chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Info has been received from a health professional concerning a 16 month old white female, with no medical history and no allergies, who, "at 13 month of age", on 1/13/2004, was vaccinated with a 1st SC dose in the right arm of varicella virus vaccine live. Concomitant vaccine administered on the same day, included a 4th IM dose in the left thigh of Prevnar. There was no illness at the time of vaccination and no adverse events following prior vaccination. It was reported that, in July 2005, the pt developed a case of breakthrough with about 50 lesions and no fever. Unspecified medical attention was sought. No product quality complaint was involved. No further information was provided. Follow-up info from a person from a pediatric office indicated that the rash started two weeks ago, on 4/13/04 (also reported as July 2005 at 13:15, with exposure to chickenpox. It was described as a blistery rash all over. It was relieved by a baking soda bath. The rash re-appeared yesterday and was described as pruritic with approximately 50 tear drop vesicles in different stages, erythematous, based on her head, back, scalp, trunk and pelvis. The pt had no fever and was otherwise well. It has reported that the pt's symptoms were treated with clinical care and subsequently recovered. Additional info is not expected.
Patient was 17 at time of immunization of dose 1. Approved for 18 & older only
pt reports having tongue swelling & tongue blisters ~ 6 hrs after administration of Pfizer COVID-19 Vaccine #1 pt states the tongue swelling & blisters gradually resolved after ~ 6 hrs w/out tx or medical attention
Legs wouldn't work; Could not walk normal, but shuffled; light headed; Legs wouldn't work; Light headache; I was beginning to tramp my foot; This Adverse event this adverse effect is scary as hell; This spontaneous case was reported by a consumer and describes the occurrence of the second episode of GAIT INABILITY (Legs wouldn't work), GAIT DISTURBANCE (Could not walk normal, but shuffled), GAIT DISTURBANCE (I was beginning to tramp my foot), FEAR (This Adverse event this adverse effect is scary as hell) and DIZZINESS (light headed) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced GAIT DISTURBANCE (I was beginning to tramp my foot), FEAR (This Adverse event this adverse effect is scary as hell) and HEADACHE (Light headache). October 2021, the patient experienced the first episode of GAIT INABILITY (Legs wouldn't work). On 30-Oct-2021, the patient experienced the second episode of GAIT INABILITY (Legs wouldn't work) and GAIT DISTURBANCE (Could not walk normal, but shuffled). 30-Oct-2021, the patient experienced DIZZINESS (light headed). At the time of the report, last episode of GAIT INABILITY (Legs wouldn't work), GAIT DISTURBANCE (Could not walk normal, but shuffled), GAIT DISTURBANCE (I was beginning to tramp my foot), FEAR (This Adverse event this adverse effect is scary as hell), DIZZINESS (light headed) and HEADACHE (Light headache) outcome was unknown.            Concomitant information was not provided.  Treatment information was reported as Stayed in Bed   This case was linked to MOD-2021-369536 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Significant Follow Up added on -event added and contact info, patient details updated, initials changed.
RASH ON FACE ARMS TORSO LEGS PELVIC REGION SO FAR  ON DAY 2 OF ONSET OF EVENT.
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided.  The vial was placed in the refrigerator on 29-Oct-2021.Vial did not undergone any temperature excursion. No adverse event was reported.  Treatment medications were not reported
I had my vaccination on 09/23/2022. On 03/05/2023 I started to have the chills headache and fatigue. On 03/06/2023 I tested COVID-19 positive. I contacted my doctor on 03/06/2023 and I started PAXLOVID. After the course of that treatment, I started to feel ill again on 03/13/2023 and I tested COVID-19 positive. I relapsed after my dose of PAXLOVID. I am beginning to slowly recover but feel the fatigue more at the end of the day.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On 10-JAN-2017, the patient was vaccinated with GARDASIL 9 dose 1 (route, lot number and expiration date were not provided) for prophylaxis. On 09-MAY-2017, the patient was vaccinated with GARDASIL 9 dose 2, lot # M040412, expiration date: 30-JUN-2019 (route not provided) for prophylaxis which is outside of the recommendations in GARDASIL 9 prescribing information. No adverse effects were reported. A product quality complaint (PQC) was not involved. Additional information has been requested.
Patient received vaccines approximately 1625, got up to go to the bathroom, while waiting outside the bathroom door, she felt dizzy and apparently had a syncopal episode with shaking of arms and legs lasting less than 15 seconds. There was no post ictal phase. She did not have orthostasis, her D stick was 97. She was noted to have strep pharyngitis. The patient remained active, alert, talkative with no post ictal phase. She drank water and was discharged at 1730.
She done okay right after the shot but now having reactions. Rash where she received the injection, red and hot, swollen. her whole arm is painful.
Swelling and hardness under skin, itching, tingling feeling down whole arm, warm to the touch began around 8:00pm the following day (4/16), worsened throughout the night and into the next morning
Headache, Arthralgia, Fatigue, chills, injection site pain and swelling, skin hypersensitive, sweating Narrative:  Other Relevant History:
Pt. had immunization at approximately 0930. Grandmother phone 05/20/04 to report child "cried for three hours straight" from 6 pm to 9 pm on 5/19/04 (day of immunization). Mother gave acetaminophen appropriately. No fever, redness at injection sites or other symptoms present.
sore upper left arm 2 days,  fatigue 5 days,  muscle & joint pain 5 days,  diarrhea 4th day rested and slept for fatigue took Tylenol first 2 days, and ibuprofen thereafter for  pain took bismuth subsalicylate for diarrhea
Was not feeling good/He was down; Felt like he had the flu; Had a sore arm; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Was not feeling good/He was down), INFLUENZA LIKE ILLNESS (Felt like he had the flu) and PAIN IN EXTREMITY (Had a sore arm) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-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 FEELING ABNORMAL (Was not feeling good/He was down), INFLUENZA LIKE ILLNESS (Felt like he had the flu) and PAIN IN EXTREMITY (Had a sore arm). At the time of the report, FEELING ABNORMAL (Was not feeling good/He was down), INFLUENZA LIKE ILLNESS (Felt like he had the flu) and PAIN IN EXTREMITY (Had a sore arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication was reported by reporter.  Patient reported of not seen a doctor.  No treatment medication was reported by reporter.  Patient said he was sick for 2 days meaning he was down, wasn't feeling good, felt like he had the flu, & had a sore arm when he got the doses.   This case was linked to MOD-2022-629960 (Patient Link).
After giving Patient Flucelvax, she waited for her mom and sister to get the shot. Patient wasn't sitting down and was standing. She felling on onto the ground and had seizure-like/spasm-like for about 20-30 seconds. Patient lips were pale but regained consciousness and lips color came back. Patient did not have any anaphylaxis reaction. We call EMS and they arrived within minutes and took over the scene. Blood pressure and pulse ox were within normal limit. EMS offered to go to hospital but Patient's guardians/patient did not want to go but will observe Patient properly throughout the day
Tearful; Anxiety; More depressed than usual; Pain in lower abdomen periodically; Pain behind ear; Burning of her chest (like a sunburn); Colder skin; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (Pain behind ear), CHEST PAIN (Burning of her chest (like a sunburn)), PERIPHERAL COLDNESS (Colder skin), TEARFULNESS (Tearful) and ANXIETY (Anxiety) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced EAR PAIN (Pain behind ear), CHEST PAIN (Burning of her chest (like a sunburn)) and PERIPHERAL COLDNESS (Colder skin). On an unknown date, the patient experienced TEARFULNESS (Tearful), ANXIETY (Anxiety), DEPRESSION (More depressed than usual) and ABDOMINAL PAIN (Pain in lower abdomen periodically). At the time of the report, EAR PAIN (Pain behind ear), CHEST PAIN (Burning of her chest (like a sunburn)), PERIPHERAL COLDNESS (Colder skin), TEARFULNESS (Tearful), ANXIETY (Anxiety), DEPRESSION (More depressed than usual) and ABDOMINAL PAIN (Pain in lower abdomen periodically) outcome was unknown.            Patient reported having the same symptoms (but more severe) after her first dose.   No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-066926 (Patient Link).
This spontaneous report was received from a healthcare worker refers to unspecified patients of unknown gender and age. Information regarding patients' medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not provided. On unknown dates, these patients were vaccinated with improperly stored doses of VARIVAX (Merck) (lot # L046888, expiry date: 23-NOV-2017; lot # L024253, expiry date: 01-JUL-2017; lot # L039093, expiry date: 06-OCT-2017; lot # L027432, expiry date: 22-JUL-2017). The vaccine underwent a temperature excursion of 21.4 degrees Fahrenheit within the time frame of 24 hours. M-M-R II appeared on the product list, however no doses of the vaccine were administered to the patients. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
The day after my 2nd dose of the Pfizer COVID vaccine I experienced a high pitched/constant ringing in my right ear.  This lasted about 2 months.  Based on my reading and knowledge of tinnitus from my mother-in-law's experience with this health issue, I believed this was tinnitus.  I did not seek treatment as I observed my family member's struggle with tinnitus -- never finding an effective treatment that worked for her.  Fortunately, my symptoms gradually went away over time.  Tinnitus significantly reduces your quality of life.  This was difficult to experience.
Information has been received from a physician concerning an 18 year old female with no pertinent medical history or drug reactions/allergies who in approximately October 2007 "about one month ago", was vaccinated with Gardasil, 0.5mL, intramuscularly.  Concomitant therapy included "several other vaccines given on the same day" (therapy unspecified).  Within one hour, the patient developed itching at the injection site.  The itching lasted about 12 hours, and then resolved.  No other symptoms were noted.  Medical attention was sought with a phone call to the office.  The product quality complaint unit was not involved.  Additional information has been requested.
very fussy & temp all weekend;checked today 24FEB97 t103.6 ear thermometer;referred to pvt MD;
ACHY BONES/BONES HURT; TASTE SCREWED UP; CANNOT CROSS LEGS THEY TOO HURT BAD; ACHY MUSCLES/MUSCLES HURTING; This spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetic.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: 21-SEP-2021) dose was not reported, administered on 09-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-JUN-2021, the patient experienced achy bones/bones hurt. On 16-JUN-2021, the patient experienced taste screwed up. On 16-JUN-2021, the patient experienced cannot cross legs they too hurt bad. On 16-JUN-2021, the patient experienced achy muscles/muscles hurting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from achy bones/bones hurt, achy muscles/muscles hurting, taste screwed up, and cannot cross legs they too hurt bad. This report was non-serious.
Initial unsolicited report received from a physician on 01 May 2015. A 02-month-old male (reported as 2.5 month old) patient, whose concomitant medications were not reported, had received a first dose of PENTACEL (batch number C4876AA, expiry date 12-Sep-2015, dose, site of administration were not reported) intramuscularly on an unspecified date. It was reported that, patient had no previous dose. Reporter denied any illness at the time vaccination and any pre-existing physician diagnosed allergies, birth defects, medical conditions. On an unspecified date, patient had experienced apnea, hypotension and paleness after seven days post vaccination. Patient required an emergency room visit and was subsequently hospitalized on an unspecified date. Laboratory investigations and corrective treatments were not reported. At the time of this report, outcome of event was not reported. Documents held by sender: none.
Pt recvd vax 22SEP92 & later that day exp pain in lt leg from anterior thigh to calf;
PT RECEIVED 7 VACCINES IN OUR OFFICE AT THE 12 MONTH APPOINTMENT. THE PT WAS SLEEPING ON HER FATHER'S CHEST THAT NIGHT AND AT APROXIMATELY 1:00 AM, THE PT HAD A SEIZURE THE LASTED 4-5 MINUTES. THE PT WAS REPORTED TO HAVE A FEVER OF 102 WHEN ARRIVING AT EMERGENCY ROOM.
12 hours after shot started having chills and body aches. The symptoms lasted 12 hours
Resident had seizure like activity followed by a vagel response with large bowel movement. Resident then began to show signs of blood clot to left lower extremity. No pedal pulse, area on leg warm to touch. Left lower leg now cold to touch, stiff, purple and white in color. No other signs of modeling, body warm to touch, no fever noted. Respirations and pulse increased with low oxygen levels. Resident not responding to stimuli.
I got the vaccine on 11/10, on the 11th I ran a fever of 100.1. I had bad body aches and a headache (not a headache person). Fatigue ? really long lasting fatigue where I fatigue very easily and then I have to rest for a day and try to do what I normally do the next day and the next couple days then I go down again. I had this coughing thing for a really long time. I went to help with my granddaughters. I had coughing spells there and I vomited due to something I ate. I also had to lift one of the girls during the time taking her to school. After that, I had severe pain in my chest that ran all the way to my back, and I couldn?t catch my breath. I went to my chiropractor, and she said I had a slipped rib. I went in the morning and left in the afternoon for two days to get treatment from her. She?s been treating me since and I?m fine and breathing. I believe the rib is back in place. The slipped rib could be caused from coughing and throwing up. All of that together happened before I realized that something is wrong with my body. I also think I?m fatigued because my body is trying to heal.   cough is still lingering - unsure if cough is in relation to vaccine or medicine i was taking
Johnson & Johnson Janssen COVID-19 EUA Patient not 18 years of age; 17 Discovered during chart audit Community clinic
Non stop migraine since day of injection  Nausea Chills Fever Fatigue
Patient became warm and diaphoretic after getting the vaccine and in the observation section for about 5 minutes. Patient report this is not the first time incident like this has happened. Patient experienced these symptoms twice before after getting and IM shot.
Vaccine brand: Pfizer / BioNTech/Product: COVID-19 treatment; Vaccine brand: Pfizer / BioNTech/Product: COVID-19 treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Mar2021 at 14:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 23 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medication(s) included: NAPROXEN; BROM/PSE/DM. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Vaccine brand: Pfizer / BioNTech/Product: COVID-19 treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Covid Positive; Covid Positive; This is a spontaneous report from a contactable consumer (wife). A 72-year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL1283  and Expiration Date unknown) via Intramuscular on 12Jan2021 16:30 (vaccine location: right arm ) at single dose for COVID-19 immunisation. The patient's medical history included Kidney stones and heart issues (sees a cardiologist). The concomitant medications was reported as unspecified drugs. No previous vaccine in four weeks. Patient went to urgent care this morning and had a rapid test that came back positive and had covid.  Lab test included positive rapid covid test on 21Jan2021. The outcome of event was unknown.
patient complained light headedness and cloudy vision. denied shortness of breath cutaneous symptoms.  patient reported symptoms resolved almost immediately. patient instructed to call medical Team with any worsening signs or symptoms.
This case was reported by a nurse via sales rep and described the occurrence of fever in a 16-year-old female patient who received BEXSERO (batch number 169821, expiry date 31st January 2019). On 27th September 2017, the patient received the 1st dose of BEXSERO (intramuscular). On an unknown date, less than a month after receiving BEXSERO, the patient experienced fever (serious criteria disability and other: As per reporter), injection site warmth (serious criteria disability and other: As per reporter) and injection site swelling (serious criteria disability and other: As per reporter). In October 2017, the outcome of the fever, injection site warmth and injection site swelling were recovered/resolved. The reporter considered the fever, injection site warmth and injection site swelling to be almost certainly related to BEXSERO. Additional details were reported as follows: The reporter stated to a field representative that, the patient experienced a softball like mound at the injection site for BEXSERO that was warm to the touch. The reporter stated there was an intervention with KEFLEX. The symptoms resolved after about 1 week.
7 years old / has received / vaccination / in July 24th 2015 / has to restart the series all over again?; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 7-year-old female patient who received HAV (Havrix) for prophylaxis.   Previously administered products included Havrix (1st dose received on 24th July 2015 (batch no: AHAVB703AA, expiry date:5th October 2015).).   On an unknown date, the patient received the 2nd dose of Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional case details were reported as follows: The age at vaccination was not applicable for this report.. Till the time of reporting patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination. The reporter were wondering if patient need to restart the series all over again. All patient identifiers were provided. The reporter mentioned that, no further clarification were performed. The reporter consented to follow up.
Significant chest pain, shortness of breath, fatigue, continuing for over 3 weeks, worse shortly after vaccine, worse after exercise.  Recommended to seek EKG/diagnostics by medical provider (unable to afford diagnostics)
On April 10, 2021, patient reported losing vision in right eye. Saw primary physician on 4/14/2021 and had ultrasound of the neck done on 4/14/2021.  Patient reported per phone on 4/15/2021 that she was told that she had a stroke in her right eye.  Was placed on ASA 325mg and Clotidogrel 75mg.
just tested positive for covid and had the three Covid-19 vaccine from Pfizer; just tested positive for covid and had the three Covid-19 vaccine from Pfizer; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2 NOS), 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 and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "just tested positive for covid and had the three Covid-19 vaccine from Pfizer". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive.  Clinical course: It was reported that he just tested positive for covid and had the three Covid-19 vaccine from Pfizer. He hasd question about the updated version of the booster shot and he was asking it was still going to protect him.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.