chrisvoncsefalvay/vaers-outcomes huggingface dataset:
kind of skin disorder - neurofibromatosis which are benign tumors/The neurofibromatosis got worse after the 1st dose and it got even worse after the 2nd dose; This spontaneous case was reported by a patient and describes the occurrence of NEUROFIBROMATOSIS (kind of skin disorder - neurofibromatosis which are benign tumors/The neurofibromatosis got worse after the 1st dose and it got even worse after the 2nd dose) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     The patient's past medical history included Weight loss (since she lost over a 100 lbs 3 years ago.) and Neurofibromatosis (She had it since she was a teenager.). Concurrent medical conditions included Blood pressure (She said that her BP has been fine.).   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NEUROFIBROMATOSIS (kind of skin disorder - neurofibromatosis which are benign tumors/The neurofibromatosis got worse after the 1st dose and it got even worse after the 2nd dose). At the time of the report, NEUROFIBROMATOSIS (kind of skin disorder - neurofibromatosis which are benign tumors/The neurofibromatosis got worse after the 1st dose and it got even worse after the 2nd dose) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details not reported by the reporter. Patient reported that she had the 2 Moderna shots and have a kind of skin disorder neurofibromatosis which are benign tumors. She had it since she was a teenager. She further stated gotten worse after she got the 2 shots. Caller did not have the vaccination card at the time of the call but states that she had the 1st and 2nd doses in 2021. The neurofibromatosis got worse after the 1st dose and it got even worse after the 2nd dose.  Treatment details was not reported by the reporter.
Pt reports progressive pain approx initially 10 hours after vaccination and a rash developed as well. Rash is slightly raised, red, painful x 4 inches square.
Spots and rash developed on torso, hands, arms and legs.; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8731) via an unspecified route of administration in the left arm on 06Apr2021 at 12:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient previously did not receive any past drug medications. The patient did not receive any concomitant medication within two weeks prior to the vaccination. 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. On 07Apr2021 the patient experienced spots and rash developed on torso, hands, arms and legs. The clinical outcome of the event spots and rash developed on torso, hands, arms and legs was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
I had previously received both moderna vaccinations, and did not have any reactions. I received the moderna booster, and one two weeks later have developed skin problems- hives, burning, hot, swollen areas, big red patches. These come and go randomly during the day and night. I have never had hives or skin issues like this. A dr has put me on prednisone, two allergy meds, and Pepcid. The skin issues come back quickly if I don?t keep up with the meds. I got severe heartburn after several days on these meds.
pleurisy; This is a spontaneous report from a contactable consumer or other non hcp.     A 43-years-old female (non-pregnant) patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 12Feb2021 08:45 (Batch/Lot number was not reported) (at the age of 43-years-old) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history was not reported. Concomitant medications (other medications in two weeks) included biotin, rosuvastatin, valaciclovir hydrochloride ,levocetirizine dihydrochloride (XYZAL). The patient did not have any known allergies. The patient did not have covid prior vaccination. The patient did not have any  other vaccines within 4 weeks. On 13Feb2021 08:00, After receiving the dose early on Friday morning, the patient woke up Saturday (8:00 AM ) with pleurisy. She had it before so she knew what it was and how to treat it. The patient had not tested post vaccination. No treatment was received for adverse event. The outcome of the event was not recovered   No further information expected.
had the vaccine, still get shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 26-FEB-2023 Reporter's comment: This case was reported by a patient via interactive digital media. The reporter reported that the patient had the vaccine and it did not work. The reporter reported that you could got the vaccine and still got shingles.  The reporter know, it happened him/her.  The PRN told that it was just like any other vaccine, some people it works for and some it did not, just like a flu shot. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. This case was 1 of 4 cases for the patient reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR032444:same reporter US-GSK-US2023AMR032445:same reporter US-GSK-US2023AMR032461:same reporter
Pt. came in for her 2nd shot on 4/22. She informed staff she received the 1st vaccine on 3/26 and developed a DVT on her right leg. She is now on Xarelto as a blood thinner.  Her physician stated she could still receive the second dose.  Her MRN number is 3934866.
Right breast burning/ Right breast pain; This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (Right breast burning/ Right breast pain) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Breast cancer in 2018.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BREAST PAIN (Right breast burning/ Right breast pain). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, BREAST PAIN (Right breast burning/ Right breast pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided. Treatment provided include aspirin which did not resolve the symptoms.
Myalgia, Fever, FATIGUE, Narrative:  FEVER TO 102 WITH ERYTHEMA UNDER RIGHT BREAST AND BOTTOM OF FEET  Other Relevant History:
5/19/10 - Fever/chills, not eating, sleepy, pain at site of injection, 1/4 size swelling, redness, headache. Body is warm from head to abdomen and cold from knees to toes. Inner thighs warm, outer thighs cold.
48 hrs /p vax given, injection site was sore &red, increased in degree along /w moderate local swelling, hardness, warm or hot to touch, over next 5 days. Benadryl RX by physician, not to have 2nd measles inj.
Rash appeared on the patient's back 2 days after receiving the booster vaccine. Patient has a fever and puffy eyes as well as a sore arm. Patient came to the doctors office, urine had traces of blood, Glucose and Ketones. Urine was sent for culture. There was pararectal irritation, culture of the area was sent.
she proceeds to break out in hives almost every week.; her left hand is numb and she can't use it; rash on her hand; her hands broke out and were so sore and red and she has no feeling in her left hand.; her hands broke out and were so sore and red and she has no feeling in her left hand.; her hands broke out and were so sore and red and she has no feeling in her left hand.; This is a spontaneous report from a contactable consumer (patient). A 86-years-old female patient received an unknown dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on Feb2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. vaccine that she got in Feb and Mar. Consumer states she phoned about 3 weeks ago and she got an answer back and they said they would send papers to fill out, but she hasn't received them. On unspecified date consumer states she took a very severe reaction, and she is still suffering, and it has been 4 months, and she proceeds to break out in hives almost every week. In Feb2021, her hands broke out and were so sore and red and she has no feeling in her left hand. Consumer states in Mar2021, she doesn't know why she got another one so quick with the rash on her hand, but they said it was the sanitizer but it wasnt sanitizer and they are still red and sore. Her left hand is numb, and she can't use it. Consumer states she doesnt know what the matter with it is, it was never like that before the vaccine. Consumer states she is 86 years old, and she needs a bit of help and she is not getting it here. Consumer states she don't want any more fooling around, she wants something done about it. The outcome of events was unknown.
Information has been received from a consumer referring to a female patient of unknown age. The patient's concurrent condition, medical history and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, strength, route, lot# and expiration date unknown) for prophylaxis. Sometime in 2007 while using ZOSTAVAX (also reported as "after getting the shingles shot"), the patient got shingles and that the shingles got into her right eye. The patient sought medical attention and was able to be treated (treatment not specified), but later lost vision in her right eye. The outcome of the events was reported as not recovered. The causality between the events and ZOSTAVAX was not provided. Upon internal review, the events of lost vision in the patient's right eye and shingles got into right eye were considered to be medically significant.
Systemic: Blood Disorder  (diagnosed by MD)-Mild, Systemic: PATIETN HAD HIGH BLOOD PRESSURE. PATIENT MISSED HIS LISINOPRIL DOSE. HE FELT ALITTLE DIZZY AFTER THE SHOT AND BLOOD PRESSURE WAS CHECKED AND IT WAS FOUND TO BE HIGH 180/90 PATIETN WAS MONITIERED
Patient received an expired vaccine as 2nd dose; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine as 2nd dose) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine as 2nd dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine as 2nd dose) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No relevant concomitant medications reported.  No treatment information was provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable     Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non significant follow up
per patient report: onset was feeling light-headed followed by swelling of tongue and closing of throat, joint pain, malaise, Within 20 minutes of onset taken to ER where given Epi-Pen injection and IV bolus of steroid.  While under ER observation began to have uncontrolled shaking of body and sense of "delirium". Kept overnight for observation and sent home with decreasing dose pack of steroid.
Red itchy hives at and around the injection site starting 4 or 5 days after vaccination administered. Still ongoing  3 days later.
Headache, Myalgia, inj site soreness, chills, muscle aches/soreness, fatigue Narrative:  inj site soreness x 4 days; chills, muscle aches/soreness, fatigue, HA x4 days
Service member with c/o persistent bilateral multiple joint pains since receiving Anthrax and Smallpox vaccine (as well as several other vaccines) prior to going overseas in 2003 for her second deployment. Symptoms: nausea w/ vomiting, headache, general, blurred vision, fever, flu-like symptoms>96 hours.
THROWING UP, DIZZY HEADACHE, RAPID HEART BEAT, DIFFICULTY BREATHING
Per pt, her arm at site of injection has "a dent" and is painful at the site.
10/23/03 child c/o soreness of left upper shoulder at 11 PM, mother also noted red and swollen. Assessment: IZ site of left upper shoulder noted. Redness, swelling, warm to touch and mother gave her Tylenol 1:30 PM. Instructed mom to ice pack and Tylenol every 4-6 hours prn for pain. Temp 99.1. Reassess in 2 days. Also instructed mother to call Health Dept or see pediatrician if gets worse. She said OK.
High fever (103)  for more than 48 hours.  Arm so stiff, couldn't move it. Hives all up and down arm and on neck.  Arm has remained slightly painful to raise, even 6 months later.
Flu like symptoms- body aches, fever, sleepiness, weakness, dizziness, needle-like leg pain (both legs), skin on legs painful to touch.
it did nothing for me; it did nothing for me; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "it did nothing for me".  Clinical course: Patient stated that patient did not believe in the booster and got the 2 does vaccine [Pfizer COVID-19 vaccine] and it did nothing for the patient.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I had severe headache in back of my head; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on 14Apr2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. It was reported that three weeks ago on 14Apr2021 patient took the vaccine and then patient had severe headache in back of head, very severe headache, it goes and it comes right away on an unspecified date. Patient stated that had been taking Tylenol but it does not really work so patient started taking Aspirin. Patient don't want to report it, patient want to know what should do, is this normal, this is the headache. The patient received treatment as a result event. Outcome of the event was not resolved.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Diarrhea (10 episodes) with blood in stool. Will breast feed + pedialyte and have follow up visit on 9-5-19.
This is a spontaneous report from a contactable pharmacist. A 65-year-old female patient received PREVNAR 13, (lot#: R49358, expiry date: Apr2018, NDC #: 00006197102), intramuscular in left deltoid on 31Oct2017 at 0.5 ml, single for immunisation. Vaccination was done in a pharmacy/drug store. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patent experienced arm was red and inflamed, sore to the touch although not as sore today as it's been since she got the shot, it was swollen and red about 3 to 4 inches in diameter it's itchy, she said she was not running a fever and she wanted to find out if she should go to the doctor or if this would be considered normal. The outcome of the event sore to the touch although not as sore was recovering while the outcome of the remaining events was unknown.
pt devel achy legs, h/a;APAP given;awoke AM w/ achy body, T101, 8AM nauseous,h/a; legs hurt, drinking well, resting quietly in bed;pt delayed in starting his vaccine series, secondary to prolonged hospitalization when 8 mo old
9/27/16 1pm after FLUCELVAX vaccine, 1/2 hour nausea, dizziness, itching, hives on arms legs, face, trunk, back 50mg BENADRYL. Offered EPI PEN. Patient ref and directed to follow up as needed if not better of if worse at ER. To see primary for follow up.
2 days after arriving from trip, developed URI, fever, cough, and irregular heart rate. Covid test negative. Heart beat confirmed with monitor as atrial fibrillation. No previous history of cardiac arrthymia.
o Complaint The patient is a 41 year(s) old Female complaining of allergic reaction, nausea. o Chief Complaint Quote Patient complained of allergic reaction that started about 45 mins ago. She got her 1st dose of Pfizer Covid vaccine yesterday morning. She complained of rash all over the body, swelling on the hands and face including eyes and lips. She denied chest pain, abdominal pain, fever, cough, vomiting and difficulty breathing. She complained of nausea that started 5 mins ago. She has not taken any meds yet for her symptoms. o Time Seen 02-18-2021 01:20 o Historian patient  ADDITIONAL HPI: o Additional HPI Pt here with concerns of allergic reaction.  Pt fell asleep on the couch approx 2200.  She awoke 2 hours later with itching of her hands.  Over the next hour she developed a full body rash, itching, and swelling of face.  No wheezing, no difficulty swallowing.  Upon arrival to ED pt started to feel nauseated. Pt had first dose of COVID vaccine approx 16 hours prior to onset of sxs.   No h/o allergic reactions, no h/o asthma.  Emergency Department Course and Clinical Decision Making:   Patient presents with urticaria and swelling to her face eyes and lips.  Shortly upon being roomed she started to feel very nauseated and started vomiting.  No stridor or wheezing, no immediate airway compromise but given both cutaneous and GI symptoms, significant concern for anaphylaxis.  Patient was immediately given epinephrine intramuscularly, 0.3 mg.  An IV was placed and she was given Solu-Medrol, Benadryl, Pepcid, and Zofran.  Patient's urticaria and swelling started to nearly immediately improved after the epinephrine.  She is feeling much better though slightly anxious. To be reaction from the Pfizer vaccine, no other obvious triggers, patient has no history of allergic reactions or other sensitivities. We will observe in the emergency department in a monitored setting for several hours to assure no rebound symptoms, patient updated on plan.  0500 Pt has been resting.  Urticaria resolved, swelling to face resolved.  Discussed with pt reporting reaction to CDC, info provided. Also discussed the second dose of vaccine, recommended reaching out to Epi response team or PCP to get recommendations.  Will give short course of prednisone, 4 days, Benadryl as needed, ED return precautions discussed, will dc home.
I noticed a more severe menstrual cycle the month of my second dose. More severe hormonal imbalance, painful cramps, heavier flow, and painful constipation.
He stated his throat is scratchy, hurts and started to get hoarse, slightly SOB, itchy race and head and lips were tingling.  He was given 25mg of Benadryl.  he admitted that when he gets his "infusion for MS" this also happens.  He admits Benadryl and predisone helps with symptoms.  Nurse and provider with patient.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22May2022 at 03:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Inflammatory arthritis" (unspecified if ongoing); "asthma" (unspecified if ongoing). Concomitant medication(s) included: HYDROXYCHLOROQUINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Symptoms returned after negative test. Therapeutic measures were taken as a result of covid-19.  Clinical course: Patient did not have any known allergies. Patient received anti-viral as Covid-19 treatment from 28Jun2022 to 02Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The company cannot completely exclude the possible causality between the reported COVID-19, which is considered as failure of vaccine BNT162B2, and the administration of BNT162B2, as the efficacy of a vaccine varies individually and may be affected by different factors including drug potency.
Patient received the flu shot at 3:00 PM today through my work.  He has had the flu shot in past seasons with no side effects.  This time however he broke out in hives and a fever of 101.3 F.  I gave him a bath around 5:00 PM and thats when I noticed the hives.  I called the doctor and they made an appointment for him at 7:20pm.  They told me to give him Benadryl and to watch for respiratory problems or difficulty breathing.  When we got home around 8:30 PM his hives worsened and he would not eat.  I phoned the doctor and the nurse called back and told me to continue with the Benadryl and that I could also give him Motrin.  She also told me to continue to monitor his breathing and swallowing and if problems arise in that area to immediately take him to the ER.  Doctor also referred him to allergist.