chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired vaccine administered beyond 12 hours expiration for punctured vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours expiration for punctured vial) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Sep-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 06-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours expiration for punctured vial). On 06-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours expiration for punctured vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date the vial was initially stored in the refrigerator was 31-Aug-2021. Date first punctured: 05-Sep-2021 at 11AM Kept in Refrigerator Date of administration of vaccine when applicable: 06-Sep-2021 4:30PM Room Temperature on 06-Sep-2021 then discarded the vial. The vial did not undergo any previous temperature excursions. Total amount of time the vial was exposed to room temperature range (46° to 77° F): From 06-Sep-2021 9:00AM and discarded vial after 4:30PM.   This case was linked to MOD-2021-311383 (Patient Link).
Adverse event: Flu Shot Symptoms: Chills, Fever, Aches, Sore Throat.  Time Course: Friday 9/28 4:00 PM - Sunday 9/30 6:00PM Treatment: Home treatment: Advil, NyQuil
(Left) Arm/muscle pain at site of injection of PPSV23. Eventual red, splotchy skin rash near site of injection that eventually subsided.  Continued muscle pain in left arm to date (1/9/2015) with some restricted movement that was not present before injection of this vaccine.
Presented on 2/24 with shortness of breath. Admitted to ICU due to hypoxemic respiratory failure and hypotension requiring vasopressor support.  Diagnosed with COVID-19 pneumonia on 3/4, unclear if present on admission. Required diuresis due to CHF exacerbation with removal of over 5L of fluid. Weaned off vasopressors but had to stop diursis due to persistent hypotension. Renal fucntion continued to worsen. Started on enoxaparin but developed rectal bleeding and epistaxis and stopped. Completed antibioitc therapy but restard on 3/11 due to worseming condition. Famiy continued wanting full support. Broadened to antifungal therapy in addition to borad-spectrum antibiotics and steroid therapy. Patient suddenly stopped breathing on 3/16 and expired.
On 4/17/2000, the vaccinee received her 3rd dose (right arm) of Engerix-B and 2 days later, on 4/19/200, she experienced a bruise on the right forearm. She experienced pain and swelling to the right forearm post vax. She denied local trauma and on 4/20/00, was referred to the local ER. There, the pt was prescribed Vicodin, warm compresses, and a sling. Aspirin was not prescribed. Medical leave records note that the pt had right forearm thrombophlebitis extending up the right arm. Reporter stated that she received a release for the vaccinee to return to work on full duty, 7/7/00. She added that no further issues/complications have been reported. The most recent information, received on 8/15/00, reports the condition of the vaccinee is resolved.
PATIENT RECEIVED 2 MODERNA COVID VACCINES ONE ON 1/15/21 AND ONE 2/15/21.  PATIENT ADMITTED TO OUR HOSPITAL ON 9/21/21 FOR FATIGUE, NOT FEELING WELL, BODY ACHES, AND DIZZINESS ON 9/20.  THIS IS A BREAKTHROUGH VACCINE CASE
Consistent pain in left deltoid/shoulder joint since 2 hours after injection.  Injection was given correctly in deltoid muscle, proper depth, proper needle.  In the first 30 days pain would come and go but after one month it became constant.  I went to physical therapy and had dry needling of the deltoid muscle and muscles surrounding the shoulder with no relief.  In April I went to a chiropractor and after treatment I was finally able to lift my arm while holding weight.  It did improve after that but there is still constant pain in the joint and deltoid muscle.  Also starting in March one month after the vaccine I noticed pain in other joints that would come and go.  My great toe joint was swollen and red for 4 days and I couldn't walk on it (I have never had gout or arthritis).  I have had pain in other joints that greatly affect my walking or ability to do things but then it is gone the next morning including my hip, elbow, finger, thumb.  I randomly have muscle/tendon pain like shin splints or low back strain that will also affect my ability to do certain activities but then will be gone when I wake up the next morning.  I have never had pain like this before, it is very random and difficult to describe.
second dose of ROTATEQ was administered to the 14 month old patient as a make up dose; This spontaneous report as received from a certified medical assistant refers to a 14 month old patient of unknown gender. On 22-JUN-2021, the patient was vaccinated with a second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1742460 exp date 16-NOV-2021) orally.
Client received adult dose (0.3ml) of Pfizer vaccine at 3:55 PM. He is only 11 years old, 8 months. He should have received a 0.2 ml Pfizer dose for that age. The mom and client both told the vaccinator he was 12 years old. The client did not experience any adverse symptoms. T3 Lead was notified right away and said per CDC guidelines there is a 5 month grace period for that age. He was observed for 30 minutes by medical staff after the vaccine injection and left with a steady gait and no adverse symptoms.
Patient has experienced severe headaches since her injection on 4/9/21. She was treated by her primary care provider.
I had had a bad headache, Then I got shingles, then the following day, i had a rash, It stared on my forehead then it went in my eye. I went to the ER, the ER doctor & was prescribed Valacyclovir I was told that if it gets worse to seek medical emergency. I went to see my ophthalmologist & I was prescribes medicated eye drops.
I was injected with pneumavara 23 on Sunday, July 26, 2020. I experienced the typical systems of a vaccine injection, swelling, heat, aches and took 1 Aleve OTC on Monday , July 27, 2020.  Wednesday, July 29, 2020 I noticed a yellow streak  about 4-5 inches below the  injection and about 7-8 long. It looked like a bruise that was healing but I had not banged my arm at all.
This spontaneous report as received from a nurse refers to a 21 years old female patient. The patient's medical history and concurrent conditions were not reported. On an unknown date in 2005 (when she was 10 years old), the patent was vaccinated with GARDASIL, (route: intramuscular). The patient came to the hospital on 17-OCT-2016, to receive additional dose of GARDASIL 9 to complete the series. No adverse effects reported. The outcome of the events was unknown. Additional information has been requested.
Started with heart palpitations. Wore halter monitor. Diagnosed with PVC's. Then swelling and water retention and a much elevated blood pressure. I am not having to take Metoprolol and Trianterene/HCTZ daily
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB injection, lot # M010439, expiration date 08-DEC-2018, lot # N003698, expiration date 31-OCT-2018 (dose, route and site of administration were not reported) for prophylaxis. No adverse effects were reported. The administered doses of PEDVAXHIB were stored in the temperature between 9 degrees Celsius and 25 degrees Celsius for 9 hours and 5 minutes. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA006295: US-009507513-1707USA006294: US-009507513-1707USA006296: US-009507513-1707USA002309.
Child presents with pain in upper right arm.  Outer aspect of upper arm is noted to be red, raised, increased temp hard & 35 mm x 25 mm blistered weaping area noted in center of site.
J96.00 ACUTE RESPIRATORY FAILURE 8/6/2022 SMALL BOWEL OBSTRUCTION J96.00 ACUTE RESPIRATORY FAILURE 8/6/2022 SMALL BOWEL OBSTRUCTION J96.00 ACUTE RESPIRATORY FAILURE 8/6/2022 HYPOTHYROIDISM
This was the clients first injection with GARDASIL 9 as she received GARDASIL-11/07/2012 as her first one (lot # H011350 in Right Deltoid IM thru Family Medicine) this was the first injection received at out clinic. She called the MD on call @ 1935 and reported she "felt like she was having a reaction, reported hives from her Right eye down to her collar bone and reported chills and sweating, feeling slightly SOB. Reported she sent spouse to go get BENADRYL" which she reported she took it. The MD on call encouraged her to go directly to the ER. Patient reported she did not go and felt better after the BENADRYL. I call her 12/13/18 and she reported this to me. I inquired if she remembered having any problems after the first HPV in 2012 and stated "she did not recall any as she was 18 @ the time I received it" I encouraged patient to continue to take BENADRYL or ALLEGRA, CLARITIN as the do not make you drowsy. She is also on ZYRTEC daily. Pt denies any SOB or difficulty swallowing at this time. She feels better. Encouraged to Push PO fluids to help flush this through system. I also informed her that I would advise against getting the last HPV in light of what has happened with the 2nd injection. I informed her I would speak with MD concerning this as well as reporting the adverse reaction to the Vaccine reaction Reporting line. I encouraged her to come in and be seen or if any further problems outside of office hours to go directly to nearest ER. Doctor is in agreement with the above and also not to get the 3rd dose of the HPV vaccine.
Swelling of face and feet; swelling of face and feet; headache; Left arm where shot was administered was hot to the touch.; This is a spontaneous report from a contactable other Health Care Professional (patient). A 50 years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: En6205 and expiry date was not provided) via unspecified route of administration in the left arm on 05Mar2021 at 02:15 PM as a single dose for COVID-19 immunisation (age at vaccination was 50 years). The patient's medical history was not reported. Patient had no known allergies. Patient's concomitant medication included melatonin, multivitamin and diphenhydramine HCL at 50 mg; all for unknown indication on unspecified dates (with in two weeks of vaccination). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Mar2021 at 02:30 PM (same day of vaccination) the patient experienced headache and Left arm where shot was administered was hot to the touch. Patient had swelling of face and feet on 06Mar2021. Headache happened right after shot, swelling was the next day (06Mar2021). Patient took Benadryl 50 mg twice as a treatment. The outcome the events headache and Left arm where shot was administered was hot to the touch was recovered on an unknown date in Mar2021; and the events swelling of face and feet were recovered on 06Mar2021.  No follow-up attempts are possible. No further information is expected.
Two days after the 1st injection I observed thousands of tiny red itchy spots on my mostly inner thighs.  They went away after about one week.  Three days after my second injection the dots returned all over the thighs again. Over the coming days the red spots started moving though out my body, moving upward to my lower belly and chest.  On May 3 the redness and tiny spots moved up towards my neck.  Very red and painful itchy  burning spots throughout my thighs, stomach and chest, and the lower third of my neck.  My neck was best red and hot and painful to the touch, nearly purple in color.  I went to an Urgent Care on May 3.   I was given a steroid shot in the butt.  The next day on May 4th about 24 hours after the steroid shot, the rash continued to spread.  It now was visible on my arms as well and covered my entire neck up to my jawline.  My neck burned severely and was a purple shade of red.  I went to the emergency hospital on May 4 about 10pm est.  I was given a second steroid shot via iv, and told to take Benadryl 50mg, three times per day.  It is now May 5 at 637pm est,  some of the redness subsided in the neck area, but still very visible.  The rash has now spread to cover my arms and hands fully, along with spreading to below my knees to my lower legs and feet.  The rash continues to spread and is now present throughout my entire body.
Pt received the ZOSTAVAX in mid-August. In early September he developed diffuse lesions on his body and was diagnosed with chicken pox. He states he had that for a while and then recovered. In early October he surgery for cataract removal on the right eye. He's scheduled to have surgery on the left eye some time this month. He states however in the last three days he's developed significant worsening of his vision. He has now total loss of vision in the right eye and progressive loss of vision on the left. He has since been diagnosed with VZV of the eye with over 6 million copies in the retinal fluid.
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 60-year-old female patient who received SHINGRIX (batch number PK9BY, expiry date 19th March 2021) for prophylaxis. Concomitant products included FLUZONE VACCINE. On 3rd October 2018, the patient received SHINGRIX. In October 2018, less than a day after receiving SHINGRIX, the patient experienced fever and chills. On an unknown date, the outcome of the fever and chills were unknown.  It was unknown if the reporter considered the fever and chills to be related to SHINGRIX. Additional information was reported as follows: The patient experienced fever and chills at night following administration of SHINGRIX and FLUZONE QIV concomitantly.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L024993, expiration date 17-OCT-2017; lot # L043214, expiration date 30-AUG-2017 (dose and route of administration were not reported). Administered doses of vaccine experienced the temperature excursion of 34 degrees Fahrenheit for 3 hours. Data logger was not involved. There were no previous excursion reported. This is one of several reports received from the same reporter. Additional information has been requested.
Massive nose bleeds; Headache almost every day; This is a spontaneous report from a contactable consumer (mother reporting for son). A 14-year-old male received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EWO177) via an unspecified route of administration in left arm on 22Jun2021 as dose 2, single (at the age of 14-years-old) for COVID-19 immunization. Patient medical history included known allergies. The concomitant medications included cetirizine hydrochloride tablet (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose and frequency of 10 mg, 1 tablet as needed for allergies, vitamins NOS (FLINTSTONES) at a dose and frequency of 1x/day (2 gummies once a day). Mother stated he takes ZYRTEC the generic kind.  He had been taking it since he was six about, on and off with allergies. He started taking flintstone vitamins last year for health. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number-EWO177) via an unspecified route of administration in right arm on 01Jun2021 as dose 1, single for COVID-19 immunization. Mother was calling about the Pfizer Covid-19 Vaccine and wanted to report a side-effect her son had after second dose. She added they just got back from doctor office. This all happened after the second vaccination, ever since he got the second one on 22Jun2021. He has had headache almost every day since then. He had massive nose bleeds this week on Tuesday and Wednesday. After the first vaccine he had a headache for a few days also but it was not bad at all.  After the second, it was constant. It did not last all day, it came and went. She was unable to answer if symptoms were still going on and stated they come and go. The nose bleeds he has not had any today so far. They took some blood they are checking, including his clotting platelets or whatever that is, and they are checking to see if he has been bit by a tick.  Just for precautionary reasons.  She does not know results yet as he just got the blood today and they just got back from the doctor. When the headaches got bad, he would take Tylenol the first few days and then he took Motrin. She corrected and stated he took Ibuprofen, not Motrin. The adverse events did not result in emergency room visit but resulted in physician office visit. The outcome of the events was unknown.
Around 6 to 7 hours from the time of the vaccine I got hives on my face started feeling very tired and lethargic with a headache. The next day 5/14/21 I had lots of pressure in my face, jaw, head, neck and behind my eyes as well as shortness of breath and extreme tiredness, brain fog and confusion that has not gone away. The symptoms did not go away so I did not go for the second dose. It has been 3 months now and I still have these symptoms and have frequent headaches.
No additional AE details; LPN calling to report expired MMR II administered to 2 patients. MMR II experienced temperature excursion in the past but the TE details are not available at this time. Informed nurse stability date cannot be given until we have TE details. Nurse sta; temperature excursion; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. Concomitant medication included sterile diluent. Pertinent medical history and drug reactions/allergies were not reported.  On 15-FEB-2022, the patient was vaccinated with expired and improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin (rHA)) (M-M-R II) (lot #T001212, expiration date: 12-JAN-2022) for prophylaxis (strength, dose, and route of administration were not provided) (expired product administered and product storage error). Regarding the temperature excursion details were not available. Informed nurse stability date could not be given until having temperature excursion details.  No additional adverse event details were reported (no adverse event).  This is one of the two cases reported by the same reporter. ; Sender's Comments:  US-009507513-2204USA006151:02148137
Chills, Fever,  Aches, Fatigue - all for 24 hours. Treated all of the above with acetaminophen.
Fist size redness around the injection site that has been itchy for the past 4 days. Began approximately Sunday morning January 22, 2023
Patient reported receiving anthrax and typhoid at a event. Within 10 minutes, she reported fainting off and on. She experienced SOB with a feeling of chest heaviness and a feeling of throat swelling. Epinephrine was not administered at the event, however a medic and doctor dispatched 911 where she was taken to a local ER for evaluation. She reports an initial 3 day stay in the ICU then released. She then reported going back due to back pain, vomiting, and continued fainting. She stayed another 4 days and was released. She was unsure what medications they were providing during her hospital stay, but reports she did have IVF running with several other meds being administered via the IV.
Severe pain at the shoulder down to elbow.  pain progressively getting worse ; ice packs and IBP 800 is not reducing any pain. worsening by the hour.
pt said he had myocarditis a day after shot and severe chest pain. he told me the doctor wanted him to get second shot but when i asked him to call dr he said he doesn't have one and just wanted second shot for travel to mexico. I told him i would like to get more information and my manager said to see if he could get the shot at a hospital setting. He didn't want to wait for me to call for more info.
extreme exhaustion and body aches day after injection.  2nd day those symptoms subsided but injection site is red and feverish with itching.  day 3 the red spot is larger, still feverish and itchy.
Same day and over the course of a week following, the muscle around the injection site was very sore, i.e. could not sleep on the left side. Seven days following receipt of the shot a rash developed at the injection site and the area around it on the arm was very hot, feverish. I had no fever though, just hot at the injection site.  After reading about this side-effect, I took NO additional action and within about 2-3 days it all went away.