chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itchy rash on both arms chest shoulders and back; Red rash on both arms chest shoulders and back; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation solution for injection, lot number: unknown) via an unspecified route of administration in the right arm on 20Mar2021 at 11:15 (at the age of 44-years-old) as dose1, single for COVID-19 immunization. Medical history was not reported. The patient had no known allergies. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the 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. On 31Mar2021, the patient experienced red itchy rash on both of her arms, chest, shoulders and back; the rash had not gone away. The events resulted in emergency room or department or urgent care. Therapeutic measures were taken as a result of events and included treatment with unspecified medication. The clinical outcome of the events red itchy rash on both arms chest shoulders and back was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Vaccination Facility Country was added as United States and concomitant therapy selected as none.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 at 14:00 as dose 1, single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient took Paxlovid from 20Oct2023 to 25Oct2023. Patient had no known allergies.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300350855 Same patient, different drug/AE;
Swelling around the face and upper chin; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Swelling around the face and upper chin) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    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 SWELLING FACE (Swelling around the face and upper chin). At the time of the report, SWELLING FACE (Swelling around the face and upper chin) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Two weeks after the 2nd dose, "I" had 4 days of low grade fever; Chills; Fatigue; Headache; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Apr2021 at 13:00 (at the age of 47-year-old), as a single dose for COVID-19 immunisation. Medical history included essential tremors and high blood pressure. The patient had no known allergies to medications, food or other products. 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 propranolol (MANUFACTURER UNKNOWN), primidone (MANUFACTURER UNKNOWN) and hydrochlorothiazide (MANUFACTURER UNKNOWN); all for an unspecified indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 13Mar2021 at 13:00 (at the age of 47-year-old), as a single dose for COVID-19 immunisation. On an unknown date in Apr2021, two weeks after the second dose, the patient had 4 days of low-grade fever, chills, fatigue and headache. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination patient had been tested for COVID-19. On 15Apr2021, the patient underwent COVID-19 test via nasal swab and tested negative. The clinical outcome of the events low-grade fever, chills, fatigue and headache was resolved on an unknown date in Apr2021, after the duration of 4 days.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Started with fever of 100.5, loss of appetite, extreme lethargy, runny nose, cough for 5 days.  Then a rash for a week.
RMA gave Kinrix instead of Tdap. Patient is fine but I advised RMA to give Tdap and Ipol separate. She gave Kinrix because she forgot.
IM shot received at 0750. Went to sleep for the day since I work nights. I work up at noon with severe headache and numb bilateral hands. I took Tylenol 1000mg and went back to sleep. I woke up for work at 1630 feeling flushed. I took naproxen and went to work(in the ER). I developed a rash on my chest that evening. Over the next 3 days the rash progressively worsened across torso, back, and extremities. Since I received the vaccine on Christmas eve, employee health has not answered my calls or messages with the holiday. I also am scheduled to see PCP for this after the holiday weekend. I have been medicating with Zyertec BID, Benadry Q4hr, Pepcid BID, Tylenol TID since 12/24. I started a prednisone taper on 12/27.
Initial unsolicited report received from a healthcare professional (Pharm D) on 05 May 2015. A female patient, whose medical history and concomitant medications were not reported, had received a dose of TDAP IPV (batch number, route of administration, site of administration were not reported) on an unspecified date. On an unspecified date; after vaccination, the patient had reaction. Laboratory investigations and corrective treatments were not reported. At the time of this report outcome of event was unknown. Documents held by sender: none. Follow-up information received from a Pharmacist on 8 June 2015. No new information reported as the reporter was unable to recall who the patient was. Documents held by sender: none.
Outcome of the event: Multiple doctors visits. First misdiagnosed as poison ivy, treated for a month with prednisone. Returned in force after prednisone course finished. Has slowly diminished over the course of August and September so far but is still a significant distraction from my day. In July and August, from 2 weeks to 10 weeks post vaccination, the itching was so severe it necessitated multiple doctors visits and treatments tried before I found ones that worked well enough for me to be productive. But even so, it was a serious distraction. In September the hives have abated significantly, but remain a significant distraction.  Covid Vaccines administered to me:  Moderna 3/26/21 Moderna 4/23/21 Pfizer 12/28/21 Moderna 6/18/21  Characteristics: Hives that itch and appear in patches all over my body and come and go. They often appear in streaks. Episodes tend to last 30 minutes to an hour in each area and move around gradually to different parts of my skin surface. They can appear anywhere. Episodes tend to start after I?ve been awake a couple hours and might be worsened by greater eating or metabolism.   Treatments that were effective: Maximum strength Benadryl itch relief gel, and Fexofenadine (Allegra) 180MG.   Treatments that were only moderately effective: Zyrtec and Diphenhydramine.
Patient received vaccine on Monday morning and felt fine Tuesday, but woke up feeling extremely dizzy on Wednesday.  Patient states she was unable to get up without feeling very dizzy and needing help to walk. Patient also stated she had a pressure behind her eyes.
shingles; neuropathy; Information has been received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age or gender. The pt's concurrent conditions, medical history and concomitant medications were not reported. In or around March 2011, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, anatomical location, lot number and expiration date were not provided) for its intended purpose, the prevention of shingles. Shortly after being vaccinated, the pt suffered shingles (herpes zoster) and neuropathy (neuropathy peripheral). As a direct and proximate result of the pt's use of the defective zoster vaccine live (ZOSTAVAX), the pt's symptoms resulted in physical limitations not present prior to using the company's product. The pt also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the company's wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of company's conduct, the pt has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the claimed events was not recovered, and causal relationship was reported as related to zoster vaccine live (ZOSTAVAX).  The reporter considered herpes zoster and neuropathy peripheral to be disabling events.  Upon internal review, neuropathy peripheral was determined to be medically significant event.
Arm became immediately sore leading to COVID arm upper Bicep swollen and itchy. Applied topicals. On 2/19 notice rash on left neck which by yesterday night spread to neck and upper back on left side. Seen at ER; Dx Shingles  Prescribed Valtrex
Swelling/ redness at and below injection site, "size of soft ball"; heat also at site; lasted 2 days- started 12/4/08.
PRESENTING PROBLEM: Stroke-like symptoms [R29.90] Stroke determined by clinical assessment (HCC) [I63.9] COVID-19 [U07.1]   HOSPITAL COURSE: Recrudescence of Prior Left MCA Infarct in Light of + COVID-19  48 y.o. female w/PMH of HLD, Obesity (BMI 44.29), T2DM, Esophageal spasm, Constipation, and COVID-19 (+) 06-2022 (is Vaccinated w/Medorna w/booster), who was hospitalized in 06-2022 w/Chronic Non-Occlusive dural sinus thrombosis (MRV) w/late subacute venous infarcts Echo had showed Left Apical Thrombus s/p Eliquis 5 mg BID, pt also had undergone heart cath w/Stent placement s/p Plavix, during that hospitalization pt also had one reported witnessed seizure at home but negative EEG thus, started on Vimpat 100 mg BID, pt follows cardiology. This pt presented again on 8/19/2022 w/20 Hour R. U/L Ex and R. Face paresthesia which then resolved. Advanced imaging including MRI were negative for any acute new findings. Pt was (+) again for COVID-19 but without symptoms, is in room air and denies SOB, chest pain. Pt states she is back to her baseline and would like to go home. Pt's home pantoprazole was discontinued due to pt being on Plavix. Famotidine was ordered instead.
took Tylenol n between doses; injection site pain; This is a spontaneous report from a contactable consumer or other non-health care professional reporting for her sister (Patient).  A 59-years-old female patient received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Batch no/ Lot number: not reported) via unspecified route of administration on an unknown date in Feb2021 as dose 2, single for covid-19 immunization, and Paracetamol (TYLENOL), start and stop date were not reported for an unspecified indication. Medical history and concomitant medications were not reported. Historical vaccine included patient received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Batch no/ Lot number: not reported) via unspecified route of administration on an unknown date as dose 1, single for covid-19 immunization. It was reported that patient got second dose of vaccine 5 weeks ago. Reporter stated that patient was not aware of CDC recommendation of not taking Tylenol and patient took Tylenol in between doses of dose 1 and dose 2. On an unknown date patient experienced with very little reaction after second dose and reports injection site pain. Reporter wanted to know if patient should get a third vaccine since she took Tylenol or should she consult with her HCP and asking should get an antibody test. Action taken with drug paracetamol was unknown. Outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be requested.
Chest pain; Little bit of tongue numbness; Chronic prostatitis, interestingly since I got the vaccine I haven't not been feeling symptoms of it; Working out felt really tiring and weird; Working out felt really tiring and weird; Felt something in my arm, like on the side of my arm, on my chest area; just pains; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 25-years-old patient of an unspecified gender received dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6206; Expiration Date: Jun2021), via an unspecified route of administration (at the age of 24-years), on an unspecified date as dose number unknown, single for COVID-19 immunization. Medical history included chronic prostatitis from an unknown date and unknown if ongoing. There were no concomitant medications. The patient did not received any other product. On an unspecified date, the patient experienced chest pain, little bit of tongue numbness, chronic prostatitis, interestingly since i got the vaccine i haven't not been feeling symptoms of it, working out felt really tiring and weird, felt something in my arm, like on the side of my arm, on my chest area and just pain. It was further reported by the consumer that, I am calling because the other day I got my vaccine (Further clarified as COVID Vaccine) through Pfizer and I was experiencing chest pains and a little bit of tongue numbness, the only thing I wanted to know is it normal or not? I got the vaccine yesterday and experiencing chest pains and slight numbness to the tongue and I wanted to know if that was alright. Event details: Start date: Consumer stated, the day I got the vaccine, starting March 14th. When probed if the event is still ongoing, consumer stated, Chronic prostatitis, interestingly since I got the vaccine I have not been feeling symptoms of it. When probed for the outcome of the event, consumer stated, symptoms are kind of wavering, they are not persisting but they came after getting the vaccine, just pains and slight tongue numbness. Consumer stated, that the thing was when I got the shot, immediately I felt something in my arm, like on the side of my arm, on my chest area but I thought it was normal and when I did a work out, I did a work out soon after my vaccination, I felt really really tired even just about an hour after and I felt really weird, like really tiering and that was a small workout, just a body push up and I felt like very tiring and then I thought maybe there is something wrong because maybe that was not good to workout after that, everyone says its fine supposedly but I do not know if it is. The clinical outcome for all the events was reported as unknown.  Follow-up attempts completed. No further information expected.
Headache, fever to 100? F, chills, feeling cold, severe muscle aches, spine (back) pain, fatigue.  On and off for 10 days. .
Pain in left arm (deltoid), cannot lift arm over head. Cannot make rt hand turns in car.
I was to get a yearly physical and lab work done. I was asked if I wanted the pneumonia vaccine, and I decided to have this injection. I did not sign a form that vaccine could have any side effects. I went home and several hours later I began to itch. I then called the doctor's office and they said to take some BENADRYL. I again called the office the next day (August 12th), and they told me that I should go to the E.R. I talked to the guy on the phone, and ask him to please talk to the doctor. I received no call that evening, but I found out later that they had called me Thursday morning (August 13th). I was on the way to their office, because I wanted one of them to look at my arm. It was then red all the way down my arm with a huge know below my elbow. They reminded me that this was not a walk-in clinic and they took appointments. Of course, I though they might make an exception because of the severity of my arm. The office told me that I could have an appointment at 1:00 p.m., but I had an appointment with an orthopedic doctor. I asked if I could wait and see if they could work me in. She reminded me again that they only took appointments, and I could see the doctor at 1:00 p.m. They had not any cancellations. I had waited for two hours, and left approximately at 11:35 a.m. I called my husband, and he told me to go back in the office and ask for the office manager. When I went back in the office, the gal at the front desk told me that she had just called my name. I finally saw the office manager and not the doctor. I ask for my medical records since I could not see the doctor. She told me that there would be a charge for my medical records. I told her no since they had not treated me like a doctor should treat a patient. Later in the afternoon, I went to E.R. I did have cellulitis in my arm and they had to give me an IV of antibiotics. They did a test to make sure there was not a blockage in the blood flow of my arm. I was also sent home with a bacterial antibiotics and pain medicine to take at home. I believe I was treated unfairly and they did not have me sign any form. This is very serious and if it is not treated you could die. I now have received a certified letter that they would only treat me on an emergency basis for approximately 30 days. They did not see me on an emergency basis when I had a reaction to a vaccine that the doctor's office administered.
Mom reports yesterday after shot at home patient was tired and was not active like before and did not want to walk. Mom tried to move him while he was laying in bed last night and he cried out in pain. Patient was also "hot." Mom gave Motrin at 12am and temp went away. Patient is walking now and is limping and not running. Mom reports the right leg is affected, it is a little swollen, no redness, no bruising.  RN advised mom to use cool compress on area and watch for fevers or any worsening signs and symptoms.
Pfizer-BioNTech COVID-19 Vaccine EUA Strong dizziness, full body aches and tingling, joint pain, chills and fever.   Symptoms persisted for nearly 24 hours, much of the time limiting mobility or even ability to sit up in bed.  Bad enough that I would have contacted a medical professional if there hadn't been warnings that dose #2 of the COVID vaccines could hit you hard.
Scalp abscess after first dose. Axillary abscess after second dose. Pulmonary mass after third dose.
HA, low grade fever, muscle aches, site injection pain, palpitations. morning after receiving second vaccine. Pt treating at home. ER precautions given. Denies chest pain, SOB.
Initial report received from a health care professional on 09 Dec 2009: It was reported that a 3 year old patient received 0.5 ml dose of FLUVIRIN inadvertently on 07 Dec 2009. The outcome of the event was not reported. No further information was provided.
Information has been received from a healthcare worker (also reported as an office administrator) referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients received improperly stored VAQTA injection (lot# L043209, expiration date 17-SEP-2017, dose and route were unknown). The vaccines were exposed under 49 Fahrenheit degree (F) for 24 hours. No digital data logger was involved. There was no prior temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a physician concerning his son who on an unspecified date was vaccinated with a dose of Varivax. Subsequently the patient now "suffers from breakouts of Zoster". Thee was no other information provided. There was no product complaint involved. Additional information has been requested.
Patient was underdosed- approximately 0.3 as opposed to 0.5ml.  Patient advised to receive a full booster dose when she is able to do so.
Patient called back in the evening of the same day. Reported swelling and redness in left are, where vaccine was give.  Patient advised to take benadryl, famotidine, and ibuprofen OTC, and to seek medical attention as soon as possible. Swelling continued into the next day; moved from upper arm to lower arm according to patient