chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects reported; from 2/14/2020 after closing to 2/17/2020 during the day the data logger malfunctioned; temperature could not be provided, a potential adverse event was recorded; On 2/17/2020, one male patient was administered VARIVAX and M-M-R II; This spontaneous report was received from a medical assistant referring to a 12 month old male patient. Information about patient's concurrent condition, medical history, drug allergy/reaction was not reported.   It was reported that from 14-FEB-2020 to 17-FEB-2020, the data logger was malfunctioned (product storage error). Since the temperature could not be provided, a potential adverse event was recorded (circumstance or information capable of leading to medication error). On 17-FEB-2020, the patient was inadvertently vaccinated (before the discovery of the data logger malfunction) with varicella virus vaccine live (oka/merck)(VARIVAX) lot # S024364, expiry date: 06-AUG-2021 for prophylaxis (strength, dose, dose number, route was not reported) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) recombinant Human albumin (rHA) lot # S015284, expiry date: 19-MAY-2021 for prophylaxis (strength, dose, dose number, route was not reported) (inappropriate schedule of product administration). Both the vaccines were reconstituted with properly stored sterile diluent, lot # S025291, expiry date: 23-APR-2022. Temperature was not reported and the time frame was reported as 42 hours and 50 minutes. There was no previous temperature excursion. The call was because of a data logger. No additional adverse effects were reported. No product quality complaint was involved.
I20.9 ANGINA, UNSPECIFIED 3/24/2023 ANGINA, UNSPECIFIED
Information has been received from a health professional concerning a female who was vaccinated with the first dose of Gardasil. Subsequently the patient experienced pain when receiving the vaccine and subsequent doses were given in the buttocks. Medical attention was sought. The patient's outcome is unknown. No product quality complaint was involved. Additional information has been requested. 03/25/2010 The patient's date of last menstrual period was 25-APR-2007. Subsequently, the patient developed blood clots and was hospitalized. Medical attention was sought. The representative reported that the nubmer of doses administered were unknown, the number of days the patient was hospitalized was unknown and the details for the patient's pregnancy was unknown. Follow-up information was received from the nurse practioner. The patient was administerd GARDASIL on 18-MAY-2007. The patient was scheduled to be induced on 09-FEB-2008 since she was past her due date which was 30-JAN-2008. The details regarding the intervention for the blood clot in the hospital was unknwon.  Follow up information was received from the physician's office via phone. THe patient's name was updated. On 8-FEB-2008, the patient went into the hospital with contractions. The patient failed to progression and then the patient was induced. The patient delivered "as far as they know a healthy boy". The baby weighed 7 pounds 10 ounces. Follow-up information was received via pregnancy forms. On27-JUN-2007 and 31-AUG-2007 ultrasounds were performed for dating of the pregnancy. During the pregnancy the patient had deep vein thrombosis in the left leg and a urinary tract infection. On 10-JUN-2007 the patient was given nitrofurantoin (MACROBID) 100mg BID for 7 days for UTI, enoxaparin sodim (LOVENOX)1.5 mg on 30-NOV-2007 and heparin was given subcutaneously on 15-JAN-2008. The patient gave birth on 08-FEB-2008 41 weeks from LMP. Additional information is not expected.
Temperature Excursion Heplisav-B Administered to 15 Patients; Initial Report Received on 14-Sep-2021 and 15-Sep-2021  A Registered Medical Assistant reported that approximately 15 patients (age, gender, race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization after the vaccine was out of temperature range with multiple excursions over a maximum of 10 days.  This report is for patient 15 of 15.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date, the patient 15 of 15 received a dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) after the vaccine was out of temperature range with multiple excursions over a maximum of 10 days. The route and site of vaccine administration were not reported.   No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Moderna COVID-19 Vaccine EUA- fever, chills, sweats, headache, nausea, pain in arm
I caught a cold from my grandson on Feb. 22, 2022 and it developed into pneumonia 3/8/22. I spent one night in the hospital on oxygen with a breathing treatment, steroids and antibiotics. It had nothing to do with the vaccine.
BOOSTER DOSE WAS ADMINISTERED 4 1/2 MONTHS  TOO EARLY. 1ST DOSE WAS ADMINISTERD 09/21/21 2ND DOSE WAS ADMINISTERED ON 10/19/21.
This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unknown dates, the patients were administered improperly stored doses of ROTATEQ orally, lot # L028645 with expiration date 25-MAY-2017 and lot # L033693 with expiration date 31-MAY-2017 (dose not reported). The vaccine underwent a temperature excursion of 0.5 degrees Celsius for 2 hours. Digital Data Logger was involved. There was no pervious temperature excursions. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. In March 2017, the patient was vaccinated with the improperly stored dose of VARIVAX (dose, route and anatomical location were not reported) (lot # M038225 and expiration date 07-SEP-2018) for prophylaxis. Additionally, a propped stored sterile diluent (manufacturer unknown) (lot # and expiration date were not reported) was used to reconstitute the vaccine. There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion between 6 to 14 degrees Fahrenheit for 480 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA004456: US-009507513-1704USA004454: US-009507513-1704USA004455: US-009507513-1704USA004452: US-009507513-1703USA013275.
According to mother they had taken the child to the ER due to arm being red, hot and swollen.  Mom stated the ER physician said it was infected. Requested that mom bring child into the health department for us to see the injection site.  She said she would but did not.
Patient received both vaccines, spikevax and fluzone HD in the same arm (left arm) on Saturday, November 4th. The following day, Sunday, 11/5/23, she started to experience redness, pain at the injection site, and has been worsening since then. She stopped into the pharmacy today to have me look at it, and her upper left arm is swollen, red, painful and warm to the touch. She didn't report having a fever or any other symptoms, but I recommended her to be seen by a doctor today in case it's turning into an infection which would need antibiotics. She did go to express care today and was prescribed cephalexin.
Rt arm inject site was unremarkable until 24NOV91 when became warm to touch & rosey red; On 27NOV91 erythema 37mmx 20mm w/whitish area in ctr about 12mm; induration was 20mm, sore & warm to touch; t100 R;
Pt received Pneumovax 23 injection on 08/04/04 and reported to emergency dept on 08/08/04 reporting redness and peeling associated with the minimal swelling. Involves most of his cheeks and forehead. No difficulty swallowing, seeing, breathing, eating, He states that he has had a reaction to a vaccine in the past.
Respiration problems, dizziness, near fainting, rapid heart beat, broke out in rash all immediately. Now: MS, Graves Disease, Fibromyalgia, daily migraines, possibly Lupus.  4/8/09 Employee heath records received. Pt received Varivax (Lot # 1177U) on 6/23/08.  Returned on 6/26/08 with c/o rash-fluid filled vesicles. Had earlier exposure to pt with shingles on 6/9/08. VZV PCR  (-) for both wild type  vaccine type VZV. Assess:  Rash of unknown etiology.  Referred to derm.  6/3/09 Letter from pt stating she does not wish to release any records.  Case in litigation. Follow-up: Since vaccination, pt's condition has continued to decline. After vaccination she was hospitalized approx. 15 times, inpatient. She has since been diagnosed w/ MS, Graves Disease, and Fibromyalgia. She has had multiple surgeries for joint-tendon thickening problems such as Carpal Tunnel and "trigger fingers." She had to have her thyroid stopped w/ radiation due to the Graves. She takes 17 medicines daily and is on methadone for body pain along w/ LYRICA, TOPAMAX, and CYMBALTA for neuropathies. She cannot drive, handle personal affairs, and had to quit nursing school and work. She is now on Social Security Disability and is virtually bed ridden 4-5 days per week. Pt is lucky to be up and "moving 4-5 hrs. on one of her good days. Her neurologists and several other specialists attribute the onset of her problems to be directly attributable to the vaccination 6/23/08. She will never recover to the level she was prior vaccination. The contradictions should be much stronger for patients who have to get it!
pt was given 1st dose of Pfizer covid 19 vaccine at apporx. 1525hrs on 4/6/21. Approx 5 minutes later the pt starting having a rash that was visible on her chest and was complaining of itching globally.  Pt reported no previous allergic reaction to a vaccine in the past. Pt was given an Epipen 0.3mg in the left thigh. Symptoms began to improve and pt was transported to the local hospital via local Emergency Services for further evaluation
pt recvd vax JAN93 & in APR93 lab eval showed a neg titer for mumps; No further details were provided;
Patient reported spotty rash on chest, back, stomach, genitals. No fever, pain, or itchiness. No other symptoms besides rash. MD prescribed OTC cortisone and BENADRYL. Still red at this time but has improved.
seen 21OCT94 cries & holds hand & lt foot w/pain beginning 14OCT94; seemed more clumsy & fell more 19-20-21OCT; c/o pain 3-4 days; pt irritable;
subjective fever, chills, myalgias, arthralgias, mild nausea, diarrhea;
On the evening of 12/16/2021, when I hopped into bed, I started having an insane itching spell on my scalp and the back of my neck/hairline. I was really confused because I had never experienced anything like that before. I was able to fall asleep, but when I woke up, the hives continued. I took a shower shortly after waking, thinking that maybe something in the bed had caused the irritation, but I was still itching after the shower. My ENTIRE body was covered in hives...hives absolutely everywhere. I have an autoimmune disorder (mixed connective tissue disease), so I called my rheumatologist begging for Prednisone, thinking that the problem was possibly related to my disease. My whole left forearm, wrists, and ankles were red hot and swollen. The 5mg Prednisone 3x/day did absolutely nothing for me, and I ended up in urgent care on 12/19. The doctor there prescribed 20mg Prednisone, to take qty 3 per day (60mg total, in the morning), as well as hydroxyzine to take as needed. At the time, I didn't have any trouble breathing, but I did have a persistent feeling of a pill being caught in my throat. (That sensation lasted a couple of days.) Since the 60mg of Prednisone and hydroxyzine didn't provide relief, the following day, I ended up at my rheumatologist's office for a steroid injection and bloodwork. My bloodwork showed elevated inflammatory markers. I was able to get into my dermatologist on 12/23, and he said he couldn't complete a biopsy of my skin while I was on Prednisone. I have follow-up appointments with my rheumatologist and dermatologist.  A few days after developing the hives, I noticed I was having trouble breathing. The wheezing starts in the early evening and continues on/off through the night. There have been nights and mornings that I have woken up gasping for air. When I told my rheumatologist about my breathing issues, she told me to contact my primary care doctor. When I tried to schedule an appointment with my primary, a nurse got on the line and told me to rush to the emergency room. I listened and did just that, only to be given an inhaler and more steroids...neither of which have proven to be extraordinarily beneficial. Hives appear all day, every single day. Sometimes the hives itch, and sometimes they don't. However, I have not gone one whole day without at least some intense itching/flare-ups. Often times, I can feel something of a "heat wave" come over my face, and I look in the mirror to see my face inflamed and marked up. My eyelids swell, my lips swell. My ears get hot. This morning, I took the last 5mg Prednisone my dermatologist prescribed to help me taper off the 20mg pills, and I am having an intense flare up right now. Last week, I started taking 5,000 IU Vitamin D, Vitamin C, and Magnesium/Calcium/Zinc tablets each morning, in case of any possible deficiencies. I saw my primary care doctor today, who prescribed Tagamet (at my request), but my pharmacy is out of stock. I will hopefully have the prescription filled tomorrow. My primary care doctor said I am not his first patient to develop hives after the vaccine.
Mild fever, intense body aches/pain, soreness at the injection site, unable to sleep
Information was received from a nurse referring to a currently 18 years old male patient of unknown age. The patient had no medical history, concurrent condition and no known drug allergy. On unspecified dates in 1998, the patient received 3 doses series of RECOMBIVAX HB (lot #, expiration date, frequency and route unknown). On an unknown date, titers were drawn for college admittance and were negative. No treatment was given to the patient. The patient had sought for medical attention via coming to the office. The outcome of the event was unknown. The causality was not reported. Additional information is not expected as no contact information was provided.
Hives, redness, swelling, warm area of skin below injection site and on other parts of body (non injection arm, leg).
Information was received from a physician via a company representative referring to a male patient of unknown age. The patient's medical history, concurrent condition and concomitant therapy were unknown. On an unknown date, the patient was administered with a dose of PNEUMOVAX 23 (lot#, expired date, dose and route unknown). On an unknown date, the patient experienced acute renal failure and disseminated intravascular coagulation. Then the patient was admitted into the hospital due to the events. It was unknown if the patient received the treatment. The outcome of the events was unknown. The causality assessment between the events and PNEUMOVAX 23 was not reported. The reporter considered the events to be life-threatening. Upon internal review, acute renal failure and disseminated intravascular coagulation were determined to be medically significant events. Additional information has been requested.
Patient was given PENTACEL vaccine, diluent was not mixed with powder. Patient received only the diluent (DTaP/IPV)component.
One day post vax, pt developed an injection site reaction characterized by redness, swelling, warmth and induration.
Patient presented to the emergency department 12/29/20 7 AM, reporting hyperglycemia since receiving COVID vaccine one day earlier.  Had been 140 at time of immunization.   Highest reported was "high 300's". At time of presentation glucose 360 and accompanied by nausea, shakes and sweating.  Also reporting fatigue.  Patient reporting having felt like this when she is in DKA
5AUG96 recv vax;16AUG96 noticed wart like things on hands w/blisters spread to arms, abd, groin, legs;19AUG96tried calamine lotion, children's allergy elixir;21AUG96 to MD given med;23AUG96 to ER dx severe allergy rxn med given;
Information has been received from a registered nurse referring to an 8 week old patient of unknown gender. On 06-JUL-2015 the patient was vaccinated with ROTATEQ (oral, lot # K017573, expiration date and dose were unknown) which excursed the storage temperature. No reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
pt fainted , heavy breathing , semi unresponsive .. Epi pen administered EMS called . Pt came to shortly after epi pen administration .. She told us after vaccine administration she has experienced Syncope in the past post vaccine admin
Patient says hand is swelling slightly, told him to watch it since it didn't look red and the injection site looked fine. Patient said he felt fine but there was slight swelling
Around May 2021, I noticed swelling around my anklse and feet.   It did not matter if I was sitting or standing, they were alway swollen and it never away.  I went to the doctor and the doctor prescribed a diuretic.  The medication did not help with decreasing the swelling.  I was also instructed to also elevated my feet. None of this help.  The doctor got concerned and sent me for ultrasound in my leg to rule out blood cot.  I was also sent for echocardiogram which was normal.   My medication diuretic did get increased and that did seem to help. The doctor is going to send me to a vascular specialist.
Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 07-Jun-2022; No adverse event; Dose administered after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date), PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 07-Jun-2022) and NO ADVERSE EVENT (No adverse event) in a 77-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 003K21-2A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: COVID-19 Vaccine (Dose: 1, lot number: EN6203, route: intramuscular, body site: left arm, Dose: 0.3 ML.) on 26-Feb-2021, COVID-19 Vaccine (Dose: 2, lot number: ER8727, route: intramuscular, body site: left arm, Dose: 0.3 ML.) on 19-Mar-2021, COVID-19 Vaccine (Dose: 3, lot number: 32030BD, route: intramuscular, body site: left arm and Dose: 0.3 ML.) on 25-Oct-2021. Past adverse reactions to the above products included No adverse event with COVID-19 Vaccine, COVID-19 Vaccine and COVID-19 Vaccine.    On 07-Jun-2022 at 3:16 PM, the patient received fourth dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .25 milliliter. On 07-Jun-2022 at 3:16 PM,  after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 07-Jun-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date), PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 07-Jun-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related and EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date) to have an unknown relationship. No further causality assessment was provided for PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 07-Jun-2022).    No concomitant medication was reported.  It was reported that, expired vaccine was administered to the patient; the health care professional thought that Moderna had an extension like Pfizer and assumed vaccines would expire on the 13-Jul-2022 but it was expired on the 13-May-2022, they realized this on the 08-Jun-2022.  The used vials were placed refrigerator on the same day of administration (07-Jun-2022) and vials did not undergo any temperature excursion.  Event did not cause the patient to seek medical care.  It was unknown if there were any other potential causes or patient experience similar events in the past.  No treatment medication was reported.
About a month after my vaccine, I was in pre-menopause, my periods were slowing down and I did not have it very often, after the vaccine my periods became very heavy, they were becoming more frequently and they were so heavy that I was not able to leave the house. There was not a pad or tampon that could control it. I have a history of heavy periods that were always on schedule and the same every month, they were not so heavy that I had issues controlling them. I was tired all the time, I was hardly able to stand up as I was so fatigued. I ended up having to have two iron infusions because I bled so much. I ended up having to have a Hysterectomy on 03/28/2022. They took my uterus, cervix and fallopian tubes, I was able to keep my ovaries. We tried birth control to control the bleeding and that did not work. So the surgery was the solution.
My daughter received the Pfizer Bivalent booster on 9/17/2022. On the evening of 9/20/2022, I noticed that she had hives above the waist and on the chest, back, and neck. She also seemed to have a hive around her groin area. I called an urgent care clinic to inquire about the condition of her skin, as I didn't know what the welts were exactly. After I described the condition of my daughter's skin, I was advised that she had hives, and they told me that hives are normally caused by a virus. The only recent change I could think of that may have triggered it was the booster shot. I set up an appointment at the urgent care clinic for 9/23/2022. When we went to the urgent care clinic, they took her blood pressure, listened to her heart and lungs, and examined her back and chest. Aside from the hives, everything was normal.  They suggested that she could take OTC medicines like Benadryl or chlorpheniramine. She has been taking one chlorpheniramine pill every 6 hours. Since taking it, my daughter says that she doesn't itch as much now as she did before.