chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and PYREXIA (Fever 100 Fahrenheit) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.  Concurrent medical conditions included Diabetes and Blood pressure.  On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced HEADACHE (Headache) and PYREXIA (Fever 100 Fahrenheit). At the time of the report, HEADACHE (Headache) and PYREXIA (Fever 100 Fahrenheit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications of the patient were not provided. No concomitant medications of the patient were provided.
AFTER RECIEVING VACCINES  PT WAS SITTING DOWN WITH MOM AND LOST CONTROLE OF HER BODY AND FELL TO THE FLOOR AND HIT HER HEAD. PT HAD A SEIZURE WITH FOAMING AT THE MOUTH WITH HYPERTONIA AND LOSE OF URINE. THAT LASTED ABOUT 30 TO 45 SECONDS LONG. EMS CAME AND TOOK THE PT TO THE HOSPITAL.
Patient received her 0.25mL Moderna Booster and in just a few minutes began to feel itchy, hot, anxious , SOB and like her throat was getting tight. She felt similarly after her second dose of Moderna and received benadryl, which helped. She did not require epinephrine with the second shot or this current booster
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Additional Details: Patient received vaccine, went out to sit on chair in waiting area. Leaned over and passed out, pharmacist ran out to patient, bystander helped lower patient to ground, all the while the patient was breathing very heavily, sounded seizure like or that he was gasping for breath. Asked tech to call 911. While being lowered to ground patient regained consciousness. Mother came around the corner and stated patient has history of reacting this way to vaccines, neither pt nor mom told us this before.
A report has been received from a Physician concerning, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The reporter stated that patient had been tested positive for flu. The outcome of the event of tested positive for flu is unknown. The reporter was considered to be non-serious.
Hive/rash at injection site within 10 minutes. Treated with BENADRYL. Hive/rash began to shrink within 30 minutes after dose of BENADRYL.
Other manufactures reference number WAES0609USA06293. Initial information received on 10/11/06 from another manufacturer. An eight week old female pt received initial doses of the following vaccines on 9/13/06, IPOL lot Z04205 (not a valid lot number), administered SC in the right thigh, Tripedia lot number U1985AB administered IM in the right thigh, Comvax lot number 65425/0507F administered IM in the upper left thigh, and Rotateq lot number 653915/0389F administered per OS. Concomitant medication included Tylenol infant. there was no illness at the time of vaccination and no adverse events following prior vaccination. That evening, at 7:00pm, the pt experienced frequent stools/diarrhea. Four days post vaccination, on 9/17/06, the pts mother began noticing flecks of blood in the diarrhea stool. There were two episodes. The pt was afebrile, had normal activity, and had a normal appetite. It was noted that the pts diet was Similac advance. It was noted the OV was pending for 9/19/06. At time of the report the pt continued with diarrhea and had not recovered. The other company considered the events of flecks of blood in the diarrhea stool to be an other important medical event (OMIC).
This spontaneous report as received from a nurse refers to a patient of unknown age. The patient's medical history was not reported. On 10-JUL-2017, the patient was vaccinated with an improperly stored dose of VARIVAX (Strength, dose, frequency, route, anatomical location and expiration date were not reported) of lot # M042496 for prophylaxis. Concomitant therapies included sterile diluent. The nurse confirmed that the sterile diluent used to reconstitute the VARIVAX was properly stored. No adverse effect reported. The vaccines were exposed to multiple defrost cycles with respect to temperature for an unknown timeframe. There was no temperature excursion. There was no digital data logger involved. There was no product quality complaint involved.; Sender's Comments:  US-009507513-1708USA008368: US-009507513-1708USA008905: US-009507513-1708USA008907: US-009507513-1708USA008904:
Pt experienced onset of throbbing localized h/a in lt temporal area; H/a was unrelieved w/Medipren & Naprasyn; On 30APR91 h/a became worse & was accompanied by nausea; No vomiting; Treated in ER;
Breathing issues; Asthma; Lethargic; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargic), RESPIRATORY DISORDER (Breathing issues) and ASTHMA (Asthma) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 08-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) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In 2021, the patient experienced LETHARGY (Lethargic). On an unknown date, the patient experienced RESPIRATORY DISORDER (Breathing issues) and ASTHMA (Asthma). At the time of the report, LETHARGY (Lethargic), RESPIRATORY DISORDER (Breathing issues) and ASTHMA (Asthma) outcome was unknown.            No concomitant medication information was reported.   No treatment medication was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna.
no adverse effect; a baby girl received improperly stored ROTATEQ; This spontaneous report was received from a registered nurse, referring to a female patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions and concomitant medications.  On 01-APR-2019, a baby girl received an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally, lot # R002516 (expiration date: 13-SEP-2019) for prophylaxis (strength, dose and frequency were not reported). The highest temperature excursion was in total, temperature above 9°C (9.1 C) for 17 minutes as recorded by a data logger. No adverse effects were reported.
non-stop crying for 5 hrs-bgan 24 hrs p/admnistration of DTP/OPV/HIB titer;
A report has been received from a health professional concerning a 14 year old, male patient. No medical history, concurrent disease or concomitant medication was provided. On 24-Oct-2012, the patient receiving nasal FLUMIST. The patient had positive test for influenza B on 03-Jan-2013. At the time of reporting, the outcome of the event of positive test for influenza B was unknown. The report was considered to be non-serious by the reporter.
Son had a fever from 4/14 to 4/16, along with a rash forming on both vaccination sites on thigh. Afterwards forming small rash and bumps all over body from head to bottom of his feet and starting scratching, crying, unable to sleep, and miserable. Went to the ER twice, first treated with antibiotic, benadryl, and steroid. Second time, antibiotic, discontinued and steroid shot given, and told to continue with Benadryl. ER physician told me the reaction was due to MMR vaccine. I made a follow up appointment with Dr. on 4/19. All of this happening between 4/14/2011 to 4/17/2011.
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for himself/herself.  The age at vaccination was not reported. After receiving Shingles vaccine, the patient got a bad case of shingles from the vaccine. It was told to the patient that, it sometimes happened. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR180544:same reporter
Breakthrough case admission after 5 vaccines Moderna 3/19/21 Lot# 045A21A;  Moderna 4/16/21 Lot# 038B21A;  Moderna 8/8/21 Lot# 088D21A;  Moderna 4/10/22 Lot# 001M21A;  Moderna 9/1/22 Lot# AS7143C
Minor arm pain, fatigue,  headaches, lethargy, chills, sweating, 12-36 hrs after 1st and 2nd shots. Fatigue, headaches, lethargy  6-10 days after 2nd shot. Fatigue,  headaches, lethargy, with chills and  sweating 10 days  after 2nd shot
This spontaneous report was received from a healthcare worker refers to 37 patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored doses of GARDASIL 9 [lot # L013429, Expiry date: 21-JUL-2017]. No adverse effect were reported. This is one of the several reports from the same reporter. Additional information has been requested.
PT REPORTED FEELING LIGHTHEADED AND DIZZY. SHE DID STATE THAT SHE HAD RUN 17 MILES PRIOR TO COMING TO THE PHARMACY AND DID NOT EAT BEFORE HER VACCINE.
S/S: Swollen joints, numbness. Rx: Indocin, Keflex.
12 days after the vaccination (on April 24th) my left armpit got swollen and stated to ache. The pain radiates to my elbow and I can't use my arm.
Upper arm is very sore; His wife's left upper arm, injection site, was very sore and painful.; can't raise her arm.; Caller explained the symptoms are getting worst; This is a spontaneous report from a contactable consumer or other non hcp (patient's husband) via medical information team. A 41-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 27Apr2021 as DOSE 1, SINGLE, and second dose via an unspecified route of administration, administered in Arm Left on 18May2021 (at the age of 41-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in Apr2021, the patient's left upper arm was very sore and she cannot raise her arm. It was not getting better despite a few treatments. The reporter explained the symptoms are getting worst on an unspecified date in Apr2021. It was also reported that after the vaccines, his wife left upper arm, injection site, was very sore and painful. The patient has been going to the acupuncturist for a few weeks, and it has not improved, and was getting worse. The patient received treatment for all the events experienced by her. The outcome of the events was not recovered.     The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
ActHIB was reconstituted with sterile water and the DTAP-IPV portion was not administered at all, no AE; ActHIB was reconstituted with sterile water and the DTAP-IPV portion was not administered at all, no AE; Initial information received on 29-Jan-2020 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 6 months old female patient who received ActHIB portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], that was reconstituted with sterile water and the DTAP-IPV portion was not administered at all.  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation.  On 28-Jan-2020, the patient received ActHIB portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Act-Hib lot UJ053AA expiry date 27-Oct-2020 and Box lot UJ053AAA expiry date 27-Oct-2020) that was reconstituted with sterile water and the DTAP-IPV portion (lot number U6257AA expiry date 27-Oct-2020) was not administered at all, via intramuscular route in the right thigh for prophylactic vaccination.  It was a case of actual medication error due to wrong solution used in drug reconstitution and Inappropriate reconstitution technique.  At the time of reporting, no adverse event was reported.  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.
long COVID syndrome; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization. The following information was reported: POST-ACUTE COVID-19 SYNDROME (non-serious), outcome "unknown", described as "long COVID syndrome".  Additional information: The caller wanted to know any information for "more than 40 years old age group" having myocarditis and pericarditis after receiving the bivalent vaccine. Th caller was asking if there is any risk of developing long COVID after receiving the bivalent vaccine and if there is any data on incidence of developing actual COVID after receiving the primary and booster dose for the same age group. Stated that he has one patient who developed long COVID syndrome after getting the bivalent dose of Pfizer COVID vaccine but that was a younger person.   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.
Pfizer Dose 1 2/10/21 (el3302) Pfizer Dose 2 3/5/21 (EN6199) Pfizer Dose 3 10/12/21 (EW0171) COVID Positive 1/8/22  1/8/22: This is an 83 years old female patient who presented to the emergency department today because of generalized weakness and feeling tired  Patient has a past medical history notable for aortic stenosis status post TAVR procedure, heart failure with reduced ejection fraction, pacemaker in place, hypertension, obesity, neuroendocrine cancer, chronic kidney disease, insulin-dependent diabetes mellitus  For the past 3-4 days she has been having subjective fevers, fatigue, nausea, vomiting and right upper quadrant abdominal pain  She also reports a productive cough with production of yellow/green sputum.  She denies any diarrhea, dysuria, chest pain.  She is vaccinated against COVID-19 and denies any recent COVID-19 exposure.  She is anticoagulated with Eliquis for history of DVT.  In the emergency department she was found to be febrile and hypoxic requiring 2 L of oxygen via nasal cannula.  Chest x-ray did not show any acute finding.  She was given empiric IV antibiotics and IV fluid boluses and is admitted to hospitalist service for dehydration  For the history of neuroendocrine cancer she has been having for the past 4 years, she has been undergoing treatment with octreotide injection monthly with the next injection due January 17th approximately  Patient did not take her insulin last night due to decreased oral intake and vomiting.  1/11/22: An 83-year-old woman with a history of carcinoid tumor with metastasis who presented to the emergency room with complaints of generalized weakness and malaise.  Symptoms associated with productive cough and shortness of breath.  Emergency room, she was febrile, hypoxic requiring 2 L of oxygen by nasal cannula.  Clinical exam was consistent with dehydration.  Patient received IV fluids for hydration, she was started on IV remdesivir and dexamethasone due to hypoxia.  She was also start on empiric antibiotic therapy.  Patient had improvement in her symptoms, she reports feeling better, improving oxygen requirement, she had oxygen walk prior to discharge, she does not require oxygen at discharge.  She is being discharged home in a stable condition with VNA services.
I had first experienced mild Covid symptoms July 15, 2021 that evolved into moderate Covid two days later.  I was bed ridden with Covid for seven days.  Ten days after onset of Covid symptoms (Dry cough, chills, headach, loss of smell) I took a PCR Test on July 25.  The results came back positive for Covid-19.  On August 10, seventeen days post Covid test, I took first dose of Pfizer vaccine.  Eleven hours latter I was immediately hit with a sudden onset of flu-like symptoms (Chills, body ache, headace) which sent me to bed through the entire next day,  Now two days latter I am out of bed but very weak and light headed.
T104 febrile seizure on 20JAN99 1115AM;supportive-clear airway;02 sponging to dec temp;
5/16/23 I started with a tickle in my throat. I tested positive for COVID. Later that evening, the symptoms began to worsen, and I spiked a fever of about 100.3. I also began having a headache, severe congestion, sore throat, a minor cough, pain in my sinuses making my eyes hurt, extreme lethargy and body aches. The most intense symptoms were the body aches, sinus headache and the sore throat. On 5/17/23 I called my doctor that morning and had a telehealth. I was prescribed PAXLOVID. I started taking the PAXLOVID that day. By that evening, I was feeling much better. I had no fever, body aches and other symptoms were ended quickly. I had a lingering fatigue, but it was dramatic how it changed after taking the PAXLOVID. I was symptomatic for about 24 hours. I continued taking the PAXLOVID for the 5 days. On 5/22/23 I was still testing positive. On 5/23/23, I tested negative. The morning of 5/26/23, I did not feel well. I tested positive for COVID again. For three days I had extreme congestion, sore throat, a lot of mucous, and malaise. On 5/28/23, I was turning the corner and feeling much better. I am almost back to normal, was still testing positive yesterday.
PATIENT IS 16 YEARS OLD AND SHOULD HAVE RECEIVED PFIZER 0.3 ML AS THE BOOSTER DOSE. HOWEVER, PATIENT WAS ADMINISTERED MODERNA 0.25 ML.
Pt recvd vax 11SEP92 & 12SEP92 devel rt-sided Bell's palsy; No further details were provided;
My wife and I went to the pharmacy to get the new Bivalent Covid booster manufactured by Pfizer, as well as our annual flu vaccine. The pharmacist assured us on 3 different occasions that this was indeed the new Bivalent booster. I received a call from the pharmacy on 09/09/22 that we were given the wrong booster and now have to wait 3 months to get the one we intended to get. We both suffered with fever, body aches and general malaise after our vaccines. The pharmacy should have an internal system in place that prevents this from happening. Thank you.
Patient had got the covid vaccine that very day she had swollen eyes she continues to have itchy swollen eyes and is starting on prednisone.
Information has been received from a registered nurse concerning a 19 month old patient who on 02/07/02 was vaccinated with a dose of Varivax (site unknown). On 02/21/02, the family reported that the patient developed a localized rash at the injection site. The patient unspecified medical attention. Additional information has been requested.
pt recvd vax & c/o localized redness & swelling @ inj site;
Rash at injection site on 9/1/13 in AM. Pt noticed small red, hot circular rash. Today 9/2/13 pt has larger circumference and hotter rash with dull ache from elbow to wrist and she feels feverish (low-grade).
an essential tremor both resting and action, face numbness, chronic headaches and dizziness, upset stomach and chronically tired.
eyes swelled shut, lips swelled and became tinggly, lost feeling in both legs from waist down.  Legs feel like nails are in me and a searing hot pain mostly at night.  Lost a lot of strength in my legs.  Hurt to stand, sit, and walk.  Most of the feeling came back in 3-4 months.   Right thigh is still dull to touch and has the feeling of nails under my skin.  For 6 weeks I was on benadril 24/7 oral and topical.  that helped dull the pain in the legs and made my face swelling go away.  After 6 weeks I was put on a course of steriods.  that helps stop the leg pain and help repair my legs.  After the steoids I was able to slowly feel my legs,
This is a spontaneous report received from a contactable consumer HCP (patient). A 63-year old female patient (non-pregnant) received the second dose of BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number unknown, expiration date: unknown) via unspecified route of administration on 18-JAN-2021 at a single dose for COVID-19 immunisation. historic vaccine include first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number unknown, expiration date: unknown) via unspecified route of administration in on DEC-2020at a single dose for COVID-19 immunisation. concomitant medication was not reported. patient experienced diarrhea, she is unable to control her bowels at all and her stools have never gone back to normal, "anterior mandibular sensations in trigeminal nerve". numbness, tingling and now issues with her teeth. She wants to know how long this will keep lasting and wanted to also report it again. She stated she has called before and reported it.
10/08 - Friday day - very tired, slept most of day, then started feeling achey that night. 10/09 - Saturday - woke with fever and aches, chills. 10/10 - Sunday - fever, chills,  and tiredness continues 10/11 - Monday - fever, chills,  and tiredness continues, appointment with primary doctor put on Cipro and floxmax 10/13 - Wednesday - no fever, but no urinary output, primary Dr sends me to hospital ER - confirmation of Monday's results - was give Foley catheter and sent home for follow-up with urologist. 10/15 - antibiotic was changed to Macrobid 10/17 - appointment with urologist - catheter removed
Pt began to feel nausea, palpatations and diaphoretic. Pt was given water and told to lay down on exam table. Blood pressure was taken, normal. Pulse was rapid and patient was clammy.
Cardiac arterial clot on right side of heart. Signs began on 4-9-21 and culminated 7-5-21 with a stint in artery
Administered on Apr 5, 2023 Manufacturer: Merck & Co. Inc Product: Gardasil 9 (PF) Lot #:W013845 NDC: 0006-4121-01 Dose:0.5 mL Route: Intramuscular Site: Left deltoid Location Clinic Patient Side Effect: Skin lump and a burned scar on injection site of the left deltoid
this is my second moderna shot - first shot got covid arm on 9th day, told pharm to use other arm he refused so got in same left arm, day after vaccine got covid arm again - swollen, red, hurt and spreading around and down top of arm.
Local reaction to Left thigh from vaccine. Area approximately 10x16 cm raides, warm to touch, reddened, itching. Remains enlarged to 3x4 cm with redness.