chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 13 week old male patient with a history of gastrooesophageal reflux who on 31-OCT-2009 was vaccinated with the first dose of ROTATEQ (oral administration, "three times").  Concomitant therapy included MOTILIUM and RANIMED.  On 31-OCT-2009, the same night that the patient received the vaccine, the patient developed acute vomiting.  The vomiting sustained for 48 hours till he felt relief and recovered 48 hours later on 02-NOV-2009.  Additional information is not expected.
Red and swollen area, size of a quarter,on upper arm 3inches below vaccination site.  Area is now much larger today, 03/05/21. Now the size of at least 4 quarters and trailing down arm to the elbow.  Itches occasionally, but not severe. Warm to the touch. No treatment or doctor visits.
Incorrect product storage; A patient received 2nd dose of vaccine from an expired vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A patient received 2nd dose of vaccine from an expired vial) and PRODUCT STORAGE ERROR (Incorrect product storage) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (A patient received 2nd dose of vaccine from an expired vial). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Incorrect product storage). On 20-Sep-2021, EXPIRED PRODUCT ADMINISTERED (A patient received 2nd dose of vaccine from an expired vial) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Incorrect product storage) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment medication was provided.  The vial was punctured on 17-Sep-2021. The vial was kept in refrigerator at 39 degree F until 20-Sep-2021. The reporter did not had exact excursion time it was within 72 hours.
Vaccine expired at time of administration. It was past the bud of 10 weeks in the fridge.  Expired 3/30/22. Called patient to discuss cdc recommendation of re-vaccination.  Patient is thinking about it and will call me back.
Right arm pit pain. Difficulty lifting arm,  continuous pain, swollen lymph node . Heat made pain worse,   cold  compresses relieves some pain.
Discharge Provider: MD  Primary Care Provider : DO   Admission Date: 3/4/2023 Discharge Date: 3/7/2023     Discharge Diagnoses:   Superimposed bacterial pneumonia COVID-19 pneumonia Electrolyte derangements - resolved Fall History of seizure Compression deformity of the T12 Adrenal insufficiency Immuno deficiency secondary to chronic steroid use Crohn's disease High output ileostomy Anemia of chronic disease Anxiety Hypertension Hyperlipidemia Coronary artery disease status post stenting Chronic diastolic heart failure Chronic pain syndrome Chronic nausea History of CVA MGUS Neuropathic toe ulcer  Hospital Course: Patient is a 71 y.o. female with obesity (BMI 35) and Crohn's disease on chronic prednisone, s/p ileostomy, short bowel syndrome on TPN who presented on 3/4/2023 with acute respiratory failure and acute renal failure secondary to infection and dehydration.  For the past 2 weeks, patient had shortness of breath, low po intake with continued high volume ileostomy output.  In the emergency department, patient was dehydrated, hypotensive and hypoxic requiring 2 L nasal cannula, and altered beyond baseline.  Labs showed metabolic derangements including metabolic acidosis, hyponatremia, hyperkalemia, hyperphosphatemia along with an AKI. She was found to be COVID positive.  Imaging showed superimposed pneumonia.  Patient was given IV vancomycin and Levaquin along with fluid replacement.  She was admitted for acute renal failure, pneumonia and electrolyte derangements.   Acute hypoxemic respiratory failure Superimposed bacterial pneumonia COVID-19 pneumonia Patient was treated with 5 days of IV Rocephin and 3 days of a mix of IV and oral azithromycin.  Her respiratory failure resolved and blood cultures remain negative.  Patient's symptom medically improved before discharge.
Within 10 minutes of injection, left side of face starting  tingling and went numb. Started under chin & rose up face to the area above the eye.  As of today's date, feeling has not returned 100% to areas of the face. Also, all 4 limbs went weak and tingly, making walking extremely tiring.  Body, particularly limbs, felt heavy. (3 of 4 limbs have recovered sufficiently; right arm continues to be weak.)
Shingles just a couple of days after 1st dose; This case was reported by a physician via sales rep and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, couple of days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 09-AUG-2022 Reporter's comment: The patient developed shingles just a couple of days after the Shingrix vaccination. The reporter asked how long must they wait to get 2nd dose. No other details were provided via request. The submission was marked by the representative that the HSI was resolved, however per Medical Information processes it was being submitted for safety review. The reporter consented to follow-up.
Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Medium, Additional Details: Patient walked into the pharmacy on 10/30 to ask if she had recieved a bad dose of the moderna bivalent shot. Patient showed the arm to the pharmacist and the arm injection site was black and blue very bruised. Patient reported getting 2 shots in same arm the FLUAD and Moderna Bivalent shot. Patient reported arm hurting 2 days later and then realizing that it was bruised. Counseled patient on treatment and recommened urgent care or ER visit if bruise persists. Immunizer: staff
Following say I was sick, headaches, dizziness, nausea, and body aches. Developed reoccurring migraines still to this day, have chronic fatigue, infertility, cervical cancer.
Pelvic pain for four days (June 28-July 2) Heavy bleeding the following days after vaccine Period at 61 days (still has not ended yet)
Headache, Sedation, Myalgia, Arthralgia, UrticariaPruritus, NauseaVomiting, fatigue, pain, redness, and swelling at the injection site. Narrative:   Other Relevant History:
rash with blistering on left arm; deep muscle pain in left arm, shoulder, and elbow; blistering on left hand and pain.  No fever or nausea.  Fatigue.  Rash on left arm and hand very painful.
02/06/2021: 30 hours after injection, mild stiff neck began on right side. 02/07/2021: Neck pain traveled up to lower skull, around to front of neck including lymph node. 02/08/2021: Pain became severe, swallowing became difficult and painful to lymph node. Developed a fever of 100.3 an hour after taking 2 Tylenol.
No adverse event; the patient was supposed to have received PREVNAR 13 but the pharmacist accidentaly gave the patient a second dose of PNEUMOVAX; the patient was supposed to have received PREVNAR 13 but the pharmacist accidentaly gave the patient a second dose of PNEUMOVAX; This spontaneous report was received from the patient's wife referring to her husband of unknown age. No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.     On an unspecified date approximately in 2020 (reported as "last year"), the patient received pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis (dose, route and site of administration, lot number and expiration date were not reported).   On 04-OCT-2021, the patient was supposed to have received pneumococcal vaccine conj 13v (crm197)(PREVNAR 13), but the pharmacist accidentally gave the patient a second dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis (dose, route and site of administration, lot number and expiration date were not reported) (extra dose administered and wrong product administered).  No adverse events or product quality complains were reported.
Breakthrough COVID infection resulting in hospitalization. Symptoms include fatigue, rhinorrhea, cough, nausea, and vomiting. Unsure of symptom onset. Positive test collected 09/10/2022 on admission.
Information has been received from a physician concerning an approximately 23 year old female who on an unspecified date was vaccinated with a first dose of GARDASIL (lot # not reported). Subsequently the patient developed hives and a rash. It was reported that "the adverse experience lasted a couple days". On an unspecified date the patient recovered. The physician has decided to discontinue the series. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/13/2008.  Initial and follow up information has been received from a physician concerning an approximately 23 year old female who on an unspecified date was vaccinated with a first dose of GARDASIL (Lot # site and route not reported).  Subsequently the patient developed hives and a rash.  It was reported that "the adverse experience lasted a couple days".  On an unspecified date the patient recovered.  The physician has decided to discontinue the series.  The doctor "feels that it was unrelated" to GARDASIL, that it was a "pre-existing viral condition".  No additional information was provided.  Additional information is not expected.
After the first dose of Moderna on April 1 my arm was incredibly sore and I could not even lift it at all for the next two days. After the second dose on May 5 I cannot move my arm entirely for the next several course of days and following the night of the injection, I was convulsing uncontrollably for the whole night. I was very ill but the convulsing was the most concerning. For five months after receiving the first dose of the COVID-19 vaccine of Moderna. I did not get my period. I have gotten my period regularly for the last 5 years, even through bouts of stress and an active eating disorder. Always on the same day. The vaccine is causing problems with m fertility post injection.
Patient felt nauseous immediately after vaccination. Nausea resolved fairly quickly afterwards. Pt also felt flushed and clammy. These symptoms lasted about 1 hour before he was back to normal. Pt asked and was given water, which he says helped him get better.
10:35 WAS SWEATING SITTING IN CHAIR IN POST VACCINE AREA.  C/O DIZZINESS, NAUSEA.  NO HIVES, NO SWELLING OF FACE, NO SOB.   10:40 BP 168/90 P 80 R 18 CHEST CLEAR GOOD AERATION GAVE WATER ,POWERADE, STAYED RESTING IN CHAIR OFFERED COT, DID NOT WANT TO LAY DOWN 10:47 BP 138/90 80 R 18  HAS HYPERTENSION DID TAKES MEDICATION AT NIGHT ATE CEREAL FOR BREAKFAST 10:47 FELT BETTER, NO LONGER NAUSEATED NOR DIZZY 11:00 AM AMBULATED WITH STEADY GAIT ACCOMPANIED BY LINE FLOW TO HIS SISTERS CAR WHO DROVE HIM TO THE VACCINE SITE.
initial and prolonged swelling with itching and hardness at the injection site which has escalated RT shoulder ache.
Client vaccinated with Pfizer vaccines for Covid x 2 in April 2021.  Symptoms started 12/13 - cough, weakness, myalgia, sore throat, dx with pneumonia when admitted to hospital on 12/16.  Received monoclonal antibody infusion and Remdesivir.
Severe pain in all joints, extreme, treatment 2 hospital visits, blood work, put on prednisone for 10 weeks
This case was reported by a physician and described the occurrence of a sore shoulder in a 40 year old male pt who received Twinrix. On 11/4/04, the pt received the first dose of Twinrix in the right deltoid. On the same day, the pt also received Typhim VI, in the right deltoid, TD vaccine, in the left deltoid and yellow fever vaccine, in the left arm. At an unspecified time following the administration of the vaccines, on 11/4/04, the pt experienced soreness in the right arm "at the site of injection" and soreness "that extended up towards the neck and shoulder on the right side". The pt was seen at a physician's office on 12/13/04. The physician stated that as of 12/13/04, "the soreness is still present and upon physical examination, the soreness is aggravated by turning his neck from side to side". Follow-up received on 3/11/05 from the reporting physician indicated that the pt was, "symptomatic for six weeks", however, the date that the events resolved was not provided. The reporting physician considered the events to possibly be related to vaccination with Twinrix and possibly associated with the overuse syndrome.
ActHiB was frozen and then administered to a patient/No AE; Initial information was received on 19-May-2020 regarding an unsolicited valid non-serious case from a physician.  This case is linked to cases 2020SA133784, 2020SA133785, 2020SA133715 and 2020SA133786 (same reporter).  This case involves a patient of an unknown demographics who received HIB (PRP/T) VACCINE [ACT-HIB], which was frozen.  Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication were not reported.  On an unknown date, the patient received a dose of suspect HIB (PRP/T) VACCINE lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to incorrect product storage as ActHIB that had been frozen and then administered.  At the time of report, 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.  There will be no information available on the batch number for this case.
noc of vax 3FEB98-anxious, insomnia, polyuria;AM 4FEB bilat CVA tenderness, resolved during day, eve of 4FEB lt CVA tenderness, dull ache;AM 5FEB dull ache cont;denies any other GI dx;no CNS c/o;
According to the mother, the pt complained of nausea, loss of appetite, irritability, crying, high fever. Symptoms lasted approximately 36 hours. Mother gave child Motrin.
Severe lower back pain, joint pain and muscle pain- could not stand or walk w/o extreme pain for two- three weeks- could not put any weight on right hip and leg for four months at which time I had an injection of cortisone in hip joint at which time pain was localized to muscles in right leg that continue to be painful.
Arm pain, spread to shoulder, neck; Arm pain, spread to shoulder, neck; Arm pain, spread to shoulder, neck; Malase; Headache; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 52-years-old non pregnant female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: GP6955), via an unspecified route of administration, administered in Arm Left on 23Mar2021 02:15 (Age at vaccination: 52-years-old) as single dose for covid-19 immunization. Medical history included glaucoma, migraine both from an unknown date and unknown if ongoing. Concomitant medication included almotriptan (ALMOTRIPTAN), diclofenac (DICLOFENAC) both taken for an unspecified indication, start and stop date were not reported. The patient previously took lidocaine and experienced Allergy. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination patient was not diagnosed with covid-19.On 23Mar2021 22:00 patient experienced Arm pain, spread to shoulder, neck, and headache, malase. patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included sars-cov-2 test: negative. The outcome for the events was reported as resolving at the time of this report.  No follow up attempts are needed. No further information is expected.
Full body fatigue and headache, fairly impacting for the first 24 hours, somewhat impacting for the next 24 hours. Soreness at injection site was mild for first 72 hours (Tuesday afternoon through Friday night), but woke up Saturday with a much more sore arm, with soreness spread over an approximate 6-8 inch area laterally down my left shoulder.  It was the increased soreness in the arm so late after the injection that prompted me to fill out this form.
FEVER RECTALLY 102.7 CONTINUED OFF AND ON 1/30/2010 105.3 RECTAL AT 4:00 am MOM ALTERNATED TYLENOL & ADVIL CLINIC VISIT 1/30/2010.
Shortly after getting flu shot patient complained of the following symptoms--ringing in ears, shortness of breath/chest tightness, lower body muscle aches. These were severe enough that the patient has missed 2 days of work thus far due to symptoms.
This spontaneous report was received from a healthcare professional via Pfizer refers to a patient of unknown age. The patient had hypertension and atrial fibrillation. On an unknown date, the patient was vaccinated with PNEUMOVAX 23. Other suspect therapies included LYRICA. Concomitant therapies included folic acid, hydrocodone, levothyroxine sodium, pravastatin, ramipril, cyanocobalamin and vitamin D (unspecified). On an unknown date the patient experienced an adverse event. The outcome of the event was unknown. The causality was not reported. Additional information has been requested.
Has COVID/ tested positive twice; Has COVID/ tested positive twice; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 92-year-old female 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; BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10Dec2022, outcome "unknown" and all described as "Has COVID/ tested positive twice". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Course of events: Patient is the reporter's mother. She had no fever yet. She was at her apartment isolating. She got Paxlovid Mon 11Dec (as reported). She had very bad cough. No fever. Her symptoms started Saturday (09Dec2022 as reported). She got worse Sunday (11Dec2022). She has tested positive twice. She was sick. She took all vaccines including Omicron.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Patient immunized with FLUVIRIN and PNEUMOVAX on 9/18. FLUVIRIN administered IM using standard deltoid technique. PNEUMOVAX admins SC. No apparent reaction at time of admin. On 9/21, pt called reporting local injection site redness and swelling (severe). Worsened over 2 days. Treated in ER.
Redness pain and itching at injection site and from left shoulder down to left elbow area. Patient treated with Cephalexin BID for 10 days.
Patient stated it felt like her throat got scratchy like when she consumes soy products which she is allergic to.
Within minutes, felt like she was going to fall.  Patient's eyes were droopy but able to respond to questions.  BP 93/98, HR 93, RR 20.  No SOB.  VS rechecked and BP 169/78, RR 18, HR 92.  No lightheadedness.  Able to stand and patient was relaxing.  BP 175/93, HR 60 bpm and RR 16.  Released home with daughter.  Received shot #2.
Mom & dad requested flu vaccine for baby - Brought baby to office for vaccine 1/10/13. 103 degrees Temp sudden onset with dry cough. Spoke to mom 1/17/13. Mild cough remains. Fever gone. The symptoms began on the 14th.
Muscle tremors, Loss of motor function, Loss of Appetite, Dry mouth, Fever, Blurred vision, Incontinence, Disoriented, Headache, Memory Loss.
bleed clot in my left eye; now I have just 40% vision in left eye; This is a spontaneous report from a contactable consumer (patient).   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on Apr2021 as dose 2, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on Mar2021 as dose 1, single for covid-19 immunisation. The patient had a bleed clot in my left eye. Patient was healthy before the shot and had 20/20 vision. Patient had just 40% vision in left eye due to which getting shots in the left eye. The outcome of the event was unknown.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
The patient received the second dose of the Covid vaccine on 4/30/21, on 5/2/21 at 0230 the patient reported an episode of palpitations, chest pain, and left arm pain that was relieved after 1 hour. On 5/3/21 at 0230 the patient reported a second episode of palpitations, chest pain, and left arm pain that was not relieved, pt presented to the Clinic, to ED at 0340 on 5/3/21, the patient had an EKG and lab work done. Troponin I lab level was 4.52, which is over 100 times the normal limit.  Pediatric cardiology was consulted and the patient was sent to Hospital via life flight.
Vaccine was stored at -20 Degrees F so outside of the Temperature range; A spontaneous report  was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) that was stored at -20 degrees F, so outside of the temperature range. The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. The reporter stated the COVID-19 vaccine was stored at -20 degrees Fahrenheit; outside of the recommended temperature range. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event, vaccine that was stored at -20 degrees F so outside of the temperature range, was considered resolved.; Reporter's Comments: This case concerns a patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product storage error without any associated adverse events.