chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine). On 10-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  The pharmacist reported about the administration of expired Moderna vaccine that were given as booster shot to the patients around 490 to 500 on the last date 20-OCT-2021 to 29-NOV-2021. The Lot number of vaccines were as 006C21A (10-OCT-2021), 026B21A (17-SEP-2021), 031B21A (22-SEP-2021). It was reported that the vaccines was stored in freezer,  took out one to two vials and place in fridge each day as needed.  No treatment was provided to the patient.
pt recvd vax 7PM 8NOV94 & cried all noc-cry sounded different than usual; began 2AM crying & was still crying 1230PM 9NOV94; t102.4; given APAP q 4 hrs;
chills, fever day after injections, The following day blurred vision occurred, couldn't see print on the computer screen. Went to eye doctor for treatment. diagnosed with Cystoid Macular Edema. treatment to go to specialist
No strength, can't walk, severe headache. Husband called pharmacy and notified he was taking her to the hospital to be seen.
Patient came in pharmacy on 09/14/2018 complaining of large red spots on her back. Patient stated that she started feeling itchy after receiving the shot (on 09/10/2018) but ignored it until 09/14/2018. Advised patient to take BENADRYL and follow up with PCP. Patient was going to see the doctor on 09/15/2018.
RAISED, RED REACTION AT INJECTION SITE.  it was red and warm to the touch
PATIENT DEVELOPED SHORTNESS OF BREATH - RESOLVED PARTIALLY,  (THEN RECOVERED FROM ADVERSE EVENT PRIOR TO RELEASE)
pt inadvertently received 0.5 ML dose instead of 0.3 ML dose of vaccine
Fever (2 hours after vaccine) up to 103. Treated with Ibuprofen/Tylenol PRN fever.
flu; Initial information received on 06-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who experienced flu while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (form, strength, dose, frequency, route, lot number, expiry date unknown) in unknown administration site as prophylactic vaccination.  On an unknown date the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event flu.
None 11/6/09 Medical records received for date 10/29/09. Pt 37 weeks pregnant arrived to L&D for PIH workup. Pt. c/o HA daily, occasional left flank pain. Pt. states past 10 days fetus will "shake" 4-5 times a day for 10-20 sec. Assessment WNL. Plans to return to L&D on 11/4 for induction.
FULL BODY RASH-SHOWED UP ABOUT 15 DAYS AFTER 2ND VACCINE RECEIVED LYMPH NODES IN NECK SWOLLEN-SHOWED UP ABOUT 7-21-21 AND ARE STILL SWOLLEN
SYNCOPE  (SLUMPED OVER ) WHILE SEATED AFTER ABOUT 5 MINUTES POST VACCINATION. AS WE LOWERED HIM TO THE FLOOR HE INSTANTLY REVIVED AND JUMPED UP. HE WAS CONFUSED AND I MADE HIM SIT. WE GAVE HIM WATER  AND HE HAD TO STAY FOR AN ADDITIONAL 15 MINUTES FOR OBSERVATION
Barky cough, wheezing, fever, hoarseness - gave 3 puffs of Albuterol inhaler to settle the cough and wheezing.  Tried to give Nyquil for cough and fever but the strong cough prevented it from staying down.  We are on the third day after and the cough persists.  The fevers lasted 2 days.
Burning during injection, injection arm burning throughout day until reported, vomiting, tremor, pale, heavy but NOT difficult breathing.
This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age and gender. Patients' medical histories, concomitant medications and drug histories were unknown. On unknown dates, patients received oral ROTATEQ as a single dose, given one time for immunization (lot # K020182 and expiration date 25-JUN-2016, route of administration was unknown). The (oral) ROTATEQ was not stored in proper storage conditions and not supported by stability date. The reporter stated that no patients reported any unwanted effects to her. Those patients' laboratory data were unknown. At the time of the report if was unknown if any of those patients still received oral ROTATEQ. Additional information has been requested.
Office visit progress note 09/08/2018: "61 yo F Pt states 1 week ago (8/29/18) she had the SHINGRIX vaccine and that evening developed a fever and nausea. The nausea decreased but the fever never ceased. Last night her temperature was at its highest at 103.2 temporal. Nausea has since returned coupled with sharp abdominal pains. Her abdomen has also been tender to the touch. Every day she feels warm, 99 or 100. Never really felt sick, just more tired. Feels weak and tingly in her legs. Now today stomach is tender and she endorses a lot of weakness. The stomach pain is not localized to one location at this time, although earlier in the week it seemed to be only to upper stomach that was sharp. Different than her burning with acid reflux. Otherwise now it is in a generalized lower area and is more tender in quality. Appetite is decreased. Denies n/v/d. Also endorses intermittent pain in L armpit, sharp stabbing pain that happened 3-4 times for only brief episodes. Endorses generalized body aches and weakness. Feeling tingling sensations in both legs. No difficulty walking. Later while in the office today she endorses feeling like her skin is crawling. Feels like her Bell's palsy tightness has been gone, today it feels tight again. Wonders if something viral is going on. Does have VALTREX on hand, needs this less than once a year. Pt has been taking TYLENOL and tums with moderate relief. Pain associated with headache and body aches. Ibuprofen this morning, around 10:00." Patient's symptoms worsened the next day 09/09/2018 per telephone encounter with PCP: "Patient states the tingling and pain in her legs have gotten worse. Patient states last night she was laying on the couch and got up to walk and fell down. States she is having a hard time keeping her balance. States her hands are shaky. Patient also c/o blurry/double vision this morning. Patient states he stomach is still tender. Fever has been up and down, last time she took temp. it was back to normal. Last took Ibuprofen 4-5 hours ago. States she doesn't have a appetite. Patient states she has been looking on the internet, states there is a post vaccination reaction called Guillain-Barre syndrome. Patient states she is having some of these symptoms." Patient was advised to go to the ED by her PCP.
Urticaria onset shortly after injection.  Worsening over the next several hours, seen in the emergency room at 2230, treated with diphenhydramine and methylprednisolone.
This case was reported by a physician and described the occurrence of an injection site reaction in a 26 year old female pt who received Infanrix. On 8/6/04, the pt received a dose of tetanus and diphtheria toxoids in her right thigh. On 8/6/04, the pt also, inadvertently, received a dose Infanrix, in her left thigh. Approximately 5 days after the administration of Infanrix, on 8/11/04, the pt experienced an injection site reaction on her left thigh characterized as swelling. The injection site reaction occurred "at the site of the Infanrix injection". The outcome was unknown. The reporting physician considered the events to probably be related to vaccination with Infanrix.
Evening after injection, pt developed severe 8/10 (L) deltoid pain, decreased ROM. This lasted for 4days. On the 5th day he developed a red confluent macular rash in block pattern distal to injection site approx 20 x 5 cm.
within 24 hours the patient experienced mild/moderate nausea, mild dizziness and severe headache.  He was treated with ibuprofen 600mg tid.
Patient said flu shot site was very painful and red and hot. Swollen out 3-4 inches. Had to use hydrocortisone. Still swollen and hot on 9/17/16.
NO ADVERSE EVENTS, BUT PATIENT WAS NOT ELIGIBLE ACCORDING TO HIS AGE PER CURRENT CDC GUIDELINES
This spontaneous report as received from a pharmacist who is 35 year old male patient concerning himself. Patient had no medical history and previous drug reaction. On 19-MAY-2012 the patient was vaccinated wit VARIVAX (Merck) (dose number, dose unit, lot# and expiry date unknown), subcutaneous. No concomitant medications were reported. On 19-MAY-2012, the patient experienced a reaction of small red bump that increased in size to approximately 3/4 of an inch, and mild itching. It was reported that patient visited physician and no treatment was given for the events. No laboratory tests were performed. The outcome of reaction of small red bump that increased in size to approximately 3/4 of an inch and mild itching was unknown. No  further information was provided. Additional information is not expected.
Sudden death in sleep- no rationale reason.  Patient had recent labs and MD visits showing all chronic medical conditions were stable and under control.  Reporting death as patient did have both recommended COVID vaccine injections about 1 year prior.  Since long term safety and efficacy is still unknown for this vaccine for patients with medical history such as the patient we wished to have it reported as possible adverse event.
This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 19-FEB-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had an excursion of 27 degrees Fahrenheit (-2.77 degrees Celsius) (lowest recorded temperature) for 1212 hours (sum of hours in excursion). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Beginning at 0530, 01/27/2021 patient describes feeling "dizzy," experiencing slight headache, large amount of pain (6 on 0-10 scale) at injection site. Patient also described "neck stiffness," and a "knot" just above her collar bone. On examination, patient presents with noticeable lymphodenopathy over medial 1/3 of right clavicle; located just supraclavicular. The "mass" is larger than a large grape - approximately 4cm in diameter and ovoid shaped. The mass is tender to palpation and the patient describes a "tight" sensation in Zone 1 of her anterior & R side of neck.
Patient felt dizziness and giddiness . Onsite EMS was called vitals HR 78 BP 126/78  99% O2.  Patient refused evaluation or care. Released against medical advise.
Pt recvd 3 doses of Engerix-B 30OCT90, 30NOV90, & 2MAY91 & 12SEP91 it was determined that pts titer was neg p/3 doses of Engerix-b;
It started with a dull pain in my lower right abdominal. I went to the ER.  They did not find anything and everything was normal.  They did blood work.  They sent me home.  On Monday, I went to my primary care.  He order ultra sound of my kidneys and bladder. Then, I got an appointment with my transplant doctor.  He order a CT scan. All of them still don't know what is causing it. I also have had an upper and lower an coloscopy done, normal results. These symptoms are still ongoing.
patient reported having a sore/scratchy throat ~10 minutes after her first COVID shot. She was originally given 25mg of benadryl and a bottle of water and was watched for ~10 minutes. She was then given another 25mg of benadryl. She reported feeling better after the 50mg of benadryl. She denied further medical assistance and reported that she felt well enough to go home. She had a husband waiting at home to watch her, and she was counseled on s/s that she should go to the hospital for.  She was contacted the next day to check on her, but she was not available. She was contacted on 6/14 to check on her, and her husband reported that she felt better soon after her shot, and has had no other side effects since the original sore/scratchy throat.
Textured (bumpy) Injection Site; Painful Injection Site; Hot to the touch Injection Site; Red Injection Site; Raised Injection Site/Swollen about a Quarter size; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot to the touch Injection Site), VACCINATION SITE ERYTHEMA (Red Injection Site), VACCINATION SITE SWELLING (Raised Injection Site/Swollen about a Quarter size), VACCINATION SITE PAIN (Painful Injection Site) and INJECTION SITE MASS (Textured (bumpy) Injection Site) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reportd).    On 19-Jan-2021 at 5:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red Injection Site) and VACCINATION SITE SWELLING (Raised Injection Site/Swollen about a Quarter size). On 21-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Hot to the touch Injection Site) and VACCINATION SITE PAIN (Painful Injection Site). On 28-Jan-2021, the patient experienced INJECTION SITE MASS (Textured (bumpy) Injection Site). On 25-Jan-2021, VACCINATION SITE WARMTH (Hot to the touch Injection Site) and VACCINATION SITE PAIN (Painful Injection Site) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Red Injection Site) and VACCINATION SITE SWELLING (Raised Injection Site/Swollen about a Quarter size) had not resolved and INJECTION SITE MASS (Textured (bumpy) Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medication and treatment provided; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
TINGLING SENSATION ON FACE AND RIGHT ARM; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 12-APR-2021 08:45 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On APR-2021, the subject experienced tingling sensation on face and right arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tingling sensation on face and right arm was not reported. This report was non-serious.
Caller reported an Improperly stored administered PROQUAD; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. Information about pertinent medical history, concomitant medication or drug reactions/allergies was not provided.  On 17-SEP-2020, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD); lot # T013539, expiration date 17-OCT-2021 (strength, dose and route were not reported) for prophylaxis (product storage error).   The storage temperature of the vaccine was reported as 6 Fahrenheit degrees to 14 Fahrenheit degrees (11.7 Fahrenheit degrees) for a time frame of 25 minutes recorded by a data logger. There was no previous temperature excursion. No product quality complaint involved. The outcome of the event was unknown.
Tested positive for COVID 19; Tested positive for COVID 19; runny nose; scratchy throat; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Apr2021 as dose 1, single (Lot number: EP7534), in left arm, on 26Apr2021 as dose 2, single (Lot number: EP7534), in left arm and on 26Nov2021 as dose 3 (booster), single (Lot number: 330268D) at the age of 59 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa; "If COVID prior vaccination Yes" (unspecified if ongoing), notes: If COVID prior vaccination:Yes. There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 22Jul2022, outcome "unknown"; RHINORRHOEA (non-serious) with onset 22Jul2022, outcome "unknown", described as "runny nose"; THROAT IRRITATION (non-serious) with onset 22Jul2022, outcome "unknown", described as "scratchy throat"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 23Jul2022, outcome "unknown" and all described as "Tested positive for COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Jul2022) Positive, notes: COVID test type post vaccination: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19, rhinorrhoea, throat irritation, headache. Clinical course: Patient did not receive other vaccine in four weeks. Patient did not receive other medications in two weeks. Prior vaccination, the patient was diagnosed with COVID-19. Post vaccination, the patient had been tested for COVID-19. Adverse event COVID symptoms (runny nose, scratchy throat, headache) started on 22Jul2022. Tested positive for COVID 19 on 23Jul2022, using home antigen test. The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect.
On the above-listed date, a vaccination clinic was held for staff to receive the COVID-19 booster vaccination. On this day we had Bivalent Moderna Booster dosed vials on hand to be given to those requesting the booster dose.  At the time of the clinic, the vaccinator was operating on incorrect information that the Moderna Booster vaccination for the Bivalent vaccine was 0.25 mls rather than the new dosage of 0.5mls.  The error was not noticed until the end of the clinic.  Immediately the error was communicated to those affected.  All patients requesting so were vaccinated with the remaining 0.25 mls within 24 hours in line with the FDA and CDC recommendations for this specific error.  Two patients were contacted but requested the full dosage of the booster vaccine in the coming weeks.  Three patients were contacted and chose not to be vaccinated further.  There were no reactions noted upon follow-up.  All patients were advised to communicate with their primary care doctors and follow up with them should there be any adverse reactions.  The entire department debriefed and confirmed all new information and rehabilitated the draw-up and delivery of or all vaccinations in the future. This error was taken very seriously and all means of ensuring this is to not happen in the future were implemented.
Patient's arm was extremely swollen, MD gave prednisone 40 mg daily for 4 days.
She took vaccination at 11 AM, she slept 12, woke up at 5 PM with 40 degrees C. Very high temperature and crying all night, looking very sick. She stayed with high fever despite using 120 ml gram TYLENOL and cool shower. The baby temperature went down on the third day. This is the third day and baby look sick with eyes really sick and irritable and without energy.
A headache that starts in the back of the neck on the left hand side, spreads through the front of the head. Headache is constant with temporary relief.
Headache  within 15 minutes of vaccine given.  Some nausea with next hour. Chest felt tight but no shortness of breath about one hour after vaccine given. Chest tightness gradual increase over the course of 4-5 hours.  Took Benadryl  25 mg much later and after one hour chest loosen considerably.
I accidentally gave patient a Flu vaccine instead of a Shingrix vaccine. Provider was notified. No reaction noted. Patient was given the correct vaccine.
Patient received PROQUAD in (R) arm. Redness/swelling occurred same day and worse on (18) next day and painful at site. Next day (19th) redness increased but swelling improved and not c/o'ing of pain. On Thurs (19th) redness improving.