chrisvoncsefalvay/vaers-outcomes huggingface dataset:
10 days p/flu vax felt poorly-tired; MD tests done found to be very anemic; dx rare acute myleofibrosis of the bone; gets blood transfusions every 2 wks; has also had ear infects & now swelling of the feet is very weak;
Felt tingling from head to to complained of not feeling right, symptoms persisted, ems contacted taken to ED
CHIEF COMPLAINT/REASON FOR VISIT Fever (Pt covid positive 10/1. Pt reports temp of 105 at home today with SOB. Pt 88% on room air with EMS. temporal temp 40.4)     HISTORY OF PRESENT ILLNESS  He presents to the emergency by ambulance for a fever and shortness of breath.  He states tonight the fever spiked and he was having a hard time taking a deep breath as it was triggering a cough.  He called EMS and they treated him with IV acetaminophen and a DuoNeb during transport he is feeling a little better now.  He 1st had symptoms of body aches and shortness of breath going back to September 24th after getting his influenza immunization on September 23rd.  After having the symptoms persist for a week he got tested for CO CHIEF COMPLAINT/REASON FOR VISIT Fever (Pt covid positive 10/1. Pt reports temp of 105 at home today with SOB. Pt 88% on room air with EMS. temporal temp 40.4)     HISTORY OF PRESENT ILLNESS  He presents to the emergency by ambulance for a fever and shortness of breath.  He states tonight the fever spiked and he was having a hard time taking a deep breath as it was triggering a cough.  He called EMS and they treated him with IV acetaminophen and a DuoNeb during transport he is feeling a little better now.  He 1st had symptoms of body aches and shortness of breath going back to September 24th after getting his influenza immunization on September 23rd.  After having the symptoms persist for a week he got tested for COVID on October 1st and was positive.  He has had intermittent fevers, body aches, weakness, cough, and shortness of breath.  He states his pulse oximetry has gotten as low as 86%, but most the time has been in the 90s at home.  He has cystic fibrosis and follows with the adult cystic fibrosis clinic at University Hospital.  He has been in contact with them and they had him on what I believe was prednisone and is he has not fully improved they switched him to dexamethasone 6 mg, which he last took yesterday morning.  Infectious diseases-focused impressions: 1. COVID-19 pneumonia with mild hypoxemic respiratory failure 2. Chronic cystic fibrosis 3. On empiric oral trimethoprim/sulfamethoxazole started by the patient's local cystic fibrosis group 4. COVID 19 directed therapies:  Currently dexamethasone plus remdesivir
bad reaction; leg cramps; swelling at the injection site; vomiting; fever; This spontaneous report has been received from a 65 years old (currently was 67 years old) female patient. Concomitant therapies included levothyroxine sodium (SYNTHROID). The patient was allergic to sulfa. Information about medical history and concurrent conditions was not provided.     On 13-JUL-2018, the patient was vaccinated with 1 dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot #, expiration date and dose details were not provided) intramuscularly for prevention of pneumococcal disease. On an unknown date, the patient started therapy with generic formulation of atorvastatin calcium (LIPITOR) (lot #, expiration date, strength, route and dose details were not provided) for unknown indication.   On 13-JUL-2018, 6 hours after administration of the vaccine, the patient experienced swelling at the injection site, fever and vomiting. On an unknown date, the patient had a bad reaction after vaccination of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). On an unknown date, the patient experienced leg cramps from the generic formulation of atorvastatin calcium (LIPITOR). The patient was seen by her doctor on 14-JUL-2018 (reported as the next day) and did not recall if any treatment was provided for her symptoms or when she recovered from these symptoms.      At the time of this report, the outcome of the events was unknown. The causality assessment between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.
That night my arm was extremely sore, to the point that I could not perform mundane daily activities without severe pain. Over the next couple of days my mucus turned brown and red. Later it hanged to yellow and green. My body was achy and I had a headache.
Presented to the hospital with right sided weakness and small L MCA stroke 3/3/22, which evolved to a large hemispheric left MCA stroke 3/8/22 with malignant cerebral edema requiring decompressive hemicraniectomy 3/9/22. Examination remained poor with essentially vegetative state. She underwent tracheostomy and PEG tube placement.
Sudden rash; large, red, itchy patches on upper arm. Head discomfort, dull pain in jaw and neck region.
Information has been received from a health professional concerning a female consumer who in March 2007, was vaccinated with Gardasil. In March 2007, the patient experienced petechiae rash all over her body within 24 hours after receiving the first dose of Gardasil. No medical attention was required. This is one of two reports received from the same source. Additional information has been requested. This is in follow-up to report(s) previously submitted on 05/14/2007. Information has been received from a licensed practical nurse concerning a female patient who in March 2007, "past few weeks," was vaccinated with GARDASIL. Within 24 hours the patient developed a petechiae rash all over her body. No treatment was required. This is one of two reports received from the same source. Additional information is not expected.
Flu shot given to employee 1/7/00. On set of hives on 1/8/00, 2:00 am. Hives have improved but still present on 1/10/00.
I RECEIVED MY VACCINATION IN THE AM ON 31 MAR 99. AFTER RECEIVING THIS VACCINATION I BECAME VERY ILL WITH VOMITING, MUSCLE AND JOINT PAIN, AND CHILLS ALSO LOCALIZED REDNESS AND SWELLING. I WAS SEEN AT THE MILITARY CLINIC AND TOLD THAT I HAD A VIRAL INFECTION AND NOT A REACTION TO THE ANTHRAX VACCINE.
Client received H1N1 injectable vaccine at approximately 11:00 am and presented at 11:40 am stating "my upper body feels on fire" with noticeable erythema at site and injection. Along with erythema along B shoulders and back, chest. Administered CLARINEX po and ice pack.
Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Severe
Approximately 15 minutes after being vaccinated with second dose of Moderna COVID 19, client began complaining of numb lips, and itching with no hives. She denied any respiratory involvement. Staff observed client scratching both arms. Per adverse reaction standing order, client was given 100 mg diphenhydramine IM and EMS was called. Blood pressure, pulse and respirations observed and recorded over 30 minutes and remained normal. EMS arrived on scene and evaluated client, client declined transport, clients son was called and clients son transported client home.
patient got Gillian Barre and almost died from the flu shot; Initial information received on 19-Oct-2020 regarding an unsolicited valid serious case from a non-health care processional (patient's mother) via social media.  This case involves a female patient of an unknown age who got Gillian Barre and almost died (Guillain-Barre syndrome), after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed Gillian Barre and almost died (Guillain-Barre syndrome), (Unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was not reported for the event Guillain-Barre syndrome.  Information on the batch number to be requested.; Sender's Comments: This case involves a female patient who presented with Guillain-Barre syndrome, after vaccination with INFLUENZA VACCINE. The time to onset is unknown. Moreover, patient's medical condition at the time of vaccination and lab tests were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
c/o soreness @ site immed p/vax & w/in 24 hrs c/o site was sorer, red, hot to touch, swollen & hard approx 4"x2" oval area; Is able to move arm but it hurts when raises it only;
This spontaneous report as received from nurse refers to a patient of unknown age and gender. Pertinent medical history was unknown. On 29-DEC-2014 the patient was vaccinated with expired dose of (Oka/Merck) VARIVAX (lot # H020587, expiry date: 13-NOV-2014, dose, route of administration was unknown). Concomitant medications were unspecified by reporter. No adverse effects reported. The outcome of the events was unknown. No further information was provided. Additional information has been requested.
SORE LEFT ARM; This spontaneous report received from a patient concerned a 34 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and abstains from alcohol, and other pre-existing medical conditions included patient had no known allergies, no significant medical history and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included ascorbic acid/ergocalciferol/folic acid/nicotinamide/panthenol/retinol/riboflavin/thiamine hydrochloride. On 14-MAR-2021, the subject experienced sore left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore left arm on 16-MAR-2021. This report was non-serious.
Diagnosed with Bell's Palsy six days after receiving the vaccine; This is a spontaneous report from a contactable other HCP (patient). A 25-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular in the right arm on 06Jan2021 14:30 at first single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. No other vaccine was received in four weeks. On 12Jan2021, the patient was diagnosed with bell's palsy six days after receiving the vaccine. COVID was tested post vaccination: Nasal Swab: negative on 13Jan2021. AE resulted in: Doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Event treatment included oral steroids. Outcome of the event was not recovered.; Sender's Comments: Based on the temporal relationship, the association between the event Bell's palsy with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
I normally have where my heart skipped a beat but it was not really noticeable. So after 48 hours after the vaccine, my heart started to skip a beat about 4-5 times a hour.  I decided to go to the cardiologist,  they did a EKG.  They also did a echo stress and they gave me a heart monitor.  Within 3 days I had enough data from the monitor that I turned it into the doctor.  The doctor advised that he was not concerned that these were a serious tachycardia.  He advised another stress test.  He also advised that it should go away over time, which it did after a few weeks.  I had the symptoms for about a month.
her vision is blurry; pain on her left leg, left arm and back; pain on her left leg, left arm; Rash; This case was reported by a consumer via call center representative and described the occurrence of blurred vision in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of headache (1st dose received on an unknown date, refer case US2021027610).   On 31st December 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced blurred vision, back pain, pain in extremity and rash. On an unknown date, the outcome of the blurred vision, back pain and pain in extremity were not recovered/not resolved and the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the blurred vision, back pain, pain in extremity and rash to be related to Shingrix.  Additional details were provided as follows:  The patient reported for herself. It was reported that patient had a severe reaction to the first and second dose of the shingrix vaccine.  After getting the 2nd dose, patient's vision was blurry, she had pain on her left leg, left arm and back.  The patient gave consent to contact her health care professional, but she did not have contact information available. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021027610:same reporter, 1st dose
Initial unsolicited report received from a consumer (patient-herself) on 25-Oct-2017. This case involves a 72-year-old female patient, who was vaccinated with a dose of 0.5 ml of FLUZONE HIGH-DOSE via intramuscularly once (batch number, expiry date, dose in series were not reported) in the right deltoid on 16-Oct-2017. The patient's medical history and concomitant medications was not reported. On an unspecified date, following the vaccination, the patient felt like sick as a dog, can't eat, nauseated, diarrhea, thirsty, weak, light headed, fatigued and thirsty. Lab data and corrective treatment was not reported. The outcome was not reported. List of documents held by sender: none.
I technically had 1 week of flu immediately. I was having fever and other flu like symptoms. My fever was not higher than 38.3 Celsius. I had body aches and was very tired, but it was nothing major. Then I got well but contracted flu again after the 30th. I tested and was negative for COVID-19. I was tired with fever and body aches. These symptoms lasted about 5 or 6 days. I experienced muscular pain. The issue with my stomach started again in December. I had difficulty with digestion, nausea, and feeling like burning in the stomach with lots of air. The worsened in the beginning of January 2023. I began having contraction like feelings in the esophagus area. I also had pain and burning in the esophagus. I called the doctor.  The doctor told me these were due to heartburn and inflammation of the stomach. The provider completed a blood panel in the middle of January. I also completed a stool test at the January and both tests were normal. I was given an ultrasound as well and they said everything was fine. The doctor prescribed Famotidine 40 mg. The symptoms improved in the beginning but then got worse again. He changed the prescription to Pantoprazole Delayed Release. I am still taking them. I started taking them February 2, 2023. The symptoms did not go away 100%. I still have them every once in a while.  Its still ongoing.
she states that she is calling about a patient who received two flu shots a month with no reported adverse event; Initial information received on 13-Nov-2023 regarding an unsolicited valid  non-serious case received from a consumer.  This case involves an unknown age and unknown gender patient and the reporter reports she states that she is calling about a patient who received two flu shots influenza quadrival A-B vaccine [fluzone QIV]. a month with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect influenza quadrival A-B vaccine, Suspension for injection (strength, lot number, expiry date, route, administration site: unknown) for Prophylactic Vaccination (immunization) and she states that she is calling about a patient who received two flu shots a month with no reported adverse event (inappropriate schedule of product administration) (unknown latency).  Reportedly, She states that she is calling about a patient who received two flu shots a month or so apart and she would like to know if there are any side effects to watch out for. The caller was asked what flu shot the patient received and if both were Fluzone Quadrivalent but it was unclear and she states that they had a message about a patient who was seen today who received a flu shot and they are in a group home and they received a flu shot in the last month or so.   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.
Patient is 17 years old and got the Moderna shot. Spoke with patient, no adverse events.
2nd shot given 2/28/2021, reaction occurred on 3/5/2021.   Shot site swelled a little, was sore, reddish, hurt and itched.  Reddish site was the size of a silver dollar.   This lasted 3 days with no other adverse effects.
Numbness on the entire shot arm, nose, face, side of face; injection site soreness; tingly on the entire shot arm, nose, face, side of face; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness on the entire shot arm, nose, face, side of face), VACCINATION SITE PAIN (injection site soreness) and PARAESTHESIA (tingly on the entire shot arm, nose, face, side of face) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced PARAESTHESIA (tingly on the entire shot arm, nose, face, side of face). On 25-Jan-2021, the patient experienced HYPOAESTHESIA (Numbness on the entire shot arm, nose, face, side of face) and VACCINATION SITE PAIN (injection site soreness). At the time of the report, HYPOAESTHESIA (Numbness on the entire shot arm, nose, face, side of face) and PARAESTHESIA (tingly on the entire shot arm, nose, face, side of face) had resolved and VACCINATION SITE PAIN (injection site soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.
Patient reports feeling "funny" and notes this is similar to what she feels with her anxiety.  After lying down and relaxing, patient reports relief of symptoms by 10:30am
My period came the day after the shot, and was extremely heavy and painful. Since getting vaccinated I have had wildly varying cycle lengths, averaging a 35 day cycle as opposed to my original 30. I have had the worst periods of my life since getting the vaccine- excruciating cramping and pelvic pain that sends me to the fetal position for a day. If I am out and about, sharp pains can send me to a squatting position for fear of fainting.
This initial spontaneous report was received from a Registered Nurse and refers to a patient of unknown age and gender. Medical history and concomitant medications were not provided. On an unspecified date, the patient received an improperly stored dose of PROQUAD (lot # M033215; expiration 09-JAN-2018). Temperature: 6 degrees F to 14 degrees F (6.8 degrees F). Time frame: one hour. Call was because of a data logger. The diluent used to reconstitute the PROQUAD was properly stored. No adverse effect was reported. Additional information has been requested.
See attached. I am 69 years old. Good shape. On 9/22/2012, I went to the gym that morning. I worked out. Right shoulder was not a problem any other than discomfort at limitation of range of motion. This was due to 1995 fracture of the shoulder. I have never had any treatment for the shoulder since 1995. I was first aware of it in 2003. I have some traumatic arthritis in my left shoulder. By and large, it has been asymptomatic since 1995. I would get soreness when I played golf. That is about it. I had a flu shot in left arm and pneumonia shot in right arm at about 2 to 3 PM. The sheet from the provider shows the date. I had no immediate reaction that was unpleasant. I had prior flu shots. To my knowledge, no prior history of pneumonia shot. I went home. No stress on shoulder. Went to movie starting at 710 PN. About 15 minutes into the movie, my right shoulder, arm, and forearm began to throb. By the time the movie was over, I could not move my right arm. For example, I could not out my right hand in my right pocket due to pain. I went home. Pain started at 8 PM and was intense, throbbing and constant pain in shoulder, top of shoulder, radiation into chest from my shoulder, radiation down the back of my right arm into my right forearm and lower forearm. This was a 9 of 10 pain. I have had morphine level pain for L4-L5 pain. This was greater. I got Narco 10 Hydrocodone at 11. Started it at midnight. The Narco 10 did not touch the pain. I got zero sleep on the night of 9/22/2012. At 4 Am on 9/23/2012, I went on Internet. Found reported issues with flu shot as being brachial neuritis. I knew the pain then was nerve pain. I went to the ER. Took Morphine. Got to sleep. Started steroids. Slept 13 hours. Got up today, 9/24/2012 much better with still 3 or 4 of 10 pain on movement of right shoulder. Can not do pants. Keys in car are big problem.
Initial report received from a healthcare professional on 21 December 2012. A 39-year-old female patient, had received an intradermal dose of FLUZONE ID (Lot number: UT4470BA, dose number, side and site of administration were not reported) on 20 December 2012. The patient's medical history included allergy to Penicillin (PCN). The patient's concomitant medications were not reported. The patient had no illness at time of vaccination. On 20 December 2012, about 20 minutes after vaccination, the patient developed redness around injection site. Through the night, the site became swollen to the size of a softball and redness had increased. The patient also had pain from the site to her shoulder and had ROM (range of motion) in the arm with little discomfort. Corrective treatment details were not reported. Relevant diagnostic tests/laboratory data were none. At the time of this report, the patient had not recovered from the events. Follow-up information was received from a healthcare professional on 08 April 2013. Based upon the new information, this case has been upgraded to serious. FLUZONE INTRADERMAL was given in the right arm. Treatments included cephalexin 500mg one pill three times a day and Prednisone 10mg two tablets two times a day. Concomitant medication included fluocinonide 0.05% cream. Outcome was recovered. Documents held by sender: None.