chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Redness; Warmth on the injected arm; allergic reaction; This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced erythema of extremities, skin warm and allergic reaction. On an unknown date, the outcome of the erythema of extremities, skin warm and allergic reaction were unknown.   It was unknown if the reporter considered the erythema of extremities, skin warm and allergic reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient had an allergic reaction to the 1st dose of Shingrix, stated that the patient experienced redness and warmth on the injected arm that was spreading down the arm.  The reporter consented to follow up. No other details were provided.
Rash, blisters, flaking skin at injection site. Patient presented to Pharmacy 2 days after receiving immunization.
Time Course/Signs/Symptoms: 8-10minutes after vaccine -> bilateral arm "paralysis", Then, syncope. Was laid down. Awake and spoke her name. Then, Hyperventilation x 3-5 minutes @ about 100 rpm. Lost consciousness. O2 applied. BP=135/90; HR = 90/min. No wheezing, good B breath sounds.  Ambulance arrived @ about 11:40am.  Reportedly prolonged seizures and severe hypertension.  Helicopter ambulance met road ambulance in route. Personnel immediately intubated the patient.  Reportedly, this led to "a fountain of blood".
This spontaneous report as received from a medical assistant via a company representative refers to a 65 year old female patient. On an unknown date, when the patient was 64 years old, she was vaccinated with ZOSTAVAX dose 1, 0.65 ml, subcutaneously. On an unknown date, when the patient was 65 years old, she inadvertently received a second dose of ZOSTAVAX, 0.65 ml, subcutaneously. No symptoms were reported. Additional information has been requested.
Initial misuse report received from a healthcare professional on 02 January 2014. Pregnant women had received a dose of ADACEL on 02 January 2014 and then found out it was previously given on 12 November 2014. No adverse event was reported. List of documents held by sender: none.
Patient wanted Qaud flu vaccine. Gave then FLUVIRIN multidose. No adverse event.
No additional AE information provided.; VARIVAX was administered to a patient on 15-DEC-2022 after a supported temperature excursion that took place; This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug allergies/reactions, or concomitant medications was not provided.  On 15-DEC-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) at a dose of 0.5 ml, (lot W018825 had been verified to be a valid number; expiration date 14-JUN-2024, and upon internal validation established as the same date) for prophylaxis (vaccination scheme, frequency, route of administration, and anatomical site of injection were not reported). On 01-DEC-2022, the administered dose of the vaccine was stored at a temperature of 19.47 degrees Fahrenheit (F), during a time frame of 0 hours and 50 minutes, as recorded by a digital data logger. There was no previous temperature excursion reported. There was no adverse effect reported.
received 2nd dose of Menveo; This non-serious case was reported by a physician via call center representative and described the occurrence of extra dose administered in a male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced extra dose administered (Verbatim: received 2nd dose of Menveo).  The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 16-Sep-2023 The reporter is the patient himself who was MD physician but did not see patients currently and work in Medical Education.  The patient reported that he got the Menveo vaccine 2 months ago and had no reaction to it whatsoever, not even a mild inflammation, pain or anything at all. The pharmacy where he received the vaccine felt a bit unorganized.  He did some reading and decided to wait 2 months and get a second dose just in case. However, the second dose had not produced any reaction either at all. Given that he was an MD, he would assume that if he developed any antibodies from his first dose, there would at least be some kind of reaction against the vaccine, some inflammation or pain. But he had nothing at all. He enquired if he was missing something and would love to get an answer. The patient received 2nd dose of Menveo which led to extra dose administered. The reporter consented to follow up.
SHE WAS GIVEN LATEX VACCINE INSTEAD OF THE LATEX FREE VERSION BY MISTAKE. SHE WENT HOME AND CALLED DR. TOOK BENADRYL. LATER THAT NIGHT C/O SWELLING AROUND MOUTH.
Patient felt pain with the injection and immediately afterward. It was reported as shooting pain at the site and "and a sort of painful heat sensation right after". Since then, she experienced shooting pain between her left shoulder and elbow and had pain upon movement of that arm. The pain was significant enough to interfere with sleep. Patient sought medical attention at urgent care on 10/22/20. She was given injection of Toradol and told to alternate between Tylenol and ibuprofen. Patient is feeling much better today, 10/23/20, and is able to move her arm with little discomfort.
RASH NOTED TO UPPER CHEST AREA AND UPPER BACK AREA-TOOK BENADRYL 25MG AT 1715 ON 12/31/20, RASH ALMOST ALL  CLEARED UP BY 01/01/21, TOOK BENADRYL 25MG AGAIN AT 0900 ON 01/01/2, RASH ALL GONE BY 1700 01/01/21. NEVER HAD ITCHING OR PROBLEMS WITH SWALLOWING
The day after receiving the shot i was very tired.  Slept part of the day.  I am a runner and was unable to run that day but could tell i was very winded even going up and down stairs.  The rest of the week was unable to run from being winded.  Then after a week was able to slowly get back to my normal routine.  I had a calcium score scheduled for 7:00 am on May 19th.  I was called into my doctors office to be given the results the next week because my calcium scan came back fine...but doing the scan they found a 3mm nodule on my lung.  I have never had any type of lung issues.  I do not know that this is related to the shot.  But because of how my lungs felt for a week after the shot, i feel this could be related.  I am not a smoker and never have been.  They say the majority of these type nodules are formed from inflamation or infection.  At the time they told me about the nodule they also did my yearly physical.  Since i know some are getting inflamation around the heart...i'm curious if there can also be inflamation around the lungs which would have given me the nodule.  At this point..the doctor plans to do a ct scan in one year to see if the nodule has grown.   I felt like i should report this since this may not be discovered by many others unless they just happen to go from some type of scan of the lungs.
Product storage error; doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (Product storage error) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (Product storage error) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  Date the vial was initially stored in the refrigerator was 29-Oct-2021. There was no temperature excursion. The reporter reported that that there was a confusion between the expiration date printed in the carton and the expiration date when the code was scanned.  The patient did not experience any adverse event.  No treatment information was provided by the reporter.
Diffuse mildly erythematous maculpapilar rash trunk, cheeks peri area and thighs
Symptoms: injection site is red warm and had evidence of swelling. Treatment: physician prescribed KEFLEX 500mg T.I.D.
ALLERGIC TO VACCINE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: Unk) dose was not reported, administered on 09-MAR-2021 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 MAR-2021, the subject experienced allergic to vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of allergic to vaccine was not reported. This report was non-serious.
Consistent bruising on both upper thighs and legs; some soreness to the touch and tingling in lower legs/feet.
Headaches behind eyes and constant nausea 2 days after the shot. Dizziness, high fever on 12/28 with shivering and vomiting. After 2 weeks still experiencing nausea and headaches. Never had flu shot reactions the years before. Not subject to migraine, neither to nausea. My husband had the same vaccine on same day. He experienced the same symptoms with diarrhea.
Rash on trunk and groin area. Rash looks like pimples or bug bites (more than 20-30 bumps).
Sharp chest pain in sternum area accompanied by difficulty breathing. Pain was gone two hours after taking Tylenol.
No additional adverse event reported; VAQTA was administered after a temperature excursion of 47.9°F for 47 min on 01-DEC-2022; This spontaneous report was received from a certified medical assistant and refers to a 5-year-old male patient. The patient's concurrent conditions, drug reactions or allergies, pertinent medical history, and concomitant therapy were not reported.  On 01-DEC-2022, hepatitis a vaccine, inactivated (VAQTA), lot # W023937, expiration date 06-DEC-2023 had temperature excursion of 47.9 Fahrenheit degrees (°F) for 47 minutes as a result of reading from Data Logger.  On 16-DEC-2022, the patient was vaccinated with this incorrect storage second dose of hepatitis a vaccine, inactivated (VAQTA), intramuscularly in left deltoid, lot # W023937, expiration date 06-DEC-2023 for prophylaxis (quantity dose was not reported) (product storage error).    No additional adverse event and nor product quality complain were reported.
Missed miscarriage of 11 week old, mo/di identical twins. Discovered as lack of heartbeat on ultrasound on June 21.
My arm turned bright red from shoulder to elbow and was very swollen.  It lasted for 2-3 weeks.  It is still discolored.
Information has been received for the Merck Pregnancy Registry for GARDASIL from a Registered Nurse concerning a 14 year old female patient who on 05-DEC-2008 was vaccinated with first dose of GARDASIL (Lot # not provided).  Concomitant therapy included Diphtheria Toxoid (+) PERTUSSIS ACELLULAR vaccine (unspecified) (+) TETANUS TOXOID (manufacturer unspecified), FLUMIST and MENACTRA .  After the patient received the vaccines she went to the Emergency Room with a fever of 102.6F and vomiting.  It was at this time she discovered she was about 8 to 12 weeks pregnant.  Additional information has been requested. Thisi s in follow-up to report (s) previously submitted on 1/16/2009. Additional information has been received from a prengnancy registry for GARDASIL from a registered nurse who reported that a patient on 10-Dec-2008; the patient was vaccianted with the first dose of GARDASIL (lot # 661046/0381X). Concomitent medication included an unspecified psychiatric medication and DEPO PROVEN. Additional information has been requested.
Leakage during administration; Needle hub was not fully connected to syringe; This spontaneous case was reported by a health care professional and describes the occurrence of UNDERDOSE (Leakage during administration) and DEVICE CONNECTION ISSUE (Needle hub was not fully connected to syringe) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced UNDERDOSE (Leakage during administration) and DEVICE CONNECTION ISSUE (Needle hub was not fully connected to syringe). On 26-Feb-2021, UNDERDOSE (Leakage during administration) and DEVICE CONNECTION ISSUE (Needle hub was not fully connected to syringe) 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.   No concomitant medications provided. No treatment information provided.
This spontaneous report was received from a registered pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, after 24-DEC-2016, the patient was vaccinated with an expired dose of ZOSTAVAX (expiration date of 24-DEC-2016; strength, dose, route, anatomical location and lot number were not provided), for prophylaxis. It was not specified if the diluent used to reconstitute the expired ZOSTAVAX was expired as well. No adverse effects were reported. Additional information is not expected because there was no consent to contact the registered pharmacist.
Patient came in for catch vaccination of DTaP (Left Arm) and Hep B (Right Arm) yesterday on 11/17/2020.  Both vaccines given without any immediate adverse reaction noted.    The  guardian called and stated she stated she gave Tylenol last night because she complained her left arm was a little sore.  She was sent home for school today, 11/18/2020,  when the nurse assessed her and  she had a low grade temp of 99, redness and swelling that traveled up her arm to her shoulder and it is warm to touch.  I explained she was more tense when I vaccinated the left  arm first and was lot less tense with the 2nd vaccine on the right arm.   She has given her Tylenol since she has been back home and has a cold compress on her arm as well.   I informed her as mentioned in the VIS form that DTaP is known to cause swelling to the site and tend to not after the 4th or 5th dose.  This was her 3rd dose and first episode.  I advised her on the severe allergic reactions and to get her to the ER if those symptoms occurs.  I asked her to please call me at the location on Friday with an update or sooner if anything else arises.
Injection site reaction; Injection site swelling; Injection site redness; Vaccination site Itching; This spontaneous case was reported by a health care professional and describes the occurrence of INJECTION SITE REACTION (Injection site reaction), VACCINATION SITE SWELLING (Injection site swelling), VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE PRURITUS (Vaccination site Itching) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Osteoporosis since 2016.    On 18-Feb-2021 at 1:30 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021 at 9:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INJECTION SITE REACTION (Injection site reaction). In 2021, the patient experienced VACCINATION SITE SWELLING (Injection site swelling), VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE PRURITUS (Vaccination site Itching). On 06-Feb-2021, VACCINATION SITE SWELLING (Injection site swelling), VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE PRURITUS (Vaccination site Itching) had resolved. On 06-Feb-2021 at 9:00 AM, INJECTION SITE REACTION (Injection site reaction) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was reported. Treatment Information was not provided by Reporter.   This case was linked to MOD-2021-019671, MOD-2021-019671 (Patient Link).
Right upper arm (vaccine site) very sore, progressed to extreme pain (8-9 out of 10) by 7 PM, severely limited ROM at shoulder, ie 40 degrees abduction and flexion. Any amount of movement at shoulder/elbow produced extreme pain, unrelieved by Ibuprofen and Acetaminophen. Pain and limited ROM continued through 7/16/2015; by 7/17, pain decreased and ROM began to return; by 7/18, near full ROM, although some pain persists. Call was made to nurse on 7/15, who advised contacting clinic, which I did also on 7/15. Clinic nurse advised use of cold compress, then heat.
Joint pains in hands, elbow, shoulders, hips, knees, feet and low grade temperature.
Fever (38.5 C?) lasted 2 hours ,  Pail and Swelling in Left Arm lasted 2 days Headache lasted 12 hours  Used Tylenol 1 gram each 12 hours for 2 days
Fatigue, swollen glands, body pain, heart palpitations, lump in breast (gland)
The side effects I am reporting that have not gone away are two things. Since the evening of December 30, 2021, I have outer thigh leg pain that is best described as nerve pain. It wakes me up at night and most times it is an intense itching sensation and also a tingling and numbness feeling. I've never had anything like this ever. It mainly occurs while I'm sleeping but has occasionally happened when I'm on the treadmill walking.  The other issue is after the initial swelling and redness at the injection site, the swelling had gone away but the warmth and redness area has increased in size to about 5" diameter and it also itched. It is now 2 weeks out and the rednes is still there though the itching has disappeared
About 10 hours after the vaccine, I had deep bone pain in my pelvis, sacrum and spine. I was extremely fatigued, fever and headache. I basically slept for two days curled up in a ball. On April 7, I was diagnosed with COVID.
Facial/tongue swelling, myalgia, nausea, vomiting, weakness, numbness & tingling in arms and legs.
Information has been received from a physician concerning an adult female employee who "sometime last week" on approximately 05-Jan-2005 may have been vaccinated with an intradermal dose of hepatitis B virus vaccine rHBsAg (yeast) (Lot #646996/1093N) while 7 months pregnant. It was reported the patient developed a red, indurated area about 35 mm in diameter. The patient's status was reported as recovering. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Patient reports waking up in the night (10/3/12) with a sweat and that the next morning (10/4/12) he could not move his right arm from his shoulder to his elbow.  Patient states he does not have a fever and there is no redness or swelling at the injection site.  Patient is following up with his primary physician.
This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 72-year-old female patient who received SHINGRIX (batch number 7FY22, expiry date 25th April 2020) for prophylaxis. On 20th June 2018, the patient received the 1st dose of SHINGRIX. On 21st June 2018, 1 days after receiving SHINGRIX, the patient experienced headache. On 22nd June 2018, 2 days after receiving SHINGRIX, the patient experienced pain in arm, erythema of extremities and swelling arm. On an unknown date, the outcome of the headache was recovered/resolved and the outcome of the pain in arm, erythema of extremities and swelling arm were not recovered/not resolved. It was unknown if the reporter considered the headache, pain in arm, erythema of extremities and swelling arm to be related to SHINGRIX. Additional information was reported as follows: On the next day of the vaccination the patient experienced severe headache. The patient's arm was very sore, even to a very light touch. The patient's arm was also red and swollen. Till the day of reporting, the events seemed to be resolved. However, the patient reported that her arm was again swollen and sensitive to touch. No further information was provided.
Pain at the injection site, he reports he also has pain radiating into the shoulder.  Not clear how these symptoms occurring from injection site in Deltoid region. I make sure the injection is administered in the mid point of Deltoid muscle (at lest 3 fingers width  below from the shoulder joint), not too close to the shoulder joint. Not clear why he took this long to report. When asked when the symptoms began, he said the symptoms began post vaccination, He did not see any provider yet, he said he will see his doctor in the near future and will let us know.
pt stated started feeling weird the noc of 24OCT96;face swelled & got hives a day later;
rash all over body; itchiness all over her body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash all over body) and PRURITUS (itchiness all over her body) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007821A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (rash all over body) and PRURITUS (itchiness all over her body). At the time of the report, RASH (rash all over body) and PRURITUS (itchiness all over her body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Child woke up AM of 8/27/04 with upper right arm swollen, hot and hard. Swelling from shoulder to just above elbow. Mom giving Tylenol for relief of pain. No other sx. Advised mom to continue with Tylenol or Ibuprofen for swelling and cold compresses and to call MD if sx worsen or don't get better over next 7 days. 9/8/04 TC: child is fine arm swelling lasted  6 days from onset.
Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant medication were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (therapy type was rHA, dose, and route were unknown, lot # and expiration date were L050907, 14-JUN-2017; M002058, 11-JUL-2017; M006107, 01-AUG-2017; M011661, 08-SEP-2017). No adverse event was reported. This is one of two reports received from the same reporter. Additional information has been requested.