chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Became immunocompromised; This is a spontaneous report from a non-contactable consumer (patient reported for herself) from Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported) via an unspecified route of administration on 2021 as dose 3 (booster) single for covid-19 immunization. The patient's medical history was not reported. Concomitant medications included unspecified steroids after the Pfizer covid-19 vaccine. Patient received the dose 1 and dose 2 of BNT162B2 as covid-19 immunisation on unspecified dates. The patient became immunocompromised on an unknown date in 2021. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
immunocompromised; kidney transplant; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team, Program ID.  A 55-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in 2021 as dose 2, single (Batch/Lot number: unknown), on 19Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 19Feb2022 as dose 4 (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: IMMUNODEFICIENCY (medically significant), outcome "unknown", described as "immunocompromised"; RENAL TRANSPLANT (medically significant), outcome "unknown", described as "kidney transplant". Clinical course: patient was a female and had a kidney transplant. Patient is immunocompromised. Patient received dose 1 and dose 2 of the Pfizer COVID-19 vaccine, and instead of getting dose 3 at the recommended time frame, the patient received the 3rd dose on 19Aug2021, which was 6 months after the 2nd dose. And then the patient received the 4th dose on 19Feb2022, which 6 months to the day after the 3rd dose. Caller clarified that the patient did get the doses within the recommended time frame, but caller knows someone that is immunocompromised and a transplant recipient, should receive the 3rd dose in the primary series, so caller is asking if the patient can get a 5th dose of the vaccine. Had a kidney transplant: Unable to confirm if this occurred prior to the patient receiving the vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported serious events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Unusual arm soreness appearing third or fourth day after administration. After conversation the patient indicated that the extremity had been sore prior to administration. Instructed patient to recontact vacine administrator if problem persists.
Headache, Arthralgia, Sore arm, fever Narrative:  Other Relevant History:
No other AE reported; received the second dose of GARDASIL 9 on 30-JUL-2021/received the third dose of GARDASIL 9 on 12-AUG-2021; 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 30-JUL-2021, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route of administration, anatomical location, lot# and expiration date were not reported) for prophylaxis.    On 12-AUG-2021, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # T028583, expiration date 04-MAR-2023; strength, dose, route of administration and anatomical location were not reported) for prophylaxis, which was given too soon after the second dose (inappropriate schedule of product administration). No other adverse event was reported. No product quality complaint (PQC) was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T028583; expirationdate: 04-MAR-2023; deviceage and unit: 0; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Right arm muscle in which vaccine was injected became increasingly sore throughout the day after receiving in the morning of that same day.  Very painful that night and had difficulty sleeping although I took ibuprofen.  Next 2 days (2nd and 3rd days), could not lift arm up.  On 4th day, could only lift arm with much pain to take off shirt, undergarments, or pour water from a tea kettle, etc.  On 5th day, still very sore but noticed slight improvement.  By 6th day, could perform all normal activity but still feel slight soreness when doing so.
This spontaneous report as received from a pharmacist refers to a 30 years old male patient. The adult client with unknown vaccination history for MMR II (lot number not provided) had low seropositive antibody titers for rubella. No other co-suspects were reported. No concomitant medications were reported. It was unspecified if the patient had sought medical attention. Additional information is not expected.
Swelling in her arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling in her arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swelling in her arm). At the time of the report, PERIPHERAL SWELLING (Swelling in her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use and treatment information was not provided.   This case was linked to MOD-2021-024495 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Reporter contact information is updated.
Shaking and chills 8 hours after shot shortness of breath , painful sensation in lungs. 3/19- lungs still do not feel right. Other symptoms resolved.
It was reported that a female pt received a Fluzone SV '99-'00 and a Pnu-Imune 23 vaccination mixed in one syringe, on 11/4/99. Reportedly, on 11/6/99, the pt developed urticaria, erythema and an induration. Benadryl 25mg per oral, every 4 hours, was prescribed. The symptoms resolved on 11/9/99. No additional information was provided from follow-up correspondence returned on 12/6/99.
Fatigue, blurred vision, increased thirst, increased urination  after receiving second vaccination (Started 2/10/21)
Information has been received from the patient's mother concerning her daughter with allergy to latex, who on an unknown date was vaccinated with a dose of GARDASIL. The patient's mother stated that on an unknown date, her daughter experienced symptoms that "mimicked a stroke". Upon internal review "mimicked a stroke" was considered to be an other important medical event. Additional information has been requested.
(L) arm at site of ZOSTAVAX - 7x11 cm indurated, erythematous, warm. Local reaction vs. cellulitis -> amoxicillin/clavulanic acid.
Cellulitis with abscess. Seen by Dr (Occ. Med) and treated successfully with Bactrim DS.
24 yo female who presents to the ED for concern for anaphylaxis after receiving her second dose of the COVID-19 vaccine. Patients presents as a rapid response after receiving Epi pen to her thigh at 11:18AM.  She reports that after getting the vaccine, she was sitting in the monitoring area. At the 10 min mark she noted that she had a slight cough and some eye tearing. She went to the bathroom and noticed that her eyes were swollen and she could barely open them. Someone told her that her lip looked swollen but she did not look at it in the bathroom. She also felt some throat tightness but no wheezing. She had nausea prior to vaccine, no vomiting. She had no lightheadedness or palpitations and no itching or rash anywhere. She got an Epipen at 11:18AM.  A rapid response was called and she was brought to the ED.   She has no personal or family history of allergic reactions and no known allergies.
Began Saturday with headache over right side of head, rash across right side of forehead, began on Sunday and has multiplied in same are over last 2 days. On Monday fluid began collecting in upper right eyelid.
I had noticed over a period of time sleepiness , unplanned weight loss, extreme anxiety. My thyroid levels were abnormal.
Information has been received from a physician concerning a 6 month old healthy full term born female patient with no pertinent medical history and no drug reactions/allergies, who on 25-JUL-2011 and on 23-SEP-2011, was vaccinated orally with the first and the second dose of ROTATEQ (Lot# 668341/0526Z for both doses), respectively. The patient did not experience any adverse event with the first or second dose. On 02-DEC-2011, the patient was vaccinated orally with the third dose of ROTATEQ (Lot#669825/1347AA). There was no concomitant medication. On 15-DEC-2011, the patient presented with vomiting and decreased oral intake but no bloody stool and was taken to the hospital, where an ultrasound was conducted and the patient was diagnosed with intussusception. The patient was admitted overnight for observation and on 15-DEC-2011, was treated with air contrast enema, On an unspecified date, the patient recovered without surgery. Additional information has been requested.
pt recv vax & exp pain @ the inj site & felt jarring of the arm as was walking;then devel redness & a lump @ the inj site;self tx advil & hot compresses;next day exp dizziness;lump @ inj site resolved but was till red & sore;
Patient had syncopal episode. He slid to the floor and then vomited. Vitals stable. Pt laid on exam bed x 20 minutes after. He ate crackers and juice and was able to stand. Vitals remained stable. Patient left clinic.
Rash (likely Lichen Planus) on bilateral forearms, abdomen, and bilateral legs
Had the 1st of the 2-part vaccine on 08/30/2021, within 48 hours was having some difficulty walking, but sustainable.  Had the 2nd of the 2-part vaccine on 09/20/2021, within 48 hours, was not able to walk 10 feet.  To this day, my legs feel as if I am carrying around cement blocks strapped to my legs, and cannot walk more then 25 feet without having to sit down.   I cannot go hiking or do anything that would include walking (using my legs) a distance without the use of a cane or mobility scooter.  My quality of life dropped since these vaccines were taken.
pt brought to ED via EMS for an increase in SOB over past week; positive for COVID; given dexamethasone, remdesivir; O2 supplementation; COVID pneumonia and severe sepsis with septic shock; AHRF; pt's condition worsened and he became more obtunded; COVID encephalopathy; pt transitioned to comfort care and passed away in the hospital
Elevated heart rate at around 105. Usually my heart rate stays near 70. I also have body ache, low grade fever of around 99.5.
2-3 day after hives around vaccination site later and to this date muscle aches, joint pain and skin hypersensitivity.
fatigue, HA, episodes of SOB and chest pressure, hasn't been able to work since vaccine, pain in waist going to knee to ankle on both sides, bone pain, body pain.
Extreme joint pain. Cannot bend my right knee. Numbness and tingling in hands and left side of my body all the way down to my toes
Sore arm, chills, fever, dizziness, nausea, aching muscles, diarrhea
Information has been received from a health professional and a women in a physician's  office concerning an 82 yr old white male with an allergy to the "flu vaccine" who on 12/18/2001 in the am was vaccinated with the second dose of pneumococcal vaccine 23 polyvalent (lot number 640981-1050L) in the right deltoid. Concomitant therapy included clopidogral bisulfate (Plavix), amlodipine besylate (+) benazepril hydrochloride (Lotrel) and cetirizine hydrochloride )Zyrtec). On 12/19/2001 in the am, the pt developed swollen right arm, red down to the elbow, painful, very warm to the touch and apprx. 7in oval red mark right above the elbow (below the injection site). It was noted that the pt had initially been seen for a routine office visit. The pt sought unspecified medical attention. The outcome was not reported. Additional information has been requested. A 15-day follow up report received 8/5/2003 adds: Follow-up info received indicated that the pt had fully recovered. No further info is available.
About 6 hrs after shot while bike riding, had tingling of lips, felt throat closing. Thought it was asthma. Next morning had puffy face eyes, lips, congestion. Called Dr advised Benadryl. Took 2 doses- symptoms resolved.
6x7cm area of redness, induration and mild tenderness. Cellulitis vs local reaction. Treatment Keflex 250 mg 3 QID, Atarax syp 1/2 tsp TID. Pt advised to follow-up.
Flublok flu vaccine was given to a patient less than 18 years of age. He should have received an age appropriate vaccine like Fluzone.
Patient diagnosed with COVID-19 in 3/2021 after two doses of the Moderna COVID vaccine
Patient was not feeling well. Next day she got pale, could not breathe, collapsed, and got seizure.  Patient taken to ER and was released. Has followed-up with primary care several times. In August, gynecologist (Women's Clinic) identified that pt had cyst in her ovaries. Patient still has fainting spells, weakness in her legs, and is very agitated. Took her to ER visit for similar symptoms a second time. Since first incident no other seizures but pt goes regularly to school nurse because she feels like she will pass out. For lower extremity pain, patient takes over-the-counter ALEVE but does not seem to help. Problems are getting worse because she is not getting better.
Headache in temple area, new onset shortly, post vax, (20-25 minutes). Pt was evaluated and released with headache.
Immediately after injection some blood came out I placed a band aid and with in 40 second like a nodule raised to size of slightly more than quarter to half dollar diameter bruised showed. I had the patient wait longer. No other affect on patient. I called patient a today. Nodule went away no bruising but soreness in arm. Patient to call doctor and in have documented in his records what occurred.
shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced DYSPNOEA (shortness of breath). On 23-Mar-2021, DYSPNOEA (shortness of breath) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        Concomitant medication includes 22 different medication  Treatment medication include IV Benadryl, IV steroids and Benadryl by mouth .   This case was linked to US-MODERNATX, INC.-MOD-2021-089077 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089077:2 nd Dose case
Nausea, vomiting for 2 days  Diarrhea 3 days Left upper extremity weakness and vertigo that is ongoing
I went to work after the vaccine and I got a bad headache and my muscles around my heart were hurting and my heart was racing. My muscles all over were weak. I was pale and cold and my heart was still racing that night.
Patient complained of lightheadedness, dizziness, almost fainted, nausea. Treatment: head between knees, took BP & pulse, fanning.
Itchy rash near injection site. Started middle of the night Saturday into Sunday. Woke up and it was red and a little puffy. Warm to touch and itchy still. Doesn't hurt.
C/O neck pain, arm pain, some anxiety symptoms. Then developed neck pain on both sides, shoulder pain and some leg aches/pain. Just not feeling herself. In addition some behavioral changes. She was not herself. Seen in office on 5/30/18. No further treatment.
Information has been received from a licensed practical nurse concerning a patient who was vaccinated with ZOSTAVAX (Oka/Merck). Subsequently the patient experienced adverse event. A product quality complaint was not involved. Additional information has been requested.
Fever; Chills; Pain at the injection site; This is a spontaneous report from a contactable healthcare professional. This healthcare professional reported similar events for two patients. This is the first of the two reports.  An 11-year-old male patient received the first dose of meningococcal group b rlp2086 (TRUMENBA, Lot number and expiration date were not reported), with route of administration and therapy date unspecified, at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had fever, chills, and pain at the injection site. The outcome of the events, 'fever', 'chills' and 'pain at the injection site', was unknown.  Information on the batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019341527 same reporter/drug/events, different patient
Patient received vaccines ~ 20 hours later developed diffuse, macular rash with some papular areas. Afebrile but fussy.  inconsistent with topical clotrimazole reaction that was put on neck. Not consistent with viral exanthem. Treatment of Benadryl PRN.
I was having the stated symptoms of  fever (102); chills, fatigue starting the evening after receiving the vaccine (3/26/21).  Felt these symptons all day on 3/27/21.  Got up to go to the bathroom at 3:00AM on 3/28.  Started feeling weird while going to the bathroom.  Finished and tried to make it back to bed but passed out before I could get to the bed.  This woke my husband up and he wanted to get me up but I could not--too week  Laid on floor for about 30 minutes before I felt strong enough to get up with assistance.  Pregnancy History: 1 Child (9lbs. 1ox.) via C-Section
Patients caregiver reported via phone call that patient developed shingles after receiving his first dose of the Moderna vaccine. She also reported that after speaking with his primary care physician, she determined the outbreak to be an adverse reaction of the Moderna vaccine based on her asssessment of patients symptoms and review of his medical history
Patient had an allergic-type reaction from her vaccine with symptoms starting about 8 hours after the vaccination was given. She had hives and a rash on her face and neck. She also is experiencing a ringing in her ears that has not gone away.
48 hrs after varicella and PPD placement client presented w/(R) tricep swelling, warmth about 50 mm, fever. States she had hives on (R) arm day before very itchy. States she had hx of varicella disease as a child, didn't mention it before she said. No fever of hives today (5/16/13). Education provided.
Bloods developed in left leg and both lungs. Diagnosed with Deep Vein Thrombosis and Pulmonary Emboli. Went to ER at  Hospital late night Wednesday 7/21 and was admitted. Ultrasound of leg and CAT scan used to diagnose blood clots. Was admitted and started on heparin IV and discharged on Saturday.
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, (tris) single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "2 babies died during the trial period". The patient date of death was unknown. The reported cause of death was "2 babies died during the trial period". The reporter wanted to get information about the first 400 pages documents for the Pfizer vaccine. She mentioned that she is very concerned about the documents being released publicly. She also mentioned about the 3 month trial period where there is a recall on babies and she also mentioned that 2 babies died during the trial period and she's very concerned about it. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Linked Report(s): US-PFIZER INC-202200354814 Same reporter / drug / event, different patients.; Reported Cause(s) of Death: 2 babies died during the trial period.
Pt received a flu vaccine, very shortly after receiving the vaccine, the patient felt very hot and started to turn white. Patient lost conciousness and an ambulance was called. The patient regained conciousness by the time the ambulance showed up. While waiting for the ambulance the pt stated that she had vision problems and her hands were tingling. Pt refused to be checked out by the EMS crew and signed an AMA form with them.