chrisvoncsefalvay/vaers-outcomes huggingface dataset:
High Fever; chills; chest pains; This is a spontaneous report from a contactable consumer (patient's mother). A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via unspecified route of administration, on 02Mar2021 at 11:00 AM, as dose number unknown, single for COVID-19 Immunization. The patient medical history and concomitant medications were not reported. On an unknown date (reported as: this morning), the patient was not feeling well with high fever and chills. The patient said he's having some chest pain when he takes a breath it kind of hurts. The reporter stated that she knows that was the part of the side effects. The one side effect that the patient having, and she was concern about chest pain because she was not sure if it was normal cause, or she haven't heard anything about it. The outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Headaches 3-4 days continuous, sore muscles (upper back). Took Excedrin 1 x daily for headaches, usually in the afternoon.
Swelling on the joints; Sore arm; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and JOINT SWELLING (Swelling on the joints) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 15-Jan-2021, the patient experienced JOINT SWELLING (Swelling on the joints). The patient was treated with IBUPROFEN ongoing since an unknown date at a dose of 1 dosage form. On 15-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, JOINT SWELLING (Swelling on the joints) outcome was unknown. Not Provided      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.
Patient received incorrect dose after CDC discontinued monovalent dose.  Patient given Moderna Bivalent Pink Cap/yellow label 0.2ml/10ug. Should have received Moderna Bivalent Blue cap/gray label 0.25ml/25ug.
Anovulatory cycle (trying to conceive since 8/2020 & track ovulation with ovulation test strips) & menstration changes  (very short / light period)
A MEDICAL ASSISTANT  ADMINISTERED A PRESYRINGED VACCINE  TO THIS PATIENT, THEREAFTER PICKED THE EMPTY SYRINGE SHE HAD JUST ADMIN ISTERED  TO THE PATIENT AND INSERTED THE NEEDLE WITH NO VACCINE IN IT AGAIN THINKING SHE WAS PICKING UP PREVNAR THEN REALISED IT WAS EMPTY. SHE THEN BROUGHT OUT THNEEDLE WITHOUT INJECTING ANYTHING. MOM REALISED IT AT SAME TIME GOT UPSET AND REFUSED TO CONTINUE TO GIVE THE PREVNER.
4 days after the vaccine she had significant worsening of her chronic tinnitus - still ongoing months later.  Was previously mild and intermittent.
Expired vaccine administered more than 12 hours post puncture for 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered more than 12 hours post puncture for 2nd dose) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033H21A and 059H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2022 at 12:40 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jan-2022 at 12:40 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered more than 12 hours post puncture for 2nd dose). On 20-Jan-2022 at 12:40 PM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered more than 12 hours post puncture for 2nd dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drugs were reported.   It was reported that the vial was initially stored in refrigerator on around 09-Jan-2022 and was first punctured on 19-Jan-2022 at 08:50 AM. The patient received expired vaccine beyond 12 hours post puncture on 20-Jan-2022 at 12:40 PM. The vial was stored at room temperature post puncture and did not undergo any temperature excursions. The vial was exposed to room temperature for 28 hours.  No treatment drugs were reported.
Have a pericardial cyst as it is; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERICARDIAL CYST (non-serious), outcome "unknown", described as "Have a pericardial cyst as it is".  Additional information: It was reported I am 42 and have a pericardial cyst as it is.  Follow-up (03Feb2022): 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 completed. No further information is expected.
11/13 discharge cancelled d/t elevated temp - 101.6 to 103.3 after TYLENOL and chills which occurred after receiving influenza and pneumococcal vaccine. 11/14 c/o soreness where she had her vaccine, in her left shoulder. Improved with warm soaks but sore. Temp 99.4. 11/16 left shoulder tenderness improved but erythema is increased on left shoulder. Rt. shoulder erythema and itchiness but no pain or tenderness (site of influenza vaccine. Left deltoid, ecchymotic area which was slightly dark in center at vaccination site. Too tender to deep  palpitation but no drainage or odor.
throwing up all night, vomiting; massive headache; diarrhea; constipation problems; This is a spontaneous report from a contactable consumer (parent). A 33-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number: EN5318, Expiry Date: unknown), via an unknown route of administration on 04Feb2021 (at the age of 33-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patients medical history was none. Concomitant medication was not reported. On 10Feb2021 (wednesday), the patient started having constipation problems, sometimes this happens, and she would take a stool softener or laxative and everything was fine. She did have little bit of diarrhea through the weekend but mainly the onset was on the 14Feb2021 but mainly right now she was throwing up on 15Feb2021. It was confirmed that patient received vaccine they were 11 days out and she had been throwing up since last night. She said medical information was not any help only had it happening about 7 days out. The vomiting and massive headache began 15Feb2021. She also had a massive headache that she started complaining about yesterday. The outcome of the event throwing up all night was not recovered. The outcome of the event constipation problems was recovered on an unknown date in 2021; while the outcome of the remaining events was unknown.  No follow-up attempts are needed. No further information is expected.
Dizziness, dry mouth, excessive thirst. Fatigue. Headache.  Still ongoing since 04/06/2021
pt recvd vax; 1 wk began having cough;2 wks later cough  much worse;saw MD,dx: bacterial bronchial infect & prescribed ATBs;
Fluzone Quad had given to a patient yesterday that was invalid, due to delay in shipping time, no AE; Fluzone Quad had given to a patient yesterday that was invalid, due to delay in shipping time, no AE; Initial information received on 12-Nov-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2019SA317566, 2019SA320727, 2019SA320730, 2019SA320731 and 2019SA320729 (same reporter).  This case involved a 15 year old male patient who received a dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number-UJ3058A, Expiry date- 20-Jun-2020) via an unknown route in an unknown administration site on 11-Nov-2019, which was delay in shipping time.  Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant drug were not reported.   It was a case of actual medication error due to incorrect product storage and product shipment delay. Vaccine was invalid due to prolonged shipping time.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Injection sight warm to touch; pain at injection sight; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6203, expiration date not reported), via an unspecified route of administration, administered in the right arm on 11Mar2021 13:00 (at the age of 55-years-old), as first dose, single dose for COVID-19 immunisation. There was no pertinent medical history. Patient has no known allergies. Concomitant medications included lisdexamfetamine mesilate (VYVANSE); venlafaxine hydrochloride (EFFEXOR); atorvastatin (LIPITOR [ATORVASTATIN]); lisinopril; omeprazole (PRILOSEC [OMEPRAZOLE]), all taken for an unspecified indication and start and stop dates were not reported. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced injection sight warm to touch (for 1 day) and pain at injection sight (for 2 days) on 11Mar2021 16:00. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 30Nov2020. No treatment was received as a result of the events. Patient did not seek consult to physician or urgent care. The outcome of vaccination site pain was recovered on 13Mar2021 and vaccination site warmth was 12Mar2021.  No follow-up attempts are possible. No further information is expected.
Approx 18 hours after vaccination site of injection swelled became red and hot and sore. It is from my upper shoulder down to my elbow and almost all the way across my arm - big area.  Using a thermometer it reads 103.5 degrees.  After 36 hours my fever went down but my arm is still the same 3 days later.
admitted with cardiac arrest from STEMI, emergent stenting, intubated in the ICU, hypothermia protocol, acute hypoxic respiratory failure, required IABP.  acute blood loss anemia due to retroperitoneal bleed during the same hospitalization.
right arm from shoulder to elbow got swollen; right arm from shoulder to elbow got hot; right arm from shoulder to elbow got red; right arm from shoulder to elbow got tender; right arm from shoulder to elbow got itchy; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (right arm from shoulder to elbow got swollen), FEELING HOT (right arm from shoulder to elbow got hot), ERYTHEMA (right arm from shoulder to elbow got red), TENDERNESS (right arm from shoulder to elbow got tender) and PRURITUS (right arm from shoulder to elbow got itchy) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concomitant products included CYCLOBENZAPRINE HYDROCHLORIDE (FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]) and OXYBUTYNIN HYDROCHLORIDE (OXYBUTIN) for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced PERIPHERAL SWELLING (right arm from shoulder to elbow got swollen), FEELING HOT (right arm from shoulder to elbow got hot), ERYTHEMA (right arm from shoulder to elbow got red), TENDERNESS (right arm from shoulder to elbow got tender) and PRURITUS (right arm from shoulder to elbow got itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (right arm from shoulder to elbow got swollen), FEELING HOT (right arm from shoulder to elbow got hot), ERYTHEMA (right arm from shoulder to elbow got red), TENDERNESS (right arm from shoulder to elbow got tender) and PRURITUS (right arm from shoulder to elbow got itchy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient reported the events lasted for over a week.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 14-OCT-2015 13:43, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 5.0 and 0.7 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
A non-serious spontaneous report of inadvertently given half dose of H1N1 was received from a nurse/health professional concerning a 38-year-old female. The patient's medical history and concomitant medications was not reported. On 27-Oct-2009, the patient was inadvertently given half dose of H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Low grade temp (98.8), chills and headache. The symptoms were gone the morning of 3/8 when I woke up
27 YO FEMALE - 26.4 EGA - COMPLAINED OF PAIN AND SWELLING 3 DAYS AFTER THE INJECTION - COMPLAINED THAT IT SEEMED TO BE GETTING WORSE -  SPOKE WITH PRESCRIBING PHYSICIAN'S OFFICE AND THE ADVISED THE PATIENT TO US ICED PACKS AND TAKE TYLENOL.
Headache, Myalgia, Fever, Nausea Vomiting, FATIGUE; ARM PAIN Narrative:
Fever, chills, sweating, fatigue, headache -48 hrs  Muscle aches, fatigue, brain fog - still happening since
Neuropathy and tingling in my hands and feet as well as fatigue.  I had a physical in May 2021.  Who suggested I take vitamin b12 to help w/ neuropathy.  In December I went to a neurologist who determined I may have sjogren's  disease.  I then saw a rheumatologists who confirmed the diagnosis
Suspected vaccination Failure; shingles; This case was reported by a pharmacist via call center representative and described the occurrence of suspected  vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received 3 years before the time of reporting).   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, 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 Shingrix and Shingrix.  Additional information was reported as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. Last year, the patient completed a series of Shingrix. In 2019, the patient had a shingles outbreak. The reporter did not have any patient details to provide or dates of vaccination. This case was considered as suspected vaccination failure as details regarding, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
This spontaneous report as received from a pharmacy technician refers to a patient of unknown age. On 02-JUN-2014, the patient was vaccinated with GARDASIL (dose, route and lot # not provided) that was improperly stored. The product was supported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, since the reporter does not want to be contacted.
Area of redness, swelling, and pain approximately 6" x 3" lasting for 1 week. No treatment.
Chills, fever 101.5 degrees, exhaustion, sense of extreme sickness, anorexia but no nausea. The acute phase lasted about 14 hours & symptoms disappeared in about 18 hours. Treatment: I went to bed with electric blanket on high.
fever; This is a spontaneous report from a contactable consumer or other non hcp. A 13-years-old female patient received BNT162b2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for injection, Lot No: was not reported), via an unspecified route of administration on 12Jul2021 as dose 2, single for covid-19 immunisation. The patient previously received first dose of BNT162b2(Pfizer-BioNTech Covid-19 Vaccine, Solution for injection, Lot No: was not reported), via an unspecified route of administration on unspecified date as 1stdose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced fever on an unspecified date.  Therapeutic measures were taken as a result of fever. Patient parents want to confirm about the patient had a fever around 3am last night and his wife gave her acetaminophen on the bottle it says to give 2 for people over 12 years old, but his wife only gave her one, should she have given her 2 and it is ok to give Tylenol. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Severe radiating arm pain during injection of Hep A vaccine booster. Pain radiated through out the arm that was injected, and I felt faint after injection. Nurse mentioned that she had a hard time (had to press hard) to inject a full cc of vaccine in arm. I had to lie down for a few minutes to get my arm feel less pain. Shoulder pain started approximately one hour after I was sent home. Limited range of lifting my left arm. Pain got worse, and at 14 hours post vaccination, pain grade is 9/10 and arm cannot be lifted without severe pain. The injection point is high (1-2cm below shoulder joint). Pain keeps me from sleeping. Very anxious about current status.
Sore throat; Very tender lymph node under right arm; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 15Apr2021 at 14:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high, ADD (attention deficit disorder), eczema, COVID-19 and sulfonamide allergy. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included methotrexate (MANUFACTURER UNKNOWN), olmesartan medoxomil (BENICAR) and amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) all for unknown indication from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 25Mar2021 at 14:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Apr2021 at 07:00, second day after injection, the patient experienced sore throat and very tender lymph node under right 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore throat and very tender lymph node under right arm were not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
CMA was mixing a new vial of the Pfizer Covid Vaccine with the diluent.  After giving the medication to the patient it was discovered that there wasn't any vaccine left in the vial.  CMA had consulted with 3 other staff members prior to dilution that she was using the correct process.  After the discovery of the empty Vaccine Vial we walked through the steps she took again.  We extracted the remaining diluent from it vial and there was 1.5 mls left.  There should have only been 0.2 mls left.  What we believe happened was when she first punctured the diluent vial the pressure from the inside of the vial pushed the plunger up and she continued to pull back on the syringe not realizing it was mostly full of air.  She mixed only 0.5 ml into the medication vial.  When she drew up the 0.3 ml  dose it was actually 6 times the dosage the patient should have received.  There was only 0.1 ml of medication left in the Pfizer vial.
Severe headache, history of seizures-headache before and after seizure according to mom. Became very sleepy and tired. Observed and vital signs checked. 10:40. home with mom. To call PCP or ER if further problems.
Experienced weakness of the left arm. He was unable to lift his arm.  On 10/14/99, the strength in his left arm started to return.
This case was reported by a other health professional via call center representative and described the occurrence of allergic reaction in a 57-year-old female patient who received Influenza vaccine. Concurrent medical conditions included latex allergy. In 2013, the patient received Influenza vaccine. On an unknown date, an unknown time after receiving Influenza vaccine, the patient experienced allergic reaction (serious criteria life threatening). On an unknown date, the outcome of the allergic reaction was recovered/resolved. It was unknown if the reporter considered the allergic reaction to be related to Influenza vaccine. Additional details: The name of the flu vaccine (Lot/expiry date) and the manufacturer's name were unknown. The dosage given was unknown. Date vaccine was given was unknown. The reporter was unaware if other vaccines were given. The date of adverse event was unknown. The time frame after receiving vaccine and start of allergic reaction was unknown. Per the reporter, the patient was told the allergic reaction was to latex being on the syringe. It was unknown if the patient was hospitalization.