chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Booster; Chills; Fever; Headache; Nauseous; Sore arm; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 66 year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number unknown, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; CHILLS (non-serious), outcome "unknown", described as "Chills"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; NAUSEA (non-serious), outcome "unknown", described as "Nauseous"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm". Additional information: Events took place after use of Booster shot of COVID-19 vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Baby screaming with pain intermittently and vomiting. Seen in ED on 8/22 had intussusception, reduced by air enema and observed overnight inpatient x 24hr.
rashes; welts; blisters; Pin spots; itchy spots on hands, upper thigh and back of leg, gradually spread more; stomach pains; This case was reported by a consumer via call center representative and described the occurrence of localized itching in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 9435L, expiry date 8th April 2023) for prophylaxis.   Concurrent medical conditions included meat allergy (had alpha-gal syndrome) and dairy intolerance (Dairy is a trigger for Alpha -gal Syndrome.).   On 28th October 2021, the patient received the 1st dose of Shingrix (intramuscular). On 29th October 2021, 1 days after receiving Shingrix, the patient experienced stomach pain. On 30th October 2021, the patient experienced localized itching. On an unknown date, the patient experienced rash, welts, blister and petechia. On 4th November 2021, the outcome of the stomach pain was recovered/resolved. On an unknown date, the outcome of the localized itching, blister and petechia were not recovered/not resolved and the outcome of the rash and welts were unknown.   It was unknown if the reporter considered the localized itching, stomach pain, rash and petechia to be related to Shingrix.The reporter considered the welts and blister to be possibly related to Shingrix.  Additional details provided were as follows: The case was reported by patient and follow up was by pharmacist. The patient received first dose of Shingrix in the Left arm and about a day later she experienced stomach pains that lasted about a week then it was resolved. The patient also experienced itchy spots on both of her hands, the upper thigh of one leg and the back of the leg of the other leg. The patient also reported the itchy spots started about 2 days after the Shingrix vaccine and had gradually spread more and more. The itchy spots are related to the Alpha-gal Syndrome she contracted about 3 years ago. The itchy spots were manageable but have not resolved. The patient also reported that she had eaten food in the past 2 weeks that contains dairy which might be added to the itchy spots. Dairy is a trigger for Alpha -gal Syndrome. The pharmacist mentioned and the patient believed that the Shingrix vaccine caused welts and blisters. The patient also experienced rashes, welts and blisters. The patient currently had pin spots and blisters at the time of reporting. The pharmacist initially called in to inquire about any milk based protein or meat (alpha gal) in Shingrix. The reporter did not gave permission to contact Health care professional.
Soreness L arm, erythema, warm from deltoid to mid lower arm with fluid pooling under skin dependently. TX: Cephalexin 500mg QID for 10 days, benadryl 25mg.
At around 10 pm. I started feeling really cold. By 10:30 I had really bad chills. I tried to lay down and warm up but by chills were extreme by the time I got in bed. They were so bad that I couldn't even hold my phone or drink water without extra effort. Then as I tried to sleep I started to feel really hot. I eventually went to sleep but woke up about two hours later feeling like I had a fever. I was hot and sweaty. During the night I woke up every two hours feeling this way, hot, and tired. Then at 6 am I woke up still feeling bad, but better. Now I had a headache that wasn't there before. I drank a lot of water and took advil. After a cold shower I started to feel a lot better.
ASTHMA EXACERBATION; HEART PALPITATIONS; YELLOWISH FLUID WAS DRAWN FROM SWOLLEN LEFT LEG; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic obstructive pulmonary disease(copd), asthma, penicillin allergy, and unspecified food allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced asthma exacerbation, heart palpitations, yellowish fluid was drawn from swollen left leg, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from asthma exacerbation, heart palpitations, and yellowish fluid was drawn from swollen left leg, and had not recovered from headache. This report was non-serious.; Sender's Comments: V0-  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
On 5/21/99, the pt received his first treatment with Lymerix. The same day, he experienced muscle and joint pain.  No treatment was given. The most recent information received on 9/9/99 reports the symptoms resolved after approximately one month. The reporting physician considered these adverse events to be disabling and incapacitating.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 56.06 for dose administered on 27-Feb-2021.  No concomitant medications were reported.  Batch number 014M20A underwent temperature excursion on 27-Feb-2021 with temperature 33 degrees Fahrenheit from 12:00 PM to 01:00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-MAR-2021. Product moved to clinic on 27-Feb-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.
Varicella rash 10 mos s/p varicella vaccine after flu vacin.
I thought it was diabetes, I felt light headed, shaky, sweaty. I contacted my cardiologist and went and was told I was having a hear attack. I'm now on 3 additional medications.
Hair loss after vaccines; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer of an unspecified age reported that received bnt162b2 (Covid 19 Vaccine, Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had both doses of Covid vaccine. The patient would like to know if her side effect has been reported by anyone else. The patient said having hair loss after vaccines. There were unaddressed medical questions referred or forwarded to Medical Information. The outcome of event was unknown.  No follow up attempts are needed; information about lot/batch number cannot be obtained.
Pt had an immediate inflammatory response at the injection site.  Pt also became lightheaded, pale, slightly tight in his chest and BP dropped to low of 96 systolic. Pt was given epi 1:1000 1cc and Benadryl 50 mg IM.  Pt did rebound and was able to be d/c to home.
Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 33-year-old female patient (gravida 1, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (on weekends). Concurrent medical conditions included Ovarian cancer, Drug hypersensitivity (Sulfa Drugs), Blood pressure high and Lymphedema. Concomitant products included UBIDECARENONE (COQ10 [UBIDECARENONE]), MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 05-Jan-2021 at 7:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 22-Jun-2020 and the estimated date of delivery was 29-Mar-2021. On 05-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-eighth week of the pregnancy. The delivery occurred  on 13-Mar-2021, which was reported as Normal Pregnancy Outcome. For neonate 1, The outcome was reported as Delivered NOS. The patient was induced early for hypertension. On 05-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Aug-2020, Pregnancy test: positive (Positive) Positive. On an unknown date, Glucose tolerance test: positive (Positive) 2 weeks ago, Passed. On an unknown date, Ultrasound abdomen: normal (normal) at 12 and 20 weeks.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported.  Company comment: This is a case of product exposure during pregnancy with no associated AEs for this 33-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.   Most recent FOLLOW-UP information incorporated above includes: On 15-May-2021: Updated patient delivery details.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 33-year-old female patient. Patient gave birth to a healthy baby but the delivery date was moved earlier because the patient had Increased in BP
A lot of dreams during night. Very strange things in the dream.  Everyday . Never happened before.
DIZZINESS; FELT BAD; FEVER; HEADACHE; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included pain issues before, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced dizziness. On APR-2021, the subject experienced felt bad. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, headache, and dizziness, and the outcome of felt bad was not reported. This report was non-serious.
Patients mother called and states that child is breaking out in hives, itching, and states she is cold. Mother states hives are on her whole body from vaccination.  Mom is going to administer Benadryl and review symptoms. If hives continue or any other symptoms develop                                                                                                                                              Mom to take patient to ER right away for evaluation and call 911 if things are significantly worsening. Mom agrees to plan.
Receive one dose of M-M-R II with diluent through the intramuscular route; No adverse effect; This spontaneous report as received from a pharmacist and refers to a patient of unknown age and gender. Patient's current conditions, medical history, concomitant medications, drug allergies or reactions were not reported.       On an unspecified date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rha) (M-M-R II) by intramuscular route (incorrect route of product administration) lot # R028003, expiration date 01-OCT-2020, (strength, dose and anatomical site were not provided)  for prophylaxis. Also it was reported the used of sterile diluent lot # N002579, expiration date 10-JUL-2019. No adverse event was reported. And the outcome of the event was  unknown.
p/vax pt devel an inj site rxn characterized by redness, tenderness & swelling extending tot he elbow;
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: ER8735), in right arm, on 21May2021 as dose 2, single (Lot number: ER8731), in right arm, on 27Nov2021 as dose 3 (booster), single (Lot number: F58757), in right arm and on 10May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: other medical history: Asthma; "Narcolepsy" (unspecified if ongoing), notes: other medical history: Narcolepsy; "known allergies: Yes" (unspecified if ongoing), notes: known allergies: Yes. There were no concomitant medications. 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: Positive. Therapeutic measures were taken with Paxlovid as a result of drug ineffective, covid-19.   Clinical Course: COVID 19 Treatment Paxlovid received from 27Aug2022 to 31Aug2022. No other medication received in 2weeks.
Within 5 minutes of administering MMR, developed throat pain and abdominal pain. Emesis x4. Rash developed within half hour (diffuse erythematous maculopapular rash) Able to swallow with ease. Breathing comfortably without wheeze. Throat and abd pain resolved within 1-2 hour, rash persisted
soreness in the arm that the Pfizer dose was administered; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm (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: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "soreness in the arm that the Pfizer dose was administered". Additional information: it was queried if after someone got the Pfizer vaccine dose in the arm, and their arm was sore, if it was ok to take medications like Tylenol and Ibuprofen.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Following administration of Td, pt devel erythema @ inject site; Also exp aches, fever, & flu-like sx;
Breakthrough case admission after 2 vaccines Pfizer 3/3/21 Lot# En6202;  Pfizer 3/24/21 Lot# ER8732;
Abdominal pain; severe nausea; headache; numbness in hand; itching on body on the side on injection; itching on body on the side on injection; dizziness; insomnia; night sweats; low grade fever; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient started to received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: unknown, unable to locate or read details), via an unspecified route of administration on 23Jan2021 16:15 (04:15 PM) at single dose on right arm for COVID-19 immunization. Patient was not pregnant at the time of report. The patient medical history was not reported. Patient was not diagnosed with COVID-19 prior vaccination. Concomitant medications included fluticasone, salmeterol, montelukast and paracetamol (TYLENOL). Patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The most recent COVID-19 vaccine was administered in School or Student Health Clinic  The patient experienced abdominal pain, severe nausea, headache, numbness in hand, itching on body on the side on injection, dizziness, insomnia, night sweats, low grade fever, all on 24Jan2021 02:00. No treatment was received for the events. The events were assessed as non-serious. Outcome of the events was recovering. Patient has not been tested with COVID-19 since the vaccination.  Information on the lot/batch number has been requested.
Mother reports : 3 shots in 1 arm 2 dots by shoulder on side of arm, but problem area surrounds the 3rd dot kind of the back of the arm. Has redness, swelling, warmth, c/o not feeling well, hives - arm swelling = whole upper (R) arm.
pt recvd vax; inconsolable crying , high pitched crying x 8 hrs; will no longer give dtp to this pt;
Developed cellulitis at injection site.  8/5/08 Reviewed hospital medical records of 7/2-7/4/2008. FINAL DX: no d/c summary available.  Admit dx: LUE cellulitis Records reveal patient experienced LUE rash, erythema, edema & pain where had received vaccination.  Erythema noted immediately s/p vax & then spread & worsened.  Seen by MD & tx w/antibiotics.  Continued to worsen & admitted.  ID consult done.  Area at injection site indurated w/fluctuance.  Improved & d/c to home on continued oral antibiotics.
My left arm is sore and I cannot straighten it out straight or lift it over my head.
Fever, chills, sweats, body aches, nausea for more than 72 hours
On 07/18/2021 late that night my right knee swollen rapidly, about 1:30am called EMS, Xrays indicated fluid, Blood testing said my INR 7.1, the DR took my off Warphrine and bed rest.  I was in the hospital for 6 days.
left leg had big jerk; numbness in the left foot; tingling in the left foot; numbness in the right hand; tingling in the right hand; right hand fingers were tingling and numb too; right hand fingers were tingling and numb too; wrong with her left leg; left leg toes those were tingling and numb; left leg toes those were tingling and numb; lower back pain very badly; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (lower back pain very badly), LIMB DISCOMFORT (wrong with her left leg), PARAESTHESIA (left leg toes those were tingling and numb), HYPOAESTHESIA (left leg toes those were tingling and numb) and PARAESTHESIA (right hand fingers were tingling and numb too) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cold extremities.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced BACK PAIN (lower back pain very badly). On 04-Apr-2021, the patient experienced LIMB DISCOMFORT (wrong with her left leg), PARAESTHESIA (left leg toes those were tingling and numb) and HYPOAESTHESIA (left leg toes those were tingling and numb). On 05-Apr-2021, the patient experienced PARAESTHESIA (right hand fingers were tingling and numb too) and HYPOAESTHESIA (right hand fingers were tingling and numb too). On an unknown date, the patient experienced DYSKINESIA (left leg had big jerk), HYPOAESTHESIA (numbness in the left foot), PARAESTHESIA (tingling in the left foot), HYPOAESTHESIA (numbness in the right hand) and PARAESTHESIA (tingling in the right hand). At the time of the report, BACK PAIN (lower back pain very badly), LIMB DISCOMFORT (wrong with her left leg), PARAESTHESIA (left leg toes those were tingling and numb), HYPOAESTHESIA (left leg toes those were tingling and numb), PARAESTHESIA (right hand fingers were tingling and numb too), HYPOAESTHESIA (right hand fingers were tingling and numb too), DYSKINESIA (left leg had big jerk), HYPOAESTHESIA (numbness in the left foot), PARAESTHESIA (tingling in the left foot), HYPOAESTHESIA (numbness in the right hand) and PARAESTHESIA (tingling in the right hand) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  Concomitant medication included menopause depression medication of very low dose on regular basis.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Nurse reported other adverse events and patient's current condition.
Patient came in to pharmacy day after receiving shingles vaccination and presenting a red area, warm to touch and hard approximate 6 inches long. Followed up w/ pt on 07/27/13 and she was in contact with physician and is to follow up on 7/29/13. Area got larger, but today she stated the area is getting lighter in the red color.