chrisvoncsefalvay/vaers-outcomes huggingface dataset:
reaction  pretty bad after a week o so/allergies all over the body; itching and redness; rush al over the body/pretty bad on her face,; hives/breaking up into hives,; itching badly/itching all the time/itching badly it been 10 days  and it si not going away/continuously itching all over  her body sometimes goes away and then comes back; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching badly/itching all the time/itching badly it been 10 days  and it si not going away/continuously itching all over  her body sometimes goes away and then comes back), HYPERSENSITIVITY (reaction  pretty bad after a week o so/allergies all over the body), URTICARIA (hives/breaking up into hives,), ERYTHEMA (itching and redness) and RASH (rush al over the body/pretty bad on her face,) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058h21a, 026b21a and 008c21a) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Fully recovered from COVID) on 12-Dec-2021.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jan-2022, the patient experienced PRURITUS (itching badly/itching all the time/itching badly it been 10 days  and it si not going away/continuously itching all over  her body sometimes goes away and then comes back), URTICARIA (hives/breaking up into hives,) and RASH (rush al over the body/pretty bad on her face,). On an unknown date, the patient experienced HYPERSENSITIVITY (reaction  pretty bad after a week o so/allergies all over the body) and ERYTHEMA (itching and redness). At the time of the report, PRURITUS (itching badly/itching all the time/itching badly it been 10 days  and it si not going away/continuously itching all over  her body sometimes goes away and then comes back) and HYPERSENSITIVITY (reaction  pretty bad after a week o so/allergies all over the body) had not resolved and URTICARIA (hives/breaking up into hives,), ERYTHEMA (itching and redness) and RASH (rush al over the body/pretty bad on her face,) outcome was unknown.            Concomitant medications were not reported. Patient had no allergies of food, medicine, and other products. Recent change in status worsening, continuously itching all over the body, sometimes goes away and then come back. Patient was prescribed with allergy medicine, and steroid medicine by local doctor.
OUT OF SPECIFICATION PRODUCT USED; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A expiry: 07-AUG-2021) dose was not reported, administered on 25-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-JUN-2021, the subject experienced out of specification product used. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of out of specification product used was not reported. This report was non-serious.
Information has been received from a nurse practitioner concerning a 16 year old female with history of mild reaction (itching) to orange who on 23-DEC-2008 was vaccinated with the first dose of GARDASIL (Lot# not reported), on 5-MAR-2009 11:00 AM was vaccinated IM with the second dose of GARDASIL (Lot# 655604/0052X) in the upper deltoid. On 05-MAR-2009 the patient had an anaphylactic reaction. The patient left the office at 11:45 AM with no reactions. The patient went back to school, had basketball practice and around 4 PM ate an orange and took a shower. The patient's lips at an unspecified time started to swell. The mother of the patient called the office and the patient went back to the office. The patient arrived at the office at 4:30 PM and the patient went into respiratory distress. The patient was treated with Epipen, Benadryl and a breathing treatment while waiting for the ambulance. The patient's "pulse ox" was 78 when she 1st arrived at the office. The patient's "pulse ox" was 92 or 93 after treatment and when the ambulance arrived. The patient was taken to medical center. The nurse practitioner checked on the patient at 7 PM and the patient had fully recovered and was released that same night. The mother of the patient mentioned that the patient had shown a mild reaction (itching) to an orange before. The nurse practitioner mentioned there had been reports of people having reactions after eating oranges in her center. The nurse practitioner would not giving the 3rd dose of GARDASIL. The patient did not have any problems with the 1st dose of GARDASIL. It was reported that the patient sought medical attention: in the office. Respiratory distress, lip swelling and anaphylactic reaction were determined to be other important medical events, and life threatening. Additional information has been requested.
Prior to the vaccination, the patient was nervous about receiving the shot, but chose to do so.  She had also received a flu shot in 2009.  Patient complained of dizziness and stiffness in the arm where she received the vaccination 45 minutes after receiving it.  She later said that her neck and upper back were hurting.  While sitting down, an ice pack was applied to the injection site.  Two hours after the vaccination, she reported that her stomach was hurting and she was having chills.  The paramedics were called to the store to check out the patient since she was still not feeling well.
This case was reported by a physician via sales rep and described the occurrence of fever in a elderly female patient who received 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 fever, pain localized, chills, erythema and skin warm. On an unknown date, the outcome of the fever, pain localized, chills, erythema and skin warm were unknown. It was unknown if the reporter considered the fever, pain localized, chills, erythema and skin warm to be related to SHINGRIX. Additional details were provided as follows: The patient's age was in 70's. The patient experienced local pain, chills, fever and body temperature was recorded as 100 to 101 degree F, redness from shoulder almost to elbow and warm to touch. The doctor advised not to take second shot due to severity of reaction. The reporters did not consent to receive follow up. Lab Comments: Lab test was performed on an unknown date.
swollen near the site of the injection; severe chills; fever of 102.4/ low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (severe chills), PYREXIA (fever of 102.4/ low grade fever) and VACCINATION SITE SWELLING (swollen near the site of the injection) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-May-2021, the patient experienced CHILLS (severe chills) and PYREXIA (fever of 102.4/ low grade fever). On 28-May-2021, the patient experienced VACCINATION SITE SWELLING (swollen near the site of the injection). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 26-May-2021, CHILLS (severe chills) had resolved. On 27-May-2021, PYREXIA (fever of 102.4/ low grade fever) had resolved. At the time of the report, VACCINATION SITE SWELLING (swollen near the site of the injection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-May-2021, Body temperature: 102.4 (Inconclusive) fever of 102.4.         no concomitant medications reported.
I did not have an adverse reaction to the booster, but I did contract COVID-19. I contracted COVID-19:  COVID-19 home test on 04/20 was positive, Rapid test and PCR test on 04/21, on 04/26 the PCR test was positive. I was prescribed Doxycycline, Mucinex and an inhaler.  I also took Tylenol and Advil for headache and pain. Flonase for my nose.
little pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (little pain at injection site) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced INJECTION SITE PAIN (little pain at injection site). The patient was treated with PARACETAMOL (TYLENOL) for Prophylactic, at a dose of UNK dosage form. At the time of the report, INJECTION SITE PAIN (little pain at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Noted red warm area to left upper arm area onset 5/6/07, area slightly raised. Mother gave child Tylenol and Benadryl child complained of mild pain.
This case was reported by a healthcare professional via a sales representative and described the occurrence of extensive swelling of vaccinated limb in multiple subjects of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date between the end of November 2007 until 18 January 2008 the subject received unspecified dose of FLULAVAL (.5 ml, unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced swelling of vaccinated limb that was described as "severe arm swelling at injection site with redness", injection site redness, unspecified adverse reactions and pharmaceutical product complaint. At the time of reporting the outcome of the extensive swelling of the vaccinated limb, injection site redness and unspecified adverse reactions were unspecified. Per the source document it was also noted that "multiple patients report adverse reactions to immunization." It was also noted that the FLULAVAL had not been compromised and had been stored properly. The report questioned if issues with this lot number had been reported by other facilities or was her facility the only one. Lot number AFLLA032AA
ABOUT 2 WEEKS AFTER GETTING VACCINE i NOTICED HUGE KNOT ON LEFT ELBOW ALONG WITH EXCRUCIATING PAIN IN SHOULDER TO THE POINT WHERE I COULD NOT RAISE MY ARM  TO PUT CLOTHES ON. THEN NOTICED PAIN WAS GOING FROM SHOULDER TO NECK. BEING VERY UNCOMFORTABLE COULD NOT LAY ON LEFT SIDE OR SLEEP. AROUND MARCH REALIZED THAT I WAS STUTTERING WHEN I SPOKE.
Patient developed temperature of 101*F two day after receiving Pentacel and inadvertent Trumenba.
Pt recvd 3 doses of Engerix-B vax on 1NOV90, 1DEC90, & 11JUN91 & on 9OCT91 it was determined that pts titer was neg p/3 doses of Engerix-B;
Patient was given the seasonal flu vaccine on 11/4/09. She claimed to have allergy to sulfa only. Since this was the first time she had ever received the flu shot she was requested to stay a period of time after the vaccine was admin. She displayed no S/s of a reaction while waiting in the health unit and she was allowed to leave after 15-20 minutes. That evening she stated she started itching which continued to get worse. Was seen by her Doctor 11/6/09 and hospitalized 11/10/09. 12/11/09 Medical records and ER records received for date 11/6/09 to 11/11/09. DX: allergic reaction. Chief c/o rashes over entire body since flu vax. Pt states rash as gradual onset of rash, (+)itching. Assessment: (+)diffused rash,  Pt seen on 11/6/09 and again on  11/10 w/ no improvement. Pt had f/u appt 11/25/09 some improved. Pt states began pravastatin shortly before onset of rash.
Inflammatory response within 3 months that resulted in a 10 day hospitalization and detection of 2 new autoimmune disorders.
Seizure like episode lasting approx 10 seconds. 2/14/08-records received for DOS 1/22/08- Became light-headed after vaccination, eye began rolling back, unresponsive to voice. Began jerking movements of right and left arm and head. Post ictal state. 5/27/08-DC Summary received for DOS 1/22-1/23/08-DC DX: Reaction to HPV vaccine. Light headed few seconds after vaccination.
BODY ACHES; CHILLS; HIGH FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced body aches, chills, and high fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from high fever, chills, and body aches. This report was non-serious.
Right shoulder pain, possible bursitis. Pt has tried ADVIL, with little relief. The pain has lessened over the weeks but not resolved. Currently, pain returns when moves her arm across body and up and when she wakes up in the morning.
Rash on upper part of body and under arm.  She also had a headache, fever and nausea
Approx 5 min after injection, verbalized feeling dizzy and slightly nauseous. Seated and instructed to lower head between knees. Lower his head approx 1 foot above knees. Verbalized similar sx with venipunctures. Also had not had anything to eat/drink this AM. Cool compress to forehead and back of neck. B/P 124/78, P 64 started nibbling on breakfast bar and sipping on diet coke. Feeling better, sat up and talking + sx reoccurred. Assisted to sofa to lie down. B/P 116/76, P 72, returned to work after lying down for 10 min. Nurse followed up prior to departing work site and client stated no return of symptoms. Course of episode 20 min.
Localized reaction:  Area on the arm was very red, swollen, hot to touch, painful.  Mom gave him benadryl but it did not help the symptoms
26 y/o female hx fragile x syndrome, ADHD, anxiety who presents with syncope after receiving her first covid vaccine. She reports a similar episode in 2019 after a flu shot where she fainted. This episode was witnessed by her mother, as well as several others. A Rapid response was called, she was unrespsive for about 1 minute and required sternal rub. She was mildly hypotensive at the time, IV was placed and given 500 cc bolus, cart team took her to the ED. Since then she has been asymptomatic, only complaining of hunger. She denies dizziness upon standing, no chest pain or dyspnea. No known hx of anemia.
Hot reddened knot at injection site. Swollen lymph nodes on same side in neck.
Patient feels a lump at the injection site. First felt this shortly after the vaccination. Feels pain frequently depending on how arm is moved. Wakes her up at night. Received second dose in other arm and no adverse effects. This lump has lasted since the first shot in March
All was fine until December 22nd, when I developed shingles. Visited doctor on January 3, 2022 to get it confirmed.
Pressure in ears and head a few hours after receiving first dose.  Lasted for a couple hours.  I still have these symptoms  intermittently and lasts for a couple hours.  Happens 2-4 times a week.  After the second dose I began getting a ringing in my left ear and continued having pressure and my ears feeling clogged.  Difficulty sleeping since first dose administration.
This spontaneous case reported by a consumer, describes the occurrence of inappropriate schedule of product administration (2nd dose administered 5 weeks, 4 days after 1st dose) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Aug 13, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Sep 21, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Aug 13, 2021, patient experienced inappropriate schedule of product administration (2nd dose administered 5 weeks, 4 days after 1st dose). On Sep 21, 2021, inappropriate schedule of product administration (2nd dose administered 5 weeks, 4 days after 1st dose) resolved. No concomitant medication or treatment information reported. This case linked to MOD-2021-329095 (patient link).
Took my shot at 1:00pm. Around 8:00pm, I started to have stomach cramps. At 1:00am the next morning I started having chills and shaking which continued until 4am when I started having back cramps and arm cramps where I had my shot. I also felt feverish and had a very bad headache, so I took 600mg  of ibuprofen. I went in to work that morning and had chills and my skin hurt when my clothes touched my skin. I continued to have a headache also. I was sent home by my boss at 12pm on 1/5/21 because I looked and felt so bad and slept through the afternoon and for 10 hours that night. The next day, I continued to take 6oomg of ibuprofen every 6 hours and still had a lot of fatigue. The day after I was tired but them remained symptom free.
COVID 19 Treatment; 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 48-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 21Aug2023 to 25Aug2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300291520 Same patient, different event/drug;
This spontaneous report as received from a pharmacist, via a EPBU/Publicis field representative, refers to a 63 year old patient of unknown gender. On an unknown date the patient was vaccinated with ZOSTAVAX (dosing information and route was not provided). The pharmacist reported that the patient experienced hives after receiving ZOSTAVAX. The outcome of hives is unknown. No reporter causality provided. Additional information has been requested.
The injury that led to the death occurred within 1 day of the decedent receiving the vaccine
about 5 hrs after injection started to get headaches, during the night i felt really hot but then i had to get extra blankets because i was freezing.  Then when i woke up i had Muscle pain. Then i started throughout day i started Sneezing, watering up, coughing, runny nose.  muscle pain is getting better but still have the other symptoms
Pt indicated was vaxed w/Engerix-B & had a borderline titer result;
pt recv vax 4NOV95;mom reported pt devel a fine rash (felt like cornmeal) a couple of day post vax;rash began @ the inj site & spread to the back, neck & chest; c/o itching & denied other sx;
Caller and his wife used a Paxlovid prescription back in 19Sep; Caller and his wife used a Paxlovid prescription back in 19Sep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A female patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, 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 "Caller and his wife used a Paxlovid prescription back in 19Sep". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Caller and his wife used a Paxlovid prescription back in 19Sep and it worked perfectly with no problems and wanted to know how long to wait before getting the new Pfizer Vaccination for Covid-19.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300172112 same reporter/product/event, different patient;
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 21-JUL-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # M000442, expiration date 31-MAR-2018 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
I still caught Covid; I still caught Covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly male patient received bnt162b2 (BNT162B2 NOS), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I still caught Covid". Additional information: patient just did not know yet what to think about these vaccines. He still caught Covid even though he was fully vaccinated.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.