chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A serious spontaneous report of seizures was received from a non-health professional concerning a 26-month-old male, subsequent to H1N1, Intranasal. The patient had heart murmur when he was born. The patient never received flu vaccine before and never experienced seizure. No concomitant medications have been reported for this patient. There was no family history of seizures. On 25-Oct-2009, the patient received first dose of H1N1, Intranasal for an unknown indication. On 27-Oct-2009, the patient experienced shaking of his body that lasted a few seconds, which occurred again on the same day, then the child was taken to the emergency room for evaluation and testing. The patient was sent for CT scan and some lab work. At the time of the report, the patient has had no further seizures, had been scheduled (on an unknown date) to undergo an electroencephalogram and was to be seen by a neurologist within a month. The reporter stated that there was no further information available. The outcome of the event was resolved. Additional information was received on 11-Nov-2009 and incorporated into the narrative. Additional information about further evaluation of progression, frequency and outcome of the event and additional scheduled investigation was included.  12/01/09 ER notes for DOS 11/27/09  DX: Tonic clonic seizures. Pt received H1N1 vaccine and within 48 hrs later developed tonic clonic seizures. Pt underwent brain CT scan.  Upon neurological examination, Pt was alert and oriented. Pt discharged home in stable condition and to follow up with a neurologist if needed.
Initial report received on 11 February 2013 from the Investigator participating in the study under the reference number M5A16. A case of pertussis disease in a 10-month-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance electronic database. The subject had received 3 doses of PENTACEL; Lot number C4131AA received on 26 March 2012, lot number C4144AA received on 22 May 2012, and lot number C4270AA received on 27 July 2012 (routes and sites of administration not reported). The subject developed a cough on 07 December 2012, approximately 4 months after the last dose, and a paroxysmal cough with a whoop on 08 December 2012. The subject also developed cold like symptoms on 07 December 2012 and posttussive vomiting and sleep disturbance (start dates not reported). Laboratory testing included positive PCR on 09 December 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 09 December 2012 for 5 day. The subject was not hospitalized. At the time of final contact on 07 January 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 31 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
I received the shot at my local grocery store's pharmacy on Tuesday, Sept. 6. On Sunday, Sept. 11 I woke at my son's home at 6 a.m. unable to open my eyes, could not sit or stand because of violent vertigo and intense nausea. 911 responders took me to local Hospital where I was was admitted as a possible stroke patient. CT determined no cranial bleeding. Severe vertigo continued. I was treated with anti-nausea medications and admitted to the hospital. Dr. Private, was my attending physician, though she is not my primary care doctor as I was visiting my son. I was discharged on Wednesday, Sept. 14, with the diagnosis of no stroke, but no reason for the vertigo. I was referred to vestibular therapist who recommended seeing ENT doctor. On Sept. 21 Dr. diagnosed vestibular neuritis. I am now in PT and am recovering gradually. When I l do a search engine I find vestibular neuritis I found abstracts and reports relating it as a rare side effect of the COVID vaccine. Which is what prompted me to report this event to you.
Donor started having headaches for 2 days starting around 2:57 am on 10/18/19.  Also started having achy painful joints that is still having.  Nodule formation to injection site.
Dose number: 3; Nausea; Fever; Body aches; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the parent.   An 18-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 12Jan2022 (Lot number: unknown) at the age of 18 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing) and "Anxiety" (unspecified if ongoing). Concomitant medications included: FAMOTIDINE; NEXPLANON; SERTRALINE and WELLBUTRIN. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: Unknown; Route of administration: Unspecified), administration date: an unknown date in May2021, when the patient was 18 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: Unknown; Route of administration: Unspecified), administration date: an unknown date in Jun2021, when the patient was 18 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 12Jan2022, outcome "unknown", described as "Dose number: 3"; NAUSEA (non-serious) with onset 12Jan2022, outcome "recovered" (an unknown date in Jan2022), described as "Nausea"; PYREXIA (non-serious) with onset 12Jan2022, outcome "recovered" (an unknown date in Jan2022), described as "Fever"; PAIN (non-serious) with onset 12Jan2022, outcome "recovered" (an unknown date in Jan2022), described as "Body aches".  Additional Information: It was unknown if any therapeutic measures were taken as a result of the events. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. 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 events did not result in doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Patient's husband called in around noon stating patient not feeling well. Her symptoms are as follows: headache, fever, stomach ache/nausea and some diarrhea.
54 y/o F with PMH of Crohn's disease presents to ED on 12/05 with acute onset right facial numbness that started approximately one month prior to admission along with mild dysarthria. She reported headache, neck pain and generalized weakness. It initially started with bilateral foot numbness and hand numbness which then progressed upwards. She started to have gait instability, bilateral lower extremities weakness and numbness. The numbness went from her feet up to her knees, with the right side being worse. She denies recent sickness or change in health. In the ED, stroke alert was activated. NIHSS:7 for mild to moderate sensory loss and bilateral lower weakness. CTA was negative for stroke. LP was performed and CSF was remarkable for elevated protein, normal glucose, and normal WBC. She reported that she received influenza vaccine 2 months prior, and weakness began shortly thereafter. Physician diagnosed the patient with Guillain-Barre Syndrome as a possible result of the influenza vaccine. On 12/06, she received Immune Globulin 24 GM Q24H IV one time. The patient's symptoms became worse with increasing lower back pain and worsening of respiratory effort; therefore, she was deemed to have failed IVIG treatment. On 12/07, she was transferred to the ICU for intubation and closer monitoring of her respiratory status. Neurologist discontinued IVIG and started the patient on plasmapheresis for 5 exchanges every other day starting on 12/07 and last exchange was on 12/14. On 12/09, she was extubated, and developed Pneumothorax, which led to place a tube in her chest and she was receiving pain management for her back pain, which was radiating down into her legs. On 12/12, she suffered from another episode of respiratory distress, and she was placed on BIPAP, Duonebs, and nystatin to swish and swallow. In addition, she developed dysphagia contributed to GBS. Hence, speech therapy was consulted with advanced diet recommendation. She had significant weakness throughout, although lower extremities are improving. As of 12/14, she is gaining her strength slowly and she stated feeling weak but better and able to move arms and legs.
her face is very red; rash all over her face; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team. The reporter is the parent.  A 12-year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 10Jan2022 15:45 (Lot number: 33036BD) at the age of 12 years as dose 1, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Asthma" (ongoing). There were no concomitant medications. The following information was reported: RASH (non-serious) with onset 10Jan2022 21:15, outcome "not recovered", described as "rash all over her face"; ERYTHEMA (non-serious) with onset 12Jan2022, outcome "unknown", described as "her face is very red". Therapeutic measures were taken as a result of rash, erythema.  Additional information: The reporter who was a pharmacist stated that she gave her daughter the first dose of the Comirnaty vaccine in left arm on Monday 10Jan2022 and that the rash started on same day and by Tuesday 11Jan2022 her daughter's entire face was covered, and today 12Jan2022 her face was very red. She said that she treated her daughter's rash with Benadryl gel and said that the rash keeps changing and that was what concerning to her. It was really red and almost like it was white heads all over her face now. She said that she has never seen this reaction before. The reporting parent asked about any information on reports of children 12 years and older that developed a rash on the face following administration of COMIRNATY and what was the percentage. Dates for Comirnaty: (10Jan2022). NDC number of Comirnaty: 59267100002 and confirmed this was the adult dose of the Comirnaty vaccine. Vaccination Facility Type: Pharmacy. No history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). No additional Vaccines Administered on Same Date of the Pfizer Suspect. The start time of the event was unknown but noticed it when she got home from work at about 2115 10Jan2022. The events did not require a visit to Emergency Room or Physician Office. Prior Vaccinations (within 4 weeks) was none. AE(s) following prior vaccinations was none. Family Medical History Relevant to AE(s) was none. Relevant Tests were none, she has just been monitoring her daughter herself.
Gave Moderna to a 17 year old patient-did not realize they were under 18 until after vaccinating-patient is doing fine.
Unable to eat or drink; severe fatigue; malaise; Site pain; Chills; Profuse shaking; severe nausea; This is a spontaneous report from a contactable other health care professional. A 23-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN), via an unspecified route of administration on the left arm on 14Mar2021 at 17:45 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history included ibd (inflammatory bowel disease), ulcerative colitis and connective tissue disease/lupus. The patient had history of known allergies to penicillin (MANUFACTURER UNKNOWN), cefprozil (CEFZIL) and ibuprofen (MANUFACTURER UNKNOWN). Concomitant medications included hydroxychloroquine sulfate (PLAQUENIL), mesalazine (MESALAMINE) and others, from an unknown date for an unknown indication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14Mar2021 at 18:05, 20 minutes after 1st injection, the patient experienced chills, profuse shaking, and severe nausea, went to emergency, followed by 2 days on 15Mar2021, severe nausea (unable to eat or drink), severe fatigue, malaise and site pain. The patient also reported that she began to recover on 3rd day. The adverse event resulted in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  Therapeutic measures were taken as a result of events chills, profuse shaking, severe nausea, unable to eat or drink, severe fatigue, malaise and site pain, which included treatment with ondansetron (ZOFRAN). The clinical outcomes of chills, profuse shaking, severe nausea, unable to eat or drink, severe fatigue, malaise and site pain were recovered on an unknown date in 2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient complained of dizziness about 15 minutes after vaccine was administered. After another 5 minutes symptoms progressed to include shortness of breath and chest pains. Was sent to the Emergency Room immediately.
Patient received first dose 12/17/2021 and second dose1/7/2022. Developed URI between two vaccines. One month after URI and second dose, developed fever, rash, red eyes, red lips, hypotension and findings consistent with MIS-C
dizziness, bradycardia, change of mental status no loss of consciousness, no anaphylactic vasovagal O2 given and IVF referred to ER recovered successfully.
Appendicitis. Pain in upper right abdomen over course of 2 weeks. Treatment was appendectomy.
Began vomiting in large amounts in the morning on the day after immunizations. He vomited after every feeding all of his milk. Then in the evening around 5:30 he started crying uncontrollably and we couldn't console him. He had a fever and cried for hours and refused to eat. The fever has spiked up a few times since then and we can always tell he has a fever because of the way he cries uncontrollably. As of 04/30/2017 his fever is back tonight.
Vertigo, nausea, chills, fever (102+), headache--took Advil and fluids.
Body pain; Knee Soreness; Joint soreness; Did not feel good; Headache; Chills; Fever; This spontaneous case was reported by a physician and describes the occurrence of MALAISE (Did not feel good), ARTHRALGIA (Knee Soreness), ARTHRALGIA (Joint soreness), MYALGIA (Body pain) and HEADACHE (Headache) in a 30-year-old 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 ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced MALAISE (Did not feel good), ARTHRALGIA (Knee Soreness), ARTHRALGIA (Joint soreness), MYALGIA (Body pain), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, MALAISE (Did not feel good), ARTHRALGIA (Knee Soreness), ARTHRALGIA (Joint soreness), MYALGIA (Body pain), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MALAISE (Did not feel good), ARTHRALGIA (Knee Soreness), ARTHRALGIA (Joint soreness), MYALGIA (Body pain), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever) to be probably related.    Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medication was reported.  The patient was treated with TYLENOL.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The patient received 1st dose COVID-19 Vaccine manufactured by Manderna.  The patient received 2nd dose COVID-19 Vaccine manufactured by Manderna.    The reporter's causality for the event(s) of CHILLS, DID NOT FEEL GOOD, JOINT SORENESS, BODY SORENES, FEVER and KNEE SORENESS with HUMIRA (ADALIMUMAB) was no reasonable possibility.
Lymph node in neck (collar bone area)  is swollen on the same side I received the shot on. (Left Arm/Side)
Patient previously got a single dose of Janssen. As a booster, he was supposed to received half a dose of Moderna. He was mistakenly administered a full dose of Moderna
approx 2mo p/8OCT97 vax pt had cold/sinus infect which resulted in swelling of eyes, face & body;went to ER & was given a cortisone shot & a 10 day dose pack;pt had splotches that resemble mosquito bites;
developed a severe adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (developed a severe adverse reaction) 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 07-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Oct-2021, the patient experienced VACCINATION COMPLICATION (developed a severe adverse reaction). At the time of the report, VACCINATION COMPLICATION (developed a severe adverse reaction) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.  On October 07 2021, Patient received the first shot of the Moderna COVID-19 vaccination series. After 10 to 15 minutes, patient developed a severe adverse reaction and was transferred to the Emergency department  via ambulance.
After 4 hours from injection had nausea and very rapid heartbeat. Went away after 2 hours
First Vaccine given on 3/9/2021. Pfizer. Lot # EN6206. Intramuscular. Left Deltoid.
I woke up feeling flu-like symptoms but without a cough or nasal symptom. My left arm was very swollen, hot, hard sore, and had some red areas on the bicep and tricep area, a couple spots about 2 inches in diameter. I had a fever varying within 100.5-101.7 and severe fatigue and weakness.   The reason I am writing is that I started having difficulty breathing. No wheezing, cough, pain, congestion BUT I felt that I need to exert a lot of effort to breath and take very deep breaths. I put on a finger oxygen saturation measuring device. It consistently read below 90%, getting as low as 78%. With conscious effort of breathing deeply, I could get it back up to 99%, but natural breathing had it drop below 90%. This lasted hours. The device is a Bodimetrics pulse/oxymeter that I have been using for years and have worn for many hours and never saw readings like this. I bought the device for exercise. I put on a new finger probe and got the same readings. After several hours, my readings returned to normal. this wasn't an instrument error, I think my oxygen dropped and it was related to symptoms and fever in an apparent reaction to Shingrix. My fever and most symptoms were gone after a day, but weakness persisted a few days, then I recovered.
On July 18, I came down with like a bad cold. I never got a temperature. I went to the doctor and they thought it was just a cold. They did not test me for COVID. They gave me antibiotics and steroids for my lungs to see if that could help clear them out. My wife came down with the same symptoms and they tested her for COVID but it came back negative. We still have the same symptoms and we even lost our smell and taste. It is getting worse. I had an appointment with my PCP and they said I probably had COVID. I had a very bad cough for several weeks and at the same time we are getting a lot of smoke from the state that I live and that made it worse. I still have a little bit of lung congestion but not too bad and I still cannot smell or taste.
Groin pain; Intense cramping; Significant slowdown of GI tract/ constipation/ leaving a trail of stool in intestines; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the right arm on 12Apr2021 at 09:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient had not reported any other health issues. The patient had no known allergies to medications, food or other products. Concomitant medications included over the counter (OTC) allergy medications, from an unknown date for unknown indication. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 13Apr2021 at 10:00, the patient experienced significant slowdown of GI tract (constipation), leaving a trail of stool in intestines. He also had intense cramping and pain in the groin area which required ER visit to rule out obstruction. He further clarified that he was prescribed with laxative to address. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of significant slowdown of GI tract (constipation), intense cramping and pain in the groin area which included treatment with CT to rule out obstruction, prescribed laxative. The clinical outcome of the events groin pain, intense cramping and significant slowdown of GI tract/ constipation was resolving at the time of report.   No follow-up attempts are needed. No further information is expected. .
Information has been received from a 80 year old female consumer with a history of insomnia from Ambien who on 9/7/06 was vaccinated IM with a 0.65 ml dose of varicella zoster virus vaccine live. Concomitant therapy included alendronate sodium, Simvastatin and levothyroxine (Synthroid). A week and a half after vaccination, the pt developed a rash on her inner thigh which was bright red with 4bumpy things that are not pimples. She reported that the rash was not at the injection site. The consumer reported that she had shingles in the past and this rash was not the same as the rash she had with shingles. At the time of the report she was recovering. Medical attention was not sought. There was no product quality complaint involved. Additional information has been requested. 6/17/10 Additional information from the ocnsumer indicated that she was vaccinated on 06-SEP-2006 (previously reported as 07-SEP-2006). She thinks she developed shingles on her left breast. She can't remember when the shingles developed but she was "sure it happened after the vaccine was given". At the time of the report, she had not recovered. No further information is expected.
The morning after receiving the vaccine, the patient had pain in her left elbow area (same arm but not same area as injection) over the next couple days the area became red, swollen and hot to the touch. She went to the ER on 7/8/10 and was diagnosed with cellulitis (around her elbow). She was given a Z-pak and the redness and other symptoms resolved.