chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have been feeling a little tired and weak; may be some body aches; I have been feeling a little tired and weak; may be some body aches; I have been feeling a little tired and weak; may be some body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 28Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), ASTHENIA (non-serious), PAIN (non-serious) all with onset 2021, outcome "unknown" and all described as "I have been feeling a little tired and weak; may be some body aches".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Right behind his teeth was swollen and inflamed after the 1st dose; More severe soreness in the shoulder after the 1st dose; Swelling of the lymph nodes in his mouth after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of MOUTH SWELLING (Right behind his teeth was swollen and inflamed after the 1st dose), ARTHRALGIA (More severe soreness in the shoulder after the 1st dose) and LYMPH NODE PAIN (Swelling of the lymph nodes in his mouth after the 1st dose) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     no medical history reported.  Concomitant products included AMLODIPINE BESILATE, BENAZEPRIL HYDROCHLORIDE (AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE) for Blood pressure.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced MOUTH SWELLING (Right behind his teeth was swollen and inflamed after the 1st dose), ARTHRALGIA (More severe soreness in the shoulder after the 1st dose) and LYMPH NODE PAIN (Swelling of the lymph nodes in his mouth after the 1st dose). On 04-May-2021, ARTHRALGIA (More severe soreness in the shoulder after the 1st dose) had resolved. At the time of the report, MOUTH SWELLING (Right behind his teeth was swollen and inflamed after the 1st dose) and LYMPH NODE PAIN (Swelling of the lymph nodes in his mouth after the 1st dose) 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.   Concomitant medication included Vitamin D 50000 IU
got so sick/very sick; flu like symptoms; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: got so sick/very sick) and influenza-like symptoms (Verbatim: flu like symptoms). The outcome of the sickness and influenza-like symptoms were resolved (duration 2 days).   The reporter considered the sickness and influenza-like symptoms to be related to Shingles vaccine.     The company considered the sickness and influenza-like symptoms to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR067426   Additional Information: GSK receipt date: 31-MAR-2023 The case was received from the patient via interactive digital media. The patient got the vaccine and got so sick from both doses.  The patient said so would he or she never get shingles or was it supposed to be like covid vaccine in that if he or she did get shingles it won't be as bad now. The patient asked as did feel sick. Curious, the patient got flu like symptoms, very sick for 2 days, with both doses.  The 1st time he or she thought maybe flu but when it happened 2nd time, he or she knew it was the vaccine. The follow-up could not be possible as no contact details were available. For tolerance to the 2nd dose refer case US2023AMR067426.; Sender's Comments:  US-GSK-US2023AMR067426:Same patient
On day 7 my left arm became very itchy and as the day progressed I developed a large painful, hot, hard, red area that grew to cover most of my upper arm. Day 8 I was seen by a PA who diagnosed me with Cellulitis and prescribed me a 10 day regimen of Doxycycline. I also developed a sudden headache and shakiness/weakness. Today is Day 12 and all that is visible is a darker area around the injection site that is smaller than the original area but is no longer hot, red or hardened and is still sensitive. I am still taking the Doxycycline as of today.
This case was reported by a physician and described the occurrence of shortness of breath in a female subject aged between 50 and 59 years old who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. The reporter is a radiologist. On 10 November 2005 the subject received 1st dose of Fluarix (lot number not provided). On 10 November 2005 4 hours after vaccination with Fluarix, the subject experienced shortness of breath. The subject was seen on 10 November 2005 by the reporting physician for a chest x-ray. The chest x-ray results were not provided. The outcome of the shortness of breath was not reported.
I saw my doctor because of relentless fatigue. We did a blood test. Blood test came back pretty much good except for an extremely high ferratin count. We did a genetic marker test. Hemochromatosis can be hereditary. I do not have genetic markers for Hemochromatosis. I'm being referred to a hematologist. I do not know if this is related to the vaccine, but you're asking so I'm answering. I have a new health issue.
One hour after my vaccination I had shortness of breath, my lungs felt very tight, my arm (which I got the shot) was really red, my throat, my chest (my upper body) was covered with rash. I took Benadryl for 3 days and combined with bed rest and then my symptoms subsided after then for the rest of the week I felt like I have a flu and I took Advil and Tylenol for it to keep the fever down. Then the week after I felt normal and back to 100% again.
I had diarrhea after the second dose every single day. It was chronic diarrhea, sometimes 3-4 times per day. I spoke with my gastrologist and rheumatologist about it and they recommended colonoscopy and stool samples. They all came normal. The diarrhea continued. June 2, 2021 my doctor prescribed my cholesterol medicine that they use to treat diarrhea, I took that for about 2 weeks. It dried out my mouth terribly. The doctor then prescribed another Rx, I took that until June 23, but that also gave me a dry mouth so I stopped taking that. Since then I have had no diarrhea.
Redness, firm, warm to touch 6.0cm X4.5cm, chemical taste in mouth approximately 20min after administration patient normally has chemical taste with vaccines.
When I had my Rheumatology labs run 20 days after my vaccine, my kidney function was at a 50%.  I've never had a problem with my kidney function (Creatinine).
Information has been received from a nurse concerning a female patient (age not reported) with a nerve compression (NOS) who on an unknown date in October 2006, was vaccinated intramuscularly in the left deltoid with the second dose of HPV Vaccine (date of first dose and Lot # were not provided). On an unknown date in Oct 2006, the patient experienced numbness in her left arm. The patient was referred to a neurologist, because of her history of pinched nerve. At the time of this report it was unknown if the patient had recovered from the event. Additional information has been requested. 04/06/07: This is in follow-up to report (s) previously submitted on 12/14/2006. Initial and follow up information has been received from a nurse and a physician concerning a 24 year old female patient with nerve compression (NOS), cervical pain, chronic anxiety, insomina and leg pain and a history of "localized cervical cancer (diagnoses February, 2006)", lumbar laminectomy and a motor vehicle accident (NOS) who at 10:00 on 30-OCT-2006, was vaccinated intramuscularly in the left deltoid with the second dose of HPV rL1 11 16 18 VLP vaccine (yeast) (Lot#653650/0702P), (date of first dose and Lot # were not provided) no concomitant therapies were reported by the OB/GYN. It was reported that at 10:30 am post-vaccination the patient experienced left upper extremity paresthesias and numbness. The patient was seen for follow up by the OB/GYN for the event on 09-NOV-2006 and was referred to a neurologist, because of her history of a pinched nerve. On 29-NOV-2006 the patient was seen by a neurologist. The patient reported the following concurrent medications at that time: cyclobenzaprine hydrochloride (MSD), metaxalone (Skelaxin), acetaminophen (+) hydrocodone bitartrate (Vicodin), oxycodone, alprazolam (Xanax) and diclofenac. conduction studies and electromyography (EMG) with follow-up somatosensory evoked potential studies of the left arm. The patient was seen by the neurologist for a follow up appointment on 06-DEC-2006. The neurologist noted that "she continued to have insomnia, arm pain, dysesthesias, etc which she dates from her motor vehicle accident." The results of her nerve conduction studies and EMG were normal. Her somatosensory evoked potential studies through the brachial plexus and cervical spinal cord were also normal. The neurologist noted "we cannot find an organic explanation for the patient's arm pain complaint's." The neurologist recommended the "Tincture of time" and symptomatic treatment at a pain center. At the time of this report the patient had not recovered from the event. Additional information has been requested.
Experienced intermittent wheezing and tachycardia 4 weeks later; Experienced intermittent wheezing and tachycardia 4 weeks later; This is a spontaneous report received from a contactable Nurse. This Nurse reported for a patient (reporter's mother).   A 98-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 18Mar2021 (at the age of 98-years-old) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Retired nurse stated, On unspecified date of Apr2021, experienced intermittent wheezing and tachycardia 4 weeks later (No history of this before, no history of smoking). She did not receive the second dose and would like to know how to proceed on receiving it now.  Should she start all over or just have second dose. The clinical outcome of the event was unknown at the time of report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report as received from a consumer reporting on himself. The patient was a 60 year old male with a SEPTRA sensitivity Meniere's disease. The patient also had a history of unspecified adverse events to unspecified vaccines (manufacturer unknown). On 03DEC2014 the patient was vaccinated with PNEUMOVAX23. Concomitant therapies included CLARITIN. On 04DEC2014 the patient woke up and vomited "about a cup of bile". After waking up to vomit, he noticed redness and pain at the injection site and also experiencing chills, aches and pains through out his entire body. because the aching worsened, the patient was only able to sleep about an hour that night after waking up to vomit. He reported that the aching and chills persisted through the following day on 05DEC2014. On 05DEC2014 the patient was flatulent and wound up inadvertently passing three to four table spoons of blood and stool into his undergarments. He noted the stool was rose colored with pink mucosal blood droplets. He reported that his stool became less pink over the weekend and on 08DEC2014 it was back to normal. The patient also complained of a decreased appetite since he received PNEUMOVAX23. The patient took one TYLENOL every six hours to treat the body aches. he reported that he recovered from all of his adverse effects except for redness at the injection site. The patient had blood testing done on 05DEC2014 that showed an increased white blood cell count. The patient reported the expiration date for the PNEUMOVAX as March 2016 because the clinic provided him only with the month and year. The clinic did not provided the lot number. The patient reported seeking medical attention and visited his physician (NOS). Additional information has been requested.
She called this morning 1115 am to say that her arm was swollen up twice its usual size. No shortness or breath, just "local" swelling and redness. Advised her to put ice pack on it and take pain reliever and call back. Phoned back at 240pm and reported that it's no better. She has "no elbow" and is allergic to BENADRYL. Still no breathing issues. Advised to continue ice and pain reliever. Reassured patient.
This spontaneous report as received from a pharmacy technician concerning a currently 5 years old child. Gender was not reported. Medical history and concurrent conditions were reported. On 09-APR-2014, the patient was vaccinated with VARIVAX lot#J009165; expiration date: 24-JUL-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
103F (axillary) fever beginning 8 hours after the injection and lasting 36 hours.  No reaction at the injection site.
Woke up with hives, took Benadryl and hives went away, hives came back and pt took Benadryl again and hives went away. ON 11/09/2009 woke up with fever and sore throat by 12:30pm R eye was swollen shut, then L eye started swelling and pt went to ER.  Pt received Benadryl and Decadron Pt developed nausea and was given Zofran, had blood work taken.  Pt was given Zantac 150 mg BID for 7 days  and Medrol Dose Pack to use at home.
Patient shaking non stop, she can't even eat, because of the shaking the whole body, the symptoms last for around six hours.
Approximately 5 minutes after vaccine administration, the patient informed me she was having difficulty breathing. She was gasping for air but able to speak. As we pulled an epipen from our emergency kit, I asked the patient to remove her mask to assess for swelling of lips and tongue--no swelling of lips or tongue were present. We administered an epipen and called 911. The patient's symptoms resolved within a minute. The patient did not have any more difficulty breathing while waiting for the paramedics. When paramedics arrived, they assessed the patient who said she felt perfectly fine. The patient remained symptom free and paramedics cleared the patient to leave the pharmacy and return home.
The left hand/fingers (injection site was left deltoid) became very swollen which lasted for about 3 days.  Initially the hand was very warm but that dissipated after day #2.  There was no pain or loss of function at any time.
This spontaneous report as received from a consumer refers to a female patient now in her 30's reporting on herself. On an unknown date when the patient was 18 months old, the patient was vaccinated with combination of MMR (manufacturer unknown), (dose, route, lot number and expiration date not reported). On an unknown date the patient was hospitalized with seizures and she stated that she "almost died". Brain scan was done (results not provided). Patient visited different physicians and allergists and it had been determined that the patient experienced a severe immune reaction to the combination of measles and mumps in her body at the same time. At the time of the report the outcome of the events was unknown. She stated that her mother had a similar reaction after being infected with community acquired measles and mumps virus. Upon internal review the event of seizures was considered to be medically significant. Additional information has been requested.
Mother contacted RN. Day after vaccinations received pt. developed red, swollen, warm to touch right thigh. PCV13 was given on this thigh. She also mentioned that the same reaction happened to the same thigh with the previous vaccines given, which PCV13 was given on that same thigh. I advised to put some thing cool on the area of the thigh and the redness and swelling will go down. I advised to go see a Dr. if the redness and swelling do not subside.
Patient complained of feeling light-headed and a little dizzy at 10 minutes post-administration.  Pulse-oximetry applied revealed normal spO2, but tachycardia to 140bpm (this patient's resting HR is approximately 55-65).  Apple Watch data confirmed rapid increase in HR at that moment.  BP increased from normal baseline to about 150-160 SBP.  No chest pain reported.  No signs/symptoms of anaphylaxis (rash, wheezing, etc.).  HR gradually recovered to normal levels within 30 minutes and patient was released after 60 min observation.  Patient reported generalized fatigue in weeks following injection.   Nineteen (19) days after injection, patient developed unprovoked resting tachycardia to approximately 180bpm (following some moderate weigh-lifting exercise).  Symptoms did no resolve sufficiently and patient was transported by EMS to ER for evaluation
Loud ringing in ears; Head bussing sensation; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11May2021 13:00 (Lot number: ew0172) at the age of 60 years as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: TINNITUS (non-serious) with onset 12May2021 16:00, outcome "not recovered", described as "Loud ringing in ears"; FEELING ABNORMAL (non-serious) with onset 12May2021 16:00, outcome "not recovered", described as "Head bussing sensation". The events "loud ringing in ears" and "head bussing sensation" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of tinnitus, feeling abnormal.  Additional information: Loud ringing in ears, request head bussing sensation, for over 4 weeks. The patient did not receive any other vaccine within four weeks prior to COVID vaccine. The patient did not receive other medications in two weeks prior to COVID vaccine. Adverse events resulted in: Doctor or other healthcare professional office/clinic visit. The patient did not have COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient had no known allergies.  Follow-up attempts are completed. No further information is expected.
So on May 11th, 2021 my right leg just randomly went numb. That led me to go to the ER and they didn't really find anything urgent at the time. They got me stable at the time and I followed up with my PCD on May 18, 2021. She sent me for a lumbar MRI and then when I got that MRI there was a boatload of things that were not normal on that MRI. They also saw something strange in my brain apparently. So then on I think like June something - I don't have that date, I was scheduled for a Brain MRI on June 12, 2021 because of what they saw on my lumbar MRI. I have two other specialists that I have to see because results were not conclusive and I have to get more tests done. My leg numbness comes and goes at this time but I now have these other ongoing issues and questioning what caused it.
Immunization given 3/7/05, temp 103.8, on 3/9/05 referred to ER crying fussy runny nose, 3/10/05 to office bacteremia, Rocephin given in ER 3/9/05 and our office 3/10/05.
Pain started within hours of vaccination. Muscle tenderness worsening to pain on movement of shoulder; decreased range of motion; injection given near top of left shoulder - pain continues.
felt like crab; This case was reported by a consumer via interactive digital media and described the occurrence of feeling abnormal in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling abnormal. On an unknown date, the outcome of the feeling abnormal was recovered/resolved.   It was unknown if the reporter considered the feeling abnormal to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine and stated that he/she felt like crab for a day, but way better than he/she would had felt with shingles. The follow-up would not possible as no contact details were available.
Initial unsolicited report received from the literature on 01 June 2016. This case is linked to case 2016SA108588, 2016SA108584, 2016SA108575 (same literature). Background. Many adult immunization schedules recommend that tetanus and diphtheria vaccination be performed every 10 years. In light of current epidemiological trends of disease incidence and rates of vaccine-associated adverse events, the 10-year revaccination schedule has come into question. Methods. We performed cross-sectional analysis of serum antibody titers in 546 adult subjects stratified by age or sex. All serological results were converted to international units after calibration with international serum standards. Results. Approximately 97% of the population was seropositive to tetanus and diphtheria as defined by a protective serum antibody titer of greater than or equal to 0.01 IU/mL. Mean antibody titers were 3.6 and 0.35 IU/mL against tetanus and diphtheria, respectively. Antibody responses to tetanus declined with an estimated half-life of 14 years (95% confidence interval, 11-17 years), whereas antibody responses to diphtheria were more long-lived and declined with an estimated half-life of 27 years (18-51 years). Mathematical models combining antibody magnitude and duration predict that 95% of the population will remain protected against tetanus and diphtheria for greater than or equal to 30 years without requiring further booster vaccination. Conclusions. These studies demonstrate that durable levels of protective antitoxin immunity exist in the majority of vaccinated individuals. Together, this suggests that it may no longer be necessary to administer booster vaccinations every 10 years and that the current adult vaccination schedule for tetanus and diphtheria should be revisited. This case involves a 58-year old patient (gender not reported) who was vaccinated with a dose of Tdap (lot number, expiry date, route and site of administration: not reported) on an unspecified date. Patient's medical history and concomitant medications was not reported. On an unspecified date, post vaccination the patient lacked immunity to both toxins (diphtheria and Tetanus). A serum antibody titers was performed (results not provided). Other laboratory data and corrective treatment was not reported. The outcome of the event was not reported. Documents held by sender: none.
Pt recvd vax & arm became warm to touch, devel rt arm swelling, raised wheal @ site; sx subsided in 3 days;
about 48 hours after injection, patient complained of pain in shoulder, lack of movement of shoulder .  Tx unknown.  Pt reports symptoms decreased with time and near normal movement on 10/18/08