chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy patients, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication error that occurred shortly after the product expired. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.
Typical side effects 24 hours later chills, muscle aches, general feeling of being unwell. Strong ache in lower back requiring heating pad.    48 hours: felt fine but had strange pains in organs on lower right side. I?ve been pregnant and have very good sense for strange sensations in my body. Pain was for about an hour and was sharp and on and off for the hour. Pain subsided and hasn?t come back.  72 hours: extremely painful migraine with nausea all day. In bed from the pain. Finally took meds since it?s unbearable. Excedrine.   I?m in good health, underweight but other than that my last medical samples when pregnant 2 years ago were all normal.    Today is day 3 and unknown what tomorrow will be like.  Recovery could come soon but unkown
Information has been received from a 30 year old female with a history of loop electrosurgical excision procedure and no drug reactions/allergies who on 02-MAY-2007 was vaccinated with a first dose of Gardasil (lot# unknown) injection. There was no concomitant medication. In 02-MAY-2007, "right after receiving the first dose", the patient experienced itchiness on eyes like crazy and both of her eyes turned pink and then reddish at times. The patient reported that she had never had allergies before, she dose not play outdoors and she doesn't  have any pets. The patient also reported that she would always experience the itchiness on her eyes in the morning and this symptom has started since May 2007 after receiving the first dose of Gardasil. The patient did not seek medical attention. On an unspecified date the patient had blood work and regular check up performed, the results were unknown. Further information was not provided. Additional information has been requested. Follow-up information was received from the registered nurse. On 03-JUL-2007, the patient was vaccinated with a second dose of GARDASIL (lot# 02110) IM in the left deltoid. The lot numbers were updated. The patient had no illness at the time of vaccination. Follow-up information was also received from the consumer. Almost immediately thereafter (within days or a week), the patient's eyes started to itch and water daily, mostly in the mornings. It didn't occur to the patient until a couple of weeks after the second GARDASIL vaccine shot (July) that maybe it was an adverse reaction to the vaccine. At the time of reporting the patient reported that the itching is still present, but it has tapored off a lot. Additional information is not exected.
POOR COLOR, FLOPPY, REFUSED ORAL INTAKE 3 HRS P/ DTP.  CRY WEAK, BORDERLINE HIGH; T=102.4 LATER IN DAY.  TX W/ PHENOBARB & TYLENOL FOR COMFORT.  TOOK 2-3 DAYS FOR DISPOSITION TO RTN TO NL.
he is experiencing sore arm; severe headache; stomach pain; overall body pain; This is a spontaneous report from a contactable consumer (patient) by Pfizer- sponsored program COVAX US Support.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 23Apr2021 morning (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced sore arm, severe headache, stomach pain and overall body pain all in Apr2021. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
upper lip swelling; cheeks turned to red; cheeks turned to red and burning; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that this female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced mild reactions such as upper lip swelling, cheeks turned to red, and burning that lasted for 2 hours. The outcomes of upper lip swelling and cheeks turned to red was unknown. The outcome of burning was recovered.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sudden onset of numbness to left face, left upper extremity, left lower extremity, with weakness in the left upper and left lower extremity. He presented to the emergency department and a code Nuro was initiated. I received a phone call from the radiologist stating that he has a significant 3.2 x 2.1 x 1.6cm brain hemorrhage on his non-contrast CT brain. A CT angiogram of his head and neck showed no evidence of aneurysm or other vascular lesion to account for the hemorrhage. It was a right thalamic hemorrhage.  He was admitted to the hospital for further neurologic monitoring for expanding hemorrhage and to get follow up MRI exam. He will also likly need physical therapy/occupational therapy.
Extremely Sore. Pain radiating down entire arm, under arm, armpit, front & back of arm & across & under shoulder blade. Slightly warm to touch & whelps appeared on upper arm the next day 11/08/2011.  Took ibuprofen, Benadryl & used Arthritis Cool Blue Alcohol on upper arm. This date 07/09/11 still extremely sore & with some whelps, tenderness & warm to touch. Would have gone to back to facility had it not been so far away.
Patient developed painful swelling of left foot in 6/08.  At one point, pain had traveled up her leg to her back/spine and neck.  She continues to have painful swelling of the foot.  There was no injury reported.  Bloodwork and xrays have not yielded a diagnosis.  She is on pain medication only with minimal improvement.  She has been referred to a rheumatologist.
had second dose several months after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had second dose several months after the first dose) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062E21A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had second dose several months after the first dose). On 01-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had second dose several months after the first dose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment drug were reported.   No concomitant medication were reported. Patient inquires if they should get the booster in a month. Patient inquires if these 2 doses they received, with several months in between, render them fully vaccinated.     This case was linked to MOD-2022-445409 (Patient Link).
DTaP given 3/4/08 and patient seen 3-7-08 for small 0.5cm bruise right deltoid at injection site. 2cm below bruise, 7cm diam mild redness/dependent erythema, no warmth, no induration, no complained of pain/itch.
59-year-old. 3 male see Johnson & Johnson vaccine March 23. A few days after receiving the vaccine, he reports he developed left-sided neck pain and right-sided lower back pain. The left-sided neck pain radiating down left arm and right-sided low back pain radiates down right leg. He denies any injury, car accident, or any sort of heavy lifting. He does drive a limousine many hours per days and remains sitting most of the day. However, he has been performing this order work for many months and never had this order musculoskeletal problem before the vaccine. He has been taking Advil with no improvement. Cervical radiculopathy at C7   Start Medrol (Pak) Tablet, 4 MG, as directed, Orally, AS DIRECTED WITH FOOD, 6 days, 1 Pack, Refills 0 Start Cyclobenzaprine HCl Tablet, 5 MG, 1 tablet, Orally, every 8 hours as needed for muscle spasms, 10 days, 30, Refills 1 Notes: Neck Strain or Sprain: Rehab Exercises material was printed.
Long existing large varicose vein behind knee suddenly erupted in pain transmitting down the leg to the foot.  Lasted a week then pane subsided and after months the long lasting bulge went away.
Patient received dose Janssen  J &J at Retail Club on  03/06/2021 Lot number 180529 She came to public health clinic 8/6/2021, received a dose of Pfizer Lot Number EW0176, Received another dose Pfizer At public health clinic lot number EW0175  09/19/2021.  This person writing report unable to tell why patient received 2 full series, 1 of J&J and 2 Pfizer. Unable to determine why not able to confirm Dose of J&J at time in clinic for 1st dose of Pfizer. Reaction unknown. This issue was found when patient came into clinic today 1/5/2022 requesting new Covid-19 vaccine card when staff at public health clinic checked in web, issue was noted. Patient ask staff when getting new card with vaccines dates noted she ask that dose J&J not be put on vaccine card.  Staff gave new vaccine card all doses confirmed.
Fatigue; Slight muscle aches in my neck; This is a spontaneous report from a contactable consumer or other non hcp.   A 23-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: Solution for injection, second dose on 25Jan2021 08:00 (Age at vaccination was 23-year-old) via an unspecified route of administration at arm Right as a 2nd dose, single for covid-19 immunisation. Medical history included asthma and known allergies: sulfa. Patient did not receive any other vaccine prior to four weeks. Concomitant medications included methylphenidate hydrochloride (CONCERTA); buspirone hydrochloride (BUSPAR); ethinylestradiol, etonogestrel (NUVARING); and cyanocobalamin (B12-VITAMIIN). Historical vaccine included BNT162B2 (First Dose on an unknown date and lot number and expiry date was unknown) for COVID-19 immunisation. The patient previously took Lorabid for product used for unknown indication and experienced drug hypersensitivity, keflex [cefalexin] for product used for unknown indication and experienced drug hypersensitivity. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Jan2021 12:00, the patient experienced fatigue and slight muscle aches in her neck. No treatment was received due to events. The outcome of the events was recovered on an unknown date.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. Patients' pertinent medical history, drug reactions or allergies and concomitant therapy were not reported. On unknown dates in 2016 (reported as starting on or after 06-JUL-2016), patients were vaccinated with improperly stored doses of GARDASIL 9  (lot # L024993 and expiration date 17-OCT-2017, lot # L038503 and expiration date 18-DEC-2017, dose and route of administration were not reported). The temperature of excursion was 31F and the time frame was 2 hours. There was no previous temperature excursion and the call was not due to a data logger. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Client received immunizations on 9/13/07. This CHN received phone call from clients mother on 9/28/07. Mom states that on 9/27/07 patient was noted to have a few "spots" on her body. Mom states no fever, however had a fever 1 week prior. Mom states that on 9/28/07 patient had "spots" from head to toe" and described them as "pimply" in appearance. Mom states she has over 100 "spots" and that she is itching her body at those spots any other symptoms.
Shingles; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was not reported), via an unspecified route of administration, on 26Mar2021, as first dose, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The pharmacist was asking if the company had any information regarding the Pfizer COVID-19 vaccine with acyclovir. A provider contacted the pharmacist and said that a patient received the first dose on 26Mar2021 and now had shingles (from an unspecified date in 2021). They didn't want to interfere with the vaccine by treating the shingles. The event was considered non-serious. The outcome of the event was unknown.  Follow-up attempts are completed; information about batch number cannot be obtained. No further information is expected.
pt recv vax 10OCT96 for flu vax;18DEC96 devel chills, throat & ear infect, congestion, & ached all over;pt was eval by MD & prescribed ATB;pt recovered;pt revaccinated w/one of recalled lots but unable to ID specific lot#;
On 10/29/18 patient received both FLUARIX QUAD and PNEUMOVAX 23 (indicated for COPD) in the right arm. No adverse reactions at the time of administration. The patient returned to pharmacy 11/13/18 to pick up other medications, and at this time let me know that he normally tolerates the flu shot well. However this time, after receiving both vaccines, he did not feel well at all. He claims his arm was red, sore, and he was "unable to get out of bed" for two days. He claims it must have been the PNEUMOVAX vaccine because he normally tolerates the flu vaccine well. He is feeling better at this time, but just wanted to let us know so we can report it through VAERS.
First shot was 2/16/21.  Also had Pfizer Lot # EN6206 on 3/9/21 I didn't really have any symptoms with the first dose except mild soreness in arm.   I had mild dizziness right after the 2nd dose for about 10 minutes and then the next day I had chills, fatigue and aches. But I started having weird symptoms a few weeks after the 2nd dose and I'm not sure if any of all of them are due to the vaccine. First I started having achy knees and some other joints about 2-3 weeks later. It is only a problem once in a while and presents in my left knee, my fingers, wrists, feet and shoulders.  Then on May 1st I had a vmild case of what has now become more common and severe.  I got tingly feet and became very thirsty.  Then on May 23rd I went to the Emergency Room because my feet, hands and mouth/tongue became tingly.  After about 20 minutes I became shaky.  I was also very thirsty, so thirsty that after about 6 glasses of water I was still thirsty.  We thought it was blood sugar issues, but my blood sugar was only slightly elevated and not enough to cause the symptoms I had.  I was having fun with my family watching a movie when it started. Then on May 28th it happened again.  I went to the school nurse with tingling, dizziness and thirst.
Pain/swelling at injection site, radiating down arm to inner elbow. Slight warmth on inner elbow area described "muscle soreness" malaise, listlessness. Symptoms began day of vaccine through 11/5/11 (4 days). Symptoms gradually subsided on their own.
high fever (102+), chills, severe headache, body aches... Tylenol, ice packs on head and neck... fever lasted about 12 hours, head and body aches lasted for two days.
Migraines, tightness/pounding in chest, lightheaded, dizzy, nauseous, pain in left-side of breast, arm soreness and inflammation and burning sensation.
Slight soreness and numbness around injection site noticeable 20 May 2021; 3 weeks 1 day after receiving second dose.
Swelling and redness of ~10cm in diameter, improved with Benadryl and cool compresses.
PATIENT RETURNED TO  DEKALB COUNTY, IN COVID VACCINE CLINIC ON 3-8-2021 TO RECEIVE SECOND MODERNA VACCINE AND STATED 24 HOURS AFTER RECEIVING FIRST MODERNA VACCINE HE DEVELPOED GOUT. HE WAS TREATED AT  HOSPITAL  WALK IN CLINIC WITH PREDNISONE.  PATIENT DECIDED TO GO AHEAD AND RECEIVE THE SECOND DOSE OF MODERNA ON 3-8-2021.  HE HAS NOT CONTACTED THE HEALTH DEPT TO LET US KNOW IF A FLARE UP OF GOUT OCCURED AFTER THE SECOND VACCINATION , BUT HE WAS INFORMED ON 3/8/2021 TO PLEASE DO SO.
C/O malaise, diaphonic, dizzy, feels hot itching around nose, numbness left arm. Intermittent SOB. Orange juice given, placed in legs elevated. Evaluated by medical MD. Discharged stable condition instructions given to go to ER if symptoms returned.
Temperature of 99.0, Entire body aches, Extreme fatigue, Extremely sore arm at injection site
" Per a Regulatory Authority and FDA proclamation of moratorium on use of mRNA monovalent vaccines and as booster doses after 31 AUG 2022, and DHA instruction to enter doses administered as such into VAERS; this report was entered for documentation purposes."
An evident RASH on the torso, flanks, shoulders, of various sized spots. Sizes of pea size and pencil size and a little larger. They aren?t symmetrical in shape. They are red pink hue and  within each rash bump then it looks like a mottled bumpy pattern within each rash-bump.  He Still has the rash and it is currently July 11th 2021, as I type this. The rash is worse in the right abdomen than it is elsewhere.  The rash is slightly lessened or lightened up on the left abdomen. We?re hoping that it eventually goes away or lessens greatly. It?s Not an totally adverse effect as it is minimal in effecting me, yet I would like to know IF I should attempt to get next year?s vaccine from a different manufacturer in hopes that it?s chemical makeup is slightly different and then it may not, provide a body rash. We have seen pictures of other people online that got same exact abdomen rash, just like mine from their vivid vaccine.
Information has been received from caller started her daughter concerning an 18 year old female with history of asthma who on 11-JUL-2008 was vaccinated with GARDASIL vaccine. Concomitant therapy included ALBUTEROL. On approximately 14-JUL-2008 the patient experienced arthritic symptoms and pain throughout her body shortly after receiving her initial dose of GARDASIL. The patient's arthritic symptoms and pain throughout her body persisted. Caller stated her daughter will not receive any future dose of GARDASIL. No further information is available.  2/23/09 MR received from Rheumatologist which include PCP recs as well.  Initially seen by PCP 7/18/08 & 8/1/08 with c/o joint pain x 2 months.  PE (+) for finger edema with decreased ROM and pain in toes. DX:  Synovitis and tenosynovitis. Referred to ortho. Pt reports knots around elbows, wrists, ankles, fingers and toes with morning stiffness. Referred to rheum.  OV 8/6/08. PE (+) fro swelling of digits and trace in hands. DX:  Polyarthargias.  Tenosynovitis. Tx with NSAIDs and steroids Labs:  ANA (-).  RF (-). anti-CCP (-). X-rays hands and feet WNL. Gliadin Ab (H) at 14.
All my muscles hurt Headache Fever Reaction Lasted 1 1/2 days
-Swelling of upper left arm on deltoid region on the same day of vaccination. Swelling is stable; Has warmth; No pain but her itchiness. Dx: Allergic reaction
pt recvd vax; rxn started w/ fever & runny nose; irritable; 7 days later t 102; went to MD & prescribed meds for ear infect;
CALLED ON 11/1/07 C/O SORENESS AND REDNESS R ARM. SPOKE WITH HER AROUND 4 P.M. ARM WAS BETTER. CALLAED AGAIN 11/2/07 SWELLING AND REDNESS IN ARM IS WORSE AND RUNNING FEVER 101. REFERRED TO PMD AS SOON AS POSSIBLE
Vaccine given at 9:43 am. Patient passed out and hit the ground at 9:50am, sat her up against the wall on the floor. She complained of being hot and we gave her cold water and an ice pack. She started feeling better around 9:55 am and asked to leave at 10 am.
This study case was received from the investigator on 19 September 2012. A 23-year-old female subject with no reported past medical history had received ACAM2000 (lot number, route, site and date of administration not reported) and an unspecified amount of time later was found to have on 22 February 2011 an elevated Troponin, central laboratory level of 10.07ng/ml (also with as reported date of 24 February 2011). The subject had a rapid Troponin I level on 22 February 2011 that was NOT within normal limits (Positive). An ECG on 22 February 2011 revealed normal results. Action taken was reported as none. On 24 February 2011, the subject had a Central Lab Troponin level drawn with result less than (<) 0.10ng/mL and an ECG with results reported as normal. The subject had no allergies to medications, no prior use of topical steroids to treat an eye problem or disease, no surgical history and no past medical history (also reported as never). The female patient had a history of prior pregnancy. The patient was reported as a smoker, less than half a pack per day, but has smoked greater than five packs of cigarettes in lifetime, with onset at age 18- years-old. The subject had no concomitant medications. No further information was available at the time of the report. The subject's outcome was recovered 24 February 2011. According to the investigator, the event of elevated Troponin was considered an other important medical event and possibly related to vaccination. Per the investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. Documents held by sender: none.
Recommended Prevnar 20 was not available at the time and pharmacy only had Prevnar 13. Patient also had a script from the doctor for and patient requested Prevnar 13.  Patient is aware that she has to return 1 year later (3/2/2023) to receive her second dose in the pneumonia series (Pneumovax 23).
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Feels warm at site of injection), VACCINATION SITE PRURITUS (Site of injection is itchy) and VACCINATION SITE ERYTHEMA (Site of injection is red) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 29-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Feels warm at site of injection), VACCINATION SITE PRURITUS (Site of injection is itchy) and VACCINATION SITE ERYTHEMA (Site of injection is red). At the time of the report, VACCINATION SITE WARMTH (Feels warm at site of injection), VACCINATION SITE PRURITUS (Site of injection is itchy) and VACCINATION SITE ERYTHEMA (Site of injection is red) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment details included Tylenol. No relevant concomitant medications were reported.