chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fatigue; chills; fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Nov2021 10:30 (Lot number: Fh8030) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Partial thyroid removal" (unspecified if ongoing); "allergy to pineapple, kiwi" (unspecified if ongoing); "penicillin allergy" (unspecified if ongoing); "COVID-19" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID. Past drug history included: Z-pak, reaction(s): "z-pak allergy"; Biaxin, reaction(s): "biaxin allergy". The following information was reported: FATIGUE (non-serious) with onset Nov2021, outcome "recovering", described as "fatigue"; CHILLS (non-serious) with onset Nov2021, outcome "recovering", described as "chills"; PYREXIA (non-serious) with onset Nov2021, outcome "recovering", described as "fever". Therapeutic measures were not taken as a result of fatigue, chills, pyrexia.  Additional information: The patient didn't receive other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Follow-Up (07Dec2021): Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a physician refers to a 15 month old patient of unknown gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 28-AUG-2017, the patient was vaccinated with an improperly stored dose of PEDVAXHIB, lot # N000235 with expiration date on 26-OCT-2019 (dose and route of administration were not reported). Since 21-JUN-2017, the administered dose of PEDVAXHIB underwent multiple temperature excursions between 32 degrees Fahrenheit and 49 degrees Fahrenheit, which lasted for 16 hours. A digital data logger was not involved in recording the excursion. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012766.
LOCAL SWELLING AND HOT TO TOUCH (LEFT ARM) FOLLOWED BY EPISODE OF THROAT ITCHING AND POSSIBLE TONGUE SWELLING.  BENADRYL GIVEN BY PARENT.  NO VISIT TO ER OR MEDICAL OFFICE.
Hives - began on (L) leg about 24 h after vaccine and then spread to abdomen - Mom gave BENADRYL.
PATIENT REPORTS HAVING SEVERE REDNESS AND "POPPING" OF BLOOD VESSELS UNDER/IN RIGHT EYE, GOING ALL THE WAY TO HER NOSE. EYES LOOKED BLOODY/BLOOD SHOT IN THE SCLERA. PRESSURE AND REDNESS HAS STARTED TO GO DOWN AS OFF TODAY 03/07/23.
Employee returned to vaccine clinic 3 hours post vaccine with red rash on face and neck, and very mild throat discomfort. Evaluation by Dr. and treated with Benadryl 25mg po and Pepcid  40mg oral. Symptoms resolved after medications.
human leukocyte antigen (HLA) sensitization subsequent to vaccination; Literature report:   This literature marketed report has been received from authors of the literature article entitled as stated above and refers to an unspecified pediatric patient waiting for kidney transplant. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date after vaccination, the patient's anti-HLA antibody test was positive; the patient experienced human leukocyte antigen (HLA) sensitization subsequent to vaccination. The outcome of the event was unknown. The authors considered the event to be related to suspect vaccines.  This is one of five reports derived from the same literature article.  A copy of the published article is attached as further documentation of the patient's experience.; Sender's Comments:  US-009507513-2209USA001761: US-009507513-2209USA010292: US-009507513-2209USA010291: US-009507513-2209USA010290:
Approximately 15 minutes after administering the vaccine, the patient reported feeling dizzy.  I checked her blood pressure and pulse and both were normal.  On 4/8/21, an email from our manager of Human Resources stated that the patient was in the hospital since 4/7/21.  It also stated she had a heart attacked and issues with her gallbladder.
Can not stop using the bathroom; This spontaneous case was reported by a consumer and describes the occurrence of INCONTINENCE (Can not stop using the bathroom) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCONTINENCE (Can not stop using the bathroom). At the time of the report, INCONTINENCE (Can not stop using the bathroom) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter.  No treatment medication was provided.
Pt received vaccination and left after 15 min. observation symptom free. He drove a short distance away from the clinical site when he felt profuse sweating and had syncope (seconds) crashing into curb. He was aroused from impact and was able to stop car. He then developed profuse nausea and sudden urge to defecate. He went to restroom. Given these events he returned to the clinical site in another vehicle. Upon arrival he denied chest pain, shortness of breath or ongoing nausea or abdominal pain. He reported his AM blood sugar was 72 and does not take insulin. No history of coronary disease or syncope. EMS was activated and assumed care.
On August 15th I have a temperature elevation and deep in the lung coughing, body weakness and loss of taste and smell. August 17th, 2021, I was positive for Covid 19. No treatment was received, I was home and rested and recovered in eight days. I had maintained 98% O2 saturation throughout the week and that is all the information I have. I had contacted the Dr. on Monday August 16th and that was why I went to get tested.
Case number PHEH2015US023393 is an initial spontaneous report received from a pharmacist on 09 Nov 2015. This report refers to a 10 year old female patient. Past medical history and concomitant medications were not reported. She was inadvertently vaccinated with FLUCELVAX (batch number: 173906) intramuscularly at a dose of 0.5 ml on 07 Nov 2015. No adverse events were reported following the maladministration.
Starting exactly 9 hours after injection, a headache set in, very high fever causing shivering, felt weak.  Fever and shivering and weakness continued for the next 24 hours. Extreme headache continued for the next two days.
The patients did not experience any symptoms; patient was vaccinated with improperly stored varivax; This spontaneous report as received from a medical assistant refers to a 10 year old male patient. The patient's pertinent medical history and drug reactions or allergies were not reported. The patient's concomitant therapy included sterile diluent. On 04-FEB-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) for prophylaxis (strength, dose, route of administration and anatomical location were not reported) of lot # S006647 is an invalid lot number, expiry date reported as 05-MAR-2021 for prophylaxis (product storage error). The patient did not experience any symptoms. The outcome of product storage error was unknown. The temperature excursion for varicella virus vaccine live (oka/merck) (VARIVAX) was reported as -9 degrees Celsius (C) to 8 degrees Celsius (3.3 C) for 53 hours. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-1911USA011629:
Nausea, high fever, dizziness, chills, extreme body aches, feeling of un-erupted shingles in rt arm pit & rt side of back, fatigue
Guillain Barre Syndrome start 11/14/05. Started with blurred vision, dysphagia, nausea. Discharge summary states amblyopea, cerebrovascular disease, dizzy, dehydration, NPN increased, peripheral vascular disease.  Discharge summary states ischemic cerebrovascular disease, abnormal gait.
This spontaneous report was received from a physician referring to a 17-year-old patient of unknown gender. Pertinent medical history or concurrent conditions were not reported. On 23-JUN-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # M043731, expiration date 22-JUN-2019 (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32°F and the higher was 54°F for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012764.
11/14/22 presents to ED for "shortness of breath". PMHx of "hypertension, HFpEF LVEF 60, ESRD on HD (Monday, Wednesday, Friday), chronic anemia"
Pt. presented to the hospital with;  Fatigue, malaise, loss of appetite, diarrhea, shortness of breath, hypoxia. Pt required supplemental oxygen and steroids. The pt was discharged, but was readmitted shorty after and the pt expired.
shingles; red spot forehead, bridge of nose and top of head; burning sensation; itchy; get hot; This case was reported by a consumer via media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 13 days after receiving Shingles vaccine, the patient experienced shingles, localized erythema, burning sensation, pruritus and feeling hot. The patient was treated with antibiotics nos (Antibiotic (Active Ingredient Unknown)). On an unknown date, the outcome of the shingles, burning sensation and pruritus were unknown and the outcome of the localized erythema was not recovered/not resolved and the outcome of the feeling hot was recovered/resolved.   It was unknown if the reporter considered the shingles, localized erythema, burning sensation, pruritus and feeling hot to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine and 13th days later woke up with red spots forehead, bridge of nose and top of head.  The patient felt it like a burning sensation and itchy. The Pharmacist informed see urgent care and they informed it was shingles, gave he/she antibiotic to take for 7 days and informed that red spots may still be visible, but that he/she wouldn't need any more medications. Two months later, still had some on forehead that were light colored. When the patient got hot, they sorta came back to life it seems, by being red spots. The follow-up would not possible as no contact details were available.
I started to feel that my heart was gradually becoming achy. Once the chest pain started, my pain was a 3 on scale of 0-10. Over the course of the day, my chest pain increased to a 10. I was feeling as if an elephant was sitting on my chest. I was feeling like I couldn't catch my breath and was only able to sit tripod position. I tried to lay down, the pain became unbearable. I was unable to climb a flight of stairs and decided to go to the Emergency Room. They did bloodwork, a chest X-ray, and an EKG. They said that the bloodwork/enzymes and EKG were incongruent with having a heart attack and a pulmonary embolis. They said that my chest x-ray showed an inflamed chest wall- myocarditis
Patient developed acute myositis and transverse myelitis within a few days of flu shot, involving elevated transaminases and CPK; lower extremity weakness and numbness, responsive to IV steroids and acute rehab, still with residual disability.
Pt experienced throat tightness and difficulty breathing within 1 hour after receiving flu vaccine. She took BENADRYL and symptoms resolved.
Narrative:  Patient received Janssen COVID 19 vaccine on 30 April 2021. The patient tested positive for COVID 19 on 31 July 2021 and was hospitalized on 9 August 2021 with COVID pneumonia and Sepsis. The patient's condition did not improve and the patient died on 24 Aug 21. The EUA requires that any patients that tested positive for COVID 19 and required hospitalization after receiving the vaccine must be reported.
Vaccination failure; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Feb2021 as dose 1, single (Lot number: EN6198), in right arm and on 12Mar2021 as dose 2, single (Lot number: EN6208) at the age of 59 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "Hbp" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Morphine, reaction(s): "Known allergies: Morphine". The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: High, notes: other medical history: Hbp; SARS-CoV-2 test: UNKNOWN RESULTS. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
Patient had ZOSTAVAX administered on 10/30/15. On 10/31/15 the site was itchy, warm to touch and there was a lump. She applied hydrocortisone cream. On 11/1/15 she didn't feel good so she went to clinic and was prescribed cephalexin.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  ADULT OBSTRUCTIVE SLEEP APNEA ACUTE ST ELEVATION MI, ANTERIOR WALL ACUTE ST ELEVATION MI, INFERIOR WALL ACUTE ST ELEVATION MI, UNSPECIFIED
Swelling and induration and redness at site of injection, rash started on 4/3/06, RX Motrin 1% hydrocortisone locally.
Ipol was exposed to 52.3F for 2 hours and 41 minutes with no reported adverse event; temperature excursion product administered to a patient with no reported adverse event; Initial information received on 07-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a patient of an unknown gender and age and administered Ipv (Vero) [Ipol] was exposed to 52.3f for 2 hours and 41 minutes with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a unknown dose of suspect Ipv (Vero) Suspension for injection (strength: unknown, expiry date: 14-Feb-2025, lot W1A191M) via unknown route in unknown administration site as Immunization (poor quality product administered) (latency: same day) and was exposed to 52.3f for 2 hours and 41 minutes with no reported adverse event (product storage error) (unknown latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Arm is so sore; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 16-MAR-2023, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Arm is so sore). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK receipt date: 31-MAR-2023 The case was received from the patient interactive digital media. The patient got the Shingles shot one day before reporting. The patient's arm was so sore but it was worth it. The follow-up could not be possible as no contact details were available.
Severe, itchy rash (hives) on face, neck, torso, arms, hands, legs
-Pt is an employee in dental. -Reporting reaction at site of vaccine (left deltoid). -Received vaccine 1/8/2021 (Moderna). -No rxn at time of vaccine, was observed.  -Presented TODAY (7 days later) 1/15/2021 while at work for rash at injection site and on her face and neck. -Pt denies itchy throat, difficulty swallowing, shortness of breath, chest pain, n/v, abdominal pain, fevers, chills, numbness/tingling.  -Denies allergies to food, meds, seasonal allergies.  -Denise hx of allergic rxns. -Denies hx of anaphylaxis reactions.   -Of note pt also has asthma. Reports she has not seen PCP about it in awhile.  -She is using her albuterol inhaler 4x/day. Some dyspnea on exertion. -Not on controller inhaler.  -No cough, wheezing, shortness of breath at rest.   -Not taking any other medications besides albuterol inhaler.  -Pt with itchy rash at site of injection and on face. -Pt without signs of anaphylaxis. -Denies respiratory symptoms. -Gave pt 25mg Benadryl PO.  -Observed pt for 1 hour. -Vitals normal besides elevated HR - likely due to reaction/anxiety about situation. -Pt's rash diminished and she was less itchy ~10 minutes after Benadryl. -No worsening of symptoms during observation. -Pt discharged after 1 hour. -Will f/up with patient (she is employee) later today. -ED precautions given.
A few minutes after client received the vaccination he felt light headed, dizzy, chest pain, disoriented, throat discomfort, and difficulty breathing.  Was transported to Medical Center for further evaluation.
One day after receiving the vaccine (her second covid vaccine) she had a  convulsive syncopal episode.
Currently 33 weeks pregnant?due 7/5/21. Fever of 101 lasting 7 hours. Body aches, chills, nausea. Treated with Tylenol and rest.
Severe pain in right arm at injection site, swelling, inability to raise arm or use at all.
10 mins post vax pt fainted & hit head upon falling; pt lost consciousness for approx 7 seconds;
Within approximately 30 minutes of getting the vaccine my left arm started to itch, then the itching spread across my back and to my other arm. The itching was accompanied by some nausea and moderate joint pains. As time went on I started to experience nausea, stomach pain, increased salivation, rhinorrhea, post nasal drip, itching in my throat and swelling in my throat. These symptoms developed over the course of a few hours and continued to worsen. I eventually went to the ER around 8:00 pm. In the emergency room I was given Benadryl, Pepcid and prednisone, after which symptoms gradually resolved and I was able to discharged around 10:00pm
Twenty-four hours after the vaccine I got fever, chills and body aches. Three days after the vaccine I had irritation in my right eye. The next day my eye was more irritated, and it was uncomfortable. I had a telehealth visit and they gave me antibiotic drops. I was diagnosed by an optometrist on the five days after the vaccine with the Shingles virus. The Shingles are still present on my eye after three weeks and I am taking steroids for that.
Rash and itching starting within 12 hours of receiving Zostavax.  On 70% of body.  Using Benadryl 25mg two Q6h and hydrocortisone topically.
Pt had 1st dose of Shingrix on Friday 3/6/2020. Pt called today, 3/23/20, to ask us if Shingrix could possibly cause a seizure. Pt states she left store after her vaccination in a MartCart with a stockman and the groceries she purchased before the vaccination. Says she got to her car, got off the MartCart to unlock the car, then went down and doesn't remember the rest. The stockman told her that he saw her go down to a seated position against the car and was having a seizure. He called Code White, an ambulance was called, and pt taken to the hospital. There, she was kept overnight and had a second seizure. Pt said many tests were done, and showed inconclusive of any head issues that otherwise may have caused a seizure. She was released on Sunday 3/8/2020 with a prescription for Keppra. Pt stated today that she gets annual flu shots, has had both her pneumonia shots and Zostavax. Pt states she has never had any adverse reactions with any prior vaccination. Pt states she still has some tenderness at the injection site (left arm) with pushing, as well as some soreness and bruising on the right arm, thigh, and right back side of her head
Information has been received from a physician concerning a male who was vaccinated with a dose of VARIVAX (Merck). Subsequently the patient experienced shingles. Unspecified medical attention was sought. No further information is available.
Pt called at 1530 today and stated her left arm was painful, red, swollen bigger than a half dollar, nauseated and her back hurt.
Pt. returned for her 2nd dose on 11.11.21 and stated she experience sharp numbing about 30-mins to 1 hour post 1st dose.  pt also mentioned she started getting elevated heart rate with episodes of pulpiations for about 1 week after.  Instead of giving her the 2nd dose, I had her refer to her primary physician regarding this concern in fear of myocarditis.