chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse referring to multiple unknown patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. In November 2016, the patients were vaccinated with improperly stored VARIVAX (lot # reported as M015731, expiration date 27-OCT-2017; dose and route not reported) for prophylaxis. The doses of vaccine were improperly stored as follow (date, temperature, duration of temperature excursion): 26-NOV-2016, 6 degree Fahrenheit (F), 6 min 26-NOV-2016, 7 F, 6 min 26-NOV-2016, 8 F, 6 min 26-NOV-2016, 9 F, 9 min 26-NOV-2016, 10 F, 4 min 25-NOV-2016, 6 F, 10 min 24-NOV-2016, 6 F, 8 min 24-NOV-2016, 7 F, 6 min 13-NOV-2016, 7 F, 8 min 13-NOV-2016, 6 F, 7 min 12-NOV-2016, 6 F, 10 min 12-NOV-2016, 7 F, 7 min 12-NOV-2016, 8 F, 10 min 06-NOV-2016, 6 F, 8 min 06-NOV-2016, 7 F, 6 min 04-NOV-2016, 6 F, 6 min 04-NOV-2016, 6 F, 6 min 04-NOV-2016, 7 F, 6 min 04-NOV-2016, 8 F, 7 min 04-NOV-2016, 6 F, 6 min Data logger was involved. No adverse effects were reported. This is one of several reports received from the same source.    Additional information has been requested.; Sender's Comments:  US-009507513-1703USA007361: US-009507513-1703USA007362: US-009507513-1703USA007363: US-009507513-1703USA007364: US-009507513-1703USA007365: US-009507513-1703USA007063: US-009507513-1703USA000989:
Began experiencing  sharp, sporadic, excruciating pain on L side of face, in 08/2022. Saw dentist on 09/09/2022, who ruled out TMJ.  Appointment with PCP, at the time, the MD on 09/22/2022.  Dr. diagnosed condition as Trigeminal Neuralgia, she prescribed  Carbamazepine 200 mg 3 x a day.  Referred me to a Dr.  Neurologist, appt on 10/03/2022, he concurred with diagnosis and the prescribed medication, he scheduled MRI for 10/17/2022. I experienced an allergic reaction to Cabamazepine, visited Urgent Care on 10/07/2022, for shot and medication, stopped Cabamazepine.  Started taking Advil and Extra Strength Tylenol 3 times a day, and mouth guard at night. I saw Dr. on 11/23/2022 for MRI results.  No abnormalities on MRI.
Myalgia, Arthralgia, Diarrhea, fatigue, swollen gland, redness to inj site Narrative:
Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 17-FEB-2022; Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 17-FEB-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 17-FEB-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 17-FEB-2022) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2022 at 11:30 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 17-Feb-2022 at 11:30 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 17-FEB-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 17-FEB-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 17-FEB-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 17-FEB-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported by the reporter.  Patient received booster dose. Patient received Moderna vaccine past its 30 day of expiry date. Vaccine went into 2 to 8 degree Celsius thaw state on or about 24-Dec-2021. This vaccine was administered up until its manufacturing expiry date of 04-Apr-2022. Treatment medications were not reported.
I was given the Moderna Covid Vaccine, exactly 7 days later the injection site became itchy, raised, red, and tender
Polymyalgia Rheumatica; Synovitis; This case was reported by a lawyer and described the occurrence of polymyalgia rheumatica in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number unk, expiry date unknown) for prophylaxis.   On 8th August 2018, the patient received the 1st dose of Shingrix (intramuscular). On 30th August 2018, 22 days after receiving Shingrix, the patient experienced synovitis. On 30th October 2018, the patient experienced polymyalgia rheumatica (serious criteria GSK medically significant). The action taken with Shingrix was unknown. On an unknown date, the outcome of the polymyalgia rheumatica and synovitis were unknown.   It was unknown if the reporter considered the polymyalgia rheumatica and synovitis to be related to Shingrix.  Initial information received via legal complaint on 27 May 2021.(This case is medically confirmed now).The patient received 1st dose of Shingrix on 8 August 2018 and he experienced polymyalgia rheumatica  and synovitis on 30 October 2018.
This spontaneous report sa received from nurse refers to a patient of unknown age. On 25-APR-2014, the patient was vaccinated with ZOSTAVAX, expiry date 10-APR-2014, 0.65 ml (milliliter), subcutaneously. No concomitant medications were reported. No adverse effects were reported. No Product quality complaint was involved. The outcome of events was unknown. No further information was provided. This report is linked to 1405USA001930 by the same reporter link. Additional information has been requested.
I95.9 HYPOTENSION 8/10/2022 TOXIC MEGACOLON I95.9 HYPOTENSION 8/10/2022 TOXIC MEGACOLON
Information has been received from a physician via Company representative concerning to a patient of unknown age and gender. Concurrent and historical conditions were not reported. Concomitant therapies were not provided. On 03-FEB-2015, the patient was vaccinated with an improperly stored dose of GARDASIL "10x1 sdv" (Lot No. K001631, exp. 06-NOV-2016) (dose and site not reported). On an unspecified dates, the GARDASIL vaccine had two temperature excursions: 444 and 336 hours respectively. The lowest recorded temperature was -3 (-3 Celsius degrees). The highest recorded temperatures was 59 (15 Celsius degrees). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Pressure in chest, shortness of breath irregular heart rate.  Was diagnosed at the hospital with bilateral pulmonary  embolism.
patient had high fever (101.5), large welt at injection site, and headache lasting >7days
Patient developed sudden right sided sensorineural hearing loss 2 days after her second COVID booster shot, Moderna. This was confirmed on urgent audiogram.
Whole body shaking. Lasted about 5 min. Unable to wake patient during episode. Afterwards patient "out of it" staring into space for at least 10-15 min ambulance ride total duration about 45 min.
This spontaneous case reported by a consumer, describes the occurrence of injection site warmth (hot), injection site pain (hurts really bad), injection site swelling (swollen) and injection site erythema (pretty red) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 002A21A) for COVID-19 immunization. No medical history reported. On Feb 27, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced injection site warmth (hot), injection site pain (hurts really bad), injection site swelling (swollen) and injection site erythema (pretty red). At the time of the report, injection site warmth (hot), injection site pain (hurts really bad), injection site swelling (swollen) and injection site erythema (pretty red): unresolved. The action taken with mRNA-1273 (Moderna COVID-19  vaccine), intramuscular: unknown. No concomitant medications reported. No information regarding corrective treatment reported.
The evening of the booster, I could not make a fist/could not close my hand. Now, 6 months later, I have "trigger finger" in my middle finger; severe swelling on the top knuckle of the forth finger and pinkie finger on the same hand.
Vaccine Received expired on 4-17-22, reported to Moderna, information from internal audit "Analysis of the vials associated with your storage excursion is complete. The vaccine administered on April 19, 20, 21, 2022 from lot number 016J21-2A maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration."
I did not give the vaccine in my office, it was given to pt at a public health event. I am pt's PCP and she reported this information to me in April 2021. Her symptoms are : " since second dose has had HA on top of head and feels like nerves are jumping behind both eyes, has never actually seen any twitching, also severe fatigue since the vaccine symptoms started the next day after second dose no other neuro symptoms hx of migraines but they resolved and she hasn't had a HA since being off pain meds so this HA is new no associated visual changes, dizziness, blurry vision, numbness or weakness in arms or legs, slurred speach no sinus symptoms no fevers or chills eating and drinking normally doesn't feel sick
Some times feel hard to breathe, heart beating irregular, some times heart pains couple times in a day
Left anterior thigh at sight of injection with irregularly shaped lesion with raised erythematous borders with 2 central papules. Rash lesion was tender to palpation. Patient also had fever along with this rash on 1May, 9 days after the injection. This rash on the left leg started with small bumps a few days after the vaccine administration of the right thigh on which she also received Hib, Influenza and MMR. But those small bumps resolved and did not grow like the one on the left thigh.
Event 1: Severe Tachycardia (hr 133), elevated BP (130 over 110) with temporary paralysis. Drove to Hospital ER where BP was measured, and EKG performed. EKG was normal and I was sat in the waiting room with a "panic attack". I left the ER 2 hours later as there was no hope of a Dr seeing me within 12.   Event 2: Noted today, 7/7/2021, spontaneous bruising on the right big toe. I also have a series of unexplained bruises down my left leg.
weakness; chills; fatigue; little bit headache; feverish; A spontaneous report (United States) was received from a healthcare professional concerning a 33-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events chills, fatigue, little bit headache, feverish, weakness,   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 8 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: LOT# 030M20A) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) Chills, Fatigue, little bit headache, feverish, weakness, Tylenol did not help.  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), chills, fatigue, little bit headache, feverish, weakness, tylenol did not help was unknown.
Painful (L) arm after flu vaccination marked redness and edema distal from shoulder to elbow. Very painful to touch and very warm to touch.
Intense pain in hips and knees; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 60-years-old female patient (patient was not pregnant at the time of vaccination) received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: FE3592, Expiration date: unknown) via an unspecified route of administration, administered in right arm on 28Sep2021 at 15:45 pm (age at vaccination was 60 years) as dose 3 (booster), single for COVID-19 immunization. The patient's medical history included known allergy to contrast dye from an unknown date. Concomitant medications and other medications the patient received within 2 weeks of vaccination included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), levothyroxine, cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and sumatriptan all taken for an unspecified indication. The patient previously took tigan and experienced known allergy to it. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6198, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 02Feb2021 at 13:30 pm (age at vaccination was 60 years) as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8727, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 27Mar2021 at 10:00 am (age at vaccination was 60 years) as dose 2, single for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was Doctors office/urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 29Sep2021 at 07:00 am, the patient experienced intense pain in hips and knees. No treatment was received for the adverse event. The case was assessed as non-serious. The outcome of the event was not resolved.  Follow-up attempts are completed. No further information is expected.
Genital lipschutz ulcers  acute  non sexually active girl negative to all STD negative mono no symptoms of anything  No Covid symptoms no viruses nothing  Horrible vaginal ulcers unable to urinate tremendous pain.
Flu shot 2005-swelled up, hives, 0 breath, ER, Rxn lasted 2 days for full recovery. Unsure of treatment.
below.     The patient's past medical history included Lyme disease. Previously administered products included for an unreported indication: influenza vaccine (allergy to influenza vaccine.) since an unknown date.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced FLUSHING (Sensation of flushing and heat), DIZZINESS (dizzy) and VACCINATION SITE PAIN (Minor injection site pain). On 11-Feb-2021, the patient experienced MOBILITY DECREASED (Immobility of her limb). On 19-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Developed red pinpoint dots on her chest and arms). On 21-Feb-2021, the patient experienced VISUAL IMPAIRMENT (loss part of her vision), PALPITATIONS (heart palpitation) and MIGRAINE (horrible migraine). On 25-Feb-2021, the patient experienced MUSCLE TIGHTNESS (tight arm) and VACCINATION SITE INDURATION (Developed a goose egg at the site of administration). On 10-Feb-2021, FLUSHING (Sensation of flushing and heat) and VACCINATION SITE PAIN (Minor injection site pain) had resolved. On 12-Feb-2021, MOBILITY DECREASED (Immobility of her limb) had resolved. On 21-Feb-2021, RASH ERYTHEMATOUS (Developed red pinpoint dots on her chest and arms) had resolved. At the time of the report, VISUAL IMPAIRMENT (loss part of her vision), DIZZINESS (dizzy), PALPITATIONS (heart palpitation), MIGRAINE (horrible migraine), MUSCLE TIGHTNESS (tight arm) and VACCINATION SITE INDURATION (Developed a goose egg at the site of administration) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Platelet count: negative (Negative) negative for abnormal platelet count..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 25-Feb-2021: No specific follow-up information recorded.
I got the vaccine around 11am. Waited 15 minutes for any side effects when the back of my throat started to feel a little bit warm. The hospital staff told me to wait a bit, after 25 minutes the back of my throat started to get hotter and it started to get harder for me to swallow. I was taken to the emergency  room for treatment. They gave me benadryl and took an exray of my throat and monitored me for the next few hours. For about 2 hours my throat continued to burn. I first was able to swallow then my throat was burning a little less. Around 3 or 4pm my throat stopped burning altogether.
Temperate as low as 94.7, chills, stomach pain, runny nose, diarrhea, exhaustion, joint pain, headache --- still experience 4 days later
Client stated at 9 pm she started having pain behind her breast bone that radiated to her back, she also got nauseous and vomited x 2.  By 8 am the pain/vomiting/nausea had resolved.
NO ADVERSE EVENT - DOSE ADMINISTERED Higher-than authorized dose (CONSENTRATION) of the formulation administered - PATIENT CONTACTED 2 HOURS AFTER DOSE ADMINISTERED NO ADVERSE EFFECT REPORTED
Cellulitis; face was weeping serous fluid; sores; Swelling; face was so swollen; swollen cheeks; Pain in face; This is a spontaneous report from a contactable nurse. An 88-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6202), intramuscular in left arm, on 25Feb2021, at a single dose, for COVID-19 immunization. The patient's medical history included Alzheimer's and other conditions, but family did not disclose. The patient was taking unspecified concomitant medications. The patient previously took piroxicam (FELDENE) and experienced allergies. The vaccine was administered in a public health clinic or Veterans administration facility. On 25Feb2021, the patient noticed pain in face in the evening of day he was vaccinated and then the patient developed swelling by the next morning (26Feb2021). On 27Feb2021, the patient's face was so swollen that his face was weeping serous fluid and family took him to the ER. The swollen cheeks bilaterally progressed to cellulitis (27Feb2021) requiring oral steroids, famotidine (PEPCID), and antibiotics including cefalexin (CEPHALEXIN). The patient remains on steroids and creams to treat swelling and sores. The adverse events resulted in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient was recovering from the events.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported event of cellulitis due to temporal relationship.  Case will be re-assessed upon the additional information provided. 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.
Pt began wheezing and complaining of breathing problems. Started 10 minutes after vaccination. Pt given Benadryl and Albuterol and recovered within about 20-30 minutes.
This case was reported by a consumer via call center representative and described the occurrence of joint lock in a adult female patient who received SHINGRIX for prophylaxis. In April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, 21 days after receiving SHINGRIX, the patient experienced joint lock and shoulder pain. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the joint lock, shoulder pain and injection site pain were not recovered/not resolved. It was unknown if the reporter considered the joint lock, shoulder pain and injection site pain to be related to SHINGRIX. Additional details were reported as follows: This case was previously not reported to anyone. The age at vaccination was not reported. The patient received SHINGRIX on the left arm. In 2018, less than a month after vaccination the patient had injection site pain. In 2018, about 3 weeks to a month after receiving the SHINGRIX, the patient's shoulder would lock up on occasion. She stated, the locking up was like a pain in her shoulder that would resolve once she moved it around a little. The patient also stated that, there was still a small amount of pain at the injection site and she compared it to a mosquito bite.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were no provided. The registered nurse stated that on 24-MAR-2018, the patient received a dose of GARDASIL 9, intramuscularly, for prophylaxis, lot# N032284, expiration date: 22-SEP-2020 (strength and dosage were no provided) and another doses of GARDASIL 9 intramuscularly for prophylaxis (strength, dosage, lot# and expiration date were no reported), were administered to the patient on 18-MAY-2018 and 27-JUL-2018, not in accordance with the prescribing information. No adverse effects were reported.
Symptoms of anaphylaxis.  Had to be transported via ambulance to the hospital.  She was admitted.
Evening: night sweats Day 2: 100F fever in a.m., headache in afternoon Day 3: large (2-3 in diameter) red welt at injection site; raised skin was warm and slightly numb.  Fever and headache gone.  Day 4: welt reduced in size, no longer warm or numb.  Day 5: all symptoms resolved.  Treatment: test, acetaminophen Days 1 and 2, lots of fluid all days.
The vaccine did not prevent shingles as intended; herpes zoster or shingles; Information has been received from a lawyer regarding a case in litigation referring to a male patient of unknown age. Information about concurrent condition, medical history and concomitant therapy was not reported. In 2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date not reported) at a clinic, as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later in 2015, the patient was treated by a physician, for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. The patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events herpes zoster and vaccination failure was not reported. The lawyer considered the events to be related to zoster vaccine live (ZOSTAVAX).
LPN withdrew greater than 20 doses from a single vial.  No untoward effects to the patient's arm.  MD notified and assessed patient
Per documentation by clinic staff: Client was monitored for 15 minutes after vaccine was administered with no adverse reaction noted at that time. Client had no complaints.
I had a flare up of rheumatoid arthritis. I haven't been able to use my body to its full potential. My right arm is affected. The more I try to do the more my body will start to hurt.
Developed fever, pain, swelling in R knee that had surgical TKA about 10 yrs ago. Pain lasted about 48 hours. Treated with OTC ibuprofen for muscle aches and fever.
swelling to uvula seen in Emergency department observed for 4 hours in Tele unit sent home on 12/21/2020