chrisvoncsefalvay/vaers-outcomes huggingface dataset:
induration, erythema, swelling Narrative: Developed swelling, induration, erythema over deltoid of injection site starting ~1 day after the first vaccination, lasted for ~ a week. No therapies tried or applied other than occasional ice pack. D/w her PCP at an appt (previously planned), who did not recommend any intervention other than ice packs at that time). No other reported adverse effects.
Patient received a Pfizer BioNTech Adolescent/Adult Vaccine (Lot# 301458A) that was stored in the regular freezer (-25 to  -15 oC) beyond 14 days. On 22JAN22 Pfizer responded to the Health Clinic that stability data does not support the use of the Pfizer Vaccine (Lot# 301458A). Pfizer further states decision to release or dispose of the product is the responsibility of clinic. The CDC website states that if the manufacturer does not have the information to support the stability of the vaccine, repeat the dose immediately with no minimum interval.
Almost a complete lack of sleep due to ache all over body; Almost a complete lack of sleep due to ache all over body; felt exhausted; arm where the shot was is sore and very tender; This is a spontaneous report from a non contactable consumer, the patient. A 52-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: Unknown) via an unspecified route in the left arm on 23Mar2021 at 15:00(at the age of 52 years old) as a single dose for COVID-19 immunisation. The patient had no medical history and  did not have any allergies to medications, food, or other products. The patient did not take any concomitant medication and did not receive any vaccination within four weeks prior to the COVID-19 vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. On 23Mar2021 at 22:00, the patient experienced complete lack of sleep due to ache all over body, felt exhausted, arm where the shot was is sore and very tender, though there are no swelling or shot location issues. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported event. The clinical outcome of the lack of sleep, ache all over body, exhausted, pain in arm and tenderness was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
A week after receiving the vaccine, my right arm developed a bump, almost like a mosquito bite in the injection site.  During the following days it grew redder and the area became larger, very itchy, warm to the touch and hard.  I have not had it looked at but if it continues to worsen, I will.
The pt experienced a high fever, flu-like symptoms, and severe joint pain. The pt was seen by an orthopedist and a neurologist. Two MRI's have been done which reveal no degenerative changes or arthritis. The most recent information received on 6/27/00 reports the outcome of the event as unresolved.
Patient originally complained of "numb lips" and feeling nauseous. Later also said that she was experiencing tightness in her chest and a headache too. Never had any problems breathing or anything like that. Never emergent enough to need Epipen or Benadryl, but we called paramedics as a precaution and they ended up taking her to a hospital for observation.
0.1ml of Td was given to the patient intradermally, instead of giving PPD.  Redness and induration 10x10 at the injection site.  03/14/2005 - small raised area.  No redness, no inflammation, no soreness.
day of 2nd vaccine and following day I was not able to leave my bed due to feeling so sick. About a month later I had a massive flu for 6 days, was not covid variant. 4 days ago I had a focal seizure and I have zero history of epilepsy. Went to the ER yesterday for testing as I am still having neurologic symptoms since then. Being referred to a neurologist which could take months. Within the last couple months I have regularly had some health issue pop up when before the vaccine I had a clean bill of health. I had COVID in Sept and still had antibodies when I gave blood in January. Likely that I still had antibodies when I received the vaccine.
Patient is a resident at an independent living facility. The company went to their facility to do three off site COVID vaccine clinics that were spaced at least 21 days apart per our CDC contract. Patient received 3 doses total of Pfizer. They were vaccinated on 1/08/21, 1/29/21, and 2/19/21. The facility has been notified of this incident. At this time, no adverse affects have been reported.
itching; having back and side pain; having back and side pain; The week before my second vaccination I broke out with a rash; This is a spontaneous report from a contactable other health care professional (Patient). A 49-years-old  non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not reported), intramuscular at arm right on 15Jan2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications was not reported. No known allergies were reported.The patient did not receive any other vaccines within 4 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.The patient took second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular at arm right on 05Feb2021 as single dose for COVID-19 immunization and experienced Shingles. On 29Jan2021,about 2 weeks after the first vaccination the patient started itching and having back and side pain. the patient didn't think anything of it. The week before my second vaccination the patient broke out with a rash. I thought something bit me. The outcome of the events was reported as recovering.  Information on the lot/batch number has been requested
There was a hard spot at the injection site, as expected, for the first 24 hours. At 48 hours, a large area around the injection site turned bright red, almost purple in some spots, was hot to the touch and was the size of an adult's palm. Went to Urgent Care and was told it was a vaccine reaction, to give Benadryl and use Hydrocortisone cream. It faded in about 3 days.
pain next day after immunization then bruising appeared, bruising as of this date visible approximate  2inch by 1inch area
Shot received Thursday evening.  Sunday evening, left arm get very itchy.  When I checked out why, my upper arm below the injection site was swollen and bright red and very itchy.  What I would call a large 4 inches in diameter hive.   Didn't know it could be adverse reaction to the shot.  Thought I got bit by something but had no instance of getting bitten.  A mystery to me.  It didn't get better with time and remained as it had been and very itchy.  I had been applying OTC hydrocortizone cream. No reduction in size or itch.
Information has been received from a physician concerning a female (age not reported) with no known medical history and/or drug reactions/allergies who on 02-MAR-2007 was vaccinated intramuscularly with the first 0.5 mL dose of Gardasil (lot # 653736/0868F). On 14-MAY-2007 the patient was vaccinated with the second dose of Gardasil (lot # 655324/0089U). The physician reported that the patient had intercourse in early August 2007. On 05-SEP-2007 the patient took a home pregnancy test which was positive. She contacted her doctor. On 06-SEP-2007 a serum pregnancy test was performed with positive results. On 19-SEP-2007 the patient had an ultrasound done which showed that she was 8 weeks and 4 days pregnant. On 22-SEP-2007 the pregnancy was terminated. The patient's status was not reported. There was no product quality complaint. Additional information has been requested.
Pt recvd vax & exp herpes zoster, corneal ulcer lt eye & pain in scalp 30JAN93;
Cellulitis at the site of vaccination, pain and redness. No fever. Admitted to Emergency department at hospital an was treated with antibiotic.
I've had Covid (01/2021) and Monoclonal Antibodies (01/2021). Was told to wait 90 days before vaccination (04/29/2021 and 05/20/2021). After Covid I began experiencing severe tiredness, headache, brain fog and muscle pain. No issues after 1st vaccination. About 10 days after 2nd vaccination, the muscle pain started becoming severe. Getting up in the morning, muscle pain in legs (mostly things) started mildly, then became so severe it was impossible to put my full weight on my legs. Am able to "walk it off" after an hour or so. NSAIDS are somewhat effective. Other symptoms include tiredness, headache, muscle pain, generally feeling unwell, joint pain, diarrhea.
Symptoms started 4-5 days after vaccination. Symptoms include swelling, redness and itchiness at the injection site.
Fever to 101 and C/O pain at vaccine site, red and raised area, no streaking not warm to touch.
Experienced screaming episode p/vax; Feet turned purple; Seen by MD dx Ecchymosis & tremor. Tx w/Phenobarbital.
No adverse event; Past lot that had been expired, administered to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Past lot that had been expired, administered to patient) and NO ADVERSE EVENT (No adverse event) in a 79-year-old male patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Past lot that had been expired, administered to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Past lot that had been expired, administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Past lot that had been expired, administered to patient).      ID number was reported as 80777027399.  Concomitant product use was not provided by the reporter.  It was reported that patient were administered Moderna vaccine between 08-Apr-2022 and 15-Dec-2022.  Treatment information was not provided.
PATIENT RECIVED THE VACCINE AND PASSED OUT, PATINET WAS SITTING IN THE CHAIR AND WAS DIRECTED TO STAY IN PLACE UNTIL RECOVERING. PATIENT RECIEVED A BOTTLE OF WATER. PATIENT RECOVERED AND WAS ESCORTED HOME WITH HIS PERSONAL NURSE.
Extreme fatigue, intermittent headache, Chills, no appetite,  slight fever.  Lasted 7 to 10 days.  Lost total of 16 pounds.
A report was received from a health professional on 10/23/02, concerning 40 vaccinees of unknown demography who experienced injection site reactions fro an unspecified length of time after receiving Fluvirin vaccine in September 2002. On various dates the physician received various anecdotal reports from up to 40 vaccinees of localized muscular reactions such as soreness, inflammation, warmth and lumpiness at the site of injection of the Fluvirin vaccine since the end of September 2002. The symptoms were self limiting and the vaccinees did not experienced sequelae from the events. The nurses administering the vaccine had received training for the proper administration of the vaccine. The reporter has assessed the relationship of the vaccine to the events as probable. Case closed, no other follow up received.
Vaccine site at Lt arm hot, red, swollen that eve. Next morning Rt arm at vaccine site hot swollen & red. Denies fever or streaking. (Info given by mother) she took to Dr & hx dx with cellulitis.
Severe local reaction of redness & swelling to injection sites. Tdap site measured 5 by 5 cm redness & swelling. MCV4 site measured 5 by 5 cm redness & swelling. VARIVAX site measured 12 cm redness & swelling.
pt recv vax & began coughing & couldn't stop;on PE found to be wheezing;was crying & wheezing;prolonged expiration w/ poor air movement (P120, R16, T97.6, Bp 115/75);anaphylaxis dx;pt wheezing & less responsive;911 called epi given;
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment medications were reported.
After the vaccination I began to suffer from SOB and tested positive for covid-19 on 12/29 and was given an enhaler to help with the breathing.  I had a sore throat, fatigued, a headache and diarrhea
On 04/01/2021, I had a doctor's appointment. I had a 40 pulse at that time and the doctor did not talk about it. This is the first time I had my pulse that low. On 07/01/2021, I saw the doctor, he did an EKG and referred me to my cardiologist. The EKG they found bradycardia. Right bundle branch block and left ventricle enlargement. I saw another doctor on 07/13/2021- he did an Holter monitor it him on 08/25/2021- he did an EKG sinus bradycardia, rest PAC, RBB-right bundle block, and LVH- Left Ventricular Hyper. He scheduled me for a pacemaker- on 09/17/2021. Unknown about my AEs because I am still being monitored and still recovering.
Patient with daily/consistent headaches and complaints of "cannot focus", decline in school performance (math) and emotional liability (crying every evening) beginning with in 24 hours of vaccination. Never had theses symptoms prior. No other medical explanation of symptoms.
Within 2 mins of receiving vaccination, experienced a vasovagal reaction, and tachycardia.  Symptoms resolved within 10-15 mins without any intervention.
We received the following literature report on 15 JUN 2009: 15 children between 6 and 59 months of age were vaccinated for the first time with an influenza vaccine (batch no. and manufacturer unknown) at the start of each influenza season (defined from 01 NOV to 30 APR) from 1999-2000 through 2006/2007. The children received a total of two doses (fully vaccinated). Vaccine effectiveness among fully vaccinated children as compared with unvaccinated children was 86% (95% confidence interval: 29-97%) for medically attended, laboratory-confirmed influenza illness. Vaccine effectiveness for the partially vaccinated group was 73% (95% confidence interval: 3-93%) as compared with the unvaccinated group. This case refers to one child (for other children, please refer to reference cases MA2009-1692, MA2009-1709 to MA2009-1710 and MA2009-1712 to MA2009-1722). Laboratory-confirmed influenza illness was reported (date?). Request was sent on 22 JUN 2009, no follow-up information received.
Patient states received flu shot 12-14-05.  States nurse stated blood ran down arm.  Arm hurt that day and next day arm blue around injection site and remained for two weeks.  Patient noticed 1-7-06 that deltoid swollen and appeared bruised.  Patient states they were applying alcohol since injection received.  States arm is stinging and feels hot today.
Rt deltoid red, swollen, tender to touch, hard, itchy, area 4 1/2 in in diameter, papule in center;
Right away had pain, tingling and pressure around right eye and felt light headed. Ongoing ME, POTS, muscle weakness, eye pain and weakness, double vision and difficulty with reading, overall muscle fatigue and weakness, right eye drooping, suspected myasthenia gravis, cognitive concerns, brain fog, difficulty chewing and swallowing, dermatitis, abnormal sweating and lighthadedness and fainting, joint pain and muscle pain, hyperlipidemia, muscle twitching
coughing, sneezing, headache, mucus.  took Paxlovid, lasted around 5 days. Still a little coughing.
bout 3 to 4 hours after having shot my head started hurting. I woke up in AM with body aches, headache and blurred vision in both eyes. Right worse then left. then I started seeing something in right eye sight.  When this was not better I called Thursday 10/28/21 to Eye DR. They thought best to come for an appt to have eyes examined.
I had a sore throat, sneezing, fatigue, body aches, and congestion. I tested positive for COVID-19 test, then I went to an urgent care. They prescribed me prednisone and nasal spray. The fatigue and body aches lasted for a couple of weeks. I still have a little fatigue.
states noticed rash-10PM w/itchiness 7JAN98;DPH inj per MD;no redness or swelling @ vax site;gen differentiated rash noted on trunk, arms & legs 8JAN98;
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 12 months old infant patient and unknown gender. On 08-SEP-2014 the patient was vaccinated with a dose of PROQUAD (Merck) (lot K006771, expiration date 07-NOV-2015)(dose, route not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. The reporter stated that as of 29-AUG-2014 they had 18 doses left of this lot number. This is one of several reports received from the same source. Additional information has been requested.
Red and swollen rash on left upper arm at injection site; with hard bump/bumps 3"x3" diameter. Itchy and bruised feeling.
Pt recvd 1st dose of Hep B vax 11AUG89 & 0n 20AUG89 devel pruritus w/ urticaria.On 11SEP89 pt recvd 2nd dose & later devel urticaria.Pt tx w/ DPH.
On 10/24/15, patient developed fever and febrile seizure which lasted no more than two minutes. Was seen in ER on 10/24/15 and followed up in office on 10/25/15.
This case was reported by a consumer via call center representative and described the occurrence of pain in joint involving hand in a 62-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On 18th December 2018, unknown after receiving SHINGRIX, the patient experienced pain in joint involving hand, chills, headache and nausea. On an unknown date, the outcome of the pain in joint involving hand, chills, headache and nausea were not recovered/not resolved. It was unknown if the reporter considered the pain in joint involving hand, chills, headache and nausea to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. After receiving SHINGRIX injection, the patient experienced joint pain in both arms and hand, chills, headache and nausea. The reporter wanted to know how long does the side effects lasts.
I broke out in gradual hives on extremities especially hands blistered and shed new skin, (still healing after a month)arms, legs, hives then rash worsening at night and better upon wakening; I broke out in gradual hives on extremities especially hands blistered and shed new skin, (still healing after a month)arms, legs, hives then rash worsening at night and better upon wakening; Very horrible reaction burned me from inside out; I broke out in gradual hives on extremities especially hands blistered and shed new skin, (still healing after a month)arms, legs, hives then rash worsening at night and better upon wakening; I broke out in gradual hives on extremities especially hands blistered and shed new skin, (still healing after a month)arms, legs, hives then rash worsening at night and better upon wakening; This is a spontaneous report from a contactable consumer (patient). This 54-year-old non-pregnant female patient reported for herself that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0176) via an unspecified route of administration on 27May2021 at 13:00 in right arm (at 54-year-old) as dose 2, single for COVID-19 immunization at Pharmacy or Drug Store. The patient medical history was not reported. Concomitant medications included estradiol, estriol (Biestrogen), testosterone cypionate and progesterone all were taken for an unspecified indication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0162) via an unspecified route of administration on 28Apr021 at 15:00 in right arm (at 54-year-old) as dose 1, single for COVID-19 immunization at Pharmacy or Drug Store. The patient had no known drug allergies (NKDA). It was mentioned that patient received no other vaccine in four weeks, did not have covid prior vaccination and was not tested for covid post vaccination. Six-days later, on 02Jun2021 at 12:00 hours patient broke out in gradual hives on extremities especially hands blistered and shed new skin (still healing after a month) arms, legs, hives then, rash worsening at night and was better upon wakening. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment with MEDROL pack and improved but returned as soon as tapered off med, she had very horrible reaction that burned her from inside out (onset: 02Jun2021 12:00 hours). The patient was recovering from all the events.  No follow-up attempts were possible. No further information was expected.
Friday night she had a 103 fever, mother administered Tylenol and fever resolved. She had started with hives around the shot site, raised welted hive at injection site that started to spread. Mother gave Benadryl and she woke up the next morning no fever but was covered in hives from head to toe. Mother gave her more Benadryl when she had woken up that morning. Hives would go away slightly but would come back when the Benadryl wore off. She went to an urgent care, they prescribed prednisolone for her. It helped with the hives but then it almost made the hives worse.
I had the Shingrix vaccine administered Monday morning.  My symptoms were normal  - moderate soreness and redness and swelling at the injection sight followed by flu-like symptoms Tuesday.  Those were body aches and headache.  But overnight tonight I have pins and needles severe pain in my left ring fingertip.  It's making it difficult to sleep.  There isn't a physical sign, the pain is within.  Pressure helps alleviate the pain a little. I read online that these symptoms are supposed to occur in the trunk of the body but that's not happening.  I've got a stinging fingertip.
30MAY91 mom called  c/o fever last night but has t104 this AM; c/o eye pain advised to phone MD; Pt seen by MD on 30MAY91-no further f/u done @ MD office, unable to reach mom by phone for f/u;
Patient presents to ER with SOB, cough, sore throat, and no relief after using cough medication.
both eyes swollen; both eyes red; both eyes watery; both eyes itching; This is a spontaneous report from a contactable consumer. This consumer reported for 2 patients. This is the 2nd of 2 reports.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on 07Jan2021 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient woke up with both eyes swollen, red, watery and itching on 24Jan2021. The outcome of the events were not recovered.   Information on the Batch/Lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021105990 similar report from same reporter