chrisvoncsefalvay/vaers-outcomes huggingface dataset:
70 year old female complaining of headache ,nausea.No chest pain or SOB.BP 110/72, Pulse 74 Pulse ox 98%.Patient has not taken any oral fluids or eaten since last night .Pt started feeling better with being reassured and resting.Feels comfortable going home.advised to increase oral fluids and eat well in the next 24-48 hours.
NOT MUCH REACTION; This spontaneous report received from a patient concerned a 63 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 (Dose number in series 1) (suspension for injection, route of admin and batch number were not reported) dose was not reported, 1 total, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in MAR-2021, following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series was 1), the patient had not much reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of not much reaction was not reported. This report was non-serious. This case, involving the same patient is linked to 20211259371 (Dose number in series 2 case).
Vaccinated-1005 immediate-stomach crampy, injection site itchy BP 90/60 headache. Rest-home with mother. Mom reports felt fine by noon.
Muscle aches, lymph node swelling all over body, rash all over body, fatigue, pain under arms and in groin area.
fever, chills & arthralgia & myalgia p/2nd & 3rd dose in series;
Patient noticed pain at injection site 24 hours post injection. Redness, swelling about 1.5" diameter; grew to about 3" diameter within about 48 hours. Pt took BENADRYL and went to Urgent Care 48 hours after shot. MD prescribed Z-pak.
The pt experienced swollen upper right arm from deltoid to mid arm, which was hot to the touch.
Low grade fever started at 2 a.m. of 100.9 and continued for 12 hours.  On 3rd day, in early hours, woke up with pain, swelling and soreness of neck area below jawline on right side.  Tenderness and soreness seems to be going down on 4th and 5th day.  Swelling is same on 6th day with soreness and tenderness.
Initial information received on 01-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 25 months (also reported as 2 years) old male patient received a dose of vaccine PENTACEL on 26-Feb-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); VARICELLA ZOSTER VACCINE (VARICELLA VACCINE); and PREVNAR. On 26-Feb-2019, the patient received a 4th dose of suspect 0.5 ml DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (Liquid vial: Lot: U6216AA and expiry date: 30-Sep-2019, Lyophilized Powder: Lot: UI989AC Expiry date:30-Sep-2020 and Package: Lot:UI989ACA Expiry date: 30-Sep-2020) via unknown route in right vastus lateralis. It was a case of actual medication error due to extra dose administered. Nurse reported that Pentacel was given to a 2 year old male on 26-Feb-2019 and that he did not need the polio until 2021 and patient got an extra dose of the polio vaccine. No side effects were 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. List of documents held by sender: none.
About a day after shots, Mom feel hard area on patient's left upper arm. It is red and hard to the touch - 4" in diameter. Patient not c/o pain, has full mobility.
Pt had urticarial rash on upper extremities initially then to buttocks back and lower extremities. Vitals-stable. Playful. Given BENADRYL P.O. No progression of symptoms.
This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. A 66-years-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date (about 3 years before) at single dose in arm with 5/8" needle for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced severe swelling and pain at injection site and was hot to touch. Patient went to doctor and was prescribed Prednisone. The outcome of the events was unknown.
Right arm and shoulder has been hurting for the last week; Shoulder aches; Range of motion is limited in right arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Right arm and shoulder has been hurting for the last week), ARTHRALGIA (Shoulder aches) and JOINT RANGE OF MOTION DECREASED (Range of motion is limited in right arm) 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 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Right arm and shoulder has been hurting for the last week), ARTHRALGIA (Shoulder aches) and JOINT RANGE OF MOTION DECREASED (Range of motion is limited in right arm). At the time of the report, PAIN IN EXTREMITY (Right arm and shoulder has been hurting for the last week), ARTHRALGIA (Shoulder aches) and JOINT RANGE OF MOTION DECREASED (Range of motion is limited in right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment information not provided
no adverse event; administered an expired dose of PROQUAD; This spontaneous report was received from a nurse and refers to a 4-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies were not reported.   On 18-SEP-2023, the patient was vaccinated an expired dose of with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 milliliter, (lot #W006583 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date: 23-AUG-2023), administered as prophylaxis (strength, and route of administration were not provided) (expired product administered) that was reconstituted with albumin human (+) phenol (+) sodium chloride (STERILE DILUENT FOR ALLERGENIC EXTRACT) (not expired, concomitant medications). No temperature excursion (TE)s reported. No symptoms reported. No additional AE/PQC (no adverse event).
pt recvd vax 1OCT95 & few hrs later there was a numbing sensations;started @ inj site, the numbing sensation spread form rt side of body to let side, the numbing sensation was also affecting the rectal, vaginal, breast areas;saw MD
Pt informed on 4/27/15 ADE with flu shot on 10/14/14. Sometime in November noticed a knot with pus at site of injection which grew from the size of quarter to dollar coin. Received AMOXIL and then later AUGMENTIN on 1/26/15. Infx resolved but now left with black indentation size of quarter. Was told by MD that it could be infx due to flu shot but can't confirm.
Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and drug reactions/allergies were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored VARIVAX (dose, strength, frequency, lot# and route were not reported). No adverse effects were reported. This is one of several cases from the same reporter. Additional information has been requested.
Eight hours post injection very rapid of fever, severe headache, aches and nausea. At 12 hours, I awoke with HR above 150. After it not resolving within 5 minute, I went to the ER. Rate had gone down by arrival but EKG showed depressed ST waves.  By second EKG, two hours later., it looked normal.  I since have had bouts of a racing heart both during day and awaking from sleep.
Warm to the touch at the site of injection; Red sore knot at the injection site; Red sore knot at the injection site; Headache; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Warm to the touch at the site of injection), VACCINATION SITE INDURATION (Red sore knot at the injection site), INJECTION SITE ERYTHEMA (Red sore knot at the injection site), HEADACHE (Headache) and PYREXIA (Low grade fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 91M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced INJECTION SITE WARMTH (Warm to the touch at the site of injection), VACCINATION SITE INDURATION (Red sore knot at the injection site), INJECTION SITE ERYTHEMA (Red sore knot at the injection site), HEADACHE (Headache) and PYREXIA (Low grade fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INJECTION SITE WARMTH (Warm to the touch at the site of injection), VACCINATION SITE INDURATION (Red sore knot at the injection site), INJECTION SITE ERYTHEMA (Red sore knot at the injection site), HEADACHE (Headache) and PYREXIA (Low grade fever) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided.
T78.40XA ALLERGIC REACTION, INIT 3/4/2023 CHRONIC LOW BACK PAIN W LUMBAR RADICULOPATHY
Patient fainted for 3-4 seconds after receiving the Janssen vaccine. Patient fainted in chair, woke up after a few seconds. Per patient, has history of fainting (but not due to vaccines). Patient stated that she worked an overnight shift and had nothing to eat or drink all day.
Associate was started developing side effects on 1/20/21 -developed a migraine; 1/22/21-developed blurry vison; 1/25/21 - had an e-visit ; 1/26/21 - evaluated by her PCP referred to ophthalmologist; 1/27/21 - evaluated by ophthalmologist and referred to retina specialist as she had pressure behind her eye; 1/29/21 - retina specialist used laser to decrease pressure behind her eye.
Nerve pain in left arm starting under armpit and traveling down outside of arm into pinky finger began about 3 hours after vaccine and ramped up to extreme, debilitating pain by 12 hours after vaccine (8 to 9 out of 10).  Pain could shoot across left side of back if I moved at all. Pain was debilitating to the point of requiring me to remain as near motionless as possible for about 48 hours.  By Monday morning Nov. 7 pain reduced to 6 to 7 and I could push myself to go to work and prepare meals but it impaired my ability to think or sleep.  Doctor advised me to take 600 mg ibuprofen at a time but it had no effect on the pain so after several days I ceased taking the ibuprofen and used box breathing to help endure the pain.  Pain remained at 6 to 7 through Nov 12 (this was the last night I was woken up by pain). It has since gradually reduced to a 1 to 2 but there is now constant tingling along the line from my armpit into my pinky finger and there is noticeable new weakness in my left hand. I have not seen the doctor other than communication through chart due to her indication that there was nothing to be done for the pain but take ibuprofen - which has continued to have zero effect throughout this ordeal.
A non-serious, spontaneous report of aching, hot then cold, headache, nausea, sinus infection and stomachache was received from a consumer concerning a eight-year old female patient, subsequent to FLUMIST.  Consumer indicated there is no medical history and no concomitant medications.  The patient received FLUMIST on Wednesday, 24-Sep-2008.  Approximately two hours after dosing the patient experienced aching and headache.  The following morning the patient was seen in the doctors office and diagnosed with a sinus infection.  Later the same day the symptoms were reported as worse and the patient was prescribed CODEINE/acetaminophen, which barely took the headaches and aching away.  On Friday, 26-Sep-2008 the patient cried for hours and experienced stomachache, nausea and reported feeling hot then cold.  The patient was taken to the emergency room and the physician diagnosed her with having adverse side effects from FLUMIST and prescribed HYDROCODONE/acetaminophen just numbed the pain but did not make it go away.  The patient was taken back to the emergency room at a different hospital and blood work and a contrast MRI of the head to the abdomen were collected.  All results were normal and he said it must be some adverse reaction to FLUMIST.  The consumer stated she does not think the patient has a sinus infection.  Events of aching, hot then cold, headache, nausea and stomach ache are ongoing as of 03-Oct-2008.  The outcome of the event of sinus infection is unknown.  The reporter assessed the events as possibly related to FLUMIST. Required follow-up attempts have been performed, requested information unable to be obtained.
Information has been received from a medical assistant referring to a 4 years old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 05-JUN-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K016153 with expiration date 24-SEP-2016; dose and route of administration were not reported). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Expired ADACEL was given to patient. No reaction. CDC was contacted - they said to re-administer. Parent wants to wait. Expired 1-18-2014.
C/O "TINGLING PIN PRICKS" WITH SLIGHT ITCHING SENSATION, NO SOB, NO HEADACHES B/P 136/100 SYMPTOMS SUBSIDED 10 MIN. LATER
On 16-Dec-2021, moderna vaccine was pulled from freezer. On 26-Jan-2022, staff brought it to attention that it was still in the freezer and expired.; Expired dose had been given; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose had been given) and PRODUCT STORAGE ERROR (On 16-Dec-2021, moderna vaccine was pulled from freezer. On 26-Jan-2022, staff brought it to attention that it was still in the freezer and expired.) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2022 at 9:53 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 23-Jan-2022 at 9:53 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose had been given). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (On 16-Dec-2021, moderna vaccine was pulled from freezer. On 26-Jan-2022, staff brought it to attention that it was still in the freezer and expired.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose had been given) and PRODUCT STORAGE ERROR (On 16-Dec-2021, moderna vaccine was pulled from freezer. On 26-Jan-2022, staff brought it to attention that it was still in the freezer and expired.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  On 16-Dec-2021, moderna vaccine was pulled from freezer. Beyond use date was reported as 15-Jan-2022, which was printed in red and taped to the top of boxes. On 26-Jan-2022, staff brought it to attention that it was still in the freezer and expired. Total 5 doses had been given at that point. On 27-Jan-2022, remaining sites were checked. All other clinics found to have same error of not noticing the beyond use date. The date was then added to daily covid usage and wastage report. On 31-Jan-2022, moderna responded as revaccination was not required.  The patient was notified about medication error and she denied of any adverse events.  No treatment medication were provided.
Received Typhoid and Anthrax injection w/ subsequent rash to lower extremities after 7 days. Rash progressed to arms. Denied SOB or cough; afebrile. ER MD prescribed Triamcinalone 0.1% 4 times/day and Benadryl 50mg po every 6 hrs prn.
States about 4 hrs after receiving the vaccine, woke up with cough and "respiratory distress", could not lay down.  States she took ibuprofen and some cough syrup, had her husband observe her, was frightened and crying which made her respirations more difficult.  Was able to fall back asleep in a sitting position, slept about 3.5 more hours and now feels ok except for feeling general aches.  Denies any further respiratory symptoms, denies fever.
Gave them a full vial of the COVID Vaccine without diluting; Gave them a full vial of the COVID Vaccine without diluting; My oldest is currently in the hospital experiencing dizziness, nausea and her heart rate is up; My oldest is currently in the hospital experiencing dizziness, nausea and her heart rate is up; My oldest is currently in the hospital experiencing dizziness, nausea and her heart rate is up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A child female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT PREPARATION ERROR (hospitalization), OVERDOSE (hospitalization), outcome "unknown" and all described as "Gave them a full vial of the COVID Vaccine without diluting"; DIZZINESS (hospitalization), NAUSEA (hospitalization), HEART RATE INCREASED (hospitalization), outcome "unknown" and all described as "My oldest is currently in the hospital experiencing dizziness, nausea and her heart rate is up". The patient underwent the following laboratory tests and procedures: heart rate: heart rate is up. Clinical course: Patient had a nurse administer the wrong dose of vaccine to the child. She was supposed to dilute it, it was supposed to be something like 0.02ml and instead she gave them (as reported, not further specified) a full vial of the COVID Vaccine without diluting and the reporter's oldest was currently in the hospital experiencing dizziness, nausea and her heart rate was up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This study case was received from the investigator in a trial on 05 February 2013. A 21-year-old female subject, who had a past medical history of headaches, developed chest pain, unspecified, nine days after receiving a injection of ACAM2000, SP Biologics Co., (lot number not reported) on 26 September 2012; TYPHIM VI, sanofi pasteur SA, (lot number not reported) on 24 September 2012; ANTHRAX, other manufacturer, (lot number not reported) on 24 September 2012; and intranasal INFLUENZA, LIVE, other manufacturer, (lot number not reported) on 11 September 2012. On 05 October 2012, the subject was diagnosed with chest pain unspecified. On 05 October 2012, laboratory and diagnostic testing was reported as: Troponin I result abnormal, with highest value 06.29 (no unit for reference range reported); an abnormal electrocardiogram (ECG) and a normal Echocardiogram. Magnetic resonance imaging, (MRI) of brain, MRI of spinal cord, MRI of heart and lumbar puncture (spinal tap) were not performed. The subject's outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
On July 23, 2021 stated she caught covid-19 and her teeth started to hurt that lasted about two days. On day 7 she went to the hospital because she was experiencing headaches and chills.
Information has been received from a registered nurse concerning a patient of unknown age and gender. Patient's pertinent medical history, drug reactions or allergies were not reported. On 04-JAN-2016, the patient received an improperly stored dose of PROQUAD (Merck) with the lot # L032761, expiration date 24-FEB-2017 and albumin status therapy type as rHA (dose, route and anatomical location of administration were not reported). The condition storage was 7F for 10 minutes. There was previous temperature excursion with 8F for 40 minutes and 18.2 F for 5 minutes. No concomitant therapy was provided. No adverse effects or reactions to this vaccine were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
102.1°F fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (102.1°F fever) and CHILLS (Chills) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced PYREXIA (102.1°F fever) and CHILLS (Chills). At the time of the report, PYREXIA (102.1°F fever) and CHILLS (Chills) outcome was unknown.            No concomitant medications were provided.  Treatment medications were not provided. Action taken in response to mRNA-1273 was not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Most of dosage spilled out of the needle. Per DOH guidelines, full dose was re-administered
p/vax pt devel an inj site rxn characterized by redness & swelling;also exp radicular pain;pt instructed to apply ice & to call MD if no improve;pt eval for paresthesia of fifth finger of lt hand & swollen lt forearm;MD dx frozen shoulder
Information has been received from a pharmacy intern referring to unspecified patients of unknown age and gender. The patients' medical history and concurrent conditions were not provided. On unknown dates, the patients were vaccinated with dose of ZOSTAVAX (lot # L034724, expiration date 09-DEC-2016, route not provided) (incorrect product storage). Concomitant therapies were not provided. The doses were exposed to the following conditions. No adverse effects were reported. The outcome of events was unknown. There were no product quality issue (PQC) involved. Temperature: 29F. Time frame: less than 30 minutes. Was it administered (AE)? Yes. Was previous temperature excursion? No.  Was call because of a "data logger"? No. Additional information has been requested.