chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was considered medically important (OMIC). Information regarding Hib titer vaccine (haemophilus B conjugate vaccine (diphtheria crm 197 protein conjugate) injection) was received from a consumer regarding a male patient who experienced autism. The patient received a dose on an unspecified date. Relevant medical history was not provided. Indication for Hib titer vaccine was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. Additional suspect medication included Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection). Concomitant medications were not reported. On an unspecified date, the patient was diagnosed with autism. Outcome was unknown. No additional information was available at the time of this report.
Flushing/red and warm face and neck. Allergist had me take Pepcid and Allegra 1 hour before because the first shot I also had flushing and hives.   I told the ladies giving me the shot and they told the nurse and she monitored me after the vaccine. She gave me Benadryl at 4:10pm and then I got picked up by a family member after my redness started going down.   It?s 8pm now and still monitoring my symptoms but the red warm face has seem to finally fade away.
Deviated from his course of Vivotif / did not complete the Vivotif course in time; Spontaneous report received on 24FEB2020.  A nurse reported that a male consumer who "deviated from his course of Vivotif / did not complete the Vivotif course in time" (PT: Incomplete course of vaccination). The consumer was receiving Vivotif capsule for immunisation. The consumer did not take the Vivotif doses according to the schedule. The doses were taken on 13FEB2020, 16FEB2020, and 18FEB2020. He has yet to take the fourth dose. Action taken with Vivotif with respect to reported event was not applicable. The outcome of the event was unknown.  Company Comment: A consumer deviated from his course of Vivotif  and did not complete the Vivotif course in time (Incomplete course of vaccination). Vivotif should be taken every other day. Considering the nature of the event, the causality of Incomplete course of vaccination is assessed as not applicable to Vivotif.; Sender's Comments: A consumer deviated from his course of Vivotif  and did not complete the Vivotif course in time (Incomplete course of vaccination). Vivotif should be taken every other day. Considering the nature of the event, the causality of Incomplete course of vaccination is assessed as not applicable to Vivotif.
Approx. 2? diameter circular bruise/abnormal ring spot appeared within 24 hours of first injection.  Abnormal circular region is located on same left arm as injection, however, not at injection site.  It is located under my left bicep region, not the deltoid region.
Pneumonia Due to Aerobic Bacteria (Cms-Hcc),cute Hypoxemic Respiratory Failure (Cms-Hcc), Chronic Viral Hepatitis C (Cms-Hcc),ype 1 Diabetes Mellitus With Hyperglycemia (Cms-Hcc), Diabetic Ketoacidosis (Cms-Hcc), Severe Sepsis (Cms-Hcc), Benign Prostatic Hyperplasia
This spontaneous report was received from a health care professional refers to a 60 year old patient of unknown gender. On 18-FEB-2016 the patient was vaccinated with an expired dose of ZOSTAVAX vial 19400 PFU (plaque-forming units) (lot # K021953; expiry: 10-FEB-2016). No adverse experience has been reported. No additional information was provided. Additional information has been requested.
COULD NOT WALK FOR A PERIOD OF TIME; CAN'T SLEEP; INTENSE BURNING IN BACK AND IT ALL WENT TO FINGERS; TERRIBLE SHOULDER PAIN; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 15-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced could not walk for a period of time, can't sleep, intense burning in back and it all went to fingers, and terrible shoulder pain. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from terrible shoulder pain, and can't sleep, and the outcome of could not walk for a period of time and intense burning in back and it all went to fingers was not reported. This report was non-serious.
This spontaneous report was received from a pharmacist regarding a 72 year old female patient. There was no patient's pertinent medical history or concurrent conditions. On 07-APR-2015, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot number and expiration date were not provided). There was no concomitant medication. On an unknown date in April 2015, the patient experienced anaphylactic reaction such as difficulty breathing, numbness and pain in her arm where she got the injection. The patient sought medical attention, she saw the pharmacist. The patient did not receive treatment for the adverse events. Laboratory test was not performed. At the time of the report, the patient had not recovered from the adverse events. Additional information has been requested.
01 7mm Erythemic induration, hot to touch and hard to touch. At vaccine administration site on R arm over triceps region. Induration appeared 02 days after administration of vaccine.
Client states onset of symptoms began "2-3 days after the injections". She complained of soreness and swelling to area of injection that extends to elbow. Client presented to the Health Department 03/15/17 (6 days post injection).
This case was reported by a physician via call center representative and described the occurrence of general body pain in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced general body pain and influenza-like symptoms. On an unknown date, the outcome of the general body pain and influenza-like symptoms were unknown. It was unknown if the reporter considered the general body pain and influenza-like symptoms to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The reporter had no information about the vaccine lot number or expiry date. The health care professional (HCP) reported that the patient received SHINGRIX and experienced body aches and felt like he had the flu. The adverse event (AE) collected via chat.
Reportedly, pt. developed symptoms eventually diagnosed as Guillain-Barre Syndrome. Starting a few days after vaccine, she dvlped flank pain, numbness, and ataxia. She is currently at Rehab.60 day follow-up received on 10/17/00 states that the pt has partially recovered.
9 days after the injection there was swelling, redness and warmth  at and around the injection sight.  The area around the injection sight was warm and and firm and tender to the touch.
Person was fully vaccinated by 1/25/2021 and then was diagnosed with COVID infection 3/31/2021
MS relapse (fatigue, vision problems, intractable headache). Prolonged redness and soreness at site of injection (>2 wk out).
3hr p/vax the area under this pt necklace became very itchy;that evening pt devel a low-grade fever & a band of hives around neck;the next day pt had a fever up to 101 & a red warm knot @ the inj site;
Patient 10 years of age presented to clinic with Mother. Patient identifiers verified with specific age "10"  not stated by Patient, or Patient's Mother. Pre-vaccination screening questionnaire for COVID-19 Vaccine completed,  consent signed by Patient's Mother and witnessed by Staff Nurse. Staff Nurse proceeded to administer Pfizer COVID-19 Vaccine, 0.3mL intramuscular injection into Right Deltoid x1, to patient.  completed follow-up with Mother upon discovery.  Mother denies any adverse signs or symptoms, and/or illnesses with patient.
Vertigo and nausea beginning on  3/16/2021 (day8) and ongoing. Red, hot rash on right arm at injection site starting day 3/20/2021 (day 12).
tested positive for COVID; tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 73-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Jun2023 as dose 6 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "recovered" (Oct2023) and all described as "tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2023) Positive; (Oct2023) Negative, notes: one day before this report she tested negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was treated with nirmatrelvir, ritonavir (PAXLOVID).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received Moderna COVID vaccine on 1/8/21 and 2/5/21. After 1st dose, she experienced a rash that resolved. After the 2nd dose, she experienced a debilitating headache that lasted for 6 months requiring  multiple doctor visits and additional treatment (gabapentin, oxcarbazepine, baclofen, indomethacin, prednisone, cyclobenzaprine, and ibuprofen). Only the last 2 medications helped relieve the headache.
Per client self report:  Experienced LLE extremity pain beginning on 4/11/2021, but thought nothing of it at the time.  Client was previous scheduled for testing/procedure for asthma with pulmonologist on 4/15/2021, with pre-test/procedure lab work scheduled for Monday, 4/12/2021.  Client presented for lab work on 4/12/2021 as scheduled and shortly thereafter received phone call from pulmonologist's office stating that the labs showed and elevated D-dimer and that she would be scheduled for a follow-up CT Scan of the chest and ultrasound of the lower extremities, which was scheduled on 4/14/2021.  Client presented for CT scan of chest and ultrasound of lower extremities as directed and returned home on 4/14/2021.  Client reported in conversation that she "didn't feel right" and noticed some SOB, and had planned to rest outside of going in for scheduled tests.  Client received a phone call on 4/14 from pulmonologist's office advising her to go immediately to the emergency room due to a blood clot being found in the left lung as per CT scan report.  Client presented to Emergency Room and was started on Eliquis 5mg tablets - 2 tablets by mouth twice daily X1 week and then 1 tablet by mouth twice daily and discharged to home.  Client remains at home at the time of interview with no additional or worsening symptoms.
When the patient returned for her second dose  she reported that she  had pain and a marked decrease in mobility in that arm and shoulder for about 2 weeks. She stated it is much better but still sore to the touch. She left the original band-aid in place from that vaccination and indeed, a worn band-aid was in place. The injection site was very high in the left shoulder, near the boney prominence.
PATIENT STATES SHE DEVELOPED SORENESS, REDNESS AND HEAT SPREADING DOWN ARM THAT VACCINE WAS ADMINISTERED. PAIN HAS SINCE SUBSIDED. SEEN BY DOCTOR 10/22/2015. DOCTOR RULED OUT CELLULITIS AND PRESCRIBED PREDNISONE.
This spontaneous report was received from a registered nurse refers to a patient of unknown age who on 29-NOV-2012 was vaccinated with an improperly stored dose of PROQUAD (dose and route unknown), Lot #: H015623, Exp date: 21-FEB-2014. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. Patient outcome was unknown. This is one of several reports from the same source. Additional information is not expected.
stroke; vertigo attack; severe headaches; severe dizziness; A spontaneous report was received from a consumer who was also a male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced severe headaches / headache, severe dizziness / dizziness, vertigo attack / vertigo, and stroke / cerebrovascular accident.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 13 Feb 2021, prior to the onset of the events, the patient received their second dose of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 13 Feb 2021, about 12 hours after receiving the vaccine, the patient experienced severe dizziness and severe headaches which lasted for about 4 days.   On 17 Feb 2021, while driving, the patient thought he was having a vertigo attack and went to the emergency room. He had a cat scan (results not provided) and was treated with TPA (tissue plasminogen activator). After three days in the hospital, they determined he had a stroke.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the events, severe headaches, severe dizziness, vertigo attack, and stroke, was not provided.; Reporter's Comments: This case concerns a male patient, who experienced a serious unexpected event of cerebrovascular accident among others, 5 days after receiving 2nd dose of mRNA- 1273 (Lot# unknown). Very limited information regarding this event has been provided at this time. Further information has been requested.
Systemic: Confusion-Medium, Systemic: Shakiness-Severe, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Weakness-Mild, Additional Details: Patient described the night he got the vaccine, he started shaking while laying in bed. He could not control his movements and he stated his mental state was not normal. This lasted about 10 minutes. He has since recovered and only has a sore arm/tingling on the opposite arm of the one he got the vaccine in (right arm) from the shoulder to elbow.
Mild tingling in tongue, felt "funny allover",  itching, mild shortness of breath, difficult shallowing,  hives, swelling in arm (right administered 75mg of Diphenhydramine oral 10 minutes apart, symptoms leveled out until assisting to restroom, needed assistance ambulating to and from toilet felt dizzy and weak, itching in arm became unbearable, itching all over became severe, administered patient's epipen, called EMS,  patient was responsive when sent in ambulance to ER.
no adverse event; Patient given expired dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient given expired dose) and NO ADVERSE EVENT (no adverse event) in a 22-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.  In 2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. In 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient given expired dose). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient given expired dose) and NO ADVERSE EVENT (no adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient given expired dose).    Concomitant product use was not provided by the reporter.  Patient given expired dose. It was unknown if the patient experienced any additional symptoms/events.  Treatment information was not provided.
Fever onset less than 24 hr after vaccines with seizure lasting less than 10 minutes.  Treated symptomatically and with azithromycin for otitis.  Temp decreased.  Fever reoccurred 24 hr later with 2nd seizure.  Child admitted to hospital.  Maximum temp 104.5.  5/9 Received only partial hospital medical records for 4/8-4/10/2008 consisting only of lab reports.  8/5/08 Reviewed hospital medical records of 4/8-4/10/2008. FINAL DX: complex febrile seizures & acute viral illness.  Records reveal patient experiened fever of 104.5 & seizures w/flexion, clenched fists, shaking, eyes rolled up, frothing at mouth for approx 10 min then sleepy afterward.  Seen in ER & dx w/OM & febrile seizures.  Tx w/antipyretic & d/c to home.  Following day, fever of 102 despite antipyretic & had another seizure lasting 15-30 min.  Exam revealed injected TMs bilaterally, erythematous oropharynx w/enlarged tonsils & shotty lymph nodes.  No further seizure despite additional fevers.  D/C to home w/outpatient EEG & neuro f/u.
XXXXXXX (patient's) mother was holding him while I administered a flu shot. When I pierced his skin with the needle he and his mother moved away from me and the needle came out before all of the vaccine had been injected. This happened at a flu clinic at a school. I spoke with his mother several days later and her son was doing fine. I attempted to notify XXXXXXX (patient's) physician but he was out of the office until tomorrow. Medication administered to or used by the client: Yes. Outcome: I spoke with his mother several days later and her son was doing fine. I attempted to notify XXXXXXX (patient's) physician but he was out of the office until tomorrow. Patient counseling provided: Unknown. Relevant materials provided: None.
Arthralgia, Diarrhea, NauseaVomiting, Chills, fatigue, Positive COVID test 9/11/2020
pt recv vax 5JUN98 & c/o h/a;8JUN98-9JUN98 pt c/o n/v & diarrhea;10JUN98 pt is still home w/diarrhea;no vomiting;has eaten toast, orange juice & milk w/APAP;has been around people who also have had gastric sx;as of 10JUN98 is alive but stil
Information has been received from a physician concerning a "16 year old" female with no pertinent medical history who on 13-NOV-2007 was vaccinated with a first dose of GARDASIL (lot# unknown) 0.5mL IM. Concomitant therapy included MENACTRA (lot# unknown). On 13-NOV-2007 the patient fainted after receiving GARDASIL. Medical attention was sought. No additional information was provided. Additional information has been requested.
Pt's mom reported itching 1 hr after vaccines. Gave Benadryl. Pt's boyfriend states she started twitching/shaking head & neck & eyes rolled back in her head. 9/22/08-records received-9/9/08-Seen in office day after C/O itching, twitching and shaking head and neck. Eyes rolled. PE grossly WNL.
This case involves an unknown age female patient who experienced excruciating pain in arm, muscle aches; debilitating aches in her legs and buttocks and headache while receiving vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. In December 2021, the patient received a dose  dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE, formulation, strength, dose and lot number not reported via unknown route in unknown administration site for immunisation. In DEC-2021 the patient developed a non-serious event "excruciating pain in arm" (pain in extremity) (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. In DEC-2021 the patient developed a non-serious event "muscle aches; debilitating aches in her legs and buttocks" (myalgia) (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. In DEC-2021 the patient developed a non-serious event "headache" (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. It was reported that "Patient had excruciating pain in her arm, but not the arm the vaccine was administered in. Pain went away after 15 minutes. Compared pain to heart attack. - Muscle aches that are not normal muscle aches. Caller stated they were debilitating aches in her legs and buttocks for about four days. - Headache; caller stated she does not usually have headaches". Action taken with QUADRIVALENT RECOMBINANT INFLUENZA VACCINE (FLUBLOK QIV) was not applicable for all the events. It was not reported if the patient received a corrective treatment for the events (excruciating pain in arm, muscle aches; debilitating aches in her legs and buttocks, headache). At time of reporting, the outcome was Recovered / Resolved in December 2021 for the events (excruciating pain in arm, muscle aches; debilitating aches in her legs and buttocks) and was Unknown for the event (headache).
The 26th, I woke up and my knee joint hurt me terribly and my elbows were hurting. Sunday, the same joints hurt, and my right shoulder joint also hurt and my wrists. Then Monday neck and throat hurt and Tuesday more joints hurt. Wed, I couldn't lift my right arm and my fingers and hands, and wrists hurt. I went to the doctor, shot of Kenalog in my butt. I didn't go to work. Gradually over the following days my symptoms subsided. My ear and joint in my shoulder still hurt.