chrisvoncsefalvay/vaers-outcomes huggingface dataset:
p/vax pt noted approx 1inch area pink, swelling surrounding inj site w/a hive w/in the area;pt MD notified & oral DPH ordered;
RIGHT POSTERIOR LOWER LEG PAIN, PAIN FELT LIKE SHOOTING PAIN GOING DOWN LEG , SEVERY OF PAIN WAS 5,  NO RECENT TRAUMA , PAIN INCREASES WHEN STANDING .
Patient was hospitalized at local hospital and diagnosed with henoch schonlein purpura on 2/1/23 after presenting with abdominal pain, refusal to walk due to joint pain and rash.
This spontaneous report was received from a registered nurse referring to a patient of currently 5 years age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of PROQUAD (Merck) with lot # L006390, expiry date 25-AUG-2016, (dose, route of administration and anatomical location not reported). The doses of PROQUAD (Merck) underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports from the same reporter. Additional information has been requested.
Pt referred to hosp for focal seizure 1 10 min sz @ home & another 10 min sz in ER, t101.4, was postictal & lethargic but cried when stimulated;
Pt was given HPV vaccine at 4 months of age. No adverse effects at present time. Pt's Mother and provider were notified. Will monitor and research info on possible side effects.
This spontaneous report was received from a pharmacist refers to her son of unknown age. Information on the patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with PROQUAD intramuscular (Incorrect route of drug administration) (dosing details, lot/batch number and expiration date: unspecified) for prophylaxis. No adverse event was reported. Outcome of the events was not reported. Causality assessment was not reported. No product quality complaint was involved.
Information has been received from a consumer concerning a 9 year old male who on 26-JAN-1998 was vaccinated with a dose of Varivax. On 27-JUL-2006 the patient developed a chickenpox rash. On 29-JUL-2006 the patient was triaged by the office. No information on the number of lesions or related symptoms were available. Subsequently, the patient recovered. The patient's siblings (WAES # 0608USA04853 and 0608USA04854) also had adverse experiences after vaccination. Additional information is not expected.
Information has been received from a registered nurse concerning a 21 year old female who on 05-AUG-1999 and in August 2000 was vaccinated with Varivax. There was no concomitant medication. On 07-MAR-2006, the patient had a low varicella titer of 0.45. The patient's outcome was not reported. Additional information has been requested.
sore arm; GETTING WORSE INSTEAD OF GETTING BETTER; Fever of 101,102 for 2 Days; Chills; Nausea with no Vomiting; HAVING FLU-LIKE SYMPTOMS ON FRIDAY AND SATURDAY; A spontaneous report was received from a consumer concerning a 62 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm /pain in extremity, tiredness /fatigue, hurting for 2 days /pain, fever of 101, 102 for 2 days /pyrexia, chills, shaking /tremor, nausea with no vomiting /nausea, having flu-like symptoms on friday and saturday, getting worse instead of getting better /condition aggravated.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 21 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013L20A) via unknown route for prophylaxis of COVID-19 infection. On 19 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 026L20A) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) sore arm, tiredness, hurting for 2 days, fever of 101, 102 for 2 days, chills, shaking, nausea with no vomiting, having flu-like symptoms on friday and saturday, getting worse instead of getting better.  Treatment details included acetaminophen.  The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.   The outcome of event(s), sore arm, tiredness, hurting for 2 days, fever of 101, 102 for 2 days, chills, shaking, nausea with no vomiting, having flu-like symptoms on friday and saturday, getting worse instead of getting better was unknown.
body aches; headache; fever; fatigue; sore arm; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8731) via an unspecified route of administration in the left arm on 10Apr2021 at 13:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included ascorbic acid (vitamin C) (MANUFACTURER UNKNOWN), zinc (MANUFACTURER UNKNOWN), vitamin b (MANUFACTURER UNKNOWN) and acetylsalicylic acid (baby aspirin) (MANUFACTURER UNKNOWN) all from unknown date for unspecified indication. The patient previously took erythromycin, and experienced allergy to it. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021, the patient experienced body aches, headache, fever, fatigue and sore arm. Therapeutic measures were taken as a result of the events which included treatment with Tylenol from unknown date for unspecified indication and unknown if ongoing. The clinical outcome of the events body aches, headache, fever, fatigue and sore arm was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Flu like symptoms: Tiredness, headache, cough, chills, nausea, soreness at injection site
Information has been received from a pharmacist concerning an approximately 30 year old female who was vaccinated with her second dose of MMR II. subsequently the patient had a negative  titer for rubella by ELISA testing. The patient had a missing vaccine record. The patient sought unspecified medical attention. The outcome was unknown. There was no product quality complaint. No further information is available.
developed rash around injection site.  red and itchy.  started 10 days after injection. used corticosteroid cream and symptoms greatly improved after couple of days.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Day 1 ? sore arm, fatigue, headache Day 2 ? fever, chills, nausea, dizziness, extreme fatigue (weakness), much lighter period than normal (period had just started when I got the shot and is always very heavy), headache Day 3 ? clammy, intermittent fever, fatigue (weakness), lack of appetite, lighter than normal period, sleeplessness, headache Day 4 ? weak,  tired, lighter than normal period, sleepless , strange dreams, headache ongoing but returning to normal
PATIENT EXPERIENCED SWELLIN, REDNESS AND HIVES 8 DAYS AFTER VACCINE ADMINISTRATION
Immunization given 4/25/06 A/R noted 4/26/06 pm. Into office 4/27/06 reassurance just Tylenol/Motrin. Right thigh 11cm x 9cm erythema, indurated.
noticed crankiness around 8-9PM; 24FEB95 if mom would touch leg baby would scream; area of inject sl swollen but around knee was red hot to touch & that where all pain was coming from per mom; mom said pt wouldn't put any weight on leg;
a patient received a dose of PROQUAD following a temperature excursion.; No adverse symptoms were reported; This spontaneous report was received from a medical assistant referring to a patient, age and gender were not reported. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with improperly measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for prophylaxis (lot # S017240  has been verified to be a valid lot number measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date reported and establish as 01-DEC-2020) (strength, dose, route of administration and frequency were not provided).  The temperature of storage and time frame of the excursion were 47° Fahrenheit (F) to 77° F and 47 hours. A digital data logger was involved but there was no previous temperature excursion. No adverse effect was reported.
FACIAL REDNESS TOOK ORAL BENADRYL AT HOME 1 HOUR LATER PT FELT IMPROVED
Symptoms like a strong flu. as CC reported , no further details provided; Pain in the arm of the injection, as CC reported , no further details provided; Chills, as CC reported , no further details provided; ¨Pain in the axilla after the vaccination¨; Fever, as CC reported , no further details provided.; Body aches, as CC reported , no further details provided; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Symptoms like a strong flu. as CC reported , no further details provided), VACCINATION SITE PAIN (Pain in the arm of the injection, as CC reported , no further details provided), CHILLS (Chills, as CC reported , no further details provided), AXILLARY PAIN (¨Pain in the axilla after the vaccination¨) and PYREXIA (Fever, as CC reported , no further details provided.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided.     On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Symptoms like a strong flu. as CC reported , no further details provided), VACCINATION SITE PAIN (Pain in the arm of the injection, as CC reported , no further details provided), CHILLS (Chills, as CC reported , no further details provided), AXILLARY PAIN (¨Pain in the axilla after the vaccination¨), PYREXIA (Fever, as CC reported , no further details provided.) and MYALGIA (Body aches, as CC reported , no further details provided). At the time of the report, INFLUENZA LIKE ILLNESS (Symptoms like a strong flu. as CC reported , no further details provided), VACCINATION SITE PAIN (Pain in the arm of the injection, as CC reported , no further details provided), CHILLS (Chills, as CC reported , no further details provided), AXILLARY PAIN (¨Pain in the axilla after the vaccination¨), PYREXIA (Fever, as CC reported , no further details provided.) and MYALGIA (Body aches, as CC reported , no further details provided) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
My balls started to hurt me so god damn bad and the tip of my dick was in pain I could not piss at all for the entire night thought I would have to go to the hospital but I kept drinking some milk by early morning the pain went away it was the worst god damn feeling I ever experienced in my life.
9/28/2018 (10:20am) Patient reported by phone having neck pain in both sides (left and right) but more discomfort on the right side. On 9/29/2018 (6:20pm) pt returned to pharmacy and complaint about having Neck and upper back pain.
Blinding headaches; Shortness of breath; Dry cough; Feeling very bad; This is a spontaneous report from a contactable consumer or other non hcp. A female patient unspecified age (82 unspecified units) received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 07Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 08Feb2021 the patient experienced  on Monday she woke up with horrible, horrible blinding headaches, shortness of breath, dry cough, feeling very bad patient wanted to know whether he can receive Tylenol for his headache. The outcome of the event headaches was not recovered and other events were as an unknown.   Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
General malaise (slight nausea, headache, weakness) for first two days, but on second day the injection sight began itching, has hardened about a 2 inch diameter around injection sight, and feels painful when pressed down.
After receiving 2nd COVID -19 Pfizer Vaccine I began to have uncontrollable hypertension. blood pressure had been about 130/75 prior to vaccination, and was elevated to 180/115 for several months after vaccination. Doctor continued to increase medication with minimal changes. in April started a Holter monitor and was found to have started having A-Fib. In November of 2021 had cardiac nerve ablation which has helped with the A-Fib. I continue to have elevated blood pressure that is being controlled with 40mg lisinopril and 12.5mg HTZC to allow BP to continue to be around 130/85. I have also had increased difficulty with respiration since the vaccination. I had asthma as a child but had not used an inhaler in years and now have to use one 6-8x a month.
Information has been received from a physician via a company representative concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history or concomitant medications were not reported. On 27-JAN-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 2.5 ml, five dose vial, (lot number J004332, with an expiration date of 26-SEP-2014) (route and anatomical location of administration were not reported) that was improperly stored. The lowest temperature excursion was of 32 degrees Fahrenheit (F) (0 Celsius) for a total of 72 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "refrigerator (R)". No adverse effects were reported. Furthermore, no product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
ill for a month and half; This is a spontaneous report from a contactable consumer or other non hcp (patient) via medical information team.   A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient was ill for a month and half. The patient reported that according to the current regime - there was no vaccination for Covid until after 20Jan2021. Patient was given 2 Pfizer shots prior to that date that he was told was the Pfizer covid vaccination. Since the current regime was saying there was no vaccination prior to 20Jan2021 what he was given and that was why he was ill for a month and half. He felt he do have a right to know what was put in his body. Outcome of the event was unknown.  No follow-up attempts are possible. information about lot/batch number cannot been obtained.
pain, swelling in rt arm when pt woke up on 5/28/99;also c/o nausea & mild fever;pt took APAP;
Approximately an hour to an hour and a half after receiving vaccines patient developed hives to his face, eyelid, swelling and wheezing and difficult breathing given epinephrine SC: Zantac, Benadryl : all IV. Was observed in  ERx3hrs.
Mother noticed a rash on her daughter's back, and notice 3 spots at first and then increased in number over time. At time of visit mother could count 12 spots.
Pt with nausea immediately after vaccine. Mom reports that nausea continued from 9/5 - 9/6/18.  Pt vomited twice during the evening of 9/5/18. However, also noted was the fact that pt's sister concurrently with viral stomach process also experiencing nausea and vomiting.
Breakthrough case admission after 3 vaccines PFizer 2/13/21 Lot# EL9267;  Pfizer 3/6/21 Lot# EN6206;  Pfizer 10/30/21 Lot# FF2593
When I have had a brain bleed, I have experienced tingling then numbness on the left side of my face.  I experienced that after the 2nd dose but it has stopped. I still have the numbness, but that does take some time to dissipate. I have spoken to my doctor and will have an MRI.
Information has been received from a physician's assistant concerning a 65 year old white female with allergies to penicillin, sulfa, neomycin, FLAGYL, AVELOX and macrodantin and a history of two previous episodes of shingles (1970 and 1980) who on 13-MAR-2007 was vaccinated IM in the right deltoid with a first dose of ZOSTAVAX(Merck) (lot # "U163U"). There was no illness at the time of vaccination. Subsequently on 23-MAR-2007 the patient developed "onset rash" on her leg. On 30-MAR-2007 the patient was seen by the physician assistant to look at the rash that had been developing for the last week. The patient noticed clusters of red bumps under her right thigh. The patient reported that the muscle in the area was tender to touch but "thinks that it is related to her sciatica". The patient wondered if her past shingles has been reactivated by the vaccine, or if this is a new activation. The patient had shingles on her chest in 1970's in her vaginal area in the 1980's and has not had any shingles since then. In the past her rash was very painful with lots of blisters. This is not painful, but is itchy and no blisters were noted. The patient did apply triamcinolone cream to one of the lesions at home and no change was noted. On exam, she was alert and oriented and in no acute distress. Her blood pressure was 130/86. Her skin exam showed: on the back of her right thigh a few inches above her knee was a cluster of 10 red papules roughly 2 mm in diameter, one appears to have a flat yellow white colored vesicle, though hard to discern. She has other clusters of similar papules ranging from two papules to five papules which travel up along the back of her right thigh. Tenderness to palpation was noted over the area of her hamstring muscles and not in the area of the papule clusters. The assessment was rash, suspect activation of shingles, do not know if it is related to the vaccine or new onset shingles. The physician assistant felt that based on the duration of her symptoms that it was too late to start antiviral therapy, although a therapy could still be started. The patient declined due to her multiple allergies to antibiotics because she "didn't want to risk a potential reaction". On 03-APR-2007 the patient called the physician's office to let them known that more spots had broken out and it was painful to sit down, no blisters were noted. The patient reported she gets shooting pain every once in a while. The patient was still not interested in starting anti-viral suppressions. There was no product quality complaint involved. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 5/14/2007. Additional information has been received from the physician's assistant who reported that the patient had recovered. No further information is expected.
*chills Narrative: Patient reported headache and chills after first dose of covid vaccine. Pt reported to nurse at covid vaccine clinic when receiving his dose #2.
Starting that night, and lasting for about two days after, i would get a 10-15 minute flash of illness every few hours. Symptoms consisted of nausea, sweating, lightheadedness, and tiredness.
PATIENT STATED FEELING ITCHING UNDER THE ARMS AND TINGLING IN THE LIPS APRROX. 10 MINUTES AFTER VACCINATION GIVEN. PATIENT PURCHASED BENADRYL AND DIDN'T WANT TO WAIT LONGER AT PHARMACY.
PATIENT CALLED A FEW HOURS LATER COMPLAINING OF PRESSURE IN THE EAR. PATIENT WAS ADVISED IF SYMPTOMS BECAME WORSE OVERNIGHT TO GO TO ER OR IF THEY CONTINUE THE NEXT DAY TO GO TO HER DOCTOR. THE PROBLEM RESOLVED THE NEXT DAY.
Arm became red w/ rash around site. Arm became swollen and red. Glands under (R) arm became enlarged. Pt reports she could not sleep that night. Pt. used BENADRYL with successful recovery.
Patient began having tingling around her mouth on 12/20/20, stated that cold sore has gotten larger and is worse than previous sores.  Patient is cautious to not spread fluid from sores but they are spreading.  Patient was advised to contact PCP.
Initial misuse report received from health care professional on 25 Sept 2013. A dose of FLUZONE HD was administered to a 64 year 11 month old patient on an unspecified date. No adverse event was reported. List of documents held by sender: none
Moderna COVID-19 Vaccine EUA Experienced injection site soreness, Body and Joint aches, Fatigue, Sleeplesness
Pt (and sister) requested the booster Pfizer on 12/7/21/ injecteion given one month early.  Previous dates  7/1/21 and 7/22/21 No adverse reactions, however given one month early
The diarrhea began by 7 pm & felt like I had a 105 degree temp! I didn't thankfully, but I ached & my heart raced, etc.! I almost called 911. It is horrible & I have bad allergies & started coughing & wondered if I was going to die! It took a few days but I lived!