chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tuesday 1/5/21 AM tender arm and small raised bump at injection site.  Tuesday 1/5/21 PM felt flushed but no fever and still raised bump with a welt at injection site and tender. Took Benadryl. Wednesday 1/6/21 AM felt flushed but no fever and still raised bump got larger with a welt at injection site still tender. Wednesday 1/6/21 PM felt flushed but no fever and still raised bump got larger with a welt at injection site and my legs felt like they had ants on them. Took Benadryl Thursday 1/7/21 Welt went down and started to feel better however still redness and tender. Friday 1/8/21 Just bruised at site of injection and arms welt is down a lot more. Sat 1/9/21 PM Felt fatigued by evening time Sunday 1/10/21 Headache, joint pain and extreme fatigue. Had rash on both arms appear and still felt flush with no fever. Slepts 15 hours Monday 1/11/21 Headache, joint pain and extreme fatigue. Had rash on both arms/face/neck appear and still felt flush with no fever.
significant arm pain-with decrease ROM to less 90'; significant arm pain-with decrease ROM to less 90'; Chills; Brain fog; Felt agitated and unsettled; Headache-moderate; This is a spontaneous report from a contactable nurse (patient). A 55-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot Number: EL3246; Expiration date was not reported), intramuscularly, administered in the left arm on 26Jan2021 (at the age of 55-years-old) as dose 1, single for COVID-19 immunisation at a hospital. Medical history included blood transfusion for lacerated liver repair in 1986, seasonal allergies and allergies to cats/dogs, various trees and various nuts. Concomitant medications included estradiol (ESTROGEN), progesterone and mesterolone (RESTORE); all taken for an unspecified indication, start and stop dates were not reported. The patient previously took acetylsalicylic acid, caffeine, phenacetin, promethazine hydrochloride (SYNALGOS) and cetirizine hydrochloride (ZYRTEC) and experienced drug allergy. No other vaccine was received by the patient in four weeks. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. The patient experienced significant arm pain-with decrease ROM to less 90', chills, brain fog and felt agitated and unsettled, headache-moderate on 26Jan2021. No treatment was taken for the events. The outcome of the events was recovered on 29Jan2021 (Side effects lasted 3 days).  No follow-up attempts are possible. No further information is expected.
Patient received the vaccine around 2:50PM; checked in around 2:46PM.  He was seated during his monitoring phase when the nurse reported that the patient was complaining about:  ? Dizziness ? Lightheadedness ? Weakness of extremities & general overall weakness ? Fast heartbeat ? These were noted to be part of the signs of severe allergic list for the vaccine.    Upon assessment around 3PM, the nurse noted that the patient said he felt some of the symptoms were improving; no shortness of breath noted or facial swelling or rashes.  Patient offered juice and crackers and advised to stay and continue monitoring.  Patient compliant with plan.  Around 305PM patient reassessed and patient started complaining of increasing weakness and dizziness and racing heartbeat.  Patient also noted to have labored breathing, pale, clammy and tripoding.  Vitals taken = 101/64; 100% in room air; HR = 80; RR = 32; lung sounds clear to auscultation.   Patient kept on vital sign monitoring and noted that saturations started decreasing to 90%, then 80%, then down to 70% in a span of several minutes + HR = reduced to 55.  Patient also stated he was feeling faint & started feeling very weak & stopped talking &  having difficulty breathing.  MERT called and patient placed in a wheelchair & oxygen administered.   Patient continued to look worse and not as responsive.  MERT arrived around 317PM and took another set of vitals and brought patient to ED.
Patient reported to the pharmacy for Moderna booster 0.25mL in the left deltoid on 12/7/21. On 12/9/21, patient contacted the pharmacy regarding an adverse event. Patient reports having a swollen or tender bump that appeared under the left armpit approximately 24 hours after vaccination. Patient did not have any adverse reactions to the first two Moderna vaccines.
MILD FEVER; CLINICALLY CONFIRM COVID 19  DIAGNOSIS; PCR TEST POSITIVE FOR COVID 19; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, weight  and medical history were not reported. The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018) dose was not reported, administered on 05-MAR-2021 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported.  The patient received PCR test the next day (on 06-MAR-2021) which came back positive for COVID 19. He reported mild fever as his only symptom. On 07-MAR-2021, the subject experienced clinically confirm COVID 19 diagnosis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the clinically confirm COVID 19 diagnosis, mild fever and PCR test positive for COVID 19 was not reported. This report was serious (Other Medically Important Condition). This case is associated with product quality complaint (PQC) number 90000172118.; Sender's Comments: COVID 19 diagnosis and PCR test positive for COVID 19. This event(s) is considered not related. The event(s) is deemed to be scientifically implausible, i.e., there is scientific evidence against a drug/event relationship; AND there is no known class effect.
Patient was diagnosed with perforated appendix.  Surgery was consulted.  Patient did get laparoscopic appendectomy done.  Patient had postoperative ileus.  Eventually resolved.  Pain is controlled with Norco.  Patient is currently cleared for discharge needs to follow-up outpatient with surgery.  Patient was also evaluated by Infectious Disease because of COVID-19 being positive. Patient was diagnosed with Covid-19 pneumonia and acute respiratory failure.  Patient kept on dexamethasone.  Discussed with Infectious Disease will be on 10 days of antibiotic Omnicef/Flagyl, dexamethasone. Patient was discharged home.
3-27-10 Pt. developed feeling of anxiety as if he couldn't breathe if he did not get up and walk around. Reappeared around 4 PM, then all day on 3-28-10 to around late evening when lessened then returned on 3-29-10 in AM and cont. but not as severe.
Pain at location of shot - unable to move arm on day of shot. Day 2 fever of 101.3, chills, body aches, and extreme fatigue with pain at shot location. Day 3 still severe pain in arm with limited use, fatigue. Same reaction to first series of shot, but thought it was due to flu shot last time.
By 2pm L arm painfully sore to even lift. By 6pm started with joint pain- elbows, fingers, hips, ankles and h/a. During that night h/a and chills most of night. Next 24 hours had alternating chills with sweating, continued joint pain and h/a which resolved by morning of 8/4/19.  Arm pain at injection site continued for 4 days. Treatment was ibuprofen every 4 hours for about 36 hours.
Injection site rash, hard, red, itchy -8 days after injection Chills, sweats, fever - 8 days after injection.
Hospitalization for acute CHF exacerbation (also COVID-19 infection) on dates 12/13/22- 12/16/22. Treated with vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Information has been received from an investigator concerning a male child with a history of acute myeloid leukemia who received his 4th dose of Prevnar on 10/17/96 as part of a post-marketing safety surveillance trial. Approx. 2 years, post vax, at 31 months of age, he developed sepsis. Culture revealed Streptococcus pneumoniae serotype 19F. Sepsis was considered to be an "Other Medically Important Event". The Medical Monitor and Investigator's assessment of the relatedness between septicemia streptococcal (expected per the package insert) and Prevnar was unknown. Additional information was received on 5/6/02. The child had a history of bleeding episodes since 14 months of age. A probable dx of acute megaloblastic leukemia was made and the child was treated with standard induction chemotherapy including intrathecal cytarabine. He was re-admitted to the hospital on 11/15/98 for his 2nd course of chemotherapy and was febrile. Blood culture grew penicillin resistant Streptococcus pneumoniae. A repeat blood culture on 11/16/99 was negative. He was afebrile and was started on chemotherapy. "Stormy" hospital course was complicated by Streptococcus viridans sepsis and he was transferred to another facility because of increased respiratory distress. He developed a right pleural effusion which grew Aspergillus. His respiratory condition improved and the child was transferred back to the hospital facility. He was discharged on 1/1/99 and died at home. Both the investigator and medical monitor's assessments were unknown. Per F/U 5/28/02 autopsy: COD ureteral and GI bleeding, Aspergillos meningitis and pneumonia and myelodysplasia/pre-leukemia.
Severe entire arm pain that began about 2 hours after injection. It became so severe I was unable to move or lift arm without assisting with other arm! The pain was so intense it woke me from sleeping. Advil helped but the pain was still severe for the entire day.  I Have been taking advil around the clock and the pain has improved slightly and is more bearable but its been 48 hours and I still have pain while taking advil.
stroke after receiving vaccine; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke after receiving vaccine) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (stroke after receiving vaccine) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (stroke after receiving vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       NO Concomitant medication was reported NO treatment medication was reported  Company comment: This case concerns a subject of unknown age and gender, with no reported medical history, who experienced the unexpected event of CEREBROVASCULAR ACCIDENT. The event occurred on an unknown moment after the dose of Spikevax. . The rechallenge was not applicable, as there is no information that states vaccination dose number or any information about the vaccine. The benefit-risk relationship of Spikevax is not affected by this report.   This case was linked to MOD-2021-345616, MOD-2021-345450, MOD-2021-345677 (Patient Link).; Sender's Comments: This case concerns a subject of unknown age and gender, with no reported medical history, who experienced the unexpected event of CEREBROVASCULAR ACCIDENT. The event occurred on an unknown moment after the dose of Spikevax. . The rechallenge was not applicable, as there is no information that states vaccination dose number or any information about the vaccine. The benefit-risk relationship of Spikevax is not affected by this report.
This spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 20-AUG-2014, the patient was vaccinated with an improperly stored dose of GARDASIL injection, lot # K005083, expiration date 04-NOV-2016 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to temperature excursion (date unspecified) lasting for 24 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.111111111 degrees Celsius). the vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Symptoms for 2 days. Warm bluish large area behind arm and headache; pains on both arms and across neck.
3/25/2022 at 1015 Employee called the Nurse Vaccine Support line to report symptoms post COVID-19 booster vaccine. Vaccine Name - Pfizer Vaccine Date - 3/24/2022 Booster Dose - Yes Location - Left Deltoid Date of Symptom Onset - 3/25/2022 (~0200) Symptoms - Feeling Tired, Body aches, Belching continuously, Injection Site Pain Last Day of Work and Shift - 3/24/2022 (7a - 3p) Home Remedies - Ibuprofen 600 mg x2 today (0200 & 1000), Cold Compress to Injection Site Any Improvement - Yes (Body aches/Pain). Tiredness continues.
Pt received vaccines ordered for father who has the same name.  Pt. received Twinrix #1 and Tdap.  He was to receive MGC. NO REACTION.
Hep B shot given at 11:00 AM. Pt reports at 5:00 PM-itching all over her body and even in throat, rash on her hairline. Took BENADRYL which has improved.
This spontaneous report as received from a physician via a company representative refers to a 16 year old male patient with asthma. On 06-JUN-2014 the patient was vaccinated with a dose of GARDASIL (lot#, dose, route not reported). Other suspect therapies included VARIVAX (Merck) (lot#, dose, route not reported) vaccinated as a second dose on the same day. Concomitant therapies included albuterol (manufacturer unknown). On 06-JUN-2014, when being observed while lying down for 10 minutes after receiving the two vaccines, the patient started having chest pains, sweating and vomiting. The physician sent the patient to the Emergency Room (unidentified name and location) and the Emergency Room physician diagnosed him with "chest pains". No treatment was given. Electrocardiogram (EKG) was performed and the result was normal. Symptoms gradually went away. Outcome of the event was reported as recovered on 07-JUN-2014. Additional information has been requested.
Information has been received from a health professional concerning a 19 year old white female student who on 04-OCT-2007 was vaccinated IM with a first dose of GARDASIL vaccine (yeast) lot #658560/1062U. The reporter reported that approximately 5 minutes after the injection patient complained of lightheadedness. Her blood pressure measurement (BP) 88/58, Heart Rate (HR) 72 and Respiration Rate (RR) was 20 at that time. She was put in trendelenburg position and given snack and water. Her blood pressure measurement (BP) 100/58, Heart Rate (HR) 80 and Respiration Rate (RR) was 16. Within 10 minutes her lightheaded subsided. The patient recovered fully. Additional information has been requested.
pt recvd vax on 20JUL; On 25JUL 830AM started having upper back pain; 29JUL could hardly walk; severe pain; hurt to ride in cars because of bumps; h/a; liver enzymes elevated; hospitalized for 3 days; fatigues easy;
Injection site is swollen and looks like a water blister.; Injection site is swollen and looks like a water blister.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Aug2021 (Lot number: FC3181) at the age of 40 years as dose 2, single and administered in arm left, administration date 24Jul2021 (Lot number: FA7484) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Migraine" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE VESICLES (non-serious), outcome "not recovered" and all described as "Injection site is swollen and looks like a water blister.". Therapeutic measures were not taken as a result of vaccination site swelling, vaccination site vesicles.  Additional information: AE does not result in emergency room/physician office. No COVID prior vaccination. Not tested for COVID post vaccination. There were no known allergies. No other vaccine in four weeks. No other medications in two weeks.  No follow-up attempts are possible. No further information is expected.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2014 the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster also known as shingles and other complications. On or about 05-JUL-2016, the patient was treated at a medical facility for a blistering vesicular outbreak, that was diagnosed as herpes zoster. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
loss of peripheral vision; extreme light sensitivity; Initial information regarding an unsolicited valid non-serious case was received from a Pharmacist via consumer/non-health care professional via physician via  Medical Information  (Reference number- 00836974) and transmitted to Sanofi on 01-Nov-2021 in a specific country.  This case involves a 36-year-old male patient who experienced loss of peripheral vision (visual field defect) and extreme light sensitivity (photophobia) after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past vaccination(s) included INFLUENZA for prophylactic vaccination without any adverse events.  The patient's medical history, medical treatment(s) and family history were not provided. Patient had no other vaccines   On 01-Nov-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE produced by Sanofi Pasteur (lot number: UT7384JA and expiry date: 30-Jun-2022) via unknown route in unknown administration site for prophylactic vaccination.  On 01-Nov-2021, the patient developed a non-serious loss of peripheral vision (visual field defect) and extreme light sensitivity (photophobia) (unknown latency) about 20 minutes following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was reported "Pharmacist who works for Johnson and Johnson heard from her brother-in-law that he experienced a reaction about 20 minutes after receiving FLUZONE QUADRIVALENT about 2 hours ago. Have reactions such as this been reported? The pharmacist state, "he called me and reported loss of peripheral vision and extreme light sensitivity about 20 minutes after receiving the vaccine." She stated that the reaction did not seem to be related to possible syncope and seemed "different". She did not have information about the National Drug Code (NDC), presentation or injection site. She said the reaction was "dissipating" and is not now as bad as was"  No laboratory data was provided.  It was not reported if the patient received any corrective treatment for the events.  At time of reporting, the patient was recovering from the events.
Woke up on 10/20 with swollen and painful axillary glands which started to get worse and seem to become symptomatic in the throat glands as the day progressed. Just before 10pm on the evening of 10/20 (2 days post-booster) I started feeling prickly and noticed a full body rash all over my arms, back, and torso. As it is now after 10pm I've taken some Benadryl and will hope it passes.
Initial report received from a non-healthcare professional on 12 September 2013. The patient had administered YF-VAX 5 doses, multidose vial, powder vial reconstituted with the single dose diluent of 0.6 ml. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Student received H1N1 vaccine 11.16.09 and student went to Clinic and received another dose on 12.7.09.
Initial unsolicited report received from a consumer on 25 March 2016. This case was linked to 2016SA062194 (same vaccine). This case involves a 41-year-old female patient who was vaccinated with a dose of INFLUENZA QUADRIVAL A-B VACCINE (FLUZONE QIV) (batch number, expiration date was unknown and did not remember route of administration) in the arm on an unspecified date in September or October 2015. The patient was vaccinated at a family clinic. Pre-existing physician diagnosed allergies included allergy to doxycycline and feathers. Patient had a history of diabetes. She had also received flu vaccine every year for past 30 years. Concomitant medications were not reported. On 24 March 2016, few months following the vaccination, the patient had developed elevated fever of 102.5 Fahrenheit and was diagnosed with flu and had a positive flu test for A strain of Flu. It was a case of suspected vaccination failure. The patient required ER/doctor visit. It was reported that she was seen by health care professional on 24 March 2016. Other laboratory data and corrective treatments were not reported. The outcomes of events were unknown. Upon medical review, the case was considered as serious due to important medical event: flu/positive flu test for A strain of Flu and suspected vaccination failure. List of documents held by sender: none. Sender's Comments: This is a non-medically confirmed case. Reportedly, the patient was tested for Influenza type A approximately 4-5 months after vaccination. As with any vaccine, INFLUENZA QUADRIVAL A-B VACCINE may not protect 100% of vaccinated individuals. Further information including but not limited to patient's medical history, details of symptoms, test results confirming the diagnosis and the strain identified and immune status at the time of vaccination would be needed for complete assessment. Based on the information available, a role of the vaccine cannot be assessed.
Red, warm, heard, and raised area that covers area of vastus lateralis around the back of the right thigh 11x5 cm.
pt recv vax 6/15/98 & on 6/16/98 pt exp mild facial swelling of the eyelids;no treatment was given & the rxn is presumed to have resolved;
Information has been received from a nurse concerning a adult female who on 24-JUN-2009 was vaccinated with a dose of VARIVAX (Merck) (Lot # not reported).  On an unspecified date, the patient has chickenpox.  The patient two days ago had what she thought were bug bites until a ton of these bites showed up.  The patient sought medical attention at office.  No other information is available at the time of this report.  Additional information has been requested.
Hospitalization: 2/7/2023 - 2/10/2023 (3 days) Presentation to the ED: unwitnessed fall with trauma to the head. COVID + date: 2/10/23 Treatment: asymptomatic, no treatment. Discharge to: SNF 006B21A 3/18/2021 009C21A 5/5/2021 013B22A 8/17/2022