chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was received from a health professional on 15 June 2007. A two-year-old male patient with no reported medical history developed pertussis after receiving an injection of Trihibit (Tripedia plus ActHib, lot number U1857AA). The patient had previously received three doses of Daptacel: dose one on 17 March 2005 (lot number C2129AA), dose two on 18 May 2005 (lot number C2129AA), and dose three on 22 July 2005 (lot number C2184AA). On 24 April 2006 he received a dose of Trihibit. Thirteen months later he developed a persistent cough lasting 11 days, "mainly at night, which was getting progressively worse", and his physician noted the cough had a "whoop at the end". On 10 June 2007 he was diagnosed with pertussis, confirmed by the Laboratory Services in the state. The reported stated that "bilateral lungs were okay", and no fever or respiratory distress was noted. The event was treated with Zithromax and albuterol inhalers, and had not yet resolved.
tested positive for virus after having two dose of Pfizer; tested positive for virus after having two dose of Pfizer; 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) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single 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) all with onset 2021, outcome "unknown" and all described as "tested positive for virus after having two dose of Pfizer". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) positive; (2021) negative.  Additional Information: Consumer asked that why would be tested positive for virus after having two dose of Pfizer and after that booster and was tested positive. Consumer further stated what the patient was saying that had a hard time understanding patient name and all the patient just wanted to report if would know what was going with the Pfizer booster that was all the patient wanted to say and the patient was not expecting to be positive, that it was did not have anything more to say. Product details (LOT#, Expiration Date, NDC# and UPC#) and Pharmacy details could not be probed as consumer hung up the call abruptly. Hence further probing could not be done. Limited information available over the call.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021 at 1:21 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Feb-2021 at 1:21 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 24.14.  Concomitant products were not provided.  On 27-Feb-2021 Excursion time and temperature respectively 9AM :33, 11AM: 35, 12 PM : 35, 1PM: 35, 2PM: 35, 3PM: 34, 4PM: 34, 5PM: 35. total doses given for the day was 199, condition of vaccine prior to administration was not frozen,vaccine was moved to fridge on 24-Feb-2021.vial was moved to clinic on 27-Feb-2021,20 vials were sent to clinic.Vaccine BUD date was 26-Mar-2021.  On 27-Feb-2021, vials were stored in cooler 1, at following time and temperature respectively 9 AM: 33, 10AM :36, 11 AM: 35, 12 PM :35, 1PM: 35, 2PM :35, 3PM :34, 4 PM : 34, 5PM :35.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
chills and restlessness sleeping Sunday / Monday night,  Tuesday  9A: quick onset of severe flu like symptoms: dizziness, significant fatigue, loss of any concentration, nausea, lack of appetite.   Dimished quickly after 400mg advil taken in afternoon.  Mostly gone by 4:30P.  Wed 4/7 most symptoms gone.
CHILLS; This spontaneous report received from a consumer concerned a male 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, route of admin not reported, batch number: 1805031 and expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 at around 11:45 AM on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills. This report was non-serious.
Fever of 102 degrees, chills, dizziness, headache, soreness throughout entire body, weakness, headache, trouble standing, tiredness
Injury from Pfizer vaccine for Covid 19. First vaccine on 1/29/21 caused a rash on leg and sick all over, when to urgent care for treatment.The second vaccine on 2/19/21 caused swollen lips, red gums, that causes me pain, and when I smile or laugh when ever lips are stretched. Behind lips feel like burned skin. When washing mouth out  with listerline I see lose skin. Using a lip medicated numbing ointment for gums and lips . I take buprofen along with Benadry for my condition. Also tip of tongue turned red with lose of taste of food. My condition has not changed, expect for leg and I'm still sick. I have seen family doctor and dentist for my condition.
I recall having several abnormally heavy period, with breakthrough bleeding within the next 2 months August and September. Starting December I have not had a period.
Felt bad last PM (about 5-6 hours after injection) very fatigued then this AM 6/4/09 dizzy, nauseated. Now slightly better. No rash - No difficulty breathing. No numbness ...tingling in legs.
non stop since 6/17/2021: right arm shoulder elbow wrist thumb and first two digits numb tingle, feels like pinched nerve.   Parasitic general energy suck.
Swelled as golf ball size knot at injection site; Swelled as golf ball size knot at injection site; I shivered; felt like I was coming down with the flu; Cold; pain in my arm; I'm exhausted; Trembled for 2 days; This case was reported by a consumer via interactive digital media and described the occurrence of injection site lump in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. In August 2022, unknown after receiving Shingles vaccine, the patient experienced exhaustion. On an unknown date, the patient experienced injection site lump, injection site swelling, shivering, influenza-like symptoms, feeling cold, tremor and pain in arm. On an unknown date, the outcome of the injection site lump, shivering, influenza-like symptoms and feeling cold were unknown and the outcome of the injection site swelling and exhaustion were not recovered/not resolved and the outcome of the tremor was recovered/resolved and the outcome of the pain in arm was recovering/resolving.   It was unknown if the reporter considered the injection site lump, injection site swelling, shivering, influenza-like symptoms, feeling cold, tremor, exhaustion and pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 13-AUG-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient received the first dose. Even though it was 85° outside in the house patient had to turn off all the air conditioning. The patient had to put blankets and quilts on the bed to get warm and could not get warm for 4 hours. The patient was shivered and felt like coming down with the flu. The patient's shoulders swelled up like a golf ball size knot at the injection site. The patient trembled for 2 days and was cold.  This was day 4 the patient was exhausted and the pain in arm was lessened but still swollen.  The pharmacist said the second dose would be even worse. Follow-up would not possible, as no contact, details were available.
Abdominal pain, diarrhea. Symptoms started 30-60 minutes after receiving Dtap vaccine and lasted at least 24 hours.
headache; fever; very tired; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), PYREXIA (fever) and FATIGUE (very tired) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache), PYREXIA (fever) and FATIGUE (very tired). At the time of the report, HEADACHE (headache), PYREXIA (fever) and FATIGUE (very tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
A non-serious spontaneous report of administration of FluMist to a Nine-month-old was received from a physician concerning a nine-month old female subsequent to the administration of FluMist. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. Relevant medical history and concomitant medications were not reported. On 15-Oct-2009, the patient was accidentally administered FluMist. There was no adverse event associated with this vaccination error, therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered to be resolved.
Pt notified provider that she was in the ER experiencing shortness of breath, lightheadedness and rapid pulse. Friend in the ER found BP to be elevated. Symptoms began roughly 3-4 hours post immunization. Pt was seen in the ER and reportedly received a steroid injection, Benadryl and was sent home.
injection site has become swollen, inflamed; injection site has become swollen; injection site has become swollen, inflamed & sore.; Redness has spread; This case was reported by a consumer via Shingrix GSK Chatbot and described the occurrence of injection site swelling in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site swelling, injection site inflammation, injection site pain and erythema of extremities. On an unknown date, the outcome of the injection site swelling, injection site inflammation, injection site pain and erythema of extremities were unknown.   It was unknown if the reporter considered the injection site swelling, injection site inflammation, injection site pain and erythema of extremities to be related to Shingrix.  Additional details were provided as follow: The case was reported by the patient itself. The age at vaccination was not reported. The patient received Shingrix and the injection site was swollen, inflamed and (amp) was sore. The redness was spread and the patient asked if that could be shingles in the injected arm. No further information was provided
Itchy rash on arms and across shoulders Treating with Benadryl (at this time)
bruise at injection site swollen lymph node under left arm in armpit - appeared around day 4
Information has been received from a physician concerning a 49 year old male patient who on an unspecified date was vaccinated with a dose of MMR II (Lot # not reported). On an unspecified date the patient developed measles. Source of exposure was unknown. The patient's outcome was not reported. Patient sought medical attention by a visit to the physician. No further information is available.
Hours after the second dose I began to feel very tired by the next morning I felt as if though every bone in my body was broken and my head was pounding beyond belief.
Since the day after getting the vaccine, the muscles in my upper left arm, around the site of the injection, hurt when I stretch them.  It feels like a permanently pulled muscle.  The effect is most noticeable first thing in morning but occurs to some degree throughout the day, every time I stretch my left arm.  It's been almost four months since I received the shot, but my muscles still haven't recovered.
dizzy spells/gets up or sits down too fast experiences dizziness; room feels like it is spinning/thinks it is vertigo; arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt), DIZZINESS (dizzy spells/gets up or sits down too fast experiences dizziness) and VERTIGO (room feels like it is spinning/thinks it is vertigo) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN and ALLOPURINOL for an unknown indication.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm hurt). On 21-Apr-2021, the patient experienced VERTIGO (room feels like it is spinning/thinks it is vertigo). On 22-Apr-2021, the patient experienced DIZZINESS (dizzy spells/gets up or sits down too fast experiences dizziness). On 21-Apr-2021, PAIN IN EXTREMITY (arm hurt) had resolved. On 28-Apr-2021, VERTIGO (room feels like it is spinning/thinks it is vertigo) had resolved. At the time of the report, DIZZINESS (dizzy spells/gets up or sits down too fast experiences dizziness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Significant follow up appended: the information added were address, email was provided, new event was added, stop date for events was provided.
Night of 08/28/2003, child crying and saying her leg hurt.  Next day 08/29 leg became very swollen.  08/30, leg was swollen, red and had rash that spread around the 2 injection sites.  ER visit: given Benadryl.  Child slept through night and swelling/soreness/had lessened the next day 08/31.
Information has been received from a registered pharmacist concerning an 87 year old female patient with recurrent shingles (about every two months) who on 09-JAN-2009 was vaccinated with one dose of ZOSTER vaccine live (Oka/Merck) SQ.  Since receiving the vaccine, the patient continued to develop shingles about every three months.  The patient had contacted the pharmacist for medical attention.  Additional information has been requested.
This spontaneous initial report was received from a physician referring to a patient of unspecified age and gender. Patient's medical history, current conditions and concomitant medications were not reported. The physician reported that on an unknown date an unspecified patient was vaccinated with  GARDASIL 9 (strength, route, frequency and lot number not provided) or GARDASIL (strength, route, frequency and lot number  not provided); it was not specified which of the two vaccines was used; indicated to treat anogenital warts. The physician informed that after receipt of the vaccine, the lesions disappeared.
Within minutes of receiving the vaccine the patient expressed she didn't feel too good. Face became flushed and then she said she felt woozy and nauseous. Breathing was ok but called 911. EMS arrived and checked all vitals which were normal. Flushing, woozy, and nausea resolved within 15-20 min. No meds given.
Received flu vaccine Friday 9/23/16, rash appeared and was visible when patient presented 9/26/16. Patient received FLUZONE HD.
Freezed dose administered; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received HBV (Engerix B) (batch number 39a3l, expiry date 23rd February 2024) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The reporter reported that, a freeze dose of Engerix-B was inadvertently administrated to one or two patients, which led to incorrect storage of drug.  The healthcare professional had no details on the exact amount or patients or date of administration at the time of reporting but agreed to be contacted for follow up through provided email address.  No further events were reported. The reporter consented to follow up.  The Vaccine Administration Facility is the same as Primary Reporter.
getting sick; flu symptoms; exposed to his brother with covid 19; 38 celcius fever; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 8-year-old patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "getting sick"; INFLUENZA (non-serious), outcome "unknown", described as "flu symptoms"; EXPOSURE TO SARS-COV-2 (non-serious), outcome "unknown", described as "exposed to his brother with covid 19"; PYREXIA (non-serious), outcome "unknown", described as "38 Celcius fever". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Description of Event: Kid 8 years old fully vaccinated being exposed to his brother with covid 19 and getting sick, with flu symptoms and 38 Celcius feber, Event took place after the use of the product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Additional Details: Patient experienced vasovagal response to covid booster vaccine dose which resulted in fainting for a few minutes.  BP was monitored during episode and patient's caregiver requested to call 911.  The paramedics came and checked bp which showed orthostatic hypotension.  Patient was trasporoted to ER.  Pt was followed up by the pharmacist,  and informed by a patient that pt was discharged with 2 hours with all vitals back to normal. Patient is back to work the next day.
1. Sever Cough; 2. Detection of Lung Nodules; 3. Acute Kidney Injury; 4. Microscopic Polyangiitis Vasculitis (MPV); 5. Currently on Long term Dialysis Treatment
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 13May2022, outcome "unknown", COVID-19 (medically significant) with onset 13May2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (12May2022) Negative, notes: Tested negative on Thursday 12May2022; (13May2022) Positive, notes: On Saturday 13May2022 I tested positive again via home test. I took 2 different tests to confirm. Therapeutic measures were taken as a result of covid-19.  Clinical course: It was reported that completed the treatment on 08May2022. Patient tested negative on Thursday 12May2022, and most symptoms went away. On Friday 13May2022 started feeling very congested and had a headache. On Saturday 13May2022, tested positive again via home test. Patient took 2 different tests to confirm. He still feel very congested.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Soreness in both knees and right elbow.   (I  struck right elbow a couple of days earlier but it only hurt for a couple of minutes .  The day after the shot it became sore.
Pt recvd MMR vax on 16MAY91 & 28MAY91 had fever for several days; 2 days later fever spiked to 104; CBC & UA were nl; 3JUN91 fever rose to 105.1; no further details were provided;
Pt given MMR #2 and after approx. 10 minutes, developed 1 hive approx. 10mm X 10mm. He was given 2 1/2cc po Benadryl at 09:50; (subsided at 10:10).
Patient vaccinated on 9.5.12 with HPV4 & VARICELLA. Mom states on 9.6.12 he came home from school with swollen (L) arm & warm to touch with a fever. Mom states she took him to ER where they measured swelling of 9 x 9 dx him with cellulitis & prescribed KEFLEX & BENADRYL. Mom states swelling increased so she took him back to ER on 9.7.12 & states ER measured swelling at 14 x 13. They prescribed BACTRIM & prednisone.