chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) had resolved.     No concomitant medication information was reported. No treatment medication information was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Pt was to receive Pfizer vaccine. Had multiple doses of Moderna available on table and a single Pfizer dose.  Proceeded to administer Moderna dose into the left arm of Pt around 1030. Pt was informed directly afterward, and was given appointment 1 week from March 2, 2021 to receive 2nd Pfizer dose.
Shortly after the vaccine I noticed a rapid heartbeat then vomiting, diarrhea then fever and weakness.
Inflammation, redness, temperature change at site x72+hrs.  Affected area was from R shoulder to elbow
General feelings of malaise and spent a day in bed; Patient had taken 3rd dose of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (General feelings of malaise and spent a day in bed) and EXTRA DOSE ADMINISTERED (Patient had taken 3rd dose of the vaccine) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 054C21A) for COVID-19 vaccination. No Medical History information was reported. On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (General feelings of malaise and spent a day in bed) and EXTRA DOSE ADMINISTERED (Patient had taken 3rd dose of the vaccine). At the time of the report, MALAISE (General feelings of malaise and spent a day in bed) outcome was unknown and EXTRA DOSE ADMINISTERED (Patient had taken 3rd dose of the vaccine) had resolved. No concomitant medications are reported by reporter. No treatment medications are reported by reporter. This case was linked to MOD-2021-290368.
24 HOURS AFTER VACCINE PATIENT REPORTS HAVING FLU LIKE SYMPTOMS IN ADDITION TO INJECTION SITE PAIN AND SWELLING. FLU-LIKE SYMPTOMS CONTINUED UNTIL PATIENT BECAME REALLY NAUSEOUS, WHILE VOMITING (OR SHORTLY AFTER) PATIENT EXPERIENCED A SEIZURE AND FAMILY MEMBERS CALLED 911. PATIENT RECEIVED A CT SCAN WHILE IN THE HOSPITAL TO RULE OUT CONCUSSION OR BLEEDING ON THE BRAIN. AS OF TODAY PATIENT IS FEELING BETTER, BUT STILL HAS INJECTION SITE PAIN.
On the 8th day developed 2 enlarged, hardened red bumps that became very itchy at the injection site on left arm. Also developed hives on back and backside. Unsure if it was related to vaccine.
Around 12 hours after the second dose of the Moderna COVID vaccine I experienced the expected severe fever, chills, and rigors.  This eventually subsided to a large extent by hour 30; however at hour 36 I slightly bent over to pick up an item from my nightstand and felt what seemed to be a pulled muscle in my left back.  I immediately went to bed and awoke with severe muscle spasms in that same area.  The muscle spasms continued lying, standing, and sitting.  Nothing relieved them and they were intermittent brought on spontaneously and also by movement.  I could not perform most daily functions and sought medical attention at the local urgent care.  There they diagnosed it as a thoracic myofascial strain.  They prescribed me cyclobenzaprine which helped decrease the frequency but not completely alleviate the spasms.
Breakthrough infection. COVID positive PCR on 4-8-2021. Symptomatic since 4-4-2021
Pfizer-BioNTech COVID-19 Vaccine EUA within 5-30 minutes: dizziness, weakness, palpitations, chest tightness, injection site pain, left arm numbness and weakness, headache, nape pain, drop in BP, high BP, left shoulder and elbow joint feeling like to be detached. Sent to Hospital ER, was given Zofran and Ativan
I had chills, low grade fever, headache, congestion, scratchy throat. I started PAXLOVID on the 17th and felt much better after that. The symptoms lasted about 5 days and they were moderate.
A non-serious spontaneous report of we administered expired FLUMIST was received from a health professional concerning an eight-year-old male patient. Neither medical history nor concomitant medications have been reported. The product expired on 20-Feb-2010. The patient received the expired FLUMIST on 22-Feb-2010. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was received on 08-Jun-2011 and incorporated into the narrative: The patient did not have any late occurring adverse events.
Pt stated that a couple hours after getting vaccine right arm became swollen and tender. She also stated fever and chills. Pt took TYLENOL. Pt called back next day to complain of symptoms. She said swelling subsided some but still painful. i instructed her to try ice pack on arm, BENADRYL, and ibuprofen, and call doctor. Called pt back in few hours. Pt stated she took ibuprofen and took a nap. She woke up and said the ibuprofen seemed to help with pain but still felt feverish. Pt was instructed to try ice pack and BENADRYL again and to notify doctor.
Initial information received on 13-Sep-2018 regarding an unsolicited valid non-serious case received from an Non-Health Professional. This case is linked to case 2018SA261690 (same reporter). This case involves an 11 years old patient he/she received vaccine FLUBLOK QIV. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MENACTRA for Immunization. On 23-Aug-2018, the patient received a dose of suspect Influenza Quadrivalent Recombinant Vaccine, lot 2FAA1802 via unknown route in the right deltoid. It was a case of actual medication error due to inappropriate age at vaccination as 11 year old patient received FLUBLOK QIV. It was not reported if any adverse event was occurred or not. 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 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. List of documents held by sender: none.
This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 18-NOV-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported, lot # L008684, expiration date: 13-MAR-2017) (incorrect product storage). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Chills, body aches, sweating, joint pain, dizziness, and fatigue.
The patient had transient, cutaneous numbness, right side of face, on right side of nose, right cheekbone, and right upper lip; lasting approximately 2 minutes then resolving. It happened on 11/20/00 and on 11/21/00. No pain, headache, or swelling noted.
This medically confirmed spontaneous report (initial receipt: 19-Oct-2012) concerns a male patient, who received an unspecified flu vaccine (manufacturer, brand name and batch number were not provided) on an unspecified date and developed an unspecified allergic reaction. The event outcome was not reported.
Information has been received from a healthcare worker (operations manager) referring to unknown number of patients. On unknown dates, the patients were administered improperly stored RECOMBIVAX HB lot # K010535, expiry date: 27-AUG-2016, (route, dose and frequency were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient received monovalent Pfizer instead of bivalent Pfizer. No adverse side effects to report at this time.
pt had a baseball size rash on her arm where the injection was. I told pt that this does happen and to monitor it. It is not getting worse and will call us if it does. pt did not have any reactions to first three shots
Initial report received on 13 February 2008 from a health care provider.  A 49-year-old male patient with a medical history of hypertension, bipolar, and thyroid hormone replacement had received a first dose intramuscular left deltoid injection of IMOVAX RABIES vaccine, lot number A0257-2 on 31 January 2008 and four days later developed a rash on the left side of his thorax.  It was described as a "classic shingles outbreak of vesicles along dermatomal distribution over left ribs (9th or 10th rib) in a narrow band".  The patient had been taking SYNTHROID, lisinopril and PROZAC concomitantly at the time of vaccination and had a history of allergy to DEMEROL.  No other vaccines were received during the four week period prior to receipt of IMOVAX RABIES vaccination.  The patient's recovery status was unknown at the time of the report.
The  patient received a third Pfizer booster dose (first dose received 5/11/21, second dose (6/2/21), third dose (12/23/21). This dose was not indicated due to their age at the time of administration (15 years of age).
Experienced extreme fatigue, pain, headaches, fever due to both vaccines at the same time. Informed PCP.
Right upper arm swollen, redened, warm to touch, tender, muscle tight- referred to family MD for evaluation.
Moderna COVID-19 Vaccine EUA Covid Arm - Red patch that got larger, was hot to the touch as well as sore and swollen. Treated at home with cortisone creme and ice packs.
This report describes a red rash in a 30 to 35 y.o. female who received an injection of Havrix. Medical history and concurrent conditions were not specified. There were no concurrent medications. The vaccinee had no adverse experiences following receipt of prior immunizations. On 2/18/02, the vaccinee received her 2nd injection of Havrix. On 2/20/02, 2 days post-vax, she experienced a red rash on her neck and both arms. The vaccinee was treated w/50 mg diphenhydramine hydrochloride (Benadryl) and the event resolved on 2/23/02. The Havrix immunization series was discontinued.
nerve pain; This spontaneous report was received from a consumer of unknown age and gender referring to itself via social media. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On an unknown date, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (dose, route of administration, lot number and expiration date not reported) and in April 2021, received covid-19 vaccine(COVID-19 VACCINE) (dose, route of administration, lot number and expiration date not reported) both fro prophylaxis.      On an unknown date in 2021, the patient experienced nerve pain (neuralgia).      The outcome of neuralgia was reported as ongoing. The causal relationship between neuralgia and the vaccines was not reported.
I contracted COVID-19 with symptoms of severe sore throat, fever, congestion, headache, fatigue and cough. I was pain free except for just my COVID-19 symptoms, and once my symptoms resolved the arthritic pain returned. I was ill for 3 days before my symptoms began to resolve. I am fully recovered but did experience lingering fatigue for 2 additional weeks.
herpes zoster; Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On or about on 27-OCT-2007, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions.    On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a physician. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.    The outcome of the event herpes zoster was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).    Additional information has been requested.
Tiny soreness at injection site; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a 69-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox (had chicken pox as a child).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced injection site pain (Verbatim: Tiny soreness at injection site). The outcome of the injection site pain was resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.     It was unknown if the company considered the injection site pain to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR050560   Additional Information: GSK Receipt date: 16-MAR-2023 This case was reported by a patient via interactive digital media. The patient got both shots and had absolutely no side effects at all, may be some tiny soreness at injection site, perfectly fine. The patient would be 70 this year, and had chicken pox as a child. The follow-up could not be possible as no contact details were available. Note: As in narrative it was not clear after which dose event occur hence only one case retain without dose number.; Sender's Comments:  US-GSK-US2023AMR050560:Same patient (2nd dose)
ACUTE RESPIRATORY FAILURE 10/25/2021 MYCOBACTERIUM AVIUM COMPLEX  ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 10/23/2021 MYCOBACTERIUM AVIUM COMPLEX  ACUTE RESPIRATORY FAILURE 10/25/2021 ACUTE RESPIRATORY FAILURE  ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 10/23/2021 ACUTE RESPIRATORY FAILURE
Symptoms - ? at time of vaccine, pain at injection site, worsening overnight.  EE reports arm as feeling heavy.  EE reports unable to sleep over night and tossed and turned.  EE reports feeling chilled this am and took temperature.  Tmax 102.2 taken at 08:45.  EE reports + runny nose and congestion. EE denies travel and COVID-19 exposure without proper PPE.  Home remedies? -   motrin 600 mg at 08:55  Any improvement? ? none at this time  Recommendation?  After completely algorithm, EE meets criteria to be COVID tested and removed from work at this time.  EE provided with EH command center and instructions to notify them need for COVID-19 testing.  EE educated to notify his manager.  EE verbalized back understanding and denied further questions at this time.
COVID arm 7 days. Arm area by injection easily 1/3 bigger, swollen. Area is red with rash, burns and itches. Site has been very sore since injection
Breathing problems- sent to hospital a few times; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient. A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 15May2021 10:00 (Batch/Lot number: unknown) at the age of 57 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. No known allergies. No covid prior vaccination. No covid tested post vaccination. There were no concomitant medications (No other vaccine in four weeks, no other medications in two weeks). Vaccination history included: Bnt162b2 (Dose 1, in left arm), administration date and time: 24Apr2021 10:00 AM, when the patient was 54 years old, for Covid-19 immunization. The following information was reported: DYSPNOEA (hospitalization, life threatening) with onset 16May2021 12:00, outcome "not recovered", described as "Breathing problems- sent to hospital a few times". The patient was hospitalized for dyspnoea (hospitalization duration: 1 day(s)). The event "breathing problems- sent to hospital a few times" was evaluated at the physician office visit and emergency room visit. Therapeutic measures were not taken as a result of dyspnoea.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Mom reports child c/o left leg pain about 3 hours after injection. She gave TYLENOL at bedtime. Child was bearing weight and ambulating. Woke up this am (3/2) c/o increased leg pain. Wouldn't & couldn't stand or bear wt. MD exam 3/2 am 8cm firmness at site, not red. Blanches well. Still refuses or wont stand or walk 3/2/11 at 2pm.
Headache, Myalgia, Pain/Discomfort at injection site, fatigue Narrative:
Fever (37.8), Vomiting and diarrheas, site of administration became red , hot and hard and patient developed a cellulitis in the right arm.
Patient came to ED complaining of sore throat, cough, weakness, chest tightness, and shortness of breath.  Patient admitted for Covid and  significant macrocytic anemia.
This spontaneous report as received from a healthcare student refers to a patient of unknown age and gender. On 13-AUG-2014 the patient was vaccinated with the first dose of GARDASIL (dose, lot #, route and application site not reported). On 05-JAN-2015 the patient was vaccinated with the second dose of GARDASIL (dose, lot #, route and application site not reported). No adverse events were reported. The outcome of event was unknown. Additional information has been requested.
High fever of 102. Chills, nausea, entire body ache. Arm sore for 3 days, shooting pains for 1 day.
1.  A month following vaccination #4, soreness and swelling at vaccination site on left arm.  Still experiencing these symptoms on 5/6/22. No treatment received as of 5/6/22 2.  Recently Diagnosed with Osteoporosis.  Prescribed Evista.  Have not started to take yet.  Unsure if this is related to the series of COVID 19 Moderna vaccines received. 3.  As of 4/18/22 LDL and TSH are elevated.  T4 Free is low.  Prescribed increase in Armour Thyroid Med.  Unsure if this is related to the series of COVID 19 Moderna vaccines received.
pt recv vax AUG95 & on 9NOV96 pt presented to MD office w/vesicles;nurse noted it was a mild case;
Case number of PHEH2013US022972 is an initial spontaneous report from the nurse received on 30 Oct 2013. This report refers to a 25-year-old female nurse. On 30 Oct 2013, during reconstitution of the vaccine MENVEO (batch number: X11081), the needle got detached from the syringe and the vaccine just squirted up straight from the syringe into the eyes of the nurse. No adverse event reported. The vaccine was discarded and no patient was involved. No other information was available.
The patient came in for the Moderna Spikevax +12 vaccine and was asked to wait in the waiting room for 15 after the injection. The patient left without adverse event. The patient returned to the clini at 6 PM 11/14/2023 with four red whelps bilaterally under her chin; she denied itching or shortness of breath. The patient stated that she took benadryl at home. The patient was instructed to go the the emergency room if her symptoms worsened, or if she became short of breath. The patient left the clinic in no distress. The patient was called vis the phone 11/15/2023 at 8:40 AM and reported that her symptoms resolved withiin an hour of taking Benadryl; she voiced no other complaints.
Pt recvd 2 doses of Hep B vax on 19JUN90 & 23JUL90 & 1 hr following 2nd vax pt exp numbness & tingling in upper lt arm, elbow, fingers & palm; Also exp pain & stiffness in neck; w/in 4 hrs of onset sx resolved;
This is a spontaneous report from a contactable nurse received via a sales representative. A 8-month-old male patient of an unspecified race/ethnicity was fully vaccinated with PREVNAR 13 on unspecified date(s), at single dose(s), for immunisation. The reporter stated the patient was sick but did not provide further details. Concomitant medications were not reported.  The patient died on an unspecified date in 2017 from pneumonia which developed on an unspecified date, after being fully vaccinated up to 8 months. Clinical course of event included the following information: the patient was sick and he had gone to the hospital. He first came to the doctor's office who sent him to the hospital for an X-ray. He was sent home, then he went to see the doctor for follow-up and he was blue, he could not breathe. He went back to the hospital and died that night. It was not reported if an autopsy was performed. Sero-grouping test to confirm the strain was performed on an unknown date (pending result).; Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded.  Further information like confirmative pathological/serotype results and vaccination schedule are needed for full medical assessment.  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.; Reported Cause(s) of Death: died from pneumonia and was fully vaccinated up to 8 months; died from pneumonia and was fully vaccinated up to 8 months.
I ADMINISTERED A FLUMIST ON 03/20/2023 THAT EXPIRED ON 03/15/2023.  NO ADVERSE REACTION OCCURRED.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. In approximately 2016 (reported as on or after 23-APR-2016), the patients were vaccinated with improperly stored doses of GARDASIL lot # reported as L044475, expiration date reported as 12-MAY-2017, lot # reported as M003659, expiration date reported as 20-SEP-2017 (dose, route and site of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of 34.8 degrees Fahrenheit for 6 hours 43 minutes and 53.2 degrees Fahrenheit for 8 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.