chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax 8MAR95 & 11MAR95 pt exp wrist pain & devel elevated liver enzymes;reporter felt that there was a possible problem w/the lot of vax;
Cloudy vision, headache, sleepiness in left arm and mouth since 7pm.
get the shingles even with the shot/ shingle shot, came down with the shingles/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient's friend. The age at vaccination was not reported. The reporter stated that the shingles were not prevented and one could still get the shingles even with the shot. The patient had the Shingles shot and a few years later, she came down with the shingles.  The reporter saw them, as did her doctor. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation for shingles were unknown at the time of reporting.
While driving home after leaving facility 15 minutes after shot, I started having an increased heart rate.  Once home, the rapid heart rate continued and I noticed throat swallowing was getting a little tighter.  I started drinking water and just breathed normally sitting down.  I went to a mirror to see if I could see any swelling of my face and noticed my neck right under my chin was red about half way down.  My chest seemed fine.  I continued to just sit & drink water and soon the heart rate was getting back to normal.  I noticed the redness on my neck was getting lighter also.  I looked at my watch and it had been a little over an hour since my vaccination.  I did not seek treatment, nor have I called my doctor.  There have been no more adverse reactions.
Injection site sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site sore) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Injection site sore). At the time of the report, VACCINATION SITE PAIN (Injection site sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
pt experienced pain in upper arm 4 hours post vaccination. 8 hours post, pt also experienced red rash and generalized swelling in an approximate radius of 12 inches from the injection site and swelling/rash extending down the arm to a point about 2 inches past the elbow. Pt self treated with BenadrylMotrin until 48 hours post vaccination at which time she was seen at a medical clinic. She received prescriptions for hydroxyzine and for a medrol dose pack.
Experienced brief, minor dizziness about 10 minutes after the shot. On my drive home about 15-20 min. after the shot, I experienced more severe symptoms of anaphylaxis. I was able to breathe but my airway was constricted and swollen. After arriving home, I called pharmacy but their pharmacists were out on lunch. My primary care doctor was closed (Good Friday). I waited until the pharmacist was back from lunch and they advised Benadryl (I took 50 g at 2pm) and to have someone with me for the next 24 hours. Symptoms improved some but by 5pm I still couldn't take a deep breath normally and was concerned about eating food. I went to the ER where they admitted me and administered Pepcid and dexamethasone at 6:22pm. After about an hour and a half, I felt better and was released. Once home, I ate food and that irritated my throat again so I kept an EpiPen nearby that evening just in case. The next morning I felt 100% with no side effects.
Within 15 mins, inject site rxn of red, raised, circular rash measuring 2 to 3 inches in diameter.
pt recvd vax 14MAY93 & w/in 12 hrs of vax exp nausea & vomiting (hematemesis); taken to hosp ER: w/in 12-13 hrs of dose 2 exp dizziness, fatigue, seizure; pt began to shake all over; seemed unresponsive; not sure if was breathing or not;
Info has been received from a nurse practitioner concerning an adult female with no drug allergies or illness at the time of vaccination who at 13:00 on 10/11/2002 was vaccinated with a 1st dose of pneumococcal vaccine 23 polyvalent (lot #641116/1160L) IM in the right deltoid. On 10/11/2002, the pt subsequently developed redness, soreness and swelling. The pt was seen and was treated with warm compresses, acetaminophen (TYLENOL), and diphenhydramine (BENADRYL). The pt was told to elevate her arm. On 10/12/2002, the pt recovered. The nurse indicated that she would like a lot check performed on lot 641116/1160L. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. No additional info is expected.
PATIENT WAS ADMINISTERED A FLUARIX VACCINE INSTEAD OF A PFIZER PEDS COVID SHOT.
coughing, difficulty breathing, vomiting, fever, fell unconscious, seizures taken by ambulance to hospital
Swelling in left arm and left elbow. The arm was hot and swollen to touch with some edema. Seen in ED and received 125 mg of Solu-Medrol and was discharged with a 3-day dose of steroids.
Client reported that she had fatigue from 3/26/21-3/28/21 and fever with body aches from 3/26/21 to 3/29/21.  Today noticed rash from injection site on left deltoid to left elbow with itching.  Advised to notify her PCP for further instructions
fever, rash, leukocytosis, elevated ESR, irritability; pain swelling & dec use of rt arm & elbow; ESR 73; WBC 29,500 50S/20B/21L/7M/2EOS; Tmax 103.6; rash papular, diffuse, eryth-x 3 days;
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unspecified date in 2009, the patient was vaccinated with a dose of GARDASIL (dose, lot#, expiration date and route not reported). On an unspecified date in July 2016, the patient was vaccinated with a dose of GARDASIL 9 (dose, lot#, expiration date and route not reported). No adverse effect was reported. Additional information has been requested.
This report has been received from the nurse reported that VARIVAX (Merck) (lot# H020587, expiration date 13-NOV-2014) and PROQUAD (Merck) (MARRS# 1311USA012185) were trough unsupported temperature excursions on 26-JUN-2013, 01-JUL-2013, 22-JUL-2013 thru 31-JUL-2013 and the entire month of August 2013. On 04-SEP-2013 two patients (age and gender not reported). No adverse effects reported. This is one of several reports received from the same source (MARRS# 1311USA002616, 1312USA003307, 1312USA003308, 1312USA003309, 1312USA003306, 1312USA003310, 1312USA003312, 1312USA003313, 1312USA003314, 1312USA003315, 1312USA003316, 1312USA003317, 1312USA003399, 1312USA003400, 1312USA003401).
Case number PHEH2013US018020, is an initial spontaneous report received from a nurse on 23 Aug 2013: This case refers to an 11 years old male patient. He received only Men A lyophilized conjugate component of MENVEO (batch number: M12098) reconstituted with sterile diluent intramuscularly on 22 Aug 2013: No adverse reaction was reported following this administration error.
ANTIGEN IMMUNITY WAS VERY LOW; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced antigen immunity was very low. Laboratory data (dates unspecified) included: COVID-19 antigen test (NR: not provided) very low. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of antigen immunity was very low was not reported. This report was non-serious. This report was associated with product quality complaint: 90000224750. The suspected product quality complaint has been confirmed to be voided (this record does not contain a product quality complaint and is not considered a lack of effect) based on the evaluation/investigation performed.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
stomach issues; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach issues) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (stomach issues). At the time of the report, ABDOMINAL DISCOMFORT (stomach issues) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was reported.   Reporter did not allow further contact.
Considering that baby was born as a perfectly normal and healthy baby, who was eating, sleeping, and gaining weight great, right after the vaccination baby had fever, followed by inflamed with bright red color cheeks, started to have congested nose and developed wheezing. Breathing became an issue and inflammation in the skin of the face started to bleed badly. Baby became very restless, nights became a nightmare as he could not breathe, and was itching like crazy. He stopped being himself and was in constant pain. We had to visit emergency, because he could not breathe. Visited numerous specialty doctors, who said the baby has severe eczema, asthma, allergies, etc. he also stopped gaining weight, had low hemoglobin.
This spontaneous report as received from a healthcare worker refers to a patient of unknown demographics. No current condition was reported. No pertinent medical history was reported. On 03-SEP-2014, the patient was vaccinated with VARIVAX, .5 ml, subcutaneous. No concomitant medication was reported. On 03-SEP-2014, the patient received improperly stored VARIVAX, exposed to 23F for 3 hours. No adverse effects were reported. The outcome of patient received improperly stored VARIVAX was unknown. No further information was provided. No PQC was involved. This is one of several reports. Additional information has been requested.
In March, right side leg and arm couldn't lay on it. Can't put full weight on it so use canes to carry something. Takes 2 TYLENOL PM (500 mg acetaminophen and 25 mg diphenhydramine). Had doctor appointments CAT, MRI, ultrasound in March, also on March 20 had follow-up appointment with urologist due to blood in urine before vax. On 5/11 went back for back x-rays. Also had appointments in 9/24. Had to increase dosage of some medications after vax. At this point can not do things by himself.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 12-NOV-2018, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # R001084, expiration date 07-NOV-2020) and ROTATEQ (lot # R015432, expiration date 15-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccines were exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
expired DAPTACEL was administered with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from nurse and physician via Medical Information (Reference number- 00748869) and transmitted to Sanofi on 31-Aug-2021.  This case is linked to case 2021SA290049 (same reporter).  This case involved 5-year-old female patient who administered expired DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (expired product administered)  Relevant medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE for prophylactic vaccination.  On 12-Aug-2021, the patient received second 0.5ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot: C5643AA and expiry date: 17-Jul-2021) (Frequency: Once) (Strength: Standard) via intramuscular route in the right thigh for prophylactic vaccination (expired product administered).  It was reported,"Nurse asks if there are any recommendations for when expired DAPTACEL is administered".   This case was an actual medication error due to (expired vaccine used) (latency: same day).  At the time of reporting, no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
after the shot, back pain intensified.  Throughout the day, the back pain turned into severe stomach issues.  Took stomach meds (pepto bismol) with no effect.  Went to sleep and woke up in the middle of night with stabbing pain in my stomach. used a heating pad to help me go back to sleep.  the 2nd day my stomach felt as if it was a balloon- extremely bloated and it hurt to breath deep, and stand straight. Took pepto, gas x, and also tried tums- nothing helped.  Today is day 3, and I am back to feeling normal aside from still being very tired, and hazy.  No more stomach issues.  Called doctor to see what I should do today, and was advised to not take the second dose.  Would like a second opinion.
About 10 days after the first Moderna Covid vaccine I experienced intermittent light-headedness - a feeling of being about to faint. It was accompanied by much worse tinnitus than I normally have. These symptoms have not gone away and it has been about three weeks since they started.  I am very concerned about having the second vaccine, especially as the adverse reaction caused by the first vaccine has not lessened or gone away.
The vials were frozen and underwent 4 temperature excursions total; 7 doses given from 5 vials were eventually punctured and used after the 2nd excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (The vials were frozen and underwent 4 temperature excursions total) and POOR QUALITY PRODUCT ADMINISTERED (7 doses given from 5 vials were eventually punctured and used after the 2nd excursion) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (The vials were frozen and underwent 4 temperature excursions total) and POOR QUALITY PRODUCT ADMINISTERED (7 doses given from 5 vials were eventually punctured and used after the 2nd excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (The vials were frozen and underwent 4 temperature excursions total) and POOR QUALITY PRODUCT ADMINISTERED (7 doses given from 5 vials were eventually punctured and used after the 2nd excursion) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  On 13-Jan-2022 the freezer got to 5.4F for 15 minutes, then returned to the appropriate temperature range. On 20-Jan-2022 the freezer got to 6.1F for 15 minutes, then returned to the appropriate temperature range. On 11-Feb-2022 the freezer got to 10.8F for 10 hours and 15 minutes overnight into 12-Feb-2022, then returned to the appropriate temperature range. On 25-Feb-2022 the freezer got to 22.6F and was out of range for 20 hours total into 26-Feb-2022 then returned to the appropriate temperature range. The storage condition at the time of the excursion was frozen.  The vials were moved from freezer to refrigerator on 1 dose/vial on 30-Jan-2022. No visual inspection was done, noting any vaccine state change.  Treatment information was not provided.
Suspected vaccination failure; Shingles; Warm shooting pains which spread up his back to the should blades; Nerve pain; Muscle pain; welts on neck; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and VARICELLA ZOSTER VIRUS VACCINE, LIVE, OKA STRAIN (ZOSTAVAX) for prophylaxis.   The patient's past medical history included chickenpox (the patient experienced chickenpox as a child and then again around age of 32 years).   On 11th April 2018, the patient received the 1st dose of Shingrix. On 23rd August 2019, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received ZOSTAVAX at an unknown dose. In August 2019, between 1 and 2 years after receiving Shingrix and less than 2 years after receiving Shingrix, the patient experienced welts. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain, nerve pain and muscle pain. The patient was treated with antivirals nos, antivirals nos, antivirals nos, antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the vaccination failure, welts, nerve pain and muscle pain were unknown and the outcome of the shingles and pain were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, welts, pain, nerve pain and muscle pain to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient received 1st and 2nd dose of Shingrix on an unknown arm (right or left unknown). The reporter did not sure if the injection was in the muscle or just under the skin (subcutaneous) as he did not look at the length of the needle. About a month before the date of reporting (August 2019), the patient noticed welts on his neck. He went to the physician because he thought he might have poison oak. The doctor diagnosed him with shingles. The welts were also on his right shoulder. He was prescribed unspecified antiviral tablets which he took for about a week and the shingles resolved. The patient stated that the shingles outbreak was brief and not bad perhaps because he caught it early. It had fully resolved. The patient also mentioned that occasionally he got warm shooting pains which spread up his back to the should blades. The pain was nerve or muscle pain and was very mild and it came occasionally. It was happening before the shingles outbreak. The patient stated that he had been exercising lately so he was not sure if it could be related to exercising but not had the shingles rash in that area. It was unknown if the reporter considered the vaccination failure, shingles and welts to be related to Shingrix and Shingrix. It was unknown if the reporter considered the pain, nerve pain and muscle pain to be related to Zostavax as well. The reporter consented to follow up.
Severe soreness in neck and shoulders. Moved over three day period from left to right. Started to dissipate on third day(Sun). Still sensitivity when turning head.  Received some relief with aspirin and/or acetaminophen.
After the shot a minute after: hands twisted seizures, convulsions, eyes rolled over, saliva on her mouth, fainted, tiredness, then after episode: fatigue, weakness, loss appetite, somnolence, lack of interest, non responsive.
her leg was swollen with pain; blood clots/whole right leg was filled with blood clots; her leg was swollen with pain; a little cramp; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clots/whole right leg was filled with blood clots), MUSCLE SPASMS (a little cramp), PERIPHERAL SWELLING (her leg was swollen with pain) and PAIN IN EXTREMITY (her leg was swollen with pain) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 22B214 and 016C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jun-2021, the patient experienced MUSCLE SPASMS (a little cramp) (seriousness criterion hospitalization). On 23-Jun-2021, the patient experienced PERIPHERAL SWELLING (her leg was swollen with pain) (seriousness criterion hospitalization). On 25-Jun-2021, the patient experienced THROMBOSIS (blood clots/whole right leg was filled with blood clots) (seriousness criteria hospitalization and medically significant). On 23-Jul-2021, the patient experienced PAIN IN EXTREMITY (her leg was swollen with pain) (seriousness criterion hospitalization). The patient was hospitalized on 25-Jun-2021 due to MUSCLE SPASMS, PAIN IN EXTREMITY, PERIPHERAL SWELLING and THROMBOSIS. At the time of the report, THROMBOSIS (blood clots/whole right leg was filled with blood clots) was resolving and MUSCLE SPASMS (a little cramp), PERIPHERAL SWELLING (her leg was swollen with pain) and PAIN IN EXTREMITY (her leg was swollen with pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jun-2021, Scan: abnormal (abnormal) her leg and the whole right leg was filled with blood clot.         Patient was treatment medication of a diuretic or something like that for the blood clots Concomitant product use was not provided by the reporter.  Company comment 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.; Sender'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.