chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She had developed some type of outbreak with little, red marks; They thought she had an allergic reaction to something and couldn't figure out what it was; An allergic skin reaction; Several red bumps on my arm and legs and 2 of them formed water blisters; Water blisters; Has one on her leg that is healing now, but still visible; It's extremely big and red itchy one; One blister is burning; Turned jet black in color; This is a spontaneous report from a contactable consumer (patient reported for herself). A 49-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0196), via an unspecified route of administration, administered in Arm right on 22Jul2021 17:40 as dose 1, single and a second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: FC3181), via an unspecified route of administration, administered in Arm right on 12Aug2021 17:30 (at the age of 49-years-old) as dose 2, single for COVID-19 immunisation. Medical history included was none. The patient concomitant medications were not reported. On an unknown date 2021 patient experienced an allergic skin reaction, Several red bumps on his arm and legs and 2 of them formed water blisters. After they drained, they became hard and turned jet black in colour. On 07Sep2021 she had developed some type of outbreak with little, red marks that looked like water blisters or a bug bite. On Sep2021 patient experienced they thought she had an allergic reaction to something and couldn't figure out what it was. Patient touched anything, but nothing had changed other than getting the vaccine. Patient Stated the outbreak started 07Sep2021. Has one on her leg that is healing now, but still visible On an unknown date 2021. Have not had any new ones since then. Patient didn't received other vaccines on same day and no problems with vaccines in the past. List all vaccines administered on same date with the Pfizer vaccine considered as suspect was none. What are her options to counteract this. If it was the vaccine she definitely would not be getting the booster. both of the Pfizer Covid19 shots and patient experienced a little red marks that turned into water blisters, Patient described it as itchy little red marks scattered over her arm and legs that turned into blisters and it's extremely big and red itchy one. The blisters will leak out and will turn into a black scar. And as we speak one blister is burning on an unknown date 2021. This side effects of the vaccine will have a mark on her body. Patient went to the first emergency room probably almost 3 weeks ago or it could have been sooner than that and the second emergency room about 2 weeks ago. Patient was visited to Physician Office. The outcome of the event erythema was reported as not recovered and while for all other events was unknown.
A few minutes after getting the vaccine, patient stated they had some double vision, and was seeing stars and black spots. Patient was seated in chair and was given a water bottle when offered. Patient also get a cold pack and placed on the neck. Was stable for a few minutes. Called a code white to alert store management. After a few minutes, she requested 911. They were called and they came to get patient. Patient additionally started to shake (not seizure like) and had difficulty standing. Patient went to hospital and was discharged a few hours later in good health
Tiredness; Itching is not constant, "like an itch you cannot get under your foot"; Itching of left arm injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching is not constant, "like an itch you cannot get under your foot"), VACCINATION SITE PRURITUS (Itching of left arm injection site) and FATIGUE (Tiredness) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A, 026L20A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, the patient experienced PRURITUS (Itching is not constant, "like an itch you cannot get under your foot") and VACCINATION SITE PRURITUS (Itching of left arm injection site). On an unknown date, the patient experienced FATIGUE (Tiredness). At the time of the report, PRURITUS (Itching is not constant, "like an itch you cannot get under your foot"), VACCINATION SITE PRURITUS (Itching of left arm injection site) and FATIGUE (Tiredness) outcome was unknown.            Concomitant medication was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-376919 (Patient Link).
This spontaneous report as received from a Registered Nurse regarding a 9 year old Child patient of unknown gender. There was no information about concurrent condition, historical medication and concomitant medication. On 10-JAN-2019, the patient was vaccinated with improperly stored PROQUAD for prophylaxis (product storage error). Vaccine was stored out of range at -6 degrees for an approximate time of 15 minutes. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1902USA001085.
Pain with arm movement, was sore post injection but by 10-20-14, was hard to lift arm and very painful with movement to present.
I can barely stay up all day; extremely tired to the point of exhaustion; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Apr2021 08:30 (Batch/Lot number: unknown) at the age of 43 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "Fibroids" (unspecified if ongoing). Concomitant medication(s) included: LUPRON; HUMULINE. Vaccination history included: Bnt162b2 (1st dose, administration time=09:00 AM), administration date: 13Mar2021, when the patient was 43 years old, for COVID-19 immunization. The following information was reported: HYPERSOMNIA (non-serious) with onset 04Apr2021 12:00, outcome "not recovered", described as "I can barely stay up all day"; FATIGUE (non-serious) with onset 04Apr2021 12:00, outcome "not recovered", described as "extremely tired to the point of exhaustion". The events "i can barely stay up all day" and "extremely tired to the point of exhaustion" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were not taken as a result of hypersomnia, fatigue.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Since vaccination, the patient had not been tested for covid-19. Device date was reported as 21May2021. Other medications in two weeks: Lupron and Humlin Insulin. No known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Breakthrough case admission after 4 vaccines Moderna 2/20/21 Lot# 023M20A;  Moderna 3/16/21 Lot# 002B21A;  Moderna 11/12/21 Lot# 034F21A;  Pfizer 8/22/22 Lot# FN2908
Patient received first dose of Moderna COVID19 vaccine on 03/10/2021. On 04/07/2021, 4 weeks later, the patient received the Pfizer-BioNTech COVID19 vaccine for her second dose. Patient did have any side effects noted and did not take any medications for the event.
Information has been received from a physician concern a 2 month old patient who was vaccinated with a dose of RotaTeq vaccine. The next day the patient developed severe to moderately severe diarrhea for 8 days. It was unknown whether medical attention was sought. No medication was dispensed and there was no hospitalization. The baby was noted to be okay. Additional information has been requested.
Received H1N1 nasal spray vaccine 10-27-09, next am fever 103, 102.2 x 2 days, chills, body ache, weak, 3 day low grade fever 99.3. 4 day normal temp. Also fever blister developed.
p/vax pt exp swelling, redness, pain along w/restricted use of arm;
Full blown head cold night right after injection with a low grade fever; metal taste in mouth.; a sore arm; headache; lymph nodes in the back of head/neck area that are swollen and hitting some branches of her occipital nerve; Full blown head cold night right after injection with a low grade fever; This is a spontaneous report from a contactable consumer or other non-HCP (patient). A patient of an unspecified age and gender received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as dose number unknown single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient experienced full blown head cold night right after injection with a low-grade fever and metal taste in mouth. Woke next morning not stuffed at all and just had a sore arm and headache. Headache had lasted 3+ days but believed this was due to the lymph nodes in the back of head/neck area that were swollen and hitting some branches of her occipital nerve. The outcome of the event headache was resolved while that of the other events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Around Thanksgiving I spotted for over a week. I could not see the doctor see the doctor until January 17, 2023. They collected history as I had had a pap test that was normal. They told me that if the cramps didn't stop to return but the cramps stopped. I started having symptoms of a bad cold around December 05, 2022. I had chills, sneezing, sore throat, tiredness and a little bit of brain fog. I also had coughing and a head could that lasted 2 weeks. The tiredness wore off after 2 days. I ran a fever around 99 degrees which was gone after 24 hours. I tested positive for COVID-19 on December 05, 2022. I did not contact my doctor. I took Tylenol Cold and Flu, Rested and drank Gatorade. The majority of the symptoms subsided with a trickle of a cough that last an additional week.
Sedation, Myalgia, Fever, chills, shakes and fatigue. Narrative:  Other Relevant History:
Allergic reaction: Generalized itching and generalized rash. Weakness. Diarrhea
Pt was administer medication (Pediarix) via incorrect route (orally) due to confusion with packaging similarities to Rotavirus.
legs were aching; fever was 100.8 degrees; could not sleep; could not lift her leg; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: EN6205; Expiration Date: Jun2021 at 10:20), via an unspecified route of administration, administered in left arm on 31Mar2021 (age at vaccination was 77-year-old) as dose 2, single for COVID-19 immunization. The patient's medical history included allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities, diabetes and obesity. There was no concomitant medications. The patient previously took aspirin [acetylsalicylic acid]. The patient's historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: EL9254; Expiration Date: May2021), via an unspecified route of administration, administered in left arm on 09Mar2021 (age at vaccination was 77-year-old) as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. On 31Mar2021, the patient experienced fever was 100.8 degrees at 08:57, legs were aching at 10:21, could not sleep and could not lift her leg. It was further reported that the patient woke up and her legs were aching. It was reported that it felt like someone was stabbing her with a butcher knife in her legs and she could not sleep. It got worse and better and at the report date it was a little better. The patient's fever was 100.8 degrees and at time of report it was under 100 degrees. She can lift her leg a little now since she could not before. The patient would like to know if she can take an aspirin or paracetamol (TYLENOL), 24 hours after having the second vaccine. The patient underwent lab tests and procedures which included body temperature of 100.8 degrees (fever) on 31Mar2021 at 08:57 and  under 100 degrees on an unspecified date of 2021. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
It started out normal at night and my arm got sore and I ran a low grade fever. I took some Tylenol and I was tired and I took a nap and I woke up and felt just fine. The next day was fine, but on the 3rd day (possibly in the evening) I started getting blisters on roof of my mouth and into throat. I called my Doctor and he was out of state so I had to see someone else and at first he didn't think it had anything to do with vaccine but my best friend had blisters on her tongue after vaccine. My doctor called me in 2 bottles of nystatin 100,000 units mL suspension 4x a day, liquid antacid over the counter CVS brand 3-4 times a day. He told me to gargle with salt water 5-6 times a day. I did that for about two weeks and it went away. I also had chronic diarrhea since vaccine.
Diabetes came back after second dose of the Covid Vaccine; " Disease recurrence"; This is a spontaneous report from a Pfizer sponsored program  from a contactable physician. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot Number: Not Provided) as single dose for covid-19 immunisation. Medical history included pancreatic transplant for diabetes, the patient was fine for 2 years. The patient's concomitant medications were not reported. The patient experienced diabetes came back after second dose of the covid vaccine on an unspecified date with outcome of unknown.     No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: -Based on the current limited available information a possible contributory role of the suspect product BNT162B2 to the development of event diabetes cannot be totally excluded  "The impact of this report on the benefit-risk profile of the Pfizer productand on the conduct of the study 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 Committees, and Investigators, as appropriate."
Positive COVID test with symptoms; Positive COVID test with symptoms; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient of received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), on 22Feb2021 (batch/lot number: EL3247) as dose 1, single; on 15Mar2021 (batch/lot number: EL-3247, at the age of 54-year-old) as dose 2, single, both via an unspecified route of administration, administered in arm left for COVID-19 immunization. Medical history included T1 DM (type 1 diabetes mellitus), the patient was Known allergies to PCN and CDN. Prior to vaccination, the patient was no diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Concomitant medications included insulin aspart (FIASP) and desvenlafaxine succinate monohydrate (PRISTIQ); both drugs received within 2 weeks of vaccination. The COVID-19 vaccine was administered at workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Jul2021, the patient experienced Positive Covid test with symptoms. The events was resulted at Doctor or other healthcare professional office/clinic visit. The patient underwent lab data and procedures included on 26Jul2021; he was tested Nasal swab with positive results. The events did not required hospitalization prolonged. The patient did not take the treatment for the events. The outcome of the event was recovering.
pt devel erythema & induration the size of a baseball @ the site of vax;pt was treated w/DPH;
I was sick for a week and half. I also have neck and shoulder pain. I had heart complication randomly that started 24 hours from the shot. This is still happening as of today. My joints have been hurting since about a month after the vaccine. Also my periods are going from 9 to 15 days. Then first period, my period was heavy for 9 days and I was late. The second one was late and lasted for 14 days. The three started on time and was 8 days. The next month, I was early and lasted 15 days. Then last month, I started early and lasted for 14 days. Before the vaccine, I started on time every month and my periods lasted for 6 days.
Redness and swelling noted L deltoid, 5 cm x 10 cm.  Reportedly had fever to 100.7 in past 2 days and has vomited 3 times total since injection, once this a.m. Now able to keep down sips H20 and had an egg sandwich this a.m. In with wife who states he "is maybe some better than yesterday".
mixed Menveo with sterile water; mixed Menveo with sterile water administration; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) (batch number MAA902A, expiry date 31st January 2024) and (batch number AMXA902A, expiry date 20th February 2025) for prophylaxis.   On 3rd February 2023, the patient received Menveo. On an unknown date, the dose was an unknown dose. On 3rd February 2023, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt date: 10-Feb-2023. Reporter's Comment: Medical assistant reported having mixed Menveo with sterile water. Additional adverse event details unavailable at this time per HCP. Lot number MAA902A was reported by HCP, batch number not found by medical information agent. HCP gave consent for safety team follow up. Additional Supportive Information: Patient received mixed Menveo with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.; Sender's Comments: inappropriate preparation of medication and inappropriate dose of vaccine.
Fever 101 body aches sweat chills arm pain weak headache  naseua
At approximately 12:30 pm on the day following the vaccination, I began to feel tired. With about 30 minutes, I began to get chills and felt very cold. Took two Tylenol and went to bed. Fell asleep and slept approximately 5 hours. Woke up feeling very tired but not chilled or headache.  Ate soup and a grapefruit. Went back to bed and slept until approximately 06:30 the next morning. I felt great except for the soreness around the injection site. The injection site showed no evidence of swelling or redness at any time.
Noticed loss of strength on right arm when lifting arm, needs to assist w/other arm. No pain, non fever. Noticed couple of days later. Informed pt to seek medical evaluation for further assistance on event.
I had pain at the injection site and headaches for three days then since then from the seventh I had had red dots appear around my neck and left shoulder
This spontaneous report was received from healthcare worker regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date, the patient was vaccinated with improperly stored, oral, ROTATEQ which were exposed to 1.0 C for 5 hours (Dose strength, route and lot number was unknown). No concomitant medication was reported. No adverse event was reported. No product quality complaint was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a consumer concerning her 24 month old son who on approximately 17-APR-2006 (reported as when he was 18 months old) was vaccinated with a dose of MMR II (Lot number not reported). There was no concomitant medication. On approximately 17-NOV-2006 (reported as when he was two years old) the mother noticed that her son stopped talking and he showed symptoms of autism. The mother reported that the patient went to a "genetic testing" to check if he contracted mercury or aluminum but the results came back fine. At the time of reporting on 07-AUG-2009 the patient was recovering. Upon internal review symptoms of autism was considered as other important medical event. Additional information has been requested.
Within less than an hour receiving the vaccime, I started feeling sharp stabbing pain on my right side below my breast. It was for a short period at first then stopped. However, in the middle of the night I was in so much pain that got worse when I take deep breaths. I also experienced shortness of breath and difficulty breathing especially when I make efforts like walking up stairs. On the afternoon of Friday April 9th, I went to Health center to get checked after reporting my symptoms. The doctor said that it could be an inflammation of the lungs so recommended rest and taking Ibuprofen to help with the pain and if symptoms persist, I go get checked again. I felt slightly better on Saturday but from Sunday evening, the pain came back and got worse Monday night. I couldn't sleep on my back or sides, heavy breathing, shortness of breath I felt all night. I went to the hospital physician ordered different X-rays that came back negative. Her diagnosis is that I have inflammation of the lungs but not sure what the cause is. She prescribed predniSONE.
pt recvd vax & exp fatigue & malaise; these sx lasted 3-4 days from inject date (1APR94);
This case was considered medically important. Information regarding Prevnar was received from a physician regarding a male patient who developed a pneumonia due to respiratory syncytial virus and a possible pneumococcal pneumonia. The patient received the first dose in Oct-2006. In Oct-2006, at approximately 2 months of age, the patient received a first dose of Prevnar. On 06-Dec-2006, the patient was hospitalized with respiratory syncytial (RSV) pneumonitis and pneumonia. A 'urine test' done on the same day of admission, identified Streptococcus pneumoniae antigen. The patient was treated with Rocephin and Zithromax for a possible pneumococcal pneumonia as the reporter noted no 11-Dec-2006, the patient was reported as recovering. Bacteria urine (results: urine antigen for Streptococcus pneumonia identified) was done on 06-Dec-2006. No additional information was available at the time of this report.
Mild to moderate malaise, myalgias, chills, headache; lasted about 24 hours
Pt had temp over 102 which didn't respond to APAP & lethargy w/in 24 hrs; p/inject seen by MD had difficulty breathing;  dx virus;
Sore arm, 102 fever, chills, sweats,  CONGESTION IN MY LUNGS, PERSISTENT COUGH
Narrative:  Hospitalization- Fully vaccinated, admitted for SDH with incidentally positive COVID (asymptomatic)
About 26 hours after vaccination, patient had a generalized tonic clonic seizure which spontaneously resolved. He was subsequently taken to the emergency room, treated with normal saline and acetaminophen.