chrisvoncsefalvay/vaers-outcomes huggingface dataset:
All of a sudden got super cold; had some back pain; Felt a little shaky; fever; This is a spontaneous report from a contactable consumer, the patient. A 18-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6207) via an unspecified route of administration in the right arm on 21Apr2021 at 10:15 (at the age of 18-year-old) as a single dose for COVID-19 immunisation. Medical history included unspecified allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included ethinylestradiol, norgestrel (LOW-OGESTREL) and fexofenadine hydrochloride (ALLEGRA) both for unknown indications on unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN5318) via an unspecified route of administration in the right arm on 31Mar2021 at 10:15 (at the age of 18-year-old) as a single dose for COVID-19 immunisation. On 21Apr2021 at 21:30, all of a sudden, the patient experienced super cold, some back pain, felt a little shaky and fever.  On 21Apr2021, the patient felt little shaky so checked her body temperature and the result was 100.5 degree Farenheit (degF). On 21Apr2021, fever reached 102.5 (degF) during the night. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events super cold, some back pain, felt a little shaky and fever was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
exhausted; broke out in rash; sinus infection; congestion in chest; really sick; Initial information received on 07-Nov-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional.  This case is linked to case 2023SA352986(CLUSTER).  This case involves Elderly male patient who was exhausted, broke out in rash, sinus infection, congestion in chest and really sick after receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer (lot number, strength, form, dose, expiry date not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date about 10 days later the patient developed exhausted (fatigue), broke out in rash (rash), sinus infection (sinusitis), congestion in chest (respiratory tract congestion) and really sick (illness) following the administration of INFLUENZA VACCINE.  It was reported "patient is a truck driver hence prescriber not sure if rash was a result of irritation from sitting all day or flu injection or something else."  Action taken: not applicable.  Prescribed a cream and rash is now better was a corrective treatment for the event (broke out in rash). It was not reported if the patient received a corrective treatment for the events (exhausted, sinus infection, congestion in chest, really sick).  At time of reporting, the outcome was Unknown for the events.
I was noticed that my arm was starting to itch very badly, and it was hot to the touch and really big, and the redness covered my whole bicep. I went to immediate care for a UTI, and the doctor took a look at it and said it was COVID arm.  I had chills and body aches and a low grade fever.
I was administered by 2nd dose of the Pfizer COVID-19 vaccine on April 19, 2021, while I was approximately 3 months pregnant.  I was instructed by the CDC and my medical providers that the COVID-19 vaccine was safe notwithstanding my pregnancy status.  At my next OBGYN pregnancy appointment on May 11, it was discovered that I had suffered from a late-term miscarriage.  It was estimated by my medical team that the miscarriage occurred at approximately 14 weeks of gestation (or the week of April 28th), approximately one week after I received the 2nd dose of the Pfizer vaccine.
24SEP sore throat, sl temp, runny nose, aches & watery eyes, sleepy;25SEp temp, sleepy, no appetite & soreness all over;rest of week no appetite, phlegm & cough;MD visit on 29SEP97 lung clear;still coughing;
"Pt found lying on the ground next to vehicle. Pt received the vaccine just 5 minutes ago, then suddenly began experiencing hot flashes. Pt claims hot flashes are familiar to him where he will need to lay down; hence why he is now. Pt to stretcher without incident."
I had the vaccine on a Thursday around noon.  The following Thursday my arm (upper arm near injection site) was very itchy and the itch has continued now for a second day.  My upper arm feels warm and is just slightly tender.  But it looks normal and I feel normal other than the itching.
The next day I had body aches. I noticed pain in my neck, both sides but more on my right. I had enlarged lymph nodes, tender to touch. I had the same reaction with the first dose but it was not as bad. I could feel the lymph nodes and the pain was not going away. It lasted a couple of weeks. My doctor referred me to an ENT.
Rash developed at injection site. Patient (pt) did not notice adverse effect until 5/7/12. Rash is red, raised, associated with itching and warm. No fever is reported. Rash was reported to MD by pt during an unrelated visit. No treatment or follow-up was provided by MD. Immunizer advised pt to report to MD and immunizer if rash worsens or does not subside.
bowel perforation; pain in her upper abdomen; This is a spontaneous report from a contactable consumer.   An 86-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2) at single dose on 13Jan2021 for Covid-19 immunisation, administerd at nursing home/senior living facility  Medical history included dementia, arthritis. No known allergies. Patient was not pregnant. Patient had not COVID prior vaccination. Concomitant medication in 2 weeks included: memantine (manufacturer unknown) 10 mg BID, diclofenac (manufacturer unknown) BID, carbidopa, levodopa (manufacturer unknown) 25-100 mg TID, quetiapine (manufacturer unknown) 12.5 mg q HS, escitalopram oxalate (LEXAPRO) 10 mg q HS, paracetamol (TYLENOL) 650 mg BID, glucosamine (manufacturer unknown) drink. The patient received the 1st dose of bnt162b2 (BNT162B2) at single dose on 24Dec2020 for Covid-19 immunisation. No other vaccine received in 4 weeks.  The patient experienced bowel perforation and pain in her upper abdomen on 18Jan2021 07:30. The events resulted in Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event), and death. On 18Jan2021 07:30 AM, less than a week after the second shot, she had pain in her upper abdomen and was taken to the ER on 18Jan2021. CT showed a bowel perforation in the small bowel. She had never had bowel surgery or diverticulitis. She had been healthy other than her dementia and arthritis. Patient received treatment for the events: hospice and pain management. COVID-19 was not tested post vaccination. The cause of death was bowel perforation.  An autopsy was not performed.  Information about lot/batch number has been requested.; Reported Cause(s) of Death: bowel perforation
This spontaneous report has been received from a medical assistant referring to multiple unspecified patients. On unknown dates multiple unspecified patients were vaccinated with dose of VARIVAX (lot # L037565, expiration date 29-SEP-2017; lot # L048465, expiration date 02-DEC-2017), which was improperly stored. No adverse effects reported. Additional information has been requested.
Covid Rash. Inflamed abdominal and pelvic regions. I felt as though I had eaten something I was allergic too. Everything felt inflamed and tight, then bloated from my diaphragm down. Starting Tuesday the 11th 5 days after receiving my first dose. The Covid rash started appearing that morning, then my body proceeded to get worse. The shot also inflamed glands in my back, where I could barely walk, these symptoms started Thursday afternoon and I went to urgent care Saturday morning, and they sent me to the ER.
Information has been received from a physician concerning a 13 month old male child with no past medical history and no known allergies who on 09/04/2001 was vaccinated with a dose of varicella vaccine. There were no concomitant medications or current illnesses. On 09/11/2001, the pt presented to the ER with symptoms of an upper respiratory infection. The child's mother stated that the child had a fever of 103 deg F for the last four days. A chest x-ray was performed and read by the ER physician as being "positive for pneumonia." However, the following day, the same x-ray was read by the radiologist, who stated that the chest x-ray was negative and that the child did not have pneumonia. The child was never admitted to the hospital and was discharged from the ER on Zithromax. On 09/13/2001, the child presented to the physician for the follow-up visit with what appeared to be an upper respiratory infection as well as some diarrhea. It was reported once again that the child did not have pneumonia. The physician noted that the child was not seriously ill and that he appeared to have "what everyone else had at the moment." It was reported that the child was "fine" and that he appeared to be recovering from his experiences. The physician felt that the child's experienced were not related to the therapy with varicella vaccine. No further info was provided. Follow-up info received from a physician indicated that the pt had a viral roseola-like illness with some associated GI symptoms. Additional info has been requested.
Pt received Moderna COVID-19 vaccine at 1023. Approximately 6 hours later, she began to develop "hives" which were primarily around her jaw and hairline on the right side. Pt also reports swelling around her eyes. Pt took Benadryl at home with no relief of symptoms. Pt presented to local Urgent Care, they directed her to the Emergency Department. Pt arrived in ED at approximately 8PM. The Pt received 10mg IM dexamethasone, 25mg IM diphenhydramine, and 20 mg PO famotidine. Pt reports resolution of symptoms after medication administration.
On the evening of 3/4/21 after receiving my 2nd dose of Moderna at 3:30 pm that same day, I experienced fatigue, body aches, chills, loss of appetite and fever over 101 degrees F lasting for approximately 36 hours. I also had 9/10 soreness and large well-defined area of redness at the injection site that started 12 hours after injection and lasted for 5 days. Today is 2 weeks after this injection and I continue to have dull, throbbing pain in my left deltoid that runs up the left side of my neck, it is worse when my arm/shoulder is unsupported and it tends to be worse in the evening.
Arm is very very very sore; I can hardly walk through the house; I'm just so tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is very very very sore), GAIT DISTURBANCE (I can hardly walk through the house) and FATIGUE (I'm just so tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia. Concomitant products included TRAMADOL for Fibromyalgia, NAPROXEN.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm is very very very sore), GAIT DISTURBANCE (I can hardly walk through the house) and FATIGUE (I'm just so tired). At the time of the report, PAIN IN EXTREMITY (Arm is very very very sore), GAIT DISTURBANCE (I can hardly walk through the house) and FATIGUE (I'm just so tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.  No concomitant medication was provided.   Reporter did not allow further contact
Pt received injection on 02/19/2003. On 02/20/2003, pt returned back to out office for reaction to DTaP.
Vax recvd 1st dose 17Sep90.Headache occurred the same day & resolved, /wout treatment. No treatment has been given for cont rash, hives (onset 20Sep90)
5 cm, local erythema (+) surrounding injection site (left deltoid). Given ZANTAC 15 mg/ml 1/2 tsp, BID.
Patient felt the need to lay down, sweating profusely. We had him take a seat and provided water. The patient spent a total of 10 minutes sitting/laying down. After he had some water he was able to speak with us and stopped sweating. We recommended that he not drive home so we were able to help him call for a ride.
When I checked the chart and found patient has turned 12 yrs. I did incidence report and educated the staff who were involved his care. I reviewed CDC Covid 19 VC for 5-11 yr protocol and called CDC and spoke with an agent who sent Email to me for how to further manage the case: plan give the second dose with covid 19 vaccine for 12 yrs and old at 21 days of interval. I called mother: pt has had no side effect so far and I told mother the administration error and scheduled the second dose with pharmacy at 1/17/2022 5PM, case reported to VAERS.
Pt reported "blacking out" after injection; transferred to observation; given food, water and juice and then felt better. VS stable (BP 105/62; HR 83; RR 18; O2 sat 100%), NAD, tested ambulation and reported no dizziness or fatigue, pt steady on feet. Pt deemed stable and released from vaccination site.
pt recvd vax 21SEP94 & devel diffuse papulovesicular rash on body,face,arms,& eyes,accompanied by itching & sore throat;culture for bacillus strep was neg;pt had nl sinus rhythm & clear lungs;pt went to ER;pt exp rash,flu-like sx
Initial information received on 29-Mar-2019 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 18 years old patient (gender unknown) who received an expired dose of vaccine MENACTRA. The patients past medical history, concomitant medication and family history were not provided. On 28-Mar-2019, the patient received injection of suspect MENACTRA lot number not reported, expiry date 05-Mar-2019 via unknown route in unknown administration site. It was an actual medication error due to expired vaccine used. It was reported that patient received a dose of MENACTRA on 28-Mar-2019 which had expired on 05-Mar-2019. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
since the administration / the anxiety has become worse; This case was reported by a consumer via call center representative and described the occurrence of anxiety aggravated in a 36-year-old male patient who received Rabies NVS (RabAvert) for prophylaxis.   The patient's past medical history included anxiety (prior to receiving the vaccine).   On 16th September 2020, the patient received RabAvert. On 16th September 2020, less than a day after receiving RabAvert, the patient experienced anxiety aggravated. On an unknown date, the outcome of the anxiety aggravated was not recovered/not resolved.   It was unknown if the reporter considered the anxiety aggravated to be related to RabAvert.  Additional details were reported as follows: The patient received Rabavert for post-exposure prophylaxis. The patient experienced some anxiety prior to receiving the RabAvert vaccine and since the administration of it, the anxiety had become worse, which led to anxiety aggravated. The reporter consented to follow-up.
Myalgia, injection site pain, chills Narrative: Employee reports injection site pain/discomfort, chills, and body aches which began the afternoon of receiving the vaccine.
It was discovered 2/2/2022 that when this injection was given on 1/26/22, that the pharmacist failed to add saline to reconstitute it before adminstering the dose. The patient was given the dose on 1/26/2022.  When it was discovered that the pharmacist failed to reconstitute the immuniazation, the pharmacist contacted the patient's father. The parent stated that the son got along OK after this was administered except he was a little dizzy and had a slight headache.
Severe swelling, pain and fever in right armpit.  Ice pack and Ibuprofen per doctors office.  Still painful and swollen but has gone down some. Temp.  check on 07/06/2021 was 99.1 for next 2 days.
menstrual changes; she had heavy period for several months now; This is a spontaneous report from a contactable nurse (Patient). A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EK9231, Expiration Date: Apr2021), via an unspecified route of administration on 10Jan2021 as single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (Lot/Batch number: EK5730, expiration: Mar2021) on 20Dec2020 for covid-19 immunization. She was wondering if there had been studies about menstrual changes or if Pfizer is getting a lot of complaint about women having menstrual changes after the Pfizer COIVD-19 vaccine. She said that after taking the two doses of the vaccine she had heavy period for several months now. She received her first dose on 20Dec2020 and second dose on 10Jan2021. She wanted to know heavy period she is experiencing is one of the side effects of the vaccine. The outcome for the events was reported as not resolved.   Follow up information requested.
Within a minute of receiving HPV vaccine pt began to have a seizure. Tonic clonic movements with eyes rolling, foaming at the mouth with vomiting. 12/2/2009 PCP records for 11/16 and 11/25/2009, patient with c/o's lightheadedness, vomiting, LOC for 10 seconds post vaccine. Dx vasovagal syndrome. No tx noted
fever & swollen glands given APAP every 4-6 hrs h/a, very swollen gland lt side; not seen by MD very inflamed tonsil on lt side 20SEp92; rash fine pimply irrupted fever continues-referred to clinic for eval;
Patient presents to the ED with nausea vomiting for the past few days.  Patient has developed loose stools but denies any abdominal pain.  COVID-19 PCR was positive, chest x-ray was negative for acute intrathoracic process. Patient continues to do patient extreme lethargy intermittent confusion she has advanced anorexia p.o. Intake.  Nasogastric tube been placed patient is started tube feeds.  Patient was diagnosed with Metabolic encephalopathy due to covid 19 infection
22MAR96 fever 103, stomach cramping, arm swollen & pain where shot was given, weakness;23MAR96 pain in rt ear;24MAR96 pain in both ears;pain in back, neck & gums & teeth;no toothache but pain in teeth;rt eye burns;lightheaded feeling
Exacerbating of severe symptoms of rheumatoid arthritis after AVA 1-3: reproduced and increasing with each shot.
HALF AND INCH LUMP UNDER VACCINATION SITE; SORENESS AT INJECTION SITE; SWELLING AT INJECTION SITE; This spontaneous report received from a patient concerned a female of unspecified age. 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: 1805022, expiry: 25-MAY-2021) dose was not reported, administered on 10-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced swelling at injection site. On 18-MAR-2021, the subject experienced half and inch lump under vaccination site. On 18-MAR-2021, the subject experienced soreness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from half and inch lump under vaccination site, and soreness at injection site, and the outcome of swelling at injection site was not reported. This report was non-serious.
Persistent pain in the arm in the area of the injection site.   Pain and restricted motion range of thumb on the  hand of the same arm.
I broke out in hives on my face, arms and stomach and light vomiting. The first time the hives appeared on my arms later on that evening. The second day, the hives spread to my face besides my arms. The third day that Friday was when the light vomiting occurred and it was on the rest of my body.
Information has been received from a 48 years old nurse referring to herself with no drug allergy/reaction. She was not pregnant. The patient experienced chicken pox with she was 13 years old. On an unspecified date in 2013 (reported as "approximately 2 years ago")) the patient was vaccinated with a dose of ZOSTAVAX (concentration, dose, frequency and route were unknown). Concomitant therapy included ZOLOFT. On an unspecified date in April 2015 (reported as "approximately 3 months ago"), the patient developed 3 "spots/clusters" of shingles. On an unspecified date in June 2015 (reported as "approximately 1 month ago") the patient developed 3 to 5 "spots/crushes" of shingles. The patient currently has 2 areas of "spots/clusters" of shingles. The patient had made appointment to see her Primary Care Physician for treatment. VZVIP packet was not sent as Reporter/Patient was going to discuss with her Primary Physician first. No lab was performed and no treatment was given. The action taken was not applicable. Additional information has been requested.
Heart pain and chest pain with boutd of a fib, high blood pressure and tachycardia
Numbness to left arm and leg, redness, swelling, and warmth at injection site, nausea, fatigue. Given Zofran, monitoring symptoms
Fever blister; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (Fever blister) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis relapse. Concomitant products included OCRELIZUMAB (OCREVUS) for an unknown indication.    On 25-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced ORAL HERPES (Fever blister). At the time of the report, ORAL HERPES (Fever blister) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided by the reporter.
So, when I first got the vaccine, my arm was sore, and I was fatigued. Then I felt like I had a slight fever, then on the Monday, 2/8/2021, after I got the shot, I was at work and I got a fever up to 102. It would go down then back up every day until Saturday 2/13/2021. Then it slowly went down until the following Sunday 2/21/2021. It was just going up and down, I was taking Tylenol and Motrin to help with that. It took about three weeks for it to really subside. I contacted my doctor probably on 2/10/2021 and because COVID nobody would see me. I dropped in and they did a Covid test outside in the parking lot, which was negative. I was kind of upset because nobody would actually see me. I went and got a chest x-ray from a clinic (urgent care) because my doctor was nonchalant about it. I went to the ER at hospital, and they did all the tests, bloodwork, urine, chest x-ray. The following week I went to my doctor and she did blood work. The only thing that was elevated was something to do with a histamine reaction. Nothing was ever actually determined.