chrisvoncsefalvay/vaers-outcomes huggingface dataset:
During a vaccine event for COVID-19 boosters the patient indicated on the consent she was immunocompromised with a hx of lung cancer in the past. She had 2 primary COVID vaccines, the last one on 12/01/22. At the time, the current orders we had were to give a third dose of monovalent due to her indicating she was immunocompromised. We had not received the updated orders at this time that monovalent COVID-19 vaccine was no longer authorized so this patient received an unauthorized dose of monovalent Pfizer Covid vaccine.
COVID-19 vaccine given May 20 and June 20. She had fever and chills 1 day following the second vaccine. 2 weeks following the second vaccine, developed itchy and painful eczema vs psoriasis rash.
husband got the third dose of Pfizer yesterday for COVID; rash in his whole body is really itchy is starting on the leg on the upper part of leg up to all the neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 22Dec2021 (Lot number: 33025BD) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 22Dec2021, outcome "unknown", described as "husband got the third dose of Pfizer yesterday for COVID"; RASH PRURITIC (non-serious) with onset Dec2021, outcome "unknown", described as "rash in his whole body is really itchy is starting on the leg on the upper part of leg up to all the neck".  Additional information: Reporter stated that reporter's husband (patient) received the third dose of Pfizer vaccine for covid on the morning of 22Dec2021. Patient experienced rash in his whole body, and was really itchy, started on the leg, on the upper part of the leg up to all the neck. Reported stated that it was pretty bad and enquired if any medication was available for the itchiness.   No follow-up attempts are possible. No further information is expected.
Patient received the 2nd booster dose; 0.50mL administered rather than 0.25mL.
patient has significant injection site reaction which was red and swollen; patient has significant injection site reaction which was red; patient has significant injection site reaction which was swollen; bruised appear on injection site; patient has significant injection site reaction which was itchy; Based on the information received on 13-Oct-2020 the case became valid from non-valid as the reactions were specified for the patient.  Initial information regarding an unsolicited valid non-serious non-valid case was received from an other healthcare professional via global medical information (GMI) (reference number- 00307600) and transmitted to Sanofi on 08-OCT-2020.  This case was considered as non valid case since no clear adverse event was reported.  This case involves female patient (age unspecified) who experienced significant injection site reaction which was red and swollen, itchy and appeared bruised (Vaccination site inflammation, Vaccination site erythema, Vaccination site swelling, Vaccination site bruising, Vaccination site inflammation pruritus) while she received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious severe reaction which was red and swollen, itchy and appeared bruised (Vaccination site inflammation, Vaccination site erythema, Vaccination site swelling, Vaccination site bruising, Vaccination site inflammation pruritus), (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome for reported events was unknown.  There will be no information available on the batch number for this case.  Additional information was received on 13-Oct-2020 Events were added (added events: Vaccination site inflammation, Vaccination site erythema, Vaccination site swelling, Vaccination site bruising, Vaccination site inflammation pruritus) ).
This spontaneous report as received from a medical assistant refers to a 18 month old child patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 02-OCT-2018, the patient was vaccinated with improperly stored dose of VAQTA ped 0.5 ml vial (dose, frequency and route were not reported) (lot # R009953, expiry date: 12-JUN-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) for 3.5 hours from 06-SEP-2018. Previous excursion was 50.37°F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868: Original Case: 1809USA002868; US-009507513-1902USA009324: Original Case: 1902USA009323; US-009507513-1902USA009325: Original Case: 1902USA009323; US-009507513-1902USA009326: Original Case: 1902USA009323.
I have been breaking out in rashes on my arms, legs, neck, face and hands. My eyes swell and I have constant tightness on the left side of my chest since June, 2000.
C/O feeling hot, dizzy, lightheaded. Skin warm & dry. BP 120/80 82 - 18. Went in cool area. Felt better. VS stable, returned to work at desk. Symptoms returned. Primary Care MD called - told to take Ibuprofen & rest. BP 134/84 - 92. After 15 min - felt better & to return home. BP 118/70 - 72 - 18.
About 7 weeks after receiving the 2nd vaccine, I woke up on 7/6/21 with one red welt on the side of my neck and little bumps on  the rest of my neck. It initially didn't itch and wasn't painful. Each day that passed it got more red. Could not figure out what caused it. W/o 7/19 I thought it could be some skincare product I put on my face. I eliminated it just in case. But rash kept getting worse. Four days of Benadryl didn't help at all. Within 2 weeks, I had more welts and the small bump rash on my neck and nowhere else. By end of July,  the rash started calming down. Then after eating a meal one day the rash came back worse than before - more red, itching and hot.  I noticed that I was reacting within 1-2 hours after eating. It took some time before I realized I was reacting to food: e.g. garlic, onions, spinach, goat cheese, pineapple. A random assortment of foods that are not related. I started a very strict elimination diet and tested one food every 4 days to confirm all the foods I just mentioned I was reacting to. As I was trying to figure out which foods I was reacting to, the rash got worse. It moved to my mouth, eyelids, bridge of nose, with water bumps on my forehead. It dried out my skin to the point of it peeling and incredibly painful. Just eating 5 leaves of spinach set the rash off again all over my face. Same happened with just 1/2 tsp of grilled onions. This kept going on for months. Eventually my hands and feet started itching and tingling intermittently throughout the day. Then it moved to my arms, legs. IT wold move around my body throughout the day. Sometimes consistently itching and other times not.  I saw an allergist, who sent me to dermatology. The dermatologist sent me back to the allergist, which is when we agreed to test for food allergies... even though my symptoms were not indicative of food allergies. So something else it causing my immune system to be overstimulated. Since I don't react to vaccines, except a sore arm, and I eat a super healthy diet (no processed foods), the only thing that was different in my system was the vaccine. I have discussed with this 4 doctor and no one has any idea. I asked if infectious disease could help, and they don't think so. I think it was either the vaccine itself or the batch I had was contaminated. This reaction I'm having is just too strange.
Vaccinated on Monday. Nasal congestion 24 hrs post vaccination, then within 96 hrs (on Firday)had voice hoarsness that worsened to complete voice loss on Sunday with gradual return on Monday. 10 days post vaccination voice remains hoarse but improving. No fever, no sore throat, no throat reddness or pustules, no fatigue or change in appetite, no enlarged nodes. Did not have cough, just slight irritation in throat area.
Nodule p/1st shot lasted 2-3 days & resurfaced 7 days later w/rash around pt neck;muscle & joint pain that lasted approx 36hr;
flu like symptoms; This is a spontaneous report from a contactable consumer or other non hcp (neighbour of patient) via Pfizer sponsored program COVAX US Support.   A female patient of an unspecified age (Age:71, unit: unknown) received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown, expiry date: unknown) via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown, expiry date: unknown) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. On an unknown date, the patient experienced  flu like symptoms. Reporter stated that patient was due to get second shot on Sunday but doctor prescribed a 5 day Z-Pak for her, could she take it before the vaccine or start afterward. Reporter stated that neighbour had a reaction to the second shot with flu like symptoms and told her to take an antihistamine and Tylenol two days prior and two days after. Reported asked if it was recommended. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Dizziness.  Patient presents with light HA, Hypotensive, no signs of resp distress, N, or V.  Offered water and vitals taken.  BP 102/47, HR 50, RR 18 -- > 109/66, 59.  Pt stable and released from vaccination site.
Five mins after Hep B and Hep A vaccination, the pt developed dizziness. Then started crying with complaint of earache and hands stiffened up for few minutes. Pt improved without medication and sent to the hospital for evaluation.
Pt received vaccines on 8-18-14 and developed a T of 104, vomiting and pustular rash at injection sites within 24 hours. Fever lasted 48 hrs, rash persists today but is faded.
Initial report received on 21 January 2009 from a health care professional. A 2-year-old child, who has past medical history of respiratory syncytial virus (RSV), had received on an unknown day in October 2008 a dose of FLUZONE SV 2008-2009 (lot number unknown, route and site of administration not provided). At the time of the vaccination, the patient was taking Synergis. Approximately three months post vaccination in January 2009; the patient was hospitalized and diagnosed per a flu test with influenza B. It was unknown what type of flu test was administered, or if a sub-strain had been identified. It was reported the patient had received two previous doses of flu vaccine in 2007. The recovery status of the patient was not provided. Documents held by sender: None
There are no symptoms. Vaccines MMR and Varicella should have been administered seperately.
The day after the vaccine I had a round red rash a little below where I got the shot. It was the size of a silver dollar. It really hurt. The next day the pain went away. The red rash got larger over time and today is the 9th day after the  vaccine and it is 2.5 x 3 inches large. Covid arm? I contacted my doctor but it is the weekend and I probably won't hear from him until the middle of next week.
Incorrect second dosing was given, pt should have received Pfizer as a second dose but inadvertently received Moderna.
Rash down from the elbow to the fingers; slept all day; Fatigue; Fever; Severe chills; Allergic reaction; Severe pain in th e arm down to the elbow; Couldn't raise the arm; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (Allergic reaction), PAIN IN EXTREMITY (Severe pain in th e arm down to the elbow), MUSCULAR WEAKNESS (Couldn't raise the arm), SOMNOLENCE (slept all day) and RASH (Rash down from the elbow to the fingers) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced ALLERGY TO VACCINE (Allergic reaction), PAIN IN EXTREMITY (Severe pain in th e arm down to the elbow), MUSCULAR WEAKNESS (Couldn't raise the arm), PYREXIA (Fever) and CHILLS (Severe chills). On 24-Feb-2021, the patient experienced SOMNOLENCE (slept all day) and FATIGUE (Fatigue). On an unknown date, the patient experienced RASH (Rash down from the elbow to the fingers). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. At the time of the report, ALLERGY TO VACCINE (Allergic reaction), PAIN IN EXTREMITY (Severe pain in th e arm down to the elbow), MUSCULAR WEAKNESS (Couldn't raise the arm), SOMNOLENCE (slept all day), RASH (Rash down from the elbow to the fingers), PYREXIA (Fever), CHILLS (Severe chills) and FATIGUE (Fatigue) outcome was unknown.            No concomitant medications provided.  Follow-up received on 09-Jul-2021 included no new information.    Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow-up information received on 09-JUL-2021 contains non-significant information.Updated Reporter's information-Corrected Reporter's Name, Address, E-Mail.
ARM ACHE; SLIGHT FEVER; TIREDNESS; This spontaneous report received from a patient via a representative. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced arm ache, slight fever, and tiredness. The action taken with covid-19 vaccine was not applicable. The outcome of the arm ache, slight fever, and tiredness was not reported. This report was non-serious.
Gave patient 2 Flu Vaccines instead of 1 flu shot and 1 Covid Booster. In the end, patient still wanted Covid Booster so she received a total of 3 vaccines on 10/22/22
Swelling (full circumference) of left arm with erythema from injection site at deltoid- elbow area.
pt recv in 1995 & w/in a few hr of vax pt began to vomit & p/36hr was adm to hosp w/severe dehydration;pt devel diarrhea & would not feed;pt recovered p/5 to 6 wk;
Get the shot then get shingles/Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patient's who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Get the shot then get shingles/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-SEP-2023 This case was reported by a patient's friend via interactive digital media. The reporter reported that his or her friends received the shingles vaccine and experienced shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Initial unsolicited report received from a nurse via other company, Pfizer (under the reference number:2016336790) on 24 October 2016. This case involves a 64-years-old of female patient who was vaccinated with INFLUENZA VACCINE (Flu shot) (lot number, expiration date, dose, dose in series, route of administration and site of administration were not reported) on an unspecified day. The medical history was reported as arthritic and stomach ulcer (that causes stomach to hurt) and the previous medication were reported as prevacid equivalent for stomach ulcer. Concomitant medication was not reported. On 07 Oct 2016, following vaccination, the patients developed body aches all over the body and sleepy whole day. The laboratory test and corrective treatment was not reported. The outcome of the events was not reported. List of the documents held by sender: none.
Patient was administered the above vaccine after the "Use By" date as assigned when vaccine was removed from freezer.
severe stomach cramps, frequent bowel movements (4 to 5 per day);rx for med by MD on 27AUG96;pt also on bland diet;
approximately 2 days after the vaccine, I became light headed and dizzy. I felt pressure in my head. The symptoms progressed to feeling unbalanced and dizzy and never resolved. I also was subsequently diagnosed with MS approx. 3 weeks after the 2nd vaccine. Likely was not a result of vaccine but may have triggered the symptoms. Felt that the dizziness was part of MS and still has never resolved to present.
acute kidney injury; gross hematuria; This is a literature report in 2 pediatric patients after receiving the Pfizer COVID-19 vaccine. This Other Health Professional reported similar events for two patients. This is the first of two reports.  To the editor: With great interest, we read the recent reports of IgA nephropathy (IgAN) flare-up presenting as macroscopic hematuria, following the second dose of coronavirus disease 2019 (COVID-19) vaccination in adult patients. The Food and Drug Administration granted an emergency use authorization for the Pfizer-BioNtech COVID-19 vaccination in Dec2020 for individuals aged $16 years; the emergency use authorization was recently expanded to include children aged 12 to 15 years on 10May2021. Herein, we report 2 pediatric patients with IgAN presenting with macroscopic hematuria <24 hours after Pfizer COVID-19 vaccination. Neither patient had COVID-19 infection before vaccination nor any history of reactions to any vaccinations. The first patient is a 13-year-old boy with a history of type 1 diabetes mellitus and known IgAN (IgAN with minor histomorphologic alterations on light microscopy. Representative glomerulus showing mild mesangial matrix expansion without mesangial hypercellularity on periodic acid-Schiff stain, original magnification x40. Immunofluorescence microscopy with 3+ granular mesangial reactivity for IgA, original magnification x10). His initial IgAN diagnosis was made 6 months before this event during an evaluation for subnephrotic proteinuria and microscopic hematuriawith normal renal function, and he was receiving treatment with lisinopril. Before COVID-19 vaccination: Microscopic hematuria and subnephrotic proteinuria noted on routine urine screening for diabetes, leading to IgAN diagnosis. Within 24 hours following the second dose of the COVID-19 vaccine, he developed new onset gross hematuria and acute kidney injury. His gross hematuria self-resolved, and his kidney function recovered without intervention within 1 week. Variables: Serum creatinine mg/dl, Before COVID-19 vaccination: 0.54; Following COVID-19 vaccination: Day 2: 1.31; Day 6: 0.66; Serum albumin, g/dl, Before COVID-19 vaccination was 3.4; Day 2: 3.8; Day 6: 3.0; Urine protein-tocreatinine ratio, mg/mg Before COVID-19 vaccination was 1.6; Day 2: 1.07; Day 6: 0.86. Oxford MEST-C score Before COVID-19 vaccination was M0 E0 S0 T0 C0. Stopped lisinopril on day 5.; Sender's Comments: Based on the review of available information, the causal relationship between the adverse reaction Acute Kidney Injury (AKI) and the suspect product  Pfizer-BioNtech COVID-19 vaccination is assessed as possibly related.  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.,Linked Report(s) : 202101224443 Same article/ patient and different drug/event
Pt presented on 9/14/18 pm with significant bruising, red band of swelling and welts wrapping around from left deltoid around to inside of upper arm, warm to touch, but without pain/tenderness after vaccination on 9/11/18. She reported this reaction started 9/12/18 pm.
Patient claimed that she did not have a previous Covid vaccination when she came in. We administered Pfizer vaccination on 7/23/21. We were unable to locate vaccine records at the time of vaccination and went by patient's word that this was a first covid vaccination. However, when pulling records for second dose, we did find the report and noticed that she had received the Johnson and Johnson vaccination on 3/5/21. We did not administer her second Pfizer vaccination.
Woke up in the am very achy, stiff neck, headache. Relieved with pain reliever.
EPILEPSY, UNSPECIFIED 5/25/2021 PRESENCE OF TRACHEOSTOMY  ACUTE RESPIRATORY FAILURE 5/24/2021 PRESENCE OF TRACHEOSTOMY