chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Beyond 36 days for second dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Beyond 36 days for second dose) 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 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Beyond 36 days for second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Beyond 36 days for second dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
pt recvd vax 1JUN94 & 01JUN94 pt exp an anaphylactic rxn,allergy to yeast & was hospitalized;reporter felt that the anaphylactic rxn was related to therapy w/hep B vax,recomb
Very fatigued, low grade fever, arm so sore it hurts to use, 1.5? raised red welt.
Information has been received from a registered nurse concerning a 16 year old female with allergic reaction to minocycline, and warts, who on 02-MAY-2008 was vaccinated with the first dose of GARDASIL, 0.5 milliliter, intramuscular. The patient had one or two warts at the time of vaccination. Concomitant therapy included MENACTRA and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. Since the first vaccination with GARDASIL, the patient developed 40 leg warts and she sought medical attention to a dermatologist for the wart removal. No exact time frame for the development of the warts was available. The mother of the patient did not want her daughter to receive the second dose of GARDASIL and the patient had not received the second dose at the time of the report. Additional information has been requested.
Incorrect product administered. Pt should had received bivalent however got monovalent. Pt tolereated injection well.
CLIENT STATES SHE FEELS LIKE A "LUMP IN HER THROAT". DENIES ANY TROUBLE BREATHING OR SWALLOWING. NO EDEMA OF LIPS, FACE OR TONGUE. RESP REG WITH EASE. SKIN PINK, WARM AND DRY. NO NOTED RASH OR HIVES. SYMPTOMS RESOLVED AFTER 10 MIN WITHOUT ANY TREATMENT.
(R) cheek w/2-3 mm vesicular lesion. (R) mid thigh area with a cluster of vesicles no d/c - appear to be varicella per MD. Nontender.
30min following receipt of flu vax pt exp dizziness w/nausea;blood glucose was 79;
received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination. No Medical History information was reported. On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date). On 11-Jun-2021, EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date) had resolved. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications information was reported. No treatment medications were provided. Date of Refrigeration is reported as 07 May 2021. 318 patients received dose from vials beyond 30-day use by date. This case was linked to MOD-2021-364566 (Patient Link).
First day: headache Second day: fatigue, pain at the injection site, nausea, muscle aches, joint aches Third day: fatigue, pain at the injection site decreased, increased nausea, increased joint aches, increased muscle aches, mild diarrhea, stuffy nose
The adult strength Comirnaty vaccine was given to a 9 yr old. There are no symptoms yet when speaking with the mother to advise her to watch for adverse reactions.
first dose of Shingrix 10 months ago / didn´t get the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose of Shingrix, 10 months prior to the reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follow: The age at vaccination was not applicable for this report. Till the time of reporting, patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter stated that, patient had not received the 2nd dose at the moment of call. The patient was called and was given information about right protocol to follow. The reporter consented to follow up.
Severe congestion immediately following booster, followed by allergy-like sneezing throughout the evening. Congestion and sinus discomfort continued until 12/21/2021. On 12/21/2021 in the morning, patient started to show possible herpes flair-up in her usual location. Just below her nose, but significantly more severe than usual and on both nostrils, halfway to her lip.
started off with itching- then redness and swelling at injection site. NOw more intense itching- will go and get benedryl OTC and cream and reck in 2 wks
headache; flu-like symptoms; injection site was very red; rash; itchy; very hot to the touch; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), INFLUENZA LIKE ILLNESS (flu-like symptoms), INJECTION SITE ERYTHEMA (injection site was very red), RASH (rash) and PRURITUS (itchy) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METFORMIN, AMLODIPINE, LISINOPRIL, TAMSULOSIN, LEVOTHYROXINE, FINASTERIDE, ATORVASTATIN and DOXYCYCLINE for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, 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 experienced HEADACHE (headache), INFLUENZA LIKE ILLNESS (flu-like symptoms), INJECTION SITE ERYTHEMA (injection site was very red), RASH (rash), PRURITUS (itchy) and INJECTION SITE WARMTH (very hot to the touch). At the time of the report, HEADACHE (headache), INFLUENZA LIKE ILLNESS (flu-like symptoms), INJECTION SITE ERYTHEMA (injection site was very red), RASH (rash), PRURITUS (itchy) and INJECTION SITE WARMTH (very hot to the touch) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided No Treatment information provided    This case was linked to MOD-2021-056440 (Patient Link).
Woke up on 5/2/21 with just a sore arm at vac site.  About 3 hours later, 9:30 a.m., I felt extreme fatigue setting in.  By 11 a.m. I was in bed with a fever of 101.2 and from 11 a.m. until 4:30, I could not stay awake and slept most of that period except for using the bathroom and drinking fluids.  Fever reduced in the evening to 100.4.  Very slight body ache and headache throughout the day, so the fever and fatigue were the biggest issues.    Today, 5/3/21, feel much better, but still have a fever--fluctuating between 99.3 to 99.8 this morning--it is actually going up, not down but I am not feeling any worse.
Seizure activity x 2 hospitalized given anti seizure medication.  Well child exam of 10/18/06 received from pediatrician.  Hospital record of 10/19-20/06 also received which reveals tonic/clonic seizure activity x2.  Tx'd with Ativan IM and IV as well as Cerebyx.  No further seizures during 1 night admission. Tmax=100'F.  Discharge dx: Seizure Disorder probably 2' to vaccine./pc
Right upper arm with 7 x 8 cm localized area warm with erythema. Tx: ice packs, BENADRYL 12.5mg/5mL 6mL po.
Shortness of breathe Hot Flashes Body Rashes Ears get hot  Face and eyes get very red for no reason Body begins to itch Night Sweats
Since around the 10th, not quite sure, but around that time, I have been feeling very, very tired and weak and slight headache.  It did not occur to me until about 1/2 hour ago that these feelings could be related to the 2/5 shot.  Not bad enough to go to the doctor,  just not feeling normal.  Blamed it on the lack of sun (SADS).  I have a special light that I just started to use 3 days ago. Therefore, I am now reporting my feelings.
After leaving examination room went to waiting room to wait for sibling. Daughter started moaning and slumped over on my shoulder and then started slipping out of chair and onto floor. When woke up a minute later was unaware of what happened. Nurses came to our aid and laid her on the floor, raised her legs, gave her a wet washcloth and some water. She stayed on the floor for about ten minutes before they would let her get up. She came home and had a headache the rest of the day.
EE here today regarding symptoms that occurred after getting the flu vaccine. She received the FLUBLOK vaccine in the left deltoid (Lot number QFAA1820 Manufacturer Sanofi Pasteur) at 7:44am on 11/30/18. That same day she began with forceful vomiting at 1:00pm. 45 minutes later she was vomiting again. The episodes of vomiting then were only 15 minutes apart until about 5pm she had to leave work. She continued intermittent vomiting on 12/1, 12/2, 12/3, and 12/4. On 12/5 the vomiting stopped but she began having severe diarrhea. On that day she had 6-8 episodes. Since 12/4 she has also been experiencing feeling extremely cold but then breaking out in a sweat at intermittent times. She tried taking PEPTO BISMOL since the vomiting began but could not keep anything down. She is still trying to take it as the vomiting has subsided. She states her throat is very raw from the vomiting causing her to cough a lot and she is having to use her inhaler more often. Per EE she had a written note from her doctor that she should not have the flu vaccine as 15 years ago she stopped taking them due to these symptoms. Per EE she was told by someone that she could not do a medical exemption unless it had to to do with Guillian Barre. She did not complete a medical exemption form and turn it in. She had no illness or virus before receiving the flu vaccination. She stated she missed 2 and a half days of work due to her symptoms.
but felt hotter; tested positive for covid (Developed a sore throat/ fever of 98.8/ cough/ thought it was a cold); This spontaneous case was reported by a patient and describes the occurrence of FEELING HOT (but felt hotter) and COVID-19 (tested positive for covid (Developed a sore throat/ fever of 98.8/ cough/ thought it was a cold)) in a 57-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 013H22A) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: JANSSEN COVID-19 VACCINE (Dose Number: 1 Lot number: 1805025) on 12-Mar-2021. Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE.    On 10-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Nov-2022, the patient experienced FEELING HOT (but felt hotter) and COVID-19 (tested positive for covid (Developed a sore throat/ fever of 98.8/ cough/ thought it was a cold)). At the time of the report, FEELING HOT (but felt hotter) and COVID-19 (tested positive for covid (Developed a sore throat/ fever of 98.8/ cough/ thought it was a cold)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Nov-2022, Body temperature: 98.8, but felt hotter than that. On 15-Nov-2022, SARS-CoV-2 test: Positive.         No concomitant medications were reported. The patient received Moderna Booster 1 with dose of 0.25 ml (Lot number: 037C21A) on an unknow date. On 23-Mar-2022, the patient received Moderna Booster 2 (Lot number: 056A22A).   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-Nov-2022: Follow-up contains no new information.
Chills started Saturday evening around 8:30 pm  and continued until early Monday morning 1:00am Slept on & off the entire time Fever started around 3:00am and continued till around 9:30 am. Woke with severly chapped lips, wet and extremely week.  Bad headache &  sensitve to light  and noise mostly all day Sunday body aches and fatigued starting to fade today Tuesday, May 4th
arm pain; chills; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (arm pain) and CHILLS (chills) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, 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 experienced PAIN IN EXTREMITY (arm pain) and CHILLS (chills). At the time of the report, PAIN IN EXTREMITY (arm pain) and CHILLS (chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had arm pain and slight chills after first and second dose.  Concomitant product use was not provided by reporter.  Patient took booster dose on 02-Nov-2021, lot number 014F21A and site was left arm.   This case was linked to MOD-2021-403254, MOD-2021-403028 (Patient Link).
Patient deceased on 5/4/21 - learned of this on 8/23/21 and filed report.  Unknown cause of death.
Generalized urticarial rash to arms, legs, face & swelling to face. No respiratory distress. DECADRON 5mg IM given ORAPRED & BENADRYL rx given. Pt parents instructed to call back if not better in am. Pt's parents also instructed to return to ER or call 911 if airway constriction occurs.
Dose administered beyond 12 hours after first vial puncture; We had an excursion where product was administered 30 hours after the vial was punctured. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered beyond 12 hours after first vial puncture) and PRODUCT STORAGE ERROR (We had an excursion where product was administered 30 hours after the vial was punctured.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L218) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2022 at 5:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2022 at 5:00 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered beyond 12 hours after first vial puncture) and PRODUCT STORAGE ERROR (We had an excursion where product was administered 30 hours after the vial was punctured.). On 20-Jan-2022 at 5:00 PM, EXPIRED PRODUCT ADMINISTERED (Dose administered beyond 12 hours after first vial puncture) and PRODUCT STORAGE ERROR (We had an excursion where product was administered 30 hours after the vial was punctured.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications are provided. No treatment medications are provided.  Reporter stated that the Moderna vial was taken out of the freezer and placed in the refrigerator on 18-JAN-2022. The vial was punctured on 19-JAN-2022 at 11:00 AM and the last dose was administered on 20-JAN-2022 at 5:00 PM. The punctured vial remained in the fridge.
Within about 5 minutes of patient of patient receiving the vaccine, he had a seizure in the lobby of the pharmacy. The seizure was not witnessed by any employee, but by his companion and a customer. I immediately had a technician call 911 and ran out with our emergency kit when I heard the patient's companion screaming for help. When I got to the patient he was in a seated position in a chair in the lobby and was coming to.  He was disoriented and looking around. I asked if he knew his name and what day it was, he did know. I asked if he knew where he was and he responded correctly. He said he felt week and hot, he appeared sweaty. I checked his blood pressure (100/58) and pulse (50 bpm). His temperature was 97.1. His companion stated he had never had a seizure before when asked. I gave him some water and sat with him until EMS arrived. He remained seated the entire time and said he felt week. A few minutes after EMS arrived, the patient left via stretcher by ambulance, but remained conscience.
Crying, irritable for several hours in the evening after shots given that day. Thought I'd call the doctor to see if reaction was normal. Autism Spectrum Disorder dx'd in 6/00. Showed slowing in speech development, motor skills all after vaccinations.
Pt had bad headache, dry heaves, lightheaded, strange eye movements & visual changes. Ears felt like they were bleeding. Seizure x2, hands shakes, very sick feeling.
Reports low grade fever which began about 4 hrs after receiving the injection on 1/14/2021.  Fever reached a tmax of 103.6.  Tylenol taken with good effect.  Temperature resolved at time of reporting (1/19/2021).  Also experiencing extreme fatigue which started at the same time as the fever.
On day two I was extremely achy. On day three I threw up all night, since then I have had digestive discomfort. Yesterday, 5/4/2021 I went to urgent care and was diagnosed with diverticulitis
pt recvd vax & an allergic react (rash, itching, redness of ears & neck) 15 mins p/each dose; react lasted 30 mins on each occasion;
arm hurt; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included COVID-19 VACCINE UNKNOWN with an associated reaction of pain in extremity (received in 6 months ago from the date of reporting) and shingles vaccine (received on an unknown date).   On 26th August 2021, the patient received the 1st dose of Shingrix. On 26th August 2021, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had the older one 12 years ago from the date of reporting and just got the new one Thursday on the date of reporting. The arm hurt more on the Shingrix. No contact details were reported.
A burning sensation as it went in/ got the second one and it burns; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE: solution for injection), via an unspecified route of administration on an unspecified date in 2021 (Batch/Lot number was not reported) as single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE: solution for injection), via an unspecified route of administration on about 3 and half weeks ago in 2021 (Batch/Lot number was not reported) as single for covid-19 immunization and patient was fine. Patient stated that she got the Pfizer COVID-19 vaccine a month ago. She said the first shot was fine but with the second one, she felt a burning sensation as it went in on an unspecified date in 2021. She wanted to know if the first and second dose of the vaccine are exactly the same and if not, what could have caused the burning sensation and she told her experience with each of the doses. Everything was set-up during her first dose appointment. During her second dose, the lady was running back and forth with the vaccine and it kind of struck her for being odd. She thinks something must've screwed up that's why she felt the burning sensation. Patient also stated she got the first Pfizer vaccine about 3 and half weeks ago, didn't feel the same, got the second one and it burns as it went in and she wanted to know what was the difference between the first and the second and what could have caused that. The outcome of the event was unknown.  No follow-up attempts are possible; Information about Lot/batch number cannot been obtained.