chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reported swelling of face and throat - top lip swollen very significantly.  (Dx:  Angioedema) Went to ED same day as vaccinations administered.  (influenza and COVID booster dose)  Hospital Emergency;  11/20/2021 CHIEF COMPLAINT: POSSIBLE ALLERGIC REACTION (Had Flu shot and Pfizer booster shot today, now having swelling to upper lip worsening. Took tylenol at 2215. Was having neck pain and chills - resolved with tylenol. ) DIAGNOSIS at time of disposition: 1. Angioedema, initial encounter  Follow-up Information  Call, MD.  Specialty: Family Medicine  ED Course as of 11/21/21 0151 Sun Nov 21, 2021 0137 Patient is a very pleasant 19-year-old female that presents emergency department with swelling to her upper lip that she noticed about 40 minutes prior to arrival.  She states she received her Pfizer booster and her influenza vaccine around 11:00 a.m., just after 10:00 p.m. she began developed some subjective fevers chills and body ache and neck ache and noticed swelling to her upper lip.  The Tylenol resolved all the symptoms except her lip and thus she presented to the emergency department for evaluation.  She denies any tongue swelling, no feeling her throat closing, no difficulty swallowing or breathing.  On exam she had mild upper lip swelling but thankfully the rest of her exam was reassuring.  She states her lips felt pruritic but she had no evidence of urticaria on exam.  An IV was started, the patient was provided Solu-Medrol, Pepcid, Benadryl and monitored closely for the last nearly 3 hours duration.  The patient was checked several times, the most recent of which showed improvement of her lip swelling (although not full resolution). Thankfully she is well-appearing and not showing evidence of anaphylaxis.  She has had no new symptoms or worsening symptoms.  Plan is for the patient to be able to go at the 3 hour mark.  I have written her for Prednisone for home for the next 5 days, and discussed use of OTC Benadryl and Pepcid for the next 5 days.  I have advised her that she should likely not receive any additional Pfizer COVID vaccine or the standard flu vaccine in the future.  We also discussed emergency department return precautions including a worsening of her lip swelling, swelling to her tongue, the feeling of swelling to her throat, difficulty breathing, or difficulty swallowing.  The patient verbalized understanding instructions all questions were answered.  She and her mother were agreeable with the plan of care discharged home. [EC] 0150 Patient has been in the emergency department for 3 hours, continues to be doing well and to be discharged as previously discussed. [EC]
Started over night. Worst flu feelings, headache, chills, aches from the top of head to soles of feet. Feeling the need to vomit always. Up and down fever of 101.5 Sleep for 6 hours awake for 1.  This has been for 4 entire days now! Tonight I am feeling slightly better
This spontaneous report was received from a nurse practitioner via a company representative and refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and known drug reactions or allergies were not reported. On unknown dates, the patient was vaccinated with an unspecified number of doses of GARDASIL injection (exact dose, route of administration, lot # and expiry date were not reported). The reported stated that since then (date not provided), the patient has been tested positive for human papillomavirus, either type 16 or 17. The outcome of the event and causality between the event and GARDASIL were not provided. Additional information has been requested.
Pain at site of injection; Moderna vaccine administered to patient of 17 years; first dose on 14 APRIL 2021 and second dose on  27MAY2021; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Jul-2021 and was forwarded to Moderna on 01-Jul-2021.     This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (Pain at site of injection), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine administered to patient of 17 years) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 14 APRIL 2021 and second dose on  27MAY2021) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     No Medical History was provided by the reporter.   On 27-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 27-May-2021, the patient experienced VACCINATION SITE PAIN (Pain at site of injection), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine administered to patient of 17 years) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 14 APRIL 2021 and second dose on  27MAY2021).   On 27-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine administered to patient of 17 years) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 14 APRIL 2021 and second dose on  27MAY2021) had resolved. On 30-May-2021, VACCINATION SITE PAIN (Pain at site of injection) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered VACCINATION SITE PAIN (Pain at site of injection) to be possibly related.   No further causality assessments were provided for PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine administered to patient of 17 years) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 14 APRIL 2021 and second dose on  27MAY2021).    Concomitant product information was not provided. Treatment medication was not provided.   This case was linked to MOD-2021-162254 (Patient Link).
was in clinic room with Mother and sister for 15 minute wait after HPV dose; on exam table; heard Mother yelling child name, went to room and he had passed out, was sitting on table and started to fall backwards, he responded slowly to verbal stimuli; placed in prone position for approx 3 minutes then he sat up, given crackers and tea, had not eaten prior to visit; VS 98.1-80-18  112/70
Patient was having hot and cold flashes and pain from neck to elbow and under the arm. Said she would have gone to the ER had she been able to get out to drive. Severe headache. Patient had to leave work.
INFECTIOUS DISEASE NURSE HAS NOTED APPROX 25% OF ALL PTS WHO RECEIVE ENGERIX-B EXP INJECTION SITE PAIN /WIN 1-2 DAYS OF VAX. Pt c/o that vax hurt when injected (painful for 24 hrs), arm felt heavy, recovered
Pt. came in the following day c/o pain in arm, redness. There was noticeable redness/swelling in entire upper arm (L). Pt. was advised to see MD ASAP. Pt. saw her PCP and was put on 7 day regimen of Cephalexin 500 mg. Dx: cellulitis.
Acute onset of screaming and slight decrease in this mental status.  In emergency room was noted to have mottled skin, heart rate 140-150, pulse oximetry 97 percent, was transferred to the emergency room in Youngstown.
side effects; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events side effects.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: UNKNOWN) of unknown  for prophylaxis of COVID-19 infection.   on unknown date patient experienced side effects.  Treatment details included UNKNOWN.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), side effects,  was unknown.
Extremely severe, crippling widespread pain all over the body; OTC painkillers were ineffective at lessening pain severity; lasted approximately 2 days; only reason I did not go to the ER is I could not afford it.   THIS INFO FOR 2023 SHOT
Rash on chest and arms that is thought to be from Shingles Vaccine, Zostavax Injection, Single Dose Vial 10PK.
Cold sweats; Fever of 102; Headache; Fatigue; Nausea; Pain in arm; This is a spontaneous report from a contactable nurse.  A 25-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), lot number=Ec0142, via an unspecified route of administration, in right arm on 30Dec2020 at 19:30 (at the age of 25 years-old) as a single dose for COVID-19 immunization. The patient did not receive any vaccinations 4 weeks prior to vaccination with COVID-19 and also had not taken any other medications in 2 weeks. The vaccine was administered at a hospital. Prior to the vaccination, the patient had not been tested for COVID-19. Medical history included an allergy to Kiwi fruit.  There were no concomitant medications.  On 30Dec2020, the patient experienced cold sweats, fever of 102, headache, fatigue, nausea and pain in arm. The patient was not hospitalized for the events and no treatment was administered. The clinical outcome of the events of cold sweats, fever of 102, headache, fatigue, nausea was recovering. After vaccination, the patient had not been tested for COVID-19.
Patient with herpes Zoster 5/10 despite 2 doses of VARIVAX (+ hx varicella per parents).
Information has been received from a physician concerning a 5 year old male with no allergies to eggs, gelatin or neomycin and a history of prematurity and CP who on 09/28/2004 at 12:40PM was vaccinated subcutaneously with a dose of measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live in the right thigh.  It was reported that the patient had previously been vaccinated with measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live.  Concomitant therapy included diphtheria toxoid, pertussis vaccine, tetanus toxoid and inactivated poliovirus vaccine.  The reporter indicated that within minutes after the patient received the vaccination he developed swelling in the right leg, and that he developed rash and itching in right leg.  It was reported that the patient had been given DPT IPV in opposite leg the same day and there was no swelling.  Ice was given for treatment for the right leg.  The patient's outcome was unknown.  Follow up information has been received from a health professional concerning the patient's hive at site.  Upon vaccination with measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live, the patient immediately started developing swelling right below the injection site with redness.  The patient was kept in the office for observation.  He complained of itching, but there was no pain or breathing problems.  The physician evaluated the injection site, and diphenhydramine hydrochloride was ordered.  On 09/29/2004, the patient recovered.  No further information is available.
Swelling in lymph nodes under both arms, right arm lymph node is larger; Right arm pain every 30 seconds; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swelling in lymph nodes under both arms, right arm lymph node is larger) and VACCINATION SITE PAIN (Right arm pain every 30 seconds) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A, 002A21A and 030A21A) for COVID-19 vaccination.     Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] and ATORVASTATIN CALCIUM (STATIN [ATORVASTATIN CALCIUM]) for an unknown indication.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced LYMPHADENOPATHY (Swelling in lymph nodes under both arms, right arm lymph node is larger) and VACCINATION SITE PAIN (Right arm pain every 30 seconds). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Pain, at a dose of 1 dosage form and IBUPROFEN for Pain, at a dose of 1 dosage form. At the time of the report, LYMPHADENOPATHY (Swelling in lymph nodes under both arms, right arm lymph node is larger) and VACCINATION SITE PAIN (Right arm pain every 30 seconds) outcome was unknown.
Information has been received from a physician assistant concerning a 15 year old female who on an unspecified date was vaccinated with the first 0.5ml dose of GARDASIL (IM, lot number unspecified). Originally the patient's pediatrician sent the patient to the physician assistant to have DEPO-PROVERA inserted (on an unspecified date). The patient went back to her pediatrician (on an unspecified date) and received the first dose of GARDASIL. The GARDASIL vaccine and DEPO-PROVERA administration were started "around the same time". It is reported that the information for DEPO-PROVERA stated that seizures had been associated with it. Approximately 4 weeks after administration she developed seizures. An electroencephalography (EEG) was performed and the technician performing the test asked the patient's mother if the patient have had a head injury so the physician assistant thought there might have been some "activity" showing up (not further specified). The patient had not received any further doses of GARDASIL and the DEPO-PROVERA had been removed. At the time of the report, the patient's status was unknown. Upon internal review, seizures was determined to be an other important medical event. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Head ache 20-30 min after shot. Took 2 TYLENOL @ 10:40.
Breakthrough case admission after 2 vaccines Moderna 3/20/21 Lot# 038A21A;  Moderna 4/17/21 Lot# 037B21A
Initial unsolicited report received from the literature on 14 September 2015. This case is linked to 2015SA146032, 2015SA146043, 2015SA146044, 2015SA146045, 2015SA146046, 2015SA146047, 2015SA146048, 2015SA146049, 2015SA146050, 2015SA146051, 2015SA146052, 2015SA146054, 2015SA146055, 2015SA146056, 2015SA146057, 2015SA146058, 2015SA146059, 2015SA146060, 2015SA146061, 2015SA146062, 2015SA146063, 2015SA146064, 2015SA146065, 2015SA146066 and 2015SA146067 (Same literature). The following is verbatim from the article: Background. Reporting of adverse events (AEs) following vaccination can help identify rare or unexpected complications of immunizations and aid in characterizing potential vaccine safety signals. We developed an open-source, generalized clinical decision support system called Electronic Support for Public Health-Vaccine Adverse Event Reporting System (ESP-VAERS) to assist clinicians with AE detection and reporting. Methods. ESP-VAERS monitors patients' electronic health records for new diagnoses, changes in laboratory values and new allergies following vaccinations. When suggestive events are found, ESP-VAERS sends the patient's clinician a secure electronic message with an invitation to affirm or refute the message, add comments, and submit an automated, prepopulated electronic report to VAERS. High-probability AEs are reported automatically if the clinician does not respond. We implemented ESP-VAERS in December 2012 throughout the System, an integrated healthcare system. We queried the VAERS database to determine System's baseline reporting rates from January 2009 to March 2012 and then assessed changes in reporting rates with ESP-VAERS. Results. In the 8 months following implementation, 91,622 vaccinations were given. ESP-VAERS sent 1385 messages to responsible clinicians describing potential AEs. Clinicians opened 1304 (94.2 percent) messages, responded to 209 (15.1 percent), and confirmed 16 for transmission to VAERS. An additional 16 high-probability AEs were sent automatically. Reported events included seizure, pleural effusion, and lymphocytopenia. The odds of a VAERS report submission during the implementation period were 30.2 (95 percent confidence interval, 9.52-95.5) times greater than the odds during the comparable pre-implementation period. Conclusions. An open-source, electronic health record-based clinical decision support system can increase AE detection and reporting rates in VAERS. This case involve a patient (age and gender not reported), who was vaccinated with a dose of TDAP (Manufacturer: unknown, batch number, route, dose in series and site of administration were not reported) and a dose of Varicella-Zoster Vaccine Live (Manufacturer: other, batch number, route, dose in series and site of administration were not reported) on an unspecified date. Medical history and concomitant medications were not reported. On unspecified date following the vaccination, the patient experienced hypothyroidism. Lab tests and corrective treatments were not reported. Outcome of event was not reported. Upon medical review, case was upgraded to serious due to the important medical event: hypothyroidism. Documents held by sender: none.
It was reported that after receiving vaccines a pt developed pain and swelling at the injection site within 48 hrs of vaccine being administered.
death  - Nontraumatic subarachnoid hemorrhage, unspecified  - Nontraumatic subdural hemorrhage, unspecified
The patient reported that she received a TD Adult vaccination on 3/26/01. Immediately after vaccination she developed pain in arm and stiffness in arm. That evening patient had swelling and pain in entire upper arm, now has muscle spasms in upper right arm. Patient also had red welts around site.
No adverse reactions client was given  MMRV off label. Child was 13 recommendation was for no older than 12
Dose 1 15Mar2021: Dose 2 17Apr2022; After the second shot he really didn't feel good, and neither did his son; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 36-year-old male patient received BNT162b2 (BNT162B2), on 17Apr2022 as dose 2, single (Batch/Lot number: unknown) at the age of 36 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot Number: Unknown.), administration date: 15Mar2021, when the patient was 35-year-old, for COVID-19 Immunization, reaction(s): "Elevated heart rate", "Felt like he was having a heart attack", "Elevated heart enzyme", "he took the first shot and didn't feel good after". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 17Apr2022, outcome "unknown", described as "Dose 1 15Mar2021: Dose 2 17Apr2022"; MALAISE (non-serious) with onset 2022, outcome "unknown", described as "After the second shot he really didn't feel good, and neither did his son". Therapeutic measures were not taken as a result of malaise.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201197909 same reporter/drug, different patient/event;
Hematoma and bruising starting within 24 hours of injection, Redness, itching, and swelling 1 week after the injection
About a day or two after receiving the shot, I would experience intermittent headaches throughout the day. This lasted for about 4-6 days after the initial injection. No other noticeable effects occurred.
-incredibly horrible, debilitating menses ~3 weeks post shot #1, continued bleeding until equally debilitating additional menses <3 weeks later.  Physically, violently ill, cramping etc unlike any menses I've ever had, and I've birthed 3 children. Reporting at time after debilitating menses #2, not sure what subsequent will be like, can update if necessary.  Skin issues, sensitivity, rash etc noted ~1 week after shot #2.  No history or sensitive skin/any issues at all - also no changes in diet, detergents etc.  Lastly fatigue and brain fog set in 5-10 days post shot #1 and has yet to relent.  Struggle to focus, come up with words, multitask etc, think super amplified pregnancy brain - able to perform my occupation but with notably increased effort needed, resulting in perpetual exhaustion.   I originally had COVID in November of 2020 and despite having an extremely high viral load I was not physically ill whatsoever.  Antibody titers taken in 11/2021 showed extremely elevated levels of natural immunity antibodies despite being nearly 12 months from initial infection.
Initial misuse report received from a healthcare professional on 25 September 2013. The cases wer4e received on 21 March 2014 at GPV. The patient received two 0.5 ml intramuscular doses of FLUZONE. (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none
Patient received her flu shot prior to her appointment for a screening mammography.  She has received flu shots yearly without problems.  During her mammogram procedure, she suddenly felt lightheaded and nausea.  Thought she was going to get sick.  She sat for a few minutes, drank some juice and then felt better.  Client did not appear to be anxious about her mammogram.  Vital signs were normal.  Spoke to patient today 11/10, she is feeling fine.  Denies any symptoms or adverse affects today.  VAERS form submitted due to the sudden onset on feeling light headed and nausea.
Administration error : Vaccination (booster) was given to patient 5 mins before expiration date.
This spontaneous report as received from a nurse refers to a 10 months and 28 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Death certificate received on 2/5/2003 indicates GBS as the cause of death.
(L) deltoid area itchy rash-raised first night had chills day 2 and 3 very tired and slight HA.
some of the vaccine leaked out of patient's arm; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (some of the vaccine leaked out of patient's arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 an unknown date, the patient experienced UNDERDOSE (some of the vaccine leaked out of patient's arm). At the time of the report, UNDERDOSE (some of the vaccine leaked out of patient's arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided  No treatment medication was provided
Within weeks of getting the hepatitis b vaccination series, my joints began swelling and hurting. I have subsequently been diagnosed with rheumatoid arthritis. It began suddenly and severely and has been disabling since 1995. Accidental needle stick with contaminated needle. The medical record received on 1/13/04 states deep vein thrombosis. Chronic arthritis pain. Per annual follow up report continued debilitating arthritis pain.
C/O chest pain 45 min after flu injection. 11:30 B/P 120/70 P96 Denied previous problems. Denies difficulty breathing. Repeat B/P 11:40 90/60 c/o wore throat prior to injection. Called mom who said could remain @ school B/P 108/60 @ 11:50