chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a certified medical assistant regarding unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with improperly stored GARDASIL lot # L035105/expiration date-14-MAY-2017 (incorrect product storage). No adverse event was reported. The outcome of the event was unknown. Temperature excursion was 35 F and 52.5 F for unspecified time. There was no previous temperature excursion and call was not because of the data logger. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information is not expected as reporter does not wants to get contacted.
Eczema flared up immensely. Multiple areas, large blotches, very itchy.
Information has been received from a physician concerning a 4 year old who was believed to have been vaccinated with a dose of varicella virus vaccine live. It was reported that the vaccination record could not be confirmed but the mother insisted that the child had received varicella virus vaccine live. On 6/19/2005 the patient developed a complicated case of breakthrough with a rash and was hospitalized on 6/22/2005. It was reported that the child's hospitalization was not for chickenpox. The discharge diagnosis was cellulitis. It was noted that the child recovered and was discharged from the hospital a few days later. There was no product quality complaint involved. The child was exposed to her brother 14 days ago. Additional information has been requested.
Patient received an extra dose of MMRV , CDC alerted stating no adverse  event  nor harm to the child would occur patient received Dose 1 .at 1 year 1 month Second dose at 2 years and 5 months old (too early) 3rd dose given at  4 years and 8 months old.  Patient has not had any reactions nor has been ill from vaccination.
Approximately four minutes after receiving the vaccine,  I felt dizzy while I was seated. The feeling subsided and returned a couple more times within 15 minutes.  After approx 10 min, I felt a  burning sensation on the top of my right hand and it spread to both hands and arms.  My skin looked a little blotchy  and red. The girl next to me said my face looked flushed. I also noticed I was sweating.  The Rn brought me a bottle of cold water to drink. I drank half the bottle and that seemed to help cool off my skin.  Thereafter, I had the chills.  Then I noticed  a tingling sensation in my feet. My shoes started to feel uncomfortably tight , so, I loosened my shoe laces. That subsided after a while.  After sitting for a few more minutes, I believed I was feeling better. I stood up to prepare to leave and I felt a little bit dizzy.  I sat down again, notified the RN and waited some more.  I tried to stand up again and I felt slightly dizzy again . I remained standing and I was talking with two RNs. At that moment, I became dizzy again.  I remained seated for another period of time before being escorted by the RN back to my department where I sat down and ate my lunch. Thereafter I was fatigued with  the occasional chills and hot spells . I went home and  rested on my couch.
Vaccine 2/27. Chills, fatigue, headache, and dizziness - 4/28. Yesterday morning (second day after vaccine 4/29) I felt fine, slight headache. In the afternoon, the headache intensified, very specifically a sinus headache, isolated to my left side (left brow, toothache with left side molars, and an ear ache also on the left side). This morning (third day - 4/30), the sinus pain cleared but I had some sinus congestion upon first waking. I lightly blew my nose and had some blood in the tissue.  Nothing further, seems to have been the last of it, just a bit odd. I figured it was worth documenting.
A report was received from a health care professional on 10/23/2003 concerning 39 adult vaccinees of unknown gender who inadvertently received Fluvirin subcutaneously on 10/23/03. On 10/23/2003, 39 adult vaccinees inadvertently received Fluvirin subcutaneously with a 26 gauge half inch needle. No vaccinees had exhibited any adverse symptoms at the time of the report. There was insufficient information to determine the reporter's causality assessment. No follow up. The reporter declined to provide any further information.
I'm not sure if this is related to the vaccine, but it's really strange timing. I received my 2nd COVID vaccine last week and now my period is 5 days late. I'm not pregnant. My period hasn't been this late in the last 15 years. It seems likely that this is a vaccine side effect? I decided to report it just in case!
Only diluent was given, when MA went to put vaccine in EMR she realized she had only given diluent and immediately gave another dose
SWELLING/REDNESS AT INJECTION SITE AND WARM TO THE TOUCH. REDNESS EXTENDS TO ELBOW.
PT NOTICED ERYTHEMIC MACULOPAPULAR LESIONS STARTING ON HIS BACK 11 DAYS AFTER VACCINATION. LESIONS SPREAD TO TRUNK, UPPER EXTREMITIES, AND NECK. ONE PUSTULE ON HIS LEFT UPPER THIGH THAT BROKE OPEN AND LESION EXPANDED BUT IS NOW RESOLVING. PT DID HAVE LOW GRADE FEVER ON DAY 10 AND 11 BUT NOW AFEBRILE. DENIES HIVES, PAIN, ITCHING OR RESPIRATORY DISTRESS.
Pain and tingling of entire arm that was vaccinated. I'm not sure the treatment and outcome.
General health issues thruout life, stomach, left ovary cysts, learning disabilities, kidney.
Early period lasting for 9 days. Normal period is 5 days. Started after 21st day if previous cycle. Average cycle length is 30 day. Very light flow with dark brown color for first few days. Started 5/14, ended 5/22
REOCCURENCE OF SKIN PLAQUES; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included skin plaques. The patient received combination product guselkumab (solution for injection in pre-filled pen, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. Product constituent parts included one press (route of admin, lot, serial number, model number, UDI number, and expiration were not reported).The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. 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 subject experienced recurrence of skin plaques. The action taken with covid-19 vaccine ad26.cov2.s, and guselkumab was not applicable. The outcome of recurrence of skin plaques was not reported. This report was non-serious.
death  - Gastrointestinal hemorrhage, unspecified - Acute kidney failure, unspecified
Patient received COVID vaccine Moderna series on 2/1/21 and 2/27/21. On 8/11/21, patient was admitted to our facility Hospital for COVID virus infection (mildly symptomatic, chest x-ray w/out signification findings of PNA), chronic respiratory failure with hypoxia (on home O2 therapy for COPD). Patient was discharged back to assisted living facility on 8/13/21 in good condition.
Information has been received from a Nurse Practitioner concerning a female with a history of fainting with drawing of blood and other vaccines, who on 14-JUL-2008 was vaccinated with the the third dose of GARDASIL vaccine (yeast) and fainted in the hallway after walking out of the office. The patient sought medical attention. She sat down and was given orange juice and was fine 5 minutes later. It is unknown if this occurred with the first and second doses of GARDASIL vaccine (yeast). No further information is available.
Ringing in my ears that started the night of my injection and still ringing now.  I have gone to my primary Dr , and , Went to allergy Dr. twice.
PVC's that started and continued for four weeks. Extremely heavy period on day five after the vaccine, and irregular, period started two weeks early.  40 years of like clockwork and light periods, to a mess of  irregular periods with heavy cramping and heavy flow with large clots, and ovulation sometimes twice in one cycle.
He completed two COVID vaccines in Feb 2021. He was exposed to COVID one week ago, but he could not test due to his basal cell carcinoma of the nose. He received a Monoclonal antibody as an outpatient on 12/15/21. He had a fever of 101, dysuria, and high BP, so he decided to come to hospital, where he was eventually admitted. On hospital day 2, He is afebrile and on room air.
(R) upper arm deltoid with reported hematoma 2 x 2.5 cm. HO infection.
pt recvd vax & devel pos hepatitis b core antibody; lab evaluation revealed pos anti hbs & neg hepatitis b surface antigen;
Client was vaccinated at 14:02 with Janssen vaccine and was then going to be observed for 15 minutes.  Client requested to be observed in the lobby waiting area instead of in the exam room. Client walked himself to the chair, sat down and began to type on his phone. About 8 minutes into his observation, client began to fall forward and did not appear as responsive. Staff immediately tended to client and spoke to client requesting a response. Minimal response was given. 911 was called and responded within 2 minutes. Client was clammy, cool to the touch and eyes appeared glossy and dark. Client's blood pressure was 70/50 at 14:12. Med then arrived and BP was 53/35. At 14:20 (first BP taken when med arrived). Client became responsive but blood pressure minimally improved. Client was taken to the hospital and in agreement.
This case was reported by a nurse and described the occurrence of an injection site reaction in a 4 year old male patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix).  The patient had no pre-existing medical conditions.  On 02/14/2005, the patient received the fifth dose of Infanrix in the left thigh.  On the same day, the patient also received the second dose of measles, mumps and rubella virus vaccine, the second dose of inactivated poliomyelitis virus vaccine, and the second dose of Hepatitis A vaccine inactivated (Havrix) at unspecified site of administration.  At an unspecified time following the fifth dose of Infanrix, on 02/14/2005, the patient experienced an injection site reaction at the site of the Infanrix administration characterized as swollen, hard, red, warm, and painful.  The outcome of the injection site reaction was not reported.
Information has been received from a physician concerning a 20 month old male pt with no known drug allergies and no history of chickenpox or recent exposure to chickenpox who on 02/19/03 was vaccinated in the left arm with a 0.5mL dose of varicella virus vaccine live (Lot # 644149/0967M). Concomitant therapy included Zyrtec. A rash did not occur at the injection site or elsewhere within 42 days of the vaccination. On 11/05/03, the pt presented to the medical office with herpes zoster and an onset date of 11/05/03 was noted. The pt had 4 crops of papular/vesicular lesions on the right thorax in the T10 dermatome. The pt's maximum temperature was 98.9 degrees. There was no pain or systemic symptoms. A photo was taken. On 11/06/03, a specimen was collected from a papule for polymerase chain reaction strain identification.  DNA was amplified and revealed vaccine-type strain. Subsequently, the pt recovered. Additional information has been requested.
spike in blood pressure; spike in blood sugar; This is a spontaneous report from a contactable/non-contactable Consumer or other non HCP[C.2.r.4 (Reporter Type)].  A [D.2.2a; age]-None[ D.2.2b; age unit]-old Female[D.5; gender] patient received BNT162B2[G.k.2.2; suspect product(s) generic name(s) BNT162B2[G.k.2.3.r.1] 1[dose number .G.k.4.r.13] dose:,None[ G.k.4.r.1a; G.k.4.r.1b], None[route(s) of administration or unspecified route G.k.4.r.10.1], administered in Arm Right[add the anatomical location G.k.4.r.11.x1] on 202103041200[G.k.4.r.4; start dates or unspecified date; and time if provided], EN6203[G.k.4.r.7 batch/lot number [Lot #], Expiration date [EXPIRATIONDATE Expiration Date or indicate if they were not reported], [for vaccine indicate the following information] at the age of vaccination [.D.2.1a]; as dose(s) with unit] single[DRUGDOSEFREQUENCY], for COVID-19 immunisation[G.k.7.r.1;  indication(s). Medical history included [any information regarding past medical history, concurrent conditions, social history, and family history].   Concomitant medication(s) included Suspect[G.k.1 with value of 2: all concomitant medication names] taken for [indication(s) (if provided)] from [start dates] to [stop dates]. The patient previously took [D.8.r.1; past product] for [indication] and experienced [past event]. The patient experienced spike in blood pressure,spike in blood sugar[E.i.1.2; AE(s)] and [indicate the appropriate seriousness criterion at the appropriate point in the description] on 20210306[E.i.4; AE(s) onset date(s)]. The patient underwent lab tests and procedures, which included 20210306[F.r.1 ;any information regarding laboratory tests and procedures]. [He/She] was diagnosed as having [provisional/differential/definitive diagnoses]. The [non-vaccine suspect product(s) only do not add this statement for vaccines products] was/were [action taken] on[date of temporary interruption/withdrawn to be included if applicable]. Therapeutic measures were taken as a result of [AE] and included treatment with [treatment product(s)] from [start date(s) of treatment product(s)] to [stop date(s) of treatment product(s)]. The patient not recovered/not resolved/ongoing[E.i.7: outcome(s) of the event(s)]/died] on [E.i.5; AE(s) stop date(s)].
Pt had a bad reaction to the second vaccine. She had body aches, fever/chills, sweating, headache for about 12 hours after the vaccine, then the next day face was bright red with a rash bumps all on her face and down to her chest denies itchiness to the bumpy area. Significantly flushed. Wednesday today her rash is almost resolved but her face is "puffy" visibly looks puffy on video. She has taken benadryl, zyrtec, tylenol without much improvement to symptoms.   Pt to continue symptom management at home with benadryl, zyrtec and tylenol. Aloe and otc hydrocortisone to the face since it feels raw per pt report. Rash is resolved. Pt instructed if it returns to let us know. No steroids at this time as they would negate the response of the vaccine in the body.
Headache, facial pain, neck pain, numbness and tingling face, right arm and leg
Patient received Moderna Bivalent Pink cap/yellow label 0.2ml/10ug after CDC changes to discontinue monovalent.  Should have received Moderna Bivalent 0.25ml/25ug.
ALTERED MENTAL STATUS: after flu shot yesterday; received flu shot at 12:30pm; when they got home (approx 1 hour after flu shot) he went to his room mother noticed his whole body looked tense; no LOC; still responsive to parents but seemed incoherent; kept moving around wouldn't keep still; seemed uncomfortable wasn't speaking correctly saying "playgwound" instead of "playground"; increased crying yesterday therapist was with them at 3pm said he looked "off"; could not focus ; couldn't play a game; hard time getting his attention yesterday; went to school this AM ; mom had to pick him up b/c he wouldn't stop crying ; Mental status improving today after waking up from nap; eye contact getting better. No fever yesterday; +fever today Tm 100.9. Seen in clinic today and was back to baseline; no treatment needed.
1st Hep B 5/22/12 Sq tired with T - 100.5 2 hours post vaccine 2nd Hep B 6/25/12 by Tues. evening developed T 104.5 sore throat fever reduced to 101 with antipyretic tonsil swollen. Saw MD on 6/28/12 Dx Ear Infection & Pharyngitis Not Strep. Tx with 2000mg. Amoxicillin BID x 10 days. Practitioner, mother, & patient feel symptoms were related to vaccine especially the extreme tiredness.
Starting about 15 minutes after receiving shot, patient states that her muscles started tightening up. She had difficulty getting to her car and driving home, then had difficulty walking for the next week and had to use a walker when previously not having to use a walker all the time. She told her doctor about the event but is not sure if it was ever reported, and she received no treatment. She said it was "a few weeks" before she recovered to near normal condition.
Pt experienced numbness in left arm and hands, light-headedness, nausea and weakness
Covid-19 Vacc Mrna (5-11yr) (Pfizer) 10Mcg/0.2 Ml IM Susp (orange) use for COVID-19 under Emergency Use Authorization (EUA): Covid Vaccine was not diluted properly resulting in wrong dose of vaccine given to patient.
The patient was administered a dose with an incorrect ratio of diluent.  The vial was mixed with 0.8ml of diluent instead of 1.8ml.
Received 2nd Shigrix vaccine on 11/20/18: headache, body aches, low grade fever.
light headed upon leaving pharmacy.  Took 1 hr nap at home, woke up with loss of motor skills in legs and some in arms/hands, blurry/double vision both eyes.  8/11 went to GP she prescribed meclizine . 8/12/23 went to ER dizziness and blurred vision prescribed diazepam and was given shot of Toradol  had CT head wo contrast, which showed sinus conjestion.  On 8/13 went to ER extreme headache sinuses, arm pain, vision, no motor skills extensive tests and blood work  4 days in Hosp .  8/17 Dr indicated covid shot attacks weakness in body.  eye prob def was caused by covid shot.  some test determined spinal stenosis.  laminoplasty c3-7 needed and scheduled for 8/22.  8/21 went to ER for sinus headache and bilateral shoulder pain Neurology determined I have GBS, Miller Fisher Syndrome had 5 days IVAG therapy.
Red rash noted at site of DTaP injection two days after administration Seen by MD on 9/13/02. Symptomatic Tx.
Patient complained of nausea and dizziness. EMT was called. Vital signs BP 128/64 HR 76 O2 sat 97% and respirations 16. Patient given water. Patient refused need to accompany EMT to hospital. Patient states she is feeling ok.
Information has been received from a nurse practitioner concerning a 15 year old female who was the daughter of the nurse practitioners patient. It was reported that on 02-SEP-2007 the girl was vaccinated (dose not reported) with GARDASIL vaccine (yeast) (Lot# not reported). Subsequently, the experienced that her menstrual period was delayed two weeks post vaccination. Subsequently, she recovered from the delayed menstrual period. It was also reported that the patients other daughter had the same experience (WAES#0710USA03994). Additional information has been requested.
Legs, hips, back, arms, and neck joint and muscle pain. Heart palpitations,  Extreme fatigue and muscle weakness, Brain fog.
Saw strange visions; diarrhea; slept a lot; Fatigued; Felt sick; A spontaneous report  was received from a Consumer and other HCP  concerning a  79Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events like Felt sick, Fatigued, Diarrhea, Slept a lot, Saw strange visions.   The patient's medical history was not reported. No Relevant concomitant medications were reported.  On 16th Feb 2021 , prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:unkown) intramuscularly  for prophylaxis of COVID-19 infection.   On date 16th  Feb 2021, The patient experienced the event like Felt sick, Fatigued, Diarrhea, Slept a lot, Saw strange visions. She stated that she's feeling better now.  Laboratory details not provided.    No treatment information was provided.    Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the events are unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
After leaving Dr., mom said child began coughing/wheezing, eyes swelling and lips purple. Stopped at UC/ER where they gave steroid and albuterol Tx's.
Muscle tension in upper left arm and shoulder left side of face, went numb. Effects lasted for 3 days. Feeling came back, but not completely. Still have minor contact numbness.
APPETITE LOST; JOINT PAIN; FATIGUE; This spontaneous report received from a patient via a company representative concerned a 35 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. Non-company suspect drugs included: adalimumab (solution for injection, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for psoriatic arthritis. 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 14-MAR-2021, the subject experienced appetite lost. On 14-MAR-2021, the subject experienced joint pain. On 14-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient recovered from appetite lost, joint pain, and fatigue on 15-MAR-2021. This report was non-serious.
had them, popped up 3 days after my jab; This case was reported by a consumer via media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 3 days after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient reported that he/she was not a medical expert and never had shingles before. The patient got the shingle shot and shingle got popped up 3 days after jab. The patient had to wait 6 weeks in between the shingles vaccine and booster.  The patient told doctor that he/she want the shingles vaccine first because he/she rather take chances with COVID than go through that misery again.