chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report was received on 22 July 2011 from a health care professional which involved a case of misuse. A five year-old male patient with no reported past medical history and no reported adverse events following prior vaccinations had received on 21 July 2011 a fifth dose subcutaneous left upper inner thigh injection of PENTACEL, lot number C3664AA (also reported C3553AA) and the next day experienced left leg tenderness, warmth, pain in upper thigh and a red spot at the injection site. The patient was evaluated by a physician. Treatments were not reported. The patient's previous vaccination history included four DTaP, three ACTHIB and three IPOL but no previous PENTACEL injections. No further information was available at the time of the report. The patient's  outcome was not recovered. Documents held by sender: none.
Headache, Diarrhea, Fatigue, Injection site soreness Narrative:
Pt with history of grand mal seizures since the age of 6 years old. Condition medically managed with prescription Lamictal and has not had a seizure in 2 years. Within an hour of receiving the Johnson & Johnson vaccine, pt suffered a grand mal seizure lasting approx 20mins. Symptoms included convulsions, foaming of the mouth, stiff muscles, urinary incontinence and unresponsiveness/nonverbal. Treated with Versed and Ativan. Typical post-ictal state: lethargy, body aches
Swelling, redness in right thigh-baby crying  in pain-afebrile (98.4 axil).
On 1/7/13 6pm headache, aching - sharp over the body, shaking. 1/8/13 Temp 101 degrees weakness. Missed 2 days work. Rash red over left arm injection site. Took ALEVE Q6 hrs on advise of MD. Diminished appetite, No N&V.
Fever at 10 days 102.6 degrees. Rash at 2/17 on face & trunk.
Pt. received 2nd dose 5 days early.  Discussed recommendations, pt still wished to receive the dose sue to being unable to return.
HCW has (+) child at home with high risk exposure, HCW has no symptoms but on routine testing related to high risk HCW was (+) for covid-19
Began with headache and eye pain/strain/fatigue on 01/05/2022, presumably related to computer based job / computer vision syndrome.  Reported fever to 99F prior to vaccinations administration at pharmacy facility.  Worsened headache and new lightheadedness while driving to facility for vaccinations.  Advised facility of symptoms; received vaccinations regardless.  Increased headache and eye symptoms beginning Sunday (01/06/2022).  Body aches.  Photophobia.  Worsened headache, prompting presentation to emergency department for evaluation on 01/10/2022.  History of Bell's palsy affecting right side of face diagnosed on 11/26/2021 and treated successfully with short course of oral steroids; no residual effects/deficits.
Had normal period, followed one week later by another heavier period.  This has never happened before.
Patient came to PCP office on 08/22/2023 for vaccination  only as scheduled. interpretation was provided. LMP was 07/12/2023. Patient reports hx of irregular menses. Denied pregnancy and declined urine HCG. HepB, HPV and varicella vaccines administered, patient left office without complaints. Patient went to see GYN on 09/28/2023 due to menses delay. Early pregnancy confirmed by urine HCG and bedside sono.  Physical examination without abnormal findings. After initial visit with GYN, PCP and GYN were unable to reach out patient for f/u. feeling normal as usual. Denied any side effects from vaccination day. Nurse informed pt to  continue to monitor for side effects, and encouraged patient to call clinic PRN. Pt voiced understanding.
1) Tingling, pins and needles on left side of left hand (pinkie finger and down the hand), immediately after shot. This is on-going. B12 supplement has helped, but it has not completely resolved (on and off tingling). 2) Pain at injection site
started 3/5/2021     tired, scattered thinking,    sore developed above top lip.  muscle in both legs and into top of feet painful til 3/10/2021
"Covid arm"-- painful, red rash developed about 6 inches below injection site, accompanied by a fever of 102 & fatigue for 2 days, rash lasted close to a week
Information has been received from a physician concerning a 36 month old pt from another country with no pertinent medical history and no allergies, who "recently" (approx June 2005), was vaccinated with a first dose of hepatitis B virus vaccine rHBsAg (yeast). Other concomitant vaccine therapy administered at the same time included a first dose of Hib conj vaccine and a fourth dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid. There was no other concomitant medication. Within 8-10 hrs of receiving the vaccines the pt experienced hives. It was reported that diphenhydramine (Benadryl) was given and the pt's symptoms resolved in a few hrs. The pt's outcome is recovered. There were no lab studies performed. There was no product quality complaint reported. The pt sought unspecified medical attention. Additional information has been requested.
Systemic: Lymph Node Swelling-Mild, Additional Details: Patient experienced swelling on back of arm, not injection site. Also it was itchy and appeared reddish. It was more swollen around the elbow. Bruise present at back of arm. Sharp pain below left armpit area, maybe lymph nodes. Some night sweats, no fever, no bodyaches.
(R) arm swelling - sore - itchy reddened deltoid & in near armpit all over muscles.
Racing heart; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 15Apr2021 at 15:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included sulfa allergy. 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 levothyroxine sodium (SYNTHROID) and estradiol (ESTROGEN) via topical and vaginal route of administration and more other medications (unspecified); all taken for an unknown indication from an unknown date and unknown if ongoing. The patient previously received influenza vaccine (flu shot) (MANUFACTURER UNKNOWN) in 2017 and experienced adverse reaction. On 15Apr2021 at 17:00, the patient experienced racing heart. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had been tested for COVID-19. On 26Aug2021, the patient underwent PCR test (nasal swab) and the result was negative. The clinical outcome of the event racing heart was resolved on an unknown date in 2021. The patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0168) via an unspecified route of administration in the left arm on 06May2021 at 15:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation.
RSV WAS SUPPOSED TO BE ADMINISTERED, BUT SHINGRX WAS ADMINISTERED ACCIDENTLY INSTEAD. BASED ON PATIENT'S IMMUNIZATION HISTORY OVER THE YEARS SHE HAD A SHINGRIX ON 6/12/18, 10/4/21, AND NOW OUR INCIDENT ON 10/28/23  FOR  A TOTAL OF 3 SHOTS IN 5 YEARS. SHE HAD NOT FOLLOWED SHINGRIX RECOMMENDED DOSING SPACING. ONYL A SORE ARM REPORTED, NO ADDITIONAL PROFESSIONAL SERVICES NEEDED, JUST A SORE ARM THAT SHE MANAGED AT HOME.
Parent returned to office approx 40 minutes after vaccine given. Presented with hives near injection site as well as arms and face. No resp. distress. Oral BENADRYL given immediately after MD exam. Patient remained in office for hour and a half - hives resolved.
ON THE SAME ARM AS INJECTION, NOT AT INJECTION SITE. PATIENT'S ARM BECAME VERY RED AND INFLAMED. WENT TO DR AND THEY THINK IT IS INFECTED AND GAVE PT ANTIBIOTICS.
During prescreening questions stated that she had a reaction to her Pfizer covid vaccine the first time but not the second time. She said that she had a hard time breathing but the medical staff where she got the vaccine (previously) did not do anything to treat this and said it was just anxiety. Was to wait 30 mins after the vaccine to make sure she doesn?t have a reaction. During that time, medical staff  went to sit down next to her periodically to make sure she was okay. During the observation time, they noticed that she was breathing a little faster. Administered the auto inject .3mL epi pen in her left thigh at 1542. She had hives to her extremities prior to injection. Administered another .3mL of the epi at 1547 (5 mins after 1st dose), after the patient stated she felt her throat was still tight and that she was still having trouble breathing. EMS arrived 1 min after the second epi administration and they assessed the patient. The medics arrived about 3 mins after that and assessed the patient.
Presented to hosptial after having 3 days bloody diarrhea.  Found to have metastatic colon cancer
90 minutes after receiving injection - low grade temperature, shortness of breath, numbness of lips. Patient called her Dr & after hours number and was instructed to take BENADRYL. A red rash developed around injection site several hours after injection given and increased in size by the 2nd day. Patient visited Dr's office 10/3/11 and nurse practitioner prescribed doxycycline.
Began with about discoloration in my urine and then on the morning of the 6th, I was passing blood and I went to ER. They gave me an injection of something and a 10 day course of a different antibiotic. Symptoms were pretty much gone the  next day. Have a dr visit scheduled next week.
her lymph nodes are swollen on the right side of her neck; Fever; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), VOMITING (vomiting) and LYMPHADENOPATHY (her lymph nodes are swollen on the right side of her neck) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (blood clots, stents, and COVID toes) in December 2020. Concomitant products included METOPROLOL, NIFEDIPINE and LOSARTAN for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PYREXIA (Fever). On 13-Apr-2021, the patient experienced LYMPHADENOPATHY (her lymph nodes are swollen on the right side of her neck). In April 2021, the patient experienced VOMITING (vomiting). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 04-Apr-2021, PYREXIA (Fever) had resolved. In April 2021, VOMITING (vomiting) had resolved. At the time of the report, LYMPHADENOPATHY (her lymph nodes are swollen on the right side of her neck) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Body temperature: 102 (High) Temperature ranged from 101 to 102.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient is also taking fluid pill and blood thinners concomitantly.
On Saturday evening fever of 103 occurred which lasted until monday morning On monday and tuesday (11/8/2010 and 11/9/2010 patient had diarhea On Tuesday and Wednesday  (11/10/2010 and 11/11/20101)patient developed horrible rash which looked like measles
This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 1st December 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 2nd December 2021, 1 days after receiving Shingrix, the patient experienced tiredness and dizziness. On an unknown date, the outcome of the tiredness and dizziness were not recovered/not resolved. It was unknown if the reporter considered the tiredness and dizziness to be related to Shingrix. Additional details were provided as follows: This case was reported by the patient herself.  The reporter did not provide a batch or expiration date for the Shingrix. The patient had received a dose of Shingrix yesterday (from the date of reporting). This morning on the day of reporting, she began to feel dizzy and tired.  She had nothing else to report. The reporter consented to follow up.
Myalgia & Fever Per nursing report: "took 2nd dose of Moderna vaccine yesterday [2/22]. States did not come into work today [2/23] due to states c/o body aches, soreness and states mild fever today."
At 7pm I began having body aches all over, chills, and fever that lasted about 5 hours with no medication taken. At 3am, I then woke up to an extreme headache/migraine and immediately took Excederine Migraine medication which took the headache away about 30 minutes later.
On friday 9/17/21 I recieved the first dose of the shingrix vaccine at approximately 12:45pm. little or no side effects. saturday 9/18/21 Arm was sore (hard) at injection site. Felt achy all day but managed to do some chores around the house. About 10:00 pm decided to take 3 - 200 mg ibrupropen (600mg total) due to sore joints and arm. Sunday 9/19/21 5:00 am Awoke with tongue swelled filling my entire mouth. Breathing thru my nose was not effected. Eventually took 2 - 50mg benadryl. By 3pm the swelling had reduced considerably, allowing me to eat. Monday 9/20/21 6:00 am Left hand ring finger was swollen and itchy. I removed my wedding ring. As the morning progressed my left hand swelled considerably but I managed to do some outside chores.Tuesday 9/21/21 Swelling in my left hand had reduced. All seemed better. As the day progressed the left side of my throat became quite sore along with my left ear.  By 9:00 pm it became more difficult to swallow. Wednesday 9/21/21 6:00 am  Woke up with a very painful sore throat. I could not swallow due to the pain. By 10:00 am I managed to drink a little coffee thru a straw. The pain eased up as the day went on but swallowing was difficult due to ear and throat pain. About noon the bottom of my right foot started swelling. the edema was a hacky-sac size bubble of fluid near my heel. walking was difficult due to floating fluids in the skin. Around 7:00 pm the bottom of my left foot started swelling. this seemed to cover the entire botttom of my foot. The swelling causes severe itching across the bottom and toes.  I eventually took 1 -25 mg benadryl to ease the itching. Thursday 9/23/21 6:00 am Both feet are still swelled up and nearly impossible to walk on. My throat was still sore but getting better. Still very painful to swallow. spent the day off my feet. by 9:00 pm the swellling had reduced considerably. My left ear was still infected causing pain swallowing. Friday 9/24/21 6:00 am throat and ear are much better. Both right and left wrists are red and itchy.  Left side of tonque is slightly swollen  but  swallowing pain is minimal.  My feet have returned to normal with the exception of some itching. My experiance with the second Moderna covid vaccine had similar reactions.  About day 4 the bottom of my feet swelled for two days with bubbles of fluid traveling from heel to toe as the day progressed.  I also had typical reactions such as sore arm and fever on day two .
Day after vaccine - just below injection site, developed a red welt, itching, 2" x 2" - welt, 2" circle (red) under the welt. Remain with.
Hep A given 6/22/07 noted rash 6/23/07, arthralgias onset 6/25/07, fatigue 6/27/07.
Bad cramps, diarrhea, chills and then very liquid diarrhea with blood
Hello - following my second Pfizer COVID shot I had a low grade fever and body aches.  24 hours following this incident, by 100% breastfed 9 month old baby also had fever and developed intense stomach pain and diarrhea.  He was sick for 5 days.  I am writing to report the side effects on Breastmilk on children following the second PFIZER COVID shot.
contracted COVID-19, was diagnosed with COVID-19 and was asymptomatic; contracted COVID-19, was diagnosed with COVID-19 and was asymptomatic; This is a spontaneous report from a Pfizer sponsored program COVAX US Support received from a contactable consumer. A 100-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (reported as late December or early January) (Batch/Lot number was not reported) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration in Jan2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunization; paracetamol (TYLENOL), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included atrial fibrillation. The patient's concomitant medications were not reported. The patient previously took amiodarone. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. In Apr2021, it was reported that the patient contracted COVID-19, was diagnosed with COVID-19 and was asymptomatic. The patient got COVID even though she received the vaccine. Patient is in a nursing home. Every week the nursing home test her, every single week for everybody. In Apr2021, they did the PCR, she is asymptomatic and it says that she is positive. The action taken in response to the events for paracetamol was unknown. The outcome of the events was unknown.  Information about batch/lot number has been requested.
Counseled the patient about what had happened, and suggested watchful waiting. Patient is to report to the pharmacy and MD if anything outside of a natural immune response occurs (including fever, body aches and chills).
Pfizer 5/27/21, 6/17/21. Positive on 12/14/22
Information has been received from a Certified Medical Assistant and a Nurse Practitioner concerning a 19 year old male student with asthma, seasonal allergies, iodine allergy and a history of repeated pneumonias and supraventricular tachycardia (SVT) s/p ablation and no illness at the time of vaccination who on 10-JUL-2006 was vaccinated intramuscularly in the deltoid with a 0.5mL first dose of Pneumovax 23 (lot 651172/1210R). On 13-JUL-2006, the patient developed a severe cellulitis at the injection site with a 10 inch diameter, high fever, and chills. The patient went to the local emergency room and was hospitalized. The patient was transferred to another hospital and received unspecified IV antibiotics and steroids. At the time of this report, the outcome of the patient's condition was unknown. Injection site cellulitis was considered to be immediately life-threatening by the Certified Medical Assistant. Follow-up information received from the Nurse Practitioner did not indicate that the patient's cellulitis was considered life threatening. The release of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. No additional information is expected.
Hospitalized 6/12/22-6/13/22 RUQ pain, Covid +, decreased appetite, appendicitis
Trigeminol Neurlagia; Severe Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of TRIGEMINAL NEURALGIA (Trigeminol Neurlagia) and FATIGUE (Severe Fatigue) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048AZ1A) for COVID-19 immunisation.     Concomitant products included LISINOPRIL, HYDROCHLOROTHIAZIDE, AMLODIPINE, CITALOPRAM, ROSUVASTATIN, PIOGLITAZONE and DULAGLUTIDE (TRULICITY) for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced FATIGUE (Severe Fatigue). On 26-Mar-2021, the patient experienced TRIGEMINAL NEURALGIA (Trigeminol Neurlagia). On 19-Mar-2021, FATIGUE (Severe Fatigue) had resolved. At the time of the report, TRIGEMINAL NEURALGIA (Trigeminol Neurlagia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported went to the emergency department on 26MAR2021 and was diagnosed with Trigeminal Neurlagia. Patient reported that patient received second dose on 15APR2021 and had another episode of Trigeminal Neurlagia on 1MAY2021. Patient also reports having severe fatigued the first night after the first dose.
This spontaneous report as received from a healthcare worker refers to a patient of unknown demographics. No current condition was reported. No pertinent medical history was reported. On 02-SEP-2014, the patient received improperly stored VARIVAX, exposed to 23F for 3 hours. No adverse effects were reported. The outcome of patient received improperly stored VARIVAX was unknown. No further information was provided. No PQC was involved. This is one of the several reports. Additional information has been requested.
received her second dose of Shingrix past the 6-month period/due to COVID vaccine; This case was reported by a consumer via call center representative and described the occurrence of social problem in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 21st September 2020).   On 16th July 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 16th July 2021, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional case details were reported as follows: The case was reported by the patient.  The patient received her 2nd dose of Shingrix on left arm into the muscle past the 6-month period as she was due in March 2021 for her 2nd dose.  However, due to COVID vaccine, she was advised to not get Shingrix vaccine for some time. Therefore, she gotten second dose of Shingrix later than recommended schedule The reporter gave a consent to follow-up with health care professional (HCP).  However, the patient seen by different health care professionals on each visit, she did not had name of health care professional, fax number or email address to health care professional.  The patient provided her email address, she did not have lot number or expiration date of the Shingrix dose.  The reporter consented to follow up.
Patient does not have any signs or symptoms from vaccine. Treatment will be checking on injection site and how patient is doing after today.
Tired; Flu like symptoms; Can't breath through his nose; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired), INFLUENZA LIKE ILLNESS (Flu like symptoms) and DYSPNOEA (Can't breath through his nose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jun-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and DYSPNOEA (Can't breath through his nose). On an unknown date, the patient experienced FATIGUE (Tired). At the time of the report, FATIGUE (Tired), INFLUENZA LIKE ILLNESS (Flu like symptoms) and DYSPNOEA (Can't breath through his nose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Caller stated that patient received his 1st dose of the Moderna COVID 19 last week. No concomitant medications were mentioned. No treatment details were reported.