chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient with history of COVID vaccines who admitted to hospital with COVID detected PCR.  Provider d/c note:  "82-year-old  male PMH DM2, HTN, HLD, GERD, who was previously vaccinated for COVID but not boosted.  His wife tested positive for COVID-19 approximate 1 week prior to his presentation. He reported that symptoms start roughly 7 days prior to presentation with shortness of breath on fatigue. He was noted to have oxygen saturation in the 80's on day of admission both at home and in the emergency department.    On admission he responded well to 2 L NC requiring it for roughly 24 hours and since then has bee maintaining oxygen saturation in the 90's. His chest x-ray showed no acute process and his WBC normalized during his admission. He received decadron for 2 days until discharge. PT/OT evaluated and recommended home independently. While I did encourage him to stay for one more day he was adamant that he is ready to go home. Given he is likely around the 10th day of illness and is improving I think that is reasonable. He was noted to have a mild microcytic anemia which was stable, but should be followed up as an outpatient. "
32yo M,  presents to clinic after episode of syncope, and on presentation to clinic c/o SOB/DOE SpO2: 88-90%, left calf swelling, EKG showing S1Q3T3 signs and symptoms concerning for PE.  Pt denies any prior history of blood clots and no risk factors on initial presentation.  Pt  reports only thing new has been receiving Moderna COVID-19 vaccine on 16 Jun 2021.  He was transferred immediately via ambulance to  hospital for high level of care, where PE was confirmed w/ Chest CT, and also noted to have markedly elevated D-dimer and cardiac enzymes.  Pt was then reportedly transferred to hospital for definitive tx.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information on patients' medical history or concurrent conditions was provided. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection, lot# K023432 with expiration date 18-JUN-2016 and lot# K011562 with expiration date 18-APR-2017 (dose and route of administration were not reported). No information on patients' concomitant medications was provided. No adverse symptoms were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Pain and soreness; pain in her Left arm; Having problems with the soreness and moving her arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 52 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Apr2021 (Batch/Lot number: unknown) at the age of 52 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset Apr2021, outcome "not recovered", described as "Pain and soreness"; PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "not recovered", described as "pain in her Left arm"; LIMB OPERATION (non-serious) with onset Apr2021, outcome "not recovered", described as "Having problems with the soreness and moving her arm".  Additional Information: The caller is calling about the Pfizer BioNtech vaccine. The caller and his wife had their first dose on 28Apr2021. The patient experienced some soreness where she took the shot, in the left arm. The patient is really having problems with the soreness and moving her arm. Is this natural or something to worry about it. It has been like 10 days since receiving the vaccine. The patient is still experiencing pain. Does the patient need to see a doctor.  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-2021514567 Same reporter/product/event, different patient
I had nausea, throwing up, diarrhea, the next day I had coughing. I used a home COVID-19 test that came back positive. I called my doctor and was able to have a telehealth visit. We discussed my positive test result and symptoms, I was prescribed the Paxlovid, I was able to start taking it that day. By my second day I was starting to feel better, today is day five and I feel much better.
Felt soreness in injection site on the day of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Felt soreness in injection site on the day of injection) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Felt soreness in injection site on the day of injection). At the time of the report, VACCINATION SITE PAIN (Felt soreness in injection site on the day of injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.
After receiving the SHINGRIX vaccine, the patient was so weak that she could not get out of bed for three days. She was nauseous and vomited multiple times. She is still light headed. Her arm was so weak that she could not lift anything. What she experienced was more than general malaise.
Observed a red spot yesterday at injection site of vaccine. Today I have two red spots in the injection site area. One spot is larger than the other. Both spots are red in color and are warm to the touch.
Patient got the Pfizer vaccine on 9/24/21 and starts to have numbness and tingling on right face on 9/26/21. Patient is advised to call her doctor.
pt recv vax  3DEC97 & that noc exp severe pain on both arms;APAP given & improved;10DEC97 pain came back & could not lift arm up-pain down to lt foot & ankle;could not walk;chilly & warm;limping because of pain lt foot;swelling of lt foot;
Patient received second dose of influenza vaccine 6 weeks apart. No signs or symptoms of adverse events reported by the employee.
pt recvd booster dose of MMR in JAN91 & recvd initial dose of vax 1974; Lab eval revealed pos titers to MMR however, titer for mumps was 1:4 & was less than protective;
Headache, Fever, NauseaVomiting, chills, fatigue, pain, redness and swelling injection site Narrative:
child vax 12JUL95 & devel varicella (WAES95071232) then sibling devel varicella
Vaccines that were administered beyond use date after thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 27-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported. Patient reported no adverse reactions after the administration of vaccine. Vaccine number 1 code was reported as 80777-0273-99  Vaccinations Requested was Pfizer-BioNTech COVID-19 Vaccine
SORE THROAT, NAUSEA, CHILLS, GENERAL NOT FEELING WELL, TIRED.  AS ADVERSE EFFECTS STARTED YESTERDAY, PATIENT ADVISED TO TREAT AND MONITOR S/S
Pt recv vax on 9/23/97; on 9/24/97 pt exp red, swollen, warm vax site
On 5/5/22 , 1 day after the vaccines were given, red dots appeared all over the patients body, face and hands. Mom stated it looked like a Varicella outbreak.  He also had fever. This continued for 3 days  then it went away on its own.
Blood pressure gone sky high; Shaking like a leaf on a tree; Got a high temperature and high fever; This is a spontaneous report from a contactable consumer (Patient).   A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: not reported) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient historical vaccine included received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. On an unspecified date, the patient experienced blood pressure gone sky high, shaking like a leaf on a tree and got a high temperature and high fever. She stated, she never had problem with her first dose but the second dose threw her up a loop because she was shaking bad all over and got a high fever and blood pressure gone sky high. The events were non-serious. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Mother described warmth and redness, soreness to touch at the vaccine sight; Right arm, between the shoulder and elbow.
The pt received vaccines on 4/5/00 to right vastus. As of 4/6/00 a swelling of the area where injection was given about the size of a child's fist. Slightly warm to the touch, no redness, tender to touch. No drainage present, no loss of motion.
Strange sensation on side of nose and itching on tip of nose.  Developed a rash which was worse each day.  Saw dermatologist Nov 6th and was diagnosed with shingles.
No adverse effects reported; that were improperly stored./ excursion ocurred; This spontaneous non-valid report was received from a vaccine coordinator regarding a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies, and concomitant therapies were not reported.   On unknown date, the patient was vaccinated with improperly doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (product storage error) for prophylaxis, lot number N022727, expiration date 12-JUN-2020 (strength, dosage, frequency, and route of administration was not reported). No adverse effects reported.   The administered dose of vaccine experienced the temperature excursion on an unknown date with 30 Celsius for 3 hours. Data logger was involved. There were no previous excursions reported.  Follow up information has been received from the reporter, on 29-JUL-2019.   There was an identifiable patient who on 30-MAR-2019 and on 09-JUN-2019, the patient was vaccinated with improperly doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (product storage error). On 25-AUG-2018, the administered vaccine experienced the temperature excursion.    This is one of four reports, received from the same reporter.; Sender's Comments:  US-009507513-1907USA015535: US-009507513-1907USA016724: US-009507513-1907USA016725:
5 inch by 5 inch red, swollen, painful, hot localized at injection site within 24 hours of injection.  Same with 1st of series.  2 days later developed facial, chest rash with headache and anxiety.
Information has been received from a pharmacist referring to a patient of unknown age and gender. Information regarding patient's medical history and concurrent conditions were not reported. On 22-JAN-2018, the patient was vaccinated with an expired dose of VARIVAX, (lot # M002063, expiry date 12-JAN-2018). No adverse effects were reported.
Redness, fever and itching at the injection site, fever for about 10 days big red mark on arm it took about two weeks but still experiencing symptoms, I have a dermatology appointment next week.
PT VACCINATED WITH DTP 1HR LATER EXPERIENCED INCONSOLABLE CRYING X 3 HRS MOTHER IS MD - CHILD EASILY CONSOLABLE WHEN FUSSY ALSO HAD FEVER TO 103 X 72 HRS. THIS WAS HIS 1ST DTP.
Pt died on 2/13/22. He developed sepsis syndrome with hypotension and nosocomial pneumonia in the setting of severe pulmonary fibrosis. He was started on IV antibiotics and IV solumedrol.  Acute renal failure/ hyperkalemia was treated with IV fluids. His oxygen requirement continued to be markedly elevated.    Family subsequently requested comfort care and Morphine drip was started for relief of pain and suffering.
31 y/o M in usual state of good health, suddenly developed right flank pain with associated nausea. After 2 days of pain, patient sought evaluation on 15 Dec 2014. Afebrile. Normal exam except severe CVA tenderness on right. Creatinine 12/11.9 in ER. On 15 Dec 2014, admitted to Medical Center for evaluation and treatment of acute renal insufficiency, non-oliguric acute kidney failure. Started on IV normal saline fluid boluses and pain management with renal diet. Multiple labs and diagnostics completed - most consistent with acute interstitial nephritis. Pain improved over course of hospitalization and patient was discharged on 19 Dec 2014 in stable condition. He was discharged on sodium bicarbonate and OSCAL with Nephrology follow up as outpatient. 29 Dec 2014, Nephrology follow up: Asymptomatic. New onset of pruritic, bilateral papular elbow rash; no associated joint pain, warmth or swelling. No LE edema. No flank pain. Exam normal except for bilateral papular rash on elbows. FEB 2015, Nephrology follow up - Asymptomatic. Normal.
2/1/2021 Vaccinated  C/o "foggy" after vaccine, but otherwise felt well 2/7/2021 felt tired 2/8/2021 vomited 2/11/2021  vomited several times during night and went to the Emergency Dept. 2/11 had emergency appendectomy
"really,really weak"; is not her normal self; Fatigue; could not get up from bed; This spontaneous case was reported by a consumer and describes the occurrence of MOVEMENT DISORDER (could not get up from bed), ASTHENIA ("really,really weak"), FEELING ABNORMAL (is not her normal self) and FATIGUE (Fatigue) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced MOVEMENT DISORDER (could not get up from bed). On 08-Mar-2021, the patient experienced ASTHENIA ("really,really weak"), FEELING ABNORMAL (is not her normal self) and FATIGUE (Fatigue). On 08-Mar-2021, MOVEMENT DISORDER (could not get up from bed) had resolved. At the time of the report, ASTHENIA ("really,really weak"), FEELING ABNORMAL (is not her normal self) and FATIGUE (Fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were provided by the reporter.
Hives few hours after vaccine - resolved with OTC Benadryl. Fever of 101.  Tingling of right side of face, right arm, right hand,right leg.  Weakness of right arm, right hand, right leg.  Achy right face, right arm, right hand, right leg. Drooling right side of mouth at night. Fatigue.  Patient reports symptoms have been constant for past 3 weeks.  Patient states that she feels like she can not function with these symptoms.
no adverse event, vaccine given at a not recommended age. patient 17yrs old when vaccine is recommended at 18yrs old.
pt recv vax & pt exp sore throat, clamminess & fatigue;no further details were provided;
Soreness next day, tight, knot in arm. On 5/3/11 - woke with red warm area from 3 inches below shoulder to elbow.
Two weeks after his immunizations, pt spiked a high fever ( 103-105) which would not respond to medication. He was rushed by ambulance to hospital where he spent 9 days of testing. He was finally diagnosed with Kawasaki disease. He was treated with an aspirin regime and IV immunoglobulin. He spent a year following up with specialists. Pt had speech and eating difficulties, developmental delays and is now diagnosed Autism Spectrum Disorder and receives speech, occupational therapy and ABA therapy.
redness in ipsilateral arm, reddish non well circumscribed patch with warmth and slight induration. most affected area is distal and medial to the deltoid where the presumed injection occurred.
Screamed for three days, bright red with fever of 104.3 and 104.5.  Sick for eight weeks following.  Then sick off and on, developed ear issues, lost speech, developed behavioral issues.
15yo male received the COVID19 vaccine; A spontaneous report was received from a pharmacist concerning a 15-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273).  There were no medical history and concomitant medications reported.  On 10 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011520A) intramuscularly for prophylaxis of COVID-19 infection.    On 10 Jan 2021, the patient was administered the mRNA-1273 vaccine at the age of 15. The patient tolerated COVID-19 vaccine. Treatment information was not provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome for the event, 15-year-old patient receiving the mRNA-1273 vaccine, was considered resolved on 10 Jan 2021.; Reporter's Comments: This case concerns a 15 year old male who received their first of two planned doses of mRNA-1273 (Lot number: 011520A) intramuscularly for prophylaxis of COVID-19 infection. There were no reported adverse events associated with this event of  product administered to patient of inappropriate age.
Ulcerative Colitis within 2 weeks of the second shot of Pfizer ER8731; This is a spontaneous report from a contactable other health professional (patient).  A 55-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 19Apr2021 (Lot Number: ER8731) (at the age of 55-year-old) as single dose for COVID-19 immunisation. The patient did not experienced COVID-19 before or after vaccination. Medical history included high blood pressure from an unknown date and unknown if ongoing. Concomitant medications included losartan; potassium; hydrochlorothiazide and amlodipine besylate, all concomitants were taken for an unspecified indication, start and stop date were not reported.  The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on an unspecified date (Lot Number: EW0168) as single dose for COVID-19 immunisation, the patient previously took propranolol and experienced allergy.  The patient experienced ulcerative colitis within 2 weeks of the second shot of Pfizer ER8731 (as reported) on 24May2021. The event was serious, disabling. The event required doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of ulcerative colitis and included treatment with mesalamine. The patient outcome of the event was not recovered.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of ulcerative colitis due to temporal relationship.  Case will be re-assessed upon the additional information provided. 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.
The pt. reported pain, redness, and swelling at the site of injection within the first 3 hours.
She was really sick.; She was really tired; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (She was really sick.) and FATIGUE (She was really tired) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (She was really sick.) and FATIGUE (She was really tired). At the time of the report, ILLNESS (She was really sick.) and FATIGUE (She was really tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported No treatment drugs were reported
Tinnitus - pressure in head/left ear, ear feels congested, loud whooshing sound in left ear that sometimes migrates to middle/top of head and to right ear; loss of hearing (about 50% at its worst); occasional dizziness/vertigo; increased fatigue. Accompanied by pain/pressure in sinuses that comes and goes, and even a day or two of mild depression.
Severe pain on right side head and neck,  felt like pinched nerve.  Could not rotate head at all without  pain, lots of fun at 1:30 in the morning.  Approximately 12 hours after shot.  I might have been better off catching Covid, than have to go thru this.
Case number PHEH2013US014617, is an initial spontaneous report received from a healthcare professional on 03 Jul 2013: this case refers to a 14-year-old female patient. She received only Men C, Y, W-135 liquid conjugate component of MENVEO vaccine ( batch number: X11082 and expiry date: Jun 2014), intramuscularly without being reconstituted with Men A Component on 13 May 2013. This was the first dose of MENVEO vaccine. However reporter does not know which of the two patients received only a partial dose of MENVEO. No adverse reaction reported following this administration error.
p/vax pt had red, warm area upper arm @ inj site;arm OK;no further sx;
04/26/2000 Injury and laceration to left index finger, seen in ER for sutures and exam. Tetnus Toxoid given IM. Noticed pain to injection site/right upper arm 04/27/2000 PM and marked erythema, induration, warmth, approximately 8x6 cm with worsening of discomfort. Cold compresses at injection site, Benadryl for irritation. 04/28/2000 PM.