chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient given incorrect moderna vaccine. Correct dosage of 0.25ml was given, but given from moderna 12+ vial instead of 6-11 year old vial with magenta strip. Patient currently has no signs/symptoms of adverse reaction to vaccine that was administered.
After receiving the vaccine patient stated he felt really hot and felt he was going to pass out. Patient states he thinks it's because he is trying to breathe through to mask and a face shield. Patient also had gloves on and a heavy jacket. Patient started to become diaphoretic  and appear to be hyperventilating. Once pt was removed from the area and masked and jacket was removed he immediately started to feel better. Patient breathing improved and skin became dry. Patient did says he was nervous because this is the first public event he has done since before COVID. Patient was observed for 30 minutes and then released.
After the second dose, I experienced unexplained conjunctivitis, which was ultimately followed by intermittent cluster headaches.  It was ultimately diagnosed as trigeminal neuralgia, likely caused by an autoimmune response to the COVID vaccination regimen.  I was prescribed Indomethacin to alleviate symptoms, which seemed to help with the symptoms, but did not cure the condition.  I was advised by all my doctors not to get the booster, which I did not.  Ultimately, I contracted the Covid omicron variant and tested positive on 12/31/21.  After a mild case, the neuralgia seems to have resolved itself along with other symptoms I encountered previously including chronic fatigue and diminishment of taste and smell.  More info available but the additional info form below is not working
Dizziness lasting a few minutes.  Vitals; 12:42 pm: BP= 123/75, HR= 70, O2 sats RA= 97%. Temp= 36.3 C, RR=18; 13:13 pm: BP= 135/81, HR= 63, O2 sats RA= 98%. Temp= 35.7 C, RR=18
The arm where the flu shot was administered has limited range of motion and extreme pain. I cannot lift arm up to my head or to the side.
Bad Charlie horses in both legs from the thighs to the hamstrings to the calf muscles to the tops of both feet . Started about 9:15 pm and lasted 35 minutes to get them walked out . Came on without any warning. I do get muscle cramps in my calf muscles but never from my thighs to my feet and the pain was a good 0 no pain and 10 the worst pain mine was a 15 I had all I could do to stay standing up and walking them off. Called a friend and she gave me some muscle relaxing pills. Not looking for 2nd dose in Feb 12th 2021
Fever between 101 and 104 for approximately 30 hours, large red welt that is hot to the touch at injection site, intense injection site pain, inability to raise right arm for four days, body aches, an outbreak of painful white sores inside mouth
Information has been received from a physician concerning a 15 month old male pt who in 9/1998 was vaccinated and 6 days, post vax, the pt experienced a high fever and at 8 days, post vax, the pt developed a petechial rash and lab results show a WBC of 37,000. Fourteen days, post vax, the pt developed a maculo-papular rash and a low-grade fever. The reporting physician felt that the fever, rash, elevated white blood cells were not related to therapy with MMR. Follow-up information from a physician reported that there is no additional information pertaining to this case.
Chills, severe headache, fatigue, dizziness, lack of appetite, nausea, anxiety.  On 4/9/2021, I started to feel a pulsating feeling on my upper head and felt anxiety. It felt like I could not reduce my stress by taking deep breaths and letting it out slowly which was unusual because this usually works.
This is a spontaneous report from a contactable consumer received via a sales representative. A female patient of an unspecified age and race received PREVNAR 13 on an unspecified date at single dose for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient said nurse was in a hurry and she rushed when she gave the injection. Since an unknown date after vaccination her arm was red and swollen. Events outcome was unknown. No follow-up attempts possible. No further information expected.
After my interview and examination, patient was in exam room with her mother and nurse, RN receiving immunizations. While I was seeing the  next patient in next exam room, I heard a loud "thud" followed by her mother screaming as well as nurse calling out for me to come quickly. I immediately left my other patient and ran into pt's room where she was sitting in the floor with nurse holding her up and speaking to her. Patient was confused and slightly disoriented and starting to cry out in pain. Within just a brief minute of us assessing and reassuring her that we were taking care of her, she was alert and oriented but still did not recall what had just occurred. Her left lower forehead was showing some signs of possible swelling but no bleeding or indentation. She started complaining of her left knee and nurse was holding her forehead saying she fell over the right side of the exam table and onto her forehead. Patient was quickly calmed down and told she had fallen, as she was asking what happened.  It became apparent quickly that she must have fainted immediately following her last shot and subsequently fallen off the exam table when nurse was reaching for the sharps container. Nurse said she had just put the bandaid on the injection site and patient had no immediate complaints or signs of impending syncope. Patient, still sitting on floor, was quickly coherent and ice compress was applied to head within just a few minutes of fall. She mentioned she had not eaten anything at all today because she thought she might need labs drawn and wanted to be ready for them. Juice was given to patient to drink while sitting in floor with nurse. Once she completed the juice box and reported that she felt no dizziness or light-headedness, she was helped by myself and nurse to a chair directly behind her. A brief neurological exam showed no signs of confusion or changes in level of consciousness. Patient began then complaining of her left wrist, which was starting to appear slightly edematous with some erythema to top and radial wrist. Patient was alert and joking with her mother about the incident and did not appear to be experiencing any concerning symptoms at that time. Instructed her to sit for about 20 minutes and continue to drink juice and eat a snack before I reassessed her and completed a neuro exam. After about 20-30 minutes, neuro exam was unremarkable, as follows in assessment below. Patient denied any dizziness, blurry vision, HA, nausea or further feeling of faintness. CRNP.
Covid Arm - a 2 inch rash on my right arm where I received my shot. It is hard to the touch, red, raised and itchy.
Dizziness/vertigo, nausea, vomiting, headache, fatigue. Onset 26 hours after vaccine administration. Dizziness/vertigo, nausea, vomiting lasted about 18 hours. Headache lasted about 24 hours. Fatigue lasted about 72 hours.
Fussy baby, congestion, difficulty breathing, followed by apparent apneic episode, with eyes rolling back in head which resolved in less than one minute.  Fever to 38.1 noted one hour later in ED. Seizure was suspected.
felt cold; sweaty repeatedly; felt weak; This is a spontaneous report received from a contactable consumer, the patient. A 45-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207), via an unspecified route of administration on left arm on 16Mar2021 at 11:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient was not reported. Concomitant medications not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The past drug history includes the first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9266), via an unspecified route of administration on left arm on 23Feb2021 at 11:15 as a single dose for COVID-19 immunisation. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Mar2021 at 23:45 evening the patient experienced cold. On an unknown date in Mar2021 the patient experienced sweaty repeatedly through the night. On an unknown date in Mar2021 morning following second dose the patient experienced felt weak all day. No treatments for the adverse event taken. The clinical outcome of the events feeling cold, sweaty repeatedly and felt week was recovered on an unknown date in Mar2021. No follow-up attempts are possible. No further information is expected
Within 30 seconds of receiving vaccine, redness from site of injection to inner arm, swelling over band aid, nausea, dry heaves, weakness. Day after vaccine, no redness but large area of induration, vertigo and tinnitus L ear. No redness 8/26 or 8/27. Redness with pressing returned 8/27/13.
Information has been received from a registered nurse concerning a child who on 26-Jan-1996 was vaccinated with a dose of varicella virus vaccine live. Concomitant therapy included Hib conj vaccine (manufacturer unknown). Subsequently, the child developed a mild case of chickenpox. It was noted that there were no hospitalization or complications", no treatment was required and "patients were often not seen by the nurse, but were reported by parents as explanation of an absence". It was also noted that the child was part of "six cases that took place over the last school year (from 9/02 to present)". Unspecified medical attention was sought. There was no product quality complaint involved. At the time of this report the child was 9 year of age. The nurse also reported that five other children developed mild chickenpox (WAES #0305USA02461), (WAES #0305USA02459), (WAES #0305USA02458), (WAES#0304USA02457) and (WAES #0305USA02460). Additional information has been requested.
Maculopapular rash at 15 days post vaccine seen in office with rash 7/17/07
Moderna COVID-19 Vaccine EUA.   After getting vaccine, next day I had the usual pain, slightly warm and swelling at the site, this lasted for 3 days. Then 5 days later 1/18/21  I developed, hot to touch, slightly red and swelling at site. I also have pain and all this is totally on my upper arm all around arm, plus I have itching and burning discomfort in my axilla
No adverse effects reported/ no side effects for the patient; the one dose of MMR II vaccine that was administered to the patient on 7/29/2019 was administered 27 days after the first dose and was one day earlier, than the 28 days that is recommended in the prescribing information; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  The patient received the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) on either 30-JUN-2019 or 01-JUL-2019 (strength, dose, frequency, route of administration, lot #, expiration date and indication were not reported), later on 29-JUL-2019, the patient was vaccinated with a second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), 0.5 milliliter/28 days apart (strength, route of administration, lot #, and expiration date were not reported)  indicated for prophylaxis reconstituted with sterile diluent(MERCK STERILE DILUENT) 0.5 milliliter/28 days apart, this second dose was administered 27 days after the first dose and was one day earlier, than the 28 days that was recommended in the prescribing information.  No adverse effects reported by the pharmacist.
Systemic myositis. Began 2 days after vaccination.  Seen 7/2/21 as it persisted. CK elevated at 1644. CRP 15.9. Normalized 8/15/21.
On 3/11, patient complained of shortness of breath with ambulation. She was sent to the ED and diagnosed with pulmonary embolism. Negative for DVT.
Left shoulder blade bursa inflammation; This spontaneous case was received on 11-Sep-2020 from pharmacist via Agency (reference number: SEQW20-01552) and concerned a 71-year-old, female patient.  The patient's medical history and concomitant medications were not reported.   On 07-Sep-2020, the patient was vaccinated wit Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59, dose: 0.5 ml, route of administration: intramuscular and anatomical location: left arm) for influenza prophylaxis. The batch number reported was 279784 and expiry date was 12-May-2021.   On 08-Sep-2020, one day after administration of Fluad Quadrivalent, the patient experienced back pain, shoulder pain and chest pain radiating to her back. She was seen by her medical doctor (MD) and was diagnosed with left shoulder blade bursa inflammation. There was no reaction reported to injection site. The patient was given naproxen at an unknown dose for an unknown amount of time and it was helping with the pain.   On 10-Sep-2020, the patient called to report adverse reaction to the vaccine.   At the time of initial reporting on 11-Sep-2020, the patient had not recovered from the event.   The reporter assessed the event as related to Fluad Quadrivalent.   The reporter assessed the event as non-serious.  Company comment: The patient developed bursitis one day after vaccination with the suspect product, Fluad Quadrivalent. Chronology is plausible. No information about medical history and concomitant medications was provided. Based on provided information, causal relationship between the suspect product and the event is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).; Sender's Comments: The patient developed bursitis one day after vaccination with the suspect product, Fluad Quadrivalent. Chronology is plausible. No information about medical history and concomitant medications was provided. Based on provided information, causal relationship between the suspect product and the event is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).
Low blood pressure caused a syncopal event. Blood pressure was taken and reported stable within 5 minutes. EMT on scene recommends going to be checked out by higher level of medical care.
DEATH- PHARMACY NOTIFIED 3/19/21 OF PATIENT DEATH ON 3/18/21, NO OTHER DETAILS KNOWN
Patient received dose 1 of COVID vaccine 12/24.  He developed symptoms consistent with COVID infection on 12/25.  He was seen in the emergency room at Hospital on 12/27,was diagnosed as COVID positive, and was discharged to home.  He returned to the emergency room on 12/29 and was admitted to the hospital for treatment related to COVID infection. He is currently admitted to Hospital.
PT shared that she had a history of allergic reaction to multiple antibiotics. PT denied that she had had an anaphylactic response and stated she did not carry an epi-pen. PT confirmed reading the fact sheet and review of the pre-vaccination questionnaire prior to coming to the clinic.  At 5-10 min, RN checked with Patient. She stated she was feeling okay. She was reassured by RN that EMT staff were on site if she had any concerns. Pt stated "Yes, I work at the police department.  They are the reason I came here for the vaccine."  Within 20 min. of admin. she reported hives and itchy.  Pt was imm. moved to the paramedic team, emergency care was initiated.  Transfered to  Hosp. ED
shoulder pain followed that evening by chills, headache. Next day, headache, loss of appetite and fatigue.
Vaccine administered after after 4 temperature excursions; Vaccine administered after after 4 temperature excursions; No aderse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No aderse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions).    No concomitant medications were reported.   It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that vaccine was moved from freezer to refrigerator on 12/2/22 of the ten vials in question 43 injections were given and 7 doses were wasted. Vaccine administered after 4 temperature excursions.  No treatment medication was provided.  This case contains information for the 42nd of 43 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-689222 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-Dec-2022: Upon internal review on 20-Jan-2023, significant correction was performed to update the Worldwide unique case identification number; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689222:master case
Patient is a 12 month old female who presents today for reaction to vaccine. Patient received PCV 13 vaccine, MMR vaccine, and Varicella vaccine approximately 10 minutes ago. Since then, developed erythema surrounding injection sites and rash to trunk and face. She has not had allergic reactions to vaccinations in the past, no food allergies.    Patient Active Problem List:     Twin liveborn by cesarean    Screening for endocrine, metabolic and immunity disorder    Newborn product of IVF pregnancy    Newborn affected by breech presentation     No current outpatient medications on file. Current Facility-Administered Medications: diphenhydrAMINE (BENADRYL) 12.5 MG/5ML elixir 12.5 mg 12.5 mg Oral Once Lia Rosenberg acetaminophen (TYLENOL) 160 MG/5ML liquid 121.6 mg 121.6 mg Oral Once Lia Rosenberg    Review of Patient's Allergies indicates:  No Known Allergies    I have reviewed the past medical, social, and family history. All pertinent historical factors are mentioned in the HPI. The remainder are non-contributory.      Objective      Appearance: Crying, able to be calmed by father.  Skin: Swelling and erythema to b/l lateral thigh surrounding injection site, R>L.  Mildly erythematous macules to patches to trunk and face. Cardiac: RRR, no M/R/G.  Respiratory: CTA bilaterally, no W/R/R. Normal work of breathing, no signs of respiratory distress  Neuro: Alert   ASSESSMENT&PLAN:   Problem List Items Addressed This Visit    None   Visit Diagnoses    Need for prophylactic vaccination with measles-mumps-rubella (MMR) vaccine       Relevant Orders   IMMUNIZATION ADMIN SINGLE, RN (Completed)   MEASLES MUMPS RUBELLA VIRUS VACCINE LIVE SUBQ (Completed)   Need for prophylactic vaccination and inoculation against varicella       Relevant Orders   VARIVAX (CHICKEN POX VACC) LIVE SC (Completed)   IMMUNIZATION ADMIN EACH ADD, RN (Completed)   Need for prophylactic vaccination against Streptococcus pneumoniae (pneumococcus)       Relevant Orders   PCV13 VACCINE FOR INTRAMUSCULAR USE (Completed)   IMMUNIZATION ADMIN EACH ADD, RN (Completed)   Allergic reaction, initial encounter       Relevant Medications   diphenhydrAMINE (BENADRYL) 12.5 MG/5ML elixir 12.5 mg (Completed) (Start on 7/3/2019  4:45 PM)   acetaminophen (TYLENOL) 160 MG/5ML liquid 121.6 mg (Completed) (Start on 7/3/2019  4:45 PM)     Allergic reaction: Normal pulm exam, no respiratory distress. Anaphylaxis unlikely. Likely due to varicella vaccine given degree of swelling and erythema surrounding this injection site was more severe than the other injection site. Rash and swelling improved with Benadryl, patient now calm. Discussed given repeat dose of Benadryl tonight, and another dose tomorrow if needed. Told parents to seek emergency care if Patient's rash significantly worsens or she has stridor, cyanosis, lethargy, or other signs of respiratory distress.    VAERS completed.   Patient also assessed by Dr., who agrees to the above assessment and plan.  PA-C
The pt experienced redness, swelling and fever. Treated with Tylenol. The follow up received on 8/31/01 states 7/6/00 child was 15 mos at t ime of immunization. Was DGX'd with autism at 18 mos, by pediatric neurologist. Mom will fax me the record.
This spontaneous case was reported by a physician and describes the occurrence of DECREASED APPETITE (no appetite), VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE PAIN (injection site really sore), PYREXIA (Fever) and NAUSEA (Nausea) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension and Muscle relaxant. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (no appetite), VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE PAIN (injection site really sore), PYREXIA (Fever) and NAUSEA (Nausea). The patient was treated with LOVASTATIN (LOVAREM) at an unspecified dose and frequency and HYDROGEN PEROXIDE (PEROXIDE) at an unspecified dose and frequency. At the time of the report, DECREASED APPETITE (no appetite), VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE PAIN (injection site really sore), PYREXIA (Fever) and NAUSEA (Nausea) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Body temperature: 99.3 (Inconclusive) 99.3 F. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered DECREASED APPETITE (no appetite) to be possibly related. No further causality assessments were provided for VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE PAIN (injection site really sore), PYREXIA (Fever) and NAUSEA (Nausea).
Pt had rash approximately one hand breadth in size on left thigh, rash occurred one day after vaccines given, parents state pt c/o itching, rash going down 24 hrs after event. Parent advised to use hydrocortisone cream on rash, advised when to call 911/seek medical help.
My blood sugar, which is normally good (A1C of 7.3), was elevated last night. It was 380 this morning and 530 just now. I, of course, feel horrible. I have been treating with extra insulin but can hardly keep up with the constant increase. I get it down just to have it rise even higher in the next few hours. Diabetics (I am Type I) need to be warned this can happen. It is awful. I'm afraid that for the first time in 42 years I will have to go to the hospital for high blood sugar.
Sudden hearing loss in left ear, diagnosed by audiogram and doctor exam; diagnosis: Sudden Sensorineural hearing loss