chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a 38 year old white female with no known allergies and a history of a right ovarian cystectomy for a dermoid and a c-section who on 7/5/00 was vaccinated with 1 dose of varicella virus vaccine live. There were no concomitant medications. There was no local reaction at the vaccination site and no post vax varicella or herpes zoster noted. Subsequently, the pt found out that she was pregnant. The reporter indicated that she was about 3 weeks pregnant. Additional information received on 8/7/00 from an RN indicated that the pt's date of LMP was on 7/2/00. EDD: 4/8/01. Additional information received on 8/17/00 from an RN, indicated that the pt conceived 3 weeks after vaccination. Follow-up information from a health professional reports, the pt phoned the office on 3/19/01 with complaints of decreased fetal movements. She scheduled a non stress test for the following day. The results were not reported. Multiple lab tests were done which were within normal limits. The baby was in breech presentation. She delivered a baby boy by c-section on 3/28/01. He weighed 7 lbs 11 oz. and hypospadias was noted. The doctor did not know the extent of the hypospadias. On 4/3/01, the pt phoned complaining of pain in both hips. She was instructed to call if the symptoms persisted for more than 1 week. No further information was provided. Additional information is expected.
A strong pain started in the arm where the vaccine was administered three days post-vaccination.  By the fourth day, total incapacitation to move left arm. The pain persists, rigid arm, and I can barely move it. I currently cannot do any activity. The area presents a slight fever.
Sore throat; neck swelling;fever to 101.8;chills; "flu like symptoms" swabbed for Strep and Flu and both were negative.
Slight headache and sore arm at site of injection three hours after the shot (3/12). The morning after, about 16 hours after the shot, I had severe body aches and pains, a severe headache, fever, chills, and was extremely fatigued with worse pain in the arm at the site of injection (3/13). This lasted until I woke up the next day, about 40 hours after the shot, I felt physically weak the next day and still had arm soreness at the site of injection but no pain, headache, fever, or chills (3/14). Felt completely back to normal, still some slight pain on the arm at the site of injection, about 64 hours after the shot (3/15).
gave a minor their 1st dose of the Moderna Covid-19 Vaccine; Inappropriate age at vaccine administration; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (gave a minor their 1st dose of the Moderna Covid-19 Vaccine) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) in a 13-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Oct-2021, the patient experienced WRONG PRODUCT ADMINISTERED (gave a minor their 1st dose of the Moderna Covid-19 Vaccine) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration). On 21-Oct-2021, WRONG PRODUCT ADMINISTERED (gave a minor their 1st dose of the Moderna Covid-19 Vaccine) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.  No treatment medications were reported.
Per patient voice message my arm swelled up and turned red in an area the size of a large orange and when pressed at the site of the shot the tissue felt very hard. Soon after small pustules formed similar to those of chicken pox. I also got a very bad headache.
FEVER; HEADACHE; This spontaneous report received from a consumer concerned a 58 year old female. The patient's height, and weight were not reported. The patient's past medical history included open heart surgery, and concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included no known drug allergies, drug abuse or illicit drug usage .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 101.7 F. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and headache. This report was non-serious.
a small headache; Initial information received on 10-Sep-2020 regarding an unsolicited valid non-serious case received from a consumer (patient) via social media.  This case involves a patient (unknown demographics) who experienced a small headache (headache), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided. It was reported that the patient took flu vaccine from Sanofi every year with very little side effect of headache.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (reported as Sanofi vaccine) (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious a small headache (headache) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.   It was not reported if the patient received a corrective treatment.  On an unknown date, the patient had recovered from headache (it was reported as headache for a day).  There will be no information available on the batch number for this case.
coughing and vomiting immediately after vaccination. Oral benadryl and observation. Patient returned to baseline and was discharged home.
A 47 year old female consumer reported experiencing severe inflammation in right shoulder joint and painful to lift arm following immunization with BioThrax. On 20APR2016 at 10:00 AM, she received a booster dose of BioThrax (FAV602) intramuscularly in the right arm. Symptoms began 5 days after the day of vaccination. She was treated with naproxen and TYLENOL. Consumer reported that her pain lasted for 6 months. She noted that she was unresponsive to NSAIDS: increasing naproxen dose didn't help and TYLENOL did not relieve her pain. The adverse events were reported to be recovered in OCT2016. Concurrent medical conditions included: hypothyroid (Hashimoto's thyroiditis) (1991), seasonal allergies (2006), and arthritis (2010). Concomitant medications included: SYNTHROID for hypothyroid, loratadine for seasonal allergies and naproxen for arthritis. No additional information is expected.
Td given as TB test to left forearm. Kenalog 40mg given on return visit. 4.5cm by 4.5cm erythema area, tender to palpation at volar proximal aspect left forearm.
Patient received a third full dose Moderna vaccine on 12/23/21 in error when came to get a new proof of vaccine card. He had already had first dose on 8/24/21 and second dose 9/21/21. All 3 doses were administered left arm and he reports ongoing soreness to left arm below deltoid.
3 days after vaccine given mother noticed swelling on left upper thigh 2 cm redness, 2 point blisters. No tenderness. no inguinal lap.
Patients received the Moderna Covid 19 vaccine after temperature excursion; Patients received the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 14-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The reporter reported that, there was temperature excursions in freezer where the reporter worked. It had been happening for weeks since April 2022. Total 49 patients were affected, but this number was including the Pfizer vaccines that they had, so the reporter was not sure how many patients were affected and received the Moderna Covid 19 vaccine. The storage condition at the time of the excursion was frozen. Lot numbers were 065K21A and 045L21A Maximum or minimum temperatures reached was maximum: 30 Fahrenheit Degrees and minimum -18.9 Fahrenheit Degrees. The vaccines suffered 2 temperature excursions since April, both lasted less than 1 minute. The date vial(s) moved from freezer to refrigerator was unknown. The vials were stored now in frozen condition. The state of vaccine was not changed. The number of vials/doses impacted was unknown.  No treatment medications were reported.   This case was linked to MOD-2022-591989 (Patient Link).
the patient was voiting and the vomit had visible blood clots; This spontaneous report was received from a medical assistant via company representative and refers to a 2-month-old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided.   On an unknown date (on the same day), the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ)(strength, dose, dosing schedule, lot# and expiration date were not provided), orally, with diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), hib vaccine conj (menigococcal protein), pertussis vaccine acellular 5-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid(VAXELIS) and pneumococcal vaccine conj 13v (crm197)(PREVENAR 13)(strength, dose, dosing schedule, lot#, expiration date and route of administration were not provided for both). Vaccines were administered for prophylaxis.  On 17-AUG-2021, the patient was vomiting, and the vomit had visible blood clots. The medical attention was sought. Approximately in August 2021, the patient was admitted to hospital due to event and hospitalized for a one day. The patient received unspecified treatment. The patient had made a full recovery approximately in August 2021 and the physicians did not believe that the vomiting was linked to the vaccines that were administered.   The reporting medical assistant did not provide her causality assessment between the subject therapies and the event.      Upon internal review, the event of haematemesis was considered to be medically significant.
pt mom states that pt broke out w/hives & rash approx 4hr p/vax;pt mom treated rash & itching hives w/DPH tablets which resolved the rash & hives;then rash came back approx 24hr later;
This spontaneous report was received from a physician via a company representative and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patient was vaccinated with a first, second and third dose of GARDASIL 9 (dose, route of administration, lot# and expiration date were not reported). On an unknown date, after receiving the third dose of the vaccine, the patient experienced a lump at injection site. The outcome of a lump at injection site was unknown. The relatedness between the event of lump at injection site and GARDASIL 9 was not reported. Additional information has been requested.
10/26/16 received Flu vaccine 4pm pain from swelling and blotchy face -> by 7pm pain itching redness and swelling to arm 10/28/16 max swelling and redness 10/29/16 No pain less redness less swelling.
On day 3 after receiving the second dose of the Moderna vaccine I experienced soreness, redness, and swelling 3" below the injection site. I sought medical treatment. I was diagnosed with cellulitis which the PA attributed to the injection. I was prescribed 5 days of Bactrim (800mg/160 mg) and Benadryl. If after 5 days the symptoms are not resolved or if the cellulitis site dramatically increases in size, I am to seek additional medical attention.
broke out in a rash; This is a spontaneous report from a contactable consumer reporting for herself. A 68-year-old female patient received first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on 08Jan2021, at a single dose for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease (COPD) . She had many comorbidities including COPD. Concomitant medications were not reported. The patient broke out in a rash on 10Jan2021. She had a virtual HCP (healthcare professional) appointment and noticed it was on her face. Outcome of the event was unknown.  Information on batch number has been requested.
Rash onset 6-3-10, 13 days after receiving MMR, VZV and PCV13; rash started on ABD and spread to entire body.  Rash is maculopapular, blanches with confluent areas, esp. on face.  No other symptoms.  No fever.  Rash appears as measles.
Mother called, client had high temperature 103.9. Went into convulsions. Sent to ER, diagnosed with UTI. Took her to pediatrician, stated no diagnostic results showed child had UTI. It was probably caused from pertussis vaccine.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. On 10-SEP-2014 the patient was vaccinated with a dose of MMR II (Oka/Merck) VARIVAX (dose, route, lot number and expiry date were not reported). No adverse effects reported. There was no concomitant medication provided. Additional information has been requested.
injection site pain, tiredness, headache, muscle pain, joint pain, fever, injection site swelling, injection site redness, nausea, feeling unwell.
Information has been received from a Nurse Practitioner referring to 11 unspecified patients of unknown age and gender. Information about the patients' concurrent condition, medical history, drug reactions/allergies and concomitant medication was unknown. On unknown dates, one patient was vaccinated with a dose of improperly stored GARDASIL 9 (dose and route were unknown, lot # L016429 with expiration date 09-AUG-2017) and additional 10 patients were each vaccinated with a dose of improperly stored GARDASIL 9 (dose and route were unknown, lot # M024261 with expiration date 30-JUL-2018). No adverse effect was reported. The vaccines had been exposed under temperature 48.9 Fahrenheit for 1 hour. There was no previous excursion. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
face is swollen; eye is swollen underneath; has been in bed for 2 days; fever of 102F; bad body aches/she has really bad myalgia; This spontaneous case was reported by a pharmacist and describes the occurrence of SWELLING FACE (face is swollen), EYE SWELLING (eye is swollen underneath), BEDRIDDEN (has been in bed for 2 days), PYREXIA (fever of 102F) and MYALGIA (bad body aches/she has really bad myalgia) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 025B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2021, the patient experienced SWELLING FACE (face is swollen), EYE SWELLING (eye is swollen underneath), BEDRIDDEN (has been in bed for 2 days), PYREXIA (fever of 102F) and MYALGIA (bad body aches/she has really bad myalgia). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SWELLING FACE (face is swollen), EYE SWELLING (eye is swollen underneath), BEDRIDDEN (has been in bed for 2 days), PYREXIA (fever of 102F) and MYALGIA (bad body aches/she has really bad myalgia) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.   This case was linked to MOD-2021-114305 (Patient Link).
THE DAY AFTER VACCINATION THE INJECTION SITE BECAME RED ABOUT AN INCH. SHE SAID IT IS TENDER BUT NOTHING UNUSUAL (LIKE TYPICAL POST VACCINE SORENESS) AND NOT ITCHY. THE ARE IS NOT GROWING IN SIZE AND STAYING THE SAME. SHE FEELS FINE. COUNSELED PATIENT TO KEEP WATCH AND NOTIFY IF WORSENS HOWEVER LOOKS LIKE INJECTION SITE SO SHOULD HEAL ON ITS OWN.
On 2nd dose, 2/1/21: Severe body and deep joint aches, fever of 101, extreme chills, inability to sleep, headache, profuse sweating lasting until 2/3/21.  Still experiencing lingering arm pain at injection site.
Pt. called 2-5-2021 with c/o a circle the size of fist on Lt. arm at site of injection with a  red spot. No pain or itching but did have fever. Pt. did also say she had pain to upper Rt. arm starting last Sunday 1-31-2021 where she had difficulty even lifting arm.  Denies taking anything for symptoms except using heat to Rt. arm.  FNP discussed with the pt. about possible side effect from vaccine of body aches. Also recommended she get okay from PCP before receiving second dose. Pt. did say that symptoms were better today.
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 17-JAN-2013 at 07:45, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 14.25 hours. On 30-JAN-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 04-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to exact time not recorded, noted as equal to or > 12C for an estimated total time out of range of 10.5 hours. On 05-MAR-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number H019999). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
9FEB99 fever 103 R, rash generalized;12FEB99 fever 103, vasculitis-covered w/typical measles rash was seen by MD;enlarged lymph nodes;
Mom called on 10/21 to report patient experienced a 2inx3in welt on her arm near the injection site. The top of the welt was the injection site and it traveled down her arm towards her elbow.
Severe headache, weakness, dizziness, fatigue, nausea, loss of appetite.
This spontaneous report as received from a consumer refers to her granddaughter, a 15 year old female patient. On 12-DEC-2013 the patient was vaccinated with her first dose of GARDASIL (dose, route and lot# not reported). Other suspect therapies included influenza virus vaccine (manufacturer unknown) (dose, route and lot# not reported) on 12-DEC-2013. It was reported that the patient received "4 shots" concomitantly at her psychiatrist's office while the only injections supposed to be given were GARDASIL, dose 1, and an unspecified influenza shot. The patient told the reporter she "thought" 3 of the shots were GARDASIL. The reporter was positive that 2 of the 4 shots given were: 1 injection of GARDASIL and 1 unspecified influenza virus vaccine (manufacturer unknown) shot. However, the other 2 vaccines were unidentified. Therefore, 2 extra doses of GARDASIL might have been given. No side effects reported. However, the reporter stated that while she had not been able to obtain the medical records, she spoke to an unspecified nurse at the location; this nurse said that it was "possible" that the 2 unspecified shots the patient received were an unspecified "hepatitis shot" and an unspecified meningitis shot. This GARDASIL lot, while unspecified, could possibly of the recalled GARDASIL lot. In addition, the reporter stated that the patient had a tendency to faint when getting shots. At the time of reporting, the patient's outcome was unknown. Additional information has been requested.
chilling; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chilling) and PYREXIA (fever) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: FLU VACCINE VII in September 2021.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Nov-2021, the patient experienced CHILLS (chilling) and PYREXIA (fever). At the time of the report, CHILLS (chilling) and PYREXIA (fever) outcome was unknown.            No concomitant medication was provided.  No treatment information was provided.   This case was linked to MOD-2021-382275 (Patient Link).
Vaccine administered on March 10, 2021. On March 17, 2021 around 7:00-8:00 PM I noticed a subcutaneous lump, a little swelling, redness, and a little itching. On March 18, 2021 the symptoms remain the same. No treatment done.
Left arm intolerable pain. Inability to lift arm without significant  strain/pain. Inability to sleep on left slide due to excruciating pain. Inability to sleep due to inability to sleep on left side (33 weeks pregnant).
Flu like symptoms; Fever; Bad headache; Severe body aches; Sweats; Neck and back pain; Neck and back pain; Nausea; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient.  A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 13Jan2022 (lot number: FL3197) at the age of 27-years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing). Concomitant medication included: ESCITALOPRAM taken for anxiety. Vaccination history included: BNT162B2 (as dose 1, single), for COVID-19 immunisation and BNT162B2 (as dose 2, single), for COVID-19 immunisation. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 14Jan2022, outcome "recovering", described as "Flu like symptoms"; PYREXIA (non-serious) with onset 14Jan2022, outcome "recovering", described as "Fever"; HEADACHE (non-serious) with onset 14Jan2022, outcome "recovering", described as "Bad headache"; PAIN (non-serious) with onset 14Jan2022, outcome "recovering", described as "Severe body aches"; HYPERHIDROSIS (non-serious) with onset 14Jan2022, outcome "recovering", described as "Sweats"; NECK PAIN (non-serious) and BACK PAIN (non-serious) all with onset 14Jan2022, outcome "recovering" and all described as "Neck and back pain"; and NAUSEA (non-serious) with onset 14Jan2022, outcome "recovering", described as "Nausea."  Follow-up attempts are completed. No further information is expected.