chrisvoncsefalvay/vaers-outcomes huggingface dataset:
got terribly sick; Initial information was received on 07-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media.  This case involves patient (unknown demographics) who got terribly sick (illness), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got terribly sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for illness.  There will be no information available on the batch number for this case.
drowsiness, heart racing, myalgia in legs & arms w/jerky movement;gen chills, felt hot;took APAP & theraflu & then had urinary urgency & frequency & jaw muscles felt tight;7OCT95 only felt fatigued;8OCT95 just felt weak w/some sore throat;
This serious spontaneous literature report (initial receipt 24-Mar-2015) concerns a 55 year-old female patient who denied prior shoulder pain, fever, redness, soft tissue swelling, interval trauma, excessive lifting, pulling or exercising. She previously received Influenza virus vaccine and Tdap vaccine. On an unspecified date, the patient received influenza vaccine (manufacturer and batch number not provided). The patient also received Tdap vaccine (batch number not provided). On an unspecified date, less than 24 hours after receiving the influenza vaccine and Tdap vaccine, the patient experienced left shoulder pain which was described as dull/achy, 5 out of 10 (10-point scale with 10 being the worst pain) at rest. The shoulder pain exacerbated with shoulder manipulation, most notably with abduction. She also reported persistent 3-4/10 dull pain at rest, sleep disturbances due to pain, and difficulty with lifting, carrying and driving. Investigations included physical examination which was positive for left deltoid tenderness, restricted adduction, and tenderness upon passive abduction and arm elevation - reflexes, strength and sensation were intact. Serum C-reactive protein was normal. Non-enhanced MRI (Magnetic Resonance Imaging) of the left shoulder demonstrated abnormal osseous oedema in the lateral humeral head and neck, and abnormal soft tissue oedema in the teres minor muscle, including its myotendinous junction and humeral insertion. A three-month follow-up (after an ineffective subacromial corticosteroid injection) non-enhanced MRI demonstrated ongoing inflammatory disease as evidenced by new visualization of an 8-mm humeral head cortical erosion. The patient's pain persisted, but at approximately 6 weeks post-injection, her pain with sleep reduced from 4/10 to 2/10. Her rest pain reduced from 5/10 to 3/10 at approximately 7 weeks but with persistent mild restricted motion on physical exam. At around 6 weeks post vaccination, her symptoms began to improve, albeit minimally. On an unspecified date, it was diagnosed as shoulder injury related to vaccine administration (SIRVA). The humeral greater tuberosity erosion depicted on the follow-up MRI reflected not only sequel of prolonged immune response, but it also strongly suggested direct needle impact - likely secondary to the CDC (Centers for Disease Control and Prevention) recommended needle length. She did not undergo surgical repair. The outcome was recovering. Reporter's comments: The reporter reported that the post-injection findings were attributed to sequel from direct needle impact and reactive change related to the injected material. Differential diagnoses included focal septic arthritis, calcific tendinitis with intraosseous penetration, gout, and seronegative spondyloarthropathic enthesopathy. Her prolonged response was likely due in part to performed antibody existing within her synovial tissue from prior vaccinations.
8 days after injection redness, swelling, and itching at injection site.  Arm is hot to touch where red.  Itching on other parts of body.  Have treated with ice.
VERY SICK FOR EIGHT DAYS; SEVERE SIDE EFFECTS; This spontaneous report received from a patient via a company representative via social media (Social Listening) concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: severe allergies (Patient could not get Pfizer or Moderna vaccine due to severe allergies), and other pre-existing medical conditions included: Patient was told by doctor that it was too risky for health to get vaccinated for Covid. 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced very sick for eight days, and severe side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the very sick for eight days and severe side effects was not reported. This report was non-serious.
10/21/98 AM rash both thighs,groin,abd,underarms,2PM rash spread to back & back of head w/ raised whelps resembling hives w/ burn like area,10/23/98 Benadryl,rash gone 10/22/98
Occasional mild headache, occasional mild chills, a bit of gas, mild muscle aches, occasional hot flashes (more intense than usual) and occasional fatigue (usually starting around mid-afternoon) and lasting for three days, starting about 24 hours after second dose.  No fever.
Patient started getting itchy, burning rash on frontal scalp 20-22 hours after receiving 2nd Shingrix dose.  Patient presented to my office on 2/5/2020 and viral culture was performed.  Viral culture was positive for VZV.
17:50 pt. given Pfizer Covid 19 Booster. 18:00 pt. c/o "tingling" lips. Dr. notified and instructed RN to give Benadryl 25mg plus pepcid x 2 p.o. + observe 20 min and call back. 18:05 BP 133/83 P. 99 Po2 100% 18:20 pt. c/o slight improvement, denies respiratory Sx. skin warm, dry, no apparent rash. 18:20 Dr. called w/ update. advised to discuss 2/ pt. emergency protocol and comfort level if d.c'd. Pt. d-c'd. BP 130/86 P 98 Po2 100%
On 05/05/21, I noticed a red rash has formed and is covering my left bicep. The rash is itchy, warm and sensitive to the touch.  Today (05/07/21) will be day three of this rash.
sore arm started about 2 hours after.  Following day I felt terrible - felt like I had fever though my temperature was LOWER than normal.  A little bit of post nasal drip also.  By the following day I felt 60% better.  All gone by 3 days after the shot.
immed p/vax pt started to scream & cry;pt cried & was inconsolable for 45min;put ice on inj site, given APAP & calmed down & eventually went to sleep;mom states slept 2 1/2hr & when woke cried hard for 30-45min;
I have had severe facial swelling under my eyes, where I had previously received Juvederm Voluma under eye dermal fillers. I have also had chills, body aches, sweaty, feverish, and felt like I have the flu for 2 days.
On 08/01/2022, I received a cortisone injection in my knee. On 08/02/2022 I woke up drenched in sweat and had diarrhea and terrible abdominal cramps. It subsided that day, but has come back three more times. The worst occasion was this past Tuesday 08/16/2022. My blood pressure has also been very high during these past 2 weeks. I saw my doctor yesterday, 08/17/2022 who said that he has not seen a reaction like this to a cortisone injection in the past. I do have I.B.S. but I have not had episodes this severe in the past. I have had 9 different injections in a little over a year and a half so I don't know if it's related to any or all or none of these injections. I've had 4 COVID-19 shots, 2 Shingrix, a DTAP vaccine, Quadrivalent Flu vaccine, and the cortisone injection.
Resurge in aplastic anemia; Swollen arm; Been cold; Chills; Running Fever; This spontaneous case was reported by a consumer and describes the occurrence of APLASTIC ANAEMIA (Resurge in aplastic anemia) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Aplastic anemia. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), METOPROLOL TARTRATE and FEBUXOSTAT for an unknown indication.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm), FEELING COLD (Been cold), CHILLS (Chills) and PYREXIA (Running Fever). On 23-Feb-2021, the patient experienced APLASTIC ANAEMIA (Resurge in aplastic anemia) (seriousness criterion medically significant). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. On 08-Feb-2021, PERIPHERAL SWELLING (Swollen arm), FEELING COLD (Been cold), CHILLS (Chills) and PYREXIA (Running Fever) had resolved. At the time of the report, APLASTIC ANAEMIA (Resurge in aplastic anemia) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Dec-2020, Platelet count: 60 (Inconclusive) Inconclusive. On 18-Dec-2020, Red blood cell analysis: 14 (Inconclusive) hemoglobin. On 23-Feb-2021, Haemoglobin: 10.8 (Low) dropped. On 23-Feb-2021, Platelet count: 21 (Low) dropped. On 14-May-2021, Haemoglobin: 8.8 (Low) dropped. On 14-May-2021, Platelet count: 13 (Low) dropped. On 14-May-2021, White blood cell count: 2.2 (Low) dropped.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient stated her aplastic anemia gotten worse after taking vaccine. The patient also stated that she had been under a lot of stress because her husband was sick, and she was not sure if that also a contributing factor.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.    Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Additional information received captured patient demographics.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
FEVER, LETHARGY, MYALGIA, HEADACHE Narrative:  TEMPERATURE 99.8 deg; SYMPTOMS LASTED 24 HR; EMPLOYEE MISSED ONE DAY OF WORK  Other Relevant History:
Became light-headed, saw black spots, sweaty and pale after leaving clinic. Also said she felt a little nauseated.  BP: 110/72. Brought back to clinic. Later 104/64 which she said is normal for her.  Given fluids after nauseated subsided. Rested 10-15 minutes. Felt better. States she has felt fine since.
On April 9th 2021, 2 days after being vaccinated with J&J, I got my period. Very heavy flow. I am almost 52 and haven't had a period since 10/27/20. I also historically have not had heavy periods. I alerted my Dr today in an online note form about this as I find it odd and very unexpected. I have had fatigue but otherwise no additional adverse events.
Chills and moderate headache within 6 hours of vaccine. Lasted about 6 hours  Severe headache 6 days later that lasted 1 day
Patient was vaccinated on 4/19/2022 with a beyond used date Pfizer vaccine. Pfizer clinical team was consulted and they could not confirm the viability of the beyond used date product. Patient was informed on 5-6-22 about the error and patient was re-vaccinated with Pfizer#4.  Patient did not report any adverse events yet.
Severe migraine, nausea, dizziness. Swelling and redness at injection site.
worsened after getting the second dose/about 30 spots of pink light colored dots/pink dots that don't itch, they are not all round, they can be oblong, they are a lighter pink; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, on 16Feb2021 (Batch/lot number unknown), as dose 2, single, for COVID-19 immunisation, at a hospital. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection) received on 26Jan2021 (Batch/lot number unknown), at age 74 years old, as dose 1, single, for COVID-19 immunisation, after which the patient had a little rash. The patient did not notice the rash too much after the first dose. The patient described the rash as dots a quarter inch to the size of a quarter that do not itch. He stated that since they were where his suspenders go that the skin might just be getting irritated. On an unspecified date, the rash worsened after getting the second dose. The patient described the rash as "pink dots that don't itch, they are not all round, they can be oblong, they are a lighter pink". It was located only on his chest and shoulders, was not itchy, but was about 30 spots of pink light-colored dots. The patient tried NEOSPORIN (not helpful) and Melluca oil which only made the rashes darker. The patient called a local clinic to schedule an appointment and they asked him to talk to Pfizer first to see what their recommendations were. The patient would like to know if there was anything that he could put on his rash to treat it. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A non-serious spontaneous report of inadvertently given half dose of H1N1 LAIV was received from a nurse/health professional concerning a 32-year-old female. The patient's medical history and concomitant medications was not reported. On 28-Oct-2009, the patient was inadvertently given half dose of H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
pt recv vax & c/o an inj site rxn characterized by redness,soreness,& irritation;No further details known as of reporting date;
PAIN IN NECK; PAIN IN FACE; PAIN IN LUNGS WITH SHORTNESS OF BREATH; PAIN IN SHOULDER; TINGLING; NUMBNESS; PAIN IN FEET/ARM; PAIN IN HEAD; SUPRAVENTRICULAR TACHYCARDIA IN HEART; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, and other pre-existing medical conditions included: The patient is in excellent health. The patient had no history of pre-existing medical conditions. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 205A21A and expiry: UNKNOWN) dose was not reported, administered on 21-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On JUL-2021, the patient experienced supraventricular tachycardia in heart. Laboratory data included: Heart rate (NR: not provided) 167 bpm.  On an unspecified date, the patient experienced pain in neck, pain in face, pain in lungs with shortness of breath, pain in shoulder, tingling, numbness, pain in feet/arm, and pain in head. Laboratory data (dates unspecified) included: CT scan (NR: not provided) normalcy, Lab test (NR: not provided) Normal, and X-ray (NR: not provided) normalcy. The action taken with covid-19 vaccine was not applicable. The outcome of the tingling, numbness, pain in feet/arm, pain in head, pain in neck, pain in shoulder, pain in face, supraventricular tachycardia in heart and pain in lungs with shortness of breath was not reported. This report was non-serious.
This is a verbatim narrative as reported on website, accessed on 28 July 2011. According to the web site these reports were from FDA VAERS. "FLUMIST problem was reported on Nov 15, 2007. Male patient, child 8 years of age, was vaccinated with FLUMIST on Nov 15, 2007. Fever to 102.6 with chills and vomiting developed 12 hours after vaccine was given. She was evaluated 6 hours after the onset of symptoms. She received one dose of TYLENOL. Her exam revealed 3+ red tonsils and generalized abdominal tenderness. Her temp was 98.2 and patient stated she was hungry. CLARITIN 10 mg prn and TYLENOL x 1 dose. Allergic Rhinitis. Patient recovered."
Uticarial rash covering extremites, swollen face, erythematous face and neck. Treatment Benadryl 50mg every 4 hours X 24 hours, then Benadrly 25mg every 6 hours X 3 days.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history and concomitant medications were not provided. On or about 06-JUL-2015, the patient was inoculated with ZOSTAVAX (dose, route and lot # not provided). The vaccine did not prevent shingles and caused the patient to contract a persistent strain of herpes zoster (onset date not specified). Shortly after receiving ZOSTAVAX, the patient began to experience episodes of edema, weight gain, and symptoms suggestive of kidney dysfunction. Thereafter, on 02-NOV-2015, the patient presented to a hospital where she was diagnosed with minimal change disease and nephrotic syndrome secondary to minimal change disease and acute kidney injury. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. The outcome of the events were unknown. Causality assessment was considered related. Upon internal review, nephrotic syndrome and minimal change disease were considered medically significant. Additional information has been requested.
PERICARDITIS; This 37-year-old, female subject was participating in "A Phase 3, Randomized, Stratified, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1273 SARS-CoV-2 Vaccine in Adults Aged 18 Years and Older" and experienced the life-threatening serious adverse event of special interest of pericarditis.    The subject's medical history, as provided by the investigator, included polycystic ovarian syndrome, anemia, multiple cysts on ovaries, congenital atrioventricular septal defect, pulmonary stenosis, tricuspid valve regurgitation, mitral valve regurgitation, nummular eczema, and acne of the back. Concomitant medications reported included cetirizine hydrochloride, iron ferrous sulfate, methylprednisolone, metformin, betamethasone, tazarotene, colecalciferol, ethinylestradiol/norgestimate, paracetamol, and nirmatrelvir/ritonavir (prescribed for symptomatic covid-19 infection, from 7-Sep-2022 till 09-Oct-2022).   Prior to event onset, the subject received intramuscular mRNA-1273 (Dose 3) for SARS-CoV-2 vaccination on 26 Oct 2021, approximately 10 months and 29 days before onset of the event.   On 23 Sep 2022, the subject experienced pericarditis.    Treatment for the event included oral colchicine.   The subject received all scheduled doses of study drug prior to the event; therefore, action taken with study drug in response to the event was not applicable.    The event, pericarditis, was reported as resolving.    The investigator assessed the event, pericarditis, as not related to study drug and not related to study procedure.  Company comment: This case concerns a 37-year-old, female subject with a medical history of polycystic ovarian syndrome, anemia, congenital atrioventricular septal defect, pulmonary stenosis, tricuspid valve regurgitation and mitral valve regurgitation among others, who experienced the unlisted life-threatening serious adverse event of special interest of pericarditis. The event occurred 2 years 1 month 13 days after the first dose of IP, and 10 months 29 days after the third and booster dose. The event, pericarditis, was reported as resolving. The event was considered unrelated to IP in agreement with the Investigator. The event might be explained by COVID-19 infection as suggested by indication of nirmatrelvir/ritonavir that was administered from 7-Sep-2022 till 09-Oct-2022. Additional indication was requested.
I had a sore arm and headache for a few days.  My ankle hurt the next morning like it retained fluid. Then I got spots all over my body worse on ankles and feet. The spots don't look like a normal rash. It looks like tiny blood vessels broke. Then I had blood in my stool for 3 days. Not black stool unmixed blood.  I took photos of my entire spotted body and ankle the looks worse almost bruised looking and sent to my cystic fibrosis team medical not the doctor who scheduled my vaccine.
Employee signed consent for flu vaccine and was administered Fluzone Quad in left upper arm.  Once vaccine was administered, employee informed nurse that she received Fluzone Quad on 10/5/21.  This event resulted in the employee receiving 2 doses of Fluzone  Quad.  No adverse reaction was reported to nurse as a result of this event.
Vaccines administered around 10.15 am. Mom spent next door and returned at 10.30 am, child had rash and hives to entire front of neck and chin. Rash to cheeks and chest. Child in no visible distress and looked fussy. Benadryl 0.25mg PO given.
This spontaneous report was received from a registered Nurse regarding a patient of unknown age and gender. The reporter stated that on 10-FEB-2015 the patient was administered a dose of ZOSTAVAX subcutaneously and then on 20-OCT-2015 (19 days after first dose) the patient was administered a second dose of ZOSTAVAX, lot # and expiration date for each dose of ZOSTAVAX is unspecified. The patient did not experience any adverse event. There was no report of Product Quality Complaint. Additional information has been requested.
rash with bumps from arm to whole body, itchy and sometimes hurt; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (rash with bumps from arm to whole body, itchy and sometimes hurt) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced URTICARIA (rash with bumps from arm to whole body, itchy and sometimes hurt). At the time of the report, URTICARIA (rash with bumps from arm to whole body, itchy and sometimes hurt) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported
Mother states they noticed "hives" on  child's arms Sunday 8/26 then Monday 8/27 increased number of "hives" spread to chest and face. Mother contacted Dr.'s office which instructed mom to give Benadryl and contact Health Dept.