chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccination site pain; feverish; fatigue; swollen lymph node in armpit of left arm; This is a spontaneous report from a contactable consumer (Patient).  57-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0179, Expiration date: not reported) via an unspecified route of administration, administered at hospital in Left arm on 11Jun2021at 08:30 (at the age of 57-years-old) as dose 2, single, for covid-19 immunization. The medical history was not reported .There was no known allergies. Concomitant medication(s) included rosuvastatin (ROSUVASTATIN); methimazole (METHIMAZOLE), multivitamins [vitamins nos] (MULTIVITAMINS [VITAMINS NOS]). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE; Lot Number: EW0172, Expiration date: not reported), via an unspecified route of administration in the left arm on 06May2021at12:00 (at the age of 57-years-old) AM as dose 1, single for COVID-19 immunization. On12Jun2021 at 00:30, patient experienced vaccination site pain, feverish, fatigue, swollen lymph node in armpit of left arm. Patient did not receive any treatment. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks. Since the vaccination, the patient had not been tested for COVID-19. The outcome of all events was recovered in Jun2021.  Follow-up attempts are completed. No further information is expected.
I received the flu vaccination at work.  I am a RN and it is required to receive a flu vaccine every year.  This year the nurse that gave my shot, gave it very high.  I thought it was unusual but didn't say anything at the time.  The injection hurt more than usual.  I knew I would be sore the next day, but the pain continued.  I took ibuprofen and that didn't help much.  Everyday I had this ache, and pain in my shoulder with the pain worse when I moved a certain way.  In November I went to see my Orthopedic who did shoulder surgery on my other shoulder.  I was getting ready to go out of town and wanted something for the pain.  He put my on steroids and that helped greatly, taking the pain away.  But as soon as I started tapering off the steroid the pain came back.  Now, two months later I still have pain that is keeping me up at night.  I am unable to move my arm a certain way and do not have full range of motion.  I called my Dr. back and will see what is next.  I am also reporting this to our Occupational Health Department on Monday 12/29/2014.
No additional adverse events; patients received improperly stored vaccines; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions, concomitant therapies, previous drug reactions or allergies were not reported.   On unspecified date since 08-JAN-2020, the patient was vaccinated with an unknown number of doses of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (therapy type: digital data logger) for prophylaxis with lot # S017635 with expiration date reported and established as 12-MAY-2020; and lot # 1658254 with expiration date reported and established as 17-NOV-2020. Both lot numbers provided were verified to be valid for rotavirus vaccine, live, oral, pentavalent. No strength, dose, frequency, or anatomical location was reported.  Temperature excursion (product storage error) was reported as follows: temperature total time and highest temperature was above 47 degrees Fahrenheit / 9 degrees Celsius, (9.1 degrees Celsius); timeframe was 45 minutes with previous temperature excursion of 24 degrees Fahrenheit / -4 degrees Celsius and the number of cycles below 24 degrees Fahrenheit / -4 degrees Celsius (5.2 degrees Celsius) were with a timeframe of 20 minutes, 1 cycle. The product storage error was identified via a data logger. No additional adverse events. No product quality complaint was reported. No further information provided.  This is one of seven reports received from the same reporter.; Sender's Comments:  US-009507513-2001USA009326: US-009507513-2001USA009328: US-009507513-2001USA009325: US-009507513-2001USA009324: US-009507513-2001USA009323: US-009507513-2001USA009327:
hives on hands and feet/hives on knees, behind knees; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives on hands and feet/hives on knees, behind knees) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives on hands and feet/hives on knees, behind knees). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at a dose of 10 milligram and CORTISONE for Adverse event, at a dose of 1% cream. At the time of the report, URTICARIA (hives on hands and feet/hives on knees, behind knees) had not resolved.            Concomitant medications were not reported. Treatment medications  includes Anti histamines.   This case was linked to MOD-2022-476856 (Patient Link).
Injection site reaction: Pain-discomfort. General symptoms: headaches, joint pains, fatigue. Narrative:
patient never returned for their second dose; No adverse event; This spontaneous case was reported by an other health professional and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (patient never returned for their second dose) and NO ADVERSE EVENT (No adverse event) 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 31-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (patient never returned for their second dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (patient never returned for their second dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (patient never returned for their second dose).    It was reported that, reporter was a student pharmacist. No concomitant products were reported. It was reported that, patient now interested in completing the series. No treatment information were reported
The second shot has been painful; there is a significant lump and swelling at the injection site; there is a significant lump and swelling at the injection site. It is extremely painful.; This is a spontaneous report from a contactable consumer or other non hcp(patient). A 47-years-old male patient received BNT162B2 (Pfizer covid 19 vaccine, formulation: solution for injection, Batch/Lot Number: Ew0161), via an unspecified route of administration, administered in Arm Left on 15Apr2021 10:45 (at the age of 47-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162B2 (PFIZER COVID-19 mRNA VACCINE; Formulation: Solution for injection; Lot Number: Er2613 and Expiration date was not reported), via an unspecified route of administration, administration in Arm left on 25Mar2021 10:45 as dose 1, single for COVID-19 immunisation. On 15Apr2021 15:00, the patient experienced the second shot has been painful, there is a significant lump and swelling at the injection site, there is a significant lump and swelling at the injection site. it is extremely painful. The patient did not receive treatment. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
patient presented to ED (discharged 1 week prior) with new fever, chills, n/v/body aches, sore throat.   Has no known history of prolonged QTc, and during beginning of admission, she was noted to have intermittent sinus bradycardia and prolonged QTc. On 8/16, rapid response was called for pause dependent R on P leading to TdP which required shocks x2, two rounds of CPR, and amiodarone. Likely her QTc prolongation and episode of TdP are multi-factorial in etiology with contributions from potential underlying genetic predisposition, QT-prolonging medications, transient electrolyte abnormalities iso HD, and bradycardia. In the context of her prolonged QTc and TdP, she was taken off multiple QT-prolonging medications, including quetiapine, citalopram, odansetron, compazine, and remdesivir, and she was initially treated with isoproterenol with goal HR >65. EP was consulted who felt that a PPM was not indicated and to instead pursue medical management. Since discontinuation of these medications and initiation of treatment, her QTc and bradycardia have improved. However, on 8/23 overnight she was noted to have newly prolonged PR interval that has persisted. Per EP, this is a rate dependent PR prolongation. 8/28 with 3-4 second pause on rhythm strip in setting of increased vagal tone with 2-3 p waves that did not conduct, suggestive of ongoing significant conductive disease. HR down to 30s in the evening, asymptomatic, sinus with rare Mobitz 1. Feel that this is likely due to myocarditis and not a consequence of steroids. PR interval now normalized and QTc as well in setting of bradycardia. 09/01, patient continues to be bradycardic (mid 40s - low 50s) but asymptomatic at rest or with exertion.
No adverse events experienced by patient. Patient returned for dose three Pfizer vaccine but was given  Moderna 0.25 ml dose for Dose 3 booster dose as a mix and match. Pfizer vaccine was unavailable at site until the next day. Pt. family was notified and family denied any adverse event.
I traveled and was Ill on Friday morning, July 22nd.  Had no ill effects.  However, on Saturday morning, I woke up but then went to a "consciouse, but unaware" state of mind.  I was completely oblivious to everything around and do not remember anything.  My daugther drove me to the medical facility  about 2:30P where I underwent a brain scan and other testing..  By this time I was regaining consciousness and beginning to recognize my surrounds.  I was dismissed without a specific cause of my condition, and it was attribute to possibly be  a mini-stroke.  I had no other effects the remainder of the day, and drove back later that evening.
Over the course of the day after vaccination, arm pain worsened and patient found a "knot" above the injection site, near where the shoulder meets the neck. He said that pressing on the knot or moving his arm around made his arm go numb.
11/14/22 presents to ED for "fatigue" "weakness". PMHx of "advanced dementia, rheumatoid arthritis, hypertension, PUD"
Pt became diaphoretic. C/O "dizziness and blurred vision. 10:53am BP 74/42; 10:58am 84/44; 11:03am 110/54. This is atypical reaction for this patient.
Immediate sx:  facial itcing Approximately 5 hours later:  injection site pain, tachycardia , and lethargy Morning after: intermittent sharp right upper quadrant pain
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 nurse 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. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose from expired vial). At the time of the report, 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.   Concomitant medication was not provided.  Treatment information was not provided.
Case had both COVID vaccines: 1/20/21 and 2/10/21.  Case developed symptoms and had a positive Case rSARS-CoV-2 Ag Resp Ql IA.rapid~COVID19 TEST-positive on 3/23.  Hospitalized. 3/26: SARS-CoV-2 RNA Nph Ql NAA+non-probe~COVID19 TEST-positive.
This spontaneous report was received from a pharmacist refers to a 73-year-old female patient. Approximately on 04-SEP-2012 (reported as approximately 2 weeks ago) the patient was vaccinated with, 0.65 milliliter ZOSTAVAX (lot # not reported)subcutaneously, single dose vaccination (reported as vaccination). Patient had no known allergies. No concomitant medications were reported. Pharmacist reported that a patient subsequently in September 2012 developed a 3 inch diameter raised red area around the injection site. She then developed a generalized red rash on the trunk and arms, approximately on 11-SEP-2012 (reported as approximately one week following the vaccination). Pharmacist reported that the generalized rash was persisting to the date of the call. Treatment was given for the event, BENADRYL was given. It was unspecified whether patient sought medical attention. The reported events did not resolve at the time of this report. No further information is available. Additional information has been requested.
Patient received first dose of Moderna covid 19 vaccine today 3/17/2021 and neglected to inform staff that she had received both doses of Pfizer covid 19 vaccine on 2/6/21 and 2/27/21.
Memory loss, can?t walk, incontient of bowel and bladder,  hallucinations, no balance ,fine motor skills diminished,
Very high fever 6 hours after vaccine.  Up to 104.3, chills, difficulty breathing, lower back sore.   Lasted approx 2-3 hours with shivering
Pt experienced significant chills, headache, joint pain the evening of receiving the vaccine. Self reported a fever of 101 at 3am and took acetaminophen which lessened symptoms. Resolved the following morning completely. 20+ year history of receiving seasonal flu vaccine w/o incident.
This spontaneous report as received from a pharmacist refers to a 67 year old male patient. On an unknown date in 2009 the patient was vaccinated with the first dose of ZOSTAVAX (lot #, expiration date, dose, route not reported). On 02-JUL-2014 the patient was vaccinated with second doe of ZOSTAVAX (lot #, expiration date not provided) 0.65 ml, subcutaneous in the back of left upper arm. No adverse effects were reported. The reporter stated that after the patient got home, he called her to tell that he had had a ZOSTAVAX vaccination in 2009. Additional information is not expected.
Two members of a family developed abscesses @ inject site; A 25y/o male recvd this product 17APR91; Devel an abscess, which was documented on 25JUN91; Sister also recvd shot;
PATIENT COMPLAINED OF FEVER, NAUSEA, VOMITING AND DIARRHEA WHICH CONTINUED UNTIL FOLLOWING MORNING. AS OF 530 PM 10/19/2016 SHE STILL EXPERIENCED NAUSEA AND COULD NOT EAT MUCH.
Patient reports numbness in fingers and arm on right hand about a week following vaccination.  Referred to report online and to seek medical attention from Primary Care Physician as soon as possible to evaluate the numbness and cause and to monitor him
Client present with his mother and brother for immunizations.  He needs tdap and #2 varicella and mom is requesting menigiococcal.  After obtaining written permission and supplying VIS sheets to mom, I administered boostrix in the R deltoid IM and menactra im in the L deltoid.  Patient sorta had been laughing throught the entire procedure. After administering the second vaccine patient got very pale, as his color had been normal dring the vaccines. He stiffened out in the chair arching his head back momentarily.  He was able to respond and answer questions appropriately through out this but was still very pale, hot to the touch and diaphoretic.  He said he felt like he was "dreaming".  I called Rn and she came in the exam room and assisted.  After he was able to compose himself he was still very pale and we assisted him with the help of three to the exam room where we layed him on a table while checking his Bp and pulse which wer 96/40 and 72.  He gradually regained color and felt well enough to sit up and eat a container of strawberry banana yogurt and drink some water.  Patient was also up late last night and had only eaten a clementine this am.  Mother informs us after this episode that her other son had passed out in the past giving blood and that her ex husband their dad passes out when he receives shots.  We advised her to always tell any practioner ahead of time that they need to lay down for any procedures/injections.  Patient is up with good color and walking around before he leaves the clinic.  Will defer #2 varicella for about a month due to his reaction today.  Advised mom I would be filling out VAERS today.
Swelling and slight redness in Right Leg that extends to knee. Patient refused to take motrin  Recommended cold pack for discomfort and swelling.   Referred to doctor for evaluation.
Patient became progressively more irritable over 24 hours.  He then stopped interacting and had dancing eye movements.  He was brought to the local hospital and underwent a neurologic workup yielding a diagnosis of possible Leigh Disease.  He had a muscle biopsy that showed macrophagic myofasciitis that was attributed to the immunizations.
Diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This is a spontaneous report from a contactable elder female consumer. A unspecified age old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9263, expiration date: unknown) dose 2nd via an unspecified route of administration on 03Feb2021 on left arm at single dose for COVID-19 Immunization. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 13Jan2021 04:45 AM, anatomical location was left arm. The medical history included osteoporosis. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication included Metoprolol, multivitamin, Caltrate, atorvastatin. On 03Feb2021 the patient experienced Sinus headache, nausea, joint pain. The patient did not receive any treatment for an event. The outcome of events was recovering at the time of report. No follow-up attempts are possible. No further information is expected.
Information has been received from a pharmacist, concerning a patient of an unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On an unknown date, the patient was vaccinated with an unspecified dose of ZOSTAVAX vial 19400 PFU, lot number: N012615 with expiration date in 16-MAR-2018 (dosage schedule, anatomical location and route of administration were not provided) for prophylaxis. The pharmacist reported that the ZOSTAVAX vial was difficult to pierce, but was still administered to a patient. No symptoms were reported.
Severe local reaction of rt deltoid swelling with pain. Swelling of upper arm and redness 10 X 12 cm covering deltoid and biceps area. Warm to touch onset 6 days after immunization given.
Client reported loss of taste starting 2 hours after 1st dose and resolved without intervention the evening of the next day.
PALPITATIONS; COLDNESS; FATIGUE; This spontaneous report received from a patient concerned an 87 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included atrial fibrillation. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on left deltoid muscle on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced palpitations. On 11-MAR-2021, the subject experienced coldness. On 11-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from coldness, fatigue, and palpitations. This report was non-serious.; Sender's Comments: MAC not required as per standard procedure as case was assessed as Non-serious.
This spontaneous report was received from a Medical Assistant and refers to a multiple patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On unknown dates, multiple unspecified patients received doses of improperly stored LIQUID PEDVAXHIB (lot #K019701, expiration date: 17-JUL-2017, dose, route of administration and injection site were not reported). Administered doses of LIQUID PEDVAXHIB underwent temperature excursions at 58 Fahrenheit degrees, for 26 hours.  Information about the previous temperature excursions was not reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Arm was red. Rash angry looking site of injection was swollen and arm from shoulder down to elbow. Put cold packs and Benadryl every 4hrs around clock for 24hrs still red and swollen for 7 days. Went to Dr on 26 of Oct.
Sore and stiff hips, sore calf muscles. Sore and stiff shoulders. Arms, wrist and hand pain.
The next morning after I woke up with real bad nausea, diarreah, headache, shakes and chills but never developed a fever.  And to date I am still experience random symptoms listed associated.  I developed pain down both arms, down my neck and chest area also.  I have fallen 2 different times but is unsure of why I am now falling
Erythema around area of vax administration 2 days p/vax given; also some induration & inc warmness & tenderness; no tx;
flu like symptoms; This case was reported by a physician via sales rep and described the occurrence of influenza-like symptoms in a 19-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, unknown after receiving Bexsero, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The reporter did not consent to follow up.
1 day p/vax, blurring of vision, bilateral about 4-5 days p/had a burning sensation over entire body red area @ site; no fever;