chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; Extra dose; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number KJ9N5, expiry date 17th October 2021) for prophylaxis.  On 10th August 2019, the patient received Shingrix. On 10th August 2019, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional case details were reported as follows: The healthcare professional reported that patient received an accidental 3rd dose of Shingrix, which led to extra dose administered. No side effects were reported.  The reporter gave permission to follow up.   Follow up information received from the pharmacist on 9th October 2019:   The patient demographic details was updated. The patient received 0.5 ml dose of vaccine intramuscularly. The patient came to pharmacy and asked to start new Shingrix series.  The patient said his doctor mentioned that there was a new shingles vaccine that recommend to get.  The patient said he never had the vaccine before.  The vaccine was processed and covered by insurance and given upon filling the consent form.  The reporter came upon vaccination from for the patient indicating that he already received two doses. On 10th August 2019, less than a day after vaccination the patient had fever. On 11th August 2019, the patient recovered from fever. The reporter considered the fever to be unlikely related to Shingrix. The VAERS information was updated.
Became flushed, gurgling, wanted to get ill, O2 Sat range 94- 96, HR 77 , resp unlabored, B/P 141/102. Assistance from other nurses, ER kit Epi at bedside. Layed down, feet up, Amonnia smelt assisted improved color and no vomiting. Airway sounded clear, 0410 Heart rate 81 r, 140/81 lying. o2 Sat 96. Non labored breathing. 4:13 sitting up B/P 140/95 Hr 87 reg. 4:20 pm Sipping on juice, cold h20 Bp136/78, 85 reg , O2 Sat 98. Stated felt more like herself, holding toddler who was also going to get immunized this day. She was wondering if her eyes looked swollen, they did not. Left message with PCP. She will return our call. Pt left at 5:15 with daughter stated feeling like she did before appt. Has a Benedryl at home  and plans to take one at HS. Educated re: ;calling EMS if any symptoms returning and she stated ok an d agreed to f/u by phone later.
The shot was administered very high on my arm, almost at the joint, and I felt the vaccine flow down my arm. Several hours later I was already feeling a great deal of pain, and could not lift my arm. That evening I was woken up by severe shoulder pain, much more than ever felt previously with vaccines, making it impossible to lift arm or even move without a sharp pain in my shoulder. Since onset, the pain has continued in varying degrees of severity. Sometimes it is just an ache, other times it makes it impossible to lift my arm in certain directions, grasp items, turn or roll over without strong pain throughout shoulder and/or arm. I have tried resting it, warm compresses, massage and gentle yoga in addition to pain meds. Everything I have tried only works temporarily, and often the pain returns worse the next day after gentle exercise or massage. I am seeing my GP tomorrow to discuss the matter.
Covered in hives from head to toe, immediate and persistent injection site soreness, extreme joint pain, fever
Entire body itching including face, lips, upper palate , throat and tongue.  Skin slightly flushed but NOT a raised rash. Took Benadryl within 15 minutes and slept for 5 hours. 24hours later body still feels hyper sensitive /itchy but tongue and lips not so much.
On respirator 2-24-14. Still in treatment as of today 06-06-14.
Initial unsolicited report received from a consumer (patient's grandmother) on 03-May-2016. This case involves a 13-months-old (reported as one year old) male patient who was vaccinated with a dose of ACTHIB (batch number: unknown, expiry date, route and site of administration: not reported) on 28-Apr-2016. Illness at time of vaccination was reported as none. Pre-existing physician diagnosed allergies, birth defects, medical conditions included- allergies: unknown and medical history of diabetes. Patient was previously vaccinated with DTaP Vaccine in Nov-2015. Patient did not receive any other vaccinations. Concomitant medications were not reported. On 30-Apr-2016, two days post vaccination, the patient experienced fever of 101.7 Fahrenheit, dehydration and diarrhea. Laboratory investigations included elevated ketones. Patient's corrective treatment included TYLENOL. (It was reported that the "fever went down with TYLENOL but went right back up".) The outcome of the events was reported as not recovered. List of documents held by sender: none.
Seizure; This is a spontaneous report from a contactable physician (patient). A female patient of an unspecified age received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) on an unspecified date, at single dose, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On an unspecified date, after the vaccination, the patient had a seizure. Clinical outcome of the adverse event was unknown at time of this report.   The information on the lot number has been requested.; Sender's Comments: A possible causal relationship between seizure and BNT162B2 cannot be completely ruled out considering the temporal relationship.  However, more information would allow for a full medically meaningful assessment, especially medical history, concomitant medications, concurrent illness and event details description including time lag between the onset of the event and vaccination date of BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
After about one and a half months after the vaccine booster. I developed tremendous pain in and pressure in both arms. As if both arms were being squeezed by a blood pressure cuff from my hands to the shoulder. The pain and pressure would hit both arms simultaneously and last for hours. Then tapper off, then come back. This lasted for months when I also felt my hands starting to go numb as this was taking place. This lasted for over a year when it began to slowly subside. The issue lasted total about 2 years.
Had the shot at 1:00 PM on June 18, 2019.  Within an hour I felt a bit dizzy and a bit out of it.  By 8:00 PM I felt  tired, achy, had a headache, felt chilly, on and off nauseated, and my left arm at the vaccine sight, was very sore.  These symptoms  continued through the night-I didn't sleep well at all!  The  next day I had to go to work.  I was very close to calling in sick.  However, I went to work, but felt like I had the a virus or flu the whole day.  Came  home and went to bed.  Except for a quick fixed dinner, I stayed in bed.  Went to bed early-8:30 PM.  On Thursday, June 20, 2019, I started feeling better.  These are the same symptoms I had with the first Shingrix shot on April 1, 2019.  I just didn't report them.
Not feeling well.  Reported to school nurse.  Temp 103.  Nurse sent him home.
The first few days it was just normal arm pain after a shot. About a week afterward I noticed that the arm I had the shot in was swelling and itching. This slowly spread from my arm to my whole body. My joints started aching and the redness and itching would not let up. I called my PCP because my body was now in so much pain I thought maybe I had done something to move my hip hardware out of place- I have not had use my cane in a long time but was using it and my joints hurt so much that I thought maybe something happened and I did not realize it had moved. An x-ray showed it was all where it was supposed to be and not the cause but we did see swelling in my joints. I saw an orthopedic surgeon and we did more tests. I am now on a a new medication and will be doing physical therapy.
This spontaneous report as received from a other health professional refers to an approximately 63 year old female patient. Pertinent medical history and drug reactions or allergies was reported as none. On 06-MAY-2014 the patient was vaccinated with ZOSTAVAX (dosing regimen unspecified). Concomitant medications were none. Approximately on an unknown date in MAY-2014 the patient experienced symptoms of itching, local warm hot nodule. Patient sought treatment with Physician on 08-MAY-2014. Treatment prescribed was ice and BENADRYL. There was no product quality complaint involved. Symptoms have resolved with no continuing issues. The outcome of symptoms of itching and local warm hot nodule was reported as resolved. Causality assessment was not provided. This case is linked to 1406USA004610 (same reporter link). Additional information has been requested.
Chills, hot flashes, brief knee pain twinges, face flushed, headache. These effects lasted for two hours, then I had anxiety and trouble sleeping for rest of night.  The headache carried on into the morning and became severe. Upon taking Advil, the pain drastically decreased. I had a mild headache, along with fatigue, a little queasy after eating and an unpleasant spacey/dizzy/heady feeling for the rest of the day.  By morning of the 9th, all effects ceased.
Flu-like symptoms including fever, chills, body aches, nausea, extreme diarrhea for 4 days and getting worse
The pt developed itching that continued to get worse.  developed swollen/numb tonge, epi pen administered into left thigh.   EMS called and took pt for further evaluation.
Soreness at injection site, followed by periodic sharp pain in arm when extended, followed by continuous shoulder and neck discomfort / pain, periodic headache,
This spontaneous report as received from a registered pharmacist refers to a female patient of unknown age. The patient was vaccinated with a dose of GARDASIL (Lot # not reported) on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on an unknown date the patient experienced her throat swelled up after receiving GARDASIL. The patient was prescribed an unspecified medication and she fully recovered. The relatedness for throat swelled up was unknown for GARDASIL. Additional information is not expected.
anxiety, sweating, SOB 5 minutes after vaccine, Has hx of phobia to needles and says he normally feels faint after vaccines. full resolution of s/s after water and snacks. refused transport. Alert and orietned x4, NAD , able to speak full sentances. V/S stable.
24 hours after, began to notice a mild tightness in my chest ? on the left side.  Sensation came and went. Brief periods of being aware of the tightness followed by long intervals without sensation. Never painful, never distressing, just mildly there on and off.  After 24 hours sensation had not gone away. Decided to go to ER (~48 hours after the shot)  out of concern for heart. At the ER, EKG was normal, traponin levels were normal (tested it twice), chest x-ray was normal, CT with contrast showed no sign of a clot.  I did not have swelling in my legs, nor any difficulty breathing, so the doctor ruled out myocarditis.  I left ER without an explanation and with instructions to follow-up with a cardiologist.  I waited a few more days to see if the sensation would go away. It didn?t. During this time, the pattern was pretty much the same as before, but some new sensations  emerged.  A few times, I had a sharp ?lightning bolt? that lasted only a second but was like a zap.    Once it became clear that the problem was ongoing, I made an appointment with a cardiologist.  I had a tele-health appointment with her on Friday, 11/19. She believes that the shot induced mild inflammation.  She told me to take ibuprofen and within a day or so the symptoms (mostly) subsided.  I am continuing to take the ibuprofen and will stop after a full week.  The doctor ordered an echocardiogram and EKG, which I will have after the holiday.
ARM SORE; FATIGUE; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's past medical history included depression, and concurrent conditions included anxiety, and non-smoker, and other pre-existing medical conditions included no known drug allergies. The patient was previously treated with buspirone for anxiety, and clonazepam for anxiety. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 at left deltoid for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced fatigue. On 11-MAR-2021, the subject experienced arm sore. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm sore on 18-MAR-2021, and had not recovered from fatigue. This report was non-serious.
Pfizer / BioNTech 1-FEB-2022 / Treatment of COVID-19 22-JUN-2022; Pfizer / BioNTech 1-FEB-2022 / Treatment of COVID-19 22-JUN-2022; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 01Feb2022 at 14:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: COREG, start date: Dec2021, stop date: May2022; LIPITOR, start date: Dec2021, stop date: 22Jun2022; PRILOSEC [OMEPRAZOLE], start date: Dec2021, stop date: May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Pfizer / BioNTech 1-FEB-2022 / Treatment of COVID-19 22-JUN-2022". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Report about covid treatment reported as Yes. If vaccine received reported as Yes. Other medication in 2 weeks reported as Yes. Anti-viral details: Product: COVID 19 Treatment, Treatment start date: 22Jun2022, Treatment stop date: May2022, Indication: Treatment of COVID-19. Known allergies reported as No. Other medical history reported as none.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
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 Agency 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 Agency. The 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.
Pulled arm away when vaccinating, arm was scratched with needle.  Revaccinated in opposite arm - pt got full dose.
This infant had vaccination, 4 days later developed urticaria that started at the head then spread to the face and trunk over 2-3 days. Resolved spontaneously after 2 weeks. No other symptoms.
10:35a: COVID vaccine #1  Sitting in monitoring room.  11:05a: checked for symptoms and reports shortness of breath and wheezing.  Has history of asthma and has albuterol with her.  11:08a: O2 100% RA, HR 116 Took albuterol inhaler x2 puffs Ongoing shortness of breath. Reports sharp pain in her chest. Reports dizziness.  11:10am BP: 110/84, O2 99%, HR 113. No wheezes on exam Drank fluids and given snack. Reports difficulty swallowing.  Sharp pain in chest is worsening. Shortness of breath worsening. Reports nausea. 11:18a: glucose 178. HR 112, O2 100%. Ongoing sharp pain in chest and worsening shortness of breath  11:20a: Given Benadryl 25mg and orange juice.  11:30a: Requests to go to ER ? 911 was called.  Repeats albuterol inhaler 11:40a Reports shortness of breath worsening and closing sensation in her throat. Burning sensation in her mouth. Chest pains worsening and ongoing dizziness.  Given epipen 0.3mg [due to shortness of breath, sensation of throat closing, nausea, dizziness, tachycardia] 11:43a: EMS arrive, assess and transport to ER
I received doses 1 and 2 of the Pfizer COVID-19 vaccine in March 2021. Due to lack of booster dose appointment availability and desire to get Moderna booster for better antibodies, I was unable to get a booster dose exactly 6 months later and had finally was able to schedule one for 2/1/22. On January 9th 2022 I woke up feeling unwell with cold like symptoms (runny nose, cough, headache) and took two home COVID-19 rapid antigen tests which were both positive. I isolated at home per the CDC guidelines at that time. I had cough and congestion lasting 1 week and shortness of breath and fatigue lasting 2-3 weeks. I completely lost my sense of smell on Jan 11th-12th and regained most of it 2-3 weeks later. I did receive my booster dose of vaccine on 2/1/2022
Stepmother and father report that on Sunday morning 10-25-20, patient was fixing  a sandwich in kitchen. They heard him say aloud oh no, no, no and he walked to front door. They heard him fall to the floor. They found him convulsing and shaking. He was drooling and could not speak. He did defecate. They said he had steady shaking for approximately 6-8 minutes. He vomited afterwards. Report that it was about 30 minutes before he "came to".   They did not take him to the ER this time nor call an ambulance. (Report that when he had seizure 2 years ago they took him to ER, in May 2020 they called an ambulance.) They called hospital  Monday morning 10/26/20 to give report of seizure. He had an appointment with his physician afternoon of 10/26/20. Dr. is referring him to a neurologist. Parents are awaiting an appointment from the referral. He has had  no further seizure activity and no injuries from the seizure.
After vaccination on left deltoid mom noticed redness and swelling from the shoulder to the elbow. No treatment, no fever.
I had pain shooting up and down my arm and my hand is numb, and my arm and shoulder is in constant pain.
Patient presents to the ED complaining of chest tightness over last 2 days.  Also noted racing heart rate and extremity tremors while walking up her stairs.  Episode lasted for 2 minutes, continued to have these short episodes.  Pain went away when lying down.  Also felt back pain and nausea.  No SOB or dizziness.  Patient suspected of having unstable angina, with known CAD status.   Patient was asymptomatic upon discharge.
veins were hurting; bad headaches; This is a spontaneous report from a contactable consumer (patient, self-reported). A 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm Right, on 22May2021 at 14:00 PM, as a single dose for COVID-19 immunization at pharmacy or drug store. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history included hypothyroidism hashimoto and known allergies: allergic to a lot of meds but never a vaccine. Concomitant medication included Thyroid. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient reported that on 23May2021, she felt like the veins were hurting everywhere and been having bad headaches and it was recovered with lasting effects. Outcome of the events was recovered with sequel.  Information on Lot/Batch number has been requested.
THE PATIENT PASSED OUT A FEW MINUTES AFTER RECEIVING THE VACCINE. HE FELL OUT OF HIS CHAIR AND WAS FULLY CONSCIOUS WHEN I CAME TO HIS SIDE A FEW SECONDS LATER. WE HAD THE PATIENT STAY LAYING DOWN AND HE SAID HE FELT COMPLETELY FINE. THE PATIENT DID NOT WANT US TO CALL AN AMBULANCE. AFTER A FEW MINUTES, WE TOOK THE PATIENT TO OUR PRIVATE CONSULATION ROOM AND CONTINUED TO MONITOR HIM FOR AT LEAST 30 MINUTES. THE PATIENT'S MOM ARRIVED AT THE STORE, WE EXPLAINED THE SITUATION, AND THEY LEFT TOGETHER. WE CALLED THE PATIENT A FEW HOURS LATER AND HE WAS DOING FINE.
Physician discharge summary: Admit date: 7/12/2022. Discharge date: 7/15/2022. Hospital course: The patient was admitted and treated with IVF. He slowly recovered. RUQ US and CT abdomen did not show obstruction. T. bili mildly elevated but improved with IVF. He was able to tolerate a regular diet at the time of discharge with no significant increase in abdominal pain. He was noted to have a fever while here. CXR was ok and urine was clean. The fever felt due to COVID-19. He also had intractable hiccups. He was placed on baclofen and these improved. It was felt pancreatitis was the underlying cause. He was asked to follow-up outpatient. Discharge condition: Fair.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies of medical history provided. On 06-MAY-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX subcutaneously, once, lot # L036822, expiration date: 24-DEC-2016 (dose was not reported. There was no adverse effects reported. Administered dose of vaccine experienced the temperature excursion of 38 degrees Fahrenheit for 30 days since 06-APR-2016. This is one of several reports received from the same reporter. Additional information has been requested.
Immediate knot and pain at injection site, swollen and redness at injection site, warm to the touch, weakness/dizziness, headache.
This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration on 15Apr2021 at 09:15 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known drug allergy (NKDA). The patient did not receive any medication within two weeks of vaccination. 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 did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021 the patient experienced left supraclavicular lymphadenopathy. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event left supraclavicular lymphadenopathy was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.