chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A report was received from a health care professional on 10/30/2003, concerning an unspecified number of vaccinees under 4 years of age who inadvertently received Fluvirin on an unspecified date. No adverse effects had occurred at the time of report. There was insufficient information to determine the reporter's causality assessment. Update 1, 12/1/03: Follow up information received from a health care professional indicated that a 3 and a half year old male vaccinee inadvertently received Fluvirin on 10/18/03 and had not experienced any adverse event at the time of the report. No follow up pending, all information received. Cross reference with: PJP200300957, PJP200400013, PHP200400014, PJP200400016, PJP200400017, PJP200400018, PJP200400019, PJP200400020, PJP200400021, PJP200400022, PJP200400023, PJP200400024.
Mom thinks she had 2 seizures 1 day after her 18 month vaccines. Both episodes were episodes of unresponsiveness. The first time, mom found her lying face down on the floor, arms out to sides. Mom noticed that she was suddenly quiet. There was no sound of a fall. No bruises or bumps on face. She was normal in color, her eyes were open and seemed to be looking around. She would not alert to mom call her name, clapping, shook her food, and offered a cracker to her had, with no response. Suddenly she got up and was normal. The whole episode was about 30-40 secs. Later that night, aroun 7 pm, Dad was in the laundry room, next to the playroom, heard no noise, went to the playroom, and eventually found her after 1-2 minutes. She was laying under a small trampoline, with her hands in front of her face. Dad called her multiple times, with no reponse. 20-30 secs later she pulled her hands away, and then seemed to get back to normal. She had no fever. Since then she has been more sensitive and irritable, harder to soothe. She has more meltdowns.
Angioedema (swelling to tongue and side of neck) that started 4 days after vaccination. Swelling improved with steroids, epi, Benadryl and observation. Patient is on lisinopril (has been on for some time) and this is likely precipitated the event.
pain in the site of injection, muscle pain, abdominal pain the next day that stopped without treatment.
This spontaneous case reported by a consumer, describes the occurrence of SARS-CoV-2 test (tested positive for COVID-19) and product dose omission in error (second dose missed greater than day 36) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 012A21A) for COVID-19 immunization. Concurrent medical conditions included obesity. On Mar 2, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 25, 2021, patient had a positive SARS-CoV-2 test (tested positive for COVID-19). On an unknown date, patient experienced product dose omission in error (second dose missed greater than day 36). The patient treated with Bamlanivimab Mar 25, 2021 for COVID-19, at an unspecified dose and frequency. At the time of the report, SARS-CoV-2 test (tested positive for COVID-19) and product dose omission in error (second dose missed greater than day 36) outcome: unknown. Diagnostic results: On Mar 25, 2021, SARS-CoV-2 test: Positive. Tested positive for COVID-19. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medications reported.
Act-HIB  diluted with sterile water / no AE; Initial information received on 24-Feb-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 16 months old male patient  who received second dose of HIB (PRP/T) VACCINE [ACT-HIB] that was diluted with sterile water Vial lot UJ161AA (Expiry date 02-May-2021) Box Lot UJ161AAA (Expiry date 26-Nov-2020) via intramuscular route in the left thigh for Prophylactic vaccination on 11-Feb-2020 (Product preparation error).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE INACT SPLIT VIRION 4V (FLUZONE QUADRIVALENT), VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) on 11-Feb-2020.  It was an actual medication error case due to Wrong solution used in drug reconstitution.   At a time of reporting no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Fever, chills, myalsias, facial flushing,redness and tenderness at arm. Treated with rest, Vicodin, and Benadryl.
Reaction began within a few hours of vaccination.  Patient had fever, chills and diarrhea within a few hours of receiving the vaccine.  By 4:30am on 3/31 she could not walk and her legs went numb.  An ambulance was called and the EMTs had to carry her out of the house.  She was taken to Hospital where they started treating her for an infection but her fever went up over 103F so they ventilated her to try to control the fever. They did blood tests during that time and got the infections disease unit trying to figure out what was causing her symptoms.  Doctors diagnosed sepsis.  They continued to do blood test and cultures but could not determine the cause. They did MRIs as follow-ups because she was not responding. The fever never went down.  She was awake for a few days (ventilator still in) and then started getting worse again.  This is about 1.5 weeks post vaccination.  They did an MRI and found a bleed on her brain and the infection had spread to her heart valves.  Symptoms began within hours of vaccination.  She was take to the hospital the morning after the vaccine and never came home.  Patient died after 2 weeks in the ICU.
mom phoned 22AUG97 stating pt had a raised rash that almost looked like hives & was itching;rash was @ inj site, on legs, back, stomach, feet;was referred to family MD;mom reported back 25AUG97 that MD determined was allerg rxn to vax;
Pt experienced rash that started on 2/16/00, also reactive airway disease, treated with Benadryl, Neosporin, Albuterol
Pt got severe swelling at the site of injection. Very Red, about 3 inches in diameter. No pain or drainage at site. In addition, she feels tingly in her hands and feet and has a headache in the back of her head. She states 'she just doesn't feel right' after the injection. I advised her to check with her doctor due to the side effects from the vaccine. She is getting better now, as the redness has gone down to about 1" or so. Still feels the tingle but not as bad as before. We think she may have a small case of shingles from the vaccine.
Guillian-Barre syndrome. Treating at MGH. Extubated with trach in place.
Tiredness and exhaustion after the vaccination; This is a spontaneous report received from a contactable consumer. A 37-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140, expiry date: unknown), via an unspecified route of administration, on 21Jan2021, at single dose, for COVID-19 immunization, at the hospital. The patient medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since vaccination. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2 vaccine. On 21Jan2021, the patient experienced tiredness and exhaustion after the vaccination. No treatment for the event was given. The outcome of the event was not recovered. The event was assessed as non-serious.
Received immunizations 01/18/2005.  Later that day left arm was red and swollen.  Next day left arm more swollen and hot to touch - swelling spread to elbow.  Also headache.  Mother took child to doctor on 01/20/2005, doctor diagnosed with infection at injection site.  No meds given.
This spontaneous report was received from a physician via a company representative and refers to unspecified number of patients of unknown demographics. No information regarding the patients' medical history, concomitant medications and concurrent conditions was provided. On unknown dates, the patients were vaccinated with doses of GARDASIL injection (dose, route of administration, lot number and expiration date were not reported). On unknown dates, the patients experienced fainting. The outcome of fainting was unknown. The relatedness between th events and GARDASIL was not reported. Additional information is not expected as there was no consent for further contact.
Headache Sore throat Narrative: Neg covid test ordered due to sore throat and was negative  Other Relevant History:
PATIENT RECEIVED HIS 2ND DOSE OF THE MODERNA COVID-19 ON APRIL 5TH AT 11:45AM. WHEN HE WOKE UP ON WEDNESDAY APRIL 7TH, 2021, HE NOTICED REDNESS AND SENSITIVITY TO TOUCH JUST BELOW INJECTION SITE. HE WENT TO HIS PCP DR. TODAY APRIL 13, 2021. THE RE ARE MEASURED 6 INCHES WIDE AND 4 INCHES LONG. IT IS TENDER AND SENSITIVE TO TOUCH. SHE ADVISED HIM TO USE ICE PACKS AND TYLENOL AND TO REPORT REACTION TO PHARMACY.
Blurred vision; Extreme headache; Extreme migraine; This is a spontaneous report received from contactable reporter (consumer).  A 84 year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administration date 02Mar2021 (Batch/Lot number: unknown) at the age of 84 years as single dose for covid-19 immunization. Relevant medical history included: "high cholesterol" (ongoing); "high blood pressure" (ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (First dose; Lot number unknown), administration date: 03Feb2021, when the patient was 84 years old, single for covid-19 immunization. The following information was reported: VISION BLURRED (non-serious) with onset 02Mar2021, outcome "recovering", described as "Blurred vision"; HEADACHE (non-serious) with onset 02Mar2021, outcome "recovering", described as "Extreme headache"; MIGRAINE (non-serious) with onset 02Mar2021, outcome "recovering", described as "Extreme migraine". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The reporter stated, after the second shot she's been experiencing an extreme headache, with blurred vision and she had the shot on (02Mar2021) Wednesday so we are on day three. and I didn't know, I have not seen, when I had access to the internet, that as one of the side effects and  just wanted to know if this is and it is been reported in time frame of the symptom and when it should resolved?".  The reporter stated that she had blood work done 2 weeks before (unspecified date in Feb2021) for cholesterol and blood pressure, basic blood work, everything was normal; cholesterol was in the acceptable range. The reporter stated about the event that is getting better but is still persisting.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Arm sore and rash but did not report to Dr on appointment for sinus infection on 9/20/2016. On 9/21/2016 call pharmacy and came in.  Pharmacist counseled patient and examined body response to vaccine telling ptn some soreness swelling can occur and to take TYLENOL and BENADRYL every 6 hours for 48 hours and to call rx or dr if gets worse.
Extreme sleeplessness and fussiness. Around six hours after the vaccination, patient became hyperactive, continually moving his arms and legs. He went from sleeping twelve to fourteen hours a day to sleeping an hour or less. Over a five day period he slept  an estimated eight total hours combined.
Reports of having chronic headaches 3-5 times a week starting around 2:00 pm or 3:00 pm and lasting up to 3 hours. Has to take 2 Tylenol when they start and sometimes has to take one more Tylenol 1.5-2 hours later to make it go away. Headaches started 3/28/21 and continued on and off since. Notes that after his second dose the headaches became more frequent. Notes that he drank Pedialyte a couple days before is 2nd dose with the hopes it would help. Reports prior to receiving the Covid vaccine, it was rare for him to ever have a headache.
UTI (urinary tract infection); This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (UTI (urinary tract infection)) in a female 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URINARY TRACT INFECTION (UTI (urinary tract infection)). At the time of the report, URINARY TRACT INFECTION (UTI (urinary tract infection)) outcome was unknown.            No concomitant medications were provided. Treatment medications were not provided. Action taken with mRNA-1273 in response to the events was not Applicable.
Patient felt dizzy, which passed quickly.   Patient then had breakfast and became nauseous and vomited.
slight headache on the back of their neck; pain came down the left side of their breast; left arm was a little sore; tired; This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (pain came down the left side of their breast), PAIN IN EXTREMITY (left arm was a little sore), FATIGUE (tired) and HEADACHE (slight headache on the back of their neck) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced BREAST PAIN (pain came down the left side of their breast), PAIN IN EXTREMITY (left arm was a little sore) and FATIGUE (tired). On 05-Feb-2021, the patient experienced HEADACHE (slight headache on the back of their neck). At the time of the report, BREAST PAIN (pain came down the left side of their breast), PAIN IN EXTREMITY (left arm was a little sore) and FATIGUE (tired) had not resolved and HEADACHE (slight headache on the back of their neck) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Pt Mom received a call from pt daycare at 1240 on 4/24/19 telling her that her daughter had a rash on BL legs from knees to feet and that her left foot was swollen and the right one was starting to swell.  Pt Mom was directed to take her daughter into the ER to be evaluated. Pt was treated for allergic reaction and released to home with no medications. Pt f/u with provider on 5/7/19, both feet still swollen, but the swelling has considerably decreased, along with the redness and the rash did not spread, but has decreased.
Mother reports area "where shot was given", RV, has been a hard lump but on 10/17 it got red also. PC to Public Health Dept. on 10/19/10 - enc. to phone MD. 10/21/10: PC to MD - tx for cellulitis with amoxicillin, by report.
no aditional adverse effect; A female 16 year old patient inadvertently was administered PROQUAD; This spontaneous report has been received from a registered nurse referring to a 16 year old female patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.    On 27-JAN-2020, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (strength, frequency, dose, route, anatomical location, lot # and expiration date were not provided) for prophylaxis. The vaccine was diluted with sterile diluent. No adverse events were reported.
anaphylactic reaction -  chest tightness, wheezing, headache and nausea developed approximately 2 hours after the vaccination dose and progressed rapidly.  Improved rapidly after IM epinephrine.  was also given dexamethasone and diphenhydramine and famotidine.  Discharged home after observation in the emergency department in no recurrence of symptoms over several hours.
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.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 16Feb2021 as dose 1, single (Lot number: El9266), in left arm, on 10Mar2021 as dose 2, single (Lot number: En6206), in left arm, on 27Sep2021 as dose 3 (booster), single (Lot number: Ff3839), in left arm and on 08Apr2022 at 10:00 as dose 4 (booster), single (Lot number: Fk9896) at the age of 71 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing), notes: Know allergies: Sulfa. The patient's concomitant medications were not reported. No other medication received in 2 weeks of vaccination. The following information was reported: VACCINATION FAILURE (medically significant), 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 with Paxlovid from 04Jun2022 to 08Jun2022.  No follow-up attempts are needed. No further information is expected.
Severe chills starting 12 hours after the injection, then after 24 hours muscle aches, fatigue, diarrhea over the next 12 hours. I am reporting this for your information, only because of the minimal time between this 2nd dose and my 1st dose (at 9 a.m. on March 30, 2021, I received Pfizer ER8733 as my first dose from the same government vaccination site; I had no side effects at all in the days following my first dose).
Vaccine given 14:30. At 19:30 started to have runny nose, watery eyes, nausea and vomiting. Also, throat closing, rashes on face, ears and down her throat. Temperature 98 ; BP 162/54; Pulse 110; Respiration = 30. At 22:45 taken to ER and was given IV Benadryl. Came back to work the following day with symptoms resolved.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 lot # M013636, expiration date: 15-FEB-2018, intramuscularly route per reporter (strength, dose and frequency were not reported) for prophylaxis, which was improperly stored at 32 and 36 Farenheit degrees for an unknown time. This excursion was detected due to a digital data logger, however no previous temperature excursion was reported.  No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA010177: US-009507513-1701USA013133: US-009507513-1701USA013139: US-009507513-1701USA013136: US-009507513-1701USA013137: US-009507513-1701USA013138: US-009507513-1701USA013132: US-009507513-1701USA013135:
4/7/2021 vaccination About 12.5 hours later, 2AM, I woke up with violent chills, trembling, 104 temperature, shaking, achiness, HA. I probably had a HA for 25 days. 4/21 urgent care. The Dr. dismissed and stated it was upper respiratory. I wanted to timeline that something wasn't right, was dismissed and prescribed an antibiotic. 4/22 PCM. PCM stated I had all the symptoms for COVID. Tested COVID+. She had me come back in on 4/29/2021 and retest; negative. But positive for a bacterial infection, round of antibiotics. Steroid, 5 day antibiotic 4/7 - 5/16 I had had the HA for 25 days. Fever went away prob around 4/28th. I have had the dry cough, productive cough, breathing issues. *residual 'brain fog'.
I did receive a Quadrivalent Flu shot vaccine though I have not been able to confirm which exact variety it was so I choose the first flu vaccine type in item 17 above.  This was my first time getting the flu vaccine ever, so the nurse administering had me wait an extra 20mins after the injecting to make sure I had no adverse side effects. I felt fine immediately after and throughout that day.  Being that I had virtually no symptoms I actually forgotten that I had been given a shot until later that night when my arm felt sore and I thought massaging it would help alleviate the soreness. After realizing that my soreness was actually the remnants of pain from the injection site, I stopped.   Though even after stopping I felt the pain in my arm slowly permeate to my other joints and made me feel very uncomfortable. Thinking that it might just be my body needing food/water since I hadn't had anything since noon. After making my way towards my kitchen it was only until I made it to the bottom of stairs that I knew something was off and I felt like I was going to faint.  It was pretty much a slow train wreck in that at first I was forced to sit down because I was light headed and dizzy, then my vision started closing in and I could hear the tea kettle whistle in my ear as I slowly lied down and momentarily passed out. Maybe only a minute or so later I was back up though still reeling from the experience. Broke out into a cold sweat thereafter but that is where most of the symptoms subsided and I was able to get up, talk coherently, and see things in front of me clearly .  The whole episode took maybe 15-20 mins. Though the uneasiness/slight joint pains remained with me until I went to bed that night at 10PM.
Adverse effect; Vaccine rolled out of arm; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Adverse effect) and DEVICE CONNECTION ISSUE (Vaccine rolled out of arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced DEVICE CONNECTION ISSUE (Vaccine rolled out of arm). On an unknown date, the patient experienced ADVERSE REACTION (Adverse effect). On 27-Jan-2021, DEVICE CONNECTION ISSUE (Vaccine rolled out of arm) had resolved. At the time of the report, ADVERSE REACTION (Adverse effect) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Apr-2021: Non significant information added. On 23-Jul-2021: Follow up received: lot number, start date of vaccine and outcome of event added.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.