chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt was given Dtap injection on 6-23-14 in left leg. Mother called on 6-25-14 stating that pt's left leg at injection site is red and swollen about 3 1/2 inches around site. Denies warmth and fever. 6-26-still red, smaller - recovering.
About 10ish in the morning I started having a headache, when I started getting ready for work I felt very light headed and nauseous to a point where I had to sit down. I ended up staying home to rest the rest of the day taking ibuprofen and just resting. I was feeling better the next morning.
I was fine the day I received the shot, the next morning I woke up with a headache and arm pain. My breathing started to get worst. I already was having problems since I had Covid in January into February.  A week later I woke up and felt very sick, started throwing up all day into the night, had 101 fever and chills. That lasted about a day and a half. I still felt sick for the next two days. I continue using having breathing problems worst than before the shot. I am also very exhausted.
J18.9 - Pneumonia, unspecified organism CHEST PAIN SHORTNESS OF BREATH
Received full shot of the third dose not being immunocompromised; Off label use; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (Received full shot of the third dose not being immunocompromised) and OFF LABEL USE (Off label use) in a female patient of an unknown age 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (Received full shot of the third dose not being immunocompromised) and OFF LABEL USE (Off label use). At the time of the report, EXTRA DOSE ADMINISTERED (Received full shot of the third dose not being immunocompromised) and OFF LABEL USE (Off label use) had resolved.      No relevant concomitant medications was reported. Treatment information was not provided.  The patient was not immunocompromised. The pharmacist that gave the patient the shot asked if the patient wanted a half or a full dose and recommended the patient to get the full shot. The patient was unsure and the pharmacist pressured the patient to choose quickly or leave the site as there were many people waiting. The patient reported that the patient was forced to take the full dose.
Phizer-BioNtech COVID-19 Vaccine EUA. Mild, sore throat for a 30 minute period; then dizziness; then nausea /vomiting, chills; T36.2-36.7 celsius. Lasted from 6:00 pm on 2/25/21 to 3:30 am on 2/26/21.
Pretty bad looking rash on both of my legs; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Pretty bad looking rash on both of my legs) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination.     The patient's past medical history included Angioedema (angioedema/anaphylaxis when patient took a sulfa medication.).    On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2021, the patient experienced RASH (Pretty bad looking rash on both of my legs). In August 2021, RASH (Pretty bad looking rash on both of my legs) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  Treatment medications were not reported.  It was stated that the patient experienced the same rash when patient took INH in the 70s for a positive PPD.
Allergic Reaction; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergic Reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Allergic Reaction). At the time of the report, HYPERSENSITIVITY (Allergic Reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The relevant concomitant medications use were not reported Treatment details were not reported by the reporter.
We have now given our kid Rabivax after 2 weeks from the date my dog caught her wrist with no reported adverse event; Initial information received on 14-Nov-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp (Non-healthcare professional).  This case involves a 11 years old male patient and reporter reported we have now given our kid Rabies (Hdc) Vaccine [Imovax Rabies] after 2 weeks from the date my dog caught her wrist with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect Rabies (Hdc) Vaccine Powder and solvent for suspension for injection (with an unknown strength, expiry date, lot number) via unknown route in unknown administration site for immunization.  On an unknown date, reporter reported we have now given our kid Rabies (Hdc) Vaccine after 2 weeks from the date my dog caught her wrist with no reported adverse event (inappropriate schedule of product administration)  (latency: unknown).  It was reported, My kid 11 year was caught by my pet dog 2 weeks ago on the wrist . No bleeding happened but there could have been scratches. We didn't get the anti-rabies shot done at that time . My kid just washed the hand with soap. My pet dog is anti rabies vaccinated and is behaving normally . We have now given our kid Rabivax after 2 weeks from the date my dog caught her wrist which is late. My questions are Could in the above case my kid have got rabies from the pet dog even though he is vaccinated and behaving normally after the bite. Rabivax has been is taken late i.e. after 14 days from the occurrence . But will it still protect my child against rabies in future.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
From initial information received on 10/09/03, from a health care professional, regarding an adverse event occurring in the U.S.A., it was reported that a 55 year old male patient received Fluzone SV '200-'2004, lot number U1089AA, given intra muscularly in the left arm on 10/03/03. The following day, on 10/04/03, the patient developed a rash on his back, buttocks and on both legs. the recovery status was reported as unknown. The reporter of this case is the same reporter for case 200302312. From additional information received on 11/18/03 from a health care professional, the patient had been taking prednisone 50 mg two weeks before immunization. The patient was seen by his primary care physician on 10/09/03 who prescribed Allegra and Hydrocortisone for the rash, which was all over the patient's body. The patient was feeling a little better at the time. On 11/13/03, the health care provider spoke with the patient, who stated that his primary physician had diagnosed him with shingles. It is unknown if the patient recovered. No further information is anticipated, this case is considered closed.
This spontaneous report as received from a healthcare professional who was a quality control representative of a company refers to an unspecified number of patients of unknown age and gender. Doses of VAQTA that were exposed to a temperature excursion on an unspecified date may had been administered to unspecified patients (lot#, dose, dose# and route not reported) on unspecified dates since the temperature excursion. He stated that some of the improperly stored doses were administered to some patients, but he was certain that the practices that administered the doses reported the administration to Merck to request revaccination information. He was not able to provide any healthcare provider information or case numbers, nor could he provide any additional information about these scenarios. He confirmed that he was aware that the administration of improperly-stored products to patients posed a safety risk to the patients. He did not know whether or not there had been any adverse effects. This is one of several reports received from the same source. Additional information is not expected as there was no consent for follow up contact.
First dose of the COVID-19 vaccine: itching at the injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (First dose of the COVID-19 vaccine: itching at the injection site) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (First dose of the COVID-19 vaccine: itching at the injection site). On 01-Mar-2021, VACCINATION SITE PRURITUS (First dose of the COVID-19 vaccine: itching at the injection site) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient ethnicity was reported as Other  No patient history was reported and no investigation assessment was reported. No concomitant medication was provided It was reported that for first dose patient had experienced typical reaction like itching at the injection site for few minutes and then fine. Treatment information was not reported.
Sudden high blood pressure - 200 systolic, 160 diastolic.  Controlled with medication within seven days.
ED Visit Hospital 5/14/22 DIAGNOSIS at time of disposition: 1. COVID-19 virus infection  2. COVID-19 virus detected   MEDICAL DECISION MAKING: Patient is a 74-year-old male presents with a chief complaint of shortness of breath.  Upon initial evaluation he is hemodynamically stable.  He does not appear in any distress.  He is resting with eyes closed, arouses easily to voice.  Patient's complaint is rather vague today.  I have seen him multiple times in the past and he frequently has vague complaints of feeling unwell in cannot expound upon this further.  Therefore, his differential is broad and will initiate a broad workup for him with screening labs, scan of head given wife's report of decreased level consciousness.  COVID-19 test returns positive.  CT of the head and chest x-ray do not show any significant changes.  His lab work is overall similar to prior.  His BNP is elevated but mildly so, chest x-ray does not show significant fluid overload he has no lower extremity edema.  Here he maintains normal oxygen saturation, no respiratory distress or difficulty breathing.  He has no wheezing so do not believe he requires albuterol.  A reviewed his medication list he has multiple interactions with paxlovid.  Furthermore, he does not have a delineated onset time.  Wife actually says is been multiple days that he has been feeling tired in she cannot tell me that it has been definitely within 5 days.  Therefore, do not believe she currently meets emergency use authorization for this medication.  Re-evaluation he is resting, appears well.  Will have him follow up with primary care physician by phone.  Discharged in stable condition.  MD 5/16/2022 Physician Hospitalist  DIAGNOSIS at time of disposition: 1. COVID-19  2. Acute respiratory failure with hypoxia  3. Acute on chronic renal insufficiency     HISTORY OF PRESENT ILLNESS: Patient is a 74 y.o. male with chronic systolic congestive Heart failure and chronic kidney disease who has had 3 hospitalizations prior to this in the past 2 months for congestive heart failure.  Once again presents with shortness of breath and weakness.  He was COVID tested in the emergency department and it is positive.  Also patient had an elevated D-dimer of 8000 in the emergency department.  His chest x-ray shows congestive heart failure changes and bilateral lower lobe infiltrates and his BNP is at least 60,000. Creatinine has been steadily increasing over the past 2 months and is now at 2.7. As far as I can tell he is not had outpatient Nephrology follow-up, but was seen by nephrology at Hospital in early April
Patient became diaphoretic, pale. Reported dizziness. Patient had intermittent hypotension + Bradycardia. Symptoms resolved in minutes and sent home.
At 3pm, I noticed pain at the site of the vaccine. Took ADVIL. Around 9:30 noticed again pain, so used ice pack and took ADVIL. Around 3:30 am, I woke with horrible pain in site where vaccine was given. Went to kitchen to get ADVIL to take and an ice pack, stopped at restroom and as I was sitting there, was overcome with an awful flu-like feeling. Felt bad, felt weak, felt dizzy - I recall thinking I needed to get back to bed. I woke on the kitchen tile floor in a puddle of blood, spitting up teeth. I went to counter to get paper towel to clean up blood and ADVIL and again woke on floor spitting more teeth. I believe I crawled to bedroom and woke my husband that I had fallen. He woke, got towels as I was bleeding bad on my chin. It was also hard for me to breathe in on the top part of my chest. Like I hit that too. He woke our EMS son and our daughter who worked in ER to check my blood pressure and vitals. All appeared to be ok. All agreed I needed stitches, but would be ok to wait until urgent care opened to go get them. At 8am, I called my regular doctor's office and was advised they do not do stitches and to go to the urgent care or an ER. We went to urgent care. Was treated by Drs. See attached medical report with diagnosis. I received ten stitches in my chin, had to stitch up all layers of skin as it was all the way to the bone, also received an IV full of antibiotics and fluid as I was severely dehydrated. I was then sent to the dentist for an emergency visit due to my teeth. He saw the chipped top left tooth - was actually broken in half. And the 3 chipped upper right side teeth. He sent us to an oral surgeon because I would likely need to have the tooth pulled and an implant put in. The next day we had the oral surgeon visit and were advised he did not want to work on it due to the probability of me having had a concussion due to my constant headache I had had since I fainted and he did not want to cause more issues and he wanted to let the stitches heal as well. He rescheduled me for the following Monday to come to the office and have oral surgery to remove the tooth. Was out of work the entire end of the week, as well as half of a day Monday, all day Tuesday and most of the day Wed. I have since had another dental visit to have 3 teeth repaired and the day after when I finally began to eat regular food, another lower left tooth chipped. It was likely already chipped die to the fainting issue. I will have continued dental visits due to this situation, as I am in the middle of receiving a dental implant where I lost the tooth. I have had nothing but doctor and dental visits since I received this vaccine. I was advised that this was a fast track vaccine and I am not quite understanding why, as IF this is being recommended for EVERYONE to replace the old vaccine, I feel its very important to do the full testing before trying it on anyone. Its my understanding that I am not the FIRST person with an adverse reaction.
June 15 - Right side lower rear rib cage pain.  June 17 - Lightheaded.  June 20 - shortness of breath and weakness.  Symptoms progressively get worse and increase in intensity.  June 26 - go to Emergency Room.  CT scan with contrast revealed a blood clot in each lung of moderate size and several small clots. Diagnosis was pulmonary embolism.  Put on Heparin and admitted to hospital.  Administered Heparin for 2 and 1/2 days.  Upon discharge (June 29) was prescribed Eliquis.
This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired doses administered) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination. No Medical History information was reported. On 07-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses administered). On 07-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired doses administered) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant products were not provided. Treatment medications were not reported. On December 6, 2021, vaccine vials of Lot 012H21B were placed in refrigerator.
Developed two small vesicles on upper chest, almost symmetrically on either side, same size,  level, almost equidistant from midline. No pain or itching. Contained clear fluid. Did not notice second one until day 14, but appeared to be at same stage as the one noticed on day 6. Until saw the second, did not associate with vaccine. Could not associate with any other factor. Not usually prone to chest outbreaks. Other than the vesicles, only experienced tiredness and head aches for 2-3 days after vaccine.
severe itch on chest and back; lymphedema flare up of leg; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHOEDEMA (lymphedema flare up of leg) and PRURITUS (severe itch on chest and back) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     The patient's past medical history included Lymphedema.    On 10-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 12-Feb-2021, the patient experienced LYMPHOEDEMA (lymphedema flare up of leg). On 05-Mar-2021, the patient experienced PRURITUS (severe itch on chest and back). The patient was treated with HYDROCORTISONE for Adverse event, at a dose of UNK dosage form; HYDROCORTISONE (SARNA HC) for Adverse event, at a dose of UNK dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of UNK dosage form. On 03-Mar-2021, LYMPHOEDEMA (lymphedema flare up of leg) had resolved. At the time of the report, PRURITUS (severe itch on chest and back) had not resolved.            No concomitant medications reported.
Pt stated that she experienced fever, nausea, vomiting, diarrhea, weakness, joint pain, loss of appetite, blurred vision, heart palpitations and was unable to focus mentally. A physician evaluated the pt. Pt treated herself with Benadryl. From additional information received on 9/23/99, additional pt and vaccine information provided.
5/18/18 Patient noted swollen glands at base of skull, collar bone, under jaw, side of neck but stated improving 5/21/18 and feeling "normal". 6/4/18 Developed "chipmunk cheek" on right side with achiness in cheek and feeling tired. Seen in clinic and recommended to stay out of work for 3 additional days and avoid young children/elderly and discussed ways to prevent transmission to roommate.
Itchy and burning rash over both arms and legs. Benadryl and Zyrtec no help. Topical pain reliever and Benadryl no real effect. Scratching myself silly! It is all over me. I have pictures I can send if it helps.
Patient developed hives within few minutes after receiving PREVNAR vaccine. Patient was given PO BENADRYL in office and was observed in office for 30 minutes. Hives improved upon leaving the office.
The pt states that the biggest problem is short term memory loss, he says it never used to be like that. The pt felt dizzy and his arms fall asleep very easily.
2 hours after getting injection she experienced body aches and joint pain (generalized), severe headache, intermittent dizziness and nausea. symptoms have steadily worsened per pt report
Immunized a 17-year-old with Moderna; A spontaneous report  was received from a nurse concerning a 17-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 03 Mar 2021, the patient received their dose of mRNA-1273 (Batch Number: 022M20A) intramuscularly for prophylaxis of COVID-19 infection.  Director of nursing reported a medication error, on 03 Mar 2021, immunized a 17-year-old patient with Moderna.  No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not applicable.  On 03 Mar 2021, the outcome of the event, immunized a 17-year-old with Moderna was considered resolved.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old male) for mRNA-1273 (lot number 022M20A) with no associated AEs reported.
Headaches, nausea,dizziness,diarrhea, tingling in the hand s feet arms legs.
Awakened w/ intense sinus pain. Looked in mirror and facial swelling noted. Treatment: BENADRYL 50mg every 6 hours. CLARITIN x1. I spoke w/ the nurse on Monday 9/18/2017. Symptoms resolved by Tuesday 9/19/2017. I saw Dr. on 11/7/2017 and he recommended not receiving influenza vaccines in the future.
Headache, Sedation, Myalgia, Arthralgia, Fever,  NauseaVomiting,  Pain/Redness/Swelling/Itching/Rash @ injection site,  Swollen lymph nodes
irregular menstrual period; headache; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 and experiencing an irregular menstrual period. After the second dose she has a headache that hasn't gone away and an irregular menstrual period, her menstruation comes and goes, she hasn't stopped bleeding (she doesn't bleed much) but for one day and the next it comes back. She would like to know if this is normal or of she need to go with her doctor and gynecologist. The outcome of events was unknown. The events were considered as non-serious from reporter.  No follow-up attempts are needed; information about batch/lot number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021376721 the same patient and product, different doses and partial similar adverse events
Patient received SHINGRIX in the right deltoid and AFLURIA in the left deltoid on 10/1/2018. Per 10/2/2018 Primary Care note, patient reported generalized myalgias and dizziness 6 hours after receiving vaccines. Also has bilateral erythema and possible early cellulitis at both upper arms R greater than L. Given push fluids, TYLENOL prn fever, and Z-PAK.
pt recvd vax 22SEP94 & 23SEP94 pt presented in sick call w/either fever &/or a local or systemic rxn;sxs resolved p/several days;