chrisvoncsefalvay/vaers-outcomes huggingface dataset:
about 10 minutes after vaccine was given patients lips started to swell and tongue. 2 tablets of Benadryl were given. a few minutes later patients throat started to close. 911 was called and an Epi-pen was given to patient
I95.9 HYPOTENSION 10/17/2022 LIVER CYST I95.9 HYPOTENSION 10/17/2022 ABNL LIVER IMAGING
pt recvd vax; itching at neck & waist 36 hrs p/ vax progressing to generalized urticaria w/ swelling of lips; tx w/ epinephrine & dph
developing a prickly heat rash on chest and arms a few days after getting the first shingrix dose; This case was reported by a consumer via call center representative and described the occurrence of heat rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2022, the patient received the 1st dose of Shingrix. In October 2022, several days after receiving Shingrix, the patient experienced heat rash. On an unknown date, the outcome of the heat rash was not recovered/not resolved.   It was unknown if the reporter considered the heat rash to be related to Shingrix.     Additional Information: GSK receipt date: 26-OCT-2022 Reporters comment:  The patient received the first dose of shingrix and then developed a prickly heat rash on chest and arms a few days after received the first shingrix dose.  No other information reported to the agent by the patient.  The reporter did not consent to follow-up.
Horrible crying, (blarkness) staring, labored breathing. He also stopped breathing (5-10 sec). It happened Monday July 1, 2002 about 10:47pm, no treatment was given he bounced back about 5-10 mins later.
About three days after the first dose, the skin around and underneath my daughter's nose started to develop discolored patches that looked like vitiligo. My wife and I thought it might could be a rash or the normal skin changes that happen in young children. This was Tuesday, Nov. 16. On Nov. 18, a dermatologist confirmed that my daughter had vitiligo patches around her nose. In the course of two days, the spots had quickly become lighter in color, as if the discoloration was accelerating. She was prescribed Elidel cream for six weeks.
pt recv 3rd dose of vax 1JUL96 & 13AUG96 lab eval  revealed varicella-zoster antibody IgG 0.75;
Initial report received from a pharmacist on 15 Jan 2010: The patient was vaccinated with FLUVIRIN (batch no: 104045P1) 0.5 ml, intramuscular, that had been stored at temperatures as low as 34 F and 35 F on an unspecified date. No adverse event was reported.
devel rash on rt & midline abd above the umbilicus on 9OCT97;a cluster of erythematous papules, some umbilicated, but no vesicles +itch no pain;
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date in 2014 (reported as since 08-AUG-2014), the patients were vaccinated with (Merck) VARIVAX which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received from the registered nurse who stated that it will take some time to get the (Merck) VARIVAX information (patient identifiers, lot numbers, expiration dates and dates of vaccine administration) together and that she may send the information at a later time. Follow up information has been received from the registered nurse concerning a patient (age range reported as 13-18, units not reported) of unknown gender. On 24-OCT-2014, the patient was vaccinated with a dose of (Merck) VARIVAX which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). The reporter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
The day after the vaccine I started feeling tightness in the chest, tiredness, and higher than normal blood pressure ~130 - ~160. The symptoms persisted for a couple days and got progressively worst where it was uncomfortable to lie down or sleep without being propped up. It wasn't painful but it felt like there was a lot of pressure right in the center of my chest below my rib cage as if someone was pressing on it.  The symptoms lasted for about a week with the peak of the symptoms on 5/20.
Patient tested positive for COVID19 3/2/21 after having received a complete Pfizer vaccination series.
Chest pain trouble breathing irregular heartbeat lightheaded dizzy feels like I?m not getting oxygen
Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: DEHYDRATION. LOSS OF APPETITE-Severe, Systemic: Vomiting-Severe
Nausea, headache, ill feeling, rhinorrhea, chills, cough, loss taste
Hospitalization for fevers in the setting of COVID 19 while being treated with chemotherapy for Stage 3 anaplastic large T cell lymphoma .
warm; Red; pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE PAIN (pain) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 044B21A) for COVID-19 vaccination.     Concomitant products included METFORMIN, GLIPIZIDE, LISINOPRIL, PRAVASTATIN SODIUM (PRAVACHOL) and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (warm), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE PAIN (pain). At the time of the report, VACCINATION SITE WARMTH (warm), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE PAIN (pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-081706 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081706:2nd dose of vaccine
Patient describes severe vertigo, occurring the first day after vaccination and impeding work activities for several weeks. Patient visited physician at place of employment.  Patient states vertigo is less severe now (at second vaccine appointment), but is still present.
Local rxn p/MMR; 3.5 cm area of redness; fine rash extending to wrist & rt back; given DPH;
Information has been received from a published article. This literature case was initially reported on 29-MAR-2010. This article concerned 32 patient's (8 male and 24 female) aged between one to 57 years (mean age of patients was 29 years). The patients received a RECOMBIVAX HB, manufacturer, batch number, route and site not reported, on unreported dates. This report concerns patient #10 of 32, a 35 year old female. On an unreported date between 1982 and 2009, one to fifteen days post vaccination, the patient experienced uveitis (mean time to onset of three days). The uveitis was reported to occur after the first vaccination in 15 patients, after the second vaccination in three patients and after the third vaccination in three patients. The duration of the uveitis was not reported for nine patients. One patient had recurrent uveitis after the first and second doses of vaccine. One patient had recurrent uveitis after both the second and third doses. Patient outcome had not been reported. A 35 year old female on an unspecified date was vaccinated with her first dose of RECOMBIVAX HB (lot number, route and site not reported). There was no concomitant medication. One day after vaccination, the patient developed uveitis. At the time of the report, the patient's outcome was not reported. The authors stated the RECOMBIVAX HB may have a possible association with the development of uveitis in some patients. Immune complex deposition and adjuvant effects are potential pathogenic mechanisms. Uveitis was considered to be an other important medical event. Other business partner numbers include E2010-02312. Additional information has been requested. The article also discussed the experience of an additional 31 patients while on therapy with RECOMBIVAX HB (WAES #1004USA01716, WAES # 1004USA02327 to WAES # 1004USA02334, WAES # 1004USA02336 to WAES # 1004USA02357). A copy of the published article is attached as further documentation of the patient's experience.
BOOSTRIX VACCINE EXPIRED 9/21/23 WAS ACCIDENTLY GIVEN TO PATIENT 10/2/23
Trying to re-schedule the second shot; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (Trying to re-schedule the second shot) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Trying to re-schedule the second shot). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (Trying to re-schedule the second shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication use was provided by the reporter. No treatment of events was reported.
Pain and heavy in the injection site , severe headache, feeling tired and chills started around 6.p.m on Dec. 20, 2021.
This spontaneous report as received from a physician refers to a 8 week old male patient. On 17-AUG-2017, the patient was inadvertently vaccinated with VAQTA, intramuscular, instead of an unspecified hepatitis B vaccine (manufacturer unknown) for prophylaxis (wrong drug administered, inappropriate age at vaccine administration). The patient was showing "no untoward side effects" (no adverse event).
I developed muscle aches, fatigue, dry cough that turned into a barking cough, I had a fever for over a week it ran around 101.6. I had a tele visit with my own doctor through video he diagnosed me with Pneumonia and Bronchitis. He prescribed me antibiotics, steroids , and an inhaler I was using every four hours and a cough suppressant with Codeine that was 10 days after I had tested positive for COVID-19.  I lost my taste and smell. I still don't have my taste and smell, and have some lingering brain fog.
Jan 26, 2023, 3 months after last dose (5th overall), I experienced rapid heartrate; was advised to go to ER where I was diagnosed with Atril Fib and Atrial flutter. I have been seeing a cardiologist since to address these issues.
Had an incredibly high fever of 104 for two days, was incredibly irritable and would not eat.  Motrin would only bring his fever down to 101-102.  The spot where the shot was administered was incredibly swollen and red for almost a week.
sore arms both arms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arms both arms".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe exhaustion lasting all day, every day since morning of 2/24/2021.
reported to ER with 1 day history of change in status of left arm weakness/imbalance with walking.   Within 1 day symptoms were improving by time of presentation to ER.   Ultimately was admitted and found to have an area of 1 to 2cm area of acute infarction in right posterior frontal lobe found on MRI after initial CT scan and other labs were normal.
The day after, I had a sore arm. This was much better by the following day. However, one week later, the are started to tingle in the spot of the injection. Later it became itchy, a pink circle formed around it,, and it swelled up. I am writing this the next day after this delayed reaction started, and it is not resolved, although it seems to be improving slightly. I will see my doctor tomorrow if it persists.
While administering the vaccine to the patient, the vial burst and vaccine liquid was splashed all over my face (I am the Pharmacist), including into my eyes.
Confirmed breakthrough case:  COVID-19 (Moderna) 1  02/16/2021 Moderna 007M20A   COVID-19 (Moderna) 2  03/16/2021 Moderna 010A21A   COVID-19 (Moderna) 3  08/25/2021 Moderna 09D21A   COVID-19 (Moderna) 4  03/04/2022 Moderna 083J21A
-Pressure/tightness in chest during several runs and any exertion above 170bpm for 2-3 weeks following 1st dose. -Tightness/Numbness left arm and hand day 10-21 following first dose -Headache, lightheaded and dizzy, visual focus off, and general 'off' feeling day 2-15 following 1st dose -Numbness lip and chin area thru week 4 following 1st dose -Dexterity/Tactile issues in hands for 2-4 weeks following 1st dose
ADMINISTRATION ERROR We had a drive through influenza clinic.  We had volunteers helping.  This 62 year old was given the High Dose Influenza vaccine meant for 65 and older.
w/in 24 hrs of MMR devel fever; no temp taken was hot to touch, c/o h/a, dizziness; on 12MAY92 MD tx'd w/Septra; no rash or other side effects devel w/in 10-14 days;
Five days after receiving first dose, red, itchy bumps appeared on my right wrist. Days following, the bumps started spreading to my left hand, abdomen and continued. I received my second dose on 01/31/2021, and have continued to have the itchy rash spreading to different body parts (thighs, chest, and face). Benadryl controls the itching, but bumps continue to appear and itch.
Redness, warm area, itchiness. Dr. ordered labs (all within range) and a course of antibiotics.
Patient appeared at health department on 10/29/04, complaining of sore right arm at injection site, fever, loss of appetite, lightheadness and complete exhaustion.
14 x 20 cm raised, red, swollen area covering right upper thigh. Treated with Keflex.
This spontaneous report was received from a licensed practical nurse, and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On unknown dates, the patient was vaccinated with VARIVAX lot N022995, expiry 23-AUG-2019, lot N012619, expiry 21-APR-2019, for prophylaxis and PROQUAD lot N023965, expiry 28-FEB-2019), lot N015625, expiry 15-NOV-2018 for prophylaxis. (routes of administration were not reported for any of the aforementioned vaccines). The sterile diluent (MERCK) used for reconstitution was properly stored (lot number and expiry date unknown). No adverse effects were reported. On unknown dates, the doses of VARIVAX and PROQUAD underwent temperature excursions of 6 degrees Fahrenheit (°F) to 14 °F (6.1°F) for 16 minutes. Previous temperature excursions were reported as follows: 6 °F to 14 °F (9.7°F) for 30 minutes, 6 °F to 14 °F (6.3°F) for 15 minutes and 6 °F to 14 °F (6.8°F) for 8 minutes. Total cumulative: 6 °F to 14 °F for 69 minutes. This is one of several cases received from the same reporter. Sender's Comments: US-009507513-1802USA005899: US-009507513-1802USA005900: US-009507513-1801USA010912.
5/8 61y.o. male who presents for confusion. He has known history of type II diabetes mellitus, morbid obesity, and dilated cardiomyopathy with normal coronaries. 5/10 He is stable for discharge home. He is to have outpatient endocrinology and primary care physician follow-up.
Immediate redness and tender area measured 0.72 by 5.3 ml right arm after MMR immunization.
Fever of 100.5-100.7 Deg. F; Swollen axillary adenopathy that is 5cm; Redness of injection site of 4cm.; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (Fever of 100.5-100.7 Deg. F), LYMPHADENOPATHY (Swollen axillary adenopathy that is 5cm) and VACCINATION SITE ERYTHEMA (Redness of injection site of 4cm.) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Oct-2021, the patient experienced PYREXIA (Fever of 100.5-100.7 Deg. F), LYMPHADENOPATHY (Swollen axillary adenopathy that is 5cm) and VACCINATION SITE ERYTHEMA (Redness of injection site of 4cm.). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 03-Oct-2021, PYREXIA (Fever of 100.5-100.7 Deg. F) had resolved. At the time of the report, LYMPHADENOPATHY (Swollen axillary adenopathy that is 5cm) and VACCINATION SITE ERYTHEMA (Redness of injection site of 4cm.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Oct-2021, Body temperature: 100.5-100.7 (High) 100.5-100.7 Deg. F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided.
woke from sleep groaning & churning about in bed the noc of day of vax;generally miserable;T100.0;
Extreme neck pain, difficulty moving neck, gout like symptoms in feet, extreme fatigue, shakiness, flu like symptoms, swollen red knuckles on left hand that were stiff and painful, fainted, dizziness, vision disturbances
On 2/28/2021 patient was seen in PCP office with large open wound to her left lateral arm, roughly 4cm with 2-3cm surrounding erythema and induration. After having her pneumonia vaccine last week she began to have a large vesicle to the area. Wound cultures and ultrasound was ordered and pt referred to general surgeons office. Prescribed Augmentin for 10 days. In office debridement was performed at surgeons office and Santyl ointment ordered.
Patient administered vaccine after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration) in a 51-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  It was reported that vials had not undergone any temperature excursion.Total of 173 doses/vials were given for LOT 070H21A.  No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received contains non significant information.
5-7 days after receiving vaccination a lump appeared on right breast, was treated with antibiotics; abscess was drained.
Under 18 Years Old and Received Heplisav-B; Initial report received on 24-Aug-2023  A physician in the reported that a 17-year-old female patient (race and ethnicity not provided) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  Medical history at the time of vaccination was reported as unknown. The patient had no known allergies.   Concomitant medications at the time of vaccination were not reported.   On unknown dates, the patient received an earlier 3-dose hepatitis B vaccine series (unknown brand and details) and was being re-vaccinated due to low titers (not specified).  On 14-Aug-2023, approximately one and a half months, she received a dose of HEPLISAV-B (Lot # 943006, expiration date 30-Sep-2025, and NDC # unknown) intramuscularly (injection site not reported). The patient did not report any side effects.   No additional information was provided.  Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.   ?
patient received the vaccine and 10 minutes later came back to the pharmacy saying that he was weak and that he couldn't walk and felt dizzy and nauseous.  Patient was told to remain seated and was brought water after 30 minutes he felt the same so EMS was called.  Ems discharged patient didn't take him to hospital his vitals were okay but patient was pick up by a family member.
Patient got both vaccines in left arm and came in the day after complaining of redness and swelling (started experiencing the day she got the vaccine).  Her arm was swollen and red from her shoulder to her elbow.  She said it was warm to the touch and a little sore.  Patient was doing okay, just wanted me to look at her arm.  I told her she could take benadryl for the redness and swelling or tylenol/ibuprofen for pain or discomfort.  I told her if anything worsened to see the doctor.
Initial report received on 18 May 2010 from an investigator participating in the above-mentioned trial under the reference number M5A11. A 3-month-old male subject died 28 days after he received a first dose injection of PENTACEL, lot number C3385AA on 12 November 2009. The subject also received the following vaccines on the same date: a first dose of PREVNAR (lot number D74804), a second dose of RECOMBIVAX HB (lot number AHBVB761CA), and a first dose of ROTATEQ (Lot number 0088Y). The subject was last seen on 12 November 2009 for normal well baby care which was unremarkable. The subject died on 10 December 2009. The reporter had no additional information pertaining to the cause or description of death; therefore the "Event Start Date (Date of onset of symptoms)" was reported as unknown. At the time of the report, the county coroner's bureau confirmed the death but would not provide preliminary information. The bureau did indicate that the manner of death was determined to be natural causes and autopsy results would be available as soon as they were considered final. According to the investigator, the event was not related to PENTACEL.
Patient came in 48 hrs after PNEUMOVAX 23 and complained of redness/soreness/swelling on injection arm closer to armpit area but not under the arm.
Pt vaccinated with DTP/OPV developed depressed atrophy of lt ant thigh 3-4 months. Patch 3-4 cm diameter w/central clearing & volacious periphery.
This spontaneous report as received from a registered nurse, refers to a patient of unspecified age and gender. The patient's pertinent medical history, concomitant medications, and information about drug reactions or allergies, if any, were not provided. The registered nurse reported that, on an unspecified date, the patient was inadvertently vaccinated with improperly stored PNEUMOVAX 23 for prophylaxis (dose, dose number, frequency, route and anatomical location of administration were not provided; lot number N025563, expiration date 08-APR-2019). The doses of PNEUMOVAX 23 were exposed to a temperature excursion of 47 degrees Fahrenheit (°F) to 77 °F (also reported as "47.6 °F") during a time frame of 2 hours, which was detected by the Digital Data Logger. There was no previous temperature excursion. No adverse effects or product quality complaints reported. Further information was not provided.