chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician assistant refers to a patient of unknown age and gender. The patient's pertinent medical history was not reported. On approximately 15-FEB-2016 (reported as about 2 weeks ago), the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiry date, dose, route of administration and anatomical location not reported). On the same date, the patient was vaccinated with an unspecified influenza virus vaccine. On an unknown date in February 2016, the patient experienced what appeared to look like shingles; not at the injection site. The rash was spread over the arm, torso, and on the lower chest. The rash looked like vesicular lesions, no particular dermatome. There was no rash on the lower extremities. On 29-FEB-2016, the patient presented with these symptoms in the office. The patient did not recover from the adverse event at the time of reporting. The relatedness between the adverse event and ZOSTAVAX was not provided. Additional information is not expected as there was no consent for follow-up.
Dizziness, tingling, heart rate increased, blood pressure increased-stayed longer in the tent with paramedics but then another person fainted nearby and I signed off to leave so they could assist the other person.  After getting home, nausea, chills, high fever of 102.9, severe headache, sore muscles,  My skin turned red on my chest soon after the shot and I took Benadryl.  Took ibuprofen for the high fever.  The next day still had a severe headache, muscle aches, fatigue and still feel that way today.
Injection site reaction. 5 cm area of erythema, tender to palpation. Also with subjective fever/malaise. Occurred 1 day after vaccination was given. R deltoid. Treated with CLARITAN, ACETAMINOPHEN, and topical HALOG cream.
Post vaccination pain in shoulder of arm shot was given in. Next week he felt same pain in other shoulder. Pain has moved into other joints & is painful over whole body now.
Gulliam Barre   general  weakness  ,numbness all extermities up to the breasts ,unable to  ambulate,w/c  bound. Tahycardia  ,high  blood  pressure,general muscular pain,insomnia,sweats,loose of appetite,constipation,dizziness
Pfizer-BioNTech COVID-19 Vaccine  Low grade fever, chills, body ache, swollen lymph nodes, headache, tired, upset stomach and blisters on my tongue
MODERNA COVID-19 VACCINE EUA. IMMEDIATELY AFTER VACCINATION, PATIENT REPORTED FEELING NAUSEOUS, HER HEAD THROBBING, YAWNING FREQUENTLY, MUSCLE PAIN/TIGHTNESS ON OPPOSITE SIDE SHOULDER OF INJECTION AND OVERALL WARMTH. PATIENT STATED SHE HAS HYPERTENSION, CHRONIC PAIN, AND MUSCLE TIGHTNESS AT BASELINE AND WAS NOT SURE IF THESE SIDE EFFECTS WERE DUE TO VACCINATION OR ANXIETY ABOUT GETTING THE VACCINE. SHE WAITED AN ADDITIONAL 15 MINUTES AND WAS GIVEN WATER AND DECIDED TO LEAVE THE VACCINATION CLINIC WAITING AREA. PATIENT STATED SHE WAS NOT HAVING PROBLEMS BREATHING, DENIED THE OFFER TO CALL A FRIEND, FAMILY, OR EMS SERVICES.
ACUTE HYPERCAPNIC RESPIRATORY FAILURE CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 3/18/2022 &   3/29/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Myalgia, NauseaVomiting, fatigue no appetite both shots Narrative:  Other Relevant History:
Pt. had a 9 day febrile illness starting <24hrs after receiving MMR, VARIVAX and PENTACEL. Large local reaction about PENTACEL site. Grew light growth of Strep A Group on throat culture in evaluation of fever. Dr spoke with family Saturday evening - no longer febrile but still listless (11 days after vaccine). 13 days after vaccine dad reported pt. doing better since starting.
Pediatrician messaged because he wouldn't stop vomiting after vaccine after about 5 hours later. He did not have any symptoms immediately after the vaccination was administered. Our pediatrician asked if he was experiencing other symptoms that seemed like an allergic reaction, such as hives, swelling, pale color which he did not. Given recommendations on helping control the vomiting and hydration, and to keep them updated on his symptoms. He is now feeling much better from yesterday, and has now had no episodes of vomiting.
Developed hives - Tx in ED with meds PO (prednisone, ATARAX, PEPCID) - discharged stable. Left upper arm at site reddened.
Pain in right arm, exhaustion, body aches and pains, flu type symptoms, Pain in right lymph node under arm pit
Myocarditis; headache; body aches; joint pain; Fatigue; This is a spontaneous report from a non-contactable consumer or other non hcp.     A 36-years-old non pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 07Sep2021 09:00 (Lot Number: FC3181) as single dose (at the age of 36) for covid-19 immunisation. Medical history was none. No known allergies. There were no concomitant medications. No other vaccine in four weeks. The patient experienced myocarditis on 14Sep2021 18:15, headache on 14Sep2021 18:15, body aches on 14Sep2021 18:15, joint pain on 14Sep2021 18:15, fatigue on 14Sep2021 18:15. No treatment received. No covid prior vaccination. Unknown if covid tested post vaccination. The events outcome was not recovered.    No follow-up attempts are possible. No further information is expected.
"Pfizer-BioNTech COVID-19 Vaccine EUA".... dizziness
High fever at night (parents did not measure), cough at night, vomiting and stomach ache on 1/16/01 and 1/17/01. Epistaxis X3 on 1/18/01. No local reaction. Temperature 101.4F on 1/19/01 at 10:30.
Approx 2wks /p recving inject pt exp weakness,dizziness,lt chest pain,lt shoulder/neck pain that radiated.Tenderness along scaplua & "knots" from occipital area to scapula.Jan84 went to MD,tx /w meds.Mar84 hosp due to spasms of muscle..WORM
Shot given inadvertently believed to be his 1st shot, but he had actually had one previous a week ago.
More than 24 hour after receiving the Hepatitis B vaccine, he started experiencing papules on scalp. Non itching.
I had terrible bloating and gas January 22, all day diarrhea  January 25 and gas all this week which is only helped by heating pad on stomach and when ready to exit standing to release gas from bowels, plus have had to take the simethicone 6 to 7 times per day.
was to get pentacel and inadvertently got just the hib component mixed with sterile water , instead of the dtap/IPV component to dilute it with no reported adverse event; was to get pentacel and inadvertently got just the hib component mixed with sterile water , instead of the dtap/IPV component to dilute it with no reported adverse event; Initial information received on 26-Oct-2022 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 4 months old and unknown gender patient who was to get diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] and inadvertently got just the hib component mixed with sterile water , instead of the dtap/ipv component to dilute it with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On an unknown date, the patient received suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination(immunisation).  On an unknown date the patient was to get pentacel and inadvertently got just the hib component mixed with sterile water, instead of the dtap/ipv component to dilute it with no reported adverse event (single component of a two-component product administered, product preparation error) (same day latency).  Action taken: Not applicable.  Outcome: Unknown for both the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error
More than 36 days from fist vaccination/9 weeks out of the recommended window; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 36 days from fist vaccination/9 weeks out of the recommended window) 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 07-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 36 days from fist vaccination/9 weeks out of the recommended window). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 36 days from fist vaccination/9 weeks out of the recommended window) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.
Red blotchy raised rash (L) thigh. Fever x2 days. Heavy rhinitis.
Information has been received from a health professional concerning a 9 year old female who on 03/24/1997 was vaccinated with a first dose in the LA of varicella virus vaccine live.  On 02/24/2005 the pt developed less than 50 lesions. The pt was reported as recovering. Additional information has been requested. This is in follow-up to report (s) submitted on 5/16/2005. Information has been received from a physician concerning a 9-year-old female who on 24-MAR-1997 was vaccinated with a first dose in the left arm of VARIVAX (Merck) (Lot # 620630/1345O). On 24-FEB-2005 the patient developed a very mild case of vericella of less than 50 lesions. The patient was reported as recovering well. No additional information is expected.
Possible Cellulitis to right arm. Pt states 4 hours after receiving vaccine arm started to swell up. Favor just an allergic reaction.
At the time that symptom started I had itchiness and hives going across my chest and my palms of my hands were itchy. The itchiness in hives spread across my entire back and stomach. At this point I had taken Benadryl at home. I noticed my chin was starting to go numb and I felt Some slight itchiness in the back of my throat. I went to the emergency room at my local hospital, got triage and taken back right away to see an emergency doctor. At this point my skin had redness all over from head to toe in the itchiness was all over my body. After being assessed the doctor had prescribed me prednisone, Pepcid, and an epi-injection. After I was given the Epi injection I was monitor for an hour and a half and emergency room to make sure that my heart rate did not spike and that my symptoms were relieved, which they were.
Lymph nodes on armpit very painful and very swollen.; Lymph nodes on armpit very painful and very swollen.; Arm sore for 2 days; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 21Apr2021 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Other medical history not reported. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sertraline hydrochloride (ZOLOFT) from an unknown date for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 31Mar2021 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Apr2021, the patient experienced arm sore for 2 days, lymph nodes on armpit very painful and very swollen. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events lymph nodes on armpit very painful and very swollen was resolving at the time of this report; while that of the arm sore was recovered on 24Apr2021, after the duration of 2 days.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a consumer concerning her 20 year old granddaughter with no pertinent medical history and no allergies who in approximately 2007 ("approximately three years ago") was vaccinated with three doses of GARDASIL (lot#s not reported). There was no concomitant medication. It was reported that the patient had an unremarkable papanicolaou test (PAP test) prior to vaccination. Subsequently the patient had her first PAP test following vaccination came back positive for an unspecified serotype or serotypes of human papilloma virus, and her second PAP test following vaccination come back positive for unspecified abnormal (described as possible cancer) cells. No specific dates were available for either vaccinations or for any of the PAP tests. No specific information was available for any of the results of the PAP tests. Unspecified medical attention was sought via office visit. At the time of this report, the patient's outcome was unknown.
pt recvd vax & exp fatigue, h/a, vomiting, joint pain, abdo pain, nausea & skin rash following vax;
On 10/9/14 patient stated she noticed a rash on left side of her neck 30 minutes after receiving the Hep B vaccination; Rash also noticed on right side of her neck 45 minutes after the Hep B vaccination was given. Patient stated the rash was accompanied by itching. Itching has since resolved. Patient reported adverse event 20 days after receiving vaccination.
Rash, redness, tenderness at injection site. Small lesion like rash across the body. Not very itchy.
ABOUT 5 MINUTES POST-VACCINATION PATIENT BEGAN TO FEEL LIGHT-HEADED AND DIZZY, AND COMPLAINED ABOUT NUMBNESS IN HER HANDS AND THAT HER THROAT FELT "THICK"
Patient presented to pharmacy on 5/2/17 stating that she is still experiencing constant, mild muscle pain in the right arm where her FLUZONE HIGH DOSE shot was given on 10/17/2016.
Pain in the injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Pain in the injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. H012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Drug allergy (Allergic to Demerol.).    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain in the injection site). At the time of the report, VACCINATION SITE PAIN (Pain in the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included for Blood pressure. Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
89-year-old female presents the emergency department by EMS from home.  She did not appear to be in any acute distress was nontoxic appearance.  She was mildly febrile.  She was unaware she had a fever.  Chief complaint is weakness with multiple falls over the past day or 2.  She does not report any injuries and did not hit her head.  No blood thinners.  She has been ambulatory.  She came in with make up on.  She was ambulatory to the ambulance according to paramedics.  She denies chest pain difficulty breathing abdominal pain nausea vomiting or diarrhea.  No UTI symptoms.  She does have a very minor skin injury on her left lower leg that she states she got 2 weeks ago when climbing over a fence.  She has a history of kidney stones and chronic back pain that she takes tramadol and Valium for.  She also has a history of GERD and hypertension. Associated Symptoms: fall, fatigue, injury, redness, weakness
diagnosed as shingles although had ZOSTAVAX 3 years prior; Ramsay hunt syndrome/ Herpes Zoster Oticus; teeth extracted; Dermatitis; Shingles; Information has been received from an approximately 67 years old male consumer with a history of stent in heart 12 years ago and with no drug reactions or allergies, concerning himself who in approximately 2009 ("about 3 years prior") was vaccinated with a dose of zoster vaccine live (Oka/Merck) (dose, route and lot # not reported).   Concomitant therapy included unspecified pain medication.  In October 2011, the patient had some teeth extracted and after that the patient developed a rash on his face that got worse. The patient went to the emergency room where it was diagnosed as dermatitis, but 2 days later it was diagnosed as shingles, although he had had the zoster vaccine live (Oka/Merck) vaccine about 3 years prior. From that he developed Ramsay Hunt syndrome that was diagnosed by an ear doctor. The patient still had pain. The patient was given ointment and pain medications. Blood test was performed (results not reported). At the time of the report, the patient did not  recover.  Follow up information was received from a health care professional reporting that the approximately 67 year old white male patient "3 to 4 years ago" in approximately 2009 was vaccinated with a dose of zoster vaccine livec(ZOSTAVAX) (dose, dose number, route, lot number and expiration date not reported). It was reported that the patient developed shingles 3-4 years after getting zoster vaccine live(ZOSTAVAX) vaccine. No adverse reactions were reported.   Follow up report was received on 17-JUL-2019, from a lawyer regarding a case in litigation and referred to a male patient (currently 76 years old). No information was provided regarding concurrent conditions, or concomitant medications.   On or about 04-JAN-2008 (previously reported as "approximately 2009"), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient was treated by a physician for Ramsay Hunt Syndrome. The outcome of the event Ramsay Hunt Syndrome was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event Herpes Zoster Oticus was determined to be medically significant.  Additional information has been requested. Company Causality Assessment: Episode Profile: Medically Confirmed: N
This spontaneous report as received from a licensed practical nurse refers to a multiple unspecified patients of unknown age and gender. There was no information about patients' concomitant medications and pertinent medical history reported. On an unknown date, unspecified patients were vaccinated with doses of improperly stored ROTATEQ (lot # L000433, expiry date 09-JUL-2016 (routes and sites of administration, doses were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
I experienced SOB, feeling of hot ,dizzy, lightheaded and tachycardiac and hypotensive, shivering and generalized body aches.
Case received PHEH2017US002001, is an initial spontaneous report received from a pharmacist on 16 Jan 2017. This report refers to a 29-year-old pregnant female patient. Patient's last menstrual date was not reported. It was reported that this 29 year old pregnant patient was vaccinated with one single dose of FLUAD (lot number: 166101, expiry date: Apr 2017) at a dose of 0.5 ml intramuscularly on 15 Jan 2017. No adverse event was reported following vaccine exposure during pregnancy and inappropriate age at vaccine administration.
Patient reported a 3 inch rash at the injection site, with swelling, redness and warmth
This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history, concomitant medications, drug reactions or allergies provided. On 29-OCT-2015, the patient was vaccinated with an improperly stored dose (Oka/Merck) VARIVAX injection (lot# K010437, expiration date 22-JUL-2016, dose, anatomical location and route of administration were not reported). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Severe chest pain started Thursday evening, May 27th. Chest pain lasted throughout the night but went away. Friday, May 28th chest pain came back at 10:00am and progressively got worse. Chest pain was localized in the mid- sternum region.
Slight raised, redness, warm to touch, softball sized area at injection site. Patient instructed to take TYLENOL prn and pharmacist states recommended not to receive any TD vaccines within 10 years. Per 2nd conversation w/RN - area originally described as round, elevated, softball sized area on arm. Upon follow-up conversation - pt's arm had no elevation or nodule. Only reddened & warm to touch.
Breakthrough COVID-19 Case: April 16th, I started having sinus drip down my throat and I started having a little tickle in my throat. Symptoms increased Tuesday the 19th. I had a painful sore throat, a very bad headache, and I was extremely exhausted all day. On Wednesday the 20th, I woke up feeling even worse. My head hurt like a migraine almost. I was sensitive to light. I had pain in my eye especially when looking to the right. My face was swollen. I had a headache that wrapped around my head from my forehead around the back of my neck. I had chills, sweats, and aches. That morning, I took 2 at home COVID-19 tests that said I was negative. On Thursday, I felt the same way with increased pain in my knees, hips, and ankles, but my knees really hurt. Friday, the 22nd I wok up around 630 or 7am. My head was really hot. I had all the same symptoms. Although, my sore throat had gone away. My temp was 99.96 after taking fever reducing medicine. I called a nurse at my health insurance. She advised me to go to the ER. I went to the ER and got medication called Paxlovid. I did a 5 day course of that. I had a positive test on the 22nd.
Pt had severe itching, redness, swelling, and blistering at injection site in left shoulder
Information has been received from a licensed practical nurse concerning a female patient in her 20's who was vaccinated with a dose of Gardasil and experienced mild soreness at the injection site after the vaccination was given. The same source reported that another patient had the same reaction (WAES # 0706USA01310). Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Initial and follow-up information has been received from a licensed practical nurse concerning a female patient in her early 20's who was vaccinated with a dose of GARDASIL and experienced mild soreness at the injection site after the vaccination was given. The same source reported that another patient had the same reaction (WAES # 0706USA01310). Additional information is not expected.
No adverse event.  Parent wanted pediatric dose on child who was able to receive her second dose of adult dose pfizer. The parent was educated and was adamant that her child receive the pediatric second dose.