chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rashes all over body; Hives/ welts; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 22Jul2022 at 13:00 as dose 4 (booster), single (Lot number: FP7139) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine". Vaccination history included: Covid-19 vaccine (Dose: 3, Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose: 2, Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose: 1, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: URTICARIA (non-serious) with onset 23Jul2022, outcome "not recovered", described as "Hives/ welts"; RASH (non-serious) with onset 23Jul2022, outcome "not recovered", described as "Rashes all over body". Therapeutic measures were not taken as a result of rash, urticaria. Additional information: The patient had no covid prior vaccination and has not been covid tested post vaccination.  Follow-up attempts are completed. No further information is expected.
Information has been received from a mother and aunt concerning a 16 year old female patient with no known medical history, who was vaccinated with all three doses of GARDASIL by June 2008. Concomitant suspect vaccination included influenza virus vaccine (unspecified) (name and manufacturer unspecified). The consumer reported that her niece was HPV (unknown type) positive after getting all three doses of GARDASIL. The mother subsequently reported that about one month after receiving all three doses of GARDASIL her daughter had a yeast infection and then two weeks later had another infection. The patient was the due for her yearly checkup and so she went and had a pap test done and the test showed the patient had genital warts and a "large lesion on her insides". The mother stated that her daughter is going to a specialist and will have to get "some work done on her" for the lesions. The mother reported that the patient does not feel well and has a loss of appetite. It also reported that the patient received the flu vaccine and "wound up in the hospital" (specifics not provided). The patient sought unspecified medical attention. At the time of the report it was reported that the patient was not recovered. No further information is available.  1/28/2009 MR received for GYN visit 12/5/08 for colposcopy for (+) PAP smear. Final DX: Mild to moderate dysplasia with HPV.
Could not raise his arm by the evening of the shot. Trouble sleeping due to pain for 2 nights.
approx 72 hours after receiving vax I started feeling hot then cold. through the night I also started experiencing body and muscles aches. during the next day I also had a 100.6 temp and diarrhea. all symptoms were gone within 24 hours except the diarrhea, which lasted another 2 days.
4 days after the vaccine administration  patient developed frequent emesis. US of abdomen  showed Intussusception.  The intussusception reduced  by  Barium enema with air contrast at hospital.
Uvula swelled 3-4 X normal size and had difficulty swallowing. No stridor or wheezing. Rx'd with Benadryl and Prednisone.
After getting the shot I had instant metal/ chemical taste in my mouth, it lasted all day. I also felt it go into my body like a warm rush throughout. I got a little light headed.
Patient has rash and swelling at injection site rash is warm to touch, and itchy. Rash is about the size of palm. Patient's PCP diagnosed the rash as cellulitis and pt is treated with 7 days at KEFLEX.
I have been diagnosed with Ulcerative Colitis where I had sporadic diarrhea.  After the first Pfizer shot I started light bleeding.  After the my second shot I started bleed heavily.  I reported this to my doctor; underwent a quick mini-colonoscopy;  and I was quickly put on Humira.  After 4+ weeks on Humira, the bleeding appears to be slowing.
Information has been received from a physician concerning a female who was vaccinated with the first dose of GARDASIL 0.5ml, IM. The physician reported that the patient developed a severe rash on the left side of her body after administration of GARDASIL. She also developed a fever. At time of reporting, the patient had recovered. The patient sought medical attention via office visit. Additional information has been requested.
Usual vaccine response: swollen, red area on arm around injection site. Unusual response: aches throughout body, chills, perhaps mild fever. Aches prevented usual activities.
Extreme Exhaustion-day of shot (01/06/2021 - 01/09/2021,   Body aches - day after shot (01/07/2021),   fever  -  day after shot  (01/07/2021 - 01/08/2021,   Chills -  day after shot (01/07/2021),   Headache  -  day after shot (01/07/2021-01/09/2021)
Began having severe chest pain and shortness of breath at 3:30 Sunday morning morning 4/10/22. I went to the ER and the ruled out heart attack and blood clot but diagnosed me with inflammation of the lining of the lungs.  (Pleurisy)Z I have not been sick; no flu, no pneumonia, no  cold, nothing.  They said it could just be a viral infection but they usually see this type of thing when a patient has been sick. I??be NEVER had heart issues, never had lint issues and have not been sick.  They only thing different is the  2 shot vaccine I took.  I 100% believe it is related to the vaccine.
Swelling and redness started the same night. It covered from shoulder to elbow. Fever of 102 degrees for 2 days. Received doxycycline - redness has diminished but is still very painful. Patient stated he always gets fever and feels ill after flu shots. Patient also stated when he got the PREVNAR 13 vaccine in 8/2016 he felt ill with fever and aches for 7 days after vaccination.
About 36 hours after vaccination, I experienced incredible "brain" fatigue/fog. My physical body did not seem affected by the fatigue but my brain/head felt very "fuzzy". I had a hard time getting words out. Similar feeling to etoh intoxication. I was a bit off balance and dizzy. I remember shaking my head to try to clear it. I also had a very"plastic" taste in my mouth and felt nauseous. At the 48 hour mark (almost exactly) I felt better. At 60 hour mark brain/head symptoms completely resolved. Only experienced a very slight nauseated feeling.
Lymph node enlargement under arm of vaccine injection lasting 1 week, Shingles out break on face starting 11/21/2023
Sweating like crazy (bed was soaking wet); Felt like he had COVID-19 all over; Pain; Lot of gas; Exhausted; Chills; Had a headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating like crazy (bed was soaking wet)), MALAISE (Felt like he had COVID-19 all over), PAIN (Pain), FLATULENCE (Lot of gas) and FATIGUE (Exhausted) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Two weeks before vaccine (tested negative prior to vaccination)).    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced HYPERHIDROSIS (Sweating like crazy (bed was soaking wet)), MALAISE (Felt like he had COVID-19 all over), PAIN (Pain), FLATULENCE (Lot of gas), FATIGUE (Exhausted), CHILLS (Chills) and HEADACHE (Had a headache). The patient was treated with IBUPROFEN for Pain, at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (Sweating like crazy (bed was soaking wet)), MALAISE (Felt like he had COVID-19 all over), PAIN (Pain), FLATULENCE (Lot of gas), FATIGUE (Exhausted), CHILLS (Chills) and HEADACHE (Had a headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Patient did not remember getting a flu shot already this year, and received a 2nd flu shot 1 month after the first.
injection site erythema; injection site pruritus; This spontaneous case was reported by an other and describes the occurrence of VACCINATION SITE ERYTHEMA (injection site erythema) and VACCINATION SITE PRURITUS (injection site pruritus) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (injection site erythema) and VACCINATION SITE PRURITUS (injection site pruritus). At the time of the report, VACCINATION SITE ERYTHEMA (injection site erythema) and VACCINATION SITE PRURITUS (injection site pruritus) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment information was provided. No relevant concomitant medications reported.
patient had previously had Pfizer vaccine and requested Pfizer booster but received Moderna booster
Seizure- tonic clonic movements of entire body and abnormal posturing for 30 seconds.
Information has been received from a 66-year-old female with a history of genital herpes and no known drug allergies who on 12-OCT-2007 was vaccinated with a dose of ZOSTAVAX. Concomitant therapy included CYMBALTA and hormone replacement therapy (unspecified). On approximately 12-OCT-2007 (after vaccination) the patient experienced numerous outbreaks of genital herpes. No diagnostic labs were performed. At the time of the report the patient's status was not recovered. A product quality complaint was not involved. No further information is available.
Rash on face waiting on test result Bumps indicative of hsv 1(no prior oubreaks) , shingles , impetigo
slight headache, upset stomach, tired, muscle soreness in back and shoulders, soreness of thigh muscles. started around 5pm 1/12/2021. relieved by 1/14/2021 0800 am
shingles; Information has been received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age or gender. The pt's concurrent conditions, medical history and concomitant medications were not reported. On an unspecified date in 2013, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, lot number and expiration date were not provided) as prescribed and/or administered by a healthcare provider (HCP) for the long-term prevention of shingles and/or zoster-related conditions. Subsequently, the pt's was treated by a licensed clinical social worker (LCSW) at her office for shingles. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of shingles was not provided, and causal relationship was reported as related to zoster vaccine live (ZOSTAVAX).
This spontaneous report was received from a more than 80 year old female consumer (reporting on herself), with allergy to penicillin and to sulfa, who had shingles when she was 8. On 15-MAR-2013 the patient was vaccinated with ZOSTAVAX (lot number and expiration date not reported) (dose, frequency not reported, route unspecified, injection in the arm). No concomitant medications were reported. On 16-MAR-2013, the patient experienced her hands had broken out in a rash in between her fingers, on the back of her hand by the wrist, down to the tip of her thumb and her hands were swollen. The patient did not sought medical attention and no treatment was given. Laboratory diagnostic studies were not performed. At the time of the report, the patient's outcome was unknown. Additional information is not expected.
12 hours after vaccine flu like symptoms, lasted 48 hours. Swelling and fluid on right knee, decreased range of motion started Friday after the vaccine.
Describes reaction of welt (redness and warmth) at previous vaccination site (~2000). then received half dosage. This year, no vaccine. Vaccine administered 10/28/04 at left arm: denies any mark / irritation on left arm. Complained of itching and redness chest and neck about 4 hours later and blotchy red areas (itchy) on both legs 10/19: legs red. today 11/01/04 notified health department.
pt recvd vax;to er w/ pt crying,high pitched crying;mom states unable to calm pt down;dx:severe rxn to immun poss DTP;also dx w/ otitis med & placed on ATB in er;
Muscle ache in left arm and in muscles on left side of body...continuing on past the second vaccine.   Hard to lift arm.  Taking daily ibuprofen
Symptoms began around 9am the next morning and progressively worsened over the day (lower body muscle aches, chills, headache, fatigue, overnight sweats. Symptoms worsened in the evening. Took Tylenol PM, showered and went to bed early. Felt better next day.
My daughter vomited a large amount per her daycare provider at 4 PM.  When I picked her up at 4:45 PM she was very lethargic - she did not want to walk, kept falling asleep.  Doctor recommended child be taken to ER.  At the ER (around 5:15 PM) my daughter vomited again and then started to perk up some and was not as sleepy.  Evaluation at the ER showed no fever, no redness in throat, no ear infection, no breathing issues.  My daughter was given a medication to calm her stomach and was kept at the ER for about an hour to be watched.  She ate a sucker and did not vomit and was sent home.  At home she drank water, ate a popsicle, and had a little juice.  Then at 7:30 PM she threw up again.  Vomited once more at 8:00 PM.  At this time it felt like she was getting a fever so I gave her 1.875 ml of ibuprofen and administed 5 ml of Pedialyte every couple of minutes for 45 minutes (about a cup of fluid).  My daughter then went back to sleep.  Prior to getting her shot, she did not appear ill at all and was running around and eating well.
This spontaneous report was received from a health care professional refers to an unspecified number of patients of unknown demographics. On an unknown dates the patient were vaccinated with improperly stored VARIVAX (Merck) lot # L023589; expiry: 26-JUN-2017. M-M-R II, K021152/ expiry. 02-NOV-2016, lot # L011528/ expiry: 03-APR-2017 was within recommended range at 32F. No adverse effects were reported. No further information was provided. This is one of several reports received from the same source. Additional information has been requested.
On 08/15/2021 I experienced strong head pain, dizziness, nausea, body aches, fever and cold chills. On 08/16/2021 at 10:00 pm I felt right sided chest tightness, discomfort and shortness of breath. The symptoms continued into 08/17/2021 and at 11:00 am I went into the  Clinic. I saw Dr and she assessedme. She ordered an X-Ray and it did not show any abnormalities. Due to financial constraints, I was unable to receive further testing and was told to contact the facility if anything changes or go to the hospital if condition worsens. I was given a prescription of Diclofenac Potassium 50 mg. I was unable to this medication, due to vomiting. Currently, shortness of breathe has improved without and taking OTC Tylenol.
severe hypotension, dizziness . 09:15 80/41 p55 r16 09:29 110/60 p58 r16
Patient given 0.5 ml instead of 0.25 ml as recommended. Pt tolerated well. No adverse reaction. Mom made aware.
12/06/2021 she had fever of about 101 and was tired and had a little bit of a headache and she stayed home from school on that day. 12/07 an d12/08 a little nt of a headache and was not running a fever and she went to school on 12/05 and 12/07 she was jumping rope she mentioned she felt like the pulse in her ears. The evening of 12/08 she went to basketball practice and when she came home she was complaining  she was dizzy standing up and laying down with her eyes closed.  12/9 when she woke she was still dizzy.  She was okay when she was laying down. And we did not send her to school on that day. We thought it was an ear infection with the dizziness. She did not have any symptoms. We went to the doctor she gave her a basic neurological test and looked in her ears and her ears were fine. The doctor thought that her immune was on hyperdrive because of the vaccine and that she should start to feel better within the next few days.  We were told if the symptoms don't clear by the following week to go back 12/10 she felt fine and  went to school.  on 12/11, 12/12, and 12/13 she had a minor headache and we did not go back to the doctor.  I would say unknown of the AE, because in the last 3 weeks she was jumping and she was complaining of dizziness, not as bad as the 1st time.
my arm is swelled up / arm is still swollen; arm  / got red all the way around the lower part of where the shyness; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 18th June 2021, the patient received Shingles vaccine. In June 2021, less than a week after receiving Shingles vaccine, the patient experienced swelling arm and erythema of extremities. On an unknown date, the outcome of the swelling arm and erythema of extremities were not recovered/not resolved.   It was unknown if the reporter considered the swelling arm and erythema of extremities to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient for himself/herself. The age at vaccination was not reported. The patient received Shingles vaccine last Friday and arm was swelled up and got red all the way around the lower part of where the shyness was. The patient wanted to know was that ok as it was still there. No other information was provided.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 65 year old male. The patient's height, and weight were not reported.  The patient's concurrent conditions included: hypertension and an unspecified drug allergy. The patient initially received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total, administered on 21-FEB-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination was 63 year old. Concomitant medications included lisinopril.  The patient additionally received non-company suspect vaccine included: Moderna covid-19 vaccine (elasomeran, dose number in series 2) (form of admin, route of admin and batch number were not reported, expiry: unknown) dose was not reported, administered on 10-DEC-2021 for covid-19 prophylaxis. It was unknown whether patient had any adverse event following vaccination Moderna covid-19 vaccine (elasomeran, dose number in series 2). The patient additionally received non-company suspect vaccine included: Moderna covid-19 vaccine (elasomeran, dose number in series 3) (form of admin, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, administered on 31-MAY-2022 for covid-19 prophylaxis.  On 09-JUL-2022, the patient underwent COVID-19 virus test which was positive for COVID-19 (confirmed covid-19 infection) (dose number in series 3), which led to confirmed clinical vaccine failure (dose number in series 1). The patient was treated with Paxlovid (nirmatrelvir, ritonavir) (batch number: GC8123) first dose on 09-JUL-2022 (evening) and last dose on 14-JUL-2022 (AM) for treatment of covid-19 (no missed doses). The patient recovered from COVID and on 15-JUL-2022, the patient underwent COVID-19 virus test which was negative.  On 21-JUL-2022, patient again experienced COVID-19 symptoms. On 22-JUL-2022, the patient underwent COVID-19 virus test which was positive. The patient received OTC (over-the-counter) medications (unspecified) and isolation for the treatment of COVID-19. The action taken with covid-19 vaccine ad26.cov2.s, elasomeran, and elasomeran was not applicable. The patient was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0-20220806679-Covid-19 Vaccine ad26.cov2.s -Confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Systemic: Dizziness / Lightheadness-Mild, Additional Details: patient was lightheaded after receiving both vaccines. she said she has history of this happening to her, also afraid of vaccines. called 911, she was assessed and all was normal. patient felt better and left.
PATIENT STATES THAT THE DAY AFTER SHE RECEIVED HER VACCINATION HER ARM BECAME RED, SWOLLEN AND HAD A BASEBALL SIZE KNOT. SHE SOUGHT MEDICAL TREATMENT AND WAS TOLD SHE HAD CELLULITIS. SHE RECEIVED IV STEROIDS AND WAS PRESCRIBED ANTIBIOTIC THERAPY.  SHE STATES THE ISSUE HAS RESOLVED
Localized swelling to (L) arm. Onset for x 2-3 days.
2 weeks post injection, numbness and tingling radiating down (Rt) arm to fingertips which continues to present, with intermittent sharp - burning, pain, muscle weakness. 21/2 weeks post injection, numbness and tingling, radiating down (Rt) leg to toes which continues to present with interment sharp burning pain.