chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician assistant concerning a female patient who on an unknown date was vaccinated with the second dose of GARDASIL (Lot number was not available). Subsequently, the patient experienced a day long seizures and severe headaches after receiving her second dose of GARDASIL. The patient was currently seeing a neurologist but was not yet recovered. On an unspecified date, a magnetic resonance imaging (MRI) was performed (results was not provided). Additional information has been requested.  04/14/2009  Neurology records received for eval of dysphasia, dizziness, H/A from 11/14/08-3/23/09. Pt had recently presented to ER on 11/10/08 with c/o chest pain upon inspiration.  Initially thought to be asthma by parent and tx with nebs. Pt developed tachycardia and became frightened. Dx with anxiety and tx with Ativan in ER and D/c. The next day pt was difficult to arouse and was feeling dizzy. Parent noted pt was having problems with speech, halting and with problems expressing self which continued throughout the day in addition pt very sleepy.  On 11/12/08 pt developed H/A which has continued on/off until 11/14/08 appt.  PE (+) for halting speech with stuttering quality. DTRs 1-2 in UEs and 3+ in LEs. DX: Dysphasia-etiology unclear.  Sent for MRI. Started on Topamax 1/12/09. Pt presented again 1/6/09 with several episodes of fogginess, cognitive sluggishness, falling asleep and H/A. Reports increased menstrual cramps. DX:  H/A and altered mental status. ? migraine variant.  Started on Topamax 1/12/09. Parent reports pt falling during skating practice with H/A and later H/A, neck pain, back pain, muscle and joint pain. Tx with medrol dosepak.  By 3/2009 having frequent H/A often preceeded by neck pain, back pain with fogginess.  2nd opinion neuro consult 3/18/09. PE WNL except (+) trigger point pain of trapezius. Etiology of sx unknown. ? seizure despite normal EEG.
Patient presented to the ED on 8/16/21 for a 5 day history of nonproductive cough and anorexia. Over the past two days he developed fevers, generalized weakness and non-bloody diarrhea. Had two falls prior to hospital admission due to weakness. No prior COVID-19 infections but tested positive upon arrival to the hospital. COVID-19 vaccination received July 7, 2021. Not requiring oxygen at time of admission, saturations >94%.
Moderna Covid 19 Vaccine EUA  I had an averse reaction to both shots (excessive fever, pain, muscle  pain) that took me approximately 4 days to fully recover. After that, I noticed my heart starting to flutter, and beat very fast. I didn't think too much of it because according to Moderna, this may occur and "goes away" on his own. Well, it hasn't gone away at all for me 3+ months later. I recently took my physical (October 4th) , where my doctor noticed that my heart resting rate was at 115. I have since been taking measurements of my heart pulse and have been consistently over 100. As you know having a consistent resting rate over 100 is an independent predicator of all-cause and cardiovascular death/heart disease. I do believe the cause of this is the vaccine as I have a track record of great health (which my medical record can speak to), I do not smoke, drink or take medication. The only change I have done is take this vaccine and since then  all these problems started to pop up. Now I have to watch what I do because my pressure is so high and this is taking a negative toll on my everyday life., as now I am scared I can have a heart attack or stroke.
Testing positive for covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Testing positive for covid-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced COVID-19 (Testing positive for covid-19). On 10-Apr-2021, COVID-19 (Testing positive for covid-19) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  No treatment information was provided.
Fainted / I fainted with both doses; This is a spontaneous report from a contactable consumer (patient). A 15-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 20Jul2021 10:00 (Batch/Lot Number: EW0187) (at the age of 14 years old) as single dose, and dose 2 via an unspecified route of administration, administered in left arm on 10Aug2021 10:15 (Batch/Lot Number: EW0187) (at the age of 15 years old) as single dose, for Covid-19 immunisation. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. There were no concomitant medications. The patient fainted on 11Aug2021 at 12:00. The patient reported that she fainted with both doses. She did not receive any treatment. Outcome of the events was recovered with sequelae.  No follow-up attempts are needed. No further information is expected.
Shots given 9/23/11 (VARIVAX & flu shot). Rash (local inflammatory reaction) on (R) thigh developed about 7-8 days later.
Information has been received from a physician's assistant concerning a female who on 09-Aug-2007 was vaccinated SC with a dose of Zostavax.  Concomitant therapy included atorvastatin calcium (Lipitor).  It was reported that the patient had severe outbreak of the shingles that the office had seen in 30 years.  The patient was vaccinated at a pharmacy.  It was reported that the patient was not immunocompromised, not on longer term coritcosteroids, nor allergic to gelatin or neomycin.  The patient was prescribed a 7 days steroid pack and the patient had recovered on an unspecified date.  No diagnostic laboratory tests were undertaken.  A product quality complaint was not involved.  Additional information has been requested.
Nurse did not add enough diluent.  Max dose drawn was 5 doses.  Parents told to observe child and as of today there have been no report adverse reaction.
Severe joint pain Severe muscle pain 102 Fever for 2 days Nausea Redness in mouth Aphthous ulcer in mouth Neck stiffness Trouble opening mouth due to swelling  Received vaccine 1/25/21 at 7:26 am. Symptoms started at 11:00 pm that night and lasted until 1/31/21
dizziness; felt like she had to vomit; Low grade fever 101.9; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), NAUSEA (felt like she had to vomit) and PYREXIA (Low grade fever 101.9) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Osteoporosis. Concomitant products included CALCIUM PHOSPHATE DIBASIC, ERGOCALCIFEROL (VITAMIN D2 AND CALCIUM HYDROGEN PHOSPHATE) for Osteoporosis, RIVAROXABAN (XARELTO) and ATENOLOL for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced DIZZINESS (dizziness), NAUSEA (felt like she had to vomit) and PYREXIA (Low grade fever 101.9). At the time of the report, DIZZINESS (dizziness), NAUSEA (felt like she had to vomit) and PYREXIA (Low grade fever 101.9) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Feb-2021, Body temperature: 101.9 (Inconclusive) Low grade fever 101.9.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided   This case was linked to MOD-2021-257168 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Non significant follow up received on 06-MAY-2021. Patient say's she could not figure out how to send the filled out ADR form. On 14-Jul-2021: No new information received
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 78 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer", start date: 2014 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient did not receive any other medication in 2 weeks. The patient was treated with Paxlovid from 26Feb2023 to 02Mar2023. Patient did not had any known allergies.  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-202300110136 Same reporter/patient, different drug/AE.;
Patient received the booster dose of Pfizer. Immediately upon vaccination, she had lightheadedness and nausea. She stated she never experienced symptoms like this after any vaccine.
Severe Rash on both arms. Centering in the creases in both elbows.  Look like a severe sunburn
Headache; Was achy; Fever; She reacts differently than other people; This case was reported by a consumer via call center representative and described the occurrence of headache in a 62-year-old female patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   The patient's past medical history included conjunctivitis. Concurrent medical conditions included pre-diabetic, allergy to animal dander and house dust mite allergy.   On an unknown date, the patient received Tdap Vaccine. On an unknown date, 1 day after receiving Tdap Vaccine, the patient experienced headache, pain, fever and feeling abnormal. On an unknown date, the outcome of the headache and pain were recovered/resolved and the outcome of the fever and feeling abnormal were unknown.   The reporter considered the headache and pain to be related to Tdap Vaccine. It was unknown if the reporter considered the fever and feeling abnormal to be related to Tdap Vaccine.  Additional details were provided as follows: The reporter was the patient. The patient was allergic to dust mites and pet dander. The age at vaccination was not reported. A number of years ago, the patient had received a tdap shot and had a little reaction the next day.  The patient had every symptom and mentioned she had headache and that she was achy. The second day after receiving the tdap vaccine, the patient had fever, achy and she reacted differently than other people.  The patient was not asked regarding the name of the vaccine and MD contact information. This case has been linked to US2021059714 and US2021AMR060203, reported by the same reporter while the linked case US2021AMR061311 has been invalidated from the database.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR060203:Same reporter, Tdap vaccine US-GLAXOSMITHKLINE-US2021AMR061311:Same reporter. Invalid - case.
Pt became listless, temp 105.1 in ER, 12 hrs post vax;
redness in the injection site in the right arm; arm swollen; extremely itchy; pain; nausea; fever; aches; chills; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (extremely itchy), PAIN (pain), VACCINATION SITE ERYTHEMA (redness in the injection site in the right arm), VACCINATION SITE SWELLING (arm swollen) and NAUSEA (nausea) in a 73-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7163B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient did not received other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Patient never had COVID positive test or diagnosis.  Concurrent medical conditions included Dust allergy, Hypothyroidism (20 years ago) and Acid reflux (esophageal). Concomitant products included PANTOPRAZOLE for Acid reflux (esophageal), LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder, ROSUVASTATIN CALCIUM (CRESTOR), VITAMIN D NOS, AMLODIPINE and PARACETAMOL (TYLENOL) for an unknown indication.    On 05-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Oct-2022, the patient experienced PAIN (pain), NAUSEA (nausea), PYREXIA (fever), MYALGIA (aches) and CHILLS (chills). On 07-Oct-2022, the patient experienced VACCINATION SITE PRURITUS (extremely itchy), VACCINATION SITE ERYTHEMA (redness in the injection site in the right arm) and VACCINATION SITE SWELLING (arm swollen). The patient was treated with CORTISONE at a dose of 3 times a day. On 07-Oct-2022, PAIN (pain), NAUSEA (nausea), PYREXIA (fever), MYALGIA (aches) and CHILLS (chills) had resolved. On 10-Oct-2022, VACCINATION SITE SWELLING (arm swollen) had resolved. At the time of the report, VACCINATION SITE PRURITUS (extremely itchy) and VACCINATION SITE ERYTHEMA (redness in the injection site in the right arm) was resolving.            Patient height was reported as 5 feet and 2 inches.  It was reported that on 10 Feb 2021 patient received first dose of Moderna COVID-19 Vaccine with LOT number 015M20A and expiration date as unknown. On 12 Mar 2021 patient received second dose of Moderna COVID-19 Vaccine with LOT number 048A21A and expiration date as unknown. On 26 Nov 2021 patient received  first booster of Moderna COVID-19 Vaccine with LOT number 031H21A and expiration date as unknown.   After receiving bivalent booster patient experienced nausea, fever, aches, pain and chills during 2 days on 07 Oct 2022 and experienced redness in the injection site in the right arm, was swollen and extremely itch used Cortisone 3 times a day. On 10 Oct 2022 patient called to the pharmacy and asked for medical advise, treatment given was Claritin. Currently redness was almost resolved but itchiness was still ongoing but improving. Patient did not experienced a similar event in the past.  Treatment medication also included Claritin.   This case was linked to MOD-2022-657160 (Patient Link).
Information has been received from a health professional concerning a 11 year old black female with no medical history who on 28-MAY-1998 was vaccinated in the right arm with a first dose of varicella virus vaccine live (Oka/Merck)(lot # 624644/1329E). There was no illness at the time of vaccination. Concomitant therapy on an unknown date was reported as a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD), a dose of poliovirus vaccine and a dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid. "Now", on approximately 15-AUG-2005, the patient has experienced full blown chicken pox with greater than 50 lesions. She is being treated with hydroxyzine hydrochloride (ATARAX) and calamine (+) camphor (+) pramoxine hydrochloride (AVEENO). No additional information is available. No product quality complaint was involved. Follow-up information indicated that on 13-AUG-2005, at 15:00, the patient developed distorted vesicles diffusely over the body. Some vesicles were dried and some still oozing. It was reported that on 20-AUG-2005 the patient recovered. The chickenpox was considered an other important medical event (OMIC) by the reporter. Additional information is not expected.
swollen lymph nodes; Painful swollen lymph nodes under her arm; This is a spontaneous report from a contactable consumer or other non hcp. A 30-years-old female patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm on 28Sep2021 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced Painful swollen lymph nodes under her arm, in the arm that was injected on an unspecified date. Painful reaction lasted about 2 days. Booster injection believed/estimated to be Wednesday 28Sep2021. The event outcome for swollen lymph nodes under her arm was reported as unknown and event outcome for painful swollen lymph nodes under her arm reaction was reported as resolved.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Numbness, starting at feet going upward to entire leg. Weakness in muscle affected by polio (legs). Unexplained physical and mental fatique, wants to sleep all the time. Trouble walking up and down stairs or around curves. Chronic joint and muscle pain. Restless legs. Trouble with swallowing. Cold intolorance. Sleep disorders. Low endurance. Memory and concentration problems.
Muscle aches, fatigue, chills, pain at injection site. Got worse this morning. No fever.
This case was reported by a physician via a GSK representative and described the occurrence of vaccination failure in a 7-month-old subject of unspecified gender who was vaccinated with ROTARIX (GlaxoSmithKline). On unknown date, the subject received 1st dose and 2nd dose of ROTARIX (unknown). At an unspecified time after vaccination with ROTARIX, the subject experienced vaccination failure and rotavirus. The subject was hospitalised. At the time of reporting, the outcomes of the vaccination failure and rotavirus were unspecified. The subject was administered two doses of ROTARIX. At the age of seven months, the subject was admitted to the hospital after developing rotavirus, and was reported as a product failure. No additional information was provided.
patient called today to say she had fever, vomitting, and dizziness after receiving vaccine; states still having dizziness today
Initial information received on 16-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA290123 (same reporter). This case involves a 13 months old patient who received a 0.5 mL dose of IPOL lot P1A171M, expiry date: 30-Apr-2020 via intramuscular route in the right thigh on 11-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE for Immunisation; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation. It was a case of actual medication error due to incorrect product storage. It was reported that excursion was 51.8 degrees F for 1 Hour. 101-hours worth of excursions since 18May - 15Oct. These excursions were not included on one vial of the Unopened and Opened IPOL. There were Two Injections given during the most recent Excursion of 51.8 degrees F. x 1 Hour of the Opened IPOL Vial. It was not reported if the patient experienced any administered or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
24 hrs later high temperature (101.5) chills body aches, loss of circulation to fingers lasting several hours. Later, elevated temp, body aches, sweats for 4 days then fine
Patient states around 12:00pm after eating and swallowing a  small piece of chicken she felt short of breathe and could not speak. Her husband performed heimlich maneveur on her and her breathe returned. She reports incident lasted 1-2 minutes.
ax temp of 103 x 24 hrs; despite APAP; vomiting x 1 morning p/inject; mom states pt extremely drowsy; advised to to sponge, remove excess clothing, cont APAP;
This is a spontaneous report from a non-clinical study program, by a contactable physician. A 70-year-old male patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration at single dose on 28Jul2015. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced leukocytosis that required hospitalization on 29Jul2015 09:41. The outcome of the event was unknown.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Unknown number of improperly stored PNEUMOVAX 23 (dose, route, lot # not reported) were administered to patients. There was one cycle that reached -40C, with the balance of the excursions at 0 C. The total excursion timeframe was less than 300 hours. PNEUMOVAX 23 excursion not supported. The nurse stated that she believed at least one or two individuals have received these various vaccines, but does not have specific data. She had not received any reports of adverse effects to patients post vaccination. This is one of several reports from the same source. Additional information has been requested.
Severe hives that covered every inch of my body for 6 full days. It's started with Itching  feet, hands and ears for days, stomach pain, body aches, headaches and then painful hives and extreme swelling of hands and feet.
Patient complained of heaviness of the right arm approximately 5 minutes after receiving vaccination. She then developed edema of the upper and lower eyelids soon thereafter. Patient was administered 50mg IM of Benadryl and the reaction subsided.
pt recvd vax 15JUN95 & 18JUN95 pt exp a sore mouth & devel low grade fever;21JUN95 pt recovered;No further details were provided;
PT WAS 17 YEARS OLD AND WAS ADMINISTERED MODERNA VACCINE INSTEAD OF THE PFIZER VACCINE  BY ACCIDENT PT DOING FINE AND NO ADVERSE EVENTS AFTER ADMINISTRATION OR LATER
SWELLING AROUND AND ON SITE OF INJECTING. RED, RASIED SKIN, 8 INCHES LONG, AND WARM TO THE TOUCH.
Patient received last year's influenza stock by mistake  (Fluzone - Sanofi Pasteur; Lot # UT3576CA, expiration 6/30/11).  Patient had no adverse reactions.
This spontaneous report as received from a registered nurse refers to a 6 month old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 17-OCT-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M006112 with expiry date: 16-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 has been requested.; Sender's Comments: US-009507513-1610USA014706:
Dizziness upon receiving the shot (immediate after effect) lasting. It lessened after about 10 min but I was dizzy for a few hours after. I had the same (more severe) reaction to Moderna shots 1 & 2