chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The soreness in her arm was the same as the first injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Apr2021 (Lot number: EN6205) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "melanoma and removal of lymph nodes" (unspecified if ongoing), notes: two melanomas in that arm. She has Had Melanoma 4 times all on her left side.; "surgeries in her left arm" (unspecified if ongoing); "melanoma and removal of lymph nodes" (unspecified if ongoing); "breast surgery was on her right side" (unspecified if ongoing); "mastectomy" (unspecified if ongoing); "nerve damage from 20 years ago" (unspecified if ongoing); "pain" (ongoing); "had 10 surgeries in the past" (unspecified if ongoing). Concomitant medication(s) included: HYDROCODONE taken for pain (ongoing). Past drug history included: Flu vaccine, reaction(s): "aggravated the nerve damage", notes: four years ago in that arm, and she gave it too high; Flu vaccine for she couldn't use her arm for a year. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "The soreness in her arm was the same as the first injection".  No follow-up attempts are possible. No further information is expected.
Face was paralyzed/Bells palsy; Tongue felt fat and my lips numb; This is a spontaneous report from a contactable consumer (Patient, self-reported). A 59-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8736), dose 1 via an unspecified route of administration, administered in Arm Right on 17Apr2021 10:30AM, as 1ST DOSE, SINGLE for covid-19 immunization. Patient did not have medical history and no known allergy. Concomitant medication's included meloxicam and Multivitamins. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID-19, prior vaccination. Patient has not been tested for COVID-19, post vaccination. On 02May2021, (reportedly patient stated that, 8 days after the vaccination), his tongue felt fat, and had lips numb. 2 days later symptoms spread. By Wednesday 05May2021 his face was paralyzed. He went to my physician the next morning and was told he have Bell's palsy. Patient states that, my face may never be normal again. AE resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Therapeutic measures were taken as a result of adverse events as prednisone 20 mg twice a day. Outcome of the events was not recovered.
pt recv vax & 21 days post vax pt devel over 100 papular lesions w/only a few vesicular lesions;pt was hosp;A specimen was obtained from the vesicular lesions: on stain it was shown to have contained varicella virus, but cult neg;
Patient reports receiving Hepatitis A injection in Rt. upper arm on 10/3/18. States swelling developed a month prior to coming to office. I&D performed, Cultures obtained, wet-to-dry dsg BID.
Foggy; Really hot; Hot flushes; Weird dreams; Fatigued, tired; A little nauseated; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Foggy), FEELING HOT (Really hot), HOT FLUSH (Hot flushes), ABNORMAL DREAMS (Weird dreams) and FATIGUE (Fatigued, tired) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension.   On 25-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 25-Mar-2021, the patient experienced FEELING ABNORMAL (Foggy), FEELING HOT (Really hot), HOT FLUSH (Hot flushes), ABNORMAL DREAMS (Weird dreams), FATIGUE (Fatigued, tired), NAUSEA (A little nauseated) and PYREXIA (Fever). At the time of the report, FEELING ABNORMAL (Foggy), FEELING HOT (Really hot), HOT FLUSH (Hot flushes), ABNORMAL DREAMS (Weird dreams), FATIGUE (Fatigued, tired), NAUSEA (A little nauseated) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Blood pressure increased: other (High) Increased blood pressure.         Concomitant medications included normal blood pressure medication and a diuretic. The patient did not receive any treatment. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, the action taken with the drug in response to the events was not applicable.
This is a non serious spontaneous case from a physician who reports a pt experienced influenza like symptoms after receiving FluMist. The reporter did not provide causality between events and FluMist. A female pt experienced flu like symptoms within 48 hours of receiving FluMist IN (date unknown). The pt recovered one week after the start of the events. The reporter did not provide causality between event and FluMist vaccination. Follow up 03/07/05: Lot number for vaccine not recorded.
I got moderna vaccine 04/06/2021; my menstrual cycles went haywire.  My period came on 03-30-2021. I started having heavy cycles, extensive bleeding, went for 24 days of period. My doctor recommended I get the booster shot and so I did.  I bleed non stop then I will not bleed for 4-5 days. On 09-01-2021, she attempted to do a uterine ablation. My lining was so thick that she was not able to do that. My fibroids are growing at high rate. She placed me on a injection to help with the bleeding but my period came back and I had for six days then it came back two weeks later. My period stayed on for almost three weeks. My periods are longer in duration since the vaccine. I have not been able to predict when my period comes.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received FLULAVAL QUADRIVALENT (batch number 379MY, expiry date 31st May 2015). Concurrent medical conditions including high blood pressure. Concomitant products included amlodipine, losartan, omeprazole and pravastatin. On 17th November 2014, the patient received FLULAVAL QUADRIVALENT (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. On 17th November 2014, an unknown time after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site pain, pain in arm and sleep disorder. The patient was treated with ibuprofen and gabapentin. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the pain in arm and sleep disorder were not recovered/not resolved. The reporter considered the injection site pain, pain in arm and sleep disorder to be related to FLULAVAL QUADRIVALENT. Additional information received: Pharmacist reports a patient who has been experiencing pain in her left arm since receiving a FLULAVAL QUADRIVALENT injection on 11/17/2014. The injection itself was very painful for the patient and she cried out during the injection. Since that time she has experienced pain in her upper left arm, that goes up the back of her arm and down towards her breast. She has been taking ibuprofen around the clock to treat the pain, as well as some gabapentin cream. The gabapentin cream does seem to help the pain. The pain is significant enough that it wakes her up at night and she cannot sleep on her left arm. Sunday night and into Monday she had a significant pain day, but she is feeling 90% better today, Tuesday. The reporter thinks it is likely that a nerve was hit during the injection and that is the cause of the continuing pain. The reporter spoke with the pharmacist who performed the injection, and it is not thought that bone was hit, so the reporter does not think it is a bone problem. The patient thinks the injection was placed too high, but the reporter believes the injection was in the correct place. The reporter thinks it is possible the patient overdid it over the weekend with shopping, and that is why her arm hurt so much on Monday. The patient has seen her HCP, and an MRI will be performed if the pain does not improve.
Swelling of lymph nodes, tenderness/discomfort, edema into right collar bone and neck, pain posterior ribs.  Injection site swelling approx size of a large egg
Broke out in hives (face, neck, arms and back) the night after vaccine. Pt took one dose of Benadryl and within 12 hours, she complained of only a "few itchy spots" on her head. Never had any respiratory concerns.
Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 10-AUG-2015 the patient was vaccinated with expired (Oka/Merck) VARIVAX (0.5 ml, lot # J009729 with expiry date 07-AUG-2015), subcutaneously. No adverse effects were reported. Additional information is not expected as there was no permission was given to contact reporter.
1st Pos. COVID-19 test, resulted on  7 Dec 21 Symptomatic. Second  COVID -19 pos. resulted on 29 APR 21, s/s: fatigue, difficulty breathing , SOB w/ exertion Onset 29 APR 21. fullness in the trhroat, COPD Chronic Glaucoma, GERD. 1st COVID vac,14 Jan 21,  2nd 6 Feb 21. Since the second onset of symptoms was more than 90 days from the first infection and more than 14 days after the second COVID vaccination. This is considered a new case.
about 10min p/vax pt began to cry loudly of sharp stomach pains; became pale & lethargic then passed out for about 5 seconds; responded to name still pale & sweating resp shallow 6 per min called 911; BP low;
Patient given HepA pedi dose at school clinic and approx 10 mins later she stated she had no sensation in her left arm or fingers below the injection site. She was unable to squeeze fingers or pick anything up. Ice applied until parent picked her up and then student was taken to doctor's office.  Student was seen by her PCP a few hours later.  RN who administered vaccine at clinic spoke with mom at 1:00pm and they were still at MD's office. MD did not think it was vaccine related and could be a stress induced reaction.   Nurse followed up with mom the next day and she statied her arm was getting better, had increased sensation but fingers were still a little swollen and she would follow up with doctor if needed.
mom states 30 mins p/vax, pt's fever went to 105; APAP was given, temp dropped to 102, 1 hr later temp went back to 104.6-mom called clinic & was told to take pt to ER; mom did not take pt to ER because pt went to sleep & slept 6 hr;
unusual results following antibody testing after administration of Moderna COVID19 vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of ANTIBODY TEST ABNORMAL (unusual results following antibody testing after administration of Moderna COVID19 vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANTIBODY TEST ABNORMAL (unusual results following antibody testing after administration of Moderna COVID19 vaccine). At the time of the report, ANTIBODY TEST ABNORMAL (unusual results following antibody testing after administration of Moderna COVID19 vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided Treatment information was not provided
Immediately upon receiving H1N1 (L) arm began to hurt. Called 11/16 stating painful with "kernel" at injection site when she pressed on it. Rec. heat; unble to take NSAIDS- taking Tylenol- 11/19 followed instructions- to call me back if no improvement. Called still sore, "kernel" gone. Taking Trimadol for pain- Rec. ER if continuance of pain.
NAUSEA, HEADACHE, FEVER, MYALGIA, CHILLS Narrative:  FEVER 102; SYMPTOMS LASTED 36 HRS  Other Relevant History:
swelling, itching, pain began day after injection  rash and further swelling appeared 8 days after injection date
103+ fever for three days, no relief with Tylenol or ibuprofen. Minimal appetite. After fever broke, developed full body rash with much discomfort. Appetite stayed minimal and rash lasted 3-4 days.
suspected vaccination failure/Got them after taking his shingles vaccine; Shingles truly the pits, Got them; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   The reporter considered the vaccination failure and shingles to be possibly related to Shingles vaccine.     Additional Information: GSK receipt date: 16-Jan-2023 Reporter's comment: The case was received from the patient via interactive digital media. The patient reported that shingles was truly the pits. The patient got them after taking the shingles vaccine. The patient stated never again. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
pt devel induration @ the inj site following vax;no further info was available @ the date of this report;
Persistent arm pain that sounds neuropathic based on history.  EMG/NCS pending.
Severe chest pain, coming in waves, over 2 hours until I?ve Motrin given.  EKG. And blood work normal. Vital signs normal.
Very cold and full body aches; Very cold and full body aches; This is a spontaneous report received from a contactable consumer (Patient, self-reported). A 44-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiry date: not reported), dose 2 via an unspecified route of administration, in the left arm, on 24Feb2021 at 15:30, as single dose for COVID-19 immunisation in the school or student health clinic. The patient's medical history and concomitant medications was not reported. The patient was not allergic. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiry date: not reported), dose 1 via an unspecified route of administration, in the left arm, on 03Feb2021 at 17:30, as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medication within 2 weeks. The patient was not diagnosed with COVID-19 prior to vaccination. On 26Feb2021 09:00, the patient experienced very cold and full body aches. No treatment was received. The patient not tested for COVID-19 since the vaccination. The outcome of the events was recovered on an unknown date in 2021.  No follow-up attempts are Possible. Information on lot/batch cannot be obtained.
RMA administered immunization of PNEUMOVAX 0.5 ml IM in patients right deltoid. Within 3 minutes patient developed SOB, facial flushing, anaphylaxic symptoms. Injected given at 12:15 pm on 7/2/12, minutes of symptoms ice applied to injection site, pt given hydroxyzine symptoms subsided within 45 minutes. Hydroxyzine HCL 25 mg/ml. Administered in Lt. deltoid by RN.
Doses given after 20 minutes temperature excursion; Product storage error; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses given after 20 minutes temperature excursion) and PRODUCT STORAGE ERROR (Product storage error) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses given after 20 minutes temperature excursion) and PRODUCT STORAGE ERROR (Product storage error). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses given after 20 minutes temperature excursion) and PRODUCT STORAGE ERROR (Product storage error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant drugs were not reported.  Treatment medications were not provided.  The vial had a 20 minute excursion in the freezer.   This case was linked to MOD-2021-403721, MOD-2021-404722 (Patient Link).
dizziness; She had a really sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 16Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Mild lingering dizziness", start date: Jan2021 (unspecified if ongoing), notes: In January caller had complaints of dizziness but did not get tested for covid-19 vaccine; "She was ill", start date: Jan2021 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "recovered" (21Mar2021), described as "dizziness"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "She had a really sore arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
1 week after Flu and Sporadic pain, numbness, tingle all over body. Neurological symptoms. Darvocet, Celebrex, Elavil Rx. Follow-up received on 3/31/2005 states now diagnosed with fibromyalgia after flu vaccine.
Information has been received from a consumer concerning her four and a half year old son with no pertinent medical history and no known allergies or reactions who in August 2005 ("at 12 months of age"), was vaccinated with the first dose of MMR II. One week before the patient also received VARIVAX. Subsequently the patient experienced speech delay problems. Therapy with MMR II was discontinued. At the time of reporting, the patient had recovered. The patient sought unspecified medical attention. No further information is available.
fever of 102.4 starting aprox 12 hours after injection, lasting about 8 hours. Accompanied by 8/10 headache. sore arm. lethargy for 24hours
5 days after the 2nd vaccine experiencing sweats; 24 hours after the 2nd vaccine experienced vomitting; 24 hours after the 2nd vaccine experienced chills; 24 hours after the 2nd vaccine experienced fever; 24 hours after the 2nd vaccine experienced diarhea; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 06May2021 at 16:30 (at the age of 32-year-old), as a single dose for COVID-19 immunisation. Medical history included borderline thyroid and childhood asthma. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included unspecified vitamins and thyroid supplement; both for unknown indications from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 15Apr2021 at 16:45 (at the age of 32-year-old), as a single dose for COVID-19 immunisation. On 07May2021, 24 hours after the second vaccine, the patient experienced vomiting, chills, fever, diarrhea. On 10May2021, 5 days after the second vaccine the patient experienced sweats. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events vomiting, chills, fever, diarrhea and sweats was resolved with lasting effects on an unspecified date in May2021.  No follow-up attempts are needed. No further information is expected.
high fever, delirius, cellulitis @ site of inject; PCN given by MD, advised warm packs & f/u appt;
After second shot, I had the following adverse affects: tender/swollen testicles, burning sensation when I urinated . I had this after the first shot, too. I visited my local doctor. No UTI. Prostate was enlarged which I did not have before.
10/27  VACCINATION 10/30  GENERAL MALAISE FIRST FOLLOWED BY SEVERE        VOMITING. 10/31  FEVER OF 99.6. ACHINESS LOWER EXTREMITIES        JOINTS AND MUSCLES ONLY. 11/01  DISCOMFORT LEFT LEG, PRIMARILY IN LEFT         CALF 11/02  DISCOMFORT LEFT CALF AND LEFT ANKLE  11/03  INCREASING DISCOMFORT LEFT CALF AND ANKLE        SAW SPECIALIST PHYSICIAN FOR UNRELATED        MATTER.  ULTRSOUND OF LEFT LEG ORDERED. 11/04  ULTRASOUND OF LEFT LEG: UNREMARKABLE. 11/05  INCREASING PAIN, LEFT LEG, PRIMARILY        LEFT ANKLE AND CALF. 11/07  SAW FAMILY PHYSICIAN. UNABLE TO SIT, STAND        OR LIE.  WALKING ONLY RELIEF.  PAIN         SEVERE LEFT LEG HIP TO ANKLE.  MEDICATION:        BEXTRA AND SKELAXIN PRESCRIBED. 11/08  PAIN CONTINUES. UNABLE TO TURN IN BED         WITHOUT SEVERE PAIN. MEDICATION OF NO         BENEFIT. 11/10  PAIN SUBSIDING SOMEWHAT BY EVENING. 11/12  PAIN RETURNS FULL STRENTH, UNABLE TO BEND        AT HIP.  NEED ASSISTANCE TO DRESS.  WALKING        /PACING STILL ONLY RELIEF. LEFT HIP AND         CALF PRIMARILY.   11/13  PAIN SUBSIDING 11/14  SAW FAMILY PHYSICIAN. PAIN REDUCED TO         DISCOMFORT IN AFTERNOON.  11:00 PM PAIN        MOST SEVERE YET.  CONTEMPLATED TRIP TO         EMERGENCY ROOM.  TOOK A VIOCIN.  SLEPT 4        HOURS. 11/17  PAIN SUBSIDED TO ACHE LEFT HIP, TIGHTNESS        LEFT CALF. 11/18  SAME 11/19  ACHE AND CALF LESS UNCOMFORTABLE. 11/20  INTERMITTENT SLIGHT DISCOMFORT LEFT HIP.  PLEASE NOTE:  I HAD NO REACTION TO THE FIRST VACCINATION RECEIVED OCTOBER 8TH (I THINK).  SECOND VACCINATION ON OCTOBER 27TH WAS A MISTAKE ON MY PART.
on 4/25 client c/o headache and body aches and continued through 4/26/07.  Mother called CCHD adn i spoke with her.  No elevated temp.  Had her contact their private physician.
The child was reported to be sick with a virus and diarrhea for a couple of weeks. The pt was taken to the ER by EMS after mother found the child unresponsive. The baby was pronounced dead on arrival at the Hospital.   The cause of death was dehydration, vomiting, diarrhea, viral gastroenteritis.
Vaccination at 1040. At 1045 client was pale, diaphoretic. Client was conscious and breathing. Hr was 80, BP 80/50. Stated her throat "felt funny". 911 called, arrived within 3 mins. Physician on scene with ambulance. Stated client had a vagal response. Transported to ER per Mom request.