chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It is worse at night and sometimes "I" cant sleep on my left side. The pain comes and goes throughout the day. "I" feel it from "my" shoulder to "my" elbow.; Pain on "my" left arm started near injection site.; The pain is sharp, sometimes stabbing pain which at night prevents "me" from sleeping.; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 02Apr2021 at 11:15 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. The medical history included gastroesophageal reflux disease (GERD), high blood pressure, asthma (controlled) and hypothyroidism. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ALLERTEC), estrogens conjugated (PREMARIN) and zol (unspecified); all for unknown indications from unknown dates and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 12Mar2021 at 13:15 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. The patient previously took hydrocodone bitartrate/paracetamol (VICODIN) and erythromycin (MANUFACTURER UNKNOWN) on unknown dates and experienced allergy. On 09Apr2021, the patient underwent SARS-CoV-2 test and the result was found to be negative. On 23Apr2021 at 14:30, the patient had pain on her left arm near injection site. It was worse at night and sometimes she can't sleep on her left side. The pain was sharp, sometimes stabbing pain which at night prevents her from sleeping. The pain came and went throughout the day and she felt the pain from her shoulder to her elbow. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events pain on her left arm near injection site, stabbing pain and felt the pain from shoulder to elbow were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Had live influenza vaccine Wednesday Sept 22 and had two febrile seizures requiring hospitalization on Friday the 25th of September  Temps still high now and breath smells of urine.  Fever blisters on tongue decreased appetite and fluid intake.
This spontaneous report was received from a physician concerning to a patient of unknown age and gender. On 20-FEB-2013 the patient was vaccinated with a dose of M-M-R II (lot number H013041, expiration date 17-JUL-2014) (dose and route not reported). The vaccine administered was improperly stored, was exposed to 66F since 21-JAN-2013. No adverse effect reported. This case is linked to the following MARRS cases: 1304USA007561, 1304USA008124, 1304USA008126, 1304USA008127, 1304USA008128. Additional information has been requested.
Rash to left side of body. Where immunizations gave seen by dermatology and biopsy done Diagnosed with Lichen Striatus, likely caused by the vaccines. Patient got rash 1 wk after MMR/Varicella given.
Information has been received from a medical assistant referring to a 26 years old patient of unknown gender. The concomitant medication, medical history and drug allergies/reactions regarding the patient were not reported. The reporter reported that the patient was vaccinated with dose one of GARDASIL 9 (route, dose detail, lot# and expiration date were unknown) on 17-JAN-2019 and dose two (route, dose detail, lot# and expiration date were unknown) on 21-FEB-2019 for prophylaxis. This time interval was shorter than recommended (inappropriate schedule of vaccine administered). No adverse effect was provided.
no reaction or other AE in patient; high temperature excursions; This spontaneous report was received from a registered nurse and refers to a 2 -year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 23-SEP-2020, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB), lot # R006746, expiration date 09-NOV-2020 for prophylaxis (dose, route of administration and anatomical location were not reported). The nurse reported that the vaccine had undergone the following high temperature excursions: 49.1 degrees Fahrenheit (15 minutes in August 2020), 46.6 degrees Fahrenheit (1 minute on 09-SEP-2020), 46.9 (8 minutes on 17-SEP-2020) and 46.8 degrees Fahrenheit (6 minutes on 20-SEP-2020). A data logger was involved. The nurse confirmed no reaction or other adverse event in the patient. No further information provided, and no product quality complaint (PQC) identified.
Severe fatigue, headache, temp of 99.8, nausea, chills, sweats, irritable, muscle aches. Every day 7 days after 1st shot.
I had a headache, sore throat and a fever. I had coughing and sneezing as well as other flu like symptoms. The symptoms increasingly getting more severe. I kept waking up with a sore throat. I called the doctor to let him know I was positive. I was not able to take Paxlovid due to Eliquis. I took OTC Mucinex which made the symptoms tolerable. I still have a cough and my throat is still scratchy. It is getting better though. I still sleep a lot and I am tired.
Nausea; Chills; Fever; Soreness at injection site; Headache; Muscle soreness; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), CHILLS (Chills), PYREXIA (Fever), VACCINATION SITE PAIN (Soreness at injection site) and HEADACHE (Headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Headache (Occurred may be once a year), Fever (Occurred maybe once every 5 years, if even), Chills (Occurred maybe once every 5 years, if even) and Nausea (Occurred maybe once every 5 years, if even). Previously administered products included for Drug use for unknown indication: Flu shot. Past adverse reactions to the above products included Bedridden with Flu shot. Concurrent medical conditions included Allergy to antibiotic (Sulfa Antibiotics) and Ulcerative colitis (Flared up after first vaccination, none since) since 01-Apr-1995. Concomitant products included MULTIVITAMIN [VITAMINS NOS] from 01-Jan-2000 to an unknown date and CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) from 01-Jan-2021 to an unknown date for Routine health maintenance, BALSALAZIDE DISODIUM from 01-Jan-2012 to an unknown date and CALCIUM, COLECALCIFEROL (CALCIUM +D3) from 01-Jan-2000 to an unknown date for Ulcerative colitis.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced NAUSEA (Nausea), CHILLS (Chills), PYREXIA (Fever), VACCINATION SITE PAIN (Soreness at injection site), HEADACHE (Headache) and MYALGIA (Muscle soreness). The patient was treated with BALSALAZIDE DISODIUM at a dose of increased my dosage. At the time of the report, NAUSEA (Nausea), CHILLS (Chills), PYREXIA (Fever), VACCINATION SITE PAIN (Soreness at injection site), HEADACHE (Headache) and MYALGIA (Muscle soreness) had not resolved. Not Provided          Concomitant medication include spore probiotic 6 billion CFU + triphala once daily which was taken for general health from 01 Jan 2021 and route of administration was oral. Route of administration of vaccine: VSC. Patient did not had any similar events in past and no other potential causes. In anticipation for a flare up patient increased the dosage of balzalazide. Later decreased the dosage after about 3 weeks (return to twice/day.   This case was linked to MOD-2022-487474, MOD-2022-490806 (Patient Link).
didn't do well; This spontaneous case was reported by a nurse and describes the occurrence of MALAISE (didn't do well) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (didn't do well). At the time of the report, MALAISE (didn't do well) outcome was unknown.      The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Nurse as a patient stated she only received one dose of the primary series and she did not do well and did not want to received another dose but would like to receive a bivalent dose.   No treatment medications were reported.   Reporter did not allow further contact
2 days p/vax pt came in AM w/erythema @ thigh inj site;came back in PM w/hives on neck, trunk, arms, face swelling & red;no resp distress or wheezing;epi given;sx resolving;atarax given;pt d/c to take atarax x 2 days;
Patient developed rash on torso on  the injection site.  With swelling arms patient became cranky- 24 hrs after the administration of DAPTACEL.
bad case of the flu; Initial information received on 14-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult male patient who had bad case of the flu while receiving vaccine INFLUENZA VACCINE.  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  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported in unknown administration site.  On an unknown date the patient developed a non-serious bad case of the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (bad case of the flu).  At time of reporting, the outcome was Unknown for the event bad case of the flu.
No adverse event; The patient was administered with improperly stored VAQTA; This spontaneous report was received from a certified medical assistant (CMA) referring to a 12-month-old female patient.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On 14-NOV-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # S007770, expiration date: 24-JUL-2020, strength, dose number, anatomical location and route of administration were not reported) for prophylaxis (product storage error). It was reported that the vaccine was exposed to the temperature above 47 degrees Fahrenheit/9 degree Celsius (9.3 Celsius) for 23 minutes. The previous temperature excursion were at the temperature above 47 degrees Fahrenheit/9 degree Celsius (10.7 Celsius) for 33 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.7 Celsius) for 36 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.9 Celsius) for 15 minutes and at the temperature above 47 degrees Fahrenheit/9 degree Celsius (9 Celsius) for 12 minutes. The call was because of a data logger. No adverse event was reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S007770; expirationdate: 24-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1910USA012749:
Patient stated on 10/19/18 over the phone that after the IMZ on 10/18/18 she noticed her arm hurting more and more as the day  progressed to the point of it hurting with any movement. Patient did state that she could still function in her normal daily routine. Patient is going to wait and see if the pain subsides over the next few days.
Systemic: Chills-Mild, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Medium
localized swelling, pain, itching, redness at injection site.  Painful facial lesions on same side that injection was give that developed redness and pus, later scabbing and scarring. Swelling on side of face where lesions were present, ear pain.
patient presented 10 days post vaccine with measles like rash - macupapular rash at hair line and down torso with convalescing lesions of varying sizes.
fluid build up in lungs; difficulty in breathing; weakness; tiredness; This is a spontaneous report from a contactable consumer received from a Pfizer sponsored Program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as a 2nd dose, single dose for COVID-19 immunisation. The patient's medical history included open heart surgery, preexisting condition Mac bacteria complication during open heart surgery a few years ago that caused the other side of the heart to weaken that led to ascites. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as a 1st dose, single dose for COVID-19 immunization. It was reported that, during 2nd Co-Vid vaccine injection side effect of weakness, tiredness and fluid build-up in lungs. Complained of difficulty in breathing. It had been 10 days since the second vaccine injection and no change. The outcome of the events was not recovered.
weakness and shortness of breath reported during the observation period. Patient taken to ED for observation and evaluation. Pepcid and Benadryl given. Patient discharged home
Feverish; injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Feverish) and INJECTION SITE ERYTHEMA (injection site redness) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced PYREXIA (Feverish) and INJECTION SITE ERYTHEMA (injection site redness). At the time of the report, PYREXIA (Feverish) and INJECTION SITE ERYTHEMA (injection site redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Information has been received from a nurse practitioner and a licensed practical nurse concerning a teenage female (age not reported) who on an unspecified date was vaccinated with 0.5 mL of Gardasil. Subsequently, the patient ended up crying and reported she had pain, when the vaccine was being administered, either left or right arm and had some pain afterwards. Unspecified medical attention was sought. At the time of this report, the patient had recovered from the events (date unknown). Additional information has been requested.
Took the vaccine for menningitis on May 29, 2007, since he planned to attend University as a freshman. One week later patient suffered the following symptoms: difficulty breathing, rapid heart rate, aching muscles in his chest, arms and legs and problems with his vision.  We took him to the emergency room at Hospital on two occasions with several doctor visits over the summer months.  He has also received several blood tests (high white blood cell count).  Plans to visit a pulmonary specialist early September.  09/24/2007 MR received for 2 ER visits dated 6/10/2007 and 6/21/2007 for c/o chest pain and palpitations. Additional symptom of dyspnea on 6/21/07 visit, reported as being unable to get a good breath. Discharge DX 6/10/07: Chest wall pain.  Palpitations. Discharge DX 6/21/07 Dyspnea.  10/02/2007 Spoke with parent.  Pt has seen an opthomologist for visual disturbances without definative dx, and seen a pulmonary MD for breathing problems/exacerbation of asthma also without definative dx.  Pt has been referred to 2 other specialists in neurology and pulmonary later in the month.   10/29/2007 MR received for neuro consult of 10/8/2007 for c/o headaches and body weakness onset June 2007. Assessment: Headache follwed meningio vaccine.  Visual disturbances, unspecified DDX-vascular, optic neuritis.  Weakness Fatigue, DDX-SMN, myopathy, polyrad inflamm.  10/29/2007 MR received from pulmonary consult done 10/16/2007 for c/o shortness of breath, chest heaviness, blurred vision, diffuse myalgias, and palpitations since May 2007.  Symptoms have slowly been improving. PE WNL. DX: serum sickness reaction from meningococcal vaccine. 10/31/2007 F/U OV received from Neurology. Workup was negative. Still with vague symptoms.
took both of her shots and has shingles/suspected vaccination failure; horrible/bad case of shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, several weeks after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 3-Oct-2022 Reporter's comment: The case was received from the patient's cousin via interactive digital media. The patient who was working in a hospital took her both shingles shots and still had a horrible case of shingles in a couple of weeks of her vaccines, that were supposed to prevent or make shingles milder did neither. The reporter asked that what's up with that. The reporter denied to follow-up. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
administered Engerix Recalled  lot; administered Engerix Recalled  lot; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B pediatric) (batch number CP23D, expiry date December 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric 10  mcg .5 ml and Engerix B Pre-Filled Syringe Device 10 mcg. On an unknown date, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error 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 medical assistant reported that, the patient administered Engerix B recalled Lot number back in June 2021 through July 2021, which led to recalled drug administered and drug dispensing error. The medical assistant unable to provide patients details. The reporter did not consent to follow up. This case was 1 of 70 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR224750:Same reporter US-GLAXOSMITHKLINE-US2021AMR224751:Same reporter US-GLAXOSMITHKLINE-US2021AMR224752:same reporter
My migraines went away as quick as they came for my second vaccine. I didn't get any symptoms after 6 hours later. Then at 3AM, I woke up with a severe migraine. It took almost 12-16 hours after my second shot before anything happened. I haven't experience that in the past. The migraine lasted for about 3 1/2 weeks. I haven't experienced them any further, and I'm not experiencing the blood pressure issues, but my chest pains would last longer. My chest pain issue, I'm still dealing with it, and I've had it since May. On September 1st, I could not breathe, I was getting no air and they ran an EKG on September 2nd, they've done blood work and chest x-rays. Thyroid and blood cloth test. I also had a heart monitor test.
Mom reports palpable fever, devel rt sided sz w/eyes deviating to rt; sz continued for 1.5 hrs; Pt taken to Hosp; Afebrile during hosp; Transferred to another Hosp; MD reports rt hemiparesis;
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Shakiness-Medium, Additional Details: patient became pale and felt uneasy and had to lay down on the floor
mom describes react to prev vax entire lt thigh swollen & bright red-pt cried for 2 1/2 hrs; swelling lasted 1 wk fussy p/24 hrs; called ER told to use ice seen by MD;
Right after injection, prickly and pinchy at site of injection and almost immediate arm soreness.  Arm soreness remained the rest of the day 4/1/21.  On 4/2/21, muscle and joint aches and pain increased and reached full intensity by 7:00pm.  Upset stomach intermittent unproductive nausea.  All joints hurt with movement (including knees, toes, shoulders, ankles).  All muscles hurt (including calves, stomach muscles, chest front and back, breasts, fingers, lower back, shoulders, neck...etc).   Skin was extremely and uncomfortably sensitive to touch.  Serious fatigue accompanied the muscle aches and pains.  Advil/Tylenol did not help.  On 4/3/21 awoke with milder overall muscle pain, though still present.  Minor Fatigue.
About a week after my second dose my Ulcerative Colitis began to flare which I contribute to my immune response reaction considering I have been in successful remission for over 6 years.
Patient had had hyaluronic acid lip filler to 1/2 of the lip several months prior. Patient states that the lip area that was filled became itchy and swollen.
5 cm firm swelling, sl tender w/erythema up & down most of triceps area;