chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No signs or symptoms reported; PEDVAX HIB was administered to patients after the excursion occurred; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.   On 26-OCT-2021, haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced temperature excursion with 35.0 Fahrenheit degrees (F), 35.1 F, 35.3 F, 35.2 F, 34.9 F for 53 minutes (cumulative). There was no previous temperature excursion. On an unknown date in 2021, after the excursion occurred, the patient was vaccinated with the improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (1 time dose, lot # U003873, expiration date 15-APR-2023; strength, route of administration and anatomical location were not reported) for prophylaxis (product storage error). No signs or symptoms reported. No other adverse event (AE) or product quality complaint (PQC) was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2112USA003883: US-009507513-2112USA003884: US-009507513-2112USA003885: US-009507513-2111USA004277: US-009507513-2112USA003882:
arm was hot; Arm was red; Arm was swollen; it was not injected in the muscle; A spontaneous report was received from a reporter (consumer) concerning a 52 year old female patient, who received second dose of Moderna's COVID-19 vaccine(mRNA-1273)  and experienced inappropriate route of vaccination and arm was red, swollen and hot.  The patient's medical history was not provided.  Relevant concomitant medications included Levothyroxine, weight loss medication, Paracetamol, and Ibuprofen.  The patient received the first of two planned doses of mRNA-1273 on 15 Jan 2021.  On 12 Feb 2021, patient received the second  dose of mRNA-1273 (Lot number: 013L20A) intramuscularly for the prophylaxis of COVID-19 infection.  The dose was given 5 inches below the injection site of the 1st dose and the patient's arm was swollen, red and hot.  Treatment medications included Minocycline.  Action taken with mRNA-1273  in response to the events was not reported.  The outcome of event, inappropriate route of vaccination, was considered resolved on 12-FEB-2021.  The outcome of the events arm was red, arm was swollen, arm was hot was unknown.; 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.
missed the second dose in the Moderna series/skipped her second dose; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed the second dose in the Moderna series/skipped her second dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed the second dose in the Moderna series/skipped her second dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed the second dose in the Moderna series/skipped her second dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jul-2021, SARS-CoV-2 test: negative (Negative) NEGATIVE.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included birth control pills and medications for anxiety.   Treatment information was not provided by reporter.
flu like symptoms (malaise, fever) > 1 day 5 days after: numbness in hands (bilateral) low grade fever, dizzy, tongue tingly/numb resulted in Urgent Care/ER HTN ~ 160/90
This spontaneous report was received from a registered nurse referring to a unspecified number of patients of unknown ages and genders. The patients' concurrent conditions and medical histories were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB (routes, doses, frequency and anatomical place of vaccinations were not provided), lot # K026532, expiration date 07-AUG-2017). The doses of the vaccine were exposed to 47.6 degrees F for 85 minutes before been administered. Concomitant therapies were not provided. No adverse effects reported. There was not product quality complaint involved. This is one of several reports from the same source.
About 48 hours after both shots I had intense menstrual cramps, the worst cramps I have ever had in my life, it was hard to walk. It lasted with both shots about a few hours and subsided with Motrin
The next morning on 7/18/2018, I woke up with a headache, flu-like body aches, fever to 100.2 degrees, chills, sweats, and fatigue. After suffering all day, these symptoms went away by about 6pm that evening and I felt perfectly fine.
Immediate soreness at injection site which has persisted for >6 weeks, limited range of motion.
Vaccine underdose; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (Vaccine underdose) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and 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 an unknown date, 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 an unknown date, the patient experienced UNDERDOSE (Vaccine underdose) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Vaccine underdose) 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 UNDERDOSE (Vaccine underdose).    Concomitant medications were not reported.                                       No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live Significant follow up-(Case narrative received)
site of vax inject rt deltoid muscle became erythematous condition lasted approx 24 hrs-resolved & undetectable afterwards;
After each Covid 19 shot experienced severe joint pain (arthritic like pain).  Assumed that this pain would subside over time but has not.  Must take Tylenol to sleep due to joint pain.  Most severe is in shoulder joints, hands and feet.  Also experience pain in hip and knee joints.  I have not gone to the doctor for these pains since I am managing with Tylenol.  Thought I should report due to length of time the joint pain has endured.
24 hrs post vaccination,  my left axillary began to hurt and was tender to touch. I noticed a lump start to form and did not go away until 5 days post vaccination.
Information has been received from a pharmacist purchaser concerning a senior citizen patient ( age and gender not specified) who was vaccinated intramuscularly with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot 650452/0753P) in a senior center during an immunization clinic.  On an  unspecified date" recently", the patient developed "severe pain at the injection site", so much so that the patient " could not sleep at night".  It was also reported that the patient had "swelling present".  It was "unknown" if the patient sought unspecified medical attention.  At the time of the report, the outcome of the events were unknown.  Additional information is not expected.
About 3 hours after injection patient reported experiencing high fever, shivers & swollen lips. By the next morning all symptoms were gone.
Presented to the local ER on 2/14/23 with complaints of fever, cough, generalized weakness, chill, shortness of breath and wheezing.  Placed in observation status with a diagnosis of Covid, hypoxemia, hypotension and altered mental status.
dizziness; cough; shortness of breath; sore throat; has irregular heartbeat; fatigue; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), COUGH (cough), DYSPNOEA (shortness of breath), OROPHARYNGEAL PAIN (sore throat) and HEART RATE IRREGULAR (has irregular heartbeat) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81) and SIMVASTATIN for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-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 DIZZINESS (dizziness), COUGH (cough), DYSPNOEA (shortness of breath), OROPHARYNGEAL PAIN (sore throat), HEART RATE IRREGULAR (has irregular heartbeat), FATIGUE (fatigue), HEADACHE (headache) and NAUSEA (nausea). At the time of the report, DIZZINESS (dizziness), COUGH (cough), DYSPNOEA (shortness of breath), OROPHARYNGEAL PAIN (sore throat), HEART RATE IRREGULAR (has irregular heartbeat), FATIGUE (fatigue), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown.            The action taken with mRNA-1273(Moderna COVID-19 vaccine) was not applicable  Other concomitant medications include High BP medications  For treatment patient has not tried any medication besides her normally taken low dose aspirin.
Minor soreness in arm; fever; chills; Minor muscle ache; Minor fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Minor soreness in arm), PYREXIA (fever), CHILLS (chills), MYALGIA (Minor muscle ache) and FATIGUE (Minor fatigue) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 14-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced PAIN IN EXTREMITY (Minor soreness in arm), PYREXIA (fever), CHILLS (chills), MYALGIA (Minor muscle ache) and FATIGUE (Minor fatigue). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 2 dosage form once. On 15-Apr-2021, PAIN IN EXTREMITY (Minor soreness in arm), PYREXIA (fever), CHILLS (chills) and FATIGUE (Minor fatigue) had resolved. At the time of the report, MYALGIA (Minor muscle ache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, Body temperature: 100.4 (High) 100.4.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow up information included additional event. On 11-Jun-2021: Follow-up information included Concomitant drug and Medical history.
Patient had Moderna Bivalent Booster in Left arm, Fluarix Quad in Right arm on 12/13/2022. No contraindications listed on VAR form completed by patient. Pharmacist had patient wait for 15 minutes prior to leaving for observation for immediate adverse reaction, none reported. Patient checked out after 15 minutes. Patient called on 02/02/2023 and reported continuous pain in arm and pain recently started radiating down arm into elbow and has numbness in 3rd, 4th, and 5th digits.
Information has been received from a registered nurse concerning her 10 year old son who in January 1997 was vaccinated with varicella vaccine. In approximately January 2001, the pt develped moderate to severe chicken pox described as hundreds of pox all over including the throat. The reporter was concerned about the effectiveness of the vaccine. The reporter's youngest son, who was also vaccinated with varicella vaccine but at another physician's office did not develop chicken pox. The mother also reported that her oldest son also developed the chicken pox after vaccination with varicella vaccine. The reporter noted that one of her son's required acyclovir during the outbreak to minimize it as much as possible. Additional info has been requested.
low testosterone; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for a female patient of unknown age that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route on an unknown date at single dose for COVID-19 immunization. Concomitant medications and past drug/medical history were not reported. Caller wanted to know if a patient should stop taking a medication for low testosterone after having gotten the vaccine. Outcome of event was unknown.  Information on the lot/batch number has been requested.
4 hours after vaccines administered developed pruritic rash on thighs and upper (L) chest. Treated next day with Benadryl. Depo Medrol 40mg and Decadron 4mg.
DX COVIE, Presented to ED with fatigue, generalized weakness and a fall.  Presented to the hospital with acute shortness of breath related to COVID-19 pneumonia.  Continued with Acute respiratory failure with hypoxia. Also, normochromic anemia on admission.
Pts recv vax in 10/95; in 12/98 pts exp chicken pox
Patient states that her arm has been hurting ever since and the pain is very intense sometimes and she thought it would go away but after 3 weeks she is still having the pain.
Information has been received from a physician concerning a 24 month old female with no known drug allergies, who on 30-APR-2007 was vaccinated into the right thigh with a first dose of Pneumovax 23 (lot# 651437/0899F) instead of PREVNAR.  Concomitant therapy included an IM dose of poliovirus vaccine (batch# Y0576) into the left thigh and Daptacel into the left thigh (batch# C2431AA).  It was noted that product confusion occurred since both vaccines read pneumococcal vaccine.  The physician suggested the print to be larger on the vials.  On 30-APR-2007, the patient developed swelling in her thigh.  Unspecified medical attention was sought.  In a follow-up evaluation the patient was doing fine and no issues were reported by the patient's mother.  No product quality complaint was involved.  Additional information is not expected.
INJECTION SITE IS RED, RAISED, HOT TO THE TOUCH, AND ARM IS SORE AND STIFF.
Flu-like sx, fever, chills, aches. ER to hospital admission. Sepsis.
Numbness in hands, feet and legs. Numbness caused inconsistent issue with gait pattern. Unable to feel sensation of hot, cold or amount of pressure, particularly in lower leg, primarily my left leg. Constant pain in back of neck and mid-spine area. Severe fatigue mixed with numbness causing an inability to walk for a short time. The fatigue continues and tingling numbness is frequently onset without any reason. Many symptoms have subsided with sporadic tingling and numbness remaining.and persistent fatigue
slight soreness at the injection site started with severe chills about 12 hours after the injection.  After 3 hours had sweats for about 30 minutes.
pt reacted that evening +edema/redness;pt was treated @ urgent care facility & given a course of keflex;
Rash started on 4/7 and continues to grow.  Rash /hives/inflammation all over both arms and left leg.  Spreadig to stomach and upper thighs.  Painful pinching in uppper left arm, skin tightness, redness, itchy.  Very uncomfortable.
@ approx 6AM on 21SEP93 mom awoke found pt had expired; pt taken to ER:
Horrible allergy, rash, hives, burning & itchy skin across my chest.. I had to see a Dermatologist to seek help.
High fever, headache, body aches, vomiting  4 weeks later -episode of severe dizziness and SOB
Information has been received from a health professional concerning a 5 year old female patient who on 04-AUG-2010 was vaccinated inadvertently with a dose of PROQUAD (Merck upgrade process) and with a second dose of VARIVAX (Merck) (MSD) (lot number not provided) in different arms. The nurse reported that the patient was to receive the second dose of MMR II (MSD) as PROQUAD (Merck upgrade process) injection. Concomitant therapy included a dose of poliovirus vaccine and a dose of DTAP. No adverse symptoms were noted. The nurse reported that this was not a product confusion or quality assurance (QA). Additional information has been requested.
I began experiencing sharp shooting pain down my left lower leg within 24-28 hours of receiving the shot. The pain occurs often when sitting or laying down.  The excruciating sharp pain occurs every time the anus area is wiped from the use of the bathroom or when bathing. The pain feels like an electric shot shooting down my leg that causes me to become unbalanced and at times to tears because it is so painful.  It's weird because you do not feel the pain starting from the injection site or even from the buttocks upon wiping; it just shoots from the bottom part of my leg.  During the first dose; the pain lasted for over a week.  I am now one week out of my second dose and I am still experiencing the discomfort.   I did not think anything of it when it occurred during the first dosage until it occurred again in the same left lower leg and in the same manner.
lt upper arm red, swollen hot to touch, painful, temp inc taking APAP q 4 hrs; entire lt upper arm from elbow to shoulder involved front & back;
This is a spontaneous report from a contactable nurse. A 3-month-old male patient (race unknown) received a dose of PREVNAR in the thigh via intramuscular route of administration on 11Apr2011. Past vaccine history included ROTARIX. Relevant medical history and concomitant medications were not provided. On 11Apr2011, the patient continuously coughed for 2 hours after PREVNAR was administered. The patients dad reported that he felt the cough was a cold symptom instead of a reaction to PREVNAR. Therapeutic measures taken in response to the event were unknown. The clinical outcome of the event at the time of the report was unknown. Follow-up attempts completed. No further information expected. Follow-up (10MAY2011): New information reported from a contactable nurse includes: patient age; patient gender; dose details for suspect product; and past vaccine history.
Pfizer on 12/28 and 1/18. Positive on 8/14 admitted on 8/14-current
Immediately after administering influenza and meningococcal vaccines patient had a syncopal episode and a generalized seizure for less than 1 minute.
Ringing in the ear after 36 hours of vaccine; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07May2021 at 15:15 (at the age of 42-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within 2 weeks of the vaccination and other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Apr2021 at 16:15 (at the age of 42-years-old), as a single dose for COVID-19 immunisation. On 09May2021 at 07:00, the patient experienced ringing in the ear after 36 hours of vaccine. It was reported that on Sunday the patient got up with ringing in the ear. It was unknown whether any therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event ringing in the ear after 36 hours of vaccine was not resolved at the time of this report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Appendicitis the following Sunday requiring surgery; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 01Apr2021 15:30 (Batch/Lot number was not reported) at the age of 28 years old, as single dose for COVID-19 immunisation. Medical history included COVID-19 from an unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination. The patient has no known allergies. The patient's concomitant medications were none. No other medicines received within two weeks of vaccination. No other vaccines within 4 weeks prior to vaccination. The patient experienced appendicitis the following Sunday (18Apr2021 00:00) requiring surgery. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). Treatment was surgery. It was unknown if the patient has been tested for COVID post vaccination. The patient was recovering from the event.   Information on the lot/batch number has been requested.
Only sore arm for first two days. Then 7 days after vaccine, my arm was swollen in a large circle (about 3 inches ). It was red and hard. It later became itchy and over the next few days started to spread all over my upper arm. No pain and the hardness went away after a couple of days. But redness, swelling, and it itchiness remains at day 12 post vaccine.
Patient woke up with swelling, redness and soreness at injection site. The site at peak reaction had a diameter of about 6 inches in diameter and hot to the touch. The patient took ibuprofen over the next couple of days for the soreness and swelling and diphenhydramine at night for itching. As of today (1/21/18),  4 days after the vaccination, the swelling has gone down and the pain is significantly reduced. The site is no longer warm to the touch. The area around the injection site is still red but it is shrinking. We will continue to monitor the patient's condition.
Cough pt states that she has had a cough x 3 days with congestion. pt states that she got her 1st COVID shot 2/6/2021