chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a female patient who on 10/23/01 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot number 636158/1456K). The patient subsequently experienced pain at the injection site and it was reported that the injection site was inflammed. No further details were provided,and at the time of this report, The outcome of the events was unknown. Unspecified medical attention was sought. The nurse reported that the patient's brother developed cellulitis, injection site inflammation, skin erythema and swelling and experienced injection site pain and muscular weakness following vaccination, on the same day and at the same location, with pneumococcal vaccine 23 poilyvalent (WAES01111425) The nurse also reported that two other consumers developed injection site pain and injection site inflammation following vaccination, on the same day and at the same location, with pneumococcal vaccine 23 polyvalent. (WAES01111426). The reporter expressed a concern regarding the lot. The records of testing prior to release of this lot has been checked and found to be satisfactory. The lot complies with the standards and was released. No further information is available.
7min after vaccination ee developed "dryness , heaviness and need to clear her throat"-- Just on the right side of throat" 25 mg ofBenedryl given-- symptoms resolved.
took 1st capsule had stomach cramps; took 2nd capsule & has blury vision; had sweating of palms & nausea;
This spontaneous report was received from a registered nurse and refers to a 12 months old patient of unknown gender. No medical history, concurrent conditions and concomitant therapies were reported. On 22-APR-2015, the patient was vaccinate4d with an improperly stored dose of VARIVAX (Merck) lot # K021933, expiration date 10-NOV-2016, dose 0.5 ml, subcutaneously (anatomical location was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, as all required information has been received.
No signs of prior illness, developed a fever of 101.7 this morning and within an hour time span became limp and stopped breathing.
Severe fatigue for 5 days, 3 degree temperature for 3 days, pain redness and arm swelling for six days, one period of rapid heart rate, 90/100 for several hours.
7 Day after receiving vaccination, sharp "twitching" pains on my back from waist to shoulders started at 230 AM May 2. No relief from Aleve. Called RPH at pharmacy. Advised Benadryl: 4 pills in a 12 hour period - pain was gone.
Dose one, mouth felt numb.  Dose three (booster) slow and gradual allergic reactions on left side of upper body and head.
Bad sore throat, 102.5 fever, swollen lymph nodes in neck.  Lots of crying.
Within 30 seconds of the shot my heart started racing and my throat went into spasms opening and closing.  This went on for over 45 minutes.  The pharmacist said I was nervous and said I was dehydrated which was why and gave me a Benadryl after 45 minutes which after another 25 minutes the symptoms started to slow down, but never stopped.  I had chills and the feeling of ice water in my veins within 10 minutes of the injections.  He kept telling me my signs were common for someone having an adverse reaction.  I eventually drove home and continued on Benadryl.  The next morning when I woke my throat continued closing I called my doctor(pulmonologist) and headed to the ER.  At the ER I received an epi=pen shot, Toradol, Benadryl, Pepcid and Prednisone.   I was monitored and treated for over 4 hours.  Sent home with directions to see my allergist on Monday (was on the meds from ER for 5 days.  Saw the allergist on Monday, 4/5th (the day I finished all the prescribed meds from the hospital) and she has me on Allegra.
While waiting the required 15 minutes after receiving the Covid-19 vaccine, I felt a warm whooshing sensation start from my hips and go up my sides and down my arms. Then the under sides of my arms felt like they were burning. This occurred within 10 minutes of receiving the vaccine. The burning sensation lasted about 10 minutes. I did experience a few other smaller hot flashes during the next hour. No more after that point. The next morning I discovered a bruise at the injection site.
2 noticable issues-  The first started 12 hours after the vaccination - (Saturday, March 6) Fever, chills, aches, headaches, nausea.  Went away after 24 hours. The second began with profound feelings of mania 2 days later (Monday, March 8). This subsided in 24 hours. 4 days later- (Wednesday March 10) I began having difficulty standing upright.  This steadily became worse over the next several days until one week after the vaccination, where I was hugging walls and crawling on the floor to move from place to place.   This continued until Monday, March 15, when I was hospitalized.  Everything cleared up after 3 days in the hospital.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 27-JAN-2010, the patient was inoculated with the ZOSTAVAX vaccine at a physician office as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 02-JUL-2016, she was treated at a physician office for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Initial report received from a health care provider on 05 October 2007. A female patient (age and date of birth not reported) had received a left deltoid injection of Menactra, lot number U1640AA. The date of administration was reported as "two years ago". The patient had been hospitalized in an intensive care unit and was listed in serious condition with meningitis (group C) at the time of the report. No additional information was provided at the time of the report.  1/8/08 Reviewed hospital medical records which reveal patient experienced sore throat, fever, chills, whole body aches, HA,  which progressively worsened over 4 days.  Returned home from college & went to pcp who noted petechial rash. Admitted to hospital 9/27-11/12/2007 & placed in ICU. Exam revealed BP of 72/50, bilateral rales, tachycardic & tachypneic, globally weak.  Intubated & tx w/steroids,  IV antibiotics & multiple pressors.  ID, pulmonary, renal, hematology, cardiology, vascular surgery, rehab consults done.  Hemodialysis started due to renal failure.  Developed DIC secondary to sepsis & received multiple transfusions of PRBCs & platelets. Eventually stabilized, was extubated & weaned off pressors although hemodialysis continued.  Developed necrosis of finger/toes secondary to purpura fulminans.  Transferred to rehab center for hyperbaric treatment after PE tubes inserted & hemodialysis was to continue as needed at rehab. FINAL DX: meningococcal meningitis & septicemia, resolved; bilateral feet/fingers ischemia with dry gangrene; respiratory failure, resolved; renal failure on dialysis; DIC, resolved.
Patient came to the pharmacy on 10/27/18 reporting that she had experienced a lot of soreness for 2 days after receiving her influenza shot (FLUZONE QUAD) on 10/18/18. She said it hurt too much to move her left arm for approximately 2 days, but has currently recovered except for minor soreness when moving her left arm.
Within four hours of receiving the vaccination, I felt nauseous.  I went home early from work, laid down for a half hour, then felt the need to vomit.  I vomitted several times throughout the evening and night.  I noted a fever of 102 by 6:00 pm, with a rash on my forearms.  I experienced diarreah for a short period of time, in the early evening.  My fever continued until about midnight, vomitting resolved around the same time.
2 months after vaccines, symptoms of low blood counts were apparant.  Bruising, petechia and bleeding gums.  Aplastic anemia was diagnosed on Feb 14th 2005.  Went through drug treament in hospital for a month.  Continuing drug treatment currently.  Was considered in remission at one point after treatment for a year and once the drugs were stopped the condition relapsed.  It took 2mos again for counts to be low like they were at diagnosis and it became obvious it was something that had occurred about 2mos prior to his initial diagnosis that had to have triggered this disease process to occur.  Vaccines were the only thing he had.  Unfortunately a bone marrow transplant is likely in his future.  04/27/2007 MR received for several hospitalizations (3/6-11/2005, 3/14-21/2005, 3/23-26/2005 & 10/5-6/2006) for management of fevers and neutropenia due to recent dx of severe Aplastic Anemia. Initially presented with 8 day hx. of bruising,  petechia, and fevers in February.    Infusaport placed 2/23/2005 for Immunosupressive therapy and potential Bone Marrow Transplant in future. Currently presents (3/6/05)with fever and rhinorrhea. Txd with Abx, Anti-virals, cyclosporine, and transfusions as needed. Final DX: Severe Aplastic Anemia. 1/4/10 Patient is still undergoing Immunosuppresive medication and hopefully will nto relapse again as the medication is slowly being decreased.
ALTE-patient noted to be blue, not breathing, with mucus discharge at mouth and nose.  Recovered spontaneousley s/p back blows by father w/in several seconds. 12/30/2009 MR for 11/19-11/21/2009 Discharge Diagnosis: 1. Apparent life-threatening event. 2. Rule out sepsis. Patient admitted with episode of choking and cyanosis, runny nose and congestion. Tx: IVF, IV ABX, Pulse ox, LP done, Ped neuro consult
Within the first 12 hrs. became nauseated all night. Went to church a few hours later and was severely dizzy, clammy and weak. Went to E.R. my blood pressure was 220/101 and I had already taken my regular blood pressure medicine. They had to give me another Bl. Press. med.
-patients arm (upper) is swollen, red & feels heavy & in pain -stomach was upset -I had our clinic nurse  practitioner look at it - she said rest  & take ibuprofen
This spontaneous report as received from a nurse refers to a 14 years old patient (unknown gender). No concurrent condition, medical history or allergy/drug reactions were reported. On 08-APR-2015, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) GARDASIL injection, dose number 3, lot # K004204, exp. date: 12-JAN-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaint (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
COMPLAINED OF ITCHING. ON 11/20/14 AT 5 AM SHE HAD RAISED RASH, ITCHING, SORE THROAT. THEN ON 11/20/14 AT 11PM SHE HAD NAUSEA. 11/21/14 HAD SHORTNESS OF BREATH.
ONGOING DEBILITATING CONDITIONS; LOTS MANUFACTURED AT THE TIME OF KNOWN CONTAMINATION; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a consumer concerned multiple patients. 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, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced ongoing debilitating conditions, lots manufactured at the time of known contamination, and out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ongoing debilitating conditions, and the outcome of lots manufactured at the time of known contamination and out of specification product use was not reported. This report was non-serious. This report was associated with product quality complaint: 90000272579. The suspected product quality complaint has been confirmed to be voided since this record was identified as a duplicate/follow up to original complaint 90000193699 and all information in this record has been transferred and included in the original report. no new information was received that would impact the outcome of the original report under 90000193699- patient is describing a series of additional side effects for other people, including herself, results of her own investigation for lot 1805031 and general FDA document describing cross-contamination at one of the plants and is looking for safety to reach out to her directly about additional plants and products produced between nov-2020-mar-2021. No new PQCS were reported that weren't already covered under primary case 90000193699. complaints are linked and this case is being submitted for void approval, based on the PQC evaluation/investigation performed. This case, from the same reporter is linked to 20210340967.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case is assessed as non-serious.
About one hour after receiving Pfizer-BioNTech COVID-19 Vaccine EUA, my left arm felt somewhat sore.  About four hours later, I noticed that the injection site was red and raised, about 3 mm wide, surrounded by 15 mm clear flesh, which was surrounded by a blotchy, pink, scaly rash of about 15mm width.  24 hours later, it remains unchanged in appearance.
a lot of pain in my arm; couldn't regular body temperature; pounding headache; fever of 99.6 F; chills; light-headed; as soon as my head hit the pillow, I fell asleep/felt like I had just taken a Benadryl; Tired; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (light-headed), PAIN IN EXTREMITY (a lot of pain in my arm), BODY TEMPERATURE ABNORMAL (couldn't regular body temperature), SOMNOLENCE (as soon as my head hit the pillow, I fell asleep/felt like I had just taken a Benadryl) and FATIGUE (Tired) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 21-Jan-2021, the patient experienced DIZZINESS (light-headed), SOMNOLENCE (as soon as my head hit the pillow, I fell asleep/felt like I had just taken a Benadryl) and FATIGUE (Tired).   On 22-Jan-2021, the patient experienced PAIN IN EXTREMITY (a lot of pain in my arm), BODY TEMPERATURE ABNORMAL (couldn't regular body temperature), HEADACHE (pounding headache), PYREXIA (fever of 99.6 F) and CHILLS (chills). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) on 21-Jan-2021 at an unspecified dose and frequency.   On 24-Jan-2021, DIZZINESS (light-headed), PAIN IN EXTREMITY (a lot of pain in my arm), BODY TEMPERATURE ABNORMAL (couldn't regular body temperature), SOMNOLENCE (as soon as my head hit the pillow, I fell asleep/felt like I had just taken a Benadryl) and HEADACHE (pounding headache) had resolved. At the time of the report, FATIGUE (Tired), PYREXIA (fever of 99.6 F) and CHILLS (chills) had resolved.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medications reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: No significant information received. Updated reporter's email address.
Information has been received from a licensed practical nurse concerning a 19 year old female with seizure disorder, asthma, a papanicolaou smear with epithelial abnormality and cellular changes suggestive of HPV on 15-Mar-2007, and a papanicolaou smear that was negative two years earlier, who on 15-Mar-2007 was vaccinated intramuscularly with a 0.5mL first dose of Gardasil (Lot #654535/0960F).  On 21-Jun-2007 the patient was vaccinated with a second dose of Gardasil (Lot #655617/1447F).  On 13-Sep-2007 the patient was vaccinated with a third dose of Gardasil (Lot #655205/1426F).  Concomitant therapy included albuterol inhaler as needed and a seizure disorder medication (therapy unspecified) that was stopped on an unknown date by the patient before the pregnancy.  On 13-Sep-2007 a urine pregnancy test was taken and was negative.  On 15-Oct-2007 the patient experienced a syncopal episode and a urine pregnancy test was negative.  On 25-Nov-2007 the patient was seen in the office and a urine pregnancy test was positive.  The patient's last menstrual period was 15-Oct-2007 and her estimated delivery date was 21-Jul-2007.  At the time of the report, the outcome of the patient was unknown.  No product quality complaint was involved.  Additional information has been requested.
Immediately after injections pt developed severe sneezing, coughing, itching at injection sites. SX escalated rapidly to anaphylactic rx. Pt treated with Benadryl, Epinephrine, Breathing Tx (Albuterol) Transferred to hospital via ambulance.
Initially after the vaccine I felt fine, after some time I began to feel very tired, drowsy and had a headache. As time past I started to get cold and began to get the chills. At this time I started taking my temperature which was running about 99-100F.  The chills became worse and I felt colder and sicker. My temperature climbed to 102.1 at which time I took some tylenol. My fever continued to climb to 103.1 within the next hour. The chills and fever lasted about 6-8 hours and then went away and I became very hot. I went to sleep that night after taking more tylenol just in case. The next morning I had severe fatigue, mild nausea  and a headache that stayed with me the rest of the day. I ended up going home from work due to the nausea and migraine type headache as well as intermittent chills that would come and go. By the next day 1/22 I was feeling much better over all. However a mildly painful red spot that was warm to touch appeared on my arm where the injection site was that stayed for the next 48 hours before disappearing.
Within minutes after administration the patient reported feeling sick to his stomach.  He looked extremely pale and soon after began vomiting.  He vomited 3 times in the span of about 2 minutes then reported feeling better.  Ten to fifteen minutes later the patient stated he was feeling well enough to leave the store.
mild lightheadedness 20 minutes after vaccine.  Starting on the day following the vaccine- parasthesias in the right and left hands, right occipital region of head.  2 days after vaccine developed generalized muscle fasciculations and muscle fatigue which progressed to weakness (diffuse, worse in arms).  Tinnitus developed in the first week after vaccine.  Symptoms have persisted now 5 weeks out from vaccination (parasthesias have improved, muscle symptoms and tinnitus continue).
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 34-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 01-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported. no treatment drugs were reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up information included no new information.
Developed med size mass underneath left axilla.  Ordered - Levaquin 500 mg tab 1 qdly #10 on 3/30/21 Follow up Visit Post tx was on 4/7/2021 - mass resolved.
Over the course of 7/12/19 and 7/13/19, I experienced the following: Strong muscle aches all over body Stiffness in joints and muscles All over tiredness and weakness Chills Fever Headaches Upset stomach Mild diarrhea  Pain, redness and swelling at injection site  These symptoms began to decline on 7/14/19.  As of 7/15/19, the only symptom remaining is redness, swelling and soreness at injection site.
At 15:30, post vax, states "didn't feel good". At 21:30, complained of tongue felt like it was swelling and throat hurt and was hard to swallow and found it difficult to swallow water. Mom took to ER. Pt was put on penicillin and Tylenol until culture results back. On 11/4/00, still not feeling better. Had vomiting X 1, also felt weak and dizzy. No temperature taken but feels warm to touch and has hot/cold chills. Mom did speak with ER on 11/4/00 to find out culture results. Was told light growth and to continue with penicillin. On 11/7/00, went to MD for follow-up. Mom notes that child's cheeks are bright red today. MD aware and wants child to continue with Tylenol for pain and penicillin until test results are back. Child received adult formulation of Hep-B however, Public Health nurse was told by School Nurse that child did receive dose of Hep-B prior to 11/3/00, but it was the 3rd dose formulation after 2 dose formulation injection was given.
Chills, body aches, headache, fever of 102 (orally), fatigue, nausea, vomiting, pain, swelling, and redness at injection site,.
Patient received flu shot, passed out shortly after - father caught him before hit head on ground - BP 130/66 & pulse 52 shortly after awakening. Came to while paramedics on way - able to sit up - vomited upon standing - paramedics felt just vasovagal response & was not transported to hospital - went home & felt okay couple hours later per mom (when I called to check on him).
2200 - 9-15. 9-15-09 - Presented to E.D. with pain, swelling, redness @ injection site into L supraclavicular region of neck. Also complaining of chest tightness and shortness of breath. BENADRYL and MOTRIN given in E.D. Flu vaccine given 9-14.