chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a clinical medical assistant referring to patient of unknown age and gender. On 13-JAN-2015 the patient was vaccinated with improperly stored VARIVAX (Merck) lot K005180, expiration date 10-APR-2016, (dose, frequency, therapy route unspecified). No adverse effects were reported. The outcomes of events reported were unknown. No product quality complaint (PQC) was involved. This is one of the several reports received from the same source. Additional information has been requested.
After injection client states that pain and pressure started immediately. Client reports soreness at the injection site and shoulder with limited ROM. Reports sharp pain with movement only. 10/26/18 continues to report sharp pain with movement and aches at night when trying to sleep. Client scheduled US for 10/31/2018. Will continue to follow up.
Covid-19 treatment; Covid-19 treatment; Moderna Dose1, Dose 2, Dose 3, Dose 4/Pfizer Dose 5; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Nov2022 at 12:30 as dose 5 (booster), single (Lot number: GJ6738), in left arm for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 19Mar2021 at 13:45 as dose 1, single (Lot number: 045A21A), in left arm, on 19Apr2021 at 14:30 as dose 2, single (Lot number: 044B21A), in left arm, on 05Nov2021 at 14:30 as dose 3 (booster), single (Lot number: 058F21A), in left arm and on 02Apr2022 at 13:45 as dose 4 (booster), single (Lot number: 048L21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Thalassemia minor" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 02Apr2022, outcome "unknown", described as "Moderna Dose1, Dose 2, Dose 3, Dose 4/Pfizer Dose 5"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19 treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.
feel like migraine; Disruption in sleep; pain in eyes; hot flashes; not sleeping well; Weak; tired; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MIGRAINE (feel like migraine), SLEEP DISORDER (Disruption in sleep), EYE PAIN (pain in eyes), HOT FLUSH (hot flashes) and POOR QUALITY SLEEP (not sleeping well) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and SERTRALINE for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced HEADACHE (Headache). On 16-Apr-2021, the patient experienced MIGRAINE (feel like migraine), SLEEP DISORDER (Disruption in sleep), EYE PAIN (pain in eyes), HOT FLUSH (hot flashes), POOR QUALITY SLEEP (not sleeping well), ASTHENIA (Weak) and FATIGUE (tired). On 16-Apr-2021, MIGRAINE (feel like migraine) and HEADACHE (Headache) had resolved. At the time of the report, SLEEP DISORDER (Disruption in sleep), EYE PAIN (pain in eyes), HOT FLUSH (hot flashes), POOR QUALITY SLEEP (not sleeping well), ASTHENIA (Weak) and FATIGUE (tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. Treatment information was not provided.
COVID-19 treatment; COVID-19 treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 43-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: 33130BA) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 was not reported. The patient took concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19. This report was about COVID-19 treatment. Patient did receive the vaccine. Patient received other medication in 2 weeks. Patient received paxlovid as a treatment for COVID-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200781668 Same patient, different product and event
Client states her arm became sore 10/10 at 3:10 on 11/10/15 after receiving flu shot at 2:50 in (R) deltoid. Pain radiates from shoulder to neck. No decreased ROM. 9 cm x 9 cm pink area at injection site warm to the touch.
After client returned home, child stated to mother that his arms hurt and that he also had a headache. Child then was checked for fever by the mother and his fever was 103 F. Mother states she gave him Tylenol and Motrin in 4 hour increments with little relief of fever x 24 hrs. Child also had "very smelly flatulence" per mother and stomach pain. Mother came into our clinic on 08/01/19 and I spoke with her about the child's symptoms.  I asked if child had a pediatrician and that I advise that with a 103 F fever x 24 hrs that the child should be seen by a physician. Mother states that she will try and take him there and I said if you can't get him there now to take him to the ER.  Called mother today and she states that the fever did finally break but that he still has stomach pains but that he is feeling much better. Mother states she is holding off on taking him to the doctor unless his fever comes back.
This spontaneous report as received from a registered nurse refers to a 3 months infant of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 03-NOV-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M031802 with expiry date: 09-NOV-2017, for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705.
After my second dose a day later I got a big red bump on my right fore arm that started to itchy, a few hours later my entire body was full of rashes and are very itchy, my face is the worst it burns and is very itchy.  It has been 5 day since my second dose and the rashes have not gone away and the itchiness has worsen
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 39-year-old male. Neither medical history nor concomitant medications were reported. On 05-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.
Side effects began the next morning after vaccine, which included fatigue and body aches, sore left arm then the next couple of days were fatigue and headache and now fatigue and nausea with vomiting and chills.
Initial report received on 02 August 2011 from a company representative who had received the original information from a physician. This is a cluster of two 13-year-old twin patients (dates of birth and genders not identified) with the same reporter, same vaccine (ADACEL), same lot number (C2888AA) and same event of suspected pertussis. This case represents one of the 13-year-old twins. Information regarding the other twin is captured in case number 2011-06199. A 13-year-old patient, who has a twin sibling, was vaccinations at age 11 in November 2008 with a dose of ADACEL (lot number C2888AA) and subsequently was found to have a suspected case of pertussis. The patient had been coughing and showing URI (upper respiratory symptoms) for a very long time (onset date not reported) and her physician treated her for suspected pertussis, but never performed any lab testing to confirm the diagnosis. Treatments received were not reported. The physician eventually referred the patient to a pulmonologist who agreed with the diagnosis of pertussis, but who also did not test for pertussis since a prolonged period of time had elapsed. It was not reported whether the patient recovered. Documents held by sender: None.
elevated T 8 days post vax;T106,14DEC evening;mom reported lethargy, cyanotic lips, blank staring, possible sz activity (tremors in extremities) x 15min; inc cervical gland swelling;c/o h/a;apneic, papular rash on trunk, limbs;face ra
Within 24 hours of receiving TDAP in left deltoid, developed pain and swelling in left axilla. CBC-WBC 5,900, no fever, no erythema. Ultrasound - enlarged left axillary nodes, non-supporative. Elected to observe without intervention. By 12/21/10 - swelling and adenopathy had resolved.
Covid symptoms came back. Congestion, sneezing, fatigue; Covid symptoms came back. Congestion, sneezing, fatigue; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2, as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Systemic lupus erythematosus" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16Jun2022, outcome "not recovered" and all described as "Covid symptoms came back. Congestion, sneezing, fatigue". Therapeutic measures were not taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This is a spontaneous report from a contactable consumer. This consumer reported that:  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date as UNKNOWN, SINGLE for covid-19 immunisation.  Medical history included hypothyroidism from an unknown date and unknown if ongoing (Optional Information: Hypothyroidism-NP). The patient's concomitant medications were not reported.  The patient experienced headache, muscle aches, injection site pain, fever, joint pain on an unspecified date. Event took place after use of product. The outcome of events was unknown.    No follow-up attempts are Possible; information about lot/batch number cannot be obtained.
I received my pre employment physical and flu shot at 10 am 10/13/22 and it hurt during administration. I have had the flu shot every year my entire adult life as a fellow HCP and never had a reaction. She administered it and a few hours later I had typical arm soreness but a novel neck pain. In the morning today, I can barely move without sharp shooting pain in my neck. I did not do anything else yesterday to warrant this and I slept as usual on my back. I called occupational health to report it but they did not seem willing to do so. I am unemployed currently without health insurance so cannot go to the doctor. They advised me to go to the ER if pain persists or worsens. I start working there Monday.
Pfizer covid vaccine diagnosed with small fiber neuropathy, bilateral ulnar neuropathy, brain inflammation, tinnitus. All my limbs are numb tinnitus pots dysautonomia, nerve pain everywhere swelling hands can't close my fist extreme weakness legs drop out temporary paralysis tremors neuropathy of the whole body vascular inflammation everywhere including the brain   This vaccine has ruined tens of thousands of people's lives causing a whole array of neurological damage. I don't know how you can keep hiding this
ittle white bumps/goose bumps; legs red from scratching; rash on legs stomach, back and neck; itchy on my thigh and legs; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy on my thigh and legs), PILOERECTION (ittle white bumps/goose bumps), ERYTHEMA (legs red from scratching) and RASH (rash on legs stomach, back and neck) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A2JA or 011A21A) for COVID-19 immunisation.     Concurrent medical conditions included Hypertension. Concomitant products included METOPROLOL for Hypertension.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced PRURITUS (itchy on my thigh and legs). On 28-Feb-2021, the patient experienced PILOERECTION (ittle white bumps/goose bumps), ERYTHEMA (legs red from scratching) and RASH (rash on legs stomach, back and neck). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (itchy on my thigh and legs), PILOERECTION (ittle white bumps/goose bumps), ERYTHEMA (legs red from scratching) and RASH (rash on legs stomach, back and neck) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Pt has big red rash on the injected arm 2 days after injection. Dr. gave CIPRO 500mg twice x 10 dy.
Knelt down approximately 8hours after receiving vaccine to pet my dog, felt dizzy and strange, stood up and heart was beating fast. Episode passed.
Patient fainted after leaving booth . It appears she may have whacked her head on the concrete floor. No blood. She was back to consciousness but didn't remember what happened. Ambulance came, took her away in stretcher.
Developed a fever and mild rash. Rash worsened on the following day located mostly on hands / feet, then spreading to back, torso, then arms / legs and face.  Rash consisted of small red spots. Mild fever notable in afternoon. Difficulty sleeping at night, discomfort, and mood changes.
THE VACCINE ACCIDENTALLY ADMISTERED ON 11/22/2022, BUT HAS EXPIRED ON 11/17/2022. PARENTS HASN'T REPORTED ANY SIDE EFFCTS YET.
Low grade fever, muscle pain, chills, sweating profusely, headache, nausea, sore throat, hurts to take a breath
Pain in joints (dispersed throughout body), blister, rash, fatigue, pain so intense he could not leave bed for 1 day
c/o peeling skin and burning sensation in and outside of nose and across the cheeks that started over the weekend (11-7-09). Saw dermatologist who prescribed cream and diagnosed contact dermatitis from H1N1 nasal.
22 year old male report with reaction to Anthrax Vaccine to lt arm extending down to elbow.  Erythema, itchiness and swelling.
shingles; Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication.   In 2012, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (dose, route, lot# and expiration date were unknown) for the long-term prevention of shingles and/or zoster-related conditions(for prophylaxis). Subsequent to patient's zoster vaccine live(ZOSTAVAX) inoculation, patient was treated for shingles.  As a direct and proximate result of patient's use of the zoster vaccine live(ZOSTAVAX) vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
Severe Hives on trunk, back, buttocks, neck, arms, armpits, extremely itchy. BENADRYL given, along with hydrocortisone 2% cream. Dr.'s office notified of reaction.
patient wanted moderna bivalent vaccine but got moderna booster vaccine instead 0.5ml lot 064a22a
Palms of hands and soles of feet sloughed skin in sheets, full body rash, large red spots that swelled then decreased and cleared up.  Saw several family practice physicians and a dermatologist.  Skin rash and constant itching continue past the fourth month since vaccination.
No other AE; medical assistant reporting an expired dose of ROT ATEQ was administered; This spontaneous report has been received from a medical assistant, referring to a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history, concomitant medications, previous drug and/or allergy reactions were not provided.  On 07-JUL-2021, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) dose reported as "1 injection" (expired product administered) (strength, vaccination scheme, anatomical and route of administration and formulation were not reported; lot number 1684155 has been verified to be a valid lot number for rotavirus vaccine, live, oral, pentavalent (ROTATEQ) ,expiration date upon internal validation established as 25-JUN-2021) for prophylaxis.  No other adverse event was reported.
Right eye twitched non stop and corner right side mouth would not meet lt side when smiling (slightly drooping) from 730pm to 130am day of injection.
Diarhea, fever, chills, sweating, change of behavior (irritable), and dizziness.
Later that evening, started experiencing the same symptoms as when I had COVID-19 (July 2020).  Lasted for about 3 days, tapering off.  Still experienced fatigue for a few more days.
Had vaginal spotting (bleeding) that has continued to get heavier. Not due for period to start for another week.
Information has been received from a line listing obtained on request by the Company from the FDA under the Freedom of Information: Refers to a 73 years old patient with no illness noted at the time of vaccination. On 08-JUL-2008 at 10:30, the patient was vaccinated subcutaneously in the left arm with ZOSTAVAX (lot # 0886U; exp. date: unknown). The patient went to the doctor on 15-AUG-2008 after having pain and 3-4. None of the above blisters on face for approximately 1 week and was diagnosed (dx) with Shingles. The patient was treated with Azithromycin pack and Prednisone at that time. On 04-OCT-2008, the patient had a reoccurrence of Shingles in the waistline area and was seen by the doctor on 06-JAN-2008 and was treated wit Famciclovir 500mg TID x 3 days with 1 refill. The patient still has lesions but much improved and pain was also lessened. The relatedness for the events was unknown for ZOSTAVAX. Additional information is not expected.
Had shot, still got Shingles/suspected vaccination failure; still got Shingles; pain; 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), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 26-JAN-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received a dose of Shingles vaccine and still got the shingles and reported never had the rash just the pain. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding, primary schedule, laboratory test and time to onset confirming shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
States after getting vaccine day 1-5 arm became red and swollen. Then on day 8 ran temp and hurt all over on day 10 had a rash.
First dose on 25 Jan 2021 and second dose on 18 Jan 2022; Booster dose given as a 2nd primary dose, instead of a full dose received it as a booster dose of 0.25 mL; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 25 Jan 2021 and second dose on 18 Jan 2022) and ACCIDENTAL UNDERDOSE (Booster dose given as a 2nd primary dose, instead of a full dose received it as a booster dose of 0.25 mL) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 18-Jan-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 25 Jan 2021 and second dose on 18 Jan 2022) and ACCIDENTAL UNDERDOSE (Booster dose given as a 2nd primary dose, instead of a full dose received it as a booster dose of 0.25 mL). On 18-Jan-2022, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 25 Jan 2021 and second dose on 18 Jan 2022) and ACCIDENTAL UNDERDOSE (Booster dose given as a 2nd primary dose, instead of a full dose received it as a booster dose of 0.25 mL) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.   This case was linked to MOD-2022-455746 (Patient Link).
(P) approx 20 vesicles, crusted over. S/P VARIVAX (MMRV) 3/22/07