chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administrated beyond 30 day use by date; Vaccine administrated beyond 30 day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administrated beyond 30 day use by date) and PRODUCT STORAGE ERROR (Vaccine administrated beyond 30 day use by date) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     It was reported that patient is not immunocompromised.     On 07-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administrated beyond 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine administrated beyond 30 day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administrated beyond 30 day use by date) and PRODUCT STORAGE ERROR (Vaccine administrated beyond 30 day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   HCP reported that there was an error in documentation that occurred in their facility. The 30 day use by date was written inadvertently as 16-Apr-2022 and they found out that it was supposed to be 06-Apr-2022. No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-538899, MOD-2022-538939 (Patient Link).
(L) upper arm red/swollen. Seen 3/19/08 11x8 cm area of erythema/induration. Treated with Augmentin for cellulitis (Cat Scratch abrasion on left anterior cerb fossa).
Pt presented to the ED on 1/3/22 for worsening lethargy, failure to thrive. Worked up by GI during admission. On 1/13 patient was tested and was positive for COVID-19.  Developed COVID Pneumonia, treated and was discharged 1/24/22.  Patient has previously been vaccinated with Pfizer 3/13/21 & 04/03/21.
High fever resulting in seizure. Spike in temp to 103 recorded by ear. Seizure lasting about 90 seconds. Treatment: rest, children's ibuprofen and Tylenol, pedialite.
approximately 2 hours after admin of Engerix B, he returned to the clinic reported shortness of breath, numbness and tingling in extremities, and nausea.  He was transferred to the ER where he was given Benadryl, Solu-Medrol, Pepcid and Phenergan.  The ER doc noted he was hyperventilating and "A large component of his symptoms are anxiety related."
Hypotension and presyncope within 2 min of receiving the vaccine Tingling on face and both hands lasted for 2 hrs Following day- chills and abd cramping Day 3 -headache
Intense screaming and crying; high fever of 105.5* and higher.  Large, purple knot formed at the site of the injection.  Lymph nodes swelled and became hard.
Left side extremities are constantly cold.  Wrist, calf, shin (especially the shin), ankle, hand, and sometimes foot.  It hasn't stopped yet, I still have the cold extremeties.  I wrap them in ace bandages to make them feel better.  I was hoping this would go away, but it hasn't.
Agitation; Aggression; Delusion; Paranoia; An autoimmune induced condition; Psychosis; Mania; This is a spontaneous report from a contactable physician. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number and Expiration date: not reported) via an unspecified route of administration on an unspecified date as an unknown dose, single for COVID-19 immunization. The patient's medical history included bipolar disorder from 2017 and ongoing. The reporter stated that certainly remote family history of bipolar disorder. The patient's concomitant medications included quetiapine fumarate (SEROQUEL) 400mg tablet once at night taken for bipolar disorder from 2019 to May2021. Vaccination facility type was reported as large clinic not military facility. No additional vaccines administered on same date of the Covid-19 vaccine. The physician was not aware if the patient was on any other medications 4 weeks prior to vaccination. The reporter was not aware if the patient had any other adverse events prior vaccination. On an unknown date in Feb2021, the reported stated that, he had a patient of his that had been having varying psychosis. Psychosis was ongoing and persisting. On 01Feb2021, the patient had mania. It was ongoing. He was admitted to the psychiatric hospital for the last 5 or 6 months. We are beginning to suspect it as autoimmune induced condition. There have been other reports of mania, agitation, aggression, delusion and paranoia. He was trying to figure out what to do. He doesn't want to assume it's the vaccine, he knew some autoimmune causes psychotic episodes. The physician stated that he had no idea who that was. He was a college student and he's seeing him. The reporter clarified that patient had only experienced psychosis and mania as the adverse events. Pfizer had reports of people what have gotten covid and had mania. The events psychosis and mania resulted patient to visit emergency room/physician office. He's been in and out of the hospital since roughly February. Hospitalized immediately from emergency room to the psychiatric unit. He saw him in his office. Most recent hospitalization was 35 days. No Relevant test and investigation assessment were reported. The outcome of the events mania, psychosis was not recovered, and the outcome of other events was unknown.  No further details were provided. Information on the lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events autoimmune disorder, psychosis, mania, paranoia, delusion, agitation, and aggression and the suspect drug.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Fatigue, aching, vomiting blood, diarrhea beginning one day post vaccination.
Case number PHEH2012US003918 is an initial spontaneous report received from a medical assistant on 15 Feb 2012 with a follow up received on 24 Feb 2012. This case refers to a 16-year-old female patient. She was vaccinated with MENVEO (batch number: A11033/X11033 and expiration date: Jan 2014) at a dose of 0.5ml intramuscularly on 09 Feb 2012. It was reported that the administered MENVEO vaccine before reconstitution was stored in temperature of 32.7F on 01 Feb 2012 and was then at 35.6F at 4:30 pm on the same day. The reporter stated that the vaccine was not frozen. No adverse event was reported following vaccination. Follow up information received from the medical assistant on 24 Feb 2012: Updated patient's age and date of vaccination.
Red - Near Injection Site; Swollen - Near Injection Site; Itchy Sensation - Near Injection Site; Sore Arm; A spontaneous report was received from a consumer concerning a 74-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm, red near injection site, swollen near injection site, itchy sensation near injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 21 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 032L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 21 Jan 2021, the patient experienced the events sore arm .  On 31 Jan 2021, the patient experienced the events red near injection site, swollen near injection site, itchy sensation near injection site.  Treatment details included Benadryl. Action taken with mRNA-1273 in response to the events was not reported.  On 1 Feb 2021 the outcome of events sore arm was resolved. On 1 Feb 2021 the outcome of events red near injection site, swollen near injection site, itchy sensation near injection site was not reported.
Redness, swelling, & warm to the touch. Also, very itchy to the patient. Advised to keep skin cleaned with soap & water. Continue oral antihistamine & oral ibuprofen as needed. Cool compresses for comfort. Follow up if erythema worsening/spreading, red streaking. Fever, discharge.
Numbness and slight swelling on entire left side of face within half hour following shot, accompanied by severe stiff neck (left side).  Headache and slight transient facial rash  with skin discoloration under eyes about two hours later.  Mostly subsided by 10:30 PM- about eight hours later, although some numbness remained l through the night.  Symptoms were mostly gone the next morning, replaced by arm soreness and bruising at the injection site.  Black and blue remains (3 days later).
had SHINGRIX dose one over a year ago; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose over an year ago, from the day of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. The reporter wanted additional guidance on whether to administer dose 2 or restart the series.  The patient did not have exact date of first dose but noted it was over a year ago.  Provided Healthcare professionals information per content on Centre for disease control and prevention recommendations to take second dose as soon as possible.  The reporter asked if there was any additional info, warm transferred to Medical Information for further assistance.  The reporter did not consent to follow-up.
Arm swollen, red, ached very bad for 3 days. Dr prescribed steroid cream and cellophane wrap. In 2 days swollen went done, but pain still remain when she sleeps on arm.
This spontaneous report as received from a healthcare worker, refers to a patient of unknown age and gender. No pertinent medical history, concurrent conditions or drug reactions/allergies were reported. On 08-MAR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9, which had a lot of L016428 and an expiration date of 30-AUG-2017 (dose, dosage number, route of administration and anatomical location were not reported). It was stated that the temperature excursion was 28.9 F for a time frame of 7 hours. This excursion was found due to a data logger. Additionally, it was stated that no previous temperature excursion had occurred. This is one of the several reports received from the same reporter.
Report A0374097A describes diabetic ketoacidosis in a 39 year old female who received hep b vaccine recombinant (Engerix B). Medical history, concurrent conditions, and concurrent medications were not provided. On an unspecified date, the vaccinee received an injection of Engerix B (lot ENG5260B6). The number of previous injections of Engerix B was not provided. Within twelve hours post-immunization, she experienced "severe" nausea and vomiting and lapsed into diabetic ketoacidosis. The vaccinee was hospitalized in an intensive care unit. Treatment and outcome were not provided. The follow up states that the pt's medical history also included type II diabetes mellitus and hypothyroidism.. There was no history of alcohol or tobacco use. Concurrent medications included insulin, Armour Thyroid, Levoxyl and Premarin. On 5/13/02, the pt received her third injection of Engerix B. On the morning of 5/14/02, she experienced dry mouth. She also developed an injection site reaction characterized by erythema, edema and a 4-inch wheal. Serum glucose was found to be elevated. These events resolved after an unspecified period of time. The reporting physician considered the events to be related to Engerix B administration.
Patient injected and then stated that he felt dizzy. head dropped forward. Patient stopped responding to verbal commands. Pulse 45 Resp 8. patient responded to verbal stimuli 30 seconds later, c/o headache, lightheadedness. patient was pale and sweating. Water provided. HR85 resp 16. Cold compress provided to back of neck.
Patients received the 2nd dose of the Pfizer Covid-19 vaccine after BUD-expiration date. as per Dr. he recommends patient to repeat the dose. Patient's parents were contacted to informed of the Adverse event and to inform that the vaccine is recommended to be repeated. Patient's parents reported no symptoms or signs related to the vaccines received.
No adverse effects were reported; Multiple unspecified patients were vaccinated with improperly stored PROQUAD and VARIVAX; This non-valid spontaneous report was received from the office manager and refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' medical history, concurrent conditions or concomitant medications.    On an multiple unspecified dates since September 2018, the patients were mostly vaccinated with doses of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot number N027000 with expiration date of 28-SEP-2019 or lot number N022979 with expiration date of  23-AUG-2019) or doses of improperly stored rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (lot number R017628 with expiration date of 18-DEC-2019 or lot number N025929 with expiration date of 18-MAR-2019) (dose and route of administration) for prophylaxis. The vaccines were stored in the range of 6 Fahrenheit degrees to 14 Fahrenheit degrees (13.9 Fahrenheit degrees) for an unknown time frame. There were previous temperature excursions, however the details were unknown. It was reported that no doses of the and varicella (oka-merck) virus vaccine live(PROQUAD) (Lot number N025929 with expiration date 18-MAR-2019) were given after it expired; however doses were given after the first and subsequent temperature excursions, dating back to an unknown date in September 2018.   Digital data logger was involved.  Follow up information has been received from the office manager on 22-APR-2019. No dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) was administered to the patient. Sterile diluent was properly stored. No adverse effects were reported. On 06-MAR-2019, the patient was vaccinated with dose of improperly stored rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (lot number N025929 with expiration date of 18-MAR-2019). The vaccine was stored in the range of 6 Fahrenheit degrees to 14 Fahrenheit degrees (13.9 Fahrenheit degrees) for 69 hours and 11 minutes (multiple excursions). No prior excursion was confirmed. Digital data logger was involved.  This case was previously considered non-valid but upon receipt of follow-up with patient identifiers, it was determined that the case is valid now.  This one of ten reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA012656: US-009507513-1904USA012657: US-009507513-1904USA012658: US-009507513-1904USA012659: US-009507513-1904USA009929: US-009507513-1904USA012654: US-009507513-1904USA012653: US-009507513-1904USA012655: US-009507513-1904USA012652:
Client reports he started to "feel bad" and had a headache, fever, nausea and vomiting. Reports on 10/11/00, during the night, wetting the bed. He called health dept to report not feeling well on 10/12/00, denies SOB or itching and was referred to PMD.
patient reported flu like symptoms, pain at the injection site, swelling, numbness in arm and was wearing a sling
chills that night and slight headache, then next morning had two occurrences of hot flashes and headache till 12 noon
Status epilepticus (48 hours); seizure activity confirmed by EEG after hospitalization.  Paralysis of right arm, speech and motor aphasia.  Vitals stabilized during hospitalization.  Placed on Keppra.   After 6 weeks of PT, OT, Speech Therapy, she could not return home to self-care.  Now in assisted living.  Still experiencing "brain fog", motor skills have recovered to 90% of pre-episode levels.
patient passed out 15 minutes after receiving shot.  fell out of chair onto floor. helped up and sat in chair. pt was pale, tunnel vision and could not answer questions.   gave some water and a granola bar because patient had not eaten since night before. called squad, pt refused treatment. stayed for another 30 minutes until determined  ok to leave on his own volition.
Information has been received from a nurse concerning a patient who was vaccinated with Gardasil.  The patient fainted after receiving the vaccine.  No other details were available.  Additional information has been requested.
My thumbs hurt, I can't squeezed without feeling pain, when I wake up my hands are numb and in pain. I have to open and close my hands to be able to have mobility since they remain rigid after waking up.
Started with chills shortly after getting the injection, which got progressively worse. At 9:30 pm, the evening of injection, chills got worse, along with a headache and muscle aches that started with my shoulders and moved quickly down my body, eventually, ending at my toes. It hurt to move, even my fingers. I took 2 regular strength Tylenol, which helped get me to sleep. I then woke up around 4 am in a puddle of sweat... I took my temp and no fever, but body aches, headache and chills were still prevalent. I spent the next day in bed without moving or eating much - drank a lot of water. Tylenol every six hours. An hour after taking Tylenol, I seemed to be well enough to not be moaning and groaning, but it wore off too quickly and I had two hours of feeling horrible before taking more Tylenol for a bit of relief. I woke Sunday morning around 5 am in another puddle of sweat and severe body aches and headache. I took more Tylenol, went back to sleep and woke around 9 am feeling groggy, but quickly realized that I was feeling 100% better! Just like that. I also had pain at the injection site that for some reason seems to be getting worse today, Sunday (April 4). I do not have swelling or redness. It just feels hot and very very sore and getting worse. Heavy and hard to lift.
Soreness in her arm that her hurts her arm to lift up and at night she cant lay on it.
For my first dose I had no significant side effects, LOT: EJ1686. )   After receiving my second dose injection, I felt lethargic, had cold, chills with soreness to left arm. I had significant abdominal pain, my abdomen was distended and swollen. Two weeks prior to the 1st dose injection I had had abdominal surgery. I experienced peristalsis with pain with possible obstruction. I have an ileostomy., and with the vaccine I experienced (high pitched noise coming out of my stomach which caused me to vomit and fee weakness to my abdomen. i took Octeotide injection for my abdominal pain. I also took Ibuprofen for pain. My doctors said that my abdominal pain was most likely related to the injection.  I went into surgery 12-14-2020 for removal of an abdominal mesh due to the ileostomy and infection. I currently can not lift no more than 10 pounds.  At this time, I feel better and will be returning to work.
having vaccine he has been losing energy; and losing muscle strength by the day; This case was reported by a consumer via call center representative and described the occurrence of loss of energy in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included blood pressure. Concomitant products included atorvastatin calcium (Lipitor).   On 20th January 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced loss of energy and muscle weakness. On an unknown date, the outcome of the loss of energy and muscle weakness were not recovered/not resolved.   It was unknown if the reporter considered the loss of energy and muscle weakness to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient himself. The age at vaccination was not reported. Since, having the vaccine the patient had been losing energy and losing muscle strength by the day. The reporter limited information provided. The reporter did not consent to follow up.
Burning in scrotom, difficulty breathing, chest pain mimicking heart attack symptoms, headache, nausea, vomiting,  muscle aches, shortness of breath, dizziness, fatigue all began by 8 a.m. 9/14 (the morning after the injection)  Started feeling better by midday on the 9/16 but still has lingering effects today.
Patient was due for a second full dose of Pfizer, but Medical Assistant accidentally gave a Moderna booster instead.
This case was reported by a healthcare professional and described the occurrence of injection site cellulitis in an child male subject who was vaccinated with KINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of KINRIX (unknown route, unknown deltoid). The lot number was reported as PY3D2 from the reporter; however, based on a safety lot number review, the lot number was updated to PY3DZ. Less than one week after vaccination with KINRIX, the subject experienced injection site cellulitis, injection site warmth, injection site blisters, injection site redness, swelling injection site. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified. This case was associated to a product complaint. This case was one of 8 cases of injection site reaction reported from the same reporter regarding the same lot of vaccine.
About a week after my 2nd vaccine, I started to notice a rapid heart beat and an irregular heart beat, from time to time.  My physician said it could be attributed to stress and anxiety related to an upcoming surgery on 6/21, however I later read a report regarding instances of rapid and irregular heart beats following the 2nd COVID vaccine.  I have noticed these episodes have decreased significantly at this time to about 1 or 2 per week.  I am wondering if this could be an effect of the vaccine.
Cellulitis - from hospital today 3/13/18 rec'vd 2 antibiotics cephalexin and SMZ-TMP DS.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 12-OCT-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB (exposed to the following temperatures and cumulative time frames colder than 36F: In September of 2015, the coldest temperature was 34F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34F for 192 hours, for a total of 1,031.3 hours (43 days)) with lot number: L010595, expiry date: 12-NOV-2016 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
swollen upper arm-hard knot- 21OCT-24OCT;24OCT rash on stomach & breasts-still ongoing;
PATIENT IS UNDERAGE. LOOKED UP RECOMMENDATION ON CDC WEBSITE. PATIENT STILL ADVISED TO GET 2ND DOSE OF MODERNA.
Dizziness upon waking, inability to focus, nausea, headache, unsteadiness, blood pressure higher than normal, pulse faster than normal, weakness, pallid.