chrisvoncsefalvay/vaers-outcomes huggingface dataset:
TOOK FOUR DOSES OF EXPIRED VIVOTIF; This spontaneous case (PVX2019-1558) report was received from a pharmacist on 17-Jun-2019. It describes a 32-year-old female consumer who "took four doses of expired Vivotif". She was receiving oral Vivotif (one dose every other day; expiry date: May 2019) for typhoid fever prophylaxis.  Case report: The consumer took four doses of expired Vivotif. The vaccine got expired in May 2019. However, she completed all the doses in Jun 2019 and the last dose was taken on 17-Jun-2019.  Action taken with Vivotif was not applicable.   The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took four doses of expired Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took four doses of expired Vivotif" was considered as not applicable.
This spontaneous report as received from a Licensed Practical Nurse. On 29-APR-2013, multiple unspecified patients were vaccinated with GARDASIL (lot # H014645, exp. 27-MAR-2015). The nurse reported the dose of GARDASIL were exposed to 30.1 degrees fahrenheit for three hours, which was unsupported by stability data. No adverse effects reported. This is one of several cases received from same source. Additional information has been requested.
10/29/21 Possible TIA during a bike ride. Over 45 minutes developed increasing severe nausea, headache & bodily weakness, finally deciding to stop and get off the bike before possibly losing control and crashing. Once off the bike, began to vomit and continued to feel same symptoms waiting for my wife to pick me up. Took several hours before symptoms resolved, but left me very tired for the next two days. Did not think it was a TIA until after the events that put me in the hospital 11/9/21. Even the neurologist who evaluated me on 11/10/21 did not consider this episode a TIA or related to the two episodes that followed 9 days later. The hospital discharge papers, however, lead me to conclude this was definitely ?signs of a stroke?: Sudden, very bad headache with no known cause; Nausea; Vomiting; Uncontrolled jerky movements. 11/7/21 Definite TIA: Sunday afternoon at my daughter?s house after playing (roughhousing) with the grandkids (6 & 3). Sitting on the couch relaxing sudden onset tingling numbness radiating from my lip on the left side of my face up toward my eye, and weakness in my left arm and leg. Observed left-side droopiness of my mouth. Initial inability to speak, lasting less than a minute. Resolved quickly and we drove 3+ hours back home with the promise to my daughter and son-in-law to stop and call 911 if the symptoms repeated, which they did not. 11/9/21 Definite TIA: Tuesday evening after eating dinner, while watching TV sitting in a recliner. Sudden onset of tingling numbness at my left lip, able to speak, however, but my left arm went dead. And my left leg seemed weak. 911 call at around 6:30pm. Paramedics and fire personnel arrived by 6:40. Did their assessment and I arrived at a Hospital ER soon thereafter. Closely monitored neurologically followed by CT scans, before being admitted to an ICU private room for further observation. Had an MRI and Echocardiogram on 11/10/21, with an extensive evaluation by Dr. Discharged.  11/18/21 Definite TIA: following initial appointment with cardiologist, through a HCF. Suspects etiology for TIAs Athletic Heart Syndrome and Atrial Fibrillations. Affixed a ZIO Holter Heart Monitor. On the way home, an hour later, I experienced sudden onset dizziness and feeling lightheaded, as if I might pass out. My right arm went weak and tingly and I felt like I might not be able to control the steering wheel. I immediately pulled to the shoulder of the freeway and my wife drove to the local Hospital ER. Was immediately evaluated for possible stroke with an EKG, CT scans, and another MRI. Similar to earlier in the week. Discharged. Three months later I am still being evaluated for possible causes.
have got a little bit of infection on it.; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6202), via an unspecified route of administration on 08Mar2021 as dose 1, single (age at vaccination 75 year old) for covid-19 immunization. Medical history included chronic obstructive pulmonary disease (COPD), atrial fibrillation, emphysema from an unknown date (Emphysema and AFib. Yes, I have COPD or Emphysema and AFib with my heart, Atrial fibrillation). Concomitant medication included CEFALEXIN [CEFALEXIN SODIUM] 500mg twice daily, rivaroxaban (XARELTO) 50mg once daily, tiotropium bromide (SPIRIVA) 18ug, once daily, ciprofloxacin hydrochloride (CIPROWIN [CIPROFLOXACIN HYDROCHLORIDE]) 75 mgs 2 tablets a day. The patient have got a little bit of infection on it on an unspecified date. She was scheduled to receive the second dose of Pfizer BioNtech Covid 19 vaccine this Monday (confirmed as 29Mar2021) coming up and she reports that she had been on Cefalexin for a week now this entire week and her dose was going to be this Sunday and she was just calling to see if it was okay to get second dose of the vaccine but patient got her over here to report it the use of that medication. patient did not want to go if the antibiotic was going to interfere with the potency of the shot. The patient underwent lab tests and procedures which included minor surgery resulted to infection on an unknown date. Therapeutic measures were taken as a result of have got a little bit of infection on it which includes CEFALEXIN. The clinical outcome for the event was unknown.  No follow-up attempts are needed. No further information is expected.
Shortly after taking shingles shot (SHINGRIX) became very lightheaded and forgetful. Forgetfulness continues even today. Have continued episodes of inability to remember.
This spontaneous report as received from an health care worker to 5 patients of unknown age and gender. Medical history was not provided. Between 19-SEP-2013 and 23-SEP-2013 the patients were vaccinated with 2 ml ROTATEQ lot # 1539AA with expiration date 15-JUN-2013. No adverse effect was reported. Additional information has been requested.
pt said had soreness in left arm and swelling and redness at injection site that lasted for 3 days
This case was reported by a nurse and described the occurrence of leg swelling in a patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. On an unspecified date in August 2003 the patient received a dose of Infanrix injected into a thigh. At an unknown time post -immunization, in August 2003, the patient experienced swelling of the injected leg. The patient's parent telephoned the physician, who prescribed an unspecified "pain reliever". The event resolved after an unspecified period of time. The nurse considered the event was probably related to vaccination with Infanrix. The reporter indicated that several patients experienced swelling of the injected leg or arm following receipt of Infanrix. However , they are not presently identifiable.
Mom called this AM 7/7/03 and stated that she noted a pink blotchy rash on arms and legs this AM, no fever noted.
Last night developed hives on her left thigh around injection site. This morning she woke up with hives from neck to toes that are itchy. No trouble breathing. Gave BENADRYL & sent her to school.
Patient stated after 3 minutes of vaccine administration, Left arm was numb, feels heavy and cold to touch. BP 138/90, HR 94, o2 sat 98%. Alert and oriented x3, LCTA. No acute distress noted after. after 25 minutes patients a=states she feels better  and ready to go. Patient aslo stated she has not eaten since 12 noon and takes Phentermine for weight loss.
Within 20 minutes of injection pt. showed redness at inj. site. By 72 hours later, pt. had inner raised, bumpy red area the size of quarter surrounded by lighter pink area size of silver dollar. Area warm to the touch. Pt to see MD 5/17/11.
Patient started to develop a cough on the second day of the vaccine around 6 pm. The cough was accompanied by shortness of breath, given his asthma we assumed this was some asthma related reaction to the vaccine. Nonetheless, that evening he started to complain about chest pain every time he laid back on his bed. This symptom is not common in previous asthma attacks. Sitting up alleviated the symptom, chest pain and shortness of breath lasted for 2 nights (Sunday and Monday evening), by Tuesday he felt better. We assumed this was an asthma episode, but recent reports of Myocarditis leads us to believe the had a mild myocarditis episode, given the chest pain while lying down.  He also had typical COVID vaccine symptoms such as low grade fever (100F), pain in the vaccination site, congestion, and itchy throat.
Initial non-serious report received from the patient's parent on 01 August 2007. A twelve-year old male with history of migraines had received an intramuscular injection of Menactra (Lot number not reported) to his left arm on 31 July 2007. On 01 August 2007, approximately 16 hours following vaccination, the patient experienced redness at injection site, fever of 100.9 degrees Fahrenheit and headache. The patient had no illness at the time of vaccination and no concomitant medications were reported. Recovery status was reported as "resolving". On 02 August 2007, the patient's mother called to report an additional symptom of left axillary lymph node swelling (the size of a lemon). The patient went to the Emergency Room and was placed on "steroids". It was reported that Infectious Disease specialist was being consulted. No additional information had been provided at the time of this report.
Pregnant, due date 07/12/2021 Got fever for two days, starting 12 hours after the second dose covid-19 vaccine. Used tylenol for fever.   Starting from the second day (05/13/2021), noted rapid heart rate. Normal resting  heart rate before was 70-80 BPM, after taking the vaccine, increased to 100-110 BPM.  Two weeks after the vaccine until now, it is around 90 BPM.
arm is quite swollen still/after the second dose had similar or some problems but faded quickly; redness / after the second dose had similar or some problems but faded quickly; itchy / after the second dose had similar or some problems but faded quickly; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm is quite swollen still/after the second dose had similar or some problems but faded quickly), ERYTHEMA (redness / after the second dose had similar or some problems but faded quickly) and PRURITUS (itchy / after the second dose had similar or some problems but faded quickly) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (arm is quite swollen still/after the second dose had similar or some problems but faded quickly), ERYTHEMA (redness / after the second dose had similar or some problems but faded quickly) and PRURITUS (itchy / after the second dose had similar or some problems but faded quickly). At the time of the report, PERIPHERAL SWELLING (arm is quite swollen still/after the second dose had similar or some problems but faded quickly), ERYTHEMA (redness / after the second dose had similar or some problems but faded quickly) and PRURITUS (itchy / after the second dose had similar or some problems but faded quickly) had resolved.            No concomitant medications  were provided. No treatment medications  were provided.  The arm looked like the size of a huge egg.   This case was linked to MOD-2021-391831 (Patient Link).
Presented to ED on 11/28 and was admitted.  chief complaint of shortness of breath.Patient states this evening when getting ready to go to sleep she felt very short of breath She states she has taken all of her medications as prescribed. She does admit to eating more salty foods with thanksgiving and not watching her fluid intake. She also isn't as active as usual after losing her husband. Of note, patient was recently admitted 11/21/2021 to 11/24/2021 for acute CHF exacerbation due to noncompliance with medication.  Apparently patient's husband died recently and since then she has not been taking her medication daily.  She did not require any oxygen at the time and was discharged on regular home dose of Lasix.  During her hospitalization it was recommended she go , but family wanted to bring her home. Patient lives with one of her daughters. Uses walker for assistance. Denies recent falls. Denies fever, chills, cough, chest pain, abd pain, n/v/d/c, dysuria, hematuria, pain in BLLE.   In the ED, patient hemodynamically stable and afebrile.  Vital signs 98.2 F, 89 beats per minute, respirations 20, BP 138/68, 97% 4 L nasal cannula.  Was put on BiPAP but could not tolerate.  COVID negative.  Procalcitonin 0.08.  BNP was 1540. Glucose 349, anion gap 9.9, BUN 22, creatinine 1.30, albumin 3.1, calcium 8.7, alk-phos 203, ALT 57, GFR 46. Troponin 0.015.  Magnesium 2.0.  PTT 31, PT 16.1, INR 1.3.  WBC 4.44, H&H 9.5 and 29.8.  Chest x-ray shows worsening bilateral opacities which can be in the setting of congestive failure.  Interventions ED include albuterol 6 puffs, doxycycline 100 mg p.o. 1 dose, and Lasix 80 mg IV 1 dose. Patient gradually improved addendum prior to discharge from the hospital to nursing home she was tested positive for COVID-19.  Patient was given dexamethasone, IV antibiotics (ceftriaxone, doxycycline) and remdesivir.  Patient responded well to the oxygen, patient has been clinically stable, patient had prolonged hospitalization , case management has been admitted for patient to go to nursing home.  Will discharge patient home with instructions to follow up with PMD. Discharged on 12/20/21
Itchy lesions on both legs, shins, and ankles at and below the knees.  Nothing above the knee.  Roughly 12 lesions per leg.  Only symptom is scratching and discomfort.
Got MMR (L thigh) and Varicella (R thigh) last week.  Got swelling in groin lymph nodes L>R for 5 days.  Yesterday red swelling on R thigh.  Little rash on arms by elbows but nowhere else.  No fevers.  Little less wet diapers but drinking and eating well.  No fevers. Happy, smiling and playful like normal.
He had extreme fatigue for 2 days after the vaccine. About 2 days after the vaccine, he developed watery diarrhea that has persisted for 2 weeks.
seen by PMD; fell & loosened tooth; noted eyes were twitching; opiclonus, fever of 102; adm  to hosp; tx w/ ibuprofen; no sz; no rash; no behavior changes;
One day post vax, on 6/16/00, the pt experienced fever, chills, then symptoms progressed nausea then back pain and insomnia, irritability. Pt went home sick with fever and nausea.
Swollen lymph gland in neck(huge), headache, stiff neck, fever, chills, sore throat/difficulty swallowing, cough, fatigue, nausea, loss of appetite, very difficult to sleep.  All symptoms have been present since evening of 7/31 or morning of 8/1.  Lymph gland on right side of necks is about the size of a golf ball.  Throat have become progressively worse and inflamed each day.
This spontaneous report was received from a nurse who was referring to an unspecified patient of unknown age and gender. On 05-APR-2017, the patient was vaccinated with expired dose of PNEUMOVAX23 lot number L019836, expiration date 24-MAR-2017, for prophylaxis (exact dose and route of administration were not provided). No adverse effect was reported. There was no product quality complaint involved in this case. Additional information has been requested.
Fatigue; This is a spontaneous report received from contactable reporter (Other HCP). Other Case identifier(s): LRN4778579.  A 47-year-old female patient received BNT162b2 (BNT162B2), on 05Mar2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (ongoing). Concomitant medications included: OCREVUS taken for multiple sclerosis. The following information was reported: FATIGUE (non-serious) with onset 10Jul2021, outcome "recovered".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown ages and genders. The patients' medical history and concurrent conditions were not reported. On unknown dates, the patients were probably received doses of improperly stored PROQUAD (lot # M018635; expiry date: 11-OCT-2017) (route: subcutaneous). The vaccine was stored at a temperature of -13.7 degrees C for 48 hours. There was no previous temperature excursion. Data logger was involved. No adverse effect reported. The outcome of the events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
PATIENT HAD PFIZER VACCINE, Dose 1 date: 12/23/2020,  Dose 2 date: 01/13/2021, AND TESTEED POSITIVE TO COVID.
Uncontrollable hand and Finger Spasms / Twitching, High Fever (102), Nausea, Heavy Chills unable to stand up.
Janssen COVID-19 Vaccine  fever that peaked at around 100 degrees and lasted for about 30 hours took Tylenol to keep the fever down tired and achey headache
Large lump 24 hrs after injection, headache, body ache.... Lump present for 5 days the disappeared ( i thought all was well no reaction.  Jan. 7,2021 Then overnight the lump reappeared and arm is itchy really bad, site hot to touch  arm swollen. Lump softball size, painful when bumped
Adult patient was administered 10 mcg; Adult patient was administered 10 mcg; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 23-year-old patient who received HBV (Engerix B pediatric) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th November 2021, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 26th November 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacy manager called and reported that, the patient was administered 10 mcg of Engerix B, which led to underdose and adult use of a child product. The reporter stated that, the patient needed full immunity. Patient had not been exposed. The reporter declined to provide any vaccine or patient details. The reporter did not consent to follow up.
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 23-FEB-2015 the patient was vaccinated with ROTATEQ lot # K008140 (expiration date, dose, route, frequency and indication were not reported) that experienced a temperature excursion, which was later supported as well. There was no concomitant medication reported. At the time of the report, the patient's status was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Received vaccine on 8/30/02. On 8/31/02 developed swelling, redness, and low grade fever right upper arm. Mom applied warm-salt water; improved 9/01/02. Seen in clinic 09/3/02 much improved.
Hives developed under my ears and under my chin. They disappeared the next day, approximately 12 hours after my shot.
Information has been received from a health professional concerning a 75 year old female with hyperlipidaemia, anaemia and hypothyroid who on 15-DEC-2006 was vaccinated in the right arm with a 0.65 ml dose of Zostavax (lot#654604/1406F). Concomitant therapy included atenolol (manufacturer unknown), NASONEX, TRICOR, ALTACE, RELAFEN and SYNTHROID. At a visit to the doctor's office on 03-JAN-2007 the patient mentioned that post vaccination she experienced redness at the injection site and her entire body felt itchy. Subsequently the patient recovered. There was no product quality complaint involved. Additional information has been requested.
On 4/8/21, the day after my 2nd COVID vaccine shot, I felt like I was having a heart attack the entire day.  My chest hurt and it just felt like I was having a heart attack the whole day.
Patient developed hives from upper thigh up to her neck bilaterally.  These were more localized in the torso area, to the point they overlapped.  These lasted for 3 days heavily but decreased in size and quantity over time.   They continue but are now much smaller and less frequent.  Claritan has helped to calm the hives.  Patient also noticed minor swelling of lips two days after vaccine.  No swelling of throat and no shortness of breath per patient.  The lip swelling would come and go and has disappeared.
herpes zoster; This case was reported by a physician via call center representative and described the occurrence of herpes zoster in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced herpes zoster. On an unknown date, the outcome of the herpes zoster was unknown.   It was unknown if the reporter considered the herpes zoster to be related to Shingrix.  Additional case details were provided as follows: The age at vaccination was not reported. The patient received the dose of Shingrix and after 2 days the patient experienced herpes zoster. The reporter was on chat and was not at the office. The reporter did not have the patient initials, age, date of vaccination and lot number or expiration date.
After receiving the Pfizer vax on 12/2/21, I ended up going to the ER on 12/3 with severe back pain near the tailbone and pelvic pain. I was diagnosed with arthalgia and pelvic pain after multiple x-rays and ultrasounds. My tailbone showed no signs of trauma and I had an inflamed uterus and cervix. I tested negative for any infections. On 12/10, I felt a burning sensation at the very sight of the pain in my tailbone. I went right to the employee health department and was examined. Diagnosis were localized skin eruption ndue to drugs & medications taken internally and also adverse effects of other viral vaccine. I now walk with a limp and am in terrible pain all day and night.
Pt became anxious, sweaty and dizzy. Developed tunnel vision and loss of consciousness. Staff with pt at time of syncopal episode and assisted pt to floor. Pt regain consciousness within 1 minute. Pt placed on stretcher and arrived to med obs at 1558. Vitals obtained. At this time pt states she is feeling normal. At 1611 c/o dizziness and nausea. BP rechecked and notably dropped. Pt placed in the trendelenburg position. BP increased. Nausea and dizziness resolved. Snacks and water given.  Pt left facility 1712, friend driving. Vitals as follows; 1600 BP 107/74 HR 85 RR 22 spo2 98%     1611 BP 97/68 HR 78 RR 20 spo2 100%     1625 BP 109/76 HR RR 18 spo2 99%     1705 BP 95/66 (standing, asymptomatic)
CDC reports: 4 yo experienced fever to 104 & vomiting same day of DTP/OPV immunization. MD told mom child had the "flu", hospitalized 3 days, duration of illness - 5 days.