chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A report has been received from a Health Professional concerning a patient born on 30-Mar-2010, Male subject, who had been receiving Nasal FLUMIST. FLUMIST started on 21-Jan-2013. The reporter stated that they had accidentally administered expired FLUMIST to patients. The outcome of the event of ADMINISTERING EXPIRED FLUMIST is unknown. The report was considered to be non-serious. Follow-up of insignificant information received by AstraZeneca/MedImmune 31-Jan-2013 from consumer. The reporter's details updated. Corrected reported 08-Jan-2013. Patient was added as an additional reporter. Event onset date was removed.
Pt admitted to hospital with Sepsis. Fevers and malaise for 1 day before admission. Extremely elevated WBC. New pneumonia. Requiring oxygen.
Myalgia, Fever, swollen lymph nodes, Right knee swollen, hard to walk Narrative:
Patient is a 67-year-old female with a past medical history of chronic cough, factor V Leiden (not on anticoagulation), anxiety, depression, bipolar 2, and PTSD presenting today for multiple concerns.  Patient reports that 4 days ago she got both her fifth COVID shot as well as a "high-dose" flu shot.  Since then she has been having multiple symptoms.  She initially had some nausea and vomiting which has since subsided.  She then developed severe throat pain radiating up to her ear.  She is concerned she has otitis media.  She has also developed a productive cough with thick white sputum and excessive sneezing.  She is concerned that she has drainage dripping down and causing pneumonia.  Has had body aches and fatigue.
I tested positive for COVID 6 months after receiving the 2nd dose. No underlying health conditions. There are a lot of people who are getting COVID that have been fully vaccinated. I worry that it is not being properly reported.
This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (hard time trying to elevate her arm), INJECTION SITE PAIN (Soreness at the injection site), CHILLS (chills), PYREXIA (fever) and NAUSEA (Nausea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included VITAMIN D3 from 2000 to an unknown date for Bone density decreased, MONASCUS PURPUREUS (RED YEAST RICE) for Cholesterol, FISH OIL (OMEGA 3 FISH OIL [FISH OIL]) from 2000 to an unknown date for Dry eye, MAGNESIUM GLUCONATE for Muscle cramps, PARACETAMOL (TYLENOL) and VITAMIN C [ASCORBIC ACID] from 2000 to an unknown date for an unknown indication. On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced PAIN IN EXTREMITY (hard time trying to elevate her arm). On 23-Jan-2021, the patient experienced INJECTION SITE PAIN (Soreness at the injection site), CHILLS (chills), PYREXIA (fever), NAUSEA (Nausea), HEADACHE (severe headache) and FATIGUE (A little fatigue). On 24-Jan-2021, INJECTION SITE PAIN (Soreness at the injection site), CHILLS (chills), PYREXIA (fever), NAUSEA (Nausea) and HEADACHE (severe headache) had resolved. On 25-Jan-2021, FATIGUE (A little fatigue) had resolved. At the time of the report, PAIN IN EXTREMITY (hard time trying to elevate her arm) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2021: Follow-up received on 24-April-2021. Added concomitant medications, patient demographics
Tongue pain with swelling, blistering & white coating; blisters inside cheeks;slight headache; sore throat; fatigue
recvd vax on 03sep94;18sep94 devel temp102.8;tx atb;noticed vaginal discharge,seen by md on 28sep94;prescribed terazol for yeast infect
Became ill after first dose; fatigue; high fever; dizziness; sweating; glands swollen and achy; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Became ill after first dose), DIZZINESS (dizziness), HYPERHIDROSIS (sweating), LYMPHADENOPATHY (glands swollen and achy) and FATIGUE (fatigue) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: TYPHOID VACCINE (In 1983 and Experienced similar events) in 1983. Concurrent medical conditions included Allergy to antibiotic (Tetracycline), Allergy to antibiotic (Dicloxacillin), Allergy to antibiotic (Levofloxacin), Hypertension, Lymphadenopathy, Drug allergy (Compazine), Drug allergy (Statins) and Drug allergy (Prochlorperazine). Concomitant products included CITALOPRAM from 07-Jul-2021 to an unknown date for Anxiety, TELMISARTAN from 24-Aug-2021 to an unknown date for Hypertension, AMITRIPTYLINE and MELATONIN from 17-Jul-2021 to an unknown date for Sleep disorder NOS, ACETYLSALICYLIC ACID (ASPIRIN) from 16-Mar-2021 to an unknown date for an unknown indication.    On 05-Feb-2021 at 11:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced DIZZINESS (dizziness), HYPERHIDROSIS (sweating), LYMPHADENOPATHY (glands swollen and achy) and PYREXIA (high fever). On an unknown date, the patient experienced ILLNESS (Became ill after first dose) and FATIGUE (fatigue). At the time of the report, ILLNESS (Became ill after first dose), DIZZINESS (dizziness), HYPERHIDROSIS (sweating), LYMPHADENOPATHY (glands swollen and achy), FATIGUE (fatigue) and PYREXIA (high fever) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jun-2021, Thyroid gland scan abnormal: abnormal (abnormal) Very small nodules bilaterally in the thyroid, nonspecific appearing and difficult to characterize further because of small size. No surrounding adenopathy noted..     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ILLNESS (Became ill after first dose), DIZZINESS (dizziness), HYPERHIDROSIS (sweating), LYMPHADENOPATHY (glands swollen and achy), FATIGUE (fatigue) and PYREXIA (high fever) to be possibly related.    No  treatment medications were provided   This case was linked to MOD-2021-300020 (Patient Link).
I'm experiencing continued tingling/burning sensation on my arms (i believe referred to as paresthesia). It has been present for the past few months, which aligns with when I got my booster shot. Initially it was primarily at night, disrupting sleep, but now it often persists all day long. It is worse in my left arm, but present in both.
Rec'd first set of immunization 9/5/2008 an am.  fussy in afternoon of Friday.  By Saturday, very gassy and would arch back and cry in middle of most all feedings.  very irritible and fussy until 9/14/2008.  No redness at site, didin't act lkie it was from injections.
Major joint replacement surgery; This spontaneous case was reported by a consumer and describes the occurrence of JOINT ARTHROPLASTY (Major joint replacement surgery) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced JOINT ARTHROPLASTY (Major joint replacement surgery). At the time of the report, JOINT ARTHROPLASTY (Major joint replacement surgery) outcome was unknown.            No concomitant medications were reported. It was reported that Patient just had major joint replacement surgery and wanted to know if it was okay to get her second booster. No treatment medications were provided.   Reporter did not allow further contact
Itching, dizziness, headache 2 hours after receiving FLUZONE. Administered in 2 step process per CDC recommendation. Received PEPCID and BENADRYL before vaccine.
This is a 61 yo female with pmh dm2 presented to the hospital 12/10/22 and was admitted to the ICU with necrotizing fasciitis of the labia and groin, HHS, sepsis and acute respiratory failure.  She was treated with ivf and iv insulin.  She has required 4 operations for debridement of necrotizing infection thus far.  She has been treated for covid-19 pneumonia and has completed remdesvir and dexamethasone.  She required mechanical ventilation and has been extubated.  Hospital course complicated by acute bilateral upper and lower DVT, hematology consulted due to concern for HIT/DIC and further evaluation. Negative HIT/DIC workup. Negative inpatient hypercoagulability workup. Anemia is  most probably reactive/hypoproliferative bone marrow response with acute significant infection inflammation. Negative hemolysis, negative iron deficiency.  ID on board and recommend for MRSA, B frag, continue vancomycin through tomorrow, meropenem through 1/31/23. Continue empiric fluconazole. Actinomyces on blood culture. Continue wound care.  Patient accepted to go to LTAC.  We will discharge in stable condition.  Continue with meropenem until January 31.
chest was swollen and couldn't breath good, vomiting, went to ER and was given an anti-inflammatory
Pt had completed their covid vaccine course at the hospitals and then came to pharmacy to get a third shot. Pharmacy did not catch that the series was already completed.
This spontaneous report was received from a medical assistant who referred to an unspecified number of patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant therapies and drug reactions or allergies was provided. On unknown date, the patients were vaccinated with improperly stored doses of PROQUAD lot# M031567 with expiration date: 24-DEC-2017, lot# M035143 with expiration date: 30-JAN2017 (dose and route of administration were not reported) as prophylaxis. The sterile diluent (manufacturer unknown) used was stored properly (lot# and expiration date not provided). The doses of vaccine were stored between 6 degrees Fahrenheit (F) to 14F for 54 minutes. No previous temperature excursions were detected. Digital data logger was involved. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA006289: US-009507513-1707USA009050: US-009507513-1707USA009051: US-009507513-1707USA009052: US-009507513-1707USA009053:US-009507513-1707USA009054: US-009507513-1707USA009055: US-009507513-1707USA009057.
This spontaneous report was received from a physician refers to unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with VARIVAX (Merck) (dose, frequency, lot# J012252 and expiration date 01-OCT-2015. On unknown date the patients experienced redness and swelling at the injection site. The physician believes most of the phone calls she received from the parents of children (who were vaccinated) are actually the usual type of reactions, which happen after a vaccination. The physician wanted to under if what she heard from parents concerning the injection side effects, their children had experienced, were worse than what was listed in the Prescribing Information, for frequently reported events. The physician stated she had not received any information from the company. The physician has no patient identifiers to share. The outcome of redness and swelling at the injection site was unknown. Causality was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
About a week after the shot my lips became chapped. Didn't think much about it, until middle of March when I went to dentist and they were still chapped. Looked up the condition online and it appears to be cheilitis. Carmex lip balm provides temporary relief, but as of today I still have it, as well as sensitivity to spicy foods on my tongue and roof of mouth. Went to my primary care physician two weeks ago and he prescribed Vitamin B complex and Vitamin C. Twelve days later, no noticeable change in symptoms. After that appointment I was contacted by VAERS for a follow-up and it occurred to me that the issue could be a side effect of the vaccine
Flu-like symptoms with fever during afternoon/night after. Woke up at 6 am, felt nauseous and fainted on the bathroom floor, hitting head on a drawer pull, causing laceration and concussion. Low-grade fever over the next 24 hours, with bouts of nausea, dizziness, and labored breathing.
Fever 104.2 max the day after shots and febrile seizure. However, patient also began URI and AOM diagnosed 6/8/05 that began about 6/5/05.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 15-JAN-2019, the patient was vaccinated with improperly stored dose of PROQUAD (lot # R017800, expiration date: 19-DEC-2019, dose and route of administration were not provided) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. No adverse effects were reported. Administered dose of PROQUAD experienced temperature excursion between -14 to -10 Celsius degrees for 30 minutes. There was no previous temperature excursion reported. Digital data logger was involved. This is one of seven reports received from the same reporter. Sender's Comments: US-009507513-1901USA009536.
This spontaneous report as received from a pharmacy student refers to a patient of unknown age. On 21-OCT-2013 the patient was vaccinated with a dose of VARIVAX (Merck) (lot #, dose, indication, route not reported, expiration date August 2013), but the reporter could not be sure. The reporter did not believe any adverse effects were reported by the patient. Additional information is not expected.
2:00 PM mild headache, nausea/stomach pain -- Tylenol 8:00PM symptoms feeling worse -- 3:00 AM sweating, shivering, muscle aches, temple pressure and tension headache. 6:00 AM intensified symptoms, no relief.
1+ swelling of hand & wrist;numbness +3 digit lt hand;DPH given;pt instructed to take DPH;
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, medical history, any known allergies or reactions or concomitant medications. On an unknown date, the patients were vaccinated with improperly stored GARDASIL 9 lot # M030380 with expiration date of 01-FEB-2019, lot# M032650 with expiration date of 31-MAR-2019, lot# M034780 with expiration date of 15-APR-2019, and lot# M037770 with expiration date of 01-JUN-2019, for prophylaxis (dose and route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of 47-77 degrees Fahrenheit (°F) for 3 hours. There were not previous excursions. Data logger was involved. No adverse symptoms were reported. No product quality complaint was involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA001009: US-009507513-1705USA001228: US-009507513-1705USA001230: US-009507513-1705USA001231: US-009507513-1705USA001232.
School RN reported that pt. experienced redness, swelling, pain to injection site after varicella vax. Parent iced x24 hrs, administered ADVIL et child's BENADRYL. No c/o fever, SOB, or other systemic response. Pt now recovered, site observed by school RN as per usual.
Incorrect BUD had been written on label for vaccine and dose was given 1 day post manufacturers expiration date.  Manufacturer contacted and they performed a viability test on the lot number and determined that the dose was still viable and that there was no need to re-vaccinate.  Patient was contacted and dose entered in database as a historical dose.
Pt received Shot Thur and reported "some reaction Sat. to MD. Dr. reassured patient. School nurse and mom report the side polio was received on ended up becoming hives and swelling from groin to knee and hives from midchest down into lower groin.
had a lot of the general side effects; fast heartbeat; dizziness; fatigue; headache; muscle pain; chills; fever; A spontaneous report was received from a consumer concerning a 76-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events had a lot of the general side effects, fast heartbeat, dizziness, fatigue, headache, muscle pain, chills, fever.  The patient's medical history was not provided. Concomitant medications reported were Synthroid for drug use for unknown indication.  On 3 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 026A21A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) had a lot of the general side effects, fast heartbeat, dizziness, fatigue, headache, muscle pain, chills, fever.  Treatment details included ASPIRIN.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), had a lot of the general side effects, fast heartbeat, dizziness, fatigue, headache, muscle pain, chills, fever was unknown.
No adverse event, this was a duplicate FLUAD Vaccine administration.  Provider spoke with patient regarding the duplicate vaccine. Patient has not had any side effect or adverse effect.
This was full dose booster per dr  recommendation and prescription due to being immunocompromised.    Increased tinnitus to preexisting tinnitus.  Previous vaccinations for Covid have also elicited tinnitus which did lessen.  This is worst tinnitus I?ve experienced and does not currently appear to be lessening
approx 12 hrs p/vax pt devel focal sz w/tonic clonic contraction of rt hand later rt leg & blinking of eyes; sz recurred x 4 episodes on subsequent days;
At 1700 MA approached LVN stated PT felt dizzy. LVN approached PT and assessed. PT stated feeling dizzy, VS Pulse 89 RR18 BP 124/81, O2 100% RA.  At 1710 PT stated throat feels like it's closing up, and chest feels tight. RRT was called. RRT arrived 1712 with MD and 2 members of staff. RRT  Assessed and administered epinephrine. RRT administered O2 via NC.  Pt was released to family member in stable condition.
Patient tested positive for COVID by PCR on 3/14/21; >2 weeks after fully vaccinated. Patient had H/A, SOB, rhinorrhea. Received Monoclonal antibodies on 3/18/21.
Patient describes heart rate as "pounding and beating more," radial pulse is 110 after vaccination. Patient is given food and water and instructed to take deep, slow breaths and is taken into Med OBVs. Vitals at 11:40 were: HR:116, RR: 24, BP: 150/85, SPO2: 100. At 12:02 patient states that palpitations seem lighter. States patient has stress and anxiety makes her heart rate increase, asks "Is my 15 min injection over," informed it was, VS were: HR: 126, RR: 126, BP: 152/96, SPO2: 100. 12:20 patient states " I feel so much better and I want to get out of here and take my mask off." VS were: HR: 110, RR: 20, BP: 142/86, SPO2: 100.  patient's vital were stable and was released at 12:20 with spouse.
Patient said wanted BOTH on right arm due to nerve damage on left arm from IV at hospital in previous years. Patient was moaning & deep breathing before the shots, he said he was nervous of needles from previous experience.  Gave one shot, waited in between shots, then gave 2nd one.  He seemed ok and handed the printout.  Then he said he was feeling lightheaded.  Told him to stay seated.  Seemed like he was passing out. Patient kept eyes open but seemed out of it for 1 min or so, while I kept calling his name.  Then patient seemed alert.   Sat and talked to patient got water to drink, pulse good.  BP 181/84.  Pt stated he felt better and ok to go.  I observed patient sitting, talking, standing, walking, before he left with girlfriend. Called the patient the next day to confirm and stated  they felt better.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 15 years old adolescent patient and unknown gender. On 03-SEP-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot J015378, expiration date 09-APR-2016) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Case PHEH2016US023015, is a spontaneous report initially received from a pharmacist on 08 Sep 2016. This is also a quality complaint report (QA reference number: 1016686). This report refers to a 52 years old female patient. Past vaccination history included administration of Pneumo-poly vaccine on 26 Dec 2001 and diphtheria tetanus pertussis vaccine received on 23 Sep 2015. Current condition of the patient included unspecified allergies and metabolic disorders and smoking. She was vaccinated with FLUVIRIN (batch number: 168805, expiry date: 30 Apr 2017) at an unknown dose on 08 Sep 2016 at 11:30 hours. The pharmacist stated that at the time of administration, part of the vaccine squirted out. The needle was all the way in and the syringe luer lock, appeared to be connected correctly. She received an incomplete dose. The luer was checked and the needle was screwed tight to the syringe. The needle was also pushed into her arm as far as it would go. No adverse event was reported following this administration error (underdose and syringe issue). Follow up information received from a pharmacist on 22 Sep 2016: Added patient demographics, vaccination history, current condition, vaccination time and reporter's comment regarding vaccination.
Pt returned to clinic 25-30 minutes after TD and Varicella administered with severe itching, facial swelling and agitation. Given 25mg Benadryl per mouth and 0.5mL Epinephrine SQ.