chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm is painful; her body feels warm inside and outside; her arm is hard; aching all over; could not keep warm/ but was still cold; woke up with chills; had a fever of 100°F; This spontaneous case was reported by a nurse and describes the occurrence of FEELING COLD (could not keep warm/ but was still cold), PAIN IN EXTREMITY (arm is painful), FEELING HOT (her body feels warm inside and outside), INDURATION (her arm is hard) and CHILLS (woke up with chills) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004FC1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Allergic reaction (she had a chemical reaction 3 years ago). Concurrent medical conditions included Alopecia, Vitiligo and Sweating (for one year she has sweats: constantly wet and dripping. Her PCP took her off from trazadone (for sleep) 2weeks ago, but she still gets the sweats). Concomitant products included TRAZODONE for Sleep disorder.    On 05-Oct-2021 at 1:30 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (had a fever of 100°F). On 06-Oct-2021 at 3:00 AM, the patient experienced FEELING COLD (could not keep warm/ but was still cold). 06-Oct-2021 at 3:00 AM, the patient experienced CHILLS (woke up with chills). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm is painful), FEELING HOT (her body feels warm inside and outside), INDURATION (her arm is hard) and MYALGIA (aching all over). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency and PARAFLU [CLOFEDANOL HYDROCHLORIDE;DIPHENYLPYRALINE HYDROCHLORIDE;GUAIFENESIN;PARACETAMOL;PHENYLEPHRINE HYDROCHLORIDE] ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, FEELING COLD (could not keep warm/ but was still cold), PAIN IN EXTREMITY (arm is painful), FEELING HOT (her body feels warm inside and outside), INDURATION (her arm is hard), CHILLS (woke up with chills), MYALGIA (aching all over) and PYREXIA (had a fever of 100°F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (High) fever of 100°F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient is currently using other Concomitant medications that she does not want to disclose further. Treatment information also included she put on socks and a cover but was still cold, a hot tea that she is about to have.   This case was linked to MOD-2021-343838, MOD-2021-343839 .
broke out into hives; This is a spontaneous report from a contactable consumer (Patient). A 23-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: En6206) dose 2 via an unspecified route of administration, administered in right arm on 06Mar2021 at 13:30 (at the age of 23-year-old) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: El9267) via an unspecified route of administration, on 12Feb2021 09:30 AM at single dose for COVID-19 immunisation. The patient was not COVID prior vaccination and did not test COVID post vaccination. After receiving the second dose, on 07Mar2021 at 12:00 AM, the patient broke out into hives and had them since. The patient did not receive any treatment for the vent. The clinical outcome of events was not recovered.  No follow-up attempts are needed. No further information is expected.
Herpes Zoster/painful blistering rash; Information has been received from a lawyer regarding a case in litigation and refers to a male patient (pt) of unknown age. No information regarding the pt's medical history, concurrent conditions and concomitant medications was provided. On an unknown date, the pt was inoculated with zoster vaccine live (ZOSTAVAX) injection (dose, route of administration, vaccination site, lot # and expiry date were not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered a painful blistering rash. The pt presented to his medical provider and was diagnosed with herpes zoster. Despite receiving treatment, the pt continued suffering from herpes zoster. As a direct and proximate result of the Company's defective zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms have resulted in physical limitations not present prior to using the Company's product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company's conduct, the pt have suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was not recovered. The causality was related.  The event of herpes zoster was considered to be disabling.
h/a for several, nausea, probable fever (very thristy) denies feel awful like getting flu;
Woke up during the night with aa headache on Friday early am.  Side effects continue to come on during the next three days.  Effects include:  Severe chills (teeth chattering), Severe headache, tiredness, muscle and joint pain, low grade fever, nausea and diarrhea, chest discomfort/heart burn.  Today, (day 3) he reports he feels that he may be dying.
Patient states that he had vaccinations administered on Tuesday and wednesday afternoon around 1:30 p.m. he began having fever and chills. He also had body aches on Thursday, with some residual body aches today. Patient was febrile on Wednesday and Thursday, with fever resolving itself on Friday morning. Patient also has erythemia to posterior side of left upper arm. According to consent, the vaccinations administered in this region were MMR and PPV23. Patient has no swelling to any other areas of arms. Patient has had no anti-biotics therapy, but has been taking Alieve for fever and body aches.
This spontaneous report as received from a pharmacy technician refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (lot # reported as L003347 (an invalid lot number for GARDASIL) and expiry date 23-JUL-2017; dose and route not reported). No adverse effects were reported. This one of several reports received from the same reporter. Additional information has been requested.
17MAR90 t106, hospitalized p/ER tx; 18MAR90 AM released 18MAR90 t106; sz lasting 20-30 min; Admitted p/sz was stopped, lost ability to speak, understand, recognize people, knowledge of toy use, etc; w/in wk began tonic/clonic sz;see WORM;
Swelling at injection site of dose 6 that was received on 5/6/00. Area is bruised and tender, firm but no nodule.
Pt recv vax 24MAY95 & 25MAY95 devel a fever of 102 & approx 9 to 12 raised blisters on trunk, arms & legs; No further details were provided;
First dose at pharmacy on 6/7/21 - Pfizer ER8736.  After shot was administered, pt had a vasovagal response in the chair, with pseudo-seizure response less than one minute.  Lowered to the ground and pt came responsive and aware, pale diaphoretic.  Transferred to wheelchair to med evaluation area.  Denies any pain or discomfort, resting on cot with mom at side.  Cold pack given and Gatorade.  Resting with no c/o, color pink and warm.  Taking sips Gatorade.  Vaccination site intact, sitting up for short time c/o nausea.  Laying back down with cold pack.  Transitioned to sitting then standing after 35 minutes.  Denies any dizziness or nausea.  Reviewed with mom to follow up with doctor regarding the events.  Discussed hydration and rest for today, verbalized understanding.  Discharged ambulatory at 1230 home with parents.
Pt recvd vax & had very itchy rash (small red pimples from neck to thighs); pt was put on Pred for 6 days & Atarax for 3 days;
Missed periods; This is a spontaneous report from a contactable healthcare professional, the patient. A 29-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date in 2021 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 13Apr2021 at 10:45 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. On 21May2021 at 00:00, the patient experienced missed periods. The event did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event missed periods was unknown at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Patient's pertinent medical history, drug reactions, allergies and concomitant medications were not provided. In January 2015 (one year ago), the patient was vaccinated with the first dose of pneumococcal vaccine (manufacturer unknown); the second dose was administered on 26-JAN-2016 (dose, route of administration and lot number were not reported). The next day, on 27-JAN-2016, the patient was vaccinated with a dose of ZOSTAVAX lot # L026414, expiry date 15-OCT-2016. No adverse effect was reported. Additional information has been requested.
Child had a reaction after getting a Rabies shot in ER". Reaction started 2 minutes after shots given. Benadryl  given. Symptoms-swollen feet, legs and slight rash. Symptoms subsided 1 hour after Benadryl taken.
Shoulder / arm pain began about 36 hrs after the initial vaccine. Couldn't lay on my left arm but assumed it would go away. Received second vaccine 6/7/2021  by same clinic and it's gotten progressively worse. Can't sleep & difficulty working  Reduced range of motion. Constant pain from shoulder down nearly to the wrist. Dr diagnosed as SIRVA. Prescribed steroid pack and physical therapy. Steroids have not provided any relief. Next suggestion is cortisone shot. Dr said it may never get better.
Presented to MC on 8/12 with progressive SOB, weakness and fatigue. Previously diagnosed with COVID.  Evidence of sepsis and pneumonia with increased O2 support. Given remdesivir, dexamethasone and broad spectrum antibiotics.  Due to long stay her isolation was discontinued and got first vaccination for COVID on 8/31.  On 9/2 experience recurrent respiratory decompensation. Again treated with steroids and antibiotics for pneumonia as well as dialysis. Respiratory status continued to decline and patient requested DNR/DNI with family agreeing to comfort care.
mild headache right after shot than fatigue so bad could not get off couch and slept a lot.  second day got a bloody nose dark red blood went away quickly,  had stomach ache high up and bad fatigue for 4 days.  still tired
Two days after vaccine administration, patient developed redness, swelling and bruising to her left arm. Advised to use ice and otc pain relievers prn. Patient seen for sick visit that day and was cleared by MD.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. Medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL injection, lot # J002641, expiration date 10-DEC-2015 (dose and route were not reported). Concomitant therapies were not reported. The reporter stated that GARDASIL vaccine was exposed to a highest temperature of 12 degree centigrade for a time out of range of 147.5 hours which was an excursion that was not supported by in-house stability data. No adverse effect reported. This is one of several reports received from same source. Additional information has been requested.
I had stomach pain, heat sweats, chills, nausea and vomiting. It let to me going to the emergency room for it. Cat scan showed gallbladder inflamed and stomach infection. galls-stone present.
Flu-like symptoms; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms) and PAIN IN EXTREMITY (sore arm) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms) and PAIN IN EXTREMITY (sore arm). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms) and PAIN IN EXTREMITY (sore arm) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment medication was reported. This case was linked to MOD-2021-427701, MOD-2021-427775 (Patient Link).
MINIMAL SIDE EFFECTS; This spontaneous report received from a patient concerned a 28 year old female. 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced minimal side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of minimal side effects was not reported. This report was non-serious.
Sore arm; Lethargy; heavy-feeling limbs on full day 2; Fatigue on full day 2; This is a spontaneous report from a contactable consumer (patient) received. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm, on 22Feb2021 at 06:30 PM (Lot Number: EM9810) (at the age of 37 years old) as dose 1, single for COVID-19 immunisation. Medical history included insulin resistance, anxiety, depression, and generalized panic disorder, all from an unknown date and unknown if ongoing. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. Concomitant medications included fluoxetine hydrochloride (PROZAC); lisdexamfetamine mesilate (VYVANSE); levocetirizine dihydrochloride (XYZAL); erenumab aooe (AIMOVIG); Montelukast sodium (SINGULAIR); cholecalciferol (VITAMIN D), all taken for an unspecified indication, start and stop date were not reported. The patient previously took sertraline (ZOLOFT) and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Feb2021 at 05:00 AM, the patient experienced sore arm , lethargy, heavy-feeling limbs on full day 2, and fatigue on full day 2. The patient did not receive any treatment for the events. The outcome of events was recovering.
Severe sore arm, could not lift arm for 2 days. Fever and chills (shaking) the night after the shot.  Tiredness, achy muscles, chills comes back when Advil wears off around 6 hours after taken.  Woke up the next night sweating, muscles ache.
Pt was receiving their Jynneos MPX vaccine intradermally. Nurse used proper technique, however the needle was too superficial, so when she injected the vaccine content, the content leaked out of the injection site. Notified team and pt received a different dose to give Subcutaneous route.
very bad runny nose; fever of 100°F-101°F; This is a spontaneous report from a Pfizer-sponsored program. A contactable 63-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 04Mar2021 as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 05Mar2021, patient began to experience a "very bad runny nose" and a fever of 100 degree F-101 degree F. She reports the symptoms are getting better but still persisting. She was concerned if that was a potential side effect or she needs to get tested for covid. On 05Mar2021, the patient underwent lab tests and procedures which included body temperature resulting 100 degree F-101 degree F. Outcome of the events were recovering/resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
One hour after vaccines began with fussiness. By two hours inconsolable, breath holding, spitting up. Seen at hospital - noted tachycardia and fever. Evaluation with blood work completed (WNL). Symptomatic care provided.
Full body chills; head to toe muscle aches; took Tylenol every 4 hours; symptoms lasted approximately 19 hours
This literature marketed report was received from the authors of the literature article. The authors conducted a retrospective cohort study among the patients of unknown age (reported as "older"), with autoimmune or inflammatory (AI) diseases, including rheumatoid arthritis (RA), ankylosing spondylitis (AS), inflammatory bowel disease (IBD), psoriasis, and psoriatic arthritis (PsA), using 2006-2013 insurance data. The aim of the study was to evaluate the duration of herpes zoster (HZ) vaccine (manufacturer unknown) effectiveness. The vaccinated cohort consisted of 59627 patients. 53.1% of the patients had RA, 1.4% had AS, 20.9% had IBD, 31.6% had psoriasis and 4.7% had PsA. 11.0% of the patients used biological drugs prior to index date, 46.1% used disease-modifying antirheumatic drugs (DMARD). 14.0% used unspecified glucocorticoids at the dose lower than 7.5 mg/day, 2.5% used them at the dose higher or equal to 7.5 mg/day and 83.5% of the patients did not use them at all. Upon evaluation of potential confounders, 26.7% of the patients had diabetes, 24.9% had chronic obstructive pulmonary disease (COPD), 10.4% had renal disease, 11.3% and heart failure, 44.8% had outpatient infection during baseline, 50.7% used narcotics, 27.7% used unspecified antidepressants and 21.8% used unspecified nonsteroidal antiinflammatory drugs (NSAID). On unknown dates, the patients were vaccinated with a dose of  zoster vaccine live (manufacturer unknown) (dose, route of administration, lot # and expiry date were not reported) for prophylaxis. To understand long term effectiveness and avoid misclassification related to healthcare associated with vaccine administration, follow-up started from 30 days after the vaccination date or corresponding calendar date in the matched cohort, and ended at the earliest of first HZ, death, loss of coverage, or 31-DEC-2013. Matched patients were censored if they were subsequently vaccinated, and then included in the vaccination group and re-matched. The maximum follow up time was 7 years post-vaccination. HZ was diagnosed using an International Classification of Diseases, 9th (ICD-9) inpatient diagnosis code alone or an outpatient diagnosis code plus antiviral medication (famciclovir, acyclovir, valacyclovir) within 7 days of HZ diagnosis. This report refers to 328 patients who, on unknown dates, developed HZ in the 1st year after the vaccination (considered as lack of efficacy). The authors concluded that the duration of HZ vaccine (manufacturer unknown) effectiveness waned over about 5 years among older patients with AI conditions, many of whom were treated with immunosuppressive and immunomodulatory agents. This is one of several reports from the same literature article (cross-referenced with MARRS # 1703USA010592, 1703USA010593, 1703USA010594, 1703USA010595, 1703USA010596, 1703USA010597). Additional information has been requested. Sender's Comments: US-009507513-1703USA010595: US-009507513-1703USA010596: US-009507513-1703USA010597: US-009507513-1703USA010593: US-009507513-1703USA010592: US-009507513-1703USA010594.
Patient received expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  No treatment medication were reported.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 09-NOV-2015, the patient was vaccinated VARIVAX, lot # L015045 (dose, dose number, vaccination site, route, expiry date unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
24JUL92 pt recvd Engerix-B vax & 25JUL92 devel h/a, feeling bad, & flu-like sx; 9AUG92 devel red knots on legs & swelling lymph nodes; 10AUG92 went to ER inc BP, inc temp, red knots on legs & thigh & sweling lymph nodes;
No symptoms day of.  Woke  4:30 AM on 3/31, headache and chills, no fever, sore left arm.  Took IB 800.  Started to feel better, later in the afternoon however, 3:00 PM sore throat swollen glands, low-grade temp 99.8, foggy brain. That is where I am at this time.