chrisvoncsefalvay/vaers-outcomes huggingface dataset:
terrible headache / brutal headache; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th March 2021, the patient received Shingrix. On 18th March 2021, 1 days after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was unknown.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received a vaccine a day before reporting, expereinced a terrible and brutal headache on the day of reporting. The patient wanted to know if he/she could take acetaminophen.
Reported an episode of syncope. Transferred to the ED and will follow up with PCP.
4 1/2 hrs p/immun pt had sz while in babyseat in car, taken to ER-no known fever, no high pitched scream; upon arrival to ER responding, but lethargic, ER did spinal tap, blood work; discharged to home;
With in 10 min after Varivax vaccine was administered patient began with throat itching, hives, lower lip swelling and throat tightening.  No audible wheezing, B/P stable. At 3pm patient was given three tsps of benadryl and epi-pen Jr 0.15 in each thigh with good improvement and transported to ER.
Seasonal FLUMIST given instead of H1N1 mist (dispensed by pharmacy-packaging very similar).
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. Information regarding medical history and drug reactions or allergies was not reported. The nurse reported that on unspecified date in approximately 2014, unspecified patients were vaccinated with (Oka/Merck) VARIVAX (subcutaneous injection, 0.5 ml once, subcutaneous, strength, lot #, expiration and anatomical location not reported), that was improperly stored at maximum of 7.5 degrees Fahrenheit for up to 11 hours in July 2014 and August 2014. Concomitant medications were not reported. No adverse effects reported. Follow-up information has been received from medical assistant on 27-AUG-2014. The medical assistant was able to provide patient identifier, lot number and expiration dates of (Oka/Merck) VARIVAX that was administered to a 12 months old patient on 13-AUG-2014: lot# J013067 and expiration date: 16-OCT-2015. This is one several reports received from the same source. Additional information has been requested.
Left supraclavicular lymphadenopathy Observed 3 days post first vaccine persisting over 2 months  Only lymph node observed enlarged
Information has been received from a licensed practical nurse concerning a 6 month old female with no medical history or drugs allergies, who on 16-JAN-2009 was vaccinated with the first dose of ROTATEQ.  The patient received a second dose of ROTATEQ on 20-MAR-2009 and a third dose of ROTATEQ (lot # 663841/0083Y) on 22-MAY-2009, oral.  There was no concomitant medication.  The patient vomited the third dose.  The patient had no problems with dose 1 and 2.  No laboratories studies performed.  The patient sought medical attention through an office visit.  The patient recovered on 22-MAY-2009.  Additional information has been requested.
Pt. states that after receiving the 2nd dose of Moderna (03/2021), started experiencing symptoms (06/2021) of  severe chest pain, 101.2 fever, joint pain, persistent sweating, shoulder down to the hands extreme pain lasting 15mins. 06/2021 ER visit (EKG, blood work, Cat-Scan)
A physician reported that a 61 year old male received a dose of influenza virus vaccine in September, 1999. On 6/22/00 he was hospitalized. There a neurologist made a diagnosis of Guillain Barre syndrome, the pt was treated with Iv immunglobulin. The reporter indicated that he is not sure the neurologist's diagnosis is correct for Guillain Barre syndrome at this time. This report is of a serious labeled event.
May 12 received second dose  Symptons reported as of today 7/25/2021, 3 months later and gradually worsening:  Constant self-motion sensations consisting of rocking/swaying or gravitational pull of the body, which are accompanied by fatigue  Arthritis in the wrists, elbows, knees and ankles
This was the 3rd, Booster shot of Moderna.  Fever of 103 for 12 hours; then fever of 100.  Extreme headache, extreme pain at shot site; body aches, dizziness, chills, nausea, fatigue.  All this lasted for 4 days (including day of shot).  Day 4 profuse sweating, continued headaches, pain throughout body, fatigue. This reaction was far worse than the side effects of shot #2, which were typical - fatigue, some chills and discomfort, gone after 1 day.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 19-OCT-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot # L015047 with expiration date 29-APR-2017, dose, route and anatomical location were not reported). Other suspect and concomitant therapies were not reported. No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested.
Information has been received from a medical assistant concerning a female who in October 2007, was vaccinated with the first dose of GARDASIL, after receiving the first dose the patient developed a severe case of mononucleosis. The provided did not have treatment information because the patient received the vaccine and treatment for mononucleosis at a college health center. The patient fully recovered by an unspecified date and on 19-AUG-2008 received the second dose of GARDASIL. Additional information has been requested. 10/08/08 This is in follow-up to report(s) previously submitted on 9/15/2008. Follow-up information was received. The patient received the vaccination of GARDASIL at her college. The patient came to office requesting her second injection. The office did not have any information regarding the vaccination and her illness. No further information is available.
Client states that approximately 3 minutes after sitting in the waiting room for observation time, she noticed increased breathing/bright flashing lights/very warm/remembers being picked up off the floor by a man. The man that assisted our client to chair states that she had fallen forward out of chair and possibly hit head. Client states that she thinks she had hit the left side of her face and right knee. No redness/swelling/bruising noted.
reported arm red & warm to touch (local area only) & a feel low as if coming down w/flu last approx 3-4 days;pt stated arm was fire engine red & hot & felt chills over rest of body;
Pt recv vax on 10/6/98; on 10/7/98 pt exp swelling & itching of LA w/ warmth, erythema
Joint pain, stuffiness, muscle pain, increased fatigue unable to sleep, No taste, Rash on face + arms, chills, skin crawling, joint sensitivity - worse lasting 5 days. then 2 wks for most to subside Chest pain + anxiety Have taken flu vaccine for many years, No reaction until this HD  Have had flu in the 1970s + 1990's - this was worse than the flu, but I'm older. Talked with State Immunization Dictor (we are cousins) She state Immunity Response, a Super one. I'm public Health ARNP about 43 years and would agree a Super Response, But Im real sure thats my last flu shot. This was not fun.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 60-year-old female 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The reporter was an internal medicine manager. It was reported that, there had been no power outages that would have impacted the Moderna vaccine. However, the healthcare professional reiterates that because her facility was unable to download the database, they would need to treat this issue as a temperature excursion. The database was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the RA at this time. It was reported that, no adverse reactions were reported by the patient. The reporter mentioned that the patient had been administered dose while the temperature excursion assessment was ongoing. The reporter also reported that, no adverse reactions were reported by the patient. No treatment medication was reported.
On Friday, the next day less than 24 hours, I broke out in a rash, hives/whelps, on my arms, torso, upper legs, that was itchy and very uncomfortable, I took 2 Benadryl about 5pm, then 2 more about 9pm, went to bed and woke up several times during the night itching, Saturday morning took 2 more Benadryl and it started to fade and was less itchy, I felt achy and my knees hurt, I have arthritis in my knees.  Saturday evening the rash/hives came back and today my knees are extra achy.   Today, Sunday, still achy and a little of the rash still visible.   Wondering if I should get my 2nd shot in a few weeks.
The dose was undiluted and the entire vial was administered to the patient.; he dose was undiluted and the entire vial was administered to the patient.; The patient experienced her heart racing and was sent to the Emergency Department; This is a spontaneous report from a contactable nurse.  A 26-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EW0202 and expiration date: not reported), via an unspecified route of administration, on 15Oct2021, as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter seeking guidance about a Booster dose of the Pfizer Covid-19 Vaccine she gave on 15Oct2021, to a 26-year-old, 4 months post-partum female.  The dose was undiluted, and the entire vial was administered to the patient. The reporter further stated that, accidentally injected the full vial in to somebody, the vaccine instead, without being diluted.  The patient experienced her heart racing and was sent to the Emergency Department. The reporter is asking for guidance about inadvertent higher than recommended dose administered. The outcome of the event Heart racing was unknown at time of report.
lightheadedness; anxiety; hot flash; dry mouth; headache; pain in the right wrist and hand; chills; general pain at the injection site; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (lightheadedness), ANXIETY (anxiety), HOT FLUSH (hot flash), DRY MOUTH (dry mouth) and HEADACHE (headache) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced DIZZINESS (lightheadedness), ANXIETY (anxiety), HOT FLUSH (hot flash), DRY MOUTH (dry mouth), HEADACHE (headache), ARTHRALGIA (pain in the right wrist and hand), CHILLS (chills) and INJECTION SITE PAIN (general pain at the injection site). On 19-Feb-2021, HOT FLUSH (hot flash) outcome was unknown. At the time of the report, DIZZINESS (lightheadedness), ANXIETY (anxiety), DRY MOUTH (dry mouth), HEADACHE (headache), ARTHRALGIA (pain in the right wrist and hand), CHILLS (chills) and INJECTION SITE PAIN (general pain at the injection site) outcome was unknown.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.    Concomitant product use was not provided/unknown by the reporter.  Treatment information was not provided/unknown.   This case was linked to MOD21-034353 (Patient Link).
Patient presented with acute flaccid myelitis.  Progressive weakness and sensory changes starting in the upper extremities bilaterally and then progressing to the lower extremities with the right lower extremity relatively spared comparatively.  MRI of the spine shows extensive T2 hyperintensity of the central gray matter of the cord from c2-3 level to T1.
Appearance of red rash at the site of injection of approximately 10 cm, without itchiness, without bulging
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Hypertension-Mild, Systemic: Hyperventilation-Mild, Systemic: Shakiness-Mild, Systemic: Tachycardia-Mild, Additional Details: COLD, CLAMMY SKIN
pt did not have a reaction to vaccine. Pt was given a beyond use of refrigeration vaccine. Lot number was not expired.
If I get the flu shot I will be in bed for 3 days. I haven't had one since I was forced to the swine flu shot. I have not neen sick since; Initial information received on 07-Feb-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves adult and unknown gender patient who experienced if i get the flu shot i will be in bed for 3 days. i haven't had one since i was forced to the swine flu shot. i have not neen sick since while receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza vaccine (strength, dose and formulation: unknown) produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious if i get the flu shot i will be in bed for 3 days. i haven't had one since i was forced to the swine flu shot. i have not neen sick since (illness) (unknown latency) following the administration of Influenza Vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (If I get the flu shot I will be in bed for 3 days. I haven't had one since I was forced to the swine flu shot. I have not neen sick since).  At time of reporting, the outcome was Unknown for the event if i get the flu shot i will be in bed for 3 days. i haven't had one since i was forced to the swine flu shot. i have not neen sick since.
From initial information received on 23Feb05 from a health care professional regarding an adverse event occurring, it was reported that a four year old female pt received a fourth dose of Ipol vaccine, lot number X1240, administered IM in the right thigh, a fifth dose of Daptacel vaccine, lot number C2103AA, administered IM in the left thigh and a second dose of Tubersol 5 TU vaccine, lot number C1954AA, admin in the right forearm on 15Feb05. Two days later, on 17Feb05, the pt's father reported that the pt developed a quarter to half dollar size red swollen area on the right leg where IPOL was given, and was seen by a physician on 17Feb05. In addition, she was started on Keflex for cellulitis secondary to immunization. The following day, on 18Feb05, pt's father reported again that the pt's injection site area became larger with streaks. The pt was seen in the ER and treated with Benadryl. Reportedly, her recovery status was unk. From additional information received on 01Apr05 from a RN, it was reported that the physician's office made three attempts to contact the pt's parents following the event, but a return call was never received. Per the reporter, the pt's parents have since called the office with other issues and there has never been mention of the incident again. As per a physician, the pt is considered to have recovered from these events. No further information is anticipated, this case is considered closed.
Information has been received from a Registered Nurse concerning an "about" 60 year old male patient with high blood pressure and high cholesterol who on 26-JAN-2012, was vaccinated with ZOSTAVAX (Merck), 0.65 ml., SC (lot number 671660/1254AA). The Registered Nurse reported the patient that had been given ZOSTAVAX (Merck), from 31-JAN-2012, was complaining of a "bad headache and double vision". It was noted that the ZOSTAVAX (Merck) had been given at a local pharmacy and not by the nurse. The health care professional advised the patient to go see his eye doctor. The health care professional said the eye doctor referred the patient to a Neurologist. The Neurologist diagnosed the patient with cerebral embolism with infarction. Treatment with COUMADIN was given. At the time of the report the patient's outcome was unknown. Upon internal review, cerebral embolism with infarction was determined to be an other important medical event. Additional information has been requested.
Pregnant; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 32-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included Spontaneous abortion in April 2010. Family history included Cardiac disorder (Paternal Side) since an unknown date. Concurrent medical conditions included Drug allergy (Omeprazole), Acid reflux (esophageal) since 2019, Food allergy (sweet potato), Fish allergy (Fish) and Food allergy (Mustard). Concomitant products included FAMOTIDINE, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 23-Nov-2020 and the estimated date of delivery was 30-Aug-2021. On 30-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fifth week of the pregnancy.  On 30-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Dec-2020, Pregnancy: positive (Positive) Positive.     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.   Reporter did not allow further contact; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 32-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Intense headache, red splotchy patches on arms and face, itchy arms, torso, back, neck and head.
severe,painful and debilitating shingles, consisting of bands of blisters and lesions across chest,stomach and back; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient (pt) of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 04-AUG- 2016, the pt was inoculated with the zoster vaccine live (ZOSTAVAX) vaccine at a health department as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). Subsequently, pt. vaccination the pt, suffered severe painful and debilitating shingles, consisting of bands of blisters and lesions across pt's chest, stomach and back, on an unknown date. 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 significant conscious pain and suffering, consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as  mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company's conduct, 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 event was considered not recovered/not resolved. The event was considered related to zoster vaccine live (ZOSTAVAX).  Herpes zoster was considered to be disabling.
became very sleepy immed p/returning home; did not wake up to eat @ all during noc; took 2oz following day; dec urine output; slept all day; MD visit 11AUG95; MD found pt hyporesponsive, sl dec tone
After 1st dose, high fever, body ache and fatigue, headache, nausea, dizziness, confusion, general distress.   Fatigue, confusion, headaches and body aches lasted several days requiring 12+ hours of sleep per night and 2-3 hour naps during day.  no energy, loss of appetite.  this lasted 3 weeks. then started to feel better just before getting the second vaccine n 4/7/21 and 11:30am at same location.  Severe reaction started at 2am on 4/8/21, with all of the above same symtoms only more severe.  I couldn't navigate to the restroom without help of my spouse.   Very confused and disorented.  Later that day i had trouble taking in enough air.   As the days progressed, breathing became more difficult and i had trouble walking.   My feet and legs started to ache daily.  I had a CT of the chest on 4/16/21 and and EKG.  A pulmonary embolism was found in the left lung.   I was admitted to the hospital with further testing including a Venous duplex leg bilateral screening.   The results showed a deep vein thrombosis in both lower extremities.    Treatment consisted of shots of Levenox, followed by prescription Xarelto.   It has been over 2 months and I am still fatigued in excess sleeping 4-6 hours more than my usual pattern  per night.   I have no energy as yet.   I have been told this will be a long process of recovery.  This has effected all areas of my life.