chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Besides the normal reactions to the vaccine, headache, body aches,  extreme fatigue, I developed a red itchy rash under and above both of my armpits. This happened after the first vaccine and lasted two weeks. Then I got it again with the second vaccine.  The itching seemed to be worse at night and when I woke up. The second time however the itching is  during the day as well. As of today it still exists, hoping it will heal soon.
Woke up at 0205 with fever and severe chills. Standing in bathroom, began to faint, sat down. Emesis occurred immediately after sitting down. About 2 minutes later had one loose stool. Took Tylenol. At 0800 chills, Tylenol taken. At 1200 chills, Tylenol taken. At 1800 chills resolved.
pt recvd vax; redness & itching at site p/ dose 1 & 2; ha p/ dose 1;
Pt recvd Engerix-B vax & devel classical sx of MS; Reporter indicated event is permanently disabling; 17JUL92 pt hospitalized x 2 days;
Information has been received from a registered nurse concerning a multiple unspecified patients of unknown ages and gender. The patients' pertinent medical history, drug reactions/allergies and concurrent conditions were not informed. Concomitant therapies were not reported. On an unknown dates, the patients were administered improperly stored doses of GARDASIL 9 lots # L037554 and M011117 with expiration dates 25-DEC-2017 and 07-DEC-2017 respectively, (dosages and therapy routes were not provided), for prophylaxis. No adverse effects were reported. The doses of GARDASIL 9 were exposed to a temperature below of 32F and lowest of 31.74F and were out of range for 2 hours and 50 minutes. A data logger was used to track the temperature and there were no prior excursions. No product quality complaint (PQC) was involved. Additional information has been requested. This is one of several reports from the same source. Sender's Comments: US-009507513-1701USA009320.
Blood pressure spiked to 181/152, pt experienced severe headache. Pt taken to ER where he was given torradol and Benadryl IV
This case was reported by a other health professional via call center representative and described the occurrence of fatigue in a patient who received dTpa vaccine for prophylaxis. On an unknown date, the patient received dTpa vaccine at an unknown dose. On an unknown date, less than a year after receiving dTpa vaccine, the patient experienced fatigue. On an unknown date, the outcome of the fatigue was unknown. It was unknown if the reporter considered the fatigue to be related to dTpa vaccine. Additional details were reported as follows: The age at vaccination was not reported. The patient received an unknown brand of Tdap a few months before the reporting date. This was reportedly already submitted by a sales representative, but no record of case could be found in CAMEL search. This was possible repeat report.
12/16/2022 I had a cold, stuffy and runny nose, headache and a little bit of a sore throat. I was sick for about a week. The symptoms changed to be more like an infection with green mucous. I took three at home COVID tests which were all negative. I eventually went to an urgent care on 1/7/2023. I was diagnosed with a bacterial sinus infection and was prescribed amoxicillin-CLAV and began taking it that day for 10 days. The prescription cleared the infection up pretty quickly.
I received the shingles vaccination on the 9th and developed hives about 1 cm from the injection site on the 12th.
Patient developed hives. Patient states that she "Breaks Out" when she gets nervous. Patient took Claritin prophylactically prior to receiving vaccine. Physician in clinic ordered Benadryl 25mg po while patient was in clinic. Patient notified Healthcare team that all symptoms resolved by 0800.
Patient reported within minutes after receiving her first Shingrix dose she had pain radiating down her arm, side, and leg. It almost felt like a sharp line of pain on the left side only from the injection site to her fingertips, down her left side and a little into her back, and down her left leg. I explained that severe arm soreness is unfortunately a known side effect of the vaccine. She said it lasted 5-6 days. I hadn't heard of the sharp radiating pain before, almost sounded like some kind of nerve pain. I told her I would report it.
PT INJECTED. PT FELT BETTER REPORTS FEELING LIGHTHEAD AND TINGLING TIGHNESS OF THE JAW. DENIES SOB DYSPNEA OR HIVES. PT HAS A HISTORY OF ASTHMA IN WICH SHE HAS A RESCUE INHALER FOR EMERGENCY. REPORTS THAT SHE HAS ONLY A PAIN @ THE INJECTION SITE WITH FIRST DOSE. PT INSTUCTED TO STA HYDRATED AND EAT AS PT DID NOT BEFORE GETHING INJECTED. PT FELT BETTER AFTER A FEW MIN. AS SYMPTOMS SUBSIDED. INSTRUCTED TO FINISH OBSERVATION TIME AND TO ALERT TEAM IF SYMPTOMS RETURN OR WORSEN
No known adverse reaction to patient. Patient received PCV-7 and Hep B exposed to freezing temp in fridge. CDC and manufacturer contacted. To repeat Hep B in 2 weeks. Repeat Prevnar at 18 months WCC per doctor.
Pt was given bivalent Pfizer Booster before completing primary series w/monovalent Pfizer (only had 1 monovalent Pfizer from 1/15/22)
lightheaded/dizzy, left side facial numbness, flushing. Evaluated by EMS-Cleared
2 days after started developing hives by the 3rd day all upper body was covered and upper lip was swollen - - that day I took a flight and went directly to emergency room - was given a shot of methy/PredniSolone sodium and a prescription for tablets - 2 a day for 5 days
Per hospitalization:  Myopericarditis NSTEMI Heart failure with reduced ejection fraction Hypotension Fever
Case number PHEH2016US030167, is an initial spontaneous report received from a pharmacist on 14 Nov 2016. This report refers to a 27 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUCELVAX QUADRIVALENT (batch number: 185284 and expiry date: Apr 2017) at a dose of 0.5 ml, intramuscularly on 09 Nov 2016. It was reported that, patient began to thrash arm about, and needle bent and part of the vaccine leaked out and patient did not receive a full dose of FLUCELVAX QUADRIVALENT on 09 Nov 2016. No adverse event was reported following this medication errors (needle issue and underdose). The case was assessed as non serious by the pharmacist.
Pfizer-BioNTech COVID-19 Vaccine EUA: 1. Injection site tenderness x 2-3 days, no treatment 2. Fatigue, severe headache, muscle pain, fever x 8-10 hours (started about 10 hours after getting the vaccine), Tylenol
Tickle in throat and severe coughing for 1/2 to 1 minute. Diarrhea. Nosebleed, went to ER for treatment, 4-26-14.
Ran 103-104 temp for a weeek straight, did not eat, did not sleep. 3/24/08-records received for DOS 12/7-12/17/07DC DX: Partially treated meningitis. Presented with 5 day history of fever.  Fever spiked 103 associated with cough, nasal congestion, diarrhea. Inconsolable and fussiness. Decreased oral intake.
Onset 12 hours after injection of alternating fever and chills, nausea, vomiting, myalgias, arthralgia, and headache.
Swelling, redness, tenderness  on the injection site (Rt Deltoid), fever .
Arm reaction.  Hot and swollen, muscle hardened, red, itchy (feels like a sunburn).  I had the same reaction with dose 1.  They told me to take an allergy pill 1 hour prior to this shot.  And I am still taking benedryl and allergy pill, icing the arm every 4 hours.
Received varicella vacine 1/24/98 now presents with diagnosis of chickenpox.
Patient received Gardasil (#3) and a TB test. Within a minute of receiving, patient fainted while sitting. Blood Pressure was 84/43 and pulse 45 initially. Five minutes later BP was 115/61, pulse 53. By this time patient was feeling better and drinking juice. Thirty minutes after patient fainted her vitals were normal at 121/70 and pulse 60. She stated her mother also has fainted with shots.
This spontaneous report as received from a registered nurse and refers to a 3 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 25-OCT-2016, the patient was vaccinated with an improperly stored PROQUAD lot # M022402 with expiration date of 01-NOV-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 28 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1705USA013888:
Death J18.9 - Pneumonia, unspecified organism N17.9 - Acute kidney failure, unspecified
11:20 PM on April 1, 2020 I had major chills cold sweats terrible headache bodyaches and a Fever of 102.3. I have continued to have those symptoms often on especially in the evenings up until present day, 4-6-2021. I have taken Tylenol and naproxen.
15 minute post vaccination observation patient denied any symptoms. Later in the day patient experienced significant nausea and vomiting followed by mild SOB and throat swelling.
Swollen lymph glands in legs causing 2"swelling in both legs/a reaction of lymphatic swelling.; Osteoarthritis lumps on my fingers; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Feb2021 14:30 (Lot number: EN9581) at the age of 74 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Lymphadema" (unspecified if ongoing), notes: Lymphedema, no thyroid gland; "overweight" (unspecified if ongoing), notes: overweight; "Food allergy" (unspecified if ongoing), notes: Allergies to medications, food, or other products: Yes; "allergies" (unspecified if ongoing), notes: known allergies : Yes. Concomitant medication(s) included: TIROSINT SOL. Vaccination history included: Bnt162b2 (1st dose, lot: EL3248,, Time: 2:30 PM, Arm Left.), administration date: 17Jan2021, when the patient was 74 years old, for COVID-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 15Feb2021, outcome "not recovered", described as "Swollen lymph glands in legs causing 2"swelling in both legs/a reaction of lymphatic swelling."; OSTEOARTHRITIS (non-serious) with onset 15Feb2021, outcome "not recovered", described as "Osteoarthritis lumps on my fingers". The events "swollen lymph glands in legs causing 2"swelling in both legs/a reaction of lymphatic swelling." and "osteoarthritis lumps on my fingers" were evaluated at the physician office visit. Therapeutic measures were taken as a result of lymphadenopathy, osteoarthritis.  Additional information: The patient received treatment with lymphatic therapy and Celebrex. The patient not had covid prior vaccination. The patient was not tested for covid post vaccination. Facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had allergies to medications, food, or other products. The patient stated that after taking the Covid vaccine she had a reaction of lymphatic swelling. Not had covid prior vaccination and covid tested post vaccination. Facility where the most recent COVID-19 vaccine was administered was other. List of any other medications the patient received within 2 weeks of vaccination was Tirosint sol 125. The adverse event result in any of the following the doctor or other healthcare professional office/clinic visit. Prior to vaccination, was the patient diagnosed with COVID-19 and since the vaccination, has the patient been tested for COVID-19 reported as no. Allergies to medications, food, or other products reported as yes. Reporter states after taking the Covid vaccine she had a reaction of lymphatic swelling. New AE description but same as initial event term. so, follow-up received with no new AE/SD and follow up activities were already closed and completed.  No follow-up attempts are possible. No further information is expected.
After coming to clinic in stable state on 11/23 and receiving flu vaccine, she went home and prior to making any of the minor adjustments planned to her LANTUS, levothyroxine and Buspirone, she went to bed and reportedly did not get up for 8 days. Family did witness her going to the bathroom, eating, taking medications. Patients recollection of the day symptoms started is fuzzy (doesn't remember coming to my office, thinks she went for an MRI) and she does not recall many details from her week in bed. Family report that she was not unconscious and would respond to them if the spoke to her but resisted their attempts to get her up or to have her eat. She was taken to the ER on 12/1 where she had unremarkable work up but was offered admission which she declined. Since returning home, she continues to be fatigues and desire to spend most of her time in bed. She took her medication on 12/2 but not on 12/3. She has eaten some at urging of family. She has exhibited confusion regarding how to operate a TV remote and her computer. At the time of her visit with me on 12/4, she was speaking slowly in response to questions as if she had a delay processing the question and formulating the answers. She did not have any other significant neurologic findings, and the rest of her exam was benign. I have diagnosed her with encephalopathy.
Patient felt itchy throat and felt like her tongue was tingling about 12 minutes after vaccine administration. Was evaluated in clinic and found to be AAOx3, NAD, nontoxic, no swelling of lips or tongue, lungs CTA with good air entry, regular rate and rhythm, given x1 dose of diphenhydramine and transported to the Emergency Center where she was evaluated again. Found to be in similar condition as above so given an additional 75 mg total of diphenhydramine. Sent home after short observation period.
Received AVA #1 on Jan 11, 2003. in R arm. there was no burning at the time of injection, there was a slight amount of swelling later that day. The next morning he awoke with aches everywhere in joints. No headache, no dizziness, did have weakness. Drove from his home and spoke with his senior who told him to check with the flight chief and go to clinic. He was given 24 hours rest and sent home, he had no meds at that time. The aching continued "everywhere" throughout Jan and Feb. He went to a civilian MD, was tried on Vioxx, Mobic, Celebrex, Naproxen. Was combining prescriptions to try to obtain relief. Experienced Bloody stools, quit naproxen, then quit Celebrex. Developed skin condition requiring dermatological consult due to overuse of hot water to relieve pain in joints and back. He is now unable to change tires, or hold his arms up long enough to check an aircraft. He is able to hold a full time job, but due to problems with short term memory must make frequent use of note taking, and is unable to pass tests to requalify for upper levels of aircraft technician. Although his level of symptoms has not decreased, he has developed coping skills that have allowed an improvement in his mental status scores on SF36 evaluation. 3/14/06-Review of 9-page clinical summary indicates the final assessment was chronic joint pain, malaise & fatigue, insomnia, headache, and short-term memory loss all with onset temporally related to receipt of anthrax vaccine.
Mom reports felt warm @ 7PM then had sx; pt placed in cold water & became apnec; grandad did CPR & pt began breathing & color returned; seizured @ hosp; MD reported BOM; pt taking Phenobarbital; t101 & 103 in ER;
Big blister on right deltoid like sunburn type blister that has popped several times releasing  clear fluid.  Ran fever for first 24 hours of shot but no fever once blister appeared.  Blister, since popped, is doing better today 4/12/21.
When the needle was removed, a stream of blood came out that ran down to my elbow; They inserted the needle slowly which caused much pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 12Sep2022, outcome "unknown", described as "They inserted the needle slowly which caused much pain"; VACCINATION SITE HAEMORRHAGE (non-serious) with onset 12Sep2022, outcome "unknown", described as "When the needle was removed, a stream of blood came out that ran down to my elbow".  Additional Information: I received the updated booster on 12Sep2022. The person giving the vaccination was not very skilled. They inserted the needle slowly which caused much pain. When the needle was removed, a stream of blood came out that ran down to my elbow. My questions: 1) Could enough of the vaccine have come out to compromise its effectiveness? 2) Would a second dose of the vaccine be recommended?. Comirnaty, Pfizer-BioNTech COVID-19 Vaccine [Monovalent] and/or Bivalent. Dose/Dosage Form: Gray cap, Original/Omicron BA.4/BA.5 (Bivalent), greater or equal to 12 years - 15/15 mcg per dos.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Patient states she became itchy all over her body after she got home. She took OTC BENADRYL.
Patient received vaccine (Fri) 8/2/13 at 1642. Sat morning 8/3/13 patient had low grade fever, lumps on legs where vaccines were given. Treated w/ warm baths. Monday morning 8/5/13 at 0700 patient was warm to touch, temp was 100.4. Mother nursed child, when he finish he started to have a seizure. Called EMS. Went to ER. 1 day stay. Labs, treated with TYLENOL and MOTRIN.
Had injection site soreness. Comes & goes, usually upon retiring for sleep - 11:30 & awakened within hour. Only cold "ice pak" numbs upper (L) arm, below shoulder, Only relief. Advil doesn't touch/affect, relieve pain.
Received adacel after a temperature excursion where the product was not suitable for use with no reported adverse event; Received adacel after a temperature excursion where the product was not suitable for use with no reported adverse event; Initial information received on 16-Jun-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 21 years old male patient who experienced received adacel after a temperature excursion where the product was not suitable for use with no reported adverse event while receiving vaccine diphtheria-2/tetanus/5 ac pertussis vaccine [adacel].  The patient's past vaccination(s) included pertussis vaccine acellular. The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.   On 15-Jun-2022, the patient received a 0.5 ml dose of suspect diphtheria-2/tetanus/5 ac pertussis vaccine lot U7453AA, expiry date: 29-Jun-2024, frequency: once, unknown strength via intramuscular route in the left deltoid for immunization.  On an unknown date the patient developed a non-serious event received adacel after a temperature excursion where the product was not suitable for use with no reported adverse event (product storage error) (unknown latency) following the administration of diphtheria-2/tetanus/5 ac pertussis vaccine.  On 15-JUN-2022 the patient developed a non-serious event received adacel after a temperature excursion where the product was not suitable for use with no reported adverse event (poor quality product administered) latency: same day following the administration of diphtheria-2/tetanus/5 ac pertussis vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (poor quality product administered and product storage error).  At time of reporting, the outcome was Unknown for the event poor quality product administered and product storage error.     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.
This case was reported by the mother of a consumer and described the occurrence of developmental delay in a 2-month-old male subject who was vaccinated with INFANRIX, GlaxoSmithKline.  A physician or other health care professional has not verified this report.  Concurrent vaccination included HIB, Sanofi Pasteur and IPV, Aventis both given on 7 May 2007.  There were no concurrent medications.  On 7 May 2007 at 13:30 the subject received 1st dose of INFANRIX at 0.5 ml in the left thigh.  On 7 May 2007, less than one day after vaccination with INFANRIX, the subject experienced developmental delay, high pitched screaming, chest congestion unspecified and low grade fever (101.5 degrees).  This was a systemic reaction.  The screaming resolved on 10 May 2007 and the chest congestion about 1 month after onset.  Fever resolved at an unspecified time and developmental delay was unresolved.
Hallucinations, and other.  Took 1 Delta8 gummy, as sold to me by being CBD only, stated Hmp 25mg, on jar, by an unlicensed store. Purchased in April 2021, had not used until 12/9. Had received Covid Moderna boosted on 12/8, and on 12/9 was achy all over. Was drinking coffee, and took 1 gummy; 2 hours later, heart rate high, was dizzy, unbalanced, hallucinating, could not complete a sentence, or a thought or a task, confused as to time of day, season. Paranoid. Felt stoned- and had not had any experience like this, in 50 years, since I smoked pot at age 17. Felt desperate, cold not find the poison-control number, called a friend for help; was readying to go to the hospital. Hospital is full of Covid so I remained at home, drinking copious amounts of water, watched a film. formed myself to stay awake, so that I did not fall asleep; I was fearful that I would stop breathing. I use no illicit drugs, little liquor, no smoking, only prescriptions, no anti-anxiety meds, am a medical nurse...never had experienced this situation. 5 hours after symptoms started, I began clearing and 7 hours after the start, felt much closer to normal. Scared! Did not seek medical care.
Patient c/o itching to left arm during 15 mins observation following covid-19 vaccination. She denies medication or food allergies. Hives noted on face, denies SOB or difficulty swallowing.  No lip swelling, or throat redness. No nausea or vomiting,  lungs clear, no wheezing.  Clinical lead  assess patient  and administer benadryl 50mg PO,  itching and hives resolved. Closely monitored for another 45 mins.  Vital signs as followed: BP 148/99, P66, R18, O2sat 98%, repeated  BP 147/97 and 142/92. Patient states she is feeling much better, instructed to follow-up with primary care provider, she agree with same. Left with family member in stable condition.
Nausea, vomiting and diarrhea. Also, swelling and tenderness at injection site.
I was playing tennis and I started to feel like I had a cold and was coughing up phlegm. Later that night I had a headache, chills, and I felt very fatigued. The next day I took a COVID-19 at home test that came back positive. On 6/1/2022 I had a phone visit with my doctor. He prescribed me Paxlovid to take and that has relived my symptoms. I have since started to feel better and my headache has gone away, and I have gotten some energy back. I was instructed to isolate for 5 days.
pt devel chickenpox;fever 9-101.2, achiness, rash blistered 200+ lesions, breaking, itchy rash on upper torso, arms & one on cheek;