chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Went to see pcp yesterday for fever, myalgia, headache and LLR at injection site of pneumococcal vaccine. PCP prescribed Cefdinir 300 mg twice a day X 10 days. Moc reports that pt continues to have headaches, fever of 102.0-101.0 that reduces with MOTRIN. Pt also has nasal stuffiness and post nasal drip that started yesterday. Nasal symptoms, myalgia and headache with sinus tenderness started 2 days after receiving vaccine. Day cough which pt feels is post nasal drip. Not doing saline rinses. Treating in the GZ. Instructions: Saline rinses twice a day until symptoms resolve and then as needed. AFRIN 2 squirts each side twice a day for up to five days. NASONEX and PATANASE as prescribed. Can use MUCINEX 600 mg twice a day for post nasal drip. Treat in the YZ for day cough. If night cough develops, treat in the RZ for 24-48 hours. Continue MOTRIN for fever and pain. Ice packs or warm compresses at injection site. Phone update for new or worsening symptoms. Has not started BACTRIM yet. Continue Cefdinir?...RN August 12, 2011 9:54 AM Moc called to report that pt's fever has increased to 103.0. Instructed moc to adm MOTRIN and abx prescribed yesterday by pcp...RN August 12, 2011 11:48 AM Fever of 103.3. Headache is worse. Unable to move head up or down. Instructed to go to ER immediately...RN August 12, 2011 12:11 PM. Agree. Straight to ED...MD August 12, 2011 12:21 PM.
Minor Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 026B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMIN.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY. On 04-Mar-2021, PAIN IN EXTREMITY had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment information was not provided.   This case was linked to MOD-2021-075218.   Most recent FOLLOW-UP information incorporated above included  On 05-May-2021: Reporter's contact information updated. Concomitant medication updated.
Patient woke up next morning with nausea, chills, low grade fever (99.6), muscle aches.  Slept in bed all day due to reaction.  could not eat anything other than ice chips and some crackers later in day.
Medical Assistant saw two different dates for vaccine vial -one on vial and one on tracking of access of vial. Thought that date on vial was a mistake since it was early in the morning and this was the first access recorded.  MA drew up vaccine and administered to patient.   Date on vial was correct and vial was supposed to have been disposed of at end of day.  This did not happen.
Neuralgia across left side of head leading to eye indicative of beginning of shingles type rash.
patient received both IPOL and Quadracel inadvertently.  She did not have any negative side effects from this.  Parents were informed to monitor child and contact the office if she was having any type of reaction.
LARGE AREA OF REDNESS EXTENDING FROM DELTOID TO ELBOW, COVERING BICEP DEVELOPING ABOUT 10 DAYS AFTER VACCINE. NO PAIN OR ITCHING, NO OTHER SYMPTOMS.
After vaccine, pt reports L arm and hard tingling- after covid vaccine in L arm . History of anxiety. Never taken meds Oxy 99 BP 130/70 talkative. Tingling stopped
Patient complained of swollen eyes, throat tightening, tongue tingling, jaw tightening that persisted for a good 2 hours even after taking a Benadryl tablet.
Mild swelling on left side of face, neck and back of tongue.  Began to fade after appx. 1 hour.
The adult patient received one pediatric dose of Heb B vaccine. The patient received a pediatric dose of Dtap
Soreness & pain in left arm then moving into shoulder area by morning -pain getting progressively worse 3 days later. Ice & NSAIDs for pain relief.
3/20/2021  @ 1:00 vaccination I sat in a chair for 5 minutes. After, I felt warm, I was flushed. Fifteen minutes later I walked out, driving down road with friend and I said 'something is wrong'; really bad 'metal taste' in mouth, blurred vision, grabbed her arm and said I am going to throw up, I was so dizzy and I said I can't think. My face was drooping, I couldn't say my A,B,C's, and by the time I got to the ER they got me on an IV. I couldn't talk, think, and had the metal taste for a few hours. The dr. said we are going to give you fluids, my BP was elevated for 6 hours 198/130, no clots. BP went down to  178/98, taste started to go down, I was drinking fluids, I was able to talk a little bit. I felt like in a 'bubble', I couldn't think. When I was discharged I had no temp, my BP was normal.  *my body reacted to the vaccination.  *6 hours my body reacted *body had felt like I was recovering from the flu for 2 weeks *Never ran a temperature
Systemic: Other- cold finger tips, raised bloodpressure;  lasted 1 day
Patient received vaccine prior to age approved for use.  The vaccine is approved for emergency use in persons age 18 and older.  This patient received the vaccine at age 17.
Vaccines administered approx. 12:30 pm 10/5/17 - at 4:30 pm pt experiencing shakiness, hot flashes, excessive sweating. At 6 pm pt reports feeling better, but cold.
From telephone contact with reporter, it was stated that a 4 year old patient (1 of 3) received a Tripedia vaccination (date not specified). Sometime after the vaccination, the patient developed swelling at the injection site. Further information is requested.
ACUTE COR PULMONALE HYPOTENSION ACUTE HYPOXEMIC RESPIRATORY FAILURE
I had swollen lymph nodes under my left arm pit that were sore.  This lasted about 3-5 days. I had extreme fatigue during this time as well. No fevers.  I still have reactivated EBV symptoms, and it seems ongoing. This was present before my booster & flu shot, but may have started around my original vaccinations in March 2021, or possibly prior to that as well.
ACUTE NON ST ELEVATION MI ACUTE CORONARY SYNDROME, UNSPECIFIED 3/3/2023 -- RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Began crying approx 1 1/2 hrs p/immun; crying then turned to screaming & lasted approx 1 hr; pt's head began shaking about 3PM; Was seen by MD about 6 to 7 PM & ER;
Nurse went to administer the vaccine in his thigh the pediatric patient pushed away and then most of the dose trailed down his leg.; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ACCIDENTAL UNDERDOSE (Nurse went to administer the vaccine in his thigh the pediatric patient pushed away and then most of the dose trailed down his leg.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 28-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jul-2022, the patient experienced ACCIDENTAL UNDERDOSE (Nurse went to administer the vaccine in his thigh the pediatric patient pushed away and then most of the dose trailed down his leg.). At the time of the report, ACCIDENTAL UNDERDOSE (Nurse went to administer the vaccine in his thigh the pediatric patient pushed away and then most of the dose trailed down his leg.) outcome was unknown.      Concomitant medications details were not reported by the reporter.  The reporter reported that she had a son in the 6 month thru 5 year old age range who received Moderna Covid-19 vaccine, when the Nurse went to administer the vaccine on  thigh the pediatric patient pushed away and then most of the dose trailed down his leg. This was due to the patients reaction and not due to the Moderna Covid-19 vaccine.  Treatment details were not reported by the reporter.
16 hrs after Tdap administered, awoke after sleep with headache, muscle aches, fever. No treatment - seen by PCP.
COMPLAINED OF INCREASED PAIN IN UPPER LEFT ARM, SITE OF PNEMONOCOCCAL VACCINE. SITE IS VERY SWOLLEN, WARM TO TOUCH AND HARD FROM THE SHOULDER TO APPROX 4 INCHES DOWN ARM. PAIN AND DECREASED RANGE OF MOTION DUE TO THE PAIN.  11/14/2008 MR received for DOS 9/23-/28/08. Pt admitted for CVA and received Pneumovax during hospital stay. No mention of any reaction in D/C summary. Case closed
Covid-19; Covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group, Program ID.  A 78-year-old male patient received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: EM9809), in left arm and on 09Sep2021 as dose 2, single (Lot number: FF2588) at the age of 77 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 08Aug2022, outcome "unknown" and all described as "Covid-19". The patient was hospitalized for drug ineffective (start date: 08Aug2022); for covid-19 (start date: 08Aug2022, hospitalization duration: 30 day(s)). The patient underwent the following laboratory tests and procedures: Blood electrolytes: (unspecified date) Low, notes: electrolytes were very low; Oxygen saturation: (unspecified date) Low, notes: oxygen was low; SARS-CoV-2 test: (08Aug2022) Positive; Weight: (unspecified date) 152 lbs, notes: He went from 177lbs to 152lbs.  Clinical course: It was reported by the patients Wife that patient had a reaction to the serum on 25Mar2021. Got another Covid-19 booster. Was on a ventilator for 30 days last Aug2022 after catching Covid-19. Had adverse reactions to the first Covid shot. On 09Sep2021, he got the booster and the same thing happened with the foot. He ended up getting covid anyway and on 08Aug2022, the ambulance had to come get him. He couldn't keep any food down before the ambulance came to get him, not even water or crushed ice. When he got to the hospital, his electrolytes were very low, oxygen was low, kidneys were shutting down. He was lucky to be alive. Got the vaccine in his left arm at a hospital parking lot vaccine drive. Can't remember which arm the Dose was given in.
I tested positive for COVID-19 on 1/2/23. I had chills, fatigue, shortness of breath, body aches, and a slight cough. I contacted my doctor and was prescribed 5 days worth of PAXLOVID and a cough medication, but I did not take the cough medicine. I started to feel better after taking PAXLOVID, but I still get fatigued easily.
have both now been diagnosed with COVID; have both now been diagnosed with COVID; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: was not reported; Expiration Date: was not reported), dose 1 via an unspecified route of administration on 08Jul2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced have both now been diagnosed with COVID-19 and feeling sick on an unspecified date. Caller stated both her and her son received their first dose of the Pfizer COVID-19 vaccine on 08Jul2021 and have both now been diagnosed with COVID-19. Caller was looking for information about when her and she son can get the second dose. She was still feeling sick so would like to know when she can receive her second dose and it's going to be after the three-week mark is that going to be a problem. The patient underwent lab tests and procedures which included sars-cov-2 test was positive on an unspecified date. The outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100958348 same reporter/drug, different event/ patient
Migraine-type headache beginning 8 hours after injection, lasted 6 days. Still experiencing tiredness (20 days since injection). Itchiness began within 18 hours. Hives on upper arm at injection site, began 6 days following injection. The hives and itch subsided until this past Saturday, 10 days since injection. Itch subsided on Monday (May10). Hives remain present.
on blood thinners; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A patient (no qualifiers provided) 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: THROMBOSIS (medically significant), outcome "unknown", described as "on blood thinners". Therapeutic measures were taken as a result of thrombosis.  Clinical course: It was reported as Two of my friends have ended up with heart problems and four are now on blood thinners for the rest of their lives.  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-PV202300014834 same reporter/drug, different patient/event;US-PFIZER INC-202300035010 same reporter/drug/event, different patient;US-PFIZER INC-202300035009 same reporter/drug/event, different patient;US-PFIZER INC-202300035001 same reporter/drug/event, different patient;US-PFIZER INC-202300035000 same reporter/drug, different patient/event;
Received An Expired Dose; Initial Report Received on 08-Mar-2023  A nurse reported that a 36-year-old female received HEPLISAV-B for hepatitis B immunization.    Medical history was reported as unknown.   No concomitant medications were reported.    On 07-Mar-2023, the patient received a dose of HEPLISAV-B (Lot #937232, NDC 4352-003-05, Expiration 04-Mar-2023) intramuscularly in the right deltoid. The dose of HEPLISAV-B administered was 3 days past the expiration date.  The reported denied that the patient had reported any adverse effects related to this.   No other information is available.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Left arm little swollen for two day.  It was itchy really bad that it would not go away. The next on a Friday, it swelled up again but bigger.  I called doctor and sent picture of my arm.  They give me antibiotic and steroid cream for the itch.
screaming 2  1/2hr, rapid breathing, rt leg swelling (3x size);tx advised to seek MD & get possible allergy testing;mom did not seek MD or ER;
PRURITIC ERUPTIONS RIGHT CALF ANT RIGHT TORSO AND GENERALIZED BODYACHE
She received the shot at 1:00 PM by approx. 6:00 PM she said her arm was swollen, tender and hot, with nerve pain. However by the next evening she said the swelling was down and the pain had lessened, by two days after she said her arm was better.
Information has been received from a nurse concerning a female who was vaccinated PO with a dose of Rotateq. Subsequently the patient experienced intussusception. The patient was seen in the physician's office. The patient's outcome was unknown at the time of this report. There was no product quality complaint. Upon internal review, intussusception was determined to be an other important medical event. Additional information has been requested.  12/14/07 Received vax record from pcp.  VAERS database updated w/same. 12/28/07 Reviewed hospital medical records which were only x-ray reports & reveal patient experienced diarrhea x 5 days, reduced oral intake & bloody stools.  BE successfully reduced ileocolic intussusception.   FINAL DX: ileocolic intussusception, enema reduced. 1/4/08 Reviewed hospital medical records which reveal patient experienced ileocolic IS 9/13 & was reduced by BE.  Also had congestion & runny nose at that time.  Returned to clinic 9/14 due to reduced oral intake.  Assessment at that time was resolved IS & irritated stomach & was placed on clears.  Returned to clinic 9/18 with continued reduced oral intake & cough.  Exam at that time revealed dull TMs & tx w/antibiotics.  Returned to ER 10/14 with diarrhea x 7 days & reduced oral intake.  Abdominal x-ray at that time was WNL.  Dx w/diarrhea possibly due to recent formula change.
Information has been received from a registered nurse concerning an infant who was vaccinated with an oral dose of Rotateq.  Subsequently, the patient spit up the dose.  Unspecified medical attention was sought.  There was no product quality complaint. Additional information has been requested.   .
Early complaints of weakness and fatigue progressing to inability to ambulate or stand when he presented to the ED on 11/10/2011.  Is currently in ICU in a local tertiary hospital.  Underwent a partial nephrectomy on 10/25/2011.
This patient had a generalized seizure lasting one minute. The was taken to the ER at night. The patient had  received DTAP, HIB vaccine during the during the day.
After vaccination at 915 AM,  patient developed isolated shortness of breath at 1730. The shortness of breath was progressive and not relieved by albuterol. Presented to a local ED at 1930 where she was given an unknown dose of steroid and was, by history, hypoxic enough that intubation was discussed.  She was not intubated, but was transferred to hospital for allergy and cardiology assessment. This SOB was the only symptom that she developed. She was euvolemic on my exam today and does not appear to have had diuresis prior to my assessment. Her asthma is well controlled by history.  She was placed on high flow o2 via NC and improved substantially overnight. She was on 3L of o2 at the time of my assessment (1215) today.   There are several confounders to her case. She has a history of methamphetamine abuse and though she denies recent ingestion (last use was reportedly months ago) her UDS is positive at 0600 today.
received frozen Moderna covid-19 vaccine that was stored in a freezer which did not have a separate freezer door; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of PRODUCT STORAGE ERROR (received frozen Moderna covid-19 vaccine that was stored in a freezer which did not have a separate freezer door) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (received frozen Moderna covid-19 vaccine that was stored in a freezer which did not have a separate freezer door). At the time of the report, PRODUCT STORAGE ERROR (received frozen Moderna covid-19 vaccine that was stored in a freezer which did not have a separate freezer door) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported.  No treatment information was reported.   Reporter did not allow further contact
This case was reported by a consumer and described the occurrence of seizures in a 2 month old female subject who was vaccianted with hepatitis B vaccine recombinant (Engerix B) hepatitis B vaccine recombinant) unknown on an unspecified date. Co suspect vaccination included four other unspecified vaccines given on 3/14/2006. The reporter mentioned some specific manufacturers, but it was unknown if there were other manufacturers. On 3/14/2006 at 12:45 the subject received the 2nd dose of Engerix B (unknown, unknown thigh) and four other unspecified vaccines. On an unspecified date in 2006, and after an unspecified time after vaccination with Engerix B, the subject experienced twitching or seizures. This case was assessed as medically serious by manufacturer (OMIC). At the time of reporting, the outcome of the events were unspecified.
Swollen arm (from wrist to shoulder). Cellulitis? Levaquin 725.
I got both shots / most hurtful of any shot I have ever had.; This case was reported by a consumer and described the occurrence of pain during injection in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced pain during injection. On an unknown date, the outcome of the pain during injection was recovered/resolved.   It was unknown if the reporter considered the pain during injection to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The patient got shingles shots and stated that it was most hurtful of any shot ever had. The case was linked with US2021AMR088678 reported by same reporter for 2nd dose.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR088678:same patient (2ND dose)
Pt recvd vax &  had rash on arms, legs, underarms; sx persist;
Initial report received on 15 August 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 4-year-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 4 doses of DAPTACEL; lot number C2651AA received on 31 October 2007, lot number C2797AA received pm 18 January 2008, lot number C2798AA received on 01 April 2008 and lot number C2957AA received on 15 January 2009 (routes and sites of administration not reported). The subject developed a paroxysmal cough without a whoop on 28 July 2012, approximately 42 months after the last dose. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 29 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 01 August 2012 for five days. The subject was not hospitalized. At the time of final contact on 13 August 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 16 days. According to the reporter, the event was outbreak-related. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Tinnitus in both ears. It has impacted hearing and is nonstop in both ears. Going to audiologist next week. Ringing in ears nonstop since the first Moderna dose.
Slight pain in left arm; This is a spontaneous report from a contactable other healthcare professional, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0162) via an unspecified route of administration in the left arm on 13May2021 at 14:30 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. Medical history included protein allergy (Egg protein). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included hydroxyzine (MANUFACTURER UNKNOWN) and escitalopram oxalate (LEXAPRO) both from an unknown date for an unspecified indication. On 13May2021 at 16:00, the patient experienced slight pain in left arm. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event slight pain in left arm was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.