chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information was received from a pharmacist regarding an approximately 76 year old male patient, with an allergy to iodine. On 08-MAR-2014, the patient was vaccinated with ZOSTAVAX, lot # J011830, expiration date 26-DEC-2014 (dosage and route of administration not provided). Concomitant therapies included AUROBINDO, VICTOZA, LUPIN, and hydrochlorothiazide (+) spironolactone, metformin, levothyroxine sodium, and glimepiride (manufacturers unknown). The pharmacist reported that the patient developed transient numbness and tingling at the injection site following vaccination with ZOSTAVAX that has continued through the date of the report. The pharmacist did not know how soon after the ZOSTAVAX the patient developed the transient numbness and tingling. No treatment was given. The outcome of the transient numbness and tingling at the injection site was reported as not recovered. Additional information has been requested.
Foggy brain, headache,  fatigue,  abdominal pain, leg cold, dizziness
About 24 hours after my second shot severe pain in back an lower extremities. Lasted at the severe level for about 12 hours. Mild pain continued for 2 weeks like sciatica nerve pain in both legs.  2 and a half weeks later pinched nerve in back . L5 to S1.  Disc degeneration found but unexplained why the pain started at time of shot.
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. On 05-SEP-2013 the patient was vaccinated with an expired dose of M-M-R II (lot# 1293AA, expiry:09-AUG-2013). No adverse effects reported. Additional information has been requested.
Pt received moderna vaccines on 03/04/21, 04/01/21, and 11/26/21. Pt presented to the ED on 12/11/21 after a recent COVID positive at a nursing home. Pt was started on Remdesivir and required high flow oxygen.
Hives on chest, itchy rash - BENADRYL 25 PO at pm. Mild wheezing, cough, hoarseness, tight throat and chest. IV BENADRYL 25 mg 10:15am, PEPSID 20mg IV 10:17am. Prednisone PO 20mg 10:10am. Discharged from ED 1:10p with Rx oral Prednisone 60mg daily x 4 days.
Rash covering arms and legs, extreme fatigue, fainting occurred approx 6.5-7hrs after shot. Unconscious for under 2 mins. Dizzy and light-headed.
T-100.3 1 day after imms., fussy, TYLENOL, cool compresses, monitor, call if change/worse.
RECEIVED REPORT STATING PT WAS DIAGNOSED WITH ILEOCOLIC INTUSSUSCEPTION REDUCED AT HOSPITAL
Information has been received from a licensed practical nurse referring to unspecified multiple patients of unknown age and gender. On unknown dates unspecified number of improperly stored M-M-R II (lot# L039551, rHA, expiration date 07-OCT-2017) was given to the multiple unspecified patients. No adverse effects reported. The temperature excursion was 48 degree Fahrenheit for 24 hours, data logger was used. There was no prior excursion. The temperature was back in range at the time of reporting. This is one of several reports received from the same source. Additional information is not expected as there is no consent to contact the physician.
Leg red and swollen 10cm circum noticed 5/10/06 at 1600.
Employee reported to office that he tested positive for COVID-19. requires that we submit breakthrough cases to VAERS reporting system.
Pt recv vax on 11/16/98; on same day pt exp red & swelling at vax site
Vestibular Neuritus, accompanied by extreme vertigo and nausea. The initial bout of intense vertigo and vomiting subsided and continued as dizziness (lasting 3 days so far) when the patient moves head suddenly, bends, or rises from laying down. Inflammation of the vestibular nerve appears to be the issue.
Chest, abdomen, neck and proximal arms with erythematous 1-2 cm macule & papules complacent in some regions.
Trouble breathing in the 5 days after shot received. Felt like I couldn't take a full breath. It scared me so much that I decided not to proceed with my second vaccine shot. Turns out this may be a side effect of Myocarditis.. But I don't have this side effect anymore so maybe it wasn't that. It's not an extremely serious side effect by any means, but I felt I should report it because it caused me to decide not to go with the second shot.
LIght headed - almost fainted.  This lasted for about 10 minutes.  I sat down and felt better a bit later.    Cramping / stiffness in my right thumb that lasted for several minutes.  Then after that, I had cramping / stiffness in my left index finger that lasted for several minutes.  No pain, just could not move my fingers.
Patient received Tdap vaccination and had fever for a day then the fever went away.  The day after vaccination she had arm pain and had limitation in range of motion til today, 9/23/19.
Patient developed new-onset atrial fibrillation 12 days after receiving the 4th dose of the COVID Pfizer vaccine. She was 37w3d pregnant with her second child at the time of developing atrial fibrillation. She was otherwise well - no recent illnesses. She converted into normal sinus rhythm after two doses of metoprolol.
Headache, Myalgia, Arthralgia, Fever, "arms heavy" ; pain and soreness in arms and shoulders Narrative:  advised employee to see PCP
mom states pt woke up 2OCT95 w/rash on body that later turned into hives;went to ER & then to MD was told pt had a type of allerg rxn & also dx'd w/an ear infect-pt recvd a shot today & placed on med for rash; & Suprax for ear infect
Headache cold sweats, local injection site soreness used sl on 2-8-21
No reaction to the vaccine, three months later I got COVID-19. I had a home test, and it was Positive. I went to the doctor, and he did his own test and confirmed Positive for COVID-19.  Doctor gave me Paxlovid for 5 days, after 5 days I tested myself and it was Negative.
The pt experienced a temp of 103, muscle aches, productive cough, slight shortness of breath. Taken to the ER by wife and admitted to hospital on 11/19/00. Treated with Cortisone.
Extreme arm pain; Unable to straighten or lift the arm; Sporadic itching at the injection site; Sporadic twitching in the bicep, tricep and shoulder; This is a spontaneous report from a non-contactable consumer, the patient. A 39-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 arm left on 03Apr2021 at 13:30 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications taken within two weeks were not reported. On an unknown date in Apr2021, the patient experienced extreme arm pain and unable to straighten or lift the arm, for the 2 weeks after sporadic itching at the injection site and sporadic twitching in the bicep, tricep, and shoulder. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme arm pain and unable to straighten or lift the arm, sporadic itching at the injection site and sporadic twitching in the bicep, tricep and shoulder 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.
9 days after injection, at the injection site, it is swollen to about the size of a half dollar. It is red, sore, and sometimes itches.
This is a spontaneous report from a contactable pharmacist. A patient of unspecified age, race, ethnicity and gender received a single dose of PREVNAR 13 via an unspecified route of administration in Sep2016 for immunization.  The patient medical history and concomitant medications were not reported.  On an unspecified date in Sep2016 the patient experienced severe arm pain and extremely limitation of arm movement. Outcome was unknown.
9/18 Next morning lg whelp under right arm by afternoon developed 2 cm whelps inside left bicep itching and reddened, persisted for 5 days used OTC CORTAID ointment for itching.
Confusion, Myalgia, Fever, Diarrhea, Nausea Vomiting, ElevatedLiverEnzymes, Jaundice, ElevatedBunSCr,  , Continues to feel weak and following up with PCP. Reports had no health issues prior to her second vaccine dose. She reports had fever, joint pain and nausea with first dose. Patient reports receiving her first COVID vaccine 12-23-20 and  developed nausea, joint pain and fever. She had her second dose on 01-11-21 and  noted nausea,vomiting, weakness, become jaundiced and fevers that required  hospitalization and developed autoimmune problems. She reports hepatitis and  kidney problems and PCP following.
Severe joint pain and swelling in the arm/shoulder - continuing even 3 months now. Knot still present at the injection site. Muscle spasms in the deltoid area where the injection was provided and radiate pain and spasms up to the neck and down through the hands. Color in the hand is  darker than other hand. Circulation is decreased in the hand on the side that the shot was given.
This spontaneous report as received from a licensed practiced nurse refers to 5 patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On 05-NOV-2015, the patients were vaccinated with improperly stored doses of GARDASIL 9 was vaccinated with improperly stored GARDASIL 9 (lot# was reported as L014239, expiration date 21-JUL-2017, dose and route were unknown). No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Vaccination failure; Shingles; This case was reported by a pharmacist and described the occurrence of vaccination failure in a 75-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and 183 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that, 6 months before the date of reporting, the patient received Shingrix. At the time of reporting, the patient had just been diagnosed with shingles. It was reported that, unlike many people who had shingles the patient did not experience any pain.  The patient asked if there were any studies indicating that when one who receive Shingrix, had experienced the shingles that was less intense.
Mother called on 4/12/2005 to report that after her son received his immunizations on the AM of 4/11/05, he retruned to school. She stated that when she picked him up from school at 3:30 pm, he was c/o of generalized itching and was beginning to break out in hives. She states she took him to his dr's office where he was given Benadryl, and itching subsided. She reports that @ about 9:30 pm, the child c/o difficulty breathing, and she called 911. She further reports that the paramedics gave the child O2, his breathing got better, and she refused to have the child transported to the ER opting to take the child back to her pediatrician on 4/12/05. She reports that she kept the child home from school today 4/12/05, and has a 1:45 pm appt. She denies that the child was having any difficulty breathing this morning. She also added that she had a 10 month old cousin that died after receiving immunizations, but did not know all of the circumstances.
The pt stated that on 6/22/01 he had right side pain, under collar bone and across chest. Saw PMD on 7/1/01 with Rx of anti-inflammatory meds. Saw a chiropractor on 7/5/01 who thought he had a rib out of place. Saw this doctor on 7/11/01 and had a CXR with was normal. Pt states pain has been moving moving around since then, according to his wife on 7/22/01.
Pt c/o flushing, red skin, hot flashes, scratchy throat, congestion in ears at about 30 minutes post vaccine.  Pt had pre-medicated with 3 zyrtec per MD recommendation after 1st dose.  VS were stable and O2 sats 94-97% on RA.  Pt given 50 mg oral benedryl.  After 30 minutes, patient's voice became more hoarse and she felt a greater sensation of throat swelling.  Pt given epipen x 1 with immediate improvement in sx.  Pt sent to hospital for observation.
I had such bad chills I felt like my bones inside were freezing /frozen. I had to take almost all hot water baths to defrost my bones. After about 20 min bath got back in bed and froze and sweated, more than ever before in my life. All bones, skin ached like the flu but much worse. Couldn't hardly move left arm. Sypmtoms lasted about 20 hours, then slowly disapated.
PSA is 4.49 which should be 2.2; her liver enzymes were off the charts; AST which is 158 and it should be 28; ALT is 101 which should be 12.; A spontaneous report was received from a female patient, concerning herself unknown years of age, who received Moderna's COVID-19 vaccine and experienced Hepatic enzyme abnormal, Enzyme abnormality, Alanine aminotransferase decreased, Prostatic specific antigen decreased,  The patient's medical was not provided by the patient.  Concomitant product use was not provided by the patient.    On 12-Feb-2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (unknown batch number) via unknown route for COVID-19 infection.  On 14-Feb-2021, the patient experienced Hepatic enzyme abnormal, Enzyme abnormality, Alanine aminotransferase decreased, Prostatic specific antigen decreased. The test result shows changes in his AST which is 158 and it should be 28and his PSA is 4.49 which should be 2.2 and his ALT is 101 which should be 12.   Action taken with mRNA-1273 in response to the event was not applicable. The outcome of the event was considered to be recovered/ resolved at the time of this report.
I had the shingles vaccine and still got shingles/suspected vaccination failure; shingles; It was still painful!; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was self-reported by the patient. The age at vaccination was not reported. The reporter stated that, he/she had the Shingles vaccine and still got shingles, just not as severe and it was still painful. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Approximately 4 hours after receiving the vaccine, she experienced blurry vision, stated it was hard to focus and felt some generalized numbness.  RN at her side, checked BP 156/94, pulse 90.  Patient awake, alert and oriented.  RN called 911.  EMS arrived approximately 10 minutes after the call. Patient taken to Emergency Department for evaluation.
Information has been received from a consumer concerning her son who was vaccinated with various childhood vaccines including DPT, polio, and hepatitis B vaccine (manufacturer unknown) also reported as hepatitis. The reporter stated the vaccines contained thimerosal. Subsequently the child developed autism. The patient sought unspecified medical attention. The mother believes the vaccines containing thimerosal caused the autism. Upon internal review the autism was considered to be other important medical event (OMIC). Additional information has been requested.
uncontrollable crying >8hrs;erythema from inj site to knee;DPH/APAP
This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unspecified date in 2016 (reported as "1 years ago"), the patient was vaccinated with the first dose of GARDASIL 9 (strength, dose, route, lot number and expiration date were not reported) for prophylaxis. The pharmacist reported that the patient had not received the second dose and at the time of reporting, the patient was in the pharmacy to received her second dose of GARDASIL 9 lot #M033583, expiration date 20-APR-2019 (product use issue). Additional information has been requested.
Redness and swelling; Muscle pain; Body Ache; Immune system responses; Headache; Fever.
limitation of movement of left arm/she was unable to use her arm for the entire week/She had limitation of movement/Her arm was immobile for 3 days; Low grade fever; Pain in the left arm/tenderness at the site; swelling in the left arm; This is a spontaneous report from a Pfizer-sponsored program. A contactable 75-year-old Female Physician reported for herself that she received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration at deltoid left on 09Dec2019 around 13: 00 at single dose for immunization at physician office. Medical history and concomitant medications were none. After she received the vaccine on 09Dec2019, she was unable to use her arm for the entire week. Her arm was immobile for 3 days, pain and swelling in the left arm. She had a low grade fever for 3 days and it was tender. She had limitation of movement of left arm. It still hurt but she had 95% function back again. She said that the events started within a few hours of receiving the vaccine. Swelling was gone. She still had tenderness at the site. The reporter seriousness for limitation of movement of left arm was medically significant. The outcome of the limitation of movement of left arm was resolving, the outcome of low grade fever was resolved on 12Dec2019, pain in the left arm was not resolved, swelling in the left arm was resolved in Dec2019.; Sender's Comments: Based on the information currently available, a contributory role of the suspected vaccine towards the occurrence of events cannot be fully exclu considering the temporal association and the known adverse event profile of the suspect vaccine.  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 had vaccine friday 10/27/23;   started having symptoms sunday 10/29/23 of swollen eyes, red and itchy eyes and sore throat and tested positive for covid per home test
Pt stated they observed redness the day following administration.  The redness began to subside days following administration and then roughly a week after the redness and itching came back.
Patient was vaccinated for SARS-CoV-2 on 6-Jan-21 at his site of employment, a Nursing Home. Patient presented to Urgent Care on 15-Jan-21 complaining of left sided chest pain that started the evening before with an associated slight cough.  Pt was afebrile with a heart rate of 88 and an O2 sat on room air of 98% in triage.  His EKG showed a sinus tachycardia of 114 with a slightly prolonged QTc of 463 ms. Physical exam was significant for bibasilar crackles and X-ray showed bibasilar infiltrates consistent with COVID pneumonia but bacterial pneumonia could not be excluded. The patients BP was documented as 97/64.  He was treated with Zofran for nausea and tylenol. He was prescribed a five day course of Azithromycin, an Albuterol inhaler, guaifenessin with codeine cough syrup, and Zofran. Labs were drawn and he was discharged.  His lab results were reported after his departure and were significant for a white blood cell count of 1.33, platelet count of 73, 2% myelocytes, 1% metamyelocytes, an absolute neutrophil count of 0.75 K/ul, a creatinine of 1.83, total bilirubin of 1.3, with direct bilirubin of 0.8, alkaline phosphatase of 294 and AST of 112 with ALT noted to be within normal limit. His COVID nasopharyngeal swab from the visit was reported as negative and a swab performed at his employment on 13-Jan-21 was also reported to be negative.  Patient could not be reached by phone after discharge from Urgent Care about these labs. On the evening of 16-Jan-21, Police Department received a 911 call about an adult at the patient's address who was found unresponsive. Upon arrival on scene, the patient was found to be deceased and a decision was made not to attempt to resuscitate. The death was deemed to be non-suspicious and the patient's body was transported to a funeral home.  On 19-Jan-21, I contacted the State Medical Examiner's Office.  They have decided to perform an autopsy and have recovered the CBC and chemistry specimens obtained for further testing.
Subsequent to receiving vax, pt developed an injection site reaction characterized by severe redness, swelling and pain.
This spontaneous report was received from a healthcare worker refers to female patient of approximately 1 year old. No information on concurrent conditions and medical history was reported. On 13-JUL-2015 the patient was vaccinated with improperly stored MMR II (unknown strength, route and dose) lot # K004949 with an expiry date of 04-APR-2016, stored at improper temperature (<46 degrees). Concomitant medications were not reported. No adverse effects were reported. There was no product complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Arthralgias (in knees/ankles/feet i.e small jts) finges/toeswrist, Fever Sx approx. 2-3 days after Gardasil
1hr post vax pt developed severe arthralgia; 2 hrs later she developed diarrhea;
Within 10 minutes of receiving the vaccine, the patient passed out and began convulsing.  Convulsions lasted about 6-7 seconds and she was unconscious for about 10 seconds. She regained consciousness and was semi-alert for maybe 30 seconds and then passed out again and convulsed again for a longer period of time (approximately 10-20 seconds).  She turned whitish/green in color, lips were white and she reported that she could not hear.  I called 911 to our residence and she was assessed.  Her blood pressure was on the lower end. Her heart rate was within normal range for her age. The paramedics noted that her reaction was not typical for a flu vaccine.