chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient / 40 years old with a prescription to get vaccinated; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a 40-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced intercepted drug prescribing error. On an unknown date, the outcome of the intercepted drug prescribing error was unknown.  Additional details were provided as follows: The age at vaccination was not applicable to this report. The pharmacist inquired about the approved age of the Shingrix vaccine because he has a patient at his pharmacy that is 40 years old with a prescription to get vaccinated, which led to intercepted drug prescribing error. The pharmacist states was not planning on administering the vaccine initially and only wanted to verify. The reporter consent to follow up.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 1:20 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On 27-Oct-2021 at 1:20 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 76.70.  No concomitant medications were reported.  Batch number 035C21A administered on 27-Oct-2021 underwent temperature excursion with temperature range 29 to 32 degrees Fahrenheit from 09:00 AM to 10:00 AM. This vial was moved to fridge on 29-Sep-2021, 05-Oct 2021 and beyond use date for the vial was reported as 29-Oct-2021, 04-Nov-2021. Product moved to clinic on 27-Oct-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. No treatment medications were reported.
pt rcvd vax; devel inject site rxn w/ a red, hard lump 1 to 2 inches in diameter.
This case was reported in a literature article and described the occurrence of membranous nephropathy in a 60-year-old female subject who was vaccinated with Flu vaccine (manufacturer unspecified). Parent's medical history included Guillain-Barre after influenza vaccination (her father). He died from it. On an unspecified date, the subject received an unspecified dose of Flu vaccine (administration site and route unknown, batch number not provided). 5 days after vaccination with Flu vaccine, the subject experienced abrupt onset of lower extremity pitting edema and hypertension. This case was assessed as medically serious by GSK. Her laboratory data revealed acute kidney injury with serum creatinine of 10.2. Her spot urine total protein to creatinine ratio was 23. Serological workup was negative. She underwent kidney biopsy which was showed stage 1 membranous nephropathy with acute interstitial nephritis. She was started on daily oral prednisone (0.75 mg/kg) with tapering doses over the next two months. Her renal function normalized (Serum creatinine-0.9) five weeks after initiation of oral prednisone. Her spot urine total protein to creatinine ratio decreased to 1.3. After one week of completion of therapy, patient was found to have elevated Serum creatinine of 2.3. Her spot urine total protein to creatinine ratio increased to 28. At this time, patient underwent repeat kidney biopsy which showed membranous nephropathy with resolution of acute interstitial nephritis. Patient was restarted on daily oral prednisone (0.75 mg/kg) which was tapered over the next 4 months. One month after initiation of oral prednisone, her serum creatinine decreased to 0.9. Her spot urine total protein to creatinine ratio decreased to 0.2 upon completion of therapy. She continued to be in remission, six months after completion of oral corticosteroid therapy. The abrupt onset of nephrotic syndrome after influenza vaccine was suggestive that there was activation of the immune system which was triggered by the vaccination.
Approximately 6 hrs after injection felt weak, pain in arm which quickly lead to severe shaking chill, nausea and extreme weakness and need to lie down. Could not get warm or stop shaking. Took BENADRYL 50 mgm which helped in about 30 min. Was in bed for 24 hours. Malaise lasted sev. more days. Have had flu shot x 40 yrs - no previous reaction.
Within hours, feeling of malaise and sore at injection site. Developed a fever and was in a flu-like state for the next 4 days. This resolved.  Although there is a history of mild nosebleeds due to dry weather, my child began having regular and hard to control nosebleeds after receiving the second dose. He is passing clots up to six inches in length and going through dozens of tissues to soak up the blood and clots. Bleeds are lasting roughly 15 minutes
Soreness at injection site continues several weeks after receiving vaccine. Advil taken daily.  Hurts when pressure applied at injection site.  Ache in shoulder experienced when sleeping or waking feels dull.
I had painful arm from Flu shot for 3 Days. I usually do every time I get the Flu Shot. I noticed this time around I was having worst side effects which I never had before. I started  getting a slight fever off and on. I also started breaking out in hives/skin rash off and on . It itches. I use antiitch ointment for it. I continue to have the same symptoms. I thought I would report it to you as the paperwork I received from the pharmacy stated.
Itching all over her body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching all over her body) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itching all over her body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; METOPROLOL at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZIRTEC) at an unspecified dose and frequency. At the time of the report, PRURITUS (Itching all over her body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications reported.
At 15 mins I was released. As I drove away from the clinic, 20 mins, I was flooded but a wave. My heart started pounding, my throat and mouth were tingling and tightening, my face and ears turned red and flushed.  At about 45 mins, I became extremely dizzy like I was intoxicated .  My mouth and throat kept tightening and tingling in waves. My skin was itchy and red in patches.  I felt like I was having a stroke on the right side of my face. My right eye and face felt odd. Over the night and next days, my chest was tight on the left side and pain in my left arm and sharp stabbing pain in my left back and side.  The next day I had heavy chest and shortness of breath and remained dizzy.
10 minutes after receiving the vaccine, my left hand went numb.  The numbness started at my wrist and went all the way to my fingertips.  Approximately 20 minutes after receiving the vaccine, my left food went numb.  My hand was still numb at this time.  Approximately 25 minutes after receiving the vaccine, part of the left side of my face was slightly numb.  The facial numbness started at the edge of my left eye and went straight down to my chin and over to the left all the way to my ear lined up near the earlobe.  My hand and foot were still  numb at this time.  Approximately 35 minutes after receiving the vaccine, all of the numbness went away.  At approximately 3:00 a.m. on 1/16/2021, I woke up with a splitting headache and the chills so severe that my teeth were actually chattering and banging into each other.  Later, I woke up overheated with the sweats.  At 9:00 a.m. on 01/16/2021, I had symptoms that were flu-like.  I was dizzy, light-headed, and nauseous as well.    For the remainder of the day, I felt flu-ish, had generalized fatigue, my headache continued, and my left arm near the injection site was extremely sore.  On 01/17/2021, I was still suffering from a severe headache and had generalized fatigue.  My left arm near the injection site was still extremely sore and was now also red in color.        To combat the headache, it required both ibuprofen and acetaminophen simultaneously.  One medication on it's own was not enough.  By 01/18/2021, my headache was gone as was my body aches.  The only lingering effect on this day was a sore arm at the injection site that was still red in color.
Symptoms of headache, fever, and vomiting for many days, leading to eventually weakness in the upper/lower extremities, altered mental status, and loss of bladder control. Diagnosed clinically and radiographically with acute disseminated encephalomyelitis (ADEM). She received high dose solumedrol, followed by a steroid taper. She relapsed approximately one month later, and required re-hospitalization and IVIg.
arm pain, mild chest pain, mostly around the sternal area, more with on palpation,  extremely elevated troponin levels (high normal is 0.04 for our labs, patient had 20) echocardiogram negative transferred to a more complex center, Hospital
Pt reports area of injection hot and swollen for the 4 days prior to reporting to me. Stated the irritation began the day after injection (6/29/22) and was reported to me on 7/4/22. Pt took acetaminophen with minimal relief of symptoms. Discussed taking ibuprofen, seeing provider for treatment of possible injection, hot/cold therapy.
A 48-year-old female patient was in the observation area after receiving her first dose of Pfizer and referred to the EMT feeling tachycardia.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2010, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 06-MAR-2013, the patient was treated at a medical facility for a persistent and severe vesicular rash, which was diagnosed as shingles. The patient was prescribed VALTREX for management of her painful symptoms. As a direct and proximate result of the VALTREX vaccine, and/or despite receiving VALTREX for long-term prevention of 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. Additional information has been requested.
Violent behavior; death from natural cause; First Primary monovalent dose on 06MAR2021 2nd Primary monovalent dose on 27MAY2021; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (death from natural cause) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016J21A and 004C21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Mental impairment (He was crazy).   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Primary monovalent dose on 06MAR2021 2nd Primary monovalent dose on 27MAY2021). On an unknown date, the patient experienced AGGRESSION (Violent behavior). The patient died on 26-Mar-2023. The cause of death was not reported. An autopsy was not performed. At the time of death, AGGRESSION (Violent behavior) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Primary monovalent dose on 06MAR2021 2nd Primary monovalent dose on 27MAY2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that the patient died of natural causes. Reporter stated that Moderna vaccine was causing all kinds of problems. Patient had violent episodes prior to his death. No treatment details were reported. Company comment This spontaneous case concerns a 70-year-old male patient with no relevant medical history reported, who received 4 doses of mRNA-1273 and experienced the serious, medically significant, fatal, unexpected event of death and the non-serious event of violent behavior. Death occurred almost 1 year after the 4th dose of mRNA-1273. Violent behavior occurred on an unknown date. The primary doses were received with an interval of approximately 2 months between the 2 doses, therefore, inappropriate schedule of product administration was considered as an additional event. The patient afterwards received the two booster doses. It was reported that the patient died of natural causes and had violent episodes prior to his death. Since the event death occurred almost 1 year after the 2nd booster dose and it was reported that it was due to natural causes, therefore, the causality was considered as not related. No further clinical information was provided for medical review. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Reported Cause(s) of Death: died of natural causes
He felt nauseous, got up to go to kitchen sink and passed out for a few seconds.  When I got to him, he was on the ground, eyes open, but seriously disoriented. He got up to the couch. He was very, very clammy and his heart rate was 44 bpm.  I held three fingers for him to identify, he correctly answered. He has a small gash on his forehead.  His heart rate came up to 70, 20 minutes after episode. Refused to go to urgent care.
No adverse event from the vaccination.  However, the VAERS lady who called me said that I had to complete this form because I had an unrelated medical diagnosis of breast cancer in November 2021 and a bilateral mastectomy on December 22, 2021.
pt fainted p/leaving the clinic area;pt became dizzy & began to loose balance;pt brought back to clinic area & placed on chair;wet towels placed on forehead & neck;H20 given to pt;pt placed on exam room to lay down sx subsided;
The patient received a short dated (expired 9/30/22) immunization which was told to the immunizer after the fact.  There was no adverse reaction.  The stability data from the manufacturer supports the use through oct 19th and revaccination is not indicated.
Expired Vaccine given on 10/24/23, expiration date of 10/08/2023
Pt presented to Hosp several hrs p/immun  w/t105.1 & area of induration on rt leg 15-18mm; Pt had 15-20sec sz w/apnea @ home; dx febrile seizure w/secondary OM; Given ATB;
Case number PHEH2011US01363 is an initial spontaneous report received from health care professional on 11 Aug 2011. This report refers to a patient of an unknown age and gender. The patient was vaccinated with MENVEO (batch number: unknown) on unspecified date. But, the patient received only the Men CWY liquid conjugate without reconstituting it with the Men A lyophilized powder component. No adverse reaction had occurred following this drug administration error.
LUPUS ERYTHEMATOSUS; STOMACH UPSET; SPASM MUSCLE; BODYACHE; HEADACHE; This spontaneous report received from a patient via other manufacturer (AbbVie) concerned an adult female of an unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown and expiry: Unknown) dose was not reported, 1 total (Dose 1), start therapy date was not reported for covid-19 prophylaxis. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number: 1164824 expiry: UNKNOWN) dose, frequency, and therapy dates were not reported for moderate to severe hidradenitis suppurativa. No concomitant medications were reported.  On an unspecified date, the patient experienced lupus erythematosus, could not handle the heat, sick, depressed, angry, stomach upset, spasm muscle, headache, and body ache. The patient experienced spasms throughout her whole body in her muscles, when she received covid vaccination it really made her sick for a day and experienced a massive headache, entire body ached and her stomach was upset. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient had not recovered from lupus erythematosus, and the outcome of sickness and stomach upset was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220853574-covid-19 vaccine ad26.cov2.s-lupus erythematosus. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
The day after the shot, there was mild irritation in left shoulder. The 2nd day, it  got a little worse. One the 3rd day the discomfort started to decline.
I had received the Moderna Covid vaccines on 1/13/2021 and 2/09/21.  On 9/10/2021, I received the J&J vaccine as a booster.  On 9/16/21, I was working in the garden which included pulling plants (including poison ivy) and bundling branches from our oak trees.  On 9/17/21, I noticed a pruritic rash, first on the right arm and later on the left arm.  I started treating it with triamcinalone cream 0.1% and oral antihistamines without much help.  The rash later began on my legs.  On about 9/21, I began having a rash on my abdomen.  Initially, I assumed a rhus dermatitis and when it didn't improve, oak mites.  On 9/23/21, I departed for another area.  After several days of unsuccessful treatment with topical  steroids and antihistamines, I came to the realization that this may be a reaction to the J&J immunization.  I found several examples in the literature and I treated myself with a medrol dosepack.  I had rapid improvement with 90% improvement after 6 days or oral steroids.  The remaining rash and pruritis resolved over the next 2 weeks without any other treatment.
First time having COVID symptoms; tested positive; First time having COVID symptoms; tested positive; COVID symptoms started on day 7 including loss of smell.; Horrible chest pressure 3 days after vaccination.; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Intramuscular in left arm on 15Jan2021 15:30 at single dose for Covid-19 immunization. Medical history was not reported. Concomitant medications included progesterone and estradiol. The patient was not Pregnant at the time of vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no Allergies to medications, food, or other products. The patient had Horrible chest pressure 3 days after vaccination (18Jan2021 07:00). COVID symptoms started on day 7 (22Jan2021) including loss of smell. First time having COVID symptoms; Nasal Swab tested positive on 26Jan2021. The patient was unknown if diagnosed with COVID-19 Prior to vaccination. The patient had been tested for COVID-19 Since the vaccination. The events resulted Doctor or other healthcare profession-al office/clinic visit. Treatment received for all events included Chest xray. The outcome of all events was resolving.  Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded.  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.