chrisvoncsefalvay/vaers-outcomes huggingface dataset:
4 year old patient was administered Kinrix as the third dose in the DTaP series; This case was reported by a nurse via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 4-year-old patient who received DTaP-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate schedule of vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-Sep-2022 Reporter's comment: The nurse reported that a 4 year old patient was administered Kinrix as the third dose in the DTaP series. At the time of reporting, the nurse did not have the patient details, date of administration, lot number/expiration date, or the information of what vaccines were given for the first two DTaP series.  The vaccine administration facility was the same as primary reporter.   The consent to follow up was granted. Additional Supportive information: The patient was administered Kinrix as the third dose in the DTaP series which led to inappropriate age at vaccine administration. This case was one of 10 cases, reported by same reporter.; Sender's Comments:  US-GSK-US2022136453:Same reporter US-GSK-US2022136454:Same reporter US-GSK-US2022136446:Same reporter US-GSK-US2022136451:Same reporter US-GSK-US2022136456:Same reporter US-GSK-US2022136459:Same reporter US-GSK-US2022136461:Same reporter US-GSK-US2022136463:Same reporter US-GSK-US2022136465:Same reporter US-GSK-US2022136466:Same reporter
Local reaction to vaccine (swelling at least a few inches from the site of administration going down the elbow and wrist (left arm).
Fever, chills, fatigue lasted a day. Then vertigo started with back of neck dull pain. Vertigo still ongoing
Patient came to pharmacy 10/4 at 4:15. He showed me a swollen, red, tender, warm right deltoid. It was "much better" than Saturday. He felt he was "hit by a truck, with malaise, body aches, flu symptoms".
Cellulitis at injection site. Started patient on antibiotics for cellulitis today (10-31-08) advise if not improved tomorrow see PCP if worse later today go to ER.
RPh gave patient Shingrix vaccine on 8/15/19.  Patient came in to my pharmacy 8/16/19 around 6:15 PM complaining of numbness in both forearms, hands and fingers.
Patient's mother called within 15 min of departure stating child c/o sudden onset of chest pain describe as sharp in character. Denies SOB. Mother states child "looks weak". Advised to report to E.R. immediately.
Patient walked away from site of immunization and proceeded to slowly faint within 5 minutes following the shot, looked pale and white, felt dizzy.
Patient came back an hour after the shot complaining of dizziness, heart racing. Did a BP check was 160/80. Patient said she usually has low BP. Caregiver took her to hospital. Patient was so dizzy they went to emergency room.
patient received vaccine at Hospital and presented to our office w/ reaction 1.5 in x 2 in desquamation of skin with bleeding present to left upper arm, no purulent drainage, Cleansed area with sterile saline and covered with non adherent pad and Tegaderm, PLAN OF CARE:  Obtained culture. Will start prophylactic antibiotic. Discussed skin care. F/u 2 days with prescribed clindamycin 300mg oral TID
Increased menstrual bleeding. Heavy flow for 3 wks out of the month, ongoing for 8 months Left breast burning pain
Fever injection site pain Narrative:  symptoms today (vaccination 2nd dose yesterday) include Fever 101.2, chills, extreme fatigue, slight headache, and injection site pain.
Patient had redness around red bump (pimple like formation dry and crusty), itchy at injection site.
the day  after  2 nd  covid shot, family called to report fever 101.3 , mental status changes, incoherence, fatigue/tiredness, was instructed to call 911/visit ER for eval/tx. was admitted at Hospital  and discharged after 24 h.
Left arm showing indurated rash, mild pain experienced- Varicella and TD given. Pt. given Benadryl per physician- seen 5/20/04 and also prescribed Triamcinalon am- Home was called on 5/24/04 and pt doing well- no redness, or swelling.
PATIENT COMPLAINED OF BODY ACHE, FEVER, FATIGUE, CHEST CONGESTION, AND UPPER BODY RASH LASTED 12 HOURS ONLY.
I received my ZOSTAVAX shot (the vaccine to prevent shingles) yesterday afternoon. The area became very itchy, and after I finished my work and remove my lab coat realized that posterior to the area of injection it was swollen, red, indurated, and warm. It had a circumference of 2 inches. It was extremely itchy overnight. Today the redness traveled posterior to my arm and is getting more diffused. Still indurated but less. Very itchy. Arm feels heavy and yesterday night felt like numbed. Today feel better. Still very itchy and warm.
4/13/2022- Presents to ED, c/o hypotension and SOB. covid + test 10 days ago.  eGFR: 51, BUN/creatnine:35/1.8. CXR: moderate emphysematous changes both lungs. Admit AKI, pre-syncope d/t orthostatic hypotension.  4/14/2022-Troponins neg x 2. VS wnl. 02 sat wnl RA. 4/15/2022-VSS, BUN/creatnine 22/1.3. Discharged to home.
Pt became lightheaded and dizzy. Pt vitals evaluated and found to be within limits. Pt symptoms resolved without intervention. Pt refused transport to ED.
lymphadenitis; gland swelling; periorbital edema; severe muscle cramping; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unspecified route of administration, administered in the left arm on 21May2021 08:00 am (batch/lot number EW0161 and expiry date unknown) at 60 years of age as dose 1, single for covid-19 immunization. The patient informed that the facility where the most recent COVID-19 vaccine was administered was in the hospital. Medical history included graves disease. The patient had no covid prior vaccination/was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included levothyroxine for unspecified indication from unspecified. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. In May2021, the patient experienced lymphadenitis, gland swelling, periorbital edema, severe muscle cramping. The events resulted to emergency room/department or urgent care and doctor or other healthcare professional office/clinic visit. The patient was hospitalized for 1 day due to the events. The patient underwent lab tests and procedures which included COVID-19 (BP) (nasal swab) on 24May2021, 01Jun2021, 10Jun2021, 15Jun2021, 21Jun2021, 29Jun2021, and COVID-19 (RAPID) (nasal swab) on 24Jun2021; all negative. The patient received treatment of prednisone w/taper, magnesium. The outcome of the events was not recovered.; Sender's Comments: The contributory role of the suspect product  bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), (batch/lot number EW0161 and expiry date unknown) to reported events is possible based on temporal association and known profile of the product.
Fever 101.4; Soreness of the left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of the left arm) and PYREXIA (Fever 101.4) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), ETHINYLESTRADIOL, NORGESTIMATE (ORTHO TRI-CYCLEN) and CICLOSPORIN (RESTASIS) for an unknown indication.   On 03-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, the patient experienced PAIN IN EXTREMITY (Soreness of the left arm). On 04-May-2021, the patient experienced PYREXIA (Fever 101.4). At the time of the report, PAIN IN EXTREMITY (Soreness of the left arm) and PYREXIA (Fever 101.4) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details were not provided
received the two part series shingle shots, got the shingles/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received the two part series shingle shots and still got the shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Became very dizzy and nearly fainted within 5 minutes of receiving the vaccine. Needier assistance walking. Felt discomfort in leg for for 2 days.
36 hr. after vaccine. Mild rash and itching developed. By 48 hr. rash was severe widespread. Treated with 40 mg. predisone X 4 days along with benedryl. Symtoms gone after 3 days.
burning lymph nodes and burning down the legs; burning lymph nodes and burning down the legs; her hipped popped four times; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2), administration date 11Apr2021 (Lot number: EP7533, Expiration Date: 31Jul2021) as dose 2, single for covid-19 immunisation. Relevant medical history included: "osteoporosis" (unspecified if ongoing), notes: But I have my best friend and her, sister they have osteoporosis they take medication for that. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization.  The following information was reported: LYMPH NODE PAIN (non-serious), BURNING SENSATION (non-serious), outcome "recovered" and all described as "burning lymph nodes and burning down the legs"; SNAPPING HIP SYNDROME (non-serious) with onset 30Apr2021, outcome "unknown", described as "her hipped popped four times". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of snapping hip syndrome.  Additional Information: It was reported that Caller was a patient. Pfizer covid 19 vaccine, purple cap formulation confirmed. Caller would like to know which "medication", or ingredient(s), in the vaccine caused the reactions she experienced in her body. Caller reported having additional symptoms after the second dose of the vaccine including: vomiting, tired muscles, her hipped popped four times, and her legs kicked at night; these symptoms lasted four months. Her symptoms began on 30Apr2021. Bengay and Tylenol used as treatment during that time. She was tested for Lyme's disease as well which came back negative. Caller reported that she had reactions after the Pfizer covid 19 vaccine (number of doses not discussed) including burning lymph nodes and burning down the legs for seven weeks and did not experience any reaction after the Moderna vaccine. I had the second shot; I had the sore arm and vomiting was Unspecified. I had the second shot on April 1st and on the second day I had the sore arm and vomiting and my legs were so tight and my joint hurt and it lasts for four months. I had a problem for 4 months with my joints and my muscles. My legs were so tight, my left hip was popping and I couldn't move my left leg back very well. So, I went to my doctor and she test me for Lyme disease and I didn't have Lyme disease but I was bit by tick so that's why she said well I rule that out. She didn't think it was a Lyme disease thing. medication for that and their lymph nodes when they have the second Pfizer shot their lymph nodes were burning under their arm pits and at the back of their legs for seven weeks and then it went away.
pt recv vax & noticed redness in rt deltoid 2-3 days p/vax; 1 wk later has warmth & erythema w/induration; swelling 4cm x 4cm;
Information has been received from a physician concerning an 14 year old male patient who on 11-Sep-1996 was vaccinated with the first dose of MMR II, on 06-May-1999 was vaccinated with the second dose of MMR II.  On 10-NOV-2009 the patient experienced mumps.  Diagnose on 31-DEC-2009 revealed the patient had parotitis L and the patient was afebrile.  Other symptoms included vomiting once.  Follow-up information was received which reported that on 12-NOV-2009 the patient experienced mumps.  Diagnose on 12-NOV-2009 revealed the patient had parotitis R and the patient was afebrile. Additional information has been requested.
Pt recvd 3 doses of Engerix-B & failed to convert to HBSAB pos; recvd 4th dose & converted;
FLUZONE QIV MDV administered on 10/12/15 at approximately 10:50am. At 8:30pm I developed shaking and chills, oral temp at 10:45 pm was 101.6 F. PCP notified I took 400mg Ibuprofen. Afebrile in A.M. 10/13.
Symptoms started around 3AM with chills, sore arm, head ache, joint pain in my hands, and sore throat.
Fever, jerking, high pitched crying and refusal to eat. Follow up information noted that this child is doing fine but will receive any additional pertussis vaxs.
looked like cellulitis; rash at 7 days at the injection site; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE CELLULITIS (looked like cellulitis) and VACCINATION SITE RASH (rash at 7 days at the injection site) in a 55-year-old female patient 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE CELLULITIS (looked like cellulitis) and VACCINATION SITE RASH (rash at 7 days at the injection site). At the time of the report, VACCINATION SITE CELLULITIS (looked like cellulitis) and VACCINATION SITE RASH (rash at 7 days at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Treatment for the events included oral prednisone for 5 days.   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.; 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.
This spontaneous report as received from a nurse refers to a 9 months 13 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Extremely high fever 105.9, confusion, severe headache, body aches, fatigue, mottling of hands and feet, weakness, lethargy, dehydration
0.5 cc Pfizer vaccine administered instead of 0.3 cc for dose 2 this morning - No adverse reactions thus far
pt recv vax 4SPE97 9AM;by 1PM pt noticed rt arm & shoulder were very sore;began aching all over by 8PM;had chills & ached all noc;took temp 6AM & it was 97;chilled & ached all day on 5SEP97;saw MD & was told was having allerg rxn;serum sick
Approximately 2 hours post injection I experienced a rapid heartbeat and a drop in blood pressure.  This lasted somewhere between 30 and 60 minutes.  The event was similar to what I might feel during an anxiety attack, but was not feeling anxious at the time it happened.   I had arrived home after a short stop at the store, had lunch and was getting ready to visit our children and grandkids.  I am concerned about receiving the second dose in case this was a reaction to the vaccine and could be more severe the second time.
Developed moderate to bad tinnitus shortly after first vaccine.; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 07Feb2021 at 16:00 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history was healthy and took no medicines and prescriptions. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 15Feb2021, the patient developed moderate to bad tinnitus shortly after first vaccine. The patient would be making an appointment with a physician in the next few weeks as it had not subsided at all from the time of onset. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event moderate to bad tinnitus shortly after first vaccine was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Pain in the arm; A spontaneous report was received on 25-Jan-2021 from a consumer concerning a 70 years old female patient who received Moderna's COVID-19(mRNA-1273) vaccine and experienced pain on the arm .  The Patient medical history includes arthritic pain. No concomitant medications was reported.  On 19-Jan-2021, one day prior to the onset of events, patient received her first dose of mRNA-1273(Batch:029K20A) intramuscularly for the prophylaxis of covid-19 infection.  On 20-Jan-2021, patient experienced pain on the arm.  No laboratory information was provided. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event was recovering/resolving.
1 HOUR LATER WELTS ALL OVER BODY. ATARAX GIVEN AND CLARITIN
Never had that pain before, still had almost every day little pain left; cramps in her intestine, never had that before; strange felling in her stomach; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ABDOMINAL PAIN (Never had that pain before, still had almost every day little pain left), GASTROINTESTINAL PAIN (cramps in her intestine, never had that before) and ABDOMINAL DISCOMFORT (strange felling in her stomach) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 042L204) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Feb-2021, the patient experienced ABDOMINAL PAIN (Never had that pain before, still had almost every day little pain left), GASTROINTESTINAL PAIN (cramps in her intestine, never had that before) and ABDOMINAL DISCOMFORT (strange felling in her stomach). The patient was treated with LIDOCAINE HYDROCHLORIDE (ASPERCREME WITH LIDOCAINE) at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN (Never had that pain before, still had almost every day little pain left), GASTROINTESTINAL PAIN (cramps in her intestine, never had that before) and ABDOMINAL DISCOMFORT (strange felling in her stomach) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Computerised tomogram: normal (normal) shows nothing. In February 2021, Imaging procedure: normal (normal) shows nothing. In February 2021, Ultrasound abdomen: normal (normal) shows nothing.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.
Nurse gave flu shot. Provider in to see patient minutes after shot administered. Pt c/o difficulty breathing, flushing. Provider ordered BENADRYL 50 mg IM. Patient was monitored in exam room for 30 min. Symptoms not improved with BENADRYL. Provider instructed mother to take patient to local ER for evaluation, continued monitoring.
Headache SWELLING AT INJECTION SITE AND PAIN; HA Narrative:  DAY 1 AND DAY 2 SWELLING AT INJECTION SITE AND PAIN HA
Arm started swelling at injection site and got red around 01:00 am. Couldn't sleep because of the pain. I woke up with a headache and some mild nausea - body aches,  as well.  I had these symptoms max of two days, I think.  I took Tylenol. Pregnancy - 2nd pregnancy; 1st one was full term. Date of delivery expected - September 9, 2021.
On 09/21/2022, at approximately 08:00PM, I took my blood pressure and it was high.  I contacted the doctors and was put on Lisinopril. I am still running 180/90.
Pt reported red, warm, swollen area below injection sight. It was painful for a couple days but is now only painful if touched or bumped.
104 fever, violent chills, severe headache, nausea, diarrhea, body ache, sore arm 9/26 and 9/27 and swollen axillary lymph node on 9/28.