chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received dose from expired vial; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dose from expired vial) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose from expired vial). In November 2021, EXPIRED PRODUCT ADMINISTERED (Received dose from expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was opened on Sunday 14-Nov-2021. Vial did not undergo temperature excursions. Dates of administration of vaccine: 14-Nov-2021 6 doses and 15-Nov-2021 6 doses. Total 13 patients who received expired vaccines.  No concomitant medication was provided.  No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: Follow up received Includes additional information - total number of patient received expired vaccine was updated to 13 (previously 12). On 23-Nov-2021: Follow up received contains Non Significant Information
Fever three days Muscle aches three days Tachycardia continues till this date Headache two days
Pt recvd 3 doses of Engerix-B & 13AUg91 lab test indicated nonreactive for HBSAG & HBSAB;
Patient stated she didn't feel good; she had extreme joint pain; flu like symptoms that lasted for 36 hours; Patient stated she had extreme abdominal pain down to the top of her knee.; Patient expressed that she could not get out of bed because of pain; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms that lasted for 36 hours), ABDOMINAL PAIN (Patient stated she had extreme abdominal pain down to the top of her knee.), BED REST (Patient expressed that she could not get out of bed because of pain), FEELING ABNORMAL (Patient stated she didn't feel good) and ARTHRALGIA (she had extreme joint pain) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B121A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DEXTROPROPOXYPHENE HYDROCHLORIDE, PARACETAMOL (PAXALGESIC) for an unknown indication.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms that lasted for 36 hours), ABDOMINAL PAIN (Patient stated she had extreme abdominal pain down to the top of her knee.), BED REST (Patient expressed that she could not get out of bed because of pain) and ARTHRALGIA (she had extreme joint pain). On 04-May-2021, the patient experienced FEELING ABNORMAL (Patient stated she didn't feel good). At the time of the report, ABDOMINAL PAIN (Patient stated she had extreme abdominal pain down to the top of her knee.), BED REST (Patient expressed that she could not get out of bed because of pain), FEELING ABNORMAL (Patient stated she didn't feel good) and ARTHRALGIA (she had extreme joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medications included Colonithin. Treatment information was not provided.
very swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (very swollen arm) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced PERIPHERAL SWELLING (very swollen arm). At the time of the report, PERIPHERAL SWELLING (very swollen arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
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 40-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 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of expired moderna vaccine). On 29-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.   No concomitant medications were reported. No treatment medications were reported.   Expired Vaccine was given as booster shot to 500 people.
needle half way filled; This spontaneous case was reported by a consumer and describes the occurrence of WRONG TECHNIQUE IN DEVICE USAGE PROCESS (needle half way filled) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced WRONG TECHNIQUE IN DEVICE USAGE PROCESS (needle half way filled). At the time of the report, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (needle half way filled) had not resolved. Not Provided
Patient came to see his PCP on 10/22/15 because the right arm where he received a PREVNAR 13 vaccine was red, a little swollen, and warm/hot to the touch per staff at Dr's office.
My arm has been hurting since receiving the vaccination in October. I am experiencing weakness and pain upon movement that seems to be consistently getting worse. The shot was given where I do not have  much muscle. It was not given in the muscle up by my shoulder, but rather nearer to my elbow.  I am quite thin and tall and wore a short sleeved shirt under a thick sweater that day. When I arrived to the nurse, I pushed up my sweater and asked if that was high enough. She said yes. But now that I have had endless pain, I am thinking she gave me the shot too low and missed my muscle.  I am afraid it will continue to worsen.
FAINTING, DIZZINESS 3 MINUTES AFTER THE DOSE WAS GIVEN, SWEATING
History per MOC. My daughter went in for her 4 yo check up and received her 4 yo shots---DTaP, IPV, MMRV. That was 0900. We ran around all day, got home and she went to sleep at 1530 until 1830. Now that she is up her temp is 102.2, nausea with no vomiting, drowsy. She won?t eat, not even her birthday cake from yesterday. I just gave her some Tylenol that she took without a problem. PMH:  chronic kidney disease; chromosome duplication disorder; recent diagnosis of autism.  She is often sick and has been hospitalized several times. Rec that they encourage sips of clear fluids and go to ED. I could well be the vaccinations that caused these symptoms, but with her PMH she may respond differently than other children. Concern esp because she has more than one symptoms. It may be another condition causing the problem. FOC called back 4 hours later---waiting in a very busy ED. He called again on 21 July---they waited 3 hrs and went home, but back to their own pediatrician on the 21st.  She was fine then, negative u/a.
This spontaneous report as received from a physician vie a company representative refers to a 70 year old male patient. The patient had no pertinent medical history, concomitant therapy and drug reactions or allergies. On an unknown date, the patient was vaccinated with PNEUMOVAX23, "one injection", subcutaneous (site of administration, lot # and expiration date were not reported). On an unknown date, the patient experienced unspecified adverse event. Within 24 hours of receiving the injection, the patient developed a fever with a temperature of 102 degrees (exact units not provided). No treatment was given for the adverse events. There were no lab diagnostic studies performed excluding body temperature. The patient sought medial attention by visited doctor's office. The outcome of the events was unknown. The relatedness between the events and PNEUMOVAX23 was not reported. Additional information is not expected, because the reporter did not wish to be contacted.
pt recv vax 28SEP95 & 27JUL97 pt exp chickenpox w/less than 20 vesicles;A visit to MD was required;pt devel a second coxsackie-like rash while chickenpox were drying  up;pt recovered from sx;
This spontaneous report as received from a consumer refers to a 61 years old female patient with arthritis, allergic to penicillin and allergic to CIPRO. The patient was vaccinated with one dose of ZOSTAVAX (lot number, dose and injection site were not reported) subcutaneous on 23-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. On 03-SEP-2012 the patient experienced pain in her finger joints. There was no treatment given for the adverse event. There was no laboratory diagnostics study performed. The outcome was unknown at the time of report. The patient did not seek medical attention. Additional information is not expected.
Patient reported dizziness. Pt was asked to sit down and provided with cup of water.  Pt states symptoms resolved after about 7 minutes.
mom stated pt awoke 2AM making funny noise; stated felt hot to the touch, that had about 5 mins of twitching of facial muscles & arms; eyes also appeared dilated; given APAP & sponged w/cool water; asymptomatic until 10AM;sz activity
Patient states the the morning after she received the Moderna vaccine she woke up with a fever that took two days to control with Tylenol. It's been three days and the patient now has diarrhea and nausea. Patient states she is very lethargic and the injection site is still swollen.
Hospitalization: 9/9/2022 - 9/17/2022. Presentation to the ED: encephalopathy status post dialysis treatment. COVID-19 + date: 9/9/22. Treatment: Remdesivir. Discharge to: PATIENT LEFT AMA TO HOME UNDER CARE OF ORGANIZED HOME HEALTH SERVICE IN ANTICIPATION OF COVERED SKILLED CARE.
Ipol being administered post excursion with no reported adverse event; 1.8C for 15 minutes due to a refrigerator malfunction with no reported adverse event; Initial information was received on 16-Dec-2022 regarding an unsolicited valid non-serious case received from a physician.  This case involves 4 months old male patient who was administered  ipol  post excursion with no reported adverse event and the vaccine had excursion 1.8c for 15 minutes due to a refrigerator malfunction with no reported adverse event while receiving vaccine IPV (VERO) [Ipol].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (Daptacel) for Immunisation; HIB VACCINE CONJ (TET TOX) (Acthib) for Immunisation; and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (Rotateq) for Immunisation.   On 04-Oct-2022,  the reporter state that the vaccine was 1.8C for 15 minutes due to a refrigerator malfunction (not human error)(product storage error)  On 10-Oct-2022, the patient received a Once total  dose of suspect IPV (VERO) (lot V1B901M  and expiration date: 02-Jun-2024) at a dose of 0.5ml via intramuscular route in the right thigh for immunization.  On 10-Oct-2022, the patient developed a non-serious event of ipol being administered post excursion with no reported adverse event (poor quality product administered)(latency: same day) following the administration of ipv (VERO).  Action taken :not applicable  It was not reported if the patient received a corrective treatment for the events.   Outcome: unknown for both events  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 guidelines. 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.
reaction for 14 days. She went to dermatologists to check about those marks if it's cancerous or something/did a biopsy; she's not feeling well; This is a spontaneous report from a Pfizer Sponsored Program from a contactable consumer (patient).  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Jan2021 at SINGLE DOSE for COVID-19 immunisation. The patient medical history and the concomitant medications were not reported. The patient got her 1st dose of Covid 19 Vaccine on 11Jan2021 and now already experiencing a reaction for 14 days. She went to dermatologists to check about those marks if it's cancerous or something, she was there 4days ago and did a biopsy, then after that Doctor asked if she took the covid 19 vaccine because they knew about it. She wanted to ask as well if it's Okay if she will not take the 2nd dose because she's not feeling well now and can't take it. The outcome was unknown.  Information about Lot/Batch has been requested.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included hip bursitis. On 25th June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient had 1st dose in left arm and he stated sometime after that he noticed pain from his shoulder down to his elbow. He added within the 1st week it was more severe and worse when he attempted to lift objects. He stated his physician referred him to physical therapy for the pain. He noted he had a wellness check visit and mentioned the pain to his physician. He notes the pain was better but he was not back to 100 percent. The reporter gave consent to follow up.
Patient developed bruising over entire body, diagnosed with ITP on 5/19/15 per lab studies.  Followed by Hematology.  Patient had to be seen twice in ED for head injuries, once required a CT scan due to low platelets.  Symptoms resolved completely in 9/2015 without any further sequela.
Seizure; This is a literature report.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, 0.2 ml single (Batch/Lot number: unknown) and as dose 2, 0.2 ml 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: SEIZURE (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: Body temperature: unknown results.  VAERS is a passive vaccine safety surveillance system managed by CDC and FDA that monitors adverse events after vaccination. VAERS accepts reports of postvaccination adverse events from health care providers, vaccine manufacturers, and members of the public. Signs, symptoms, and diagnostic findings in VAERS reports are assigned Medical Dictionary for Regulatory Activities preferred terms (MedDRA PTs) by VAERS staff. Reports of serious events to VAERS were reviewed by CDC and FDA physicians to form a consensus clinical impression based on available data. VAERS reports were described by serious and nonserious status, demographic characteristics, and MedDRA PTs. VAERS is a passive reporting system and is subject to reporting biases and underreporting, especially of nonserious events.  No follow-up attempts are possible; information about the lot number cannot be obtained. No further information is expected.; Sender's Comments: Based on the temporal relationship, the association between the event seizure with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202200058294 Same article/drug, different patient/event;
Pt. received a flu immunization Oct. 4, 2010 - has received every year, also received H1N1 in the past on Oct. 6, 2010 pt. woke up with a sore throat Oct. 7, 2010 fever, - pt is not recovered she has been hospitalized twice (once for 3 days, 2nd time 1 week) had to be transported by ambulance, has had 2 MRI's, 6 CT's Multiple Lab's - 5 and S -> re-occurring fevers, airway obstruction and constriction, shortness of breath, lymph nodes swollen to the size of eggs, a symmetrical tongue swelling, constant sore throat, fatigue, achy, respiratory stridor. Pt. has been to multiple Dr's - immunologist, oncologist, tongue biopsy. Pt. said all the Dr's are stumped - they don't know what is wrong with her or how to help her - she will be going to the clinic in the next month - request by her Dr's. Pt is very concerned as she is not improving, she indicates nothing has changed in her life except the FLUZONE vaccination on Oct. 4, 2010. Pt. indicated it is fine if we need to contact her for hospitalization information or test results. Pt is a paramedic - works in the ER.
Spontaneous blood clots; very swollwn leg; Fever; Chills; leg being lightly swollen; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (Spontaneous blood clots) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included DONEPEZIL HYDROCHLORIDE (ARICEPT), EMPAGLIFLOZIN (JARDIANCE), LEVOTHYROXINE, LISINOPRIL, METFORMIN, PRAVASTATIN, METOPROLOL, ARIPIPRAZOLE (ABILIFY), VENLAFAXINE HYDROCHLORIDE (EFFEXOR), FENTANYL, APIXABAN (ELIQUIS) and TESTOSTERONE for an unknown indication, CEFIXIME (FLEXERIL [CEFIXIME]).   On 24-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced PERIPHERAL SWELLING (leg being lightly swollen), PYREXIA (Fever) and CHILLS (Chills). On 25-Apr-2021, the patient experienced PERIPHERAL SWELLING (very swollwn leg). On an unknown date, the patient experienced THROMBOSIS (Spontaneous blood clots) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Spontaneous blood clots), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown and PERIPHERAL SWELLING (leg being lightly swollen) and PERIPHERAL SWELLING (very swollwn leg) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Ultrasound scan: blood clots blood clots.         On 25-APR-2021, patient experienced a very swollen leg and was scheduled an ultrasound which reveled blood clots on an unspecified date in 2021. No treatment information was provided. Action taken with mRNA-1273 in response to events was not applicable.  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. For the event Thrombosis concomitant medication interactions are a confounder.; 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. For the event Thrombosis concomitant medication interactions are a confounder.
per patient - "08/13/2021 pressure in chest started throwing up and a lot of pressure. a log of sharp pains. went to hospital and was diagnosed as heartattack."
Fever, body (muscle/joint) aches, chills, headache - lasting about 24 hours Weakness - still experiencing at 48 hours
Bruising and swelling at injection site for 1 week headache, nausea, high fever/chills severe joint pain, difficulty walking weakness; symptoms lasted for 4 days. Still some soreness in muscles.
Pt. came pharmacy to show reaction to PREVNAR 13 vaccine given 3/6/17. It appears red around the deltoid area all the way down to elbow and an large circular area. I called his MD and he prescribed 50 mg of BENADRYL x 1 dose and a MEDROL dose pack. Pt. was instructed to call his MD if not better by Wed 3/15/17 in AM.
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 48-year-old female patient who received mRNA-1273 (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        mRNA-1273 (Intramuscular) dosing remained unchanged.
unconsolable crying < 3 hrs, redness @ site; APAP given per protocol p/sx appeared; cool cloth to affected limb; crying stopped approx 430;
Swelling in the neck//shoulder area; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling in the neck//shoulder area) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 SWELLING (Swelling in the neck//shoulder area). At the time of the report, SWELLING (Swelling in the neck//shoulder area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications are provided .  No concomitant medications are provided .   Reporter did not allow further contact
Vaccination site became very swollen, red and itchy like a Mosquito bite.  I complained to doctor during a March 22nd visit and then I got the idea to apply Apple Cider Vinegar.  It made the itching stop within 48 hours and the swelling began to go down as well.
Underaged patient (17 years old) came in to get their 3rd dose (booster shot) of Pfizer Covid-19 vaccination but were given Moderna Covid-19 vaccination instead by mistake. No symptoms or signs of adverse reactions were noted at the time and both the patient and their guardian were informed of the mistake and to contact their prescriber.