chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable pharmacist (father of the patient). A 17-year-old female patient received the first dose of TRUMENBA at single dose on 13Jul2018 for immunization. Concomitant products included doxycycline since 09Jul2018 and ongoing at 100mg once a day by mouth for acne and minocycline in Jun2018 at 100mg once a day by mouth for acne, for one month. On 14Jul2018 the patient experienced fever up to 103°F that resolved on 15Jul2018, on 15Jul2018 the patient experienced weakness, she can't stay awake for long, only wakes up to eat and goes back to bed, fatigue, she had mental issues "says she doesn't feel real", hallucination and she was very weird. The patient was treated for the fever with TYLENOL 500mg and Ibuprofen 600mg alternately. The outcome of the events weakness, somnolence and hallucination was reported as not recovered, the outcome of the other events was unknown. The events weakness, somnolence and hallucination were considered serious. Information on the batch number has been requested. Sender's Comments: 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, as appropriate. The case will be reassessed if additional information becomes available.
Treatment of COVID-19; Treatment of COVID-19; Off label use; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 15Jan2021 as dose 1, single (Lot number: EL9262), in right arm, on 13Feb2021 as dose 2, single (Lot number: EN6201), in right arm, on 31Aug2021 as dose 3 (booster), single (Lot number: Fc3184), in right arm and on 09Feb2022 as dose 4 (booster), single (Lot number: FM0698) at the age of 75 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "High cholestrol" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; ATORVASTATIN; ZETIA; FINASTERIDE; LISINOPRIL; POTASSIUM CITRATE. The following information was reported: IMMUNISATION (medically significant) with onset 09Feb2022, outcome "unknown", described as "Booster"; OFF LABEL USE (medically significant) with onset 09Feb2022, outcome "unknown"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.
15 month male twin with 20-30 seconds seizure on 9/24/06.  Emergency medical services evaluated sleepy but otherwise normal.  No treatment given, in office today, red throat but normal exam.
Client's wife called on 5/5/00, regarding pt. She states that pt had spots about thumb size all over both legs, the next day, post vax. No itching and "it doesn't bother him." The nurse suggested that client should go to see the doctor to be dx'd. Wife states that he has the appt and is going to see the doctor. Will call from seeing the doctor. Not yet (5/15/00).
10/18/2018 11am sore left arm, weakness.Took two ADVIL 2pm. Relief noted. A day or two later woke with left side sore throat, large node on left side of neck. When swallowing, pain radiated to left ear. These symptoms lasted 1-1/2 days. Resolved itself spontaneously.
Headache, Myalgia, Arthralgia, Fever, Diarrhea & NauseaVomiting Narrative:  1/21-1430 chills;2030 fever 103.2,bodyache,skin hurt;muscle &joint pain;1/22-fever 101.2 to 102.9 with tylenol; 1/23-fatigue/weak; 1/24-gi distress/diarrhea
Patient was screened given Afluria appropriate dose into Left Deltoid. Next day patient complained to HR person at his work that his arm was hurting and he said it was about the time he had his shot.
58 year old received Fluzone HD which is intended for 65+ age group - no side effects.
Narrative:  64 yo male with hx of HTN, joint pain, allergic rhinitis and asthma reported having SOB and chest tightness 4-5 hours after receiving Pfizer vaccine (2/8/2021). Pt reported this ADR on 3/1, when he returned for his second vaccine.  Both vaccines were administered without complications.
Ringing in ear over 2 hours on 9/30 at 3AM. Ringing in ear over 1 1/2 hours on 10/3 at 9:40pm. Ringing multiple times a day, lasting only seconds now.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient (pt) of unknown age and gender. No information regarding the pt's pertinent medical history, drug reactions or allergies, and concomitant medications was provided. On or about 02-FEB-2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, dose number, route of administration, anatomical site of vaccination, lot number and expiration date were not provided), as prescribed and/or administered by a healthcare provider at the medical clinic, for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, reported as subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a healthcare provider at a hospital for shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries; including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was considered as not recovered. The reporter assessed that the event was related to zoster vaccine live (ZOSTAVAX).
This spontaneous report as received from a mother refers to her 12 month old male patient with drug allergy to penicillin and no pertinent medical history. On 29-JAN-207 the patient was vaccinated with M-M-R II (lot#,dose and route unknown). No other co-suspects were reported. There were no concomitant medications. About ten days after received M-M-R II, on approximately 08-FEB-2007 the patient experienced severe rash and fever of 106 degrees Fahrenheit. The patient was seen in the emergency room of an unspecified hospital, but was not admitted to the hospital. The patient's physician has run tests on the patient's immunity to M-M-R. "Three years ago," the patient was still immune to all three diseases. Presently, the patient was only immune to Measles and Rubella. The patient was treated with TYLENOL and MOTRIN. The outcome was reported as recovered/resolved on an unknown date. Additional information has been requested.
Tinnitus, dizziness, headache.  Prescribed: 10/19/2021- fluticasone propionate nasal spray 50mcg x 1 daily 11/17/2021- Prednisone 10mg , 12 day course  No change
No streaks but a 1" purple line 1" above elbow front part of arm. Patient didn't treat. Color change to light yellow and is all slowly disappearing. Started night of shot. Pt had pain 1st night - better by 2nd day.
approximately 1 hour after injection  the following : metallic taste, itchy eyes, nose, ears, then face. My face became bright red and also itchy. the metallic taste lasted about an hour. the redness 6 hours. The itchiness until the following morning approx. 15 hours
I had headaches, fever, severe joint pain , skin hurt to touch, very large about 6-8 inches  red swollen with heat spot on the arm the injection was given itching on the same spot as the red swollen place a knot about 3 inches across the injection site. Nausea Exhaustion
EMPLOYEE STATES "AFTER FLU SHOT HAVING NUMBNESS IN LEFT SIDE OF MOUTH/TONGUE." SENT FOR EVALUATION.
significant fatigue; peculiarly sticky but productive afebrile cough; shortness of breath; hospitalized with apparent cardiomyopathy for just over a week now (including a brief stay in CVICU) with an ejection fraction of 20%-25%; Afebrile chills; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in right arm on 17Apr2021 11:00 (at the age of 45-year-old) (Batch/Lot Number: EW0162) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient has not been diagnosed with covid-19 prior to vaccination and has been tested for covid-19 via nasal swab on 21May2021 which showed negative. Medical history included hypertension, depression, anxiety, attention deficit hyperactivity disorder (ADHD), and known allergies to Bactrim and Modanifil. Concomitant medications included methylphenidate hydrochloride (CONCERTA); vortioxetine hydrobromide (TRINTELLIX); bupropion; losartan; and zolpidem. Historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: ER2613) in the left arm on 23Mar2021 (at the age of 45-year-old) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. On 18Apr2021, the patient experienced afebrile chills which was resolved after about 18 hours bedrest. Furthermore, four days post-vaccination (20Apr2021), it was reported that suddenly back in bed, this time with significant fatigue and a peculiarly sticky but productive afebrile cough that responded to neither dextromethorphan nor guaifenesin, nor to liberal and frequent coadministration of these two drugs. Partial resolution by Friday, 22Apr2021. No chills that he remembers. Much more debilitating than the initial reaction (afebrile chills) described earlier. Cough has come and gone for weeks, never resolving for more than about three days at a stretch. About three weeks ago, patient began to suffer shortness of breath for the first time in his life - while making a very easy (and routine) walk from his car into CVS and back. The patient has been hospitalized with apparent cardiomyopathy for just over a week now (including a brief stay in CVICU) with an ejection fraction of 20%-25%. The onset date of shortness of breath and cardiomyopathy was 18Apr2021. All events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of all events which includes Lasix, milrinone, metoprolol, and carvedilol. On an unspecified date in Apr2021, the patient recovered from afebrile chills while outcome of the rest of the events was not yet recovered.
Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild
My the skin of my jaw and chin started to feel numb.  The sensation progressed rapidly to include numbness of my cheeks, eyebrows, and ears.  The symptoms appeared rapidly after leaving the clinic (as I was driving away on my from work to home).  Less than 30 minutes after receiving the vaccine.  Both sides of my face were impacted equally.
ON 14 MAR 06, PT WAS SCREENED FOR TYPHOID (LT ARM), HEP B (1ST DOSE) LT ARM, PPD LEFT FOREARM. PT STATES" HE BEGAN TO BREAK OUT WITH A RASH ON 17 MAR. RASH WAS ON BOTH UPPER INNER THIGH REGION, INNER AND OUTER UPPER RIGHT ARM. RED SPOTS APPEARED ON HIS FACE NECK AND FINGERS. HE SAID IT APPEARED TO LOOK LIKE POSION IVY. PT STATES HE WAS OUT IN THE WOODS AND BRUSHES THE SUNDAY PRIOR. DENIES FEVER, CHILLS OR PAIN. HE DOES HAVE A DARK BRUISE AT ONE OF THE INJECTION SITES.
This spontaneous report was received from a female patient referring to herself. Patient demographics were not provided. Concurrent conditions, medical history and allergies were not reported. On an unknown date in June 2010 the patient was vaccinated with ZOSTAVAX (dose, route, lot number and expiration date were not reported). On an unknown date in June 2013 (also reported as three years later) the patient stated she developed shingles. The patient sought medical attention and was given as treatment gabapentin. The physician demographics were unknown. No further information was provided. The outcome of the patient developed shingles in "June 2013" was unknown. Additional information is not expected because the patient decline to participate in this report and the reporter details were not provided.
After receiving the vaccine, no problems until I woke up in the middle of the night, and I was sore and my arm was hurting and I was sweating. I started having chills. I have a fever, still with aches and pains. The soreness at the injection site is about gone. Yesterday, 01.03.21, I was running a fever between 99-101 all night long. Last night I took one Tylenol to help slow it down a little. It's been pretty severe up until now. Right now my temp is 98.1.  I did not go to the ER and my wife has the lot number in her purse with her right now.
A localized reaction with erythema and tenderness in the arm; A localized reaction with erythema and tenderness in the arm; This spontaneous case was received on 11-Dec-2020 via Health Authority (reference number: SEQW20-05719), reported by a physician and concerned a 23-year-old, female patient.  The patient's relevant medical history and concomitant medications were not reported.  On 04-Sep-2020, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular and anatomical location: not reported) for influenza prophylaxis. The batch number reported was 279847 and expiry date was 30-Jun-2021.  On an unreported date in 2020, after receiving Flucelvax Quadrivalent, the patient developed a localized reaction with erythema and tenderness in the arm. The patient did not receive any treatment.  On an unreported date in 2020, within 48h to 72h, the patient recovered from the events.  The reporter did not provide a causality assessment.  The reporter assessed the events as non-serious.  This case is linked to cases 202007626, 202007627 and 202007631 due to the same reporter.  Company comment: A 23-year-old patient was administered Flucelvax Quadrivalent. An unknown amount of time after receiving Flucelvax Quadrivalent, the patient developed a localized reaction with erythema and tenderness in the arm. Causality is assessed as possibly related for both events.; Sender's Comments: A 23-year-old patient was administered Flucelvax Quadrivalent. An unknown amount of time after receiving Flucelvax Quadrivalent, the patient developed a localized reaction with erythema and tenderness in the arm. Causality is assessed as possibly related for both events.
Pain, swelling of the shoulder, onset of raised red rash. Rash spread on Tuesday 10/07/2013 and spread again on Wednesday 10/08/2014. Swollen lymph nodes in armpit and left side of the neck. Sore throat and itchy ears.
Initial unsolicited report received from physician a via other company (Pfizer) (Manufacturer Report Number: 2016424298) on 15-SEP-2016. This case involves a female patient (age not reported) who was vaccinated with a dose of INFLUENZA VACCINE (batch number, expiry date, route and site of administration: not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, patient developed allergic to flu vaccine. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Sore muscles in the lower back; Intense Headache; Cramping in the thighs, knees, calves, and feet; nausea/Light Nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 04Mar2021 11:15 (Lot number: EN6202, Expiration Date: 30Jun2021) at the age of 73 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "migraine" (unspecified if ongoing). There were no concomitant medications. The following information was reported: NAUSEA (non-serious) with onset 04Mar2021, outcome "recovered" (Mar2021), described as "nausea/Light Nausea"; HEADACHE (non-serious) with onset 05Mar2021, outcome "recovered" (08Mar2021), described as "Intense Headache"; MUSCLE SPASMS (non-serious) with onset 05Mar2021, outcome "recovered" (07Mar2021), described as "Cramping in the thighs, knees, calves, and feet"; MYALGIA (non-serious) with onset 06Mar2021, outcome "not recovered", described as "Sore muscles in the lower back". Therapeutic measures were taken as a result of nausea, headache, muscle spasms, myalgia. Additional information: the light nausea was more like queasiness. The headache got so bad it was at a point where it hurt to even put her head on a pillow. She had had migraines, and this was worse. It was double what a migraine was. She couldn't even move her head it hurt so bad. The sore muscles was more in the lower back and may be due to being in bed for 3 days. The patient took ADVIL 200 mg at 400 mg 2-3 times during the events. The patient just bought the ADVIL and they were current, that she changed the ADVIL Into a bottle that was easier to open. Patient was due to go back in April and just wanted to know if she had to get the second vaccine or if she was covered enough with the first vaccine. She is worried she would experience these side effects again and does not want to go through that.   No follow-up attempts are possible. No further information is expected.
Fever, chills, shakes, burning sensation, body and backache, headache day of vaccine. Migraine day 2. Muscle pain x 10 days. Fatigue Day of vaccine x7 days. Alteration of smell day of vaccine to current date.
slight headache; joints have been really achy; hot and cold; feeling a little foggy; flu- like symptoms; This is a spontaneous report from a contactable consumer (patient himself). A 69-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8727), via an unspecified route of administration in left arm on 06Apr2021 at 08:10 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. COVID prior vaccination was none.  On 07Apr2021, the patient reported slight headache and stated that his joints have been really achy. The patient also had flu- like symptoms and stated that he was hot and cold, and felt a little foggy. Patient stated that his light Headache started this morning around 9:00 and has eased up a bit. Joint ache started around midnight last night, have eased up a bit and was not as bad as last night. Patient also stated that he got the shot yesterday about 8:00 in the morning and the symptoms have eased up but were not as bad as last night. The patient stated that he was a little foggy this morning and last night he was in bed, so he wasn't sure and feels it more whenever he got up and moves around. Patient stated that when he was lying in bed, he didn't notice it as much. The patient in clarifying flu-like symptoms, stated that achy joints, headache, nothing in the nasal cavity, just all in his body and felt like he's been run over by a truck. The patient stated that he had some extra strength Tylenol, and he didn't know, what he could take for comfort. Caller stated that, he was just wondering if he could take something for the events. The patient queried whether he could use extra strength Tyelnol to treat his side effects or if it would interact with the vaccine. The outcome of the events was resolving for headache, joint pain, feeling hot and cold and not resolved for feeling foggy and unknown for flu like symptoms.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Pt is an 84-year-old female who was hospitalized for sepsis/ pyelonephritis secondary to obstructive  uropathy status post stent from 2/9-2/11 discharged home on 10 days of Ceftin twice daily only to return on 2/26 with complaints of diarrhea resulting in C. difficile positive status treated with Flagyl and PO vancomycin with her diarrhea completely resolving on 3/4 when she was discharged to for rehab and reported no recurrence of diarrhea and normal stools up until 3/20 when she began to have copious amounts of diarrhea again 2 days after receiving her 1st Moderna covid 19 vaccination- resulting in readmission for c diff colitis on 3/22. She remains hospitalized with severe c difficile colitis and is possibly progressing to megacolon or need for fecal transplant.
Fever, chills, nausea, headache, vomiting, severe abdominal pain, shortness of breath, myalgia, severe joint aches, severe fatigue
aunt called clinic states pt lt arm is blue & swollen from shoulder to hand; aunt took pt to MD 20APR93; pt sent to MD for test;
Pt recv vax on 10/13/98; 1 hr later pt exp fever, hives, aches, dizzy, irritable, fast heart rate, shaky, congestion &diarrhea.
Fever and chills after three hours, body aches within one hour, sore throat, tight lungs, all lasting for more than 24 hours after injection of first dose of vaccine
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. The registered nurse reported that, on unknown dates, an unspecified number of improperly stored PROQUAD (Merck) (Lot # reported as K025760 and expiry date 8-JUN-2016) doses had been administered to these patients (dose, lot numbers and routes were not provided). No adverse effects were reported. Product quality complaint was not reported. The outcome of the event was unknown. This is one of the two reports received from the same reporter. Additional information has been requested.
Bell's Palsy; jaundice; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of BELL'S PALSY (Bell's Palsy) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BELL'S PALSY (Bell's Palsy) (seriousness criterion medically significant) and JAUNDICE (jaundice). At the time of the report, BELL'S PALSY (Bell's Palsy) and JAUNDICE (jaundice) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided by the reporter.  No concomitant medication was provided by the reporter.  Company Comment: Very limited information regarding these events has been provided at this time.   Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2021: Additional initial.; Sender's Comments: Very limited information regarding these events has been provided at this time
Throat started to close slightly with first Covid vaccination after 20 minutes Throat started to close within 5 minutes with second Covid vaccination.