chrisvoncsefalvay/vaers-outcomes huggingface dataset:
just administered the diluent portion of the ACTHIB without reconstituting it with the lyophilized vaccine component with no reported adverse event; Initial information received on 27-Jan-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 16 months old female patient who was just administered the diluent portion of the HIB (PRP/T) Vaccine [ACT-HIB] without reconstituting it with the lyophilized vaccine component with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 23-Jan-2023, the patient received a 0.6 ml dose of suspect diluent portion of the HIB (PRP/T) Vaccine without reconstituting it with the lyophilized vaccine component with no reported adverse event (product preparation issue) (Powder and solvent for solution for injection) (lot UJ677AAB, Expiry date: 07-Apr-2023 with strength unknown) via intramuscular route in the left thigh for immunization.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.    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 guidelines. 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.
Itchiness on her arms, legs and body. Feeling hot. Given 25mg Benadryl IM RD. Patient referred to ER by  NP.
This initial spontaneous case, was received from other health professional on 13-Nov-2017, concerns a 63-year-old female patient. The patient's medical history and concomitant medications were not reported. On 13-Nov-2017, the patient was administered with FLUCELVAX (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch no: 195230 and expiry date: May-2018). The reporter stated that the patient received two flu shots, the second one was FLUCELVAX and the details of the first flu shot was unknown. It was reported that the first shot was received a month ago but the exact date was unknown. The reporter stated that there was no adverse events after second vaccination and the patient was fine. The reporter assessed the case as non-serious.
Fully vaccinated with Three doses of Moderna. Tested positive for COVID 19 on 01/24/2022. Admitted to Hospital on 01/31/2022. Expired on 02/11/2022 while still hospitalized.
This spontaneous report was received from a pharmacist (also reported as healthcare student) refers to a patient of unknown demographics. On 27-OCT-2014 the patient was vaccinated with an expired dose of PEDVAXHIB (thimerosal free), lot # unspecified, expiry date: 24-OCT-2014, intramuscular. Dose supported. No adverse experience was reported. Outcome of the event is unknown. No product quality complaint (PQC) was reported. Causality assessment was reported as not related to therapy with PEDVAXHIB. Additional information has been requested.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS ACUTE DVT OF LEFT TIBIAL VEIN 2/8/2023 -- RECURRENCE OF SAME SYMPTOMS
This spontaneous case reported by a consumer, describes the occurrence of asthenia (very weak), pyrexia (101+ fever) and fatigue (very tired) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced asthenia (very weak), pyrexia (101+ fever) and fatigue (very tired). At the time of the report, asthenia (very weak), pyrexia (101+ fever) and fatigue (very tired): resolving. No concomitant medications  provided. Reportedly, patient experienced fever of 101+ most of the day following the second dose of Moderna COVID-19 vaccine. The patient felt better after lots of rest and water. Sender's comments: Very limited information regarding these events has been provided at this time. No further information expected.
Information has been received from a nurse refers to a 27 year old female patient without pregnant. No current or historical conditions were reported. On 21-JAN-2015 the patient was vaccinated with an expired dose of 0.5 ml GARDASIL (lot # H010123, expiration date 16-JAN-2015), intramuscular which was potency supported. This was patient's first dose in the GARDASIL series. No adverse effects reported. The patient had not sought medical attention. Additional information has been requested.
Fever, chills, vomiting, nausea, extreme headache, muscle ache, blurred vision Chills and vomiting subsided within 12 hours Fever and blurred vision subsided within 18 hours Nausea, headache and blurred vision subsided within 24 hours Muscle aches subsided within 48 hours Treated with ibuprofen
Client in clinic for TB skin test reading and COVID vaccine booster. Client reports no reactions to previous 2 COVID vaccines (Dose 1& 2 pfizer). Pfizer booster administered today. Does discuss PCN allergry, including anaphylactic reaction. COVID vaccine adminsitered at 12:27, client advised per protocol needs to wait 30 minutes after vaccine administration for observation. Client's 30 min timeframe concludes at 12:57.  Client up to bathroom twice during monitoring timeframe. Client then at front desk checking out to leave clinic at 12:37.  Nurse advised client she must remain in clinic to be monitured until 12:57. Client asked if she may go to car to retrieve cell phone, nurse requested that she remain in clinic until post Covid vaccination monitoring timeframe concluded. Client verbalized understanding and sat down in lobby. 12:39: person noted seizure activity, and called for nurse. Nurse immediately to lobby. Client sitting in chair, leaning against wall displaying seizure activity, and unable to respond to commands and displaying violent muscle convulsions. Nurse and person 1 assisted client safely to floor, and turned on left side. 911 called simultaneously by clerical staff. Client continued to display seziure activity until 12:43. 12:43: blood pressure 137/60. 12:45: Client assisted by nurse to sitting position. Client oriented to name only, and able to tell nurse that she does have seizure disorder and has not taken medication.  12:46: Seizure activity begins again. Client unable to repsond to commands, and displaying violent muscle convulsions. 12:48- Paramedics and Fire Staff arrive to the local Health Department lobby, seizure acitivity subsiding, blood pressure 120/61. 12:50: Client alert and oriented x4, able to tell nurse and Paramedics, and Fire staff that she has recently changed medications, and has not been taking them as she should (switched from Keppra to Phenobarbital). Client refused transport to hospital at this time. Paramedics took client to ambulance for further evaluation. 13:15- Paramedic comes back in to health department to give report to nurse. Per paramedic, client continued to remain alert and oriented x4. Client did not sustain any injuries. Clients husband to health department to pick her up and transport her home. Client's mother retrieved her car from the health department parking lot.
The Flu vaccine given to a 10 month old was a flu vaccine that is for 2year of age and older. Come to attention of the provider later on the evening of the visit The next day parent was called and was informed of the occurrence. Parent ( the father) was asked how patient was doing . The father stated patient was doing fine. Patient was seen in followed on 10/27 for a recheck of the Hemoglobin and at that visit the father reported the patient was doing well.
dyspnea, positive COVID test, HTN, aches, non-small cell CA, taking chemo
pt had t103 ax, lethargy, difficulty w/gait, batting @ head as if headache; cont w/above sx & high temp for 5 days;
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 2012, a pharmacist administered the ZOSTAVAX (lot# and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 2014, the patient was treated by a physician for shingles.  The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Patient was given VARIVAX in equally divided doses due to prior reaction to vaccines at 2 years of age, after second dose of VARIVAX patient started having coughing that became more persistant and developed hives on his back, patient was given BENADRYL and epinephrine with complete resolution of his symptoms.
I took two CLARITIN due to an auto immune disease flare up. On July 24th about noon I noticed I had post nasal drip. I ignored it because I thought it was due to taking too much CLARITIN. I woke up later that night my drainage from nose had increased and I had body aches. I tested positive that night for COVID-19. The next day I had fever, chills, body aches and crying with emotions. I had a severe headache. I started PAXLOVID. Highest temperature was 101.9. Tuesday my fever decreased and as of today it is gone. I am really short of breath. I have started on steroids for that. I still have the post nasal drip and a bad headache. I do have more energy and not as much short of breath.
This spontaneous report as received from a physician refers to a 13 year old male patient who was enrolled in a Varicella Zoster Virus (VZV) Identification Program. The patient's concurrent conditions included autism, delayed puberty, Basedow's disease, hydrocephalus, hypothyroidism, Adrenal insufficiency (iatrogenic), juvenile idiopathic arthritis, chronic respiratory disease and chronic kidney disease. The patient was allergic to Beef, Casein, Cashew, Chloral hydrate, COBAN 60, Lactose, Lactulose, Milk, Nuts, Peanut, THORAZINE and Wheat. The patient's medical history included gastrooesophageal reflux disease, Visceral hyperalgesia, premature birth (at 24 weeks gestation) and Oral aversion. Concomitant therapies included Acetaminophen, Albuterol, Baclofen, Budesonide, Cholecalciferol, Citalopram, Diazepam PRN, AQUAPHOR topical ointment, Etanercept, Gentamicin, Histrelin implant, Hydrocortisone (enteral), Ipratropium, Levothyroxine, Meloxicam, Mupirocin, Occular lubricant, Omeprazole, Risperidone, Simethicone, Sodium chloride inhalation and Sodium chloride nasal spray. On 17-MAY-2002 the patient was vaccinated with the first dose of VARIVAX (dose/route/frequency unknown). Following the first vaccination the patient presented disseminated rash. On 28-JUL-2014 the patient was vaccinated with the second dose of VARIVAX. On an unknown date in November 2014 the patient experienced prolonged intestinal ileus (first episode) with severe abdominal pain which alleviated with gabapentin and nalbuphine. On 01-FEB-2015 the patient experienced second episode of prolonged ileus. The Polymerase Chain Reaction (PCR) test of the saliva performed on 26-FEB-2015 was positive for VZV. The patient was treated with Valacyclovir (started 3 weeks after symptom onset of February 2015 ileus). The outcome of first occurrence of prolonged intestinal ileus was reported as resolved but the second episode was ongoing at the time of this report. The outcome of disseminated rash is unknown. Reporter's causality was unknown. Additional information has been requested.
6-21-13 VARIVAX was given subq in lt arm. Approx 8 days after inject rash appeared at site of inject and increased over next 4 days. Pt. called on day 12. Previous night had fever and chills. Random blister-like pox on body today, itchy; rash hot, red, itchy.
One day post vax, the pt experienced pain at the injection site, fatigue, flu-like symptoms, and headaches which lasted two weeks.
12 hours post vaccination, joint pain in hips and legs. 16 hours post vaccination chills and body aches.  Followed by fatigue, continued body aches and loss of appetite for about 36 hours
Itchy eyes, scalp, and waste-band which developed over a few hours into generalized urticaria. Symptoms lasted overnight and continued to have generalized hypersensitivity across whole body (whenever scratched/rubbed urticaria would develop) for 3-4 days. Treated with antihistamines (zyrtec and benadryl) and NSAIDs (tylenol).
July 28 2021 woke up with slight cough , sore throat, also had some knee pain July 29 woke up 4;30 am  With Excruciating  knee pain and swollen knee , could not walk .  My husband  and son In law had to help me get up  Also had sore throat and laryngitis  Not sure if the above is related to my second shot 7/22/21 or not
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. On 14-AUG-2015, the patient was vaccinated with incorrectly stored dose of VAQTA (route of administration, dose and frequency were not reported, lot #L009445 with expiration date: 01-JUN-2017). No adverse effects reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Periods of itchiness a week and a half later.  Redness still visible a week and a half later. After itching a bit, the red patch got larger and had a darker pink/red line on the outside.
Case number PHEH2016US002216, is an initial spontaneous report received from a pharmacist on 26 Jan 2016. This report refers to a 50-year-old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1516501) intramuscularly on an unknown date. After vaccination from 02 Nov 2015 (almost 03 months), the patient was experiencing a knot at the vaccination site. The outcome of the event was reported as condition unchanged. Seriousness and causality of the event was not reported.
Abnormal Vaginal spotting outside of mensural window. Currently on day 3 of consistent light spotting
Right thigh with extensive swelling and redness. Redness and swelling from injection site to knee. Improved by 6/29 without intervention.
c/o soreness in rt arm approx 5min p/vax 310PM;approx 6-7PM entire arm, hard & fingers were swollen;on the following morning the rt arm (from elbow), hand & fingers remained swollen;
There are no known adverse reactions.  Patient was given 0.2ml of diluted (1.3ml diluent) Pfizer RTU instead of the Pfizer Pediatric
day of vaccine - red rash starting on chest and spread to parts of neck and face it felt like a buring sensation not itchy, no trouble breathing and no other signs/symptoms, took 1 benadryl and rash faded/died down days 2-5 - rash would flare up in the afternoon time, take 1 benadryl and it would fade days 6-7 -  no noticable rash (mild headaches took tylenol) days 8-12 - small splotchy red rash like spots (mild headaches took tylenol) day 13 - same as day one and slightly worse, flaring on my arms as well, I went to urgent care and the doctor said "I can not say if this is from the injection or from her stresses" and to contact/report what has been happening and doc put me on prednisone
Woke up with hives and welt-like swelling on both sides of face and neck, one hive on wrist.
COVID 19 Treatment: Paxlovid; COVID 19 Treatment: Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old male patient received BNT162b2 (BNT162B2), on 05Dec2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 32 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: SUSPECTED COVID-19 (medically significant) with onset 06May2022, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment: Paxlovid". Therapeutic measures were not taken as a result of drug ineffective. Therapeutic measures were taken as a result of suspected covid-19.  Clinical course: Patient had no known allergies. Patient did not receive any medications within two weeks.
Patient is a 57 year old female with past medical history of rheumatoid arthritis and epilepsy who presented to ED on 8/7 for shortness of breath accompanied by cough, fever, chills, and diarrhea. Tested positive for COVID at PCP office on 8/7 and recommended to come to ED as the patient is immunosuppressed and there were concerns about pneumonia. Found to have acute hypoxic respiratory failure secondary to COVID infection. She is being discharged on Decadron, albuterol, and supplementary home oxygen.    Discharge diagnoses:  Acute hypoxemic respiratory failure-secondary to COVID-19.  Received 3 doses of remdesivir.  Needed supplemental oxygen while inpatient. Patient qualifies for 2 L nasal cannula on exertion. Albuterol inhaler as needed.   Covid infection-completed 3 doses of remdesivir.  Would not prescribe paxlovid due to contraindication while using carbamazepine.  Continue Decadron taper with 10 mg x 10 days, 4 mg x 5 days, then resume home 5 mg prednisone daily.
Administered expired vaccine to patients/ Dose administered after 30-day use by date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patients/ Dose administered after 30-day use by date or after manufacturer date of expiry) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patients/ Dose administered after 30-day use by date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patients/ Dose administered after 30-day use by date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided The vial did not undergo any temperature excursions Total of 168 doses were given from LOT 048C21A It was reported that the date vial initially stored in refrigerator was unknown  Treatment medication was not provided by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Non Significant  follow up was received
Patient reports that her whole arm hurts. She tried ice. Benadryl helped her sleep but didn't improve the arm pain. As of 11/20/2014, the pain still exists.
ACUTE STROKE DUE TO OCCLUSION OF LEFT MIDDLE CEREBRAL ARTERY ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/24/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
This spontaneous report was received from a healthcare worker refers to 8 unspecified patients of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date the patient was vaccinated with improperly stored dose of VAQTA (lot # L023232, exp. 25-FEB-2017). No adverse effect was reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the several reports from the same reporter link. Additional information is not expected as the reporter did not wish further contact.
Initial numbness/tingling  in right arm, then numbness/tingling in right cheek and foot ~4-5 hours later. 24 hours later still have a little numbness in cheek and right arm and hand
I felt dizzy, nauseated; I had headache; I still have the headache, my arm still hurt a lot; I felt dizzy, nauseated; I had headache; I still have the headache, my arm still hurt a lot; I felt dizzy, nauseated; I had headache; I still have the headache, my arm still hurt a lot; I felt dizzy, nauseated; I had headache; I still have the headache, my arm still hurt a lot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 19Jun2021 13:00 (Lot number: EW0187) at the age of 48 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Coeliac disease" (unspecified if ongoing), notes: Verbatim: Celiac disease; "Fibromyalgia" (unspecified if ongoing), notes: Verbatim: Fibromyalgia; "Ankylosing spondylitis" (unspecified if ongoing), notes: Verbatim: Ankylosing spondylitis; "Sacroiliitis" (unspecified if ongoing), notes: Verbatim: Sacroiliitis. Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL]; ESTRADIOL. The following information was reported: DIZZINESS (non-serious), NAUSEA (non-serious), HEADACHE (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 19Jun2021, outcome "recovering" and all described as "I felt dizzy, nauseated; I had headache; I still have the headache, my arm still hurt a lot". Therapeutic measures were taken as a result of dizziness, nausea, headache, vaccination site pain.  Additional information: The patient stated that she was calling because she went to the Withheld yesterday at 1 o clock and got a shot for COVID and they give us a paperwork after getting the shot which listed some common side effects but not all possible side effects. Patient stated she immediately after getting the shot when they give the shot, she felt dizzy, nauseated and she had headache and she still have it. Her was a problem last night and of course she knows its normal and this morning this morning it got worse for her and now it's much better. She took Ibuprofen, Tylenol. Ibuprofen Acetaminophen they told her yesterday the pharmacist told her yesterday to take acetaminophen for her headache, when she got home she did and then she took Ibuprofen last night and she took Ibuprofen this morning and then she took acetaminophen this morning and dosage was 800 mg Ibuprofen, 1000 of the Tylenol last night and today this morning, she still have the headache, her arm still hurt a lot, but she feeling the most part, feeling little better (Hence, not captured as suspect) not so weak, not so achy, not so much pain. The patient did not take any other vaccine 4 weeks prior to the COVID vaccination.  No follow-up attempts are possible. No further information is expected.