chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vasculitis; mouth feeling chapped; nose feeling very sore; skin started peeling from the roof of mouth; nose began to bleed; rash; Initial information received on 24-Nov-2020 regarding an unsolicited valid serious case received from a consumer via Medical Information (Reference number- 00370045).  This case involves female patient of an unknown age who experienced vasculitis, mouth feeling chapped (stomatitis), nose feeling very sore (nasal discomfort), skin started peeling from the roof of mouth (skin exfoliation), nose began to bleed (epistaxis) and rash, while she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIFLUNISAL (DOLOBID).  On an unknown date (years ago), the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was also reported that Flublok has been suggested to her as a good alternative to the regular flu vaccine.   On an unknown date, the patient developed a non-serious mouth feeling chapped (stomatitis) (within a day) following the administration of INFLUENZA VACCINE.  On an unknown date, the patient developed a non-serious nose feeling very sore (nasal discomfort), skin started peeling from the roof of mouth (skin exfoliation), nose began to bleed (epistaxis), rash (unknown latency) following the administration of INFLUENZA VACCINE.  On an unknown date, the patient developed a serious vasculitis (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Relevant laboratory test results included: On an unknown date, biopsy skin - [The results came back as vasculitis due to a drug reaction]  Therefore, she doesnt know for sure that it was a reaction to the vaccine, but she has never had a problem taking anti-inflammatories.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of events were reported as unknown.  Information on the batch number was requested.; Sender's Comments: This case involves a female patient of an unknown age who had vasculitis, stomatitis, nasal discomfort, skin exfoliation, epistaxis and rash, after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. Concomitant medications included DIFLUNISAL. However, patient's medical condition at time of vaccination, laboratory data excluding other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Fever, body aches, chills, headache, flank pain, nausea. Has not taken any medications. Currently has all side effects
Patient was given the pediatric vaccine, 0.3ml, instead of the adult vaccine. No treatments given or adverse reactions noted following administration.
Warmth, redness, tender around injection site. Ibuprofen/cool compress.
Severe headache and high fever; the headache persisted until around 12 Noon on 4/11. Just lost a nights sleep. Feeling well as of 4/12.
X Ray tech got Tdap and TST 2 days before swelling, redness and itching of Lt deltoid. No axillary pain or other skin rash or wheezing. Erythema, induration, warmth but no tenderness. Reports itching and limited soreness with movement. Afebrile. Area of induration 3x4 inches. Treated with cool compress and Zyrtec 10 mg P.O. qd. (Tue shot.-Thur reported and treated-Resolved by Sat P.M.)
This spontaneous report was received from a registered nurse, referring to multiple unspecified patients of unknown ages and genders. Medical history or concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L020015, expiration date: 16-AUG-2017, lot# L043213, expiration date: 28-AUG-2017)(dose and route were not provided). Concomitant medication was not reported. It was also mentioned that no adverse effects were reported, temperature was low 32 degrees F, the time frame was 28 days, there was not previous temperature excursion and there was not product quality complaint involved. This is one of several cases from the same reporter. Additional information has been requested.
Shortly after the first vaccine, I started to have some reactions (slight fever, sore muscles, sore arm at injection site, exhaused) and I expected that. I started to have loose watery stools several times a day. It seemed to decrease to a couple times a day and then I received the second vaccine. The watery loose stools came back but now it was 10+ times a day, shortly after eating, and to the point I was completely incontinent and couldn't feel it coming on or going sometime and waking me up at night. I lost about 15 pounds from the second does until late July.    I went to my primary care doctor and then to a Gastroenterologist. After bloodwork, stool samples, and many appointments, the GI ended up doing a colonoscopy and endoscopy late July. The GI found "eosinophils" in my colon.
1 week post flu shot pt c/o flu like symptoms low grade fever, headache, stuffiness, cough, some mild aches - lasted 2-3 days - now recovered - did not seek care of MD.
Initial information received on 23-Jul-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves Adult patient who experienced patient had fainting, while he/she received vaccines GARDASIL and ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect GARDASIL not produced by Sanofi Pasteur lot number not reported via unknown route. On an unknown date, the patient received a dose of suspect Diptheria-2/Tetanus/5 AC Pertussis vaccine lot number not reported via unknown route. The patient developed a non-serious patient had fainting (syncope) following the administration of Diphtheria-2/Tetanus/5 AC Pertussis vaccine and following the administration of GARDASIL. (Other relevant tests included No lab data.) Final diagnosis was patient had fainting. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for patient had fainting.
Flu shot given 11-30-05.  Pt states right arm started hurting same day, and has gotten progressively worse-Pt states took pills from doctor and physical therapy without relief-Pt complained of weakness right hand.  Right upper arm appears normal; no redness, swelling or masses.
Headache, Myalgia, Arthralgia, Fever, Tachypnea, NauseaVomiting, shaking chills first night, 5x2.5 wheal at injection site Narrative:
sore arm; This is a spontaneous report from a contactable consumer reporting for herself.  This female patient of unspecified age received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced a sore arm after her first dose, on an unknown date. Event outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Mom called at 2 pm on 3/9/06 state pt woke up this am with rash on side of neck. Had pizza for dinner before taking a bottle and going to bed at 7 pm on 3/8/06. Instructed to come to clinic. Arrive at 2:45 pm, rash red raised upper L shoulder and left side of neck. Called Dr. left message to call. Client had to leave before Dr returned phone call. C/O Allergy to food. Instructed to take child to ER and give Benadryl. Ok'd la, Dr-  3-10-06 T/E to mom  rash fading Dr at ER reaction to varicella taking Benadryl improving.
Several hours after receiving the vaccine had chills, fever, myalgias, vomiting and headache. Sxs were severe enough that she was admitted to the hospital for 24 hours for hydration. Fever, Nausea w/vomiting, Headache, general  2/25/09 Received medical records of 2/6/2009. FINAL DX: none provided Records reveal patient experienced chills, fevers, myslgias, vomiting, HA within few hours of 2005 flu vaccine.  24 hr admission for rehydration.  Allergy consult done.  Recommended to have previously tolerated Flu-Mist vaccine(2007) in future.
This case was reported by a nurse and described a 38 year old male patient who did not respond to immunization with hepatitis B vaccine recombinant (Engerix-B). The nurse reported that the patient "is not overweight and is not a smoker." On 25 February 2004 and 25 March 2004, the patient received the first two dose of Engerix-B (lot ENG5401A2). On 02 September 2004, the patient received a dose of hepatitis B immunization series. Approximately eight weeks after the third dose of hepatitis B vaccine, on 29 October 2004, a hepatitis B surface antibody titer was negative. As of 11 January 2004, no adverse event had occurred.
This spontaneous report as received from a nurse and refers to multiple patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On 29-SEP-2016, the patients were vaccinated with improperly stored GARDASIL 9 lot # M023169, expiry date 13-JUN-2018 (dose, route and site of administration were not reported). No adverse effects were reported. Administered doses of vaccines were exposed to 40 to 50 degrees Fahrenheit for 24 hours. There were no previous excursions reported. Additional information has been requested.
mom states pt had a dimple in lt thigh where shot had been administered on 14APR93; pt seen by MD 26MAY93; MD informed mom that pt had infect in lt thigh; indentation lt upper thigh;
Information has been received from a registered nurse concerning an elementary school aged child who on 14-JUN-2001 was vaccinated with a dose of VARIVAX. On 01-MAR-2006, the patient developed breakthrough chickenpox. Unspecified medical attention was sought. There was no product quality complaint involved. No further information was available. Additional information has been requested.
Lymph node inflammation, especially under/around armpits, radiating nerve pain in arms and legs and across chest,  joint pain, and the feeling of skin crawling. The nerve pain in arms continues, as does the lymph node pain. Both have moderately improved, but still problematic. Have taken tylenol, advil, and benadryl for treatment.
1st Covid vaccine Moderna  12/26/20 2nd Covid vaccine Moderna 1/25/2021 3/18 ill 3/19 tested positive for Covid Luminara DX AG test
Sneezing noted in office after immunization but left office well otherwise. Upon arriving home (within 30 min) was flushed head to toe with hives, itchy, red and watery eyes. Skin very itchy as well. Returned to office with above symptoms documented. There was no wheezing or respiratory distress. The pt was treated with benadryl and IM steroids. The symptoms resolved within 1 hour.
Swelling, erythema, hyperthenia, right arm with changes extending to anterior chest wall.  Mild periwound, itchy, ecchynosis.
This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 23-NOV-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported, lot # L023385, expiration date: 25-JUN-2017) (incorrect product storage). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Patient received pediatric dose of Pfizer when it should have 12 and up Pfizer dose.
Patient admitted on 11/15/2021 for scheduled TAVR. He underwent successful transfemoral aortic valve replacement with a 29 mm Edwards Sapien 3 bioprosthetic valve with placement and subsequent removal of the Sentinel cerebral protection system. Recovered in in hospital. Admission within 6 weeks of receiving the CVOID vaccine.
Immune thrombocytopenic purpura; petechia/ blood spots in his legs went from his feet up to his mid thigh; nose bleeding, heavy bleeding, more than 20 minutes to make it stop; blood pressure fluctuation; Fear; pain; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of IMMUNE THROMBOCYTOPENIA (Immune thrombocytopenic purpura), PETECHIAE (petechia/ blood spots in his legs went from his feet up to his mid thigh) and EPISTAXIS (nose bleeding, heavy bleeding, more than 20 minutes to make it stop) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0181321H) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bleeding nose (No reported medical history).    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced EPISTAXIS (nose bleeding, heavy bleeding, more than 20 minutes to make it stop) (seriousness criterion hospitalization). On 04-Apr-2021, the patient experienced IMMUNE THROMBOCYTOPENIA (Immune thrombocytopenic purpura) (seriousness criterion hospitalization) and PETECHIAE (petechia/ blood spots in his legs went from his feet up to his mid thigh) (seriousness criterion hospitalization). On an unknown date, the patient experienced FEAR (Fear), PAIN (pain) and BLOOD PRESSURE FLUCTUATION (blood pressure fluctuation). The patient was hospitalized on 08-Apr-2021 due to IMMUNE THROMBOCYTOPENIA and PETECHIAE. On 09-Apr-2021, EPISTAXIS (nose bleeding, heavy bleeding, more than 20 minutes to make it stop) had resolved. At the time of the report, IMMUNE THROMBOCYTOPENIA (Immune thrombocytopenic purpura), PETECHIAE (petechia/ blood spots in his legs went from his feet up to his mid thigh), FEAR (Fear), PAIN (pain) and BLOOD PRESSURE FLUCTUATION (blood pressure fluctuation) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Platelet count: 130 (Inconclusive) raised to 130. On an unknown date, Blood pressure measurement: 150/90 (High) high and 90/50 (Low) low. On an unknown date, Platelet count: 0-2 (Low) down to  0-2 and 50 (Inconclusive) raised to 50.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       His treatment were steroids and ivIG. In the hospital, they told him that given the treatment they had to apply he no longer has a functioning immune system and that he will have to seek for constant medical care, all that will interfere with his life and work plans.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
About 12-14 days after the vaccination, the injection site began to feel warm and itch. On 9/3, a day or so after the itching began, I awoke with my arm swollen at the injection site and an extremely red rash had begun to form. There was no pain associated with the rash, it felt very warm, a little itchy, but mostly looked worse than it was. Over the next couple days it had begun to spread down my arm, about 4-6 inches. I treated the rash with ice packs (3-5 times a day), benadryl pills (3 a day), and hydrocortisone cream (3 times a day). The rash lasted about 6 days. After the rash went away there was still occasionally some warmth at the injection site but the rash did not come back.
pt recv vax; w/in less than 2 min dizziness,light headedness, nausea,tongue tingle,felt very sick; given dph;elevated IGE-CBC etc..sensitive smells;muscle weakness;fatigue;dec energy ;no appetite;
she only had a minor sore arm for her 1st two doses; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 15Feb2021 (Lot number: EM9809) at the age of 70 years as dose 2, single and administered in arm left, administration date 25Jan2021 (Lot number: EL9262) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CYTOMEL taken for hypothyroidism, stop date: Nov2021. Vaccination history included: Flu vaccine (had a flu vaccine every year since she was probably 20 years old.), for Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "she only had a minor sore arm for her 1st two doses".  Additional information: The reporter stated that she only had a minor sore arm for her 1st two doses and she was fine. The reporter stated that there was nothing that she had taken that had been changed. The medications that she was on were ones that she had taken for years. The only thing that did change was Cytomel for underactive thyroid was switched to the generic version at the end of Nov2021.  Follow-up attempts are completed. No further information is expected.
Itchy red rash on right arm near injection site, appeared fully about 7 days after shot. About 2-3 inches by 2 inches or a little bigger, with another little spot of rash below it
Information has been received from a registered nurse (R. N.) concerning a female patient at one of the local schools who had an aluminum poisoning. The patient received a dose of GARDASIL at an unspecified date. The patient sought medical attention and was seen by a doctor. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and unknown gender. The unspecified patients pertinent medical history was not reported. On an unknown date the unspecified number of patients were vaccinated with PROQUAD (Merck) (Lot # K001854 and expiry date: 06-AUG-2015) which was improperly stored. Reporter provided that there have been no reported adverse events following administration of the vaccinations. There has been no need for revaccination. This is one of the several reports from the same reporter. Additional information has been requested.
Moderna Covid19 Vaccine was inadvertently administered as the 2nd dose in the series where Pfizer Covid-19 Vaccine was administered as dose 1.  Patient notified.
her fast blood glucose was higher than normal; sore arm; scratchy throat; metallic taste; fatigue; sore muscle; A spontaneous report was received from reporters (a consumer and a health care professional) concerning a 68-years-old diabetic female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events like increased fasting blood glucose, soreness in arm, sore muscle, fatigue, scratchy throat, metallic taste.   The patient was diabetic currently taking Metformin ER 750mg once daily.  On 21-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273(lot/batch: 025J20-2A ;expire- 19-FEB-2021) in the right upper arm for prophylaxis of COVID-19 infection.  The patient experienced increased fasting blood glucose levels for the next two days and became normal the next day, also the patient experienced events like soreness in arm, sore muscle, fatigue, scratchy throat, metallic taste.  On the next day of vaccination was higher than normal about 224BG, the next day 132BG and back to normal 108-110BG on the other day. The patient was on Metformin ER 750mg once daily as she was diabetic. The patient had taken Tylenol PM 500mg once at night to relief soreness in the arm, also water to get relief to the metallic taste.  Action taken with mRNA-1273 in response to the events was not reported.  On 24-JAN-2021, the outcome of the events has been resolved/recovered. The reporter assessed the events as related to the study drug.
on Friday, August 5 at 6:30 pm the incorrect vaccine was administered, from toddler to pediatric to patient of 4 years of age accompanied by her parents. At the time of performing the salvage process it is observed that the toddler vaccine was not administered. The vaccine prepared by Employee was the pediatric vaccine of 5/11 years of age. Case was reported.
Being a diabetic, my blood sugar was in the 300's, and even after changing my insulin pump because I believed there may have been an issue with delivery, my blood sugar continued to rise.  I did not eat anything until about 6 PM when my blood sugar began to lower.  At that time, I tried to eat some chicken soup, but after a few mouthfuls, my throat began to constrict and my tongue and the inside of my mouth began to itch.  This continued every time I began to try to eat something and I still could feel what felt like some constriction in the back of my throat the next day (Monday).
NUMBNESS, EAR RINGING, BLUR VISION, CHRONIC PAIN, THROBING, FALLING, LACK OF SLEEP, NO APPITITE, ITCHING TINKLING ALL OVER, BURISING, TENDONITIS
Vomiting in the middle of thr 3rd night; Exhaustion; underlying nausea; had to force myself to eat and drink.; Low grade fever and chills day 3-4.; Low grade fever and chills day 3-4.; Nights sweats for thr firstv3 nights.; This is a spontaneous report from a contactable Nurse (Patient). A 57-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6198), dose 1 via an unspecified route of administration, administered in Arm Left on 12Feb2021 15:30 (Age at Vaccination 57-year-old) as DOSE 1, SINGLE for COVID-19 immunization at  clinic. Medical history were not reported. Concomitant medications included Low dose ASA, vit C & D, estroven, & multi vit. The patient has reported Known allergies: NKA. Patient had no other vaccine in four weeks. Patient did not covid prior vaccination and not covid tested post vaccination. On 12Feb2021 the patient experienced nights sweats for thr firstv3 nights, on 15Feb2021 03:30 vomiting in the middle of thr 3rd night, exhaustion, underlying nausea, had to force myself to eat and drink, low grade fever and chills day 3-4. The patient did not receive any treatment for the event. The patient underwent lab tests and procedures which included body temperature: low grade on 15Feb2021. Patient did not received treatment. The outcome of the events Nights sweats for there firstv3 nights was recovered on 15Feb2021. Vomiting in the middle of thr 3rd night, Exhaustion, underlying nausea, had to force myself to eat and drink, Low grade fever and chills day 3-4 and Low grade fever and chills day 3-4. was recovered in Feb2021  No follow-up attempts are possible. No further information is expected.
Rxn. in left arm starting Wed. 8/18/04 area below injection became red, swollen and hot to the touch very tender.
no adverse effect; 74 year old patient received first dose of GARDASIL 9; This spontaneous report was received from a pharmacist regarding a 74-year-old patient. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 27-SEP-2018, the patient was vaccinated with first dose in hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (Dose, frequency, route, lot# and expiry date were not reported) series for prophylaxis (product administered to patient of inappropriate age). No adverse effects were reported (no adverse event). The outcome of product administered to patient of inappropriate age and no adverse event was unknown.
Bodyache and headache since she got J&J shot yesterday . Had 100.5'F temp 20mins PTA.  Denies URI symptoms, chest pain or difficult breathing.
"15mins post vaccination pt c/o chest pain ""pinching"" 2/10, non-radiating.  No other new/abnormal sxs. Vitals @9:57 BP 112/72, HR 90, O2Sat 100%.  Pt given fluids and monitored until the pt was given the ok to be released from clinic.  Pt verbalized ok to leave.  ED precautions given. Pt left w/ steady gait. A&Ox4.
Shot given at 5:30 am. Within 2 hrs dizzy/light headed, nausea. Also - aching/chills for 8 hrs. Sleep was fitfall, leaving me exhausted. Stayed in bed all the next day (New Years) trying to get enough fluids, was hard. Duration 48 - 60 hrs 4 days later I'm back to my energy level, at all. Other symptoms have gone.