chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a Certified Medical Assistant referring to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with and improperly stored dose of PNEUMOVAX 23 lot # L038669 with expiration date of 11-AUG-2017 (anatomical route of vaccination and dose number were not provided). The patient's concomitant medications were not reported. No adverse event were reported due to vaccination with PNEUMOVAX 23 and no product quality issue was involved. The certified medical assistant (C.M.A.), stated that PNEUMOVAX 23 was exposed to 18 degree C on a time frame of 1.5 hours on an unspecified date, additionally it was reported that the vaccine was not involve in previous temperature excursions. Additional information has been requested.
AE:  Lymphomatoid Papulosis Treatment:  Clobetasol Outcomes:  As many as 30 small red lesions on arms, shoulders and a few on legs behind knee; they come and go in different locations (always on arms and legs); still have several as of today 6.14.23 (started around May 2021)
feeling sick; feeling awful; shaking chills; chills; fever; headache; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION COMPLICATION (feeling sick), FEELING ABNORMAL (feeling awful), TREMOR (shaking chills), CHILLS (chills) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION COMPLICATION (feeling sick), FEELING ABNORMAL (feeling awful), TREMOR (shaking chills), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache). At the time of the report, VACCINATION COMPLICATION (feeling sick), FEELING ABNORMAL (feeling awful), TREMOR (shaking chills), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Treatment for the events was not included.  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
I experienced a skin rash initially and extreme pain in my left shoulder.  The pain progressed to my chest and caused shortness of breath so  I went to the ER and was diagnosed with pericarditis. I am currently being treated. I almost died! Weeks
Patient died on July 7, 2021 of a pulmonary  embolism.  The clots were in his lungs.
Approximately 16 hours post vaccination, Pt experienced a baseball size red, hot area 2-3 inches below the vaccination site.  she reports the had "covid arm" with her previous two doses of Moderna vaccine (a different vaccine product).
pt says she had violent shaking, like tremors for hours.  She stayed in bed for about 4 days due to the fatigue.  She had brain fog, dizziness and is unbalanced.   She went to her PCP on 3/17/21.  She had blood work with normal results.  These symptoms continued all the way through to her 2nd vaccine.
Left deltoid area hot to touch, hard apprx. 2cm diameter. tender. Rx Benadryl 1/2 tsp Augmentin 2mg x 7 days Cool compress
Severe gout like symptoms a few days after first injection. Severe migrating joint pain and inflammation in knees, ankles, and right elbow.  Unintentional weight loss.
No cough after 2nd injection, stop 10Mar2021. Dr. had no answer why my cough stop, Good thing.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 06Mar2021 13:00 (Lot number: EN6199) at the age of 78 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Cough", stop date: 10Mar2021, notes: Onset Date: 2 years; "Headache", start date: 12Feb2021, stop date: 06Mar2021, notes: no more headache. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1st, Time: 11am, Anatomical Site of injection: Left arm, Route of administration: Intramuscular, Batch/lot number: EN6201), administration date: 12Feb2021, for Covid-19 immunization, reaction(s): "Headache". The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 06Mar2021, outcome "recovered" (10Mar2021), described as "No cough after 2nd injection, stop 10Mar2021. Dr. had no answer why my cough stop, Good thing.".  No follow-up attempts are possible. No further information is expected.
40 minutes post vaccination patient reported rash on cheeks, then became lightheaded, developed itchiness in eyes and forehead and feet swelling and rash on legs.  Patient was given Benedryl and released to home.
The 1.3ml vial of pediatric Pfizer Covid vaccine was not diluted with 1.3ml of 0.9% sterile sodium chloride injection prior to injecting intramuscularly into the pediatric patient.
Paitent had a stroke for no identifiable reason.  They saw little bloodclots in his brain.  Because he has heart stints, the doctors at the hospital said everything that prevents strokes was already being done for him.  They had a heart monitor placed in his chest and today the cardiologist read the results.  There is nothing in his heart that would cause the clots.  Blood clots are not part of his family health history.  The only thing "different" during the time previous to the stroke was the covid shots.  Just reporting in case it is part of a trend. He hd mobility issues and had to be in physical therapy for a few weeks.  His balance is still weak.
BREAKTHROUGH COVID INFECTION. PATIENT TESTED POSITIVE ON 08/01/2021. PATIENT FULLY VACCINATED ON 03/12/2021.
Large red swollen spot on the right cheek; Large red swollen spot on the right cheek; Tenderness; This is a spontaneous report from a contactable other hcp (Nurse). This report based on the information received by Pfizer.   A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported), dose 1 via an unspecified route of administration on 13Mar2021 (Batch/Lot number was not reported) as dose 1, single and dose 2 via an unspecified route of administration on 03Apr2021 as dose 2, single for covid-19 immunisation; hyaluronic acid (RESTYLANE), via an unspecified route of administration from 14Jun2021 (Batch/Lot number was not reported) to 14Jun2021, at unspecified dose for an unspecified indication. The patient's medical history included leukaemia for 7 years and had gotten clearance from her oncologist to receive HA Fillers. The patient is currently taking multiple medications. Patient is a female that smokes daily. The patient's concomitant medications were not reported. On an unspecified date in 2021, the patient experienced tenderness; On 15Jun2021, large red swollen spot on the right cheek. It was reported that the patient was injected on 14Jun2021 with Restylane Refyne and Restylane Defyne into her nasal labial folds and Restylane Kysse injected in her lips. On 15Jun2021 she developed a large red swollen spot on the right cheek. It was treated with ice, Tylenol, and Augmentin 875/125/ po BID for 10 days. No fever was noted. Tenderness subsided and swelling was improving. The outcome of event tenderness was recovered on an unspecified date in 2021, while outcome of event large red swollen spot on the right cheek was recovering.  No follow up attempts are possible; information about lot number/batch number cannot be obtained.
Patient had raised, painful, red itchy mark on deltoid that could be possible allergic reaction. Still present 9 days after vaccination. She is following up with primary care physician for evaluation.
Client received Pfizer for the first dose of the series. He reports only a minor sore arm after receiving Moderna for the second dose.  Pfizer EN5318 IM on 1/29/2021
This is a spontaneous report from contactable consumer (patient). This is based on the information received by Pfizer (Mfr. Control No: 21K-163-4051214-00).   A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: Not reported) via intramuscular route of administration on Mar2021 (at the age of 72 year) as a Dose 2, Single and via intramuscular route of administration on 03Mar2021 (at the age of 72 year) as a Dose 1, Single, both doses for COVID-19 immunization.The patient also received Adalimumab (HUMIRA, Formulation: Solution for injection in pre-filled pen, Batch/Lot number: Not reported) via Subcutaneous route of administration on an unspecified date as Dose number unknown, Single for Moderate to Severe Rheumatoid Arthritis. The patient's medical include allergies. The patient's concomitant medication were not reported. On an unknown date in 2021, osteoarthrosis, rash on the arms all the way up to the shoulders and big knots on the arms a lot of itching for 3 to 4 month after covid injection, shaking when administered Humira/ get nervous when giving the injection. It was unknown if patient was enrolled in a Covid-19 vaccine trial. Outcome of the event Osteoarthrosis was unknown while for all other events it was recovered on an unknown date in 2021.  The reporter assessment the causality relationship between BNT162B2 and events Rash over arms, Itchy upper limbs was assessed as possible while causality of the event osteoarthritis, Fear of injection, Shaking was not reported.   The causality relationship between Humira and events Rash over arms, Fear of injection, Itchy upper limbs, Shaking was assessed as no reasonable possibly while causality of the event osteoarthritis was not reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information was expected.
This case was reported by a nurse and described a 45 year old female patient who did not respond to the hepatitis B vaccine recombinant (Engerix B) immunization series. On June 4 2004, July 7 2004, and Dec 7 2004, the patient received three dosed of Engerix B (lot numbers ENG5540A2, ENG555B2, and AHBVA064AA respectively). Subsequently on 2/25/2005, a hepatitis B surface antibody titer was negative. The nurse considered the event to be unrelated to vaccination with Engerix B.
dizziness; vertigo; fatigue; have been feeling poorly/am still miserable; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  An 82-year-old patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 13Nov2023 at 12:15 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 14Nov2023, outcome "not recovered"; FATIGUE (non-serious) with onset 14Nov2023, outcome "not recovered"; FEELING ABNORMAL (non-serious) with onset 14Nov2023, outcome "not recovered", described as "have been feeling poorly/am still miserable"; VERTIGO (non-serious) with onset 14Nov2023, outcome "not recovered".  Additional Information: The patient started side effects on Tuesday upon arising and have been feeling poorly. Ever since with dizziness vertigo (visited ENT MD) and fatigue ever since today, Friday 17Nov2023 03:30PM and still miserable.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Gave a booster dose to a patient under 16 years old. Called number given on consent form and unable to contact parents. Left a voice mail for parents to return my call.
Patient was given 0.5mL of vaccine instead of 0.2mL dose for the Orange Cap Pfizer vaccine. No adverse reaction occurred.
Patient had apneic event with loss of pulse, required resuscitation by mother and EMS, was stabilized in ED and transferred to PICU, and observed overnight with return to normal health/behavior.
(R) deltoid swelling with erythema without induration. Nontender palpation.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 49 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative; Negative.  Clinical Course: Anti-viral details: Product: COVID 19 Treatment, Treatment start date: 14Dec2022 Treatment stop date: 18Dec2022 Indication: Treatment of COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
first dose/on 29Sep2020 and the second dose is scheduled for 11Jun2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug schedule prescribing error in a 57-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 29th September 2020).   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug schedule prescribing error. On an unknown date, the outcome of the drug schedule prescribing error was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details was reported as follows: The patient's 2nd dose of Twinrix was scheduled on 11th June 2021 which was approximately 9 months later than 1st dose, which led to drug schedule prescribing error. Lot number was not available to the caller. The second dose was scheduled at a specific date in the future at time of call. The reporter consented to follow up.
Pfizer vaccine  sudden onset dramatic sneezing and runny nose March 6-8 very painful lower back started March 7 and continues as of today
One week after her vaccine she was VERY lethargic, fever, no appetite, and lower right quadrant pain. We brought her to the hospital where they suspected appendicitis. They did an MRI and ultrasound and we?re unable to get a clear view of her appendix but did note some fluid around her appendix. She also broke out in hives. 18 hours later she was slowly feeling better so they decided it must be ?a virus that mimics appendicitis.?
4 (3mm x 3mm) dried scabs under left breast, very itchy. Occurred on day 15 (2/6/03). 2/14/03 Mult more lesions ~ 9 total in same localized area under left breast only. Scabbing.
Gave 2 immunization over (L) Deltoid on 10/17 On 10/19/07- 5" x 4" area redness, swelling arm (L) biceps
A non-serious spontaneous report of sore throat and stuffy nose has been received from a consumer concerning a 46-year-old male, subsequent to FLUMIST. Neither relevant past medical history nor concomitant medications had been reported for this patient. On 01-Oct-2011, the patient received FLUMIST. On 01-Oct-2011, after receiving FLUMIST, the patient had sore throat and stuffy nose. The patient did not receive medical attention for the events. The outcome of the events sore throat and stuffy nose was unknown.
Fever, rash - small papules (a few scabbed on 6/8/16). TYLENOL, OTC calamine (symptomatic care).
c/o of lt arm swollen about 1/4" & hurts, fever 102, h/a
Day after first vaccine (Tuesday March 30) was administered, developed severe headache, chills, neck pain, and slight abdominal cramp. By Friday April 2, severe abdominal cramp, headaches, nausea, slight high temperature. Persisted throughout the whole weekend. Called in sick Tuesday April 6 for abdominal cramp, temperature, confusion - admitted to ER.
serious all-over body aches; This is a spontaneous report from a non-contactable consumer (patient). A 69-year-old female consumer received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Jan2021 13:15 at single dose in left arm for COVID-19 immunization. Medical history included Hypertension, allergies to Mango. Concomitant medication included lisinopril and colecalciferol (VITAMIN D). The patient had no other vaccine in four weeks. The patient had no covid prior vaccination. The patient had no covid tested post vaccination. The patient had no immediate discomfort. No sore arm at all. But 2 days after the shot on 28Jan2021 18:00 she experienced serious all-over body aches. They were painful, and lasted about 30 hours. No treatment was received for the event. The outcome of the event was resolved.   No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained.
Anaphylaxis: 1:45pm- Immediately upon receiving vaccine noted dry mouth 1:45-2:15pm- Waited at facility to monitor for reactions. Dry mouth sx increased and noted increased sweating from under arms. Cleared to go home as no other sx noted. 3:00-5:00pm- intermittent dry cough started 5:00-6:30pm- interior mouth, cheeks, lips and tongue started to feel like they were swelling, took 2 Benadryl 6:30pm-7:00pm- tongue, lips. and cheeks swelling increased. Lisp when speaking.  7:23pm Took 1st Epi-pen and headed to ER. On route to ER chest developed rash and voice became hoarse with episodes of nausea. In ER hands and forearms showed rash. Received IV Benadryl, Epi, and Pepcid. Discharged after 3 hours observation.
About 1-2 mins after vaccine was administered, pt started to have nausea and muffled hearing, pt looked pale. Rph provided tissues and plastic bags (for vomitting) and tried to call 911 for pt, however it was busy tone both times 911 was called (the area just had storm 2 days ago, maybe 911 line was over-whelmed?). after vomitting, pt felt much better and ask rph not to call 911, a store manager accompanied pt to use the restrooom. Rph advised pt to stay at the pharmacy resting area for 10 mins, after that  Pt's parents came to pick her up. Rph spoke to parents about the situation and suggested pt might want to speak to md about the 2nd and 3rd dose to be administered at the dcotor's office when she might be closely monitored. and also suggested to have benadryl on hand just in case.
Chills, temperature 100.5, starting about 2:15 am and contiuing through current time, 6:30 am. Also mild weakness.
Dark Redness, unusually painful rash just below and medial to injection site,  approximately 6 by 4  cm.  Warm to touch
Menopausal female began bleeding day after shot was given.  Continues to have bleeding on and off, very tender breasts, nights sweating and nightly fevers everyday since first shot.
pt recv vax 13JUN95 & analysis of IgG showed that the pt did not seroconvert;
Information has been received from a registered nurse referring to a patient of unknown age and gender. On 04-SEP-2015 the patient was vaccinated with improperly stored ZOSTAVAX (lot # L003216, expiration date 30-APR-2016, strength, dose and route were unknown). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt recv vax on 1/30/99; on 1/31/99 pt exp swelling, firm area, redness, sore vax site; dx=cellulitis; tx=Keflex
Information has been received concerning a case in litigation regarding a female minor child who, during the period of May 1994 through June 1995, was subjected to very high doses of mercury contained in thimerosal by being inoculated during the first two years of her life with thimerosal adulterated infant injections. It is alleged that as a result of the cumulative doses of mercury contained in the thimerosal that the patient now suffers from and in the future will continue to suffer from the toxic neurological effects of mercury poisoning. An immunization history record was received and reported that the patient was vaccinated with the first, second, and third doses of hepatitis B virus vaccine rHBsAg on 3/10/94, 5/11/94, and 9/14/94. Other vaccinations received included the first, second, third, and fourth doses of diphtheria toxoid (+) haemophilus B conjugate vaccine (+) pertussis vaccine (+) tetanus toxoid vaccine and the first, second, and third doses of oral polio vaccine on 5/11/94, 7/13/94, 9/14/94, and 6/28/95; MMR (second generation) received on 3/22/95, and tuberculin purified protein derivative received on 12/17/94. Upon internal review, the mercury poisoning and its toxic neurological effects were considered to be other important medical events. No further information is available. A copy of the patient's complete medical records is available up on request.
Severe arthralgias and myalgias. Patient can not walk due to joint pain/stiffness. Patient to be seen by doctor in her hometown.
Shortness of breath; fever; nausea; vomiting; diarrhea; arm soreness; This is a spontaneous report from a contactable other healthcare professional (patient). A 39-year-old female (non- pregnant) patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: En6198) via an unspecified route of administration, administered in right arm on 02Mar2021 08:30 (at the age of 39 years) as dose 2, single for covid-19 immunisation. The patient's medical history was none. No known allergies were reported. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL9262) administrated in right arm on 28Jan2021 15:30 (at the age of 39 years) as dose 1, single for protection of Covid. The patient did not take any other vaccine in four weeks. No covid prior vaccination. Not tested for covid post vaccination. On 02Mar2021 09:00, the patient experienced shortness of breath, fever, nausea, vomiting, diarrhea, arm soreness. No treatment was given for events. Outcome of all the events were unknown.  No follow-up attempts are needed. No further information is expected.