chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a 27 year old female with no pertinent medical history who on 21-MAY-2007 was vaccinated with a first dose of Gardasil.  There was no concomitant medication. On 28-MAY-2007 the patient experienced pain at injection site.  She also had limited mobility and severe weakness in the entire arm for six weeks.  Unspecified medical attention was sought.  Subsequently, the patient recovered.  On 27-JUL-2007, the patient was vaccinated with a second dose of Gardasil.  On approximately 27-JUL-2007 the patient experienced pain at injection site.  Subsequently, the patient recovered.  Additional information has been requested.
I began breaking out in hives 4 days after getting the J&J vaccine back in March.  Never had hives before in my life.  I continue to have severe hives on back, neck and underarms.  I've been to my doctor no less than 15 times since March to get steroid shots and pills to keep the hives calm.  I'm 6 months in now and if I am not on steroids the hives return within 24 hours.  My doctor had me get off all other prescribed medications just to make sure it wasn't causing the hives.  Also changed all soaps, detergents, sheets, underwear, diet, etc... not changes.  My dermatologist and primary doctor are confident that the hives are a reaction to the vaccine.  It is very bad.
fever, chills, nausea, loss of appetite, myalgia, burning, itching rash. The rash appeared on BLE and BUE with vesicles and that ulcerated
9/1/2022 Doctors Visit - Respiratory w/ Chest Congestion, Vomiting. Out of School 9/2/2022 to 9/6/2022.  9/8/2022 Doctors Visit - Respiratory w/ Chest Congestion, Vomiting. Out of School 9/9/2022 to 9/12/2022.   10/26/2022 Vomiting at School Runny Nose Congestion  10/27/2022 Doctors Visit - Ear Infection Received Flu Shot Out of School 10/27/2022 to 10/31/2022  Medication Prescribed by Doctor - *ProAir HFA : 108 (90 Base) MCG/ACT 2 puffs needed Inhalation every 4 hours  *Cetirizine HCl Children 5mg/5ml 5 ml orally twice a day (Malakai would not keep down Vomiting when taken)  *Prednisolone 12mg/5ml (Malakai would not keep down Vomiting)  Children's Tynol 5ml  Children's Motrin 5ml Children's Muconex Multi Symptom Cold 5ml
On 9/6/2017 child had febrile seizure and was transported to hospital via ambulance; mom reports eyes rolled back, child was non-responsive for one minute and temp was 102.2.
This spontaneous case, initially received on 06-Feb-2018, was reported by a pharmacist and concerns an 83-year-old female patient. The patient's medical history was not reported. The concomitant medications included, atenolol 50mg, levothyroxine 1.37mg, lisinopril 40mg, furosemide 40mg atorvastatin 40mg and felodipine ER 10 mg. On an unspecified date in Sep-2017, the patient received first dose of FLUZONE quadrivalent. On 03-Feb-2018, the patient was administered with second dose of FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 179003, expiry date: not reported), accidentally for the flu season (considered as inappropriate schedule of vaccine administered). It was reported that, the patient had no adverse reactions after vaccination. The reporter assessed the event as non-serious.
w/in 24hr of vax pt devel an inj site rxn characterized by redness & swelling which extended to the elbow;
Vomiting, diarrhea in the evening. Diarrhea and headache the next day.
Generalized hives, especially on trunk. The follow up states, "I treated him in the ER. When I called I was told that the lot number was not available."
102+ fever, violent shakes, einter body in pain, coughing, intense thirst.
Receive flu shot vaccine - 4 hrs. after receiving the vaccine developed red hive like rash on trunk of body. Left side face and bilateral eyes swelled, c/o malaise.
At 10:30 AM patient felt numbing in lower lip, tingling also was noted. Rt. side of face started to feel strange, looked in the mirror and noticed that smile was not even. Rt. eye felt tired and strange, patient thought might be having a stroke. As the day went on was feeling very tired and had a headache still which patient woke up with. Was having no problems with arms or legs, so patient decided was not having a stroke. Went to the Dr. the next day, and was diagnoised with Bells Palsy on the right and left side, but more on the right. Patient was put on prednisone and antiviral. By the 2nd. day was alot worse patient's speech was affected, it was slurred and could not eat or drink without the drink or food drooling out of mouth. After about 4-5 weeks patient was better, but not completely back to normal.
Patient called drs. office on 06/12/09 to report redness in area of the injection and that area was warm to the touch. The drs office called back patient immediately but patient could not be reached. Patient did not show up for their next appointment (scheduled for 06/16/09).
Itching in eyes; Little pain; Felt tired; This spontaneous case was reported by a patient and describes the occurrence of EYE PRURITUS (Itching in eyes), PAIN (Little pain) and FATIGUE (Felt tired) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis.   On 22-Feb-2022, the patient received third 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) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On 22-Feb-2022, the patient experienced EYE PRURITUS (Itching in eyes), PAIN (Little pain) and FATIGUE (Felt tired). At the time of the report, EYE PRURITUS (Itching in eyes), PAIN (Little pain) and FATIGUE (Felt tired) outcome was unknown.            No concomitant medications were provided. No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
felt really rough like she was trying to shake the flu, like a truck ran over her; felt flushed; shoulder woke her up when she rolled on it; left shoulder became very swollen; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt really rough like she was trying to shake the flu, like a truck ran over her), FLUSHING (felt flushed), SLEEP DISORDER (shoulder woke her up when she rolled on it) and VACCINATION SITE SWELLING (left shoulder became very swollen) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A. and 020L20A) for COVID-19 vaccination.     The patient's past medical history included Cancer (bone marrow cancer) in 2007 and Bone marrow transplant in 2007.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE SWELLING (left shoulder became very swollen). On 15-Sep-2021, the patient experienced FEELING ABNORMAL (felt really rough like she was trying to shake the flu, like a truck ran over her), FLUSHING (felt flushed) and SLEEP DISORDER (shoulder woke her up when she rolled on it). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) ongoing from 15-Sep-2021 for Sleep difficult, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (felt really rough like she was trying to shake the flu, like a truck ran over her), FLUSHING (felt flushed), SLEEP DISORDER (shoulder woke her up when she rolled on it) and VACCINATION SITE SWELLING (left shoulder became very swollen) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The night of the vaccination, her shoulder became very swollen and she iced it. She drank tea and fluids for adverse events.   This case was linked to MOD-2021-320894, MOD-2021-320886.
Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. As a former member of the military, I received my first injection of the Anthrax vaccine in December 2003 and the second injection in February 2004. Following both injections, I suffered from flu-like symptoms, low grade fever, fatigue, and muscle aches. Four months after the second injection, I realized that my left, upper arm was completely numb and realized that my energy level never returned to normal. After numerous visits to the medical facilities available to me overseas, I was diagnosed with severe depression. I declined to take further injections but was ordered to do so regardless of medical opinion and was in the process of undergoing court martial  when it was ordered to stop the mandatory vaccines. I have since received an Honorable Discharge, but my health continues to suffer from what I believe is an adverse reaction to the vaccine. I was diagnosed with Bradycardia. My heart rate was discovered to be a low 48bpm with no explanation. The physician merely scratched his head and said he did not know or understand the cause of my low heart rate. I also suffer from light-headedness, dizziness, lower back pain, joint pain, occasional blurred vision, difficulty concentrating, trouble sleeping, and chronic fatigue. The military does not deny that I have these symptoms but claim these symptoms are a result of depression and not the vaccine. I disagree.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swollen arm around the injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced VACCINATION SITE SWELLING (swollen arm around the injection site). At the time of the report, VACCINATION SITE SWELLING (swollen arm around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Information has been received from a physician concerning a 23 year old female health professional with no known drug allergies who on an unspecified date was vaccinated with one dose of MMR II. In 1994 the pt had her measles, mumps and rubella titer checked and her rubella titer was found to be low. In 1994, the pt was vaccinated with a booster dose of MMR II. In 1996 the pt had a negative measles titer. On 9/23/96, the pt was vaccinated wi0th a booster dose of MMR II (614225/0098D). There was no illness at the time of vaccination. On 5/14/02 the pt's lab test revealed an equivocal rubeola and negative mumps titer. Her rubella titer was positive. The test was re run to confirm the results. It was also noted that the pt was vaccinated with a dose of varicella virus vaccine live on 1/12/96 and 2/28/96 and experienced a negative varicella zoster IgG test (WAES0205USA03298). No further info is expected.
Itchy upper arm; pain in arm; arm swelling; soreness at injection site; itchiness near injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm), PRURITUS (Itchy upper arm), PERIPHERAL SWELLING (arm swelling), VACCINATION SITE PAIN (soreness at injection site) and VACCINATION SITE PRURITUS (itchiness near injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     Concurrent medical conditions included Low sodium diet (she has been hospitalized about a year ago for low sodium).    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced PAIN IN EXTREMITY (pain in arm). On 14-Apr-2021, the patient experienced PRURITUS (Itchy upper arm). In April 2021, the patient experienced PERIPHERAL SWELLING (arm swelling), VACCINATION SITE PAIN (soreness at injection site) and VACCINATION SITE PRURITUS (itchiness near injection site). At the time of the report, PAIN IN EXTREMITY (pain in arm), PRURITUS (Itchy upper arm), PERIPHERAL SWELLING (arm swelling), VACCINATION SITE PAIN (soreness at injection site) and VACCINATION SITE PRURITUS (itchiness near injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medication were reported no treatment information were provided   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Follow up was received event was added
Site of injection is hot to touch; Body achiness; Fever up to 102 degrees and is going down; chills/cold; Site of injection is bright red taking up the whole shoulder; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Site of injection is hot to touch), MYALGIA (Body achiness), PYREXIA (Fever up to 102 degrees and is going down), CHILLS (chills/cold) and VACCINATION SITE ERYTHEMA (Site of injection is bright red taking up the whole shoulder) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A and 046B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced VACCINATION SITE WARMTH (Site of injection is hot to touch), MYALGIA (Body achiness), PYREXIA (Fever up to 102 degrees and is going down), CHILLS (chills/cold) and VACCINATION SITE ERYTHEMA (Site of injection is bright red taking up the whole shoulder). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Site of injection is hot to touch), MYALGIA (Body achiness), PYREXIA (Fever up to 102 degrees and is going down), CHILLS (chills/cold) and VACCINATION SITE ERYTHEMA (Site of injection is bright red taking up the whole shoulder) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-May-2021, Body temperature: 102 (High) Unknown.         No concomitant medication was reported.
had both, got it again/ suspected vaccination failure; got it; big red mark on my scalp; This case was reported by a consumer viainteractive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and erythema. On an unknown date, the outcome of the vaccination failure, shingles and erythema were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and erythema to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had both Shingles shot and still got shingles physician said had shingles again no blisters n itching just a big red mark on scalp. The patient stated he/she vaccine did not always work. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Participant tested positive for COVID-19 with a home test two months after vaccination. Had a Telehealth appointment and was prescribed molnupiravir; Took another COVID-19 test 10 days later and it negative.
Patient came in for his Immunizations yesterday and his parents bring him in today with a large reaction at the site on the left anterior thigh. He had received DTAP's in the past with out difficulty. Yesterday he got an MMR on the right side, DTAP and HIB on the left. Has not had fever. Has been his normal active happy self. Well appearing and playful boy. Left anterior thigh shows a large area of erythema, induration, and warmth which measures 7.0x 11.0 cm 1). Large local reaction to immunizations likely HIB. P: Discussed with RN, who will file an Immunization report, although this is clearly just a local reaction and even though it is fairly significant, should not be a problem as far as completing the course of Immunizations. Parents are reassured. Follow up PRN.
Pt complained of L eye burning and then R eye burning. She states her face became reddened and swollen. Complained of body aches, sore throat, chills, temp of 100.5 and heart rate 115. States developed severe headache that lasted to the following day. She went to an urgent care where she was observed for an hour. She did not receive any treatment for symptoms.
Itchy rash both arms above and below elbow left, below right elbow; both thighs; neck/chest; back of hands; bridge of nose and cheeks Treated with oral Pred, Benedryl, topical steroid cream Lasted about a week.
Approx. 5 minutes after vaccine administration child c/o itchy throat. He then vomited followed by diarrhea, then severe flushing. He then became hypothermic. He was dx with anaphylactic reaction. Given EPIPEN 0.15 mg and escorted to ED for further treatment and monitoring. There he was given another dose of epinephrine 0.15 mg 15 mg BENADRYL injection, and 10 mg Dexamethasone. Condition stabilized and patient was discharged to home.
Body ache (resolved in 24 hours), headache (resolved in 24 hours), mild fever (resolved in 24 hours).
I went to the doctor more than 20 times between March 1999 and December, 1999. My symptoms included: neck pain,
This spontaneous report as received from a certified medical assistant (C.M.A) also reported as  healthcare worker who refers to a female patient of unknown age. On 03-MAY-2014 the patient was vaccinated with the first dose of RECOMBIVAX HB (route of administration, anatomical location and lot # not provided). On 12-SEP-2014 (also reported as today), the patient was getting the second dose of RECOMBIVAX HB (route of administration, anatomical location and lot # not provided). No concomitant medication ws reported. No adverse effects were reported at the  lime of the report. No product quality complaint (PQC) was involved. Additional information has been requested.
Chest tightness; Fever; Pain in the left arm; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the left arm), INFLUENZA LIKE ILLNESS (Flu like symptoms), CHEST DISCOMFORT (Chest tightness) and PYREXIA (Fever) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Drug allergy (Allergy to Erythromycin), Drug allergy (Allergy to Clindamycin), Sulfonamide allergy (Allergy to Sulfa), Drug allergy (Allergy to Flonase), Allergy to molds, Allergic to cats (Allergy to cats), Grass allergy, Allergy and Cockroach allergy (Allergy to cockroaches). Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) and DENOSUMAB (PROLIA) for an unknown indication, DIPHENHYDRAMINE.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in the left arm), INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Fever). On 09-Jan-2021, the patient experienced CHEST DISCOMFORT (Chest tightness). At the time of the report, PAIN IN EXTREMITY (Pain in the left arm), INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Fever) had resolved and CHEST DISCOMFORT (Chest tightness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication includes Allergy shot received on 04-jan-2021 due to allergies. No treatment information was provided. Patient reported that chest tightness was from Benadryl which she took before vaccination.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow-up received, updated event outcome and reporter's causality.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and PYREXIA (fever) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 029K20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included APIXABAN (ELIQUIS), CARVEDILOL, PRAVASTATIN, EZETIMIBE (ZETIA), CALCITRIOL, eylea injections and LATANOPROST for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jan-2021, the patient experienced CHILLS (chills) and PYREXIA (fever). At the time of the report, CHILLS (chills) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details was not reported by the reporter.
Pt with cellulitis overlying injection site, diagnosed about 50 hours after vaccination with influenza and pneumovax.