chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Attending Physician:  DO      Date of Admission:  1/25/2022   Chief Complaint:  SOB   Source of Information:  Patient and Available medical record   History of Present Illness:  This is a 59y.o. female with a past medical history significant for GERD, B-cell lymphoma, chronic back pain, hypertension.  She presents to Hospital on 1/25/2022 for evaluation of shortness of breath.  She states that the duration has been approximately 2 days with a slow gradual onset.  She states that the shortness of breath is worse with exertion but has now progressed to being constant.  She states that she has also had accompanying cough which is been progressively getting worse.  She states that approximately 1 week ago she was having cough with productive sputum that she believes might have blood in it.  She states that originally symptoms of upper respiratory infection started approximately 7 days ago.  She states that she is vaccinated for Covid.  She states that she has been receiving chemotherapy for her B-cell lymphoma since July 2021.  She states that she completed her final round of chemo approximately 5 days ago.  She states that she has not had any close contact with people outside of her chemotherapy center with regards to Covid positive individuals.  She denies any recent antibiotic use.  She states that she is unable to lie flat in bed due to shortness of breath.  She denies any recent lower extremity worsening edema.  She denies any history of blood clots.  She states that she does not take a blood thinner.  She states that she recently completed her 5-day course of prednisone status post chemotherapy treatment for her B-cell lymphoma as of yesterday. Admits to Headache and sore throat.  Currently denying any chest pain, fever, vomiting, abdominal pain.  Patient is currently receiving chemotherapy for lymphoma now on day 5 of treatment.     In the ED, Vitals on arrival of T 98.2°F, BP 145/75, HR 137, RR 30, SpO2 80% on room air Labs remarkable for white blood cell count 0.8, hemoglobin 8.2, platelets 87.  Sodium 129, potassium 3.3, chloride 98, bicarb 18, BUN 11, creatinine 0.66.  Alk phos 128, AST 33, ALT 18.  D-dimer 1113.  Lactic acid 3.5.  Magnesium 1.5.  Phos 2.3.  TSH 2.86.  Troponin 0 0.01x1.  Covid positive, flu and RSV negative.  Blood cultures pending.  Repeat lactic acid 0.9. Imaging: Chest x-ray diffuse interstitial and airspace opacities throughout the lungs concerning for multifocal pneumonia. Patient received 2 L fluid bolus, vancomycin, aztreonam.  Maintenance fluid started 125 cc an hour of normal saline. Infectious disease and hematology oncology consulted.
Patient has a quarter sized lump that is firm and has pain to the touch at the injection site 11 days after injection.
fussy, rash was noticed 6/28/2005 that got worse that am and fever treatment observation fluids and motrin
I came down with 101-degree fever on Monday, October 17th, 2022. The fever lasted for three days. I was also coughing. After three days, my nose started running. I was given the antiviral, molnupiravir. By Thursday, my temperature came back down to normal. I continued to have nasal congestion and coughing. I've been slowly improving. It's mainly nasal congestion and coughing now.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication reported.  No Treatment medication reported.  The patient received vaccine which was stored in an ultra-cold freezer at minus 82 degrees Fahrenheit. There was no product complaint associated.   This case was linked to MOD-2021-402935 (Patient Link).
Shortly after the shot, I developed a painful cyst on my left eyebrow. In a few hours this cyst went down, and almost immediately after a cyst on my right palm appeared. I still have this cyst and it is not painful.
Onset of Fever, Cough, Congestion on 11/5/09 a.m. with increasing work of breathing during the day.  Seen in clinic 5:00 p.m. with tachypnea, wheezing and moderate respiratory distress.  Albuterol neb x 2 administered in clinic and admitted to Hospital for further management11/6/2009 Admission note for date 11/6/2009. Patient admitted with c/o's respiratory distress, fever, anorexia and tachypnea. Tx: IV Steroids, Protonix, Resp Tx's w/albuterol. 11/10/09 DC summary received from date 11/7/09.  DX: Influenza A,  RAD. SX: admitted on 11/5/09 with acute onset of respiratory distress. Received flumist H1N1. Developed progressive tachypnea, dyspneathe, fever, anorexia. Assessment: prolonged expiratory phase.
Shortly after being vaccinated I broke out in hives. Idiopathic urticaria, treated by antihistamines and steroids. They were starting to go away when I contracted Covid-19 a second time early January this year. They are now worse.
Red rash and hives developing on torso, thighs, neck and arms.  Accompanied by minor itching.
Nausea; vomitting; Head feel like its broken; Severe staggering not able to walk without walker; Weakness; sore arm could not lift arm; fall; neck feel like its broken; Hit her head; sweats; Dizziness; Chills; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Severe staggering not able to walk without walker), ASTHENIA (Weakness), PAIN IN EXTREMITY (sore arm could not lift arm), FALL (fall) and NECK PAIN (neck feel like its broken) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cancer.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced GAIT DISTURBANCE (Severe staggering not able to walk without walker), ASTHENIA (Weakness), PAIN IN EXTREMITY (sore arm could not lift arm), FALL (fall), NECK PAIN (neck feel like its broken), HEAD INJURY (Hit her head), HYPERHIDROSIS (sweats), DIZZINESS (Dizziness), CHILLS (Chills), VOMITING (vomitting) and HEADACHE (Head feel like its broken). On an unknown date, the patient experienced NAUSEA (Nausea). On 03-Mar-2021, DIZZINESS (Dizziness) and CHILLS (Chills) outcome was unknown. At the time of the report, GAIT DISTURBANCE (Severe staggering not able to walk without walker), ASTHENIA (Weakness), PAIN IN EXTREMITY (sore arm could not lift arm), FALL (fall), NECK PAIN (neck feel like its broken), HEAD INJURY (Hit her head), HYPERHIDROSIS (sweats), NAUSEA (Nausea), VOMITING (vomitting) and HEADACHE (Head feel like its broken) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications and treatment information were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-076181 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076181:Second Dose
Pt had flu-like symptoms: Vomiting, nausea, fever. 2 weeks after vaccine patient had first seizure, and was diagnosed with mesenteric lymphadenopathy.
This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. The patient's medical history was not reported. On 23-AUG-2017, the patient was vaccinated with an expired dose of M-M-R II, (rHA) (Strength, dose, frequency and anatomical location were not reported) of lot # L030162 with an expiry date of 11-AUG-2017, subcutaneously for prophylaxis. The M-M-R II was reconstituted with a sterile diluent of lot # L042473 with an expiry date of 23-AUG-2017. There were no adverse effects reported. There was no product quality complaint involved. Lot number, L042473 has been verified to be a valid lot number for sterile diluent. The therapy type of the lot number, L030162 is recombinant human albumin (rHA).
received a Shingrix dose with only the liquid portion, without the lyophilized portion; received a Shingrix dose with only the liquid portion, without the lyophilized portion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number 7BC5F, expiry date 4th October 2022) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows:  The age at vaccination was not reported.  The nurse informed that a patient received a Shingrix dose with only the liquid portion, without the lyophilized portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
A non-serious spontaneous report of leg pain and tingling has been received from a mother/health professional concerning a eight-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on an unknown date in Oct-2010 for an unknown indication. On 26-Oct-2010, the patient began to have symptoms of leg pain and tingling. As per the reporter the symptoms did not resolve with ibuprofen. The patient had not sought medical attention at the time of report. The outcome of the events leg pain and tingling was not resolved.
No adverse event occurred, but individual also received his hepatitis B dose four days prior to his covid vaccine.
Information has been received from a licensed practical nurse referring to multiple, unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients received improperly stored doses of ROTATEQ (lot # L042215, expiration date 02-JUN-2017; dose was not reported) orally for prophylaxis. No adverse effect was reported. Follow-up information has been received on 02-DEC-2016. All telephone attempts to obtain follow-up information have been unsuccessful. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA012350: MERCK 1610USA005649:Mfr number.
This spontaneous report as received from a licensed practical nurse refers to unknown age and gender. The patient was vaccinated with RECOMBIVAX HB (lot # 66957/0294AA and expiry date was 06-SEP-2014, route and dose were not reported) that was exposed to 25 Fahrenheit for an unknown period of time on 05-NOV-2012, No concomitant medications were reported. No adverse symptoms reported. This is one of several reports received from the same reporter. Follow up information was received from the licensed practical nurse who confirmed that none of the patients complained of any adverse experiences after receiving the above vaccines that had been stored incorrectly. Additional information is not expected.
No additional AE reported; Caller is a nurse practitioner calling to report multiple temperature excursions for GARDASIL 9.; This spontaneous report was received from a nurse practitioner, referring to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 13-JUN-2022, the patient was vaccinated with an improper storage HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), 0.5 ml (valid lot #T036444, expiration date: 09-APR-2023) (strength, anatomical location and route of administration were not provided) for prophylaxis. No additional adverse events were reported.  This is one of several reports received from the same reporter (captured in the following cases: MARRS#2207USA007332, MARRS#2207USA007630, MARRS#2207USA007632, MARRS#2207USA007383, MARRS#2207USA007612, MARRS#2207USA007323 and MARRS#2207USA007382). ; Sender's Comments:  US-009507513-2207USA007332: US-009507513-2207USA007630: US-009507513-2207USA007632: US-009507513-2207USA007383: US-009507513-2207USA007612: US-009507513-2207USA007323: US-009507513-2207USA007382:
This spontaneous report as received from other, as part of a marketing research program, refers to a female patient of 33 year old. On an unknown date the patient was vaccinated with a dose of pneumococcal vaccine (manufacturer unknown) (dose, route, lot# and expiration date were not reported). Concomitant therapy was not reported. On an unknown date the patient experienced hypersensitivity. The outcome of hypersensitivity was unknown. Relatedness between the pneumococcal vaccine (manufacturer unknown) and the adverse event was not provided. Upon internal review, hypersensitivity determined to be medically significant since the seriousness of the case was reported as unknown. Clarification has been received on 23-FEB-2015. The primary reporter of this case was confirmed to be the patient. Additional information is not expected because there is no contact information. Reporter type has been updated.
Headache, Myalgia, Arthralgia, Fever,  chills, injection site hard bruising, swelling pain,  itching  Narrative:
RECEIVED T/C FROM PATIENT ON 11/15/18, REPORTING HAS BEEN EXPERIENCING BAD PAIN ON LEFT ARM, SINCE RECEIVING HEPATITIS A & FLU VACCINE ON 10/20/18, ADMINISTERED BY US; REPORTED PAIN HAS BEEN ONGOING SINCE VACCINES RCVD, DENIED ANY OTHER SYMPTOMS, STATED HAS NEVER TAKEN ANY PAIN MED OR APPLIED ANY COMFORT MEASURES TO ALLEVIATE PAIN. SHE WAS ADVISED TO TAKE MOTRIN (otc) & SCHEDULE MD APPT ASAP FOR EVALUATION; SHE AGREED TO SEE MD TODAY(11/15) & CALL BACK WITH OUTCOME OF VISIT.
Blurred Vision; Shortness of Breath; Fogged Mind; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurred Vision), DYSPNOEA (Shortness of Breath) and FEELING ABNORMAL (Fogged Mind) 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 14-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2021, the patient experienced VISION BLURRED (Blurred Vision), DYSPNOEA (Shortness of Breath) and FEELING ABNORMAL (Fogged Mind). At the time of the report, VISION BLURRED (Blurred Vision), DYSPNOEA (Shortness of Breath) and FEELING ABNORMAL (Fogged Mind) outcome was unknown.            No concomitant medications reported by reporter No treatment medications provided by the reporter.
Approximately 1 week after my vaccination, I began losing hearing in my right ear.  Coincidentally the same side I received my vaccination; This is a spontaneous report received a contactable consumer, the patient. A 52-year-old adult [non-pregnant] female received a single dose (unspecified dose number) of BNT162b2 (solution for injection; Lot provided as unknown and expiry information not reported) via unspecified route in the right arm on 25Mar2021 at 13:30 (at 52-years-old), for COVID-19 immunisation. Relevant medical history included depression. Concomitant medications sans indication, posology and therapy dates included fluoxetine hydrochloride (PROZAC), bupropion hydrochloride (WELLBUTRIN) and sulfamethoxazole/ trimethoprim (BACTRIM). The patient previously received treatment for an unspecified indication with codeine and experienced a drug allergy. The patient denied any COVID diagnosis prior to the vaccine. The patient reported that on 29Mar2021 she began to lose hearing in her right ear. The patient noted that it was coincidentally the same side that she received the vaccine on. The event did not result in any visit to an emergency room, physician office or hospital. It was unknown if any treatment was received. The outcome of the event began to lose hearing in her right ear was unknown.   Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Severe Headache, left leg tingling, nausea, nerve pain in left leg and arm. All started on 4/13 in the PM and are currently ongoing.
Very painful injection site; chills; fever; cough; muscle and joint pain; muscle and joint pain; nausea; headache; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 65 year old non pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on an 09Sep2021 12:00 PM (Batch/Lot number FC3182) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing, arthritis from an unknown date and unknown if ongoing, autoimmune thyroiditis from an unknown date and unknown if ongoing, rheumatoid arthritis from an unknown date and unknown if ongoing , breast cancer from an unknown date and unknown if ongoing. The patient experienced very painful injection site, chills, fever, cough, muscle and joint pain causing myalgia, muscle and joint pain causing arthralgia, nausea and headache on Sep2021 with outcome of recovering. The patient underwent lab tests and procedures which included pyrexia at 102 Fahrenheit.    .    Follow-Up (16Sep20211): Follow-up attempts are completed. No further information is expected.
a rash of the arm and legs; This case was reported by a consumer via call center representative and described the occurrence of rash in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix, the patient developed a rash of the arm and legs. No additional information was provided. The reporter did not consent to follow up.
This spontaneous report was received from a nurse refers to a 53 year old female patient. The patients pertinent medical history and drug reactions or allergies were not reported. On 19-AUG-2014, the patient was vaccinated with ZOSTAVAX (lot # J005849, expiry date: 17-AUG-2014), 0.65 ml, subcutaneously in the right arm. No concomitant medications were reported. It was reported that the patient was vaccinated with expired vaccine on 19-AUG-2014. No adverse effects were reported. There was no product quality complaint (PQC) involved. The outcome was unknown. Additional information has been requested.
Parent said child had high fever (39C) and headache that occurred two days after vaccination. She still has c/o headache and mild fever today 3/30.
passed out or fainted; Initial information received on 21-Apr-2023 regarding an unsolicited valid  serious case received from a other health professional.  This case involves a 11 years old and unknown gender patient who experienced passed out or fainted while receiving vaccine meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection strength, dose, expiry date not reported lot number unknown via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the patient developed a serious passed out or fainted (loss of consciousness) (unknown latency) following the administration of meningococcal A-C-Y-W135 (T CONJ) vaccine. This event was assessed as medically significant.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event passed out or fainted.  At time of reporting, the outcome was Unknown for the event passed out or fainted.  Seriousness criteria: This event was assessed as medically significant.; Sender's Comments: Sanofi company comment dated 25-Apr-2023: This case involves a 11 years old and unknown gender patient who experienced passed out or fainted while receiving vaccine A-C-Y-W135 (T CONJ) vaccine [Menquadfi]. Based on information provided, the causal role of company suspect cannot be excluded. Case will be re-evaluated post further update on information regarding underlying disease, risk precipitating factor, concomitant medication, past medical history and patient lifestyle which will preclude a comprehensive assessment of this case.
tightness in the throat; facial swelling; hives/very small hives on the trunk; lip swelled; lost her voice; A spontaneous report was received from a consumer (patient's daughter), concerning a 73-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and  experienced tightness in the throat, facial swelling (swelling face), hives/very small hives on the trunk (urticaria), lip swelled (lip swelling), and lost her voice (aphonia).  The patient's medical history was not provided.  Concomitant product use was not provided.  On 04 Feb 2021, about 40 hours prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (batch number: 041L20A ) intramuscularly for the prophylaxis of COVID-19 infection.  On 7 Feb 2021, 40 hours later, the patient experienced hives, facial swelling, and tightness in the throat. The reaction started with very small hives on trunk, face and lip swelled, and she lost her voice.  The daughter reported that events worsened at night.  The reporter's sister took the patient to the emergency room, where she was treated with saline, steroids and diphenhydramine. The patient was still taking the diphenhydramine and steroids.  The daughter said they were going to have more specific allergy tests done on the patient.  Action taken with mRNA-1273 in response to the event was unknown.  It was noted that the patient was reluctant to have the second dose.   The outcome of the events of tightness in the throat, facial swelling, hives/very small hives on the trunk, lip swelled, and lost her voice was unknown.
Day 1: Moderate Headache, chills, low fever, moderate joint pain and body ache, and injection site pain and swelling  Day 2: chills, low fever, moderate to severe joint pain and injection site pain, severe fatigue Day 3: mild to moderate joint pain,  mild to moderate body ache, moderate to severe fatigue, malaise Day 4: moderate to severe fatigue, malaise, mild body ache Day 5: moderate fatigue, malaise, mild body ache Day 6:  moderate fatigue, malaise, mild body ache