chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was given Tdap (ADACEL) LD upper, Varicella LA lower, HPV4 RD upper, MENACTRA RD lower at approx. 930 AM on 5/17/12. Patient returns today reporting spontaneous bleeding from MENACTRA inj site. Area does not appear bruised or that he had scratched at it in his sleep. Mom states "a lot of blood".
swelling of lips; hives/Welts; This is a spontaneous report from a contactable consumer. A 66-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot no. and expiry date were unknown), via an unspecified route of administration in Left hip on 23Oct2015 at single dose for pneumonia shot. There were no medical history and concomitant medications. The patient experienced hives/welts on 24Oct2015 and swelling of lips on 21Nov2015. Further reported as follows: In Oct2015, received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) pneumonia shot. Next day in late afternoon of 24Oct2015, she broke out in hives and continued to have it, was sometimes quite severe but didn't itch. She had big welts mainly on the lower part of her body. Had a few welts on face and eyes. On 25Oct2015 called up to the hospital and was advised to use Calamine lotion and Benadryl. First time she saw a doctor was on 31Oct2015 and was prescribed Prednisone. On 04Mar2016 was the first time she didn't notice hives. One morning on 21Nov2015, Top lip was swollen and saw another PA. Was prescribed 1 Zantac daily, 1 Zyrtec daily, and 1-2 Benadryl at night. It looked like she had botox on her lips. She had that until the first week in March. On 28Nov2015 she was put back on Prednisone. On 30Dec2015 she went to Dermatologist and was prescribed some kind of tube of medicine. Was informed by dermatologist that pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) caused the reaction. It was confirmed that she has not yet received the COVID-19 Vaccine. Stated she is not in the group to receive it. The event hives/welts recovered on 04Mar2016 and the outcome of the remaining event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Treatment of COVID-19; Treatment of COVID-19; Moderna x2 + 2 Moderna boosters, + Pfizer bivalent; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 74-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 at 13:00 as dose 5 (booster), single (Lot number: GJ2524) at the age of 74 years, in left arm for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "compromised renal fxn eGFR about 60" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tetracycline, reaction(s): "Known allergies: Tetracycline"; Doxycycline, reaction(s): "known allergies: doxycycline"; Oxycodone, reaction(s): "known allergies: oxycodone"; Hydrocodone, reaction(s): "known allergies: hydrocodone". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Sep2022 at 13:00, outcome "unknown", described as "Moderna x2 + 2 Moderna boosters, + Pfizer bivalent"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28Sep2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: EGFR status assay: (unspecified date) 60; SARS-CoV-2 test: (28Sep2023) Positive, notes: Positive COVID antigen test 28Sep2023 and 03Oct2023; (03Oct2023) Positive, notes: Positive COVID antigen test 28Sep2023 and 03Oct2023; (05Oct2023) Negative, notes: Negative antigen test 05Oct and 07Oct2023; (07Oct2023) Negative, notes: Negative antigen test 05Oct and 07Oct2023; (11Oct2023) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid).; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness and COVID-19 cannot be ruled out. Events are considered related conservatively. Case will be reassessed upon receipt of additional information.
C/O swelling, redness tenderness, pain in R delt. Parent reports no fever, no NVD. Parent states, "She is normal except her arm is sore." Client examined by RN. One palpable R axillary lymph node approx 8mm: client reports slight pain to touch. Submandibular and submental lymph nodes nonpalpable. Advised cool pack and suggested Tylenol per manufacturers direction and to seek immediate tx at hospital if S/S worsen. All questions answered.
No other AE or PQC reported; a temperature excursion happened/unsure if ROT ATEQ and VAQTA had been administered since the excursion occurred; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.      On 05-NOV-2021, rotavirus vaccine, live, oral, pentavalent (ROTATEQ) experienced temperature excursion. On 10-NOV-2021, the patient was vaccinated with the improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (1 time dose, lot # 1742078, expiration date 06-JUL-2022; strength was not reported) orally for prophylaxis (product storage error). Current temperature excursion was 47.1 Fahrenheit degrees for 36 minutes. There was no previous temperature excursion. No other adverse event (AE) or product quality complaint (PQC) was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2112USA000877: US-009507513-2112USA000882: US-009507513-2111USA005243: US-009507513-2112USA000879:
Left arm cellulitis, 6x6 area of erythema noted to L elbow and upper arm.
Immediate very intense arm pain that lasted 4 (+) weeks after vaccination. After a few months pain lessen a little but never went away. New symptoms developed shoulder pain, weakness, difficulty / limited movement of the left arm, impossible to raise the left arm above a certain level. Pain level fluctuates between 4-8, but never below 4.
Pt began to have normal arm pain later that night. Over the next 48 hours the pain worsened,swelling occurred at the site and down the arm to the wrist.  She became unable to lift the arm due to pain and swelling, It worsened over 8 days,Did not respond to NSAIDS , ICe or rest.  then decreased a small amount at the visit on 9/28/2020. At times of visit she is unable to use an active ROM to lift the left arm at the shoulder joint. PROM is painful but possible. There is visible swelling from left mid deltoid to the AC joint, ROM is limited similar to a significant Rotator cuff tendonitis type event.
Platelet count went from 102,000 to 37,000 two weeks post Flu Mist. Blood Sugars began increasing and remain high. Platelet count 12/8/08 still low at 39,000
Plans on getting 2nd dose more than 3 months after first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Plans on getting 2nd dose more than 3 months after first dose) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Sep-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Plans on getting 2nd dose more than 3 months after first dose). On 26-Sep-2021, PRODUCT DOSE OMISSION ISSUE (Plans on getting 2nd dose more than 3 months after first dose) had resolved.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant medications were not reported. Treatment medications were not reported.
Information has been received from a certified medical assistant (CMA) concerning a 4-week-old patient who on 18-JUN-2007 was vaccinated PO with the first dose of Rotateq. It was unknown if medical attention was sought. No adverse experience was related to the event. Additional information has been requested.
LOST LEFT KIDNEY; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total, administered for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced lost left kidney and almost lost life. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the lost left kidney was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230308677- lost left kidney. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Ringing in his ears; Headache; sore all over body like somebody just beat him up; A spontaneous report was received from a consumer concerning a 54-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore all over his body like somebody just beat him up, headache, ringing in his ears.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 21 Feb 2021, prior to the onset of the events the patient received  second of two planned doses of mRNA-1273 (lot/batch: Unknown) via unknown route for prophylaxis of COVID-19 infection.  On 21 Feb 2021, the patient experienced the events sore all over his body like somebody just beat him up, headache, ringing in his ears.Consent for safety to follow up given.  Treatment details included acetaminophen and didn't help.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of event, sore all over his body like somebody just beat him up, headache, ringing in his ears was unknown.
Tired, slept 6 hours after getting 1st  vaccine dose.  Woke up at 6:30 pm 1-17-21 with chills, dull, headache, very painful right arm difficult to lift, achy joints.  took extra strength Tylenol .  Back to sleep at 7:00 pm 1-7-21 and slept 4 hours til 11:00 pm.  Took another extra strnength Tylenol .slept another 6 hours till 5:30 pm 1-18-21.  still having aches in joints , dull headache, temp only 97.5.  no chills.  took another extra strength Tylenol.  Ate breakfast and all symptoms left except very sore arm.  Did not expect a reaction with 1st dose.  Never have reacted to any vaccine before.
This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red running towards her elbow) and SKIN WARM (warm to the touch) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013l2oa) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure. Concomitant products included HYDROCODONE for an unknown indication. On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced ERYTHEMA (red running towards her elbow) and SKIN WARM (warm to the touch). At the time of the report, ERYTHEMA (red running towards her elbow) and SKIN WARM (warm to the touch) had not resolved. Patient use Stomach medicine for concomitant medication. Patient used no treatment medication.
she got the flu; Initial information received regarding an unsolicited valid non-serious case from a consumer via Social media and transmitted to Sanofi on 29-Oct-2020.  This case involves a 74 years old female patient who got the flu (influenza), while she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, reporter said that if anyone gets INFLUENZA VACCINE ends up a week later with the flu. Reporter never had INFLUENZA VACCINE but reporter's mom (patient) also never received INFLUENZA VACCINE but except one year patient received INFLUENZA VACCINE on her job her take and (Unknown latency) she got the flu (influenza).   Final diagnosis was influenza.  It was not reported if the patient received a corrective treatment.  Event outcome was reported as Unknown for influenza.  Lot number was unknown for this case.
Fever, muscle ache, new loss of taste and smell, runny nose, shortness of breath chest pain, fatigue and tiredness, nausea and headache
Severe headache which developed into uncontrollable throwing up.; Fever; Severe headache which developed into uncontrollable throwing up.; This is a spontaneous report from a contactable consumer (parent). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot Number: not reported), via an unspecified route of administration on 10Jun2021 as unknown, sin-gle for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The reported stated that all their three children were vaccinated and two of them just had fever (in Jun2021) which was normal. One daughter (Patient) had severe headache (in Jun2021) which developed into uncontrollable throwing up. Patient has fever on an unknown date in jun2021. Since then, they were at hospital. She had been tested and had a lumbar punch, CT scan and X-ray were performed, and she was schedule for MRI. She never had migraine or anything before. On 17Jun2021, the patient underwent lab tests and procedures which included CT scan: unknown result, lumbar punch: unknown result and x-ray: unknown result. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
12/22/2021Per nurses note this resident had nausea and  dark brown emesis. Zofran 4mg administered. Then on 12/23/2021 Resident had increased dark brown emesis, zofran was not effective. Abdomen was distended, RUQ hyperactive and there was increased confusion. Resident was sent to Hospital ER. She was tested there for COVID and had positive results. She was admitted to Hospital and per information from the hospital she expired on 01/03/2022.
After she received 1st injection she kept complaining of her knees, joints aching, fainting and migrine. Then the 2nd injection she really started complaining. Now she was just recently diagnoised with fibromyligia because she aches so bad. She has been hospitalized many of times after injections with migrines and aching joints. I refused the 3rd injection  06/17/2008 MR received for 7 ER visits.  Seen 8/8/07 and 10/23/07 r/t pre-existing platelet aggregation defect. Seen 10/28/2007 with dx chest pain.  Reproduceble tenderness on exam. Seen 11/20/2007 with dx vomiting and diarrhea. Pt had passed out day prior and hit head. Seen 12/10/2007 with dx Headache Seen 12/22/2007 with dx tremors. Tongue fasiculations noted on exam. Seen 1/14/2008 with R hand fx after hitting a wall. Dx: Danger to self. Depression.
Complaints of pain after immunizations and then 12/01/04 pm noticed redness and swelling halfway around and down to elbow (8x14cm)
Patient experienced dizziness the next day along with blurry vision which has not gone away. She states it is better with reading glasses. She is yet to see her eye doctor however I advised her to.
pain in (L) deltoid area with tingling in fingers, (+) fever, vomiting diarrhea and headache, ice compresses and Motrin 600 mg tid
This spontaneous report was received from a Licensed Practical Nurse regarding a patient of unknown age and gender. The patient's medica history or concurrent conditions were not reported. On 04-MAR-1999, the patient was vaccinated with the first dose of MMR II (0.5 ml, subcutaneous, lot number and expiration date were not provided). On 18-JUN-2003, the patient was vaccinated with the second dose of MMR II (0.5 ml, subcutaneous, lot number and expiration date were not provided). Nurse reported unspecified patient's office record did not show the initial two doses of MMR II and the patient received another two doses of MMR II. Patient received the first dose of the second series of MMR II (0.5 ml, subcutaneous, Lot # 0128AE, expiration date 10-JAN-2014) on 14-NOV-2012 and the second dose of the second series of MMR II (0.5 ml, subcutaneous, Lot # K0166153, expiration date 24-SEP-2016) on 09-SEP-2015. No adverse effects were reported. Additional information has been requested.
chest pain, palpitations admitted for myocarditis now with troponin of 17 today 5/15
Onset lower lip swelling 14 hours after vaccine.  Urticarial  rash 18 hours after vaccine. No respiratory associated S&S. Treated with Allegra and Zytrec with improved S&S. Also had fever 100.5 with HA, myalgia and fatigue.
Headache, Myalgia, Fever, chills. symptopms resolved on 2/15 but headache returned on 2/16 and has  not resolved Narrative:  Symptoms resolved on Day 4 Monday 2/15 however on Tuesday  morning 2/16, headache returned and has not resolved. Will follow up with  primary physician if headache persists or worsens   Other Relevant History:
diaphoric, pale, decreasing LOC immediately after injection. Did not fully lose consciousness. EMS immediately at patient side along with NP and RN staff.  O2 Sat on RA 98.  VSS.  EKD- NSR. Blood suger 118.  Patient stated he had not eaten breakfast or had a lot to drink.   He also stated he has fainted in the past when at a medical facility.  BP 188/70/hr 84
feeling a little bit off; she moves it is when it hurts, it's tender.; she doesn't know how to explain, its an odd feeling; getting a little bit panicky; lightheaded; arm tenderness; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 66-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0186 and expiration date was not reported), first dose via intramuscular route of administration, administered in arm left on 19May2021 11:00 (at the age of 66 year old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19May2021 16:00 patient experienced arm tenderness. On 20May2021 the patient experienced lightheaded, feeling a little bit off and patient stated that she moves it is when it hurts, it's tender and she doesn't know how to explain, its an odd feeling, getting a little bit panicky. Patient enquired with the first shot, since she did not experience severe allergic reactions/side effect she should be ok with the second dose. The outcome of the events arm tenderness, feeling a little bit off, she moves it is when it hurts, its tender were not recovered. The outcome of other events were unknown.   Follow-up attempts are completed. No further information is expected.
Patient was taking a nap and started having a febrile seizure after sleeping for 3 hours. It lasted approximately 5 minutes. He was extremely lethargic/non-responsive for an hour afterwards.
patient states that she had soreness at inj site on 5/18/22.  This progressed into pain, numbness, tingling feeling in arm and back and 3 fingers on 5/19/22
Patient presented to Clinic for first HPV vaccine and was administered the first dose in the series.  Patient was then instructed to wait 15 minutes in clinic lobby for observation. Once the patients 15 minute wait was up they left the clinic only to return approximately 3 minutes later complaining of itching at the site as well as nausea. patient was immediately moved to a patient room for evaluation and base line vital signs. Vital Signs normal and no hives preesent with itching. The Immunization clinic medical Director was then notified of the patient. Medical director administered Benadryl while Immunizations staff coordinated transfer of patient to a local E.R.
I woke up the next day 4/9/21 with terrible chest pains. It happened with the first dose so I ignored it but it kept lingering on for 2 weeks. So I made an appointment with my doctor to be seen. I had an EKG and referral to a cardiologist. The cardiologist is doing a stress test on Thursday 7/15/21. I was given no medication. The pain is infrequent now.
Red rash appeared 4 days after receiving the first shot. Went to doctor, did a biopsy & returned as psoriasiform dermatitis, keeps getting worse, still has it. Itches intensely, using a prescription cortisone cream.
3/21/08 Per Dr. w/ swelling + redness around injection site on left arm.
Patient notified a warm, red spot at the injection site after returning home. When I woke up on  1/24/21, I texted a photo to my physician. Symptoms resolved in 48 hours.
nodule presented 1 1/2wk p/vax;red area on 10/6;ringing in the ears immed p/vax;fatigue on 10/4 that went away;
The parent falsified the child's birthdate to make it look like he was 12 years old and eligible to receive the covid vaccine. There was no known adverse reaction.
had shot and it didn't do any good; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of malaise in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced malaise (Verbatim: had shot and it didn't do any good). The outcome of the malaise was not reported.   It was unknown if the reporter considered the malaise to be related to Shingles vaccine.     It was unknown if the company considered the malaise to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 02-MAR-2023 This case was reported by a patient via interactive digital media. The patient had the shingles shot and it did not do any good.
severe chills of over 1 hr within 4 hrs of vaccine, severe weakness, slept for about 4 hrs, then fever of 102.7 detected at 7:30pm, general body aches, arm of innoculation extremely sore, tylenol given, temp downward trend for 3 hrs, then upward trend, advil give at 10:30pm, downward trend for 4 hrs, down to 100.0.  normal to low grade fever--99.7 to 100.3, tylenol and advil given for body aches  after this. symptoms and fever continued day of shots and following day.  flu and pneumonia shots given at same time in same arm.  patient has cancer and had a tooth extracted, with no ill affects, the day previous to shots (person admisistering shots was notified. physician office notified of events post innoculation.