chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Punctured vial was stored at room temperature for over 12 hours; Patient received vaccine after allowed expiry time; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after allowed expiry time) and PRODUCT STORAGE ERROR (Punctured vial was stored at room temperature for over 12 hours) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 078C21A and 051C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after allowed expiry time). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Punctured vial was stored at room temperature for over 12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after allowed expiry time) and PRODUCT STORAGE ERROR (Punctured vial was stored at room temperature for over 12 hours) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medication was reported. No treatment medication was reported.
This is in follow-up to report(s) previously submitted on 10/12/2007. Information has been received from a licensed practical nurse concerning a 16 year old female student waitress (136 pounds, 63 inches) with allergy to white oak who on 08-JUN-2007 was vaccinated with her first dose of GARDASIL (Lot#657621/0387U, exp. February 2010) in the buttocks by a different physician's office than the reporting physician. There was no concomitant medication. On 16-AUG-2007, the patient was vaccinated with her second dose of GARDASIL (Lot#655849/0263U, exp. 04-AUG-2009) in the right deltoid. "Two weeks after the vaccination," on approximately 30-AUG-2007, the patient developed little white bumps (also described as little red bumps)that come and go, over and over, on her hands, knees, and wrists. The bumps appeared and disappeared 2 to 4 times a day and last about one half an hour. They were also described as hive-like bumps on her knees and elbows that appeared small, flat, round, red and itchy developing on her bony joints. The patient's hive-like bumps on hands, wrists, knees and elbows persisted. On 13-SEP-2007 the patient presented to the office to show the "hives" type red circles, raised and circular areas. No tests were performed. The patient was treated with CLARITIN. As of 18-OCT-2007 the patient was still having symptoms. The patient sought medical attention at the physician office. According to the LPN, there were no definitive connection to the GARDASIL. The LPN also provided information regarding "a couple" patients' experiences with GARDASIL (WAES# 0710USA00228) and "some" patients' experiences with GARDASIL (WAES#0710USA00229). Additional information has been requested.
made me sleepy; This case was reported by a consumer and described the occurrence of sleepiness in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine, the patient experienced sleepiness. On an unknown date, the outcome of the sleepiness was unknown.   It was unknown if the reporter considered the sleepiness to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per vaccine indication. The vaccination made the patient sleepy.  So the patient set up for Friday mornings, and slept on weekends. For tolerance of 2nd dose of Shingles vaccine, refer case US2020AMR246383.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR246383:same reporter
Patient reports very high fever (104 Degrees self-reported) with chills and nausea starting approximately 18 hours after third dose of Pfizer vaccine. I encouraged patient to contact his prescriber. At time of reporting, I am unsure of resolution of symptoms.
Arm is hot; Tingling in arm her arm; Extreme soreness in her arm like truck ran over it.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Arm is hot), VACCINATION SITE PARAESTHESIA (Tingling in arm her arm) and VACCINATION SITE PAIN (Extreme soreness in her arm like truck ran over it.) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Arm is hot), VACCINATION SITE PARAESTHESIA (Tingling in arm her arm) and VACCINATION SITE PAIN (Extreme soreness in her arm like truck ran over it.). At the time of the report, VACCINATION SITE WARMTH (Arm is hot), VACCINATION SITE PARAESTHESIA (Tingling in arm her arm) and VACCINATION SITE PAIN (Extreme soreness in her arm like truck ran over it.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant information  provided. Treatment included Ibuprofen
Information has been received from a licensed practical nurse concerning a 16 year old female patient, unspecified if she is pregnant, with no pertinent medical history or drug reactions/allergies; who on 03-SEP-2009 was vaccinated with her first dose of GARDASIL, 0.5 ml, intramuscular. There was no concomitant medication. The nurse reported the patient called the office to report she "was late for her period". The date of the last menstrual period was not available. The patient would be scheduled for an evaluation in the office. At the time of the report the patient had not recovered. No laboratory diagnostics studies were performed. No further information is available.
Client reported his date of birth as (Privacy)on the vaccine screening and consent form, which would have made him 18 years old on the day of his vaccination. We were notified the following day by the immunization registry that his actual date of birth was (Privacy), making his actual age on vaccination day as 17 years and (almost) 11 months.
2 days p/vax pt devel a rash on legs & back;rash resolved w/o tx;addtl info recv 13JUN97 indicated that pt  remained recovered;
pt recvd vax in 1087 & in 1990 pt devel mumps & pancreatitis; No further details were provided;
Within a few days I experienced dips in anxiety and mood.  After a couple of weeks, I had a flat affect.   On 2/16 requested assistance, admitted to hospital on 2/17.  Symptoms upon admission were intrusive thoughts and dip in mood.  Released 2/27 after having meds adjusted.  Took off Blood pressure meds and doubled Abilify.
Patient came to pharmacy requesting  Moderna booster. She presented Covid record card showing Janssen dose 4/8/21. Upon processing claim we discovered patient had already received Pfizer 7/6/21.
Knot appeared on my left side of chest near clavicle. The knot moves around.
Approximately one hour after receiving his second dose of DTaP, patient was brought back to the clinic because mom was not able to awake him.  He was pale and listless though vitals were stable - RR of 24, P 110, afebrile - 96.5.  Vitals were monitored and remained stable and attempts were made to awaken him.  After 2-3 minutes he came to and cried loudly for several minutes.  His pulse went to 140, RR 30.  He was alert, responsive and easily consolable by mother.  He was observed breast feeding before leaving the clinic.  Discharge summary rec'd on 03/02/2005 states pt experienced hypotonia and hypotension.
The patient received a dose of Johnson and Johnson Covid-19 vaccine on 04/09/2021. The patient lied about this and denied having had any other prior vaccinations against Covid-19. The pharmacist administered a 0.5 ml dose of Moderna assuming that the patient needed an initial dose of Moderna rather than the 0.25 ml booster dose.
COVID-19 Vaccine EUA. Redness, slight swelling and slight itching at injection site.
Pt reported that the day after her vaccine, she was having severe dizziness, she went to see her doctor who prescribed Meclizine.  She took one dose, then the next day had fatigue and dizziness for the next three days.  She is now doing fine.
Fever of 101.5 commenced at about 9 am on 28 Sept 2022, almost one week after the covid and flu vaccines were administered. Fever abated about 7pm that same day but a slight headache remained.  Took ibuprofen during the day. The fever returned the next few evenings accompanied by slight headache, but I didn't record the temperature or the days; took ibuprofen.   Fever recordings I did make are as follows:  100.4 at 7 pm on 3 Oct 2022; resolved by next morning but a slight headache remained until noon.  Took ibuprofen. Telemedicine visit on 4 Oct 2022 with Physicians Assistant; prescribed Amoxicillin 875 mg, 2 tablets daily for 10 days. 100.4 at 7 pm on 9 Oct 2022; resolved by next morning but a slight headache remained for the morning. Took ibuprofen. No fever 10 Oct or 11 Oct 99.5  at 10 pm on 12 Oct 2022; resolved by next morning but a slight headache remained for the morning. Took ibuprofen. No fever 13 Oct thru 18 Oct 99.7  at 10 pm on 19 Oct 2022; resolved by next morning but a slight headache remained for the morning. Took ibuprofen.
Left arm sore from shoulder to fingers day after the injection which was expected.  At around 12:00 PM on 2nd day after injection (1/7) pain went up neck and entire left side of head.  Left eye pain/heaviness.  Sensitivity to light and noise.  Had to take Motrin 800mg. Still present on 1/8 but less severe.  However at 12:00 PM on 3rd day after injection (1/8) developed pain/numbness/tingling in left leg.  Called PCP office and was instructed to take Tylenol and/or Motrin and to go ahead with 2nd injection.  ? hemiplegic migraine?
temp and chills began at 6pm(1/5/20) , starting at 99.9 and the highest was 101.2 lasted until 1/7/21 at 2AM-also had headache,body aches and nausea . on 1/7 at 7AM I noticed increase pain in my rt arm with a distinctive red area at the vaccine site approximately 3 inches around and swollen lymph nodes in the rt under arms.   Had to call out of work for two days so far.   I am covid recovered from 4/1/20
Excruciating shoulders pain.  Had my first shot on February 10,  2021,  right arm, had second shot March 9, 2021, left arm.   It?s been almost 7 months now and it keeps getting worse.  Cannot find a confortable position to sleep because of the pains, mostly on my left shoulder where I had the second shot.
No adverse event; Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date were administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date were administered) and NO ADVERSE EVENT (No adverse event) in a 73-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Dec-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 19-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date were administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date were administered) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date were administered).    Concomitant medication was not provided.  It was reported that patient was administered with the Moderna vaccine which was beyond the 30 day beyond use date. The beyond use date of lot 023H22A was 15-Dec-2022.  Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jan-2023: Upon internal review on 03-Feb-2023, significant correction was performed to update Suspect product start date,  dose, units, lot number, expiration date, event start date and narrative description. On 24-Jan-2023: Live Significant follow up ; Patient information updated, vaccinations details updated On 24-Jan-2023: Live Non-significant follow up On 27-Jan-2023: Follow-up received contains non significant information. Narrative was updated. On 01-Feb-2023: Follow-up  received, updated non-significant information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
Deep cold shakes Deep headache, head, neck and shoulder pain  left side, undulating Feels "like a giant bit my arm" Upper arm pain, numbness down arm Stiff joints, quads sore Nausea Constipation , lethargy, exhaustion, shortness of breath
After waiting 10 minutes patient completely tilts to her right side and is awakened by an employee. Patient states that she feels dizzy, very warm, whole body was twitching and was sweating profusely. Patient also felt the urge to vomit.
Information has been received from a RN concerning a 5 year old female who on 06Aug2003 was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). Concomitant therapy on 06Aug03 included a dose of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (DTAP) and a dose of poliovirus vaccine  (IPOL). On 08Aug03, it was noted that the child presented with rash again. There was no prescription drug required for treatment. The child has not been seen by a physician for this condition. There was no product quality complaint involved. The reporter also mentioned that on 27Jan1999 at 12 months old the child had received a dose of varicella virus vaccine live and developed a rash around the site of injection described as "bumpy varicella-like" that was confined in a 2x2 inch area on the child's thigh. It was noted that every year around the anniversary of her original immunization, the child developed a rash in the same confined area of her thigh as when she was a baby. Additional information has been requested.
No Adverse Event reported by patient -- Pfier 12 and up monovalent given instead of Bivalent (incorrect booster)
Client stated that the evening after receiving vaccine she experienced body aches, high temperature, headache.  Clients states symptoms improved by the next evening 2/6/21.
Patient was administered a SHINGRIX vaccine on 09/11/18 and a few hours after receiving the vaccine she reported impaired vision, describe to us as "crossed eyes" and sensitivity to light as she was driving her vehicle. She had to pull over and wait several minutes and put on sunglasses to continue her drive but still reported some difficulty seeing. She reported to us that she had seen her ophthalmologist approximately 3 months ago and they reported no significant issues with her vision.
Information has been received from a nurse concerning a 14 years old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 20-DEC-2016, the patient was vaccinated with a dose of improperly stored GARDASIL 9 (lot # L024993, expiration date 17-OCT-2017, dose and route unspecified) for prophylaxis. The vaccines were stored at 11.6 degree centigrade for 1 hour and 50 minutes. Data logger was involved in the case. There was previous temperature excursion at 9.3 degree centigrade for 50 minutes. No adverse effect was reported. It was reported that the excursion involved a total of three lots of GARDASIL 9. Two lots (L024993 and M024261) were involved in the event "doses of GARDASIL 9 administered after 13-DEC-2016 temperature incident". This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA008047: US-009507513-1612USA007442: US-009507513-1703USA002792: US-009507513-1703USA002793: US-009507513-1703USA002794: US-009507513-1703USA002796: US-009507513-1703USA002797: US-009507513-1703USA002798:  US-009507513-1703USA002799: US-009507513-1702USA010448:
Systemic: Dizziness / Lightheadness-Medium, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Patient has a history of Sycope during shots and in medical setting. She was put in a prone position to recover which she did within 15 minutes
The lady that gave me the immunization rubbed my arm with disinfectant then looked away at something or someone, then went on to give me the shot about two inches above from were she had rubbed my arm with the disinfectant. In that moment I was just concerned with not having that area disinfected, but since I felt no pain I was happy and I thought she was the greatest. In that same evening I began experiencing pain in my arm. My arm has been in so much pain and my range of motion with that arm is about two inches. When I first stared to feel that my arm was hurting I attributed that to the vaccine. I then stared noticing that I was loosing the range of motion with that arm and yet I had no other symptoms from the vaccine.  Every night the pain is intolerable as my arm hurts so much, even when doing nothing. Even the pull from gravity makes my arm hurt. I went to the Health Department on April 19, 2021 to let them know what was going on with my arm and that I have no other symptoms and they totally dismissed my concern, they said, that since it is not bruised or swollen there is no reason to be concerned. They did say that the shot was given to me in a unusual high spot, but that it  was nothing to be concerned about. They also said that it was totally normal to have arm pain after the vaccine and didn?t even acknowledge that I can?t move my arm and that I am in so much pain. I ended up going to urgent care and the doctor there gave me a splint and said that this was normal pain due to the vaccine. He put me off of work for two days, but my arm is not getting any better. On 4/21 I went to follow up with my primary physician as the pain on my should was expanding and now I have shooting pains toward my neck. She gave me tramadol and ibuprofen for the pain, she also told me to ice my arm and do range of motion stretches. I went back to the doctor on 4/26 as the pain has not gotten better. I have some improvement in my range of motion as I have been doing the stretches that the doctor advised me to do but the pain in my shoulder is still very intense, especially at night. I was told to continue taking tramadol and to now apply heat to my shoulder. She told me to give the healing process more time as my bursa keeps healing.
Feel terrible; Post herpetic neuralgia; This case was reported by a consumer and described the occurrence of feels awful in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included post herpetic neuralgia.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced feels awful and drug use for unapproved indication. On an unknown date, the outcome of the feels awful and drug use for unapproved indication were unknown.   It was unknown if the reporter considered the feels awful to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient had active post herpetic neuralgia and received the shingrix vaccination.  The patient asked would it still work and the patient felt terrible and asked was that normal.
tested positive for COVID after receiving the COVID Vaccine; tested positive for COVID after receiving the COVID Vaccine; This is a spontaneous report from a contactable other HCP from a Pfizer-sponsored Program Pfizer First Connect. A female patient (sister) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Caller stated that her sister tested positive for COVID after receiving the COVID Vaccine. Caller stated that her sister is a respiratory therapist and she has it (COVID) at the same time as the caller. Caller's sister tested positive at the same time as the caller on 01Jan2021. Caller's sister received the COVID Vaccine from a different facility from the caller. The outcome of the events was unknown.  Information on the Batch/Lot number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded.  Further information like confirmative virus genome /nucleic acid detection is needed for meaningful medical assessment.
Patient became faint. He was pale, diaphoretic and complained of tunnel vision. He never passed out.
Initial unsolicited case received from a nurse on 25 May 2018. This case involves a female patient (age not reported) who received a dose of QUADRACEL (Batch number: C5248AA, expiry date, dose, dose in series, route and site of administration was not reported) via subcutaneous route on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unknown date, post vaccination, the patient presented with redness, hot and swelling at the left arm, the itchy bumpy was which was 3 inches in diameter. Lab tests and corrective treatment were not reported. Outcome of the events was not reported. List of documents held by sender: none.
1-2 days following injection patient notices pain and swelling at lymph nodes on right side of body including neck, armpit, groin and ankle lymph nodes. 3-4 days following injection  for a period of 7 or so days  patient experiences acute moderate stuttering in speech which did not previously exist. Patient also experiences acute moderate cognitive impairment like trouble with fluid cognitive abilities like cognitive reasoning, problem solving.  Normal cognitive abilities were impaired. Patient also experienced acute moderate confusion.  Patient was able to perform normal daily tasks
Began as itchiness the night of 2/18 and developed into hives by evening of 2/19. Allegra 12 hour keeps it controlled. Don?t think it?s the vaccine but better to be safe