chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a temperature excursion states that doses have been administered; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about pertinent medical history, concurrent conditions, concomitant medication and drug reactions/allergies was not provided. On 10-JUN-2021, the patient received improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 ml, lot number T010298, and expiration date 24-MAR-2022 (route were not provided) for prophylaxis (product storage error). The vaccines were exposed to temperature excursion of -7.2 degree Celsius for 2 hours 21 minutes. The vaccines were exposed to previous temperature excursion of -5.9 degree Celsius for 2 hours 31 minutes. Data logger was involved.
No additional AE reported; Office manager reports ROTATEQ was administered after a temperature excursion to 23 patients.; This spontaneous report has been received from an office manager referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, previous drug reactions, or allergies were not provided.    On 28-JUN-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) once, (lot number W011279 has been verified to be a valid lot number, expiry date 02-NOV-2023) as prophylaxis (strength, dose, route of administration, and anatomical location, date were not provided) (product storage error).  The rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was stored at a temperature of 9 degree Celcius (C) for the time frame of 1 hour and 32 minutes. There was no previous temperature excursion.  No additional adverse events reported.  This is one of several reports received from the same reporter.
Information has been received form a health professional concerning a 5 year old white female with a peanut allergy and an egg allergy, but otherwise healthy who on 12/01/1999 was vaccinated SC in the LL with a first dose of varicella virus vaccine live. There was no illness at the time of vaccination. On 06/16/04, the pt presented to the office with a scattered vesicular rash on his right leg and thigh, left thigh and trunk.  There were 40-50 lesions. The rash started on 06/14/04. Medical attention was sought, but no tx was required. No product quality complaint was involved. Follow up information indicated that the pt was seen in the office on 06/16/04 with a rash for 2-3 days. It was described as scattered vesicular lesions on the right leg and thigh, left leg and thigh and right upper extremity: "trunk". There were 40-50 lesions without fever. There were no labs or diagnostic tests performed. It was reported that the pt recovered.  Follow up information indicated that the pt was diagnosed with varicella. Additonal information is not expected.
Patient with sudden onset shaking chills without fever, nausea.  Significant shot site reaction with erythema and tenderness.
Employee experienced dizziness, weakness, almost fainted very soon after receiving the vaccine. Employee felt fine the next day.
01/13:BODY ACHES, HEADACHE,FATIGUE, 01/14: FEVER AND CHILLS,  01/15: HIGH BLOOD PRESSURE,NAUSEA 01/16: HEADACHE AND MINDGRAINE
3PM on 10/22/13 pt. received HD flu shot. Within 2 hrs, she felt as though she had a lump in her throat and had diff. swallowing. At 6PM, she continued w/ lump in throat and chilling. At 8PM her hands and face were red and itched. At 815 took a shower and had hives over body. To hosp.
Infant screaming in tantrums which would last 15minutes to one hour off an on.  Flailing arms, legs, shaking head.  Diarhea, vomiting, no fever.  Initial symptoms were on and off for 48 hours.  Additionally infant is now unable to sleep through the night, as well as will no longer take milk.
Fainted, seizure (10 seconds), red stripe from palm to elbow joint on the anterior left forearm. (same side as immunization was administered.) EMT called and did an assessment. She declined further assessment at the ER. Instructed to go to ER if any symptoms reoccur and to follow up with an appointment with her primary care physician. Observed for 15 minutes upon recovery and instructed to continue on light duty with continued observation by coworker.
vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant medication were reported no treatment medication were reported   This case was linked to MOD-2021-395985 (Patient Link).
Generalized seizures leading status epilepticus requiring intubation and pediatric intensive care. MRI and eeg normal, started on Keppra. Since then has had two episodes of seizures with fevers requiring intubation again with picu care.
severe vertigo with sudden head movements, ei: lying down, standing up, turning side to side, these will make me loose balance, everything spinning, for 10 to 20 seconds.  severity differs,  but this has been a consistent ongoing event from march 10th 2021 upon awaking in that morning and still to this day. loosing my balance often, its like my equilibrium is off or affected in some way..
She only got the HIB shot because she's had bad reactions in the past. She broke out in hives on her face. Had a bad rash severe eczema and swelling of the injection site. I gave her BENADRYL for the next 24 hours and the hives and rash went away. Still has bad eczema. We are not giving any more vaccine until we see an allergist.
About 3-4 days after the shot I was walking in food city and my left foot felt like it was asleep like it wouldn?t wake up later that day it kept getting stiffer and stiffer and eventually went all the way up the whole left side of my body went kind of numb it  The next day I woke up it was completely stiff hard to walk so I went to my doctor he thought it was something to do with the spinal cord I told him it could possibly be from the shot I thought maybe went through many thousands of dollars of tests they tested me for MRIs I?ll kinds of stuff they have yet to find anything wrong with me I?ve been in and out of the doctors I still have left sided numbness at times left side of my head feels numb left chest left but area and all way down to my toes At this point after going to the neurologist only thing they?re all just could find was I was low on vitamin B 12 I have started injections on vitamin B 12 I still have no notice no change
Whole body muscle pain, lymph node swelling and pain, chest pain, difficulty breathing,  difficulty sleeping, headache, light sensitivity
Information has been received from a pharmacist concerning an approximately 74 year old female who on 06-MAY-2009 was vaccinated with ZOSTAVAX (Merck). The patient had a "red spot" at the injection site where ZOSTAVAX (Merck) was given. The patient sought medical attention by contacting the pharmacist and was not recovered. Additional information has been requested.
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient. A 61 year-old male patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 2, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, sometime in April), administration date: Apr2021, for Covid-19 Immunization, reaction(s): "sore arm". The following information was reported: FEELING ABNORMAL (non-serious) with onset 2021, outcome "recovered" (2021), described as "brain fog". Additional information: Reporter stated he had a "sore arm" after first shot, received "sometime in April". Reporter stated that he had second shot at recommended interval on a Thursday and Friday "within a day" he had "brain fog", "didn't feel quite myself" "couldn't concentrate very much" and this resolved approximately on Sunday. Reporter queried for if booster shot was the same as primary series. In response to the query it was provided that Yes. COVID-19 booster shots are the same formulation as the current COVID-19 vaccines. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Swollen lymph nodes under arm and collar bone. Appendicitis resulting in appendectomy
gradual onset of paresthesias beginning exactly 14 days after vaccine administration.  patient was then admitted to hospital on 5/22 when symptoms worsened and he was ultimately diagnosed with Guilliam Barre Syndrome.
pt came in reporting that she had to go to the ER after receiving her 2nd shingrix. She stated that she had chills, nausea, weakness, pain all over the body, and fatigue. While at the ER, they informed her that she was dehydrated and had drug toxicity. She was treated with fluids at the hospital and is feeling better now.
having a horrible rash all over my body; Very itchy; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Mar2021 at 03:30 (at the age of 50-year-old) as a single dose for COVID-19 immunisation.  The patient did not have any relevant medical history. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications within 2 weeks of vaccination (didn't take any medications before 1 dose reported by patient). The patient did not receive any other vaccines within four weeks  prior to the vaccination. On 11Mar2021 the patient experienced having a horrible rash all over her body and very itchy. The event resulted in doctor or other healthcare professional office/clinic visit. On 24Mar2021, the patient underwent Nasal Swab, SARS CoV-2 test  and the result was Negative. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the event having a horrible rash all over her body, very itchy were not resolved at the time of the report.  The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Apr2021 at 03:45 (at the age of 50-year-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Redness, swelling, subcutaneous fluid at injection site. Still present after over a week. One week after administration onset of pain in armpit. Practicioner prescribed treatment with antibiotics for 5 days because of a likely cellulitis.
Seriousness criteria other medically significant (OMIC). Initial report received on 10/17/06 from a family member of the pt who is also a health care professional. A 40 year old female pt, with a past medical history of asthma and dust and pollen allergies, had received a left deltoid injection of Fluzone SV 2006-2007 lot number unk, on either 10/9/06 or 10/10/06. Fifteen minutes post vaccination, the pt experienced wheezing, and itchy throat, cough, nasal congestion and chest tickle. The event required a physician examination. She was treated with a Zopinex inhaler, and the symptoms resolved after 45 minutes. The pt had experienced the same symptoms following an cortisone injection two weeks prior to these events. Relevant diagnostic testing included an IgE of 630 and neg testing for egg and chicken allergies. The pt recovered from the event.
Treatment of COVID-19; Treatment of COVID-19; Dose Number 1 and Dose Number 2: MODERNA; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 70 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 23Oct2021 as dose 3 (booster), single (Lot number: 320308D), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 10Feb2021 as dose 1, single (Lot number: 031M20A), in left arm, on 10Mar2021 as dose 2, single (Lot number: 003A21A), in left arm and on 02May2022 as dose 4 (booster), single (Lot number: 045L21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 Diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Byetta, reaction(s): "known allergies: Byetta". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Oct2021, outcome "not recovered", described as "Dose Number 1 and Dose Number 2: MODERNA"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19, treatment: Paxlovid.
Exhaustion, extreme tiredness. Very sore arm.   Currently 25 weeks pregnant, first pregnancy, est due date aug 9 2021.
Vaccine leaked out while administering the shot; Vaccine leaked out while administering the shot; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (Vaccine leaked out while administering the shot) and DEVICE CONNECTION ISSUE (Vaccine leaked out while administering the shot) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced UNDERDOSE (Vaccine leaked out while administering the shot) and DEVICE CONNECTION ISSUE (Vaccine leaked out while administering the shot). On 11-Mar-2021, UNDERDOSE (Vaccine leaked out while administering the shot) and DEVICE CONNECTION ISSUE (Vaccine leaked out while administering the shot) outcome was unknown. Not Provided
Administered a dose of Moderna vaccine from a vial that had been punctured the previous day; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered a dose of Moderna vaccine from a vial that had been punctured the previous day) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered a dose of Moderna vaccine from a vial that had been punctured the previous day). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered a dose of Moderna vaccine from a vial that had been punctured the previous day) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment information was not provided.  The reporter was an immunization coordinator at the facility.
Left arm pain began on Thurs. 1/7/21, approximately 30 minutes after vaccine.  Severe headache and pain radiating to left side of neck began approximately 22 hours after vaccine (around 2pm on 1/8/21) and left arm pain worsened.  On 1/9/21, unable to get out of bed-felt like I had been drugged- severe HA, fatigue, and left side of neck soreness.  Felt slightly better on 1/10/21 and 1/11/21, however stil unable to get out of bed due to severe HA and fatigue.  On morning of 1/12/21, fatigue relieved and severe HA relieved around 1pm.  Since 1/12/21, Severe HA, left arm tightness and left neck soreness has continued intermittently.  This is a HA I have never experienced before.  Yesterday, on 1/21/21, I had a severe HA all day at work and when I went home, I had to lie down the rest of the day/evening d/t severe HA, fatigue and left neck tightness.  I was unable to do daily chores and help my children with their homework.  I also woke up this morning with the same severe HA and left neck soreness/tightness.  I do feel this HA is from the vaccine as I have never experienced this type of HA prior to receiving the vaccine and I am not someone who gets HA's often.    I know the vaccine was given too high, as I give vaccines often for my career, and I am wondering if that has anything to do with my neck pain.  I did bleed a lot with the injection (do not think it went into my muscle) and am wondering if that has anything to do with my adverse reaction.  I am fearful these severe HA's will continue and I am extremely hesitant to receive my second dose!
PT ARRIVED IN OBSERVATION AREA, AND STATED THAT SHE FELT TINGLING AROUND HER LIPS.  VS WERE INITIATED. 3:52PM HR 90 BP 126/64 O2 96%.  MONITIORED VS EVERY TEN MINUTES. PT WAS ADMINESTERED 25 MG OF DIPHEHYDRAMINE 0.5 ML AT 4:05PM. AT 4:30 PT STATED THAT THEY STILL FELT TINGLING. ANOTHER DOSE OF 25MG OF DIPHENHYDRAMINE WAS ADMINESTERED. MONITORED PATIENT FOR AN ADDITIONAL  30 MINUTES. PT WAS ESCORTED BY SPOUSE STABLE.
Inflamation in skin, hives, swelling of extremidies; took 2nd dose (1/25/2021, Pfizer, EN5318, IM, LA) Worsening of Psorisis (covering entire body) Extreme pain, discomfort, itching, restlessness, Tingling all over body, numbness in arms and hands, sometimes in feet. Heart palpatations, intermitted hypertension
Moderna COVID-19 Vaccine EUA Eleven minutes after receiving the vaccine, my tongue became very swollen and tingly. My throat also started to tingle. I walked up to the pharmacist and advised her of the potential allergic reaction and asked for Benadryl. I was given liquid Benadryl to drink. Within about 30-45 minutes after taking the Benadryl, the swelling was going down rapidly.
achy arm; This is a spontaneous report from a Pfizer- sponsored program. A contactable  female consumer reported for herself via telephonic activity that includes: A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6205), dose 1 via an unspecified route of administration on 04Mar2021 as 1ST DOSE, SINGLE DOSE, dose 2 via an unspecified route of administration on 23Mar2021 (Batch/Lot Number: ER8730) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that patient had both doses of the Pfizer vaccine 3 months ago and got a (Name) email and she don't know why she got it. It was reported that she had a side effect of a little ache here and there, nothing major and that she has not called us. It was reported that Caller states the real reason she called is 1, she worked for 50 years in IT and the Pfizer logo is different and she though it was a phishing email kind of thing and she don't know if this is a legal email. It was reported that she didn't complain about her Pfizer shot. She had concerned about that email. It was reported that she had an achy arm like you would with a flu shot. It was reported that Caller is asking if making a report about her achy arm is important, she states it was no big deal and she was expecting that at the least. Caller declines to make a report. The outcome of event was unknown.
Pre-menstrual symptoms; Belly cramping; This spontaneous case was reported by a consumer and describes the occurrence of PREMENSTRUAL SYNDROME (Pre-menstrual symptoms) and ABDOMINAL PAIN (Belly cramping) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PREMENSTRUAL SYNDROME (Pre-menstrual symptoms) and ABDOMINAL PAIN (Belly cramping). At the time of the report, PREMENSTRUAL SYNDROME (Pre-menstrual symptoms) and ABDOMINAL PAIN (Belly cramping) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-173201, MOD-2021-041184, MOD-2021-082803 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Reporter email was updated.
Ten days after vaccine had severe abdominal cramps; diarrhea and rectal bleeding. Subsided after 4 hours. This reaction happened after the 4th booster as well.
6 months later - I was diagnosed with Type 1 diabetes. My blood sugar was over 300, and my A1C was a 10.7.
Patient received Pfizer COVID vaccine on 4/27/21 and 5/18/21. On 2/23/22, patient admitted to our inpatient facility (med/surg unit) with acute respiratory failure with hypoxia due to COVID-19 pneumonia, and rectal bleeding (secondary to rectal cancer). Patient discharged home on 2/25/22.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information about concurrent conditions, concomitant medication and medical history was not provided. The nurse reported that the patient was administered doses of GARDASIL (injection, intramuscular, 0.5 ml, lot# and expiry date were not provided) outside of the recommended schedule in the prescribing information on 16-APR-2014, 26-AUG-2014 and 07-NOV-2014. No adverse event was reported. Additional information has been requested.
Client states he woke up feeling hot. He ate breakfast then lay on the couch in the living room watching TV. He then got up, walked to the table and back to the couch. Per his wife he collapsed onto the couch and had snoring respirations for about 15 minutes. She was unable to arouse him. She did not call 911. Client states he felt disoriented, confused, and sweaty for about 30 minutes after regaining consciousness. He has felt well since then. No further episodes or symptoms.
pt recvd vax 15SEP95 & 3 days prior to LMP 18SEP95;pt became pregnant;@ gestation week 13, exam failed to reveal a fetal heart tone;ultrasound exam revealed a 6.2 wk fetus w/o a pulse;pt had a spontaneous miscarriage
Covid symptoms, sore throat, runny nose, congestion, shortness of breath, coughing, worsening asthma symptoms 7 days after the shot, ongoing Oral Prednisone Albuterol Rescue Inhaler