chrisvoncsefalvay/vaers-outcomes huggingface dataset:
he had a reaction to the Moderna vaccine that caused him to go to the hospital; Two different doses administrated; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (he had a reaction to the Moderna vaccine that caused him to go to the hospital) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH 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) (Intramuscular) 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (he had a reaction to the Moderna vaccine that caused him to go to the hospital) (seriousness criterion hospitalization) and INTERCHANGE OF VACCINE PRODUCTS (Two different doses administrated). At the time of the report, VACCINATION COMPLICATION (he had a reaction to the Moderna vaccine that caused him to go to the hospital) outcome was unknown and INTERCHANGE OF VACCINE PRODUCTS (Two different doses administrated) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported. Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the event Vaccination Complication, a causal relationship cannot be excluded. A causality assessment of Interchange of Vaccination Products is not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow-up received provided reporter contact details, patient details and additional events. Case upgraded to serious.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event Vaccination Complication, a causal relationship cannot be excluded. A causality assessment of Interchange of Vaccination Products is not applicable.
Around 11:30am patient was having vomiting and mom described patient as "out of it" mom says child looked pale and weak, mom says patient had about 7 episodes of vomiting and sleeping a lot.
pt exp severe upper resp infect for 30 days; it cleared up but persistent continuing h/a followed-still present-3 months later;
Information has been received from a registered nurse (R.N.) referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates, these patients were vaccinated with improperly stored doses of ROTATEQ (lot # K016263, expiration date 26-JUN-2016l; temperature: minimum 30.9 Fahrenheit (F) to maximum 31.6 F, time frame 292 hours, previous excursion: No; dose not reported) orally. No adverse effects were reported. Additional information has been requested.
Friday 9:30am given flu and pneumonia in right and left aut thighs at pt request. At 5:30pm while in a meeting, experienced sharp pain in left leg (given pneumo in LAT), left the mtg and went home and took pain meds. Slept through the night, slight pain in the morning. At about 2:30pm on Saturday while doing work outside, pt noticed a rash like hives on her upper body and back. Still red on Monday.
Had the second Moderna injected placed on 2/2/2021 in the late morning, and within 2 hours started feeling sore and achy.  By 5:00, my eyes were itchy and burning like they were on fire, then my throat, nose, ears, and then my hands swelled up and itched and felt like they were on fire.  I also had chills.  I took Tylenol and Benadryl and also felt the need to increased my Flovent HFA 220 mcg from once a day to twice a day on Tuesday and Wednesday.  I continued to take Tylenol and Benadryl when and as the symptoms reappeared.  I only needed Benadryl Wednesday night and woke up this morning with a bit of a headache.  Took Tylenol and went to work today.  I feel tired and my hands still hurt this afternoon(Thursday 2/4/2021) .
herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown  age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. In or around 12-OCT-2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, frequency, lot # and expiration date were not reported) for routine health maintenance and for it's intended purpose the prevention of shingles (herpes zoster). On an unspecified date, shortly after receiving zoster vaccine live (ZOSTAVAX), Plaintiff suffered a painful itchy rash on his back which was diagnosed as herpes zoster. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), Plaintiff's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Plaintiff also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result Plaintiff sustained severe and permanent personal injuries. Plaintiff 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 Defendants' conduct, Plaintiff has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.
Developed Shingles eruption after receiving the 1st dose of Moderna vaccine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (Developed Shingles eruption after receiving the 1st dose of Moderna vaccine) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Concomitant products included ALENDRONATE SODIUM (FOSAMAX), LOSARTAN, ROSUVASTATIN, METFORMIN, TRAZODONE, TRIAMTERENE, CALCIUM, FISH OIL (OMEGA 3 [FISH OIL]), VITAMIN E NOS (VITAMIN E [VITAMIN E NOS]) and VITAMIN D3 for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced HERPES ZOSTER (Developed Shingles eruption after receiving the 1st dose of Moderna vaccine). At the time of the report, HERPES ZOSTER (Developed Shingles eruption after receiving the 1st dose of Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication include Acyclovir for 7 days
I started itching uncontrollability. I went to take a shower at 5PM and was covered in large raised whelps all over my body that was very inflamed. I went to my doctor and started on a round of steroids and was prescribed an antihistamine. That only helps when I take them all of the time. They make me sleepy. When I go without taking them the whelps comes back. I am now on Claritin in the mornings and Zyrtec at nights. I went to the dermatologist and an allergist which also states to stay on the antihistamine. Taking these medications makes me tired all of the time and depressed. I don't feel like myself anymore.
Shortness of breath began the first week of April. Thought I had caught Covid. Shortness of breath became increasingly worse throughout the month of April. Could not breathe at night. Went to emergency room May 5. Diagnosed heart failure 30% function. No known medical issues before vaccination. Currently wearing defibrillator. Kidney function stage three. Had a very active busy lifestyle, upstairs apartment Before vaccination. Now fighting for my life.
My symptoms started the first week after the vaccine. I am a flight attendant, and each time I would get on the plane to work, I would "feel like I was coming down with something," each of the three days per week that I flew. At the end of each workday, I would lie in bed in my hotel room for the entire overnight, until the very last minute that I had to get up to go to work, and would have to take a Sudafed, a Mucinex, a Zyrtec and some Tylenol just to "get up under it" enough to complete each trip. This went on for the month of November. Over Thanksgiving weekend, the usual "coming down with" feeling turned into a horrible (flu? cold?) which was really bad by the end of the trip on November 30th. When I got home, it had gotten progessively worse and my scalp was tingling on the left side. It took me nearly two full weeks to get over it to the point where I could go back to work on December 18th. Fast forward to January 20th. I woke up that morning, at home, and my entire left side was tingling, from my scalp down to my toes. This went on steadily without let-up for three or four days, then continued off and on for another week, until it subsided somewhat, and became more sporadic, sort of moving over to the right side, eventually kind of "moving out the right side" by the last week of March. I still get sensations of a "chill" off and on in the right arm and shoulder. In the meantime, I went to a neurologist and got an MRI on my brain, a nerve conduction study, and a complete blood workup, to rule out a stroke or neurological disease. Fortunately they were ruled out, but I was still left to deal with these scary symptoms going on in my body. I have been a healthy person all of my life, with no major physical problems. I am not sure if this will be a permanent problem or not.
HCP recommends Shingrix to patients less than 50 years old who have had a case of Shingles; This case was reported by a physician via sales rep and described the occurrence of off label use in unapproved indication in an unspecified numbers of patients who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced off label use in unapproved indication. On an unknown date, the outcome of the off label use in unapproved indication was unknown.   Additional Information: GSK Receipt Date: 24-FEB-2023 Additional Supportive Information: The health care professional (HCP) recommended Shingrix vaccination to patients who were less than 50 years old who have had a case of Shingles, which led to off label use in unapproved indication.
Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium
pt recv vax & pt looked like had mumps;cheeks swelled & had a stiff neck;
Got admitted into the ER and then later diagnosed with Pericarditis. Severe chest and neck pain.
Tightness in the chest with some pain starting on 04/22/2021 off and on throughout the day but getting worse each time. I left work around 3 pm on 04/22/2021 with major bodyaches and extreme fatigue. Around 4 pm, I felt extremely itchy and found hives all over my arms, legs, above the injection site, cheeks, and butt. All my hives seemed to be worse on my right hand side, the side I received both vaccines in. After taking 2 Benadryl around 4:30 and taking a cold shower, I could feel the cold water turning warm from running off my hives when hitting my feet. No signs of fever. Shortly thereafter, I used Hydrocortisone cream and they left. At 6:30 am I woke up covered again, by 2pm 04/23 they are off and on.
Initial report was received on 10 June 2013 from a health care professional with additional information received on 11 June 2013 from a consumer who is also the patient's parent. A four month-old female patient with no past medical history had received on 05 June 2013 the following vaccines: dose 2 intramuscular right thigh injection of PENTACEL, lot number C4374AA; PREVNAR (manufacturer, lot number, route and site of administration not reported) and ROTATEQ (manufacturer, lot number, route and site of administration not reported) and the next day on 06 June 2013 the parent reported the child was irritable, inconsolable and was having "seizure like activity". The patient was taken for evaluation by the physician who reported the patient had a seizure and was immediately hospitalized (dates not reported). According to the parent, the patient was diagnosed with unspecified intracranial right hemorrhage and right cerebral arterial bleed with infarction. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Information has been received from a registered nurse (RN) concerning a patient who on 11-JUN-2007 was vaccinated with a dose of Rotateq (Lot # 656390/0236U). The RN reported that, after receiving the dose of Rotateq, the patient vomited. The dose was re-administered (Lot # 656193/0023U). No additional symptoms were reported. At the time of this report, the outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
LOCALIZED ERYTHEMA AT INJECTION SITE (MEASURING 3"X2" ON 10/27/23, 2.5"X1.5" ON 10/30/23, 1.5" X 1" ON 11/1/2023, 0.5"X0.5" ON 11/10/23). PATIENT REPORTED SORENESS AS 4 OUT OF 10 PAIN SCALE ON 10/27/23 AND DECREASING DAILY AFTER THAT.
VACCINIA, URTICARIAL WHEALS COALESCING ON TRUNK AND FACE WITHOUT OCULAR INVOLVEMENT.  FEW PUSTULES ON BACK.  NO C/O FEVER, COUGH, OR FLU-LIKE SYMPTOMS.
Horrible rash all over her body/hives; Horrible rash all over her body/hives; nausea; Fogginess; dizziness; fever; chills; vomiting; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Fogginess), URTICARIA (Horrible rash all over her body/hives), DIZZINESS (dizziness), PYREXIA (fever) and CHILLS (chills) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced FEELING ABNORMAL (Fogginess), DIZZINESS (dizziness), PYREXIA (fever), CHILLS (chills), VOMITING (vomiting), FATIGUE (tiredness) and NAUSEA (nausea). On 30-Apr-2021, the patient experienced URTICARIA (Horrible rash all over her body/hives) and RASH (Horrible rash all over her body/hives). On 04-May-2021, FEELING ABNORMAL (Fogginess), DIZZINESS (dizziness), PYREXIA (fever), CHILLS (chills), VOMITING (vomiting), FATIGUE (tiredness) and NAUSEA (nausea) had resolved. At the time of the report, URTICARIA (Horrible rash all over her body/hives) and RASH (Horrible rash all over her body/hives) 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.   No Concomitant medications were reported No treatment medications were reported
The time that my side effects occurred is approximate because it happened during the middle of the night after I had fallen asleep. The side effects caused me to wake up. So I would say it was somewhere between 10-12 hours after I received the shot that these harsh side effects occurred.   I had chills and major body aches all over. I also had a headache. It was very hard for me to fall back asleep but it was also very hard for me to get out of bed to possibly take Tylenol to hopefully combat my symptoms.  I took a dose of Tylenol (2 pills) the following morning at 10:30AM but it did not too much. I woke up with an even more severe headache. The body aches and chills also continued but not as severe. I also maintained a temperature of 99-101 the entire day on the 14th.  By the morning of the 15th, it seemed that most of my symptoms had subsided. I took Tylenol before I went to bed and while I went to bed with chills and body aches, I was able to sleep through the night. When I woke up,  I did not have a fever, no chills and only very slight, manageable body aches.
This spontaneous report was received from an 80 years old female registered nurse reporting on herself with drug hypersensitivity to PERCOCET, ROXICET, PREMARIN tablets, medroxyprogesterone, VICODIN, lansoprazole, VIOXX (MARRS # 1209USA009591) and DEMEROL and with no pertinent medical history. The patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route not reported) in September or October 2009. No other co-suspects were reported. No concomitant medications were reported. The registered nurse reported that she developed mild case of shingles in March or April of 2010. The nurse reported that the shingles developed under her breast on the right side of her body and then traveled around her right side to her lower back. The shingles were described as few chicken pox like "blisters" that were itchy, red and warm to the touch. The nurse reported that about three weeks after the shingles developed it was resolved (date unspecified) the nurse reported that she went to the physician and he told her she had shingles. Health food was given as treatment for the event. The relatedness for mild shingles was not provided for ZOSTAVAX. Additional information has been requested.
This spontaneous report as received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 15-MAY-2013, patient received improperly stored VARIVAX dose 2, from batch/lot # 0610AE (dose and expiry date unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
2 weeks after the first dose, I had arrhythmia attacks that got so bad I went to the ER. This continued for 2 months and then stopped. The first dose, I was tired and had a REALLY sore arm. 2nd dose was so severe, I almost went to the ER. I was convulsing and couldn't hold any objects or barely walk. I had a 101.4 temp but was cold to the touch. This lasted 3 days. I had "Covid Arm" and couldn't move my arm for 5 days and was a swollen bullseye for a week.
Symptom onset: 4/18 Symptoms include: body aches, cough, fatigue, headache, nasal congestion and sore throat Social: husband also tested positive today.
Patient had Varicella and MMR as well as Dtap and Hep A. Had welts on both legs given 01/09/18.
Very bad HA, almost migraine, 21 hrs post injection. Then added nausea. Some neck soreness.  Slept/rested for 8 hours. Took excedrine and advil intermittently.
Fever to 102, loose/green/mucoid stools - both beginning 6/6 am.  Discomfort, poor eating, fussiness.  No signs of dehydration
Patient reported swelling of cheeks, tongue, and throat. Self-treated with 30mg of hydroxyzine hcl at 4pm. Symptoms improved but still present the following morning. Also, headache and fever unresolved by medication. Patient is following up with doctor immediately.
Narrative: Administered outside facility so full details limited. ADR entered per patient report by clinic staff.
This patient received the flu vaccine in the left deltoid 11/12/2000.  Two days later at the injection site erythematous raised papules appeared, then two weeks later sub Q hematoma 0.5 cm with erythematous papules came and pustules appearing sub Q fluid in concealed collection. Minimal treatment: 4 erythematous raised tender papules 0.2-0.4 cm in size with pustular appearing central area.
The author of the literature article described clinical characteristics of children alleging seizure disorder as an injury due to vaccination. Retrospective record review of vaccine-alleged seizure disorder cases in children ages <2 years filing a claim during 1995-2006. The NVICP retrieved 242 cases alleging seizure as vaccine injury. Of 96 cases retrieved thus far, 71 were filed in 1995-6, 10 in 1997-2002. Half were male. Vaccines implicated (sometimes multiple) included Measles, Mumps, Rubella  (manufacturer unknown). 17 patients had a seizure within 72 hours of vaccination. A significant number of children with alleged vaccine induced seizure disorders had pre-existing neurological or neurodevelopmental abnormalities. Among those developing chronic epilepsy, many had clinical features suggesting genetically determined epilepsy. The patients outcome was not reported. Upon internal review, the event of vaccine-alleged seizure disorder was considered medically significant. This is one of several reports from the same source. Additional information is not expected.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with improperly stored ZOSTAVAX lot # N020854 with expiration date on 31-JUL-2018 (strength, dose and route of administration were not provided) for prophylaxis. Concomitant therapies included sterile diluent (manufacturer unknown), used to reconstitute the suspect vaccine. No adverse effect was reported. Reporter stated that the vaccines were stored between -14 Celsius degrees to -10 Celsius degrees for 30 hours 1 minute. On an unknown date, the vaccine underwent previous temperature excursion from -14 Celsius degrees to 10 Celsius degrees for 24 hours, -14 Celsius degrees to -10 Celsius degrees for 9 hours 25 minutes, -14 Celsius degrees to -10 Celsius degrees for 9 hours 29 minutes. The digital data logger was not involved. No product quality complaint was reported.
Information has been received from a healthcare worker concerning her daughter, a 15 year old female with no pertinent medical history and no known drug allergies who on 26-NOV-2008 was vaccinated intramuscularly with the first 0.5 mL dose of GARDASIL. There was no concomitant medication. On 05-JAN-2009 the patient began a 15 days menstrual cycle. She experienced irregular menstrual and cramping after vaccination. On 26-JAN-2009 the patient was vaccinated intramuscularly with the second 0.5 mL dose of GARDASIL. On 02-FEB-2009 the patient experienced pain with her menstrual cycle. The patient took MIDOL tablets but the cramping did not subside. The patient never had cramping and irregular cycles prior to the first dose of GARDASIL. The patient's symptoms persisted. The patient sought medical attention by consultation with nurse practitioner. Additional information has been requested.
Fever 101.4, chills, exhaustion, body & head electrical jolts, tinnitus.   Electrical jolts starting to subside 5/9/21. Tinnitus continues still.