chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Wrong vaccine given based on age. Age of patient at time of event: 2 years 3 months
Issues with Mensural cycle - I messaged my doctor on 7/6/21. I had my first shot 4/3 and my second 5/4  My cycle was 2 weeks late and that never happens and it was a different color than normal and large clots - I asked my doc if I should come in-she prefer some blood work for me - thought I was too young for menopause.  Since July every month has been out of wack - heavier than normal - lighter than normal -off by a week or two-  cramps have been intense - can?t stand up straight sometimes  . I never even considered a issue w vaccine- but today I heard the NIH was looking into vaccine impacts on menstrul  cycle so I thought I should let you know
PATIENT IS A 2 MONTH OLD FEMALE WHO PRESENTS TO THE EMERGENCY DEPARTMENT FOLLOWING A SEIZURE AT HOME JUST PRIOR TO ARRIVAL.  HER MOTHER STATES THAT SHE HAD HER IMMUNIZATIONS EARLIER TODAY, RETURNED HOME AND TOOK A NAP.  SHE WOKE HER UP TO CHANGE HER AND GIVE HER A BOTTLE, AND WHILE SHE WAS CHANGING HER DIAPER, SHE BECAME RIGID WITH SHAKING AND JERKING OF HER ARMS AND LEGS.  SHE BECAME UNRESPONSIVE WITH FOAMING AT THE MOUTH, AND HER MOTHER CALLED 911.  PATIENT WAS CRYING EN ROUTE TO THE HOSPITAL WITH NORMAL VITAL SIGNS.  HER MOTHER STATES THAT SHE IS OTHERWISE HEALTHY.
Pt seen in PCP office on 6/2/21 CC palpitations. Pt says since had her COVID vaccine 3 wks ago she's felt her heart pounding. She also experienced swelling in her hands and feet after the vaccine. EKG done and normal. Pt referred to cardiologist (of note has past hx of Afib).
Became ill two days after vaccination, slight fever , nausea, headache, forgetful , unsteady on feet , sleepy
The patient came to the pharmacy 34 days after first dose of Moderna and while here reported that the scab from 5/8/21 had not healed.  I looked at his arm and there was a scab with a small horizontal scratch through it, no redness surrounded the area.  I asked him if he has scratched it.  He reported that he had because it was itchy at times.  He said it was never red or swollen but itchy.
Tachycardia during rest periods, shortness of breath while walking short distances, muscle cramps to bilateral lower extremities, sense of nervousness without involuntary movements.
A Moderna Covid booster indicated for patients aged 6-11 years was administered to this 1 year old patient.
heart was racing; increased respiratory rate; tingling in the tongue; full/swollen feeling in the tongue; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (Lot/batch number and expiry date unknown), intramuscular on12Jan2021 07:30 at single dose in the left arm for COVID-19 immunization. Medical history included PCN allergies from an unknown date. There were no concomitant medications. On 12Jan2021 07:45 about 15 minutes after the injection, the patient felt like heart was racing, increased respiratory rate and tingling in the tongue. Heart rate and respiratory rate quickly returned to normal but the tingling and full/swollen feeling in the tongue continued for about 1.5 hours post injection. The patient did not receive any treatment for the events. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not receive other medications within 2 weeks of vaccination. The vaccine was given in the Hospital. The outcome of the event "heart was racing" and "increased respiratory rate" was recovered on Jan2021 while outcome of the other events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a doctor of pharmacy concerning a 65 year old female with blood pressure high and a previous small pox vaccination, the patient had a scar where the small pox vaccine was given, who in February 2009, was vaccinated with a dose of ZOSTAVAX (Merck) on the left side, left arm. The patient was likely taking blood pressure medication. About a month and a half later the patient came back and stated that the scar was red, dry and scaly. The patient also stated that previously there had been blisters inside the scar. Additional information has been requested.
PT came in for 2nd dose of pfizer. Staff administered booster instead of monovalent. Staff has been coached on proper verification of vaccine. Incident report is submitted within organization to address root cause, provider proper training, and address situation.
Injection site reaction: pt. had an aprox. 3"-8" area on her underarm which was red, slightly puffy, and firm compared to surrounding area. Pt. States she also felt feverish. Vaccine admin. on 11/3/15, reaction started 11/5-11/6. Pt. stopped by pharm no showed me on 11/8/15.
The lot number LOOKS LIKE (but sloppy writing so cannot be sure):  0C0C21A (could also be 050C21A)  I was fine for the 15 minutes they had me sit in the office.  Approximately 25 minutes after the vaccine, my chest became extremely tight like I was about to have a heart attack.  The tighness faded over time.  A couple of days after the vaccine I was exercising and had shooting pains in my heart.  I called back to see if they could advise me on getting the second shot as these symptoms concerned me. they told me that because they were not my medical provider (they just gave me the shot), they could not provide any advice. I called the hotline and asked if it would be wise to get the 2nd vaccine as I had symptoms that concerned me with the first shot?  The lady on the hotline just read from a script and did not answer my question.  She did not ask or take any data from me.
This case was reported by a physician via a sales representative and described the occurrence of crying uncontrollably in a 2-month-old female subject who was vaccinated with PEDIARIX, (GlaxoSmithKline).  On 25 July 2008 the subject received 1st dose of PEDIARIX at 0.5 ml.  Immediately after the injection, on 25 July 2008, the subject began crying uncontrollably and continued to cry throughout the visit.  Approximately 3 hours later, the subject was still crying.  At the time of reporting the outcome of the event was unspecified.  The physician considered the event was probably related to vaccination with PEDIARIX.  Follow-up received on 26 August 2008 indicate that the subject cried for 4 hours and then stopped.  The reporter considered the event possibly related to treatment with INFANRIX.
lARGE AREAOF REDNESS AND SWELLING AT INJECTION SITE FOR TWO WEEKS
This case was reported by a nurse via sales rep and described the occurrence of pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were provided a follows: The age at the vaccination was not reported. Nurse at discussion table at conference shared that one of her friends had pain for 18 hours after receiving the SHINGRIX vaccine.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown gender and age. On an unknown date, the patients were vaccinated with a dose of (Oka/Merck) VARIVAX (lot # reported as J006108, expiration date 17-MAY-2015) (dose not reported) that was improperly stored. The nurse stated that (Oka/Merck) VARIVAX had excursions of 7 F for 8 days and to 22 F for 5 days. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Patient came to pharmacy to get Pneumovax 23 immunization on 9/23/20, used appropriate PPE, swabbed site with alcohol swab and injected vaccine as per usual guidelines. Discussed adverse events with patient. Patient returned to the pharmacy on 9/25/20 and received an rx for cephalexin and described cellulitis following the vaccination. Patient stated she had redness and a little swelling the night of 9/23/20, took ibuprofen and benadryl and used an ice pack. Patient then stated in subsequent days, the redness disappeared from the original site and both sides of her arm became red and swollen, she went to the doctor and the determined it to be cellulitis but did an ultrasound to rule out blood clot as well.
Patient received MCV-4 in L deltoid 0.5 ml at approx 4pm accompanied by his mother and sister.  Pt waiting in hallway for his sister to get her shot.  Pt fell to the floor.  Pt had cell phone on a chain around his neck it was in back of his head when he hit the floor.  Skin laceration noted to back of his head by EMT.  Pt awake alert.  Pressure applied bleeding stop.  Pt stated he has been getting black out spells approx 3 per month.  Pt taken to EMT.
pain in her back; dizziness; her left ankle which is twice the size of her right ankle; nausea; fatigue; lots of joint pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (pain in her back), DIZZINESS (dizziness), JOINT SWELLING (her left ankle which is twice the size of her right ankle), NAUSEA (nausea) and FATIGUE (fatigue) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, the patient experienced BACK PAIN (pain in her back), DIZZINESS (dizziness), JOINT SWELLING (her left ankle which is twice the size of her right ankle), NAUSEA (nausea), FATIGUE (fatigue) and ARTHRALGIA (lots of joint pain). At the time of the report, BACK PAIN (pain in her back), DIZZINESS (dizziness), NAUSEA (nausea), FATIGUE (fatigue) and ARTHRALGIA (lots of joint pain) had resolved and JOINT SWELLING (her left ankle which is twice the size of her right ankle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medication was provided.  No treatment  was provided.  Reporter does have some aches and she is not able to do the exact things she could when she was younger but that was normal for her age.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Severe diarrhea for 3 hours which came almost like water; Feeling very weak; Could not step out of the bed; Temperature ranging from 102-103; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Severe diarrhea for 3 hours which came almost like water), ASTHENIA (Feeling very weak), FATIGUE (Could not step out of the bed) and PYREXIA (Temperature ranging from 102-103) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced DIARRHOEA (Severe diarrhea for 3 hours which came almost like water), ASTHENIA (Feeling very weak), FATIGUE (Could not step out of the bed) and PYREXIA (Temperature ranging from 102-103). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 10-Mar-2021, DIARRHOEA (Severe diarrhea for 3 hours which came almost like water), ASTHENIA (Feeling very weak), FATIGUE (Could not step out of the bed) and PYREXIA (Temperature ranging from 102-103) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, Body temperature: 102 (High) Temperature of 102. On 09-Mar-2021, Body temperature: 103 (High) Temperature raised to 103.         No concomitant medications were provided.  Action taken with mRNA-1273 in response to the events was not applicable.
Info has been received from a registered nurse concerning a 50 year old female with allergies to naproxen (NAPROSYN), loratadine (CLARITIN) and fexofenadine (ALLEGRA) (previously reported as no history of allergies), hypertension and rheumatoid arthritis who on 10/31/2002 (previously reported as 10/07/2002) was vaccinated with a 1st dose of pneumococcal vaccine 23 polyvalent (Lot #644103/0710M) in her right deltoid. Concomitant therapy included methotrexate sodium (METHOTREXATE (methotrexate sodium)), hydroxychloroquineSO4 (PLAQUENIL), rofecoxib (MSD), levothyroxine Na (SYNTHROID), sertraline HCl (ZOLOFT), pantoprazole sodium (PROTONIX), cyclobenzaprine HCl (FLEXERIL), ibuprofen (ADVIL), folic acid and influenza virus vaccine. On 10/08/2002, the pt developed a "cellulitis like" reaction described as "erythematous and painful" in the area of the injection. The nurse reported that at an office visit on 10/22/2002, the pt complained of painful range of motion (ROM) and that the pt was treated with diphenhydramine hydrochloride (BENADRYL) and a methylprednisolone sodium succinate (SOLU-MEDROL) dose pack. The nurse further reported that as of 11/12/2002, the pt had not been back in the office since the visit on 10/22/2002 and that she assumed that the pt had since recovered. The nurse also provided info regarding other patients' experiences (WAES #0211USA00663 and 0211USA00881). Follow-up info received from the registered nurse and medical records revealed that on 10/25/2002, the pt also received a "flu shot" and on 11/01/2002 the pt experienced a localized drug reaction described as right deltoid swelling, tenderness and erythema. Following the pt's vaccination with pneumococcal vaccine 23 polyvalent on 10/31/2002, the pt made 2 visits to her physician and on 11/03/2002, she went to the ER with complaint of "severe flu symptoms" which included aches all over (myalgias), nausea, vomiting and headaches and no respiratory symptoms. The pt also complained of being unable to move her right arm 90 degrees because of the aching. A physical examination revealed a temperature of 98.6, pulse of 80, respiratory rate of 18, and blood pressure of 140/80; right upper arm with erythematous 4 inch long distinct circular erythema area; negative vesicles; negative lymphadenopathy; local warmth; some streaking; and negative signs of infection. The pt was diagnosed with an allergic reaction in her right lateral arm. While in the ER, the pt received diphenhydramine hydrochloride, 50 mg and acetaminophen (-) hydrocodone bitartrate (LORTAB), 7.5 mg, orally. Subsequently, the pt was treated with diphenhydramine hydrochloride and methylprednisolone (MEDROL DOSEPAK). Medical records indicated that as of 11/04/2002, the pt was "improving." The pt sought medical attention at her physician's office and at an ER. Additional info is not expected.
Information has been received from a physician concerning a 16 year old white female with a history of mild asthma who on 25-OCT-2007 was vaccinated in the left deltoid with her third dose of GARDASIL vaccine (yeast) (lot# 659437/1266U). On 25-OCT-2007, 20 minutes after being vaccinated, the patient became nauseous, very pale and shaky. This lasted until the next day. Subsequently, the patient recovered from nauseous, very pale and shaky within 24 hours. Additional information has been requested.
pt recv vax; lt upper arm, large reddened, warm swelling at inject site; depomedrol dph & ice recommended;
Information has been received from a certified medical assistant concerning a 61 year old female with no drug allergies or drug reactions, with hypertension and hypercholesterolamia, osteopenia and gastroooesophageal reflux disease who on 19-NOV-2007 was vaccinated with ZOSTER (Oka/Merck) (lot # 658361/1090U), 0.65ml, subcutaneous.  Concomitant therapy included hydrochlorothiazide, LIPITOR, NEXIUM and MSD.  Subsequently, the patient had been diagnosed with shingles.  Medical attention was sought via office visit.  No lab diagnostics studies were performed.   The outcome of shingles was not specified at the time of reporting.  Additional information has been requested.
Patient got vaccinated at 10:05 AM. At 10:25 AM, patient presented with tightness of throat, dizziness and itchiness on lower arms. Patient weights 165 lbs according to her. Rph gave Benadryl 25 mg by mouth once at 10:25 AM. Rph took BP at 130/80. Patient complained with chills and visible shaking. Nurse practitioner on-site arrived and monitored Pulse oximeter O2 started with 92% going down so she decided to give O2 supplement while going back to 100%. EMS called at 10:30 AM and arrived at 10:43 AM and took her. The site coordinator notified that patient is doing fine and back to work around 1:30 PM same day.
DEATH; This spontaneous report received from a consumer via other company Pfizer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) one total dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient was died. The cause of death was not reported. It was unknown whether the autopsy was done or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: 20210666298-Covid-19 vaccine ad26.cov2.s -Death. This event(s) is considered unassessable. The event(s) 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(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Patient received Four doses of Moderna Vaccine accidently, it was unclear pt had previously been fully vaccinated. 1st Dose 4/5/21 Lot number 017b21a 2nd Dose 5/7/21 Lot Number 04B21a 3rd Dose 9/3/21 lot number  019b21a 4th Dose 9/30/21 Lot number 058e21a
rt p/vax pt flushed & devel urticaria rash face & trunk;pruritus;
mass in left brachial lymph nodes 11cmX8cmX5cm i also have fever chills and night sweats  body aches
This case was reported by a consumer and described the occurrence of difficulty swallowing in a 62-year-old male subject who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  A physician or other health care professional has not verified this report.  Subject was healthy and had not experienced any adverse events following previous influenza vaccinations.  On 4 December 2007 at 17:30 the subject received 1st dose of Flulaval (unknown, left arm).  On 12 December 2007, 8 days after vaccination with Flulaval, the subject experienced difficulty swallowing, headache, chills, fever, queasiness and acid reflux.  The subject was seen at a walk in clinic on 16 December 2007.  On 17 December 2007, he was seen by his regular physician.  An upper GI series was done on 18 or 19 December 2007.  An endoscopy was done on 26 December 2007.  Results were not reported.  At the time of reporting the outcome of the events were unspecified.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On 19-OCT-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # K019502 with expiration date 14-FEB-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a Registered Nurse concerning a 14 year old female with a history of back pain and pin in hip, and no drug reactions/allergies, who on 04-FEB-2009 was vaccinated with the first dose of GARDASIL (lot# 661766/0652X), 0.5 ml intramuscular into her left arm. There was no concomitant medication. On 04-FEB-2009 the patient experienced some pain as the injection went into her arm. This pain went away but then two weeks later the patient began to experience swelling of the injection site area. It was the size of a palm and was hot to the touch. There was no redness. The patient then wasn't able to lift up her arm because of the pain. She also developed numbness of her whole arm down to her hand. On 19-FEB-2009, it was numb nut only from the elbow down to her hand. It was not as tender but it still hurt. There was less swelling. On unspecified date, the patient sought unspecified medical attention, no lab diagnostics studies performed. The patient was not recovered. This is one of several reports from the same source. Additional information has been requested.
I?ve never gained full rotation of my left arm since the vaccination. I feel a shooting pain down my arm if I suddenly move my arm a certain way.
Info has been received from an RN concerning another female nurse who had a pt spit rotavirus G1 02 03 04 P1 reassortant vaccine live (human-bovine) into her eye. The RN reported that the nurse had some burning in her eye. Unspecified medical attention was sought and it was noted that the nurse did not wash her eye. At the time of this report, the outcome was unknown. Additional info has been requested.
It happened on Saturday 10/9. I had just eaten lunch and I have a sensor for my blood sugar in my arm. I was looking at the TV and my vision turned into kaleidoscope vision for 2 minutes. I tested my blood sugar, and it was 140 which is normal for me. I called my PCP, and we went to the hospital - Hospital. Evaluated for detached retina. They did a verbal stroke test and checked to see if it was going to be a stroke. They put dye in my eye, but they didn't have the equipment to check my eye but checked for scratches. Nothing was found and we went home after. 10/12 went to the ophthalmologist and did a bunch of tests and determined that my eyes were fine. PCP said that if it happened again to go to the hospital. I went home, and the next time I had it, it was just one eye. It seemed like a lightning bolt in one eye. We went to Hospital 10/23, and they gave me a CAT scan and MRI. They couldn't find anything in my brain that would be causing it. The doctor there thought that it could have been an ocular migraine. We went to Dr. 10/22021 where he said it was confirmed an ocular migraine. It happened about 2 to 3 more times. It switches back and forth between eyes. I've never gotten headaches with it. The time I went to the doctor, I was nauseous, but that could have been due to other factors.
Narrative:  Patient received J&J vaccine and reported headache the day of vaccination. Resolved with tylenol.
vaccine past its expiration date administered to 11 patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED. On 28-Oct-2021, EXPIRED PRODUCT ADMINISTERED had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant use were reported No Treatment were reported vial was initially stored in the refrigerator 4-OCT-2021
Signs of seizures (undiagnosed) comatose state body stiffness and convulsions signs of autism no eye contact not walking nonverbal will not stand to be touched developmental delays.