chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the medication refrigerator was out of range for the time span of 15 minutes; This non-serious case was reported by a consumer and described the occurrence of intercepted product storage error in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) for prophylaxis.   On an unknown date, the patient did not receive Fluarix Quadrivalent 2022-2023 season. On an unknown date, an unknown time after receiving Fluarix Quadrivalent 2022-2023 season, the patient experienced intercepted product storage error (Verbatim: the medication refrigerator was out of range for the time span of 15 minutes). The outcome of the intercepted product storage error was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 04-AUG-2023 The reporter was inquiring about the viability of his/her supply of Fluarix Quadrivalent vaccine. The reporter's practice lost power and the medication refrigerator was out of range for the time span of 15 minutes. The temperature reached 46.184 degree F. The reporter asked would these vaccines still be able to be utilized. The Fluarix Quadrivalent vaccine stored above recommended temperature, which led to intercepted product storage error.
Medication Error: document error and response taken. Booster dose Pfizer given to 14 yo male.  Error not noted until the family had left the clinic.  No further action taken.
Sudden dizziness and fainting, possible loss of consciousness less than five seconds, stomach upset and nausea lasting five minutes. No shortness of breath itching or hives. Patient recovered and reported no symptoms within twenty minutes. Patient's mother reported she would continue to visit pediatrician after departing.
06/2021- Numbness and tingling down my legs and went it went away and it came back in July then i went to the doctor.   01/2022 i test positive for Covid and bronchitis.
Initially I did not get a period at all for the month of July and the period that I had in June mid to late June was abnormal. It was very short and almost nothing. For the month of July I did not get a period at all but I did experience some cramps. Now it's August and the period finally came but it started out very dark and not a lot of it but very stinky, as in the end of period when the dark but or clots leave the body. It has been like that for 4 days slow, dark, stinky, and with blood clots as if I was having a regular period but I am not. I am experiencing heavy cramping as if it is a full-grown period but that is not the case and it is very concerning. It is concerning because I've never had an abnormal period and never had one to smell the way that this smells. I am on day 4 and I have been taking short notes about each day not knowing how long that it's going to last.
Fever, fatigue , muscle soreness , headache  Motrin 2 tablets  Relieved next day
Developed hives over most of body with groupings on torso and head. Took BENADRYL and applied Cortisone cream with relief of symptoms x 2 days.
Localized Erythema - redness of left arm below deltoid, swelling and hardness of bicep and tricep - no pruritis reported.  to take benadryl, 25mg 4 times per day.
17MAR94 pt had episode of explosive vomiting & eyes rolled back in head, poss loss of consc 2nd episode of vomiting 10 mins later w/nystagmus & loss of color, limp;
Information has been received from a pharmacist who reported on 19Sep2012 she administered a MMR II (lot # 667244/1919Z, expiration date 17Jul2012), 0.5ml once subcutaneously, to a customer and then realized it was expired. No adverse effects were reported. No further information is expected.
I received a Moderna COVID-19 booster on 12/7/2021. On 6/16/2022, I developed a scratchy throat. I then gradually developed mild cold symptoms (mild congestion, headache, general malaise), body aches, and fever. I took a home antigen test on 6/18/2022, and the result was positive. I didn't contact my doctor. Instead, I just stayed at home and waited it out. I didn't even use any OTC medicines to treat my symptoms. Over the 4 days following the day of onset, I gradually improved. However, the malaise and lethargy lingered for about 2 more weeks. On 6/30/2022, I took another home antigen test and got a negative result. On 9/8/2022, I had severe abdominal pains and slight nausea. I did not vomit, however. I ended up going to the emergency room. I underwent an abdominal ultrasound and an abdominal CT scan, and they detected what they believed to a large cyst on the left ovary. They recommended that I see a gynecologist. They also offered me pain medication, which I declined, because I was already taking other medications and I was breastfeeding at the time. The severe abdominal pain lasted for maybe 10 hours. After that, I had tolerable pain for about a month or so. I saw a gynecologist on 9/14/2022. She recommended a surgical removal of my left ovary and scheduled  the operation for 12/8/2022. I decided to seek a second opinion, so I went to another gynecologist on 11/22/2022. The second gynecologist ordered new ultrasound imaging, and it was through this that it was discovered that I did not have one large cyst on the left ovary, but one smaller, hemorrhagic cyst on each ovary. He said that these are quite common and that they resolve on their own. He also said that surgery would be unnecessary. He did not prescribe any medications. Instead, he scheduled for me to come back for a follow-up in 3 months to verify that his diagnosis was correct. The abdominal pains had begun to subside at around this time, and I feel fine now.
MODERATE PAIN AND UNABLE TO LIFT THE ARM OVER THE HEAD FOR 4 DAYS.
Chills, fever, nausea, tiredness, redness at injection site and a sore arm.  Reaction lasted about 36 hours.  I recovered fully.
Chills, headache, fever, profuse sweating, extreme lower back ache, pain at injection sight. This was my booster. Set in about 12/22, 6pm, 7 hours after booster. By 7am on 12/24, only pain at injection site remains.
This report describes the occurrence of death in child of unspecified age who received Hepatitis B vaccine recombitant (Engerix-B) injection. The report was received as part of litigation proceeding and has not been verified by a physician or other health care professional. On unspecified dates, the pt received doses of Engerix-B (lot ENG225A2 and lot ENG2167A2. Lot number #ENG225A2 is not a valid lot number for Engerix-B. On 12/10/2003, the pt's attorney alleged that "the thimerosal contained in the vaccine administered to the children (child) contributed to and/or caused their deaths." No further info regarding the specifics of their claims is available at this time. It is unknown whether an autopsy was performed.
redness below injection site; itching below injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching below injection site) and VACCINATION SITE ERYTHEMA (redness below injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itching below injection site). On 13-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness below injection site). At the time of the report, VACCINATION SITE PRURITUS (itching below injection site) and VACCINATION SITE ERYTHEMA (redness below injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Patient declined follow up.
Patient describes pain in left arm at injection site.  Has had pain constantly since injection on 8/5/08.  Pain not relieved by NSAIDS.  Patient is referred to neurologist for further evaluation.
I was very tired starting on the day after the vaccine.  Then on the night of March 22 I had night sweats and nausea.  Nausea continues, slight, but very consistent
stabbing pain going through body, ringing in ears, tingling in whole face, headaches, back of neck is sensitive
VACCINE EXPOSURE DURING PREGNANCY; This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 38-year-old female subject who was vaccinated with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Boostrix, GlaxoSmithKline) for prophylaxis while pregnant.   On 10 May 2011 at 16:45 the subject received a dose of Boostrix at 0.5 ml in the left arm. The subject experienced vaccine exposure during pregnancy. Her date of last menstrual period and estimated date of delivery were not provided. At the time of reporting the pregnancy was ongoing. No additional information is expected as subject's at this facility are only seen once and outcomes are not known.   Upon internal review done on 13th September 2019, the pregnancy outcome was updated to lost to follow-up.
About 12 hours after receiving Pneumovax in right arm, patient experienced redness, swelling, erythema, and pain from right shoulder to forearm.  Patient contacted PCP and was referred to ER.  Patient was diagnosed with cellulitis and began IV antibiotics (drug and dose unknown) and started cephalexin, 500mg PO QID.  After PCP visit, received rocephin 1 gm IM and will continue cephalexin x7 days.
This spontaneous report was received from an approximately 75 year old male patient. The patient's concurrent conditions included blood pressure abnormal, diabetes (unspecified), a sinus disorder and other unspecified medical conditions. The patient had shingles around March 2014 (reported as ''about 3 years ago''). The patient did not have allergies or drug reactions. In approximately March 2015 (reported as ''about 2 years ago''), the patient was vaccinated with ZOSTAVAX dose 1 (dose, frequency, route of administration, lot # and expiration date were unknown) for prophylaxis. The patient reported that it was other-than-indicated in the Prescribing Information, however it was not specified. Concomitant medication included unspecified blood pressure and unspecified sinus medication and other unspecified medications. In January 2016, the patient underwent a colonoscopy and it was discovered that he had three polyps at unspecified locations and one polyp on the appendix. Subsequently, in the same month he was admitted in the hospital and he had a surgery to remove his "appendix and part of his small colon" (appendectomy and Small intestine operation). The day after the surgery, the place where the patient was operated on, ruptured (postoperative wound complication). Therefore the patient went through another surgery and he was placed in a medically induced coma and he was in a coma during almost 3 weeks. On an unspecified date in 2016, the patient was revived from coma and was hospitalized for another 3 weeks. Then he started and indeterminate rehabilitation. Consequently, after 5 1/2 weeks in hospital the patient's lung collapsed (Pneumothorax) and he acquired pneumonia. He stayed in hospital for 3 other weeks. On an unknown date in 2016, the patient recovered from pneumothorax and pneumonia and patient was discharged from hospital. In November 2016, the patient developed shingles as he experienced chills, a blister feeling, and shooting pains in the chest, back, under arm, around his stomach that felt "like someone sticking an ice pick into him, reportedly. At the time of this report he had not recovered from shingles. At the reporting time, the outcome of appendectomy, small intestine operation, polyps and postoperative wound complication was unknown. Upon internal review, appendectomy, postoperative wound complication, small intestine operation pneumothorax and pneumonia were considered to be medically significant events. No causal relationship was provided between vaccination with ZOSTAVAX and the events. Additional information has been requested.
The vaccine had a beyond use date of  01/14/2022.  I thought the beyond use date was 01/31/2022.   Pt was given the vaccine 4 days past beyond use date.   Pt had no adverse events from the vaccine.
Patient reported a "bubble" formed on her arm shortly after receiving her covid vaccine. Patient also reported that the bubble popped the morning of 4/19/21.
49 yo F here with headache. Posterior head, non radiating. Chronic but worsening for 1 week. Worsen with position (leaning forward). Associated intermittent vertigo.
A 25-year-old female patient had received an intramuscular left deltoid booster dose of ADACEL, lot number C2825AA on 14 May 2008 at 12:00 pm and 12 hours later, she developed a fever of 101 Fahrenheit, chills, aching joints, left swollen cervical glands and inflammation at the injection site which was red, hot and swollen. The event did not require a doctor's visit and the patient had no known allergies. The needle size used for vaccination administration had been 25 gauge, 1 inch. At the time of the report, the patient was recovered from the event. No further information was provided.
Swelling of arm (r) from elbow to shoulder, fever (100.2), warm to touch, blister/ lesion in the center of the red swollen area.
Patient not experiencing any adverse reactions; patient received an expired dose; This spontaneous report was received from a medical assistant and refers to a 2-year-old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history, drug reactions/ allergies and concomitant medications was provided.  On 23-NOV-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) 25 U/0.5 ml, lot # S032056, expiration date 09-NOV-2020, 1 injection (route of administration and anatomical location was not provided) for prophylaxis. No additional adverse reactions were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S032056; expirationdate: 09-NOV-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
pregnancy 31 weeks, Temp 103, chills ,body aches, tachycardia, cough tx ED, sepsis protocol, IV fluids ,
03.22.2021 - AFib Episode 1; hospitalized at hospital - 03.22-25.2021 04.18.2021 - AFib Episode 2; hospitalized at hospital - 04.18-20.2021
Starting about 4-5 hours after vaccine I noticed slight muscle twitching throughout my body. Vaccine was in my left arm and I?m mostly having muscle twitches in my right leg. (Mainly thigh or behind knee) I?ve had it in both legs and my right arm. It?s not severe by any means, just a noticeable twitch that wasn?t there before so I figured it made sense to report it.
COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, Asthma and Allergy to antibiotic (Erythromyecin). Concomitant products included LOSARTAN POTASSIUM (COZAAR) from 01-May-2022 to 05-Jun-2022 for an unknown indication.    On 29-Oct-2021 at 12:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 19-May-2022 to 24-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment.  The patient previously received a COVID-19 Vaccine. It was reported that patient had positive rapid test results after a week of negative, with respiratory symptoms including sneezing and difficulty breathing, coughing.  Device Date: 05-Jun-2022  Company comment: This spontaneous case concerns a 50-years-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving third dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid from 19-may-2022 to 24-may-2022. After a week patient was positive. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 50-years-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving third dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid from 19-may-2022 to 24-may-2022. After a week patient was positive. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
tachycardia and palpitations 6 hours post vaccine.  Sinus tachycardia randomly with PVS, and PACs, Left eye twitching constantly, feeling of overall malaise and unwell feeling
Arm broke out with little bumps; Arm was swollen; Delated cutaneous sensitivity; Arm was itching; Sore arm; A spontaneous report  was received from a consumer concerning a 73-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm, arm itchiness, arm broke out with little bumps, arm was swollen and delated cutaneous sensitivity.  The patient's medical history was not provided. Concomitant medications reported were insulin.  On 19-Jan-2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 19-Jan-2021, the patient experienced the events sore arm. On 26-Jan-2021, the patient experienced the events arm itchiness.  On 27-Jan-2021, the patient experienced the events arm broke out with little bumps, arm was swollen and delated cutaneous sensitivity.  Treatment details included hydrocortisone  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, sore arm, arm itchiness, arm broke out with little bumps, arm was swollen and delated cutaneous sensitivity, was not reported.; 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.
Vaccine given on Tuesday, Wed. morning pt woke with redness, site tender to touch, fever and dizzy. Thursday-fever and dizziness resolved. Still red and tender. Advised to let us know if it worsens.
24 hrs after injection, patient experienced sudden onset of nerve pain in left shoulder (surgery site), back (lumbar region) hips, sacroiliac and knees, affecting mobility. Pain was treatable with 200 mg Gabapentin and 325mg  oxycodone.  36 hours after injection patient experienced nausea, vomiting, low grade fever (99F), soreness at injection site, and muscle pain. Symptoms passed within 48 hours.
Information has been received from a medical assistant concerning an approximately 63 year old female with no drug allergies who on 12-OCT-2007 was vaccinated with and IM 0.65 mL dose of zoster vaccine live (Oka/Merck) (lot# 656395/0290U). On approximately 12-OCT-2007 the patient developed a 10 cm raised red area at the injection site. On 15-OCT-2007, the patient was seen in the physician's office. No labs or diagnostic studies were performed. The patient was not recovered. There was no product quality complaint. Additional information has been requested. 03/26/2008 Follow-up information from the medical assistant indicated that a 63 year old female with no pre-existing medical conditions or allergies who on 12-OCT-2007 at 11:30 was vaccinated with ZOSTAVAX (Oka/Merck) (lot# 656395/0290U) in the right upper extremity. There was no illness at the time of vaccination. On 13-OCT-2007 less than 24 hours after vaccination, the patient developed diffuse erythema with mild induration and mild warmth at the right upper extremity (upper arm posterior aspect). There was no vesicle formation. On 03-OCT-2007 the patient was also vaccinated with a dose of influenza virus vaccine (unspecified) (lot# AFLLA036AA) in the right arm. Subsequently, the patient recovered. No follow-up was necessary. Additional information has been requested.
Patient stated redness and swelling that is spreading on her arm. There appears to be a bump at the injection site, per patient. No puss or fever at this time, but area is warm to the touch. Advised patient to use a cold compress and to take Benadryl. If symptoms do not improve after 2-3 days to report to providers office (patient did speak to provider prior to calling pharmacy)
Severe pain in shoulder, locked shoulder. 2 days with no improvement, I went back to the Dr. She said I was the 3rd person this week with the same reaction. Was given anti inflammation pills and pain medication.
Day of vaccine  headache, fatigue, soreness 2nd day 2/13/21  Had issues sleeping and felt uncomfortable.  In early a.m. hours, felt dizzy, feeling of sick stomach, and fainted in the bathroom.  Paramedics were called by my spouse and they worked with me, then was transported by  Ambulance to emergency room where they ran tests and released me the same day.  I was told by the doctor that apparently my blood pressure decreased too fast causing me to faint.
dizzy; Weird feeling; Weak; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), FEELING ABNORMAL (Weird feeling), ASTHENIA (Weak) and NAUSEA (nauseous) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 041B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced DIZZINESS (dizzy), FEELING ABNORMAL (Weird feeling), ASTHENIA (Weak) and NAUSEA (nauseous). At the time of the report, DIZZINESS (dizzy), FEELING ABNORMAL (Weird feeling), ASTHENIA (Weak) and NAUSEA (nauseous) outcome was unknown. Not Provided          No concomitant and treatment medication was reported.
Pt recvd booster dose of MMR in JUL89; pt exp joint pain & was unable to work;
15:50/Patient felt weak, nauseous, pale and has stiff fingers after vaccine administered  Assessed by RN and EMT Medical Staff. 02 - 98%   HR 59   BP 110/77 Remained awake, alert and oriented, very conversational No shortness of breath 16:00/Patient walked to personal car and sat comfortably and in air conditioned vehicle. 02 - 97%  HR77   BP 120/82 16:30/Patient departed with his wife driving thier vehicle after waiting and relaxing for 30 minutes.