chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (no energy), CHILLS (Chills), COUGH (covid caused lingering cough), DECREASED APPETITE (NO appetite) and LETHARGY (lethargic) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced LETHARGY (lethargic). On an unknown date, the patient experienced ASTHENIA (no energy), CHILLS (Chills), COUGH (covid caused lingering cough), DECREASED APPETITE (NO appetite), PAIN (Body ache) and PYREXIA (Fever). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, ASTHENIA (no energy), CHILLS (Chills), COUGH (covid caused lingering cough), DECREASED APPETITE (NO appetite), LETHARGY (lethargic), PAIN (Body ache) and PYREXIA (Fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant medication were reported.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Chills and pyrexia are consistent with the product safety profile.
Information has been received from a  health professional concerning a female patient who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine.  Subsequently the patient experienced pain and swelling with erythema on the injection arm which listed for a couple of days.  Medical attention was not sought.  There was no product quality complaint involved.  The patient recovered.  No further information is expected.
Patient was given several vaccines at 6m WCC, including hepatitis A. Pt should not have received Hep A vaccine.
Pt wife states during phone call to clinic 8/29/18 that after leaving clinic on 8/27/18 at appx 1230, they went shopping at which time pt began to c/o nausea and dizziness.  Pt wife took him home and he went to bed.  Pt began running fevers up to 101 F on Tuesday 8/28/18, with continued nausea and dizziness, c/o HA, rt arm pain, and chills.  Wife states that he slept all day on Tuesday.  Tues during the night, pt woke up and "couldn't breathe", wife administered inhaler.  Wife states that pt still "feels terrible" 8/29/18 and rt arm is red at injection site with minimal swelling. Wife states that pt takes many meds for RA, is immune compromised, and has COPD.  Nurse advised wife that pt's body is building immunity to the vaccines and he may feel bad due to being immune compromised.  Nurse advised pt wife to call PCP 8/29/18 and explain s/s to see if PCP recommends being seen in office or Urgent care.  Nurse JW asked pt wife to advise how he is doing and if seen by PCP. 8/30/2018, pt wife left VM to notify that his "symptoms are subsiding, no longer has HA or dizziness", still has a "slight fever."  Wife states that she spoke with PCP 8/29/18 who prescribed a z-pack.
3-24-06 Infant received 2 month vaccines, resulting in immediate erythema, mild edema (and crying) of both legs.
Information has been received from a physician concerning a pt who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the pt developed "vaccine failure". "One child had more than 50 lesions" (WAES # 0308USA00716) "and the other child was covered." It was noted that the doctor did not provide any additional information at the time of this report. Unspecified medical attention was sought. There was no product quality complaint involved.  The reporter also mentioned a sibling that was vaccinated with varicella virus vaccine live and developed a similar experience (WAES # 0308USA00716).  Additional information has been requested.
Severe abdominal pain following final dose. Vomiting and unable to keep food in stomach throughout the second day (9/11/2019).
red rash on face, eyes swollen & itchy;pt very fussy;pt seen in office given DPH q 4-6hr x 24hr;
Adhesive Capsulitis/frozen shoulder, physical therapy and cortisone shot, still regaining range of motion
vaccine given after 12 hours of being in the refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given after 12 hours of being in the refrigerator) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given after 12 hours of being in the refrigerator). On 29-May-2021, EXPIRED PRODUCT ADMINISTERED (vaccine given after 12 hours of being in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Follow up received on 01-JUN-2021 and it contains No New Information
tested positive for covid 19; lost sense of taste and smell; lost sense of taste and smell; This is a spontaneous report from a contactable other hcp. This other HCP reported for a 17-year-old male patient received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot EW0198), dose 1 intramuscular, administered in Arm Left on 13Jul2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included dust mite allergy. The patient's concomitant medications were not reported. On 15Jul2021 (two days post vaccination) patient experienced tested positive for covid 19, lost sense of taste and smell. The patient underwent lab tests which included body temperature: normal, sars-cov-2 test: positive on 15Jul2021 (Covid 19 Ag card). Reporter seriousness for tested positive for covid 19 was not serious. received his first dose of Pfizer Covid vaccine. Reporter was wondering if that was to be expected. Second dose scheduled for 03Aug2021. Treatment declines any. He has no other symptoms, checked temperature and it was normal, sinuses and lungs are fine, no body aches. He is a healthy child, no conditions. There is a Product Complaint. Caller asking if these results mean the patient actually has Covid-19. Response: Spoke from "regulatory authority-can the vaccine cause a false positive COVID-19 test (v3.0)." "Viral tests are used to see if you have a current infection. The Pfizer-BioNTech COVID-19 Vaccine will not cause you to test positive on viral tests. The following website has information on viral tests for current infection with COVID-19:# Sending email fulfillment containing attached document per caller request. Informed caller that the Pfizer BioNTech Covid-19 Vaccine cannot cause a Covid-19 infection. Informed caller that Pfizer cannot speak to the reliability of the results of the test used. The outcome for all events was unknown.
Patient was instructed to wait 15 min. after inj. patient was waiting in the waiting room and stated she became severly dizzy, weak and nauseated. She called home for transportation and did not report her symptoms to the medical staff. The patient states her symptoms persisted all evening to bedtime, they had subsided when she awoke the next morning. The patient received the vaccine at 2:00pm.
Patient received FLUZONE HD on 9-15-13 at 7:00pm. He waited with me until we left at 7:10. On 9-16-13 he reports he had a small knot behind his ear. He waited until that afternoon to go to walk-in clinic because lymph glad was bigger. They gave him KENALOG injection and BENADRYL and stated it was a reaction to the shot.
Fevers; chills; This is a spontaneous report from a contactable consumer (patient) via sales representative. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced fevers and chills on an unspecified date after vaccination. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt states experienced ringing in the ears approx 3 hours after vaccination and has continued to experience ever since
Cholestasis of pregnancy developed at 37 weeks and 2 days. Was induced at 38 weeks. Normal LFTS and bile acids. Boy was born on 1/16 Weighing 6 pounds 0 oz. apgar 9 &9. Baby developed Coombs + Hemolysis, from presumed ABO incompatiblity.  Due date 1/30.
Pt recv vax on 11/5/98; on 11/6/98 pt exp left arm soreness x 1 wk, dull ache w/ movement; 12/98 pt exp feeling of bruise on heel of left palm (burning) up left arm; loss of muscle tissue in left arm-necrosis of fat cells
Twitching/muscle spasm in left leg; Menstrual period started 2.5 weeks early; Menstrual period heavy; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737), via an unspecified route of administration in the left arm on 06Apr2021 at 15:30 (at the age of 29-year-old), as a single dose for COVID-19 immunisation. Medical history was reported as not available and the patient did not have a history of allergies to any food or medications or other products. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) 25 milligrams XR, vitamin b12 nos (MANUFACTURER UNKNOWN) and ascorbic acid; biotin; minerals nos; nicotinic acid; retinol; tocopherol; vitamin b nos; vitamin d nos (PRENATAL VITAMINS) for an unknown indication from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 06Apr2021 at 16:00, 30 minutes after the shot the patient experienced twitching or muscle spasm in left leg which went away within an hour, menstrual period started 2.5 weeks early and heavy. It was reported that last period was 4 days from 25Mar-28Mar and patient's cycle was regular and period always starts in the morning, but this period started in the evening and no PMS signs or symptoms. No therapeutic measures were taken for the events. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The clinical outcome of the events twitching or muscle spasm in left leg, menstrual period started 2.5 weeks early and heavy were recovered with sequelae on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
The patient started to have a reaction to the vaccine two days after the KINRIX vaccine was administered. The child had an area of erythema about 14.5 cm x 10.5 cm with mild swelling noted on the right thigh. The patient was not having any fevers. The swelling was non tender. There was no limping. The patient was examined in the clinic and was clinical well appearing. The patient was treated with ice packs, BENADRYL, and TYLENOL as needed for pain. Patient site was marked and will follow up with the patient.
On 12/05/2022 I felt my left side of my throat was sore. I didn't think much of it because I have allergies. But I went to the doctor, to get cleared. She asked that I get an ultrasound on throat. She felt an issue with my thyroid. I haven't been diagnosed with anything just yet, my last test was inconclusive. They sent my results off for genetic testing I am awaiting those results. Now, my throat is feeling fine, it went away on 12/20/2022.
Site reaction on right arm- redness, warmth, and hard- less than 24 hours after given.
Red area @ inj site. Slightly hard bump 1.5 to 2 inches in diameter, hot to touch, sometimes itches but does not scratch. 5/10 pain on moving, touching, dressing. 100.5 F fever 11/26 (one day after inj). Denies fever today but may be having chills. Pt advised to use ice, Tylenol or ibuprofen, Benadryl, and hydrocortisone cream.
pt recv vax 3MAY99 & pt said ouch;p/5min later pt presented w/a numbness in thumb area;p/15min hand was noted to be sl cool to touch & had a bluish tinge to skin color;MD contacted by pt;pain down rt arm;hand color back to nl;numbness;
Day after 2nd shot: headache, chills, arm pain, swelling, rash on chest One week after 2nd shot: Extremely swollen eyes every morning starting one week after shot and continuing each day Two weeks after shot: Continue to have rash on chest and extremely swollen eyes every morning
Between second and third dose of Pfizer BioNTech Vaccines, the reporter experienced a  Covid 19 infection.; Between second and third dose of Pfizer BioNTech Vaccines, the reporter experienced a  Covid 19 infection.; This is a spontaneous report received from non-contactable reporter(s) (Physician). The reporter is the patient.  An elderly male patient received bnt162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Between second and third dose of Pfizer BioNTech Vaccines, the reporter experienced a Covid 19 infection.". Therapeutic measures were not taken as a result of drug ineffective, covid-19. Clinical course: Adverse event: Between second and third dose of Pfizer BioNTech Vaccines, the reporter experienced a Covid 19 infection. No treatment was received. No covid was prior vaccination. Covid tested post vaccination was Unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the known the information available the Causal relation between the events Drug ineffective, Covid 19 and suspect drug cannot be excluded completely
Pt blood drawn then received HEP B, TDAP and GARDASIL vaccination. Pt ask to remain sitting for few minutes per protocol. Pt voiced no complaints after receiving shots. While client was still sitting she fell forward onto floor. Pt then acceded and EMS called. Pt was transported to medical to evaluate possible nose fracture.
No adverse events were reported.; received one improperly stored dose of PNEUMOVAX 23 on an unspecified date.; This spontaneous report has been received from a pharmacist concerning to 1 of 19 patients, a 82-year-old male patient. The patients' historical condition, concomitant medications and drug reactions or allergies were not reported.   On 28-SEP-2019, the patient was vaccinated with an improperly stored dose (product storage error) of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route and frequency were not reported) lot # S012245, the expiration date: 09-FEB-2021 for prophylaxis.  The administered dose experienced a temperature excursion at lowest temperature below 36-degree Fahrenheit (32F) for 6 hours. Previous excursions were unknown by reporter. The temperature excursions were not detected by a data logger. No adverse events were reported.  This is one of several reports received from the same reporter. # 1909USA001561, 2003USA005392, 2003USA005393, 2003USA005394, 2003USA005395, 2003USA005396, 2003USA005397, 2003USA005398, 2003USA005399, 2003USA005400, 2003USA005401, 2003USA005403, 2003USA005404, 2003USA005405, 2003USA005406, 2003USA005407, 2003USA005408 and 2003USA005409. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S012245; expirationdate: 09-FEB-2021; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: No; reasonfornoneval: 81 Other; reasonfornonevalother: No information about the availability; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1909USA001561: US-009507513-2003USA005392: US-009507513-2003USA005393: US-009507513-2003USA005394: US-009507513-2003USA005395: US-009507513-2003USA005396: US-009507513-2003USA005397: US-009507513-2003USA005398: US-009507513-2003USA005399: US-009507513-2003USA005400: US-009507513-2003USA005401: US-009507513-2003USA005402: US-009507513-2003USA005403: US-009507513-2003USA005404: US-009507513-2003USA005405: US-009507513-2003USA005406: US-009507513-2003USA005407: US-009507513-2003USA005408: US-009507513-2003USA005409:
Breakthrough COVID case. COVID+ 10/19/21. Looks to have received Modern and Pfizer COVID vaccine series.
headache; muscle ache; Fever; chills; This is a spontaneous report from a contactable consumer (patient) via sponsored program.   A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number: UNKNOWN), via an unspecified route of administration on 23May2021 as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number: UNKNOWN), via an unspecified route of administration on 14Jun2021 as dose 2, single for covid-19 immunisation. The patient medical history was included cancer B cell lymphoma. She just came back from a 2week treatment of Biaxin. The patient had her last chemo treatment on 28Dec2020. She mentioned she was a part of group that could only receive the Pfizer COVID-19 vaccine in March2021. She mentioned she was tested positive for COVID before getting the vaccine. She was also hospitalized. The patient had a significant reaction to the first dose of the vaccine. The reaction with the first dose was more significant. The reaction with the second dose was milder. On an unknown date, the patient had significant fever with the first dose and second dose. she had chills and muscle ache and headache for a day. She got her antibody test 2 weeks ago later. It came back negative. Patient did another test. This was to test the level of her vaccine. she don't know what test it was. she scared now because of the delta variant. Patient was asking has Pfizer provided a statement on the need for a booster dose (3rd dose). Caller wants to know should she get three doses instead of two to ensure protection against COVID infection. Patient wants to know If MRI Godium contrast can have an impact on the effectiveness of the vaccine? Caller also wanted to know about Lymphoma Clinical Trials. At the time of this report outcome of the event fever was unknown and other event outcome was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt c/o violent shakes from 730PM-930PM on 25OCT95did not check temp
Received PPSV23 rt arm SC 5-10-11, erythema started 5-10-2011 and became worse on 5-11-11, with complaints of pain in right arm.  Area is warm to touch.  Erythema extended from distal deltoid to proximal elbow, involving posterior surface as well.  Area is warm and tender to palpation.  Area was marked and patient instructed to follow up at office if erythema extends beyond marked area.  Was ordered Doxycycline 100mg BID for 10 days on 5-10-11 for bronchitis, but had not started it, patient was encouraged to start Doxycycline at OV 5-11-11.
I had shortness of breath and tiredness, chills, cold sweat, 99-101° fever, flu-like symptoms. Messaged my care team through app. Was advised on how to care and quarantine. Currently under quarantine as of 3/18.
My second covid 19 vaccine was on 02/11/2021.  In March, my period was exceedingly heavy.  I was changing a pad every 2 hours and it wasn't enough.  I had to leave work because I am a traveling nurse and was unfit to enter patient's houses with this condition.  Prior to the vaccine my menstrual cycle lasted 3-4 days. Since the vaccine, my cycle has lasted nearly 7 days consistently, with much heavier bleeding.  Also my cycle starts very slowly and lingers at the end.
5 minutes after receiving the injection his mouth was itching. 7 minutes after his throat started closing up. 8 minutes after the pharmacist gave him one Benadryl and at 9 minutes 911 was called. He was given meds and oxygen then taken to the emergency room where he was monitored for 4 hours.
Fatigue; Extreme Body Pain; to not being able to do normal activities; Headache; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th December 2019, the patient received the 2nd dose of Shingrix. On 13th December 2019, 1 days after receiving Shingrix, the patient experienced general body pain, headache and activities of daily living impaired. On 14th December 2019, the patient experienced fatigue. On 15th December 2019, the outcome of the general body pain, fatigue and activities of daily living impaired were recovered/resolved. On an unknown date, the outcome of the headache was recovered/resolved.   It was unknown if the reporter considered the general body pain, fatigue, headache and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient's wife. The patient received dose if Shingrix in the right arm around 4 pm. The next day after vaccination, the patient had extreme body pain from head to toe and laid out on couch due to not being able to do normal activities. The following day, the patient experienced fatigue and next day the reporter stated that all symptoms were resolved than headache, which was resolved in approximately 1 to 2 more days.
The patient complained of an extremely swollen and red arm that made her call out of work and seek medical attention. She did go to urgent care.
Eight weeks post vax, the pt experienced severe peri arthralgias in every joint, the pain shifted to all joints of body except spine and TMJ. Treatment for the adverse event included Vioxx and Tylenol.
Stroke vs acute disseminated Encephalomyelitis.  1/8/08 Received vax record which confirms Aventis flu vaccine given 12/11. 1/8/08 Reviewed hospital medical records which reveal patient experienced right facial & RUE paresis x 2 days starting 2 hours s/p flu shot.  Seen in ER on 12/12, diagnosed w/weakness & d/c to home. No improvement.  Admitted 12/13-12-15/2007 to PICU.  Neuro consult done. FINAL DX: stroke, left basal ganglia infarct. 01/11/2008 Received additional hospital medical records which reveal patient experienced suspected ADEM vs stroke syndrome.  Admitted to PICU 12/21-12/23/2007.  Neuro consult done & tx w/high dose steroids.  Stable & d/c to home on continued steroids & neuro f/u. FINAL DX: none provided on d/c summary except ADEM vs stroke syndrome.  Neuro consult dx stroke.