chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Persistent strain condition of herpes zoster or shingles; The vaccine did not prevent shingles as intended; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 13-DEC-2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. In 2015, the patient was treated in a clinic for a blistering vesicular outbreak which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (ZOSTAVAX) 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, patient had suffered and would continue to suffer significant medical expenses, and pain and suffering, and other damages. At the time of this report, the patient had not recovered from herpes zoster. The reporter assessed that herpes zoster was related to zoster vaccine live (ZOSTAVAX). Herpes zoster and vaccination failure were considered to be disabling by the reporter.
Vomiting after first vaccine. Bilateral Bells Palsy after 2nd dose it resolved by October 1st. Facial paralysis worse after booster 10/29/2021.
After second shot 2 days later started experiencing vertigo. Won't  go away. Nothing else wrong besides covid shot. No fever, chills, headache,  rash or aching. Just a feeling of swaying like on a boat
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 12-AUG-2015, the patient was vaccinated with a dose of improperly stored PEDVAXHIB lot # K002746, expiration date 09-DEC-2016 (strength, dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Exactly 12 hours post second dose of covid vaccine I had 103 fever, chills, body aches, muscle and joint pain. Came about very suddenly. Fever lasted about 12-15 hours. Rotated Tylenol and Advil to calm fever. Day 2 post vaccine still suffering headache, fatigue, muscle and joint pain
Extreme aggression, jerking in sleep, diarrhea and rash all over the leg and point of injection. High pitch scream in sleep and gasps.
Left arm deltoid swollen, warm to touch, tight, pt having trouble lifting arm, dad gave him at 1:00pm. on 3-1-11 for fever. Did tell dad if not any better by tomorrow 3-2-11 after taking TYLENOL/MOTRIN and gets worse he is to bring him in. Scheduled f/u at 1:30 on 3-2-11.
Body ache, fever, chills, headache, diarrhea, muscle spasm hip
PATIENT FAINTED IMMEDIATELY AFTER BEING ADMINISTERED THE VACCINE. HE WAS UNCONSCIOUS FOR ABOUT 10-15 SECONDS AND THEN REGAINED CONSCIOUSNESS. HE FELT FINE WITHIN A FEW MINUTES AFTER AND PARAMEDICS DETERMINED HIM TO BE IN GOOD HEALTH THEREAFTER. HE DENIED FURTHER TREATMENT AND CHOSE TO GO HOME.
Acute decrease in vision started hours after vaccine. Saw ophtho and reported this is just cataract (but he had never had symptoms from it before). They saw no evidence of neuritis/uveitis. Then 3 days later didn't feel well. Day 4 - fever (102), myalgia, anorexia. Fever resolved by day 5 and myalgias and anorexia slowly improving (currently day 7). Patient has remained out of work this whole week.
fever 104 degrees Fahrenheit; Chest pain; Shortness of breath; leg swelling; Dizzy; achy muscles; Caller received the first dose on 08 Apr 2021. He received the second dose on 24 Apr 2021.; Caller received the first dose on 08 Apr 2021. He received the second dose on 24 Apr 2021.; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 22-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0171 and Expiry date: Unknown) via an unspecified route of administration on 24Apr2021(at the age of 22-years-old) as Dose 2, Single for COVID-19 immunization. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 08Apr2021(at the age of 22-years-old) as Dose 1, Single for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient did not receive any treatment and diagnosed with COVID 19 and has not been tested for COVID-19 since the vaccination. On 25Apr2021,the patient experienced fever 104 degrees Fahrenheit, chest pain, shortness of breath, achy muscles, leg swelling, dizzy. The patient underwent lab tests and procedures which included blood test: unknown on an unspecified date, electrocardiogram: unknown on an unspecified date, full blood count: unknown on an unspecified date, pyrexia: 104 Fahrenheit on 25Apr2021 104 degrees Fahrenheit ,sars-cov-2 test: unknown on an unspecified date, x-ray: unknown on an unspecified date. Therapeutic measures were taken as a result of fever 104 degrees Fahrenheit (pyrexia) and treatment included Tylenol immediately. She took him to the hospital, and he was given more Tylenol. He was discharged from the emergency room 6-10 hours later. His temperature did go down to 99 and then to normal range. The outcome of events fever 104 degrees Fahrenheit, pain, achy muscles, achy muscles, leg swelling, dizzy was recovered and outcome of shortness of breath recovering while the outcome of inappropriate schedule of vaccine administered and off label use was unknown.  Follow-up needed. Information about batch/lot number has been requested.
The first Tuesday in December, I had very low energy. I had to get a second cup of coffee; I never do that. By the time I got home I had a scratchy throat and was feeling very bad. I took a home COVID-19 test, it came negative. I checked the expiration date the test was expired. I went and bought a new COVID-19 test; this time the test came back positive immediately. I called the doctor to get a prescription of the antiviral that I started immediately. I had a fever, chills, there were times when I blew my nose that I had bloody mucus that came out. I had fatigue that seem to want to linger.
cranky, irritable did not want to be touched & nothing seemed to satisfy; site swelling 2x size fifty cents piece @ site of DTP; high pitch cry for 1 hr;
broke out in hives and itched; broke out in hives and itched; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 01Apr2021 (Lot number: EP7533) at the age of 54 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure", start date: 2016 (ongoing), notes: Verbatim: High blood pressure; "Chronic kidney disease", start date: 2014 (ongoing), notes: Verbatim: Chronic kidney disease. The patient's concomitant medications were not reported. The following information was reported: PRURITUS (medically significant), URTICARIA (medically significant) all with onset 2021, outcome "unknown" and all described as "broke out in hives and itched". The event "broke out in hives and itched" and "broke out in hives and itched" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of pruritus, urticaria.  Additional information: Treatment medication: Benadryl. The patient did not receive any other vaccines within four weeks prior to the vaccination. No AE following prior vaccinations. No family medical history relevant to AE. Follow-up attempts are completed. No further information is expected.
Patient had vomiting for a day with every feed, decreased urine output, severe dehydration. Started on 7/20, for about 10 episodes before - hospitalization. U/S abd - Intussusception. Got enema reduction and f/u x-ray showed no intussusception. He recovered after enema.
shingles; blisters; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In January 2021, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 9 months after receiving Shingles vaccine, the patient experienced shingles and blister. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the blister was unknown.   The reporter considered the shingles and blister to be related to Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient received a shot of Shingles vaccine in January and the back of his/her legs broke out with tiny blisters. The patient believed that taking shot caused them. The patient did not took the second shot, 2 weeks ago his/her back out with shingles. The patient's doctor said that it's all because of the vaccine. The follow-up could not be possible as no contact details were provided.
A vial of Pfizer-BioNTech Covid-19 Vaccine (Grey cap) had been set aside to be discarded and was unfortunately used by a technician to administer a vaccine approximately 48 hours after being taken out of the fridge, well past the recommended time (12 hours). No adverse effects have been reported as of yet.
The patient presented at an outreach vaccination clinic for unsheltered/houseless/homeless individuals.  The patient requested to receive the COVID-19 vaccination.  Patient completed the Janssen COVID-19 Vaccine Screening Form and answered "No" to the question, "Have you previously been vaccinated with any COVID-19 vaccine?"  Prior to immunization and review of screening form, client reiterated that he did not receive previous vaccination.  Client received 1 dose of Janssen COVID-19 vaccine on 03/31/2021.  He was observed for 15 minutes, post-vaccination, with no observed adverse reactions.  Upon return to the clinic and web application entry, it was found that the client existed within web application, and previously received a Pfizer COVID-19 vaccination with a scheduled 2nd dose on 04/02/2021.  Patient did not specify a contact phone number on their screening form (no working phone at this time).  However, there was a listed phone number in the patient's medical chart.  Multiple attempts was made to contact the patient at that listed number.  However, there was no answer and the voicemail is full, so unable to leave any voicemails.
Panic-like attack involving numbness in the hands and muscles drawing up...lasting about 20 minutes
After first shot (lot #EH9899), I felt fatigue, nauseated, feverish, and headache. Most of those symptoms went away except the fatigue by the time I took the second shot on January 12th, 2021 ( lot# EL1284). Within 5 minutes of second shot I felt dizzy, blurry vision, pounding headache, nauseated, and very fatigue.  Nurse that was watching me said my pupils were dilated and laid me down instantly to take my blood pressure.  I dont remember the exact reading but it was high. I went home to rest as the nurse recommended. The next day I still was feeling all the same symptoms so I went to urgent care where my BP was still very high again.  I eventually went to a neurologist where he tried a bunch of different medications, to nerve blocks, hospitalization, to ablations.  I am still experiencing severe headaches, nausea, neck pain and stiffness, blurry vision that now comes and goes, and fatigue.  I have been on a leave of absence since January 12, 2021 and still on it.
approx 2hr p/vax 7/31/99 pt broke out in hives from neck down, claims extreme pruritus called ER recommended DPH;mom states resolved p/2 doses applied DPH cream;
The patient came to the pharmacy and said that Saturday the 29th of July she woke up and had a bruised arm. she said when she props the arm up she has tingling in her hands but when she puts the arm down it goes away. She had the vaccine two weeks ago and didnt have any problems until Saturday.  There were three separate bruises going down her arm in a circular pattern. She said it felt like there were knots in the arm.
The feeling of small electric shocks in the legs, chest, and arms.  The primary place is in the right arm opposite arm of where the Covid vaccine was administered.
This is a spontaneous report from a contactable nurse (patient's mother) via a Company representative. An 18 year-old female patient of an unspecified ethnicity received the fourth dose of TRUMENBA (lot M95612, expiry date 31Jul2017, NDC 00005-0100-01) at 0.5 ml single intramuscular in the right gluteus on 03Jul2017 at 09:23 am for vaccination. Medical history included anxiety depression since childhood (started at around 7 years of age) and unknown if ongoing, bundle branch block right and orthostatic hypotension, both started at 15 years of age and unknown if ongoing. Family medical history was none. There were no concomitant medications. No other vaccines were administered the same day or within four weeks.  The patient had previously received intramuscular for immunization in the right deltoid meningococcal group b rlp2086, the first single dose (lot M95612, expiry Date: 31ul2017) on 06Jul2016, the second single dose (lot M68769, Expiry Date: 30Apr2017) on 09Sep2016 and the third single dose (lot M68769, Expiry Date: 30Apr2017) on 15Oct2016, without adverse event.  The patient experienced fever (at 101 degrees F), pain injection site, fatigue, body aches, cold hands and feet on 03Jul2017.  Her hands and feet were cold but she was burning up. The patient took paracetamol (TYLENOL) for fever. No physician or emergency room visits were needed for the events. The events were considered as serious as medically significant and related to the vaccine. The patient recovered from fever on 03Jul2017, from body aches, pain injection site, fatigue, cold hands and feet on an unspecified date in 2017. The patient received a totally of 4 doses of the vaccine instead of the recommended 3 doses.; Sender's Comments: 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, as appropriate. The case will be reassessed if additional information becomes available.
this was then the patient's 4th dose of Hepatitis B; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a adult female patient who received HAB (Twinrix) (batch number dk23d) for prophylaxis.   Previously administered products included Engerix b (received full Engerix-B series on an unknown date) and Havrix (received 1 dose of Havrix on an unknown date).   On an unknown date, the patient received Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced extra dose administered (Verbatim: this was then the patient's 4th dose of Hepatitis B).     The outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date 17 August 2023: The pharmacist reported about lot number for vaccine and if it was for Twinrix or Havrix-lot number dk23d.  The pharmacist stated she believed a patient might have been given Twinrix when they only needed Havrix back in 2021. The patient received a full Engerix-B series in the MD's office and had received 1 dose of Havrix. The dose in question should have been their second dose of Havrix. The patient received Twinrix by mistake.  As a result, this was then the patient's 4th dose of Hepatitis B.  The reporter consented to follow up. The patient received 4th dose of Hepatitis B which led to extra dose administered.
Patient had small red dots around injection site on the evening of June 29, 2011. On the morning of June 30, 2011 she had hives on her thighs, legs, feet and back. Contacted the Dr. on June 30, 2011 and started her on Benadryl. The hives have not cleared up/stopped as of now.
Headache started 4 hours after injection. 16 hours later, Fever 102, severe chills, bone pain, nausea and vomiting lasting 24 hours after starting of symptoms. Fatigue and off and on chills with 100.5 for another 24 hours with nausea but no vomiting
Pt was administered a third dose of the covid vaccine in error. nursing home staff presented the patient to staff as someone who needed a 'second dose'. Pt had already had a second dose (12/21/20, 1/11/21, 2/1/21). No adverse effects were reported. Error was discovered by healthcare supervisor on 5/10/21.
Close to "urea sepsis"; severe UTI; A spontaneous report  was received from consumer concerning a 82-years old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced severe UTI/urinary tract infection and close to urea sepsis/sepsis.  The patient's medical history was not provided. Concomitant medications was not provided by the reporter.  On 16-Feb-2021, the patient received second of the two planned doses of mRNA-1273 (lot number: 006M20A) in the left arm for the prophylaxis of COVID-19 infection.  On 16 Feb 2021, the patient developed a severe UTI. Close to urea sepsis. Took antibiotics.  Treatment medication included antibiotics.  No lab tests were mentioned.  The events severe UTI and close to urea sepsis were considered to be serious with criteria of important medical event.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  The outcome of the events severe UTI and close to urea sepsis was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
I initially noticed symptoms on January 08, 2023. I tested myself on January 09 and it was positive.  At that time, I had fatigue and thought I had the flu. I was congested and had fatigue. I reached out to my doctor on January 10. He offered Paxlovid and a milder form of treatment. I chose the Paxlovid and started the dose the same day. I immediately felt results, but it took a few days to feel better. In total it took about 10 days to go back to normal. My sense of taste and smell came back after that time. I tested negative on January 17, 2023.
This spontaneous report was received from a Pharmacist via company representative refers to a female patient of age between 14 and 16 years old at the time of vaccination. The patient's medical history, concurrent condition and concomitant medications were unknown. On an unknown date in 2017 (reported as 2 years ago), the patient was vaccinated with GARDASIL 9 (strength, formulation, dose, unit, frequency, route of administration unknown) as "routine vaccination" (prophylaxis). On an unknown date, the patient experienced neurological pain and symptoms similar to multiple sclerosis (Multiple sclerosis). It was reported that the patient sought unspecified medial attention. No Product quality complaints involved. Outcome and causality of the events were not reported. Upon internal review, the event "Multiple sclerosis" was determined to be medically significant.
BODY ACHES; CHILLS; FELT PRETTY CRAPPY; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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) dose, start therapy date were 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, the subject experienced body aches, chills, felt pretty crappy, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, felt pretty crappy, and fever. This report was non-serious.
Both Breast sore and tender; Both Breast sore and tender; Pfizer Booster; Pfizer Booster/initial COVID vaccine was J&J; muscle was sore in the arm she got injection in; 202101844781 -This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Dec2021 14:00 (Lot number: FD7218) at the age of 67 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Lumpectomy", start date: 2021 (unspecified if ongoing), notes: Lumpectomy was a month after the J&J COVID vaccine and the radiation was completed Jul2021. There were no concomitant medications. Vaccination history included: J&j vaccine (initial COVID vaccine was J&J., Batch/lot number: 206A21A, Unknown Dose. Injected in the left upper arm in the muscle.), administration date: 12Apr2021, when the patient was 66 years old, for Prevention, reaction(s): "muscle soreness in left arm". The following information was reported: IMMUNISATION (non-serious) with onset 19Dec2021 14:00, outcome "unknown", described as "Pfizer Booster"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 19Dec2021 14:00, outcome "unknown", described as "Pfizer Booster/initial COVID vaccine was J&J"; BREAST PAIN (non-serious), BREAST TENDERNESS (non-serious) all with onset 20Dec2021, outcome "recovering" and all described as "Both Breast sore and tender"; MYALGIA (non-serious) with onset 19Dec2021, outcome "recovering", described as "muscle was sore in the arm she got injection in".  Additional information: She said both breast were sore and tender, but the one that she had the lumpectomy and radiation in this past spring/summer was more sore. That was prior to getting the Pfizer vaccine. Her initial COVID vaccine was J&J. The surgery and radiation was a couple of months after the J&J vaccine. She had Pfizer COVID booster shot on Sunday, 19Dec2021, so Monday, 20Dec2021, is when the breast tenderness and soreness began. On Monday and Tuesday, it was quite uncomfortable, but today is still tender when she took shower, but a little improved. Her muscle was sore in the arm she got injection in, but she thought everyone got that. Muscle soreness has improved at injection site, but it is still a little sore. She wants to be fully protected. They put a prescription number of withheld, on the J&J card. It says RX number. She then found the lot number. The only reaction was muscle soreness to left arm after that one. She is not on any other medications. The Lumpectomy was a month after the J&J COVID vaccine and the radiation was completed Jul2021. Both breast sore and tender morning and Left arm muscle soreness at injection site right after driving home.