chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recvd flu vax on 14OCT91 & 2 wks later (about the end of OCtober) pt devel a fever of unk origin accompanied by myalgias, joint swelling & neck stiffness; pt was hospitalized & had an extensive workup w/neg temporal artery biopsy;
This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in female patient who received FLULAVAL QUADRIVALENT. On an unknown date, the patient received FLULAVAL QUADRIVALENT. On an unknown date, unknown after receiving FLULAVAL QUADRIVALENT, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: The age at the vaccination was not reported. The reporter collected adverse event report. The clinic manager asked the patient (staff member) what was experience with FLULAVAL immunization and the patient stated arm hurt for days following administration. The other reporter thought it was related to shot but one other patient commented that they thought administration technique of immunizer may have contributed. None of the immunizations led to hospitalization. This case has been linked to case US2017GSK183784 and US2017GSK182496, reported by same reporter for same event.
Seemingly neurological symptom, I completely blanked out on a finding a word on a couple of occasions. It's not like a "tip of the tongue" type of thing, I just knew the word that I wanted to say I just drew a complete blank for a few seconds
Pt felt tingling and numbness in left jaw and ear area. A few minutes later, she felt it spread to her nose and other ear/jaw area. Then she experienced tongue heaviness and tingling. She was transported to the ED for further evaluation.
PT stated he fainted after the first dose of Pfizer, after administering I verified the PT felt okay, and followed him to post-vaccination chairs.  Asked him to stay for 15 minutes.  I administered another vaccine to another person, and then I was notified this patient had fainted.  He was lying on the floor, was unconscious for less than 5 minutes, we called 911 , the EMT's arrived, had him sit in a chair- he then fainted again after about 5 minutes of sitting up.
Symptoms included headache, achiness, fatigue, soreness to left arm, fever. Symptoms lasted for approx. 36 hours.
Sunday morning he was very tired with his sore arm. Patient started to have pain on both sides of his chest around the lung area, he went to work and was sent home due to pain. Patient still has pain on his sides and it hurts when he turns to either side in bed.
3 MONTHS AFTER VACCINE PATIENT EXPERIENCED TINGLING/NUMBNESS ON LEFT ARM (WHERE THE SHOT WAS GIVEN) THEN AFTER A YEAR IT SPREAD TO HIPS AND RIGHT ARM. STATES ALSO TO HAVE PAIN IN BOTH RIGHT AND LEFT ARM AS WELL AS HIPS WORST AT NIGHT. PATIENT IS OVERALL HEALTHY, DOES NOT HAVE ANY UNDERLYING CONDITIONS AND TAKES NO MEDICINE. TAKES ALEVE BUT STATES THAT DOES NOT WORK.
Was given the flu shot on 9-24-10. I don't know the name of the person who gave me the shot, but she hurt me like hell. I never experience that before getting the flu shot. As of today I still feel pain in my arm & where she gave me the shot. I don't have a physician to go to.
Patient thought he sat in chair in observation area but he fell on the ground and began to seize. Multiple nurses and EMTs responded and found the patient in tonic-clonic seizure. Pt continued to seize for about 10 seconds and upon exiting the seizure he reported that this happened about 4 years ago The patient repeatedly declined to be transported to the hospital.. He was incontinent and finally he agreed to be transported to a nearby hospital to be checked out.
Information has been received from a physician concerning a male patient who on 03-MAY-2007 was vaccinated with a dose of ProQuad (Lot # 657190/0349U). It was reported that the patient developed redness, swelling, tenderness and induration at injection site on an unspecified date after vaccination, approximately May 2007. Additional information has been requested. This is one of several reports received from the same source.
No adverse event; HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) and NO ADVERSE EVENT (No adverse event) in a 49-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7664B) for COVID-19 prophylaxis.     No Medical History information was reported.    In August 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In August 2023, the patient experienced ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage).    Concomitant medications were not reported.  They accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage. No adverse event was reported for any of the patients.  Treatment medications were not reported.  This case contains information for patient 10 out of 25.   This case was linked to US-MODERNATX, INC.-MOD-2023-738766 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2023: Live significant follow-up received contains patient age, initials, gender and new references added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-738766:Patient 1 (Master Case)
Extreme fatigue and muscle cramps in legs, back and neck. Loss of appetite for 48 hours. Mild fever. Swelling and rash at injection site.
I woke with severe needle-like stabbing pain and heat sensation in both feet; moving in my legs and same sensation in finger tips. I went to medical facility and was given Toradal and  Magnesium in IV. After an hour, the pain did not subside; so I was given Tramadol and Gabapentin by pill. I was prescribed 50mg Tramadol, 1% Diclofenac Sodium; 100mg Gabapentin; 500mg Naproxen; 4mg methylPRENISolone Oral Dose pack.
Received allergy immunotherapy on 1/21/21 and had itching, difficulty breathing, tightness in throat/chest, flushed skin and tachycardia after.  Received Antihistamines, Albuterol treatment and steroid for treatment.
Cold sweat; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (Cold sweat) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe ).   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced COLD SWEAT (Cold sweat). At the time of the report, COLD SWEAT (Cold sweat) had resolved.            No relevant concomitant medications were reported. No treatment medication reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of second vaccine caused cold sweats for 2 hours with Humira was not provided.  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.   This case was linked to MOD-2022-620607 (Patient Link).
CLIENT GIVEN FIRST DOSE OF HEPATITIS A UNEVENTFULLY AROUND 10:20. CLIENT CALLED CLINIC AROUND 1520 COMPLAINING OF HAVING HIVES ALL OVER HER BODY WHEN SHE RETURNED HOME. INSTRUCTED TO TAKE BENADRYL, CALL PCP FOR FURTHER RECOMMENDATIONS, AND GO TO ER IF SYMPTOMS PROGRESS OF INVOLVE THE RESPIRTORY SYSTEM. F/U PC MADE 9/9/19 CLIENT REPORTS DID F/U WITH PCP VIA PC. NO FURTHER RECOMMENDATIONS WERE MADE. CLIENT WAS USING BENADRYL PO & TOPICALLY FOR 36 HOURS. REPORTS HIVES ARE STILL PRESENT BUT HAVE DECREASED IN SIZE AND SEVERITY. GIVEN CLINIC PH # TO CALL IF HAS FURTHER ?S OR CONCERNS.
There was no adverse reaction.  Reporting medication error.  Moderna bivalent booster was given to a 5 yr 10 month old.
This spontaneous report was received from a physician regarding a 67 year male patient. The patient had no pertinent medical history and drug reactions or allergies. On an unknown date in May 2016, the patient was vaccinated with ZOSTAVAX (dosing details, lot#, expiry date and route of administration not known). Concomitant therapies included CRESTOR. On an unknown date in 2016 reported as "2.5 weeks"  after receiving ZOSTAVAX, the patient developed "joint pains in the upper torso which has spread distally". On an unknown date in July 2016, the patient was seen by an unspecified rheumatologist due to the "joint pains" and had multiple unspecified laboratory studies performed which showed "Antinuclear Antibodies (ANA) was negative, Rheumatoid Factor(RF) was negative and negative antibodies". Also in July 2016, the patient was seen by an unspecified hematologist due to the "joint pains" and had an unspecified "workup" performed which showed "mono gammopathy of unknown significance". The patient was seen by his unspecified primary care provider as well due to the "joint pains" (on unspecified date, approximated to 2016). The patient was given with "multiple rounds" of unspecified steroids PLAQUENIL as treatment for the adverse reactions reported above (on unspecified date). On an unspecified date in 2016, the patient has "an increase in c-reactive protein" after receiving ZOSTAVAX. The outcome of the events were reported as not recovered/not resolved. Causality assessment was not provided. There was no product quality complaint (PQC) involved. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Lot number: ER8732), in left arm, on 16Apr2021 as dose 2, single (Lot number: EL9261), in left arm, on 18Aug2021 as dose 3 (booster), single (Lot number: FA6780), in right arm and on 19Apr2022 as dose 4 (booster), single (Lot number: 9729) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's Thyroiditis" (unspecified if ongoing); "Sjogren's Syndrome" (unspecified if ongoing); "Inflammatory Arthritis" (unspecified if ongoing); "Depression" (unspecified if ongoing). Concomitant medication(s) included: HYDROXYCHLOROQUINE, start date: 04Jan2011, stop date: 17Jun2022; LEVOTHYROXINE, start date: 06Oct2016, stop date: 17Jun2022; FLUOXETINE, start date: 10Feb1997, stop date: 17Jun2022.  The following information was reported: VACCINATION FAILURE (medically significant) with onset Jun2022, outcome "unknown", COVID-19 (medically significant) with onset Jun2022, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19  Clinical course: The patient received Anti-viral Product for COVID 19 Treatment, Brand: Paxlovid, treatment Start Date: 07Jun2022, treatment Stop Date: 11Jun2022, Lot number: GA9630.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 31-Jan-2021, PAIN IN EXTREMITY (sore arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.   Treatment information include 'rubbed hand with alcohol'.   Reporter did not allow further contact
left sided facial droop consistent with Bell's palsy; This is a spontaneous report from a contactable Physician. A 66-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not provided), intramuscularly on 22Jan2021 at single dose for COVID-19 immunization. Medical history included acral lentiginous melanoma (ALM), myelodysplastic syndrome (MDS), hypertension (HTN), atrial fibrillation, left sided facial and ear pain. The patient's concomitant medications were not reported.  The patient previously took codeine and experienced drug allergy. It was reported that the patient was evaluated in the emergency department on 06Feb2021 for left sided facial droop consistent with Bell's palsy which started from 06Feb2021. The patient was complaining of left sided facial and ear pain for several weeks prior to vaccination and development of Bell's palsy. The reported event Bell's palsy resulted in Emergency room/department or urgent care. Therapeutic measures Valtrex, prednisone were taken as a result of the reported event Bell's palsy. The outcome of the event Bell's palsy was unknown.  Information on Lot/Batch has been requested.; Sender's Comments: Event represents an intercurrent medical condition and unrelated to BNT162B2. The patient experienced  left sided facial and ear pain before receiving vaccination.  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.
Patient came in today (7/30/21) and requested for a Pfizer COVID vaccine. Patient marked she has not received any other COVID vaccines on her consent form. Counseled and confirmed with patient that this Pfizer shot would be her first COVID vaccine while inside the immunization room prior to giving the shot. When the vaccine was processed later in the day, there was a rejection from the insurance stating patient already received a COVID vaccine by a different manufacturer. It was checked and patient received Janssen (J&J) on 03/07/21. Called patient, no answer, left VM for patient to call back the pharmacy. Has cancelled patient's 2nd dose appointment.
pt recvd vax & devel leg pain & felt bad; also states pain severe in back & leg; also devel joint pain in lt fingers of migratory nature; blood test showed low pos ANA test for lupus; further testing revealed didn't have disease; depression
pt recv vax 23JUN95 & 8AUG96 pt devel a mild, typical case of breakthrough chickenpox w/more than 50 lesions;no scarring was noted;
Mild headache, muscle soreness, big red welt over injection site, itchy, swollen and painful
mild headache; mild bodyache; This is a spontaneous report from a non-contactable consumer (patient). A 40-year-old female patient received BNT162B2 (Solution for injection, Batch/Lot: unknown) via an unspecified route of administration on 03Feb2021 at single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's medical history and concomitant medications was not reported. Patient did not had Covid prior vaccination. Patient was not tested for Covid tested post vaccination. The patient experienced mild headache, mild body ache on 03Feb2021. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PVCs, tachycardia from 6:30pm to 12:00am. Took diphenhydramine, omeprazole, acetaminophen at 8:30pm. Went to sleep at 11:30. Heart rate normalized. PVCs continued. All symptoms resolved by 4am on 12/18/20.
pt recv vax 28AUG96 & on 17DEC96 pt devel a full case of chickenpox consisting of a rash composed of raised red papules that were fluid-filled on extremities & back;
Very large reaction on R arm. Shot (DTaP) administered IM and has very large welt (red-hot spot) on site where shot given. No fever, pain. No abnormalities noted by parent.
Severe bruising still visible after 2 weeks of receiving vaccine.; This is a spontaneous report from a non-contactable consumer, the patient. A 69-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Apr2021 at 15:45 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to sulfa and back pain. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included naproxen sodium (ALEVE), for relieve back pain from an unknown date and unknown if ongoing. The patient previously received codeine (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. On 03Apr2021, the patient experienced severe bruising still visible after 2 weeks of receiving vaccine. The patient reported that she typically never bruises. It was reported that it was maybe due to taking Aleve 200 mg, prior to relieve back pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event severe bruising was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
BILATERAL LEG SWELLING; FEELING HOT; SWEATY; RANDOM CHEST PAIN; BILATERAL LEG PAIN; WEAKNESS; NAUSEA; This spontaneous report received from a patient concerned a 27 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was not pregnant at the time of reporting. Patient had no known allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 29-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-AUG-2021, the patient experienced bilateral leg swelling. On 29-AUG-2021, the patient experienced feeling hot. On 29-AUG-2021, the patient experienced sweaty. On 29-AUG-2021, the patient experienced random chest pain. On 29-AUG-2021, the patient experienced bilateral leg pain. On 29-AUG-2021, the patient experienced weakness. On 29-AUG-2021, the patient experienced nausea. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from bilateral leg pain, bilateral leg swelling, feeling hot, sweaty, nausea, weakness, and random chest pain. This report was non-serious.
she got tested positive for Covid; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. This consumer reported similar events for 2 patients. This is the 1st of 2 reports. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported) via an unknown route of administration on 07Apr2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 16Apr2021, she got tested positive for covid. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 16Apr2021. She wanted to ask that what would happen and should she receive the second dose of the vaccine. The outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021438248 same reporter/drug/event, different patient
Within a few days after the vaccine my arm really hurt. I had RSV with influenza after receiving the vaccine, and I also have heart failure problems and was admitted into the hospital for 3 days due to having RSV and influenza at the same time.They did blood work and chest x-rays, as well as a COVID test, just to make sure everything was okay.
Body ache; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body ache) and PYREXIA (fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN (Body ache) and PYREXIA (fever). At the time of the report, PAIN (Body ache) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, Body temperature: 104f (Inconclusive) 104F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications was reported Treatment information was not provided
Case number PHEH2013US014623, is an initial spontaneous report received from a pharmacist on 03 Jul 2013: This case refers to a male patient of unspecified age. He was vaccinated with expired MENVEO (batch number: A10051 and expiry date: Jan 2013), intramuscularly on 03 Jul 2013. No adverse reaction was reported following this administration error.
Six days after Td vaccine, complained of redness, swelling, itching and discomfort (not severe) injection site about 3" long and narrow redness and approximate .5" from this, redness and swelling extending 6" around arm 2.5-3" wide. Advised follow up with doctor for evaluation.
Fever of 102.4, treated with Acetaminophen resolved after 18 hours. Development of cold sore on Dec 4, 7am, treated with acyclovir.
Patient was sitting in high chair, suddenly slumped over and had onset of full body convulsion and syanosis, family thought she was choking and gave several back blows, EMS was called and she was taken to ER, where she had a fever of 38.4C.  All testing was negative.