chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ABDOMINAL PAIN WHICH WAS REALLY UNCOMFORTABLE/STOMACH CRAMPING THAT WAS BRUTAL; TROUBLE SLEEPING; CONSTIPATED; FATIGUE; DEEP VEIN THROMBOSIS; STOMACH BLOATING; This spontaneous report received from a patient concerned a male of unspecified age.  The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, 1 total start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 15-AUG-2021, the patient experienced stomach bloating. The patient felt "blocked up", and thought it was just fatigue. The patient had stomach cramping that was brutal. The patient had a bowel movement the night before reporting that brought some relief, but then the pain started across his abdomen, which he described as really uncomfortable. It was reported that, he was given one dose on the day of discharge from the hospital, then was taking two XARELTO tablets daily for his deep vein thrombosis. The patient felt like someone took their fist and punched him hard in the stomach. On an unspecified date, the patient was constipated and had trouble sleeping. The patient took covid-19 test and it was negative. The patient was thinking to visit the emergency room, but was not certain if he should go.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach bloating on 19-AUG-2021, had not recovered from constipated, and the outcome of fatigue, abdominal pain which was really uncomfortable/stomach cramping that was brutal, trouble sleeping and deep vein thrombosis was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, involving the same patient is linked to 20210843197.; Sender's Comments: V0:20210859224-JANSSEN COVID-19 VACCINE Ad26.COV2.S - deep vein thrombosis,  stomach bloating ,abdominal pain which was really uncomfortable ,constipated, trouble sleeping - This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). V0: 20210859224-JANSSEN COVID-19 VACCINE Ad26.COV2.S-  fatigue-This event(s) is labeled per RSI and is therefore considered potentially related.
Patient test positive for Covid on 10/29/2021. Patient received Moderna vaccine with 1st dose 025C21A on 05/17/2021 and 2nd dose 026D21A on 06/14/2021 Patient was on an inpatient Behavioral Health unit when tested positive. Patient was admitted to unit on 10/15/2021.  Per IM Progress Note from 10/29/2021:  Assessment/Plan  COVID-19 viral illness with upper respiratory symptoms    - patient is vaccinated UTI, s/p 5 days Keflex  Hypokalemia, resolved  Hypernatremia/Hyperchloremia - secondary to decreased po intake, resolved  Anemia?stable  Mildly elevated AST question significance  Acute psychosis?catatonic?improved  Bipolar and schizophrenia  Hyperlipidemia  Tobacco dependence  Chronic opioid and benzo use per chart review   Plan: Monitor vital signs every 6 hours, if O2 sat < 93% notify IM team Check chest x-ray  Check CBC with diff and CMP  Check inflammatory markers -  Elevated D-dimer, CRP, ferritin, LDH  Start Vitamin C, vitamin D, Melatonin, and zinc  Add incentive spirometer  Add Flonase nasal spray  Maintain COVID isolation  DVT prophylaxis - start Lovenox     Subjective     Patient is seen and examined in follow-up for COVID-19 as a new diagnosis.  Patient was complaining of cold-like symptoms while in inpatient psychiatry and was tested positive for COVID-19.  Patient states she did have 2 doses of Covid vaccine although she does not remember which one at Pharmacy in May and June.  She complains of nasal congestion, productive cough, chills and weakness.  She denies any loss of taste or smell but does admit to decreased appetite.  She denies any shortness of breath at this time.  She denies any fevers.  She denies any body aches.
I had COVID-19 in 01/2022 and it was similar to a bad cold. I took Tylenol and my doctor prescribed me steroids and I was feeling better after that. I didn't actually see my doctor.
Flu Mist administered to a 8 month old child. Doctor notified the family. No signs or symptoms were noted. Parents were advised about what to watch for.
Flu like symptoms--nausea, very achy all over my body, headache; disrupted sleep; felt better after about 18 hours from onset.
This spontaneous report was received from a nurse refers to an unspecified 7-month-old patient. The patient's medical history, concurrent condition and concomitant medication were not reported. On 24-AUG-2017, the patient was administered with VARIVAX lot# N002204 with expiry: 19-JAN-2019 for prophylaxis, and sterile diluent (manufacturer unknown) (Drug administered to patient of inappropriate age). No adverse effects reported.
8/10/07 Patients mother calls to report that her daughter is having trouble lifting both arms. Also complains of numbness in arms started after receiving Imm on 7/18/07.
Discovered that patient recieved ACT HIB vaccine, outside of standard, at 4YO.
CHILD HAD SEIZURE JERKING MOVEMENT EYES ROLLED BACK LASTED FOR ABOUT 3 MINUTES NO TREATMENT DID NOT GO TO ER OR MD TILL 07/16/2015 TEMP 100.5 HAS HAD 3 SEIZURES BEFORE NOT RELATED TO VACCINE THOUGHT TO BE FEBRILE.
After first vax had tingling of tongue , headache,. After 2nd vax had whelps and itching redness.
Information has been received from a nurse concerning her 10 year old daughter with eczema and who had been immunosuppressed, was vaccinated "5 years ago" in 2002, with varicella virus vaccine live (Oka/Merck). Subsequently, the patient experienced four chickenpox episodes after receiving the varicella virus live vaccine (Oka/Merck). Each episode occurred about a year apart from each other, and the chickenpox appeared only on the patient's trunk area. The patient saw her physician, specific treatment not reported. The patient has recovered. A product quality complaint was not reported. No further information was available. Follow up information from the physician provided no further information. Additional information is not expected.
Information has been received from a registered nurse concerning a 30 year old female patient who on 22-Sep-2003 was vaccinated subcutaneously in the left arm with a dose of MMR virus vaccine live (Lot #635145/0030N). In approximately October 2003, the patient developed a rash on her chest and back and swollen lymph glands including lymphadenopathy of her neck and head, but no fever. The patient visited her doctor, who stated this was caused by the rubella vaccine. Blood work was taken and the results were pending. At the time of the report, the patient was feeling better and it was noted that the adverse experience abated. At the time of the report, the patient "still had the rash on her jaw, but the other symptoms had subsided." The reporter also noted that the outcome was "recovering with sequalea". A product quality complaint was not involved. Additional information has been requested.
Around October 14th started expert anxiety attacks with no k mown cause. During the weekend of October 15th started noticing  I was b Becoming SOB on walking , plus anxiety attacks.  The beginning of October 17, I noticed that I was noticeably more SOB .  Otherwise I was feeling as usual.  We went to visit family increased SOB continued such that I did not participate much in family activities.  SOB continued, also noticed my heart rate increasing on walking.    The SOB and increased heart rate subdued readily upon sitting and resting. We returned home on October 25th.  Retired to bed as usual around 10 pm.  I was woken up at 1:30 am with a racing, pounding heart rate of 123 and shortness of breathe I woke my husband and told him we were going to the ER
Case number PHEH2016US000960, is an initial spontaneous report received from a pharmacist on 11 Jan 2016. This report refers to a 43-years-old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 158101) in left deltoid intramuscularly at a dose of 0.5 ml on 06 Jan 2016 (earlier reported as 05 Jan 2016). On 07 Jan 2016 (earlier reported as 06 Jan 2016), the patient experienced pain, tingling/numbness in/on face that got worse. The patient went to the urgent care and did blood tests (results unspecified). Upon follow up, the pharmacist reported that, he left a message for patient and did not receive response from the patient. The outcome of the events was unknown. The seriousness and causality of the events was not reported. Follow up report received from a pharmacist on 22 Mar 2016: Updated suspect drug information (anatomical area of administration, dose and therapy start date), event information (start date of events) and pharmacist comments.
numbness in left leg 20 minutes after injection, tiredness and chills and fever nest day, headache and extreme pain in left leg similar to sciata only worse.
Received vaccination 3/4 in the afternoon.  Noticed left eye irritation/redness/swelling on 3/6 in the evening.  Progressed through the evening to have lots of discharge and watery.  Eye crusted shut morning of 3/7 and 3/8.  Symptoms of redness/irritation/swelling continued.  Diagnosed with pink eye morning of 3/9/21.
Same onset of symptoms as first dose, but different symptoms this time ( 7-8 days after shot developed symptoms).  Trunk itches and belly fat feels like someone is squeezing it, swollen hands and feet.  This time had puffy eyes and lips,with neck and genitals itching.  Over my body an erythema that turns white when stroked.  On my right arm, where I received the shot, very large splotch approximately 3 inches by two inches (red and swollen.) Feeling of malaise and dizzy.  Stiff neck and swollen joints in fingers.  Visited outpatient clinic for check up.  Given Hydroxysine HCL 25mg x 3 per day. When I was  in my early 30s had an anaphylactic reaction to something I ate???  Went to ER for shot of epinephrine.  We never discovered what it was I was allergic to.
This case was reported by a nurse via sales rep and described the occurrence of fever in a elderly female patient who received SHINGRIX (batch number 3AF9E, expiry date unknown) for prophylaxis. Concomitant products included SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX .5 ml. On an unknown date, 9 hrs after receiving SHINGRIX, the patient experienced fever, chills, malaise and vomiting. On an unknown date, the outcome of the fever, chills, malaise and vomiting were unknown. It was unknown if the reporter considered the fever, chills, malaise and vomiting to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On 23rd April 2018, the patient received 1st dose of SHINGRIX. At 9:00 am, the patient received 2nd dose of SHINGRIX on left deltoid. Approximately 9 hours after vaccination, the patient experienced feverish with chills, malaise and vomiting. The patient was seen in emergency room. The patient was discharged to home and no disposition received at this time. Reported believed that it could be related to use of the product. The batch number has been updated from 3AFPE to 3AF9E as per sales data sheet.
Around 4 hours after receiving the COVID vaccine, I had a rash develop on my right arm, where the vaccination site was. I woke up on Saturday (05/01) and the rash had spread a little.  On Sunday (05/02), the rash got bigger on my right arm and spread to my back.  On Monday (05/03), the rash is now down my arm to my forearm, on the right side of my back, both the left and right side of my upper chest and non on my left arm near my shoulder.  It is very itchy and at times will have a burning sensation.
Pt came into pharmacy on 10/2/23  and showed me his left arm which was red at inner bicep level and swollen at injection site. I told him to watch it and if does not improve seek medical attention. Pt then called 5 hrs later and said left arm is tingling and he is going to his physician to be check over
A minute after injection patient had a tonic clonic seizure. Myself and the nursing staff were able to grab him and lay him on the ground without any injury to body or head. The seizure was less then a minute.
Patient was given half dose of the Moderna Bivalent Booster, patient was to be given a full dose. Wrong dosage given.
occasional stabbing pain at the back of the neck; occasional stabbing pain when bending over; excruciating pain on the lest side of my head; my vision went white; severe headache; fatigue - slept for 15 hours; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (severe headache), NECK PAIN (occasional stabbing pain at the back of the neck), VISUAL IMPAIRMENT (my vision went white), BACK PAIN (occasional stabbing pain when bending over) and HEADACHE (excruciating pain on the lest side of my head) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Lot# 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced FATIGUE (fatigue - slept for 15 hours). On 19-Apr-2021, the patient experienced HEADACHE (severe headache). On 22-Apr-2021, the patient experienced VISUAL IMPAIRMENT (my vision went white) and HEADACHE (excruciating pain on the lest side of my head). On 26-Apr-2021, the patient experienced NECK PAIN (occasional stabbing pain at the back of the neck) and BACK PAIN (occasional stabbing pain when bending over). The patient was treated with NAPROXEN SODIUM (ALEVE) at a dose of 1 dosage form; IBUPROFEN at a dose of 1 dosage form; PARACETAMOL (TYLENOL) at a dose of 1 dosage form; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form and METOCLOPRAMIDE HYDROCHLORIDE (ANTI NAUSEA) at a dose of 1 dosage form. On 16-Apr-2021, FATIGUE (fatigue - slept for 15 hours) had resolved. At the time of the report, HEADACHE (severe headache), NECK PAIN (occasional stabbing pain at the back of the neck), VISUAL IMPAIRMENT (my vision went white), BACK PAIN (occasional stabbing pain when bending over) and HEADACHE (excruciating pain on the lest side of my head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided by reporter.
Dizziness, lightheaded, numbness/tingling, ear pain, sound/light sensitive, diarrhea, extreme headache, fatigue
Pt recvd Engerix-B 22JAN, 25MAR, & 26AUG91 & it was determined that pt did not respond; booster dose of Engerix-B was administered 1NOV91;
headach and shivering after 2nd Moderna vaccine shot.  Then several weeks of excessive tiredness, lasting about 4 hours during day
Scratchy throat, lip numbness. Symptoms faded adn PT refused further assesment
Information has been received from a health professional concerning a 9 week old female who on 30-OCT-2008 was vaccinated with the first dose of ROTATEQ (lot # 661031/0467X) orally.  Concomitant therapy included PENTACEL and PREVNAR.  On 31-OCT-2008 the patient experienced explosive diarrhea, which has been occurring after every feeding.  Parent of patient called the office.  There is no medical history and no labs were performed.  Health professional reported that the patient is showing some improvement.  Additional information has been requested.
COVID Arm.  Deep red, itchy rash at injection site, 3 inches by 4 inches initially  but kept spreading, getting bigger down my arm.    I still have it  but it appears to be fading and not as itchy.  Although, I seem to keep trying to make a comeback by sometimes getting redder again.  I've tried taking two antihistamines per day instead of one in case it is an allergic reaction (one at night and one in the morning),
phone call from mom reporting pt has had on again, off again full body hives since 9JAN99 p/vax;family physician referred mom to reporter to f/u from ?rxn from shots;child presented w/hives 24hr p/vax;
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2015, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. On or about 30-AUG-2016, the patient was treated for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related.
Whole body aches (24 hours), headache (48 hours), fatigue (72hrs +)
On 3-23-18 client went home, exercised 1 hour, no s/s change, went to bed, at 1:30 am woke up and felt like he was on fire. He went back to bed, up at 6:30 am, felt OK,  exercised 45 min with cardio. At 8:30 went to get in car and felt his equilibrium was off. Left ear "shifted", while driving, began having double vision-drove on side of road. Wife then drove. He then became nauseated and he "felt drunk", with slurring of words. Down to town, looking for furniture with wife, felt fatigued, sat down and slept for 3 hours, which he doesn't remember doing. Started with metallic taste in mouth and felt like he "lost his taste buds". Has had loss of appetite, feeling foggy. On 3-25-18 cont. with most of these S/S. 3-26-18, felt better, no vision problems, but still had foggy feeling, loss of appetite, and metallic taste in mouth. 3-27-18 cont. with loss of appetite, metallic taste in mouth and foggy feeling. Client stated he was seeing his primary care physician this evening, as other co-workers stated it sounded like he might have had a stroke.
Soreness at injection site, rash, fever, body aches, upset stomach, diarrhea, tiredness, itchy, headache, scratchy throat. I had some reaction after 1st injection almost didn't get 2nd one.
This spontaneous report as received from a physician via a company representative, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unspecified dates, the RECOMBIVAX HB had two temperature excursions of 24 hours each one. The lowest recorded temperature for one excursion was 34 F (1.111111111 Celsius) and 33 F (0.555555556) for the other one. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". On 19-AUG-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB "10 Pk 5mcg/0.5ml SDLLokCap Ped" which had a lot number of K018986 and expiration date on 03-APR-2016 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. There was no product quality complaint involved. This is one of several cases from the same reporter. Additional information has been requested.
Body ache; muscle PAIN; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body ache), PAIN IN EXTREMITY (sore arm) and MYALGIA (muscle PAIN) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included Arthritis (she was diagnosed with arthritis and gout and at that time she did not know they were autoimmune disease.), Gout, COVID-19 in November 2020 and Pneumonia in November 2020.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 06-Mar-2021, the patient experienced PAIN (Body ache) and MYALGIA (muscle PAIN). On 07-Mar-2021, PAIN (Body ache), PAIN IN EXTREMITY (sore arm) and MYALGIA (muscle PAIN) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication was not reported. No treatment medication was not reported
20 minutes after vaccination, patient began feeling numbness and tingling in bilateral hands. This progressed over the next 24 hours to include headache, bilateral forearms, and bilateral feet lasting 2 days.  On day 6,  patient reports her symptoms have mostly improved with the exception of slight numbness and tingling of finger tips.
Patient became very light headed and dizzy while sitting, following his vaccination. Patient was evaluated by EMS on site and refused transport to the emergency room. Patient vitals were stable. Patient admitted to having a similar reaction following his first dose of the same vaccine.
Papular rash on both arms, legs, and palm of right hand. Pt ran out of tegraderms to cover his vaccination site.  Over the weekend he noticed the rash had spread to the edge of his bandaid.  Pt tx with Diphenhydramine, 25MG Capsule--1 CAP PO Q6H. Pt self-medicated with Hytone 1% topical cream.  PCM discontinued the Hytone 1% topical cream.
Numbness in head; Minor headaches; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in head) and HEADACHE (Minor headaches) in an 80-year-old male patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Numbness in head) and HEADACHE (Minor headaches). At the time of the report, HYPOAESTHESIA (Numbness in head) and HEADACHE (Minor headaches) had resolved.            No concomitant medications were reported. No treatment medications were reported.
Narrative: Patient diagnosed with inoperable stomach tumor and admitted to Hospice House, where he expired.
I experienced blurriness of my vision, I feel a stabbing pain in both my eyes. Joints that have never hurt before, hurts now and my back and hip seem amplified with pain, my neck will go numb from the middle of my left ear down to my shoulder and lots of ringing in my ears 5 days out of 7 days of the week, I'm always fatigued and having brain fog. I always lack energy when it comes to doing any errands or daily tasks, I am also always having trouble remembering stuff.
Received vaccine on 2/19/07, woke up on 2/20/07, noticed rash on L lower extremity (elbow to wrist(, 2/21/07 treatment Keflex x 10 days.