chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cleft lip; This literature-non-study case was reported in a literature article and describes the occurrence of CLEFT LIP (Cleft lip) in a foetus patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.   LITERATURE REFERENCE    MEDICAL HISTORY (Parent): The mother's past medical history included Maternal exposure during pregnancy.    No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Transplacental) 1 dosage form. On an unknown date, the patient experienced CLEFT LIP (Cleft lip) (seriousness criteria medically significant and congenital anomaly). At the time of the report, CLEFT LIP (Cleft lip) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Transplacental) was unknown.   For mRNA-1273 (Spikevax) (Transplacental), the reporter did not provide any causality assessments.   No concomitant medication information was reported.  The patient's mother was having a gestation period of 29 years at the time of childbirth and the genetic diagnosis of the patient was not confirmed.  No treatment information was reported.  Company comment: This literature non study case concerns a foetal patient with no medical history information reported, who experienced the unexpected serious (congenital anomaly and medically significant) event of cleft lip. The event was diagnosed after patient's birth. Patient's mother was vaccinated with first dose of mRNA-1273 when the foetus was at gestational age of 29 weeks. As reported, by the authors all participants with fetal anomalies were vaccinated after completion of embryogenesis (ie, in the second or third trimester), supporting that the presence of anomalies was independent of maternal vaccination. Considering the afore mentioned and that cleft lip is a common birth anomaly seen in general population causality for the event is assessed as not related. The benefit-risk relationship of mRNA-1273 is not affected by this report.    This case was linked to MOD-2023-734505 (Parent-Child Link).   See case MOD-2023-734505 for details regarding the child case.  Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2023: Follow up received included: Updated event term, updated patient details and narrative updated
Pt had received Pfizer dose on 3/17, we administered moderna on 04/15 since pharmacy staff did not have any knowledge of first dose of previous vaccine, pt did not report previous shot. No adverse event reported currently
Patient presented on 10-14-21 as second dose for Pfizer COVID19 vaccine, with documentation of what she reported as first dose received on 9-23-21.  She was vaccinnated by us for presumed second dose on 10-14-21.  However, upon entering dose record into the system, it was determined that she had received an initial dose of Pfizer COVID19 vaccine on 7-15-21, which she did not disclose to us.  So she received a third dose of Pfizer vaccine at day 21 after second dose.  This would be considered a dose timing error and an error in that she received an additional/third dose that she did not qualify for.  No side effects or other adverse effects were noted.
I received the Modena vaccination 09/14/2021.  I expected side effects within 48 to 72 hours or 2 more days.  I started having extreme joint pains on Wednesday, 09/22/2021.  I have osteoarthritis, 3 hip replacements, and this pain  worsened over several days, (still going on), than I have experienced, ever.; (aside of having the flu back in 1993).  After having the joint pain x 2 days, then came to my muscles.  I ached all over, as if, I had received the injection in every muscle of my body. ( post vaccine muscle soreness).   Still having joint aches, muscle aches, and now a rash to my upper arms, across my chest, and on my abdomen.  Makes my skin feel like it is on fire.  (Try to sleep with that mess- ah, no) I am now having tingling on my tongue, which will not go away.  I still have my taste and smell.  Halaleuja
Redness on arm with raised bumps, & swelling,  vomitted 2x   After midnight the night of vaccine patient had the symptoms Called in work the next week  to recover from symptoms Patient has now re covered & returned to work
Patient was admitted with COVID-19 with fever and tachycardia.  Fever has resolved.  No more tachycardia.  Patient feels well.  Eager to go home.  Discussed with infectious disease.  Okay to discharge him home 8/15.
Patient vaccinated 8/27/2021, 8/6/2021. Patient hospitalized 1/10/22 with COVID.
Client received Janssen (lot # 1822809 exp 03/07/2022) in left arm at 11:15 am. Client also received Influenza (Lot # 3NA4M exp 06/30/2022) in the right arm at 11:16 am. At 11:45 am PHN approached client sitting on the ground after moving from the chair at outreach. PHN noticed a small, bumpy, red rash on bilateral upper arms. Client denied feeling itchy however client was observed scratching arm. Client denies dizziness, nausea, swelling of throat, or chest discomfort. Vitals taken by PHN at 11:46 am: BP 140/78, pulse 104, RR 16, 97% SpO2. Client reports history of immediate hives and itching after receiving IV Ancef, Penicillin, phenobarbital, Haldol, and Prednisone. Client has history of epilepsy, reports he is not currently on medication, last seizure in 1996. Medical consult sent to Vaccine Operation Leads prior to vaccination. Reviewed by Dr., client approved to receive Janssen vaccine today. At 11:50 am PHN observed rash past client?s elbow on left arm. At 11:50 am, 50 mg Benadryl PO given to client to drink. Vitals taken at 11:55 am: BP 144/80, HR 101, RR 20, 97% SpO2. Client reports BP ?normally reads that high.? Client continues to deny feeling itchy, denies HA, denies dizziness, denies any discomfort. At 11:55 am, rash noted to stop at left wrist, no progression noted on right arm. At 12:00 pm vitals taken: BP 146/80, HR 98, RR20, 95 % SpO2. At 12:05 pm Vitals taken: BP 150/82, HR 95, RR 20, 95% SpO2. Rash on left arm less pronounced, appears lighter. At 12:10 PM Vitals taken: 150/85, HR 95, RR 20, 96% SpO2. Client continues to sit on the ground during this time, eating soup and drinking water. At 12:25 pm rash presents with no redness, only small pimple-like red spots. PHN educated s/s allergic reactions, when to call emergency. PHN educated to follow up with PMD in 24 hours, clinic referral provided. Client agrees to go in for follow up. Client stood up with PHN, denied dizziness, denies any discomfort. At 12:30 am client walked off with steady gait to wait for ride from outreach.
Approximately 15 minutes after IM injection, patient developed chest tightness.  Patient was taken to the Emergency Department for treatment.  Was given sublingual nitroglycerin  and subsequently admitted to the hospital for observation.  Patient discharged home the following morning in good condition.
Leg and neck pain 2 days before heart attack, chest pain 4 hours; died at home; EMS attempted defibrillator and intubation with no return of normal rhythm. Heart attack/Myocardial event and death no prior history of heart attack
Patient states has a "tennis sized" area of swelling and redness with an inch sized dark spot at the site of administration
Fever not exceeding 101.4, body aches, chills, muscle pain, sore throat, hot and cold flashes, injection arm pain, tiredness, loss of appetite, winded from walking, dizziness and nausea
did not feel well; Initial information received on 27-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp via Center well specialty pharmacy.  This case involves Elderly male patient who experienced did not feel well while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (dose, formulation, strength, lot and expiry date: unknown) via unknown route in unknown administration site for prophylaxis vaccination.  On an unknown date the patient developed a non-serious did not feel well (malaise) (unknown latency) following the administration of INFLUENZA VACCINE.  Severity: Mild  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (did not feel well).  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event did not feel well.
Patient had fever; Heart palpitations; Arm sore; Nauseas; felt like she was going to faint; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Patient had fever), PALPITATIONS (Heart palpitations), PAIN IN EXTREMITY (Arm sore), NAUSEA (Nauseas) and PRESYNCOPE (felt like she was going to faint) in a 70-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Patient had fever), PALPITATIONS (Heart palpitations), PAIN IN EXTREMITY (Arm sore), NAUSEA (Nauseas) and PRESYNCOPE (felt like she was going to faint). At the time of the report, PYREXIA (Patient had fever), PALPITATIONS (Heart palpitations), PAIN IN EXTREMITY (Arm sore), NAUSEA (Nauseas) and PRESYNCOPE (felt like she was going to faint) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about concurrent condition and medical history of the patient was not provided. Concomitant medication included properly stored sterile diluent (manufacturer unknown). On 06-JUL-2017, the patient was administered a dose of improperly stored VARIVAX (lot # N001528, expired date 13-JAN-2019; dose and route were not provided) for prophylaxis (incorrect product storage). The vaccine was exposure to  temperature excursion (range of 6 Fahrenheit degrees to 14 Fahrenheit degrees) for 12 hours. There was no previous temperature excursion. The dose of VARIVAX was reconstituted with properly stored sterile diluent (lot and expiration date not reported). Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA009098: US-009507513-1707USA008903: US-009507513-1707USA009100: US-009507513-1707USA009101: US-009507513-1707USA009102:
This spontaneous report was received from an office manager and refers to a 5 year-old patient of unknown gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history reported. On 01-NOV-2016, the patient was vaccinated with the first improperly stored dose of VARIVAX, lot number M027885 with an expiration date on 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. No data logger was involved. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1704USA004460: US-009507513-1704USA004461: US-009507513-1704USA004462: US-009507513-1704USA004463: US-009507513-1704USA004464: US-009507513-1704USA004465: US-009507513-1704USA004466: US-009507513-1704USA004467: US-009507513-1704USA004468: US-009507513-1704USA004469: US-009507513-1704USA004470: US-009507513-1704USA004471: US-009507513-1704USA004472: US-009507513-1704USA004473: US-009507513-1704USA004474: US-009507513-1704USA004475: US-009507513-1704USA004476: US-009507513-1704USA004477: US-009507513-1704USA004478: US-009507513-1704USA004479: US-009507513-1704USA004481: US-009507513-1704USA004482: US-009507513-1704USA004483: US-009507513-1704USA004484: US-009507513-1704USA004485: US-009507513-1704USA004486: US-009507513-1704USA004487: US-009507513-1704USA004488: US-009507513-1704USA004489: US-009507513-1704USA004490: US-009507513-1704USA004491: US-009507513-1704USA004492: US-009507513-1704USA004493: US-009507513-1704USA004494: US-009507513-1704USA004495: US-009507513-1704USA004496: US-009507513-1704USA004497: US-009507513-1704USA004498: US-009507513-1704USA004499: US-009507513-1704USA004500: US-009507513-1704USA004501: US-009507513-1704USA004502: US-009507513-1704USA004503: US-009507513-1704USA004504: US-009507513-1704USA004505: US-009507513-1704USA004506: US-009507513-1704USA004507: US-009507513-1704USA004508: US-009507513-1704USA004509: US-009507513-1704USA004510: US-009507513-1704USA004511: US-009507513-1704USA004512: US-009507513-1704USA004513:US-009507513-1704USA004514: US-009507513-1704USA004515: US-009507513-1704USA004516: US-009507513-1704USA004517:
On the day of administration - chest pain, nausea, vomiting, diaphoretic. From Sept 27-30th general malaise. Now hospitalized as an inpatient with an NSTEMI on Sept 30, 2022.
This spontaneous report was received from a consumer refers to her grandson of an unknown age. The patient's medical history or concurrent conditions were not provided. On an unknown date, the patient was vaccinated with a dose of ROTATEQ (oral by default, dose and lot number were not provided). Concomitant medications were not provided. On an unknown date, one week and four days later, the patient developed intussusception. The patient experienced having a diaper full of blood. Subsequently, the patient underwent surgery and was currently hospitalized (length of stay was unknown). The patient sought medical attention, spoke with healthcare provider. At the time of the report, the patient did not recover from the adverse event. Upon internal review intussusception was considered to be medically significant, as patient had to undergo surgery. Additional information is not expected.
fever of 101; NAUSEA; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever and nausea. On an unknown date, the outcome of the fever and nausea were unknown.   It was unknown if the reporter considered the fever and nausea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and experienced a fever and nausea.  The reporter asked was that a normal side effect or reaction to the second injection of Shingrix.
Swelling in the right side of the face from the ear to the throat/ Then, swelling in the other side; Tiredness and general discomfort; Tiredness and general discomfort.; Light fever; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the arm left on 07Apr2021 at 09:00(at the age of 48-year-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications included vitamin d nos (MANUFACTURER UNKNOWN) for unknown indications and from an unknown date. The patient had no known allergies to medications, food or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 18March2021 at 15:00 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 07:00 the patient experienced swelling in the right side of the face from the ear to the throat, 12 hours after the shot. Then, experienced swelling in the other side, tiredness, general discomfort and light fever. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events swelling in the right side of the face from the ear to the throat, swelling in the other side, tiredness, general discomfort and light fever were not recovered, at the time of this report.  No follow-up attempts are needed. No further information is expected.
Fever or Chills  Cough  New loss of taste or smell  Congestion or running nose
Vomiting; This is a spontaneous report from a non-contactable consumer (reporting for himself).  A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unknown), via an unspecified route of administration on 29Jan2021 at SINGLE DOSE (right arm, dose 1) for covid-19 immunisation. Medical history included allergies to penicillin and mushrooms from an unspecified date. Patient did not have COVID prior vaccination. Patient was not tested post vaccination. No other vaccine in four weeks. The patient's concomitant medications were not reported. The patient experienced vomiting on 30Jan2021. No treatment was provided. Event outcome was recovering.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Patient is a 61 y.o. female patient of MD with a history of chest pain and dizziness.  Patient states that she has been diagnosed with blood clots in her legs recently and was started on Eliquis yesterday.  States that she has been having inferior substernal chest pains a mix of sharpness and pressure, over the last 3 days.  Does note that she feels short of breath.  States that she has been having fevers and chills.  Does note that she has been dizzy.  States that her husband is here in the hospital for chest pain and she has been with him upstairs.  States that the symptoms were such that she felt that she needed to be evaluated as she became deeply concerned.  Has had a dry cough.  States that she thought that she was "just getting a cold".  Has also felt nauseated over the last 4 days, worse over the last 3 days.  Denies additional clinical concerns at this time. No hypoxia, pt stabilized dced home , eliquis resumed from outpt dvt   Discharge Diagnoses:   Covid Dm Htn Dvt HFpEF SVT
Red, swollen, extremely itchy  at the site. About a 3" in diameter area
Pt had 3 x 4 cm red, raised area right deltoid from pneumonia vac. c/o pain in arm across shoulders arm red warm to touch localized elevated temp. Treated with topical steroids. Benadryl and tylenol returned to clinic on Thur to see doctor and area was smaller.
Shivering uncontrollably head-to-toe, vomiting, severe muscle aches, severe bone aches, severe joint aches, temperature, sweating, wheezing, weakness (esp hands & legs) dizziness & headache. I wish I would have gone to Emer. Rm. The real bad symptoms seemed to end approx 12:30 AM (midnight) on 2-2-10 but I was aching and sick all week long. Aching went away on Sun. 2-7-10. -Twice as bad as any flu I ever had.
Immediately after receiving 2n d COVID vaccine, Within minutes, I noticed black floaters in my eye.  I noticed this on & off for a few days after.  Wasn?t too problematic but still was concerned that this never happened before symptoms lessened over time. . On  7/26, I had even more black floaters And larger this time  after an 11 hour flight, upon return home I went to an Ophthalmologist for an examination. I never had black eye floaters prior to vaccine.
post vaccine - c/o pain to right arm and back, feeling tired and weak. and "out of it"
Felt sudden onset of numbness like novocain shot had been administered around nose lips, face, in nose, mouth and chin area.; Felt tingling lips.; This is a spontaneous report from a contactable other healthcare professional, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 10Apr2021 at 11:00 (at the age of 49-years old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any medication within two weeks of vaccination. The patient previously took Erythromycin, Levaquin, Bactrim, Phenylephrine; all on an unknown date for unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021 at 19:15 the patient experienced Felt tingling lips. On 12Apr2021 the patient experienced Felt sudden onset of numbness like Novocain shot had been administered around nose, lips, face in her nose, mouth and chin area. Felt as though she had been out in the snow and couldn't feel her face. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether the patient receive any treatment for the reported events. The clinical outcome of the events tingling lips and Felt sudden onset of numbness like Novocain shot had been administered around nose, lips, face in her nose, mouth and chin area was recovering.  No follow-up attempts are needed. No further information is expected.