chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Increased heart rate; Itching at injection site; Dots at injection site; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Increased heart rate), INJECTION SITE PRURITUS (Itching at injection site) and VACCINATION SITE REACTION (Dots at injection site) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included Tachycardia (200 beats per minute 3-4 times a year).    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced HEART RATE INCREASED (Increased heart rate), INJECTION SITE PRURITUS (Itching at injection site) and VACCINATION SITE REACTION (Dots at injection site). On 28-Jan-2021, HEART RATE INCREASED (Increased heart rate) outcome was unknown. At the time of the report, INJECTION SITE PRURITUS (Itching at injection site) and VACCINATION SITE REACTION (Dots at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medication and treatment provided; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Mom states pt woke this AM w/arms swollen & purple below inject site w/lt arm worse than rt. Hands cold bilateral.  No fever, swelling & color seemed to dec p/ extrem held up.
This spontaneous report was received from a physician via Pfizer refers to a female patient of unknown age. The patient's concurrent condition, concomitant medications, medical history, past drugs, allergies and reactions were not reported. On an unknown date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) for prophylaxis (dosage schedule was not reported). On an unknown date, the patient experienced drug allergy to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) (drug hypersensitivity). The drug allergy reaction was reported as kidney transplant (renal transplant) and mmunosuppression. The reporter considered renal transplant, drug hypersensitivity and immunosuppression to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown). Upon internal review, the event immunosuppression and renal transplant was considered to be medically significant. This is one of the two reports.
Immediately after the injection I felt light headed. Soon I could not see (very blurry vision) and I could not hear (like drowning in water). I then started to sweat profusely from every inch of my skin. I couldn?t catch my breath. I was handed water and told to sip on it, which proved difficult when my throat started to feel like it was swelling up. After about a 15 minute ordeal, it was like nothing ever happened. The only symptom that remained, was sweat soaked clothes
Extra dose of Polio Vaccine was given by mistake, mom was contact and aware. No symptoms or contraindications
Moderna Primary; Pfizer Booster 12mins post vaccination pt reported that she was feeling like her throat is swelling.  No Wheezing, pt is able to talk. Pt given 50mg PO Benadryl @ 10:59. Vitals: @11:05 152/97, 74, 20, 100% --? 130/90, 63 Pt stable and released from the vaccination site.  Recommended pt f/u w/ PCP.
Patient came to pharmacy for her 3rd dose Moderna as she  is immunocompromised patient. Instead of  Moderna  ,patient was given Pfizer as 3rd dose. patient has no adverse reactions as of now other than injection site pain.. we will follow up with  patient.
I am experiencing extreme abdominal pains during my menstrual cycle since getting vaccinated. I've never experienced this level of pain before. During each cycle, the pain has occurred for about 3 hours and then stops. During the time, it feels like I am being stabbed. The first time it occurred the pain was paired with diarrhea and the second time it occurred the pain was paired with vomiting.
Felt dizzy, laid back on exam chair and had upper body convulsions for about 10 seconds
Local Pox 3-4 lesions with cellulitic area on (L) thigh. Topical warm compress and PO Augmentin.
Severe redness and itchy  on upper left arm  from under vaccination site down to elbow  all over top and sides  of arm and pain when moving arm.to full length position.
felt a bit headache and flu-ish for 3 days after vaccine, but not horrible.  On the fifth night after the vaccine, I had wheezing in my chest, my tongue swelled up, had huge sub-lingual swelling, right eye swelled up and couldn't breathe well.  Took a ton of Benadryl and went to the urgent care the following morning where they diagnosed me with anaphylaxis and gave me more antihistimes and steroids, a five day dose of steroids and prescription for an epi pen.  Have not felt super well since the anphaylaxis and been to allergists, hematologists, naturopath, etc.  Still struggling now which is why I write to you.  Would love to know why and how to fix.
Mom reports 24hrs post vax baby developed fever 104, diarrhea & vomiting MD saw baby that day & dx ear infect & pneumonia; Rechecked by MD 1 wk later & was recovered fr pneumonia; Diarrhea persisted for 2 wks; Mom denies sz or other sx;
I get severe headaches, my body has lost energy, I felt that my leg, arm and hand muscles were weakened, along with the feeling of numbness on my right eye spasms all the time and I cannot see clearly. My vision is blurry and cloudy, strong ringing sounds in my right ear, gradually I felt that my tongue lost sensitivity to feel the food making it harder to chew as well as loss of taste. I felt that my tongue got difficult to move, I started to make noises with my mouth. Now I have terrible migraines daily and a dramatic decrease with alertness and energy.
17 years old and received the 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old and received the 1st dose) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Medical History information was reported.).    On 22-Apr-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old and received the 1st dose). On 22-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old and received the 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the patient was turning 18 years about 1.5 months from his first dose.  And also reported that the patient had No Known Drug Allergies (NKDA)  Concomitant medication were not provided by the reporter. Treatment medication were not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow-up information received on 21-JUN-2021 contains No Significant information
This spontaneous report as received from a consumer via Clinic refers to a currently 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 20-APR-2017, the patient was vaccinated with improperly stored dose of M-M-R II, recombinant human albumin (rHA) 1 dose unit (lot # M008589, Expiry date was not reported) for prophylaxis (product storage error). There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA000166:
Information has been received from a female who on an unspecified date was vaccinated with a dose GARDASIL. After receiving GARDASIL, the patient "got a pain" in her arm. The outcome of the patient was not reported. The patient did not seek medical attention. No further information is available.
1st dose Oct2018, 2nd May2019; Shingrix to prevent Chickenpox; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In May 2019, the patient received the 2nd dose of Shingrix. In October 2018, the patient received the 1st dose of Shingrix. In October 2018, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced off label use. In May 2019, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long and off label use were unknown.   Additional Information: GSK Receipt Date: 02-NOV-2022 Reporter's comment: The patient self-reported this case. The patient received her first dose of Shingrix in October 2018 and her second dose in May of 2019. The patient stated that she had never had chickenpox and her doctor confirmed this with lab work.  The patient also stated that her doctor gave her the first dose of Shingrix to prevent chickenpox and she received the second dose at a pharmacy. The reporter did not consent to follow-up. Additional Supportive Information: The patient also stated that her doctor gave her the first dose of Shingrix to prevent chickenpox, which led to off label use. The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule.
At approximately 9PM, 2 days after recieving my vaccine, I started experiencing muscle soreness in the arms and shoulders. The soreness worsened so I decided to lay down and sleep it off. While laying in bed the pain spread to my neck, jaw and teeth. After about 3 hours most of the pain subsided but was left with chest, neck, and left arm pain. I checked my heart rate on my smart watch and it was 144 BPM. It was at this point I drove myself to the emergency room and was admitted into the hospital.  Patient Discharge Summary: The patient is a 23 year old male who presented to the emergency department with four hours of chest pain after receiving COVID-19 vaccinationapproximately 48 hours prior to that. He was found to have tachycardia and STdepression of the lateral leads. Tachycardia and chest pain resolved withlabetalol and the patient was admitted for observation on telemetry. Over 48 hours on telemetry, he remained in normal sinus rhythm with heart ratesranging 60-100bpm. He did not complain of any additional chest pain whileadmitted to the hospital. He underwent daily electrocardiograms that revealedsome signs suggestive of pericarditis, however he remained without symptoms toindicate need for treatment and resolved on ECG the morning of discharge. Heremained without chest pain or palpitations.Troponins (cardiac enzymes) collected on admission and on repeat were normal. Heunderwent a coronary artery calcium scoring, which revealed a score of 0 with lowrisk of acute coronary syndrome. Finally his transthoracic cardiac echocardiogramrevealed normal cardiac function.  Overall workup suggestive of a post-viral picture in setting of recent COVID vaccine.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. The patients medical history, concurrent condition, drug allergies and concomitant medications were not reported. On unknown dates the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (Lot # M039642, Expiry date : 03-JUL-2019) (Strength, dose and route of administration were not reported) for prophylaxis, which experienced a temperature excursion between 47° Fahrenheit to 77° Fahrenheit for 30 minutes. It was unknown if there was previous temperature excursions. Data logger was not involved. There was no product quality complaint involved. No adverse effects were reported (incorrect product storage and no adverse event). This is 1 of 4 reports from the same reporter.; Sender's Comments:  US-009507513-1707USA008614:
Sore, redness approx. 3 inch/dia,  still quiet large on 09/18/2016.
PT reports redness and itching of left upper arm approx 24 hrs post Anthrax vax #2. Denies fever, chills, or systemic Sx's. Advised to use cool compress and avoid scratching - and to return to clinic as needed.
Patient describes a lump under left armpit three days following her Moderna booster vaccine. She states the lump became enlarged and tender and after two days it went away. No other s/s stated by patient.
pt  recv vax 21OCT96 & that same day pt devel 10-15 spots on the torso;
Exposure during Pregnancy; Morning sickness all day; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Exposure during Pregnancy) and MORNING SICKNESS (Morning sickness all day) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 031AZ1A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DOXYLAMINE SUCCINATE, PYRIDOXINE HYDROCHLORIDE (DICLEGIS) for Morning sickness, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and VITAMIN B12 [VITAMIN B12 NOS] for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021 at 2:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 11-Feb-2021 and the estimated date of delivery was 18-Nov-2021. In April 2021, the patient experienced MORNING SICKNESS (Morning sickness all day). On 22-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPOSURE DURING PREGNANCY (Exposure during Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  tenth week of the pregnancy.  On 22-Apr-2021, EXPOSURE DURING PREGNANCY (Exposure during Pregnancy) had resolved. At the time of the report, MORNING SICKNESS (Morning sickness all day) outcome was unknown. Not Provided          Patient described she had a history of having morning sickness with previous pregnancy which lasted up until birth. Action taken with mRNA 1273 in response to the Events is not applicable. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: NNI
This spontaneous report was received from a registered nurse and refers to an unspecified adult patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patient was inadvertently administered doses of pediatric hepatitis b vaccine (recombinant)manufacturer unknown (dose, frequency, site of administration, route of administration, lot# and expiration date were not specified) for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved.
Swelling at the site that was about 2.5 inches in diameter; A spontaneous report was received from a consumer, concerning herself, a female patient of unspecified age, who received Moderna's COVID-19 vaccine (mRNA-1273) and developed swelling at the site that was about 2.5 inches in diameter.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 31-Dec-2020, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (lot number unknown) intramuscularly for prophylaxis of COVID-19.  On an unknown date, the patient stated that, still she has swelling at the site that was about 2.5 inches in diameter and does not have any pain. No treatment information provided.   Action taken with mRNA-1273 in response to the event were not reported.   The outcome for the event, swelling at the site that was about 2.5 inches in diameter was considered not resolved at the time of this report.; Reporter's Comments: A spontaneous report concerns a female patient of unspecified age, who developed swelling at the site that was about 2.5 inches in diameter. The event occurred on an unknown day day after the administration of the first dose of the mRNA-1273 vaccine (Lot #: unknown, expiration date-unknown). Based on the information provided, which indicates the location of the swelling at the site of administration of mRNA-1273 vaccine, a causal association cannot be excluded. Swelling at the injection site is consistent with the known safety profile of mRNA-1273 vaccine.
Patient stated he started feeling bad the day after the vaccine and his Left Big Toe at the tip (toe nail area) became numb.  He stated it has not resolved.
Kawasaki Disease: patient is a 2mo F who presented to the Hospital with 7 days of fever, diarrhea, rash, and decreasing PO(fevers started on 3/28, and was admitted on 4/3). Initially required a modified sepsis workup with blood culture and urine culture drawn. All cultures  negative, but given her persistent fevers, worsening rash, irritability, conjunctivitis as well as lab values that showed elevated CRP, with pediatric rheumatology consultation, it was determined that she met criteria for Kawasaki Disease. She received IVIG and will be on low dose aspirin.  She is still admitted at this time.
She also mentions that her sister in law first got covid recovered with no problems and got more sick when she got the vaccine; She also mentions that her sister in law first got covid recovered with no problems and got more sick when she got the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "She also mentions that her sister in law first got covid recovered with no problems and got more sick when she got the vaccine".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Per MD Ambulatory care note 9/23/11: New patient to clinic who came to first appt. today. She received a Tdap injection and 10 min. or so later was found to be on floor in hallway, alert, but having some distress. She says that she was fine prior to getting the injection. She now c/o feeling tight all over and very sick. She denies chest pain. She's not on any significant meds. O - pt. ashen appearing female, clammy. BP 86/50 sitting; awake, but mentally foggy; O2 sat 99% on RA; lungs - clear; heart - RRR; ext - no edema.  Hypotension. Diphenhydramine dose not documented mg once.
pt recvd vax & exp projectile v x 36 hrs; fever x 48 hrs; prolonged crying; anorexia;
Persistent left upper arm / left shoulder pain months after receiving vaccination, limiting left arm range of motion.
Fever, headache, neck pain, neck stiffness, decreased appetite.  Redness and swelling of both arms, with right arm having much more significant swelling and redness.
A report has been received from a Health Professional concerning a patient, male subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on 28-Oct-2014. It was reported that a patient was dispensed FLUMIST QUADRIVALENT vaccine to the wrong patient population. The outcome of the event of administration to wrong patient population is unknown. The reporter's description of the event(s) was as follows: not provided. The report was considered to be non-serious.
A report has been received from a Pharmacist concerning a 14 year old, female patient, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on 12-JAN-2015. The patient received expired FLUMIST Quadrivalent which started on 12-JAN-2015. The outcome of the event patient received expired FLUMIST Quadrivalent is unknown. The report was considered to be non-serious.
Patient developed low grade temp on Saturday 6/4 and redness, pain, itching of site started 6/5. seen in urgent care and give3n steroids and advised antihistamine. Provided abx should symptoms not be improved w/in 3 days   At time of follow up symptoms still present, unchanged.
11/16 Left arm hurt in evening. 17/17 Left arm stiff and painful (AM), 10AM lightheaded fever. Pt took APAP and IBU not much improvement. 11/18 getting worse - fever out of control, didn't take temp, pain and swelling worse, missed work. 11/19 missed work drenched in sweat, saw MD. PNEUMOVAX recommendation and that both vaccines were given in same arm, MD is sending in KEFLEX Rx, and LORTAB Rx MD says we should report it as an incident.
I have had continued ongoing dizziness/vertigo after receiving the vaccine. It has now been a week since my vaccination and I am still feeling this. It it tolerable, but continues and is annoying.
METALLIC TASTE IN MOUTH, LIGHTHEADEDNESS, NECK PAIN  Narrative:
This spontaneous case reported by a paramedic, describes the occurrence of administered expired product (vaccine administered beyond-use-date after the thaw process/expired vaccine administered) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 070H21A) for COVID-19 immunization. No medical history reported. On Mar 11, 2022, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; .25 milliliter. Mar 2022, patient experienced administered expired product (vaccine administered beyond-use-date after the thaw process/expired vaccine administered). At the time of the report, administered expired product (vaccine administered beyond-use-date after the thaw process/expired vaccine administered) outcome unknown.  The reporter did not provide any causality assessments, concomitant medication or treatment information. The dose reported as a booster dose. It was reported that vaccine was administered beyond-use-date to patients. No adverse reaction noted or reported regarding these administrations.
severe anxiety; This is a spontaneous report received from a non-contactable consumer from medical information team.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown) 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: ANXIETY (non-serious), outcome "unknown", described as "severe anxiety".  Additional information: The reporter stated she has a family member who experienced severe anxiety after getting one dose of BNT162B2 because she thought she was being tracked with a microchip and something was in her body. The reporter asked if BNT162B2 induces anxiety or any other neurocognitive/mental health disorders.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.