chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE; Call transferred from specialist with a pediatric patient's mother on the back line. The caller reported that her 4 year old daughter received PROQUAD that was expired on 06/09/2023 and administered on 08/01/2023. Caller declined to; This spontaneous report was received from a pediatric patient's mother referring to her 4-year-old daughter. The patient's concurrent conditions, pertinent medical history, drug reactions/allergies and concomitant medications were not reported.  On 01-AUG-2023, the patient was vaccinated with an expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, expiration date: 09-JUN-2023, administered as prophylaxis (strength, dose, lot #, and route of administration were not provided) (expired product administered). There was no additional adverse event (AE).
Patient stated that some of the vaccine dripped out on her arm, she was worried that she did not get the full shot.   She came back a few days later and I gave her another 0.2 ml of a flu shot.
I had an extra menstrual cycle for the month of July. Approximately 12 days after my last cycle ended.
4/18/2017 - routine check up at doctor. Received shot for PREVNAR 13 Pneumococcal. 4/20/2017 - developed fever of 102 degrees, had aches and pain in back and leg. Had no energy, had to be lifted out of bed and/or chairs, tried to exert himself and could not due to exhaustion. No appetite and appeared to live in a fog (difficulty comprehending and showed signs of confusion) for approximately 2 1/2 weeks. Had difficulty sleeping and persistent cough. Also noticed rash appeared on his back and right shoulder blade. Glucose level is monitored daily and went to 177. 5/5/2017 - went to doctor due to not feeling well. Still running low-grade fever and persistent cough. Doctor ordered blood workup. No medicine given. 5/11/2017 - went back to doctor due to still not feeling well. Doctor wrote prescription for antibiotics. 5/13/2017 - glucose level back to 99 (which is normal). 5/16/2017 - fever normal, cough was diminished, he also appeared to be alert, and his normal self.
The patient was given the pediatric dose of Pfizer for ages 5-11, instead of the Adult Pfizer for 12 and older
dizzy and felt like was going to faint; headache; extreme fatigue; not being able to sleep; red rash; tongue and right arm became numb; stomach ache; joint aches; swelling in right ankle; sweating; dry mouth; watery eyes; nightmares; lethargic; spacey; Extreme hunger; tongue and right arm became numb; welps on my arms and stomach; This is a spontaneous report from a contactable consumer (patient). An adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 29Apr2021 11:00 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included an unspecified "dauphin". The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Apr2021, 11:15, 15 minutes after shot, patient became dizzy and felt like I was going to faint, headache,  extreme fatigue for a few days, followed by a couple of days of having a lot of energy and not being able to sleep, red rash on neck, lower face and welps on his arms and stomach, tongue and right arm became numb. After massage of vaccine site symptoms were stomach ache for a day, joint aches, swelling in right ankle,,sweating, dry mouth, watery eyes , nightmares, lethargic and spacey , feeling, Extreme hunger. The outcome of the events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
generalized facial rash-lasted about 2 days & stomach-not legs-no fever;
Currently 5 months pregnant when offered annual flu vaccine. Medical assistant administered needle into my upper shoulder, creating instant pain. Hours later, numb and palsy from shoulder to finger tips. Contact emergency nurse hotline with primary doctor.  Next morning shooting pain and no range of motion. Two weeks later today, limited range of motion from shoulder to elbow. Excruciating pain.
This spontaneous report was received from a pharmacist via a company representative and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with ZOSTAVAX lot # L036823 (exact dose, route of administration, expiration date and anatomical location were not reported). On an unknown date, the patient developed redness and swelling at the ZOSTAVAX injection site. The patient sought medical attention - was seen by the pharmacist. The patient was instructed to take unspecified antihistamines and use a cold compress on the area as a treatment. The outcome of the events was unknown. Causality assessment was not provided. Additional information has been requested.
11/16/2007 approx. 1:30 p.m. Fri at school admin principal called. Pt was feeling very ill. Could not walk and feeling body weak. Unable to express herself went to ER. Blood work, CT scan EGD test. On 11/18/2007 went back to ER Hosp. Referred to Neurologist w/meds. 12/04/09 ED records received for DOS 11/16/09.  Pt. brought to ED after fainting at school, feeling very tired; c/o shortness of breath, painful urination. Discharged home. DX: ataxia vs. pseudoataxia 12/04/09 ED records received for DOS 11/18/09. Pt presents with vertigo, headache, hot flashes, "legs not cooperating". Discharged home.
He received the shot on 11/5/2019 @1015-1020 and by 1030 he was throwing up and had horrible stomach pain. By 12:20 his right eye was swollen and hurt. I did not give hi. The ibuprofen the doctor office told me to give him when I first called at1104am. When I called back at 104pm I was told to give him Benadryl which I did not. Tonight at 630 it is still swollen but not as bad.
Pain in my left leg and foot, lesions on the bottom of my foot, some swelling. Treated with Valaciclovir, (3 weeks)  Gabapentin (10 days), Tylenol (PRN).  Pain is much better however I still have lesions on my foot.
Awoke on day after vaccination with a headache and tiredness.  Took medication and laid back down to rest.  Woke up for quick meeting with boss but had sensitivity to light and computer screen.  Took more medication and laid back down.  Later in afternoon when I awoke, I didn't feel well and was not hungry and started having a runny nose.  On second day after vaccination, I awoke with migraine and began vomiting.  I attempted to take Tylenol, which didn't stay in my stomach.  The headache and vomiting lasted for the whole day.  I took some anti-nausea medicine to help stop vomiting, which worked but the headache remained.  On the third day after the vaccination, I attempted to take medication to help with headache and stuffy nose, which did not resolve so I called the ER to ask what to do.  Later in the evening, my mother drove me to the ER where they administered 3 shots to bring relief to the migraine.
NO PREVIOUS COVID VACCINES GIVEN BEFORE THE BIVALANT BOOSTER DOSE GIVEN
It was reported that a pt (no specifications were given) experienced an injection site reaction, post vax.
This spontaneous prospective pregnancy report has been received from a nurse practitioner referring to a female patient of unknown age. The patient had no medical history and concurrent conditions. The patient also had no drug reactions and allergies. On 21-OCT-2015 (reported as today) the patient was vaccinated with her first dose of GARDASIL 9 (0.5 ml, once, lot # reported as K016966, expiry date: 10-MAY-2017) on the left deltoid. There was no concomitant therapy reported. On 21-OCT-2015, the patient was found to be pregnant with gestation age at 8 weeks (vaccine exposure during pregnancy). The last menstrual period (LMP) date was reported as 24-AUG-2015. The estimated date of delivery (EDD) was 30-MAY-2016. Then the nurse practitioner put a registered nurse on the phone and the nurse completed the rest of the reported. The nurse stated that the urine pregnancy test was performed on the same day at their lab and it was positive for pregnancy. The patient was in office for medical attention at the time of call. Additional information has been requested.
First dose 4 months ago, no second dose yet; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (First dose 4 months ago, no second dose yet) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (First dose 4 months ago, no second dose yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (First dose 4 months ago, no second dose yet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment was reported.
Extreme pain from my shoulder through my elbow wrist down to my fingers ever since coming and going; Little tired; develop a little pain in my arm where the injection was given; Extreme pain from my shoulder through my elbow wrist down to my fingers ever since coming and going; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). This patient (age: unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: not reported, expiration date: not reported), via an unspecified route of administration as DOSE 2, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, this patient started experiencing little tired, develop a little pain in my arm where the injection was given, Extreme pain from my shoulder through my elbow wrist down to my fingers ever since coming and going and nothing seems to be alleviating this pain. Consumer stated, "I had the Pfizer second shot (clarified as Covid-19 Vaccine) on Monday and then on Monday I was just little tired, on Tuesday morning I was little tired and then I develop a little pain in my arm where the injection was given, I realized it was a normal sort of kind of pain however this is Friday and I have had extreme pain from my shoulder through my elbow wrist down to my fingers ever since coming and going and I have been taking Tylenol, I put some on heat, I sprayed with pain reliever and nothing seems to be alleviating this pain and I don't know quite what to do about it." The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected. Information about lot/batch number cannot be obtained.
DEAD; This spontaneous report received from a consumer via social media concerned a male of an unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose and start therapy date were not reported, 1 in total was administered on an unspecified date in MAR-2021 for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date in JUN-2021, the patient died from an unknown cause of death following vaccination. It was unspecified if an autopsy was performed. It was reported as "vaccinated with J and J one dose", "dead following J and J Covid vaccine" and "It is with great sadness that I tell you all that my son (patient) passed away Monday. I will miss him to the day I die. He was a blessing to everyone that he met and brought joy in everything that he did. Fly with the angels my baby". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20230242008.; Sender's Comments: V0: 20230244421-Dead. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
This case was reported by a consumer via call center representative and described the occurrence of limbs stiffness in a male patient who received TWINRIX. Concurrent medical conditions included bronchitis. On an unknown date, the patient received the 1st dose of TWINRIX. On an unknown date, less than a month after receiving TWINRIX, the patient experienced limbs stiffness, cough and sickness. On an unknown date, the outcome of the limbs stiffness and cough were recovered/resolved and the outcome of the sickness was unknown. The reporter considered the limbs stiffness to be related to TWINRIX. The reporter considered the cough to be unrelated to TWINRIX. It was unknown if the reporter considered the sickness to be related to TWINRIX. The reporter considered the cough to be unrelated to TWINRIX. It was unknown if the reporter considered the sickness to be related to TWINRIX. Additional information was provided as follows: This case was reported by a patient himself. The age at vaccination was not reported. After the shot the patient had some stiffness in the arm where it was received. The patient was due for his 2nd dose on 3rd January 2018, but 3 weeks after the first dose he had walked his dog in very cold temperatures and it irritated his pre-existing bronchitis causing him to have a lot of coughing. His physician decided not to administer the vaccine on 3rd January 2018 due to him being too sick, but he did get an inhaler and the coughing resolved shortly after starting the inhaler. The patient had still not received his 2nd dose at the time of this report, but he might receive it later on the reporting day. The reporter declined to provide any additional information.
Pt vaccinated with Pneumovax 23 developed arthralgia, myalgia & occasional edema of the finger secondary to pseudo lupus synd.
11 days after my booster (although I believe it started probably at day 10, I lost significant vision in my right eye.. Note that I also had my flu shot on October 16th a day before my vision loss.   I do not, and my doctors, do not know if this is related to my vaccine, but I had been feeling perfectly well prior to this!
Following patients vaccinations, almost immediately, she started to gag as if she was going to vomit, but did not.  She became very pale, grey like, became clammy, sweaty and weak. I sat her down in the lobby chair, gave her some water and within a few minutes was looking and feeling much better.
Information has been received from a pharmacist concerning a 69 year old male who on 28-APR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # 669590/1507Z). On 05-MAY-2011 the patient had a rash 10 days after the vaccine given. The rash was red, itchy, vertical and under the arms. The patient called pharmacist to seek medical attention. No treatment was given for the events. At the time of the report, the patient was not recovered. Follow-up information was received from the physician indicating the patient had itchy papular rash on axilla bilateral after vaccinated by outside pharmacy This lasted 4 days and spontaneously subsided. No further information is available.
Urticaria, Hives around the neck, both upper and lower extremities, headache, itching, dyspnea.
Diarrhea and rash after 10 days. Questionable  Viral  infection vaccine related.
Narrative: -Pt's son called the facility call center to report patient tested positive for COVID on 11/13/22. Son reported patient has become confused x 5 days, esp. when temp. is up. Pt has poor appetite. Patient triaged for ER. -Patient presented to facility ED on 11/23/2022. Patient c/o "COVID I think", patient c/o confusion x 3 weeks. Patient denies any N/V, pain, urinary s/s, patient denies any other symptoms besides "I'm incoherent", it all started when I got my flu shot. Patients son states he isn't eating like normal, low pulse ox at home 89% in bed, temp 101.3 last night at 0230. Pt has been taking Tylenol 1000mg. Son reports father has not felt well since 11/13. Father has felt weak, had poor appetite, feels confused at times, and stools have been loose. (NO vomiting, chest pain, or SOB). Pt wears a condom cath d/t urinary incontinence and urine has been dark - no dysuria. -Pt hospitalized at facility from 11/23 to 12/1 with PRINCIPAL DIAGNOSIS (Reason for admission after study): Covid 19 Infection Urinary Tract Infection due to ESBL + E Coli Chronic Condom Catheter Use AKI on CKD stage III RUL Opacity - suspected due to Covid 19 Infection -HOSPITAL COURSE: Pt was admitted to hospitalist service. He was started on IV ceftriaxone and IV fluids at time of admission. He did not require any supplemental oxygen so only supportive care was provided for Covid 19 infection. His renal function improved with IV fluids and discontinuation of HCTZ and lisinopril. His urine culture grew out two species of E Coli both of which were ESBL positive so antibiotics changed to IV Ertapenem which he received for 4 days. He will be discharged on oral Bactrim for 6 more days to complete 10 day course for complicated UTI.
This spontaneous report as received from the healthcare worker (certified medical assistant) refers to a patient of unknown age and gender. On an unknown date an improperly stored ROTATEQ (oral, dose, frequency and lot # not reported) was administered to one patient on an unspecified date. No adverse effects reported. No additional information provided. Additional information is not expected as there is no consent to contact the reporter.
Pt had developed redness and swelling on injection site of right thigh 24 hours after receiving antibiotic. Redness is spreading from injection site. Apply warm soaks or warm compresses to the affected area two or three times a day. Call our office for a recheck appointment if there is increased pain, swelling, or redness, or no improvement in 48 hours.
RECEIVED HPV VACCINE, THEN MOB ELECTED FLU AS WELL.  SHE WATCHED AS NURSE PREPARED VACCINE.  NURSE ADMINISTERED FLU VACCINE, AND SHE LOST CONSCIOUSNESS WITHIN A MINUTE OF THE SECOND VACCINE.  HER LEGS WERE ELEVATED, ICE PUT ON HER NECK AND FOREHEAD.  BLOOD PRESSURE CHECK AT 2:25 WAS 112/62 AFTER SHE REGAINED CONSCIOUSNESS.  LOC WAS 1-2 SECONDS.  MOTHER REPORTED SHE HAS DONE THIS IN THE PAST.  BP AT 2:30 WHEN SHE WAS SITTING WAS 108/52.  SHE DRANK JUICE, HER COLOR BECAME PINK AGAIN, AND SHE REPORTED FEELING NORMAL.  SHE WAS LAUGHING AND JOKING WITH MEDICAL PERSONNEL FOR 20 MINUTES BEFORE SHE LEFT THE OFFICE.
0840-Synocope less than 5 minutes after vaccinations.  Pale, wet pants, limp, no loss of consciousness.  Pt had not eaten breakfast and had been anxious about shots.
Good physical shape with a low BMI. I got my 1st Pfizer shot May 05, 2021, 2nd on May 05, 2021 and booster over a year later: May 19, 2022. My first two shots gave me almost no reaction, except for a sore arm, and maybe a very tiny degree of tiredness.  Third shot, booster, knocked me down really hard---I haven't felt this sick in decades. I was sore all over, chills and night sweats, slight nausea---I could not sleep for days, until I took a OTC migraine medication [tylenol+asprin+caffeine]. Felt a little better the third day--still had soreness and sweating/chills and the 4th day, got a huge migraine and my night sweats / chills continued.  On the 5th day, all my symptoms were resolved except for a mild headache.
Varicella=large red raised nodule w/"rash" sore, "bug bite like" approx 5 cm.
Fever of 101.6, chills, body aches, back ache, head ache, diarrhea, ear ache.
Severe nausea; Severe headache; Dizziness; can't sleep; This is a spontaneous report from a contactable consumer (parent reporting for daughter). A 16-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in left arm on 23Jun2021 10:00 as dose 2, single (at the age of 16-years-old) for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was reported as Doctor office/urgent care. Patient did not receive any other vaccines within 4 weeks, prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior to vaccination. Patient has not been tested for COVID-19, since the vaccination. Patient medical history included depression and exercise asthma. Patient had no known allergies. The concomitant medications included lithium, venlafaxine hydrochloride (EFFEXOR), mirtazapine. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in left arm as dose 1, single for COVID-19 immunization. On 23Jun2021, several hours after the vaccine she was complaining of severe nausea, headache and dizziness. She also reported she could not sleep, even after taking Advil pm. We have not yet sought treatment but may if this continues or worsens. 3 of the 4 of her kids were reporting similar symptoms although 2 are effected much more. The reported case seriousness was non-serious. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Mother was unsure if they will go to the ER or urgent care. It was unknown if any treatment was received for the events nausea, dizziness and headache. The outcome of the events was not recovered.   Information about lot/batch number has been requested.
Patient received PENTACEL, PCV13 and rotavirus at 10:15 am on 10/7/15. Approximately at 4:15 mom brought patient back in crying unconsolably for approx 2-3 hr.
This case was reported by a nurse via call center representative and described the occurrence of fever in a male patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced fever, pain and feeling bad. On an unknown date, the outcome of the fever, pain and feeling bad were unknown. It was unknown if the reporter considered the fever, pain and feeling bad to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. It was reported that the patient had aches and generally felt bad. The healthcare professional did not have any patient information. No further information was provided. This case was linked with the case US2017GSK151115, reported by the same reporter.
Headache - 36-48 hours (helped by taking Tylenol) Stomach pain - 36 hours (overnight) Some muscle aches - 36 hours