chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse event; HBP calling to report the administration of an expired dose of PNEUMOVAX 23 SYRINGE to a patient on 08/15/2023.  No symptoms reported and no further details provided.  No other AE and no PQC; This spontaneous report was received from Other Health Professional and refers to a patient of an unspecified age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 15-AUG-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, lot #U027357, expiration date: 25-MAR-2023, administered for prophylaxis (strength, and route of administration were not provided). On that day, the patient was administered an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). No symptoms were reported and no further details provided. No other adverse events (AE) and no product quality complaint (PQC) were reported.
6 Hives noted on Saturday R Knee 2 on neck; 2-3 left side udner arm very itchy no difficulty breathing
Following injection immediate stinging/burning as if stung by bees. 1-2 hours swelling of injection site the size of a baseball. Redness and tenderness to the skin. Extra salivation and anxiety due to the reaction. Administered oral diphenhydamine 25 mg at 17:30. Site continued to be swollen until 19:00. 11/10/2023 at 05:00 redness and swelling had subsided but R arm muscle feels hard and sore.
Patient stated that developed itchy, red rash on the injection site 3 days after vaccination. It is not hot, or hard, just itchy with some discharge. The rash is not painful. Noticed that arm was itchy after cutting the grass outside (he is allergic to pollen). Recommend for him to take benadryl and call pcp if does not resolve.
This 69 year old woman was admitted with covid pneumonia with hypoxia.  She was treated with remdesivir and steroids.  She has improved.  She also had an exacerbation of copd.  Today her oxygen saturation is 90% on room air.  She will likely go home with oxygen and will be assessed before discharge.  She will complete steroid course orally; i will extend taper.  Follow up with pcp
4/30/21 Within 30 minutes of the shot started seeing black spots, headache and dizzy. Side effects were gone within about an hour. 5/3 11:00 Woke up saw many black spots, and was very dizzy.  Called her PC, 1:00 legs were numb, 3:00 headache stared on left side then went all over. Took to ER did CT and Labs, White & red blood count slightly low, CT results were fine. 5/5 Zoom with DR, 5/6 Opthamologist exam, 5/12 Vision got worse black spots are the size of quarters and take up about 60% of her vision. Took to ER. 5/14 had MRI results were fine. 5/19 some improvement, 5/24 Vision worse again.
Confusion. Didn't know where I was driving home. Massive body aches and headaches.
Extreme headache lasting 3; extreme body aches; swelling in upper arm; redness in upper arm; low grade temperature
This case was reported by a pharmacist via call center representative and described the occurrence of product supply issue in a adult male patient who received 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 product supply issue. On an unknown date, the outcome of the product supply issue was unknown. Additional details were provided as follows: The age at vaccination was not applicable for this report. The health care professional stated, patient would miss the 6 month window for 2nd dose of SHINGRIX next month due to backorder. This case has been linked with case US2018183699, reported by the same reporter.
T105 8 days post vax;taken to PMD advised using motrin & APAP;temp was dec next day;
3 days post vaccine she had very dark puffy circles under her eyes.  Left arm pain for 36 hours. November 23rd needed dental work for tooth pain- pulpectomy  November 24th- diarrhea for 6 days(Rotavirus?)
Within 48 hours of receiving 2nd dose, she has developed intense dry cough that is not going away; She went to ER, and they said it was angioedema; A spontaneous report was received from a consumer concerning a 31-years-old, female patient who experienced angioedema, and cough.   The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included tofacitinib citrate, duloxetine, ferrous sulfate and famciclovir.   On 11 Feb 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 batch number not provided intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 11 Feb 2021, the patient experienced lip swelling, tongue swelling and trouble breathing within twenty-four hours from vaccination. She went to the emergency room where that said she has angioedema.  On 13 Feb 2021, the patient reported that she developed intense dry cough that is not going away. Treatment for the event included humidifier and Tessalon pearls.    The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the events was not reported.; Reporter's Comments: 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.
This case was reported by a physician and described the occurrence of lethargy in a subject of unspecified age and gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine for prophylaxis. On an unspecified date before 16May05, the subject received a dose of Dtpa (dose number and lot number not reported). At an unspecified time after vaccination with Dtpa, on an unspecified date on or before 16May06, the subject experienced lethargy. The subject was hospitalized. The outcome of the event was not reported. Report received via manf.
Patient sat down in a chair to be monitored after his J&J vaccine and he immediately passed out and fell out of the chair. Suffered abrasions to left forehead, under left eye, bridge of nose, and under nose. Regained consciousness quickly. Sat back in the chair and passed out again. Eased him to the floor. He appeared to have some small seizure activity. 911 called. Patient regained consciousness, examined by EMTs. Patient refused to go to the ER. His father came to pick him up . He was up, walking, and said he felt well. He left the vaccine clinic at 2:15pm.  I called patient on 7/16/21 to check on him. He said he is fine, and that he has a needle phobia.
Delayed hypersensitivity rxn with throat/mouth/face swelling starting on 10/5/23 @ ~3pm.  Could not breathe. Took nitroglycerin SL to relax smooth muscle of airways x 2.  After breathing resumed, intense coughing began, with vomiting & intense headache.Nausea lasted ~ 4-5 days. Swelling & redness of face lasted > 2 weeks. Extreme fatigue.   Second dyspnea episode on 10/7/23, but not as pronounced as first one.
a few days after getting the first dose I noticed that my BMs has a different smell to it. Thought that it was a bit of a change due to just getting the shot. Then the next day I had breakfast and it had a hint of that smell and taste. but didn't think nothing of it thought they were just having a bad day. I still had that smell when i used the restroom. Seemed like when i got the second dose the smell became stronger. At work I walked into a certain room and it had that smell, which was weird cause it's a distinctive smell . It's hard to describe, but it's like a spoiled. sulfur, gasoline smell. I ordered the bread pasta bowl from and it had that gross smell so i couldn't eat it. I love peanut butter, but i noticed that foul taste. I smelt it and had a hint of that gross smell and a bit of PB. The coffee at work has that gross smell to it as well. Certain foods, drinks, or odors have that smell and taste to me. So I'm pretty much trying to figure out what foods and drinks i can have and what places i can go to.  I get Covid around November, and i did loose taste and smell.
This spontaneous report was received from a physician refers to a female patient of currently 17 years old. The patient's concurrent condition included asthma. The patient's medical history, drug reactions and allergies were not reported. The patient's concomitant medication included PROAIR and norgestin (further unspecified). On 14-FEB-2018, the patient was vaccinated with one dose of GARDASIL 9 (dose, units and frequency not reported) (lot # N019103 and expiration date: 03-FEB-2020) as routine immunization. On an unknown date, patient experienced worsening discomfort where the patient cannot lift their arm without redness. The physician also stated that the patient has decreased range of motion. The patient seek medical attention but did not receive any treatment. The outcome of the events was not recovered/not resolved. The reporter did not provide the causal relationship for the events with suspect therapy GARDASIL 9. No product quality complaint was involved.
about 20 minutes after the injection my  cheeks got red and warm, 5 minutes later my chin turned red. after about 30 minutes or so my chin and lower lip felt numb. this feeling  was irritating but did not get worse, just very noticeable for about 5 hours.  The next day my chin was a little tingly but was gone by the afternoon.  My arm was very sore for 3 days.
5/21/21 I was incoherent and talking crazy, My son came to pick me up and I did not know who he was. My adrenal glands cortisol was so high that i was acting crazt. I passed out. I was in 2 different hospitals for 8 weeks and was told it was high blood pressure. My retired nurse family member said it was Cushings  and said I need to go to the hospital immediately. I was hospitalized and diagnosed with Cushings. My adrenal glands were over 2,000. I was either mean or cussing people out or buying people stuff. I don't remember hardly anything. I was on psychotic drugs and antidepressants. I saw phycologists and everything. The hospital told my husband to put me in a nursing home. My husband said no and took me home. It ruined my life. My blood work just came back and its not good. I dont want to have my adrenal glands out! I feel I have aged 20 years in 2 years. I lost my job and my whole life. I cant work or even play with my grandkids. ACTH is very high today 7/31/23. I met a man 2 years ago who came in to get his hair done. He had the same shot at the same time and we were both diagnosed with Cushings. It is such a rare disease that this cannot be a coincidence!
Patient got dizzy w/ vaccines she claims she has history of getting dizzy and passing out. Vitals were taken and were WNL Patient was given some juice and felt better.
This spontaneous report as received from a physician via a company representative refers to a child patient of unknown age and gender. No concurrent conditions or medical history were provided. On an unknown date, the patient was vaccinated with a 1 dose of GARDASIL injection intramuscularly (dose, lot#, expiry date unspecified). No concomitant medications were reported. The patient's mother was concerned that her child experienced a three day headache after receiving the GARDASIL vaccine (date unspecified). The patient's mother sought medical attention and was enquired if the headache her child was experiencing was from the injection. There was no treatment given. The doctor asked the patient's mother to bring the patient to the office for a follow-up appointment. The outcome of headache was unknown. The relatedness between event and GARDASIL was not reported. Additional information has been requested.
I tested positive for Covid-19 on 1/19/21.  My symptoms included increased fatigue and burning eyes prior to testing positive.  I was treated with a z-pack, prednisone, and a proair inhaler
Soar arm the day of vaccine and 2 days after.  Mild dizziness every day after receiving the vaccine.  The symptoms are not constant but I do feel dizzy on and off through out the day.  Tingling and numbing sensation on the cheeks of my face after the vaccine, almost immediately.  Then every day after that, but not constantly, more like once a day I feel the numbing sensation.
No adverse event; Patient was administered with dose of 0.25 mL instead of 0.50 mL of bivalent booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered with dose of 0.25 mL instead of 0.50 mL of bivalent booster) and NO ADVERSE EVENT (No adverse event) in a 55-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 21-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered with dose of 0.25 mL instead of 0.50 mL of bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered with dose of 0.25 mL instead of 0.50 mL of bivalent booster) and NO ADVERSE EVENT (No adverse 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 adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient was administered with dose of 0.25 mL instead of 0.50 mL of bivalent booster).    No concomitant medications were reported. No treatment details were reported.
Red spots, hot to touch, hard  >5cm.  Ibuprofen, cool compress
Numbness and swelling on R side of face. No other anaphylaxis associated symptoms.
Headache, Myalgia, Fever, FATIGUE Narrative:  WENT HOME AT HALF DAY, STAYED HOME NEXT DAY DUE TO SYMPTOMS
APPROXIMATELY 24 HOURS AFTER VACCINE (11/3/22 @ 1400), PATIENT NOTICED FACIAL SWELLING AND REDNESS ON LEFT SIDE OF HIS NOSE AND CHEEK. PRESENTED TO PHARMACY TODAY WITH SLIGHT SWELLING AND REDNESS. PATIENT DID NOT TAKE ANY MEDICATIONS AND SAID IT WAS THE WORSE IT'S BEEN WHEN I SAW IT.  RECOMMENDED TOTAL HISTAMINE BLOCK WITH BENADRYL (IF CAN TOLERATE WHEN AT HOME) AND PEPCID BOTH OF WHICH PATIENT HAS AT HOME. WILL CALL BACK THIS AFTERNOON WITH UPDATE. COUNSELED ON WHEN TO CALL 911.
Information has been received from a registered nurse concerning an outbreak of chickenpox in a child, between the ages of kindergarten to 4th grade, who had been vaccinated with a first and second (on 04-APR-2007) does of 0.5 mL of varicella virus vaccine live (Oka/Merck). Subsequently, the child developed chickenpox. The child may have 50 lesions or more. Additional information is not expected. This is one of several reports received from the same source.
Information has been received from a physician concerning a female patient who was vaccinated with the first dose of GARDASIL on 11-SEP-2010. The patient experienced nausea, headache (HA), was pale after receiving dose. The patient was kept for 20 minutes and was pale and dizzy. Physician did not state any specific treatment other than observation in office. After 20 minutes the physician sent the patient to ER where they subsequently recovered. Additional information has been requested.
This spontaneous report was received from a physician via company representative refers to a 32 year old female patient. Medical history was not reported. On 22-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 injection, 1 ml, subcutaneous  (strength, lot number and expiration date were not reported) for asthmatic. Concomitant therapies included ADVAIR, SINGULAIR and nortriptyline and TOPOMAX. The physician informed that on 24-SEP-2014, the patient had an injection site reaction. Also informed that the patient complained of a red bump and fever. There was 12 cm by 11 c red spot on the patient's arm located by the injection site. The patient sought medical attention by an office visit. The adverse events were treated with doxycycline. The outcome of the events was recovered on 22-OCT-2014. Additional information has been requested.
NACL 0.9% bacteriostatic was given as a diluent NDC #00409-1966-01
The day after the shot I had arm pain, headaches, Muscle aches, pain on my left side and pain on my left leg. The weekend of 2/26/2021 my left arm itched and I now have a large rash on my arm injection site.
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 72-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2022, outcome "unknown" and all described as "He recently tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Tested positive for Covid. Therapeutic measures were taken as a result of Covid-19, drug ineffective. Additional information: Caller has received his primary series of Covid vaccinations plus one booster. He stated he received the Pfizer Covid vaccines. He recently tested positive for Covid. He was prescribed Paxlovid which he has been taking. His tongue has turned a rusty brown color. He wants to know if this is a reported side effect of the medication. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Shot at 3:30 on 12/31. Fever started after midnight on 1/1/2022 approx eight hours following shot.  Fever was 102.4 during night. Other symptoms included chills,, shivering, achey, headache, loss of energy. and appetite. Symptoms lasted for over 24 hours although fever went to lower grade.
Felt a lump in her throat 5 minutes after vaccination.  BP and HR elevated slightly, no swelling in lips or tongue, denies lightheaded or dizziness, Alert/oriented x3.  Vaccination site WNL. Listened to lungs and heart (WNL). Lungs clear throughout and able to move air without difficulty. Within  15 minutes slight improvements in Vital Signs, decreased feeling of lump in her throat, no swelling in lips or tongue, site WNL, alert/oriented x 3.  Listened to lungs and heart (WNL). Lungs clear throughout and able to move air without difficulty.  30minutes later 50% improvement of feeling of lump in her throat, cont. improvements in VS, no swelling in lips or tongue, Listened to lungs and heart (WNL). Lungs clear throughout and able to move air without difficulty.  75 minutes post vaccination back to normal, Vital signs back to WNL, Alert/oriented x3, no swelling in lips or tongue.  Listened to lungs and heart (WNL). Lungs clear throughout and able to move air without difficulty.  Resolved on own without medications
Received the 2 doses of Pfizer. Received the  Moderna booster. Week later arm broke out. DR. Prescribe me a topical steroid about a month ago.  Bumps left scarring. Just concerned that it may not go away.
Day 3: Soreness and itching at injection site - Benadryl Gel and Capaicin pain patch. Day 3 - week 7: itching at injection site - Benadryl Gel. Day 3 - week 7: weakness - rest in bed.  Feverish feeling. Day 3: lots of mucous in throat and stomach caused burning in chest - Theraflu with Guaifenesin and Mucinex. Day 3 - week 6: lots of mucous in throat - Theraflu with Guaifenesin and Theraflu NiteTime and Mucinex and Zrytec 20mg tablets and Zrytec syrup 20ml. Cold symptoms which included chills.  Weeks 5 & 6: chills then sweats. Week 7: Theraflu with Guaifenesin sometimes; Theraflu NiteTime sometimes; Zrytec 20mg tablets everyday.  Feverish feeling, chills and sweats often.
Extensor surfaces rash on elbows, knuckles, knees. Skin bx: leukoclastic vasculitis consistent with erythema elevatum diutinum.  5/26/09 medical records recieved DOS 5/8/09. FINAL DIAGNOSIS: Hypersensitivity Vasculitis Post vaccination developed leukocytoclastic vasculitis, erthythema elevatum diutinum.   6/15/09 Received hospital medical records for 8/6-8/8/2008 & clinic records. FINAL DX: costochondritis; leukocytoclastic vasculitis w/early findings of erythema elevatum diutinum Records reveal patient experienced chest pain, SOB x 1 day; continued pruritis, knuckle pain, elbow & knee granulomatous vesicular lesions x 2 weeks; fatigue, fevers/chills, lightheadedness, pain.  Exam revealed pallor, ill appearing, mod distress, injected sclera, dry mucous membranes.  Rheum, Derm, Allergy/Immunology consults done.  Tx /w topical & systemic steroids.  Improved & d/c to home w/outpatient w/u for autoimmune disorders. ICD9 Codes: 241 amputation for circ sys disorders; 446.29 hypersensitivity angiitis; 999.0 gen vaccinia; 695.89 erythematous condition; 86.11 skin biopsy; 88.72 US of heart.
No adverse event; expired dose of M-M-R II was administered; This spontaneous report as received from a Nurse refers to a patient of unknown age and gender.  No information was provided regarding the patient's medical history, concurrent conditions and previous drug reactions. Concomitant therapies included sterile diluent.  On 23-SEP-2019, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (strength, dosage information, route of administration and anatomical locations were unknown) (lot # N025895, Expiry date: 19-SEP-2019) for prophylaxis.     The diluent that was used to reconstitute the vaccine had not expired. No adverse event. No additional information.
39 yo M w/ no known chronic medical conditions, presents w/ subjective fevers, myalgias, HA, malaise, nausea that started approx 12h after receiving COVAX and have persisted since. No recent COVID exposures.
passed out unknowingly for hours, 2 and a half weeks later hospitalized with jaundice
Pt. received FLUMIST and later found out she was pregnant. EDC - 07/17/2013.
Tachycardia first 10 minutes, soreness in arm for 3 days and fatigue following day.