chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This non-serious spontaneous case, was initially received on 14-Aug-2017 from physician, concerning a 07-year-old child, female patient. Physician reports 10 patients who were vaccinated after multiple temperature excursions. This report was ninth of 10 reports. On 04-Aug-2017, the patient was administered with FLUCELVAX QIV (batch number: 186686 (reported as 185586, 186686), expiry date: 31-May-2017, dose, route of administration, anatomical location: not reported). Multiple temperature excursions were occurred on 02-Mar-2017, vaccine was stored at 47F for 14.7h (1st excursion), 03-Mar-2017, vaccine was stored at 47F for 16h (2nd excursion), 04-Mar-2017, vaccine was stored at 47F for 19.75h (3rd excursion) and On 07-April-2017, vaccine was stored at 35F for 14.5h (4th excursion) which was considered as incorrect product storage. As the patient was administered with vaccine which was stored at 46F to 77F up to 24 hours instead of storing at 36-46F which was considered as drug administration error. Non-significant case correction received with IRD: 14-Aug-2017: Batch number (186686) was captured in the case form and narrative was amended accordingly.
Flu like symptoms lasting 12 hours; 20 days later, severe pain in back near left shoulder blade; 2 days later, Shingles developed.
Pt. wanted prefilled syringe b/c of latex allergy. She was instructed to hang around the store for 15 min. Pt. returned 2 min. later stating throat feels is closing up. Started trying to clear her throat. Started going pale & sweating. Administered EPIPEN in rt. thigh & gave her #2 BENADRYL. Pt. didn't want 911 called. Went home to call dr & lie down.
pt recv vax & reporter did not know it the pt was pregnant @ time of vax or became pregnant shortly thereafter;an ultrasound revealed an abnormally devel urethra in the fetus;
Sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 2nd August 2022, the patient received Shingles vaccine. On 2nd August 2022, less than a day after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK receipt date: 2-AUG-2022 Reporter's comments: This case was reported by patient via interactive digital media. The patient went and had his/her vaccine today after a recommendation from doctor.  The patient had sore arm so far. The follow up would not be possible as contact details were not provided.
This is a spontaneous report from a non-contactable consumer reporting for his/her mother. This female patient of an unspecified age, race and ethnicity received PREVNAR 13 via an unspecified route of administration in the arm on 22Nov2016 at 0.5 ml single for immunisation.  The patient medical history and concomitant medications were not reported. On an unspecified day in Nov2016 after the vaccination she had fever and swelling in the injection site that were recovered in 2-3 days but since 27Nov2016 in the morning the site of vaccination started getting swelling again, red and itchy, the size of redness was 50/70 millimeters and it covered most of the upper arm, she was having fever. Outcome was unknown. The reporter asked if it was normal to have recurrence of the problem after fever went down. No follow-up attempts are possible. No further information is expected.
This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown 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 provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had Shingles vaccine and still get shingles just as bad. The follow-up would not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR084559   Additional Information: GSK Receipt Date: 15-JUN-2023 This case was reported by a patient via interactive digital media. It was reported that a patient who got the Shingles vaccine shot immediately got shingles. The follow-up could not be possible as no contact details were available. This case is linked with US2023AMR084559 and US2023AMR084563, same reporter.; Sender's Comments:  US-GSK-US2023AMR084563:Same Reporter US-GSK-US2023AMR084559:Same Reporter
Local site reaction on left deltoid 1.5" diameter erythema, warmth No lymphadenopathy, no fever, full ROM of arm
This spontaneous report as received from a physician refers to multiple patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of improperly stored PROQUAD lot# M031568 with expiration date of 24-DEC-2017, lot# N001489 with expiration date of 12-JUL-2018, lot# M035143, lot# M041082, lot# M042501 (expiration dates were not reported) (dose, route of administration and anatomical location were not reported) for prophylaxis. From an unknown date in October 2016, the vaccines underwent multiple temperature excursions (details to be determined) which were detected by a digital data logger. No adverse effects were reported.  This is one of several reports form the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA004395: US-009507513-1708USA003935: US-009507513-1708USA004392: US-009507513-1708USA004394: US-009507513-1708USA004408: US-009507513-1708USA004409.
Information has been received from a Licensed Practical Nurse concerning an unspecified numbers of patients. On a unspecified date, the patients received a batch of improperly stored GARDASIL (dose, strength, route and lot# were not reported). No adverse effects reported. This case was one of the three reports received from the same reporter. (Other two products were captured in cases 1503USA003160 and case 1502USA005910). Additional information has been requested.
The patient received her vaccination and waited the 15 minutes and the post vaccinating associate was asked to sit with her as she was feeling weak and had a bad day. She felt better and went to leave and had difficulty walking due to weakness in her legs.  We helped her to a chair, checked her BP and it was 194/106 pulse 96.   No meds were given. She explained that her mother was set to the hospital today and was just upset.  Her BP did not improve so we called paramedics.  Paramedics reviewed her situation   She refused to go to the hospital and was taken away by her father who was with her.
Headache, body aches, chills then a couple days later a rash on neck, left chest and right arm. Still had a rash one week later, yesterday. Used calamine solution and took Benadryl.
Injection Rxn at lower left arm, not at injection site, redness, slight warmer temp at lower arm (above elbow), Pt felt dizzy and anxious. Was given Loratadine to Pt, instructed to take if feel any worse.
Approximately 2-3 mins after the injection, patient can to the pharmacy jittery, and stating he couldn't see and felt dizzy. Stated his pulse was felt low. Patient became pale and stated he has ringing in the ears.
Pt given Adult Pfizer Bi-Valent Booster in accidental error. Pt family member, caregiver; mother informed of event. Informed of  outcome of reporting to regulation agency and clinic system reporting.  Understood information.  Relayed information of clinical trials of processing for vaccination of adult dosing on pediatric pts and outcome of that with no significant adverse effects as background on case but not as supplemental evidence for appropriate use.   Informed of administration of adult dose for booster was in accidental  error for pt, understood.   Relayed to caregiver to monitor  pt for adverse effects, pt may expect increased tenderness and may need additional rest. Pt caregiver will follow-up with clinic to report issues, should there be any and stay in contact with f/u  personnel . Relayed can expect a call from clinic system and regional for monitoring.   Pt tolerated injection well, at time of visit.
1 week following second dose of vaccine, left subclavicular lymohnode became swollen and tender. Chest x ray showed no findings. Two months later lymoh node edema persisted and I had a chest/abd/pelvic ultrasound which indicated a 4.5 cm mass in left lung, possible metastasis to the spine, liver, and now shows metastasis to the brain in recent brain MRI.  CT scan findings confirmed by biopsy indicating adenocarcinoma.
Received pneumococcal, Td, flu vaccine. Received pneumo in right arm. Red mass in arm, part of chest back area.  Joint pain, headache, nausea.
Vasovagal response, anxiety in Pod 7.   Pt reported dizziness and was lowered to ground, supine w/ BLLE elevated on chair.  Slight flushing in face.  No facial edema noted.  Auscultated lungs/airway, CTA, no stridor or other adventitious lung sounds noted.  Transported to Med Obs 1 via litter for further assessment.  VSS.   Encouraged water, pt drank 1 small bottle and ate 2 pretzels.  Pt reported dizziness resolved at 1025 VS prior to escorting out stable and listed below Sitting @1030  BP120/77, HR 66, RR 12, 99%RA Standing @ 1032 BP 114/73, HR 78, RR 14, 100%RA
hoarse voice; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (hoarse voice) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced DYSPHONIA (hoarse voice). The patient was treated with OMEPRAZOLE at an unspecified dose and frequency. At the time of the report, DYSPHONIA (hoarse voice) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
Patient received vaccine on 01/14/2019, Reported to clinic with chest discomfort /pressure x 2 days. No fever, shortness of breath or audible friction rub on auscultation. EKG was abnormal and indicated acute pericarditis. Lab showed very slight Troponin and CKMB elevation. Echo scheduled for Monday AM at 08:00. Patient started on anti-inflammatory. Patient advised not to exert himself and to report to ER over the weekend if symptomatic. Will follow up with PCM Monday after Echo for further eval.
Fever for 16 hours. 3in diameter bump at injection sire with discolored skin
Patient states bursitis was caused by a high injection given on 9/23/2018. Initial pain other than normal flu shot feeling began about two weeks after the shot. The patient is in constant pain when moving his arm and is process of seeking further medical attention.
On May 19th at approximately 10-1030 pm. My father suffered a heart attack with no warning and died instantly. He was fine all day long, fine since the second shot. We don?t believe the vaccine was the cause but maybe it jumpstarted something.  We wanted to alert someone for knowledge or research. We did not have an autopsy.
about 1 hour and 15 minutes post injection (I waited in area as recommended for thirty minutes because of hx), I had the sudden onset of  itchy runny nose and  chest tightness and wheezing of significant intensity that I  needed to use inhaler then and again later in the day. Noteworthy, I had  as a precaution taken prednisone 20mg p.o  about 2 hours before the injection.  I had to take more  later that afternoon because of symptoms. I then seem better but several times since the vaccine I have needed to uses the inhaler  and take prednisone  more than I have except after an infection about 6 years ago that precipitated similar symptoms to now. Today I had a flare significant enough that except for covid I might have gone to the ER or urgent care.
Fever (3+), Chills, Severe joint pain, Sweating (Profuse), Headache/NeckAche,  Dizziness, Swollen lymph node(Neck), Shooting pain in neck and joint, Dry swollen pain in throat, diarrhea (sickness lasted 6-8 days), Fatigue
I had soreness in both shoulders. I had a 101 fever, I had drainage in my throat. I also had a cough. I woke up and sweating. I had a headache, and I could hardly breath out of my nose. I did not go in to get checked out. Sometime in late June or early July I started to have allergy problems. I was sneezing a lot. I haven't had any more problems, but I was still having pain in my shoulders. I had a hard time sleeping. I could sit up and sleep but not lay down. I still must prop my shoulders up. They still hurt. It has extended to my upper back and middle of the back. At one point my left shoulder was swollen and hot to the touch that went away and I did not have it again.
Rash at injection site, right and left upper thigh, 9 days after vaccine admin. date; rash spread to stomach and face. Seen and treated for urticaria and vaccine reaction, received 5 ml BENADRYL q 4 hours prn and ORAPRED 15/5 3.5 ml po bid.
I went to oncology office where doctor mandated I get the PREVNAR vaccine for old people for tests. HOWEVER ironically oncology office did NOT provide the vaccine & the same day told me I needed to get it done. I went to my primary physician who is awesome & repeated what dr ordered. Within 30 minutes I started having side affects of the arm soreness however I couldn't even lift mine for over a week. I was dizzy I began to run a fever but being I have lupus (many days I run a fever). I also had chills but this to goes with lupus. The symptoms mimicking lupus GOT WORSE & by the first & second week of November I entered the worst lupus flare IN MY LIFE & got strep & pneumonia. After the vaccine my strep would not go away / pharyngitis. I was anemic & my blood work was at its worse. The holidays just amplified everything & sadly I could not even get into my primary til the first week of January to go over how sick I was. I consistently used teledoc & the other medicine app bc the vaccine within a week had my immunity so low I could not go in public without getting sick. My bloodwork AFTER vaccination was worse than its ever been. However oncology office at no time did anything to even remotely help. I remember crying to my friend through November, Jan & Feb bc I was afraid my body was shutting down.
Ischemic stroke Acute muscle weakness on right side Went to emergency room Felt normal three hours later Stayed in hospital two days
Left Arm became sore 2 days after receiving injection. The arm was better x 5 days. on 1/22/21 her arm became sore + swollen again. Denies fever or chills. on 1/28 still having redness in her arm. Also feeling itchy + achy.
As Hep B vaccine was being administered, needle with came unattached from syringe.  Unsure how much vaccine was delivered.  Patient family was informed and plan to give Pediarix at 2,4, 6 months will complete series.
4 inches of hot, red, swelling, upper (L) arm Same reaction in 2017 with flu vaccine
Woke up at 4am on 1/10/22 with severe dizziness. Could not walk without support.  Unable to do any ADLs and stayed in bed and on couch. Went to PCP on 1/11/2022. Prescribed methyl prednisone 4 mg do sepal and Meclizine 25mg tab P.O. q 8h. After 2 days of treatment very little improvement.
I've had 3 vaccines and still getting shingles/ Suspected vaccination failure; Shingles; I've had 3 vaccines; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 1st dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 3rd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and extra dose administered. On an unknown date, the outcome of the vaccination failure and extra dose administered were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The patient had 3 shingles vaccines and still getting shingles. The patient stated it had been over 10 years and the patient was so sick of it. The patient received 3 Shingles vaccines, which led to extra dose administered. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Primary:  arm swelling, soreness, redness at shot site...never had this in the previous 2 doses Secondary: SEVERE fever and chills over first night after shot...never anything like it...not even close...an 11 on a 1-10 scale
Vaccination was administered outside of best use time window. Vaccination is good for up to 6 hours once punctured if refrigerated; it was administered 1.5 hours outside of this window.
Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 30-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use on 15-Jan-2021. Concurrent medical conditions included Allergy to antibiotic (Allergic to lorabid, ceclor and amoxicillin.). Concomitant products included MINERALS NOS, VITAMINS NOS4r for Pregnancy.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 03-Jan-2021 and the estimated date of delivery was 10-Oct-2021. On 25-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  third week of the pregnancy.  On 25-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient showed mild redness on site on 8/10/13 redness to pharmacy 8/11/13 at 9:00 am with mild fever and 4-5 inch reaction redness hot to touch. Patient was going to ER for further workup.
4 Days after my first shot I got minor hives on my back.  4 Days after the 2nd shot I broke out in hives all over.  Since that time I have chronic hives (pretty much everyday for 6 months) that happen with pressure and/or heat in the evening  and sometimes from being in the sun.  They got worse through the summer so I went to my family doctor and she told me to try taking Allegra each day which is working.  I usually take my Allegra at 9:00 PM and I usually get hives around 8:00 PM - due to the medicine wearing off?  I get them if I am sitting or laying on the couch for more than an hour (usually on my back, sometimes on my arms, and sometimes on my legs.  I also get them on my feet if my shoes are too tight during the day.  I am a little nervous about getting the booster as I am afraid it will make this condition worse?
Information has been received from a physician concerning her 27 year old daughter who on 10-OCT-2007 was vaccinated intramuscularly with a third dose of Gardasil vaccine. On 10-OCT-2007, the patient fainted immediately. The physician reported that on 10-OCT-2007, her husband came and picked up her daughter at the physician's office and brought her home; the patient was fine then and wanted to go back to work. On 10-OCT-2007, the patient recovered. It was reported by the physician that the patient did not have a reaction to the 1st or 2nd dose of Gardasil vaccine. Additional information has been requested.
Information has been received from a physician concerning a patient who on 21-MAR-2008 was vaccinated with the first dose of varicella virus vaccine Live (Oka/Merck). On 21-APR-2008 the patient returned to the office and received zoster vaccine live (Oka/Merck) instead of varicella virus vaccine live (Oka/Merck) (human error). No product quality complaint involved. The patient did not seek medical attention. Additional information has been requested.
Hives; Rash on back, sides, butt, stomach.; Itchy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (Rash on back, sides, butt, stomach.), PRURITUS (Itchy) and URTICARIA (Hives) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 07-Mar-2021, the patient experienced RASH (Rash on back, sides, butt, stomach.) and PRURITUS (Itchy). On an unknown date, the patient experienced URTICARIA (Hives). The patient was treated with PREDNISONE at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, RASH (Rash on back, sides, butt, stomach.), PRURITUS (Itchy) and URTICARIA (Hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication were reported.