chrisvoncsefalvay/vaers-outcomes huggingface dataset:
onset of nausea, vomiting, abdo cramps & diarrhea 4 days p/taking 1st oral typhoid pill; no fever; cont taking typhoid pills on schedule; hx of side effect to typhoid inject in the past;
This spontaneous report was received from a medical assistant concerning an unspecified number of patients of unknown age and gender. On unspecified dates the patients received doses of improperly stored ROTATEQ orally (dose, lot number and expiry date were not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Case number PHEH2014US024162, is an initial spontaneous report from a health care professional received on 01 Dec 2014. This report refers to an 11-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. He was vaccinated with MENVEO (batch number: A13046) intramuscularly at a dose of 0.5 ml on 12 Nov 2014. It was reported that the vaccine reached 0 to 1 degree C sporadically for 3 days when it was not reconstituted and was subsequently administered to the patient. The reporter stated that the vaccine did not freeze and it was the first occurrence. No adverse events were reported following the maladministration.
lightheaded + some nausea. laid down, took vital signs. drank water. called MD. 5 min after 6 mo booster administed patient reported feeling lightheaded + anxious.  10 min later felt nauseaus.  No other symtoms  Walked patient to cot and laid down. Called Dr. Reported that BP slightly elevated + tachycardic Dr ordered patient to lay down; repeat vitals in 15 minutes.  After 30 min patient felt better + released to home by Dr.
I have no sense of smell whatsoever since receiving my first vaccine.  That's the only side-effect I have.  It's not bothersome (thank goodness I can still taste food) but I have been encouraged to report it to someone.
Severe swelling in arm developed within 24 hours of administration 06/21/17. Seen in ER 06/22 treated with Prednisone and BENADRYL. Swelling 7cm x 5cm with circumferential swell on follow up 6/24 decreased to 4.5cmx3.5cm.
Rigors; pain at injection site; body aches; This is a spontaneous report from a non-contactable nurse reporting for herself. A 29-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 29-year-old via intramuscular in the left arm on 28Jan2021 01:00 PM at a single dose for COVID-19 immunization in a hospital. The patient's medical history and concomitant medications were not reported. The patient was not allergic to medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. The patient experienced rigors, pain at injection site, body aches on 29Jan2021 at 03:00 AM. No treatment was received for the events. The nurse considered the events as non-serious. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.   No follow-up attempts are possible, information about batch number cannot be obtained.
Patient developed itchy rash within 24 hours of receiving vaccine.  Rash stared on arms and spread to face and stomach.  No fever or other clinical symptoms
GAS; INDIGESTION; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included gas/indigestion issues, and multiple sclerosis exposure, and other pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043a21a, and expiry: 05-AUG-2021) dose was not reported, administered on 24-JUN-2021 for prophylactic vaccination. Concomitant medications included glatiramer acetate for multiple sclerosis exposure.  On 24-JUN-2021, the subject experienced gas. On 24-JUN-2021, the subject experienced indigestion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from gas, and indigestion on 25-JUN-2021. This report was non-serious.
At 10am crashed.  Fatigue,  body aches, chills, fever (101.6), headache, and ringing in ears.
Patient experienced an afebrile seizure the evening of 3/15/11. She received the 6 month series of vaccines that morning.
Patient received two different types of vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Patient received two different types of vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Patient received two different types of vaccine). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Patient received two different types of vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitant medication was provided by the reporter. No treatment information was provided by the reporter.
Patient originally requested Moderna vaccine but received Pfizer COVID 19 vaccine instead due to communication error. No adverse event was reported by the patient. The technician verbally confirmed at the check in and just before giving a shot that if patient was pursuing for Pfizer vaccine and patient said yes. However, after the vaccine was given patient asked him that the vaccine was Moderna.
fever; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Feb2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient developed a fever after getting her second COVID vaccine yesterday. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt recv vax 14JAN97 & 2 1/2hr post vax pt devel hives on trunk & presented to MD office;pt recovered;
Information has been received from a pharmacist concerning a 72 year old female patient with no drug reactions or allergies who on 25-MAR-2011 was vaccinated SC in left arm with a 0.65ml dose of ZOSTAVAX (Merck) (lot # 667609/1354Z, exp: 26-OCT-2011). Subsequently the patient had been experiencing pain of her left arm. There was no swelling. There was no laboratory diagnostics studies performed. There was no treatment given for the adverse event. At the time of reporting, the patient had not recovered. The patient called the pharmacist to seek medical attention. Additional information has been requested.
COVID + diagnosis/Covid exposure; COVID + diagnosis/Covid exposure; This is a spontaneous report from contactable nurses. This nurse reported same events for 4 patients. This is 2nd of 4 reports. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 22Dec2020 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter stated that 4 employees that had been vaccinated with a 1st dose had to defer to 02Feb2021 due to recent COVID + diagnosis/Covid exposure. Lab test included positive covid test. The outcome of events was unknown.  Information on the lot/batch number has been requested; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.,Linked Report(s) : US-PFIZER INC-2021035084 the same reporter, product and adverse events in different patients
LIMITATIONS IN LEFT SHOULDER RANGE OF MOTION; LEFT SHOULDER PAIN INITIATED THE DAY AFTER VACCINATION; This spontaneous report received from a patient concerned a 38 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A28A, expiry: UNKNOWN) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. Age at time of vaccination 38 years old. No concomitant medications were reported.  On 08-MAY-2021, the patient experienced left shoulder pain initiated the day after vaccination. On 14-MAY-2021, the patient experienced limitations in left shoulder range of motion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left shoulder pain initiated the day after vaccination, and limitations in left shoulder range of motion. This report was non-serious.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown demographics. The pertinent medical history and concomitant medication was not reported. Since an unknown date in 2015 (reported as since 10-JUN-2015) the patients were vaccinated with unspecified number of improperly stored doses of ROTATEQ (lot # K023537 and Expiry: 22-JUN-2016); Lot: K019372 and Expiry: 16-JUL-2016) (route unspecified). No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Mild eruption on trunk and arms, all in crust stage currently.  * Not happen after vaccine
Initial misuse report received from a healthcare professional (Nurse) on 22 August 2013. The cases were received on 21 March 2014. A patient had received Td vaccine (unknown MFR) instead of ADACEL. It was vaccine underdose. No adverse event was reported. List of documents held by sender: None.
Started having seizure on 2/8/11 at 9pm taken to ER at hosp - then again on 2/9/11 at 2:30p - again on 2/10/11 in AM & 3:30p. body jerking, rolling her eyes seizure lasting 8-10 sec.
Headache - ibuprofen, 3 days nausea - no tx, 1 day dizziness - no tx - 1 day muscle aches - ibuprofen, 1 day fatigue - no tx, 3 days injection site pain - ibuprofen, 3+ days chills - no tx - 2 days fever - ibuprofen, 2 days
arm felt heavy & progressed to fever, leghargy, h/a, joint aches, & very weak lasted for 8 hrs on 7OCT95 from 1PM to approx 9PM;
Injection site pain, swollen lymph nodes under armpits, mild fever, very tired, headache, bone and muscle pain, dizziness/unsteadiness.  Worst symptoms for 6 days.  Side effects gradually waned, with swollen lymph nodes the last to resolve, after 11 days.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients' current conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored (9 °C to 25 °C for 1 hour) (incorrect product storage) VAQTA  of lot/batch# M005274, expiration date:03-APR-2018 (strength, dose and route of administration were not reported) for prophylaxis. No adverse effects were reported. No previous temperature excursion was reported.The outcome of incorrect product storage and no adverse effects was unknown. This is one of the several reports received from same reporter.; Sender's Comments:  US-009507513-1707USA009369: US-009507513-1707USA006260: US-009507513-1707USA009371:
after 9 days, site of injection (right upper arm) became very hot, red and noticeably swollen and arm felt heavy. now today (day 11) one episode of chills, upper arm is still hot and swollen and feeling fatigue
Had a rebound with mild symptoms and positive test around day 9; Had a rebound with mild symptoms and positive test around day 9; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: ER8T30), in right arm, on 12Apr2021 as dose 2, single (Lot number: EW0158), in right arm and on 13Oct2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 47 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Gout" (unspecified if ongoing). Concomitant medication(s) included: ALLOPURINOL. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "recovered" and all described as "Had a rebound with mild symptoms and positive test around day 9". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive, notes: around day 9; (May2022) negative, notes: on the 7th day. Therapeutic measures were taken as a result of covid-19, vaccination failure.  Clinical course: Anti-viral details: product COVID 19 Treatment, Paxlovid, treatment start date 04May2022, treatment stop date 08May2022. other medication in 2weeks product Allupurinol. Adverse event Symptoms resolved pretty quickly, and I tested negative and was symptom-free on the 7th day. Had a rebound with mild symptoms and positive test around day 9, and didn't test negative again until around day 16.  No follow-up attempts are possible. No further information is expected.
multiple er/admissions from february through april 27.  pt deceased on 4/27/21 2/25/21  known past medical history of hypertension and hypothyroidism.  Status-post spinal decompression due to stenosis. The patient then developed worsening issues with a surgical site infection. Patient has had numerous bouts of C diff.  Staff notes patient is to have GI consult in the near future.  Patient is seen today in her room. Patient was once again diagnosed with C diff and is currently being treated with antibiotics. Patient notes no bowel movements today.  Patient has not had any issues with intake recently.  The patient's weight has declined partially due to likely diarrhea. Patient's blood pressure continues to be monitored closely as it has been on the lower side of normal.  Patient's potassium 2.9 on CMP.  Patient's other care and therapies were reviewed. 2/28/21 Patient was admitted the hospital after found to be anemic at skilled care facility where she is being treated for C diff infection recurrent Lea. Patient was transfused. Patient was also found to have pneumonia/lung mass. Patient has struggled with electrolyte dysfunction. Patient had to be transfused a second time. Patient did well with second transfusion. Patient was found to be hypokalemic. Patient did well with potassium replacement. The patient was advised will have to do outpatient PET scan. Patient was found to have positive blood cultures as well 4/26/21 68 y.o. female who presents from nursing home with complaints of elevated white blood cell count.  According to nursing home records patient had CBC checked on Saturday 04/24/2021 and her WBC count was found to be 50,000. At that point in time no other orders were given and patient was not sent in for evaluation.   CBC was repeated this morning and WBC count found to be in the 70,000s.  Patient was sent in for evaluation this morning.  In talking with the patient, she denies any runny nose, sinus drainage or cough.  Patient does report shortness of breath.  Patient denies any chest pain or palpitations.  Patient denies any dysuria, hematuria, fevers, or chills.  Patient denies any nausea or vomiting.  Patient does report diffuse pain across the lower abdomen.  She does report chronic diarrhea.  Patient had C diff stool checked on 04/13/2021 and was negative.   (4/26 cdiff positive)  Of note patient does have known lung mass that was seen on chest x-ray and PET scan.  Patient reports that she does not want anything done and understands it could be cancer.  And continuing to question patient, she reports she wants to be a DNR and does not want any aggressive measures.
Caller's friend had a sore arm; Caller's friend had intense headache after receiving vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Caller's friend had a sore arm) and HEADACHE (Caller's friend had intense headache after receiving vaccine) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (Caller's friend had a sore arm) and HEADACHE (Caller's friend had intense headache after receiving vaccine). At the time of the report, PAIN IN EXTREMITY (Caller's friend had a sore arm) and HEADACHE (Caller's friend had intense headache after receiving vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
vaccination adverse reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (vaccination adverse reaction) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) capsule for Chronic lymphocytic leukemia.    No Medical History information was reported.   On 28-Feb-2019, the patient started IBRUTINIB (IMBRUVICA) (Oral) 140 milligram three times a day. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (vaccination adverse reaction) outcome was unknown.        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.   No concomitant medications were reported. No laboratory details were  provided. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow up information  received on 24-May-2021 contains non significant information. Possible NNI. On 28-May-2021: No new information provided.
6 month old was vaccinated with Kinrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 5-month-old female patient who received DTPa-IPV (Kinrix) (batch number 24T2N, expiry date 7th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th April 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 6th April 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 18-Aug-2022 Reporter's Comments: The nurse reported that the 6 months old patient was vaccinated with Kinrix.  The reporter consented to follow up. Additional Supportive Information: The patient received a dose of Kinrix at inappropriate age, which led to inappropriate age at vaccine administration. As per reported information, 6 months old patient received Kinrix but in system it was auto calculated as 5 months therefore auto calculated one was captured in structured field.
following the admin of DT pt had inc temp & very listless for 1 wk;
never received the second dose; This case was reported by a other health professional via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st vaccine on an unknown date more than a year ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting the patient did not receive second dose , which led to incomplete course of vaccination. The health care professional enquired that do the patient just need the second dose have to redo the two shots series again.
Client presented for 1st dose of Moderna vaccine today, and told the vaccinator that he has a history of anxiety and feeling faint with vaccinations. The patient presented to the post-vaccination observation area and requested water and juice. Patient reported not feeling well and feeling faint. Was continually observed and offered fluids and support. Patient never lost consciousness. Patient stated felt "much better" and was educated on future mitigation strategies for vaccination anxiety. Patient was able to sit and stand of own accord without assistance, and patient's friend stated he would drive the patient home. Patient left of own volition.
pt recv vax 8NOV96 & 11NOV96 pt devel 6 papular vesicles on lt side of chest, abd & back;no fever was noted;by 15NOV96 vesicles dried up & disappeared
fatigue; headache; violent vomiting; A spontaneous report was received from a consumer concerning a 64-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fatigue, headache and vomiting (violent vomiting).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 7 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 016M20A) through unknown route in the left arm for prophylaxis of COVID-19 infection.  On 8 Feb 2021, the patient experienced headache, violent vomiting and fatigue.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events was unknown.
2/5/21 2nd Pfizer COVID vaccination ~1050.  Began to feel nauseous, headache, increased BP.  She had these symptoms with 1st dose also.  Was given acetaminophen 500mg po x 1 at 1100.  During observation the headache began to resolve.  Tends to get nauseated/car sickness and is currently on Prilosec.  Placed on pulse oximeter and vital signs monitored.  Symptoms are resolving during observation period and a friend is picking her up so she does not need to drive and friend will observe her the rest of the day.