chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Skin sloughed off her gums; water blister between her teeth and gum line; Anxiety; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administration date 28Jan2021 09:00 (Batch/Lot number: unknown) at the age of 58 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MOUTHWASHGUM. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: SKIN EXFOLIATION (non-serious) with onset 30Jan2021, outcome "unknown", described as "Skin sloughed off her gums"; GINGIVAL BLISTER (non-serious) with onset 30Jan2021, outcome "unknown", described as "water blister between her teeth and gum line"; ANXIETY (non-serious) with onset 2021, outcome "unknown", described as "Anxiety". The events "skin sloughed off her gums" and "water blister between her teeth and gum line" were evaluated at the physician office visit. Therapeutic measures were taken as a result of skin exfoliation, gingival blister, anxiety.  Additional information: It was reported that patient went to the dentist, also she had changed mouthwash before this because she couldn't get normal her normal one, and the dentist said to watch it for a week. She says the dentist sent her to an oral surgeon, who she saw twice, and they put her on a prescribed mouthwash that is basically steroids and something else. She says her gums are still not healing, so she thought maybe it could be just her nerves, since this year has been awful for everyone. She says from her everyday life, and also her husband lost his job around the time she got her vaccine, she thought being emotional might have something to do with it. She says she went to see her doctor and she went on an anxiety medication, Valium basically, she takes 2.5mg of 5mg a day when she needs it. She says that she has been using salt water and baking soda rinses, has been eating bland foods, no nada, no acidic foods. She says she was wondering so she typed it in Google and saw it could be possible from COVID vaccine but she is not seeing it listed on side effect list. She says something about how it has been pretty stressful, and they originally had her gargle with salt water because if it was a reaction that messed up her gums that will heal it, which she did for a couple weeks, and it improved after first couple weeks, and then they put her on Diazepam combined with the salt water and she used the prescription mouthwash, but it hasn't healed all the way.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
arm swelling; pain in arm; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (arm swelling) and PAIN IN EXTREMITY (pain in arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Benign thyroid nodule and Thyroidectomy (Thyroid removed because she had a benign mass) in 1997. Previously administered products included for Product used for unknown indication: Synthroid (Still had parathyroid Been on Synthroid for many years). Past adverse reactions to the above products included No adverse event with Synthroid. Concurrent medical conditions included Arthritis (Thinks diagnosed in 1995, but is not sure, gets MRIs for back and hips and things like that) since 1995.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PERIPHERAL SWELLING (arm swelling) and PAIN IN EXTREMITY (pain in arm). At the time of the report, PERIPHERAL SWELLING (arm swelling) outcome was unknown and PAIN IN EXTREMITY (pain in arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported.   Treatment medication was not reported.   This case was linked to MOD-2021-034561 (Patient Link).
Client was vaccinated with Moderna vaccines for Covid on 4/29 and 6/4/2021.  Client was symptomatic with runny nose, fatigue, and loss of taste/smell on 9/1/2021.  Tested positive with PCR on 9/3 for Covid.  Reported as a case of breakthrough Covid illness in a fully vaccinated person.
pt recvd vax 1DEC92 & 1/2 following vax pt exp sl nausea, dizziness & felt generally ill @ ease because felt condition would fluctuate; 15 mins later injected arm began to ache & felt very weak & heavy; tingling;
tired; sleepy; nauseous; This is a spontaneous report from a contactable other Healthcare Professional (patient).  This 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 07Jan2021 at 7:00 at single dose for COVID-19 immunization. Medical history and concomitant medications were unknown. As of 08Jan2021, the patient reports she is now tired, sleepy, and nauseous. The events were reported as non-serious. Outcome was unknown. Information on the lot/batch number has been requested.
Two missed periods since second dose (not pregnant), haven?t missed a period in 5 years prior to this
Skin hurting/sensitivity (Day 1 forward), severe chills (day 2 forward), headache (day 1 forward), fatigue (day 1 forward), mild cough on/off, eye pain (? day 4 forward), achey (day 1 forward), chest rash (? day 3 forward), fever  (? day 5 forward 101.9 day 5), back pain (? day 5 forward), labored breathing (? day 5 forward), diarrhea (? day 5 forward), sore throat (? day 5 forward) vomit (day 7).  Symptoms of chills and miserable feeling increased day 4 on.  Tylenol, Albuterol on day 6, Day 8 hospitalized, antibiotics and oxygen, Sepsis and shock, less than one day in hospital - passed on 3/2/21 am.
sweating; Body aches; swelling; Chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), PAIN (Body aches), SWELLING (swelling), CHILLS (Chills) and PYREXIA (fever) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00045124) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced HYPERHIDROSIS (sweating), PAIN (Body aches), SWELLING (swelling), CHILLS (Chills) and PYREXIA (fever). At the time of the report, HYPERHIDROSIS (sweating), PAIN (Body aches), SWELLING (swelling), CHILLS (Chills) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment of these events were not provided.    Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Non significant follow up- Patient first name updated. No new information.
Headache, sore arm, neck, tailbone, both knees pain, left back foot, middle of right foot, right calf, and left side of my teeth, and jaw hurt,  both hands, and chest hurts.
She received her second Pfizer vaccine for Covid 4/1/2021.  This is her fourth hospitalization since April for issues f/t heart failure and Afib.     ?4/13 she was admitted with acute heart failure and recurrence of her paroxysmal atrial fibrillation.  ?4/17 she was admitted with dehydration and ongoing issues with atrial fibrillation and rate control.  She was newly on amiodarone and switched from warfarin to Eliquis.   ?4/29 she was admitted with left lower extremity cellulitis related to wound she sustained during prior hospitalization.   ?8/4 she underwent AV nodal ablation with Dr. ?10/4/2021 her pacemaker rate was decreased from 70 to 60 bpm.   -10/10/2021 she was admitted with acute heart failure exacerbation.   Prior to vaccination, she not been admitted since 2019 and her pAfib was controlled.
Adverse event actually happened nearly 5 years later. Near the end of June 2002, my son developed a painful rash on both sides of his neck. After realizing this was no ordinary rash (about a week after its appearance), I took him to the doctor. They took a culture, and called me several days later to tell me it was positive for shingles. This, they said, was most likely from the vaccine. We are no longer with the practice where the vaccine was administered. If you need the address of the practice where herpes was diagosed, email me, or contact me at the above address or phone number.
Rash starting with both hands, spread to elbows knees ears. And progressed throughout entire body including arms legs abdomen, neck, back, feet.  At 10 weeks after symptoms started, rash continues to persist
Patient experience arm weakness.  Cannot lift arm in forward raise position.  Can do bicep curls and other exercises.   He does not have pain, but just weakness.  If not better by Monday, patient is going to call in primary care md
diffuse macular rash, scaly, trunk & extremities w/24month of vax;household well;re-exam found only rash;
Dr diagnosed client with Henoch Schonlein Pupura after immunization. No treatment.
chills x 24 hours, body aches and fatigue x 3 days.  Improved x 24 hrs.  Then developed stiff neck, joint pain and inflammation in joints with arthritis
Reporting is for a vaccine medication administration error where an adult patient was administered the Pfizer-BioTech Vaccine 5-11 years formulation(orange cap), resulting in a lower than authorized dose for a booster. There is  currently no symptoms or adverse event. Patient has been called and correct age appropriate dose of vaccine has been administered  as per CDC and vaccine manufacturer guidelines.
This spontaneous report as received from a pharmacist refers to a 61 year old female patient with high blood pressure. On 16-JAN-2014 the patient was vaccinated with ZOSTAVAX lot # J007209, .65 ml, subcutaneous. Concomitant medications were not reported. On 20-JAN-2014, 5 days after onset therapy the patient experienced shingles type rash at injection site and breakout of shingles at an unspecified site. The outcome of events was reported as not recovered. The patient sought medical attention at unspecified physician's office on 22-JAN-2014. Patient was prescribed ACYCLOVIR and LIDOCAINE patch which had not been initiated at the time of this report. Additional information has been requested.
Some time after my first dose on 2/19/2021, I began to notice an increase in ringing in both of my ears. It has increased subsequent to my second dose on 3/4/2021. I had no other significant symptoms after my first dose, but did have sufficient pain at the injection site in my left upper arm the day following my shot to wake me up at night. That went away within 48 hours, but the tinnitus effects have not decreased to date.
I was driving a car and suddenly I experienced extreme blurred vision and disorientation.  the event lasted for about 2 minutes.  It then cleared up with no lingering ill effects.
pt exp rapid shallow resp, mainly abdo & appeared to be pale in color; when picked up did not improve, in fact, seemed to worsen & not seem to be as alert or responsive as usual;
Acid reflex symptoms; Felt his chest and stomach were burning; Felt his chest and stomach were burning; He had pain in his arm; Nauseas; A spontaneous report was received from an consumer concerning a 70 years old, male patient who experienced acid reflex symptoms, stomach burning, chest burning, nausea and pain in arm.    The patient's medical history included chronic obstructive pulmonary disease, high blood pressure and anomality on his heart frequency all since an unknown date.  The concomitant products included blood thinner medicine, Blood pressure medication, nasal spray, salbuterol and omeprazole.  On 29 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 004M20A) for prophylaxis of COVID-19 infection.    On 24 Feb 2021 patient experienced this acid reflect symptoms but worst than ever, he felt his chest and stomach were burning, nauseas and had pain in his arm. The patient was admitted to emergency room on 24 Feb 2021 due to acid reflect symptoms and was hospitalized on 24 Feb 2021.  Laboratory investigations included tests (not specified) which revealed acid reflex.  Treatment for the event included pill and had a via on his hand for an unknown indication.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of events acid reflex symptoms, he felt his chest and stomach were burning, nauseas and had pain in his arm were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments:  MOD-2021-026319:same reporter, different patient and event
On 12/10/2000 the patient experienced an "extreme case" of varicella. Unspecified medical attention was sought. According to the physician, there was no history of exposure. Additional information has been requested.
flat red rash at injection site. Occurred 8 days after injection. Site very slightly sore to touch
Fever; Chills; aches; Fatigue; Terrible cough; COVID-19; Case reference number MOD-2021-014599 is a spontaneous case report sent by a Other on 16-FEB-2021 00:00:00 .  The patients past medical history included: No adverse event   . .  On the patient started taking Moderna COVID-19 Vaccine for COVID-19 vaccination. Some  1 day later,  the patient developed Fever. Over a period of the next <ENTER DURATION OF EVENT> days, the patient also developed COVID-19,Chills,aches,Fatigue,Terrible cough. Relevant laboratory results included   and relevant physical signs were <LIST PHYSICAL SYMPTOMS>. The patient experienced the following serious criteria:. The eventual diagnosis made on was Pyrexia . .  The patient was treated for the event with   . <ENTER ANY PROCEDURES> The action taken for Moderna COVID-19 Vaccine was  Unknown on  . An autopsy was performed on  . The Other did not declare any relatedness between Fever and Moderna COVID-19 Vaccine In their opinion, other possible etiological factors included  <STATE OTHER FACTORS> and the patients age/ history or other factors <LIST OTHER RELEVANT  FACTORS> .  The company believes the following facts are also relevant in this case: <LIST OTHER RELEVANT FACTORS HERE> OR  <THERE IS NO KNOWN PLAUSIBLE MECHANISM BY WHICH THE DRUG WOULD CAUSE THE PRIMARY EVENT>.  The medical reviewer may provide a case evaluation statement, including other possible etiological and confounding factors, e.g. (only limited information has been obtained so far, it is difficult to assess the cause and effect relationship; the co-medications y and x should also be considered causative as the reported event is labeled for both drugs; the company's view is the event is not due to the drug for the following reasons  (probably due to pre existing disease); there is no plausible mechanism to implicate the drug.  .   Terse Narrative (for PSUR narratives and signal review) Brief 3 line summary of above for CIOMS listing: Report Source- Other,  Age-  ,  Sex- Female,  Suspect Drug- Moderna COVID-19 Vaccine,  Treatment-    Diagnosis\Outcome-  .
This case was reported by a consumer and described the occurrence of autism in a child male subject who was vaccinated with Dtpa (manufacturer unspecified). A physician or other health care professional has not verified this report. The subject received concurrent vaccinations that were not specified. On an unspecified date the subject received unspecified dose of Dtpa (unknown). At an unspecified time after vaccination with Dtpa, the subject was diagnosed with autism. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified. It was reported that this event occurred in five of the consumers children, three boys and two girls. Case A0725679A serves as the master case and the other case numbers are A0725685A, A0725686A, A0725687A, and A0725688A.
approx 3hr p/vax woke from nap crying inconsolable;contact to MD;ordered DPH & motrin;
Information has been received from a female retired nurse concerning herself with diabetes. In approximately 2015 (reported as about a year ago), the nurse was vaccinated with a dose of ZOSTAVAX (dose, route and lot# not reported). On 31-MAY-2016 (reported as last evening), the nurse found a rash under her breast which looked like a pimple and was itchy. The nurse said she had some hip pain. She also stated she had a hip replacement at an unspecified time in the past. The nurse stated she was diabetic, had ulcers and took quite a few unspecified medications. The patient stated she had not sought any medical treatment as yet and would contact her primary care physician on the same reporting day. The causality assessment of the event to the therapy was not reported. The patient's status was reported as not recovered. Upon internal view, hip replacement was considered to be medically significant. Additional information has been requested.
Pt has ischemic cardiomyopathy with EF of 45% and RA and taking medication.  Pt has felt more short of breath the last few days and was found to be COVID positive.
Patient was sitting in chair after adminstration of two vaccines. Patient stated she felt lighthead and room was turning dark.  She then fainted sideways in chair. Pharmacist was able to help her to ground. Then she was awake. She laid on the ground for 5 minutes and then was able to proceed to chair.
Within a couple of minutes, post vax, the pt broke out with generalized red, flat blotches all over her body and was fussy. Benadryl was given.
patient came back over to pharmacy and said she felt sick to her stomach and wanted to throw up but no other symptoms and pt  did not throw up
MIGRAINE; FEVER; SHAKING UNCONTROLLABLY; BODY TWITCHING; BODY ACHING; This spontaneous report received from a parent concerned a White, Not Hispanic/Latino female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 05:00 for prophylactic vaccination. batch number was not reported has been requested No concomitant medications were reported. On an unspecified date, the patient experienced migraine, fever, shaking uncontrollably, body twitching, and body aching. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the migraine, fever, shaking uncontrollably, body twitching and body aching was not reported. This report was non-serious.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Severe, Systemic: difficulty breathing, not allergy related-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Weakness-Medium, Additional Details: pt started having diffuclty breathing about 5-10 minutes after administration of vaccine. pt stated she was lightheaded, hot, sweaty, and felt like her throat was closing. i had a technician call 911 while i checked her blood pressure and gave her water and cold compress. fire showed up soon after and began assessing her vitals. when ems arrived shortly after, they assessed the patient further and determined that she most likely had a nervous reaction but was improved and okay to go home
5/23/03 9pm temp 103.4 crying, temp cont. to elevate to 104 degrees. Was seen in ER-observed for 2-3 hrs then admitted because temp cont. to remain elevated even with analgesics. Temp broke 5/25/03 evening. Dismissed 5/26/03 at 7am.
mom states that pt broke out in rash all over body x/diaper area & has been running a low grade fever;
On 02/08/2002, pt's right arm was swollen and red down to elbow. Saw doctor on 02/08/2002 and prescribed antibiotic.
large bumb under armpit; large bumb under armpit, tender to touch and moderate pain; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 20Mar2021 at 14:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received the first dose of BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 27Feb2021 at 14:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. On 21Mar2021 at 14:00, the patient experienced large bumb under armpit, which was tender to touch and had moderate pain 24 hours after receiving the second dose. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken for the event. The clinical outcome of the event large bumb under armpit which was tender to touch and moderate pain was resolving at the time of report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained"  Amendment: This follow-up report is being submitted to amend previously reported information: 1. Age and unit 43 years added in Historical Vaccine 2. Row# 1 none removed in relevant history tab  3. Final sentence should be updated to "No follow-up attempts are needed; information about lot/batch number cannot be obtained"
Chills, aches at all joints, hyper sensitive to emotions, nauseous and then finally diarrhea the next day... general malaise and couldn't get warm... Did not check for a fever, but I did have chills ? Felt very flu like.
This is a spontaneous report from a contactable physician received via a Pfizer sales representative. An 87-year-old female patient received PREVNAR 13, lot number and expiration date unknown, via an unspecified route of administration on 28Dec2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. It was reported that on an unspecified date, the patient experienced swelling at injection site the 'size of a baseball', no fever, warm to the touch. Condition persists as of 06Jan2019. The patient had not recovered from the events. Information on the lot/batch number has been requested.