chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have a rash on the back of my both of my calves.; This is a spontaneous report received from a contactable consumer, the patient. A 41-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) as a single dose via an unspecified route of administration in her right arm on 10Mar2021 at 17:30(at the age of 41-years-old), for COVID-19 immunisation. The patients medical history included diabetes, clotting disorder and history of pulmonary embolism. Concomitant medications included several unspecified medications within two weeks of vaccination. The patient was known allergic to Benadryl. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient had not tested positive for COVID-19 since having the vaccine. The patient had not diagnosed with COVID-19 prior to vaccination. On 17Mar2021at 00:00 hours, the patient reported as he had a rash on the back of his both of his calves. It appeared 7 days after he was vaccinated. It does not itch much but it does get warm, and he had no other environmental changes or new medications. The patient did not receive treatment for the reported events. The clinical outcome for the event rash was not recovered at the time of this report.  Information about lot number cannot be obtained. No further information is expected
ACHES/PAIN; CHILLS; FEVER; HAMMER-LIKE HEADACHE; This spontaneous report received from a patient concerned a 53 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 17:00 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced aches/pain. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced hammer-like headache. Laboratory data included: Body temperature (NR: not provided) 99 - 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovering from chills, fever, and hammer-like headache, and had not recovered from aches/pain. This report was non-serious.
15-30 minutes after receiving vaccine noticed a fuzzy feeling in throat, chest felt swollen, head felt funny. Took allergy medicine but no relief, so took BENADRYL 60mg PO. No relief. Went to ER at 6pm + given Epinephrine 0.3 mg SQ. PREDNISONE with relief. Chest still feeling swollen to day- sent home with Rx. BENADRYL + PREDNISONE 60mg x 5d. On 10/23/09 did vaccine Seasonal flu vaccine - No problems. 12/11/09 ED Records received for DOS 12/02/09; 12/04/04. Pt presented with throat swelling and difficulty breathing following vaccination.  Self-medicated with benadryl with some improvement. Tx. in ED with epinephrine, steroids; symptoms improved. Presented to ED again on 12/04/09 with skin rash, persistent throat swelling. Treated with Vistaril. Symptoms improved. Assessment: angioedema involving the larynx; delayed allergic reaction to swine flu shot
No adverse event; A nurse reported that a dose of improperly stored PROQUAD pursuant to a temperature excursion was administered to a patient.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), underwent a temperature excursion of -2.7 Celsius degree during 1 hour and 15 minutes.  On 31-AUG-2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rHA) (PROQUAD) lot #W010523, expiration date: 25-SEP-2023 (strength, anatomical location, and route of administration were not provided). No adverse event was reported.
Severe knee pain developed the morning after the vaccine. It got worse and worse so I went to my primary care provider. The pain would come and go and at times completely hobble me. X-rays done.  About a month later, pain subsided a little. Then the left knee began to ache. Much WORSE than the right knee. Sharp, stabbing, crippling pain. This has been going on over two months now and making me unable to walk, bend my knees at time, etc. Steroid tablets taken for six days did ABSOLUTELY NOTHING to help alleviate the pain. NOR have an anti-inflammatory OTC med. I am in constant pain now and thankfully have a temporary handicapped parking placard. My mental health is suffering, my quality of life has changed DRASTICALLY. I walking 2-4 miles a day. Now, can barely move around the house, go up/down stairs, sit, stand without pain.
high fever, broke out in hives, cough, severe h/a, loss of appetite-sick for two wk;
I began to have SHARP pain in my chest in the early morning hours while recovering from the vaccine it continued off and on for several days and continued to worsen.    I reported it to my then doctor.   She did nothing.
Admitted through the ED withchest palpitations onset x 1 days suspected to have SVT, fever 101.1
7 residents expired before receiving the second dose; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 8 patients. This report is for 6th of 8 patients.  A patient of unspecified age and gender received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient expired before receiving the second dose on an unspecified date. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Sender's Comments: The event death is assessed as related to BNT162b2 vaccine and documented as such in the  global safety database until sufficient information is available to allow an unrelated causality assessment.  The impact of this report on the benefit/risk profile of the Pfizer product 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.,Linked Report(s) : US-PFIZER INC-2021034595 same  drug, reporter and event but different patient; Reported Cause(s) of Death: 7 residents expired before receiving the second dose
This spontaneous report was received from a medical assistant and refers to a 11-year-old patient of an unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 25-MAY-2021, the patient was vaccinated with dose of improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # 1687292, expiration date 25-AUG-2022, 0.5 milliliter (anatomical location and route of administration were not provided) for prophylaxis. Administered dose of vaccine experienced the temperature excursion above 47 degrees Fahrenheit (F) (46.9 F) for 84 hours 30 minutes 0 seconds. Data logger was not involved. There were no previous excursions reported. No additional adverse events were 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: 1687292; expirationdate: 25-AUG-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
I developed a raised rash on my left arm at injection site , had chills and nausea and lots of tenderness at injection site at 3 am (1/1/21)  following injection. The nausea had resolved when I woke up, the rash subsided throughout the day as did the chills.  The most distressing event began on 1/1/2021 , that being sneezing, runny nose and watery eyes which continued and got much worse over the next two days, despite taking sudafed as often as possible.  No other cold or flu symptoms were present and it felt like allergies although I have never had any sort of seasonal allergies.  I finally took Zyrtec for it the evening of 1/3/21 and the symptoms stopped.   Congestion, light sensitivity remain.  I am reluctant to take another dose due to  drowsiness side effect.  Hoping symptoms will all be gone by tomorrow.
Pt c/o lightheadedness, dizziness after vaccination. Pt sat down looked ashen. Pt laid down. Pulse taken 35, irregular. Pt became clammy. Legs raised provider called. Dr responded. Pt placed on O2 via NRB at 15 LPM. Subsequent vitals taken. BP 120/68 pulse 68. ECG taken. Patient seen by Dr. Patient walked from Dr office.
No pain at time of injection. Several hours later the arm became extremely painful with pain radiating through the arm and around the back of the shoulder. Intense pain has resolved, however four weeks later she still has pain when raising her arm and does not have full range of motion.
Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Shakiness-Medium, Additional Details: after immunizer put the band aid on, pt started to shake and fainted in the chair, immunizer held pt in chair, she called me and I tapped pt, pt shook again and came too, had severe sweating and pale. First few blood pressure readings were low, NP from minute clinic came and measured osat and heart rate, osat was normal, heart rate was low so np recommended call 911. paramedics monitored and vitals did come back to normal, pt declined going to the hospital and pt walked out with paramedics
Pt recvd vax & exp dizziness, pain @ inject site, malaise, lymphadenopathy, pain/stiffness in arm, shoulder & neck & vertigo; pt's white blood count has been slightly elevated since the inject;
High fever High blood pressure Uncontrollable shakes and shivers Difficulty of breathing Dizziness Body aches Vomiting Extreme diarrhea  Loss of weight I took Tylenol. I also gained 5 pounds and retained a lot of water.  I still have difficulty breathing and I feel winded a lot. I feel more tired than I usually do.
This spontaneous report was received from a pharmacist concerning a male patient of unknown age. The patient's pertinent medical history and concurrent conditions were not reported. On 13-JAN-2016, the patient was vaccinated with unspecified dose of PNEUMOVAX 23 (Lot # and dose not provided). Concomitant medications were not reported. On 22-JAN-2016, 10 days after being vaccinated, the patient received another dose of PNEUMOVAX 23 (Lot # and dose not reported). No adverse events were reported. Additional information is not expected as no contact details were provided.
Breakthrough case admission after 3 vaccines Moderna 1/12/21 Lot# 011J20A;  Moderna 2/9/21 Lot# 013M20A;  Moderna 12/12/21 Lot# 058H21A
Adverse event- Diarrhea getting progressively worse. Stomach pain, nausea. Digestive inflammation. Sudden severe mental health crisis.  Tests- Multiple tests including xrays and CT Scan, stool sample, blood work. Treatment- Imodium- 2ce/day, Omeprazole- 1ce/ day, Prozac, Xanex.  Outcome- still pending.  As of 2/11/2020- stomach pain is almost gone,but still working on continued mental health and diarrhea issues
This case was reported by a healthcare professional and described the occurrence of red raised welt at injection site in an adult subject of unspecified gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On 19 September 2014, the subject received unspecified dose of FLULAVAL (.5 ml, unknown route and unknown deltoid). On 19 September 2014, 1 day after vaccination with FLULAVAL, the subject experienced red raised welt at injection site. At the time of reporting, the event was improved after 3 days. This case is one of the 5 cases reported by the same reporter for the same vaccine.
felt like it hit bone when shot was given felt like a frozen shoulder and began taking physical therapy for it because pt favored it too long.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 03-MAY-2016, the patient was vaccinated with improperly stored dose of M-M-R II 0.5 ml injection, lot # L027432, expiry date: 22-JUL-2017 (route and site of administration were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 11.1 degrees Celsius for 1 hour and 36 minutes and also at a temperature of -12.3 degrees Celsius for 1 hour and 33 minutes (excursion dates were not reported). No adverse symptoms were reported. No product quality complain (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Two weeks after the 1st injection of Shingrix, I had a detached retina in my right eye.  Two weeks after the 2nd injection of Shingrix on 05/30/2019, I had a detached retina in my left eye.  Both resulted in surgical repair.
After bone marrow biopsy, patient developed syncopal episode with right side drooling, nausea, vomiting, near loss of consciousness while obtaining post procedure BP. Patient developed responsiveness 2-3 minutes later. Patient referred to MD center for evaluation and subsequently discharged.
Mother states that on PM after shots, patient refused to walk or put pressure on left leg. Just wanted to be held. No areas of redness or warmth at injection sites however left leg was sensitive to touch at later aspect of left leg. Denied fever. On 05/15/2002 still very hesitant to use leg---gradually improved on 05/16/2002 and on 05/17/2002. No limitations in activity noted. Back to normal.
History of vasovagal responses with immunizations. Occurred 8 minutes post injection. Gave juice and crackers.    0818 BP 73/59 placed on litter in trendelenberg position.  0825 113/69, 0826 BP 116/80 standing.  At 0834 BP 127/78.  Symptoms improved.  Released from clinic.  30 minutes total observation time.
Vaccinated at 1:00pm. 2:00pm - flushed, dizzy, eyes itchy and red. 7:00pm - face, chest, legs red and itchy. Difficulty with breathing and swallowing; wheezing. Given oral BENADRAYL @ county medical unit. Seen @ urgent care - liquid BENADRYL and inhaler. Tx to hospital ER - IV, Epi and Steroid. Symptoms improved. BP improved. sent home.
Initial case received from a health care professional on 08 October 2009, via another manufacturer. A patient experienced wheezing and shortness of breath after receiving FLUZONE (lot not reported) on 23 September 2009. Four hours post-vaccination, the patient became short of breath and was wheezing. The events recovered after two and one-half hours. No additional information was provided. Additional documents held by sender: None.
Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 28-Feb-2022; Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 28-Feb-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 28-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 28-Feb-2022) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Janssen (Dose-1 andLOT:1805020) on 08-Mar-2021. Past adverse reactions to the above products included No adverse reaction with Janssen.    On 28-Feb-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 28-Feb-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 28-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 28-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 28-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  It was reported that the reporter had identified an additional issue that staff were not dating the boxes of vaccine when placing them in the fridge for storage. This lot number (084J21A) was received and placed in the fridge on 11-Jan-2022, which means that all doses administered more than 30 days after 11-Jan-2022are not in accordance with the EUA.  Date the vial was initially stored in the refrigerator was 11-Jan-2022. The vial did not undergo any temperature excursions. Patient received first booster dose on 28-Feb-2022. Patient did not reported any adverse reactions.  Treatment information was not provided by the reporter.
The pt experienced a hive on the leg the size of a plum that was warm to the touch. The pt was treated with Keflex and Benadryl.
Anaphylaxis (w/in 30 min, irritability, vomiting, hives, wheezing).  EPI SQ x1, albuterol/atrovent neb, decadron IM, prednisolone x5 days.  6/12/09 Medical records received DOS 6/8/09.  Assessment: Vaccine anaphylaxis. Post vaccination: Inconsolable, vomiting, wheezing, fussy, angry. Hives on abdomen, back, face. Nares congested.
pt recv vax & exp fever which may have been as high as 104 t104 to 105 & which lasted for more than 24hr;pt also exp infrequent rash;
When the patient stood up shortly after getting the vaccine, he slumped against the chair, and then fell on the floor, hitting his head. After a short moment, he became responsive and was able to answer questions. His head had a red mark, but no cuts. He answered questions lucidly and reported no symptoms other than a slight fogginess that cleared after a few moments. 911 was called, and EMS came to check on him. They did not feel that a visit to the emergency room was necessary. The mother then took him home. I have tried calling for a follow-up, but have not been able to reach them yet.
The next day I couldnt do anything.; Joint pain; Muscle aches/Every joint in my body was burning and aching; Unable to sleep; Chills; Fever; Headache; This is a spontaneous report from a contactable nurse, the patient. A 56-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via intramuscular route of administration in the left arm on 14Apr2021 (at the age of 56-year-old) at 17:00 as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had allergies to fluconazole. Prior to the vaccination, the patient was diagnosed with COVID-19 on an unknown date. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included estradiol (ESTROGEN), omeprazole (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASPIRIN)-all for unknown indication. On 14Apr2021 at 21:00, the patient experienced joint pain, muscle aches started, unable to sleep, chills, fever and headache. The patient reported that she couldn't do anything on 15Apr2021 and unable to get relief. Therapeutic measures were taken as a result of event and included treatment with Tylenol and the patient reported as unrelieved by the Tylenol. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of joint pain, muscle aches, unable to sleep, chills, fever and headache were recovering.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Started with Scratchy throat and headache progressively moving to tiredness, red eyes, Sinus pressure, body aches, fever, and coughing.
R10.11 - Right upper quadrant pain R74.01 - Transaminitis R93.5 - Abnormal CT of the abdomen R17 - Elevated bilirubin K80.66 - Calculus of gallbladder and bile duct with acute and chronic cholecystitis without obstruction
Pt was treated with bactrim days before COVID vaccination. Then days after COVID vaccination, had Bactrim again. Anaphylactic rxn occurred 1-2 days later. Reaction was likely related to Bactrim, but did receive COVID vaccination in same time period.
Within 5 minutes of receiving her 2nd round of Gardasil, my daughter passed out on the exam table. Since that time she has been having periodic fainting spells, including but not limited to severe stomach pains. Her recent spells have developed muscle twitches in her arms. And we took her to the emergency room. Now going to doctors looking for answers. An ultrasound showed nothing in the abdomen but the EEG is showing signs of seizures.  My daughter was the picture of health before receiving this vaccine and her doctor is convinced it is not from the HPV vaccine.  I am convinced it is. I'm praying I have not caused my daughter to be sterile! Please let me know if any remedies have yet been found!
2-3 cm red, warm area around the injection site. Right thigh was also swollen and hard around injection site. Symptoms began the morning after he received the vaccine.
Site: Redness at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium
Patient has swelling and redness at injection site.  Also reported itching "all over." No rash, SOB or fever reported.
kidney stones; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported that, A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2 solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant was not reported. On an unspecified date the patient experienced kidney stones with outcome of unknown.  Follow up attempts needed. Further information is expected
Horrible screaming for hours at 5:30, clearly in horrible agony, dramatic increase in frequency of spit up and drool ever since the vaccine was administered.
Got first dose of Moderna on 4/6, went back on 5/4 to get second shot.  Got second shot ok, got home and Pharmacist called saying they gave me the wrong shot and that they accidentally injected me with J&J one shot instead of Moderna second shot.     Pretty big mistake and felt it should be reported.