chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Quadracel was given to a 17 month old patient/no AE; patient was very behind on some vaccines so doctor ordered Quadracel and it was also administered/No AE; Initial information received on 20-Aug-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 17-months-old-female patient who was vaccinated with fourth dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] instead of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] as she was very behind on some vaccines so the doctor ordered Quadracel instead of Pentacel and also administered it (batch number and expiry date not reported) via unknown route in unknown administration site on 24-Jul-2019 for prophylactic vaccination (product administered to patient of inappropriate age and off label use).  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due inappropriate age at vaccine administration.  No adverse event symptoms experienced by the patient.  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 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.  There will be no information available on batch number for this case.
Pt cried and was very fussy for 8 hrs after DTAP and HIB given on 7/28/14. Did not eat for 8 hrs (nurse) per mom.
Within 5-minutes of vaccination, the patient reported weakness and confusion. EMS evaluated the patient on-site. No signs of stroke. EKG demonstrated NSR, rate 77bpm, no ST elevation. FSBG was 290mg/dl. EMS transported the patient to Hospital Emergency Department. Enroute, the patient became increasingly confused, forgetting their birthday and location. Patient was hypertensive (178/104) and reported a "crushing headache". EMS crew became concerned for stroke. In ED, the patient remained hypertensive (178/93). ED Physician had high suspicion of TIA versus acute reaction to COVID-19 vaccine. Administerd 650mg acetaminophen and 1mg Lorazepam. Admitted patient to critical care unit where patient stated they had developed a sudden-onset diffuse banding-like headache with associated nausea, diaphoresis, blurry vision, and confusion. MRI was negative and patient was transferred from ICU to hospital. Hospital physician believed the symptoms were likely a vagal mediated response or reaction to his COVID vaccination. Patient was discharged on 3/20 with diagnoses of TIA, Acute encephalopathy, Insulin-dependent type 2 diabetes, Essential hypertension, CAD, Unspecified mood disorder, Dyslipidemia, Obesity, and Mild neuro cognitive disorder
Breakthrough case admission 3/26/21 Moderna 017B21A 4/23/21 Moderna 043B21A 11/4/21 Moderna 939905
5 x 6 cm itching, erythemic, slightly raised localized reaction at injection site.
Client was scheduled at the Covid clinic, December 13, 2021. She is 11 years old. Client received Pfizer (adult) vaccine dose, 0.3ml/30meq. She should have received Pfizer (peds) vaccine dose, 0.2ml/10meq. At the time of her departure, there were no signs/symptoms noted.
This spontaneous report as received from a physician refers to a 24 year old female patient. She had no pertinent medical history, and no drug reactions/allergies. The patient completed the 3 dose series of GARDASIL, administered intramuscularly on unspecified dates at another practice. The patient took no concomitant medications. On 17-MAR-2014 the patient had a positive HPV DNA Pap test result. The outcome of had positive HPV DNA pap test result was reported as not recovered/not resolved and the patient received no treatment for the event. A causality assessment was not provided. This case is cross-referenced with 1403USA010840, regarding the another patient (reported by the same physician), who also had a positive HPV DNA pap test result after administration of GARDASIL. Additional information has been requested.
Information has been received from a registered nurse (R.N.) concerning a 13 month-old multi-racial female with no pre-existing allergies, birth defects or medical conditions, who on 13-JUN-2007 at 10AM was vaccinated subcutaneously in the left thigh with a first dose of PROQUAD (lot# reported as "4936"). Suspect vaccinations at 10 AM on 13-Jun-2007 included an intramuscular first dose in the right thigh of VAQTA (lot# 652294/0249U) (MSD). Concomitant therapy included an intramuscular fourth dose in the right thigh of ACTHIB (lot# UF067AA) (Sanofi Pasteur). On 22-Jun-2007, the patient had a temperature of 100.9 degrees. In the evening of 24-JUN-2007, the patient developed an erythematous, macular rash, on her face, neck, trunk and upper thighs. In the morning of 25-Jun-2007, the patient vomited once. On an unspecified day, the patient sought medical attention at the doctor's office. The outcome is reported an unknown. It is reported that the patient never had any adverse events following prior vaccinations. It is unknown if the patient's sibling had any adverse events following vaccinations. Additional information has been requested.
severe weakness, fever 100.5, heart rate varying from 41 to 112, BP varying also - low at 89/60, nausea, sustained (>4 hours) vomiting, producing nothing but liquid then dark green bile.  Dry heaving finally stopped mid-afternoon.  SO2 normal (98%).  Patient slept for 15 hours.  Recovered the next day and was able to ingest clear liquids and light food.  Back to normal the third day.
Patient complaining of dizziness and nausea the date of injection with a knot and redness at the injection site that has increased to a size of a baseball/softball with soreness and numbness down arm and across chest.  Complains of fever of 102 beginning 2 days after injection. Complains of red rash over site of reaction in arm, as well as old pox scars with some blistering.  Also complains of wheezing which she treated with her asthma inhaler.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. On 10-MAR-2018, the patient  was administered VARIVAX (lot N007930,expiration date 08-AUG-2019) that was reconstituted with SHRINGRIX adjuvant suspension component (lot B5EK2, expiration date 28-APR-2020). The pharmacist also reported that on an unspecified date, the zoster rgE vaccine (mammalian)(SHRINGRIX) adjuvant suspension had a "temperature excursion of 71 degrees Farenhit  for 8 hours" prior to being administered. No adverse effects reported.
Information has been received from a physician concerning a 1 year old male described "as a health child" who on 28-FEB-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 08-MAR-2007, within eight days of vaccination, the patient developed "generalized petechia over his whole body." The patient's petechia persisted for two weeks. The doctor was unsure the petechia was related to therapy with varicella virus vaccine live (Oka/Merck). At the time of the report the patient was not recovered. There was not product quality complaint involved. Additional information has been requested.
Pt transferred from facility for chemotherapy at facility. Pt was admitted at facility on 12/31 and tested positive for COVID on 1/6 and received remdesivir course at facility. Incidentally COVID-19, asymptomatic.
MD saw pt 28SEP92 c/o fine, itchy rash & swollen cervical lymph nodes; no fever no joint aches sx started 26SEP92; seen by MD 30SEP92 for itchy rash; glands in neck still swollen; glands swollen;
Minor allergic reaction included numbness of lips and red facial flushing after injection. No difficulty breathing. Afterward, my side effects were pretty extreme- fever, nausea, headache, body aches, sharp random pains, lethargy.
None noted. Vaccine given at too early of an age. (Hepatitis A vaccine). Hepatitis A HAVRIX given 12/10/15.
10day 28 Feb. felt I was having fatigue and no energy to walk from Mar2021. My legs felt tingling .health - fainting on 19 one week after the 2nd dose and went cardiologist and all test were benign . Saw doctor 1stMarch2021.Chest pains went to ER twice in March 2021. All test from both ER came back normal. in 30Oct2020 also fainted.
both in this shot and in my first, I had chills, fever, and achiness.  In this shot I had significant pain and red swelling right around the injection site.  In first shot 2 months ago, I experienced high fever and sweats.  All resolved within 2 days. (all are better than actual shingles!)
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 13-FEB-2017, the patient was vaccinated with improperly stored dose of M-M-R II  lot # M002418 with an expiration date 12-JAN-2018 for prophylaxis (dose, route of administration and anatomical location were not reported). There was no adverse effect reported. Administered dose of M-M-R II experienced the temperature excursion of -14.4 degrees Celsius for 54 minutes. There was no previous temperature excursion reported. A digital data logger was involved. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742: Original Case : 1705USA009742.
Participant felt flushed, feverish, fatigued with general aches and dry cough over the weekend after receiving injection, took acetaminophen and cough syrup on Monday.  He became short of breath on 1/20/2021 and was hypoxic on oximeter check, was sent to the ER.  He was intubated in ER and went into respiratory failure with sepsis due to COVID19.  He was treated with tocilzumab, became paralyzed and DVT in left lower extremity was found.  HE required pressors and diuresis, he developed AKI and hyperkalemia.  On 2/21 he was in multi-organ failure.  His level of cognition decreased until he was no longer responsive and he died on 2/24/2021.
Patient received the vaccinations around 10:15 AM on 11/9. Later that night, she began feeling "off" and went to bed. Around 2 AM, she woke up, got out of bed to go to the bathroom, and fainted. Paramedics were called and checked her vitals, which were good, then helped her back to bed. The next day, 11/10, she still wasn't feeling well, and called the paramedics again around 2 PM. The instructed her to go to the emergency room.  After telling the doctors she had fainted the night before, they decided to do an MRI and CT and found she had had a stroke. She was hospitalized for 3 days.
The left arm had usual soreness at the injection site, more the second and third day.  The evening around 11pm began to have strong shivers as if from a fever.  More than likely had a fever, but did not take temperature.  Shivers continued until around 4am.  Took 2 Advil around 6am and felt like the possible fever was gone by 9am.
The pt developed a local reaction. The pt had an inflamed area at site for at least one month. Doctor treated with antibiotic and that resolved. Also, the pt had joint pain in shoulder when moving arm. Not resolved yet; doctor is treating with Vioxx.
Headache; chills; fatigue; fever; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced headache, chills, fatigue, fever. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Started having trouble breathing within 3 minutes, left Walgreens and went to Urgent Care, received epipin shot. Then went to ER and received benedryl, steroids and breathing treatment. Received script for prednisone for 4 days. It is a week later and still hard to breathe.
Rash around injection site (still present after 3days), fatigue,  chills, hot flashes, decrease in appetite.
Intussusception, Bilious vomiting, Irritability, Listlessness. Intermittent vomiting episodes starting on 4-12-09. Increased vomiting noted on 4-21-09. Diagnosed with intussusception on 4-23-09.  5/6/09 Received hospital medical records of 4/23-4/24/2009. FINAL DX: Intussusception, enema reduced Records reveal patient experienced bilious vomiting, irritability, decreased appetite, listlessness x 1 day.  Had experienced projectile vomiting x 1 day 2 wks prior & 1 wk prior.  Seen in Urgent Care & dx w/gastroenteritis & viral pharyngitis.  Vomiting persisted & seen in ER wehre IS dx.  Air contrast enema reduced IS but continued to have considerable bowel edema.  Surgery consult done.  Admitted for observation.
Expired dose administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 1-year-old female patient who received HAV (Havrix) (expiry date 06-FEB-2023) for prophylaxis.  On 08-FEB-2023, the patient received Havrix. On 08-FEB-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Expired dose administered). The outcome of the expired vaccine used 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: 09-MAR-2023 A healthcare professional (HCP) called to report that on 08 February 2023, a patient received a dose of Havrix that had expired on 06 February 2023. The vaccine administration facility was the same as primary reporter. The HCP did not had the lot number and when being asked if Havrix was the vaccine that was administered or not to which he said he believed so. The reporter had consented to follow-up. At the time of reporting, the patient received a dose of expired Havrix vaccine, which had led to expired vaccine used.
Information has been received from a 56 year old female who in July 2008, was vaccinated with a single dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included ACTONEL. The patient reported that "in the morning" of 28-OCT-2008 she woke up with shingles. At time of reporting, the patient stated that she was now experiencing the tingling and the itching and hadn't seen a physician yet. The patient already had shingles in May 2008 and it was in the same spot and it started the same way. She started taking VALTREX that the physician prescribed the last time she had shingles. At time of reporting, the patient had not recovered. There were no lab diagnostic studies performed. Additional information is not expected.
pt recv vax 1JUL97 pt brought back per mom face swollen 7 gen urticarial rash;seen by MD around 2:45-2:55PM;3PM DPH given;allerg rxn to vax;angioedema;
a rash all over her body; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown) via an unspecified route of administration on 02Apr2021, as a single dose for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) for COVID-19 immunisation. The patient experienced rash all over her body on 20Apr2021. The patient wanted to know if this was a commonly reported side effect, if it goes away or if she would need to consult her HCP about this. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
After receiving the second shot on April 17, 2021 over a month later he still can not lift his arm up all the  way, he has been to our primary Dr, twice complaining about pain two weeks after shot. PCP stated could take a month. It has now been over a month went to PCP again 05/24/2021 and gave him a script of pain. Why is he still having this issues over a month later.  Please please explain why he can not sleep at night cause when he moves his arm in his sleep i takes him up all night long. There must be a reason for this to still be causing him this much pain.
Left arm has extreme pain and can not be extend in different directions (over head, behind back, etc.); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old male patient received bnt162b2 (BNT162B2), administered in arm left (Left Shoulder), administration date 23Mar2021 (Lot number: EL3248) at the age of 57 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication included: ZYRTEC. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3248, Location of injection: Arm Right), administration date: 02Mar2021, when the patient was 57 years old, for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset May2021, outcome "not recovered", described as "Left arm has extreme pain and can not be extend in different directions (over head, behind back, etc.)". The event "left arm has extreme pain and can not be extend in different directions (over head, behind back, etc.)" was evaluated at the physician office visit. Therapeutic measures were taken as a result of pain in extremity.  Additional information: Left area shot was in much greater pain and the time of inoculation compared to the right. Treatment included exercises.No covid prior vaccination and no covid tested post vaccination. Known allergies were none.
After a few days of the initial vaccine, red bumps, itching & weakness in my left hand & arm occurred. Now, 1 year & 5 months later the site still is red, has bumps & continues to itch & sting.
I received the vaccine on 12/11/2021. January I work up with a sore throat, got out of bed and had 101F which felt like a temperature swollen gland. I missed work for a week. My doctor gave me an antibiotic and steroid medicine which helped. The symptoms came back, my doctor prescribed another round of antibiotics and steroid and that help. I've had two sinus infections in March and April. I had a serious of really bad and intense headaches. My doctor diagnosed them to be a rare form called SUNCT.
I started off with feeling this really congested, then I started with a cough. I was treating my symptoms with over-the-counter meds. After five days I went to the doctor and was given amoxicillin, prednisone, and cough syrup. It was a five-day dose. I went to another doctor and I was prescribed levofloxacin and more prednisone for seven days. I was still in bed and pretty sick. I went again to the doctor 10 days after. He said no more antibiotics and given over the counter SUDAFED. I was sent to the hospital for a chest x-ray to make sure I did not have pneumonia. It was good. I was sick for four weeks. I still now have congestion and drainage. It been hanging on a long time. I do have a follow up appointment in a few days.
Lump in my right calf 7 days after the vaccine. Ultrasound indicated it was not DVT. Waiting for Radiologist report.
Patient received the vaccine in September and is still having pain in his arm.  It is affecting his range of motion and his pain when lifting his arm and when putting his arm behind his back
Vaccination given at 12:50  12:54?started feeling lightheaded.  Sitting in chair in observation waiting area.   RN present in observation area.   12:55? feeling not right. Water given. Feeling nauseated.   1302?unable to hear BP via manual cuff in chair times 2   Lowered to floor and feet elevated   1305 ?88/54, 60 HR still nauseated and lightheaded.   1309?911 called   13:10?felt she was improving. Nausea better. 104/66, 68  13:12?110/68 HR 68 13:15?felling better. Sat up on floor. 98/50, 88 13:18?EMS arrived. BS 98. BP 112/72 Refused to go to ER by ambulance. Medics left.  13:25? RN and RN assisted patient to wheelchair.  After talking with patient she did agree to going to ER to be seen by physician.  Wheeled to ER and care assumed by ER team.   Patient never lost consciousness and never had change in mentation. She always maintained conversation and orientation. She states didn?t feel sick enough to go to ER.    Patient was discharged from ER to home.
This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach cramps), DECREASED APPETITE (not eating much only mild bland stuff), BOWEL MOVEMENT IRREGULARITY (loose bowel movements), DIARRHEA (diarrhea) and NAUSEA (nausea) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 08-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 ABDOMINAL PAIN UPPER (stomach cramps), DECREASED APPETITE (not eating much only mild bland stuff), BOWEL MOVEMENT IRREGULARITY (loose bowel movements), DIARRHEA (diarrhea), NAUSEA (nausea), HEADACHE (headache), CHILLS (chills), NAUSEA (feeling queasy) and PYREXIA (fever). At the time of the report, ABDOMINAL PAIN UPPER (stomach cramps), DECREASED APPETITE (not eating much only mild bland stuff), BOWEL MOVEMENT IRREGULARITY (loose bowel movements), DIARRHEA (diarrhea), NAUSEA (nausea), HEADACHE (headache), CHILLS (chills), NAUSEA (feeling queasy) and PYREXIA (fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Mar-2021, Body temperature: inconclusive (Inconclusive) Inconclusive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product include OTC Thyroid medication.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.
Patient developed severe leg pain on 11/20, was seen at ER, diagnosed with viral myositis. then developed purpuric rash, returned to ER 11/25, diagnosed with Henoch Schonlein Purpura and Strep pharyngitis. ER visit only, no inpatient hospitalization, treated with Tylenol and Ibuprofen
Petechial rash with initial onset around left and right ankle at 2pm on 04/17/21, spread over entire legs, abdomen, back, and left arm by 11pm same day. Petechial rash ceased to spread significantly by 04/18/21, with new spots appearing only intermittently on left and right hand fingers on 04/19/21.
from pt. States he was in this office yesterday, received pneumonia vaccine in rt arm. Report this was he second pneumonia vaccine. States approx 3 hours after receiving vaccine, his arm began to swell. Reports arm is swollen and painful. Denies red streaks. Denies fever. Denies difficulty breathing or swallowing. Denies rash. Symptoms:, 1. swelling of injected arm