chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Developed a rash on the right in her forearm. 30 minutes after both vaccines. A month after the second vaccine I was diagnosed with shingles, with the rash/hives on my right inner forearm.  My symptoms were rash/hives on the right, inner forearm, cellulitis in right forearm, fever, chills, bodyaches, severe pain in right arm, and fatigue.  I saw my primary care physician and an urgent care physician for these symptoms and got the diagnosis of shingles. I was treated with antibiotics, an antiviral, and gabapentin.  My symptoms cleared up in a week and had a standing order for gabapentin for the neuropathy.  Approximately six months later, I had the same flare up on my right, inner forearm with the same symptoms. I was given the same treatment by my primary care physician.  Approximately two months after, I began to have nerve pain in my torso, both arms, and fevers without any explanation. My primary provider advised me to treat the fever and pain with gabapentin and Tylenol.  A year after my first dose, I developed the rash/hives on my left inner forearm. I also had all other signs and symptoms listed above. I was treated with another round of antibiotics, an antiviral, and gabapentin.  I have flareups of any combination of symptoms, at least once a month that keep me out of work for up to two days. I have filed for intermittent FMLA (Family and Medical Leave Act ) at my previous employer, and will be applying for it at my current employer.  My primary care provider has advised me to not receive any COVID-19 booster, due to increased likelihood of a flareup.
Case number PHEH2012US023530 is an initial spontaneous report received from a healthcare professional on 28 Nov 2012: This case refers to an 18-years-old female patient. She was vaccinated with MENVEO vaccine (batch number: A11082 and expiry date: May 2014), at dose of 0.5 ml intramuscularly on 13 Sep 2012. The MENVEO vaccine was stored at multiple temperatures excursion above 46F (on 27 Jul 2012 55 F for 1.5 hours, on 08 Sep 2012, 52 F for 3-hours and on 09 Sep 2012, 49 F for 1-hour (two separate times during these dates, total 3-separate occurrences on 09 Sep 2012). No adverse reaction reported following this administration error.
raised swollen red rash at injection site - recommended benadryl, hydrocortizone for itching
Pt became irritable day following vax 31MAY91; Next day 1JUN91 awakened w/t105 x 24hrs; Also had sl sore neck; no other sx; Fully recovered on 2JUN91;
I tested positive for COVID-19 in July. I had a headache, fatigue, nausea, and a low grade fever. I emailed my doctor and she prescribed me PAXLOVID. My symptoms lasted for about a week.
knees kegs ache head ache about 20 pist injection . then around 4 pm joint pain worsen. at 2am got chills headache. an arm started hurting down my arm an up into my clavical. still head ache an my joints hurt very bad. at 1220 pm friday in bed  hurtying  feels very much like  my shingling vaccination.  my ears are starding to burn.
MMR vaccine given around 9:30. Hives present right away. BENADRYL given (1/2 tsp given). Pt on Utram > 20 hours. More tired. Redness around VARICELLA site also had no hives.
This sensation expanded to her face where she developed some paralysis; Pain in the ear; Left eye unable to blink; Numb thumb/Her thumb started to fell numb; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (This sensation expanded to her face where she developed some paralysis) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced HYPOAESTHESIA (Numb thumb/Her thumb started to fell numb). On an unknown date, the patient experienced FACIAL PARALYSIS (This sensation expanded to her face where she developed some paralysis) (seriousness criterion medically significant), EAR PAIN (Pain in the ear) and EYE MOVEMENT DISORDER (Left eye unable to blink). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, FACIAL PARALYSIS (This sensation expanded to her face where she developed some paralysis), HYPOAESTHESIA (Numb thumb/Her thumb started to fell numb), EAR PAIN (Pain in the ear) and EYE MOVEMENT DISORDER (Left eye unable to blink) outcome was unknown.     Shortly after the Moderna booster dose, patient's thumb started to felt numb, this sensation expanded to face and developed some paralysis there, left ear was on pain and left eye was unable to blink. The patient was not in any medication at the time of the vaccination.  The patient took some Tylenol trying to alleviate the symptoms.  Company Comment - This case concerns a 37 year-old male female patient with no reported medical history who experienced the unexpected serious adverse event of special interest of facial paralysis. The event occurred on an unknown date relative to vaccination with the third dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as no additional dosing will be administered. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Sender's Comments: This case concerns a 37 year-old male female patient with no reported medical history who experienced the unexpected serious adverse event of special interest of facial paralysis. The event occurred on an unknown date relative to vaccination with the third dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as no additional dosing will be administered. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
Client presented back on 3/15 with myalgia, fatigue, and red raised nodules on both lower legs, and left ankle edema (mild). She stated this had occured also after her 2/1/2006 dose of Twinrix. I obtained an appt. with doctor the next day for evaluation.
Patient reported numbness on lower lip and tip of tongue within 15 minutes of vaccination.  Was given 25 mg Benedryl and improved; given second dose of Benedryl 25 mg.  Patient was released to home.
pt recv vax & c/o severe fatigue, h/a, lymphadenopathy, myalgia;s/s started about 4-8 days p/vax;pt seen by several MD who could not find dx;pt had inc bilirubin & inc amylase;pt also c/o localized erythema & swelling 1-2 days p/vax;
This spontaneous report as received from a registered nurse refers to a 44 year old female patient. The patient's current conditions included hypercholesterolaemia, B12 deficiency, vitamin D deficiency, mitral valve insufficiency, leiomyoma of the uterus, endometriosis, drug allergy to penicillin and vertigo. The patient's medical history included Methicillin-resistant Staphylococcus aureus infection (MRSA), rash and edema. Historical drug included unspecified penicillin. On 09-MAY-2014, the patient was subcutaneously vaccinated with VARIVAX (Merck) (dose and anatomical location were not provided) lot # H009634, expiration date 09-MAY-2014. Concomitant therapies included calcium carbonate, cholecalciferol, mupirocin, cyanocobalamin, vitamin D (unspecified) and vitamins (unspecified). On 01-NOV-2014, the patient had varicella titers drawn which were 135 (units not provided) and should have been more than 165 (units not provided). Nurse also noted that the patient had allergy to penicillin which manifested as a rash and edema. The patient was not given any treatment for adverse event. The outcome of event was unknown. The causality between the event and the therapy with VARIVAX (Merck) was not provided. Additional information has been requested.
Feel dizzy; Itchy; Myalgia; Hives; Extreme headache; Cramping; I would fluctuate between hot and cold; I had a hard time standing and was just exhausted; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Feel dizzy), PRURITUS (Itchy), MYALGIA (Myalgia), URTICARIA (Hives) and HEADACHE (Extreme headache) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Migraine since 01-Sep-2013 and COVID-19 on 27-Dec-2020. Concurrent medical conditions included Drug allergy (Allergic to Verapamil) and Drug allergy (Allergic to Albuterol). Concomitant products included ATORVASTATIN from 09-Jan-2020 to an unknown date for Cholesterol, SUMATRIPTAN for Migraine, LEVOTHYROXINE SODIUM (SYNTHROID) from 09-Jan-2017 to an unknown date for Thyroiditis NOS, VITAMIN D NOS and LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN-D) from 09-Jan-2015 to an unknown date for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced DIZZINESS (Feel dizzy), PRURITUS (Itchy), MYALGIA (Myalgia), URTICARIA (Hives), HEADACHE (Extreme headache), MUSCLE SPASMS (Cramping), FEELING OF BODY TEMPERATURE CHANGE (I would fluctuate between hot and cold) and FATIGUE (I had a hard time standing and was just exhausted). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE (BENADRYL ITCH STOPPING CREAM) for Itching, at an unspecified dose and frequency. On 01-Mar-2021, DIZZINESS (Feel dizzy) had resolved. On 02-Mar-2021, URTICARIA (Hives) had resolved. On 04-Mar-2021, MYALGIA (Myalgia), MUSCLE SPASMS (Cramping) and FEELING OF BODY TEMPERATURE CHANGE (I would fluctuate between hot and cold) had resolved. At the time of the report, PRURITUS (Itchy), HEADACHE (Extreme headache) and FATIGUE (I had a hard time standing and was just exhausted) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Dec-2020, SARS-CoV-2 test: positive (Positive) patient tested positive for COVID-19..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient reports visiting urgent care following vaccination for treatment of symptoms. Patient states that tests were preformed. Specific tests or results were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: VAERS
CHILLS; HEADACHE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced chills, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills and headache was not reported. This report was non-serious.
vertigo, cold sweat, vomiting, fatigue, low grade temp, body aches, cough, headache-----rest
Administration error: Notable loss of vaccine while injecting/retracting needle. Vaccine running down arm. Consulted with Doctor.  Another dose given immediately.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 65-year-old female patient 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 Rheumatoid arthritis.  No Medical History information was reported.   On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had not resolved.         This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of COVID was not provided.  No concomitant medication was provided by reporter. No treatment medication was provided by reporter.
Patient reported blotchy itchy rash on  right cheek, neck and upper chest. No difficulty breathing, chest pain or shortness of air. Ambulatory and needed no assistance moving.  Vitals HR 85 BP 126/82 pulse ox room air 98%. Benadryl 50 mg administered IM right arm at 11:40 am. Patient observed until 12:35 pm when discharged to home (HR 60 BP 110/78 100% O2). Rash was much improved by this time.  Patient called 11:20 am. 2/26. Rash almost entirely gone - just one spot on check. Will take benadryl PO. Mentioned she had small spot of rash around injection site following first dose of vaccine.
Itchy rash on both deltoids started 2 days after immunizations received. Rash is fine and papular.
I started feeling "weird" almost immediately (within 5 minutes) but it wasn't anything that really alarmed me. However, about 30 minutes after (I had already left the clinic) I started feeling lightheaded, dizzy, had a rapid heartrate, and felt like I was going to pass out (I never did pass out). I had a rapid heartrate and dizziness for about 48 hours. I also had a headache and extreme fatigue (also started about 30 minutes after the injection), but assumed those affects were normal.
This spontaneous report was received from a registered pharmacist concerning an approximately 54 year old female patient with penicillin allergy and DURICEF allergy. On 02-APR-2013, the patient vaccinated with a dose of ZOSTAVAX (lot number and expiry date reported as H019999 and 02-FEB-2014 respectively, dose and route unspecified). No concomitant medications were reported. Approximately on an unknown date in April 2013, the patient experienced swelling around injection site. The patient sought medical attention (spoke to pharmacist). The patient was treated with BENADRYL. The outcome of swelling around injection site was unknown. The relatedness for swelling around injection site was unknown for ZOSTAVAX. Additional information is not expected.
Swelling in bottom and top lips, tongue, throat, knots on head, welts on both sides of abdomen, tonsils starting around March 21. Had to go to urgent care on March 28. Strange headache on left side. Finger tips and toes went numb. Covid vaccine related illness(chills, body aches, shallow breathing) started 1 week after 2nd vaccine. Ongoing shortness of breathe.
Unconsolable screaming & high pitched cry 8-9hrs; Md called by family x 2;
83 year old man admitted to hospital  from facility after found unresponsive and hypoxemic with pneumonia. Course notable for delirium/encephalopathy, acute hypoxemic resp failure , septic shock, s/p 8 days vanc and cefepime, changed to LVQ today for Klebsiella pneumonia, R pleural effusion, paroxysmal afib, AKI, hyponatremia, anemia of critical illness, thrombocytopenia, pressure wounds, severe protein calorie malnutrition, and acute on chronic severely debilitated state.  Transitioned to LTAC ,  he looked fair on SBT. MD spoke with family  who reiterated that when ETT is removed it should not be replaced - if he had recurrent resp failure then she wanted comfort care. Unfortunately he did not protect his airway well, developed worsened hypoxemia, and she very appropriately elected transition to comfort care. He died shortly thereafter.
He had to miss his scheduled 2nd shot which was in Mid March. Doctor told him that he has to wait for 90 days; Covid infection contracted after 1st shot; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid infection contracted after 1st shot) and OFF LABEL USE (He had to miss his scheduled 2nd shot which was in Mid March. Doctor told him that he has to wait for 90 days) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced COVID-19 (Covid infection contracted after 1st shot). On an unknown date, the patient experienced OFF LABEL USE (He had to miss his scheduled 2nd shot which was in Mid March. Doctor told him that he has to wait for 90 days). At the time of the report, COVID-19 (Covid infection contracted after 1st shot) outcome was unknown and OFF LABEL USE (He had to miss his scheduled 2nd shot which was in Mid March. Doctor told him that he has to wait for 90 days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment medication was reported.   Reportedly the Doctor told the patient that he needs to wait for 90 days and then scheduled his 2nd appointment on 22-Jun-2021. Consent obtained for safety follow up.   This case was linked to MOD-2021-127903 (Patient Link).
expired PENTACEL vaccine was inadvertently administered with no reported adverse event; Initial information received on 10-Oct-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp (Non-healthcare professional).  This case involves a 4 months old female patient who received expired Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] inadvertently with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included rotavirus vaccine live reassort oral 5v (rotateq) for immunisation; and pneumococcal vaccine conj 15v (crm197) (vaxneuvance) for immunisation.  On 09-Oct-2023, the patient received 0.5 ml Total (1 X) of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection (lot number: UJ794AB) (Expiry date: 08-Oct-2023) (Strength: Standard) (Frequency: Once) via intramuscular route in unknown administration site for immunization.  On 09-Oct-2023, the patient received expired Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) vaccine inadvertently with no reported adverse event (expired product administered) (latency: same day).  It was reported, Office manager reports an expired PENTACEL vaccine was inadvertently administered yesterday, 09Oct2023 and that the product expired a day earlier on 08Oct2023. This situation is reported as a medication error due to the administration of an expired vaccine.   Action taken: not applicable.  Outcome: Unknown   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.
A spontaneous report has been received. The report concerns a 41 year old male patient (ethnic origin: Other), with weight: 260.0 pounds and height as 5 feet 10 and one half inches. Patient's relevant history and concurrent diseases were not reported. Concomitant medications included canaglifozin for diabetes. Patient took nasal FLUMIST Quadrivalent (influenza virus vaccine live, intranasal) vaccine 0.2 ml for flu vaccination from either 2008 or 2009. Patient reported that the vaccine was administered to him yearly. Patient was being diagnosed with sleep apnea in approximately 2008 or 2009. Patient used a CPAP for the sleep apnea, approximately in 2008. Patient was diagnosed with diabetes/hyperglycemia approximately two years ago but could not remember if it was 2014 or 2015. Patient stated that before diagnosis his blood sugar went up to 423, he was taken to a hospital and treated for diabetic shock. Because of his hyperglycemia patient had frequent urination. The outcome of the events of diabetes/hyperglycemia, diabetic shock and sleep apnea/use of CPAP with sleep apnea were unknown. The reporter considered the events diabetes/hyperglycemia to be serious due to seriousness criteria of hospitalization. The company physician considered the event diabetic shock to be serious due to seriousness criteria of important medical event and event sleep apnea/use of CPAP with sleep apnea was considered as non-serious. Sender's Comments: Shock hypoglycaemic and diabetes mellitus are not listed in the company core data sheet for FLUMIST. Patient's underlying diabetes mellitus could be contributory to shock hypoglycaemic. However, there is limited information on details of diabetes (type 1 or 2), exact administration of suspect, dietary history, event start date, diagnostic work up like glycosylated haemoglobin level, complete blood sugar level, risk factors like stress, obesity which makes individual causal assessment difficult.
Patient describes an acute episode of difficulty breathing, tingling in hands and feet and tension in arms and legs.  This occurred after the vaccine (woke her from sleep) and has occurred a few more times since then.  It goes away after about 45min.  Has never occurred before getting the COVID vaccine