chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received from a healthcare professional on 01 October 2013. This case is linked to case number 2013SA098091 (this case was of patient's wife) both had same reporter, received same vaccine having same lot number. A male patient (date of birth and age at the time of event was not reported) had received an intramuscular dos e of FLUZONE HD (batch number: UA714AA, expiry date: 04 April 2014, dose number and site of administration not reported) on 08 September 2013. The patient's medical history and concomitant medications were not reported. On 10 September 2013, one day after vaccination, the patient developed muscular aches in his arm. No laboratory tests were performed and corrective treatments were not reported. At the time of this report, the patient was not recovered and the event did not become worse and not improved.   Follow up information received from a healthcare professional on 17 March 2014. The patient was 49 years old. The patient had no illness at the time of vaccination. The patient had history od L wrist cyst, inguinal hernias, DJD (degenerative joint disorder) R shoulder prostatitis, obesity, EX anal fissure, asthma, renal cyst, Type 2 Diabetes mellitus, BPH (benign prostatic hyperplasia) , CKD (Chronic Kidney disease) stage 3 ASCVD (arteriosclerotic cardio vascular disease) hyperlipidemia an essential hypertension. The patient had done Quad bypass, right shoulder replacement as surgery. The patient had allergy to IV dye, iodine containing contrast media: contraindication, penicillin, sardines (fish) and rash. The patient was taking Prinivil 10 mg one tablet daily , Ziac 5-6.25 mg one tablet daily, Fenofibrate micronized 200 mg 1 capsule by oral route e very day with food, Crestor 20 mg one tablet daily, Onglyza 2.5 mg one tablet once a day, Aspiz 81 mg, Nasonex 50 mcg/ ACT 2 sprays ea nostril daily, Mupirocin 2% apply cream to affected area every eight hours, Vitamin D 2000 unit QD, Vitamin B12 1000 mcg 1 QD, Acid reducer maximum strength 20 mg QD, Advair Diskus 250-50 mcg/dose take 1 puff(s) inhaled 2 times a day, Free style lite test strip as directed each morning. Free style lancets  strength miscellaneous as directed, Tamsulosin HCI 0.4 mg capsule extended release 24 hour 1 capsule 30 minutes after the same meal each day once a day stop date: 07 December 2013. The patient had routine checkup. The patient had vital signs of height: 67.25, weight: 225, BMI: 34.97, BP: 118/62 Pain scale: 0, BSA: 220. The patient had laboratory investigation on 16 July 2013.
Intra-uterine death. Pt was 7 days pregnant when rcv'd vax. Add info rcv'd indicated that, in Nov, fetus died in utero. Hospitalized for delivery of dead fetus. Dx of fetal death due to genetic extra chromosome was made.
Information has been received from a physician concerning a 66 year old male who on 23-Aug-2007 was vaccinated with a 0.65 ml dose of Zostavax.  Concomitant therapy included a dose of influenza virus vaccine (unspecified).  On 29-Aug-2007 the patient developed a blistering rash around the injection site.  Unspecified medical attention was sought.  A product quality complaint was not involved.  Additional information has been requested.
The day after (24 hours later) the 2nd dose I began to experience light headedness, nausea, a pain on the left temple and extreme fatigue. I have had these symptoms still to this day as I write this on July 14, 2021 and it is the entire day log.  Tylenol has not helped and that is all I can take for I am allergic to Aspirin. This has taken away all ability to function on any normalcy whatsoever. I am chronically fatigued each day and my head hurts continuously. The doctor Ondansetron HCL 8 mg on 6/21/21 which did not one thing to relieve my symptoms. I am very concerned and may add "scared" about this not going away and really need to report this in case it will help me or anyone else having this difficulty. Thank you for giving me the platform to do so.
pt devel emesis & inc stooling <24 hr p/vax;pt came to ER for sx, had tonic clonic sz of upper extremities;not responsive to Lorazepam, tx w/Phenobarb;mom states pt had fever >100R since vax;stools started yellow & became green, poor feed
Hospitalized with COVID cough, shortness of breath, weakness. treated remdesivir and dexamethasone
cellulitis to forearm increasing for day 1 to day 2 post vaccination , 2 cm area of small papules
Patient was experiencing hives 10:43 am; PCP notified by LPN  Patient was evaluated by PCP , found to have decreasing o2 saturation, sob,  wheezing and hives.  Patient was treated with stat, 50mg po qd of benadryl, 80mg IM methylprednisolone and 1 inhalation of albuterol.  Pateint suffers from asthma, but denies having any wheezing prior to receiving the injection.  AFter all treatments, pt.'s symptoms improved.
This spontaneous report as received from a registered nurse refers unspecified number of patients of unknown gender and age. On an unspecified date in February 2014 until 13-MAY-2014, the patients were vaccinated with doses of GARDASIL (doses, route and lot # not reported) that were improperly stored. No adverse events were reported. This is one of several reports received from the same source.  Additional information has been requested.
Scattered light pink erythema over left upper arm, exquisitely tender, 5x5 area of induration, scattered erythematous macules in axilla and left lateral chest wall. Arm Pain (L arm pain 9/10, rash, nausea, body pain, chills, "green diarrhea". ZYRTEC daily. You may also take BENADRYL at night, 50 mg. Ice for 10 minutes every hour if possible. Continue with the scheduled ibuprofen (continue the 600 mg every 6 hours as needed); you may also alternative with acetaminophen (1000 mg every 8 hours as needed).
Information has been received from a physician concerning a "pretty normal healthy" 9 week old patient who on 14-MAR-2008 was vaccinated PO with the initial 2.0 ml dose of ROTATEQ (lot# 659913/1702U).  Concomitant vaccinations included a dose of ACTHIB, a dose of PREVNAR and a dose of PEDIARIX.  On 20-MAR-2008 the patient experienced intussusception and on 21-MAR-2008 was diagnosed with intussusception and was hospitalized for 5 days.  The intussusception did not resolve after the barium enema and the patient was taken to surgery for a loop reduction.  Per physician, "the patient's intestines were retracted and did not have to be cut."  The patient was discharged on 25-MAR-2008.  the physician saw the patient on 27-MAR-2008 and noted that the patient was recovered/resolved when it came to "feeding and everything."  The patient's stitches were still dissolving.  There was no product quality complaint.  Intussusception was also considered to be immediately life-threatening and an other important medical event (surgery) by the physician.  Additional information has been requested. 05/29/08-records received for DOS  3/21-3/25/08-DX DC: Intussusception Status post reduction. Appendectomy. Developed abdominal pain. Increased abdominal distention, emesis morning of admission. Fussy. Heart rate increased. Urine output decreased. Stool bloody. Exploratory laparotomy and incidental appendectomy. Barium enema was unsuccessful. Developed post op ileus. NG placement.
Headache after 13 days of my booster vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of HEADACHE (Headache after 13 days of my booster vaccine) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache after 13 days of my booster vaccine). At the time of the report, HEADACHE (Headache after 13 days of my booster vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment and concomitant medications were provided.
central retinal aitery occlusion; atrophic retinal hole; sudden hearing loss in her left ear; Information has been received from a lawyer regarding a case in litigation and referring to a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or around 03-JUN-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot#, expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date (reported as shortly after receiving zoster vaccine live (ZOSTAVAX)), the patient suffered sudden vision loss and was diagnosed with central retinal artery occlusion and an atrophic retinal hole. She also suffered sudden hearing loss in her left ear. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the product. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events were considered not recovered. The events were considered related to zoster vaccine live (ZOSTAVAX).  Central retinal artery occlusion, an atrophic retinal hole and sudden hearing loss were considered to be disabling.   Upon internal review, central retinal artery occlusion, an atrophic retinal hole and sudden hearing loss were considered to be medically significant.
Chills, skin sore to touch all over body and fever.  Took Tylenol  2 days including vaccination day
pt fainted roughly five minutes after shot. She came to shortly after and was helped back into her chair. Pt complained of dizziness and numbness in her arms. Blood pressure was taken 79/56. Paramedics came and checked pt out . Pt was released to mom after being given water and sitting for 10 more minutes.
It was reported that a 60 year old female received a Fluzone SV '99-'00 vaccination on 11/9/99. Approx. 6 hours, post vax, the pt developed enlarged lymph nodes in the right arm and right-side breast tenderness. There symptoms reportedly subsided 1 1/2 days later.
Patient Received pro-quad vaccine. 4/24/2006. Developed diffuse urticaria next day (4/25/06). Developed angioedema/extremity edema (4/26/06). No concurrent illness. No daily medications. No other exposures identified. Started on 3 day course of prednisone and prn benadryl for itching.
at 0300 the patient developed rigors/chills. She got up from bed to find Tylenol and Aleve in her kitchen and when she looked up, she became syncopal and fainted, fell on R side, injured R rib and had a black eye.  Felt better at 0600. At about 0900 she got up to the restroom only a few steps away from her bed and she had another syncopal incident where she hit the back of her head.  She went to the hospital ER for sutures to the back of her head.
1st vaccine, next day fever, severe headache, joint pain-severe.  Lasting 2 days 2nd. vaccine, next day fever , achy and fatigue x 5 days.  (fever lasting longer than expected) 5th day-diarrhea and fatigue
Patient reported "Covid arm" type symptoms 8 days afterwards, which is a rash that appears at injection site.  It is associated with mRNA type vaccines.  The patient let me know to help track reported side effects only, she is okay.
Deep venous thrombosis, pt was treated with blood thinners at Hospital emergency room and is being followed up by pt's primary care provider.
Sudden onset of chills- shivering hard and heart racing, blacked out and hit my head on the tile floor and required medical care.
Red swollen oblong shape on arm at injection site approx.  4-5" wide and 2" tall, hot to touch and painful. First noticed 12 hours after injection but may have started sooner.  There was also headache, body ache, stiff joints, stiff neck, chills and general fatigue. The swelling and pain started to decrease 36 hours after the time of the injection. The red area on the arm was itchy and started to darkened in redness by the next day. Two weeks later there is still a red mark on the arm at injection site about an 1 1/2 wide.
Mom called office reports baby laying with eyes half open for fifteen minutes.  Upper extremities shaking, not constant, arms twitching and jerking. Casts on feet and legs. No reports will not stop if holds arms can feel them twitching. respiration regular and adequete. No color change, Have been feeding well. Temperature 98.8. Instructed to go  to hospital.
Patient vomited and became pale about 2 hours after being administered the LAIV (intranasal influenza vaccine.) No history of prior reaction to vaccine nor egg allergy nor allergy of any kind. Resolved within 15 minutes, patient felt well and was stable.
Moderate ringing in left ear.  Ive had a mild ringing since my time in the military, but the ringing is much more noticeable and as of right now, only in left ear.   At times it seems mild, other times it seems very intense and very annoying.
2-1/2 to 3 days post dose 2, many COVID-19 "longhauler" symptoms resumed after dose 1 appeared to suppress them. Fever*, severe body aches*, nausea, headache, severe upper chest pain*, neck pain, fatigue, occasional sore throat, "burning" muscles in all limbs  *ongoing but not as severe
Elevated B/P started one week after 2nd dose. The patient only take b/p once a month and normally runs 120's/80's- However could not report exactly when they last did there b/p stated a little over a month ago. Patient states b/p has gone up to 150's/90s however coming back down to 130's/90. Will not go see a medical provider because does not want to be put on B/P medications feels they are not worth the side effects
(R) upper arm cellulitis vs. allergic reaction. Pt took 50 mg BENADRYL 9/10/18 at 7pm and 9/11/18 at 11am. Rx BACTRIM to start 9/12/18 if symptoms worsen 800mg-160mg BID. Erythema line marked.
Extreme thirst; Chapped lips; Bump on her bottom lip; Dry mouth; Lips started bleeding; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THIRST (Extreme thirst), CHAPPED LIPS (Chapped lips), LIP DISORDER (Bump on her bottom lip), DRY MOUTH (Dry mouth) and LIP HAEMORRHAGE (Lips started bleeding) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced THIRST (Extreme thirst), CHAPPED LIPS (Chapped lips), LIP DISORDER (Bump on her bottom lip), LIP HAEMORRHAGE (Lips started bleeding) and FATIGUE (Fatigue). 24-Apr-2021, the patient experienced DRY MOUTH (Dry mouth). At the time of the report, THIRST (Extreme thirst), CHAPPED LIPS (Chapped lips), LIP DISORDER (Bump on her bottom lip), DRY MOUTH (Dry mouth), LIP HAEMORRHAGE (Lips started bleeding) and FATIGUE (Fatigue) outcome was unknown. Not Provided          No concomitant medications were reported.  Patient used lip balm, but no additional treatment information for the events was reported. Action taken with mRNA-1273 in response to the events was not applicable. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications are reported.  No treatment information was reported.
Information has been received from a physician concerning a 9 year old male patient who on unspecified date was vaccinated with a dose of VARIVAX (Merck) (dose, route and lot # not reported). The physician stated that on unspecified date the patient developed varicella after VARIVAX (Merck) administration. It was unknown if the patient was administered with one or two doses of VARIVAX (Merck). At the time of the report the patient had recovered. The patient sought unspecified medical attention. This is one of several reports received from the same source. Additional information has been requested.
Employee flu vaccine was administered on Friday. Reported through the weekend, had a large knot approx., 5 cm in diameter with redness/bruising, painful/warm to touch. Also experienced nausea and headache following vaccination. Reaction started to improve following 2-3 days after immunization.
Patient was at home and reported that she felt lightheaded approximately 3 - 5 mins, then felt like she passed out for a second, couldn't hear for approximately 2 mins, sisters saw her hands shaking - unk duration and thought she was having a seizure and 911 was called, and then she had ringing in her ears for approximately 3-5 minutes. Evaluated by Fire Department on 01/20/19 and stated, she was advised to follow up with her doctor and stated, they were agreeing that she had an allergic reaction per patient but wasn't transported. States, vitals were taken, no other treatment. Sx all resolved.
This spontaneous report was received from a physician referring to a 1-year-old male patient. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 03-MAR-2017, the patient was vaccinated with M-M-R II albumin status unknown (lot # M035388) (dose, route of administration, anatomical location and expiration date were not reported) for prophylaxis. It was reported that in the period from 01-MAR-2017 to 23-MAR-2017, the M-M-R II was stored in a freezer that was not monitored twice daily for temperature variability. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA000004: US-009507513-1703USA014463: US-009507513-1705USA007311: US-009507513-1705USA007309.
Narrative: Received COVID-19 vaccine, first dose, and was monitored for 30 minutes post vaccination. Vitals ranged from 166/102 to 197/110. Patient reports usually being hypotensive at baseline. Complained of headache, which resolved after relaxation techniques (calming music), recumbinant positioning, decreased stimuli and drinking water. Patient was then transferred to emergency department for evaluation after feeling lightheaded, with mild nausea headache. Nausea resolved after 45 minutes after injection. Headache persisted. No facial swelling or difficulty swallowing and no continued nausea or abdominal pain.
Pt. C/O feeling lightheaded after getting Gardasil.  Fainted in waiting room.  BP 80/50. BP taken after 10 mins-100/40, 98/65 awake & alert.
Patient reported feeling lightheaded immediately following 2nd dose. Floating RN took serial blood pressures, documented below:1120   Rt arm 197/108, pulse 68; Left arm 214/99, pulse 74.   1130 Left arm- 217/92, pulse 64  1134 Rt arm 212/106; Left arm 222/105.   Patient reported feeling "average" with resolution of lightheadedness.      ED called and ED RN transported patient to the ED for further evaluation.
mini stroke; still weak; A spontaneous report (United States) was received from a consumer concerning an 80 years old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event mini stroke/transient ischaemic attack and still weak/asthenia.  The patient's medical history was not provided. The concomitant medications on use were also not provided.  On 26 Feb 2021, approximately 17 days prior to the onset of the events, the patient received their first of two planned doses of mRNA (Batch number: 011A21A) through unknown route of administration for prophylaxis of COVID-19 infection.  On 15 Mar 2021, patient experienced mini stroke. The patient was hospitalized on the same day till 17 Mar 2021.It was serious event which required hospitalization.  Laboratory tests performed included ultrasounds, cat scan of the brain, MRI of brain, ultrasound of arteries, and chest x-ray. The findings of lab tests were not provided. The patient was given acetylsalicylic acid and an injection in the belly to prevent blood clots.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events was unknown; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded
Flu vaccine administered subcutaneously in LUE, cellulitis developed, treated with course of Bactrim, resolved within 5 days.
CHILLIS  NAUSEA  VOMIT WEAKNESS NO APPETITE STAYED IN BED 4 DAYS  HEADACHE
Chilling, increased redness at injection site, swelling and general feeling of beginning discomfort.  This increased until my arm was swollen about two inches from my wrist and the redness increased to bright/angry red and then burgundy.  The discoloration circled my arm and swelling continued from Wednesday pm until Tuesday am when it began to dissipate.  Without constant ice the swelling was very uncomfortable and began itching Sunday. Additionally I was extremely weak to the point of feeling as though I would fall whenever I tried to ambulate around the house. My throat felt slightly constricted for about eight hours but did not feel as though breathing was compromised.  Friday morning I felt as though I would vomit and experienced dry heaves.   The MD and Pharmacist indicated ice, ibuprofen and time is all that could be done to assist.  That treatment and almost around the clock sleeping Friday, Saturday and much of Sunday was the treatment.  Today, Friday October 11 my arm continues to be slightly swollen but much diminished and redness is slight at the injection site.
Started with scratchy throat, then approx 6:30 pm had swelling, heart pounding, could feel pounding in hands, face swollen, then vomiting, then diarrhea, then bleeding.
TX for dog bite on 4/8 on anbx IV/PO for hand bite. On 5/5 #1 Rabies given, 5/8 #2 Rabies given after 1 hr complained of rash-blotches, chest, arms, back, itchy, chills, joint pain, fever. Call received 5/11 to see primary.
About 12 hours after receiving the vaccine, I felt weak, achy, and quite dizzy. I awoke approximately 20 hours after receiving the vaccine with a 101 degree fever, worsened body aches, soreness at site of injection, and increased dizziness.
0 reaction-Pt received Fluzone MDV 0.5ml, and should have received Fluzone 0.25ml.