chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No AE; Nurse calling to report adverse event regarding the inadvertent administration of PROQUAD with VARIVAX to a one year old patient.  Nurse stated that the patient involved was scheduled to be administered MMR II and VARIVAX at their appointment, but th; Nurse calling to report adverse event regarding the inadvertent administration of PROQUAD with VARIVAX to a one year old patient.  Nurse stated that the patient involved was scheduled to be administered MMR II and VARIVAX at their appointment, but th; Nurse calling to report adverse event regarding the inadvertent administration of PROQUAD with VARIVAX to a one year old patient.  Nurse stated that the patient involved was scheduled to be administered MMR II and VARIVAX at their appointment, but th; Information has been received from a registered nurse, referring to a 13-month-old (also reported as 1 year old) male patient. The patient's medical history and concurrent conditions were not reported. Concomitant medications included pneumococcal vaccine conj 13v (crm197) (PREVENAR 13) and hepatitis a vaccine inact (HAVRIX).   On 24-OCT-2023, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) "two dose series", 0.5 milliliters, lot # W036939, expiration date: 19-MAY-2024, administered subcutaneously in the right thigh for prophylaxis (strength was not provided); and with a dose of varicella virus vaccine live (oka/merck) (VARIVAX), "two dose series",0.5 milliliters,  lot # X001000, expiration date: 09-JAN-2025, administered subcutaneously in the left thigh for prophylaxis (strength was not provided).  The nurse stated that the patient involved was scheduled to be administered measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX) at their appointment; however, the nurse inadvertently administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and varicella virus vaccine live (oka/merck) (VARIVAX) to the patient on the same day (24-OCT-2023). The nurse stated that this event was due to an error in processing by the nurse while preparing the vaccines to be administered. Nurse confirmed that measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not administered to the patient. It was additional confirmed that had not received any report of medical concerns or symptoms by the patient's family at this time.
Death 5/19/2021 Causes of death listed on death certificate: 1) COVID 19
Headache, Syncopal episode, Nausea, Vomiting, Diarrhea, ears ringing, bodyaches, LUE pain/swelling
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Medium
Noticed itching on the 13 Oct then on 15 Oct he had the appearance of a rash approx 15 days post vaccination with SPV, AVA #1 Typhoid, and Influenza. The SPV site is healing well, and the SM has numerous lesions on his legs, arms and chest. Described as maculo papular with areas containing central clearing. Other than itching, he is feeling well. DX - erythema multiforme
AT 10:38, patient reports feeling anxious and tingling sensation at the occipital area / behind her ears. She denied any flushing, dizziness, headaches, cough, sob, numbness sensation around her mouth, chest discomfort
Within 1 hour start with an asthmatic type cough. Then throat started feeling tight. I took a ZYRTEC. Then eyes became infected w/mucopurulent discharge. I took BENADRYL 25 mg. Then had a fever of 100.2 with rigors. Took TYLENOL 1000 mg plus MOTRIN 600 mg. Symptoms gone the next day.
A report has been received from a Physician concerning a Child, of unknown gender and age. No relevant history and concomitant medications of the patient were reported. The patient received nasal FLUMIST quadrivalent (intranasal), in mid September, on an unknown date. The patient experienced flu in March and was found to be H1N1 test positive. Action taken with FLUMIST was unknown. The outcome of the event of Flu was unknown. The report was considered to be non-serious by the reporter. The report was considered to be non-serious by the reporter. Corrected report 26-May-2014: Key ingredient of suspect drug correct to Q/LAIV from FLUMIST.
From faxed correspondence received at Aventis Pasteur Inc. on 04/01/02, it was reported that a 4 year old male received DTAP (Tripedia) and IPV (IPOL) on 03/26/02. Patient's left arm became red, painful, swollen and hot to the touch on 03/28/02. Area measured 11cm X 10cm. patient treated with Biaxen 250 mg/5 1/2 tsp bid X 10 days
Initial report received from a non-healthcare professional on 10-Oct-2013. A 34-year-old female patient whose medical history and concomitant medications were not reported, received a dose of FLUZONE ID (lot number: UT4721BA and route was not reported) on left deltoid on 07-Oct-2013. On 07-Oct-2013 and in evening she experienced redness, swelling, at injection site and pain at injection site of deltoid that extended down to wrist. She had 6 cm. size red, swollen areas around injection site that was very tender to touch and itchy also had a fine red, raised rash at injection site. Patient stated had felt feverish the night before but did no take a temperature. She did not have a elevated temperature when seen. She stated that patient treated with cool compress for redness and swelling and Hydrocortisone cream around injection site area but not on injection site. Patient stated today, 10-Oct-13 and redness is dissipating, swelling is subsiding. The events were not resolved. List of documents held by sender: none.
Nauseous; nervous; This is a spontaneous report from a contactable consumer(patient). An 82-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 at single dose for covid-19 immunization, fish oil, lactobacillus casei (RESTORA RX), via an unspecified route of administration from 21Jan2021 08:30 to an unspecified date at unknown dose and frequency for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient was calling in regards to the Covid Vaccine. She had the shot(covid vaccine) on 20Jan2021 at about 10 or 10:15AM. After her First dose, She had a doctor appointment at 11:20, 20Jan2021, the doctor put her on a new medicine, the Restora RX was in capsule form, she started that on 21Jan2021 at 8:30AM. She was nervous. She was nauseous on 21Jan2021 at about 8:30AM. She was a little nauseous and was basically trying to find out which one was causing it, the vaccine or the new medication. The name of the new medication was "Restora Rx". The action taken in response to the event for fish oil, lactobacillus casei was unknown. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
patient presented to the emergency department with a generalized tonic clonic seizure (in the setting of fever to 103.5
*Please note, I did not have a cold or any symptoms of a cold prior to the injection. At approximately 7:00 pm, (5 hours after my flu shot) I started feeling the need to frequently clear my throat to clear mucous. Concurrently I was wheezing (raspiness when breathing in and out). The wheezing was not to the point where I felt my breathing was dangerously restricted, however it was very irritating and my airway was not completely clear. I was worried it would progress but thankfully it didn't. I took a ZYRTEC and this helped. I decided I did not need to seek medical care since it eased up. I went to sleep and when I woke I felt better.
had a medication error with Pentacel administration described as the DTAP-IPV portion was administered and the ActHIB portion was not administered; Initial information received on 28-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 2 months old female patient who received DTAP-IPV portion HIB (PRP/T) VACCINE [ACT-HIB] and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] only and Hib portion was not administered.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE). On 24-Oct-2019, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (BOX: Lot #: UJ109ABA, exp:14Oct2020,DTAP-IPV: U6396AA, exp: 14Oct2020,ActHIB: LOT: UJ109AB, exp:14Oct2020) via intramuscular route in the right thigh.   It was a case of actual medication error due to Inappropriate reconstitution technique.  At the time of reporting, no adverse event was reported.  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.  Information on the batch number was requested
w/in 2-3min of vax pt passed out w/urinary incontinence;pt came to p/60 sec pale/sweaty then exp a sz like jerking w/trouble breathing;vital signs WNL;vagal response from anxiety caused rxn;
I have polycythemia and take Jakafi. After taking the Pfizer covid vaccine my platelets have continued to increase. My count was at 490 and every since the vaccination the counts have continued to rise. I am wondering if the mRNA composition of the vaccine could have some negative affect with the use of Jakafi drug. I notice on other sites that some others are having the same experience. Has there been ant research of the Pfizer vaccine with Jakafi or with polycythemia/MF?
Patient received Pfizer vaccine for first dose.  Patient was administered Moderna vaccine for 2nd dose.
Pt was injected with a timed-out Vial. Vial timed-out on 6/23/23 and the pt was injected on 6/29/23.
Information has been received from a licensed practical nurse concerning a 5 year old female, who on 19 September 2001 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 13 February 2006, the nurse reported that the patient "now" has mild breakthrough chickenpox characterized by 13 lesions. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/12/2006. Information has been received from a licensed practical nurse concerning a 5 year old female who on 19-SEP-2001 was vaccinated with a dose of VARIVAX (Merck). Concomitant vaccination included a first dose of HEP B (lot #638841/1764X) given in the right tigh, a first dose of MMR (lot # 539617/0739L) given SC in the right thigh, and a third dose of IPOL (lot# T1310) given IM in the right thigh and fourth dose of PREVNAR (lot # 481-545) given IM in the left thigh. On 13-FEB-2006 the nurse reported that the patient "now" has mild breakthrough chickenpox characterized by 13 lesions. Unspecified medical attention was sought. There was no product quality complaint involved. Follow-up information from the nruse indicated that on 10-FEB-2006 the patient developed a few drops of early vesicles two behind the ear and couple on the chest, low back and legs. The patient was seen for a doctor visit and was treated with ZOVIRAX 8 cc QID for 5 days. Subsequently the patient recovered. No further information is available.
Client vaccinated with J&J vaccine for Covid on 3/17/2021.  Not boosted.  Symptoms started on 12/24 - nasal congestion, cough, fatigue, nausea, sore throat, low fever.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with ZOSTAVAX, subcutaneously. Dose number, lot number, dose, route and frequency were not reported. The pharmacist reported that another unspecified pharmacist (at another pharmacy) had administered an expired dose of ZOSTAVAX (date unspecified). No adverse event was reported. Additional information is not expected.
I beleive that this shot has effected by blood pressure.  My medicine was doing fine with controlling my pressure but after the shot is went very high.  My dose had to be doubled but still high
ZAPPING PAIN THROUGH LEGS AND SHOULDERS; CHILLS; LEGS BURNING AND ACHY; SORE JOINTS; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid 19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced zapping pain through legs and shoulders. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced legs burning and achy. On 08-APR-2021, the subject experienced sore joints. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, legs burning and achy, sore joints and zapping pain through legs and shoulders was not reported. This report was non-serious. This parent/child case is linked to 20210420242.
Severe ache in muscles and headaches and sweating profusely lasted for approximately 48 hours and arm is still sore over week later.
Pt had rash, itching, swelling, lump around injection area. Started day after injection and all symptoms resolved except swelling by following day.
patient experienced:COVID; patient experienced:COVID/ Double pneumonia; This is a spontaneous report received from contactable reporter(s) (Other HCP). Other Case identifier(s): LRN3451164.  A 57-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "relapsing-remitting MS" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO; VITAMIN D [VITAMIN D NOS]. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 03Feb2022, outcome "recovered", described as "patient experienced:COVID"; COVID-19 (medically significant) with onset 03Feb2022, outcome "recovered", described as "patient experienced:COVID/ Double pneumonia". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Feb2022) Positive, notes: patient experienced: COVID.  Clinical Course: On 24Mar, patient started therapy with COVID-19 vaccine for relapsing-remitting MS. On 03Feb2022, it was reported that patient experienced: COVID, Double pneumonia  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported events Covid-19, drug ineffective and the administration of the vaccine cannot be excluded.
Shortness of breath, fatigue, dizziness, ringing in ear, fogged thinking. Shortness of breath, dizziness are not getting better.
Pt came to pharmacy 5/25/14 and showed a swollen and red area at site of ZOSTAVAX administration. He complained of numbness radiating down arm and pain at site of injection given on 5/23/14. He was going to consult his doctor if pain persists.
Severe burning/itching day of vaccination, 2inch diameter raised swollen are where shot was given present the following day.
Patient planning to get pregnant per screening questionnaire. Patient has had first dose Pfizer on 3/31/21 without any verbalized reaction. 6 mins after second dose, patient felt weakness/lightheadedness. Pt. offered water and snack. Husband at client's side and advised to wait 30 minutes for post vax. Patient left after 30 minutes feeling better.
Pt recvd 6 dose of Hep B vax 14NOV91 & immediately p/vax exp severe burning pain @ inject site; later recovered;
Pt. states that after receiving the 2nd dose of Phizer 03/23/2021, started experiencing symptoms 05/2021 of DBP in the left, chest pain with inflammation, nerve pain in the head and wrist, and full body pain. Treated with blood thinner (Elaquix). Still continuing to experience symptoms.
Vasovagal, fainting, patient pale, diaphoretic and tired. O2 2L NC, EKG (sinus rhythm), transferred to hospital via EMS.
Patient presented to ED 3/25/21 for left sided chest pressure about 3 days post Moderna dose #2. Troponin elevated but patient had normal ECG.  Patient admitted to the hospital for NSTEMI.  Cardiac cath done 3/26 showed no obstruction.  Patient had resolution of chest pain during stay and was discharged on 3/28.   Discharge diagnosis myocarditis, discharged on ibuprofen tapering dose.
Fevers from 102-104 from 12/10/04 - 12/15/04.  Also experienced painful neck and headache.  Went to ER on 12/11/04.  No tests were run.  Continued to feel bad and went back to ER with fever of 103 on 12/14/04, blood tests were taken, but no answer to results.  Also experienced bloodshot eyes and blinking alot.  On 12/15/04 had diarrhea.
Dizziness; Fell down; Red Freckles; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Red Freckles), DIZZINESS (Dizziness) and FALL (Fell down) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced RASH MACULAR (Red Freckles). On 31-Jan-2021, the patient experienced DIZZINESS (Dizziness) and FALL (Fell down). At the time of the report, RASH MACULAR (Red Freckles), DIZZINESS (Dizziness) and FALL (Fell down) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication include hydrocortisone of unknown dose and frequency. No concomitant medications were provided.
Saturday night I got a sore, scratchy, burning throat, it worsened throughout the night.  I had hot tea, throat lozenges, and one Aleve.  Upon awakening Sunday morning, my throat was sore to swallow and was still burning so I took two Advil and had a throat lozenge.  Later on in the morning my nose was stuffy and running.  I had no fever either day.
Pt recvd vax & devel a fever, swelling from elbow to fingers & a swollen nose; sx subsided;
Pt. C/O Shortness of Breath and Chest Pain on 4/3/03.  Relieved with Nitrolingual spray.
During the afternoon of 9/11, approximately 20 hours after the vaccination, began feeling warm. My temperature was 99.7. I took 2 ADVIL & rested at home from 4-7pm. I felt fine from there on.
Site: Swelling at Injection Site-Medium, Additional Details: pt recieved flu shot and covid shot on same arm on 10/8..pt then realized later that already recieved flu shot at other office  a few weeks prior
Lethargy; Soreness at the injection site; Shaking; Chills; This spontaneous case was reported by a health care professional and describes the occurrence of LETHARGY (Lethargy), TREMOR (Shaking), CHILLS (Chills) and INJECTION SITE PAIN (Soreness at the injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced TREMOR (Shaking) and CHILLS (Chills). On 04-Feb-2021, the patient experienced LETHARGY (Lethargy) and INJECTION SITE PAIN (Soreness at the injection site). At the time of the report, LETHARGY (Lethargy), TREMOR (Shaking), CHILLS (Chills) and INJECTION SITE PAIN (Soreness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: No new Information
This spontaneous case, initially received from other non-healthcare professional on 08-Nov-2018, concerns a 19-year-old, adult, female patient. The patient's vaccination history included unspecified flu vaccines without any adverse events. The patient had no relevant medical history and concomitant medications. On 05-Nov-2018, the patient was administered FLUCELVAX (QIVc) [dose: 0.5 ml, route of administration, anatomical location, batch number and expiry date: not reported]. On 06-Nov-2018, the patient developed hives all over the body and swelling of the eyes, wrists, knees, and fingers. On an unspecified date in Nov-2018, the patient went to the emergency room (ER), where she was given BENADRYL and unspecified steroid shot and was sent to home. The reporter stated that the swelling and hives had not gone away. At the time of the report, the patient had not recovered from the events. The reporter assessed the case as non-serious. This case was considered as lost to follow up, as the reporter had not given the consent to follow up.
In the afternoon while talking to a friend, realize that there were behavioral type changes. Went to bed early at 6:30pm and awoke with paralysis, excruciating pain, headache and hallucinations. At one point of delirium maybe had high temperature. Had paralysis throughout body and was in and out of consciousness. This ordeal lasted about 3-4 hours. At 11pm was able to walk to get a drink of water and wash cloth for face. Was rubber legged. Considered calling 911 but did not because door was locked and dog was already quite upset. Symptoms began to subside just had fever and chills. Slept all day long to recover. Due to bladder infection doctor prescribed BACTRIM and was taking it. A cough started on Tuesday and got worse by Wednesday. Did not feel good all week long by the end of the week muscle spasms started. On Saturday had cramps in right leg, dizziness and lightheadedness so called ambulance to be taken to ER. BP was 135/70. Dr. at hospital ran chest x-ray, EKG, urine test. He confirmed that there was still a bladder infection but also heard rattling in lungs so diagnosed as pneumonia. By this day had almost finished 7 day treatment of BACTRIM--only had 1 day dose left. Doctor prescribed Levofloxacin 500mg to help with the bladder infection and pneumonia. Regularly patient is very active and intellectual - speaks multiple languages, rides horse and has high mental acuity -- but the week after the vaccine had to think doing things in steps to perform daily activities. Had to think through thoughts to be coherent. Now she feels better, relieved that her skills are coming back even her sense of humor. Called her doctor to let them know what happened.
Redness at injection site, no hives, no rash, had pain 1 day and resolved, no treatment, redness at injection site at office visit 08/01/2012, no rash, no hives, no other symptoms, no pain.