chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician via a field representative referring to a currently 27 year old female patient. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not reported. On an unknown date, the patient was vaccinated with first dose of GARDASIL intramuscularly (dose and lot # were not reported). In August 2006 (reported as ten years ago), the patient did complete the 3 series of GARDASIL. On an unknown date the patient experienced dysplasia and Cervical intraepithelial neoplasia III (CIN3). The patient sought unspecified medical attention. An unspecified treatment was given for the event. The human papillomavirus (HPV) DNA test was performed on an unknown date and showed HPV negative. The outcome of the event was reported as recovered on an unknown date. The causality was not reported. Product quality complaint (PQC) was involved in the case. Additional information has been requested.
TOOK THIRD DOSE ON DAY 4; A spontaneous case report was received from a caregiver on 28-Jan-2019 for two consumers.  Based on the information obtained from the caregiver, two individual case safety reports PVX201901-000066 (PVX2019-258; wife) and PVX201901-000067 (PVX2019-259, husband) were created and cross-linked in the database.  This case report described a male consumer who "took third dose on day 4". The consumer was receiving oral Vivotif (one dose every other day; lot number: 3003239) for typhoid fever prophylaxis.  It was reported that the consumer took two doses in a row. The doses were taken on 23-Jan-2019, 25-Jan-2019, and 26-Jan-2019, respectively.  The action taken with Vivotif with respect to the event "took third dose on day 4" was not applicable.  The clinical outcome of the event "took third dose on day 4" was unknown.  Company's Comment: The causality of the event "took third dose on day 4" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took third dose on day 4" was considered as not applicable. US-PaxVax Berna GmbH-PVX201901-000066:
Mother stated baby cried nonstop for eight hours straight. Mother stated no fever or swelling around shot site. Mother stated took to ER, and the baby stay overnight for observation. The hospital gave ibuprofen for pain, no other treatment necessary.  3/23/2009 Received hospital medical records of 1/9-1/10/2009. FINAL DX: prolonged irritability secondary to immunizations Records reveal patient w/inconsolable crying x 4-5 hr w/diet refusal. Improved & d/c to home.
Resurgence/worsening of similar symptoms associated with Meniere's disease -- dizziness, light headedness.
On set of period. Menstrual cramping and longer bleeding.  I usually  don't get cramps at all . I  pray it is not affecting my reproductive health. Jesus .
I received my 4th dose of Pfizer Bivalent Booster on 09/22/2022. My COVID-19 symptoms started on 10/11/2022 at around 8:00PM. I had a sore throat, fatigue, and lymph nodes in my neck were swollen. I did a COVID-19 home test which was positive. I didn't see my doctor. I took over the counter medications such as MUCINEX, throat lozenges, and DAYQUIL. I took it for at least 1 week. I still have the lingering fatigue as of today 12/23/2022 but all the other symptoms have resolved.
J&J vaccine for COVID received by patient on 5.2.2021. 1st stroke episode occurred on May 13, 2021. Patient was not taken for medical care. 2nd similar but more severe episode happened 6.1.2021. Patient was taken to Hosp. and then transferred the same day to another Medical Center in another location. Symptoms were loss of use & temporary numbness in left leg and also left side of face. He could not walk (but this abated after approx. 20 mins.) After various testing, including but not limited to a head CT scan, an MRI, echogram of heart and later echogram of both legs patient was released June 2. MRI showed that he had a stroke. He was put on a heart monitor for 2 weeks, Plavix & Lipitor (not previously required, as BP was low and cholesterol was not high enough to warrant medication.. he was also told to take a baby aspirin daily. Since both episodes, patient has had severe bouts of exhaustion after only moderate activity which, even though a bit better, continues to today. To date, there is no apparent reason for patient to have a stroke, as per his medical evaluations and testing. That leaves the J&J vaccine circumspect as being the cause. Therefore, it is important that this report be acknowledged and considered. Relevant tests/Laboratory Data can be provided if requested. It would be beneficial to be able to attach reports rather than have to answer complicated testing questions, the average person would find challenging. Thank you.
Received FLUZONE HD and PHEUMOVAX 23 in left deltoid on 9/30/16. Reported unresolved red, warm rash 10/2/16 covering majority of bicep. Denies fever.
After shot, I had body aches, chills, nausea and dizziness. After one day and a half every thing was gone except the dizziness. As of today, Oct. 10 I am still having dizzy spells.  On Sept. 25, I started to have trouble breathing. I could not catch my breath laying down. I thought it was the pressure on the CPAP machine. The doctor confirmed that is was working properly and to check with my cardiologist because I recently had stents put in. I saw him on Oct. 5. He took bloodwork wich came out normal and on Friday October 5 I had a nuclear Stress test which also came out normal. He also sent me for a chest x-ray. Again normal. The pressure in my chest and inability to breathe was concerning so I went to the ER Oct. 5. They couldn't find anything urgently wrong and suggested I follow up with my PCP in case it was vaccine related or something else. I am just concerned because I was fine before the vaccine. I am not afraid to have them do I wasn't worried that there would be complications. I did have Covid pneumonia in January 2021 and was hospitalized.
Inadvertently received a dose of Vaxelis instead of the ordered Fluzone high Dose Q/V; Vaccine administered to a 76years old; This non serious spontaneous safety report was received by the partner on 08-Nov-2022 and forwarded on 09-Nov-2022 with the following reference number 2022SA460825 from other health care professional.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events.  Further information is expected.  SIGNIFICANT FOLLOW-UP INFORMATION was received on 23-NOV-2022 from a health care professional.  The reporter confirmed that the patient did not experience any adverse event. Dose, batch number and expiration date of Vaxelis dose were provided.  The causal relationship between Vaxelis and the reported events were not applicable.  The case is maintained as non-serious.  No further information is expected
This spontaneous report was received from a patient's father and refers to a 5-month-old female patient. The patient had no pertinent medical history, drug reactions or allergies and took no concomitant medications. On an unknown date in 2018 (reported as about two and a half weeks ago), when she was just over 4 months old, the patient was inadvertently vaccinated with PROQUAD (therapy type, dose, route and site of administration, lot# and expiration date were not provided) for prophylaxis. In September 2018 (reported as about week later), the patient experienced erratic fevers off and on that went as high as 102.4 degrees Fahrenheit. The reporter stated that he gave his daughter acetaminophen (TYLENOL). She was then seen by the physician on an unspecified date who prescribed an unspecified antibiotic on which did not help. They returned to the provider who then prescribed amoxicillin on an unspecified date. No laboratory diagnostics or studies were performed. The outcome of the event was reported as recovering. Causality assessment between the event and PROQUAD was not provided.
Started with itching, arms, legs, torso. Hives developed. Itchy throat all within approx. 45min to 1 hour. Took a antihistamine.
Information has been received from a physician concerning a 65 year old female who on 19 SEP 2006 (previously reported as 11 APR 2007) was vaccinated, with zoster vaccine live (Oka/Merck) lot # 652965/0623F).  On 12 JUL 2007 the patient developed shingles.  Unspecified medical attention was sought.  The patient's shingles persisted.  At the time of this report the patient had not recovered.  No further information was available.  There was no product quality complaint involved.  Additional information has been requested.
BODY ACHES; FELT LIKE COULDN'T MOVE BODY; INTENSE CHILLS; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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 not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 2021, the subject experienced fever. On 2021, the subject experienced intense chills. On 2021, the subject experienced body aches. On 2021, the subject experienced felt like couldn't move body. Laboratory data included: Body temperature (NR: not provided) 103 F. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient recovered from fever, intense chills, body aches, and felt like couldn't move body. This report was non-serious.
Pain in left upper arm in region of injection extending into posterior shoulder and trapezius starting 3 days after injection was given and seen in office 2 weeks later.
platelets were tested and had dropped from 296 in Fe to 18 by 01Apr; sick; inflammation response wherein all of new/ old scars swelled up and looked fresh (including an old bee sting, csection scar, etc).; inflammation response wherein all of new/ old scars swelled up and looked fresh (including an old bee sting, csection scar, etc).; petichiae; badly bruising; This is a spontaneous report from a contactable consumer (patient). A 33-years-old female patient (not pregnant) received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 01Mar2021 09:45 at the age of 33-year-old (Lot Number: EM6203) as single dose for covid-19 immunisation. Medical history included ulcerative colitis (remission), beta thal minor, allergies to aspirin and humira; Idiopathic thrombocytopenic purpura (ITP), delivery on28Jan2021. The patient had ITP during pregnancy (delivered 28Jan2021) and had been well in the normal platelet range at/after delivery. Concomitant medications included vedolizumab (ENTYVIO) taken for colitis ulcerative; folic acid; diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) taken for an unspecified indication on 30Jan2021. The patient previously received the dose 1 bnt162b2 (Lot number: em9809) for covid-19 immunisation on 08Feb2021 09:30 AM. When the patient had the second dose (01Mar2021), she had an inflammation response wherein all of new/old scars swelled up and looked fresh (including an old bee sting, csection scar, etc). The patient also started badly bruising and having petichiae on 01Mar2021. Her platelets were tested and had dropped from 296 in Feb2021 to 18 by 01Apr2021, it continued to drop. This was the lowest they have ever been. She've been very sick on and off since having the second dose (01Mar2021) and recently finished high dose steroid treatment. The adverse event resulted in doctor or other healthcare professional office/clinic visit, life threatening illness (immediate risk of death from the event). Therapeutic measures were taken as a result of events and included treatment with high dose dexamethasone and blood monitoring. The events outcome was not recovered. No COVID 19 diagnosed prior vaccination, since the vaccination the patient hadn't been tested for COVID-19.
Vertigo, nausea and dizziness. Personal doctor prescribed antivert, Zofran and increased hydration
About 2 weeks after the shot I noticed a veiny like bruise on my left arm. Unbeknownst to me, my arm was also swelling. On February 1st my arm was very swollen and I needed to go to the ER. I had a DVT in my subclavian and axillary vein. It has also come to my attention that I have thoracic outlet syndrome which can cause clots in that area but many doctors find it very coincidental that it happened right after my first dose. I have never had any blood clots before this.
Pt c/o of hand/arm & neck pain, thought to be due to Procan intoxication , admitted to hosp. secondary to this Dx & developed progressive weakness once in hosp. Currently in ICU
Heart failure, atrial fibrillation and flutter. Spent 5 days in hospital. Ejection fraction estimated 15%. Cardiac ablation 2 months later in October 2021.
pt reported via phone on 21OCT92 that pt devel rash, hives & nausea, day after receiving flu vax;
pt recv vax 30APR97 & on 7MAY97 pt devel urticaria;
Seven days after receiving the vaccine, the area where I  received the injection started itching and became red. The red area was approx  3 inches in diameter.  I applied Betamethasone cream several times during the course of 24 hrs and had no further problems.
Initially, the event consisted of a fever on and off  for 5 days reaching 103 at one point.  Took Tylenol. Covid test on 4/15 resulted positive; Covid test on 4/18 resulted negative. Sporadic fever resumed 1st week of May on and off for a few days; visited doctor. 2nd Covid vaccine administered on 5/13 at same location (Pfizer EW0165). Since then I've experienced sporadic fevers lasting 1-3 days at a time each 2-3 weeks. Fevers are usually between 99 and 102. Most recently (7/14), experienced violent trembling with 102 fever. Visited doctor on 7/16 where bloodwork, urinalysis and chest x-rays were taken for "fever of unknown origin". Results not in yet.
patient had come in to receive a J&J vaccine already received a Moderna vaccine; did not receive second injection of moderna covid 19 vaccine within 42 days; rash from neck down; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCEPTED PRODUCT PRESCRIBING ERROR (patient had come in to receive a J&J vaccine already received a Moderna vaccine), PRODUCT DOSE OMISSION ISSUE (did not receive second injection of moderna covid 19 vaccine within 42 days) and RASH (rash from neck down) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INTERCEPTED PRODUCT PRESCRIBING ERROR (patient had come in to receive a J&J vaccine already received a Moderna vaccine), PRODUCT DOSE OMISSION ISSUE (did not receive second injection of moderna covid 19 vaccine within 42 days) and RASH (rash from neck down). At the time of the report, INTERCEPTED PRODUCT PRESCRIBING ERROR (patient had come in to receive a J&J vaccine already received a Moderna vaccine), PRODUCT DOSE OMISSION ISSUE (did not receive second injection of moderna covid 19 vaccine within 42 days) and RASH (rash from neck down) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient visited HCP and was suggested to get Johnson and Johnson vaccine as second dose. No Concomitant medications was reported. No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: patient had come in to receive a J&J vaccine.
Unable to walk and went to hospital, still in hospital as of filing this, DNR, seems to be improving
After 8 days , still having discomfort, warmth and knot at injection site.
Patient received the Fluzone High-Dose influenza IM into her left deltoid. After bandaid applied patients site started bleeding & begin to swell 1" around the site of the injection. No bruising, hardness or redness was noted. Patient was assessed for any other symptoms & there were none. Site was cleaned with alcohol & a bandaid was reapplied. She was told to ice the site &/or benadryl may help. Patient informed  if the site  becomes hard & red to inform her healthcare provider.
Received first dose on 4/17/21. Period late and not recorded on v-safe. Estimated due date was 12/21/21.  Had 6 week ultra sound and bleeding shown on ultra sound. At 7 weeks light bleeding. At 8 week ultrasound no fetal pole visible. Wanted to report incident. Expecting genetic testing of embryo.
erythema, pain, tenderness and L axillary venous swelling, possible DVT.  Pt sent to ER for further evaluation
3 weeks after the initial injection I developed symptoms in my left hand including pain, numbness, and the inability to use my muscles. I had evaluations by neurosurgeons and an EMG conducted confirmed I had brachial neuritis involving my small and ring finger on my left hand. I underwent physical therapy in an effort to strengthen the muscles to no end. I currently have little use of these 2 fingers. Ongoing symptoms include numbness, tingling, muscle weakness, inability to open hand completely.
Warm to the touch injection site; Bruise on injection site; Itching left arm injection site; Redness on the side of the injection site; Pain left arm (with movement); Urinary tract infection; Headache; A spontaneous report was received from a consumer, concerning herself, a 71-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed urinary tract infection, warm to the touch injection site, pain left arm (with movement), bruise on injection site, itching left arm injection site, headache and redness on the side of the injection site.  The patient's medical history provided included cystitis. Concomitant product use was not provided by the reporter.  On 27 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot # 004M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 27 Jan 2021, after the first dose of vaccine administration, the patient developed headache. On 03 Feb 2021 (Wednesday) the patient experienced urinary tract infection and took one capsule of cephalexin 500mg. Later, on 04 Feb 2021, the patient's left arm of injection site had started itching and her arm was hurt on movement. When she checked in the mirror, she noticed a bruise on injection site and the side of the injection site was red and also was little warm to the touch. She thought the skin reaction might have been triggered by the cephalexin, hence she did not continue the antibiotic, but she also confirmed that she had no reactions anywhere else on the body.  Action taken with mRNA-1273 in response to the events were unknown.  The outcome of event, headache was considered to be resolved on 28 Jan 2021. The outcome of the events, urinary tract infection, warm to the touch injection site, pain left arm (with movement), bruise on injection site, itching left arm injection site and redness on the side of the injection site were considered unknown at the time of this report.; Reporter's Comments: Based on the current information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded. Patient's medical history of cystitis is a confounder for urinary tract infection.
Numbness of area - any place on body. Redness in different shapes and size. Eye and face area swelling. 3-6 day.
Patient presented to hospital on 8/19/21 with abdominal pain after consuming 10-12 pack of beer over the weekend. He was found to have acute pancreatitis. He had been diagnosed outpatient with pancreatitis prior to hospital admission  on 8/16/21.
Lymph node on my neck left side (same side as I got the vaccine) on top of the neck/arm soreness.; I have schedule a second appt to follow up on this lump; arm soreness.; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0169) via an unspecified route of administration in the left arm on 16Apr2021 at 11:00 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. The medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first  dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8733) via an unspecified route of administration in the left arm on 27Mar2021 at 11:00 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. On 16Apr2021 at 14:00, the patient  went to urgent care and diagnosed with lymph node on her neck left side (same side that got the vaccine) on top of the neck/arm soreness. The patient reported that she written to saw whether this was a common side effect from the second vaccine. The patient was told to monitor the size and ensure that it was not painful, not red and to ensure the size reduced slowly. The patient scheduled a second appt to follow up on the lump. The adverse events resulted in emergency room/department or urgent care. The patient received treatment for the reported events which included cyclobenzaprine/naproxen. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events lymph node on the neck left side (same side that got the vaccine) on top of the neck/arm soreness and lump was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient started vomiting and having diarrhea at 4:30 p.m. on 08/19/2009.  She reports visualizing blood in her stool on 08/20/2009 at 6:00 a.m.
I got pregnant in May and thought I was miscarrying shortly after I took the survey. My period was a lot heavier than normal - my cramping went on for two weeks and more. I had clotting and  heavy bleeding - first time clotting. More blood and heavier bleeding then I had ever experienced. It was an Ectopic pregnancy. I just got treatment yesterday so it will be awhile before I'm recovered. I was seeing midwives or OB/GYNs.
Diarrhea within 2 hours of shot. Severe pain at injection site within 4 hours of shot. Muscle pain and weakness within 10 hours of this (second) dose.  Fatigue and headache within 12 hours. Rigors and severe muscle weakness, 102.5 degree fever, continued severe muscle pain and headache, sweating, delirium, and continued pain at injection site from 18 hours until 36 hours after shot.
45 minutes after receiving flu shot my right arm went limp felt disoriented a short time. Day of flu shot I called Doctor's office twice. VAERS and insurance company office. Following AM numbness in my right leg went to ER. MRI with and without contrast, x-ray heart carotid arteries, transesophageal Echocardiogram. Was diagnosed as having had a stroke.
Patient stated that the night after her vaccination her blood pressure dropped very low and she was taken to the hospital.
(L) arm itching and welt noted 09:25. BENADRYL 25 mg administered 09:30. Itching subsided 09:45. Denies any other symptoms.
Parent reports low grade fever beginning 2-3 days after MMR, VZ; Reports flat red rash on back 3-4 days after vaccine and macular-papular spots on wrists and abdomen. Fever persisted and reported to HD (2nd time) on 7/17/08 at which time back rash gone but with macular and maculo papillar rash on wrist and abdomen per mom on 7/31/08 per telephone.