chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse via medical assistant and refers to a 21-month-old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, past drugs and drug allergies were not reported. On 29-SEP-2017, the patient was vaccinated with improperly stored M-M-R II (lot # M034387; expiry date: 19-JUL-2018) (dosing details were not provided) for prophylaxis. Temperature excursion details of the vaccine were not provided. This is one of the several reports received from the same source. Sender's Comments: US-009507513-1709USA008861: US-009507513-1710USA013424: US-009507513-1710USA013470: US-009507513-1710USA013465: US-009507513-1710USA013440: US-009507513-1710USA013468: US-009507513-1710USA013442: US-009507513-1710USA013445: US-009507513-1710USA013460: US-009507513-1710USA013463: US-009507513-1710USA013464: US-009507513-1710USA013438: US-009507513-1710USA013439: US-009507513-1710USA013450: US-009507513-1710USA013430: US-009507513-1710USA013469: US-009507513-1710USA013467: US-009507513-1710USA013435: US-009507513-1710USA013434: US-009507513-1710USA013432: US-009507513-1710USA013428: US-009507513-1710USA013437: US-009507513-1710USA013441: US-009507513-1710USA013443: US-009507513-1710USA013444: US-009507513-1710USA013446: US-009507513-1710USA013447: US-009507513-1710USA013448: US-009507513-1710USA013436: US-009507513-1710USA013449: US-009507513-1710USA013451: US-009507513-1710USA013452: US-009507513-1710USA013454: US-009507513-1710USA013455: US-009507513-1710USA013456: US-009507513-1710USA013457: US-009507513-1710USA013458: US-009507513-1710USA013459: US-009507513-1710USA013461: US-009507513-1710USA013462: US-009507513-1710USA013466: US-009507513-1710USA013427: US-009507513-1710USA013471: US-009507513-1710USA013472: US-009507513-1710USA013473: US-009507513-1710USA013474: US-009507513-1710USA013475: US-009507513-1710USA013476: US-009507513-1710USA013425: US-009507513-1710USA013433: US-009507513-1710USA013423: US-009507513-1710USA013040: US-009507513-1710USA013426: US-009507513-1710USA013429: US-009507513-1710USA013431: US-009507513-1709USA008666: Original Case: 1709USA008666: US-009507513-1710USA014650: Original Case: 1710USA014649: US-009507513-1710USA014651: Original Case: 1710USA014649: US-009507513-1710USA014649: Original Case: 1710USA014649.
Information has been received from a registered nurse concerning a patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot number 664478/1191Y). Subsequently the patient experienced injection site reaction after vaccination, which consisted of the area of warmth, redness, and swollen. The patient called the office but did not come into the office. There were no lab studies were performed. At the time of the report, the patient had recovered (date unspecified). The reporter requested a lot check for lot# 664478/1191Y due to the patient's adverse experiences. A lot check was initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of several reports from the same source. Additional information has been requested.
No adverse events, vaccine reconstituted with 1.2ml of NS vs 1.8ml
Severe: weakness, dizziness, sweating, diarrhea, tinnitus, possible fever(unable to walk) (I checked my blood sugar and it was 110). It took 3 days for the headache to go away and 10 days before I felt OK again.
Pt contacted agency on 12/17/09 to report "tingling" in her left hand that began 12/2 - 12/3/09. Pt called MD without tx given. Client was asked to make an apt with primary care. No n/r no sob no swelling or soreness at site.
Arm swollen, red and hard at injection site x 4 days. Antibiotics for 7 days begun on 4/9/07
Days 1-4 - Very, very sore arm with  localized redness, about half dollar in size. Another symptom was my arm was very itchy.  Days 5 and 6- The soreness went away however the redness continued to stay and become a deeper shade of red and grow about a quarter inch. Itching continued. Day 7: I woke up and the redness had grown significantly in size.  The  size was approximately 3.5 inches in diameter, was red and bumpy and worse with itchiness. I ended up using a prescription hydrocortisone ointment which made it go away. For weeks later my arm was still itching and faint redness could still be visible.
Patient reports pain and redness at injection site, then noticed approximately 24 hours after injection that redness had spread across chest and back. Patient also reports swelling and tingling in lips. Patient reports that she has taken Benadryl with minimal relief.
Received rotavirus shot 7/18/06. Diagnosed with Intussusception 8/10/06. Medical record states apnea, urinary tract infection, vomiting, fever. msv
This spontaneous report as received from a company representative refers to a 68 years old female patient. The patient was vaccinated with ZOSTAVAX. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced severe rash. No treatment information was reported. The outcome of severe rash is unknown. The Pharmacist reported to the field representative that the patient received ZOSTAVAX "d days after" receiving PNEUMOVAX. The pharmacist administered the ZOSTAVAX, but the PNEUMOVAX was administered by the patient's physician (unspecified name). The patient developed a severe rash beginning at the elbow and spreading to her underarm. No further AE information was provided. Additional information requested.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 04-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product information was provided. No treatment information was provided.
macular popular rash over chest and back 1 day after vaccine and lasting 11 days so far, minimal symptoms, observing but no treatment now
Admitted to hosp 20JAN92 w/t105.6; pt exp eye rolling back, shaking all over; cough, coryza, congestion; also vomiting, rhonchi, bronchitis, OM, FE def anemia, pneumonia;
33 weeks 3 days pregnant at time of administration and on day of start of adverse event. Developed high fever to 102.8F, chills, arthralgias, nausea. Now admitted with pancytopenia, elevated liver enzymes, ongoing fever requiring supportive care.
15 minutes after receiving dizzy, lightheaded, sob pulse 140 R arm swollen from shoulder down to fingers lasted 4 hours after injections.
Pt recv vax on 11/25/97; 2 min post vax pt exp weal at varicella vax site x 20 min
Chills for 8 hours., Fatigue for 24 hours. Sore and swollen injection site for  4+ days.
swollen red hot spot at the injection site; swollen hot red spot on the injection site which was itchy; swollen red hot spot at the injection site; swollen red hot spot at the injection site; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE WARMTH (swollen red hot spot at the injection site), VACCINATION SITE PRURITUS (swollen hot red spot on the injection site which was itchy), VACCINATION SITE SWELLING (swollen red hot spot at the injection site) and VACCINATION SITE ERYTHEMA (swollen red hot spot at the injection site) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE WARMTH (swollen red hot spot at the injection site), VACCINATION SITE PRURITUS (swollen hot red spot on the injection site which was itchy), VACCINATION SITE SWELLING (swollen red hot spot at the injection site) and VACCINATION SITE ERYTHEMA (swollen red hot spot at the injection site). At the time of the report, VACCINATION SITE WARMTH (swollen red hot spot at the injection site), VACCINATION SITE PRURITUS (swollen hot red spot on the injection site which was itchy), VACCINATION SITE SWELLING (swollen red hot spot at the injection site) and VACCINATION SITE ERYTHEMA (swollen red hot spot at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Non-significant Follow Up append - Reporter Email Address updated; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Fever, Headache, Muscle pains, Body aches, Weakness, Fainted, Lost consciousness
administered an expired dose of Engerix-B; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 39-year-old female patient who received HBV (Engerix B) (batch number F73DG, expiry date 03-JUL-2023) for prophylaxis.   On 03-AUG-2023, the patient received the 3rd dose of Engerix B. On 03-AUG-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: administered an expired dose of Engerix-B). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 07-AUG-2023 The reporter administered an expired dose of Engerix-B to a patient, which led to expired vaccine used. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via postal.
Client had vasovagal response. Diaphoretic, faint, pale.  He responded after a few seconds but remained dizzy.  provided water and snack and then he laid prone with feet elevated.  Recovered in the clinic for 30 minutes prior to leaving.
Rash neck, back, chest, arms. Itching small welts on neck. Controlled with antihistamine.
pt recv vax & devel local erythema, pruritis, & hives;eyes became puffy & c/o tongue felt swelled;stated that had a feeling of fullness in throat;had associated hoarseness;adm to ICU for observation;
A FEW DAYS AFTER GOT 2nD COVID VACCINE STARTED TO HAVE RASH ON OPPOSITE ARM/SHOULDER THAT HE GOT VACCINE IN. SINCE THEN IT HAS SPREAD TO BOTH SHOULDERS AND TO NECK. SEEN PCP AND WAS PRESCRIBED SOME OINTMENT AND HAS BEEN TAKING BENEDRYL
Patient received both vaccines together on 3/31/2023  in the left arm. She reported for the first time on 7/1/2023 that she was still experience pain in her left arm from the vaccines on 3/31/2023. I asked if she had called the pharmacy prior to that date and she said no. She stated she did not have any reaction after the vaccines except just general dull pain. There was NO major swelling, rash nor it did not heat up after the vaccine. The patient stated she did have any injuries either to report on her left arm. I asked if she fell or has had pain in the left arm prior and she stated no. She stated she is still having trouble fully lifting her arm
Did not have an adverse reaction immediately following vaccine. I believe I had a delayed adverse reaction to the vaccine, once acquiring COVID-19, which I believe the vaccine exacerbated my symptoms causing an adverse reaction. I came down with COVID-19, symptoms started Jan 27. On Feb 2, I experienced extreme dizziness/vertigo out of nowhere, which led to non-stop vomiting. I had to go to emergency room, where I tested positive for COVID-19. Since Feb 2 with symptoms still persisting as of 2/12/22, I have had persistent dizziness, head pressure and ear fullness, disequilibrium, and loss of balance. I have struggled doing basic tasks, such as walking and working on the computer for my job, due to these symptoms.
pt recvd vax 17JUN93; 18JUN cranky & crying described by mom as high pitched cry & fever of 100-101; office visit 23JUN temp 38C, red throat, rapid strep/viral CBC/throat cult neg; 24JUN rash; 25JUN office visit nl temp; dx viral synd;
Pruritic, miliaria-type rash p/3rd dose HB vax; Doubt cause & effect secondary to vax, but timing is suggestive enough to file this report.
2 doses / less than 30 days apart; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 22-year-old male patient who received Men B NVS (Bexsero) (batch number abxb27aa, expiry date 22nd June 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included Men B NVS (Bexsero).   On 16th August 2021, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 16th August 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short 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 were provided as follows: The patient had received 2 doses of Bexsero less than 30 days apart, which led to shortening of vaccination schedule. No further events were reported. The reporter consented to follow up.
her blood test done and the result is different from her usual results; This is a spontaneous report from a contactable consumer (patient).  A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2) , via an unspecified route of administration on 19Feb2021 at single dose for covid-19 immunisation .  The patient medical history was not reported.  There were no concomitant medications.  The patient experienced her blood test done and the result is different from her usual results on an unspecified date with outcome of unknown.  No treatment received for the adverse event. The patient underwent lab tests and procedures which included blood test: abnormal. The patient did not receive other medications within 2 weeks of vaccination, 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 the vaccination, the patient has not been tested for COVID-19.  Information on the lot/batch number has been requested.
Finger numbness (middle and ring finger)- happened right after vaccination was given. Said numbness goes up the arm close to the shoulder. Patient did say this happened with other vaccinations and went away after half a day or so. Patient was seen in emergency department in the past but Dr. could not find anything wrong.
This spontaneous report was received from a pharmacist via company representative and refers to a male patient of unknown age. No information regarding the patient's medical history, concurrent conditions and concomitant medication was provided. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route of administration, injection site, lot# and expiration date were not provided). On an unknown date (also reported as later), the patient developed shingles. The patient sought medical attention (unspecified). The outcome of the event was unknown. The relatedness between the shingles and ZOSTAVAX was not provided by the reporter. Additional information has been requested.
RECEIVED PFIZER MONOVALENT INSTEAD OF PFIZER BIOVALENT AS 4TH SHOT
Patient participated in our Booster Clinic Wednesday 11/3/21. Thursday morning she called out due to not feeling well since the Booster has been administered and has not worked since. She stated she felt terrible all weekend with a fever and chills. The employee came to work this am; however, we had to send her out 911 this morning due to SOB, pale, shallow respirations (so shallow we couldn?t see her chest rise), she was luckily easy to arouse and was able to communicate to us she was a full code and remained alert until the ambulance came.
An expired Covid-19 pfizer vaccine was administered to the patient on 4/29/22.  The vaccine expired on 4/18/22 at 10am.  The error was discovered on 4/29/22. On 5/3, a COVID-19 Vaccine temperature related enquiry form was filled out and emailed to Pfizer.  On 5-9-22 at 7:51am, we received an email from Pfizer's quality team stating they do not have stability data to support our excursion from prescribed storage conditions. We have reached out to our affected patients informing them of the situation and offered to revaccinate them if they choose to. Spoke to patient on 5-9 and she does not plan to get revaccinated.
vomiting; fatigue; sweats; chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweats), CHILLS (chills), NAUSEA (nausea), VOMITING (vomiting) and FATIGUE (fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced HYPERHIDROSIS (sweats), CHILLS (chills), NAUSEA (nausea) and FATIGUE (fatigue). On 01-Apr-2021, the patient experienced VOMITING (vomiting). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (sweats), CHILLS (chills), NAUSEA (nausea), VOMITING (vomiting) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.
Mother reports: hives (dime-sized), starting at toes, both legs, back and inner forearms, found on awakening in the morning, post vax. Follow-up with office visit to MD and was given Benadryl and prescription for Claritin. Approximately 15:00, mother reports hives are subsiding.
Patient described bilateral "tingling" in the hands and wrists. Lasted for 15 minutes and resolved.  DID NOT manifest any symptoms consistent with anaphylaxis, including NO angioedema, no difficulty breathing, no wheezing/stridor, no urticaria, no GI symptoms of pain/N/V/D
Caller stated that her arm was sore in the muscle; Caller stated that her arm was sore in the muscle; 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 female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm (Batch/Lot number: unknown) as dose 1 single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYALGIA (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "Caller stated that her arm was sore in the muscle".  Additional information: Caller stated that when she went to receive the first dose of the Pfizer Covid 19 vaccine, the nurse was looking at the back of her arm and the caller thinks the vaccine was given more in the triceps instead of the deltoid muscle. Caller wanted to know if this is less effective and should she get a titer. Caller wanted to know if she got some efficacy after the first dose and would get the 95% after the second dose.Patient Age: 61.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient states that immediately after flu shot the area around the injection became swollen and felt bruised. She put warm compress on it. The edema resolved the next morning (around 12 hours later) but the bruised feeling continued. I saw her around 24 hours the injection at son's appointment. Area around injetiion with no erythema/edema from at LUE with no numbness. Denied F/C/N/V/P
Fever 102.9,  Chills, Muscle and Joint Pains, Slight Nausea
Arm pain for several days (started after an hour or so), fatigue (started after intense rock-climbing session a few hours later; lasted a couple of days)
After client received her vaccine client complained of itchy chest no rash.  Vital signs obtained:  BP 150/69, HR 58, O2 sat 97%.  Client stated that she feels better.  Client discharge home by EMS.  Advised to follow up with her PCP.
Enlarged lymph nodes; Itching in her scalp and wrist; Hives in neck, forehead and wrist; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching in her scalp and wrist), URTICARIA (Hives in neck, forehead and wrist) and LYMPHADENOPATHY (Enlarged lymph nodes) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included VITAMIN D [VITAMIN D NOS], MULTIVITAMINS [VITAMINS NOS], RALOXIFENE and HYDROCHLOROTHIAZIDE, OLMESARTAN MEDOXOMIL (OLMESARTAN HCTZ) for an unknown indication.    On 08-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 08-Jan-2021, the patient experienced PRURITUS (Itching in her scalp and wrist) (seriousness criterion medically significant) and URTICARIA (Hives in neck, forehead and wrist) (seriousness criterion medically significant). On 09-Jan-2021, the patient experienced LYMPHADENOPATHY (Enlarged lymph nodes) (seriousness criterion medically significant). At the time of the report, PRURITUS (Itching in her scalp and wrist), URTICARIA (Hives in neck, forehead and wrist) and LYMPHADENOPATHY (Enlarged lymph nodes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was received.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
had shingles vaccines still had shingles; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient 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: had shingles vaccines still had shingles) (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: 21-MAR-2023 The reporter reported the case via interactive digital media. The patient had his/her shingles vaccines and still had shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.