chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. I am opposed to any mandatory anthrax vaccine being given. My husband is in the military brigade. Half of this brigade had one of the most common side effects of the anthrax, pneumonia, after being given this shot when they were in training last year. And this is only one of the milder side effects. I would also like to say that I have had several men I know become ill from this shot. One man in lost complete use of his arm after the shot, another man had two hospital trips and almost died from heart problems after the shot, another man developed severe asthma, and half of the brigade developed pneumonia after receiving the shot. This is not a shot that should be given to anyone. Antibiotics work, and are safe.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies:Sulfa" (unspecified if ongoing), notes: known allergies:Sulfa. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jan2023) Postive, notes: Negative test on 4th. Positive again on 6th. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient with 2 COVID vaccines who admitted with hypoxia and COVID detected test.  Provider d/c note:  ""87-year-old male patient with past medical history of chronic obstructive pulmonary disease, chronic kidney disease stage IIIB, hypertension, diastolic CHF, coronary artery disease, status post CABG status post stenting, presents with increasing shortness of breath, cough with yellowish expectoration and some chest pain.  He was found to be COVID positive, viral respiratory panel was negative for everything else.  CTA chest showed increased bronchial wall thickening and peribronchial nodularity and consolidation.  He was also found to have COPD exacerbation and started on appropriate therapy.  Respiratory status improved and he was weaned off of oxygen.  He did desaturate with ambulation so he was sent home with oxygen.  Pt was stable on discharge.     Acute hypoxic respiratory failure 2/2 COPD exacerbation, CAP and COVID  - hypoxia resolved - CTA chest showed increased bronchial wall thickening and peribronchial nodularity and consolidation  - treated with a 5 day course of ceftriaxone and prednisone  - continue Breztri and Trelegy"
Headache, Arthralgia, FATIGUE, RUNNY NOSE, PAIN/SWELLING TO INJ SITE Narrative:
This spontaneous report was received from a physician regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 16-AUG-2018 the patient was vaccinated with improperly stored dose of ROTATEQ lot # N010709 with expiration date: 05-DEC-2018 (strength, dosing details and route of administration were not reported) for prophylaxis (product storage error). No adverse effect was reported. The storage temperature was below 0 degrees centigrade (C) (-5.3 C) (1 cycle) and time frame was 40 hours. There was no previous temperature excursion. Digital data logger was involved.
pain in stomach after the second dose; Her hemoglobin was 7. Normal for women is 12-13./ One result for her hemoglobin was 7.1 then it was up to 7.9.; She had Xrays and an Ultrasound. Those indicated she had a hiatal hernia.; She still is having blood problems.; She also had an upper GI; The pain was higher up and went from side to side and would go around to the back.; The pain was higher up and went from side to side and would go around to the back.; She continued to feel sluggish and dizzy after te second dose and had stomach pain.; She continued to feel sluggish and dizzy after te second dose and had stomach pain.; slept the whole day after getting the second dose; This is a spontaneous report from a contactable consumer. This 68-Year-Old female consumer reported for herself that received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EW0158 and expiration date: unknown), via an unspecified route of administration on Left arm anatomical location on 10Jun2021. (at the age 68-year-old) as a dose 2, single for covid-19 immunisation. Patient historical vaccine included received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EW0158 and expiration date: unknown), via an unspecified route of administration on left arm anatomical location on 20May2021 as a dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications included PAROXETINE HYDROCHLORIDE (Paxil) 20mg daily at night start from Sep2012 which was ongoing. After second dose of Pfizer vaccine patient experienced slept the whole day after getting the second dose on 11Jun2021 and pain in stomach on 13Jun2021 patient hospitalized due to pain in stomach from 23Jun2021 to 25Jun2021. Patients' hemoglobin range was decreased from unknown date which was 7 Normal for women is 12-13. / One result for her hemoglobin was 7.1 then it was up to 7.9. Patient was very close to having a transfusion. She had Xray's and an Ultrasound those indicated she had a hiatal hernia. She still was having blood problems. Patient continued to feel sluggish and dizzy after te second dose and had stomach pain. The pain was higher up and went from side to side and would go around to the back. Patient had an upper GI gastrointestinal disorder start from unspecified date. On 23Jun2021 patient underwent lab test hemoglobin which result was 7 and 7.1 and in JUL2021 again tested hemoglobin result was 7.9 range normal for women is 12-13. Patient done second test which was ultrasound and Xray which result was hiatal hernia. The outcome of the events pain in stomach was recovered in june2021, slept whole days was recovered on 12JUN2021. And outcome for another events was unknown.
Patient is complaining of numbness and a  tingling sensation in left shoulder that radiates to finger tips, tingling sensation in left foot , tingling sensation on the right side of face upon awakening.
Joint pains, breathing issues, loss of appetite, extreme aches in legs, pain and discomfort in injection shot, extremely tiredness
Patient with 2 COVID vaccines who admitted inpatient with complications from COVID and detected COVID PCR.  Provider d/c note:  "39 year old female with PMHx significant for anxiety, depression, asthma, and IBS who presented to the emergency department for evaluation of syncope and lightheadedness. She states that she has been having a productive cough for a "few months", never fully resolving upon her diagnosis of CAP in June despite finishing her Azithromycin. On Thursday (10/13) patient began noting increased fatigue, nausea, subjective fever, shortness of breath, and worsening productive cough. She has had a difficult time keeping food down due to persistent nausea with vomiting, only taking a few bites each of the last 4 days. She does endorse drinking plenty of water. She feels increasingly short of breath with exertion, using her albuterol inhaler 5-6 times per day. This evening upon standing to answer the door she had a syncopal episode, did not notice any prodromal symptoms. She denies hitting her head or having any injuries from her fall. In addition to the symptoms noted above she endorses a "lump" on her right upper arm since 10/13. This began as a small "pimple" which she expressed and has grown and become more painful over the past few days. Patient denies recent weight change, headache, rhinorrhea, dysphagia, chest pain, palpitations, abdominal pain, diarrhea, or urinary symptoms.             Upon arrival she was found to be hypoxic, SpO2 of 90 on arrival. She was promptly placed on nasal cannula with improvement in her saturations. She was found to be COVID positive. In addition she has leukocytosis, hypokalemia, an elevated D-Dimer, and an anion gap metabolic acidosis. CTA negative for PE , however does show diffuse tree-in-bud opacities bilaterally. Patient is to be admitted for acute hypoxia,  evaluation for a possible RUE abscess, and management of electrolyte abnormalities.   Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures)  Acute hypoxic respiratory failure with sepsis due to COVID with superimposed bacterial pneumonia-  Procalcitonin elevated, strep pneumoniae positive urine antigen.  MRSA nasal swab also positive. - treated with Rocephin and vancomycin for 6 days. Dc on po Doxy. .   - Continue Decadron / completed remdesivir for COVID.   - weaned off o2.  - CTA negative for PE   Right upper arm abscess- vancomycin, s/p I and D with general surgery 10/20, will need op wound care follow up. Wound culture growing MRSA. Treated with Iv vanco - > po Doxy on DC.    Hyperglycemia- likely related to Decadron, A1c only 5.4.   MDD/GAD/personality disorder/PTSD- home medications - continue Geodon, buspar, Vortioxetine.   "
My toes felt like rocks. I have two on my left foot. The toe closest to the large toe and the toe to the left of that. I can't bend them and have no flexibility in them. They are painful and stiff like rocks. The pain has lessened in the last month. On my right foot the one closest to the big toe is the exact same way. They are stiff like rocks, at night they ache, and it is difficult to sleep. They were very painful and sensitive to begin with. Now they are very sensitive. I have had to change my shoes I wear and sleep with a shoe box on my bed to ease the pain and sensitivity. They are hard and weird like a rock. I have a shooting pain in the top of my foot that went to in front of my ankle. Like a pain in my nerves in my ankle. I have a large bump on my left foot on the back of my tendon. April 11th, 2021, after my 1st shot on March 25th, 2021. I contracted chicken pox. I had three doctors look at me because it was so odd. I was covered from my neck down to my ankle.  They said it was consistent with Chicken pox. I had Chicken pox as a child, this was odd.
a child was given the adult dose of Havrix.; a child was given the adult dose of Havrix.; This case was reported by a physician via call center representative and described the occurrence of overdose in a 1-year-old patient who received HAV (Havrix 1440 adult) (batch number 3A22R, expiry date 24th May 2022) for prophylaxis.   On 28th May 2021, the patient received Havrix 1440 adult. On 28th May 2021, unknown after receiving Havrix 1440 adult, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.  Additional details were provided as follows: The patient was given an adult dose of Havrix adult, which led to overdose and adult product administered to child. The reporter consented to follow up. This case is 1 of 9 linked reports which were reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021120532:same reporter US-GLAXOSMITHKLINE-US2021120523:same reporter US-GLAXOSMITHKLINE-US2021AMR121314:same reporter US-GLAXOSMITHKLINE-US2021120525:same reporter US-GLAXOSMITHKLINE-US2021120526:same reporter US-GLAXOSMITHKLINE-US2021120528:same reporter US-GLAXOSMITHKLINE-US2021120519:same reporter US-GLAXOSMITHKLINE-US2021120521:same reporter
Generalized malaise; Chills/rigors; Diaphoresis; This is a spontaneous report from a contactable healthcare professional (patient). A 25-year-old male patient the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231; Expiration date was not reported), intramuscularly on the left arm on 12Jan2021 (17:30) at a single dose for COVID-19 immunization at the hospital. The patient had no relevant medical history. Concomitant medications included minoxidil, biotin, vitamin D3 and vitamin C [ascorbic acid]. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9899; Expiration date was not reported), intramuscularly on the left arm on 23Dec2020 (when the patient was 25 years old) for COVID-19 immunization. On 13Jan2021 (02:00), the patient had generalized malaise; chills/rigors; and diaphoresis. The patient had received acetaminophen as treatment for the reported events. The outcome of the events, 'generalized malaise', 'chills/rigors' and 'diaphoresis', was recovering. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested since the vaccination.
Mother of child reported that he screamed uncontrollably after receiving vaccinations on 10/11/04.  He did not have a fever.  Doctor determined that inconsolable crying was due to the pertussis component of the DTaP.  She ordered DT for future vaccines in the series.
My injection site has got a bump on it and I got a pain in it; My injection site has got a bump on it and I got a pain in it; It is injection site, it is little swollen up; muscle pain a little bit; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date, the patient verbalized, "My injection site has got a bump on it and I got a pain in it. It seems to be gone away a little bit. I was just wondering if it is something to be concerned about. It is injection site, it is little swollen up. There's muscle pain a little bit. Clinical outcome of injection site bump and pain was recovering, while for the other events was unknown.
Significant joint pain. Primarily in hands and knees but always significant all over joint pain.  Constant sinus issues and UTIs since vaccinated.
Two and a half after administration of flu vaccine experienced urticaria all over her body. On 10/3/07 Received 50 MG of IM Benadryl and was instructed to continue with PO Benadryl over night.  Next morning she still had the hives and continued to itch.  She came in to the Walk-In-Clinic to be treated with Claritin 10 MG daily and Benadryl 50 MG up to 4 hrs PRN if needed.  She tolerated the treatment well and has had no further problems
Breakthrough case  admission after 3 vaccines Pfizer 1/22/21 lot# EL9261;  Pfizer 2/12/21 lot# EM9810;  Pfizer 9/29/21 lot# FE3592;
Pt devel rash & fever compatible w/mild measles following vax w/measles;
Flu like symptoms; rash was very hot; rash is swollen; broke out in a rash at injection site; A spontaneous report  was received from a consumer for a female patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced flu like symptoms (influenza like illness), broke out in a rash at injection site 8 days later (vaccination site rash), rash was swollen (vaccination site swelling) and rash was very hot (vaccination site warmth).  The patient's medical history was not provided. No concomitant product use was reported.  On 06 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly in right arm for prophylaxis of COVID-19 infection. On an unknown date, after receiving the vaccines, patient experienced flu like symptoms. On 14 Feb 2021, 8 days later, she broke out in a rash at injection site. The rash was swollen, and rash was very hot.  The treatment medication was not reported.  Action taken with mRNA-1273 with respect to the events was unknown.  The outcome of the events was not reported.  The reporter did not provide the causality assessment for the events.
4 hrs p/vax mom noted pt to have dilated pupils, fixed gaze & was unresponsive; this lasted for about 1 minute; pt was taken to hosp where ER MD told mom the pt may have had a petit mal sz; no fever, no screaming;
Explosive Diarrhea, & explosive vomiting lasting over 10 hours. Rapid heart rate which began prior to above diarrhea & vomiting. Muscle cramping & muscle twitching much like electrical shock especially in lower extremities along with severe headache. Low grade fever & mild chills.  Extreme tiredness/low energy which still remains. There was also a degree of dizziness  which remains as well.
She came by after a couple of hours and said she had tingling in fingers and sense of numbness in arm. Called her a little after get info about health conditions and she said it had gotten little better.
Progressive pain at injection site moving to high fever and chills during the night. Treated with acetaminophen. Fever went down but arm remained somewhat immobile -- (severe pain when touched or moved) -- slowly getting better as the day went on.
Did not have a history of seizures and no diagnosis  and had Gran Mal Seizures following second shot of Moderna Covid Vaccine
This spontaneous report as received from a healthcare worker refers to an unspecified number of unspecified patients of unknown age and unknown gender. From 16-JUN-2015, the unspecified number of unspecified patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot# J006511 and  expiry date: 28-JUN-2016. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Patient reported lightheadedness, ringing of the ear and dizziness. Vitals: 14:03; 124/75, 82, 21, 100%; 14:12 sitting; 130/24, 88, 20 and 100%. Administered ammonia inhalants. Patient stable and released from the vaccination site at 14:18; accompanied to exit.
This spontaneous report was received from a registered nurse concerning unspecified patients of unknown age and gender. The patients' current conditions and medical history were not provided. On an unknown date, the patients were vaccinated with an improperly stored doses of oral, ROTATEQ (lot # L008057, exp. 01-DEC-2016) (dose unspecified). There was no concomitant medication described. No adverse symptoms were reported. This is one of several reports received from the same source. Additional information has been requested.
Adverse effect of other vaccines and biological substances, initial encounter on 2022-01-10.
Headache, injection site extremely sore(could hardly raise arm), extreme body , hand, and wrist pain, fatigue
small hematoma, dime size on stomach; headache; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 01Apr2021 10:00 (Batch/Lot Number: EP7533) as SINGLE DOSE for covid-19 immunization, at the age at vaccination of 67 years old.  Medical history reported as no. No allergies to medications, food, or other products. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 on 04Mar2021 10:00 (Lot number: EN6199) for COVID-19 immunisation. The patient experienced small hematoma, dime size on stomach on 01Apr2021, headache on 01Apr2021, fatigue on 01Apr2021, all with outcome of recovered on unknown date. Patient was not pregnant at the time of vaccination. The patient didn't 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 had not been tested for COVID-19. No treatment received for the adverse event.   No follow-up attempts are needed. No further information is expected.
Pfizer 1/14/21 and 2/4/21. Positive on 1/10/22
Dizziness, Myalgia, NauseaVomiting, fatigue Narrative:  Other Relevant History:
Severe Headache Fatigue Shortness of breath Cough Been 2 days  3 rd day is worse
Shills, sweats, fatigue, HA, nausea, symptoms lasted 48 hours and then resolved
When Afluria was injected IM, the patient said she felt light headed. Instructed patient to remain sitting. When she was feeling better, she and her mother walked to front of store where she collapsed.
PT C/O NAUSEA AND H/A APPROX. 1HR AFTER ADMINISTRATION OF TYPHOID VACCINE.
Rash on arm; This spontaneous case was reported by a consumer and describes the occurrence of   in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
I have had anxiety with uncontrollable body shakes, nausea, chest pressure, lips and tongue going numb, unable to speak clearly. My legs feel like tree trunks and doesn't help to walk. I take PROZAC, levothyroxine due to low Thyroid function. now. These acute symptoms started in April and the body shakes happened in June. I am doing really good now and I don't know if it was due to a low Thyroid for it but I have never been told to that is was low before but the doctor told me that it could increase the anxiety so the low dose of PROZAC and levothyroxine is helping me.
This case was reported by a consumer and described the occurrence of rash in an adult male pt who received Lyme disease vaccine recombinant (Lymerix). A physician or other health care professional has not verified this report. The reporter is the pt. On an unspecified date in 1999, the pt received the second dose of Lymerix. The pt reported that he never received the third dose of Lymerix. Approx 5 years after the second dose of Lymerix, on 12Jul04, the pt experienced rash on his leg. The  pt reported that the rash does not itch and that he suspects it may be Lyme disease. The event was ongoing at the time of initial reporting.