chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Breakthrough case admission after 2 vaccines Moderna 4/15/21 Lot# 040B21A;  Moderna 5/14/21 Lot# 005C21A
A report has been received from a Health Professional concerning a patients of unknown gender, who had been receiving Nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on an unknown date. It was reported that unknown number of patients had FLUMIST Quadrivalent during a temperature excursion while the FLUMIST was refrigerated. The outcome of the event of received the FLUMIST Quadrivalent during a temperature excursion while the FLUMIST was refrigerated is unknown. The report was considered to be non-serious.
Severe pain, swelling at site. High pitch scream through out night.  Not able to be consoled. Trouble breathing, tachypnic.  Went to ER next day.  Hospitalized for 8 days for Tachypnea.
This spontaneous report was received from a Registered nurse regarding a 12 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-JUN-2018, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. ; Sender's Comments: US-009507513-1804USA005153:
Breakthrough COVID infection. Patient admitted for altered mental status on 5/29/2022 and tested for COVID due to dyspnea on 6/4/2022
Shingles / Suspect Vaccination Failure; Shingles; painful rash on face; couldn't sleep; discomfort of the shingles; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, 3 years after receiving Shingrix and more than 2 years after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Shingles / Suspect Vaccination Failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles), exanthema facial (Verbatim: painful rash on face), sleeplessness (Verbatim: couldn't sleep) and discomfort (Verbatim: discomfort of the shingles).  The patient was treated with valaciclovir (Valacyclovir) and pregabalin. The outcome of the vaccination failure and shingles were unknown and the outcome of the exanthema facial, sleeplessness and discomfort were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, exanthema facial, sleeplessness and discomfort to be related to Shingrix. It was unknown if the reporter considered the vaccination failure, shingles and exanthema facial to be related to Shingrix.     It was unknown if the company considered the vaccination failure, shingles, exanthema facial, sleeplessness and discomfort to be related to Shingrix. It was unknown if the company considered the vaccination failure, shingles and exanthema facial to be related to Shingrix.   Additional Information: GSK Receipt date: 07-SEP-2023 A physician reported that they had a patient that had gotten Shingrix in 2020.  The physician did not have the specific dates of immunization but did know that the patient did receive both doses.  Three years later this patient ended up with severe painful rash on face which was diagnosed as shingles.  The patient was not hospitalized, and the patient could not sleep (well, due to discomfort of the shingles).  The patient was prescribed 7 days of valacyclovir and Pregabalin tablets.  The reporter consented to follow up. This case was linked with case US2023127596 and US2023127594, as reported by same reporter.; Sender's Comments:  US-GSK-US2023127596:Same reporter US-GSK-US2023127594:Same reporter
after receiving the J&J vaccine, patient admitted to RN in having one dose of the Pfizer prior (DATE UNKNOWN)
Redness, Edema to right arm, Tricep area, prescribed.  Dicloxacillin 500 mg Q 6 hrs.
"Covid arm" - large red splotch, hot to touch, itchy, swollen  Low-grade fever Headache and neck pain  Red splotch on arm resolved on its own, still have some slight arm pain (at injection site) and neck pain  Did not take any medications to resolve the issue
administration of expired Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of expired Moderna vaccine) in a 43-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of expired Moderna vaccine). On 23-Nov-2021, EXPIRED PRODUCT ADMINISTERED (administration of expired Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.   No treatment was given to the patient.   The vaccines were stored in freezer, were taken out one to two vials and placed in fridge each day as needed.
Fever, aches at 1:00 pm  9:00 pm severe stomach cramps.  10 pm diarrhea.  Had cramps and diarrhea ..  Tried  taking Imodium.  Didn't help.  Went on bland diet, rice, broth, bananas, toast.  Would let up.  In a couple of days I would go back to regular diet and it would come back.  Stuck with Imodium also.  Finally at four weeks it stopped.
4:50PM PT BECAME LIGHT HEADED - N/V, DIAPHORETIC. PLACED IN WHEEL CHAIR AND MOVED TO COT. 'FEELING A LITTLE BETTER'. A/O, RESP WITH EASE. NO PAIN, NO SOB. 5PM NOW PINK, W/D. 5:15PM FRIENDS HERE TO DRIVE PT HOME. AMBULATORY TO EXIT - GAIT BRISK AND STEADY. 4-2-21 10:30AM TC: PT STATES SHE FEELS 'FINE NOW'.
moderate pain at injection site after 12 hrs; fatigue after 12 hours; This is a spontaneous report from a non-contactable consumer (patient) received via COVAES. A 20-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm, on 20Jan2021 at 06:15 PM (Batch/Lot Number: EL1283) (at the age of 20 years old) as dose 1, single for COVID-19 immunisation in a hospital. The patient has no relevant medical history. The patient has no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination. Concomitant medication included cefdinir. On 21Jan2021 at 06:15 AM, 12 hours after the first dose vaccination, the patient experienced moderate pain at injection site and fatigue. The patient did not receive treatment for the events. The patient was recovering from the events on the time of the report.  No follow-up attempts are possible. No further information is expected.
Initial unsolicited report received from a Physician on 22 September 2016. This case involves a female patient (age not reported) who was vaccinated with dose of Fluzone Hd High Dose (batch number: UI662AA, dose, expiration date, site and route of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date following vaccination, patient feeling cold and unwell and experienced fever 103-104 (unit not reported). On an unspecified date patient was hospitalized (ICU) for pneumonia. It was reported that patient did not have pneumonia. Lab data and corrective treatment were not reported. Outcome of the events were not reported. On an unspecified date, (reported as next day) patient was discharged from hospital. List of documents held by sender: none. Sender's Comments: This is a poorly documented case concern a 70 year old female patient who received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE and developed fever, feeling cold and unwell. Time to onset of event is not provided. Patients medical history, concurrent conditions, concomitant medication, reaction to previous vaccination and etiological work up will be needed for complete assessment of the case. Based on the data provided, the role of vaccine cannot be assessed.
A report has been received from a Pharmacist concerning a 31 year old, subject of unknown gender, who had been receiving FLUMIST. FLUMIST started on 11-Nov-2013. The patient was administered only a half dose of FLUMIST in one nostril which started on 11-Nov-2013. The outcome of event of administration of only a half dose of FLUMIST in one nostril is unknown. The report was considered to be non-serious.
This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 18-OCT-2018, the patient was vaccinated with an expired dose of ROTATEQ, lot # N005972, expiration date 12-OCT-2018 (strength and dose were not reported). No adverse effects were reported. The outcome of the event expired product administered was not provided.
8 days after, I have a swollen, warm, red patch where I received the vaccine.  It is raised and itchy.  It is about 2x3 inches.
8/29/21 no significant PMH; presents with a 6 day history of malaise and cough. 6 days ago he had a positive COVID test.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: initial dizziness, loss of consiousness for roughly 30-60 seconds, body rigidity before waking up-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Weakness-Medium, Additional Details: 4-5 minutes after vaccinating patient he reported feeling dizzy, when accessing patient he became unresponsive and breathing became louder, he became pale and lost consciousness. 911 was called. His face began turning red and with the help of 2 individuals we lowered him to the floor, his arms became rigid for abotu 5 seconds, and upon trying to wake him/checking for vital signs, he came to and was aware of where he was and that he had just got a vaccine. he did not recall the event post dizzine
parent called w/report approx 28hr p/vax;no fever but onset 5/19/99 in AM of high pitched cry 20-25min duration 4-5 times during the day;very irritable & out of control w/temper tantrum;sx subsided during noc of 5/19/99;pt w/onset cold sx
April 1, 2021 (same day as second vaccine received) Ischemic stroke which lead to a Hemorrhagic Stroke While still in the hospital from the stroke, blood draws determined very low Hemoglobin.  Transfusion was given.  This lead to weekly blood draws.  Due to the critically low hemoglobin transfusions were given on an almost weekly basis.  Nov 4, 2021 was the last transfusion as the hemoglobin has leveled out to what it was prior to the Covid-19 vaccine.  Starting Dec 27, 2021 blood draws are now bi-weekly.
Breakthrough case admission after 3 vaccines Pfizer 3/23/21 lot# EP6955;  Pfizer4/13/21 Lot# EP6955;  Pfizer 10/15/21 lot# FF2590;
Administration error: patient moved while receiving the vaccine and the majority of the dose ran down the arm. Corrected this by giving the remainder of the dose to make a full dose (corrected the same day).
missed his appointment for his second shot that was scheduled 23Feb2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (missed his appointment for his second shot that was scheduled 23Feb2021) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included CODEINE for Arthritis.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (missed his appointment for his second shot that was scheduled 23Feb2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (missed his appointment for his second shot that was scheduled 23Feb2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient reported that his physician advised him to wait to receive the vaccine because he was administered two codeine shot for arthritis. The patient was seeking assistance to make an appointment for his second shot.  No treatment information was provided by the reporter.
The day after the vaccine I developed atrial fibrillation.  Per doctor today, October 27, 2023: The patient has not been feeling well for the past 9 days and has had palpitations, fatigue and more shortness of breath.  Interrogation of his ICD shows that he has been in atrial fibrillation for the past 9 days which likely explains his symptoms.
Sever muscular pain and disability in arms and left upper thigh.  Ability to walk diminished.  Lasted 4 days and disappeared suddenly after 4 days.
Patient needed verification of polio booster after age 4 and another varicella vaccine for school; documentation states patient needs another dose of varicella vaccine. Patient received a polio booster 3/15/23 - accurate and needed. Patient presented to 3/29/23 appointment with varicella vaccine in appointment notes - patient was given polio vaccine. Patient's mom brought printed immunization record to clinic and error was discovered. Patient should have received varicella vaccine ONLY on 3/29/23, which was administered 3/29/23, meeting school requirement.
14 days after receiving first dose of varicella virus vaccine live the pt developed hives which continued to spread and cover 90% of her trunk. There was some ecchymosis of the joints, including her ankles and wrists. Pt was seen by physician and treated with hydroxyzine. Pts blood culture was negative and the pts erythrocyte sedimentation rate was 9.
The symptom began 2 days ago. No fever his appetite was down. His arm was redder yesterday but today it increase in size now involving most of the external part of the lower arm. 3" oval area.
ON FRIDAY MAY THE 14TH I VACCINATED ONE PATIENT FOR THE JANSSEN VACCINE IN THE MORNING. I PLACED VIAL IN REFRIGERATOR FOR FURTHER VACCINATIONS AND AT THE END OF THE SHIFT I FORGOT TO DISCARD THE VIAL. MONDAY MORNING (05/14/2021) I RETURNED TO THE PHARMACY AND I HAD PATIENTS FOR THE JANSSEN VACCINE. AS I WAS ABOUT TO SEND MY REPORT FOR THE DAY OF MONDAY 05/17/2021 I REALIZED THAT I HAD MORE VACCINES THAN I SHOULD, COMING TO THE REALIZATION THAT I ACCIDENTALLY ADMINISTED 5 DOSES OF THE JANSSEN VACCINE FROM THE VIAL OF FRIDAY MAY THE 14TH OF 2021. PATIENTS FROM MONDAY (TODAY) 05/17/2021 THEY ALL WAITED THEIR 15 MINUTES AND THERE WAS NO REACTION AND NO FEVER AT THE MOMENT.  THE PATIENTS LEFT PHARMACY WITHOUT ANY COMPLAINTS.
This case was reported by a nurse and described a 54 year old patient who did not respond to immunization with hepatitis B vaccine recombinant (Engerix B). On 04/22/2004, the patient received the first dose of Engerix B (lot ENG5553B2). On 04/25/2004, the patient received the second dose of Engerix B (lot ENG5553B)  On 10/25/2004 the patient received the third dose of Engerix B. On an unspecified date after 10/25/2004 and on or before April 7 2005, a hepatitis B surface antibody titer was negative.
altered mental status, pt was observed x 15 min, was released, reports taking train and making bus transfer and not remembering how he got home
Severe psychotic episodes; This spontaneous case was reported by an other caregiver and describes the occurrence of PSYCHOTIC DISORDER (Severe psychotic episodes) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced PSYCHOTIC DISORDER (Severe psychotic episodes). At the time of the report, PSYCHOTIC DISORDER (Severe psychotic episodes) outcome was unknown. Not Provided.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Treatment of this event was not reported.
Pain in her arm; Swollen Lymphnodes underneath her armpit; A spontaneous report was received from a consumer, concerning a 72-year-old female patient, who received Moderna's COVID-19 vaccine and experienced pain in her arm, swollen lymph nodes underneath her armpit.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 19 FEB 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (lot/batch: Unknown) via unknown route on the left arm for prophylaxis of COVID-19 infection.   On 21 FEB 2021, the patient experienced pain in her arm, swollen lymph nodes underneath her armpit.  Treatment details was not reported.  Action taken with mRNA-1273 in response to the events was not reported.    At the time of the report, the outcome of event 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. Axillary lymphadenopathy is consistent with the known safety profile of mRNA-1273.
swelling at injection shot 3" in diameter and hot to the touch; swelling at injection shot 3" in diameter and hot to the touch; chills; fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Dec2021 14:30 (Lot number: FE3594) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid" (unspecified if ongoing), notes: if covid prior vaccination: Yes. The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE WARMTH (non-serious) all with onset 23Dec2021, outcome "not recovered" and all described as "swelling at injection shot 3" in diameter and hot to the touch"; CHILLS (non-serious) with onset 23Dec2021, outcome "not recovered", described as "chills"; PYREXIA (non-serious) with onset 23Dec2021, outcome "not recovered", described as "fever". Therapeutic measures were not taken as a result of vaccination site swelling, vaccination site warmth, chills, pyrexia.  Additional information:Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. List of any other medications the patient received within 2 weeks of vaccination: N/A. Since the vaccination, has the patient been tested for COVID-19?: No. known allergies: NKA. other medical history: N/A  No follow-up attempts are possible. No further information is expected.
redness; itchy; losing skin; This case was reported by a consumer via call center representative and described the occurrence of skin loss in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th June 2019, the patient received the 2nd dose of Shingrix. On 12th June 2019, less than a day after receiving Shingrix, the patient experienced skin loss, injection site erythema and pruritus. On an unknown date, the outcome of the skin loss, injection site erythema and pruritus were unknown.   It was unknown if the reporter considered the skin loss and pruritus to be related to Shingrix. The reporter considered the injection site erythema to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's husband for his wife. The age at vaccination was not reported. Around the same time of receiving vaccine, the patient started to loose skin on the palms of her hands and on her toes and both became very itchy.  She also experienced redness at the site of the injection. When the patient's husband realized that the caller could not provide medical advice, he ended the call, hence limited information was available.
As patient was exiting the office after receiving the immunizations, he reported feeling dizzy and like he was having difficulty seeing and walking. Patient was brought back to the exam room where he was able to lay down. Vital signs were monitored and patient was given juice. After resting for several minutes, patient was able to walk and vision returned to normal. Physician determined that this was an episode of vasovagal syncope. Patient was able to return home in the care of his mother.
VACCINE GIVEN 19 DAYS AFTER BEYOND USE DATE. NO REACTIONS OCCURED.
Expired Twinrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 63-year-old female patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 1st January 2023) 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.   On 12th January 2023, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 12th January 2023, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 Information: GSK receipt date: 12-Jan-2023 Reporter's comment: The information with regards to the patient and vaccine was given. The reporter did not wish to have specific information registered in the database, but did approve to have an e-mail address saved. The vaccine administration facility was the same as primary reporter. The e-mail address was saved in the call details information. The reporter consented to follow-up. Additional supportive information: The patient was given an expired dose off Twinrix, which led to expired vaccine used. Based upon the reported information, facility type was captured as pharmacy.
Aching joints, fatigue, flu-like symptoms, muscle tremors, sweats w/o physical activity, bi-lateral foot pain, regularly every morning.
recently experiencing severe malaise; fatigue; confusion; cough; This is a spontaneous report received from contactable Other HCP from a Pfizer Sponsored Program with Regulatory Authority support. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: not reported), via an unspecified route of administration on 24Mar2021 as Dose 1, Single for Covid-19 immunisation. The patient medical history and concomitant medications was not reported. On unspecified date in Mar2021, the patient experienced severe malaise, fatigue, confusion and cough. It was reported that Caller (MS), was calling on behalf of their patient who got the first dose. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.