chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lightheaded, chest started to hurt. Patient fell down in line for vaccine. BP 132/67 (pulse 86), 99% O2 sat. Discharged from hospital on 3/7/21 (stayed ~ 2 weeks).
fever of 104 & a sz @ home; taken to ER had another sz; am to hosp overnoc; treated w/APAP & children's Motrin;
1-3-07 MGM reports client has had no problems, but will get mother's cell phone number.  States she sees client daily.  1-9-07 MGM returned call for mother and states client did not run fever or have red or swollen arm or other symptoms following his last injection.  Reporting he continued to play and act as usual.  Mother and MGM live and work together.
Information has been received from a consumer and a nurse practitioner for the Pregnancy Registry for GARDASIL concerning herself, a 26 year old female with no medical history, and no drug reactions/allergies, who on 29-APR-2008 was vaccinated with her first dose of GARDASIL (lot # unspecified). On 02-May-2008 (three days later), the patient became pregnant (LMP estimated as 15-Apr-2008). Concomitant therapy included azithromycin (ZITHROMAX). The patient sought unspecified medical attention. At the time of this report the outcome was unknown. No further information available. Follow-up information received on 17-FEB-2009 from a nurse practitioner who reported the patient is Hispanic and has a history of smoking 2-5 cigarettes a day which she stopped with pregnancy, and an abnormal PAP s/p LEEP. Patient has had a previous pregnancy, no previous full term deliveries and a miscarriage. On 15-Jul-2008 patient had an ultrasound, which showed 12 weeks and 4 days pregnant ERA normal. On 13-AUG-2008 patient had a MSAFP testing with normal results. The lot # of the first dosage of GARDASIL received is 659180/1758U. Concomitant medications during pregnancy included prenatal vitamins (unspecified) which patient started taking on 18-JUN-08 (27 mg of Iron and folate 1mg daily) and on 08-JAN-2009 penicillin (unspecified) 3000000 international units every 4 hours for the treatment of bacterial infection due to streptococcus, group B. Date of last menstrual period on 18-APR-2008 (previously reported as 15-APR-2008) and estimated delivery date on 23-JAN-2009. Patient had a normal baby on 09-JAN-2009, male, who weighed 2975 grams, length 49 cm, Apgar score 9/9, head circumference 33.5 cm. No congenital anomalies or other complications or abnormalities. No complications during pregnancy, or during labor and/or delivery. No further information is available.
For about 30 minutes, couldn't remember where she was or how she got there, confusion, memory loss.  All memory returned after about 30 minutes.
Tenderness on the area were she got the injection.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Tenderness on the area were she got the injection.) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LETROZOLE for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE PAIN (Tenderness on the area were she got the injection.). At the time of the report, VACCINATION SITE PAIN (Tenderness on the area were she got the injection.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details were not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
Right arm red, swollen, warm, nausea, vomiting, diarrhea, elevated temperature, altered mental status.  Sent to ER.  Had elevated cardiac enzymes.  Admitted to hospital and treated for sepsis and altered mental status.
Complained of excess sweating. BP 124/84 P80 regular. Denies nausea, dizziness.
Information has been received from a physician's assistant concerning a female (age unknown), who, on an unspecified date, was vaccinated with a dose of Gardasil. Subsequently, in January 2007, the patient developed "Stevens-Johnson syndrome". The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
SHE BLACKED OUT; FELL DOWN  BUT CAME AROUND QUICKLY WITHIN 15 TO 30 SECONDS AND SAT DOWN ON THE CHAIR; This spontaneous report received from a health care professional concerned female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: 1805031 expiry: UNKNOWN) 0.5 ml, administered on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 05-MAR-2021, the patient blacked out and fell down but came around quickly within 15 to 30 seconds and sat down on the chair. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the she blacked out and fell down but came around quickly within 15 to 30 seconds and sat down on the chair was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and blacked out and fell down as related. Company causality between covid-19 vaccine ad26.cov2.s,blacked out and fell down was possible. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210314164-JANSSEN COVID-19 VACCINE-Blacked Out. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.     .
Client reports noticed rash on 4-24-11 involving Left deltoid area. Presented at Health Clinic on 4-26-11 with localized and well-defined macular, papular rash over Left deltoid area. Denies any shortness of breath, wheezing, or sore throat. Client stated she thought that she received Meningitis vaccination in Left arm and 3rd HPV in Right arm; call to Clinic-Medical Records and nurse unable to verify administration sites. Later received call from clinic nurse stating HPV given in Left deltoid and Meningitis given in Right deltoid. Client will take CLARITIN tonight and continue x 3-4 days and take BENADRYL 25-50 mg po q 4-6 hours prn. Status check 4-27-11: Symptoms no worse, still has rash, will call if not resolving.
Child developed red semi-fluctuant nodule -1.5 inch in size in area of injection. No obvious drainage from site  but crusted red point to area, ? cellulitis / abscess vs drug reaction
patient filled out the form with date of birth and when i called the insurance they said the year of birth was later than stated making the patient under age.  no adverse events reported
Sore vaccination site, chills, lethargic, slight headache,no temperature,
2 days after vaccination I noticed that I had a blood red bruise just under my left eye, close to nostril; I noticed blood in left nostril on 3rd day, and that evening noticed that I had redness in corner of my left eye with a red spot in very corner, which led me to reporting it here. I have not yet had contact with my doctor, but plan to call him and/or ophthalmologist tomorrow, Monday.
Vomiting x 1 after 10-15 min of vaccines. Child went pale, lips white, did not pass out (no syncope).
immun given in lt deltoid on 26APR94 devel redness & swelling around 24 hrs later; mom did not put cold compresses to site, applied vaseline to area; seen @ clinic on 21APR94; local reaction noted @ site, 6x6 cm erythematous & sl swelling;
no adverse event; received expired Moderna COVID-19 vaccine on 29DEC2022; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired Moderna COVID-19 vaccine on 29DEC2022) and NO ADVERSE EVENT (no adverse event) in a 41-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 29-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired Moderna COVID-19 vaccine on 29DEC2022). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received expired Moderna COVID-19 vaccine on 29DEC2022) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (received expired Moderna COVID-19 vaccine on 29DEC2022).    No Concomitant medication was reported. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-695793.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-695793:59 year old patient
Body aches, Runny nose, congestion, headaches, sore throat, cough.
I now have a rare immune disease called "Pityriasis Amiantacea". They are treating it by freezing the affected areas.
Started approximately 11 hours after shot with flu-like symptoms including headache, chills and muscle/joint aches and fatigue for a period lasting 24 hours. Severe pain at the site of shot including large patch of redness and swelling which is still occurring at this time approximately 40 hours after shot.
J18.9 - Pneumonia, unspecified organism J96.01 - Acute respiratory failure with hypoxia N17.9 - Acute kidney failure, unspecified R04.0 - Epistaxis
Swelling, heat, and redness at the injection site (left arm). It started 1 day after injection and was gone 4 days after injection. It returned 8 days after injection and is still present at this time. On day 8 I also began to have a sore throat, cough, and feel lethargic. Was sent home from work due to cough.
Pain behind right eye, headache, leading to redness and pain moving eye.  Dx: Scleritis, sent for bloodwork and auto immune markers elevated.
paresthesia In arms, hands and feet up to ankles. Started the morning after first shot and lasted consistently about 2 weeks. I still feel it periodically 4 weeks post.
11:15 am Participant was sitting in post-vaccination monitoring area.  She raised her hand and complained of lightheadedness.  Monitor offered her bottled water.  She stated she had eaten breakfast.  No other complaints.  BP 140/80, pulse 90, RR 16.  No signs or symptoms of distress.  She was able to walk 10 feet  forward and back to her chair without difficulty.  She stated she will continue to sit until she feels ready.   11:36 am stated she felt okay and proceeded to the exit.
Stomach cramps, which got much worse after the second dose. Muscle cramping, diarrhea, Gas, Cramping became severe.  Symptoms lasted for five days.  I could not finish the dosing.
Extreme escalation of existing Tinnitus. Level went from 1-2 on a 10 point scale to 7-8. Condition has worsened and is constant and chronic.
This case was reported by a physician via sales rep and described the occurrence of fever in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and joint pain. On an unknown date, the outcome of the fever and joint pain were unknown. It was unknown if the reporter considered the fever and joint pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not provided, but was selected adult as per the vaccine indication. Caller heard from the physician that he had seen three patients who after receiving SHINGRIX experienced low grade fever and joint aches. This case linked with cases US2018157973 and US2018157969, reported by the same reporter.
right side of her face swollen; extreme fatigue; This is a spontaneous report from a contactable consumer (patient). An 86-years-old female patient  received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL3246, expiration date not reported), intramuscular on the upper left arm, on 12Jan2021 at a single dose to develop immunity for Covid 19 virus. The patient has no medical history. Concomitant medication included ongoing levothyroxine sodium (SYNTHROID). The patient stated she got Pfizer Covid 19 vaccine two days ago at a hospital in the city and right side of her face was swollen and had extreme fatigue on 14Jan2021. Stated she is resting now and is feeling fine. She stated that it happened this morning. Stated that she waited for 15 minutes after the vaccine and had no side effects. She stated that her next dosage is 02Feb2021. There was no treatment received for right side of face swelling. Outcome of the events was recovering.
---RECIEIVED FIRST DOSE BY MISTAKE DURING A BUSY CLINIC DAY.. THIS REPORT IS FOR THE SECOND DOSE PER THE GUIDELINES FOR PATIENT TO STILL RECEIVE SECOND DOSE
2wks after MMR, PENTACEL. Had classic maculopapular measly rash T104 & febrile seizure
multiple spotted sores on arms, thighs, and neck. itchy with significant joint pain developed after first dose and reported during second dose
5 days after receiving my booster shot I started having severe right lower abdominal pain. The next day went to ER. Diagnosed with appendicitis. Spent the night and the next morning had my appendix removed. Also had a small hernia repaired that i did not know i had in my belly button.
Patient expressed that this vaccine "hurt more than the first" and stated that she felt she was going to pass out.  Patient experienced syncope and lost consciousness for approximately 10 seconds.  Patient was sitting at the time of the vaccination and was supported by the pharmacist until she regained consciousness.  Patient stated that she would like to lie on the floor.  She felt improvement within 2-3 minutes.  Patient was given a cool drink and felt improvement.  Patient was monitored for approximately 10 minutes and left under her own will under the care of a guardian.  Patient stated that she has passed out when she had bloodwork done in the past.  She stated that she felt ok to leave after observation.  I informed her that she should follow up with her PCP and inform them of the incident.
Numbness, swelling to right upper lip, resolved after 2 hours but paraesthia to area continues.  Severe GERD,  nausea & vomiting, gastritis have persisted since.  I have no prior history  Sudden, intermittent sharp left chest pain Migratory joint and muscle pain intermittent  Left infra orbital blephrospasms
Seven days after the shot, slight itching, a small amount of swelling, and 3 inch diameter redness showed up at the site of the injection.  When I phoned my doctor's office they recommended antihistamines and NSAIDs.  I took antihistamines a couple times and one pain pill.  I took a photo of the swelling just in case.  The symptoms are subsiding. Note: I get a flu shot every year and typically only get a small amount of soreness the next day, which goes away in a day or two.
Patient for 2nd Moderna vaccine. Immediately after vaccine patient c/o chest pain. 1203 b/p 211/108. EKG done NSR. Clonidine given at 1205. Nitro given @1230. Tylenol given at 1247 for headache. PCP in room. patient reports jaw, neck and arm pain, diaphoresis and midsternal chest pain. EMS called . Patient sent to hospital for further evaluation. Hospitalist and IPCM notified.   Vitals Vital Signs  Recorded: 29Apr2021 01:15PM  Systolic: 159 Diastolic: 82 O2 Saturation: 96 FiO2: 2L/min Recorded: 29Apr2021 12:59PM  Systolic: 131 Diastolic: 73 O2 Saturation: 92 FiO2: 2L/min Recorded: 29Apr2021 12:47PM  Systolic: 162 Diastolic: 81 O2 Saturation: 82 Recorded: 29Apr2021 12:36PM  Heart Rate: 94 Systolic: 211 Diastolic: 101 Recorded: 29Apr2021 12:20PM  Systolic: 184 Diastolic: 70 O2 Saturation: 94 Recorded: 29Apr2021 12:05PM  Heart Rate: 105 Respiration: 24 Systolic: 210 Diastolic: 108 O2 Saturation: 97
red, hot area to left upper leg: treated with ice to area, OTC Benadryl , Duricef
He developed a pink tinge to vision, and at times violet. Due to holiday and snowstorm he was not seen until 3 days after it started. The ophthalmologist did exam and ordered vitamin A levels, which were all normal. By later that day it started to fade. No vision changes by 2 days after that.
pt recv vax 27OCT95 & on 7NOV95 pt was given unspecified flu vax;13DEC95 pt exp a pruritic erythematous maculopapular rash on arms, thighs & groin which resolved by 18DEC95;
The second Moderna COVID-19 dose was given at 20 days after the first dose (first dose 7/20/22) and not at recommended interval of 28 days after first dose. Parent notified the same day and no side effects noted at that time.
Knocked out for 24-hours; Did a lot of sleeping; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Knocked out for 24-hours) and SOMNOLENCE (Did a lot of sleeping) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Knocked out for 24-hours) and SOMNOLENCE (Did a lot of sleeping). At the time of the report, FEELING ABNORMAL (Knocked out for 24-hours) and SOMNOLENCE (Did a lot of sleeping) outcome was unknown.            Patient experienced COVID before vaccination. Concomitant medications were not reported. Treatment medications were not provided.   This case was linked to MOD-2021-374814, MOD-2021-374841 (Patient Link).
Pt came to ER with nasal congestion, fever, headache, muscle aches, dry non productive cough x 2 days.
Rash and itchiness around injection site, warm to the touch.  Began the day following the immunization.  Treated with Cortisone cream.  Duration unknown at this time, still continuing 3 days after.
COVID-19 Vaccine EUA; 01/21 evening, sudden pain in left superior pectoral muscle by the arm pit. Muscular pain continued through 01/22, worsening in the evening. Additionally very mild pain/tenderness by left wrist and thumb, some numbness in fingers, possible slight dizziness earlier in the day, 2 min in length.  Pain continued 01/23, some soreness developing in lower arm, and rash developed near injection site, noticed around 12 pm but may have been present earlier. Rash: red small raised bumps close to injection site, span 3 in x 2 in. No itch at first, but has become mildly itchy.  Area tender to touch and warm. Have only taken 500mg acetaminophen, and used a heat pad on the muscle last night.
Information has been received from a medical assistant concerning a male patient who on 22-SEP-2011, was vaccinated with a dose of PNEUMOVAX 23 (lot # 669379/0453AA expiration date 08-MAR-2012 (dose and route not reported). The medical assistant reported that the patient developed arm soreness, redness and warmth to the touch at the injection site (approximately on 22-SEP-2011). The medical assistant reported that she gave 4 other patients the same lot number of the vaccine and they did not have reactions. It was unknown if the patient sought medical attention. The injection site reaction was gone by 26-SEP-2011. This is one of several reports received from the same source. A preliminary lot check investigation was performed. To date our investigation has found that this lot # 669379/0453AA conformed to quality release parameters and the manufacturing was typical of a lot of PNEUMOVAX 23. Additional information will be provided upon finalization of this manufacturing investigation. Follow up information was received concerning the 64 year old male retired patient with no illness at time of vaccination who on 28-SEP-2011, was vaccinated with a first dose of PNEUMOVAX 23 on the left deltoid. On 29-SEP-2011, the patient arm swelled to a large red, hot ball. The patient became very ill for 4-5 days, it was like a tennis ball size. Patient arm swelled to a large red, hot ball, tennis ball size, and patient became very ill were considered to be disabling by the reporter. No further information is available.
nausea, chills, and vomiting 12 hrs later fever over 101 degrees 24 hrs later severe headache lasting 30 hrs diarrhea and loss of appetite for 3 days fatigue soreness at injection site
Congestion and lethargy one day post vaccine administration. ER evaluation-hypothermia, acute respiratory failure. Required intubation from 4/5/17-4/15/17 secondary viral pneumonia.
Extreme exhaustion, headache, and difficulty raising injection arm more than a few inches, very swollen and red at shot shot site with a wheal that was about 4".  On the 4th day or so, the swollen area shifted down towards the front of my arm about 1/2" and it was like a sagging sack of fluid under the skin.  The worst part of the reaction though, was shooting pains all over my body throughout the night.  Very brief, zapping pains in my head, side of body, feet, ribs cage area, calves....just all over repeatedly.  I was in bed for 2 days miserable.
fever 103.5, irritable-red throat onset of sx 11JAN94 6-8PM;
Shortly after sitting down after vaccination, felt as body was exploding, either from sudden drop or sudden rise in blood pressure. Then severe vertigo set in, everything started spinning and nausea set in. Waited for 30 minutes and vertigo was better, but not totally gone, but nausea was still there. Left facility and nausea abated after 1.5 hours. Vertigo continued for 48 hours but fairly mild. Caused me to walk like a drunk person but no dizziness any more. Then at 10:30 PM torso broke out in hives that lasted about one hour. No hives on arms and legs.
tingling in the arm and spine; Rash on both chest and stomach with bumps only on the chest.; injection site soreness; injection site redness; headache; This is a spontaneous report from a contactable consumer (patient). A 37-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, Expiration Date: Unknown) via an unspecified route of administration, on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported, she had tingling in the arm and spine. Rash on both chest and stomach with bumps only on the chest. She experienced injection site soreness/redness and headache and noted that she felt that was normal. She has reached out to HCP and was told it does not sound normal and advised her to take Benadryl. Outcome of events was unknown.  Information on the Lot/batch number has been requested.
Pt received DTap and varicella vaccine in right thigh, had acute large amount of swelling, knee joint swelling, difficulty walking
Next AM (6/20/03) redness at site, itchy all over. No rash, itching continued but less. No problem breathing.
c/o headache beginning 1/2 hr after shots - still has today 2-11-08.