chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative:  Patient received Moderna COVID-19 vaccine on 3/22/21. Patient tested positive for COVID-19 and was admitted to ICU at outside facility on 4/13/21 due O2 Sat 58% on 4 L. Patient was treated in ICU for COVID-19 pneumonia and passed away on 4/28/21.
Information has been received from a healthcare worker from a physician's office concerning an 8 week old (10lbs., 6oz., 21.25 in) female with no pre-existing medical conditions or allergies who on 14-APR-2008 at 14:45 was vaccinated PO with her first dose of ROTATEQ (lot# 659773/0020X).  There was no illness at the time of vaccination.  Concomitant vaccinations administered on that same day at 14:45 included the first dose of PREVNAR (lot# C49920) in the lower left thigh, the first dose of PEDIARIX (lot# AC21B139AA) in the right thigh and the first dose of ACTHIB (lot# UF241AC) in the upper left thigh.  On 15-APR-2008 in the evening, the patient experienced shock-like syndrome, collapse, hypotonic, unresponsive, lethargic and pale and was hospitalized for 2 days.  Laboratory diagnostic studies included a CBC, CDD, pneumogram and BMP.  Subsequently, the patient recovered.  It was also noted that the baby's grandmother (WAES# 0805USA00049) and mother (WAES# 0804USA05564) experienced rotavirus after the baby received ROTATEQ (lot# 659773/0020X).  Shock-like syndrome, collapse, hypotonia, unresponsive, lethargic and pallor were considered to be immediately life-threatening by the reporter.  A lot check has been initiated.  Additional information has been requested.
Itchy, redness and swelling noticed on 02/18/2003 at 8pm, with fever (felt and looked hot). Tylenol given. Fever and pain decreased.
Acute bowel obstruction due to irreducible intussusception, required surgery at hospital. Tissue samples sent to CDC Atlanta for testing. Child recovered and discharged home on 5/28/08.  6/24/08 Reviewed hospital medical records of 5/24-5/28/2008. FINAL DX: bowel obstruction secondary to nonreducible intussusception Records reveal patient had been transferred from outlying ER.  Patient experienced bilious vomiting x 2 days, acute blood per rectum, abdominal tenderness & distention.  Emergent laparotomy for abdominal exploration, ileal resection w/primary anastomosis, appendectomy & CVP placement.  Did well post operatively, tolerating oral feeds well & d/c to home
Left arm was very sore; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hashimoto" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; ADVASTAT. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Left arm was very sore". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity.  Additional information: Facility where the most recent COVID-19 vaccine was administered:Pharmacy or Drug Store. Pfizer vaccine was administered on 28Sep2021 (Lot number: FF839) in left arm. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received hydrochloride 12.5 mcg within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient was tested for COVID-19. Device Date: 30Sep2021.  Follow-up attempts completed. No further information is expected.
no adverse event; Expired dose of Varivax administered; This spontaneous report was received from an officer manager, referring to a patient of unknoen age and gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 16-NOV-2021, the patient was vaccinated with an expired varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 ml. subcutaneously, lot# S033539, expiration date 22-OCT-2021, for prophylaxis (strength and frequency were not reported) (expired product administered). No additional adverse event reported.
Initially soreness, then warmth and swelling, then continued warmth, by Thursday PM a blister occured with continued warmth, tenderness, and a knot beneath skin.  By Saturday, multiple blisters and decreased warmth and swelling.
flushing, lightheadedness, increased confusion, significant increase in weakness resulting in a fall twice.
Bleeding, Black and Blue, it is 10 days later and I'm still black and blue.
pt recv vax 9JUN95 & devel varicella lesions on back, abd, chest, axilla & face on 19JUN98;
Patient was about 3-4 weeks pregnant at the time of second vaccine dose. She subsequently had a miscarriage which started with vaginal bleeding on May 30th in the evening.  Prior to this miscarriage, she had 2 gestations which resulted in 2 full term uncomplicated deliveries.
My menstrual cycle came back after receiving dose 2 of the Pfizer COVID-19 vaccine. I went to see my OBGYN regarding the adverse event and no tests were required.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. Since 08-JUL-2015, the patients were vaccinated with unknown doses of PROQUAD (Merck) (route was not reported, lot # L007228, expiry date: 03-SEP-2015), which were exposed to temperatures outside of the recommended range. Concomitant medications were not reported. No adverse experience was reported. This is one of several reports received from the same reporter. Additional information has been requested.
sick; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via Global Digital Media through social media on 30-Nov-2020.   This case involves a patient of unknown demographic who had (illness) , while the patient was treated with  INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), concomitant therapy, past vaccination(s) and family history were not provided.  On an unknown date, the patient received suspect Influenza Vaccine produced by unknown manufacturer (lot number and expiry date not reported) at an unknown dose via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date (latency: unknown) after starting the suspect vaccine therapy, the patient had sick (illness) for three days  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of the reporting , event outcome was unknown .  There will be no information available on batch number for this case .
Erythematous skin patch on the (R) upper thigh with minimal induration, size of a baseball, without any distinctive rash elements, well demarcated; appeared 8-10 hr after injection of MMRV vaccine; enlarged in 24 hr, non-itching. No fever or constitutional sx. TYLENOL as needed for pain. Traced margins, f/u in 2 days or earlier as needed.
injection site soreness; This is a spontaneous report from a contactable consumer. A 79-years-old male patient received BNT162B2 (COMIRNATY, formulation solution for injection) via an unspecified route of administration on 27Jan2021 20:30 (Batch/Lot number: Unknown) as single dose for covid-19 immunisation.The patient medical history and concomitant medications were not reported. It was reported that no underlying Heath conditions. Patient in good overall health. On 28Jan2021 8:00 the patient experienced injection site soreness. The event was considered as non-serious by reporter. The outcome of event was unknown. The action taken in response to the event for bnt162b2 was not applicable.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Narrative: COVID infection following COVID vaccine series 02/18, Pfizer, dose# 1 03/11, Pfizer, dose #2 08/28 pt cc: cough, fatigue, myalgias, sore throat, fever, headache, loss of taste or smell exposure: unknown 08/28 COVID swab, result: detected 08/28 pt admit ED cc: Cough and headache dx: COVID 19 LOS: 1 08/28 CXR impression: Clear lungs. 08/28 SARS-COV-2 Variant Sequencing result: pending 09/08 pt. admit ED cc; sore throat dx: COVID 19 LOS: 1
74 y/o WF with PMHx including fibromyalgia, chronic back pain/DDD, etc., referred to the ER from the Infusion clinic due to low SpO2.  She was diagnosed with COVID on 8/2 at her PCP's office.  She has felt progressively worse -- noting SOB, cough, myalgias, and weakness -- since about 8/1.  She was vaccinated in March 2021 (received both Pfizer vaccines at Pharmacy).  She had presented today to receive Regeneron infusion; however, she was noted to be tachypneic.  SpO2 there was 81% on room air.  She was sent to the ER for evaluation.  ABG noted hypoxemia with PO2 45.  She was placed on 3 L supplemental oxygen with improvement of her SpO2 -- she is not on oxygen at baseline.  CXR consistent with viral pneum  74 y/o WF with PMHx including fibromyalgia, chronic back pain/DDD, etc., referred to the ER from the Infusion clinic due to low SpO2.  She was diagnosed with COVID on 8/2 at her PCP's office.  She has felt progressively worse -- noting SOB, cough, myalgias, and weakness -- since about 8/1.  She was vaccinated in March 2021 (received both Pfizer vaccines at Pharmacy).  She had presented today to receive Regeneron infusion; however, she was noted to be tachypneic.  SpO2 there was 81% on room air.  She was sent to the ER for evaluation.  ABG noted hypoxemia with PO2 45.  She was placed on 3 L supplemental oxygen with improvement of her SpO2 -- she is not on oxygen at baseline.  CXR consistent with viral pneumonia and emphysematous changes/COPD.  She denies a history of COPD, never smoker, no secondhand exposure, etc.  Not on inhalers at baseline.  Labs noted leukocytosis, normocytic anemia, thrombocytosis, hypokalemia.  With concern for COVID pneumonia, she was admitted to the inpatient service for continued workup and management.  She was admitted to the COVID step-down unit and started on dexamethasone and remdesivir.  We noted interval clinical improvement, fortunately.  Her oxygen requirement was titrated down to 2 L.  She qualified for home oxygen and case management made these arrangements.      Patient was found to have microcytic anemia.  She denied any known history of anemia and also denied any abnormal bleeding or bruising.  We tried to obtain a Hemoccult but no sample was provided.   Of note, she already had an appointment with physician later this month for a diagnostic colonoscopy.  We strongly recommended that the patient follow up with this appointment.  Emphysematous changes were also noted on the patient's imaging.   She had no known history of COPD and was a lifelong nonsmoker.   She denied any smoking exposure, either.  We recommend continued outpatient surveillance.   She should continue to follow-up with her nephrologist regarding her CKD.
Feeling of warmth similar to contrast. Lightheaded.  Nausua in waves. Started 15 minutes after shot. Worst side effects after shot 1. Allegra helped at shot 2. Bad side effects, Lightheaded,  increased heart rate feeling very hot and nervous lasted for about 2 to 3 weeks after shot 1. After sbot 2 , I am still taking Allegra, wen I forgot same side effect as from dos 1 occurs.
About 12 hours after receiving the vaccine I had chills, then about 12:00 AM fever of 99, about 1:30 AM it was 101.7 and about 3:30 AM  101.8. I had a terrible headache, it was really bad. I had muscle aches. Yesterday my temperature about 101, I slept most of the day. I stay in bed all day yesterday. I felt lethargic.  I felt like I was ran over by the truck. Last night my temperature broke, this morning  I have an sore arm at injection the site. I had a bad pain in groin that goes into my lower back. I took 2 Tylenol this morning.  I did call and report my  symptoms to my doctor's office.
Pt put to bed @ 9PM; woke @ 1030PM w/high pitched scream which lasted until 330AM; Appeared incoherent, wouldn't look @ mom, t102 ax;
Developed left supraclavicular swelling 4 days after vaccination.  Developed tender swelling at injection site the day after injection.
This case was previously received from a medical assistant considered non-valid as there was no patient identity on 31-MAY-2018. Follow up information has been received from a medical assistant during a phone call on 30-OCT-2018. The phone call was answered by the receptionist and transferred to the medical assistant. This spontaneous report refers to an 8 weeks old female patient. Information of concurrent condition, medical history and concomitant therapy was not provided. On 03-MAY-2018, the patients were vaccinated with improperly stored doses of ROTATEQ (dose, strength and frequency were unknown, lot # N022008, expiry date 18-FEB-2019) orally for prophylaxis. No adverse effects reported. The administered doses of ROTATEQ underwent a temperature excursion between 9 and 25 Celsius degrees for 1 hour. There was no previous temperature excursion. Data Logger was involved. This is one of the four reports received from the same reporter. Sender's Comments: US-009507513-1811USA001370: US-009507513-1811USA001371: US-009507513-1806USA000270.
Facial flushing within 5 minutes of injection; resolved in 2 hours. Took Benadryl 25 mg.; This is a spontaneous report from a contactable consumer (patient). A 69-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: EN5318, Expiration Date was not reported), via an unspecified route of administration, administered in right arm on 05Feb2021 13:00 (at the age of 69-year-old) as 1st dose, single for covid-19 immunisation at hospital. The patient medical history included cardiomyopathy (resolved), breast cancer (hx breast cancer), blood cholesterol increased (high cholesterol), arthritis from an unknown date and unknown if ongoing. The patient does not have any allergies. Concomitant medications included atorvastatin, zolpidem tartrate (AMBIEN); omeprazole (PROTONIX [OMEPRAZOLE]); escitalopram oxalate (LEXAPRO). No other vaccine received in four weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not tested positive since the vaccination. On 05Feb2021 the patient experienced, facial flushing within 5 minutes of injection; resolved in 2 hours. Took Benadryl 25 mg. Therapeutic measures were taken as a result of facial flushing within 5 minutes of injection; resolved in 2 hours. took benadryl 25 mg. No treatment received for AE (as reported). The outcome of the event was reported as recovered on 05Feb2021.  Follow-up attempts are completed. No further information is expected.
8/28/21 developed symptoms of weakness, fatigue, body aches, and fevers.  Fully vaccinated. given IV fluids, supportive cares for at home return if 02 levels drop.
fist dose - November 6 2020 / second dose - November 9 2020; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 76-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included Men B NVS (Bexsero).   On 9th November 2020, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 9th November 2020, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short 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 details were provided as follows: Nurse reported that a male patient received a 2nd dose of Bexsero outside recommended schedule which led to drug dose administration interval too short. No know side effect was reported. The reporter consented to follow up.
6 hours post vax, the pt experienced vomiting, which lasted into the evening. He spiked a fever of 101.0. Mom called the pediatrician to report illness.
congestion; sneezing; Original symptoms (fever, chills, cough) started 28Apr Positive Covid test; Original symptoms (fever, chills, cough) started 28Apr Positive Covid test; Original symptoms (fever, chills, cough) started 28Apr Positive Covid test; Original symptoms (fever, chills, cough) started 28Apr Positive Covid test; Original symptoms (fever, chills, cough) started 28Apr Positive Covid test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm and in May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), in Dec2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Pfizer, vaccine dose number=2; pfizer vaccine dose number=1; Moderna dose number=unknown" (unspecified if ongoing), notes: Pfizer, vaccine dose number=2; pfizer vaccine dose number=1; Moderna dose number=unknown. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 28Apr2022, outcome "unknown", PYREXIA (non-serious), CHILLS (non-serious), COUGH (non-serious) all with onset 28Apr2022, outcome "recovered" (05May2022) and all described as "Original symptoms (fever, chills, cough) started 28Apr Positive Covid test"; COVID-19 (medically significant) with onset 29Apr2022, outcome "unknown", described as "Original symptoms (fever, chills, cough) started 28Apr Positive Covid test"; NASAL CONGESTION (non-serious) with onset 07May2022, outcome "recovering", described as "congestion"; SNEEZING (non-serious) with onset 07May2022, outcome "recovering". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Apr2022) Positive; (06May2022) Negative; (07May2022) Negative; (08May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures were not taken as a result of nasal congestion, sneezing, pyrexia, chills, cough. Clinical course included After completing the 5-day course of Paxlovid and testing negative 2 days in a row, symptoms returned and patient tested positive again. No allergies reported.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Moderne COVID-19 Vaccine EUA I got the vaccine in the morning 1/11/21 at approximately 8am and that night around 10pm felt really bad body/muscle aches and chills.
Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was GI hemorrhage.
Information has been received from a pharmacist who reported that on 24-AUG-2012, a patient was administered "the entire contents of a multidose vial of PNEUMOVAX 23". No adverse experiences were reported. No further information was provided. Additional information has been requested.
Hives and swelling began 11/2/22 and were progressively more severe. Angiodema caused swelling in airway, lips, hands and feet
suspected vaccination failure; now has shingles; This case was reported by a consumer via 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.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient's friend. The age at vaccination was not reported. The patient received the dose of Shingles vaccine and had shingles. The reporter stated that a shot was not a guarantee you would still get but not as bad. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Nausea, dizziness, weakness, extremely dry mouth, severe pain in right arm. Symptoms lasted approximately 12 hours.
Patient did not seek medical treatment yet. Stopped in pharmacy on way to work to show adverse reaction. No other reactions aside from local redness/swelling around injection site so far. Patient was instructed to seek medical attention if rash worsens or other side effects are experienced.
12-26-20 10:00PM patient began to have severe body aches, chills, neck and back pain. Pain continued through the night and remained severe all day 12-27-20. Temp 99.8 all day Sunday. Patient says body aches are better Monday, 12-28-20 but feels "sore" all over like "I have been run over by a truck".
10 days after vaccine #1 developed papulovesicular, pruritic, scattered lesions of extremities, right axillary, & right medial thigh, and flu-like feeling of malaise & fatigue. Today, given 10 mg of claritin orally.
Headache; Fever; Nausea; Dizziness; Fatigue; This is a spontaneous report received from a contactable nurse, the patient. A 22-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EK9231), via an unspecified route of administration in the left arm on 06Jan2021 at 18:15 (at the age of 22-years-old) and a second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL8982), via an unspecified route of administration in the left arm on 27Jan2021 at 18:15 (at the age of 22-years-old), as single doses for COVID-19 immunisation. The patient's medical history included anxiety, depression, eczema, and orthrexia. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included buspirone (MANUFACTURER UNKNOWN), bupropion (MANUFACTURER UNKNOWN), loratadine (MANUFACTURER UNKNOWN), TRI ESTARYLLA, all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 28Jan2021 at 06:00, the patient experienced headache, fever of 102 degrees Fahrenheit, nausea, dizziness and fatigue. The patient did not receive any treatment for the adverse events. The clinical outcome of the events headache, fever, nausea, dizziness and fatigue was recovered.   No follow-up attempts are needed. No further information is expected.
Headache Fever Chills /Sweating profusely Pale/Could not stand Nausea /Vomiting  Burning in stomach/intestines  Burning in legs  Loss of bladder sensation
Hard lump at injection sight. Raised and red like a rash. There is some itching as well.
From initial information received on 15Dec03 from a physician regarding an adverse event occurring, it was reported that a 12 year old female pt received a dose of Fluzone SV 2003-2004 USP, lot number U1127AA, administered IM in the right deltoid on 12Dec03. Within 24 hours, the pt developed a fever of 105 degrees F and flu like symptoms. The pt was given Tamiflu and Tylenol as treatment. Reportedly, she recovered from these events. The reporter of this case is the same reporter of case 2003-03399.