chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2-3 min after receiving vaccination while standing had syncopal episode, sweaty, shaking sore throat white lips after 5-10 mins. 12 cups of H2O felt better BP 90/60 BP normal taken prior to exam 106/62 P 80
CLIENT WAS 11YO AT TIME OF COVID VACCINATION. CLIENT RECEIVED THE FORMULATION MADE FOR AGES 12+. CHILD SHOULD HAVE RECEIVED PFIZER ORANGE-CAP FOR 5-11YO.
I woke up 2 days after my second covid vaccine to my ears ringing loudly and it has not stopped since.  I talked to my doctor on November 3rd during my physical and she said that this symptom is rare but should be temporary.
Was diagnosed with complete heart block needed pacemaker implanted on 03/05/2021. Never had any heart issues before and there is no history of heart problems in my family.
Got my second shot on June 14. On June 16 from the very morning started feeling extremely dizzy, had heart palpitations, chest pain when breathing and high heart rate (100 at rest). Spent the day in bed. Each time I would get up, I would feel as if I were going to faint. The next day felt better BUT when I was walking outside, I would get extremely dizzy, would have difficulties breathing, heart palpitations and my legs would become very heavy. At rest most of the symptoms would go away.  On June 18 I saw a doctor addressing my symptoms. The doctor suspected acid reflux but still wanted to do CT scan of lungs because I had stopped birth control pills a month or so before the vaccination. Also I was prescribed Pantoprazole. During the next two weeks I was getting much worse. The heart rate was racing ? 100-120 at rest, I was dizzy, not able to walk my dog or walk around the house at some days. Each time I walked I felt as if I was going to faint.  On June 1 I felt very dizzy walking around the house. Basically I could not take 5 steps without feeling dizzy. So I called an urgent care doctor. I was sent to have a blood test (to look for thrombosis signs) and EKG. The blood test came back normal. EKG was ?borderline? ? ?Borderline Right Axis Deviation Cors Axis >90?.  On June 9 I got CT scan which came back normal. Still, I was very weak and dizzy.  On June 14 I was given a Holter monitor for 3 days (ending June 17). As if today, June 23 I don?t have the results from the monitor.  Today I feel better, however, I still have joint pain and my legs get extremely heavy and painful after performing daily routine activities.
I had respiratory problems such as difficulty breathing, a lot of coughing, and I had mucus. I had some fatigue. My lungs were very loud. My breathing was very bad and loud. It sounded like a car engine. At first, I went to an urgent care on 10/15/2021. I had no fever or chills, but a runny nose for several days. I had a mild cough and congestion. I didn't have any acute distress or respiratory distress. They gave me an albuterol inhaler, and I was prescribed Cipro. Then I went to the ER on 10/16/2021. I had shortness of breath, and wheezing. They increased my prednisone to 60mg a day. I was also having difficulty urinating. I took the cipro one night and then I stopped taking the cipro because my doctor said to stop taking it because it may be the cause of my wheezing. I had respiratory problems such as difficulty breathing, a lot of coughing, and I had mucus. I had some fatigue. My lungs were very loud. My breathing was very bad and loud. It sounded like a car engine. At first, I went to an urgent care on 10/15/2021. I had no fever or chills, but a runny nose for several days. I had a mild cough and congestion. I didn't have any acute distress or respiratory distress. They gave me an albuterol inhaler, and I was prescribed Cipro. Then I went to the ER on 10/16/2021. I had shortness of breath, and wheezing. They increased my prednisone to 60mg a day. I was also having difficulty urinating. I took the cipro one night and then I stopped taking the cipro because my doctor said to stop taking it because it may be the cause of my wheezing.
After the vaccination I had a rash that started on my lower back and spread all through my body it was really itchy. I contacted my doctor and they did a biopsy and it said that it was a reaction to a medicine. The doctor gave me a couple of medicines a cream for the rash and the Fluocinonide and Benadryl and when I went to the urgent they gave me Pretnozol. I had to go to the urgent care because the rash was getting worst.
My left eye at the same arm I was vaccinated on is very red like it has broken blood vessels; This is a spontaneous report from a contactable consumer (patient). A 59-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration in left arm on 01Apr2021 13:15, as a single dose for COVID-19 immunisation. Patient medical history was reported as none. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient tested for COVID-19 was unknown. Concomitant medications were not reported. The patient did not have allergies. The patient did not receive any other vaccines within four weeks and no medications within two weeks prior to the vaccination. The patient experienced my left eye at the same arm I was vaccinated on is very red like it has broken blood vessels on 01Apr2021 13:15. The patient received treatment for the event was reported as unknown. The outcome of the event was reported as unknown.  Information on the lot/batch number has been requested.
Having sore, redness at injection site; Having sore, redness at injection site; This is a spontaneous report from a contactable pharmacist via Pfizer sales representative.  A female patient of an unspecified age received pneumococcal 13-val conjugate vaccine (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced having sore and redness at injection site on an unspecified date. The events lasted 2 or 3 days and were non serious. The outcome of the events was resolved on unspecified date.  No follow-up attempts are possible, information about batch number cannot be obtained
redness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th February 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient planned to follow-up with her physician. The reporter consented to follow-up. For tolerance dose refer case US2019GSK102052. There is a discrepancy with respect to the outcome of the event Injection site erythema. In the core the outcome is reported as Not Recovered/Not Resolved, however in provided source document it is recovering/resolving. The outcome of these events retains as per the structural field.
C/c of feeling dizziness/weakness after receiving her 2nd vaccine. Pt has Hx of Anxiety and takes prescribed Valium. V/S stable: BP: 120/78, HR: 78, SPO2: 98%RA. Pt stated that she did not want emergency called and did not want to go to the hospital.  Pt advised that taking an Uber was not recommended and emergency service would be called and that she is able to refuse transport thru emergency. They were called and arrived at 10:40. Pt was assessed and  refused transport. Pt signed Incident Report stating that she was refusing emergency transport and that she was claiming responsibility of being transported  home via Uber.
The MA who administered the dose did not combine (reconstitute) the two vials.  She administered only the DTaP-IPV and not the Hib.  She self-reported, notified the provider and the family.  An incident report was done at work, signs were posted on the vaccine refrigerator regarding the need to mix the two vials and they are now bound together.  An email was sent to all of the managers at the  other clinics to please do the same quality updates.
Initial information received on 18-Mar-2019 regarding an unsolicited valid non-serious case received from a physician. This case is linked to cases 2019SA077925 and 2019SA077907, same reporter. This case involves a 4 years old female patient who received vaccine IPOL. The patient's past medical history, concomitant medication and family history were not provided. On 01-Mar-2019, the patient received injection of suspect IPV (VERO) lot number, expiry date not reported via unknown route in unknown administration site. It was an actual medication error due to product storage error. It was reported that there was a power outage and the opened MDV IPOL vaccine was administered to patient that reached a temperature of 34-33 degrees F. 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 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
muscle pain, pain with walking, and now can't walk. Can not stand up and can not move legs from pain. He has a fever.
Within 12 hours I was chilling and fevering. Within 24 hours I started to break out in a rash on my chest torso and back. The rash continued to spread over my entire body. The rash was raised, itchy, very painful and miserable. I had multiple growths of skin like moles that would grow almost over night; I suffered with it for five months. I had several appointments with my dermatologist. I was treated first with Triamcinolone Acetonide cream and Allegra with no improvement. Then I was prescribed Betamethasone Dipropionate Ointment and Montelukast and Cimetidine with no improvement. I then was sent to a specialist and went through three rounds of progressive Prednisone with no improvement. I was denied Xolair by my insurance and started Methotrexate. at around five months the rash disappeared and within six months the itching and burning stopped.
Varicella vesicular papular rash broke out with lesion 6/2/06
This spontaneous report as received from a healthcare worker refers to a patient of unknown gender and unknown age. On 29-APR-2014 (reported as yesterday), the patient was vaccinated with a dose of expired PROQUAD (Merck) lot # H019439, expiry date: 25-APR-2014, 0.5 ml, subcutaneous in the left arm. No adverse effects were reported. Additional information is not expected.
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hyperventilation-Medium, Systemic: Hypotension-Severe, Systemic: Nausea-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Medium, Systemic: Weakness-Mild, Additional Details: Pt. fained ~5-7 min after vaccine administration. Said he wasn't feeling well. I asked pt. to get on the floor, and he refused. Pt. was much larger than me, and I asked again to get down on the floor and put feet up because I can't hold or catch him, and again, pt. refused. He slumped backward, looked like he had a small seizure, and then fell forward out of the chair, and hit his head on the ground. I called 911. EMS tended to him and recommended he go to the hospital for further evalualtion.
Approximately 10-15 min after vaccine given. Patient called and c/o tingling in her fingers of the arm that she received her vaccine
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 4:30 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 4:30 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 25.42  Concomitant medication information was not provided by the reporter.  Vaccine was moved to fridge on 06-Apr-2021. Vial was moved to clinic on 15-Apr-2021. On 15-Apr-2021, Excursion time was 9 AM, temperature was 34 respectively, total doses given for the day was 188, condition of vaccine prior to administration was not frozen. 18 vials were sent to clinic.   On 15-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM: 42. Vaccine BUD date was 09-May-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-566976 (Patient Link).
macular confluent red rash on extensor surface of elbows & posterolateral ankles/calves;pt also devel tonsillitis that so far appears to be not d/t strep;
shingles; This is a spontaneous report from a contactable consumer. This 90-year-old female consumer (patient). A 90-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 23Mar2021 as dose 1, single for COVID-19 immunization; varicella zoster vaccine rge (cho) (SHINGRIX), via an unspecified route of administration from 13May2021 (Batch/Lot number was not reported) to 13May2021, at dose 2, SINGLE for an unspecified indication. The patient's medical history and concomitant medications were not reported. Caller stated that she was a 90-year-old lady who received the two-dose series of the Pfizer COVID-19 vaccine. She stated that in between the two doses she had to fit her number two shingle, Shingrix inoculation. She stated that she got the shingrix vaccine on 13May2021. The patient reported that the pharmacist told her that would be a safe date away from 23Mar2021 for the first Pfizer dose and her new date for the second dose was postponed till 22Jun2021. The patient thought that would be enough time as well. She stated that something went wrong, terribly wrong. She stated that this was the second attack of shingles that she has had in-between 01Jun2021 was number one and that day (yesterday) was number two. It was on her face, in the same place and same symptoms only this time it was spreading very fast and the medication. The reporter wanted information on what to do, she stated there was a bulletin on a news network that she listened to and it said that the Pfizer COVID-19 had an unusually of people calling in that they had developed shingles after they had their inoculations. Even though they had protection like her. She wanted to know if that was correct. She stated she would love information because she was going crazy. Caller asked for a web address that her family can look up on the net so they can get further information for her. Something they could find out on their computer because she was not getting any information and her doctor was on vacation and she was suffering badly from a horrible outbreak all over her face and chest. She asked if that's the best they could do. Caller was referred back to her doctor or the doctor that was covering for her doctor while he was out of town. She stated that she had been getting help. she was just wondering and wanted more information on if this was going to be common because within six weeks, she has had exactly the same outbreak within six weeks. Treatment medication was received for the event shingles (she had been on the medication fully for 3 days then). Outcome of the event was reported as unknown at this time of the report.   Information on lot/batch number has been requested.
Patient was billed for, filled for, dispensed as, and verified, and was told receiving SpikeVax, however, pharmacist administered Comirnaty vaccine instead.  Pt had normal adverse effects associated with Comirnaty (sore arm and headache on day of administration, no other side effects reported by patient).  Updated patient's record infomation 9/28/23 to state she received Comirnaty and the lot and expiration of the vaccine, as well as the prescribing information was provided to patient 9/28/23.
Fever 101.9. Redness measured 3.25in x 2.25 in., no induration. Hard to touch and warm. Has had headaches. No drainage at injection site.
5 minutes after the injections, body warm with a flushed Sensation throughout entire body. Felt oozy, dizzy, sat about 5 minutes.  At location where she did receive the injection, was juice, crackers.  Sore arm for 2 days.
Developed lump on base of  neck around 8/22/21 lump then moved towards chin--lasted about5 days.  Stayed on the chin area for awhile. around the weekend felt on the roof of the mouth pain and swollen and moved to the eye left eye
Case number PHEH2015US026860 is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 39-year-old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501 and expiry date: May 2016) into left deltoid on 08 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information provided. Follow up information received from the nurse on 26 Jan 2016: Reporter's comment updated.
Redness, tenderness, swelling and warmth (localized) at DTAP and Prevnar sites.
No period after 1st shot, after second shot period came a week later. Heavy flow every day lasting over a week and cramps. Usual cycle is 28 days and period lasts 2 days very light. This cycle was 44 days.
local soreness; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.   Additional details were provided as follows: The age at vaccination was not reported. Age group was selected as adult as per product indication. No side effects other than local soreness with 1st vaccination of Shingrix. For tolerance in 2nd dose refer case US2020AMR210044.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR210044:Same patient, 2nd dose
No adverse events or reactions noted. Pt given Pfizer monovalent covid vaccine instead of desired Pfizer bivalent booster. Pt already received Pfizer monovalent primary series with no adverse reactions reported by pt. Pt left in stable condition.
On the day of the shot My head felt slightly foggy and my arm was sore for 3 days. About 8-9 days later on the 24 of June 2021 I Was on my computer and all of a sudden I felt a rush of fatigue and felt very weak and lightheaded almost like passing out and felt dizzy and nauseous. I was taken to the ER and they ran some blood tests to see what it could be but everything came back normal. The next day I had to go back to the ER because the symptoms had not gone away. This time they did more blood tests to check my heart, lungs, stomach, liver, pancreas, etc. All the blood work came back normal according to the doctor. I even had an x-ray of my chest done and it was normal. They sent me home with just some pill for nausea. 3 days later all those symptoms just magically went away and I was back to normal, but then about 15-20 days later I was at my computer again and then all of a sudden I felt dizzy again and nauseous and weak. I waited 3 days and then went to the ER again on the 20th of June 2021. The docotr said I could be experiencing an episode of maybe vertigo so he gave me meclizine and sent me home. The meclizine did not help and made me just feel worse. I went to see a doctor at a clinic 2 days later because the symptoms were not going away and he put me on IV fluids and gave me some antibiotic shot incase I was suffering from dehydration and vertigo due to a possible ear problem. he also gave me ciprofloxacin and prednisone and some other pills like loratidine. I took the treatment but the symptoms did not go away and have not gone away and it is now 8/6/2021. this doctor also did some blood work to test my blood sugar and blood pressure and other things but it all keeps coming back normal.
Patient had localized reaction in left deltoid with bruising and swelling and left anterior chest wall swelling. Day 6 after vaccination Patient had new onset of genital warts on day 2 following vaccination
Left upper arm pain at vaccine site 15" after, increased, radiated to upper back for 2 weeks - improving.