chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning an 8 week old male who received his first dose of oral Rotateq. On an unspecified date, he was seen in the physician's office after he had developed sudden bouts of crying and appeared to be in pain. At the time of this report, the physician was awaiting the results of unspecified test but he suspects a diagnosis of intussusception. It is reported that the patient has not recovered. A product quality complaint was not reported. No further information was available. Upon internal review it was determined that intussusception was an other important medical event. Additional information has been requested.  10/23/07 Patient demographics provided by CDC./ss 10/23/2007 Reviewed hospital medical records which reveal patient experienced emesis x 2, diarrhea, irritability, decreased oral intake x 1 week.  Seen by pcp & KUB obtained c/w IS.  Confirmed by BE as outpatient & sent to outlying hospital but they were unable to do the BE for reduction.  Transferred to higher level of care.  Repeat KUB revealed distended bowel but no IS.  Admitted 9/7-9/8/07 for observation s/p reduction. Had recurrent IS s/s.  US of abdomen confirmed IS within transverse colon recurred & air contrast enema successfully reduced.  Surgical consult done. FINAL DX: Intussusception, enema reduced. Records faxed to CDC. 11/30/07 Reviewed hospital ER records which reveal patient seen 9/6/07 with intermittent emesis, watery stools & poor appetite x 4 days.  BE revealed IS & patient transferred to higher level of care.  Records faxed to CDC.
Menstrual bleeding for three months, it stopped though but just wanted to report it now anyways
Pt woke up 5/12/18 with swollen, painful arm. Pt had headaches, body aches and fever up to 103.0. Symptoms lasted 48 hours, was taken to an Urgent Care Facility who recommended continuing ice and ibuprofen for pain.
8-9 cm diameter area of induration, heat, erythema, and tenderness surrounding immunization site.  Pain in upper arm and shoulder. Temp 99.6.  Treatment: Cephalexin 500 mg qid X 10 days
11/06/15 Pt. called at about 1500 - said her face got flushed and hot, and she had some erythema of her neck and chest, but no trouble breathing or swallowing.
Pt. came in on 10/23 and said that since he received his shot on 10/5 he has had a sore arm and shoulder that throbs at night.
When i had my first shot, I noticed that my armpits and breast started to hurt on the 7th day.  It has been like that on and off.  Sometimes it will go a week without then i feel it again.   There were times that it does not hurt for how many days but it comes back.  I never had those pains before the vaccine.  On my second shot i told that to the nurse.  She said she heard that from some people then i read also that more people were having that same effect.  So i tried to ignore it even though it still came and went after the 2nd shot.  I even followed the instructions not to get mammogram and wait 2 months before getting one.  So now it has been 5 and a half months and i have these sudden armpit pains.  They do not last very long though.  Sometimes it is breast but pain goes away .  I just put ice.  I tried to feel for lumps but i have not felt one.  I am scared to get my mammogram now and more scared to take the booster shot until I see what it is doing to my breast.  Can someone enlighten me on this?
Patient called us on 12-26-18 she called about possible reaction to immunizations. Got PREVNAR 13 and Flu vaccine on 12-19-18. Pt reports her (L) arm where she got the PREVNAR 13 was very sore and tender to touch for at least 4-5 days but seemed to get less tender and denies any swelling, but started itching on 12-23-18 and noticed on 12-25-18 she had big round red areas like welts on her back and breast. They are not raised or open, they are under the skin like a welt. Pt can't think of anything different in routine and has not eaten/drank/ etc anything new in the past few days. She was wondering if it was from the vaccines. We had her use BENADRYL and if that does not clear it up she will need to be seen.
Information has been received from a physician concerning a 14 year old female who on an unspecified date was vaccinated with her first dose of Gardasil (lot # not provided).  Subsequently the next day the patient experienced a rash on both of her arms.  On an unspecified date the patient recovered from the rash.  Additional information has been requested.
Patient was scheduled for & received a COVID 19 monovalent booster vaccine during the first week of September 2022. During this same week, the CDC published guidance recommending the bivalent booster for 12 years and up.
Approximately 5 hours after receiving vaccine, onset of severe chills, severe headache, severe body aches, tingling/stinging in face and neck followed by partial numbness in left side of face, incapacitation of left arm from above shoulder (neck) to fingers, severe pain in entire body, joint pain, ending in severe sweating.  After sleeping for a few hours the migraine lingered along with less severe body aches and strong fatigue.  Fatigue lasted another several hours, headache finally resolved after a few more hours.
One day after vaccine, pt developed low grade fever (100.8 ax) poor appetite, less active, fell twice, cried more, some nausea. Seen 5 days after vaccine. Tests showed neutropenia (ANC=238) and alkaline phosphatase 4164. Neutropenia resolved 2 days later. Alk phos normal 10/9/03. Clinically well after one week. Diagnosis: benign transient hyperphosphatasia.
Fever~100.5 for 24 hours Nausea ~ 72 hours Discolored stool~ 24 hours (green) Significant body aches ~24 hours Enlarged left lymph node under left arm with radiating pain~3 days/72 hours
He woke up with a red mark on his leg which continued to get bigger I took him to the doctors office on Dec 3rd they said keep an eye on it.  It is still increasing in size and I am taking him back for possible cellulitis today.
Injection site soreness, headache, muscular aches, fever 100F.  Started yesterday 10/27/2021 about 7:00 p.m. persisting now about 14 hours later October 28, 2021
Swollen left hand, painful and limited range of motion in left arm for 3 days; took NORCO some symptoms improvements after 4 days.
BODY ACHES; SORE GLANDS; SORE ARM; CHILLS; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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 not reported, batch number: Unknown) dose was not reported, administered on 23-AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On AUG-2021, the patient experienced body aches. On AUG-2021, the patient experienced sore glands. On AUG-2021, the patient experienced sore arm. On AUG-2021, the patient experienced chills. On AUG-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, sore glands, sore arm, chills, and headache on AUG-2021. This report was non-serious.
Information had been received on 01-SEP-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a female patient (age unknown) was inoculated with ZOSTAVAX on or about 22-MAY-2016 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles (dosage and lot#/expiration not reported). The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 10-JUN-2016, patient was treated by nurse practitioner for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. Patient has been prescribed VALTREX, gabapentin and triamcinolone for management of her painful symptoms. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
No adverse affects reported; reported a expired dose of VAQTA was administered to patient; This spontaneous report was received from a Medical assistant concerning to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions, allergies, and concomitant therapies were not reported.     On 07-JUN-2019, the patient was vaccinated with one expired dose of hepatitis a vaccine, inactivated (VAQTA) vial 50 by intramuscular route (strength and dose and were not reported; lot # R013515 with expiration date 30-MAY-2019) for prophylaxis. No adverse effects reported.   Lot number and expiration date were reported in the source document. But, when entering the lot number in the system automatically auto-populated the correct expiration date, which sometimes may differs from the expiration date reported by the source.
nauseated; headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and NAUSEA (nauseated) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     Concomitant products included NAPROXEN SODIUM (ALEVE) for Adverse event, LORAZEPAM and VENLAFAXINE HYDROCHLORIDE (EFFEXOR) for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced HEADACHE (headache). On 18-Mar-2021, the patient experienced NAUSEA (nauseated). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. At the time of the report, HEADACHE (headache) and NAUSEA (nauseated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications include blood pressure medications and thyroid medications.
She began feeling symptoms early morning of April 7th and vomited twice.  She managed to get back to sleep.  She coughed all through the night.  We were traveling and was coughing so hard and often we stopped at an urgent care.  They listened to her lungs and stated she didn't have pneumonia or bronchitis.  We got her cough syrup.  She was very weak when exiting the car.  She did not run a fever and did not have any other symptoms except a runny nose.  She tested positive for COVID-19 on April 19, 2023.
Received Men B vaccine (2nd dose) yesterday morning at a well visit; soon after, developed a lot of swelling of upper right arm, progressed during the day. Difficulty moving arm, a lot of pain, unable to sleep due to pain, no numbness or tingling, but hurts to even move elbow/hand. Tried ibuprofen. Diffuse swelling to upper arm, no redness, swelling to elbow, normal circulation. Patient treated with cool pack; arm sling; tried ibuprofen, but also provided with Tylenol 3 as needed for severe pain.
Swelling in arm where shot was administered from injection site to above elbow. Redness, hot to touch, felt like a burning sensation. Pain. Stiffness. Uncomfortable to sleep on that arm .
This study case was received from the investigator on 04 June 2012. A subject received the following vaccinations on 12 March 2012: an injection of ACAM2000 (lot number not reported), TYPHIM Vi (lot number not reported) and anthrax (manufacturer not reported). On 22 March 2012, the subject was diagnosed with unspecified disease of pericardium. Medical history was not reported. The outcome was not reported. Additional information will be requested from the investigator. There is no reported causality assessment as this is a safety surveillance study. Documents held by sender: None.
left arm swollen, red, itchy and "feverish. Patient went to the clinic initially provided "bactrim" - helpful with cellulitis. Patient then went to the Emergency Department 2/6/21 - for fever and body aches. Chest xray/labs/UA done with negative results. Recommended to stop bactrim and sent home.
Pt was seen in ER Thurs evening c/o red, raised area 2in wide, sore to touch at vaccine injection site. Hydrocortisone crm applied to area as well as 1 1/2 tsp. of BENADRYL.
Next day after injection, site very sore, all over body aches & pain, My Hair Hurt!  Unable to get out of bed without debilititating pain. Repeat of the about after the second dose. Have been in a downward spiral since.  Exhausted all the time, just extremely tired and unable to do physical activities.  Had chest pains and went to the ER.  Was hospitalized over the weekend and tested Monday.
Wheezing. Was given Depo Medrol IM and Benadryl IM and sent to ER. Pt improved by time seen in ER.
Case number PHHY2011US114396 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 440196) website on 30 Dec 2011. This report refers to a 12-year-old male patient. The patient medical history included ZYRTEC allergy. He was vaccinated with MENVEO vaccine (batch number: M10126A) intramuscularly in to the let arm on 20 Oct 2011. This patient also received BOOSTRIX vaccine (manufacturer: GlaxoSmithKline biologics with batch number: AC52B072FA) intramuscularly in to the right arm. After one day of vaccination, the patient had fever and his body temperature was found to be 103.9 degrees on 21 Oct 2011. The patient body temperature was found to be 102.3 degrees on 22 Oct 2011 and within normal limit on 25 Oct 2011. The outcome of the events was reported as condition recovered. The causality was unknown. Upon internal review performed, according sales data, Tdap vaccine was changed to BOOSTRIX.
There was pain, swelling and inflammation at the injection site. Went to the Dr when the swelling was a little bigger than a plumb. They prescribed antibiotics and the infection seemed to clear up, but I was/am still experiencing inflammation and a burning nerve pain in the area of the injection, that radiates down my arm. If I push the use of that arm the pain becomes almost unbearable, and I experience numbness and muscle spasms all the way to my fingers. Upon further diagnosis (X-ray and MRI) I was diagnosed with Scoliosis, which wasn't a pre-existing condition as far as anyone was aware.
I had suddenly developed complete paralysis from the waist down - no control, no feeling, no nothing. I have had this happen other time in the past but not as severe. This time I started to recover but collapsed again and I did this three times in a space of 15 minutes. The only difference is that this time, I did not fully recover. I had a friend take me to ER - Hospital. They noted that my potassium level was low so they gave me a large dose of that mixed with orange juice. I did have a follow up MRI on the 10th of October - it showed that my lower back is in pretty bad shape.  My primary care physician has referred me to a spine specialist. I am currently waiting for approval from the insurance company.  I am having to use a walker now. Unknown at this point if I am permanently  disabled. Immediately after the vaccine: I experienced everything you get with the flu except a fever. I had fatigue, body aches, chills and my shoulder swelled - injection site - up like an ostrich egg. All the symptoms were gone in a day.  Note: Flu shot on August 18th, 2021 on the right arm - Quadravalent (Super dose for seniors)
Patient received second dose of moderna and while in observation area starting having uncontrollable nose bleed. EMS transported patient to hospital . While in transport  started having increase heart rate and chest pain.
This spontaneous report was received from other health professional refers to an unspecified number of patients of an unknown age. The patient's past medical history and concomitant medications were not reported. On an unknown date the patient was vaccinated with improper stored ROTATEQ (incorrect product storage) lot # M035456 expiry date of 01-MAY-2018 (Dose, frequency, route, and start date unknown) for prophylaxis. No adverse effects reported.  This one of the 3 reports. Additional information has been requested.
Fever from appx. 2:10 AM 'til 5:30 AM.
Chills, coughing, exhaustion & fatigue, no appetite, throat felt closed up. Symptoms lasted about 2 days. They started about 4 hrs after shot. Also blowing nose & sneezing.
diagnosed with COVID; Itchy at site of injection; Redness which is now 2 inches at injection site; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (diagnosed with COVID ), VACCINATION SITE PRURITUS (Itchy at site of injection) and VACCINATION SITE ERYTHEMA (Redness which is now 2 inches at injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     The patient's past medical history included Chemotherapy since an unknown date.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy at site of injection) and VACCINATION SITE ERYTHEMA (Redness which is now 2 inches at injection site). On 12-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (diagnosed with COVID ). At the time of the report, SARS-COV-2 TEST POSITIVE (diagnosed with COVID ), VACCINATION SITE PRURITUS (Itchy at site of injection) and VACCINATION SITE ERYTHEMA (Redness which is now 2 inches at injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, SARS-CoV-2 test: positive (Positive) diagnosed with COVID.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.; Sender's Comments: Very limited information regarding these events has been provided at this time. The patient probably experienced asymptomatic COVID-19 infection before being administered with the mRNA-1273 vaccine.
Pain, swelling, lump in arm and redness spread to elbow. She has taken TYLENOL and ALEVE. She has felt weak. Cold compresses to arm. She plans to take BENADRYL.
Within 5 days of second dose of vaccine I began having shortness of breath and a heavy feeling in my chest that would come and go fairly frequently.  On June 12, 2021 I saw Dr. and reported those symptoms.  He listened to my lungs, ordered a chest x-ray and an EKG as well as blood tests and everything came back fine.  I am still experiencing the symptoms, although less frequently than before.
NAUSEA; HEADACHE; TIREDNESS; LIGHT FEVER; BODY ACHES/PAIN; DIARRHEA; This spontaneous report received from a consumer concerned a 52 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included lupus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 17-APR-2021, the subject experienced diarrhea. On an unspecified date, the subject experienced body aches/pain, nausea, headache, tiredness, and light fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body aches/pain, nausea, headache, tiredness, diarrhea, and light fever. This report was non-serious.
Potentially got their doses from vials punctured longer than 12 hours ago; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Potentially got their doses from vials punctured longer than 12 hours ago) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Potentially got their doses from vials punctured longer than 12 hours ago). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Potentially got their doses from vials punctured longer than 12 hours ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.
With both doses I've had headaches and dizzy spells, as well as, the normal redness and swelling. However with this second dose, the dizzy spells have been accompanied with blurry vision and have been so bad that I can't drive and I fainted. I walked to my bed and got very dizzy, my vision blurred and everything went dark. Next thing I remember, I was on the floor and it was a half hour later than when I headed to bed.
Nurse realized after administering the vaccine that she administered the diluent ONLY and not the reconstituted vaccine.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Sep2022 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "asthmatic" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received covid-19 treatment (lot number: 2692134) on 05Nov2022 and was stopped on 10Nov2022.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt woke up the next morning (8/10/18) and notice his lower lip swollen. Denies SOB/DOB/throat swelling.
this patient is 10 and was given pfizer vaccine for age 12 years and older. Any possible side effect/symptoms are not known at this time
Pt recvd 2 doses of Engerix-B on 26JUN91; 1 wk p/each dose, pt devel red itch rash under lt arm pit; pt treated rash w/alcohol, vitamin E & vaseline;
Patient discharged after 2 days in hospital. Patient is a 79 y.o. male with PMHx of BPH, Nicotine dependence, CAD s/p stenting in 2020 admitted due to COVID-19 pneumonia. Symptoms present for 37 days. CXR demonstrated bibasilar pneumonia. CTA demonstrated no PE, Bronchitis with LLL mucous plugging with infection, Opacities in RLL, New RUL 9mm nodule, small right pleural effusion, right hilar and mediastinal adenopathy. He was treated with decadron for 3 days. He did initially require 2L via NC of supplemental oxygen but was able to be quickly weaned to room air. He improved both clinically and in lab findings prior to discharge. He was discharged home in stable condition to complete 10 day decadron course.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender, who on 02-JUL-2013, was vaccinated with a dose of ZOSTAVAX 0.65 ml, subcutaneously (lot # not reported). The pharmacist noted that as she was removing the needle after administering ZOSTAVAX to a patient, a drip of fluid was expelled from the injection site. No adverse effect was reported. Additional information has been requested.