chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a non-contactable consumer (patient).  A 83-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: unknown) via an unspecified route of administration on unspecified date as single dose for COVID-19 immunisation. The patient experienced spinal stenosis, hard to walk, experience pain in my hip, my leg I felt a popping noise, the bursitis in my head, my left arm became really painful on an unspecified date. Several months after she got the second shot. She noticed that she had spinal stenosis, but it had not been bothering her at all. She noticed it started really bothering her and it became hard to walk so she went back to her pain management facility and she got an epidural that always worked in the past but it was she worked for a few days. Then the pain came back again so she got a second epidural it worked for a few days and the pain came back again and walking became difficult then she experienced pain in her hip on the left side from seemingly she meant that she was not sure if it was from the vaccine. But she was like just putting on her pants. She lived in her leg she felt a popping noise and a lot of pain in her hip. She went to the doctor and she was diagnosed so after that so now she had the bursitis in her head and her spinal stenosis was really bothering her the epidural gonna work. Then suddenly her left arm became really painful, and she could hardly lift it. He gave her a shot ceroid shot it did not help so she went to an MRI was still waiting for the results of the MRI. So now she had mmm pain in her left arm bursitis in her left hip and her spinal stenosis was really bothering her. She could hardly walk, and she never had this problem before and might be it was not related to the vaccine but when she was thinking about it. Everything happened about a month after she had the vaccine. She had been told that she been working for her. Therapeutic measures were taken as result of spinal stenosis, hard to walk, experience pain in my hip, my leg i felt a popping noise, the bursitis in my head, my left arm became really painful. The patient underwent lab tests and procedures which included magnetic resonance imaging: awaiting on (still waiting for the results). The outcome of all event was unknown.   No follow-up attempts are possible. No further information is expected.
Dizziness, near syncope and ataxia. Seen at Hospital 3:00 PM and transferred to PICU. 11/18, 11/19 and 11/23/2009 MR/Dc summary for 11/16-11/19/2009. DC DX ataxia and vaccine reaction.  Patient lethargic with sx of ataxia. Tx: IV ABX and Acyclovir. LP.
Instantly after the injection I could taste something like metal in my mouth. Then at 1:00am the next morning after receiving the shot I woke up convulsing, my teeth chattering nonstop, headache, fever, extreme body ache, couldn?t lift my head off the pillow, along with severe fatigue and these symptoms lasted almost 72 hours.
expiration of vaccine:2/4/2026 first day: soreness, red around injection site  Second thru 9/22/23: Red area became the size of 10 inches down my arm & 6 inches around my arm, very red, hot, sore. This area was very swollen like a giant red angry lump on my arm, almost looked like the vaccine ran down my arm inside my arm and cause the swelling, redness and soreness.  9/23-26/23: swelling and redness and soreness getting less each day for 3 days 9/26/23 - 10/7: injection site has a knot inside arm and it is painful, wakes me up with pain.  slowly got less but still a little painful if rubbed, had to put off a covid shot due to the knot and pain.
PATIENT'S COMPANION ALERTED ME THAT HE WAS FEELING DIZZY. I WENT TO THE PATIENT AND HE WAS ASHEN AND HIS EYES WERE LOSING FOCUS AND HE WAS SWEATING ON THE FOREHEAD THEN SUDDENLY PASSED OUT. I GRABBED THE EPIPEN AND HAD MY TECH CALL 911 AND I RETURNED TO THE PATIENT. HE HAD ALREADY STARTED COMING AROUND BUT WAS STILL SWEATING. HIS EYES WERE FOCUSED AND HE WAS MUCH MORE ALERT. I DID NOT ADMINISTER THE EPIPEN. I GAVE HIM COOL WATER AND HAD HIM SIP SOME EVERY FEW MINUTES. THE EMT'S ARRIVED AND DID AN EVALUATION AND HE SEEMED OK AND HE DENIED TRASNPORTATION TO THE HOSPITAL.
This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from a Pfizer sales representative.A male patient received bnt162b2 (BNT162B2), administration date 12Mar2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: CHILLS (non-serious) with onset Mar2021, outcome "unknown", described as "chills"; PAIN OF SKIN (non-serious) with onset Mar2021, outcome "unknown", described as "tender skin by touch"; PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "aches"; HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "slight headache".Additional information: Age:64; Units: Unknown (as reported.) No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Deafness unilateral; This case was received via FDA VAERS (Reference number: 1402921) on 29-Jun-2021 and was forwarded to Moderna on 29-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of DEAFNESS UNILATERAL (Deafness unilateral) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Asthma, Polycystic ovarian syndrome and Idiopathic intracranial hypertension. Concomitant products included ETHINYLESTRADIOL, LEVONORGESTREL (AVIANE) for Birth control, FEXOFENADINE HYDROCHLORIDE (ALLEGRA), ESCITALOPRAM OXALATE (LEXAPRO) and MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.   On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced DEAFNESS UNILATERAL (Deafness unilateral) (seriousness criteria disability and medically significant). At the time of the report, DEAFNESS UNILATERAL (Deafness unilateral) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 in response to the event was not applicable.  The patient experienced hearing loss in right ear. Laboratory investigations were Magnetic resonance imaging(may-2021),Acoustic stimulation tests(may-2021). No treatment product information was provided  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; 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, a causal relationship cannot be excluded.
When I received the injection, my arm bleed a little.  My arm was sore for a few days.  On day 8 after the injection, my arm was itchy and red, with a lesion about 2 inches in diameter around the injection site.  I had a virtual session with my PCP, and he recommended that I take 200 mg of Ibuprofen daily for 7 days.   After 1 dose, the next day the lesion was gone.  I continued with Ibuprofen daily for 7 days as directed.  I just had my 2nd Moderna dose 3 days ago, in my other arm.
The patient received a COVID 19 booster dose that was later found to be involved in a temperature excursion of 34 hrs at max temp of 8.54 Celsius. The manufacturer was unable to provide additional stability information that applied to this excursion. The patient/parent was notified and the patient did receive a repeat booster dose.
Extreme sore muscles so that moving hurt.  Nauseated.  Dry heaves.  Slight fever.  Slight chills.  Headache. Very tired.  Not hungry.
pt arrived approx. 30min after vaccine adminstartion with complaints of congestion. pt denied any complaints of throat swelling sob, nausea vomiting head ache chest pain. pt vitals were taken multiple times. pt bp 130/93 hr 96 spo2 100%ra rr 18. pt wanted to be reevaluted just to "make sure I am ok". pt appeared to be stable and not suffering from any anaphylaxis. pt refused treatment and transport. pt report can be found through agency pcr
Uncontrollably high blood pressure lasting 5 weeks post 2nd dose of vaccine.   dizzy spells headache unstable pulse /heart rate
Fine maculopapular rash L zygoma, forehead and chin. Developed into fine vesicles. Eye not involved. TX with Atarax, 1 dose 60mg prednisone po for mild edema. Localized erythema. Resolved with 96.
Systemic: Body Aches Generalized-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: Patient got dizzy within 3 minutes after receiving her Moderna booster, had to sit on ground, 911 came and took her to hospital, patient was fine after 1 hour.
Blood pressure went really high from the first vaccine and then fluctuated where now it's pretty low; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE FLUCTUATION (Blood pressure went really high from the first vaccine and then fluctuated where now it's pretty low) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immune thrombocytopenic purpura.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BLOOD PRESSURE FLUCTUATION (Blood pressure went really high from the first vaccine and then fluctuated where now it's pretty low). At the time of the report, BLOOD PRESSURE FLUCTUATION (Blood pressure went really high from the first vaccine and then fluctuated where now it's pretty low) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
Information has been received from a nurse practitioner concerning her 76 year old mother who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot number, injection site and route not  reported). Two weeks after the vaccination the patient developed shingles. Unspecified medical attention was sought. Follow-up information was received which reported that the nurse practitioner did not work for the hospital for several years. No one knew of this case. Additional information has been requested.
The needle literally was still in the patient's arm but broke away from the syringe; Needle broke off and diluent spurt from the side simultaneously; needle literally was still in the patient's arm but broke away from the syringe; Became unlock from the lower lock portion of the diluent syringe; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 75-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 26Oct2023 at 12:50 as dose number unknown ,single (Lot number: HF5522, Expiration Date: Mar2025) at the age of 75 years intramuscular, in right arm for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), described as "The needle literally was still in the patient's arm but broke away from the syringe"; NEEDLE ISSUE (non-serious), described as "Needle broke off and diluent spurt from the side simultaneously; needle literally was still in the patient's arm but broke away from the syringe"; SYRINGE ISSUE (non-serious), described as "Became unlock from the lower lock portion of the diluent syringe". Additional information:Needle broke off and diluent spurt from the side simultaneously; needle literally was still in the patient's arm but broke away from the syringe     Causality for "the needle literally was still in the patient's arm but broke away from the syringe", "needle broke off and diluent spurt from the side simultaneously; needle literally was still in the patient's arm but broke away from the syringe" and "became unlock from the lower lock portion of the diluent syringe" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v. The information on the batch/lot number for rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Rash on face, stomach, back, legs started on 2-8-09.  Pt. temp 98.5 degrees (2-9-09).  103 degrees Feb 5 + 6, 2009 cough, rhinorrhea started Feb 2, 2009.
Second dose will be given more than 35 days after first dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose will be given more than 35 days after first dose.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose will be given more than 35 days after first dose.). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose will be given more than 35 days after first dose.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided  No treatment medications were provided.
PATIENT STATES SHE GOT A HEADACHE SO BAD SHE WENT TO THE EMERGENCY ROOM, AT THE EMERGENCY ROOM THEY DID A CAT SCAN, PATIENT DOESN'T REMEMBER HAVING CAT SCAN DONE, THE DISCHARGE HER ON PAIN MEDS, SHE IS STILLING SAYING SHE HAS THE HEADACHE TODAY.
I had been feeling like I could have some sickness coming on, maybe like a small sniffle just feeling like I may be getting sick. On the 17th I woke up with horrible nasal pain and my nose was runny, it was so painful, and I had a horrible headache. I took a home COVID-19 test and that was positive. I had nausea, diarrhea, headache, muscle and body aches, fatigue, brain fog and couldn't think clearly. My Rheumatologist put me on PAXLOVID because of my auto immune disease. On the 23rd my symptoms improved but the next day I was having the nasal pain and pressure again however I am not testing positive any longer. This is also my second time having had COVID-19, I had it back in February 2022 after being vaccinated.
Blurred vision; 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. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 04-MAY-2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine adult health maintenance and for its intended purpose: the prevention of shingles (dose, dose number, route, anatomical site of vaccination, lot # and expiration date were not provided). On an unknown date (reported as shortly after receiving the vaccine), the patient suffered herpes zoster and blurred vision. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient condition. In addition, the patient sustained severe and permanent personal injuries. Further, the patient had 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. Finally, the patient had suffered and incurred damages, including medical expenses, the loss of accumulation, and other economic and non-economic damages. At the time of this report, the patient had not recovered of herpes zoster and vision blurred. The causal relationship between the events and zoster vaccine live (ZOSTAVAX) was assessed as related.  Herpes zoster and vision blurred were considered disabling events by the reporter.
Had small, red bumps all over stomach and face. Bumps didn't blister. Diarrhea and high fever of 102F.
Baby was irritable for 3 days. Refused all oral feeds for 2-3 days and became dehydrated and required intravenous fluids on 11/6/00.
Developed her first migraine headache 12 hours after vaccine receipt.  Within the next few weeks developed fatigue, restless sleep, myalgias and arthralgias that have continued to the present.  Also has headaches 1 time a week and a migraine headache every 2 months. Currently has a diagnosis of Chronic fatigue syndrome.  Fatigue, Malaise greater 60 days, insomnia, headache, migraine, headache, general, muscle pain, joint pain, multiple joints.
Initial unsolicited report received from a healthcare professional (physician assistant) on 01-Apr-2016. This case involves a female patient (age was not reported) who was vaccinated with a dose of Fluzone High-Dose (batch number, route and site of administration were not reported) on an unspecified date. Medical history and concomitant medication were not reported. On an unspecified date, after vaccination, the patient experienced acute disseminated encephalomyelitis (original diagnosis) and Glioblastoma (confirmed diagnosis). Laboratory investigations and corrective treatments were not reported. Outcome of the events were not reported. Upon internal review, the company decided to consider the event serious because of important medical events: acute disseminated encephalomyelitis and Glioblastoma. List of Documents held by sender: none. Sender's Comments: Glioblastoma and Acute Disseminated Encephalomyelitis are unlisted with INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This case is very poorly documented to assess the role of the vaccine. However, investigation results ruling out a concurrent infection and other etiologies would be helpful to further assess this case.
Severe headache, crying, vomiting, trembling 3 days after MMR vaccine.
This case was considered medically important. Information regarding PREVNAR was received from a healthcare professional regarding a 4-year-old female patient who experienced muscle atrophy (described as pitting). At 4 years of age, the patient received a dose on an unspecified date. Patient received PREVNAR therapy on an unknown date in her right thigh. On an unspecified date, the patient experienced muscle atrophy described as "pitting." At time of report, patient had not yet recovered. No further information was provided.
Had TIA 27Aug; This is a spontaneous report from a non-contactable consumer (patient). A 74-years-old female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, administered via an unspecified route in right arm in Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included asthma and blood cholesterol increased, both from an unknown date. Historical vaccine included the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, administered via an unspecified route in left arm in Feb2021 09:00 AM (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. The patient had a Transient ischemic attack (TIA) on 27Aug2021 18:00, which required Emergency room/department urgent care and then hospitalization for 2 days. The patient underwent lab tests and procedures on 27Aug2021 which included SARS-CoV-2 (nasal swab) test: negative. At the time of the report the reported event was resolving without any treatment.  No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Cannot take a deep breath; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot/batch Number: EL9266) via an unspecified route of administration in right arm in Feb2021 at 9:45 (at the age of 66-years-old) as a single dose for COVID-19 Immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had been tested negative for COVID-19. The patient did not receive any concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 21Feb2021, the patient could not take a deep breath. On 02Mar2021, the patient underwent lab tests and procedures which included nasal swab where the results found to be negative. It was reported that the patient had not received any treatment for the event. The clinical outcome of the event could not take a deep breath was not resolved at the time of this report. No follow-up attempts are possible. No further information is expected.
At 10:54am pt reports feeling "whoozy", light headed and having a dry throat. Patient states throat feels funny. Denies all other symptoms. Patient supine vitals every 5 minutes. At 10:57 patient declines diphenhydramine. Patient states she is fasting and is carrying glucose tablets and in case her blood sugar gets low. Patient takes one glucose tablet and states she feels better. Finger stick blood glucose 109 mg/dl. At 11:20am patient reports she does not feel dizzy, but her throat still feels funny and agrees to take one capsule Diphenhydramine 25mg po. Continue to monitor patient. At 12:00pm patient states she feels well and is ready to leave, she walks out of clinic.
Had DTaP and IPV on 6/25/14. Mom noticed swelling 2 days ago but the redness was right away. Left thigh swollen and hard knot under injection site 3 inch circumferential raised area.
2 days following the administration of the flu shot this pt developed nausea, vomiting, diarrhea, body-aches, fever, and cough.  All resolved in about 1 week except the cough which has been residual for the last 2-3 wks.  Wife also developed similar symptoms a few days after the onset of the patient's symptoms began.  The patients sx were not reported to this physician until the day of this report.
PATIENT HAS PAIN AT INJECTION SITE. Still hurts 30 days later.
Systemic: Fainting / Unresponsive-Mild, Additional Details: PATIENT IS AFRAID OF NEEDLES AND AFTER GETTING THE VACCINE SHE FAINTED. SHE WAS RESPONSIVE THE WHOLE TIME. WE PUT A COLD TOWEL ON HER FOREHEAD AND GAVE HER SOME WATER. AFTER 20 MINUTES SHE FELT FINE AND SHE LEFT. WE CALLED LATER IN THE DAY AND PATIENT IS FEELING FINE