chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information was received from a 29 year old non-pregnant female physician assistant via company representative, referring to herself. The patient's medical history and drug reactions/allergies were not provided. Concomitant therapy included MIRENA. Since an unspecified date in 2006 to an unspecified date in 2007, the patient was vaccinated with 3 dose series of GARDASIL (lot#, expiration date, dose and route were unknown) as routine vaccination. Subsequently on an unknown date (reported as "recently") after vaccination, the patient was diagnosed with ovarian insufficiency. The patient had seen an unspecified gynecologist for medical attention, and would be receiving an unspecified injectable medication for In-vitro Fertilization (IVF) treatment. The outcome of ovarian insufficiency was unknown. The causality between ovarian insufficiency and GARDASIL  was unknown. Product quality complaint was not involved in this event. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA012207.
Suspected vaccination failure; Got shingles; 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: The age at vaccination was not reported. The patient had the shingles shot and experienced shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
2nd shingle shot 8 months later; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received 2nd shingles shot 8 months later, which led to drug dose administration interval too long.  The patient asked that was it going to make his/her vaccine ineffective. The follow-up would not possible as no contact details were available.
Gave shot around 10:15am , chest felt tight around 10:40am not feeling well , 10:42 eyes rolled up  called EMS 10:43am, transported at 10:49am.
Pt had a placental abruption on 9/4/21. She started bleeding at 6 AM. Presented to Medical Center at 649 AM. She was taken for an emergency c/s that morning and a placental abruption was noted. Placental pathology confirmed abruption. She was 33weeks 5 days at delivery.
Headache, Myalgia, Arthralgia, Fever, chills, fatigue Narrative: symptoms only lasted 1 day
Patient suffered a stroke, and has ongoing Vertigo, Migraines, blurred vision.
This spontaneous prospective pregnancy report as received from a registered nurse refers to a 31 year old female patient with no known allergies and no pertinent medical history reported. On an unknown date the patient was vaccinated with a dose of M-M-R II (lot number and expiration date not reported) (dose and route not specified). No other suspect therapies or concomitant medications were reported. On 03-JUL-2013 the patient had a negative titer test (negative for mumps titer and low for rubeola titer) and due to this the patient received a second dose of dose of M-M-R II (lot number and expiration date not reported) (dose and route not specified). The registered nurse reported that the patient became pregnant with-in three weeks of the dose of M-M-R II. Last menstrual period was reported as 27-JUL-2013, with a calculated delivery date of 03-MAY-2014. The outcome for the above mentioned events was unknown at the time of the report. The registered nurse did not assess the causality between the above mentioned events and M-M-R II. Additional information has been requested.
Symptoms: an hour after the initial second dose injection I began to have a severe migraine. Later in the evening, I had chills, aches, same severe migraine, and my arm began to ache. Noticed a red lump the size of a silver dollar around 7:30 in the evening, it was hard, warm to the touch, and swollen at the injection site. I slept on an ice pack to see if it would bring the swelling down. The next morning (March 1st) it was still hard, warm to the touch, swollen, and very tender. I noticed it had also grown in size. It is now the size of a fist. I took measurements it was 1 1/2 inches across and 2 inches in height.
She will not be taking her third dose of Vivotif on 07FEB2020; Spontaneous report received on 07FEB2020.  A female consumer reported that "she will not be taking her third dose of Vivotif on 07FEB2020" (PT: Product dose omission). The consumer was receiving Vivotif for immunisation. She had taken her first two doses of Vivotif as per the schedule. She reported that she would not be able to take her third dose of Vivotif on 07FEB2020. She did not identify the reason why she will not be able to take her dose on 07FEB2020. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer reported on the morning of 07Feb2020 that she would not be taking her third dose of Vivotif on the scheduled date, 07Feb2020 (missed dose). Further details of the event is limited. Considering the nature of the event, the causality of missed dose is assessed as not applicable to Vivotif.  .; Sender's Comments: A consumer reported on the morning of 07Feb2020 that she would not be taking her third dose of Vivotif on the scheduled date, 07Feb2020 (missed dose). Further details of the event is limited. Considering the nature of the event, the causality of missed dose is assessed as not applicable to Vivotif.
Two weeks after the shot, light dry cough.  cough turned into shortness of breath.  Left foot started to burn.  Ringing in both ears.  Breathing is better now, but not normal.  Left foot still burns and ringing in both ears.   Sparkles in eyes/may not be related.    Hospital said could not say if symptoms were vaccine related.  I have a kidney problem, the Doctor at hosptial said to follow up with primary care physician
Localized erythema and edema to upper left arm. Associated with local pruritis. Prescribed diphenhydramine 25mg PRN.
Hives, swollen throat, itching within one hour. Took Claritin, and has continued with Claritin since then.
Sick for days (terrible reaction); This case was reported by a consumer via call center representative and described the occurrence of sickness in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-Oct-2022 Reporter's Comment: The reporter was the patient. The patient stated had a terrible reaction to the 1st dose and was sick for days. Patient did not provide date of injection, site of injection, lot expiration information or the type of reaction experienced. No additional information was provided. Not all information was available. Reporter stated she does not like giving personal information. Reporter did not provide consent to follow up with HCP. Reporter did not consent to follow up.
Arm pain, shoulder pain, numbness, tingling, nerve pain, arm weakness, armpit pain, loss of feeling in fingers, back pain
Patient received two immunizations in left arm properly spaced and at first felt ill. Friday felt weak and joint pain. Saturday, 9/16, noticed redness from below two injxn sites extended to elbow. Warm to touch. Suspect phlebitis.
tinnitus; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP/patient's friend) from a Pfizer sales representative.  A patient (no qualifiers provided) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "tinnitus".  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021443460 same reporter, drug and event/ different patient
Information has been received from a nurse concerning a 11 years old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 17-JAN-2017, the patient was vaccinated with a dose of improperly stored GARDASIL 9 (lot # M024261, expiration date, dose and route unknown) 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-009507513-1703USA002795: US-009507513-1703USA002796: US-009507513-1703USA002797: US-009507513-1703USA002799: US-009507513-1702USA010448:
Mom brings patient in because of a feared reaction to his vaccines (PENTACEL) given earlier today --8hrs ago. He received his vaccine around 10am then he slept much of afternoon. Awakened at 3pm w/fever up to 101.3 and his entire left leg, not including foot, appearing swollen w/ red w/ purple splotches. Mom applied a cool washcloth and leg sx resolved after 30min. Upon awakening, he was also "crying for a long time as if in pain". Gave TYLENOL at 3 w/ fever and crying eventually resolving "maybe after an hour or 2". Has seemed fine since then. Mom notes that he had this same problem when he received his 2 mo shots at an outside clinic. Mom had discussed this w/ Dr, whom they are established w/ now. They agreed to split his 4 mo vaccines, receiving his Pneumococcal and Rotavirus vaccine on 6/24. He had no reaction at all following these.
THE FIRST EVENING AND THROUGH OUT THE NIGHT I WAS EXPERIENCING A TIGHTNESS IN MY CHEST BUT THE NEXT MORNING IT SUBSIDED.  THEN THE NEXT MORNING AND FOR TWO WEEKS I WAS UNABLE TO BREATHE DEEPLY SINCE I WOULD ERUPT IN A COUGHING FIT AS IF I WAS EXPERIENCING AN ASTHMA ATTACK-BUT NEVER HAS ONE.  MY INJECTED ARM WAS VERY SORE FOR 10 DAYS.
Delayed vaccine reaction- injection site swelling, redness, itching, mild discomfort, 2 inch x 2  inch ?goose egg?, warm to touch. Zero symptoms prior.
4hrs post vax pt noticed erythema around inj site progressed to a rash encompassing whole arm (rash raised & itchy,hive like) also axillary swelling sx lasted 20-36hrs;
This literature report concerns a series of 10 fatalities cases after H1N1 vaccinations. These 10 cases involved 2 children, 7 adults and 1 elderly reported. This case (5 of 10) concerns a 46-year-old female patient, who had a medical history of hypertension, hyperlipidemia, pulmonary embolism and deep vein thrombosis. The patient died of pulmonary embolus (negative for H1N1 in lung tissue) two days after H1N1 vaccination (type: monovalent inactivated, split-virus or subunit vaccine;manufacturer: unknown). VAERS (Vaccine Adverse Event Reporting System) received 13 reports of deaths occurring after receipts of H1N1 vaccine: 3 deaths occurred after receipt of LAMV (live, attenuated monovalent vaccine) and 10 after receipt of MIV (monovalent inactivated, split-virus or subunit vaccines). In 9 of these deaths, significant underlying illness (including illness that might be indication for vaccination) was present; 1 death resulted from a motor vehicle crash, and the remaining 3 deaths await review of final autopsy results or death certificates by CDC (Centers for Disease Control).
Patient received first dose of Moderna on 3/18/31 while receiving second dose of Moderna on 3/31/21 - having received second dose of vaccine too early.
Fever, severe headache, dizziness, nausea, weakness, lethargy.
Saturday April 10 - Immediately after receiving injection in left arm I had great pain and felt the warm sensation moving up my shoulder, I remained at the facility for 15 minutes and took 2 Tylenol before leaving the parking lot and driving the hour back home.  At 5:00pm I took two more Tylenol, at 8:00pm the fever began, along with feeling very achy, rapid heartbeat and breathing slightly heavy. The rapid heartbeat lasted for about 11 hours. At one point my heart rate was 102 beats per minute.  The fever Sunday April 11 stayed at 101.1-101.4,  At tines I felt of balance, my throat is very sore and I had a stuffy nose, Could barely keep my eyes open.  Monday April 12, fever has broke  but now I have a rash on my face and other areas of my body.   I did not go to the ER or doctor
Guardian noticed first signs of reaction 8 days after vaccine administration around 8 PM. Symptoms were swelling in left upper thigh, skin was pink but no change in temperature to touch. Child would not bear weight on left leg. Next day (within 24 hours) symptoms were gone.
The pt experienced hives which developed 14 hours post 2nd Prevnar vax. No reaction on 1st. Treated with Benadryl only.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Sep2023 at 16:00 as dose 1, single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered" (03Nov2023 at 08:00) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) positive, notes: COVID 19 Treatment; (03Nov2023) Negative, notes: Tested negative no symptoms. Time: 08:00 AM. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient had no known allergies.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
approximately 8 days after the vaccine developed malaise, fatigue, low grade temps and lower extremity pain. 9/22 duplex: Superficial thrombus in R saphenous vein. Superficial thrombus seen in L calf area and DVT in intramuscular gastrocnemius vein. labs with mildly elevated inflammatory markers. Had Ct chest/abd/pelvis as part of malignancy workup, which was negative.  Put on anticoagulation x 3 months.
Shortness of breath, coughing, asthma, history "small windpipe" no other prior history of asthma.
Feb 5: Soreness in arm. No other symptoms Evening of Feb 5: Significantly decreased endurance, fatigue Morning of Feb 6 through evening of Feb 6: Dizziness/motion sickness worsening as the day went on (feel like I need a dramamine), Worsened with concentration and fast movements. High resting heart rate, pounding heart in chest, body feeling hot/like it's on fire, sweating randomly throughout the day, occasional chills (however not the same as chills from a fever), winded easily/decreased endurance,  Overall, the evening was the worst. Had to leave normal activities to go home as heart rate was high, had dizziness, and difficulty doing normal daily tasks due to decreased endurance.  Woke up on Feb 7 completely fine.
Light headed, runny nose, sore throat, tiredness, watery eyes. Started to get a sore throat about 11 pm on 4/5 and by the time I woke up at about 6:30 am on 4/6 turned into "cold-like" symptoms. Seems to be getting worse throughout the day.
Within 24 hours of getting vaccine booster, left arm painful, headache, chills/fever/ muscle soreness, unable to get out of bed or consume food. Over next 2 weeks pain developed up to left shoulder & neck, and persistent headaches began.  Visit to NP who ordered x-ray of cervical spine & prescribed diclofenac sod.  Persistent headaches continued and interfered with daily living activities (normally VERY physically active & healthy, low Blood Pressure).  Vision changes began at about a month post vaccine - double vision & eyelid drop (left side).  All pain on Left side of head/body.  ER visit#1 for extreme head pain (UNlike migraine pain) & vision issue.  BP notes extremely high (see ER report  (CT scan, EKG, Chest x-ray, blood work). ER visit #2 due to extremely high Blood Pressure.  Heachache & vision issues diminished.  BP continues to be erratic & now under care of cardiologist. Now muscular pain developed in rest of body, not joints, just muscles.  A continuation of smpton that came on suddenly in December after receiveing my Moderna booster.  I had a clean bill of health prior to the booster.
Fatigue and fever, overall body aches and pains congruent with a bad flu, lasting 2 days so far and continuing
Onset of fever, chills, nausea, and intense night sweats 6 weeks and 2 days after vaccination. The fever, nausea, and night sweats lasted for 8 days.  While it is unknow if the illness could have been associated with vaccination 6 weeks earlier, I am reporting it in case there are other similar cases of fever of unknown origin after vaccination.
This case was considered medically important. Information regarding PREVNAR 13 was received from a healthcare professional regarding a 29-month-old female patient who experienced status epilepticus, almost died and struggled to speak. At 29 months of age, the patient received a dose on 01-May-2010. The patient also received a dose of Hepatitis A Vaccine (manufacturer unknown) on 01-May-2010. The patient experienced status epilepticus on 02-May-2010 as described by her mother as seizing for about one hour and almost died. The patient was hospitalized and had to be intubated. That evening, the patient was extubated. The following day, the patient struggled to speak, however some words were coming back. Outcome was reported as recovering. No additional information was available at the time of this report.
I missed my period. The following month I had the period but then the following month I missed it again. It came back in April and that's when I went to my GYN. I also felt my hormones were off because I felt emotional, moody and down and wasn't sure if it was connected or not.
PUNCTURED VIAL STORED MORE THAN A DAY; RECEIVED AN EXPIRED VACCINE  DOSE/ POOR QUALITY PRODUCT ADMINISTERED; This spontaneous report received from a pharmacist concerned a 26 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1821288 expiry: 15-SEP-2021) dose was not reported, administered on 24-JUN-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On 24-JUN-2021, the subject experienced punctured vial stored more than a day. On 24-JUN-2021, the subject experienced received an expired vaccine dose/ poor quality product administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the punctured vial stored more than a day and received an expired vaccine dose/ poor quality product administered was not reported. This report was non-serious.
First shot was administered 11/16 and had a migraine for 2 days after and then a consistent headache for another 7 days.   Second shot administered on 12/7 and have had a  headache every day since.  Body has been lethargic since first shot was administered and I am an extremely healthy, fit individual that exercises 6 days a week and is nutritionally healthy.  Haven?t been able to work out to my fullest since getting vaccinated.
A female patient of unknown age, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE (lot number, route and site of vaccination were not reported) on an unknown date in 2013. After receiving vaccine, later in the day (2013) she began having tingling in her extremities and chest. She felt tired and had a headache. She was sent home from work. Symptoms persisted and she seen in the ER for these same symptoms. Corrective treatment was not reported. At the time of this report the outcome of adverse events was resolved.  Documents held by sender: none.
PATIENT EXPERIENCED PAIN UP THE ARM AND UP LEFT SIDE OF NECK AFTER VACCINATION. ARM WAS SORE FOR 5 DAYS WITH NO FEVER PRESENT.
Information has been received from a licensed practical nurse concerning a 7 year old male who on 8/5/96 was vaccinated with a dose of varicella virus vaccine live. On 4/15/03 the patient developed full blown chicken pox. It was unknown if the chicken pox required treatment. Unspecified medical attention was sought. Additional information has been requested.
This spontaneous report as received from a consumer's boyfriend consumer refers to a female patient of unknown age who on an unspecified date was vaccinated with a dose of GARDASIL (lot #, dose and site of administration were not reported). No other co-suspects were reported. No concomitant medications were reported. On an unknown date, the patient experienced infertility and she could not carry a child after the first trimester (medically significant). At the time of the report, the patient's outcome was not reported. Additional information is not expected.
This spontaneous report was received from a physician and refers to a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. It was reported that the patient was on recurrent treatment with valacyclovir (indication unknown). On unknown date in November 2014 the patient was a dose of ZOSTAVAX (route of administration, indication, lot number were not reported) and on the same day, she took a dose of valacyclovir. No adverse events were unknown. Additional information has been requested.
Injection site redness and swelling at 4:00pm on 01/15/21 after 1st dose was given at 8:45am on 01/15/21. Mild sore throat noted day before vaccine was administered, first noticed at 9:00am no 01/14/21. Treatments: ibuprofen
Shoulder, biceps, triceps pain and subjective weakness to the Right arm two weeks after dT administration to that deltoid muscle.