at vaccine administration. In July 2013, a couple of hours after vaccination with KINRIX, the subject experienced hives. The hives resolved three days after administration with KINRIX. At the time of reporting limited information was provided. KINRIX is indicated in children 4 through 6 years of age.
Patient was given 0.5ml for booster (3rd dosage) instead of 0.25ml, no symptoms of adverse reaction experienced by patient. Called and spoke with patient on 1/18/2022 and patient states just soreness on arm same as the first 2 dosage and letter sent to patient also.
Received influenza vaccine in left deltoid Oct 10. In the six weeks since I've developed pain in left arm radiating from shoulder to elbow and began having periodic burning pain, left subscapular, approx 2 days ago. Started MEDROL pack today (Nov 17),
My shoulder was sore for the first day or two after the vaccine, which seemed normal. But instead of getting better, it got worse. It wasn't exactly at the site of the injection, but higher and closer to my neck. It became painful to lift my shoulder to my desk to type. On April 15, my shoulder was hurting a lot and my fingers became numb during the day. It was significant enough that I went to an urgent care facility . The NP I saw indicated the thought that the inflammation in my shoulder was compressing on the nerves, leading to the numbness I felt and by then had spread up most of my arm. I also indicated that moving my arm was painful. She instructed me to take ibuprofen, 600 mg, 2x per day and see if that helped. I did that for about 2 weeks, but that much ibuprofen in my system actually caused me issues and I had to stop taking it.  My shoulder becomes tired and sore, making it nearly impossible to function on a daily basis. It causes immense pain and OTC pain medications do not provide relief. I have used heat and cold, which provide temporary relief at night, but by about 1 or 2 p.m. each day I am in immense pain. Using the shoulder to type at a desk or sitting in my car with the arm pushed forward accelerate the pain each day.
Red on 4/15/08-on 4/17/08 Developed redness increasing to pain and neck across to chest- Seen in ED- gave steroid and anti-inflammatory
About 2 hours after receiving the vaccine my muscles started to hurt and joints. I got a headache that started in my neck. I got a very red face and started with a low-grade fever. I feel uncomfortable in my own skin (like it hurts). My glands feel swollen. My arm is in a lot of pain (cannot sleep on that side). The pain started about 12 hours after injection and has traveled up into my shoulder and down my arm.
Patient receive a dose of HPV4 on 10/26/12 and he was fine. He received HPV9 for his 2nd dose along with Peds/Adol Hep A 2nd dose. He has received a dose of Peds/Adol before on 10/26/12 and was fine. Patient has really bad blisters that are raised located inside and outside of his mouth. They are weeping and red. Patient states that they are painful. He also has these blisters located on his penis, soles of his feet, injection site of HPV9 vaccine and his hands. Patient did go to the Emergency Department because his condition got worse and mom was very concerned.
Raised red mark on arm, extreme shoulder pain, muscle soreness, arm soreness, neck soreness, nausea.
Mother says child developed a rash and started swelling (face and neck). Itching, but no SOB. Took to ER the next day and treated for allergic reaction.
Information has been received from the authors of a published literature article, titled as stated above, regarding a male patient of unknown age.  The patient's current condition included eczema, microthrombocytopenia and presumed wiskott-aldrich syndrome.   On an unknown date, the patient was vaccinated with bcg live (manufacturer unknown) (route and dosage information was unknown) as prophyaxis.  The patient developed bacille CalmetteGuérin lymphadenitis.    The outcome of lymphadenitis was unknown; however it was reported that the patient deceased at 7-year-old (unspecified cause of death).  The authors considered lymphadenitis to be related to bcg live (manufacturer unknown).   A copy of the published article is attached as further documentation of the patient's experience  This is one of two reports from the same literature article (2206USA006251)
NO MENSTRUAL CYCLE SINCE VACCINATION, LOSS OF BLADDER CONTROL AND JOINT PAIN.
No additional AE details provided.; Improperly stored PROQUAD administered vaccine; This spontaneous report was received from a nurse, referring to a patient of unknown age and unknown gender. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.     On 30-JUL-2021, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (Albumin status: rHA, lot # T021301,expiration date was reported and validated as 19-DEC-2021(also reported as 23-FEB-2022, conflicting information); dose, strength, route were not provided) for prophylaxis (product storage error). Temperature/Time frame: 9.6 degree Celsius for 80 minutes. There was no previous temperature excursion. No additional adverse event details provided.
both shoulders inflamed to the extent that I could not move, right hip inflamed to the point I could hardly walk, both calves burning
This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach ache), DIARRHEA (Diarrhea), DIZZINESS (Some dizziness) and VOMITING (Vomiting) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. Medical history was not provided. Concomitant products included METFORMIN and GLYBURIDE for an unknown indication. On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach ache), DIARRHOEA (Diarrhea), DIZZINESS (Some dizziness) and VOMITING (Vomiting). On 13-May-2021, ABDOMINAL PAIN UPPER (Stomach ache), DIARRHOEA (Diarrhea), DIZZINESS (Some dizziness) and VOMITING (Vomiting) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided.
PATIENT REPORTED CHILLS AND POSSIBLE FEVER (DID NOT MEASURE TEMPERATURE). PATIENT ALSO REPORTED LOSS OF TIME, FELT OUT OF IT, STOMACH ISSUES AND RASH ON LEFT ARM.
died from COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (died from COVID) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced COVID-19 (died from COVID) (seriousness criterion death). The patient died in September 2021. The reported cause of death was died from covid. It is unknown if an autopsy was performed.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.  Company comment: This case concerns a 48-year-old, female patient with no relevant medical history reported, who experienced the unexpected event of COVID-19. The event occurred approximately on an unknown number of days after an unknown number of doses of mRNA-1273 and had a fatal outcome, with death occurring on an unknown date of September. No autopsy report was provided. The rechallenge was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 48-year-old, female patient with no relevant medical history reported, who experienced the unexpected event of COVID-19. The event occurred approximately on an unknown number of days after an unknown number of doses of mRNA-1273 and had a fatal outcome, with death occurring on an unknown date of September. No autopsy report was provided. The rechallenge was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: died from COVID
had a stroke; This is a spontaneous report received from a Pfizer sponsored program reported by a non-contactable female consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient had a stroke on an unspecified date. The reporter stated that today was her second dose but she just recently had a stroke, and she had been home for one day. The outcome of the event was reported as unknown.  No follow-up attempts are possible. Information about lot/ batch no cannot be requested.
I have acute ringing in my ears - much louder than before the shot. I have not been seeking treatment as I am hoping it's like when I've taken Pepto Bismal and I get ringing in my ears that it will eventually subside. However, from what I have read, people are not getting relief.  I am not looking forward to my 2nd dose in fear of it getting worse or adding dizziness to the equation.
inj given 5PM & 10PM pt woke up screaming, t105 ax, no temp med given;taken to hosp ER-in ER t102.7;lips turned blue then pt went limp;eyes red & puffy approx 30min;alert in ER;
Employee received 2nd dose Moderna lot 042L20A in left arm on 1-28-2021.  A round red swollen spot appeared at insertion site that is warm and harder than surrounding skin.
Migraine headaches within a week of the vaccine and they have been chronic ever since. Have never had one before this.
Mild vision changes, "hazy" vision, resulting in repeat visits to ophthalmologist office.  Decreased hearing, persistent fullness in ears.  Occasional dysphagia.  All symptoms persist, mild but persist.  No benefit with adjustment in glasses prescription or trials of allergy meds.
Local reaction inj. site - raised erythematous lesion 10 x 11 cm.
presented to the emergency department on 7/27/21 with chief complaint of malaise, shortness of breath and cough. During his hospital course, he was found to be COVID-19 positive (was previously immunized). CXR supported diagnosis, showing hazy, bilateral airspace opacities. He was also found to have decreased renal function.
stopped breathing; anxiety; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team.  A 68-year-old female patient received BNT162b2 (BNT162B2), as dose 1, 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: RESPIRATORY ARREST (medically significant), outcome "unknown", described as "stopped breathing"; ANXIETY (non-serious), outcome "unknown". The events "stopped breathing" and "anxiety" required physician office visit. Therapeutic measures were taken as a result of respiratory arrest. Clinical course: The consumer stated that he and his wife got their first dose of the Pfizer Covid 19 vaccine back on 17Jul to 21Jul (no year provided), when his wife stopped breathing. His wife has been on oxygen and has had anxiety ever since. Because of this his wife has not been able to get out of the house and that they had an upcoming doctor's appointment soon for her condition.     The information on the batch/lot number for (BNT162B2), has been requested and will be submitted if and when received.
rash and itching  all over the body  she said she had pain in the arm but was resolved in 2 days she was prescribed prednisone 10 mg today.
mild left arm soreness for 1 day, mild headache at 24 hrs post vaccine, alleviated with Ibuprofen; mild left arm soreness for 1 day, mild headache at 24 hrs post vaccine, alleviated with Ibuprofen; This is a spontaneous report from a contactable healthcare professional. A 26-year-old female patient started received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730, expiry date not reported), intramuscular on the left arm on 23Dec2020 09:45 at a single dose for COVID-19 immunisation. Medical history included autoimmune thyroiditis. Concomitant medication included levothyroxine sodium (SYNTHROID). On 23Dec2020 at 11:00, the patient experienced mild left arm soreness for 1 day, mild headache at 24 hrs post vaccine, alleviated with ibuprofen. Clinical outcome of the events was recovered on an unspecified date in Dec2020.  No follow-up attempts are possible. No further information is expected.
Localized swelling at inj. site. 10 cm area of swelling, redness & slight induration. No proximal streaking, no fever. Rx BENADRYL 1-2 tsp q. 6 hrs. cool compress.
Patient reports developing a productive cough just after initial injection of Moderna vaccine on 03/23/2021. Since then, dry daily cough, worse in the evening with a mild change in voice, no other sx.
Information has been received from a physician who was vaccinated with a dose of ZOSTAVAX vaccine (Merck). Two weeks later after receiving the ZOSTAVAX vaccine (Merck) the patient developed chickenpox. the patient sought unspecified medical attention. At the time of this report the patient had recovered. Additional information has been received.
Child was given Rotavirus vaccine 105 days after the maximum allowed age - uncertain if any effects will occur. None to date.
I have been having break through vaginal bleeding with cramping since I received the vaccine. These symptoms have continued on and off since I received my second dose. This is very distinct  from any previous menstrual cycle bleeding and has continued for about 8 months now.
Patient experienced vasovagal syncope after being injected with the 4th vaccine which was MMR II.  Patient lost consciousness for about 5 seconds. Patient remained seated with family member until he was feeling well again. Patient left pharmacy with father.
I was sick for three days from October 1st through October 3rd 2021.  I got better then sick again October 8th.  Went to the hospital on October 10th, 2021.  I had bleeding bruised redness and swelling in the vaccination right arm, fever, flu symptom, large lump under where vaccination was given. Right arm was bleeding under the skin, I did bleed a little after vaccination.  Hospital diagnosed my condition as Low Anemia, my Ferritin was 8 that caused me to have Low Hemoglobin of 6. I had blood transfusion, internal bleeding with black stool. I am still experiencing very low hemoglobin.
Body aches, 800mgs of Ibuprofen every 6hrs, lasted approx 2 days.
Initial misuse report received from a nurse on 01 October 2013. The patient had received FLUZONE, ADACEL and IPOL vaccine on 01 October 2013 and temperature was 30 F each day when they thought this temperature was the storage temperature. The patient was given unstable vaccine. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.