chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Generalized convulsive seizure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 4-month-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose 2, single (Lot number: EX1979, Expiration Date: 31Dec2023) for immunisation; diphtheria vaccine toxoid, hepatitis B vaccine rhbsag (yeast), hib vaccine conj (menigococcal protein), pertussis vaccine acellular 5-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (VAXELIS), as dose 2, single (Lot number: U7125AA, Expiration Date: 15Jul2024) for immunisation; rotavirus vaccine live reassort oral 5v (ROTATEQ), as dose 2, single (Lot number: 1742434, Expiration Date: 16Mar2023) for immunisation. The patient's relevant medical history included: "Ventricular septal defect" (unspecified if ongoing), notes: 'not' receiving any treatment or medication for such. The patient's concomitant medications were not reported. The following information was reported: SEIZURE (medically significant), outcome "unknown", described as "Generalized convulsive seizure". The event "generalized convulsive seizure" required emergency room visit. The patient underwent the following laboratory tests and procedures: Ultrasound head: normal; Metabolic function test: normal; Blood glucose: normal.  Follow-up (28Apr2022): Follow-up attempts are completed. No further information is expected.
Chest pain, low grade fever, myalgias, abnormal Troponin and EKG.
Itching about the body, some redness noted to lower back and scratchy feeling to left side of throat.
Soreness and Tightness presented in the injection site 8 days (5/11/21) after the first dose
During the 15 minute wait after injection:  my tongue felt strange and tingling, a little puffy. During my drive home:  noticed I felt warm, my cheeks were flushed, and my face seemed puffy. Once home (approximately 25 minutes after leaving):  cheeks were red/flushed, cheeks/face felt tight, face and throat was somewhat swollen. I took some Benadryl and over the next hour or so the swelling went down. I also had chills that same evening That evening my injection site was hurting more and I was getting a headache. I took 2 tablets of Tylenol and went to bed.  During the night, I awoke several times with the sensation/feeling like it was hard to breathe - a heaviness. I also felt nauseous during the night. The next day my face and neck were back to normal, I was not having any trouble breathing, but I had arm pain, a headache, fatigue, waves of nausea, some stomach pain, and joint pain.
Patient had vaccine on 11/3/2021. She was hospitalized on 11/11 and found to be in heart block. Will likely require a pacemaker. She denies any cardiac history.
Breakthrough case admission after 4 vaccines Moderna 2/9/21 Lot# 037K20A;  Moderna 3/9/21 Lot# 027L20A;  Moderna 12/9/21 Lot# 034F21A;  Moderna 5/12/22 Lot# 059M21A
Approximately 45 minutes post injection, started wheezing slightly and having itchy watery eyes. Eyes swelled. Significant scleral edema bilaterally but mostly left eye. Sudden chills and felt freezing in extremities. Face became tingly. Took 50 mg Benadryl, Claritin and rescue inhaler (2 puffs albuterol). Within 1.5 hours felt better and able to rest. Still Itchy but wheezing was better. On 1/12 woke with swollen eyes. Took 25 Benadryl and Claritin. Walked 1 mile and began to wheeze. Took albuterol and rested.
Severe headache Body aches Chills Fever of 106 F that would go down to 103 F with tylenol and ibuprophen Eye pain and burning Joint pain Severe fatigue Nausea Injection site intense sensitivity
Pt states that subsequent to receiving first vax (03/22/2000), he experienced soreness at the injection site for 1-2 days. Approximately one month post vax, (04/28/2000), he experienced soreness at the injection for 1 day. On 11/17/2000 pt had no complaints. On 12/02/2000 pt did not have a reaction but complained of soreness at the site of the first immunization. Area red and the size of a dime accompanied by pruritus.
syncope, pale skin, elevated blood pressure, rigid arms, non responsive x1 minute, low O2 sat.
Immediate erythema after 4th anthrax injection upper left arm. Immediate golf ball size SQ nodule that grew in size. Erythema increased by day 4 from shoulder to elbow. Swollen elbow joint - bursitis.
Patient stated she had a severe headache, numbness in her tongue and hands, and confusion that lasted for about 5 hours.
Moderna Vaccine - 2nd dose 4/14: ~3PM administered vaccine  4/15: Headache and Joint Pain 4/16: Ear started popping. Loss of hearing -- > Ringing in Ear -- > Vertigo
The pt received the vax sometime in 1996. On 12/11/99, the pt who was 10 1/2 weeks pregnant at the time developed two blotchy spots on her face. By the end of the day, the pt had about thirty itchy spots, with five or six on her back, one on her armpit, and a few on her legs. On 12/14/99, the pt was seen by her physician and was diagnosed with chickenpox. By 12/16/99, the pt's rash had started to heal with dry, crusty heads on her blotches. No further information is available.
This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 030B21A) for COVID-19 vaccination. No Medical History information was reported. On 02-Mar-2021 at 11:03 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 10:06 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In March 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Age of patient was reported as 43.43 for dose administered on 02-Mar-2021 and 43.51 for dose administered on 31-Mar-2021. No concomitant medications were reported. Batch number 014M20A administered on 02-Mar-2021 underwent temperature excursion with temperature range of 27, 29, 32, 33, 35, 36 degrees Fahrenheit from 09:00 AM to 03:00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 02-Mar-2021. Batch number 030B21A administered on 31-Mar-2021 underwent temperature excursion with temperature range of 32 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 30-Mar-2021 and beyond use date for the vial was reported as 29-Apr-2021. Product moved to clinic on 31-Mar-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35-degree Fahrenheit. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. No treatment medications were reported.
No side effects from first shot.  Second shot was different.  Got my second shot about 2PM and around 1-2 AM I was getting ready for bed.  At first I was just feeling tired but then I started shaking uncontrollably and muscles in my neck and back were spazzing out.  I lost all control of my body and fell over, convulsing for an unknown amount of time.  I apparently foamed and/or drooled all over myself.  I woke out of this effect around 3:30 AM.  This was Friday/Saturday.  Its Monday now.  I still cannot stand straight and cannot create complex thoughts in my mind.  I had a hard time perceiving colors for the first day and a half to two days after the seizure or stroke I suffered.  I still have a migraine that feels like an elephant is sitting inside my skull.  I still cannot perform complicated thoughts nor can I do complicated things with my hands because of a lack of motor skills.  I successfully pulled every muscle in my back and neck and cannot stand upright.  I'm 35 and now need a cane.  Its already been 3 days and things really have not changed.  Won't catch me lining up for a booster shot.  NO THANK YOU.  I did not seek medical attention because lets face it the healthcare system is a joke I would have needed a ride to a hospital, increasing my odds of getting the virus, to have them hold me as long as they can to stab me and poke me and take samples, give me no results, and a humungo bill.  I will die before I go to a hospital ever again because the amounts of testing I required at the time would have covered back and neck and brain scans of various types and those tests are stupid expensive and 99% of the time I've ever got one they said oh I'm sorry we don't know what's wrong go see my friend who is a specialist blah blah blah and its the "doctor-go-round" where you blow all your money on morons that only care about lining their pockets.
Pt. states that after receiving the 3rd dose of Moderna 02/09/2022, started experiencing symptoms 02/13/2022 of swelling of the lymphnoids, night sweats, migraines, and headaches. Migraines and headaches are continuous, No noted Primary visit/communications. (Covid + 11/2021 similar symptoms with previous swelling and night sweats) (Previous 1st and 2nd doses were Phizer)
Severely sick; Flu like symptoms; Chest discomfort-a heavy feeling in my heart; Chest discomfort-a heavy feeling in my heart; palpitations; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 14Jun2021 10:30 (at the age of 45-year-old) (Lot number and expiration date was not reported) as dose 2, single for COVID-19 immunization. Medical history included high blood pressure and high cholesterol. The patient had no known allergies. The patient was not pregnant at the time of vaccination. The patient did not receive any concomitant medications (within 2 weeks of vaccination). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 19May2021 (at the age of 45-year-old) (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccine with 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. After receiving the second dose on 17Jun2021,  the patient got severely sick (felt like the flu 4 days after receiving the vaccine). The patient started to experience chest discomfort--a heavy feeling in heart and palpitations. The flu like symptoms lasted a full week. The patient still felt chest discomfort presently. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent echocardiogram (EKG), results were unknown on an unspecified date. The patient received unspecified treatment for the events. The outcome of flu-like symptoms was recovered after 7 days (24Jun2021). The outcome of other events was not recovered. The events were assessed as non-serious by the reporter. On 26Jun2021, the patient had PCR COVID test (nasal swab) with negative results. On 04Jul2021, the patient had Rapid Antigen COVID test (nasal swab) with negative results.  Information about lot/batch number has been requested.
Headaches still over a month later every single day.   Mixing up of words/speech.
Severe inflammation (i.e. rash and hive) all over body, including face and eyes and lips and tongue with dramatic itching.  Lasted for over a week.  Anti-histamin and esteroid administered in 2 visits I had in the Urgent Care. Took it under control by taking medicine.  I was wary of the immunosuppressing impact of the esteroid (during the COVID-19 time). So it was debilitating to be sick and worry about getting sicker due to the medicine's side effect.
Erythema and edema approximately 2.5x2.5in over L buttock.
Within 15 minutes reaction occurred:  Both injection sites had a 1 inch circular surrounding erythema. The left thigh (MMRV) had a 0.5 cm wheal (hive) present just above the injection site. The right thigh (DtaP) had approx 4-5 0.1 cm papules surrounding the injection site.   The child was given 2.5 ml (6.25mg) Children's Benadryl and within thirty minutes, the wheal (hive) and papules hade resolved. The surrounding erythema had improved. He was sent home. Approx. thirty minutes later mom called stating he was vomiting. She was instructed to take the child to the ER. I spoke with her today and she did not take him to the ER. She states he projectile vomited four times and has since been his normal self. She denies him to have fever, rash or other symptoms/reactions.
No additional AEs or PQC reported; VARIVAX administered after temperature excursion; This spontaneous report as received from a from a medical assistant refers to a 15 month old male patient. The patient had no siblings. On 02-JAN-2023, the patient was vaccinated with the first improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # W021740 exp date 10-JUL-2024) subcutaneously in the right leg at a private hospital. The medical assistant reported that the freezer door was left ajar.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2302USA001035: US-009507513-2302USA001036: US-009507513-2302USA001037: US-009507513-2302USA001038: US-009507513-2302USA001039: US-009507513-2302USA001040:
Follow-up information pertaining to the recovery status of the patient, changes of concomitant vaccines with administration dates and correction of Prevnar lot number has been received. Information regarding Prevnar was received from a healthcare professional regarding an 11-month-old female patient who developed pneumococcal sepsis. At 10 months of age, the patient received the third dose on 17-Feb-2006. The patient also received a dose of Daptacel and Ipol on 17-Feb-2006. On 08-Apr-2006 the patient was hospitalized with pneumococcal sepsis. Blood cultures revealed Strep pneumococcus; serotyping was not performed. Spinal tap results were negative. The child remained hospitalized until 10-Apr-2006. She was treated with unspecified antibiotics and recovered on an unspecified date in 2006. Blood cultures (results: revealed: Strep pneumococcus) and lumbar puncture (results: negative) were done on 08-Apr-2006.
Approximately 5 minutes after receiving his first shot he passed out and seizured for approximately 15 seconds.  Fire and EMT called and stabilized him then taken to hospital for tests.
Face and arm on the side COVID vaccine given started tingling and got warm right away then had numbness and tingling after. For the first 15 mins also had heart palpitations.  12 hours later after waking up face sensation was dull and improved over the night.
PNEUMONIA, HYPOMAGNESIUM Narrative: Employee had second dose vaccine 8/25/2021. Employee claimed that on 08/26/21, he noticed his heart was beating faster 136/mins, there was associated sob, chest discomfort. headache, pain at the site of the ejection. Patient claimed that he went to ER , had EKG, which revealed sinus tachy, CXR pneumoinia, fever 101.6, bloodtest showed hypomagnesium Patient was discharged with keflex, magnesium supplement
- Sore arm from 18hours after injection until ~2.5 days after injection - Delayed cutaneous hypersensitivity ("covid arm"): a firm red lesion around the injection site and soreness from up upper left arm down into my hand 7 days, 15 hours after injection (1 hour ago from inputting info here)
Pt has not had a menstrual cycle since completion of her second dose. She had been menstruating since age 11.
This spontaneous report was received from a certified medical assistant and refers to a 15-month-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On 04-AUG-2017, the patient was vaccinated with improperly stored dose of M-M-R II injection (lot # M036544 (also reported as M023895), expiration date: 15-AUG-2018; dose and route of administration were not reported). The dose of the vaccine was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT) (also reported as STERIL WATER DILUENT) injection. The reporter stated that the administered dose of M-M-R II was stored at temperature 10.2 degrees Celsius for 39 hours 45 minutes. Data logger was used to detect temperature excursions. There were no previous temperature excursions reported. No adverse effects were reported. No product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1708USA004009:
This spontaneous case reported by a consumer, describes the occurrence of pyrexia (fever) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pyrexia (fever). At the time of the report, pyrexia (fever) outcome: unknown. Diagnostic results: On an unknown date, body temperature: inconclusive. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Concomitant product use and treatment information not provided.
Initially just soreness of the right arm and nothing else. On Friday, 3 days after receiving the vaccines, she started having severe body aches. On Saturday and today she can barely walk due to aches and weakness in her left leg. She has had some chills/ hot flashes but no fever. Taking over the counter ibuprofen and Tylenol without much relief.
Awoke feeling ill at 2:30, restless sleep got out of bed at 4:30 am, temperature of 99.6- 101.5 for 16 hours at rest, Awoke next am feeling tired, with no obvious symptoms or adverse events.
Patient received vaccine at 1001. Medical technician noted that the patient's face appeared pale. Patient was asked to sit in the chair and vitals were taken. BP was 110/80 and secondary reading was 102/76. Pulse was 86.  Patient was discharged and resumed normal daily activities including working out. At 1830, patient noted the appearance of hives present on back, bilateral arms, bilateral dorsum of feet, and neck. Patient woke up the next morning and noted that the hives have worsened in appearance. Patient also experienced generalized weakness with more pronounced weakness present in bilateral lower extremities. Patient followed up with physician 7 days after symptoms initially started and was given 10mg of prednisone.  Patient followed up on 11/04/2016 in regards to symptoms not improving. Was referred to urgent care by medical technician at clinic. Patient was then referred to emergency department where he received further care. Was given 60mg of prednisone and Benadryl however, noted that the Benadryl was making his chest feel "weird". Patient is currently on a prednisone taper and was prescribed zantac to take at home for abdominal discomfort due to taking the prednisone.
Hives; Chills; Fever; Sharp lower back pain; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the arm left on 06Apr2021 at 15:00 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. The patient's medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient's concomitant medication included lansoprazole (MANUFACTURER UNKNOWN) dose of 30 mg from an unknown date for an unknown indication and was unknown if ongoing. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 07Apr2021 at 10:30 the patient experienced chills, fever and sharp lower back pain. On 08Apr2021 the patient experienced hives. The clinical course was as follows: At 10:30 of 07Apr2021, the patient started to have chills, fever and sharp lower back pain. By 08Apr2021, chills and fever went away, but hives appeared and back pain persisted. As per PCP, the patient took Tylenol, Cyclobenzaprine, Benadryl but no change to the back pain. Hives were slowly going away. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events included treatment with tylenol, cyclobenzaprine, benadryl for 5 days. The clinical outcome of the events chills and fever were resolved on 08Apr2021. The clinical outcome of the event hives was recovering. The clinical outcome of the event sharp lower back pain was not recovered at the time of the report.  No follow-up attempts are possible. No further information is expected.
35 pts c/o burning & itching for several day & soreness @ inject site p/3rd dose of Engerix-B vax;
HIVES . Burning red itchy whiplash & rash type hives on back/arms/legs/mid-section, feet & hands
MILD SORENESS AT INJECTION SITE, BODY ACHE, SORE THROAT, TIRENESS. 1/28 INDIGESTION. 1/29 BUMP ON SITE RESOLVED IN 4 DAYS Narrative:
I wasn't feeling great the day after the booster, I ran a fever of 102 for around two days. My lymph node under my left arm was swollen and painful to the touch. I also had a sore neck. I don't remember the exact timing, but my chest began hurting pretty badly as well as my shoulders and the upper portion of my legs especially my right were sore and stiff. I have been measuring my oxygen levels at night which have been dropping to low 80's and occasionally high 70's. I did an at home sleep apnea diagnostic which indicated slight sleep apnea and I am on a waiting list for a APAP machine. I am still experiencing a lot of chest pain that makes it difficult to breath with pain when I sneeze and cough. I am also still experiencing pain in my shoulders and legs.
I experience Vasovagal syncope within 2 min of the J&J Jansen injection. The nurses were very nice and explain to me what it was. I got hot and sweaty and horrible tunnel vision, I almost fainted. I laid down on one of their medical beds to recover while the sweet nurse fanned me.  I was observed over 30 min before leaving.  I woke up yesterday and felt weird along with bodyaches, chills, joint pains, random stinging sensations throughout my body (almost like a pen prick), sporadic short headaches and muscle cramps.  I left work yesterday and didn?t even go in today.