chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received the influenza vaccine around 11 AM in her left arm. At around 3 PM, she began developing a hive-like rash in her left armpit, along her left bra line. The rash quickly spread all over her body and was quite itchy. She did not have any swelling of her mouth, tongue, or airway. She called the clinic at 5 PM, was told to take BENADRYL. The patient has continued to have severe flares of all-over hives (at least through Saturday 3/10/18). BENADRYL helped but she had to take large doses on a regular basis to keep the rash under control. She was advised to go back to the health clinic to be examined but she said she was unable to due to work demands.
Patient had history of fainting noted on  patient also notified immunizer of history.  Vaccine was administered and patient appeared to be ok.  She was told to have a seat and wait 30 minutes to ensure patient safety.  Immunizer notified me/pharmacist of patient's history and staff was informed to watch her for any adverse events.  5-10 minutes later patient walked up to counsel window and notified pharmacist she was going to faint.  I asked her to please return to her seat and immediately a technician and I went out and assisted her to a chair.  We provided a bottle of water and advised her to sip some.  After a few more minutes she passed out in the chair.  At that point we called 911.  The operator advised us to lay her flat.  We moved her into the training room and waited for EMT to arrive.  They arrived a few minutes later.  At that point she was beginning to come around.  I left to return to pharmacy as she was being cared for.  20 minutes later the EMT consulted me and patient vitals were good and she was feeling much better and refused to be transported to hospital.  I signed off their form as a witness of her refusal.
inject site hot & red, itchy; extensive area involving most of upper arm from elbow to the shoulder; seen by MD & dx w/cellulitis;
SORE ARM; MILD CHILLS; ALLERGIES ACTING UP; 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 not reported, batch number: Unk) dose, start therapy date were not reported 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 an unspecified date, the subject experienced sore arm, mild chills, and allergies acting up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm, mild chills and allergies acting up was not reported. This report was non-serious.
MMRV and FLUARIX given in left thigh in a pt with recent diagnosis of Type 1 Diabetes (1 month ago), with cellulitis several hours after vaccine given at injection site.
This spontaneous report was received from a physician via Pfizer (other company number 2015386420) and refers to a currently 74 years old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX23 (lot #, expiration date, dose, route of administration and indication were not reported). On an unknown date, the patient experienced drug allergy to PNEUMOVAX23. The patient also experienced arm swelled on an unknown date. The outcome of the events was unknown. The event of drug allergy to PNEUMOVAX23. The relatedness between the event of arm swelled and PNEUMOVAX23 was not reported. This is one of several reports received from the same reporter regarding the same patient. Additional information has been requested.
patchy red rash all over; patchy red rash all over; hands/feet were swollen; lips were swollen; she was allergic to in the vaccine; This spontaneous report was received from a currently 23-year-old female nurse, concerning herself. The patient stated that she was allergic to a lot of different antibiotics. Information regarding the patient's medical history, historical drug and concomitant therapies were not provided.  On 08-APR-2009 (when the patient was 11 years old), the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) (dosage regimen, route of administration, lot number and expiration date were not provided) for prophylaxis.  On 09-APR-2009, the patient experienced a severe reaction to the vaccine; she had symptoms of patchy red rash all over, hands and feet were swollen and lips were swollen. She spoke with her pediatrician and they were never able to determined what she was allergic to in the vaccine. She stated that she reviewed the ingredients in the varicella virus vaccine live (Oka/Merck) (VARIVAX) vaccine and believed that it could have been the neomycin content since she is "allergic to a lot of different antibiotics" (reported above)  The outcome of the patchy red rash all over, hands and feet swollen and lips swollen was not reported. No causal relationship was reported.
SALIVA IS CONSTANTLY COMING UP, JUST ACCUMULATING IN BACK OF THROAT; NOT FEELING SO GREAT; HIGH FEVER; WANTED TO PUKE/ FEEL LIKE THROWING UP; FEVER BLISTERS; SO SICK; PERSISTENT ABDOMINAL PAIN; HEAD THROBBING; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no difficulty in walking after vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 20-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 20-SEP-2021, the patient experienced head throbbing. On 21-SEP-2021, the patient experienced so sick. On 21-SEP-2021, the patient experienced persistent abdominal pain. On 21-SEP-2021, the patient experienced fever blisters. On 21-SEP-2021, the patient experienced high fever. On 21-SEP-2021, the patient experienced wanted to puke/ feel like throwing up. On 22-SEP-2021, the patient experienced saliva is constantly coming up, just accumulating in back of throat. On 22-SEP-2021, the patient experienced not feeling so great. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from head throbbing, persistent abdominal pain, saliva is constantly coming up, just accumulating in back of throat, and wanted to puke/ feel like throwing up, and the outcome of high fever, not feeling so great, fever blisters and so sick was not reported. This report was non-serious.
6 days s/p vaccine to (R) deltoid - 6 cm by 6 cm erythema and warmth, localized to vaccine injection site w/ subsequent satellite lesion just medial to vaccine localized reaction - 2 cm by 4 cm. Pt started on KEFLEX for concern of concurrent cellulitis w/ associated anterior axillary lymph node erythema. Pt otherwise well appearing.
Night sweats, chills, fever, body aches, itching all over body more so in face and in arm, pain in arm where shot was given,  stomach ache, nausea, lightheaded, headache, felt as if I could blackout (pass out)
Information has been received from a physician, concerning a 25 year old female patient with no pertinent medical history and no known allergies, who on 06-SEP-2007 was vaccinated in the left arm ("in the p.m.") with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # not known). There was no concomitant medication; there was no illness at the time of vaccination. On 11-SEP-2007 the patient experienced tenderness around the injection site. On 12-SEP-2007 the patient developed a "red ring" that continued to grow in size until 14-SEP-2007, when the patient visited the office and treatment with an antihistamine (unspecified) and antibiotic (unspecified) was initiated. On 17-SEP-2007, the patient had recovered events. Additional information has been requested.
COVID; has now missed a dose of GARDASIL 9; This spontaneous report was received from a pharmacist via a company representative and refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided.  On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (exact dose, injection site, route of administration, lot # and expiration date were not reported) for prophylaxis.  On an unknown date, the patient got COVID, then waited two weeks and on an unknown date (reported as "now"), has missed the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) . The outcome of the events was unknown. There was no causality assessment provided by the reporter.
Second Shot; First Day I was fine. Second Day I was freezing cold (feet, hands, nose, teeth chattering), No appetite. Third Day arm has a red circle  and the muscle is hard around injection site and felt completely drained all over my entire body. No appetite, began to eat in the evening. This is my Fourth Day feeling almost normal, arm is still red and hard where injection was administered.
Symptoms started the following evening approx. 6 pm on the 24th, had nausea, fever, malaise, headaches, arm was swollen and reddish and the site was painful. Symptoms lasted about 3-4 days by the 26 th in the afternoon it started faded way. Took Tylenol on the 24th.
headache, right sided neck pain, muscle tightness, dizziness that worsened when took maxalt.  Had unusual response of dizziness and nausea after taking maxalt.
Information has been received from a physician concerning a patient who on 20-AUG-2007 received an oral dose of Rotateq. It was reported that the patient's mother contacted their physician because her baby on 27-AUG-2007, had experienced intussusception and that the patient was being quiet". The patient was hospitalized and subsequently under went surgery, "but specifics were unknown". It was reported that the patient recovered. A product quality complaint was not reported. No further information was available. Intussusception was considered to be an other important medical event by the reporter as it required surgery. Additional information has been requested. 10/22/07-records received for DOS 8/27-/8/28/07-DC DX: Ileocolic intussusception. Two days prior to admission onset of crampy abdominal pain and diarrhea. Hydrostatic reduction attemtped, unsuccessful. Surgical reduction.
Linear isolated raised erythematous areas on left arm. Benadryl given at 3:13p. Pt complains of right side of tongue and throat feeling full. Refused EMT, another Benadryl given at 4:05p. No visible swelling upon assessment.
Patient reports that immidiately following administration of Tdap that she had pain at injection site in left arm only. Later that evening she noted reddness around injection site. Patient complaining of arm still painful and reddened area 3 days later.
States arm was a bit red & itchy day of injection following AM. Said while upper arm was red & painful and felt like it was on fire for about 1 week. Redness did not subside & 3 weeks. She did not seek medical attention for this.
Unable to create wheel on first try, administered a second time on R forearm and wheel was successfully created.
Moderna COVID-19 Vaccine EUA Area bright red and hot with swelling at injection site and pain;  the second day I had a rash that spread around my arm, approximately 15 inches wide.  Burning at site of injection and rash.  Not able to lie on that arm or put pressure on the area.
Moderna COVID-19 Vaccine Patient had third Moderna shot - very similar rtesult to second dose - chills, fever, shakes,nausea, etc. for more than 24 hours.
I received my 1st shot on April 8, 2021,  later that night I took a shower and went to bed.  Around 0100AM on April 9, 2021, I started to have chills and a fever which lasted all night until around 10 am the next morning,  after the chills and fever left I lost my appetite and my body ached all over.  I had flu-like symptoms for 3 days and I was OK after that time period.
Discomfort on the arm; Redness came back; Swelling came back; Soreness in the arm; A spontaneous report was received on 25 -Jan-2021 from a consumer concerning a 72 years old male patient who received Moderna's COVID-19(mRNA-1273) vaccine and experienced soreness in the arm, redness came back, swelling came back, discomfort on the arm, red line from injection area to 5/6 inches above.  The patient medical history includes allergies: aspirin and penicillin.   Concomitant medications includes pravastatin, allopurinol  On 13-Jan-2021, prior one week to the onset of events, patient received his mRNA-1273(Batch:041N20A) intramuscularly for the prophylaxis of covid-19 infection.  On 13-Jan-2021, patient experienced Soreness in the arm and 9 days later redness came back, Swelling came back. on 25-Jan-2021 discomfort on the arm, red line from injection area to 5/6 inches above.  No laboratory information was provided. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events were recovered/resolved.
Red streaks running from the elbow to the shoulder then red streaks radiating to chest; cold chills & a sore arm;
Patient became tired within 1-2 hours of vaccine. itching started approximately 4-5 hours later under chin and got worse through out evening resulting in red patch. Next day patch larger and spreading to neck (front and back), scalp, chest, shoulders and forehead. Accompanied by nausea and trouble breathing +fever +chills by day 3 went to urgent care day 3 for steroid shot (unknown name) MEDROL dose pack, steroid cream (unknown) names and BENADRYL 25mg. Meds relieved reaction but took about 9-10 days to do so. Patient now fully relieved as of 12/3/08.
Rash which began after immunizations which started on head - spread over all the body. Red raised bumps. Itchy.
DIFFICULT TIME THINKING/FOGGY THINKING; WEIRD SENSE OF TOUCH/COULD NOT FEEL RIGHT; NUMB RIGHT SHOULDER; VERY WEAK; This spontaneous report received from a patient 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 not reported, batch number: 1805031, and expiry: Unknown) dose was not reported, 1 total, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced difficult time thinking, felt very weak, felt her sense of touch was weird, couldn't feel right. She also experienced numbness in her right shoulder, and foggy thinking. She was upset, at one point, sounded like she was beginning to cry. She stated that the weakness and foggy thinking was the worse. The patient was poor and did not have a primary care doctor. She had been to the hospital and they could not figure it out. The patient wanted to know what to do or who to call. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from difficult time thinking/foggy thinking, very weak, weird sense of touch/could not feel right, and numb right shoulder. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210702657-COVID-19 VACCINE AD26.COV2.S -Difficult Time Thinking/Foggy Thinking. This event is considered unassessable. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
About a week later I noticed itchiness at site of injection. The next day a red welt had appeared around injection site and was hot to the touch. I applied ice and took an Aleve PM as it was time for bed. Next morning I wake up for work and redness has subsided some and is no longer as hot. I still reported it to my manager and Lab Director, who also reported it to the Pharmacy dept and advised me to report it here.
Immediately after the vaccine was given patient experienced light headedness, and ringing in the ears (said she couldn't hear). We gave her water and monitored and 1 minute later she said she felt fine.
Had low grade fever of 99 degrees.  Extreme fatigue.  Shot site is bright red, swollen.  Area around site is swollen, red, and hard to the touch.  Swelling, redness, and hard to the touch continues.  Hurts to touch or bump entire area.
Pt experiencing swelling and muscle pain. Went to PCP and confirmed as "injection site infection".
Covid arm developed within 24 hours. Redness, swelling,  hot to the touch at injection site.
No additional AE; a patient inadvertently received both VARIVAX and PROQUAD on 8/21/2023; they meant to give MMR II but instead gave PROQUAD; This spontaneous report was received from a medical assistant referring to a 12-month-old female patient. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.  On 21-AUG-2023, the patient was inadvertently vaccinated with one dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection and one dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (strength, route of administration, lot#, and expiration date for both vaccines were not provided) (overdose). The reporter meant to give Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) but instead gave Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (wrong product administered). The patient did not have any symptoms and there was no additional adverse event (AE) (no adverse event).
I was feeling shortness of breath for some time. On May 2, I had my wife drive me to the ER at the hospital because the shortness of breath was acute. On testing, they found that my hemoglobin testing was critically low. My score was at 4. While I was in the hospital, they gave me 3 units of blood and did a bone marrow biopsy. I was discharged after those treatments on May 5. I was put under the care of the hematologist on May 11. Since then, I've had 3 more blood transfusions to raise my hemoglobin level. I also received a new medication that's injected in the arm that's called Retacrit. My hemoglobin went up to 8.6 recently, which is well above 4 and 7. The doctor said that the bone marrow biopsy was inconclusive for anemia and other issues. On July 19, I was sent back to the hospital because at my biweekly scheduled blood draw, they found that my hemoglobin dropped to 5.8. I was sent to the hospital to receive two more pints of blood. This coming Thursday, I will get my second injection of the Retacrit medication.
Fever, headache, chills, and body ache. I treated with Tylenol sleep and hydrating
received a pediatric dose instead of an adult; received a pediatric dose instead of an adult; 1 dose: 11/8/2021, 2 dose: 11/29/2021; received a pediatric dose instead of an adult; patient receiving as a 2 dose of Engerix-B a pediatric dose; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 20-year-old male patient who received HBV (Engerix B pediatric) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B pediatric) for prophylaxis and hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th November 2021, the patient received the 2nd dose of Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 8th November 2021, the patient received the 1st dose of Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 8th November 2021, not applicable after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device and unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On 29th November 2021, the patient experienced underdose, adult use of a child product and drug dose administration interval too short. On an unknown date, the outcome of the underdose, adult use of a child product, drug dose administration interval too short, underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated that, a 20 year old patient received 2 doses of Engerix-B a pediatric dose instead of an adult one, which led to underdose and adult use of a child product. The patient received the 2nd dose of Engerix B, earlier than the recommended schedule, which led to shortening of vaccination schedule. The Healthcare professional didn't have more demographic data of the patient.  The reporter consented to follow up.
The day after my second shot I experienced what I am assuming is a swollen lymph node along my left collar bone. It was swollen, red, and painful to touch. it is not painful to touch and some swelling has gone down and no redness. However, it is still visible and can be felt.
Patient received 0.5 mL FLUVIRIN, then fainted about 5 minutes later walking down a store aisle. Patient appeared groggy, clammy, and was unable to stand/sit without assistance. Paramedics arrived w/i 10 minutes.
pt is an MD who reports the devel of multiple transient white dot synd p/vax;
Chest heaviness; Difficulty breathing; Not feeling well; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/lot number, NDC number and Expiry Date were not Provided), via an unspecified route of administration on an unspecified date in Jan2021 as UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, caller received her COVID vaccine about an hour and a half ago. She experienced some heaviness in her chest and difficulty breathing on 29Jan2021. The caller had declined to complete a report at that time, stating she was really not feeling well (on an unspecified date in 2021). The outcome of the events was unknown.  Lot/Batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
I been having ongoing SOB.  I went to the ER.  They did EKG, urine sample, CT scan, and MRI on me. They though it was related to a UTI but my UTI is gone and I am still having SOB.
FevER - Chills - FAiNtNG - Low B.P. HospitALIZAtion - HospitAL 11-11-2020 11-12-2020 11-13-2020 WBC > 38
ALLERGIC REACTION TO DTAP, HIB, PCV, HEPA- ALL AREAS WHERE VACCINES WERE GIVEN WERE SWOLLEN, BUMPY, RED, HOT TO THE TOUCH