chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt called to report that she has been experiencing adverse reactions starting Sunday night (around 7pm) after receiving her high dose flu vaccine Sunday morning (around 10am). The reaction started off with redness and itch, progressed to a big "bulge" that looked like a huge cyst halfway between her wrist and elbow, and she now has a black/blue mark + itch at the site of injection as if someone punched her arm.  This was the first time the pt ever reacted to the flu shot. Pt was not able to identify any other causes of the rash/bruise other than the flu shot the same morning. She has been using calamine lotion and taking Benadryl to help with the rash, but has not seen resolution of symptoms.  Pt made an appointment to see her dermatologist this afternoon. Advised pt to continue w treatment at home until further advised by her doctor at the appointment and to seek urgent care if her symptoms suddenly worsen before then.  Gave information regarding the vaccine (manufacturer, lot number) over the phone and mailed her the package insert per request. Pt already called the manufacturer SANOFI and did not seek any further information from us.
This spontaneous report as received from a nurse, concerning to a 4 year old female patient (also reported as 14 year old). Her medical history and concurrent conditions were not reported. On 11-MAR-2016 at 10:30, the patient was vaccinated for the second time with an improperly stored dose of VARIVAX subcutaneously, lot number L013826 and expiration date of 21-APR-2017 (dose was not provided). No concomitant therapies was reported. It was reported that the vaccines were stored at 26.5F for 3 hours and previously stored at 46F for 50 hours and at 46F for 20 minutes (dates unspecified). The temperature excursion was captured via a Data Logger. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up was received.
Patient had Hepatitis B vaccine 10/20/2004.  Rash and whelps started 10/28/2004 and had to go to ER for Cortisone shot and Vistaril for itching.
Patient Revieved Expired Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient Revieved Expired Vaccine) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient Revieved Expired Vaccine). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patient Revieved Expired Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information not provided.  Treatment information not provided.  Injection site was reported as left.
Patient received Janssen injection and within a few minutes reported being dizzy, diaphoretic, syncopal, and nauseous.  Patient taken to triage, laid down, and vitals taken. Patient requested water, given ice pack to neck. Patient stated feeling better, denying symptoms and released. Instructed to go to UC or clinic if symptoms occur.
Mother notified by phone the baby has been running fever 103 degrees F - 104 degrees F, very listless but she is up and talking. MOTRIN was given TYLENOL by pm and cold compress. Mother instructed to give MOTRIN and alternating TYLENOL.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) 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 had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid as treatment from 20Dec2022 to 25Dec2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Patient had PROQUAD and KINRIX three days ago. Symptoms started that night. Back pain has been mild and has a achy quality, is recurrent and is localized to the lower back. It does not radiate. The pain does not interfere with activity. The enlarged lymph nodes are located in the neck. There is not a history of exposure to cats. The fever is intermittent. The patient's oral temperature has been as high as. 102.5 degrees. A little runny nose and cough that started today. Patient also states it hurts when she urinates. The vomiting started 1 day ago, with a frequency of 3 per day. The last episode was 2 hours ago.
15 min after shot tingling of upper lip and tongue. similar to symptoms with iodine allergy. ems called
Rash to Left arm, itching. Soumedrol 125mg IM Benedryl 50mg IM
1:40P COMPLAINED OF RAPID HT RATE, SWEATING AND ANXIETYSHE WAS DIAPHORETIC, HYPERVENT, AND SLIGHTLY HYPER-   TENSIVE. 133/83  HR 97  O2 98%.  PLACED ON STRETCHER, GIVEN H2O  STATED THIS HAPPENED TO A LESSER DEGREE WITH   FIRST VACCINE. IT HAS BEEN 21/2 MTHS SINCE FIRST DOSE ASHE WAS ANXIOUS ABOUT RECEIVING SECOND DOSE. 2P 122/87   HR 88 O2 100%. COLD CLOTH TO HEAD , SEMI FOWLERS POSITITO FACILITATE BREATHING. 2:05  FEELING BETTER. DANGLED   WITHOUT DIFF. AMBULATED TO BR WITH SUPERVISION. FELT BETTER AFTER AMBULATING. 2:15 121/74  HR 87  02 100%   SKIN WARM AND DRY. DENIES UNTOWARD EFFECTS. DISCHARGED
HOSPITALIZATION - BREAKTHROUGH COVID-19 CASE: 11/29/21 TO 12/2/21
life threatening illnesses; This spontaneous report was received from a person told a friend who then told the employee's wife referring to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On an unknown date (reported as in the past), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, frequency, route, lot# and expire date were not reported) for prophylaxis.   On an unknown date, the patient experienced life threatening illness. The outcome of the event was unknown.  Causality assessment was not provided.  This is one of two reports received from the same reporter (link case # 2108USA005903).; Sender's Comments:  US-009507513-2108USA005903:
Local 6x11cm erythematous, pruritic rash developed starting 3 hours after vaccination. IPV site was at center of rash; DTaP site was only at upper margin.
Mild fever; chills; significant muscle pain throughout body; significant body aches; very significant fatigue; pain at injection site; pain radiating down arm into hand and fingers; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: ER8727) via an unspecified route of administration in the right arm on 26Mar2021 at 16:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included environmental allergies and general anxiety. The patient had no known allergies to medications, food, or other products. Concomitant medications included ethinylestradiol (+) levonorgestrel (TRIVORA), EFFEXOR XR and cetirizine hydrochloride (ZYRTEC) all used for an unknown indication and from an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6205) via an unspecified route of administration in the right arm on 05Mar2021 at 15:15 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. On 26Mar2021 at 19:00, the patient experienced mild fever, chills, significant muscle pain throughout body, significant body aches, very significant fatigue, pain at injection site including pain radiating down arm into hand and fingers. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported adverse events. The clinical outcomes of the events mild fever, chills, significant muscle pain throughout body, significant body aches, very significant fatigue, pain at injection site, including pain radiating down arm into hand and fingers were recovering at the time of this report.  No follow-up attempts are needed; No further information is expected.
Patient returned with redness, pain, heat at injection site. She was referred for medical treatment for cellulitis and given antibiotics.
Right arm was very tender to the touch, swollen, and the pain radiated to the right breast.  Face was swollen under the eyes.
This is a spontaneous report form a contactable pharmacist received via Pfizer sales representative. A 73-year-old female patient received PREVNAR 13 intramuscular, in arm, on an unspecified date, at single dose, for immunization. Medical history was not reported. Concomitant vaccination included influenza vaccine, given on an unknown date, in a different arm, for immunization. On an unspecified date, after vaccination, the patient experienced pain, inflammation and hot area. Events outcome was unknown. Information on the batch number has been requested.
Itchy & hurting eyes. Headache chills dizziness sweating fell down.
Fever, chills, malaise, body aches, headache, and erythematous, warm, tender indurated lesion on right deltoid.
Parents report child was limping after vaccine was given and continued to limp at today's visit 10/21/2019.
Fussy, then developing fever of 102. Fever reduced the following day. Second night the fever shot up to 105. Went to ER, did blood work and urine sample to eliminate risk of bacterial infection. Third night fever at 104. Fourth night fever gone. Still fussy and irritable.
Fatigue for 48 hours; This is a spontaneous report from a non contactable consumer (patient). A 52-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 12Apr2021 10:30 (Batch/Lot number was not reported) at age of 52-year-old, as single dose for covid-19 immunisation. Medical history was none. The patient did not have allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. Historical Vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) taken at age of 52-year-old, via an unspecified route of administration, administered in arm left on 22Mar2021 10:30 (Batch/Lot number was not reported), as single dose for covid-19 immunisation. The patient experienced fatigue for 48 hours on 12Apr2021 16:00. No treatment was received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of event was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Felt injection pain in opposite arm.  Took several hours to feel injection in arm vaccine was given in.   Resolved. 14 days later, rash all over torso.
Episodic ipsilateral lancinating pain in axilla and proximal/medial upper arm with occasional radiation along ulnar distribution to digits. Sometimes forearm/hand symptoms occur without upper arm/axillary symptoms. Stable since onset (60hrs). Episodes occur at day and night, more frequently with (but not intimately related to) arm movement. Immunization and symptoms in left arm, pt right-hand dominant.
Severe headache, severe body aches, intermittent nausea, loss of appetite, chills, sweats, weakness, lethargy, slight rash on 3rd day.
Patient was in bed for 3  days, from her ears to her leg she had nerve pain, she felt like a bat hit her. She consulted her doctor and was told not to get her second covid shot.
Patient woke up and started vomiting last night. No fever, body aches, headaches or other symptoms reported/noted.
Hospitalized on 9OCT91, 6 days p/immun; MD indicated poss severe blood dyscrasia & questionable brain tumor & intracerebral bleeds; thought to be preexisting & not vax related;
Patient called nurse on 02/23/2005 to complain of reactions several hours after receiving a Td shot on 02/22/2005.  The patient complained of fever of 101.7, headache, sore and achy all over; nausea; arm not sore; swollen gland in armpit of the right arm.  Patient does not feel well today (02/23/2005) but has no fever.  Patient has not been to the doctor.  Patient does not know if the reaction is due to the td shot or if he's picked up a bug.  He took Tylenol the night of 02/22/2005.  Was about to take more today (02/23/2005).  The patient received the Td shot as he had not had one in several years, the patient did not have an injury. Follow up received on 01/17/2006:  Patient recovered from all of his symptoms.
had a vaccination on 12/31/2020 late morning passed away early morning 01/01/2020.  This is a 93 year old with significant heart issues. EF of 20% among other comorbidities.  He died suddenly approximately 0430, it is unlikely it was related to receiving the vaccine.
Pt has rash "all over her body"; small patches red & pruritic. 3 days after her 3rd dose of Hep-B. Took Benadryl. Dr confirmed she has hives due to Hep-B; Dr treated w Prednisone injection & cream. Also, had Strept Throat, tx:Amoxicillin.
About a month and half after receiving my booster I had a flare up of diverticulitis. I have not had a flare up like this in over 20 years. I have had a few flare ups, but if I go on Cipro immediately, they calm down. This time I was taking Cipro and it did not help, so they added Flagyl. The two medicines together made me horribly sick, but it did help. I had a CT scan a couple of weeks ago to make sure and everything looked good. There was still some inflammation and scar tissue, but the infection is gone.
BRUISING IN LEGS AND FEET; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had a family history of Idiopathic thrombocytopenic purpura (ITP), and a genetic disposition toward bruising, mild blood disorder. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced bruising in legs and feet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bruising in legs and feet was not reported. This report was non-serious.
Woke up the day after vaccination with pain in hips that has improved with 2 Ex Strength Tylenol and much improved today.
A spontaneous report has been received from a 50 year old, female student, who had been receiving FLUMIST (intranasal). FLUMIST (intranasal) started on an unknown date. The patient experienced face numbness, headache, administration over 50 years old was reported. At the time of reporting, the event of face numbness, headache and administration to over 50 years old was ongoing. The report was considered to be non-serious.
Hives; itching, burning, swollen bumps on back, wrists and hands.
Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. On unknown dates, the patients received doses of improperly stored ROTATEQ orally (dose, frequency and lot number were not provided). No adverse effect reported. It was unspecified if the patients sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Patient completed vaccine series 2-18-2021. Was admitted to the hospital diagnosed with COVID-19 2-27-2021
patient was given ActHIB injection with expired diluent / no adverse event; Initial information regarding this valid unsolicited non-serious case was received from other healthcare professional on 08-Oct-2020.  This case involved a 2 years old female patient who was given injection HIB (PRP/T) VACCINE [ACT-HIB] with an expired diluent (Expired product administered),   The patient's medical history, medical treatment(s) and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL); HEPATITIS A VACCINE; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR VACCIN) and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) all used for prophylactic vaccination.  On 07-Oct-2020, the patient received a 0.5 ml first dose of suspect HIB (PRP/T) VACCINE (Powder Lot number- UJ079AA, expiration date 26-Oct-2020 and Diluent Lot number-U6402AA,Expiration Date :02-Oct-2020) (once single dose vial) via intramuscular route in the upper arm for prophylactic vaccination .  It was a case of actual medication error due to an Expired medical agent used. (latency- same time of vaccination)  At the time of reporting, patient had no adverse 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 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.
The first Dose I received on 4/12/21, I had a slight headache and cold chills for only 3 days. The second dose shot of Pfizer on 5/10/2021 I had really bad chills, trembles, heart palpitations, and lightheadedness. The symptoms were enough to make a trip to the local ER. I was told by the ER Physician that I was having adverse effects on the Vaccine which was a good thing because if it was making me feel like that it only meant it was working being that I have an autoimmune diseases. I was told to go home, get rest, drink plenty of fluids and if it hasn't gone away by the next day to come back.
Lightheadedness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Lightheadedness) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 032L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Blood pressure abnormal and Blood cholesterol abnormal. Concomitant products included SIMVASTATIN for Blood cholesterol abnormal, BENAZEPRIL for Blood pressure abnormal, TRIAMTERENE for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIZZINESS (Lightheadedness). The patient was treated with PARACETAMOL (TYLENOL) for Lightheadedness, at a dose of 2 dosage form every six hours and IBUPROFEN for Lightheadedness, at a dose of 2 dosage form every six hours. At the time of the report, DIZZINESS (Lightheadedness) had not resolved.            Action taken with mRNA-1273 in response to the events were not Applicable   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow up received on 02-Jul-2021 contains Non significant information
Patient received one time dose.  Shortly after administration began to experience flushing, localized swelling, warmth, pain, and erythema.  Ice was applied topically.  MD notified.
Had the most severe pain I have ever had in my life on right side of shoulder, collar bone, and upper ribs.  I have had surgeries, broken ankle, a baby etc and I have never experienced this kind of pain before in my life.  I could not bend over or lay day it would increase the intesity of the pain.  My chest hurt with every breath I took.  I went to the Er and was told that I had inflamation in my muscles in those areas.  Pain started 3 days after the shot and gradually increased until It was so painful I couldnt take it any more 4 days later.
Initial misuse report received from a healthcare professional on 23 April 2013. A patient (No information was provided regarding the patient) had received first dose of ADACEL in May 2012 and then inadvertently received second dose in March 2013. No adverse event was reported. List of documents held by sender: none.
Shivers; Cold; This case was reported by a pharmacist via call center representative and described the occurrence of shivers in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced shivers and cold. On an unknown date, the outcome of the shivers and cold were recovered/resolved.   It was unknown if the reporter considered the shivers and cold to be related to Shingrix.  Additional details were provided as follows: The patient had experienced colds/shivers after receiving 1st dose of Shingrix. The reporter also stated that the patient did not experience swelling, shortness of breath, paralysis, or anything like that. The reporter consented to follow-up and provided contact information. This case has been linked with US2020254940, reported by same reporter and same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020254940:Same reporter, same suspect, same patient, diferent dose (1st dose)
Information has been received from a registered nurse concerning a patient with blood pressure check at the time of vaccination and no known allergies or medical conditions who on 15-MAR-2010 at 8:30 a.m. was vaccinated with a first dose of PNEUMOVAX 23 vaccine in the right arm (lot# 664476/1190Y).  On 16-MAR-2010 the patient experienced cellulitis.  The patient was treated with clindamycin for 7 days.  It was unknown if the patient sought medical attention.  Subsequently, the patient recovered from cellulitis.  No laboratory or diagnostic studies were performed.  A standard lot check investigation has been finalized.  All in-process quality checks for the lot number 664476/1190Y were satisfactory.  The lot met the requirements of the Research Center and was released.  This is one of several reports received from the same source.  Additional information is not expected.
pt sister was vaccinated w/ varicella but pt was dx w/ herpes zoster; tx w/ acyclovir for 10 days;
I have 2 sons ages 15 and 12 that are on a modified vaccine schedule to accommodate severe allergies. They were to receive Tdap doses and instead received 2 consecutive doses (2-weeks apart) of D-Tap vaccine instead. They both experienced extreme tenderness and moderate swelling at the injection sites. It was even more pronounced after the 2nd dose that we now understand was not even needed as well as wrong.