chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After receiving  the vaccine, the patient began to stand up to leave and fainted. She was caught be the individuals who came in with her and returned to the chair in the immunization site. The patient sat there for about 30 minutes and was attended to and felt good after 30 minutes so she left. The pharmacist followed up with the patient later that evening and she was doing fine.
Patient first experienced swelling at the injection site as soon as the flu shot was injected. In about 5 minutes, she experienced tingling in her hands and spread through the rest of her body in another 5 minutes or so.  She was, then, given a dose of Benadryl liquid, and her blood pressure and pulse were measured and normal.  She said she hadn't eaten or drunk anything all morning, ate a piece of sandwich, then fortunately started feeling better and got taken out by a school nurse.
pt recv vax & pt exp acute resp distress synd, fever 103.5, h/a & mult focal demyelination;
Patient stated he felt cold, then he comment that he felt tired. Patient received the vaccine at approximately 3:40-3:45p. He was shivering prior to the vaccine and I asked him what was wrong and he said he was just really cold. We waited about 15-20min after the vaccine and still was the same. He was cognitive and was talking to me. We offered him water and a mint candy, but didn't want it. We called his son to see if he could come pick him up because he didn't seem as if he could drive with how anxious and shivering he was. This was about 4:10-4:159 and his son arrived about 4:30p.  When his son and daughter arrived, about 5 minutes later, he got weak and had shallow breathing. He wasn't responding to us. We called the ER and they arrived within 10-15min.
Patient and mom came into clinic reporting reaction from vaccine. R arm had an area of redness. No swelling and patient have no complaints of pain.  Mom reports previously it was swollen, and more red. Advised applying cool compress and notify us if sx do not continue to improve. Mom would like guidance on future vaccines She is concerned about receiving future vaccine and would like to avoid receiving another dose of which ever vaccine caused the reaction.
Localized reaction immediately after injection given.  Wheezing and shortness of breath at 09:00 PM.
an expired diluent was administered with PROQUAD; This spontaneous report was received from a physician referring to a 4 years old patient of unknown gender. Information regarding the patient's concurrent conditions, medical history and historical drugs were not provided.   The reporter indicated that on 24-AUG-2020, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (Dosage regimen and route of administration not provided; lot # S017255 and expiration date: 01-DEC-2020, albumin status: rha) for prophylaxis, which was reconstituted with an expired sterile diluent (MERCK STERILE DILUENT) (lot # S018821 and expiration date 22-AUG-2020). No additional information was provided.
Patient was given an expired vaccine. Vaccine expired on 09/07/2021, and was given on 09/17/2021.
Late in the day on 8/31/22, the FDA rescinded the EUA order for the use of the monovalent Pfizer and Moderna vaccine as boosters for people aged 12 years and older. The information took a little time to trickle from the local authority to  staff and then to our clinic and the staff administering vaccine. Because of this delay, some monovalent vaccine throughout clinic was inadvertently given after 8/31/22. The CDC stated that any monovalent vaccine administered as a booster dose after the EUA was rescinded would be considered a vaccine error. At a recent Immunization Subcommittee meeting, we discussed this and our medical providers stated that any monovalent vaccine given as a booster dose on 9/1/2022 or after should have VAERS report completed on them per the CDC's requirements.
Increased Blood Pressure; Fatigue; Swelling - Near Injection Site; Arm Pain; Headache; Redness - Near Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (Increased Blood Pressure), FATIGUE (Fatigue), VACCINATION SITE SWELLING (Swelling - Near Injection Site), VACCINATION SITE PAIN (Arm Pain) and HEADACHE (Headache) in an 80-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.     Concurrent medical conditions included Hypertension.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced BLOOD PRESSURE INCREASED (Increased Blood Pressure), FATIGUE (Fatigue), VACCINATION SITE SWELLING (Swelling - Near Injection Site), VACCINATION SITE PAIN (Arm Pain), HEADACHE (Headache) and VACCINATION SITE ERYTHEMA (Redness - Near Injection Site). The patient was treated with PARACETAMOL (TYLENOL) on 29-Jan-2021 for Adverse event following immunisation, at an unspecified dose and frequency. On 04-Feb-2021, BLOOD PRESSURE INCREASED (Increased Blood Pressure), FATIGUE (Fatigue), VACCINATION SITE SWELLING (Swelling - Near Injection Site), VACCINATION SITE PAIN (Arm Pain), HEADACHE (Headache) and VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported using High blood pressure medications (not specified) concomitantly to manage Blood Pressure.
Skin cancer; received his 2nd dose today, 29Mar2021; A spontaneous report was received from a consumer concerning an 80-year old male patient, who received the first dose of the Moderna's COVID-19 vaccine (mRNA-1273) and experienced skin cancer and received his 2nd dose today, 29 Mar 2021.  The patient's medical history was not provided. Concomitant medications included atorvastatin, metoprolol for blood pressure and acetylsalicylic acid.  On 30 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Batch Number: 027L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 29 Mar 2021, the patient received the second of two planned doses of mRNA-1273 (Batch Number: 006B21A) intramuscularly for prophylaxis of COVID-19 infection.  On an unspecified date, after receiving vaccine, the patient was made aware of his skin cancer and had to get the stitches removed and had his surgical appointment o the day his second dose was scheduled.   Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of the event Skin cancer was unknown. The event received his 2nd dose today, 29Mar2021 was considered to be reslved on 29 Mar 2021.; Sender's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273, lot # 027L20A with no associated AEs. Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
This spontaneous report as received from a registered nurse, refers to a patient of unknown age and gender. Patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with one dose of VAQTA (dose, administration route, lot number and expiration date were not provided). No concomitant therapies were reported. The reporting Nurse stated that on an unspecified date the administered vaccine underwent a supported temperature excursion. No adverse effects were reported. This is one of several reports from the same patient. Additional information has been requested.
This spontaneous report as received from a physician refers to a 20 week old patient (gender unknown) who on 19-FEB-2013 was vaccinated with the first dose of ROTATEQ suspension (lot #, dose not reported). No adverse symptoms reported. Additional information has been requested.
Information has been received from a physician concerning a 2 year old male with an inability to develop immunity after exposure to disease or vaccination who on 1/28/2004 was vaccinated with th first dose of hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (lot 646074/0369N). On 3/26/2004 the patient was vaccinated with the second dose of hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (lot 646074/0369N). On 05/28/2004 the patient was vaccinated with the third dose of hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (lot 646446/0730N). It was reported that the child had not developed an immunity to Haemophilus influenza. The child had developed Haemophilus influenza meningitis in July 2004 and did not develop immunity even after that disease. the patient sough unspecified medical attention. The patient was hospitalized (dates unknown). The patient underwent serologic titers (date unknown). The physician believed that the child had a deficiency which prevented him from developing immunity. At the time of this report, the patient has not recovered from the event. The reporting physician considered the event to be serious (OMIC), due to hospitalization, immediately life threatening and disabling. additional information has been requested.
Initial information has been received from physician via field representative concerning a 2 months old male patient with an unspecified pertinent medical history or drug reactions/allergies. On an unknown date, the patient was vaccinated with oral ROTATEQ (lot number 0577AE exp date October 2013 (dose, frequency and route were not reported). No other co-suspect medications were reported. No concomitant medications were reported. On 11-FEB-2013 the patient experienced vomiting. No treatment was reported. No laboratory studies were reported. At the time of report, the patient had not recovered. The patient sought medical attention by telephone contact. This is one of several reports from the same source. Additional information has been requested.
MENACTRA booster shot 23 days early than intended with no adverse event; Initial information received on 09-Aug-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 19 years old male patient who experienced menactra booster shot 23 days early than intended with no adverse event while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (TET TOX) (MENQUADFI) for Prophylactic vaccination.  On an unknown date, the patient received a  0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (strength, formulation, lot number not reported)  via intramuscular route in unknown administration site for immunization.  On an unknown date the patient reported menactra booster shot 23 days early than intended with no adverse event (inappropriate schedule of product administration) (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Action taken: not applicable.   At time of reporting, the outcome was Unknown for the event inappropriate schedule of product administration.    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 the 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.
Lot number documented on administration record is for 5y-12y Pfizer/Biontech not 6mo-<5y Pfizer/Biontech.  No adverse effects were reported.
6pm vaccine 2am: woke to Difficulty Breathing, tightness of chest, thirsty, hallucination, rash on arm. about 12hr duration Patient slept most of the day, then began walking bit by bit until symptoms resolved
rashes all over the body; This is a spontaneous report from non-contactable consumer (reporter's husband) from a Pfizer sponsored program. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on 19May2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced rashes all over the body after first dose on an unspecified date in 2021. Reporter inquired how long will take to experience the reaction of the vaccine. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient had pain in the arm, going down towards elbows. Patient suffered from pain and took Tylenol, but it did not help much. When coming into the pharmacy and complaining of pain that lasted more than 2 weeks, he was advised to see the doctor. He was then diagnosed with inflamed rotator cuff which likely become worse due to the flu shot being given.  He will now undergo physical therapy.
Fever, chills, body aches, headache. Began approximately 6 hrs after injection. Took Ibuprofen until symptoms subsided. Symptoms lasted approximately 24 hrs.
Narrative: Pt was hospitalized for respiratory failure due to testing positive for COVID 8-13-21. Patient was vaccinated in a timely manner in Early and late February. Pt recovered from COVID infection and was discharged 8-16-21.
Vaccine administration error. Order Bexsero vaccine but influenza vaccine was given instead in error. Influenza vaccine had already been received this flu season.
Fully vaccinated patient passed away due to COVID-19 pneumonia. Received second Pfizer vaccine on 3.1.2021.
PATIENT IS EXPERIENCING TINGLING IN LEFT ARM STARTING DAY AFTER VACCINATION WAS GIVEN. SHE ALSO EXPERIENCES ARM SORENESS NEAR THE INJECTION SITE IF SHE PRESSES ON HER DELTOID MUSCLE WHERE THE VACCINATION WAS GIVEN. SHE IS SEEING AN ORTHOPEDIC DOCTOR THAT IS A FRIEND OF THE FAMILY AND HE IS MONITORING HER PROGRESS. PATIENT STATES THAT THE TINGLING IS NOT CONSTANT BUT COMES AND GOES. HER ARM ALSO FEELS SORE WHEN SHE LIFTS IT. PATIENT WILL KEEP PHARMACY UPDATED OF OUTCOME.
Fever 101.9, headache, dizziness, swelling while warm to touch at injection site right deltoid.
Had strep on the 15th of March On the 26th of March, was having issues swallowing, went to urgent care. Nothing was able to be figured out, follow up tests to come.
Patient developed SVT on January 31.  He presented to the ER and received two doses of adenosine to convert back to a normal sinus rhythm.
I have chronic left lower quadrant pain/inflammation due to prior abdominal surgeries. My doctors have told me it is scar tissue/adhesions.  I have flare ups periodically.  This has been going on for more than 15 years.  I have not had a major flare up in more than 2 years.   I received the second dose on 2.10.  I had mild flu like symptoms in the next 24 hrs.  On 2/16 I began to feel like I was going to have a flare up.  The pain progressed to constant.  It was the worst flare up of this left lower quadrant pain I have had in YEARS!   I had to call my MD and ask for pain medications.  I was nauseous as well.   The pain slowly began to subside and by 2/23 I was back to normal.   The ONLY thing different in my life has been the vaccine.
Fever and body aches starting approximately 11 hours after injection, lasting about 48 hours.
I am a 95lb adult.  My antibody test result taken five days prior to the booster shot was 2.39 index value. The booster shot Lot number might not be totally accurate as it was hard to decipher the handwriting. 12 hours after the booster shot I started having an intense headache to the point of becoming nauseous and everything turning black in front of my eyes, followed by a heavy sweating. It was all accompanied by a body ache and fever (37.3C). All the symptoms above lasted for exactly 24 hours, which was 36 hours from the shot. At that point I only felt light headed. Nearly 45 hours from the shot I noticed my memory was falling me. I take my weekly language tutoring and I could not conjugate the most comon verbs I have already mastered. That's when I noticed I haven't been able to really concentrate, I still felt light headed. Nearly 60 hours from the shot I started feeling the lymph node under my left arm bothering me and it lasted for nearly 40 hours and gradually disappeared.
PT WANTED TO GET HER HEP-B VACCINE BUT WAS ACCIDENTLY GIVEN JNJ COVID VACCINE. NO SIGNS/SYMPTOMS AT TIME GIVEN
Muscle aches starting at 8pm worsening over time, still present but mild 48 hours later. Fever starting approx 9pm lasting ~24 hours. Cold chills and sweating throughout night and day. Loss of sleep (approximately 2 hours of sleep obtained). Pain at injection site still present after 48 hours.  Weakness in legs and arms and occasional dizziness for ~24 hours. Confusion related to fatigue for ~24 hours. General fatigue and loss in appetite still present after 48 hours.
After second dose of Pfizer COVID-19 vaccine, patient started "feeling weird" and "washed over". Patient denied dyspnea, nausea, DM/hypoglycemia issues, known heart issues, swelling/itchiness, adverse event with first vaccine, and no adverse event to previous other vaccines. Patient had eaten lunch, but just come off of a shift and thought she might be dehydrated. Water was provided to the patient. Patient stated that she had intermittent lightheadedness/dizziness. Patient denied performance of vasovagal maneuver. Patient also experienced tachycardia and was clammy. Cool pack was provided to patient. Clinical course below:  1530 145/81, 105, 97%, 15 1535 119/81, 88, 96% 1540 126/75, 87, 96% 1542 pt felt another wave of lightheadedness, HR 103 1546 126/79, 90, 96% 1551 128/80, 91, 96% 1555 140/60, 79, 96% 1559 110/84, 87, 97% 1600 pt reports new scratchy throat 1602 25 mg Benadryl administered by RN 1603 discussed with Pharm D 1605 131/77 91, 97% 1611 145/79, 95, 98% Pt finished 12 oz of water and 4 oz of juice 1615 pt reports throat feeling better 1615 118/62, 69, 96% 1630 109/95, 99, 97% Pt stuck out tongue, no evidence of edema 1621 127/72, 84, 97%  At 1642, patient was discharged to family's care and taken home.
Developed small red itchy spots resembling chicken pox mostly on back few on front torso 5/15/06 despite getting varivax vaccine on 7/11/03. The pediatrician is treating him for chicken pox and prescribed hydroxyine for the itching and mupiro to keep from getting infected.  New spots continued to appear 4 days after. They were small with tiny tiny bubble. He is still recovering. Note teachers at his daycare noted that they were aware of chicken pox going around in other schools.
Swelling, erythema, induration noted 24 hrs after injection. KEFLEX 500mg BID, TAC ointment 0.1%.
Swollen arms & severe rash on arms and back and right hand has numbness & some numbness in left hand
Father reports that child was fussy the night of the injections.  He awoke at 9:00 am and had a temperature of 102 degrees rectal.  Previous immunizations at 2 and 4 months produced fevers of 100 degrees.  Child also vomited his formula and refused all food.  They were able to give him Pedialyte in the afternoon. Parents took him to his pediatrician for evaluation June 21 at 2:00 pm. They felt that his symptoms were related to the vaccines he received rather than any other cause.  He experienced some dime sized redness and hardness at one injection site on upper right thigh, otherwise sites were swollen and puffy. Today June 22 at 9:30am his temp was 100.2 degrees F rectal.  He has had four doses of ibuprofen in the past 24 hours.
Pediatric patient received vaccine from a vial that had been first punctured more than 12 hours ago; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pediatric patient received vaccine from a vial that had been first punctured more than 12 hours ago) in a 2-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1416B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pediatric patient received vaccine from a vial that had been first punctured more than 12 hours ago). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pediatric patient received vaccine from a vial that had been first punctured more than 12 hours ago) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jun-2022, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of the patient reported as 2.7 years.  No concomitant medications were reported. It was reported that, the clinic began administering Pediatric doses and accidentally administered left tight  a dose for 6month to 5 year old children more than 12 hours after the vial was first withdrawn. The vial was initially stored in the refrigerator on 21-Jun-2022 The vial was first punctured on 23-Jun-2022 at 2:00PM The date and time of administration of vaccine was 23-Jun-2022 9 patients between 2 PM and 5:30 PM and 24-Jun-2022 at 10:15 AM The vial did not undergo any temperature excursions. No treatment medications were provided.
Rash started on 3/5/01 on face and spread to trunk and legs. Had a fever for 4-5 days prior to rash. (104F tympanic-1 day prior to rash). Itching started on 3/6/01. Legs hurting.
approximately 20 years ago but did not complete the series/Patient has now come in and would like to complete the 3 dose series; No AE/PQC reported; This spontaneous report has been received from a healthcare professional and refers to a 44-year-old patient of unknown gender.  The patient's pertinent medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date (also reported as approximately 20 years ago), the patient was vaccinated with two doses of either hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, administered for prophylaxis (strength, lot #, expiry date, and anatomical site of administration were not provided) but did not complete the series and wanted to complete the 3-dose series (Inappropriate schedule of product administration). No other adverse events were reported.
began not feeling well two days aster receiving his second Pfizer COVID-19 vaccine. He had a 4 month decline in exercise tolerance, ending with fever, chills and URI.  On 8/26/2021  had a stroke, MI and was taken to Hospital Center after being found down at home by his family. was diagnose with bacterial endocarditis, stroke, MI, spleen mass and underwent open heart surgery on 9/1/2021 to replace his Mitral Valve and remove the bacterial endocarditis.  remains in the CV ICU at Hospital Center under the care of Dr. , expecting discharge to home this coming week.
Patient had allergic reaction at the site of injection. It was red & slightly swollen about 3 inches in total area.
I developed a small amount of dyshidrotic eczema on one hand after receiving the first dose of the Moderna COVID-19 vaccine. I had not had a flare-up in months so believe it was related to the vaccine as I did not make any other lifestyle changes and my eczema seems to flare up in relation to autoimmune response (among other reasons). The eczema went away after a few days. I did not develop any eczema after receiving the second dose of the vaccine. I also experienced fatigue and significant soreness of the right (injection) arm after my first dose, but that was all. Muscle soreness was significantly less after the second dose, although the second dose was administered to my left arm.