chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever 103.3 p/vax APAP given; next noc woke crying consolable but high pitched cry warm packs to leg w/APAP;
Reports tongue numbness and strange taste at 4:10PM 415pm Benadryl 25mg and water 422 pm patient reports has no numbness and can't describe the taste but feels good and was able to go home instructions  of any more or worsen symptoms to go ER
Information has been received from a physician concerning an 11-15 year old female who was vaccinated with a second dose of VARIVAX (Oka/Merck). Subsequently the patient experienced chickenpox type lesions after the second dose of VARIVAX (Oka/Merck). This is one of two reports from the same source. Additional information has been requested.
Soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at the injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN POTASSIUM, DILTIAZEM HCL, ALENDRONATE SODIUM, LORATADINE, ACETYLSALICYLIC ACID (BAYER ASPIRIN) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site). At the time of the report, VACCINATION SITE PAIN (Soreness at the injection site) outcome was unknown.            Treatment medications were unknown.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.   This case was linked to MOD-2021-037157 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: On an unknown date new event (Soreness at the injection site) was added.
Headaches so severe went to ED, neg MRI brain.  Last day of work was 17 days ago, so possible vaccine reaction has lasted 17 days and not improving, better when taking steroids.
Information has been received from a nurse practitioner referring to an unspecified number of patients of unknown age and gender. Information about pertinent medical history, drug reactions/allergies and concomitant medication was not provided. On unknown dates the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L040054, expiration date 26-DEC-2017, intramuscular, dose unknown). The vaccines were stored under the temperature of 37 centigrade for 4 hours. There was no previous temperature excursion. No adverse effects were reported. The call was because of a data logger. Additional information has been requested.
11/10/18 at injection plus 27 hrs onset of slight headache, tiredness. By nightfall (inj plus 30 hrs) went to bed with severe headache, chills and body aches. By next morning (inj plus 48 hrs) noted formation of raised rash like a C-shape with a bar through it, starting about 3 inches below the injection site on R arm. It looked like a large cattle brand about 3 inches wide. I was unable to lift R arm to open cupboards or perform tasks. Felt feverish during the night but too ill to take temperature. By injection plus 56 hours, the rash also expanded along lower part of R bicep. Began to feel better by injection plus 60 hrs. Rash faded over the next 48 hours and all other symptoms subsided. More post-marketing data is needed!!
Nausea, vomiting, migraine, fever (100°), body aches, fatigue
rt thigh w/6x4cm area of erythema @ inj site;sl warm;no fluctuation;dx suspected cellulitis;
Reddened area approx. 1 3/4 x 2 1/4 cm, warm to touch surrounding injection site of left thigh.
Initial unsolicited report received from a health care professional on 30 June 2015. A female patient, whose medical history and concomitant medications were not reported, had received twice Meningococcal vaccine (batch number, route of administration, site of administration were not reported) on an unspecified date. On an unspecified date, after vaccination, the patient experienced meningococcal meningitis and lost some hearing. Laboratory investigations and corrective treatments were not reported. At the time of this report the patient was recovering from meningococcal meningitis and outcome of lost some hearing was unknown. Upon medical review, the case was considered as serious due to important medical event: meningococcal meningitis. Documents held by sender: none.
Initial misuse report received from a nurse on 03 October 2013.  The 69-year old patient had received FLUZONE HD that was expired. No adverse event was reported. List of documents held by sender: none
7 days after vaccination he seized 6 to 8 times a day for 3 months.
received 2nd dose 3/17/2021. Symptom onset 8/17/2021 beginning with SOHB which she thought was related to her anxiety Found to be (+) on 8/17/2021 . admitted to Hospital from 08/17/2021 through 8/22/2021 to home.
Employee had pain during injection and is having prolonged left shoulder pain with restriction of movement after two weeks post injection and worsen last couple of days on 10/26/2021
Pain at the injection site was typical for vaccination and was essentially gone by the next day. Headache started within one hour after vaccination and was severe 4 hours after vaccination. Next day morning I woke up with all my face swollen, runny nose, headache, stiff neck, pressure and pain at the base of the skull, pain and edema behind and below both jaws, pain in the right year and dizziness. Face edema and runny nose subsided 3 days after injection. Stiff neck, pressure and pain at the base of the skull, pain and edema behind and below both jaws, pain in the right year persists 7 days after injection. Dizziness and foggy head became  worth 7 days after injection.
bilateral renal infarcts; blood clot lower left ventrical; This spontaneous case was reported by a consumer and describes the occurrence of RENAL INFARCT (bilateral renal infarcts) and CARDIAC VENTRICULAR THROMBOSIS (blood clot lower left ventrical) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RENAL INFARCT (bilateral renal infarcts) (seriousness criteria hospitalization and medically significant) and CARDIAC VENTRICULAR THROMBOSIS (blood clot lower left ventrical) (seriousness criteria hospitalization and medically significant). At the time of the report, RENAL INFARCT (bilateral renal infarcts) and CARDIAC VENTRICULAR THROMBOSIS (blood clot lower left ventrical) outcome was unknown.            Concomitant product use was not provided by the reporter.  No treatment information was provided.  Company comment: Very limited information regarding these events have been provided at this time. Further information regarding temporal association is necessary.; Sender's Comments: MR-QC: Please don't review this case. Very limited information regarding these events have been provided at this time. Further information regarding temporal association is necessary.
Patient had fever of 102, 4cm erythema at injection site on right arm, nausea, chills, myalgia and headache. Treatment plan for patient included supportive care to get through the next couple of days. Recommended doses of Tylenol and Motrin and staying hydrated.
My Blood Pressure's High and Low readings jumped up 20-30 points on 01/16/2021 to 01/22/2021 when my PCP ordered my Lisinopril 10mg increased to 20mg. and came down 20 points each that night and normalized on 01/23/2021.
Patient felt "a little dizzy" after sitting  for 15 minutes post vaccination. Pharmacist asked for other possible reactions: tingling, itchy skin, rash, difficulty swallowing or swelling of lips. Patient denied all those reactions  stating that he only felt "a little dizzy." He decided that he would sit for 10-15 more minutes to "wait it out." Patient was given water to sip while seated for the extra time. After about 10 minutes he was able to walk without feeling dizzy and reported to the pharmacist that he was well. Pharmacist advised him to log onto the V-Safe site to report his reactions and to review the Moderna EUA.
Patient had fever of 100.7 F, body aches and fatigue 1 day after her vaccination.   Fever and other initial symptoms resolved within 24 hours but on second day following vaccination patient developed painful swelling in the axilla of her right arm.  Swelling is very tender to touch but also a constant pain without palpation.  Rates pain 7/10.  Today is day #4 following vaccination, swelling and tenderness remain however day #3 was the peak for both pain and swelling.  Swelling is diffuse and soft to gentle palpation but area is too sensitive for deep palpation.
Patient was seen in the office on  09/11 complaining about   left eye/ear/throat pain developed since  9/4/2020, the day after she received a flu shot (left deltoid) and shingles shot (right deltoid) on Thursday, 9/3/2020. On 09/10,  she has developed left sided scalp/forehead rash with blister-type bumps. Erythromycin eye drops were ordered 4 times daily in the left eye as needed for irritation Valtrex was ordered  Following instructions were given : 1. Complete the full course of antiviral medication as prescribed. 2. Use the erythromycin ointment up to 4 times daily in the left eye as needed for irritation. 3. Continue to use over-the-counter artificial tears four times daily in both eyes. 4. Expect a call from the Eye Department to schedule an appointment for an eye exam next week. 5. Refer to the included information on shingles for other home care you may use on the skin of your scalp. 6. Follow-up as needed if symptoms get worse or do not improve. Seen by Optometry on 09/16 and 09/23/2020 New medication Prednisolone eye drop was added on 09/23 by Optometry
Pain in arm; Loss of range of motion in arm; Injected into bursa space in the shoulder joint; A spontaneous report was received from a consumer concerning a 44 year old, male patient who experienced pain in the arm, loss of range of motion in the arm and incorrect route of administration.   The patient's medical history was not provided.  Concomitant medication was not provided.    The patient received their first of two planned doses of mRNA-1273 (Batch: 025J20A) on 31 DEC 2020.    On 02 FEB 2021, approximately the same day prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch : 026L20A) and was injected into bursa space in the shoulder joint for prophylaxis of COVID-19 infection.    On 02 Feb 2021, the patient experienced severe pain in the arm and loss of range of motion in the arm.   The patient was hospitalized on 03 FEB 2021 and released on 04 FEB 2021.  Treatment information was not provided.   Action taken with vaccine was not applicable..  The outcome for pain in the arm, loss of range of motion in the arm was not reported and recovered for incorrect route of administration.; Reporter's Comments: This report refers to a case of Vaccine administration error for mRNA-1273, lot #  026L20A with associated AEs. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Lower abdominal pain, nausea, vomiting, low grade fever. Patient also admits to consuming alcohol, which is a little increased. Temp 100. 8/6/08-records received for DOS 6/10-6/13/08-DC DX: Alcohol-induced hepatitis. Alcohol withdrawal. C/O acute onset of abdominal pain started 2 days prior to admission radiating to groin and bilateral lower extremities. Associated with nausea, vomiting and mild non-bloody diarrhea. History of extremely heavy drinking in past but stated that she drank at least 6-8 Tequila shots everyday for past six to seven months. Drank heavily on day before admission. C/O of early satiety for a couple fo months. Follow-up Information 30-JUN-2008: We are responding to the enclosed letter concerning this patient. The patient was evaluated by a doctor at a medical group. On the day we submitted the report we spoke with the doctor and obtained the infirmation we included on the report. We do not have the manufacturer name or lot number of her tetanus diphtheria vaccine. Similarly, the name of the manufacturer of her oral typhoid vaccine is not available to us. The doctor may be able to supply information concerning her tetanus diphtheria vaccine. The patient clinically improved. After further investigation it seems unlikely that her liver findings and symptoms were related to any vaccines she received previously. I hope you find the above information useful, please do not hesitate to contact me if you need further information from me.
4 hours after receiving Flu vaccine, voice changed. It started getting irritated & felt like something was in throat Went to Emergency room & diagnosed with Allergic reaction & Laryngitis
Patient has reported redness/swelling/pain at injection site. Visited clinic Dx: cellulitis.
tiredness; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 76-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 11Apr2021 at 14:40 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. This case classified as non-serious was reported. On an unspecified date, the patient experienced tiredness and diarrhea. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
41 y.o. female with history of selective IgA deficiency presented to urgent care with tachycardia after the third Covid vaccine that she received yesterday.  At home she noticed resting heart rate of 115.  She get up and exerting herself is 130.to 140.  Patient is otherwise have no fever, chills, nausea, vomiting, headache, dysuria change in bowel habit.  Complaining of a tachycardia give her chest pressure.  No history chest pain shortness of breath or diaphoresis on exertion.  Prior to the vaccine. Assessment 41-year-old female presented to urgent care with tachycardia after thorough Covid vaccine.  After interview and examination of electronic health record review and nursing note reviewed.  Discussed with patient recommend EKG which showed tachycardia no ST changes.  Patient had TSH and T4 ordered by primary physician yesterday the result was normal.  I discussed with patient I recommend for her to have the CBC CMP troponin all unremarkable.  I explained to patient that while in urgent care she received a liter of normal saline her heart rate went down to 90 I feel comfortable patient be discharged home her tachycardia most likely secondary to Covid vaccine side effect is not an allergic reaction normal EKG normal troponin unlikely to be acute myocardial infarction.  Unlikely to be pulmonary embolism with no tachypnea with normal O2 saturation no leg swelling.  Patient have in no distress no active chest pain unlikely of acute myocardial infarction.  I emphasized the need follow-up close with primary physician within 1 week for further evaluation.  Return to urgent care or go the nearest emergency department immediately if she develop fever, chills, nausea, vomiting, headache, chest pain, shortness of breath, weakness or numbness.  Patient acknowledged understanding agree with the plan discharged in stable condition.
This spontaneous report as received from a pharmacist refers to a 65 year old male patient. The patient had no drug reactions and no allergies. On 28-OCT-2015, the patient was vaccinated with a dose of ZOSTAVAX, 0.65ml, subcutaneously, lot # L024999, expiration date: 06-OCT-2016. Concomitant medications were unspecified. On 03-NOV-2015 (also reported as "a few days after patient received ZOSTAVAX"), the injection site became red and raised and the area was hard to touch and also itchy, it was when the patient first noticed raised area on his arm, and when he woke up the next morning injection site was more irritated with a lot of itching. On 03-NOV-2015, the patient went to see his physician. Physician told patient that the injection site was infected and doxycycline was prescribed for the patient. The raised area around injection site was about 6 inches in length with 2 inches in diameter. There were no laboratory diagnostics studies performed. The outcome of the adverse events was reported as not recovered. The relatedness between the events and vaccination with ZOSTAVAX was not reported. Additional information has been requested.
numbness in right hand, fingers and arm; lips feel different; cold as ice; she felt a little tired/more tired; Had soreness the next day after vaccine administered; arm feels heavy; she can't write as well; her fingers do not bend; eyes hurt a little, not a lot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Mar2021 20:00 (Lot number: EL9266) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism", start date: 1981 (ongoing), notes: diagnosed when she was 23 or 24 years old, around 1981 maybe. The patient's concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious) with onset 13Mar2021, outcome "not recovered", described as "cold as ice"; HYPOAESTHESIA (non-serious) with onset 14Mar2021, outcome "not recovered", described as "numbness in right hand, fingers and arm"; FATIGUE (non-serious) with onset 11Mar2021, outcome "not recovered", described as "she felt a little tired/more tired"; LIP DISORDER (non-serious) with onset 14Mar2021, outcome "not recovered", described as "lips feel different"; EYE PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "eyes hurt a little, not a lot"; VACCINATION SITE PAIN (non-serious) with onset 11Mar2021, outcome "unknown", described as "Had soreness the next day after vaccine administered"; LIMB DISCOMFORT (non-serious) with onset Mar2021, outcome "unknown", described as "arm feels heavy"; DYSGRAPHIA (non-serious) with onset Mar2021, outcome "unknown", described as "she can't write as well"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset Mar2021, outcome "unknown", described as "her fingers do not bend".  Additional information: The patient always gets a reaction from the flu shot, she will end up not feeling well, with aches and pains, a mild reaction, not enough to keep her out of work, just not feeling herself. Usually within few days or 3-4 days she is ok. No NDC, Lot or Expiration known for flu shots, does not have products with her. No further information provided and Vaccination Facility Type: Pharmacy. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) N/A. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other vaccines on the same day of vaccine vaccination.  No follow-up attempts are possible. No further information is expected.
Information has been received from a pharmacy technician referring to a 46 year old female patient. Information about patient's concurrent conditions and medical history was not reported. On an unknown date, when the patient was a child, she received an unspecified dose of M-M-R II (lot#, dose, route not reported) in an unspecified country. On an unspecified date the patient experienced measles. In April 2013 the patient received another dose of M-M-R II (lot#, dose, route not reported) (inappropriate schedule of vaccine administered). Outcome of measles was not reported. The causality was not provided. Additional information has been requested.
Went to doctors on 12/02/22 broken out with a rash, itchiness around throat and upper chest, and redness and the rash around the ears. Doctor given a prescription for Cetirizine (Zyrtec) 10mg. 2x a day for 20 days. After 2-1/2 weeks, symptoms are still here. Called doctor on 12/20/22 to tell her that I still had the rash and itchiness going on. Doctor called in a prescription for Prednisone 20mg (3-tablets) 1x day for the next 3 days. Taken 1st Prednisone on 12/22/22 and so far this is where I'm at hoping the Prednisone will take care of it.
Fatigue; Headaches after each dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Sep-2021 and was forwarded to Moderna on 10-Sep-2021.    This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (Fatigue) and HEADACHE (Headaches after each dose) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Heart attack (History of 3 heart attacks) and Stent placement. Concomitant products included LISINOPRIL, METOPROLOL and CLOPIDOGREL for an unknown indication.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue) and HEADACHE (Headaches after each dose). At the time of the report, FATIGUE (Fatigue) had not resolved and HEADACHE (Headaches after each dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   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.   This case was linked to MOD-2021-316410 (Patient Link).
Biopsy confirmed leukocytoclastic vasculitis on legs; scratchy throat; This is a spontaneous report from a contactable physician. A 41-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 11Feb2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. Medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 on 14Jan2021 for covid-19 immunisation. It was reported that biopsy confirmed leukocytoclastic vasculitis on legs which started on 01Mar2021, two weeks after the second Covid vaccine dose. No other systemic cause of vasculitis found on workup in rheumatology. Prednisone started and transient improvement. An antibiotic (Augmentin) was added because the patient also had a scratchy throat. A second tapering prednisone course was restarted for a few weeks.  Vasculitis totally improved by early May and prednisone was discontinued. The patient recovered from the events on an unspecified date.  Information on the lot/ batch number has been requested.; Sender's Comments: Based on current information available, the event leukocytoclastic vasculitis on legs and throat irritation mostly represented intercurrent condition in this patient, unrelated to Bnt162b2. Relevant medical history and concurrent disease are missing for a medically meaningful assessment.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate