chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and referred to a currently 74 years old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On an unspecified date in 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose, dose number and route not specified) for long-term prevention of shingles and zoster-related conditions.  On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Blood tests conducted by my doctor due to stomach pain revealed elevated liver enzymes.  Ultrasound of liver and surrounding organs showed nothing wrong, but three blood tests continued to show the elevated liver enzymes that are inexplicable to my doctors.
Allergic reaction to shot, lips and face began to swell felt like he was going to vomit. Stayed with patient and called 911 made sure patient was able to breathe.
Client reports that she had the following symptoms for 6 days: a low grade fever ; significant pain in her back such that she had difficulty moving; she developed hives; and had nausea/diarrhea.  She is wondering is a component of the vaccine somehow interacted with the steel plates in her back to cause such significant back pain.
MUSCLE SPASMS RIGHT SIDE, MOSTLY THIGH BUT SOME ARM ALSO. ?IMPROVED WITH IBUPROFEN
no additional AE's; temperature excursion / temperature 34.1 F; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, current conditions nor concomitant therapies provided.  On 19-MAR-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), dose/frequency reported as 1 (unit not provided), lot # 1687292, expiration date 25-AUG-2022 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered dose was stored in temperature of 34.1 degrees Fahrenheit (F) for 4 hours and 15 minutes. Previous temperature excursions were reported as follows: 34.8 F for 45 minutes and 34.7 F for 2 hours and 45 minutes (dates not provided). Digital data logger was involved. The patient was reported to be asymptomatic, no adverse events (AE's) were reported.  This is one of several reports from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687292; expirationdate: 25-AUG-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA007278: US-009507513-2104USA007277: US-009507513-2104USA007276: US-009507513-2104USA007270:
spontaneous. patient call for a refill on tyvaso and stated she experienced spots/blisters on her legs and low iron.  stated her md is aware and believes this is from her recently receiving a shingles vaccine. reviewed sided effect with patient. patient currently uses td-300 device, has two devices, reports no issues with either tyvaso decive. no other information known at this time
Extreme irritability, mucus, congestion, inability to hold bottle as previously able, fever of 100 degrees.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Batch/Lot number: unknown), on 21Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 29Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 36 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 15May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Mild intermittent asthma" (unspecified if ongoing), notes: Other medical history: Mild intermittent asthma; "interchange of vaccine products" (unspecified if ongoing), notes: Moderna on 15May2022, dose 4. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Patient experienced rebound covid-19; Unknown results, notes: Symptoms returned 5 days after completing Paxlovid. Symptoms included + Rapid antigen testing, fever, chills, malaise, rhinorrhea, and sore throat. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient experienced rebound covid-19. Symptoms improved while taking Paxlovid. Symptoms returned 5 days after completing Paxlovid. Symptoms included + Rapid antigen testing, fever, chills, malaise, rhinorrhea, and sore throat.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the Vaccination failure (LOE) and COVID-19 cannot be ruled out.
Within 12 hours of immunizations, child developed rhythmical shaking of right arm,1-2 times 10-20 seconds ever 2-3 days. Became more prevalent, spread to the opposite side with generalized events, EEG (+) for generalized seizure, No fever or uncontrollable crying. Follow up report received 11/22/02 states " Child seizure free on phenobarbital + Tegretol. We have since vaccinated thechild with IPB and HIB.".
I developed Idiopathic thrombocytopenic purpura (low levels of platelets) and menorrhagia due to the vaccine according to my doctor. I believe there have been about 30 cases of this occurring so far.   In my case, I took the vaccine and felt relatively tired for two days. There were no other symptoms. About a week later, I got my period after not having it for a couple months. The blooding was light for a few days, but then got extremely heavy. After about a week of very heavy bleeding, I went to urgent care. They took blood tests, and found that I had a critically low level of platelets (6 platelets when the normal range is 150-400). I was admitted to the ER for multiple days, and they gave a platelet transfusion and IVIG  fluids, which has helped considerably. I also had to take steroids to suppress my immune system so that my platelets could increase.
Pt first called on 08/22/17 stating she now had swelling and a fever after the vaccine that was given to her. The RN called pt back and pt stated she has a fever of 99.0 that last night and this morning the injection site was itchy, red, and swollen to the height of a mosquito bite and circumference of a baseball. Pt denied rash, hives, swelling of face or throat, difficulty breathing, tachycardia, dizziness, weakness. RN advised Pt that if she experiences any of those sx she should seek immediate medical attention at the ED; for difficulty breathing or throat swelling she should call 911. RN advised Pt to use a cool compress on the area and oatmeal bath to reduce itching and swelling. Pt voiced understanding and had no further questions at that time. The following day, the patient called regarding the reaction. She stated that she had to go to the urgent care because it became more swolen, hard and painful. The reaction covered her arm up to her tricep area. The RN returned call to Pt, the Pt stated that she had a reaction to the varicella vaccine, as documented on 8/22. Initially the affected area was the size of a baseball, redness and itching were mild to moderate. As the evening progressed the affected area became increasingly reddened, painful/burning, hard, and extended to the axillary area; Pt also had a fever of 100. Pt went to UC and was prescribed an antibiotic and steroid. Pt reported that swelling and pain have decreased slightly. Pt denied rash, hives, swelling of face or throat, difficulty breathing, tachycardia, dizziness, weakness. Pt drew a line around affected area to monitor for increase in size. RN advised Pt to seek immediate care at the ED for these sx or for increase in severity of current sx. Pt voiced understanding and had no further questions at that time.
Patient reported that he experienced numbing in his left arm and his lips 10 minutes after receiving the first dose of Covid-19 vaccine. He was provided a bottle of water and 2 tablets of Benadryl 25 mg tablets. He seemed to be anxious and walked around the store in an agitated manner. The pharmacy team kept monitoring him for another 15 minutes, he reported that his numbing condition was getting worse. We asked if we could call 911 and he agreed. The 911 team arrived within 15 minutes and checked his health condition. The blood pressure reading 143-85, the oxygen level was 100%, and the heart rate was 96. The 911 team confirmed that he did not have to go to the hospital. Patient confirmed with me that he did talk to his doctor and he was feeling well to go home.
Narrative:  COVID infection following COVID vaccine series 04/16, Pfizer, dose #1 05/10, Pfizer, dose #2 12/27 COVID swab, result: detected 12/27 pt cc: chills, cough, fatigue, headache, myalgias, rhinorrhea, exposure: unknown 12/30 clinically resolved
Flublok Quadrivalent was administered to 11 year old, no AE; Initial information received on 28-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2019SA301753 (same reporter).  This case involves a 11 years old male patient who received a 0.5 ml dose of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot: QFAA1963, expiry date: 30-Jun-2020) via intramuscular route in the left deltoid on 24-Oct-2019.  Medical history, medical treatments, vaccinations and family history were not provided.  It was an actual medication error due to inappropriate age at vaccine administration.  At the time of reporting, the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Fever, diarrhea and intermittent vomiting for  every 6-7 days for a month
Patient has history of vasovagal reaction, had flushing/sweating, dizziness, nausea. Did not eat breakfast prior to vaccination. BP 103/62 HR63, RR16, pt given juice/water/crackers, left in stable condition.
On March 14, 2014 I received ZOSTAVAX, the shingles vaccine. About 4-6 days later I was achy, had a headache and was running a fever of about 101-102. I kept the fever for a two or more days and my glands were swollen in my neck as well as my tonsils. About a week from the onset of the fever on 3/24/14, I went to my Doctor because I couldn't seem to get my glands clear. I did not have any sinus issues, runny nose, earache and my lungs were clear. Just swollen glands in my neck and swollen and painful tonsils. My doctor gave me a prescription for antibiotics, but suggested I could beat this and would not need to fill it. I waited a few more days, but when my tonsils were so bad that it was very difficult to swallow, I filled the prescription. My Doctor did agree that I must have had a reaction to the vaccine. Within a few days to a week I was fine. On June 15th I started having irregular heartbeats and went to see my doctor on the 16th. He verified the irregular heartbeats and scheduled a visit with a cardiologist. I was not able to see the cardiologist until Sept 5th. (I went to immediate care in July due to dizziness, heart ache, shortness of breath and heart arrhythmia. A thyroid test was done and it was fine. He prescribed a beta blocker, but I was reluctant to take it since my blood pressure and pulse are normally low. I continued to limit caffeine, alcohol, and I did not take any other medicines.) On Sept 5th I met with the cardiologist and he prescribed a 2 week heart monitor. I took the monitor home with me on the 5th. On Sept 8th I went to our local hospital emergency room. I had shortness of breath, pain in my left shoulder and arm, heart ache, racing heart. The hospital ER treated me like I was in cardiac distress and admitted me for more tests. I had an electrocardiogram and a stress test. My arrhythmia doctor noted the rapid pulse rate increase from the stress test and said that it appears that I have inappropriate sinus node tachycardia. But, that I would have to of had a virus that would have caused this. I told him about having the shingles vaccine I received in March and he is now treating me for this condition. I have been taking a beta blocker since September 9, 2014 until now. I am much better and trying to reduce the amount of medication that I am taking. All the tests perform indicate that heart is structurally normal.
Pt started sturning red, then breaking out into hives, whelts the following night. At ER, pt given Benadryl.
The patient received 0.5 ml of the  vaccine instead of 0.25 ml for the second booster dose
Patient had an injection site reaction including erythema (16 x 7 cm) with a center induration of 4 x 2.5 cm. She is currently treating with ice and BENADRYL. Called pt 6-25 and she states is doing better and there is less redness/swelling.
fever up to 101.8, chills ,  body aches, and fatigue.  symptoms started at about 8 am the Friday morning 1/29/2021 after the shot was given (Thursday 1/28/2021 at 430 pm) .  symptoms lasted until fever broke at about 1am Saturday 1/30/2021 morning.    today, at this time of reporting 8:52 at on Saturday 1/30/2021 ,  symptoms are gone and feeling nearly back to normal .
PT CALLED  SAYING SYMPTOMS STARTED TODAY 6/30: DROOPING ON ONE SIDE OF FACE, REPORTS TENDERNESS, TROUBLE SWALLOWING; DENIES TROUBLE BREATHING OR SIGNIFICANT PAIN IN AREA. EXPLAINED IT MAY BE BELLS PALSY. PT WILL BE GOING TO ER TO BE FURTHER EVALULATED.
Information has been received from a certified medical assistant (C.M.A.) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 19-FEB-2015, the patient was vaccinated with a dose of improperly stored (Oka-Merck) PROQUAD, lot # K014798 (expiration date 12-MAR-2016, dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
Headaches, soar throat, body aches, pain in the pulmonary area. 2 days now.
1ST SHOT MADE ME MILDLY ILL FOR 3 DAYS, SORE ARM 2ND SHOT THERE WERE NO SIDE EFFECTS
Fever, body aches, chills, sore throat started 10/29/14. Treated with ibuprofen. Patient continued to get worse through the day on 10/30/2014. Fever spiked to 104.7 on 10/30/14 at 8:00 PM. Called pediatrician's office, got the on-call answering service. Was told to give luke warm bath, keep her out of clothes (underwear only), put a fan by her, have her drink water, cool wash cloth to forehead. Also advised to take her to the ER if temp not down below 103 in one hour. Interventions done, ibuprofen also given. Temp decreased to 102.8 and continued to decrease. Temp checked again at 12:45 AM on 10/31/14 and had again spiked to 104. Advise interventions done again, also Tylenol given. Temp decreased slowly. Ibuprofen given again at 2:15 AM. By 3:15 AM, temp was down to 101.8 Temp at 6:00 AM was 100, Tylenol given again. As of this report time (10:00 AM)temp is stable at 99.8.
Initial information received on 27-Jul-2018 regarding an unsolicited valid non-serious case received from a other health professional, Physician. This case involves an unknown patient (age and gender not specified) who received vaccine FLUZONE HIGH DOSE. The patient's past 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 a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route. It was a case of actual inappropriate age at vaccine administration and Drug prescribing error. It is also an off label use as Prescriber was using FLUZONE HIGH-DOSE in patients aged 50-64, but FLUZONE HIGH-DOSE is indicated only for patients aged 65 or older. It was unknown whether patient experienced adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
11 year old patient was given adult Pfizer dose.  Patient's mother stated it was done by different Services.  Initial on vaccine card was .  Followed appendix A on CDC website and given pediatric pfizer for second dose.
She had 101.5 fever after her vaccine, but it went away within 24 hours
Shortly after the patient received the vaccination, the patient fainted briefly. She was caught by her brother and laid on the floor. He got the attention of the pharmacist. She was already awake when the pharmacist arrived. He had her lay on the ground for about 5 minutes. After that, she was helped over to a bench where she finished recovering.
This spontaneous report was received from a physician referring to a 16 year old patient of unknown gender. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. Approximately in 2013, when the patient was 11 years old, the patient was vaccinated with GARDASIL for prophylaxis (strength, route, dosage schedule, lot number and expiration date were not reported).  On 03-AUG-2018, the patient was in the physician's office in order to receive GARDASIL 9 as second dose in human papilloma virus (HPV) series. No adverse effects reported.
After vaccine slept all day.  Woke up refused to eat.  Started eating became extremely picky.  Over the next 10 days he became floppy and lost weight.  Stopped meeting milestones. Diagnosed with low muscle tone, underweight and developmental delay.  As a baby he was strong and healthy.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned an adult male of unspecified age, 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 (suspension for injection, route of administration not reported, batch number: unknown expiry: unknown) dose was not reported, 1 total administered on 20-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 06-OCT-2021, antibody test was performed with negative result (confirmed immunological vaccine failure). The action taken with covid-19 vaccine was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with regulatory authority.; Sender's Comments: V0: 20211017456-COVID-19 VACCINE -confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS
mom states pt had MMR 1 wk prior 8MAY93 pt was sleeping & during routine checking on pt husband noticed pt not breathing, not moving & had turned blue; called 911; ER called it a vax reaction to MMR;
Information has been received from a physician concerning a 10 year old male with no pertinent medical history or drug allergies, who on 13-AUG-2007 was vaccinated with a 0.5ml dose of varicella virus vaccine live (Oka/Merck) (Lot# 658021/0827U). There was no concomitant medication. On 15-AUG-2007 the patient developed injection site redness and swelling. Medical attention was sought through the reporting physician. No labs or diagnostic studies were performed. A cold compress was recommended as treatment for the patient. Subsequently, the patient recovered. There was no product quality complaint. This is one of three reports from the same source. Additional information has been requested.
Tired - around 3:00 1 round Tired & I feel like something is heavy on my chest. woke up every 2 hrs.  2:25 2 round
Patient's mom states received Flu shot on 10/15/12 at AM, late evening noticed his lips were swollen and had rash on extremities like urticaria, gave BENADRYL & sx resolved. "Did not f/u here next day. Declined any associated sx of N/V/F/D/SOB/ or CP. F/U M states pt had some lip rash with scrambled eggs. No prior hx.
had hives within an hour of the injection; itchiness all over the body; tingling on the right side which is the same side of my injection.; This is a spontaneous report received from a contactable consumer (reporting for herself) via medical information team. A 28-year-old female patient received the first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, Lot number and expiry date: Not provided) via an unspecified route of administration in Mar2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were reported. On an unknown date in Mar2021 It was reported that patient had hives within an hour of the injection and itchiness all over the body and tingling on the right side which is the same side of my injection. I had to take an adequate amount of Benadryl. The outcome of the events was unknown.  Information on Lot and Batch number is requested.
This case was reported by a pharmacist and described the occurrence of loss of left function in a female subject of unspecified age who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis.  The subject's medical history included multiple sclerosis.  On an unspecified date before 07 December 2006, the subject received unspecified dose of Fluarix at an unspecified site of injection. At an unspecified time after vaccination with Fluarix, on an unspecified date before 07 December 2006, the subject experienced loss of leg function and leg numbness. The events resolved on an unspecified date on or before 07 December 2006.  Comment: Loss of leg function was assessed as medically serious. (OMIC)
following administration, pt had progressive diarrhea, hypoglycemia not responsive to eating/drinking requiring hospitalization (glucose as low as 31 - short D5W drip); workup for infection, thyroid, or adrenal cause all negative