chrisvoncsefalvay/vaers-outcomes huggingface dataset:
In the evening of 4/6/2016 I had a fever of 99.4F and I noticed swelling and redness at the injection site (left shoulder). Thursday 4/7/2016 my fever went up to 101.6 and the injection site and the left side of my arm/ shoulder area was bright red, very itchy, painful to the touch, swollen, with a few small blisters popping up. I put cold compresses on it the heat of the site came right through the compress. I  took 600 mg of ibuprofen for pain and to reduce the fever. On Friday the fever was back down to 99F, but the site was still swollen, itchy, bright red, and blisters. Went to the Drs office that day. Took Clindamycin 4 tines a day for a week.
It was reported in a newspaper article that a child in who had received the full primary series of PEDVAXHIB (manufacturer unknown) (dates not reported) died of Hib disease, in 2008 a spokeswoman for the Health Department reported. She was unable to provide more details. No further information was available.   4/20/09 FDA spoke with the NJ health authority.  The child received 3 doses of HIBV (unknown brand) and died of a brain abscess.  The official did not know whether an autopsy had been performed, nor whether the abscess was cultured..
Patient previously received all Pfizer Covid vaccines.  She received Moderna Bivalent and stated that several days later she had a rash that comes and goes all over her feet and legs or arms and hands.  She has been taking oral Benadryl, but the rash, according to the patient can make it difficult to walk once it appears.  She states that it can only be due to the vaccine and no other cause.
swollen testicles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 11Mar2021 15:00 (Lot number: EN6207) at the age of 60 years as dose 2,single for covid-19 immunisation. Relevant medical history included: "Lyme disease" (unspecified if ongoing); "seperated adenoma of colon", start date: 14Jul2014 (ongoing); "spondylosis of lumbar region", start date: 12Sep2021 (ongoing); "asthma", start date: 11Nov2005 (ongoing). Concomitant medication(s) included: HYDROCODONE; MORPHINE. Vaccination history included: Bnt162b2 (DOSE 1,SINGLE, time-15:00, lot number-EN6201, route-intramuscular, anatomical site-left arm), administration date: 18Feb2021, when the patient was 60 years old, for COVID-19 immunization; Influenza (lot number-UT7336NA, anatomical site-Left deltoid, no.of previous dose-3, route-intramuscular), administration date: 29Sep2021, when the patient was 60 years old. The following information was reported: TESTICULAR SWELLING (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "swollen testicles". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101308295 same patient/drug, different dose/event
10/8/21 received COVID booster, reports she was very tired the day of and the day after.  Reports she woke up on 10/10/21 with nausea and some dizziness.  Reports dizziness comes and goes especially with walking, but resolves after a few minutes.  Reports nausea comes and goes.  Denies being sick.
sepsis; complications during knee replacement; aching all over her legs aching in the middle,whole legs aching; bones pain; aching in the joints, aching in the ankles,aching in the elbows and hip, the joints kill her, her artificial knee it's aching as well; aching all over,the muscles kill her; headaches off and on; This spontaneous case was reported by a consumer and describes the occurrence of SEPSIS (sepsis) and COMPLICATIONS OF TRANSPLANT SURGERY (complications during knee replacement) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  The patient's past medical history included Knee replacement in March 2021. Concomitant products included ATENOLOL, LISINOPRIL, METFORMIN, MONTELUKAST SODIUM (SINGULAIR), ALPRAZOLAM (XANAX), ACETYLSALICYLIC ACID (BABY ASPIRIN), DULOXETINE and VITAMIN D NOS for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SEPSIS (sepsis) (seriousness criterion medically significant), COMPLICATIONS OF TRANSPLANT SURGERY (complications during knee replacement) (seriousness criterion medically significant), PAIN IN EXTREMITY (aching all over her legs aching in the middle,whole legs aching), BONE PAIN (bones pain), ARTHRALGIA (aching in the joints, aching in the ankles,aching in the elbows and hip, the joints kill her, her artificial knee it's aching as well), MYALGIA (aching all over,the muscles kill her) and HEADACHE (headaches off and on). The patient was treated with PARACETAMOL (TYLENOL) for Ache and Headache, at an unspecified dose and frequency. At the time of the report, SEPSIS (sepsis), COMPLICATIONS OF TRANSPLANT SURGERY (complications during knee replacement), PAIN IN EXTREMITY (aching all over her legs aching in the middle,whole legs aching), BONE PAIN (bones pain), ARTHRALGIA (aching in the joints, aching in the ankles,aching in the elbows and hip, the joints kill her, her artificial knee it's aching as well), MYALGIA (aching all over,the muscles kill her) and HEADACHE (headaches off and on) outcome was unknown.            Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Case may be confounded by recent knee surgery. Further information is expected.   This case was linked to MOD-2021-276513 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Case may be confounded by recent knee surgery. Further information is expected.
3/17/04, Erythema & mild swelling right thigh 16cmX13cm. Induration in the middle 12X12cm vesicular eruption 4 cm X 3.5 cm. Non-tender or minimally tender. Walks without much difficulty & symptoms started within 24hours after shots.
Right arm immunizations given first, Adacel then influenza.  Left arm next: HPV first then Menactra.  Patient passed out after menactra administered, Layed down on bed. Patient given cool water bottle to put under neck and ice pack to put on forehead. Patient encouraged to stay laying down on exam table. Provider re-examined patient and she was okay for d/c after about 20 mins.
I got very short of breath, I felt like someone hit me in my chest, I could not breath. My doctor told me to go to the emergency room and I was admitted to the hospital on November 14, 2022. They found fluid around my heart and in my lungs. They said this is what was causing my shortness of breath. My doctors have changed my medications and added some to my daily regime. It took me two months, but I feel that I back to being myself.
seizures; dizziness; fatigue; passed away; This is a spontaneous report from a contactable Consumer. This Consumer reported for a 33-year-old male patient (friend) who deceased who received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number unknown), via an unspecified route of administration on an unknown date in Mar2021 at a single dose for COVID-19 immunization. The reporter wanted to know if there were any reports or information on patients having severe seizures or blood clotting, he was trying to find out for some information on similar adverse events that occurred with the Johnson & Johnson COVID vaccine, but from receiving the Pfizer-BioNTech COVID-19 vaccine the person that had the severe reaction went to the doctor and the doctor said it was highly unlikely from the vaccine. The reporter tried to look online for potential side effects, to help the family provide some type of (information about this). The reported stated the patient was very healthy, young 33 years old, never had a history of seizures, he had no past medical issues. He received second dose middle of march, he passed on 13Apr2021. On the third week after receiving second dose, he started experiencing dizziness and fatigue that later progress into seizures, he was admitted into the hospital, and was no longer under control. Doctors said was highly unlikely it was from the vaccine however every test came back negative; X-Rays, biopsies, everything negative. The patient deceased and outcome of the events was unknwon.  Information on the Lot/Batch number has been requested. ; Reported Cause(s) of Death: passed away
This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), PYREXIA (Fever), HEADACHE (Headache), EYE DISORDER (Eye abnormality) and DIARRHOEA (diarrhea) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. No Medical History information was reported. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced URTICARIA (Hives), PYREXIA (Fever), HEADACHE (Headache), EYE DISORDER (Eye abnormality) and DIARRHOEA (diarrhea). At the time of the report, URTICARIA (Hives), PYREXIA (Fever), HEADACHE (Headache), EYE DISORDER (Eye abnormality) and DIARRHOEA (diarrhea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication use was not provided. Treatment information was not provided.
Redness and swelling to right arm, subjective fever reported by patient - began the day after vaccines were given.
Fever, tachycardia, SOB, headache 24 hours TDAP/Flu last 1 hour; headache persisted 24 hours. Also chills/myalgias.
Nerve pain radiating from the injection site down to wrist, slight headache, and some congestion.
19JUL96 pt punctured finger w/contaminated needle;pt last TD in 1989;pt exp onset of aching in arms & hisp-2 days p/vax;also reports diaphoretic episode & feeling faint;mom was allergic to tetanus toxoid inj;
Vaccine site tender since injection, redness on right arm noted on 08/24/2005.  Temperature 99 degree, blood pressure 54/69.  Ice applied on 08/24/2005.
Pain in entire muscle at injection site, flu-like symptoms (headache fever chills body ache fatigue).
Patient was hospitalized for psychosis, acute kidney injury on CKD, UTI, and failure to thrive. Patient acquired COVID-19 on day 10 of hospitalization.
Pain and swelling with numbness into left arm and into neck. Also body aches and chills with cramps in arms and legs. Feelings of restless, stomach upset. Knee charley horses.
R upper arm became red and swollen on 8/3/07. Significant redness noted on 8/8/07. Tissues warm to touch. Tissues involved included around injection site to just above elbow. Seen doctor 8/8/07. Conservative tx ordered: Benadryl, Ibuprofen, Cool packs. No future tetanus containing vaccines.
I was exposed to COVID-19 on Sunday. I started feeling symptoms on Monday of scratchy throat, mild headache, and tiredness. I tested negative on Monday, but I retested on Tuesday and was positive. My sore throat was worse on Tuesday with a more intense headache, and runny nose. I contacted my doctor to try to get PAXLOVID, but they couldn't prescribe it to me at the time. My headache and sore throat went away after a couple of days. I just had a severe runny nose and head cold symptoms. I also kept coughing up phlegm although I didn't have chest pain. Although my symptoms went away, I was still extremely exhausted two weeks after that. I also had a pretty severe break out with my lichens sclerosis.
30 min after administration the left side of my face went slightly numb.  I also got a really bad head ache and nausea. Also neck stiffness on the same side of injection side. Next day numbness in face had gone away. But head ache and nausea was the same if not worse. Also stiffness in neck was still there.
fever; aches; hair loss; arm became very sore; was hot to the touch, felt like sunburn; was hot to the touch, felt like sunburn; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Nov2021 13:00 (Lot number: FH8020) at the age of 54 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Colitis ulcerative" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Morphine, reaction(s): "Known allergies: Morphine". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FH8020, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 18Oct2021, when the patient was 54 years old, for COVID-19 immunization, reaction(s): "Fever", "aches". The following information was reported: PYREXIA (disability) with onset 20Nov2021 16:30, outcome "not recovered", described as "fever"; PAIN (disability) with onset 20Nov2021 16:30, outcome "not recovered", described as "aches"; PAIN IN EXTREMITY (disability) with onset 13Nov2021, outcome "not recovered", described as "arm became very sore"; FEELING HOT (disability), HYPERAESTHESIA (disability) all with onset 13Nov2021, outcome "not recovered" and all described as "was hot to the touch, felt like sunburn"; ALOPECIA (disability) with onset 20Nov2021 16:30, outcome "not recovered", described as "hair loss". The patient underwent the following laboratory tests and procedures: body temperature: 102. Therapeutic measures were not taken as a result of pyrexia, pain, pain in extremity, feeling hot, hyperaesthesia, alopecia. Clinical course: On 20Nov started noticing hair loss, as of today 01Jan2021 hair continues to fall out and I have about 1/3 of volume left then prior to vaccine, noticed when I put a baseball hat I had not worn since October, I had to adjust back to tighten as hat was too loose on my head due to hair loss. Patient had not received any vaccine in last four weeks.  No follow-up attempts are possible. No further information is expected.
Pt was admitted for acute on chronic lumbar back pain and was tested for COVID due to nursing home placement.  He is currently asymptomatic.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 9:41 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 9:41 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was reported as 45.84. Concomitant products were not provided. For Lot no : 041L20A on 11-Jan-2021, excursion time was 09 AM and 2 PM and temperature was 34 and 35 respectively, total doses given for the day was 98, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 08-Jan-2021 and was moved to clinic on  11-Jan-2021. 9 vials was sent to clinic. Vaccine BUD date was 07-Feb-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
Pt recvd Hep B vax & 1 yr ago devel joint pain, generalized edema & desquamation; was unsure if events occurred p/1st or 2nd dose;
Fever 102.8, body aches, chills, headache.  Taking ibuprofen & Tylenol.  Will contact PCP if symptoms continue or worsen.
This case was reported by a healthcare professional and described the occurrence of strange taste in an adult subject of unspecified gender who was vaccinated with Fluarix (GlaxoSmithKline). Previous and/or concurrent vaccination included DTaP; manufacturer unspecified given on 9 December 2007; hepatitis B vaccine recombinant; manufacturer unspecified given on 9 December 2007; hepatitis A vaccine inactivated; manufacturer unspecified given on 9 December 2007. On 9 December 2007 the subject received unspecified dose of Fluarix (.5 ml, unknown) intranasally (intramuscular formulation administered by other route) and experienced a funny taste. The same day, the subject was later vaccinated with Fluarix and experienced accidental overdose. No other adverse events were reported. In December 2007, the events were resolved. Outcome of accidental overdose was not specified. The healthcare professional considered the events were probably related to vaccination with Fluarix (causality not provided for accidental overdose). Follow-up information received on 14 January 2008 indicated that the intramuscular formulation of vaccine was mistaken as "Flumist" and administered intranasally. There were no other adverse events other than "bad taste."
2 nose bleeds in one day, one in the morning (about 11am), one at night (about 10:30pm). Both were longer/heavier than any others previously had (nose bleeds do not occur frequently).
Itching and red whelps on skin, diarrhea, upset stomach, swollen lymph nodes, fever, chills, vomiting, respiratory issues, runny nose, coughing, sneezing, hoarseness.
This spontaneous report was received from a nurse practitioner and refers to a 13-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions and information about concomitant medications were not reported. On an unknown date, the patient was inadvertently vaccinated with PROQUAD injection (therapy type, dose, route of administration, lot # and expiry date were not reported) for prophylaxis. Concomitant therapies included sterile diluent (manufacturer unknown). No adverse effects were reported.
First dose on 08/26/2020, second dose on 08/30/2021; This case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too long in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 7292M, expiry date 16th April 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received 26th August 2020).   On 30th August 2021, the patient received the 2nd dose of Shingrix. On 30th August 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The physician reported that, the patient received 2nd dose later than the recommended time interval, which led to lengthening of vaccination schedule. The reporter asked if needed to do titers because the dosing was not within your guidelines The reporter consented to follow up.
Information received on 11MAY2016 from GlaxoSmithKline. The female subject was enrolled in a blinded study sponsored by GlaxoSmithKline. An approximately 28 year old female experienced drug exposure during pregnancy and a subsequent spontaneous abortion following the administration of BioThrax or BioThrax and study drug raxibacumab plus diphenhydramine which was considered medically significant. It was reported that the subject's last menstrual period was 23AUG2015 with an estimated date of delivery calculated as 29MAY2016. On 03SEP2015 and 17SEP2015 (also reported as 27SEP2015), she received BioThrax or BioThrax and study drug raxibacumab plus diphenhydramine (blind not broken). The subject received BioThrax or BioThrax and raxibacumab beginning at week 1 of the gestational period. The subject reported that she had been emotionally stressed caring for other small children, lack of sleep and financial burdens but no reports of trauma or confounding factors.  Subject stated that her birth control was oral norethindone 0.35mg qd, first dose estimated AUG2015. In October 2015, a urine pregnancy test was performed to confirm pregnancy. On 25NOV2015, 83 days after the first dose of BioThrax or BioThrax and raxibacumab, she experienced spontaneous abortion at 13 weeks gestation (also reported as 10 weeks and 5 days of gestation). The outcome of the spontaneous abortion was considered recovered/resolved on 25NOV2015.  The pregnancy ended in a spontaneous abortion at less than 22 weeks gestation with no apparent congenital anomaly present. Treatments: none reported. Concurrent medical conditions included: stress, fatigue, and financial burdens. Concomitant medications included: prenatal vitamins and oral contraceptive norethindrone. Relevant laboratory/diagnostics: urine pregnancy test to confirm pregnancy (October 2015). The investigator considered that there was no reasonable possibility that the spontaneous abortion may have been caused by BioThrax or BioThrax and Raxibacumab plus diphenhydramine. No additional information is expected. World Wide #: US-GLAXOSMITHKLINE-US2015GSK144306.
soreness @ site; twenty five cents area of reddness surrounding site tiwtching @ site;
Early morning on 2/27/2021 started experiencing some nausea, cough, runny nose, scratchy throat and mild headache. Persisted throughout the day on Saturday and overnight. On Sunday 2/28/2021 had bad headache, joint and muscle pain, cough, extreme fatigue, nausea and chills.  Symptoms are persisting into today 03/01/2021.
This spontaneous report as received from a registered nurse refers to 3 patients of unknown age and gender. Information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was not provided. On an unknown date, the patients were vaccinated with PROQUAD (dose and route of administration were not reported, lot# reported as M021729, expiry date on 29-OCT-2017) that was not delivered to the office on time due to a hurricane. No adverse symptoms were reported. No product quality complaint was involved. Additional information has been requested.
Fatigue and Fever 101.5 degrees. Gave Motrin and within 2 hours temp. returned to normal. Could also see a few hive-like blemishes on face that disappeared overnight. Fever gone next morning.