chrisvoncsefalvay/vaers-outcomes huggingface dataset:
In the middle of the night I woke up shivering with feverish symptoms, a headache, and nauseated. I meant to get up to take some Acetaminophen, but fell asleep again before I did. In the morning around 8am I woke with a low grade fever (99.17 deg F) a headache and nausea, as well as soreness at the injection site.
CHILLS TEMPERATURE NOT TAKEN; NAUSEA; TIRED; HEAD IS HURTING; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802070, and batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced nausea. On 08-MAR-2021, the subject experienced tired. On 08-MAR-2021, the subject experienced head is hurting. On 09-MAR-2021, the subject experienced chills temperature not taken. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills temperature not taken on 09-MAR-2021, and was recovering from nausea, tired, and head is hurting. This report was non-serious.
Patient developed herpes zoster, reported to ED on 5/10/15 after receiving Zostavax on 5/4/15.
Patient did not report adverse event to immunizing facility or physician until 1/19/2010.  He presented at the pharmacy with a 1 to 2 inch yellow ring around the injection site (left deltoid).  The needle part was still prominent & there was significant swelling when compared to his right arm.  Patient said he had no bruising at any time but had pain for first 2 to 3 days.  Patient stated on 1/19/2010 that he is not experiencing pain presently.
No additional AE reported; an expired ROTATEQ was administered; This spontaneous report was received from a medical assistant who refers to a 5-month-old female patient. Information regarding the patient's drug reactions or allergies, concomitant therapies and her pertinent medical history was not provided. The patient's birth weight was reported as 3.629 kg. On 11-MAY-2021, the patient was vaccinated with following vaccines (concomitant therapies):diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP), polio vaccine inact (IPV) and pneumococcal vaccine conj 13v (crm197)(PREVENAR 13). On the same date, she received an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 ml tube, 2 ml, once, orally, for prophylaxis, lot # 1660998, expiry date 03-MAY-2021 (dose number was not reported). No additional adverse event was reported. There was no prescription drug treatment required. There was a plan to re-vaccinate the patient in 4 weeks. The suspect vaccine had no prior temperature excursions.
Approx 2 min after admin of vaccines, mother of pt reported pt was "playing" & acting silly, then started to "shake all over".  Initially rhythmic jerking of arms & legs & flexion of neck & rapid respirations were observed for 15 seconds.  Approx 2-3 later, again had generalized jerking of arms & legs- lasted -1 min.  Pt was given BENADRYL 50mg IM in clinic & transported to hospital.  DC from hospital the next day.  Diagnosed with Convulsive syncope.  Had EEG as out pt on 11/13/08-normal negative CT screen at hospital.  Blood sugar in ambulance was 55. 1/26/09-records received for DOS 11/10-11/11/08-DC DX: Likely convulsive syncope can not rule out seizure due to hypoglycemia. Presetned after convulsive syncope following HPV and Hep A vaccine. Prior to event C/O feeling dizzy and flailing arms and legs with tonic/clonic movements with second episode accompanied by rapid respirations and unresponsive for several minutes and not oriented to time and place.
Initial report received on 22 November 2013 from a healthcare professional who is also the patient. The 33 year old female patient received FLUZONE intramuscularly into the right deltoid, batch # UH900AB on 13 November 2013. On Saturday 15 November 2013, the patient woke up during the night with sweats and had to change her clothes due to the sweats. She also had vomiting and nausea. This occurred again on 20 November 2013 and 21 November 2013. On 21 November, she also began wheezing and feels that this is an asthma exacerbation. The patient also experienced a red area at the injection site of a half dollar in size with no pain or swelling. The patient has a call into her physician for treatment of her symptoms. In the last 5 years, the patient received the flu vaccine, manufacturer unknown and in a week to two weeks developed asthma exacerbation and wheezing. Five years ago, the patient required hospitalization, but did not require hospitalization in subsequent years. The patient was told that FLUZONE does not contain eggs, so she was vaccinated. The patient has a medical history of asthma, allergies to milk, eggs, wheat and shrimp. Concomitant medications were not reported. The patient did not receive other vaccinations within the last 4 weeks. The patient denies illness at the time of vaccination. The patient outcome is not recovered. Documents held by sender: none.
My daughter is having strange dreams as well since her second dose of the Pfizer vaccine; This is a spontaneous report from a contactable consumer, parent. A female patient of an unspecified age received second dose of BNT162B2 (Formulation: Solution for injection; Batch/Lot number: unknown) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for COVID-19 immunization. No medical history and concomitant medications were reported. No known allergies. The patient previously received first dose of BNT162B2 on an unspecified date for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that patient was having strange dreams since the second dose of the Pfizer vaccine. The outcome of the event was not recovered.  No follow-up attempts are needed. No further information is expected.
Vaccinated on 10/22/10. Reports back pain and muscle weakness increasing through weekend. Admitted on 10/27/10.
First symptom started at 5pm fitigue followed by body aches and head ache. Then around 930 pm fever started and the fever got as high as 103.4. My fever would lower and higher. Didn't break fever into Wednesday morning at 4:30am I felt like I had the flu.
Became ill on 01/21/2022.  There are 2 issues.  1:  At the emergency room I had an EKG.  It showed Tachycardia, which I have never had before.  2:  I was diagnosed with Acute Appendicitis.  Surgery for removal was 01/23/2022.  The appendix was abscessed and perforated.
MENQUADFI administered to patient under 2 years of age with no adverse event; Initial information received on 08-Jul-2022 regarding an unsolicited valid non-serious case from a physician.  This case involves a 4-month-old and unknown gender patient to whom MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [Menquadfi] administered to patient under 2 years of age with no adverse event.  The patient's past medical history, medical treatment(s), family history and no other vaccination were provided.   On an unknown date, the patient received 0.5ml total dose (frequency: once) of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE (strength: standard, formulation, route: unknown) (lot number and expiry date: not reported) in unknown administration site for Immunization.  On 08-Jul-2022 a non-serious event of, menquadfi administered to patient under 2 years of age with no adverse event (off label use) (unknown latency).  It was reported, Caller requesting information for the parents of the patient.   Action taken with MENINGOCOCCAL VACCINE (MENQUADFI) was not applicable.  At time of reporting, the outcome was Unknown.
Medic did not dilute the vial of pfizer and patient received a full vial of pfizer vaccine undiluted
broke out in hives real bad left some bruising marks that starting to disappear now where i can see them lasted for like 3 days took allergy pill helped stop itching still have some bumps on back arms face.
Backache/side ache most of the day on Sept 25th. My mother thought it might be a kidney stone so she took Ibuprofen every 4 hours. She also had nausea most of the morning of the 25th. She woke up around 2am on the 26th gasping for air and could barely breathe. She went into cardiac arrest.
Information has been received from a registered nurse concerning a 12 month old "healthy" female pt with no known allergies who was vaccinated with a dose of MMR II, IM. There was no concomitant medication. Subsequently, the pt developed a "lump in her leg" and localized rash. It was reported to be unknown if medical attention was sought. Additional info has been requested.
3 INCH in diameter around injection site is red, swollen, warm to the touch, and itchy.
Patient Not Seroconverted; Initial Report Received on 25-Sep-2019   A nurse reported that a female patient (unknown age and race) was administered 2 doses of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and that the "patient (had) not seroconverted."     Relevant medical history and concomitant medications were not provided.     On unknown dates, the patient previously received three doses of hepatitis B vaccination (vaccine name not reported).   On 12-Jul-2019, the patient received the first dose of Heplisav-B (lot#, expiration date, and NDC # not reported). It was unknown if the vaccine was administered from a vial or prefilled syringe.  On 16-Aug-2019, the patient received the second dose of Heplisav-B (lot#, expiration date, and NDC # not reported). It was unknown if the vaccine was administered from a vial or prefilled syringe.  On 20-Sep-2019, a titer was checked and was noted that the patient had not seroconverted. No further information was provided.   At the time of the report, the outcome of the event was not reported.    The reporter did not provide a serious assessment for the event.   Company comment: The company assessed the event of therapy non-responder as non-serious. The event of therapy non-responder is listed per HEPLISAV-B USPI.; Sender's Comments: The company assessed the event of therapy non-responder as non-serious. The event of therapy non-responder is listed per HEPLISAV-B USPI and IB.
12/22/2020 1st Covid vaccine Pfizer EL3249 Left Arm 2pm 1/12/2021 2nd Covid vaccine Pfizer EK9231 Left Arm 2pm 4/16/2021 Ill 4/19/2021 Covid PCR Positive 4/27/2021 Potential to return to work
mild fever AM 24JUL98 seen in office given immun that evening had febrile sz w/temp 103.7 in ER;sz generalized tonic clonic lasted <= 2min;no prior sz;adm to hosp LP done;
After getting vaccine the cancer got reactivated.; This spontaneous case was reported by a consumer and describes the occurrence of RECURRENT CANCER (After getting vaccine the cancer got reactivated) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Cancer.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RECURRENT CANCER (After getting vaccine the cancer got reactivated.) (seriousness criterion medically significant). At the time of the report, RECURRENT CANCER (After getting vaccine the cancer got reactivated.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided by the reporter The was provided updated  contact information since his  wife  passed away and also  stated that  a  friend of his next-door neighbor's who had  cancer  and  was considered  as cured few years ago, after getting vaccine the cancer got reactivated. Lab data was not provided Treatment product was not provided by the reporter  Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
two weeks of a headache daily. First three days had chills, aches, headache and overall fatigue. Two weeks after and the site is still raised, red, warm to touch, itchy and painful if touched. It also looks like a 3" by 2" welt with an injection dent.
This spontaneous reprot as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 21-JUL-2015, the patient was vaccinated with improperly stored M-M-R II lot # K000998 and 22-JAN-2016 (unknown strength and route). Concomitant medications were not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Covid twice and have been hospitalized; Covid twice and have been hospitalized; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) 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 included: "114 brain surgeries" (unspecified if ongoing); "brain bolt" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), SUSPECTED COVID-19 (hospitalization, medically significant), outcome "unknown" and all described as "Covid twice and have been hospitalized". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Initial and follow up information has been received from a physician concerning a 54 year old female nurse (198 pounds) with hypertension and hypercholesteorlaemia and a history of mastectomy and breast cancer who on 27-JUN-2006 (previously reported as 28-JUN-2006) was vaccinated IM into the left deltoid with a first dose of Pneumovax 23 (lot # 651373/0320F). Secondary concomitant therapy included a second dose of tetanus toxoid (lot # u1584ea) (previously reported as diphtheria toxoid/tetanus toxoid) IM into the left deltoid. On 27-JUN-2006, within several hours the patient experienced fever 102.7 F, severe myalgias, nausea, general malaise, joint pain and injection site reaction with redness and tenderness. She was treated with acetaminophen (TYLENOL) prn, ice pack, and Phenergan prn. The patient required a doctor visit and improved within 3 to 4 days. Laboratory findings included a WBC 12,800, 77 segs, 14 lymphs band 9 bands. She recovered on 30-JUN-2006 from fever, malaise, myalgias and nausea. Fever 102.7 F, myalgia, joint pain and injection site reaction were considered to be disabling according to the reporter. Additional information is not expected.
I woke up and the rash had started on my arm around injection site (swollen at the injection site the day after) - 27th is when I broke into a rash over my face and chest. And it's progressively gotten worse sense. Rash is all over my chest, whole back, arms and hands. It's hot and it itches and burns. I visited my doctor on January 4th. Got a steriod pack - pills by mouth. And then I went to a dermatologist on January 13 - received steriod creme and skin biopsy of rash and lab work. I am going to see another specialist tomorrow - a rheumatologist (they know about lupus).
fever; body aches; got very ill; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included COVID-19 VACCINE (received on an unknown date) and Shingles vaccine with an associated reaction of illness (1st dose received on an unknown date, refer case US2021AMR187280).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fever, general body pain and illness. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the fever, general body pain and illness were unknown.   It was unknown if the reporter considered the fever, general body pain and illness to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported this case. The age at vaccination was not reported. The patient reported that, he/she got shingles vaccine and got very ill, had fever, body aches and so on, but mentioned it worked,  just like the Covid vaccine. The contact details were not reported. This case has been linked with US2021AMR187280, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR187280:same reporter, same patient, same vaccine, different dose
new diagnosis of ulcerative colitis. symptoms began a few days after first dose, and then progressed a few days after completing second dose. diagnosis confirmed on colonoscopy and biopsy.
Irregular menstrual cycle, right hemorrhagic ovarian cyst; Irregular menstrual cycle, right hemorrhagic ovarian cyst; This is a spontaneous report from a contactable Other HCP (patient).  A 30-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 30Apr2021 15:30 (Batch/Lot Number: Er8731) age at vaccination of 30-years-old, as single dose, for covid-19 immunisation.  Medical history was none. The patient was not pregnant and was not pregnant at the time of vaccination.  There were no concomitant medications.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced irregular menstrual cycle and right hemorrhagic ovarian cyst on 05May2021.  The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measure was taken and included prescription of birth control for ovarian cyst. Facility type vaccine: Pharmacy or Drug Store. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was not recovered from the events.; Sender's Comments: Based on plausible dose- event relationship post-vaccination  the causal role of BNT162B2 vaccine cannot be excluded for the reported events.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
left arm shoulder deltoid muscle. had a sore left arm; tired; under the weather; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (left arm shoulder deltoid muscle. had a sore left arm), FATIGUE (tired) and MALAISE (under the weather) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced VACCINATION SITE PAIN (left arm shoulder deltoid muscle. had a sore left arm), FATIGUE (tired) and MALAISE (under the weather). At the time of the report, VACCINATION SITE PAIN (left arm shoulder deltoid muscle. had a sore left arm), FATIGUE (tired) and MALAISE (under the weather) outcome was unknown.            Concomitant medication use was unknown Treatment information was unknown   This case was linked to MOD-2021-369222, MOD-2021-369381 (Patient Link).
Having itching, throat swelling, feeling flushed/hot. In ER by 1120. IV Benadryl given in ER. 12/10/2009 ED records for 11/23/2009, patient with c/o's itching, feeling flushed and throat swelling, Tx: IV Benadryl, sx resolved. DC Dx vaccine allergie reaction
Body covered in hives; This is a spontaneous report from a contactable Other-HCP. A 45-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: 3246, dose number:2) via an unspecified route of administration on 03Feb2021 at single dose for Covid-19 immunization. Medical history included hypothyroid, subcutaneous lupus and allergic to sulfa, penicillin, phenergen from an unknown date and unknown if ongoing. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: Ek9231, dose number:1) via an unspecified route of administration on 12Jan2021 02:30 PM at single dose for Covid-19 immunization. Concomitant medications included levothyroxine sodium (SYNTHROID) and celecoxib (CELEBREX). On 05Feb2021 at 09:00 AM, the patient's body covered in hives. Then she took oral Benadryl as a treatment. The outcome of event was recovered.  No follow-up attempts are possible. No further information is expected.
Very itchy; Began scratching hives; Hives on wrists, elbows, knees, more on right side, grew larger, hives were very itchy, looked like bug bites; This case was reported by a consumer via call center representative and described the occurrence of hives in a 65-year-old male patient who received Herpes zoster (Shingrix) (batch number Z4G59, expiry date unknown) for prophylaxis.   On 20th August 2022, the patient received the 1st dose of Shingrix. In September 2022, 1 month after receiving Shingrix, the patient experienced hives. On an unknown date, the patient experienced pruritus and scratch. The patient was treated with betamethasone dipropionate. On an unknown date, the outcome of the hives was not recovered/not resolved and the outcome of the pruritus was recovered/resolved and the outcome of the scratch was unknown.   It was unknown if the reporter considered the hives, pruritus and scratch to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-NOV-2022 Reporter's Comment: The reporter was a patient. The patient reporter that he received Shingrix vaccine in the right arm at the pharmacy. The patient stated that approximately one month after received Shingrix vaccine he experienced hives. The patient experienced hives which began on interior and exterior of their wrist and couple of weeks later hives spread to interior and exterior of elbows and outside of both knees. The patient stated that the hives began more on the right side of their body, before spreading to the left side. The patient stated that the hives started out as two or three that looked like bug bites, which then spread after they began scratching them.  The hives also grew larger, to about the size of a pencil point and hives was very itchy.  The patient received betamethasone diproprionate topical ointment as a treatment which was resolved the itching. The patient reported that they continued to develop two or three new hives every other day. The reporter consented to follow up.