chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 17 month old patient who was vaccinated with MMR II (0.5ml, IM), and developed rash after immediately after vaccination. The patient was given BENADRYL and recovering. Additional information has been requested.
Information has been received from a physician concerning a female patient in her late teens (maybe 18 or so) who in approximately November 2009, "about one and half months ago" was vaccinated with a second dose of GARDASIL. In approximately November 2009, the patient experienced dizziness, became very pale and came close to fainting. This was a new experience for the office. They were planning to finish the series. It was unknown if the patient sought medical attention. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
localized reaction 4x5 cm-red, hot tender to touch; temp99.3 po; c/o general malaise, chills; rx heat & APAP, changed rx to Motrin;
The second dose of the Pfizer covid vaccine was given 16 days after the first dose, 1 day earlier than the recommended window.
Continued left arm shoulder muscle soreness. Continued tinnitus in both ears but loud and unbearable in left ear especially.
The pt was administered Prevnar to left thigh IM on 7/14/00. Mom came into office on 7/19/00 stating the pt started getting red at the  site on 7/15/00. On 7/17/00, the area was 5 x 2 1/2" and slightly red. No swelling was noted.
Patient was to receive HPV vaccine. The bottle that was available did not look like the usual vaccine that is given. Consult made with medical director of immunization and technician instructed by MD to give the immunization. It was discovered the next day that this was in fact HPV antibody reagent given to the patient. Patient was by the medical director and had no symptoms. Unable to contact manufacturer until the next business day. Manufacturer contacted and MSDS obtained. Poison Control Center contacted. Per Poison Control, no adverse effects are expected.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 28 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Cavernous hemangioma" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing); "Known allergies: Spinach" (unspecified if ongoing); "Known allergies: Avocado" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No other medication in 2 weeks. Patient was treated with Paxlovid from 25May2022 for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective / COVID-19 cannot be ruled out
Patient reported throat swelling (similar to her reactions with Shellfish and Hydroxyzine,  2 Benadryl 25mg were given. Vitals taken and were normal (Nurse reported possible arrhythmia and patient states she is already being seen by a cardiologist). After 30 minutes the patient reported some improvement in the throat area  but still a burning sensation. Patient said she felt a cool rush in her body.  The patient also reported anxiety (that she had prior to vaccination).  She refused EpiPen and was going to go to Urgent Care for further evaluation (A party that came with the patient is bringing her)
Starting about 16-18 hours after shot - fever 102+, nausea (couldn't eat) , headache, body sore all over (like flu), weak as a kitten.  Symptoms lasted for about 36-48hours.  Took 2 extra strength tylenol three time during period of reaction.
Since having my second shot I have felt severally nauseated constantly and cannot function due to debilitating nausea the nausea started the day after I got my second shot on April 13, 2021 taking Zofran has helped however it comes back as soon as the zofran wears off
Information has been received from a health professional through a pregnancy registry concerning a 32 year old healthy white female with a history of three prior miscarriages who on 6/21/04 was vaccinated with a dose of varicella virus vaccine live prior to a diagnosis of pregnancy. Concomitant medication included fluoxetine hydrochloride (PROZAC) (40mg daily) for depression and daily prenatal vitamins. On 7/12/04 the patient was diagnosed and was placed on progesterone (PROMETRIUM) (200mg TID vaginally) that day for previous SAB. On 7/15/04 a serum progesterone level was found to be 20.7 and the medication was discontinued. It was reported that the patient sought medical attention, but no treatment was required. No product quality complaint was involved. Follow up information has been received from a health professional who reported that the patient has had a total of 4 pregnancies including this one. She had 3 previous miscarriages; 1991 5-6 weeks, 2001 at 8 weeks and 2004 at 5-6 weeks. It was unknown when in 2004 the third miscarriage occurred. This pregnancy, her fourth, ended in a spontaneous abortion on 8/16/04. The patient has no living children. The LMP was 6/15/04 with an EDD of 3/22/05. The patient had a prenatal panel done on 7/27/04. Results were not reported. It was reported that there were no complications during the pregnancy. On 7/30/04 the patient had an ultrasound to confirm growth. It showed a small yolk, measured 5 weeks and 5 days and no flicker was seen. On 8/5/04 another ultrasound was done and revealed an abnormally shaped sac with no pulse seen. On 8/13/04 another ultrasound was done and there was still no fetal pulse seen. The nurse noted that there was gest sac but no viable fetal growth pole seen. The abortion date was 8/16/04, approximately 8 weeks from her LMP. No additional information was provided. Follow up 03/03/05: Patient has not recovered from the event.
I had the shot given 10-23-03 in the evening. Broke out in rash 10-25-03,itching was minimum other than under arms and scalp it like to have drove me crazy.I used Gold Bond Medicated Anti-itch Cream to help easy the itch,still itching some.But is beginning to clear up.I can't afford to go to doctor for just a rash.
Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 69-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6200), via an unspecified route of administration, administered in Arm Left on 20Feb2021 10:00 (at the time of vaccination 69-years-old) as single dose for covid-19 immunization. Facility type was Doctor's office/urgent care. The patient's medical history included, Ankylosing spondylitis (hlab27 positive) and patient had known allergies with Vicodin, oral prednisone and black-eyed peas. The patient's concomitant medication included levothyroxine sodium (SYNTHROID). Patient previously took first dose of BNT162B2 vaccine, for covid-19 immunization. On 21Feb2021 07:00, the patient experienced diarrhea. Patient visited to doctor or other healthcare professional office/clinic as result of diarrhea. Imodium and Pepto Bismal was taken as therapeutic measures as a result of diarrhea. Patient not diagnosed with covid prior vaccination. Patient did not covid tested post vaccination. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
18 hours after receiving the vaccine,  I had covid like symptoms. I was out of work for 2 weeks. I had a chronic headache and nauseas. At the end of April, we started having storms, and I felt like I was having a migraine headache crisis. This was the breaking point because I couldn't tolerate the pain anymore. I get injections for the nauseas and pain, but that was only good for 2 days. It feels like something is scrambling in my head. I have constant headaches, constant nausea, and constant fatigue. I'm currently under the care of a neurologist and my PCP.  I haven't been in work since April 2021. I cant really do much now.
Nausea; Chills; Itchy at injection site; Pain at the injection site; Swelling of injection site; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), CHILLS (Chills), VACCINATION SITE PRURITUS (Itchy at injection site), VACCINATION SITE PAIN (Pain at the injection site) and VACCINATION SITE SWELLING (Swelling of injection site) in a 45-year-old female patient who received mRNA-1273 for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. In April 2021, the patient experienced NAUSEA (Nausea), CHILLS (Chills), VACCINATION SITE PRURITUS (Itchy at injection site), VACCINATION SITE PAIN (Pain at the injection site) and VACCINATION SITE SWELLING (Swelling of injection site). At the time of the report, NAUSEA (Nausea), CHILLS (Chills), VACCINATION SITE PRURITUS (Itchy at injection site), VACCINATION SITE PAIN (Pain at the injection site) and VACCINATION SITE SWELLING (Swelling of injection site) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) was unknown.       Treatment information was not provided.  Concomitant medicine include, cholesterol pill.
pain from my arm up the shoulder to the head on back of my left ear and rash on my arm and around my neck.
No additional adverse events reported; The patient was administered GARDASIL 9 in a 2 dose regimen series; This spontaneous report was received from a office manager regarding a 22 year-old patient of unknown gender. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies, and concomitant therapies were not reported.   On 05-AGU-2019, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 2 dose regimen for prophylaxis (route of administration, lot number, and expiration date was not provided) (inappropriate schedule of product administration). No additional adverse events reported.
Patient presented asking for Moderna vaccination and stated it would be his first dose.  Vaccine was billed to medicare which paid with no issues. Pharmacy gave patient first Moderna dose. Afterwards, patient disclosed that he had received 2 doses of Pfizer vaccine previously.  Patient had no issue with vaccine.
Information has been received from a physician concerning a 62 year old patient who on an unspecified date was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (MSD). No symptoms have been reported. It was noted that this was due to human error and not product confusion. There was no product quality complaint involved. No further information was provided. Follow-up information received on 04-OCT-2007 via telephone: Medical assistant indicated no adverse effect occurred from administering varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck). She stated this event was the result of human error and was essentially a lack of communication. No further information is available.
This spontaneous report was received from a pharmacy technician and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients's concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # M034894, expiration date 11-NOV-2018 and lot # M037248, expiration date 21-FEB-2019 (dose, route and site of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion from 32 degrees Fahrenheit to 35 degrees Fahrenheit, for 33 hours. Data logger was involved. There were no previous excursions reported. Additional information has been requested.
Starting on 11/21/09 I had lower leg pain on the backs of my legs from my knees to my heels. Then pain on both my arms from my elbows to my shoulders. Then lower back pain until 11/23/09 pain quit about 7:00 AM then I developed severe diarrhea which lasted until 11/26/09 I lost 12 lbs in 4 days. I took IMMODIUM AD and drank lots of fluid I ate very little. Felt fine after 11/27/09.
pt recvd vax & had joint pain 3 days after vax; 7th day after inject pt had turned red all over; general erythemia over entire body; recheck on monday if not improved;
Patient received the 1 dose J&J vaccine on 3/25/2021. Patient reports on 3/27/2021 swelling and pain and redness in LLE. Of note, patient has a hx of PE (1995) and afib, and is not on a blood thinner per cardiologist. Patient presented to ED on 4/8/2021 and u/s r/u DVT. Patient contacted physician's office on 4/19/2021 with continuation of symptoms. Unsure if this is truly an ADE as patient reports the pain/swelling/redness occurred during a walk.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On an unknown date the patient was vaccinated with a dose of ROTATEQ 3 days after the expiration date (lot#, expiration date, dose, indication not reported). No adverse effect reported. Additional information has been requested.
I am an RN and was working a Covid 19 vaccine clinic for first responders. I took my own 1st administration of Moderna at approx 6:20 then went out to vaccinate/data entry. I noticed I was a little bit shaky and more jittery than normal but I attributed that to getting first vaccination clinic off the ground and problems we were having with computers and login. When I was leaving approx 2 hours later and all settled down I went to my car and noticed small area near front of tongue in R side. I also had small feelings of tingling or what felt like small electric current around edges of my tongue. My throat was sore but I had thought that was from talking to so many vaccinated first responders and having to talk over my n95 mask.  Upon getting home approx 12 minutes later I noticed my tongue had swollen. I was not having trouble breathing. Throat was red but no swelling noted. I took my Zyrtec early and then. 50 mg of Benadryl and it was relieved within 40 minutes. I did not need to seek any medical care and over the counter meds remedied the issue.
One day later with some swelling of the lip and itchiness of the body. 2 days later with a rash on the body.
Pinching feeling in my wrist that has come and gone.  Hand of arm that got shot is blue.   Still blue - 1 week out.
Pt c/o headache, neck ache fever and nausea, temp of 101F.
developed myalgia, chest pain, fever chills, came to Emergency department found to have Right bundle branch with elevated troponin
A 34 year old female patient developed severe flu-like symptoms, fever, joint pain, and headache following her second dose with RabAvert for pre-exposure prophylaxis. The patient received the first dose of RabAvert on 1/31/02. She also received 1 dose of Hepatitis B vaccine and a PPD injection at the same time. The patient received her second dose of RabAvert on 2/5/02, and had developed these adverse events. She had no past medical history, and the nurse didn't know of concurrent meds. The patient's symptoms were relieved with ibuprofen around the clock. The patient also took ibuprofen prior to the third RabAvert dose and throughout the day with minimal reaction.
ED COURSE & MEDICAL DECISION MAKING Patient  is a 25-year-old female who presents as a first responder to the emergency department today.  On my initial evaluation she is awake, alert, and in no acute distress, she does appear drowsy.  She is fully oriented and able to answer questions.  She has a normal neurologic exam.  Her labs show negative pregnancy, mild anemia, no leukocytosis, unremarkable CMP, normal CK.  A CT scan of her head shows no acute abnormalities.  The evaluation she appeared back to baseline.  On chart review it appears that she has previously been diagnosed with psychogenic nonepileptiform seizure and so no medication been previously recommended by her neurologist.  It is possible that her Covid vaccine triggered a recurrence of these versus this episode represents a true seizure.  Therefore I did recommend against driving, working at heights, swimming alone, and recommended things to help avoid seizures.  I recommended she follow-up with her primary care doctor as well as her neurologist.  I do not think she requires any medication today.  She is ambulating with a stable gait in the emergency department.  She will be discharged home, she was provided with reasons return to the emergency department.
Intense muscle pain in arms and legs still ongoing after 3 days, along with fatigue and joint pain.
Patient awakened early 3/2/07 with fever, chills,  nausea and headache.  L arm at injection site was tender and puffy.  Temperatures ranged from 100.8 to 102.0 throughout the day.  3/3/07-c/o nausea, headache and temp of 100.0   3/4/07- c/o headache and stiff neck.  3/5/07-c/o headache
fever, chills, body aches, interrupted sleep, loss of appetite, fatigue, soreness at site of injection
This spontaneous report as received from a nurse refers to a 61 year old female patient. The patient pertinent medial history included breast cancer, GERD, vitamin D deficiency, osteoporosis and insomnia. On 13-MAY-2014, the patient was vaccinated with ZOSTAVAX, Lot # J014566, 0.65 ml, subcutaneous. Concomitant therapies included ZYRTEC, ESTRACE, OTC vitamins (manufacturer unknown) and TRAZODONE. On an unknown date in May 2014 the patient experienced a hard lump, with redness, pain, swelling, induration of 3cm and erythema of 9 cm at the injection site, after receiving ZOSTAVAX. The patient sought medical attention and was seen in the office. The patient was treated with ice compress at the injection site and TYLENOL. The outcome of the events was unknown. The reporter did not provide the causality between the events and the suspect drug. This case is linked to the case 1405USA012484 (same literature link). Additional information has been requested.
Woke up by extreme gas and belching, couldn't get out of toilet vomiting and diarrhea. By 7 am, palm of hands were itchy uncontrollably, by 9am head and neck itchiness then spread to feet. It was uncontrollable, it was embarrassing. Went to doctor on 9/26 by 9:30am, there were no hives, just redness, BP low at 89/57 (normal usually at 120/70). Given 2 prescriptions for: Hydroxyzine HCL 25mg, Ondansetron 40 mg. Doctor said BP low due to dehydration. First doses helped for the itch, good for 4 hours. Woke itching again, took another dose early (1 hour) slept for a couple of hours and woke up itchy again. By then had 3 Ibuprofen in the last 24 hours, help with vomiting. On Wednesday morning woke up left eye swollen and shut and all over the body covered in welts. Called the doctor office again and nurse suggested BENADRYL and anti-itch cream; was not asked to come to the doctor. BENADRYL helped somewhat, welts not as bad, also not as itchy. Eyes still puffy and doctor called yesterday to check in to check if the throat was not closing up; breathing was fine. BP fine as well.
Narrative:  43 yo male patient with hx of: PAST MEDICAL HISTORY: E10.621 Diabetic foot ulcer (SCT 371087003) Z59.0 Homeless single person (SCT 160700001) Z51.5 Seen by palliative care service (SCT 441874000) I10. Hypertension (SCT 38341003) - Essential (primary) hypertension (ICD- 10-CM I10.) E10.43 Peripheral neuropathy due to type 1 diabetes mellitus (SCT 71791000119104) E10.311 Diabetic oculopathy due to type I diabetes mellitus (ICD-10-CM E10.311) E10.22 Chronic kidney disease stage 5 due to type 2 diabetes mellitus (SCT 711000119100) N18.5 End stage renal failure on dialysis (SCT 236435004) E10.43 Peripheral neuropathy due to type 1 diabetes mellitus (SCT 71791000119104) E10.22 Chronic kidney disease stage 5 due to type II diabetes mellitus (SCT 711000119100) E55.9 Vitamin D deficiency (SCT 34713006) Z89.511 Amputated right lower extremity below knee (SCT 816964001) Z89.412 History of left great toe amputation (SCT 10996611000119104) K21.9 Gastroesophageal reflux disease (SCT 235595009) K31.84 Gastroparesis due to type 1 diabetes mellitus (SCT 713702000) residing in provided apartment (homeless prior) died on 11/21/2021. Per coroner death likely due to low blood sugar or heart attack. Pt had received one covid vaccine on 9/17/2021 at rehab facility. Likley pt's death not related to covid vaccine given pt's medical condition & coroner's assessment of death.
allergic reaction; This case was reported by a consumer via media and described the occurrence of allergic reaction in a 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 allergic reaction (serious criteria death and GSK medically significant). On an unknown date, the outcome of the allergic reaction was fatal. The reported cause of death was allergic reaction.   It was unknown if the reporter considered the allergic reaction to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient's friend. The age at vaccination was not reported. After receiving Shingles vaccine, the patient passed due to allergic reaction complications to the Shingles vaccine about a month ago from the date of reporting. This case had been linked with case US2021AMR188176, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR188176:same reporter; Reported Cause(s) of Death: Allergic reaction
Part of dose leaked from syringe; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete dose administered (Verbatim: Part of dose leaked from syringe). The outcome of the incomplete dose administered was not reported.   Additional Information: GSK receipt date: 28-FEB-2023 The pharmacist reported that the part of a dose of Shingrix leaked from syringe while administering the medication. The reporter did not consent to follow up. The reporter declined to provide more information. While administering the Shingrix the part of a dose of Shingrix leaked from syringe, which led to incomplete dose administered.
High pitched wailing - several hours after hot; lasted throughout night. Pea to quarter sized red welts which turned purplish after 2-3 days; began 3 days after shot and lasted for more than a week. Mostly on extremities.
Dizziness, Chills, Body Aches, Headache- Began 9 hours after injection. Lasted approximately 24 hours. Tiredness- Began 18 hours after injection. Lasted one more day.
Patient  woke up sick the following morning following her injection.  She ran a fever , 102.3 degrees for 48 hours and experienced weakness which caused her to stumble into a wall, giving her a black eye.  She also fainted briefly.  She had aches and pains--she stated she could not move her arm of the injection.  She states she has recovered now but wanted us to know about her response to this shot.