chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 13-AUG-2014 the patient was vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: J013315, expiration date: 18-OCT-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a physician via company representative regarding an adult female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patient in her late 20's received vaccination with PNEUMOVAX 23 (lot#, expiration date, strength, dosing details and route of administration were not reported) for prophylaxis. On an unknown date, the patient experienced a severe site reaction further described as marked swelling from injection site to elbow (vaccination site swelling and swelling). The patient visited physician to seek medical attention. Treatment given for the events was unknown. The outcome of vaccination site swelling and swelling was unknown. Causality assessment was not provided by the reporting physician.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown demographics. No concurrent condition, medical history or allergy/drug reactions were reported. The nurse reported that on an unspecified date, an unspecified number of patient were administered improperly stored doses of (Oka/Merck) VARIVAX injection (strength, dose, route and lot number or batch number unspecified). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaint (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
200/100 high blood pressure; stammering problems; uncontrolled shaking at my right hand; cold feet; dry mouth; Headaches; body aches; A spontaneous report was received from a 31-year old, female patient who experienced headaches, body aches, dry mouth, cold feet, uncontrolled shaking in right hand, stammering problems, and 200/100 high blood pressure.  The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient received their first of two planned doses of mRNA-1273 (Batch number not provided). On 21 Jan 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: 028L20A) for prophylaxis of COVID-19 infection.  On 21 Jan 2021, the patient was taken to the emergency room (ER) approximately four hours after receiving the second dose of the Moderna COVID vaccine. She was experiencing headaches, body aches, dry mouth, cold feet, uncontrollable shaking in her right hand, speech impairment, and her blood pressure was 200/100. The patient tested negative for all stroke tests performed in the ER.. The patient reported she received a medication that "knocked me out" and relieved the symptoms. Treatment information was not provided. On 23 Jan 2021, the patient still had shaking and stammering problems.  The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the events headaches, body aches, dry mouth, cold feet, and 200/100 high blood pressure were unknown. The outcome of events uncontrolled shaking in right hand and stammering problems were not recovered/ not resolved.  Follow up: Follow-up received on 29 Jan 2021 included the patient's report that her adverse events have been sustained and not improved. On 27 Jan 2021, the patient received an MRI that showed brain lesions existed as diagnosed by a neurologist.; Reporter's Comments: The follow-up received reports that on 27Jan 2021, the patient received an MRI that showed brain lesions existed as diagnosed by a neurologist.  Based on this information, the event of hypertensive crisis, dysphemia, tremors, is assessed as unlikely related to mRNA-1273.
Joint pain; Muscle pain; She felt dizzy; She felt hot to touch; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th May 2022, the patient received the 1st dose of Shingrix. On 19th May 2022, less than a day after receiving Shingrix, the patient experienced dizziness and skin warm. On 20th May 2022, the patient experienced joint pain and muscle pain. On an unknown date, the outcome of the dizziness and skin warm were recovered/resolved and the outcome of the joint pain and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the dizziness, skin warm, joint pain and muscle pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-MAY-2022 Reporter's Comment: The patient self-reported this case. The patient received dose of Shingrix vaccine and felt dizzy and hot to the touch. On 20th May 2022, 1 day after vaccination the patient experienced joint pain and muscle pain. The symptoms felt dizzy and hot to the touch were resolved and muscle and joint pain were not resolved. The reporter did not consent to follow-up. Additional supportive information: This case has been linked with case US2022081905, reported by the same reporter. Note: Vaccination date conservatively captured as 19th May 2022, as there is a discrepancy in source document.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022081905:Same Reporter
This non-serious spontaneous case, was initially received on 18-Sep-2017 from other health professional (HCP staff), concerning an 89-year-old, elderly, female patient. This is second case of the two cases reported. The patient had an unspecified medical history. Concomitant medication included ASA. On 08-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (batch no: 00144621A and expiry date: 31-May-2018, dose, route of administration and anatomical location: not reported). On an unspecified date, 8 unopened MDV (multi-dosage vial) and 14 syringes drawn from MDV that reached unknown temperature for unknown amount of time i.e., underwent first time excursion (explicitly coded to incorrect product storage) and the patient was administered with that vaccine (explicitly coded to drug administration error). It was reported that, the patient experienced no adverse event. The outcome of the events was not reported.
"My throat feels warm" without other signs/symptoms. Resolved in under 10 minutes time. BENADRYL 25mg PO.
severe headache, fever, chills, body aches (including in testicles), severe coughing, nausea, difficulty breathing
Patient contacted the pharmacy today and indicated she had experienced left lower leg swelling and redness at approximately 11pm on the night of her first dose of Pfizer COVID-19 vaccination. She indicated that she had slept with her legs above her chest and the next morning (April 9, 2021) the swelling had decreased and redness had gone away. She proceeded to go to work. She reports having sharp pains on right side of her chest and the swelling in the legs continued for a few more days. On the evening of April 13, 2021, she began experiencing heart flutters and took a baby aspirin as a precaution. The patient indicated she did not currently have a primary care physician. She was advised to seek medical attention (i.e urgent care center or hospital) by pharmacy staff.
FLUBLOK administered to pediatric patient with no reported adverse event; Initial information received on 27-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to cases 2022SA402510(CLUSTER), 2022SA402530(CLUSTER), 2022SA402436(CLUSTER) and 2022SA402436(CLUSTER).  This case involves a 13 years old female patient who was administered FLUBLOK with no reported adverse event while receiving vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 23-Sep-2022, the patient received 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (formulation and strength not reported; lot UJ887AA and expiry date: 09-Jun-2023) via intramuscular route in the left deltoid for prophylactic vaccination.  On 23-Sep-2022, (latency: same day) the patient had flublok administered to pediatric patient with no reported adverse event (product use issue) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  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.; Sender's Comments:  01296394: 01296472: 01296480: 01296502: 01296512: 01296528: 01296536: 01296543: 01296554: 01296563: 01296570: 01296578: 01296582: 01296616: 01296621:
This spontaneous report was received from a pharmacist referring to a 59 year old female patient. On 03-AUG-2017, the patient was vaccinated with ZOSTAVAX lot # N014018, subcutaneous for prophylaxis. Concomitant therapies included buspirone hydrochloride, hydroxyzine, clonazepam, ENTRESTO, CYMBALTA, LAMICTAL, naltrexone, carvedilol and bumetanide. On 05-AUG-2017 (reported as "in the next couple of days"), the patient experienced herpes zoster, arthropod bite, rash and pruritus. The outcome of herpes zoster, arthropod bite, rash and pruritus was unknown.
A report was received from a consumer on 10/10/2003 concerning a 75 year old female pt who experienced aches, (2 days after receiving Fluvirin on 10/02/2003), sore throat, congestion, and cough 3 days after vaccination and passed out and had tremors an unspecified length of time after vaccination and was hospitalized on 10/09/2003. On 10/04/2003 the pt experienced aches and then on 10/05/2003 the pt experienced flu symptoms including aches, congestion, sore throat and coughing but no fever. The pt contacted a hospital and was advised to take ibuprofen. She also took saline nasal drops for nasal congestion, menthol, camphor and eucalyptus oil applied topically at bedtime, and zinc salts every 6 hours for symptom relief. On 10/09/2003 the pt's symptoms worsened. Diazepam, chlorpheniramine, paracetamol and Protothazine with dextromethorphan were prescribed by the pt's physician. The pt passed and had tremors. Paramedical personnel treated the pt with diphenhydramine and she was taken to hospital. The pt had returned home at the time of the report. The pt had not recovered at the time of the report. No follow up. Permission not granted to contact treating physician.
Client received a 2nd dose of Tdap on 7-13-12; client had received first dose from another doctor's office but did not provide documentation or report (when asked) that she had received a previous dose; client provided documentation after receiving immunizations that noted a Tdap on 01-09-2012.
1/20/2021 - pt experiencing marked fatigue 01/23/2021 - pt went to ED with fatigue, sweats, cough, and low BP.  Admitted with diagnoses of cardiogenic shock, myocarditis, acute renal failure, heart failure, anemia, UTI, oral thrush.  Treated with IV fluids, dialysis, temporary pacemaker. 02/06/2021 - discharged to rehab facility 02/17/2021 - discharged home
ED Discharged  4/4/2021 (2 hours) Hospital ED  MD Last attending ? Treatment team Acute cystitis without hematuria +1 more Clinical impression Sore Throat ? Fever ? Back Pain Chief complaint ED Provider Notes MD (Physician) ? ? Emergency Medicine Expand AllCollapse All      HPI      Chief Complaint Patient presents with ? Sore Throat ? Fever ? Back Pain     80-year-old female with multiple complaints.  Patient states she had her second Covid vaccine yesterday.  Since then she is complaining of having generalized weakness, headache, body aches, back pain, cough, nausea, generalized weakness and dizziness.  No abdominal pain.  She has nausea but no vomiting or diarrhea.  No dysuria.  Denies any chest pain.
Evening of flu inj given c/o sore throat and temp 103 x 1 day.
This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received third (booster) dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8028) via an unspecified route of administration in the left arm on 15Nov2021 at 18:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown, whether, the patient received any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included rosuvastatin (MANUFACTURER UNKNOWN), ibuprofen (ADVIL), magnesium citrate (MANUFACTURER UNKNOWN) and vitamin b nos (VITAMIN B); all from an unknown date for unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6023) via an unspecified route of administration in the left arm on 28Feb2021 (at the age of 49-years-old) and received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 20Mar2021 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. On 16Nov2021 at 12:00, the patient experienced headache, sore arm, sore throat, chills, joint and muscle pain, fatigue and nausea. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events, headache, sore arm, sore throat, chills, joint and muscle pain, fatigue and nausea was resolving at the time of this report.
Information has been received from a pharmacist via a company representative referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of MMR II (dose, frequency, lot# and route were not reported). On an unknown date the patient had negative titers after receiving unspecified vaccines. The outcome of the event was unknown. The relationship between the event and MMR II was not reported. No PQC was involved. Additional information has been requested.
Vaccine given 6/7/16. Pt came to office today 6/9/16 with guardian. Pt has 8 mm wheal and 10 cm flare on R lateral thigh and has enlarged by 2 cm since onset 6/8/16. No complaint of pain. MD recommended ice and BENADRYL.
Pt recvd 3 doses of Engerix-B 3DEC90, 3JAN91, & ?3AUG91 20NOV90 (?1991) it was determined that pt did not respond to the vax series;
This spontaneous report was received from a physician (who was also the patient) via Pfizer Inc (manufacturer # 2015321469) on 30-SEP-2015, and refers to a 64 year old patient (gender not reported) with asthma and allergy to tetanus toxoid vaccine (administered when the patient was 22 year old). The patient's medical history included pyrexia and peripheral swelling (when the patient was 22 year old). On an unspecified date in 2002, when the patient was 58 year old, she was vaccinated with the first dose of PNEUMOVAX 23 (lot number, expiration date, dose, route of administration and anatomical location were not reported). On an unspecified date in 2008, the patient was vaccinated with the second dose of PNEUMOVAX 23 in the deltoid (arm was not specified) (lot number, expiration date, dose and route of administration were not reported). There was no concomitant medication reported. On an unknown date, the patient reported that her whole shoulder down to her arm swelled up and she felt lousy. The patient also reported that she did not have fever. At the reporting time, the outcome of feeling abnormal and peripheral swelling was reported as recovered on an unspecified date (reported as "it took several days for the reaction calm down"). Additional information has been requested.
patient came in stating they wanted a pneumonia vaccine.  patient was given the vaccine, pharmacist later realized patient was under 65 and for health conditions had hypertension and high cholesterol which does not fall within the chronic conditions to vaccinate under 65
Started severe back pain and behavioral problems two days after receiving vaccine. I was losing my balance all of the time which I never had a problem with before. I eventually took a fall down some stairs which resulted in me eventually having to leave my job because of throwing my back out. I still struggle with back issues and behavioral problems. I struggle standing up too long or my back gets incredible fatigued and I need to sit down. Again, I never had this issue before.
pt recv vax & exp nausea, bloating, abd pain w/cramps, loss of appetite, a high fever & had high bilirubin;
I don't have reason to believe this is caused by vaccine...but a few days later I started to have pain in my upper right jaw. Thought it was tooth pain. Dentist checked and teeth were ok. Dr. scanned sinuses, also ok. Pain spread throughout right side of face. Sent me to neurologist who thought it was trigeminal neuralgia or TMJ (or both). Pain has now spread through right side of body; pain and numb/weakness. I had brain MRI that was negative, now doing another brain MRI, and full spine MRI looking for possible MS
Injection site had redness; was sore to the touch for 3 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 at 11:00 as dose 4 (booster), single (Lot number: GJ6742) at the age of 26 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Wheat" (unspecified if ongoing), notes: Known allergies: Wheat. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 04Oct2022 at 11:00, outcome "recovered" (07Oct2022), described as "Injection site had redness"; VACCINATION SITE PAIN (non-serious) with onset 04Oct2022 at 11:00, outcome "recovered" (07Oct2022), described as "was sore to the touch for 3 days". Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site pain.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no other vaccine in four weeks. The events did not result in emergency room, physician office visit or intensive care unit.  No follow-up attempts are possible. No further information is expected.
Child was combative and required several adults to control her. The DTAP was given in left thigh, but child was resistant and may have caused vaccine needle to not go in site well.  Child developed a mass within 5-6 hours, Then impressive redness, hot to touch by next am. Redness, heat decreased by day 3 after vaccine. child was given Keflex 2 id X 5 d for possible early cellulitis.
Patient complaining of itchiness at the injection site, left rib area, and in the scalp 20 minutes after the injection. Patient is awake and alert. Denies any itchiness on the mouth and throat area.  Heart rate= 58, Oxygen sats= 97% on room air.
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 75 year old patient. Weight: not provided; Height: not provided. Concomitant medications: Not reported. Administration of company suspect drug(s): On 16-Sep-2016 the patient received AFLURIA for protection against influenza virus. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number: WT54306. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 16-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. On 04-Oct-2016, the remained 42 doses of lot number WT54306 were discarded. The patients will be contacted for revaccination.
Chills last night with localized injection site reaction w/noted today lethargy and HA, nausea. Injection site is red, swollen and warm to touch.