chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient motioned for help from this nurse and reported "I feel like I'm going to pass out." This nurse assisted patient to EMS room. Once seated on the cot, patient reports feeling better. He consumed water and snack during remainder of observation. patient reports doing well and assisted out of EMS room to exit.
Pt felt warm, flushed, tingly, denied SOB but asked for oxygen and reported that oxygen helped relieve the feeling of warmth and tingliness. Could have possibly been anxiety rather than a true reaction to vaccine.  Benadryl given IM 50mg.  EMS called and assumed care of patient. Assessed her then took her to the hospital for further evaluation.
Information has been received from a registered nurse concerning a 22 year old black female classroom assistant, who on 28-AUG-2007 at 13:50 was vaccinated intramuscularly in the left deltoid with a first dose of GARDASIL (Lot# 658554/0928U). On 28-AUG-2007 at 14:00 the patient developed bumps on her face, the rash radiated to her neck and right flank area. It was reported that the patient was at camp a few days before the injection and did not recall any problems. The rash was worse on the second day. The patient's primary care physician treated her with cortisone. The patient recovered in approximately 1 week on an unspecified date. The patient was advised by her primary care physician to see a dermatologist. Additional information is not expected.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Additional Details: Patient describes symptoms of itchiness in the face, redness (like sunburn), peeling skin and puffiness. Happened with both doses of covid vaccine.
Case number PHEH2012US023399 is an initial spontaneous report received from a nurse on 27 Nov 2012 with a follow-up received on 03 Apr 2013: This report refers to a 12-year-old female child. Her vaccination status was up to date with exception of MENVEO. She was given only MenCYW lyophilized conjugate component of MENVEO (batch number: X11050) intramuscularly in to the right deltoid on 14 Nov 2012. No adverse event was reported following this administration error. Follow-up received from the nurse on 03 Apr 2013: Updated demographics, vaccination history and site of vaccination.
Chief Complaint Patient presents with ? Cough ? Sinus Problem     facial pain, PND, sneezing, watery eyes x 3 days. OTC Tylenol and Benadryl.    HPI  Patient is a 61 y.o. M presenting today for evaluation of sinus symptoms x 3-4 days. He states that he is having nasal congestion, sinus pain/pressure, rhinorrhea, cough, watery eyes. No fevers, V/D, ear pain, sore throat. He has been taking Tylenol and benadryl. No sick contacts. No hx of COVID-19, but he is fully vaccinated. No hx of asthma or COPD. Nonsmoker.
Patient states she woke up at 1:00am with severe sweating severe sore neck left side, arm hot to touch, and patient vomited. Patient states sore neck and arm continued through 081507. Patient states she took Tylenol to relieve pain.
Patient received her first dose of Pfizer vaccine and began feeling nausea, vomiting x1, reported seeing black spots, and difficulty hearing. Pulse was 70 bpm, SpO2 was 98% RA. Patient was given water and snacks and felt better. Patient stayed in observation for a longer period until symptoms went away. Patient left in stable condition accompanied by mother.
Warm, firm, swollen, area on her posterior left arm where her shingles vaccination was administered.
Very firm swelling and redness at the injection site. redness extends from shoulder to elbow. Nausea, some vomiting. Fever 102, headache, shortness of breath, fatigue, Blood oxygen reading of 95, Body chills, Vertigo
sore injection site, headache, chills, foggy Narrative:  Other Relevant History:
Patient states he developed a rash to lower legs on 8/8/2009, intermittent itching.  Pt went to foreign country from July 29 through August 8, 2009.  Has taken Benadryl PRN for itching.  Rash still present on 8/11/09.  Referred by health unit to PMD.
Erythema and swelling around injection site, 4.5 cm x 7.5 cm. Ibuprofen given at 1300 today, Benadryl given in clinic today.
20 cm diameter, slightly raised erythema over left bicep. -Localized reaction afebrile. No shortness of breath.
Information has been received from a health professional concerning a patient (age and gender not reported) who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (date not reported) (lot not reported). Subsequently the patient experienced pain, swelling and redness at the injection site. The patient was recommended to rest and apply moist heat and given cephalexin, 7 days. It was reported that the patient recovered from pain, swelling and redness at injection site 72 to 96 hours post vaccination. The patient had no illness at the time of vaccination. Additional information is not expected.
This spontaneous report was received from a physician via an unspecified reporter referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 24-FEB-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 and lot number L014876 with expiration date of 13-JAN-2017 (route of administration and anatomical location were not reported), which was stored at a lowest recorded temperature of 27F (-2.777777778 Celsius) for 1764 hours. The vaccine status was reported as excursion and the storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
COVID; COVID; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Sep2020 at 12:00 as dose 1, single (Lot number: P220395) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course:Patient received anti-viral treatment Paxlovid (Brand: Pfizer) from 15Aug2022 to 20Aug2022.
Mother stated to MD that the baby was fed formula and at 3:00am was returned to his crib. Baby seems to be sleeping later than usual and when mother checked infant at approximately 8:00am he was on his back and unresponsive. Per mothers report, infant experienced diarrhea, nasal congestion, no fever was noted. Autopsy states cause of death as interstital pneumonitis. Autopsy shows also pulmonary edema, focal intrapulmonic hemorrhage.
42 days after her 1st dose and did not have second dose yet; Loss her sense of smell; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (Loss her sense of smell) and PRODUCT DOSE OMISSION ISSUE (42 days after her 1st dose and did not have second dose yet) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced ANOSMIA (Loss her sense of smell). On 17-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (42 days after her 1st dose and did not have second dose yet). On 17-May-2021, PRODUCT DOSE OMISSION ISSUE (42 days after her 1st dose and did not have second dose yet) had resolved. At the time of the report, ANOSMIA (Loss her sense of smell) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: unknown (Inconclusive) Unknown. She tested for Corona disease 10 days ago but had not heard back her result..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.  The patient reported that she had to cancel her schedule to receive her second dose as her husband tested positive for Corona virus disease.    Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Now new information was reported.
THE EVENING OF 6/5/21, C/O DEVELOPING HA, CHILLS, FATIGUE, COULDN'T WALK DUE TO HIS LEGS BEING SO FLACID AND COULD NOT BARE WEIGHT, ACTUALLY HAD TO BE CARRIED TO BED BY HIS SON.
Pt experienced bruising at injection site for two weeks post vax. Pts arm is continuously sore at the site and the muscles ache constantly. Area is very sore.
right arm started hurting severely; could not raise her arm.; she had a temp of 99.9; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included kidney transplant and crohn's disease. Concomitant products included infliximab (Remicade).   On 18th August 2020, the patient received the 1st dose of Shingrix. On 18th August 2020, less than a day after receiving Shingrix, the patient experienced pain in arm, injected limb mobility decreased and fever. The patient was treated with paracetamol (Tylenol) and non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the pain in arm, injected limb mobility decreased and fever were unknown.   It was unknown if the reporter considered the pain in arm, injected limb mobility decreased and fever to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vacine in her right arm and later in the day her right arm started hurting severely, she could not raise her arm. She reported that through the night she had a temp of 99.9 and took tylenol and ice her injection site.  At the time of reporting the temperature was 98.4. The injection site was never swollen or red.  The reporter did not consent to follow up. MD followup call declined provided information from Shingrix FAQ regarding second shingrix.
Case number PHEH2016US008149, is an initial spontaneous report received from a health care professional on 31 Mar 2016. This report also associated with product quality complaint (QA reference number: 1013962). This report refers to a 20 years old male patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUCELVAX (batch number: 173906) intramuscular on Sep 2015. The patient caregiver stated he had been feeling bad for about a month with flu like symptoms and was recently diagnosed with influenza. The seriousness, outcome and causality of the events were not reported. The seriousness assessment of influenza, vaccination failure and influenza like illness were upgraded based on information in the source document.
6 hours after the shot i had severe abdominal pains, followed by diarrhea,  profuse sweating, vomiting & my body went into shock.  The next day couldn't move left arm & felt really sick. Hurt all over & mild coughing.
vomiting for 2 days, diarrhea for 2 days, shortness of breath, quizziness in stomach
This is an administration error not an adverse reaction. I miscalculated the date for the second dose of the Moderna vaccine. The patient received the first dose on 5/24/2021 and was told to return on 6/14/2021 instead of the correct date of 6/21/2021. The patient received the second vaccine one week early. When the pharmacy discovered our error, we contacted the patient and called the Moderna clinical line. Moderna told us to check to make sure the patient was not experiencing any symptoms and they advised us to not administer another dose for this patient. The patient reported feeling fine even a week later.
approx 2min p/vax got very pale breathed deeply & fainted, consciousness regained immed; pt was perspiring slightly; helped to exam table, laid down for 10mins vx stable BP 108/66, P78, R20; pt left in stable condition
I have experienced an extreme inflammatory response.  My immune system is now attacking my thyroid & has put me into a hyperthyroid state (causing tachycardia, palpitations, & extreme fatigue) with no prior history of thyroid or autoimmune disease.  Symptoms began 12hrs following vaccination & have continued to present.
10/15/21 Bright red bump at injection site- hot and tender to the touch. Headaches and diarrhea.
Vulva inflammation with severe, incredible pain.  Pt stated that her vulva became rock hard a couple days after the vaccination.
Initial report was received on 07 November 2013 from a nonhealth care provider from an unverified internet source. A 14 year-old female patient (date of birth not reported) had received on an unspecified date in August 2012 a Influenza vaccine (manufacturer, lot number, route, site and date of administration not reported) and five months later on 08 January 2013 "died from complications of infection with Influenza Type A". The patient was evaluated at and urgent care with a bad sore throat, treated with Prednisone and was sent home. The sore throat evolved into a serious fever that included shortness of breath and wheezing. The patient's lungs filled with fluid and was hospitalized. The patient had a heart and lung bypass with an "ACMO" machine and blood transfusions. Diagnostic and laboratory testing were not reported. The patient's outcome was fatal. Documents held by sender: none.
Pt with large area of redness and swelling at injection site of DTaP. 24 hours after vaccine had brief generalized seizure.
Allergic reaction; This is a spontaneous report from a contactable nurse (patient). A patient of an unspecified age and gender received bnt162b2 (COMIRNATY; formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 28Mar2021 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced allergic reaction to COVID-19 vaccine on an unspecified date in 2021. The event took place after the use of product. The clinical outcome for the event was unknown.  Information on the lot/batch number has been requested.  One follow-up attempt was completed; information about batch/lot cannot be obtained.
Swelling, erythema, pain (L) thigh of side of HIB and PCV 13 shots.
within 15 minutes progressive light-headedness leading to near-syncope and diaphoresis.  After 20 minutes symptoms subsided.
Myalgia, Fever, numbness right hip/toes intermittent; fatigue Narrative:
coagulopathy, unspecified type 2 mi 1/17/2023 & 3/2/2023  --  recurrence of hospitalization with same symptoms
The pain was radiating down his arm to his elbow; His arm was swelling on his bicep; This is a spontaneous case, reported by a pharmacist to agency (SEQ19-01900) and initially received on 20-Aug-2019, concerning a 66-year-old male patient.   The patient's medical history and concomitant medications were not reported.   On 19-Aug-2019, the patient was administered with Fluad (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59), anatomical location: arm, batch number: 260386, expiration date: 30-Apr-2020, (dose and route of administration were not reported) for an unknown indication. On the same day, the patient was administered with another vaccine Imovax (rabies vaccine), (dose, route of administration, batch number and expiration date were not reported) in the same arm for an unknown indication.   On the same day, later in the evening, around 11PM, the patient's arm was swelling on his biceps and the pain was radiating down his arm to his elbow.  On the next day, 20-Aug-2019, the swelling and pain were improving, but not completely resolved. The outcomes of the events were considered as recovering/resolving.   The reporter did not provide causality assessment to Fluad.  Company comment: The patient developed pain in extremity and peripheral swelling on the same day after vaccination with the suspect product Fluad (TIV). Chronology is plausible. No information regarding medical history or concomitant drugs was provided. Based on this information, causal relationship between the suspect product and both events is assessed as related.; Reporter's Comments: The patient developed pain in extremity and peripheral swelling on the same day after vaccination with the suspect product Fluad (TIV). Chronology is plausible. No information regarding medical history or concomitant drugs was provided. Based on this information, causal relationship between the suspect product and both events is assessed as related.
Pt recvd 3 doses of Engerix-B APR91, 1MAY91 & OCT91 & 10 days p/2nd dose exp optic neuritis & blurred vision; sx resolved p/1mo or a little longer w/o tx; pt tolerated 1st & 3rd doses w/o problems;
Hives all over my body occurring 4 days after 2nd dose. No allergic reaction after first dose
Within 24 hours of receiving varicella vaccine in R arm, pt. developed erythematous, pruritic, hard induration approx.  10 cm x 10 cm.  Prescribed LORATADINE 5 mg and BENADRYL itch stopping cream.  Followed up with pt. 3 days after f/u visit, pt's caregiver reported that symptoms are resolving.
The endometriosis before the vaccine was acting up and then I got it stable. Then when I had the initial vaccine it did mess up my cycle but not enough to go to the doctor.  Then second dose was during ovulation so it messed me up. During the booster I made sure to time it better and I was fine. And the most recent was related to endometriosis I had extreme abdominal pain, my guess is that a cyst ruptured. I saw an OBGYN and she changed my medication.
Severe arm pain, lymphadenitis x 5 days, severe headache, slurred speech, malaise, and foggiest.
1 am, headache, congestion cough 2 am, fever, chills muscle soreness, 5 am nausea,  6 am itching 6:30, previous symptoms subside, breakout in hives, 7 am ems arrives, hives cover 35% of body 7:25 rapid onset heartburn, hives worsen 7:30 difficulty breathing 8:13 ER injects epinephrine, symptoms lessen immediately 8:28, ER gives IV Benadryl, Pepcid, and methyl prednisone  8:50, symptoms largely gone, hives still fading. ER monitors till 12pm
Whole left side of body goes numb, loses strength, tingly.  Headache by left temple.
Days 3-5 post vaccine extremely itchy, on stomach  Day 7-9  post vaccine very late period 10 days late, with spotting when it should have started. During period heavy bleeding for longer than normal. 3 negative pregnancy tests days when my period should have come.
Raised, painful,  erythematous and  indurated  injection site area with local increase in temperature, compatible with Arthus Reaction at injection site.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. Information about the patient's medical history, concurrent conditions and concomitant medication was not reported. On an unknown date, the patient was vaccinated with 6 doses of RECOMBIVAX HB (route of administration, lot # and expiration date were not provided). On an unknown date, the patient experienced hepatitis B antibody negative. The patient had tiers drawn on unspecified dates and it was found to had not seroconverted. The outcome of hepatitis B antibody negative was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Local rxn lt thigh; swelling & redness excessive crying & screaming for >2 hrs; children's advil prescribed; cold pack placed on inject site;
Developed a rash today 18Aug2021 on his left arm that has spread to the back of his neck; Swollen lymph nodes; This is a spontaneous report received from a contactable pharmacist. A 15-years-old male patient received unknow dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 16Aug2021 as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter called about a patient who received the Pfizer Covid-19 vaccine on 16Aug2021 and developed a rash today 18Aug2021 on his left arm that has spread to the back of his neck and has developed swollen lymph nodes as well. Health care professional was asking how long will it be before the above rash will disappear and if there are treatment recommendations for the rash. The outcome of the events was reported as unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Pt has had low grade fever (<100 degrees), chills & shakes Tuesday evening (11/8/11), lethargic for about 3 days. These symptoms started a day or two after vaccine given. Has started feeling better as of 11/9/11.
headache on left temple, said it was sharp but resolving now.  Will continue to monitor, go to ER if it worsens since she held her scheduled blood thinners this morning.
chills, body aches, headache, nausea, loss of appetite, stomach cramps, fatigue lasting 24 hours
the third time I put it, I had it administered, I felt awful, that hurts but awful; the third time I put it, I had it administered, I felt awful, that hurts but awful; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old patient received BNT162b2 (BNT162B2), in Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (dose: 01), for COVID-19 Immunization, reaction(s): "but not as bad as the first time"; Bnt162b2 (Dose 02), for COVID-19 Immunization, reaction(s): "No adverse effect". The following information was reported: FEELING ABNORMAL (non-serious), PAIN (non-serious) all with onset Apr2022, outcome "unknown" and all described as "the third time I put it, I had it administered, I felt awful, that hurts but awful". Therapeutic measures were not taken as a result of feeling abnormal, pain.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I was nauseated for 24 hrs but the real problem came 12 hrs after booster. My heart started racing at 155 bpm then dropped to 43 then raced back up to 144 then dropped again and this went on for 3 and 1/2 hours. Really scared me but I was alone and decided to ride it out. It is around 7:45 right now and all seems to be ok! Hope it stays that way. Will let you know if any more problems! Thank you
This report was received from the manufacturer for diphtheria toxoid/pertussis vaccine/ teta (INFANRIX) and was assigned a manufacturer report number concerning a 4 year old female with no concurrent conditions or past medical history who on 02Jul03 was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). Concomitant therapy, that same day, included a fifth dose of diphtheria toxoid/pertussis vaccine/ teta (INFANRIX) and a dose of poliovirus vaccine (IPOL). There were no other concomitant medications. On 03Jul03, twenty-four hours post vaccination, the pt developed fever and an injection site reaction characterized by redness and swelling. The pt was seen by the physician. The nurse considered the events were probably related to vaccination with Infanrix. It was noted that the diphtheria toxoid/pertussis vaccine/ teta (INFANRIX) had inadvertently been left unrefrigerated for an unspecified period of time. Addition information has been requested.