chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injury; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, 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: INJURY (non-serious), outcome "unknown".  Additional information: Patient had an injury. Patient wanted to know if compensation for an injury was given from the COVID vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On April 28th I noticed a bald patch on patient's head. I had previously found several of his hairs in the bathroom but thought they were my husbands. I am applying a cortisone cream to his now 7 bald patches with no improvement.
Patient received vaccine early morning on the 15th of February. Left facility with no issues after injection. Met some friends for coffee and started to develop fever and shaking. Temperature was 101.4F. Patient was instructed to report to local Urgent care center, but chose not to go. Patient was contacted next day by provider and was sleeping comfortably with no fever or rash.
After first shot of GARDASIL on 2-7-08 had dizziness, headache, missed school. Second shot 5-7-08 had dizziness and severe headache - missed school. Fever 3rd 9-29-08 major dizziness sever headache needed help getting up and walking missed school.
Fever, uncontrolled rigors, extreme/uncomfortable aching of the feet and hands that awoke from sleep
A report was received from a health care professional on 10/17/03 concerning a group of vaccinees less than 4 years of age, of unknown sex who received Fluvirin on an unknown date. The reporter did not have vaccinee details or details of how many vaccinees were involved. At the time of the report there were no adverse events associated with Fluvirin. There was insufficient information to determine the reporter's causality assessment. Following up pending.
Area on right deltoid is raised and tender to touch, but not hot.  Area within raised area with erythema and approximately quarter sized.  Affected area is marked for monitoring and provider notified.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patient's medical history and concurrent conditions was provided. On an unknown date, the patient's were vaccinated with improperly stored doses of ROTATEQ, lot # L038534, expiration date: 19-AUG-2017, orally, (dose was not reported). There were no concomitant medications reported. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
05/19/2021 Nosebleed and 20 to 30 to stop. Abdominal pain. 05/27/2021 Infection, hospitalized to prevent infection to shunt. 06/01/2021 Pneumonia
Dose 1 Pfizer given 4/1/2021 Lot # ER8737  Patient died of heart failure, multiorgan failure at hospital on 11/24/2021, this is not a covid 19 death.
Itching, mild flushing 11:00 p.o. Zyrtec 10mg administered. Rx: Epi Pen given to pt with instructions if needed.
Patient was given Zostavax 0.65ml SQ in error instead of Varicella.  He was kept in office for 15 minutes, he had no adverse symptoms.  His mother reported temperature 102-103 x 2 days and gave patient Tylenol, with relief.  No other problems reported.  Mother states patient had developed increased temperature with all previous immunizations.  Doing good now 8/22/08.
On the 19th I developed a swollen lymph node under left armpit, on the 23rd my HSV 2 was triggered after not having an outbreak over a year.
Her daughter's throat started to close; This is a spontaneous report from a contactable consumer. This consumer (patient's mother) reported for a 55-year-old female patient. (This report is for the first dose)  A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number and Expiration date: UNKNOWN), via an unspecified route of administration on 02Apr2021 (At 55-year-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.   The patient also received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number and Expiration date: UNKNOWN), via an unspecified route of administration on 03Jun2021 and experienced adverse events.   Reporter stated that on 02Ap2021, 5 hours later after receiving the first dose her daughter's throat started to close. Immediately called 911 but 911 mentioned that they she doesn't need an EpiPen. Was not advised to go to the ER. The outcome of the events was unknown.    Follow up information needed, Information related to lot/batch no. has been requested.
ambulating difficulty; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (ambulating difficulty) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Allergic to z-pack (azithromycin)). Concomitant products included METOPROLOL SUCCINATE (TOPROL), ROSUVASTATIN CALCIUM (CRESTOR), VITAMINS NOS, ACETYLSALICYLIC ACID (BABY ASPIRIN) and SIMVASTATIN (STATIN [SIMVASTATIN]) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced GAIT DISTURBANCE (ambulating difficulty). At the time of the report, GAIT DISTURBANCE (ambulating difficulty) outcome was unknown. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication use was not provided by the reporter   This case was linked to MOD-2021-316298 (Patient Link).
Right Upper arm large oval area of redness, warmth, edema, prunritis approx. 10cm X 4cm. oval no fever, no systemic signs
Neurological symptoms began on 4/5/21, migraine with numbness/tingling into right arm. Full stroke work-up done per neurologist. Echo (4/14/21) came back abnormal (mild mitral regurgitation, mild tricuspid regurgitation, trace pulmonic regurg, mitral annular calcification). Echo previously done in 02/2019 which was completely normal.
The MA assistant call me because the patient started after the Pfizer vaccine first dose with dizziness. The patient has had a history of Asthma and epilepsy. He takes Depakote 8 ml at bedtime, and Lithium 150 mg daily. The vital was normal range. After that, the patient started with facial edema. Denies swelling problems, respiratory problems, or wheezing. I called the doctor for evaluation. I administered 10 ml of Benadryl. Also, the patient started with a rash in his body. After 30 hours the patient starts to feel better. I explained to her mother the side and vaccine reaction. Although, I explained if the symptoms are worse the patient needs to ER ASAP. The provider suggests no administration of the second dose
was vaccinated for 2 doses of Pfizer covid vaccine and just tested positive and has been exposed.; was vaccinated for 2 doses of Pfizer covid vaccine and just tested positive and has been exposed; This is a spontaneous report received from a contactable reporter(s) (Physician) for a Pfizer sponsored program.  A 80 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), outcome "unknown", described as "was vaccinated for 2 doses of Pfizer covid vaccine and just tested positive and has been exposed."; DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "was vaccinated for 2 doses of Pfizer covid vaccine and just tested positive and has been exposed". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. It was concerned that, caller Dr. (name withheld) has an 80-year-old patient that was vaccinated for 2 doses of Pfizer covid vaccine and just tested positive and has been exposed. Stated that, the caller was trying to find out whether the PAXLOVID was recommended for people tested positive or at high risk and asymptomatic. Any medical questions addressed by this program forwarded/referred to Medical Information was reported as yes: Customer and/or medical inquiry forwarded or referred.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided, a causal association between reported events drug ineffective, covid-19, and the suspect BNt162B2 cannot be excluded.
(R) arm muscle area appear red, swollen. C/O soreness, itchiness, hot to touch, afebrile, ok appetite, or drinking, no fevers, no S.O.B.
Patient returned to pharmacy about a week after vaccine administration with complaint of visible irritation/discoloration at injection site and minimal pain and itching for a few days after vaccination.
09/30/2021, Thursday, the evening of the vaccination- I had chills.  On 10/01/2021, Friday, I went to the bathroom around 07:30 AM  and the next thing I know I was on the floor, and sweating a ton, I realized I passed out   I had nausea, I never vomited,    diarrhea,  fever, the highest temperature was 100.5. I didn't take anything for the fever because I was nauseas. And I had tingling in both hands, but it only lasted like 5 minutes. On Monday 10/04/2021 I went to the  Immediate care due to fainting. They had to do a CAT scan on my head due to taking blood thinners. Everything was normal.  On Saturday 10/02/2021- everything was okay. I had no more symptoms, nausea, fever, chills, vomiting, were all gone. I just had injection site pain, it was not excessive. It was swollen but it never got red and that lasted for like 4 days.
On 11/9/2021 the patient woke up with urticaria (face and lips swollen, whelps on trunk and extremities) and was treated for urticaria, but once off the steroids her symptoms returned.  She has struggled with chronic urticaria from 11/9/2021 through present 1/17/2022. She has seen an allergist and had extensive lab testing to rule out other treatable causes and none found. Pt is having to stay on a daily antihistamine and H2 Blocker to keep symptoms controlled.  The allergist she is seeing has 3 other patients who have experienced new onset of Urticaria after Covid vaccines or boosters.
*Patient scheduled by facility for 1 dose COVID vaccine.*Client give Moderna dose on 07-16-21.*Later review showed that client had received Janssen vaccine on 06/10/2021.*Inadvertent dose
red rash all over body, face & extremities per mom;also states that some of the rash has blisters on top;mom states pt is having a temp of about 101;rash & temp started 16OCT98 about 9PM;
sx devel on 25JUN w/ c/o soreness in arm; 28JUN seen MD for pain; 29JUN92 had flu like sx had MRI which showed inflammation; placed on Keflex; 1jUL h/a w/n,v adm to hosp;
PT REPORTED PAIN/ SORENESS IN LEFT ARM, ENOUGH THAT A NUMBER OF DAYS LATER SHE WENT TO MD AND RECEIVED FLEXIRIL, DICLOFENAC AND A MEDROL DOSE PACK
patient had an AE and may be paralyzed for the rest of life; patient had an AE and has not been able to work; Initial information received on 22-Mar-2021 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional (patient's step-daughter).  This case involves adult male patient (unspecified age) who had an adverse event and has not been able to work (impaired work ability), may be paralyzed for the rest of life (paralysis) while he received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient had no medical history, concomitant disease or risk factor.   Past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious an adverse event and has not been able to work (impaired work ability), may be paralyzed for the rest of life (paralysis) unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This events were was leading to disability and event paralysis was assessed as medically significant.  The reporter wanted to know if there is any compensation from the company since they were losing income and just wanting for some one in safety/quality to contact her.   No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was unknown  Information on lot number was requested for this case.; Sender's Comments: This case concerns male patient (unspecified age) who had paralysis and impaired work ability after vaccination with FLUZONE QUADRIVALENT. The time to onset is unknown. Additional information regarding medical history, condition at the time of vaccination, lab data excluding other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Case number PHEH2011US07445 is an initial spontaneous report received from a nurse on 07 Oct 2011: This report refers to an 11-year-old female child. She was given only the CYW-135 liquid component of MENVEO (batch number: X10130) intramuscularly on 06 Oct 2011. No other adverse event was reported.
A 9y/o boy got YF vaccine to travel to YF endemic area. He traveled to YF endemic areat either July 8 or July 9 until July 12. He presented to clinic on July 13 with fever 39.5, asthenia, vomiting, myalgia, arthalgia. Weak, febile, icteric sclera on exam in clinic. Had generalized tonic clonic seizure in clinic. Responded well to anticonvulsants. Hospitalized. Still in the hospital. Working diagnosis: dengue hemorrhagic fever by tourniquet test. Question as to whether adverse event is due to vaccine and whether or not this is dengue.
Cellulitis on right arm, went to ER and then admitted, had become Septic.  Right arm was red and warm to touch.  was in hospital for 4 days and sent home on Clindamycin 300mg one every 8 hours for 10 days.
A few minutes after receiving the vaccine, my left arm (side of injection site) became tingly, numb, and cold. This lasted for two days and eventually creeped up to the left-side of my neck and face. After taking ibuprophen the tingliness went away but comes back every few days. It feels like when you sit on your foot and it falls asleep. No pains or lack of mobility.
Had chills, body aches, vomiting / most aches were in neck, head , back and abdomen. Started at 1am on 4/7 till 1am on 4/8.  Took Tylenol and Advil
Narrative: COVID-19 hospitalization in fully vaccinated person. Tested positive 8/19/21. Admitted 8/26/21 with acute hypoxic respiratory failure secondary to COVID-19. On arrival, satting 75% on room air. Improved with supplemental oxygen via NC, intermittently requiring HFNC. Received dexamethasone and remdesivir during hospitalization. Received short term (4 day) antibiotic coverage for CAP but discontinued given no signs/symptoms of superimposed bacterial pneumonia. Some hemoptysis during hospitalization, CTA chest negative for PE. Oxygen needs slowly decreased, weaned to room air on 9/5. Required some oxygen with activity. Discharged 9/6 in stable condition with supplemental oxygen with activity.
PATIENT DESCRIBES DEEP ACHE IN RIGHT ARM THAT STARTED A DAY AFTER VACCINE ADMINISTRATION.  SHE REPORTS NOT BEING ABLE TO LIFT HER ARM VERY MUCH.  SHE HAS BEEN SELF MEDICATING WITH IBUPROFEN AND ICE PACKS AS DIRECTED BY ADMINISTERING PHARMACIST AND HER OWN PHYSICIAN.  AS OF 3 DAYS AFTER ADMINISTRATION, SYMPTOMS HAVE NOT SUBSIDED MUCH.
24 hours after patient received Flumist, he developed a cough.  The next day he developed fever, which persisted for 4 days.  He was seen in the ER on 19 November, 5 days after the immunization, and diagnosed with pneumonitis and RLL pneumonia.  Treated with albuterol, Zithromax and prednisolone.
Right arm redness, warmth and soreness at injection site began 10/26/2021.  right distal cervical lymph node tenderness began 10/27/2021 Both adverse events are still active today 10/28/2021
Left deltoid swelling, pain, possible cellulitis. Started approximately 16-24 hours after IM injection. Follow up 01/24/05: Patient had cellulitis on the site involving deltoid to elbow. Admitted to hospital and discharged after 24 hours.
Post prandial abdominal pain, nausea, vomiting, diarrhea, chronic fatigue, recurrent blepharitis, joint pain, candida esophagitis, memory loss, lack of concentration, weight loss and headaches. Treatment: 1/00-prednisone but reflaring during taper, not responding well to 2nd trial in 5/00; 9/00-sulfasalazine with some improvement of GI pain but side effects of migraine type headaches and nausea; also tried Asacol and continues but has flares. Too many to list.
"CHILLS AND FEVER (SUBJECTIVE, DID NOT TAKE TEMP) TOOK 2 ASPIRIN AND FELT FINE NEXT MORNING."
Menstrual periods have stopped, severe hot flashes (15+ times per day), excessive night sweats
Redness, swelling, pain, itching entire upper arm of injection site.  Treatment (self medicated) Tylenol 1000mg 4 times a day, Claritin antihistamine once a day, cold compresses. Still present today, 6 days after immunization.
Headache,  hot flashes, aching body, chest pain, flu like, leg cramps,
Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 08-APR-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K007979, exp date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Chills, Severe muscle, Joint Pain,  Treatment; Tylenol, Mobic,
After receiving Tdap yesterday, she noticed a small bump at injection site remainder of the day. She woke up this morning and noted more swelling/redness/warmth at injection site. Also noticed rash on hands and feet that is very itchy, hot. +loose stools. Similar reaction to flu/ppsv23 in past. She denies cough, SOB, tongue swelling but has noticed some tingling sensation around lips but no visible swelling. Denies fever. She took benadryl and ibuprofen this morning. Symptoms improving.
Weakness in right hand (specifically pinky, index and middle fingers), numbness and tingling in both hands. Large round  blisters on both legs.
This spontaneous report as received from a physician via a company representative, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unspecified date, the GARDASIL 9 vaccine had a temperature excursion of 24 hours. The lowest recorded temperature was 34 F (1.111111111 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". On 02-JUN-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 "0.5mL-10 Pk SD PFS-Luer-Lok" which had a lot number of M003659 and expiration date on 20-SEP-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
This spontaneous report was received from a reporter (role unspecified) via a company representative and refers to a female patient of an unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 26-MAY-2017, the patient was vaccinated with the first dose of GARDASIL 9 injection (route and site of administration, dose, lot number and expiration date were not reported) for prophylaxis. On approximately 02-JUN-2017 (reported as about a week after the injection), the patient experienced pigmentation of the skin for an unspecified reason. The outcome of pigmentation of the skin and the relatedness between the event and GARDASIL 9 were not reported. At the time of reporting no additional adverse event information was available. Additional information has been requested.
Shoulder stiffness for last five weeks. Pain in shoulder. Not able to lift shoulder. Unable to sleep at night due to pain.
It was reported that a male pt received a Fluzone SV '00-'01 vaccination on 30 Oct 2000. Reportedly the pt developed urticaria 4 hours after injection and was managed with Benadryl. Further information is requested.
Vaccination failure; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Mar2021 as dose 1, single (Lot number: EN6205), in left arm, on 11Apr2021 as dose 2, single (Lot number: EN6204), in left arm and on 29Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic low back pain" (unspecified if ongoing); "Chronic GERD" (unspecified if ongoing); "Generalized anxiety disorder" (unspecified if ongoing); "Hypercholesterolemia" (unspecified if ongoing); "Osteoarthritis of knee" (unspecified if ongoing); "History of severe acute respiratory syndrome" (unspecified if ongoing); "coronavirus 2 (SARS-CoV-2) disease" (unspecified if ongoing); "History of transient ischemic attack" (unspecified if ongoing). No known allergies. Concomitant medication(s) included: ASPIRIN (E.C.); FEXOFENADINE;PSEUDOEPHEDRINE; OMEPRAZOLE. The following information was reported: COVID-19 (medically significant) with onset 2022, outcome "recovering"; VACCINATION FAILURE (medically significant) with onset 2022, outcome "recovering", described as "Vaccination failure ". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Jun2022) Negative, notes: Had negative home antigen test on 20Jun2022; (22Jun2022) Positive, notes: On 22Jun2022 tested positive with home antigen test. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Paxlovid treatment start date=09Jun2022, treatment stop date=13Jun2022, administrator route: Oral. Covid illness rebound after Paxlovid therapy. Onset of symptoms: 10Jun2022. Treated with Paxlovid 5-day course 10Jun-14Jun2022. Felt well. The patient had negative home antigen test on 20Jun2022. Next day (21Jun2022) felt ill (URI symptoms). On 22Jun2022 tested positive with home antigen test and returned to home isolation for 5 days.  . The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, the causal association between the events vaccination failure, COVID-19 and the suspect drug cannot be excluded.
At the reported time, I started experiencing tinnitus in both ears, more acutely in the right ear. This condition persisted through the day and overnight until the next day. At the time of filing this report, the  condition persists.
Relapse of schizophrenia after 19 years of stable maintenance on antipsychotic drugs.
After the 1st injection, I had severe migraines and my blood pressure spikes. I had continuous shuddering and it got worse with the second injection. I had stroke like conditions, so I went to Urgent Care.