chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist concerning a 77 year old male with benign prostatic hypertrophy who on 10/19/2004 was vaccinated with pneumococcal 23v polysaccharide vaccine.  Concomitant therapy included aspirin, MSD, Flomax.  On 10/20/2004 the patient developed a 2 inch reddened welt at the injection site.  It was also reported that the site was warm to touch.  The patient applied ice to the site as an intervention.  Unspecified medical attention was sought.  At the time of this report, the patient was recovering from the injection site erythema and injection site warmth.  No further information is available.
Extremely light headed, faint, felt like I was going to pass out when just sitting, rapid heartbeat which caused me to have an anxiety attack, extremely sensitive to sound and light, extremely weak (bedridden), whole body ached, extremely dizzy, and loss of appetite.
Arm near injection site warm to touch, slight swelling/raised, pt reports itchy feeling.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 11-NOV-2015, the patient received an improperly stored dose of ROTATEQ 2 ml, 10 unit dose tube, (lot # L000434, expiration 10-JUL-2016). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/ Celsius) and the type of excursion (R/F) for each time were 224, 34 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
PT. EXPERIENCED PAIN,REDNESS AND SWELLING AT INJECTION SITE AND ITCHING.REDNESS MEASURES APPROX. 6 CENTIMETERS. WARM TO TOUCH. PT. COMPLAINS OF INCREASED WEAKNESS.
During the observation period, the patient became lightheaded and dizzy.  He complained of sweating and cold skin.  The pharmacist immediately went to the aide of the patient.  The patient was laid on the ground and we began to get a blood pressure reading.  We also gave the patient cold pack to place on the skin.  The patient never lost consciousness and was verbal and responding to pharmacist questions the entire time.  We asked multiple times if he needed EMS and he each time told us he did not.  His status continued to improve with deep breaths and cooling the skin.  After 10-15 minutes he felt like he could sit up in the chair and did just fine and continued to recover.  We kept watch over him.
I'm very worried my reaction could be worse after the 2nd shot-----+++In the past Ive had anaphylaxis to Cat Scan Dye- symptoms were immediate nose, ear blockages, hoarse voice, felt like breathing through a straw, chest tightness.  ***on day of 1st shot I waited for 30 mins, felt fine. Within 2hrs of shot, while I was home I experienced throat tickling/itchiness, one side of my nose felt the same, and the other side ear felt stuffy I took a benadryl and used my inhaler, while I have prednisone I didn't think I was suppose to take it after the vaccine, so I did not. The symptoms didn't get worse Spoke with my dr., we did a conference call with cdc, they couldn't tell me to get the 2nd or not, said to contact VAERS
Chest pain 10-14 days post vaccination assoc with nausea, dizziness, SOB, and radiation.  Evaluation at civilian hospital and told he had myocarditis.  Continues to have discomfort with exertion. Has not pushed himself.  Is taking ibuprofen daily.  Pt stated VAERS had been filed.  No report available for verification.  Symptoms: Chest Pain, sub-sternal.  8/12/08 Reviewed hospital records of 1/15-1/16/2007. FINAL DX: non-acute MI secondary to myocarditis; myopericarditis; dyslipidemia. Records reveal patient experienced chest discomfort during PT 1 day prior to admission.  The chest pain was sharp, shooting into his left cheek & lasted approx 8 hrs.  Pain resolved w/NSAID but returned next day, increasing w/deep breaths & radiating to jaw assoc w/nausea, dizziness & SOB, lasting approx 30 min.  Went to ER where abnormal EKG & (+) cardiac biomarkers were found & transferred to higher level of care.   Remained stable & d/c to outpatient cardiac f/u.
administered vaccine and patient reported slight shortness of breath and heaviness in her chest. after 20 minutes of observation, patient stated she felt better and patient was stable before leaving...Benadryl 25 mg given po
This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 86-years-old female patient received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, Lot number and Expiration date was not reported), via an unspecified route of administration, in Right Arm on 11Feb2021 at 13:15 (at the age of 86-years-old) as first dose, single for COVID-19 immunization. The patient medical history included ongoing type 2 diabetes mellitus. The patient concomitant medications were not reported. It was reported that, patient got 1st dose of vaccine on 11Feb2021. "Had a major fall" on 28Feb2021, patient went to the hospital and was diagnosed with broken rib, "plus other junk". patient says she was supposed to go back 8Mar2021 for 2nd dose, but was not able to go because of her injuries. patient is asking if she is able to get 2nd dose after the original scheduled date, and asking for assistance with scheduling. She was in so much pain from her fall, she couldn't even get out of bed. Patient reported she broke a rib when she had a major fall at home. She said her broken rib was very painful, and from her waistline down to her hips, she had pain. she went to the Emergency Room, and her doctor gave her a shot. She said she did not remember what the shot was, and cannot provide the NDC, Lot, and Expiration Date. She said the doctor wanted to admit her to the hospital, but she declined. She said she was kept in the Emergency Room overnight, and sent home the next day. She stated that 2 years ago she was in the hospital for 51 days. The outcome for the events was reported as unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
fatigue; severe body ache; headache; left arm site of injection pain; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), MYALGIA (severe body ache), HEADACHE (headache) and VACCINATION SITE PAIN (left arm site of injection pain) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02SO20A and 013M20A) for COVID-19 vaccination.     Concomitant products included ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D3), ZINC, VITAMIN B COMPLEX and PROLIFE for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigue), MYALGIA (severe body ache), HEADACHE (headache) and VACCINATION SITE PAIN (left arm site of injection pain). At the time of the report, FATIGUE (fatigue), MYALGIA (severe body ache), HEADACHE (headache) and VACCINATION SITE PAIN (left arm site of injection pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-048002 (Patient Link).
Homebound patient. dose was drawn up in pharmacy and transported via syringe by a CDC qualified packout container in with a home RN to administer. Data logger and external thermometer in qualified packout were verified upon return. Data logger reads that it reach greater than 25 degrees C at 1:41pm. Upon reviewing off label stability data provided by Pfizer, doses drawn in synringes are good at 2-30 degrees C for 6 hours. This excursion did not affect the validity of this patient's dose but does allow us to change policies with home visits to help prevent future excursions.
Pt had unconcolable high-pitched crying in afternoon same day of immunizations for 4 hours.
Arm reddened, swollen, painful. We have had multiple patients with similar reactions after PNEUMOVAX.
Patient reports she developed redness / hives to arms and back of her neck within 30 min observation period.  was given diphenhydramine 25mg.  by the time she got to the emergency dept there was Minimal residual erythema of bilateral shoulders - no hives currently
Nausea and watery diarrhea for one week Headache body ache 2 days Mild fatigue
I started with a severe headache and neck pain around 10PM the night of my getting the vaccine.  I woke up in a soaked bed from sweat and had chills around 7AM.  I had muscle aches, was feverish and my throat was bothering me.  I took some cough medicine to help my throat, which is soothed it for awhile.  All that day I slept a lot and when awoke felt very warm inside but chills outside of my body.  The following night while I was asleep, I woke again in a soaked bed and felt warm inside with chills outside.  This subsided as the day went on.  I do not know for sure this was from the vaccine but thought I should complete this form.  I want you to know that I lost my husband 6 months ago and have been having a hard time coping with being alone.  I have been getting flu vaccines for decades and have never had a reaction.
Vertigo upon awakening each morning after vaccination, which lasts approximately 5-15 seconds; has progressively worsened so that vertigo also occurs when tilting head up or down.
Hep A was given outside of recommended number of doses.  Havrix is a 2-dose series, patient mistakenly received a third dose.  Mother was notified of vaccine administration error at the end of visit, patient was observed, reviewed literature of adverse reactions, since administration error no harm has occurred.
two patients under the age of 65 received a dose with no AE; two patients under the age of 65 received a dose with no AE; Initial information received on 14-Oct-2021 regarding an unsolicited valid non-serious case received from a physician and consumer/non-healthcare professional via call center via Medical Information (Reference number- 00812706).  This case is linked to case 2021SA343609(CLUSTER).  This case involves a 36-year-old female patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age and overdose).  The patient's medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.  On 13-Oct-2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date not reported) via an intramuscular route at the deltoid nos for prophylactic vaccination.  It was an actual medication error case due to inappropriate age at vaccine administration and overdose (latency: same day).  It was reported "Administrative agent reported that two patients under the age of 65 received a dose of Fluzone Quadrivalent High-Dose. She requested information on the use of the vaccine for this population."  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.  There will be no information available on the batch number for this case.
Approximately 10 minutes after vaccine injection patient reported symptoms of heart pounding, apple watch showed heart rate at 177. Patient vitals obtained BP 169/105, pulse 177.  No chest pain, shortness of breath, lightheadedness, nausea. After about 5 minutes vitals improved to BP 163/105 and P 135. Patient monitored for about 2 hours, took 20 mg of propranolol that was given to her after similar reaction to moderna vaccine - dose 2(about 15 hours later). Patient seen by clinician. 2 hours after procedure vitals imprved to BP 123/82 and pulse 97. Patient went home in personal vehicle.
ulcerations in her mouth; She got lesions in her mouth; my wife is in a lot of discomfort; This is a spontaneous report from a contactable consumer. This consumer (patient's husband) reported for a female patient (reporter's wife).   A female patient received bnt162b2 (COMIRNATY, solution for injection Batch/Lot Number: FB-EW0191), via an unspecified route of administration on 16Aug2021, dose 1, single for covid-19 immunization. Patient medical history and patient concomitant medications were not reported. On 16Aug2021 (same day of the vaccination) 4 hours after they got home his wife had adverse reactions. She got lesions in her mouth and dentist called it ulcerations in her mouth. Patient is in a lot of discomfort. The outcome events was unknown.   No follow-up attempts are possible. No further information is expected.
Case number PHEH2016US029326, is an initial spontaneous report received from a nurse on 07 Nov 2016. This report refers to a 35 years old male patient. Past medical history and concomitant medications were not reported. The nurse stated that, first temperature excursion of FLUCELVAX Quadrivalent at 52 Fahrenheit for 01 hour occurred on 18 Oct 2016. Second temperature excursion occurred on 23 Oct 2016, dropped low 06 times to 34 Fahrenheit and lasted 30 minutes each time. The patient was vaccinated with FLUCELVAX Quadrivalent (batch number: not reported) at a dose of 0.5 ml, intramuscularly on 27 Oct 2016. Third temperature excursion occurred on 02 Nov 2016, dose to 32.2 Fahrenheit three times over the course of 12 hours. Vaccine had been administered. It was unknown if vaccine was frozen. Nurse did not know which lot was given to which patient. No adverse event was reported following this medication error.
Gave 2 year 8mos old flu vaccine IM Lt thigh. Our previous vaccine was 6 months and up. This vaccine was for age 4years and up.
Patient received the pediatric COVID vaccine instead of the adult vaccine. Patient didn't have any side effects and received the correct formulation on 10/16/23 per CDC guidelines.
headache, neck pain, fatigue, brain fog, fever, full body ache. sore arm with rash at injection site treated with rest, fluids and tylenol fever began to go away 27 hrs after the vaccine. Body aches and fatigue were improved  within 48 hrs. arm was sore with rash for 3 days Mild headache and neck pain persist today, 9 days after vaccine.
several generalized convuls w/in 48 hrs of dose; no prior hx of seizures or neuro problems;
Stymptoms: Vomiting. Course: About 3 hours beginning approx. midnight of day of vaccination. Treatment: None.
On the 5th in the morning my arm was sore had a knot on it ( about the size of a half dollar) and red at shot site. Today the 6th I got up and it still hurts  a much larger knot and is still red. I looked it up an it seems to be what they are calling covid arm.
This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 30-year-old female patient who received ENGERIX B pediatric (batch number UNKNOWN, expiry date unknown). Previously administered products included ENGERIX B adult (dose 1). On an unknown date, the patient received the 2nd dose of ENGERIX B pediatric 10 micrograms. On an unknown date, the dose was an unknown dose. On an unknown date, an unknown time after receiving ENGERIX B pediatric, the patient experienced drug dose administration interval too long, inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the drug dose administration interval too long, inappropriate age at vaccine administration and wrong vaccine administered were unknown. Additional information received: Pharmacist calling on behalf of LTC facility under their supervision for healthcare worker who works at risk for Hep B. She has little information on dates of vaccinations or ages when received or patient information. However, female healthcare worker now in 30s received an adult dose presumably at 20 yo or older of ENGERIX-B 20mcg, but then received a second dose at unknown time interval of the pediatric formulation of ENGERIX-B or 10mcg/0.5 mL. Now it has been some time since second dose and they want to know about the 3rd dose. They know of no titers drawn at this point. She is asking on behalf of this healthcare worker as to what they should do for succeeding doses. Sub-optimal/Age-inappropriate dose for this adult, presumably given previously, which is maladministration AE.
Cold fingers and toes; discoloration; numbness; This is a spontaneous report from a contactable other HCP(Patient). This 30-year-old non-pregnant female received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: Em9810), via an unspecified route of administration in right arm on 19Feb2021 at 07:00 PM (at the age of 30-year-old) as a single dose for COVID-19 Immunization, at hospital. Patient's medical history included Covid-19. Concomitant medications included multivitamins [vitamins nos] and melatonin;theanine (medications in 2 weeks). The patient previously took first dose of BNT62b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number El9264) for on 29Jan2021 at 07:00 PM via an unspecified route of administration in right arm at single dose for COVID-19 Immunization. Prior to the vaccination the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not receive other vaccines in four weeks of vaccination. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. Patient experienced cold fingers and toes; podiatrist said it appeared to have smaller capillaries in his toes led to discoloration and numbness. No treatment was given for the event. The outcome of events was unknown.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Patient had pain in her left arm a couple (2) hours after receiving the injection. She states it was so bad she went to the chiropractor, who did nothing. Then she got a prescription for IBU 800 mg/TID. Then the next day she got a cortisone shot in her left shoulder. She is feeling better today-(10/12/09).
Information was received from a licensed vocational nurse referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unspecified dates, the patients were administered improperly stored doses of VAQTA injection (lot# M009377, expired on 17-JUN-2017; lot# M011116, expired on 17-JUN-2017; lot# M003011, expired on 15-NOV-2017) (dose and route unknown). The vaccines were exposed under 48 Fahrenheit degree (F) for undetermined time frame and was back in range. There was no previous temperature excursion. Digital data logger was involved. No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
After 2nd dose of vaccination, patient noted gradual onset of headache, neck stiffness, nausea, vomiting, myalgias, and difficulty eating.  After the 3rd dose of the vaccination he had increasing symptoms and was sent from work to the ED for confusion and agitation.
Information has been received from a licensed practical nurse concerning a female patient who on 10/26/2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 646711/1181N).  On 10/27/2004 the patient developed redness, swelling, pain and local heat at the injection site.  She also developed a mild fever.  It was reported that she was recovering and that she sought unspecified medical attention.  No other information was available.  It was reported that another female patient had similar experience.  Additional information has been requested.
This initial non-serious spontaneous case, was received on 27-Sep-2017, reported by a pharmacist concerning an elderly, female patient of unspecified age. Patient's medical history was not reported. As reported, no vaccine was administered to any patient who had egg allergies. On an unspecified date (five years ago (as reported) from the time of this report), the patient received influenza virus vaccine polyvalent (dose, route of administration, anatomical site, batch number and expiry date: not reported). On an unspecified date (five years ago (as reported)), after administration of egg-derived flu vaccine, the patient did not feel well (as per the reporter, it was stomach ache). Outcome of the event was not reported. This report was considered as non-serious. Non-significant follow-up received on 10-Oct-2017: It was reported that, pharmacist does not have an idea about dose, route, anatomical site of suspect vaccine, whether patient experienced stomach pain after administration or any other events and outcome of the events as it was five was five ago. Significant case correction received 27-Sep-2017: "The patient did not feel well after taking an egg-derived Flu vaccine 5 years ago" was coded as 'feeling unwell' as a symptom for the event stomach ache. Amended narrative accordingly.
This spontaneous report was received from a healthcare professional referring to unspecified patient of unknown age or gender. The patients' medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with 2 improperly stored (temperature 31.7 F, time frame: 19 hours and 40 minutes) doses of oral, ROTATEQ (dose, anatomical location or frequency were unknown) lot # L013206, expiration date: 29-JAN-2017. No adverse effects reported. No product quality issue informed. This is one of two reports from the same reporter. Additional information has been requested.
Patient noticed itching at site, redness and edema one day after receiving vaccine. Patient states she put ice on site and took 50 mg oral Benadryl. Patient states redness has subsided slightly. Edema has improved as well.
On 4/23/02, the vaccinee received her 1st injection of Engerix-B. On 4/23/02, at an unspecified time post vax, the vaccinee experienced a vasovagal response; she fainted. The reporter stated that when the vaccinee fell, she hit her head. The mother "was hysterical" and insisted that the "rescue squad" be called. The physician provided unspecified treatment at the office. The reporter stated that the vasovagal reaction was probably related to Engerix-B. As of 4/23/02, the event had resolved.
pt recv vax 30JAN96 & 6JUN97 pt exp chickenpox & was covered head to toes including the area around eyes, on the tongue & in throat & vagina;there was a fever of 103;
1/19/22 positive COVID test at a HCF; increasing SOB, fatigue, cough; 1/29/22 pt to hospital; CXR showed possible pulmonary edema or atypical infection; 69% O2 saturation on RA; AHRF; O2 supplementation; Dexamethasone, Remdesivir, Rocephin; transferred to ICU; AKI; intubated; respiratory status worsened; multiorgan failure; code blue called; multiple rounds of CPR; asystole; pt passed away in the hospital
Information was received 13-OCT-2016 via telephone call from a registered nurse who reported that an improperly stored dose of Meningococcal Protein Conjugate was administered to a 15 month old patient on 10-OCT-2016. The reported lot numbers are: # M014925, expiration date 16-FEB-2019 and Lot # M010439, expiration date 08-DEC-2018. It was not specified which lot # was administered to this patient. No adverse effects reported. This report was due to data logger. This is one of several reports from the same source. Additional information was requested.