chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This non-serious spontaneous case, was initially received on 18-Oct-2017 from other health professional (nurse), concerns a patient of an unspecified age and gender. On 04-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: full dose (as reported), batch number: 195128, expiry date: 30-Apr-2018, route of administration, anatomical location: not reported). On 04-Oct-2017, the patient was given vaccine from a vial that leaked. It was reported that, after piercing the vial, when it was turned upside down and upon injecting air, vial was dripping from the rubber seal. The nurse could withdraw only 7 doses from the vial. The patient was administered with full dose of vaccine. There were 2 defective units, but the package was not damaged or wet. The nurse used 23 needle gauge of size 3 cc. The PTC (product technical complaint) number provided was 1025066. Based on the investigation performed, it can be concluded that FLUCELVAX Batch 195128 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process, or relating to the vial or stopper components, and no trends were identified for the batch. However a known trend was identified for the FLUCELVAX batches from the 2017/2018 FLUCELVAX Commercial Season for vials leaking at the stopper during dosing due to air being added to the vial. The most likely root cause can be attributed to improper handling by the user. Follow-up received on 21-Nov-2017: Added PTC number and the QA (quality assurance) report results. New event drug administration error was coded. Narrative amended accordingly. Non-significant case correction received 18-Oct-2017: The verbatim of the event 'product leakage' was corrected and the lead sentence in narrative was amended.
Received flublok flu shot 10/21/20, woke up 10/22/20 with some redness swelling and heat around the injection site, at 12:45pm it has spread and is a larger area
Extreme nausea and dizzy/ lighteheaded with weakness. Slept it off and took pepto. Returned back to normal in 10-12 hrs
No problems in getting the vaccine this time vaccine, I had a trip in late October. On 10/30 we flew home and 5-6 days later I got sick from COVID-19, I had a COVID-19 COVID home test, and it was positive. I had high fever, bad headache, nausea, cough. I called the doctor and requested a tele visit, went very well, he prescribed cold medicine, inhaler, PAXLOVID. I still persisting with this cold. I am a RNA.
The adult Hep B was given when a Pediatric Hep B should have been given. Patient had fever initially that resolved in 24 hours.
unknown quantity leaked out of the hub of the needle and down her arm; A spontaneous report was received from a health care facility staff member concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced incorrect dose administered.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19.   On the unknown date, during vaccine administration, the patient experienced incorrect dose administered. The health care facility staff member reported an unknown quantity leaked out of the hub of the needle and down the patient's arm. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not reported.  The event, incorrect dose administered, was considered resolved.; Reporter's Comments: This case concerns a female patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Incorrect dose administered without any associated adverse events.
My daughter got extremely ill after the second dose. She developed a fever, chills, racing heart, headache, stomach ache, nausea, body aches, dizziness, and fatigue.
From initial information received on 6/11/03 from a registered nurse regarding an adverse event occurring in the USA, it was reported that a 46 year old female patient received her third dose of JE-VAX, lot number EJN210B, administered SC, in the left arm and a dose of TYPHIM Vi, lot number U1511-2, administered IM in the right arm on 6/6/03. The next day the patient developed flu-like symptoms, including fever, diarrhea and fatigue. It was reported that the patient had also experienced these same symptoms following the second dose of JE-VAX (lot number EJN210B) which was administered on 5/30/03. The patient had also received Hepatitis B vaccine (lot number ENG5338B6) on 5/23/03. Concomitant medications included Adipex-P daily, Topomax twice a day and Wellbutrin twice daily for depression. At the time of this report, it was noted that the fatigue still persists and the patient's recovery status is unknown. From additional information received on 11/21/03 through a telephone call to the primary reporter, it was reported that the patient travels a lot and never returned or called back to this medical office. The reporter stated that she would place a call to the patient for additional information. A follow up phone call was made on 11/24/03 to the primary reporter, who stated that she did place a call to the patient on 11/21/03 and left a voice message to return her call regarding follow up. She has received no response back. No further information is anticipated, this case is considered closed.
Initial unsolicited report received from a consumer on 19-SEP-2016. This case involves 84-year-old female patient who was vaccinated with a dose of FLUZONE HD (manufacturer, expiry date, batch number, route of administration were not reported) in left arm on an unspecified date (in 2016). The patient's illness at time of vaccination was reported as was not reported and the pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as Allergies: no medication allergies. The patient previously vaccinated with several flu vaccines. Concomitant medications were not reported. On an unspecified date in 2016, in the afternoon, 3 weeks following vaccination, patient had experienced severe dizziness, and then developed red area on arm around injection site, and muscle at injection site became "hard like a rock". It was also reported that, last year in 2015, on an unspecified date following the vaccination with FLUZONE HD (Lot number: unknown), patient had only redness at injection site. The patient's laboratory data and corrective treatment was not reported. The events outcome was reported as unknown. List of documents held by sender: none.
6 X 9 area or erythema on right upper extremity, 100.8 temperature orally.
Office visit on 7-29-08 with rash that started 5 days ago also decreased appetite.
Pt was given wrong dose of Influenza vaccine, was given dose from private stock for ages 3+. No adverse reactions have been reported.
Severe  deep pain around injection area shooting up neck and down right side. Sweaty, clammy, excruciating pain reaching out and up my neck caused nausea and no sleep. This pain continued but radiated throughout my body over the course of the next 2 months. I felt like I had aged from 65 to 85 over night. I took ibuprofen. My joints  ie, hands, shoulders and hips plus feet were achy. This continued. My immune system compromised. I had 3 bouts of sleep coughs and general tending to get a cold, but not. Finally a cold sore, temperature, went to Primary doctor. Next went to Urgent Care. Now on  methylphenidate. My body is not so achy, but back to normal. I have cold like symptoms now.
2 szs. 2nd occurred @ hospital. Focal in nature. Had T of 104 F. No past hx of seizure, 30May90 partially reovered /p 2 days, had another seizure on 11May90.
Prior to the vaccine, I had been recording my cycles, average 30-32 day cycles. I've been having irregular periods since getting the vaccine. The first dose, I immediately began experiencing spotting and spotted for 2 weeks straight and then had a period after. I NEVER have spotting, ever, so this was VERY unusual for me. My next period came 24 days later, which is again VERY unusual for me, I NEVER experience early periods. The next cycles after that were very late, usually after 40 days. I got my second dose in December and still am experiencing late periods. Additionally, ever since the first dose I've been dealing with extreme fatigue during PMS and my PMS will last 2-3 weeks until the second day of my period. Before this, my PMS was maybe a week long, if that. NOTHING in my lifestyle or diet has changed, I am very health and exercise 3x a week and walk everyday and am very conscious of my diet.
Moderna COVID-19 Vaccine EUA. 02/04/2021: Patient called to report adverse side effects following receipt of Moderna COVID-19 vaccine on February 3, 2021, 9:05 AM. 02/03/2021, 1 hour after vaccine, patient stated left arm pain at site of injection. 02/04/2021: patient had worsening Left arm pain, vaccination site redness, inflammation, and skin warm to touch at vaccination site. Patient notified health department approximately 3 PM. Nurse provided assessment questions via phone. In addition to previous stated symptoms: client stated slight numbness and tingling at site of injection (denied radiation down arm and to fingers), and rated pain ?4 or 5? (according to 1-10 pain scale). He was advised to: use cool compress 10-15 minutes per hour (vaccination site on the arm), contact his PCP to determine for evaluation, and determine if able to take ibuprofen or acetaminophen. 02/05/2021: Patient notified by health department nurse (9:00 AM) for cont. evaluation: identical evaluation as provided on 02/04/2021. Client stated he had contacted PCP office this AM and spoke with receptionist/nurse. He stated he was waiting for return call. 02/05/2021 (2 PM). Client again contacted byRN. Client had message to NP and had not received return call. RN explained, from evaluation, arm soreness was localized. RN stated that RN would notify client on 02/06/2021 to review symptoms. It was explained to client that if there was an increase in pain severity, swelling, redness, or transmission of tingling or numbness extending to fingers that he should go to the nearest Emergency Dept. for evaluation. Client verbalized his understanding.
Information has been received from a nurse referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of improperly stored VAQTA (lot # M021124, expiration date 02-FEB-2018, route unknown). The vaccine had been stored under 50.9 Fahrenheit for 34 minutes. There was no previous exposures. Digital data logger had been involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Rash began on chest the day after vaccine 1 and has spread across torso, progressing over 2 weeks now with no relief or abatement yet
Information regarding PREVNAR 13 was received from a healthcare professional regarding a patient who experienced rash and hives. The patient received a dose on an unspecified date. On an unspecified date, the patient experienced rash and hives. The patient visited a physician. Treatment was not reported. The outcome was unknown. See related case (s): US-WYE-H15155310 (adverse event, non-expedited) and US-WYE-H15212910 (adverse event, non-expedited). No additional information was available at the time of this report.
super sick; digestive issues after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (super sick) and DYSPEPSIA (digestive issues after the 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 ILLNESS (super sick) and DYSPEPSIA (digestive issues after the vaccine). At the time of the report, ILLNESS (super sick) and DYSPEPSIA (digestive issues after the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
A non-serious spontaneous report of administration of expired FLUMIST to two patients was received from a pharmacist concerning a nine-year-old female.  The patient's medical history and concomitant medications were not available.  On 06-Jan-2009, the patient received expired FLUMIST (expiration date 30-Dec-2008) at a Pharmacy.  The pharmacist states that she did not check the expiration date prior to administration.  The patient was doing well.  There was no adverse event associated with this medication error;  therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Based on the results of the investigation, the root cause for the expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired.  Additional information was received on 09-Apr-2009:  product complaint investigation results.
Information has been received from a licensed practical nurse concerning a 79 year old female who on 10-FEB-2009 was vaccinated SQ with a 0.65 ml dose of ZOSTAVAX (Oka/Merck) (lot #: 662860/1617X). Concomitant therapy included DILANTIN, LIPITOR, PREVACID, aspirin, ACTONEL and calcium (unspecified) (+) vitamin D (unspecified). It was reported that on 12-FEB-2009 the patient developed shingles. On 16-FEB-2009, the patient was seen in the office. She had a rash on her right arm. A lesion was cultured and sent to a lab (results pending). The patient was prescribed LYRICA and LIDODERM for her pain. On 17-FEB-2009, the patient's rash was spreading. Additional information was received from the office. It was reported that the patient began taking VALTREX on 17-FEB-2009 and became dizzy and disoriented. The patient was then admitted to the hospital on the evening of 17-FEB-2009. Additional information has been requested.
The shot went in very hard.  The person came at me with the needle, like a punch.  I jumped off the table.  It really hurt. I was unable to lift my arm above shoulder level.  It was painful when driving home.  It became very stiff. I could not do the usual activities of daily living, nor could I do  farm and household chores. I was not able to perform my work in an active way.  I am a personal trainer and group fitness instructor. I am a competitive swimmer.  I am a runner and a biker.  I have never ever had a sore shoulder. I saw my PCP Doctor.  I got a referral for physical therapy.  I went to 3 sessions.  It took over 6 months to heal.
Patient experiences pain "inside and outside" of right arm. States she is able to move the arm. Dense redness or swelling.
Around 09:30 05/21/2002 for Hep A&B. Not previously eaten. Hep B given in left deltoid; briefly passed out for 30 seconds while sitting in chair. Laid to floor but awake/talking. Hep A then administered in right deltoid. Mom phones at 15:00. States has previously passed out at home complaining of numbness and extreme soreness in left arm and feeling faint. Encouraged to call private doctor. Try heat instead of ice and anti-inflammatory meds previously taken.
skin issues - hair loss on eyebrows, rash and pustules/bumps on forehead.  issue worsened over time and was not officially diagnosed immediately.  Initial diagnosis was rosacea and hyperplasia.  As of 07/06/22 it's now  frontal fibrosing alopecia
Heart palpitation after the 2nd shot; May have been anxiety; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart palpitation after the 2nd shot) and ANXIETY (May have been anxiety) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced PALPITATIONS (Heart palpitation after the 2nd shot) and ANXIETY (May have been anxiety). On 04-May-2021, PALPITATIONS (Heart palpitation after the 2nd shot) and ANXIETY (May have been anxiety) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Patient never had COVID disease nor a positive test..         Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter. Patient wife reported that patient had heart palpitation. Patient did not see a doctor and the heart palpitation went away by itself. He had been around people with COVID Disease but he never had COVID-Disease nor a positive test. His medical history was clear and healthy. Wife also stated, At that time, we thought it may had been anxiety, since it was not listed as a side effect..
APPROXIMATELY 5 MINUTES POST INJECTION PATINET STARTED WITH A NAGGING COUGH. SHE STATED SHE HAS REACTED IN THE PAST TO FOAM HAND SANITIZER WHICH WAS BEING USED IN THE CLINIC AND SHE DIDN'T REALIZE THAT UNTIL THE COUGH STARTED. UNABLE TO DETERMINE IF IT WAS THE HAND SANITIZER OR VACCINE SINCE COUGH WAS ABOUT 5 MINUTES AFTER DOSE WAS GIVEN. WAS GIVEN 25MG PO BENADRYL, REFUSED EPI SUBQ AND REFUSED AMBULANCE. DID CONVINCE PATINET TO ALLOW US TO BRING TO ED WHICH WAS IN SAME BUILDING. WHEELCHAIR RIDE GIVEN TO ED WITH EPI ON STANDBY IF NEEDED
SORE THROAT; STOMACH PAIN; FEEL MISERABLE; FACIAL SWELLING; SWELLING OF EYE LIDS; ITCHING; A LOT OF PAIN UNDER RIB CAGE; EXACERBATING FIBROMYALGIA; EXACERBATING INFLAMMATORY REACTION THROUGH BODY; PAIN; STOMACH SPASM; FEELING SO SICK; CHILLS; DIARRHEA; VOMITING; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's past medical history included: concussion, and concurrent conditions included: autoimmune issues, genetic issues lump into fibromyalgia, and fibromyalgia in upper chest. The patient was previously treated with covid-19 vaccine ad26. cov2.s (dose number series 1) (batch number:1805020) on 15-MAR-2021 for prophylactic vaccination; and experienced itching inside chest when treated with diphenhydramine hydrochloride for itching in chest ( dose number in series 1) The patient received covid-19 vaccine ad26.cov2.s (dose number series 2) (suspension for injection, route of admin not reported, batch number: 1071855194, and expiry: UNKNOWN) dose was not reported,1 total, administered on 26-NOV-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 01-DEC-2021, the patient experienced pain, stomach spasm, feeling so sick, chills, diarrhea and vomiting. On an unspecified date, the patient experienced exacerbating fibromyalgia, exacerbating inflammatory reaction through body, sore throat, stomach pain, feel miserable, facial swelling, swelling of eye lids, itching, and a lot of pain under rib cage  ( all events in dose number series 2). She denies having a temperature. She reports her symptoms are not in the medical books and she reacts differently than majority of the people. Treatment medications (dates unspecified) included: dicycloverine hydrochloride for stomach issue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the exacerbating fibromyalgia, chills, diarrhea, vomiting, pain, stomach spasm, feeling so sick, exacerbating inflammatory reaction through body, stomach pain, sore throat, feel miserable, facial swelling, itching, a lot of pain under rib cage and swelling of eye lids was not reported. This report was non-serious. This case, involving the same patient is linked to 20211206613.
Patient has a red spot where injected and has been itching all down her arm. It started the afternoon after receiving vaccine and has continued till 5 days later. Patient has been taking BENADRYL.
RASH ON ARM; This spontaneous report received from a consumer concerned a 79 year old female of unknown race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: wheel chair user, and home bound. The patient previously received covid-19 vaccine ad26. cov2. s (dose number in series 1) (suspension for injection, route of admin, batch number and expiry date not reported) dose was not reported, 01 in total was administered, start therapy date was not reported for prophylactic vaccination. On an unspecified date, the patient had few marks on her arm (dose number in series 1). The outcome of  few marks on her arm was not reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered on 30-NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced rash on arm (dose number in series 2). The reporter reported that when she visited a week and a half later the she told her that she has the rash on her arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of rash on arm was not reported. This report was non-serious. This case, involving the same patient is linked to 20220363110.
shoulder pain... which didn?t seem connected to the vaccine... which progressed to pins and needles in the L shoulder, numbness into both hands...of the left arm. And neck pain... cervical radiculopathy in the L arm... pain and pins/needles into L thumb. It reached its peak with 4 nights of disturbed sleep starting on the date mentioned. I didn?t keep track of the symptoms other than that because I didn?t initially associate the symptoms to the vaccine until early this week. Symptoms have since improved and are (almost) resolved; I was advised to have the the 2nd vaccine today as scheduled - which was recommended lower on the deltoid and on the opposite shoulder.
Information has been received from a 61 year old female patient concerning herself. Concurrent condition included hypothyroid, high blood pressure and restless legs syndrome. Concomitant therapies included SYNTHROID, HYZAAR, PRILOSEC, TOPROL, hydrochlorothiazide, CRESTOR and SINEMET (strength: 10/100 mg and 25/100 mg). The patient had no drug reactions/allergies. On 21-FEB-2017, the patient was vaccinated with a dose of ZOSTAVAX (1 dose, strength, route, lot # and expiration date unknown, in the right arm) for prophylaxis. On 21-FEB-2017 (reported as "that night"), the patient experienced a red rash, swelling and hardness at the injection site. On 24-FEB-2017 (reported as "today" as of the reporting time), the patient's whole arm was swollen but the majority of the swelling was at the injection site. The patient did not seek medical attention and no lab diagnostic study was performed. The outcome of the events was not recovered (reported as "not improved"). No product quality complaint (PQC) involved. The causality assessment was not reported. Additional information has been requested.
Had shot sat. morning... woke sunday morning at 11 am, lathargic, no energy at all, soreness in whole shoulder, slight fever of 101, no appetite, tried to hydrate with water, immediately felt nauseous, and  lost half a glass of water... went back to bed.. forced myself to get up in afternoon... still no appetite... watched TV and went back to bed at 10... woke feeling  100%  better monday morning...
Fever, Headache, Myalgias, Stomach Cramping, Nausea, Diarrhea
Skin eruption, fever 103, seizures reported by mom. Treated by another physician in another town.
Pfizer bivalent dose not diluted with 1.3mL of diluent as intended. Dose administered without being diluted first. Patient's family was notified day of event. No treatments were required or adverse outcomes noted.