chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt's mother called today 3/21/02. States child had 4 X3 round raised area which was red and hot. States this appeared over the injection site two days post the immunization. Used ice pack X 3 days. No fever. Rash over various body parts "that would come and go" X 1 week. No medical treatment sought.
Severe shoulder and arm pain within hours after immunization; call to PCP to report pain on Friday.  Was told to use ibuprofen over the weekend.  Patient saw provider on Monday and was prescribed a course of prednisone taper.  Patient still reports discomfort, although not as painful as 17 months ago.  Vaccine was administered high on deltoid muscle, close to top of deltoid muscle.
Severe chills, slight cough 5 days after shot Swollen itchy arm where shot was given 8 days after shot
Case number PHEH2016US023463, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 19-year-old patient of an unknown gender. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701, expiry date: not reported) at a dose of 0.5 ml intramuscular into left arm on 16 Feb 2016. It was reported that, the patient received FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursion and it was administered to unknown number of patients. No adverse event was reported following this medication error (incorrect product storage).
Symptoms reported include feeling itchy, hives, flushed, nausea, chills.
sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 21Jan2022 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. Vaccination history included: BNT162b2 (Dose 1, single), administration date: 11Jun2021, for COVID-19 Immunization, reaction(s): "Sore arm"; BNT162b2 (Dose 2 single), administration date: 09Jul2021, for COVID-19 Immunization, reaction(s): "Sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional information: The case was reported as not serious. No PQC present. Product: Comirnaty, Pfizer-BioNTech COVID-19 Vaccine [Monovalent] and/or Bivalent. Dose/Dosage Form: Gray cap, Original/Omicron BA.4/BA.5 (Bivalent), greater than equal to 12 years - 15/15 mcg per dose. Calling regarding the Pfizer-BioNTech COVID-19 Vaccine, Omicron Bivalent gray cap formula. The caller stated in Dec2022 "I had Covid and I was annoyed, why am still getting Covid? I didn't die but I was very sick not throwing up, a lot of chills and fever. Caller stated when he received his 4 vaccines "the only thing I ended up with was a sore arm. My sister was very sick after her Covid vaccine." 1st dose-11Jun2021- Primary series, 2nd dose-09Jul2021 -Primary series, 3rd dose-21Jan2022-Booster, 4th dose-12Aug2022-Booster. Caller stated he had taken 4 Pfizer Covid vaccines in the past. On 12Aug2022, the patient did not think patient took the "newest one out there. I think they started making the newest one the end of that month I believe - What is the newest one, Covid vaccine, you have, is that still the newest one or is there a newer one? What is the name of the current recommended vaccine? What does Bivalent mean?" Question: -Caller is asking since his last dose, do I still have immunity to Covid? "If I got my last dose in August 2022 the ER doctor told me I should've still been immune? How long will the Bivalent dose last? How long does it take to work? I have no heart issue. Can these prior vaccines effect my heart down the road or will the newest vaccine? If I get the Pfizer covid vaccine today and in less than a week I get Covid 19. Then after I get Covid 19 I end up in a coma. I already had the vaccine before this, in a few weeks would I wake up from my coma? Once I take this vaccine will I have to take another one in a few months?"  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from an office manager referring to a patient of unknown age and gender. Information on patient's pertinent medical history, drug reactions/allergies and concomitant therapies were not reported. On 12-DEC-2018, the patient was inadvertently vaccinated with an expired dose of VAQTA 25/0.5 (unit unspecified) (lot # N020689 and expiry date: 22-OCT-2018) via intramuscular route for prophylaxis (expired product administered). No adverse effect was reported. There was no product quality complaint (PQC) reported. This is one of the several reports from the same reporter.; Sender's Comments: US-009507513-1901USA001105: US-009507513-1901USA001106: US-009507513-1901USA001107: US-009507513-1901USA001108: US-009507513-1901USA001109: US-009507513-1901USA001110:
Patient received flu and pneumonia vaccines on 01/21/05. On 01/25/05 her blood pressure was high and today it is 200/100 and she has dizziness. She called her doctor that manages her HTN,  who instructed her to take additional medication. I explained to the patient that my knowledge the flu and pneumonia vaccines should not cause your blood pressure to elevate, but that she could have soreness and tenderness of the area, which she indicated she did. I advised client to recall her BP doctor, if unable to reach them go to ER, as she attempted to recheck her BP during our conversation and her machine stated twice that it was unable to read. I notified my supervisor.
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 58-year-old patient who received SHINGRIX for prophylaxis. On 26th March 2019, the patient received SHINGRIX. On 27th March 2019, 1 days after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the patient for themselves. The patient stated that they got the shingles booster and at the time of reporting, they felt like they had the flu. The patient stated that they would call their doctor.
Left upper arm with 15cm x 20cm erythema hard to palpation over shot site 4cm x 2cm non-tender.
Client given HPV9 vaccine to right deltoid. Was sitting at the time. Within 10 seconds fainted. Came to within 5-10 seconds. C/O head hurting after event.
Localized pain in left arm where the injection was placed/mild throbbing pain in that area; Developing some tingling down arm to fingers; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Apr2021 at 10:30 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. 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. The patient did not receive any concomitant medications. 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 02Apr2021 at 15:30 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. On 16Aug2021, the patient started experiencing localized pain in the left arm where the injection was placed. The patient was experiencing mild throbbing pain in that area and developed some tingling down the arm to the fingers. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 17Aug2021, the patient underwent polymerase chain reaction (PCR) test for COVID- 19 and the result was negative. The clinical outcome of the events localized pain in left arm where the injection was placed/mild throbbing pain in that area and developing some tingling down arm to fingers were not resolved at the time of this report.   The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Fever, headache, chills, bodyaches, nausea, sore arm, 14 hours later
Dose manipulated due to dull needle, vaccine wasted. A different vaccine was given to patient.
Rash started with 1 small red spot on left arm, increased in size and pruritis developed. Over course of next 2 weeks, pinpoint size raised red rash developed into rash over entire body except neck and head. Rash consisted of vesicles and some rash areas 3 cm in size with dark scaly centers. Rash extremely pruritic. The patient was referred to MD. Placed on Zyrtec, Prednisone and cream for rash, but rash continued to progress and remained quite pruritic then saw dermatologist for skin bx 12/13. By 12/14/01, pruritis decreased and no further progression of rash.
This case was reported by a healthcare professional and described the occurrence of not responding to therapy in an adult subject of unspecified gender who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date the subject received 3rd dose, 2nd dose and 1st dose of ENGERIX B (unknown). At an unspecified time after vaccination series completion with ENGERIX B, the subject experienced not responding to therapy and pharmaceutical product complaint. A total of six employees were vaccinated with three doses of ENGERIX B. All had titers drawn at an unknown period after the third dose and the titers were negative (0) for antibodies. There were two lots given to these six subjects at some point in the series, lots: AHBV13734AA and AHBV670AA. The lot numbers were reported as AHBV13734AA and AHBV670AA from the reporter; however, based on a safety lot number review, the lot numbers were updated to AHBVB734AA and AHBVB670AA respectively. For the other cases see A0891212A- A0891216A. Follow-up information was received on 09 November 2010 via Quality Assurance, who stated there was no product complaint associate with the adverse event; therefore the pharmaceutical product complaint was voided.
accidentally gave an expired FLUZONE HIGH-DOSE VACCINE (2020-2021 rather than 2021-2022 vaccine) with no ae; Initial information received on 29-Nov-2021 regarding an unsolicited valid  non-serious case received from a pharmacist via Agency number: 00876413.  This case involves an unknown age and unknown gender patient who was administered an expired dose of  INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] (expired product administered).  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number and expiry date  not reported via unknown route in unknown administration site for prophylactic vaccination.  It was case of an actual medication error due to expired vaccine used (latency: same day).  At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
I had a horrible reaction to the second shot of Covid 19; I really thought I was going to die; It was so bad; that's how bad that was; I woke up with the migraine headache, I never had a migraine; I had complete chills; I had a bad fever; I had complete exhaustion; my whole body hurt; I had complete exhaustion; my whole body hurt; I started vomiting, I had repeated vomiting; I just could not feel any worse; No, I just don't feel great yet, I lost 5 pounds truthfully; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration on 16Mar2021 (at the age of 70-years-old) as single dose for covid-19 immunization. Medical history included thyroid disorder (thyroid). Concomitant medication included thyroid (NATURE THROID) for thyroid. On 17Mar2021, the patient experienced that she had a horrible reaction to the second shot of COVID 19; she really thought she was going to die; It was so bad; that's how bad that was; the patient woke up with the migraine headache, she never had a migraine; the patient had complete chills; the patient had a bad fever; the patient had complete exhaustion; her whole body hurt; the patient started vomiting, she had repeated vomiting; she just could not feel any worse. The patient stated, "No, I just don't feel great yet, I lost 5 pounds truthfully" and with treatment, the patient stated, "No, just drink water." The patient thought maybe other people were having this, were other people calling that they got that sick and the patient was not obese or anything. The patient know they make it like if they were overweight, terribly overweight, have a worse reaction, the patient was a little overweight but hardly any. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Per Employee report: "Received COVID vaccine. Experiencing side effects (pain on left buttock, fatigue)"
Second dose 42 day period had passed; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second dose 42 day period had passed) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose 42 day period had passed). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Second dose 42 day period had passed) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Mixed series - Incorrect mRNA COVID-19 vaccine product administered for second dose in 2-dose series. Patient (myself) came in for second dose of the Pfizer vaccine (first dose administered on 04/14/21 at a different location), but was mistakenly given the Moderna vaccine instead. No other adverse effects to report so far.
NONE  PT RECEIVED THE VACCINE EARLIER THEN INTENDED  PT WAS WATCHED FOR 1 HR  NO ADVERSE SIDE EFFECT SHOWN
Pt was given product past stability period once punctured  (vial had been previously punctured  approximately 24 hours earlier)   Pt did not report adverse reactions.
positive covid 19 case; positive covid 19 case; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Lot number: EP6955), in Apr2021 as dose 2, single (Lot number: EP6955) and in Dec2021 as dose 3 (booster), single (Lot number: FL3197) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 26Apr2022, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "positive covid 19 case". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Apr2022) Positive.  Clinical course: It was reported to be non serious. Not resulted in death, was not life threatening, had not caused/prolonged hospitalization, was not caused Disabling/Incapacitating, had not resulted in anomaly/birth defect. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient not had been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
pt spiked 102 fever day of vax on & off until 5/24/99. then devel red macular rash all over body 5/23. has clear runny nose & cough.
Patient received 10 microgram bivalent dose and not the 25 microgram bivalent dose as recommended.
the patient was administered improperly stored PROQUAD; This spontaneous report was received from a medical assistant, concerning a 4-year-old female patient.  The patient's medical history, concurrent conditions, drug reactions or allergies were not provided.  On 31-AUG-2020, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (strength, dosage, anatomical location and route of administration were not provided) lot # T005406 with expiration date on 12-AUG-2021, administered subcutaneously for well check; which was previously reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT). The multiple temperature excursions included storage temperatures like -9 to 8 degrees Celsius (°C) (-6.1 °C) for 13 hours and -14 to -10 °C for 116 hours. There was no previous temperature excursion. No product quality complaint (PQC) was involved.
PER MOTHER AND SON SON GOT VACCINE AT HIS SCHOOL ON 8/20/21 AT 01:09 PM THEN BETWEEN SATURDAY AND SUNDAY, HE STARTED EXPERIENCING KNEE PAIN,AND SWELLING, HE WENT TO ER ON  8/23/21 FOR SEVERE KNEE PAIN AND SWELLING, CAN NOT BEND OR EXTEND THEM, CANNOT RAN. NEVER FELL. DID X-RAY IN ER AND WAS NORMAL. WAS SEEN BY THIS PCP, ON 8/28/21 FOR THE SAME C/O OF KNEE PAIN. MOTHER THINKS THE PAIN AND SWELLING STARTED AFTER TAKING THE VACCINE HE WAS GIVEN AT SCHOOL.AT THE TIME HE WAS SEEN IN CLINIC KNEES WERE STILL SWOLLEN . STILL HAD PAIN.
got the vaccine and then got the results of the PCR test which was positive; got the vaccine and then got the results of the PCR test which was positive; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration from an unspecified date to an unspecified date at single dose (dose number; 1) for covid-19 immunisation. Identification of the country where the drug was obtained: authorization/application: Patient's medical history and concomitant medications were not reported. Patient questioned that prior to having the first Pfizer vaccine, she had a rapid Covid test which was negative and a PCR. She got the vaccine and then got the results of the PCR test which was positive. What does she do? Does she get the next vaccine? Outcome of events was unknown.   Information on lot/batch number has been requested.
.   HAD BEEN ADMITTED 7-31-22 FOR  CONFUSION AT HOSPITAL, TESTED + FOR COVID 8-16-22  AND WAS TRANSFERRED TO ANOTHER HOSPITAL ON 8-31-22 WHERE SHE REMAINED  UNTIL 9-9-2022  DECEASED ON  11-23-2022
I became severely ill approx 3-4 hours after the shot. Ran a fever of 101.4, bad sore throat, runny nose, congestion, chest hurt, eyes and head swelled up, eyes red rimmed, bloodshot, swollen, mouth swollen, lips numb, nausea, stomach upset and could not eat for several days, ears ringing, feet, hands, neck, leg soreness, overall fatigue, lethargy, weakness.  I did not get hives, but it felt like an allergic reaction in all other ways.
After getting FLUMIST patient developed increased sniffling in an exaggerated manner. Lasted for several days and was concerning for development of tic.
Hives, itching all over body. The hives / rash outbreaks are still occurring from 09-12-2012 to date 10-18-2012.
little sensation when she touches arm; flat, pinkish to dark red 2x3 mark; A spontaneous report was received from a consumer concerning a 80-years-old female  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events flat, pinkish to dark red 2x3 mark/vaccination site erythema, little sensation when she touches arm/hyperesthesia.  The patient's medical history was not provided. Concomitant medications reported were dabigatran, Metoprolol for drug use for unknown indication.  On 17 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 022M20A) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events, flat, pinkish to dark red 2x3 mark, little sensation when she touches arm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, flat, pinkish to dark red 2x3 mark, little sensation when she touches arm was unknown.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Vaccination site erythema is consistent with the known safety profile of mRNA-1273.
11 days post vaccination, pt became fatigued, throat became sore, became febrile 101 F, By 6/24am pt had white ulcers in back of throat and inside of lip. No sores or ulcers elsewhere. Fever et ulcers continued saw MD 6/26. MD suspected mono or strep, gave RX for magic mouth wash. Fever gone 6/27, but still has sore throat and fatigue.
Case number PHEH2014US014714 is an initial spontaneous report from a nurse received on 21 Jul 2014 with a follow up report received from the nurse on 01 Oct 2014. This report refers to a 22 year old male patient. His medical history and concomitant medication was reported. His vaccination history included vaccination with MENVEO (batch number: not reported) in the past which was well tolerated. He was administered inadvertently MenA powder component of MEVNEO (batch number: A13011) reconstituted with sterile water instead of Men-CYW-135 liquid conjugate component intramuscularly into right deltoid on 21 Jul 2014 at 12:15 hours. No adverse event had occurred since the administration error. Follow up report received from the nurse on 01 Oct 2014: Updated patient demographics (height and weight), vaccination history, site of vaccination and time of vaccination.
Within 30 seconds of receiving the BOOSTRIX injection she got/felt flushed and dizzy plus light headed. BP 180/92, 162/89 and continued to go back down to normal. Patient also suffers from anxiety believe contributed to her reaction.
Information has been received from a pharmacist concerning her 9 year old daughter who in August 2008, was vaccinated with a first dose of GARDASIL and in October 2008, was vaccinated with a second dose of GARDASIL. There was no concomitant medication. In approximately October 2008 (some time after Dose 2), the patient experienced hair shedding and hair loss. The patient did not seek medical attention. At the time of reporting, the patient's hair shedding and hair loss persisted. Additional information has been requested.