chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine) in a female patient of an unknown age 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 (Patient received an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Treatment information was also not reported.  The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Not applicable) was Not applicable.  The nurse reports that the shipment of vaccines were received on 08-July-2021 to a different team and was placed in the refrigerator. The vaccines were received to her 30-July-2021 and remained in the refrigerator but was missing the expiration label of when they were previously placed in the fridge.  The nurse was unaware that the vaccines were initially received and placed in the fridge 08-July-2021. The max temperature reached was 41.4F and min 40.6F. The number of Moderna vials affected were 4 vials (Lot# 038C21A). Of those 4 vials, 3 of the vials were used to administer vaccinations to 9 patients over 3 days 09-August-2021-11-August-2021. At the time of excursion the vials remained refrigerated. The 1 vial that was not used was discarded. The nurse reported not noticing any vaccine state changes. Patient's received an expired vaccine past 30 days in the fridge. AE contains info for Patient 7.
Light-headed, diaphoretic, briefly lost consciousness. Provided snack, water. Did not eat prior to visit.
seven days p/vax devel fever; on day 8 had generalized sz lasted 1 min, temp taken 104; day 9, maculo papular rash on chest & abdo; t98.6; day 11 itchy urticarial rash on trunk spreading to extremities, lasted 2 days; APAP only;
Sometime following the vax, the pt reports a "waxy feeling", that self resolved. The pt reportedly recovered from this experience.
Bright red rash at injection site approximately 5 inches in length and 2.5 inches wide with hives located near injection site, fever of 100.6 degrees for 50 hours post injection. Severe body aches and chills for 48 hours, extreme fatigue for 48 hours, headaches for 48 hours, nausea, and loss of appetite for 48 hours. Red rash, hives, and itching at injection site still present at 72 hours post injection. Body aches 72 hours post injection.   BENADRYL, IBUPROFEN, and TYLENOL for treatment.
pt recv vax; localized hard & red on area around shot 9x6cm; tenderness on arm past elbow;
Developed a urinary tract infection 6/8/2021. Sought treatment at emergency room. Prescribed antibiotics. Cleared in 8 days.
To er for eval of seizure activity at hospital . Nurse  reported that seizure activity lasted  1.5 min and took approx. 30 minutes for her to start " coming around" to her self. Patient was bradycardic en route to hospital. er hpi: "79 y.o. female who presents with seizure activity.  Patient is brought to the ER via EMS from nursing home with new onset seizure.  Nursing home staff reports patient had tonic-clonic seizure which lasted approximately 1 min.  Patient was apneic.  Patient is slightly postictal but no urinary incontinence.  Patient has no known history of seizure disorder.   Patient is resident of nursing home and is a DNR comfort care.  Patient with underlying dementia. In speaking with patient she denies any current headache, chest pain, shortness of breath, abdominal pain, nausea, vomiting, diarrhea, fevers, or chills.  She is alert only to name."  Inpatient admission to hospital 3/24/21 dx acute hepatic encephalopathy, new onset seizure without head trauma
WILL NOT BE  ABLE TO COMPLETE COURSE BEFORE TRAVEL; TOOK UNREFRIGERATED VIVOTIF; This spontaneous case (PVX2019-1517) was received from a consumer on 11-Jun-2019. It describes a 25-year-old adult male consumer who "took unrefrigerated Vivotif" and "will not be able to complete course before travel". He was receiving oral Vivotif (one capsule every other day) (lot no: 3003272) for typhoid prophylaxis.   Case report: The consumer left Vivotif doses outside the refrigerator, then after 6 to 7 hour, he took the first dose on 07-Jun-2019, which was good to use but then he took the second dose on 09-Jun-2019, which was unrefrigerated for 30 hours at 75 degree Fahrenheit. Also, he had a planned trip for one month on 16-Jun-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the events was unknown.  Company's Comment: The causality of the event "took unrefrigerated Vivotif" and "will not be able to complete course before travel" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took unrefrigerated Vivotif" and "will not be able to complete course before travel" was considered as not applicable.
Fainted after booster.; Chills after booster; Throwing up after booster; Booster; Caller states booster almost killed him.; This is a spontaneous report from a contactable consumer (patient).   A 46-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: FF8841), via an unspecified route of administration, administered in left shoulder, on 15Oct2021 (at age of 46-year-old) as dose 3 (booster), single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9766), on 08Mar2021 and second dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6203), on 29Mar2021, both were received via an unspecified route of administration, administered in left shoulder (at age of 45-year-old) as dose 1 and dose 2, single for covid-19 immunization. On 15Oct2021, the patient had booster; on 16Oct2021, the patient experienced throwing up after booster; on 18Oct2021, the patient had fainted after booster, chills after booster. Caller also stated that booster almost killed him on an unknown date in Oct2021. Events fainted after booster, chills after booster, throwing up after booster, caller states booster almost killed him resulted in physician office visit. On 17Oct2021, the outcome of the event throwing up after booster was recovered. On 18Oct2021, the outcome of events fainted after booster, chills after booster were recovered. The outcome of events booster almost killed him and booster were unknown.
got rash, red itchy rash all over body; got rash, red itchy rash all over body; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient got rash, red itchy rash all over body on an unspecified date with outcome of unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Injection site and wrapping around arm rash. Also headache and muscle aches. Occurring for past two days
Now I have cancer; getting shingles regularly after receiving shingles vaccines; getting shingles regularly after receiving shingles vaccines; This spontaneous report was received from a consumer referring to himself a currently 58 years-old male patient of unknown race. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On 18-FEB-2010, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dose, frequency, route, lot number and expiration date were not privided) for prophylaxis.  The patient wanted to have a refund for the vaccines he had paid for. He stated that he and his wife were in disablility income and could barely afford the cost of shingles vaccines. The patient reported that on an unspecified date (reported as ''now''), he had cancer (neoplasm malignant) and this was costy. And that even after getting the shot, to this day, he had still get shingles and have gotten them regularly (vaccination failure, herpes zoster). He had paid two shots and he wondered if the price was fair. Action taken with the vaccine was not appplicable. The outcome of neoplasm malignant, vaccination failure and herpes zoster was unknown.  The causal relationship between the events and the zoster vaccine live (ZOSTAVAX) vaccine was not provided.  Upon internal review, the event of neoplasm malignant was considered to be medically significant.
Patient complained of a sore injection site arm; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (Patient complained of a sore injection site arm) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21A and 022B21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Patient complained of a sore injection site arm). At the time of the report, VACCINATION SITE PAIN (Patient complained of a sore injection site arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-732147 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732147:same patient and different product
BODY ACHE; CHILLS; FATIGUE; This spontaneous report received from a patient concerned a female. The patient's height, and weight were not reported. The patient's concurrent conditions included mild hyperthyroidism. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 in left arm for prophylactic vaccination. Concomitant medications included thiamazole for hyperthyroidism. On 06-MAR-2021, the subject experienced body ache. On 06-MAR-2021, the subject experienced chills. On 06-MAR-2021, the subject experienced fatigue. Laboratory data (dates unspecified) included: COVID-19 PCR test (NR: not provided) NEGATIVE, NEGATIVE, and COVID-19 antigen test (NR: not provided) FALSE POSITIVE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, chills, and fatigue. This report was non-serious. This parent/child case is linked to 20210357033.
Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 77 year old male patient. No information was provided regarding medical history, concurrent conditions, concomitant medications, drug reactions or allergies. On or about 14-JUL-2010, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, lot #, expiration date, route of administration and anatomical location were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced Herpes Zoster and he was treated by a physician for the event. The outcome of the event herpes zoster was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 05-AUG-2013 the patient was vaccinated with an expired dose of vaccine: M-M-R II (lot # 670618/0567AA, exp.date 15-APR-2013), 0.5 milliliters (ml) injection, subcutaneously. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Had a mini stroke  tPA via IV, ICU for 2 days Msicu for 2 nights Acute aphasia
Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: rash under breasts-Mild, Additional Details: Patient received vacccine and a day later had an itchy rash under her breasts
Member became diaphoretic, nauseous and lightheaded after receiving flu shot two hours prior. Sent to urgent care for further treatment.
patient was given undiluted vial of pfizer vaccine, 1.8mls or 6 doses undiluted
This spontaneous report was received from a consumer reports a children of unknown age and gender. On an unknown date, the patient ws vaccinated with ZOSTAVAX (dose, route and indication was not reported). On an unknown date, the patient experienced shingles. At the time of the report the outcome was unknown. This is one of several reports from the same source.  Additional information has been requested.
Information has been received from a female who in September 2008, was vaccinated with her first dose of GARDASIL. On an unspecified date, she was vaccinated with the third dose of GARDASIL. She stated that she became ill "week" after the third dose was given. She was experiencing pain at the injection site, pain up and down the arm, and feeling weakness in the legs. She also stated the pain had become painfully worse. She stated that the pain in her arm was a "sharp pain" and had been getting "progressively worse" and hurt "when I move my arm in a certain way." As of 23-MAR-2009, her experience didn't improve. No laboratory diagnostic studies were performed. The patient sought unspecified medical attention. Additional information has been requested.
12-18 0730- received vaccine at work.  I am a registered nurse. 12-19 11am feeling extremely fatigued, chills, mild aches, and temp 100.1 12-19 2pm  temp 101.8 and more severe arthalgia, myalgia, and shivering.... cant get warm 12-19 6pm temp 102.1 and rigors.... shaking head to toe and severe aches/ pains 12-19 11pm temp 104.1  12-20 temp 102.5 12-21  SOB, bradycardia to 41, dizziness, temp 100.5 12-22 SOB, vomiting, cough, temp 99.6 12-23 SOB, cough, diagnosed with Covid pneumonia
patient got flu shot and felt terrible for several days; Initial information was received on 21-Nov-2020 regarding an unsolicited valid non-serious case from a non-health care professional/consumer (patient) via social media.  This case involves a patient of unknown age who got flu shot and felt terrible for several days (feeling abnormal), while patient was treated with influenza vaccine.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was not reported.  On an unknown date, the patient received influenza vaccine [lot number: unknown and expiration date: unknown] at an unknown dose via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, patient got flu shot and felt terrible for several days (feeling abnormal).  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the events was unknown.  There will be no information available regarding batch number in this case.
Fever; Body ache; Soreness at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (at 25 years old).   On 15th April 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 15th April 2019, less than a day after receiving Shingrix, the patient experienced general body pain and injection site pain. On 16th April 2019, the patient experienced fever. On 17th April 2019, the outcome of the fever and general body pain were recovered/resolved. On 18th April 2019, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the fever, general body pain and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix on left arm. The patient expereinced fever which lasted for 24 hours after receiving 1st dose of Shingrix. The patient also experienced soreness at injection site which lasted for 3 days and body ache which lasted for 2 days after receiving 1st dose of Shingrix vaccine. No further details were provided.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative via social media concerned a male of unspecified age and of unknown race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) frequency 1 total, dose not reported, start therapy date was not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date (also mentioned as 12 day ago), the patient had suspected clinical vaccination failure and suspected covid-19 infection The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and  suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000187875. This case, from the same reporter is linked to 20210802047. Addition information was received from patient on 29-JUL-2021 It was determined that Manufacturer Case Number 20210802047 was a duplicate of this case. All relevant information regarding this case will be submitted under Manufacturer Case Number 20210801064.; Sender's Comments: V0. 20210801064-COVID-19 VACCINE AD26.COV2.S.- Suspected clinical vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Arm soreness, redness, swelling, unable to raise arm above head, neck stiffness on injection site side, and anxiety.  All symptoms started when she woke up 11/16/2021 @0530.
Patient reported having chest pain that lasted less than 1 minute. Patient was seen by EMS and evaluated.  Patient reported no longer having any pain or discomfort. Patient advised to follow up with PCP and to report to ER if  chest pain symptoms return.
After getting the vaccine in my left arm, I walked to observation area and sat down in chair. Within a minute or so, I noticed my heart rate was slightly elevated and had a strange feeling of unease. Roughly 3-5 minutes later symptoms appeared and I noticed my palms were sweating and I had slightly blurred vision. At this point, I called for a paramedic and told them I wasn?t feeling well. They arrived nearly 15 seconds later (paramedics were stationed all throughout observation area). Symptom severity dramatically increased (very blurred vision, feeling of something clearly being wrong) and was added by a ringing sound in both ears. I was helped into a wheel chair and rolled into an enclosed area with a curtain around for privacy. Gatorade was offered to me and I took a few sips and felt very mildly better. Paramedics reported that my blood pressure was extremely low (63/28). They asked if I wanted to go to the hospital. Symptoms were the same and starting to very slightly get better from the Gatorade so I said let?s wait a few minutes to see how I feel. At this point they took my blood sugar measurement and found that it was also very low (53mg). They gave me some intravenous fluids and a glucose substance that was in a tube (sort of like toothpaste) and within another five minutes I felt considerably better. I received the IV treatment for roughly 20 minutes and symptoms progressively got better over the course of the treatment. My blood pressure went back up to 117/80 and my blood sugar went up to a more normal level as well (I believe they said somewhere in the 90s or low 100?s). After they removed the IV and blood pressure monitor, I rested for roughly 20 minutes before walking to my car and driving home.
Patient fainted not more than 2 minutes after sitting down in post vaccination waiting area. Was given gatorade and ice pack and monitored 15 more minutes and left with family member.
Received Varivax 11/29/01. On 1/8/03 seen c/o red raised rash back, buttocks leap (not an adverse reaction)
With each COVID-19 vaccination my skin had became a little itchy (pin prickly) and inflamed, getting worse with each vaccination. After this 4th dose, my skin became swollen and inflamed. I went to Urgent Care and was diagnosed with Cellulitis. I was prescribed Cephalexin 2000mg X 10 days.
1 plus hour after vaccination, nausea and overheated. Emesis after supper meal. Rash around mid-night & presented to ER for treatment at 1 AM on 09/05/2010.. today 09/06/2010 reports no problems.
Fever 101.4 on 5OCT w/prolonged/complex sz afterwards; required intubation for 12+ hrs & Pb; was pt's 1st sz; Now pt seems normal; on Pb;
pt recvd flu vax & w/in 48 hrs the pt devel soreness @ the inject site;
swelling in left hand, first knuckles of index, middle and ring fingers also swelling in right index finger pain when making a fist in left hand itching in both hands especially between fingers duration: 36 hours before swelling started to subside took one Loratadine 3/9/21 7pm
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with VARIVAX for prophylaxis. Other suspect therapies included PROQUAD. Concomitant therapies included sterile diluent. On an unknown date the patient experienced accidental overdose and no adverse event. The outcome of accidental overdose and no adverse event is unknown. The reporter considered no adverse event to be not assessed to PROQUAD and VARIVAX. The reporter considered accidental overdose to be not assessed to VARIVAX and PROQUAD. Lot Number R011008 has been verified not valid for VARIVAX.
Extreme dizziness, vertigo, off balance, feeling disconnected and confused, difficulty remembering things, weakness and nausea.
Recieved flu vaccine on 11/17/07 and within 72 hours noticed clear fluid draining from both ears.  Resolved within 24 hours.  Had low grade fever and general aches/pains that on 11/27/07 are still present.
PT received vax on 2/20/03 on left deltoid for tetanus and Pneumovax. Per PT 3-4 days later, left deltoid site red and tender to touch.
Pt had hives rash to face  17 min following injection, rash did see spread to neck, back and abdomen. Epinephrine 0.3 mg ( EPI PEN) administered IM to left thigh. O2 applied , VS were stable.
lt leg swollen (golf ball size according to parents); fever 101, fussy advised ice/warm packs to leg-APAP for fever & comfort; high pitched cry off & on for 3 hrs;
Catastrophic loss of blood platelets from 140,000 to 8,000 following second vaccination.