chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received regarding a case in litigation regarding a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history. In December 2012, the patient was vaccinated with a dose of ZOSTAVAX, (dose, route, anatomical location, lot number and expiration date were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries as recommended by the healthcare professional. On unknown date, the patient experienced shingles (herpes zoster) and in June 2013, the patient was treated for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX (vaccination failure) and suffered serious physical, emotional, and economic damages (emotional distress), as a result of patient's injuries. The patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffered (pain); extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (condition aggravated); lost wages; loss of earnings capacity; and other losses and damages. At the time of the report, the outcome of herpes zoster, pain, condition aggravated emotional distress and vaccination failure was unknown. The reporter considered herpes zoster, pain, condition aggravated emotional distress and vaccination failure to be related to ZOSTAVAX. The reporter considered the events to be disabling, life-threatening and medically significant.
This spontaneous report as received from a medical assistant refers to a 12 month old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 07-SEP-2016, the patient received improperly stored dose of VARIVAX injection, lot # M004328, expiration date: 26-JAN-2018 (dose, route of administration and anatomical location were not reported). It was reported that the administered dose of VARIVAX was improperly stored at -3.5 degrees Celsius (C) for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments: US-009507513-1610USA011133:
had a sore arm for 3 days; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a 70-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain in extremity (1st dose received 5 to 6 months prior to the 2nd dose, refer case US2021AMR103055).   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 pain in arm. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient itself. The age at vaccination was not reported. The patient had 2nd dose of Shingles and had a sore arm for 3 days, that was it. The patient was happy that it was a lifetime vaccine and stated no problems at all. The follow up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR103055:same reporter, same patient, same vaccine, different dose (1st dose)
NOTHING HAPPENED TO CHILD, ADMINITERED 0.1ML OF PFIZER
I?ve had 4 injections. Last one being 10/2022. Left arm injection site periodically (2 a month) becomes sure. This started after second injection. No swelling. Aching soreness. Dr dismisses it when mentioned but don?t understand why I continue to experience.
Client was set up for 30 min monitoring after receiving vaccine. At the end of the monitoring period, she reported that she was feeling some tightness in the jaw, but no other symptoms.  Her monitoring period was continued. Initial vital signs taken, BP 160/90, P-59, SaO2-98%. After monitoring for 10 more minutes, she reported that her jaw did not feel tight any longer, but she had a slight feeling of numbness/tingling in the cheeks and tongue.  She did not report any other symptoms and was able to talk and swallow normally.  She did not develop any obvious facial swelling or rash/itching. She was administered Benadryl 25mg.  Vital signs were repeated BP 150/80, P-60, SaO2 98%.  She stated that she was feeling a bit better after the Benadryl was administered.  Her husband had accompanied her to the clinic and would drive her home, and she had family available at home.  She and her husband were instructed to call 911 if  she worsens, but she and husband were comfortable with how she was feeling and she then left the clinic in improved condition.  A follow-up call was placed on 4/15/21 and her symptoms had totally cleared up shortly after leaving the health department and she felt fine once she returned home. She was instructed to follow up with her physician regarding what happened and next steps.
Slight headache a few ours later after vaccination.  The next morning I had headache, some joint/muscle pain, right arm pain and a Fever. That evening/night Fever and chills. The following  morning still had a fever and chills. All symptoms were gone later that evening (within 48 hours of initial vaccination time)
One week from the second vaccine on Feb 10, I started showing signs of Shingles.
Ringing (Tinnitus) in both ears. One week after injection. Has not gone away.
About 1 1/2 hours, post vax, pt began having hives/itchy rash, mild shortness of breath and cough for about 4 hours. Prior flu injection yearly without problems.
swelling, warmth, tenderness @ site 2 days p/vax;rash extends to 1-2 inches above elbow;seen by MD in ER;tx w/ATB for poss staph/strep infect, poss local rxn;father states swelling, warmth, redness much relieved 26MAY98;no temp noted;
Chills, shaking so badly could not stand up to drive home from office, headache, ache over entire body. In bed for 2 days.
LOW GRADE FEVER, SORENESS, AND REDNESS AT INJECTION SITE CONSISTENT WITH NORMAL COVID VACCINATION SIDE EFFECTS
patient received moderna covid 19 vaccine "this afternoon" on 01/25/2021. "a few hours later" caller developed a feeling of dizziness, went to the bathroom and saw a diffuse rash on her chest. also felt like her throat was scratchy. advised to take 50mg diphenhydramine and go to emergency department for further evaluation. in ED pt was well-appearing, no rash or signs of distress, was discharged home with steroids.
Fever, hives, chills and swelling of hands 5 hrs after the shot and lasted for approx 8 hrs.  Resovled with Benadryl.
Immediately after vaccine, felt tingly through arm and down leg (L side both). A few minutes later, she got hot on l side of face, like a hot flash.
Approximately 30 minutes after receiving vaccination, patient gave complaint of tight chest/throat. Benadryl 25 mg was given twice and patient was placed on 8 L oxymask and was transferred to EDTC for monitoring and observation. No additional interventions occured and patient was discharged home.
This case was reported by a nurse via sales rep and described the occurrence of adverse reaction in a adult patient who received FLULAVAL QUADRIVALENT. On an unknown date, the patient received FLULAVAL QUADRIVALENT at an unknown dose. On an unknown date, unknown after receiving FLULAVAL QUADRIVALENT, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to FLULAVAL QUADRIVALENT. Additional details were reported as follows: The age at vaccination was not reported. This case described the third nurse's adverse event. The reporter told that 1, 2 or as many as 3, was not even sure, nurses who had the FLULAVAL QUADRIVALENT vaccine experienced side effects outside of clinical trials. On 23rd January 2018, the reporter spoke with nurses at a clinic and the reporter reported some nurses experiencing possible adverse reactions with FLULAVAL. There might be a third nurse that experienced an unknown adverse event after receiving the FLULAVAL. The unrelated questions from the physician were sent to Agency, but that these events had not yet been reported to safety or the Regulatory Authority. This was 1 of 3 cases, reported by same reporter.
Client's husband states her, "eyes are puffy, migraines, hives, can't function normally, very forgetful, and she's been arrested two times this week, and that's not like her."
Missed the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed the second dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
couldn't get up; severe pain in my right hip; can't move or walk; osteoarthritis; severe iliopsoas bursitis; severe iliopsoas bursitis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2), on 05Jul2022 at 10:45 as dose 3 (booster), single (Lot number: FJL1991) at the age of 42 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (prev dose lot number=EWO196,, prev dose administration date=01Jul2021,, prev dose administration time=10:00 AM,, prev dose dose number=2,, prev dose vaccine location=Left arm,), administration date: 01Jul2021, when the patient was 41-year-old, for COVID-19 Immunization; BNT162b2 (prev dose lot number=ewo191,, prev dose administration date=10Jun2021,, prev dose administration time=10:00 AM,, prev dose dose number=1,, prev dose vaccine location=Left arm), administration date: 10Jun2021, when the patient was 41-year-old, for COVID-19 Immunization. The following information was reported: GAIT INABILITY (disability, medically significant) with onset 08Jul2022 at 05:00, outcome "not recovered", described as "can't move or walk"; BEDRIDDEN (disability, medically significant) with onset 08Jul2022 at 05:00, outcome "not recovered", described as "couldn't get up"; OSTEOARTHRITIS (disability, medically significant) with onset 08Jul2022 at 05:00, outcome "not recovered"; BURSITIS (disability, medically significant), TENDONITIS (disability, medically significant) all with onset 08Jul2022 at 05:00, outcome "not recovered" and all described as "severe iliopsoas bursitis"; PAIN (disability, medically significant) with onset 08Jul2022 at 05:00, outcome "not recovered", described as "severe pain in my right hip". The events "couldn't get up", "severe pain in my right hip", "can't move or walk", "osteoarthritis" and "severe iliopsoas bursitis" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of bedridden, pain, gait inability, osteoarthritis, bursitis, tendonitis.  Clinical course: Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient had no known allergies. Patient had not received no other vaccines with in four weeks. Third day i couldn't get up, severe pain in my right hip, can't move or walk. Diagnosed with osteoarthritis and severe iliopsoas bursitis. Patient received treatment with corticosteroids. Facility type vaccine was at pharmacy or drug store.   Follow-up attempts are completed. No further information is expected.
DX: Myocarditis Onset of S/S 06/02/2021   S/S:Dyspnea on exertion, Fever/chills,Tachypnea Found to have acute basilar ischemic stroke, taken for emergent thrombectomy, but experienced progressive edema and ultimately tonsillar herniation.  35 year old man with medical history notable for likely untreated hypertension and tobacco use disorder who presented with reported fever, confusion, shortness of breath, and facial swelling, initially treated for allergic reaction/angioedema without effect, progressed to respiratory failure, found to have acute basilar ischemic stroke, taken for emergent thrombectomy, but experienced progressive edema and ultimately tonsillar herniation resulting in death.     Regarding cardiac picture, patient with abnormal ECG, mildly reduced EF on echo (though could be due to untreated hypertension or to respiratory failure/critical illness), borderline troponin (need to check reference range). ED note initially mentions concern for myocarditis due to vaccine causing heart failure and subsequent respiratory failure, but appears this piece was written prior to MRI showing basilar stroke. Death note has myocarditis listed as a cause of death (among many), though a bit unclear if this was intentionally listed or just reflects a list of all hospital problems.     Also had a CT of his head which showed scattered foci of gas within intraorbital soft tissues along with mild proptosis; unclear etiology for this (perhaps a fall with facial injuries prior to arriving at hospital?)    Awaiting additional physician notes/imaging reports.
This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to an 6-months old female patient, with no known drug allergies and no illness at time of vaccination. The patient was vaccinated with the second dose of ROTATEQ (oral, batch/lot # J004875, expiration date 17-OCT-2014), on 17-JAN-2014 at 4:04 PM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event was also reported as 27-FEB-2014 at 10:00 AM). The parents of the patient were going to consult with physician and patient was going to be revaccinated on 31-MAR-2014. No adverse event was reported for the patient. The outcome was reported by the reporter as recovered/resolved on 24-MAR-2014. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
MAR 27,2004 RECEIVED ANTHRAX, 2 HOURS AFTER HAD A HEADACHE, 6 HOURS AFTER HAD PAIN IN MY JOINTS, MARCH 28, 2004 PAIN IN JOINTS REDUCED BUT STILL THERE. AFTERNOON NOSE STARTED RUNNING AND HAD CONTINUED TO MARCH 30, 2004. JOINT PAIN IS GONE.
USA, NSTEMI, acute on chronic HF with reduced EF (25-30%) s/p stents x2 to the RCA and LAD.
Sore arm for about the first 3 days and it went away. Developed a classic bandage rash around the site (never been allergic to bandages). On day 7 my left arm was sore. My left hand and fingers started tingling. No pain.  Area of injection site was warm with a small red splotch around the area (maybe 1x1"). Day 8- worsening splotchy area. Day 9 (right now as I'm typing) the area is about 3x5". It's still warm. No tingling sensation but my left had is weak and feels numb.
Narrative: Patient received 3 Pfizer COVID vaccines 1/23/2021, 4/9/2021, and 10/14/2021. On 2/16/2022, patient was admitted to the hospital for COVID pneumonia.
Hives on trunk and neck next day Sunday. Tiredness, weakness, burning eyes, and feverish on Monday.
injection site redness; Injection site tenderness; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 61-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced injection site erythema and injection site tenderness. On an unknown date, the outcome of the injection site erythema and injection site tenderness were unknown.   It was unknown if the reporter considered the injection site erythema and injection site tenderness to be related to Flu vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient had received flu vaccines in the past and had experienced redness and tenderness at the injection site after flu vaccines. The reporter consented to follow up. This case has been linked with US2019075908, reported by same reporter.
screaming began w/in 1/2 hrs of vax; crying was unreconsoleable fro @ least 3 hrs; did not seek MD:
Pt received vaccine; then stated that he felt nauseated, dizzy, and had increased anxiety due to his fear of needles. While sitting in observation he passed out momentarily while sitting in his chair. He awoken quickly and was assisted to a wheelchair for one on one observation. Pt states this has happened before and he always quickly awakens. Water given. Pt observed for 30 minutes and left in stable condition.
Chills, severe headache, severe backache, severe abdominal pain, joint pain.
pt recv vax 30JAN98  10AM & same evening 5PM exp severe chills;this resolved the next AM;2wk later 16FEB98 began exp pain in hands, wrists, ankles, feet, knees, thigh aching, gen malaise;followed up w/MD on 21FEB98 for bronchitis;arthritic
very cold; facial numbnes mostly in the nose; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of HYPOAESTHESIA (facial numbnes mostly in the nose) and FEELING COLD (very cold) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no adverse event).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced HYPOAESTHESIA (facial numbnes mostly in the nose). On an unknown date, the patient experienced FEELING COLD (very cold). On 07-Jan-2021, HYPOAESTHESIA (facial numbnes mostly in the nose) had resolved. At the time of the report, FEELING COLD (very cold) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Severe swelling of left thigh. Review of other correspondence indicates hospitalization was only for a few hours. The diagnosis was "vaccine reaction."
Fatigue for 3 days. Fatigue subsided entirely after 3 days.
A report has been received from a Health Professional concerning a 43 year old, male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. A patient who has asthma received FLUMIST QUADRIVALENT which started on 29-Oct-2013. The outcome of the event of a patient who has asthma received FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious by the reporter.
Patient received both doses of varicella vaccines and developed shingles at age of 9 yrs old. Patient came in with (2) small lesions; sent to dermatologist, and they diagnosed shingles.
Generalized Bodily Muscle Pain; Injection Site Redness; Pain at the injection site; Feeling Tired; Feeling Weak; Felt sick; acute dermatitis; Persistent rash developed on her back and shoulder that is red and bumpy; Shivers; Terrible Headache / headache was on and off stemming from her neck into her head; Stomach Pain; Persistent rash developed on her back and shoulder that is red and bumpy; This case was reported by a consumer via call center representative and described the occurrence of shivers in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th August 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In August 2019, less than a day after receiving Shingrix, the patient experienced shivers, headache, stomach pain, erythropapular rash, dermatitis and red rash. On 16th August 2019, the patient experienced muscle pain, injection site erythema, injection site pain, tiredness, feelings of weakness and feeling unwell. The patient was treated with ibuprofen and prednisone. On an unknown date, the outcome of the shivers, headache, stomach pain, muscle pain, injection site erythema, tiredness and feelings of weakness were recovered/resolved and the outcome of the injection site pain was unknown and the outcome of the erythropapular rash, dermatitis and red rash were not recovered/not resolved and the outcome of the feeling unwell was recovering/resolving.   It was unknown if the reporter considered the shivers, headache, stomach pain, muscle pain, injection site erythema, injection site pain, tiredness, feelings of weakness, erythropapular rash, feeling unwell, dermatitis and red rash to be related to Shingrix.  Additional details were provided as follows: The patient receiving 2nd dose Shignrix in her left arm in the late afternoon and the next morning waking up with shivers followed by quick onset of a terrible headache and then stomach pains.  The patient also experienced generalized bodily muscle pain, redness and pain at the injection site, and feeling weak and tired.  The patient still felt sick but not as sick as the previous day and the patient had taken ibuprofen.  The patient reported that headache was on and off stemming from her neck into her head for a couple of weeks and taking ibuprofen for relief. Approximately 1 to 2 weeks after vaccination, the patient  reported a persistent rash developed on her back and shoulder that was red and bumpy and appears similar to acute dermatitis.  The patient was taking a 15-day course of prednisone, but reported that she still having rash as it had not completely subsided or cleared. The reporter consented to follow up. There was discrepancy in the onset date of the event tired and weak it was reported as 15th August 2019 and time to onset was given as 1 day, hence onset date was taken as 16th August 2019.
Arm was sore but pains started throbbing up and down her arm and hasn't stop, sometimes the pain starts at the shoulder blade and go all the way down. Can barely move arm at times