chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Employee felt foggy and lightheaded after vaccine. Nursing staff monitored her for 30 minutes and approved her to leave. She stated it was hard to swallow and her throat felt swollen. At 9PM she began having redness and hives on her arms and face. On Friday night she was seen at ER
I received the Covid vaccine on December 21. On December 30, I woke up and was unable to maintain my balance. I developed very severe migraine headaches and was hospitalized. I still have not regained my balance. I have had a couple of courses of prednisone and migraine medication. My neurologist is setting up IV I G transfusions feeling that I?m having an auto immune response to the vaccine.
Patient to DO         5/24/19 8:16 AM  Hi,  I got my pnu23 in your office on Wednesday morning. The injection was much more painful than usual. I went home and within 2 hours my shoulder began to hurt bad enough that my ROM was effected. The injection site is really high on my left shoulder. I think that it may gave gone into my joint. It has continued to increase in pain and has been 7/10 unless I am on ibuprofen. When on ibuprofen 5/10. My ROM is pretty limited. I have intense pain if I lift my arm to shoulder height and cannot lift it further. The top of my shoulder hurts also, even the pressure of my bra strap hurts it. My shoulder is cracking and popping frequently. I am not sure what to do. Attached is a picture of the vaccine administration site. The site looks fine, it is just high. It is above my 3 freckles. The other 2 pictures are of this slightly raised red streak going from below the injection site into my armpit.this streak is tender to the touch and is super soft almost like a blister without the fluid.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB, (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported.   Follow up information had been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share.  Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 6 months old patient of unknown gender. On 16-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported), lot#J016188, expiration date: 02-OCT-2016 that was improperly stored. No adverse effects were reported.  This is one of several reports received from the same reporter. Additional information is not expected.
chills, slight fever, aches all over body, shortness of breathe.  Occurred for almost 2 days.
Arm got really sensitive; Arm was itchy too/it was a late arm reaction; Covid arm; Having a red arm thing in the arm where she had the shot, like a rash thing; Having a red arm thing in the arm where she had the shot, like a rash thing; This spontaneous case was reported by a patient and describes the occurrence of TENDERNESS (Arm got really sensitive), PRURITUS (Arm was itchy too/it was a late arm reaction), VACCINATION SITE REACTION (Covid arm), VACCINATION SITE RASH (Having a red arm thing in the arm where she had the shot, like a rash thing) and VACCINATION SITE ERYTHEMA (Having a red arm thing in the arm where she had the shot, like a rash thing) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O36A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure (Patient is under medication) and Cholesterol (Patient is under medication). Concomitant products included TRANDOLAPRIL and HYDROCHLOROTHIAZIDE for an unknown indication.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TENDERNESS (Arm got really sensitive), PRURITUS (Arm was itchy too/it was a late arm reaction), VACCINATION SITE REACTION (Covid arm), VACCINATION SITE RASH (Having a red arm thing in the arm where she had the shot, like a rash thing) and VACCINATION SITE ERYTHEMA (Having a red arm thing in the arm where she had the shot, like a rash thing). At the time of the report, TENDERNESS (Arm got really sensitive), PRURITUS (Arm was itchy too/it was a late arm reaction), VACCINATION SITE REACTION (Covid arm), VACCINATION SITE RASH (Having a red arm thing in the arm where she had the shot, like a rash thing) and VACCINATION SITE ERYTHEMA (Having a red arm thing in the arm where she had the shot, like a rash thing) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications taken by the patient include blood pressure medication, cholesterol medication.  Treatment medication information is not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-058939 (E2B Linked Report). This case was linked to MOD-2021-124405 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-058939:Case for anonymous patient
High pitched scream for over 7 hours straight. He wouldn't eat and would randomly scream himself to sleep for 5 mins only to wake up screaming again. He would hold his head like he was in pain and got worse if we tried to hold him.
Patient said that the injection site was red for 10 days, and that she got an itchy, blistery rash on her left-side of back, 3 days after she received vaccine.  She also mentioned that her mom had a bad case of shingles.
Broke out in hives around the injection site. At first just a 3inch circle around the injection it was hot to the touch and itched stayed like that for 3 days and faded.  Then on Saturday(2/27/2021) woke up to hives covering my upper arm.  Cortisone cream relieves the itching but it?s still there.
After 2nd dose body felt like it was on fire/itchy/hot for about 24 hrs after. Was relieved by Benadryl. Continue to have breast tenderness that was never a symptom before as well as odd menstral cramping
This case was reported by a physician via call center representative and described the occurrence of headache in a 71-year-old male patient who received SHINGRIX for prophylaxis. On 27th September 2018, the patient received the 1st dose of SHINGRIX. On 28th September 2018, 1 days after receiving SHINGRIX, the patient experienced headache, skin warm, sore throat, eye pain, joint pain and polymyalgia. On an unknown date, the outcome of the headache was not recovered/not resolved and the outcome of the skin warm, sore throat, eye pain, joint pain and polymyalgia were unknown. It was unknown if the reporter considered the headache, skin warm, sore throat, eye pain, joint pain and polymyalgia to be related to SHINGRIX. Additional information was reported as follows: The batch number for SHINGRIX was not reported. The physician was unable to provide any further details. The vaccine was not administered by the reporting physician. No further information was provided by the healthcare professional. The reporter stated to follow-up with the healthcare professional for further details.
Patient received pcv and flu on same date. Both recorded as LD, however vaccines were administered in RD. Patient felt a "zing" of one vaccine compared to the other but it is unclear which. Initially presented to the ED c/o R deltoid pain radiating across chest and jaw with subjective fever, she had negative cardiac workup, CBC and chemistry were normal. She returned to the ED 10/10 with continued symptoms and a 5 x 5 cm area of edema and tenderness was noted just inferior to R deltoid with bandaid still in place. There was no fluid collection noted on bedside ultrasound and discharged with pain medication. Seen at a different ED shortly after for same sx and given oxycodone which was unhelpful. Seen in UC 10/12 and additionally c/o R arm numbness. Pain decreased to 8/10. 10/20 had some objective weakness of median nerve and continued to complain of numbness, primarily ulnar distribution. Pain with ROM of shoulder but no limitation to ROM. EMG with demyelination c/w brachial plexus neuritis.
CONVULSIONS; This spontaneous report received from a parent via a company representative concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: unknown expiry: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination (dose number in series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced convulsions. As per reporter, "My daughter went into convulsions after taking your vaccine" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of convulsions was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20211244735-Covid-19 vaccine ad26.cov2.s- Convulsions. This event is considered Unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Arm was tingly on date of vaccine minutes after injection. Arm became increasingly unusable for 48 hours. Extreme pain to move Arm at all. Then pain went away after 2-3 days. Then red blotch just below injection site appeared 2 days later, lasting about 4 days, with no other symptoms. Blotch went away. Then 7 days later, node in armpit was sore and after showering, red spottiness where blotch was occurred just below injection site. Within 30 minutes arm became increasingly cold feeling and tingly numb down to fingers. Can still use fine but feels weird. This has been happening for the last hour. But no pain and still able to move it fine. I feel fine overall, no other symptoms.
This case was reported by a pharmacist and described the occurrence of crying in a 2-month-old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline) for prophylaxis. The reporter is the mother of the subject. On 25 April 2006 the subject received lst dose of Infanrix in the left thigh. On 25 April 2006, the subject also received Haemophilus influenzae type b conjugate vaccine (non-GSK, manufacturer unknown), 7-valent pneumococcal conjugate vaccine (Prevnar, Lederle Labs), and inactivated poliomyelitis virus vaccine (IPOL, Aventis Pasteur). On 25 April 2006, approximately 90 minutes after vaccination with Infanrix, the subject "became very fussy and cried non-stop for about three hours." The crying was described as "high pitched." The reporter stated that, "Once the crying subsided," the subject became lethargic and developed a "low-grade" fever. The subject was treated with paracetamol (Tylenol). On 26 April 2006, the subject was seen by a pediatrician. The reporter stated that the pediatrician "found no signs of neurological complications." At the time of initial reporting, 26 April 2006, the outcome of the fussiness was not reported and the lethargy and low-grade fever were ongoing.
pt recv vax 8JAN98 & 18JAN98 pt devel a measles-like rash which started in palms, face & chest;rash was described as macular & erythematous;20JAN98 seen by MD who saw rash involving hand, abd, neck & perineal area;dx viral exanthema;
This spontaneous report was received from a physician and refers to a patient of unknown gender and age. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown date, the patient was vaccinated with the first dose of RECOMBIVAX HB, 40 micrograms dialysis dose, (route, anatomical location, lot number and expiration date were not reported) for prophylaxis. The physician reported that the patient was not a dialysis patient. No adverse effects were reported. Additional information has been requested.
Pregnancy history: Gravida 2, Para 1 (previous cesarean section at 42 weekS) Estimated date of delivery: 11/16/21 based on LMP consistent with 8wk ultrasound Vaccinated with Pfizer COVID vaccine on 8/10 (1st shot of series), patient pregnant at 26+0 weeks gestation.  Vaccinated with Pfizer COVID vaccine on 8/31 (2nd shot of series), patient pregnant at 29+0 weeks gestation.  Patient presented with decreased fetal movement on 9/26/21 and was diagnosed with intra-uterine fetal demise. Labor induced with subsequent vaginal delivery. Demised infant weighing 1673 grams.
Patient reports dizziness immediately after vaccine.  Upon getting home from vaccine, reports HA, redness/swelling of left arm.  HA worsened to radiate down back.  Nausea, body ache, fever over night.  Next day, patient could not raise arm for swelling/pain.  All of these symptoms continue but are lessening in severity.   Fever continues(around 100.3). Cough, sinus drainage, burning of eyes started 5 days later and continue.
leg and an ankle had swollen; leg and an ankle had swollen; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (COMIRNATY), on 05Jul2022 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 but unknown manufacturer.), for Covid-19 Immunization. The following information was reported: PERIPHERAL SWELLING (non-serious), JOINT SWELLING (non-serious) all with onset Jul2022, outcome "unknown" and all described as "leg and an ankle had swollen".  Additional information: Reporter mentioned that yesterday he received his booster shot with the COMIRNATY vaccine. He mentioned that his leg and an ankle had swollen and asked if this was a common side effect or if he had heard of this as a negative reaction to the shot. After this, caller mentioned he actually wanted to know what to do about it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Approximately 6 days post vaccination, I experienced left hip pain. The pain was also present in my low back and left leg and was exacerbated with movement, particularly sitting and standing and exercise. The pain was continuous and daily until resolving approximately 4-5 weeks post onset. Pain was managed with over-the-counter pain medication (acetaminophen and ibuprofen).
First thing I noticed were body aches, second thing I noticed was a sore throat causing trouble swallowing, third thing I noticed was a fever starting at around 99 but increasing to 102. My glands on my neck were very swollen. This went on until about 11/27.  I went to the doctor first on 11/23 and received a flu, COVID and strep tests. On 11/24 I went to see my endocrinologist because I wanted bloodwork done.
pt recvd vax & had local rxn immediately after vax; area raised & sl ecchymotic; area warm to touch;
no adverse symptoms; vaccinated with improperly stored vaccine; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, concomitant therapies and previous drug reactions.      On 21-AUG-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (lot # S000133, expiry date:02-JAN-2021 strength, dosage information, route of administration and anatomical locations were unknown) for prophylaxis. No adverse symptoms were reported. It was reported that the vaccine was exposed to a temperature of 15 degree fahrenheit to 46 degree fahrenheit (45.1fahrenheit) for a time frame of 1 hours and 51 minutes. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint was reported.
PROBLEM WITH FEET AND IT WENT UP INTO LEGS; BLOOD PRESSURE PROBLEMS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on APR-2022 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 2022, the patient experienced problem with feet and it went up into legs, and blood pressure problems. Laboratory data included: Laboratory test only have blood pressure problems. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the problem with feet and it went up into legs and blood pressure problems was not reported. This report was non-serious.
Walking around house doing chores after working from 9-6 with 90 minute lunch break as a dental hygienist.  Could feel left foot start to go numb and tingling and feel very cold. Took thin sock off foot, pinky toe was purple. Took pictures. Could not get foot to warm up with warm/hot compresses. Started having slight discomfort in lower back/butt with pain going down leg to toe within the hour. I believe this could be coincidence and have sciatic pain, but thought I should report just in case there are few other reported cases on this.   Purple discoloration was gone when woke in morning on 2/23/2021 It is now 2/24/2021 and I am still having sciatic pain and numb pinky toe.
Red swollen arm at injection site, size of a baseball, feverish, hurt to touch or raise her arm. Ice packs and Ibuprofen.
This spontaneous report as received from a pharmacist refers to a 75 years old male patient. The patient was vaccinated with lot # (669748/0760AA) ZOSTAVAX (SQ left arm) on 18-NOV-2011. On 19-NOV-2011 the patient developed a rash at the injection site, abdomen, and thigh. The pharmacist stated the rash looked a lot like hives. The patient visited office with physician and the pharmacy for medical attention and treated with prednisone. The rash resolved initially but recurred on the abdomen and thigh if the prednisone was discontinued. The patient was taking prednisone 1mg every other day to control the rash. The patient was not recovered from the events. Additional information has been requested.
103 fever; Chills; Body aces; Stuffy nose; Cough; Fatigue ; Muscle aces; Severe arm pain for 2 days; For treatment- I took Tylenol and Advil as needed for 4 days.
Information has been received from a physician concerning an 18 year old female with a history of attention deficit disorder who on 16-APR-2007 was vaccinated with her first dose of GARDASIL. The patient received her second dose of GARDASIL on 14-Jun-2007. On 19-Oct-2007, the patient received her third dose of GARDASIL. On 03-DEC-2007 the patient had a routine PAP test which was low grade positive for HPV. The patient sought unspecified medical treatment with an office visit. Subsequently the patient has not recovered. Additional information has been requested.
Redness and soreness at injection site started about 10 minutes after getting the injection.  Redness and soreness continue along with itching and some swelling.  Patient came back to pharmacy 8/17/13 at 12:30 PM to talk to the pharmacist.  Pharmacist told patient to take 50mg of diphenhydramine now and to continue OTC while reaction is still present.  Pharmacist also told patient to call back or call dr if rash continues, gets worse, or new symptoms develop such as fever.
This spontaneous report was received from a Registered nurse regarding 14 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 19-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot# N004798 with expiration date: 31-OCT-2019) (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Patient had first COVID-19 Booster vaccination (3rd total Pfizer vaccine) on 12/04/2021.  This injection was given into the Right arm. He reported typical pain at the injection site with no other issues.  Then 2.5 months later, toward the end of February 2022 he began to have intense Right shoulder pain, numbness, tingling, and frank weakness in the right arm and shoulder.  Patient was seen in our orthopedic walk-in clinic on 3/4/22 and was prescribed a methylprednisolone oral steroid taper (Medrol Dosepak).  This relieved his shoulder pains within days and he has not had return of pain since. But Patient had continued to experience weakness and atrophy in muscles innervated by C5-C6 nerve roots. This included his supraspinatus, infraspinatus, deltoid, and biceps muscles.   He also had some decreased cutaneous sensation in the axillary nerve distribution on the lateral right upper arm. His constellation of symptoms after a vaccination with no other injury, trauma, medication change, illness, is consistent with Parsonage-Turner Syndrome (Brachial neuritis/neuralgic amyotrophy).
Dizziness, fatigue, feeling nauseous, swelling at the inject site on the day of the injection, Large circle bruising on the left arm (the bruising has subsided, but is still present), fever, sweating, bad taste in mouth the night of the injection, headache, really bad body aches, feeling irritable, feeling lethargic.
Sudden puffiness around the injection site, a wide red circle about the size of a tennis ball, warm to the touch, very stiff to the touch, some itchiness
Injection site VERY SORE for 36 hours after injection. Impacting ROM. Very achy bones and skin. Headache. Chills. NO fever. Symptoms very intense for 24 hours. Symptoms have lingered throughout the week and have not resolved yet.  Did not experience anything like this with Moderna vaccines.
The patient became flushed and itchy. She is not having trouble breathing. I instructed her to call her md office and follow the directions they give. We got Benadryl from the shelf incase they want her to take some
I have coughing, fever, body ache, diarrhea, vomiting, SOB, and headache. I had a Telehealth visit with my doctor.  These symptoms been going on since Nov 5th.  She gave me an inhaler and antibiotics.  I got a COVID-19 test, positive result.
03/05/22 presents to ED for "abnormal labs (elevated Creatinine)". PMHx of "DM, HTN, HLD and CKD"
Developed fever, chills, fatigue, headache and muscle aches roughly 16 hours after vaccination. Fever resolved 10 hours later. No other symptoms the following day.
Severe Redness, Severe Soreness, Swelling, Severe Itching and Severe Heat at the site of the injection.
Two weeks after I woke with my legs super itchy. I took a Benadryl for it. I saw my doctor and he referred me to a allergist. I was diagnosed with chronic hives from an unknow cause.