chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderma COVID-19 vaccine EUA Continued symptoms of red itchy big toes from first dose. fatigue, fever 101.5 which lasted 32 hours, nausea, diarrhea, chills, body aches, joint aches, lasted 24 hours. headache  Red, itchy, swelling on shoulder and arm at injection site 5"x3" giant hive. feet, hands, and thighs have red itchy bumps and more are popping up each hour.
Adult Dose 0.5 Moderna given 4 days past the Do not use beyond Date of 1-27-2023. Given Jan 31, 2023 No adverse reaction
tightening on his chest; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the parent.  A 30 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 29 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHEST DISCOMFORT (non-serious) with onset 2021, outcome "recovering", described as "tightening on his chest".  Additional Information: caller reported that his son received the Pfizer Covid 19 vaccine and shortly after getting the 1st dose he had tightening in his chest. His son after getting the first dose of the vaccine of the Pfizer COVID Vaccine experienced tightening with his chest or tightening of his chest.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
My siatica flared up on its own but has not gone away as it typically does. Jt occurred 12hr after the vaccine  Typically it goes away but i still feel the leg numbness and my eife confirmed three werks later anf my left glut is swollen
03/15/2023 I started having a headache, pain behind the eyes, nasal discharge. After reaching out to the doctor it was confirmed I had Sinus infection. I was prescribed 17 days of levofloxacin. Symptoms lasted 2 weeks.
pt recv vax 21JUL95 & 21MAR97 & pt devel a mild case of chickenpox consisting of 35-40 pox;tx w/DPH, calamine & APAP;
Area of redness & warmth just below Kinrix injection site. It got bigger over the course of the day on 6/9. Mom went to the ER that night & patient was given benadryl, which helped.
Patient received this vaccine when it was intended for her husband, resulting in an unnecessary vaccine in a series that she had already completed.
About six months after the vaccine, I noticed I had a bug bite looking bump on my forehead. It was itchy and then it spread up my forehead, to my hairline and on my right forearm. It was red itchy patches of the rash. It spread on my navel and onto my legs. They were red bumps that were itchy and raised. I saw a nurse practitioner and they diagnosed as it an allergic reaction to something. They prescribed me a topical steroid cream, but they did not go away. After I went again, they gave me an oral steroid and it went away.
This spontaneous report was received from a registered nurse refers to a patient of unknown gender and age. Information regarding the patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 25-MAY-2016, the patient was vaccinated with an expired dose of VAQTA (lot # J014584, expired dose: 16-JAN-2016). No symptoms were reported. Additional information has been requested.
Had really sore left arm right after injection of moderna vaccine. Severe soreness lasted the first day and the whole night. But felt better the next day, and by third day, arm felt fine.  However, seven days after moderna vaccine injection, developed swelling, hardness, redness, hot to the touch, itchiness, at injection site. Hurt to raise left arm up high, left arm feels really stiff when trying to raise it.
Sickness; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness) and CHILLS (Chills) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In February 2021, the patient experienced ILLNESS (Sickness) and CHILLS (Chills). At the time of the report, ILLNESS (Sickness) and CHILLS (Chills) outcome was unknown.     No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medications were reported.
Dizzy shortly after vaccine, developed pruritis Left arm and Left Lateral thorax 24-48 hrs after along with abdominal discomfort, one episode of vomiting, one bout of diarrhea.
Patient was vaccinated on 4/18/2022 with a beyond used date Pfizer vaccine. Pfizer clinical team was consulted and they could not confirm the viability of the beyond used date product. Patient was informed on 5-6-22 about the error and was advised and he got re-vaccinated with Pfizer#4  on 5-8-2022. Patient did not report any adverse events.
I had my vaccination on 11/28/2022. In 12/2022 I started to experience swelling and puffiness on the left side of my face. The evening before I had had a different kind of headache that woke me at 430am. I noticed the left side of my face was swollen. I have a history of 3rd Occipital nerve injury due to a car accident. I went to urgent care and was prescribed amoxicillin. If it was to get worse in intensity I was told to go to the emergency room. The intensity stayed the same for a couple of days and started to resolve. It was a different kind of ache in my head and left temporal area. I have a follow up appointment 02/28/2023.
Information has been received from a physician, concerning a white female student (age not reported), with no pertinent medical history, who on 23-NOV-2007 was vaccinated with the first dose, and on 26-JAN-2008 was vaccinated, IM, with the second dose of GARDASIL (lot #659653/1448U). The physician noted that on 06-NOV-2007, the patient had been vaccinated with a dose of HAVRIX and a dose of MENACTRA. There was no illness at the time of vaccination. On 02-FEB-2008 the patient experienced paresthesias of both feet and up her legs, with some weakness, that continued through the month. On 26-FEB-2008 she experienced "pins and needles" of her arms and shoulders. The patient visited the physician, and on an unknown date, diagnostic testing included a magnetic resonance imaging (MRI) of the head and spine, a complete blood count (CBC), blood chemistries and a thyroid panel, all with normal results. At the time of this report, the outcome of the events was not recovered. The physician considered the events to be serious as disabling or incapacitating. Additional information has been requested. 6/3/08-records received-seen on 2/6/08 with C/O chronic back pain (pine and needles) both legs, hip and ankle. Trouble sleeping. Began on Monday. Feels unbalanced when standing. Urinary incontinence. PE Babinski decreased on right. Unable to stand on tiptoes. Romberg wobbly. Reflexes normal. Sensation in left toe dull. 4/30/08 symptoms continue but improving now intermittent. Neurologist: post viral syndrome. Flu vaccine administered in November along with  Gardasil. Meningitis vaccine in November.
Fatigue, headache, fever (100+ degrees F), body aches, shortness of breath/ heaviness in chest, elevated heart rate (20+ BPM above normal), anxiety.
Vulvar aphthous ulcers- resolved within 10 days.  Initially accompanied by fever, chills, myalgia, headache.
I EXPERIENCED "COVID ARM".  SYPTOMS BEGAN 6 DAYS AFTER INITIAL INJECTION. EXPERIENCED CHILLS. INJECTION SITE WAS RED , ITCHING, SWOLLEN AND HOT TO THE TOUCH. I SAW THE OCCUPATIONAL HEALTH NURSE AND DOCTOR ON FRIDAY 3/5/2021
15DEC AM aching in arms & legs, fever 9no temp taken), flu-like sx;15DEC glands in neck began swelling, throat feels like it is closing up;
COVID vaccine breakthrough case. Moderna 2/5/21 010M20A, 3/4/21 010M20A, and boosted 1/12/22 028K21A
Patient recieved first dose on 12-Aug-2021 and Second dose on 7-Oct-2021 beyond a month duration; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient recieved first dose on 12-Aug-2021 and Second dose on 7-Oct-2021 beyond a month duration) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A and 037C21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Metformin allergy).   On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 07-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient recieved first dose on 12-Aug-2021 and Second dose on 7-Oct-2021 beyond a month duration). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient recieved first dose on 12-Aug-2021 and Second dose on 7-Oct-2021 beyond a month duration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  Weight of the patient was given as 139 (No units provided).   Patient not had acute illnesses at the time of vaccination and up to one month before.  Race reported as private.  No treatment medications were reported   This case was linked to MOD-2022-546709 (Patient Link).
Dose 2 was inadvertently administered 31 days after Dose 1, instead of the recommended 2 month interval.  No adverse reactions reported.  GSK did not have information on consequences of administering early.
Dizziness, Arthralgia & NauseaVomiting  Narrative:
Area had itching and then became a large circular  raised area approx 2.5 in
Information has been received from a registered nurse concerning a 5-year-old female, who in approximately April or May 2007 at 10:30 AM, was vaccinated IM with a 0.5mL dose of hepatitis A vaccine (inactive). Concomitant vaccinations included a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process) (MSD), and a dose of diphtheria toxoid (+) Hib conj vaccine (unspecified) (+) pertussis  vaccine (unspecified) (+) tetanus toxoid and a dose of poliovirus vaccine (unknown) (IPOL). At 3:00 PM, the same day of vaccination, the patients' mother called and reported facial swelling. Unspecified medical attention was sought. Subsequently the patient recovered. No product quality complaint was involved. This information is one of several reports from the same source. Additional information has been requested.
no adverse event; The expiration date of the vaccine was on 12 Feb 2023 and the date of administration of the 6 doses was on 09 Mar 2023.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The expiration date of the vaccine was on 12 Feb 2023 and the date of administration of the 6 doses was on 09 Mar 2023.) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (The expiration date of the vaccine was on 12 Feb 2023 and the date of administration of the 6 doses was on 09 Mar 2023.). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The expiration date of the vaccine was on 12 Feb 2023 and the date of administration of the 6 doses was on 09 Mar 2023.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (The expiration date of the vaccine was on 12 Feb 2023 and the date of administration of the 6 doses was on 09 Mar 2023.).    No concomitant medications were reported. No patients had reported adverse event. No treatment details were reported. This case was reported for Patient 1 out of 6 patients reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-719560, US-MODERNATX, INC.-MOD-2023-719564, US-MODERNATX, INC.-MOD-2023-719565, US-MODERNATX, INC.-MOD-2023-719566, US-MODERNATX, INC.-MOD-2023-719567 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-719567:Patient 6 of 6 US-MODERNATX, INC.-MOD-2023-719560:Patient 2 of 6 US-MODERNATX, INC.-MOD-2023-719565:Patient 4 of 6 US-MODERNATX, INC.-MOD-2023-719566:Patient 5 of 6 US-MODERNATX, INC.-MOD-2023-719564:Patient 3 of 6
This spontaneous report was received from a registered nurse referring to a 4 year old patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On an unknown date, also reported as age 1 year old, the patient was vaccinated with the first dose of VARIVAX for prophylaxis (strength, dose, route, lot # and expiration date were not reported). Then, on an unspecified date, also reported as at 2 year old, the patient received the second dose of VARIVAX. subsequently, on 06-DEC-2017, also reported as at 4 year old, an extra dose of PROQUAD lot # reported as N020619, expiration date on 22-JAN-2019, for prophylaxis (strength, dose and route of administration were not reported) was given to the patient. No adverse effects were reported.
Felt like she was going to pass out; Had tightness in her chest; Sweating profusely; Could not walk; Felt very weak; Freezing; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating profusely), GAIT INABILITY (Could not walk), ASTHENIA (Felt very weak), FEELING COLD (Freezing) and FEELING ABNORMAL (Felt like she was going to pass out) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 06-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced HYPERHIDROSIS (Sweating profusely), GAIT INABILITY (Could not walk), ASTHENIA (Felt very weak) and FEELING COLD (Freezing). On an unknown date, the patient experienced FEELING ABNORMAL (Felt like she was going to pass out) and CHEST DISCOMFORT (Had tightness in her chest). The patient was treated with SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) for Urinary tract disorder prophylaxis, at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (Sweating profusely), GAIT INABILITY (Could not walk), ASTHENIA (Felt very weak), FEELING COLD (Freezing), FEELING ABNORMAL (Felt like she was going to pass out) and CHEST DISCOMFORT (Had tightness in her chest) outcome was unknown.            No Concomitant medications were provided
DIZZINESS; HEADACHE; NAUSEA; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 2021, the subject experienced dizziness. On 2021, the subject experienced headache. On 2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient was recovering from headache, nausea, and dizziness. This report was non-serious.
vial was initially stored in the refrigerator on 30Jun2022 and administration of vaccine on AUG-2022; No Adverse reaction; I used Moderna Covid-19 vaccine last week beyond its use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (I used Moderna Covid-19 vaccine last week beyond its use by date), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 30Jun2022 and administration of vaccine on AUG-2022) and NO ADVERSE EVENT (No Adverse reaction) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 05-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (I used Moderna Covid-19 vaccine last week beyond its use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 30Jun2022 and administration of vaccine on AUG-2022) and NO ADVERSE EVENT (No Adverse reaction). At the time of the report, EXPIRED PRODUCT ADMINISTERED (I used Moderna Covid-19 vaccine last week beyond its use by date), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 30Jun2022 and administration of vaccine on AUG-2022) and NO ADVERSE EVENT (No Adverse reaction) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse reaction) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (I used Moderna Covid-19 vaccine last week beyond its use by date) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 30Jun2022 and administration of vaccine on AUG-2022).    Concomitant product use was not provided by the reporter. Treatment information was not provided.
Vesicular rash on hand, anus and face (5 pox) 14 days after the vaccine. No fever. Irritability.
J96.00 ACUTE RESPIRATORY FAILURE 4/3/2023 ACUTE RESPIRATORY FAILURE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/25/2023 ACUTE RESPIRATORY FAILURE J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 5/3/2023 ACUTE RESPIRATORY FAILURE J96.00 ACUTE RESPIRATORY FAILURE 4/3/2023 ATRIAL FIBRILLATION, UNSPECIFIED J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/25/2023 ATRIAL FIBRILLATION, UNSPECIFIED J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 5/3/2023 ATRIAL FIBRILLATION, UNSPECIFIED
Case number PHEH203US018749, is an initial spontaneous report received from a healthcare professional on 04 SEP 2013. This report refers to a female patient of unspecified age. She received only MEN C Y W-135 liquid conjugate component of MENVEO (batch number: not reported), without being reconstituted with MEN A lyophilized conjugate vaccine component on an unspecified date. No adverse event was reported following this administration error.
Case number PHEH2014US000818 is an initial spontaneous report received from a pharmacist on 07 Jan 2014. This report refers to an adult male patient. On 07 Jun 2014, he was vaccinated with one dose of FLUVIRIN (batch number: not reported) intramuscularly, from a pre filled syringe which reached at a temperature of 34 F for the first time excursion. This pre filled syringe was placed in the refrigerator at a temperature of 38 F, since discovery of the temperature excursion. No adverse event was reported following this administration error.
pt recv vax 5AUG96 & got dizzy;pt devel bradycardia;pt never lost consciousness;pulse rate ranged from 50 to 69;no tx was given;
patient stated that around 24 hours after the shot she got a fever and it lasted 3 days then on day 4 after the shot she felt a lot of pressure on her chest that lasted about 1 day then 3 or 4 days later she broke out in rash/sores on her face, chest and arms and some sores are still present
he has a hard time being awake for the past few days after the first shot/sleepiness/drowsiness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 84 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 05May2021 14:00 (Lot number: ER8732) at the age of 84 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: SOMNOLENCE (non-serious) with onset 11May2021, outcome "not recovered", described as "he has a hard time being awake for the past few days after the first shot/sleepiness/drowsiness". Therapeutic measures were not taken as a result of somnolence.  Additional information: Reporter wanting to know if sleepiness/drowsiness is considered an adverse event after getting his first shot of Pfizer BioNTech Covid-19 Vaccine (05May2021). He claimed that he has a hard time being awake for the past few days after the first shot. Lady stated she has a patient on the line, (withheld). Stated the caller had the first dose of the Pfizer Covid Vaccine on 5May2021, and he was calling to report his experience that he feels sleepiness and drowsiness, and this is not his normal routine. Reporter confirmed his name, contact information and reason for call. He stated he was also calling to see if the sleepiness and drowsiness was in alignment with previous studies. Caller stated he has looked over the fact sheet and, on the computer, and he saw 2 indications where drowsiness was associated with it, but not enough information to see if it is tied in, so he wanted to see if there are any other reports of this. Caller stated he has some medical background, but he was not qualified in the medical atmosphere to make an assessment of his condition. Stopped from taking the flu vaccination years ago. One side of tongue swelled up, no difficulty breather. At the time heavy drinker and asthmatic, combined health condition at the time was not conducive. NDC, Lot, Expiration Unknown.   No follow-up attempts are possible. No further information is expected.