chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ED to Hosp-Admission Current  9/2/2021 - present (6 days)l  Chief Complaint Patient presents with ? Shortness of Breath   Patient is an 83 y.o. male.    Past medical history COPD, hypertension, brought into the ED by his family for weakness and altered mental status along with shortness of breath.  Patient is a poor historian but he does report having worsening shortness of breath over the past couple weeks.  During this timeframe patient does have productive cough with white and yellow sputum.  Patient denies any fevers or chills.  This morning he became so weak that he was not able to get out of bed and even his son was not able to get him out of bed.  Over the past week patient has also been having midsternal chest pain intermittently.  Patient denies any recent sick contacts, he has received 2 doses of COVID-19 vaccines.  Patient denies any changes in his weight, denies any travel history or night sweats.  Patient denies any abdominal pain, nausea or vomiting.  He has indwelling Foley catheter and has had history of urosepsis.  Per family patient is more confused compared to usual but he is able to answer certain details correctly.   In the ED patient was found to be tachypneic respiratory rate 24, he was afebrile.  Patient was placed on 2 L oxygen.  Blood work was remarkable for platelet of 84,000, D-dimer of 1.57, sodium level 129.  First set of troponin is 0.06, BNP of 103.  UA had 52 WBCs.  CTA chest was negative for PE, patient has bilateral infiltrates consistent with Covid pneumonia.  Patient was given vancomycin and cefepime in the ED.
p/vax pt lt arm pain c/numbness; felt like paralysis; could not lift up hand; rt arm hurt also had pain; numbness & tingling sensation in head; fine next day but still had pain in arm
This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 16-NOV-2015, the patient was vaccinated with first does of ZOSTAVAX (route and site of administration, lot # and expiry date were not reported). On 03-MAY-2016, the patient received second dose of ZOSTAVAX, (route and site of administration, lot # and expiry date were not reported, inadvertently. No adverse effects were reported. Additional information has been requested.
Chest pain during exertion. Intermittent Chest pain during light exertion continued for about 5 months.  Treated with prednisone 12/29/2020 Treated by cardiologist 2/2/2021
Patient's spouse called stating she is experienced swelling and pain around the injection site, which radiated into the shoulder overnight.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 23-OCT-2015 18:09, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperaure and low temperature were 4.9 and -4.7 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Client c/o shortness of breath.  Client seen and assessed by EMT.  VS are  BP 115/60, O2 98, HR 75, R 16.  Client verbalized she was very anxious prior to receiving vaccine but no longer feeling symptoms while at observation.  Client instructed to contact MD if symptoms come back or worsen.  Client cleared by EMT.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 01-JUN-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB, lot # N022167, expiration date: 08-FEB-2020 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1806USA001505: US-009507513-1806USA009026: US-009507513-1806USA009027: US-009507513-1806USA009028: US-009507513-1806USA009029: US-009507513-1806USA009030: US-009507513-1806USA009031: US-009507513-1806USA009032: US-009507513-1806USA009033: US-009507513-1806USA009034: US-009507513-1806USA009035: US-009507513-1806USA009036: US-009507513-1806USA009037: US-009507513-1806USA009038: US-009507513-1806USA009039: US-009507513-1806USA009040: US-009507513-1806USA009041: US-009507513-1806USA009042: US-009507513-1806USA009043: US-009507513-1806USA009044: US-009507513-1806USA009045: US-009507513-1806USA009046: US-009507513-1806USA009047: US-009507513-1806USA009048: US-009507513-1806USA009049: US-009507513-1806USA009050: US-009507513-1806USA009051: US-009507513-1806USA009052: US-009507513-1806USA009053: US-009507513-1806USA009054: US-009507513-1806USA009055:
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider(s) recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 11-SEP-2013, a healthcare provider at a medical center (urgent care facility) administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 27-DEC-2016, the patient was treated by a healthcare provider at a medical center (urgent care facility) for shingles.  The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Causality assessment considered events to be related to the use of ZOSTAVAX. Additional information has been requested.
Vaccine administered on 7/15/2021. Symptoms began 2nd day.  Woke and couldn't breathe like asthma  Continued to use inhalers 8 xs day. Pt thinks he had liquid in lungs. Relieved after 4th day resolved
This spontaneous report as received from the mother of a consumer and refers to a 14 year old male patient. On 28-JAN-2013 the patient was vaccinated with GARDASIL (Product Circular USPI-I-V5011303R017) dose 1, intramuscular. On 28-MAR-2013 the patient was vaccinated with GARDASIL dose 2, intramuscular. The lot numbers and doses were not reported. The patient's mother reports that following the first dose of GARDASIL her son developed headaches (hospitalization, disability). The reporter stated that her son had two emergency room visits (dates of first two emergency room visits were unspecified) and was hospitalized after a third emergency room visit on 20-FEB-2013 for 3 days. The reporter stated that her son had continually headaches and occasionally had throbbing, stabbing, debilitating headaches (headaches rated as scale 1 to 8 on a 10 point scale). The reporter also stated that her son had limited classes in school, was not allowed to read at home or participate in outside activities because of the headaches. The headaches did not change after receiving the second dose of GARDASIL. The patient tried IMITREX for the headaches, but it did not work (date unspecified). The treatment of the headaches had included use of fish oil, magnesium oxide, amitriptyline hydrochloride, riboflavin, and MAXALT (used for intense headaches). The outcome of continually has headaches and occasionally throbbing, stabbing, debilitating headaches was reported as not recovered/not resolved. Reporter causality assessment was not reported. Case is linked to case: 1304USA015288 (same reporter). Additional information has been requested.
Within the first 12 hours: sore arm, 99.4 degree fever, muscle aches, and chills.  By 24 hours fever spiked to 100 degrees, muscle aches and chills intensified, fatigue, and a major osteoarthritis flare up.  Ibuprofen was used for symptoms, which resolved within 36 hours.
Left arm swelled slightly a couple hours after injection. Staying swollen, a rash started to appear four days after injection.
My symptoms from booster; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (My symptoms from booster) in a  patient of an unknown age and gender 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 VACCINATION COMPLICATION (My symptoms from booster). At the time of the report, VACCINATION COMPLICATION (My symptoms from booster) outcome was unknown.            No concomitant medication details was provided. No treatment medication details was provided.
On November 19, not long after the vaccine, patient got dizzy. Had pre-existing headache that worsened after the vaccine. Patient waited in the parking lot of the clinic for 2 hours, still felt dizzy. Left arm pruritic. Felt sharp pain in LLQ/ovaries. Started feeling occasional pin-like feeling in chest with breathing. Throat felt slightly swollen and 'cotton mouth' feeling, did not feel dyspneic, felt tight. Pain in L shoulder, scapula, clavicle started that evening.   November 20 - more soreness in L arm. Rhinitis, sneezing, slightly dizzy, and slight headache.   November 21 - rhinitis, sharp pain in LLQ/ovaries again, increased fatigue that was different than usual. Pain in L breast with lactation (currently nursing). Slight pharyngitis, felt as though cold was starting.  November 22 - felt more fatigue, pain in shoulders and wrists, rhinitis, congestion. Had headache that became migraine. Change in vision, seeing spots, blurry vision. Otalgia, pain in eyes. L arm and hand numbness and tingling. Face felt numb, tongue felt tingly. Went to urgent care November 22 to be evaluated.  November 23 - fatigue, slight migraine but improving
"3" circle around site of injection. Very sore and kind of hard". Originally said was not to the touch but then said was not really hot.
My arm was a little sore after the first shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  A 33-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "My arm was a little sore after the first shot".  Additional information: The patient was relieved get first [Pfizer] Covid vaccine. The patient was worried about possible side effects and watched short film which mentioned the most common side effects and the fear/concern came back to the patient. The patient's arm was little sore after the first shot.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Excruciating pain on the arm the vaccine was administered from shoulder to wrist. Was unable to use a for nearly 24 hours due to extreme pain
Pt recvd vax & exp diarrhea; resolved in 5 days;
This case was reported by a healthcare professional and described the occurrence of hemolytic anemia in a female subject of unspecified age who was vaccinated with Hepatitis B for prophylaxis. The healthcare professional received the information about this case from a consumer, who is the grandmother of the subject. The consumer mentioned the event to the healthcare professional during an office visit. On an unspecified date the subject received unspecified dose of Hepatitis B vaccine (unknown). At an unspecified time after vaccination with Hepatitis B vaccine, the subject experienced hemolytic anemia. The consumer reported to the healthcare professional that the subject, "had her picture taken and was written up in a medical journal." At the time of reporting the outcome of the event was unspecified. The healthcare professional considered the event was probably related to vaccination with Hepatitis B vaccine. Comment: Hemolytic anemia was assessed as medically serious by GSK.
No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager 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 28-SEP-2020, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB), 1 injection, lot # S022584, expiration date: 31-OCT-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursion of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022584; expirationdate: 31-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
onset of fever 13OCT93 PM low grade; t104, abdo cramps & onset of vomiting; cough;
Admission Date: 7/15/2022  PRESENTING PROBLEM: Subarachnoid hemorrhage Intracranial hemorrhage   HOSPITAL COURSE: Patient is a 75 year old with a PMHx of ESRD on HD, Type 2 diabetes, CHF, HTN, HLD, GERD, SBO, diverticulitis, abdominal abscess s/p ex lap with colostomy and chronic pancreatitis that presented 7/15/2022 with an acute spontaneous subarachnoid hemorrhage. A head CT was completed that revealed a large left frontotemporal ICH, diffuse SAH, 8 mm MLS, and hydrocephalus. CTA head/neck demonstrated concern for Left MCA aneurysm. Patient was taken emergently to the OR for left MCA aneurysm clipping and left hemicraniectomy with ICH evacuation. Post operatively a DCA was completed that showed complete occlusion of left MCA aneurysm w/small neck remnant, head CT with stable postoperative findings, slight worsening of hydrocephalus, improvement in MLS to 6 mm. Patient also had an EVD placed for obstructive hydrocephalus. Patient was admitted to the Neuro ICH for subarachnoid hemorrhage management. She was started on CRRT given ESRD. Postoperatively, patient was weaned off sedation but remained a GCS <8. Right facial and upper extremity twitching was noted and EEG placed which demonstrated focal status epilepticus with left frontal origin. She was started on keppra and valproic acid with minimal improvement. Therefore, pt started on versed infusion. On 7/18, pt continued to be in focal status, therefore she was administered 4mg ativan, versed increased to 0.5mg/kg/hr and loaded with fosphenytoin with subsequent cardiac arrest. Resuscitation efforts attempted, family present at bedside and DPOA requested efforts cease. Please see critical event notes for further detail. Time of death 0928 on 7/19/2022.
Stomach hurts very bad; Hard time in morning when gets up legs hurt and cannot walk; Hard time in morning when gets up legs hurt and cannot walk; Arm hurt from injection; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach hurts very bad), GAIT INABILITY (Hard time in morning when gets up legs hurt and cannot walk), PAIN IN EXTREMITY (Hard time in morning when gets up legs hurt and cannot walk), INJECTION SITE PAIN (Arm hurt from injection) and HEADACHE (Headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    Concurrent medical conditions included Back pain (Pain from past health issues with back).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Stomach hurts very bad), GAIT INABILITY (Hard time in morning when gets up legs hurt and cannot walk), PAIN IN EXTREMITY (Hard time in morning when gets up legs hurt and cannot walk) and INJECTION SITE PAIN (Arm hurt from injection). At the time of the report, ABDOMINAL PAIN UPPER (Stomach hurts very bad), GAIT INABILITY (Hard time in morning when gets up legs hurt and cannot walk), PAIN IN EXTREMITY (Hard time in morning when gets up legs hurt and cannot walk) and INJECTION SITE PAIN (Arm hurt from injection) outcome was unknown and HEADACHE (Headache) had not resolved.            This case was identified as part of a retrospective clean-up activity received in the Moderna were missed to be booked-in.  No concomitant medication was reported.  Primary reporter contact for lot number information was not available.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication was reported.  The reporter's causality for the events of hard time in morning when gets up legs hurt and cannot walk unknown onset, hard time in morning when gets up legs hurt and cannot walk unknown onset, stomach hurts very bad and arm hurt from injection was not provided. The reporter's causality for the events of headache was not reported for co-suspect Humira.
Immunization specialist was supposed to administer Quadracel and ProQuad and instead accidentally administered PENTACEL and Quadracel.  Patient may have also been administered wrong route on top of wrong vaccine.
I initially developed soreness from the vaccine. Then on day 2-3 my arm became red in about a quarter size. That increased to golf-ball size. The pain went away and the redness stayed for a day or two more. It went away, then came back with itching and hives on around day 6. It cleared up again and came back a third time. This time baseball sized, measuring 6 cm x 7 cm in a circle with a dark red ring that was raised at times. It was itchy, warm and firm to the touch. I took Benadryl 25 mg on day 14, it started clearing up on day 15 and is totally gone at this time.
Pt's left deltoid became extremely swollen to the size of an adult fist. It was erythematous and very tender. It responded to ice.
that a patient due for her second dose of VARIVAX and was accidently administered PROQUAD instead; that a patient due for her second dose of VARIVAX and was accidently administered PROQUAD instead; that a patient due for her second dose of VARIVAX and was accidently administered PROQUAD instead; no adverse event; This spontaneous report was received from a medical assistant and refers to a 25 year old female patient. The patient's concurrent conditions, concomitant therapies and historical conditions were not provided.  On an unknown date, the patient was due for her second dose of varicella virus vaccine live (oka/merck)(VARIVAX) and was accidently administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # T021301, expiration date 19-DEC-2021, 0.5 milliliter (route was not provided), for prophylaxis, instead of varicella virus vaccine live (oka/merck)(VARIVAX).
Itchy Sensation near  injection site; Hives - Near Injection Site; Rash - Near Injection Site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (Itchy Sensation near  injection site), VACCINATION SITE URTICARIA (Hives - Near Injection Site) and VACCINATION SITE RASH (Rash - Near Injection Site) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy Sensation near  injection site), VACCINATION SITE URTICARIA (Hives - Near Injection Site) and VACCINATION SITE RASH (Rash - Near Injection Site). The patient was treated with PREDNISONE at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 05-Feb-2021, VACCINATION SITE PRURITUS (Itchy Sensation near  injection site), VACCINATION SITE URTICARIA (Hives - Near Injection Site) and VACCINATION SITE RASH (Rash - Near Injection Site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo), EAR DISCOMFORT (ears started clogging , pressure had built up in ear) and FEELING ABNORMAL (severe case of brain fog) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced FEELING ABNORMAL (severe case of brain fog). On 20-Mar-2021, the patient experienced VERTIGO (vertigo) and EAR DISCOMFORT (ears started clogging , pressure had built up in ear). On 20-Mar-2021, FEELING ABNORMAL (severe case of brain fog) had resolved. At the time of the report, VERTIGO (vertigo) and EAR DISCOMFORT (ears started clogging , pressure had built up in ear) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No laboratory details were  provided. No treatment medications were reported.