chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A report has been received from a Health Professional concerning a 6 year old, female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 18-Sep-2013. The patient experienced red raised rash which started on 18-Sep-2013. The patient recovered from the event of red raised rash on an unspecified date. The report was considered to be non-serious.
positive test; positive test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: Em6201), in left arm, on 24Mar2021 as dose 2, single (Lot number: Er2613), in right arm and on 07Oct2021 as dose 3 (booster), single (Lot number: Ff2589) at the age of 39 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Immunodeficiency" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "positive test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12May2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course included anti viral product: COVID 19 Treatment, brand was Pfizer Paxlovid, treatment from 12May2022 to 17May2022, indication was treatment of COVID-19. Conclusion: The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot FF2589, fill lot FF2558, and the bulk formulated drug product lo FE5318 and lot ER2613, fill lot EP8678, and the formulated drug product lot EP8565 and lot ER2613, fill lot EP8678, and the formulated drug product lot EP8565. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
01/28/2021,approx day 7 post COVID vaccination noted LU arm itchy near injection site, day 11 noted redness LU arm, day 12 today 02/08/21, noted redness moving down arm to her elbow, appt sched with PCP. 02/09/2021- telehealth visit with PCP, not cellulitis, dx 'COVID Arm', not prohibiting her from getting her 2nd dose of Moderna. L arm still red, not bothering her, ct glad she will be getting her 2nd dose.
This patient received her 2nd Twinrix vaccine on 6/5 and she went to the ER during that night for swollen lips, itchy tongue, and difficulty swallowing. She received rx's for prednisone and famotidine today and will be taking diphenhydramine OTC. According to the patient, the ER was not sure of the cause of the reaction (she has been battling a rash with unknown cause for several weeks and they think it is related to that).
Patient is a 79 y.o. male, currently on coumadin with a history of MI, CAD, hypertension, and atrial fibrillation who presents to the emergency department with his son for evaluation of fever, weakness, and cough. The patient reports that he has been feeling sick for about a week with fever, dry cough, nausea, and diarrhea that resolved a few days ago. He states that he has been taking tylenol for his fever, last dose yesterday, but he has not taken his other medications for the past 3-4 days. He has been drinking water but has not been eating the past few days, and he notes that he has not been urinating as much and has darker urine than normal. He came in today because his son was concerned and called him this morning and thought he sounded off. When he went to his house the patient was sitting in his chair in the living room and his TV was on in his bedroom, which was weird, but the patient has been acting normally to him. Here in the emergency department the patient endorses fever, weakness, nausea, decreased urination, dark urine, decreased appetite, and dry cough. He did not take any tylenol or ibuprofen today. He is vaccinated for COVID-19 and denies any known sick contacts. He further denies any chest pain, shortness of breath, current diarrhea, vomiting, or other urinary symptoms.
Information has been received from a medical assistant on 27-JUL-2010. A 33 year old pregnant female (twin gestation with EDD: 23-DEC-2009) was vaccinated with single dose of flu vaccine (manufacturer unknown) at 17 weeks gestation on 15-SEP-2009. At that time, alpha feto protein was drawn (no results provided). On 12-OCT-2009, the pregnant female experienced pre-term, pre-labor rupture of membranes (twins) at 29 weeks gestation. Specific outcomes were not reported. On 24-NOV-2009, the patient received the H1N1 shot. This case was originally reported to Merck (case# 0909USA01988). Additional information has been requested. The company considered event serious due to medical significance. The company considered event 'pre-term, pre-labor rupture of membrane (twins) at 29 weeks gestation' possibly related to Flu shot, however the brand name is unknown. Information derived from this AE report does not change the current safety profile of the product.
2 episodes of shaking. shots given on 01/17/2005 and on 01/18/2005 pt. stared and whole body shook x 20-30 seconds. 2nd episode length 20-30 seconds, staring to the right and generalized shaking.
30-40 minutes after vaccine was given patient felt light headed and when checking out she passed out and had a slight contraction which may have been seizure activity 5-10 seconds
This spontaneous report was received from a licensed practical nurse concerning an unspecified number of patients of unknown age and unknown gender. The patients' pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On unspecified dates, starting on or after 01-SEP-2015, the unspecified patients were vaccinated with improperly stored does of oral, ROTATEQ, lot # L008034, expiration date 05-AUG-2016, (dose and dose number were unspecified). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Headache; Chills; Body aches; Sore arm; This is a spontaneous report from a non-contactable consumer (patient). A 59-year-old male patient received BNT162B2 (Lot Number: EL3248), via an unspecified route of administration in left arm, on 02Feb2021 at 07:00 AM, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. On 02Feb2021 at 11:00 PM (23:00), the patient experienced headache, chills, body aches, and sore arm. The events were considered non-serious. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events in Feb2021.  No follow-up attempts are possible. No further information is expected.
Diarrhea day 1-4 followed by severe back/joint pain day 4+ linked with flair up in Rheumatoid Arthritis.  RA previously in remission for 20 + years and maintained with Enbrel/Methotrexate.
Weakness in all muscles especially extremitie,. Extreme jpint pain in hips, elbows shoulders and knees.
Three days post vax, the pt developed easy bruising over ankles, knuckles, and abdomen. Pt was reportedly seen in office.
One week post-injections, site of injection developed red, hot,  hard, itchy lump. Over a few hours,areas surrounding lump started to welt and itch. Took Benedryl and applied hydrocortisone cream. By next morning, area surround initial lump was swollen, red, itchy and hot to the touch. This is about 4 times size of initial lump. Today, 2 days later (9 days post-injection), are still warm to the touch and a little discolored but improving.
pt recv vax 5JAN98 & approx 2hr post vax pt was very weak, tired, sl nauseated when moved around & arm ached;the reporter indicated hat main complaint was weakness;6JAN98 pt recovered;
Patient fainted and fell to ground from standing position approximately 5-8 minutes after vaccination with GARDASIL (HPV) vaccine.  Patient was unconscious for less than one minute.  She shook briefly and yelled out prior to awakening.  Patient had hit front of head on stool when fell.  (Patient was sitting on chair when received vaccine).
SOB, cough, body aches, headache and sore throat. No batch/lot numbers or vaccine sites available in chart.
Client was seen for 7th grade immunization for school. Reviewed questions and information with client and parent, ask client was she pregnant client stated no, while giving injections mother stated she was concern about daughter because she think her daughter haven't have her menses since May.  At this time I already gave the client a Tdap vaccination and MCV4 vaccination.  I didn't get a chance to give the client the varcella vaccination.  I told the client mother that I think she need to get a pregnancy test before I can give the client the varicella injection. Instructed client and mother to go thru family planning clinic for a pregnancy test.  Client pregnancy test was positive.  After reviewing the recommendation for pregnant women, tdap recommendation is to give a pregnant women tdap late second trimester or third trimester.  We are are not sure what trimester client is in, possibly early second trimester.
Patient's mother states right arm swollen, red, and warm to touch with limited ROM in the elbow.
Numbness, tingling, itching of left arm, whereas vaccine was administered to the right arm
POOR APPETITE; WEAKNESS; FEVER; COUGHING; This spontaneous report received from a consumer concerned a 67 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, Laboratory data included: Body temperature (NR: not provided) 100 F, 97.7 F. On 29-MAR-2021, the subject experienced coughing. On 29-MAR-2021, the subject experienced weakness. On 29-MAR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced poor appetite. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and had not recovered from weakness, coughing, and poor appetite. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Staring, spacing off, falling down often. Took to emergency room in March of 2011 for falling, several visits to family Dr, diagnosed with epilepsy in June 2011. Treated with several different types of seizure medications and vagal nerve stimulator.
Localized reaction - raised erythematous rash - 5 cm diameter at site of injection. Started 4 days after injection. Topical steroid applied. Pt took BENADRYL on own prior to coming to office.
pt had bleeding and injection site and felt that in incomplete dose was administered that they "bled the dose out" , demanded another dose due to "incomplete dose administered"
pt recv vax & 3 days later pt devel local rash, swelling & pain on armpit;the pain subsequently spread to the elbow & wrist;sx persisted as of the date of this report;
About an hour after my vaccine I had dry mouth and then about 20 minutes later I realized my tongue was swollen,  to the point where I can feel the inside face of my teeth when my mouth is closed.  a little bit of a headache.
Started to black out; Trachea collapsed; Swallowed saliva; Could not breathe; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Started to black out), TRACHEOMALACIA (Trachea collapsed) and CHOKING (Swallowed saliva) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Started to black out) (seriousness criterion medically significant), TRACHEOMALACIA (Trachea collapsed) (seriousness criterion medically significant), CHOKING (Swallowed saliva) (seriousness criterion medically significant) and DYSPNOEA (Could not breathe). At the time of the report, LOSS OF CONSCIOUSNESS (Started to black out), TRACHEOMALACIA (Trachea collapsed), CHOKING (Swallowed saliva) and DYSPNOEA (Could not breathe) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information a temporal association between the use of the product and the onset date of the events, a causal relationship with the events cannot be excluded.; Sender's Comments: Based on the current available information a temporal association between the use of the product and the onset date of the events, a causal relationship with the events cannot be excluded.
tongue was tingly, woozy and nauseous 10 minutes after receiving injection.    Drank Apple Juice and symptoms subsided about 10 minutes later.  I also took Benadryl when I got home 20 minutes later.  Also, left arm is sore.
rash at the injection site; swelling; soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash at the injection site), VACCINATION SITE SWELLING (swelling) and VACCINATION SITE PAIN (soreness) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 030L20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and SIMVASTATIN for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Jan-2021, the patient experienced VACCINATION SITE RASH (rash at the injection site), VACCINATION SITE SWELLING (swelling) and VACCINATION SITE PAIN (soreness). At the time of the report, VACCINATION SITE RASH (rash at the injection site), VACCINATION SITE SWELLING (swelling) and VACCINATION SITE PAIN (soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Ice, Cortisone Cream
Employee states she has neck stiffness, fever, chills, migraine, entire right side of face is drooping, mainly eye. smile uneven. pain behind ear. Evaluation/Treatment was recommended but employee has declined.
Swelling, warmness, redness ~6" above and below injection site, blisters, itching, biting itch - resolved after 2 weeks.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  An 80-year-old male patient received BNT162b2 (BNT162B2), on 16Apr2022 as dose 4 (booster), single (Lot number: RA5797) at the age of 80 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: positive Ag test 4 days after completing 5-day course of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Recurrent Covid symptoms and positive Ag test 4 days after completing 5-day course of Paxlovid.; Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported events Covid-19, Drug ineffective and the administration of the vaccine cannot be excluded.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 85-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 85 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High Blood pressure" (unspecified if ongoing); "just diagnosed with lung cancer" (unspecified if ongoing), notes: just diagnosed with lung cancer; "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19.  Clinical Course: It was reported that, the patient received Paxlovid (Lot number: GA3588) from 24May2022 to 26May2022 for treatment of COVID-19. The patient reported that, after taking PAXLOVID for two days, it was impossible for her to get any sleep day or night. She had two almost sleepless nights. Very unpleasant worse than the COVID which was mild as she was vaccinated twice and had two boosters.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Breathing problems; Retaining a lot of fluids; A spontaneous report received from a Consumer, concerning 75-year-old male patient who received Moderna COVID-19 vaccine ((mRNA-1273) and experienced breathing problems and retaining a lot of fluids.  The patient's medical history included breathing problem and retaining fluid. No relevant concomitant medications were reported.    On 27-JAN-2021, the patient received his first of two planned doses of mRNA-1273 (Lot number: 038K20A) through an unknown route in an unknown arm for prophylaxis of COVID-19 infection.  On an unspecified date, the patient had experienced breathing problems and was retaining a lot of fluids. The patient was hospitalized on 24-JAN-2021. The patient was placed on a ventilator (defibrillator). The patient was discharged from the hospital on 28-JAN-2021. The patient stated that this had happened to him prior to getting the first dose of the vaccine.  Action taken with mRNA-1273 in response to the event was not reported.  Outcome of the events of having breathing problems and retaining a lot of fluids was unknown.; Reporter's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
This spontaneous report was received from a physician concerning an unknown number of patients (demographics unknown). On unknown dates the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose, route and Lot# not provided). No adverse symptoms were reported. This is one of several reports received from the same source. Additional information has been requested.
At 8 pm the day I had the shot I started having a headache and muscle aches on both hips. The following day I was nauseous, light-headed, had a headache, muscle aches around my hips, pain at injection site, and was weak. I passed out for an unknown amount of time around 11 am that Sunday. I was unable to eat more than two pieces of pilot bread, but I kept drinking water and was hydrated. I kept rolling around trying to get comfortable, but the muscle pains in my hips would not let me until I used a heating pd. The following day I was weak, but no longer as nauseous or have as bad a headache.  On Tuesday, I was able to get up, but both arms felt very weak and it was a strain to carry my bag and computer. Wednesday I was still very tired, but more like myself. No symptoms today February 18.
Shortly after the shingles short, I had fever, headache, swollen and sore arm,  and rashes on the arm. The fever and headache lasted < 2-day, while the swollen and sore arm and rashes lasted 5-day.  On the 5th day (7/17/23), I noticed a small bump in my right neck, which grew pretty fast.  I called my primary Dr. office on 7/20 and asked whether this may be duo to the vaccination. I was told that it could be vaccine related  and observed it for a couple more days. I ended up seeing the primary Dr. on 7/24, as the bump kept growing pretty fast. She diagnosed it as Thyroid Nodule, and thought this was unlikely related to the vaccination. It might be just coincident.  However, I am not convinced. I just had an annual exam on 4/21/23, ~2.5-month before the shingles short, when the Dr. concluded everything was normal. It is natural to relate the fast growing neck bump to the vaccination, as I didn't notice anything previously.  Now I am referred and scheduled to see an ENT doctor. I was told that I need to do an ultrasound and maybe biopsy for the thyroid nodule. I would like to know whether there were other people had similar adverse effect after shingles shot and got treated.  Also, I want to know if it is safe for me to get 2nd shingles shot. I asked my primary about 10-day ago, but she hasn't replied.  I would appreciate if you can refer me to some experts on shingles shot so that I can get more information or help. Thank you.
Patient admitted with acute onset left flank pain radiating to the left groin due to a symptomatic distal left ureteral calculi measuring 6 mm with mild hydronephrosis.Patient reviewed by urology ? s/p ureteroscopic extraction of the stone this afternoon. Cleared for discharge on oxycodone for pain control, p.o. Bactrim for UTI and Pyridium for bladder spasms. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Information has been received from a nurse practitioner concerning a female who was vaccinated with GARDASIL (lot number not provided).  Subsequently the patient experienced fever, nausea and diarrhea.  No further information is available.
PATIENT REPORTED WAKING UP ON 2/5/21 FEELING "BAD" RIGHT EAR WAS SWOLLEN, RED AND HAD HEAT. ALSO FELT VERY ACHEY. 2/6/21 PATIENT REPORTED TO DOCTOR LISTED AS POSSIBLE ALLERGIC REACTION TO VACCINE-PT RIGHT EXTERAL EAR HAS GROSS ERYTHEMA AND INFLAMMATION AND CANNOT DISCOUNT REACTION FROM COVID -19 VACCINE GIVEN 48 HOURS AGO.  PT WAS ADMINISTERED 80MG OF METHYPREDNISOLONE BY INJECTION AND  DEXAMETHOSONE 10MG BY INJECTION. PT WAS GIVEN RXS FOR AUGMENTIN 875MG 1 PO Q12H X10DAYS, AND PREDNISONE 10MG 1 PO QD X5DAYS. MD ALSO RECOMMENDED TAKING BENADRY 1TSP Q12H X5 DAYS . PT REPORTED EVEN TO PHARMACY-WE HAVE NOT BEEN ABLE TO REACH PATIENT SINCE 2/6/21 TO DETERMINE PROGRESS OR OUTCOME. PT SHOWED NO ALLERGIC REACTION AT TIME OF INJECTION OR DURING 15 MINUTE WAITING PERIOD. DID NOT INDICATE THAT THERE WAS ANY REACTION WITH 4 HOURS OF RECIEVING VACCINE.  ASKED PT IF SHE WAS TESTED FOR COVID WHEN SHE WENT TO BE SEEN FOR REACTION AND SHE SAID SHE WAS NOT.
Baby fussy after receiving DPTa, high pitched cry, more than 1 hour.
Death 4-12 hours after 1st dose administered on 7/26/21. Body discovered on 7/28/21 at approximately 9:30 am