chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a 42 year old Hispanic male, with hepatitis C and diabetes and latent tuberculosis who on the afternoon of Mar 01 2005 was vaccinated intramuscularly into the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot 650083/0746P). Concomitant therapy included metformin, glipizide (Glucotrol). isoniazid and pyridoxine. On Mar 02 2005, he experienced a large, red, swollen area on the left upper arm from the shoulder to the elbow and the underarm to the axillary area. The area was warm to the touch. he also complained of pain, It was reported that he was in the infirmary for 24 hours. No diagnostic laboratory tests were performed. The patient was treated with cephalexin (Keflex) 500g, TID, for 7 days and diphenhydramine hydrochloride (Benadryl) 25 mg, PRN, PO, every 6 hours, for tow days to treat symptoms. On Mar 04 2005, the patients arm was checked by the doctor and there was no redness or swelling. There was mild pain on palpitation, That same day, the patient was reported as recovered. No product quality complaint was involved. Additional information is not expected.
Patient received Prevnar immunization. Only sx was nasal congestion. Developed fever 103 F and generalized tonic clonic seizure. Seen in ER, nasal congestion only finding, was feeling better approx 24 hrs later. 2nd seizure after fever.
GREW ALL THE HAIR BACK; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced grew all the hair back. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of grew all the hair back was not reported. This report was non-serious.
Persistent headache that had lasted for over two weeks by the time she came to reporter's office.
pt had T 103 & subsequently had convulsions. Pt seen in ER in pm of day of vax admin.  Given meds to reduce fever & convulsion resolved
After dose 4 I began to have symptoms of shingles and then developed shingles a second time three weeks later.  I had a tiny patch of rosacea under my chin that exploded all over my face.  I saw a dermatologist for this and have received medication.  I do have scarring from this.  I began to lose my hair and lost over half of my hair.  I am no longer losing hair at this time. My migraines became much worse and will get treatment for them soon.  The tremor in my hands became so much worse that I am no longer able to write on some days.  My depression symptoms have gotten worse.  I also had geographic tongue and candida.
Pemphigus vulgari; "I have a real bad issue life long issue"; Blister is eating up skin and is getting worse started with 2 bumps and is now covering whole forehead face and chest; This spontaneous case was reported by a consumer and describes the occurrence of PEMPHIGUS (Pemphigus vulgari) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036E21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PEMPHIGUS (Pemphigus vulgari) (seriousness criterion medically significant), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES ("I have a real bad issue life long issue") and CONDITION AGGRAVATED (Blister is eating up skin and is getting worse started with 2 bumps and is now covering whole forehead face and chest). At the time of the report, PEMPHIGUS (Pemphigus vulgari), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES ("I have a real bad issue life long issue") and CONDITION AGGRAVATED (Blister is eating up skin and is getting worse started with 2 bumps and is now covering whole forehead face and chest) outcome was unknown.            Patient had received both doses of the Moderna COVID 19 vaccine  and was diagnosed with pemphigus vulgari. It took months to diagnosed him, he had to go to a dermatologist and an infectious disease doctor to get diagnosed. No concomitant medication information provided. No treatment medication information provided.  Company Comment: This case concerns a 60-year-old, male patient with no relevant medical history, who experienced the unexpected event of Pemphigus Vulgaris. The event occurred on an unknown number of days after the second dose of Moderna COVID-19 Vaccine. The event was considered related to the product per the reporter's assessment. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2021: Follow-up received on 13 Sep 2021 contains updated information on reporter details, vaccine information and new event:  Activities of daily living impaired. On 13-Sep-2021: Follow-up received on 13 Sep 2021 contains no new information. On 15-Sep-2021: Follow-up was received on 15 September 2021 and events were added.; Sender's Comments: This case concerns a 60-year-old, male patient with no relevant medical history, who experienced the unexpected event of Pemphigus Vulgaris. The event occurred on an unknown number of days after the second dose of Moderna COVID-19 Vaccine. The event was considered related to the product per the reporter's assessment. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
Severely increased side effect of Tegratol (carbamazepine). I usually have some mild dizziness lasting around 6 hours when I take it. The second night after my Moderna Vaccine the dizziness was so severe I could not walk at all for about 6 hours and needed assistance even to get to the bathroom. During the next 2 hours I walked as if I was extremely drunk.  It took approximately 11 hours from when the dizziness started to completely resolve.
Severe Migraine headache  Feverish  Extreme fatigue  Body aches
GARDASIL 9 was administered to 4 patients on 10/26/2020 after a temperature excursion and prior to having vaccines evaluated/Separate AE's filed for each patient.; This spontaneous report has been received from an other healthcare professional referring to a patient of unknown age and gender. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.     On 26-OCT-2020, the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #: T007035, expiration date: 01-MAY-2022; route and dose details were unknown) was administered to the patient for prophylaxis, after a temperature excursion (product storage error). The vaccine was stored below 36 degrees Fahrenheit/ 2 degree Celsius (0.9 degree Celsius to 1.9 degree Celsius) for 10 hours and above 47 degrees Fahrenheit/ 9 degree Celsius (9.1 degree Celsius) for 30 minutes. There were no previous temperature excursions. There was no digital data logger was involved.  This is one of several reports received from the same reporter.      combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T007035; expirationdate: 01-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA011190:same reporter US-009507513-2010USA011367:same reporter US-009507513-2010USA011375:same reporter
Day later, mild ache in left arm  which increasingly turned to pain within a week.  Using arm became painful when pushing or lifting something, raising arm overhead, turning door know or putting arm out to side or above head when sleeping.  Arm did not hurt during day, only when doing tasks as enumerated above.
mom states w/in 30 min pt had fever, temp went to 105.9, pt was taken to ER & kept for hrs; mom states MD said shouldn't receive pertussis vax again;
redness below injection site.  Ice pack applied to 10 minutes.  Then a large blister appeared,  and a cluster of small blisters.
Sore Throat; Chills; Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm), OROPHARYNGEAL PAIN (Sore Throat) and CHILLS (Chills) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025AZ1 and 043L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 04-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Sore Arm). On 05-Mar-2021, the patient experienced CHILLS (Chills). On 06-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (Sore Throat). On 05-Mar-2021, PAIN IN EXTREMITY (Sore Arm) had resolved. On 08-Mar-2021, OROPHARYNGEAL PAIN (Sore Throat) and CHILLS (Chills) had resolved.            No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2021-044232 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: The follow up received on 21-may-2021 contains no new information.
aprox 10 minues post vaccination. Patent exspessed that she was itchy and in distress. she was asked to remove her mask and some redness in face as well as swollen mouth / lips noted. Bendryl 25mg given. EMS called and Patient evaluated by RN on site.  Patient began to have chills causing severe shivering. Covered with walrm blankts and placed on the floor. Epi pen adminsited by pharmacist on site at the clinic.  Patient began to feel better prior to tranfer to ER by EMS Remained concious durring even
I was having a heart attack; having problems with pain in my left lung; my having a left ear ache; cold going on in my left lung; This is a spontaneous report from a contactable consumer (patient). A 59-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EP7534), via an unspecified route of administration, administered in arm right on 25Mar2021 at 14:15 (at the age of 59-years-old) as single for COVID-19 immunisation. The patient medical history was none. Concomitant medications includes unspecified medications (not other than her normal medications) received within 2 weeks of vaccination. The patient previously took the first dose of bnt162b2 on an unspecified date for COVID-19 immunisation. Patient did not receive any other vaccine 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 been tested for COVID-19. The patient reported that on 29Mar2021, he started "having problems with pain in my left lung" and "my having a left earache". He really did not think much about it. He just thought he had a "cold going on in my left lung" and it was going up into his left ear. This went on for a long time. Finally, on 06May2021, he had lab work at the unspecified administration and talked to the nurse about his ear and left lung. She looked at his ear and told it looked fine and sent him to the hospital for chest X-rays. The X-rays came out clear. So, he had an appointment with his doctor on 10May2021 and she did an EKG and sent him to the ER. They told the patient that "I was having a heart attack". So nothing had changed from 29Mar2021 till 10May2021. He was having a heart attack all that time and never knew it. So the second shot was what made him have the heart attack because he had no heart problems before that time. The patient underwent lab test and procedure which included chest X ray: came out clear on an unspecified date, EKG: unknown results on 10May2021, lab work: unknown result on 06May2021 and nasal swab: unknown results on an unspecified date. The outcome of the events was resolving.
Headache, swelling at injection point, body aches, stomach ache, fever of 101.8 controlled with Advil.
11/28/21 pt tested positive for COVID and was hospitalized, dc'd to home 12/1/21; pt had increasing SOB and was readmitted to hospital on 12/2/21; CTA of the chest showed evolved PNA due to COVID; transferred to ICU; dexamethasone, Vitamins C & D, zinc, ABX; BiPAP; pt's condition worsened requiring intubation; grim diagnosis; transitioned to comfort care and passed away in the hospital
Information has been received from a physician concerning a female (NOS) who was vaccinated on an unknown date intramuscularly with Gardasil vaccine (yeast) (Lot# not provided). Subsequently the patient fainted. Subsequently, the patient recovered from the syncope. Additional information has been requested.
progressive fever & listless; dec appetite; tender inject site w/redness; APAP seen in MD on 10MAR94 for probable reaction to immun;
Patient called and reported on 11/2/09, that she broke out in a rash on her extremities, similar to chicken pox. 3-4 days after receiving vaccine at clinic held at the community club house where she lives. Stated she had been seen by her Dr. and a Dermatologist, who told her it was caused by the vaccine. She stated she was using cortisone cream for the itch.
Dizziness, Headache, Arthralgia, Soreness at site Narrative:  Other Relevant History:
pt became sick w/flu, also bronchitis, upper resp infect, laryngiis; pt was out of work for 4 wks
This spontaneous report was received from a husband concerning his 67 year old wife (who is the patient). On 17-DEC-2012, the patient was vaccinated with a dose of PNEUMOVAX23, (lot number, expiry date was not reported and route was injection). Concomitant medications were not reported. On 29-JAN-2013, the patient experienced some adverse experiences after she received PNEUMOVAX23. The husband stated that the patient's baseline temperature was normally 97.6 degrees Fahrenheit, however after receiving the medication, her temperature moved up to 98.6 degrees Fahrenheit. The patient had constant fatigue and felt very lightheaded. No laboratory tests were performed. At the time of this report the patient had not recovered from the reported events. The patient did not seek medical attention. Additional information is not expected.
PATIENT EXPERIENCE SYNCOP SYMTOMS OF FELT DIZZY- ALTERED ALERTNESS- COOL CLAMY SKIN AND MILD SWEAT AFTER 1ST DOSE OF COVID- MONITOR PATIENT FOR NEXT 30 MINUTES AND PATIENT REGAIN ALERTNESS AND FELT FINE AFTER RESTING WITH FEET ELEVATED AND COLD PACK TO FOREHEAD.
Head felt like things were crawling all over; Eyes started watering; Forehead started to get red; Felt like something burst inside head/ head still feels weird; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448) via an unspecified route of administration in the left arm on 24Aug2021 at 15:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received metformin (MANUFACTURER UNKNOWN) for an unspecified indication on unknown date and experienced drug allergy. On 24Aug2021 at 15:00, within just a few seconds of receiving the shot, the patient felt like something burst inside her head and within minutes her head felt like things were crawling all over, also eyes started watering and forehead started to get red. The patient's head still felt weird where that "pop" happened. Therapeutic measure was taken as a result of the events which included treatment with diphenhydramine (BENADRYL) given by pharmacist and the patient waited around another 15 minutes or so. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events head felt like things were crawling all over, eyes started watering, forehead started to get red was unknown; whereas the event felt like something burst inside head/ head still feels weird was not resolved at the time of this report.
Less than 5 minutes after receiving his vaccination, the patient lost consciousness and fell onto the floor. He was unconscious for less than 3 minutes and suddenly woke up with no memory of the event. The paramedics were called and he was checked out by them. They found no problems and he was able to leave shortly after.
patient received expired dose; patient received .5ml for booster; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received expired dose) and ACCIDENTAL OVERDOSE (patient received .5ml for booster) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C21A, 042B21A and 041C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received expired dose) and ACCIDENTAL OVERDOSE (patient received .5ml for booster). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (patient received expired dose) and ACCIDENTAL OVERDOSE (patient received .5ml for booster) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  No Treatment information was reported   This case was linked to MOD-2021-402877 (Patient Link).
Redness and swelling started 1 day after the immunization.  Red and warm to touch extened down posteriar aspect of arm from injection site to just below elbow.
product quality issue; Initial information received on 09-Aug-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a patient who reported a product quality issue, while he/she received vaccine TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM] (lot number not reported via unknown route in unknown administration site), on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was unknown if the patient had any adverse event.  Information on the batch number was requested.  List of document held by sender: none.
Large joint arthragias and myalgia diffuse better with prednisone 15 mg daily, recurring with stopping prednisone
bronchitis; wet cough that would wake her up out of a sound sleep; This spontaneous case was reported by a non-health professional and describes the occurrence of BRONCHITIS (bronchitis) and SLEEP DISORDER (wet cough that would wake her up out of a sound sleep) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Historical condition also included removal of pain pump. Patient was also allergic to green and red peppers.  The patient's past medical history included Accident automobile, Rape victim, Claustrophobia, Cervical cancer, Lung nodule (Left Lung Node), Spinal cord injury thoracic (compound fracture of T-12), Hip discomfort, Red man syndrome, Hysterectomy, Back surgery (2 failed back surgeries) and Spinal fusion. Concurrent medical conditions included Hypothyroidism (Thyroid disease), Muscle spasms, Blood pressure high, Tiredness (Tiredness form Steroids and Benadryl), Leg pain, Weakness of limbs, Herniated disc (Herniations and disc bulging from Thoracic 11 to Sacral 1 discs), Multiple sclerosis exacerbation, Latex allergy, Drug allergy (Allergy to codeine, tylenol 3, Imitrex pills, Prozac, fentanyl, tramadol, methadone, toradol, NSAIDS, Depakote, tegretol, cymbalta and morphine IV.), Adhesive tape allergy, Allergy to topical drugs, Chronic pain, Vision abnormal, Migraine, Chronic cough, Depression, Anxiety and Sacroiliitis. Concomitant products included DIAZEPAM (VALIUM), LEVOTHYROXINE SODIUM (SYNTHROID), HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL + HIDROCLOROTIAZIDA), OCRELIZUMAB (OCREVUS), DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), OXYCODONE, GABAPENTIN, AMITRIPTYLINE, OXYCODONE (XTAMPZA ER) and SUMATRIPTAN (IMITREX [SUMATRIPTAN]) for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BRONCHITIS (bronchitis) and SLEEP DISORDER (wet cough that would wake her up out of a sound sleep). The patient was treated with BENZONATATE (TESSALON PERLE) at an unspecified dose and frequency. At the time of the report, BRONCHITIS (bronchitis) and SLEEP DISORDER (wet cough that would wake her up out of a sound sleep) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Chest X-ray: no pneumonia but they gave her tesselon perles..         It was reported that patient started therapy with Moderna Shot and developed a bronchitis wet cough that would wake her up out of a sound sleep because the phlegm was stuck and she stopped breathing.
Seizures, epilepsy. I'm now on Lemotrigine. One tablet twice a day.
fever apparent evening p/vax recvd, mom did not use thermometer; t104 R AM 30JUN, 105 R noc of 30JUN; 105 R through 2JUL92; temp was 101 R on 4JUL92; 5JUL afebrile w/pinpoint rash; pt irritable;
nerve pain spiking and constant throughout entire body, ear pain, swollen glands all over body, especially in groin and under left arm( swelling size of a small apple), muscle pain, high fever 104 and above, body aches, muscle weakness, hard to walk, exhaustion, shortness of breath, headache, sensitivity to light and sound
Muscle spasms in neck within 1 hour of receiving vaccine.  Severe cramp L calf less than 24 hours after receiving vaccine. Both these symptoms continued until medical evaluation on 07 Jan.
Chills, fever (100.1), muscle aches, arm soreness, headache, loss of appetite. Tylenol. Waiting for side effects to resolve. 4/3 - 5 pm
pt recv vax 14NOV98 & 21OCT98 pt began having itching & hives;took DPH, no relief;pt spouse called pvt MD & was given rx for dose pack;pt cont to have intermittent swelling of lips & eyelids;
Visiting Care services come to my workplace to administer flu shots on-site. I received a flu shot at my workplace on Thursday, October 5. It itched way more than usual. By about Saturday or Sunday, I noticed raised bumps at the injection site. By the following Tuesday, the bumps were raised, red and blistered. Today, Sunday October 15, the bumps are still red, but not as raised, and there is no blistering.