chrisvoncsefalvay/vaers-outcomes huggingface dataset:
not being able to move her arm due to pain; not being able to move her arm due to pain/barely able to lift arm to put her shirt on; This spontaneous report was received from a nurse referring to a 45-year-old female patient with asthma, eczema, haemorrhoids, decreased visual acuity, viral warts, night sweats, obsessive-compulsive disorder (OCD) and irregular menses. Historical drug included azithromycin (reported as "zythromycin"). The patient was allergic to azithromycin (reported as "zythromycin"). Concomitant therapies included acyclovir (ACICLOVIR), aripiprazole (ABILIFY), cetirizine hydrochloride (ZYRTEC), ascorbic acid (VIT C), clomipramine hydrochloride (ANAFRANIL), diazepam, lorazepam and propranolol.     On 11-MAY-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength and dose 0.5 milliliter, lot # T025367, expiration date 18-NOV-2022) route reported as injection for preventative (prophylaxis).    It was reported that the patient was still complaining of not being able to move her arm due to pain (onset date 11-MAY-2021). The patient was barely able to lift arm to put her shirt on. It sounded like the pain was still the same and had not decreased since receiving the vaccine (not recovered). Medical attention was sought. No additional adverse event (AE) or product quality complaint (PQC) was reported.   It also reported that the vaccination would not be discontinued. The causality assessment was not provided. 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: T025367; expirationdate: 18-NOV-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN, ASTHENIA, MOBILITY DECREASED, PERIPHERAL SWELLING, and PAIN IN EXTREMITY in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939905, 045A21A and 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Knee operation (on her right leg) on 01-Aug-2021. Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included HUMIRA from 13-May-2021 to an unknown date for Rheumatoid arthritis.  On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced OROPHARYNGEAL PAIN and PAIN IN EXTREMITY. On 08-Nov-2021, the patient experienced VACCINATION SITE PAIN. On an unknown date, the patient experienced ASTHENIA, MOBILITY DECREASED, PERIPHERAL SWELLING and FATIGUE. At the time of the report, OROPHARYNGEAL PAIN, PERIPHERAL SWELLING, PAIN IN EXTREMITY, FATIGUE, and VACCINATION SITE PAIN outcome was unknown, ASTHENIA was resolving and MOBILITY DECREASED had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Humira was paused between 24-Jun-2021 and 23-Sep-2021 and had a dose of on 28-Oct-2021. No treatment information was provided. She had knee surgery on her right leg and went to therapy for her right knee on Tuesday & Thursday of last week from the reporting day. She had taken oxycodone & Tylenol over the last 2 days every 6 hours that was left over from her knee surgery.   This case was linked to MOD-2021-382082, MOD-2021-382083 (Patient Link).
mom concerned stated pt broke out in a rash from neck, chest, back, arms, stomach, legs;states skin feels warm, pt act nl;instructed to give APAP & see pvt MD;later to clinic noted fine raised rash on legs chest & arms red in color;to MD
Note Patient came into Covid/Influenza Vaccine clinic today for both the Covid booster and Influenza vaccine. Patient reported that at times she has syncopal episodes with shot administrations, but not every time. Patient was okay with receiving both vaccines today 10/6/21 around 1215. Upon giving the influenza vaccine patient became lightheaded and diaphoretic. Laid on ground by self during that episode. At that time paramedic on scene came to help watch and assist with patient. Patient reported feeling better within a minute or two and sat back up in chair and still wanted to receive the Covid booster. The paramedic and this RN, still felt safe to proceed with Covid booster. While going through screening questions patient became lightheaded and diaphoretic again and laid back down on the floor. Felt better again momentarily and sat back in the chair. At this time Paramedic and RN were going to move patient to observation area and recliner to receive Covid booster there, and at that time patient had syncopal episode in chair and the Paramedic and RN laid patient on ground, and it took a 30 seconds to a minute before patient woke back up. Vital signs were taken and were stable. After waiting a few minutes moved patient back to observation area around 1225, and with permission from the paramedic, patient, and leadership this RN proceeded to give patient their Covid booster, patient stayed for observation until 1240 and was okay to leave per paramedic.   Electronically signed by: R.N.  10/06/21 12:41 PM CDT
PT RECEIVED COVID-19 (PFIZER) BOOSTER DOSE TOO EARLY AS PER RECOMMENDATIONS. RECOMMENDS THOSE 12+ AND AT LEAST 5 MONTHS FROM THE PRIMARY SERIES ARE ELIGIBLE FOR THE COVID-19 VACCINE BOOSTER DOSE. COMPLAINED OF HEADACHE APPRX 10 MINUTES AFTER 15 MINUTE OBSERVATION WAS COMPLETED.  PT WAS IN SCHOOL AND SCHOOL NURSE WAS CONTACTED, PARENT WAS CONTACTED AND PATIENT WENT WITH SCHOOL NURSE AND WAS SENT HOME WITH PARENT WITHIN 1 HOUR OF ONSET OF SYMPTOMS.   WE PLAN TO DECREASE THE RISK OF INCIDENCE THROUGH ADDITIONAL INSERVICE OF CLINICAL AND STAFF ON THE APPROPRIATE DOCUMENTATION AND VERIFICATION OF ELIGIBILITY OF THE RECOMMENDED VACCINE BOOSTER TIMEFRAME. CHECKLISTS DEVELOPED FOR MOBILE VACCINATION CLINICS WITH THE RECOMMENDED TIMEFRAME LISTED.
28 hours after vaxinations, a severe cough ensued. The cough was productive but only after at least 3-gut-based-extreme coughs each time. the cough was usually productive only on 3rd or 4th cough ans the phlem was dense and light beige in color. My temperature elevated to 101 to 102 on a consistent basis. The cough continued, initiated by what I'd descrobe as alightening bolt across the upper chest then 3 or 4 deep gut coughs to expel the phlem. This continued for 4 days, and the body temp briefly rose to 107.1 beofre measures were taken to reduce. My wife insisted I then visit and Emergency Room. Chest x-ray was clear and daiphram intact. no identifiable symptoms. The business where these were administered was a local grocery chain. The vaccination card had no information on FLU identifiers.  I am so very angry that the CDC recommendation was it was acceptable to have both of these vaccinations concurrently injected. It is obviously quite negative in my bodie's response, with long-lasting symptoms with sevete pain and duration including a very high fever. Today as I write this 13 days later I still have a productive cough about 10 to 12 times a day. The resulting phlem is still light beige in color. I am not a smoker for 40 years now. My guts still ache from very frequent coughing that by body was using to try and rid itself of what seemed to be an overall coating of this phlem throughout my entire lungs.  It saddens me to think other people could be forced to endure these symptoms. I think you should seriously re-consider ok'in, recommending, or allowing for any 2 vaccinations on the same day.
Hour after vaccination: muscle and joint pain bilateral arms (still ongoing next morning but feels better after ibuprofen),  right side face felt weird (numb/weakness) spouse said it looked a little swollen (face felt better next morning after benadryl)
On August I started getting what I thought were my allergies acting up but it turned out to be a sinus infection. I ended with a severe cough. Very very bad cough. In the daytime I would feel like I was getting better and I would not cough as frequently. But at night I would cough terribly. I tried some over the counter medications. They did not work very well. I finally called the doctor. Because of Covid we did a telehealth visit and he prescribed me an antibiotic. It worked and I have recovered.
Injection site red and swollen; developed cellulitis vs aseptic abscess; antibiotic was prescribed to pt for 2 courses.
This case was reported by a lawyer and described the occurrence of Bell's palsy in a male subject of unspecified age who was vaccinated with Lyme disease vaccine recombinant Lymerix for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix. At an unspecified time after vaccination with Lymerix, bell's palsy, arthralgia, myalgia, dizziness, numbness, fatigue, facial pain, foot pain, rheumatological symptoms, neurological impairment, cognitive impairment, autoimmune disease, decreased activity level and decreased ability to perform daily activities. This case was assessed as medically serious by manufacture (OMIC). At the time of reporting the outcome of the events was unspecified. This information was received via a statement of injuries.
sitting on a chair p/vax became limp, eyes rolled back, became & limp, head hit on back of chair; BP 100/60, P 70, 20R;
PT FELT FLUSHED AND TINGLY FOLLOWING ADMIN OF 1ST DOSE OF ENGERIX-B
Rash developed on thighs that evening, previous rxn same at 4months vaccines.
Menveo  mixed with other diluent; Vx given mixed with other diluent; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Menveo  mixed with other diluent) and inappropriate dose of vaccine administered (Verbatim: Vx given mixed with other diluent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 17-MAR-2023 As per description in the case, it was stated that the clinic used an unapproved diluent when mixing with the powder portion of Menveo and administering to a patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Headache after I drink a small amount of alcohol. I drink 6 ounces of wine at night and wake up in middle of night with headache almost every time. This has never happened before and I never ever had headaches and I have been very healthy. I have to take 2 extra strength Tylenol and headache doesn?t always go away for Awhile.
Macular, papular rash starting on trunk and moving outwards. Pt seen by Infectious Disease Dept.
Approximately one week post vax, the pt experienced injection site puffiness and redness. The pt was treated with Benadryl. The reporting physician felt that injection site puffiness and redness were related to therapy with varicella virus vaccine live.
Developed redness/rash accompanied by severe itching on upper right arm around and below injections site- diminished as of 03/11/2021, but still evident
Fever 102 F; chills; body aches; joint pain; morbilliform rash on abdomen, chest and neck; generalized pruritus; This is a spontaneous report from a non-contactable female consumer (patient). A 49-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: ER8737, Expiration date: Not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 05Apr2021 at 10:00 (at the age of 49-years-old) as a DOSE 2, SINGLE for covid-19 immunisation. The patient medical history included arthritis. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EN6204), dose 1 via an unspecified route of administration, administered in Arm Left 15Mar2021 at 10:00 AM, (at the age of 49-years-old) as a DOSE 1, SINGLE for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination were none. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 06Apr2021 14:00, The patient experienced fever 102 f, chills, body aches, joint pain, morbilliform rash on abdomen, chest and neck, generalized pruritus. The patient had Fever 102 F lasted from 2 am to 7 pm and would not subside with ibuprofen or acetaminophen, chills, body aches, joint pain (specially ankles), morbilliform rash on abdomen, chest and neck, generalized pruritus. All symptoms subsided at day 3 post vaccination. The patient underwent lab tests and procedures which included body temperature that was 102 Fahrenheit on 06Apr2021. The report was Non-serious. Device Date was reported as 22May2021. No treatment was received for the event. Outcome of the events were recovered.  No follow up attempts are possible. No further information is expected. Since non contactable reporter.
Experienced warmth feeling on her 13 minutes after receiving the COVID-19 vaccine. Symptoms resolved immediately.
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 21-MAY-2012, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about "26-JUN-2015," the patient was treated by a dermatologist for a  painful and blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. On or about "16-JUN-2015," the patient "was treated again" by a physician for continued and worsening symptoms that were diagnosed as post-herpetic neuralgia, a chronic condition of nerve pain and damage secondary to shingles. On or about "23-JUN-2015," the patient "was treated again" by pain management specialist for treatment of worsening post-herpetic neuralgia. The patient was prescribed gabapentin (NEURONTIN), and acyclovir, tramadol, acetaminophen, and gabapentin (manufacturers unknown). As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Shingles-like skin irritation (itchy burn) on bicep and forearm of arm that received the injection.  Note: I have had both the Zoster (2013) and the 2-shot Shingrix (2017?) Vaccines.
Information has been received from consumer concerning his 20 week old son with supraventricular tachycardia and no known allergies who on 22-MAY-2007 and 26-JUL-2007 was vaccinated with a first and second dose of Rotateq, respectively. The consumer reported that his son had an abnormal echocardiogram on 07-AUG-2007 after the second dose of Rotateq. The patient had no symptoms. The patient has been treated by a pediatric cardiologist since he was born because of a high neonatal heart rate. The patient has had two echocardiograms within normal parameters prior to the 09-AUG-2007 abnormal echocardiogram. The cardiologist will repeat the echocardiogram in one month. There was no product quality complaint. Additional information has been requested.
Severe pain in left thigh groin & knee area.  Went to ER, confirmed blood clot.  Sent home w/blood thinners - Xarelto
Second shot hurt afterwards a little bit more; nagging pain/ hurt a little bit more; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Second shot hurt afterwards a little bit more) and PAIN (nagging pain/ hurt a little bit more) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 029L20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE, ATORVASTATIN CALCIUM (LIPITOR), OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), METOPROLOL and VITAMINS NOS for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Second shot hurt afterwards a little bit more) and PAIN (nagging pain/ hurt a little bit more). At the time of the report, PAIN IN EXTREMITY (Second shot hurt afterwards a little bit more) and PAIN (nagging pain/ hurt a little bit more) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was unknown Concomitant products included Ellipta   This case was linked to MOD-2021-320166, MOD-2021-320262.
According to pt, Dr diagnosed cellulitis at site of injection. Extreme swelling, pain, redness, and warmth at injection site. Pt is given BENADRYL, triamcinolone cream and Bactrim DS.
patient has stuffy nose; scratchy throat; not able to go to school; runny nose; This is a spontaneous report from a contactable consumer. A 15-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 21May2021 15:00 (Batch/Lot Number: EW0191) as 1st dose, single dose for covid-19 immunisation. Patient's relevant medical history included none. The patient's concomitant medications were not reported. The patient experienced stuffy nose, scratchy throat, not able to go to school and runny nose on 24May2021 06:00. Patient was asking she was expecting that Pfizer can give recommendations if her son needs to have COVID testing due to his symptoms after receiving the vaccine. The Caller was calling about the Pfizer Covid-19 Vaccine. Her son got his vaccine on Friday, he was 15 and the next day he experienced nothing. He did not feel anything but he was having a stuffy nose and then he had some scratchy throat. Caller wants to know if a stuffy nose and scratchy throat are a side effect or if she should get her son checked for Covid. Caller adds that really all side effects will happen in 24 hours, but this is more than 24 hours, it is like, 48 or 50 hours later. Caller wants to know if the stuffy nose and scratchy throat are side effects. The caller clarifies that she means will he test positive for Covid -19 after getting the vaccine. The caller states she did not want to provide name or date of birth information and Pfizer can call her instead if they want. Stuffy maybe a little bit runny nose, scratchy throat, both of these occurred today morning around 6 o'clock. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment was received. The outcome for the event not able to go to school was unknown while rest of all was not recovered.   Follow-up attempts are needed; Additional information has been requested.
Day 2 after the 1st dosage of the Covid 19 vaccine (Moderna) I noticed that I had a slight cough. I was not feeling ill. Other than the tiredness. The cough would come and go. It was in no sense persistent. Day 3 after the vaccine, my cough returned in morning, around 10:00AM. I was no longer feeling any of the described side effects but this cough was now noticeable. It went away in the afternoon, around 2:00pm. It returned at night, briefly before bed time at around 11:00pm. Day 4 the cough was all day. On and off. If I got excited and if I moved around too much it felt like an asthma cough. I would then feel uncomfortable in my breathing. It persisted all day. At night I could not lay down to sleep. I needed to be propped up. I needed to use my Alvesco inhaler. Day 5, In the morning the cough was not immediate, I used an air purifier the entire night and day. Used the Inhaler again. My breathing felt unconformable but it was not as bad as day 4. Day 6, the cough was gone. Only when going up stairs or moving around too much did it come back for a few mins then would go away. Inhaler used again at night. No air purifier. Am able to sleep laying down again. Day 7 I am feeling better now and no longer have discomfort breathing. No longer need inhaler.
Patient states her arm initially broke out in hives and the spread to her legs. She noticed this on the morning after the vaccination. She called the pharmacy at 1:30pm to report the reaction, stating the hives were already fading from this morning. I suggested she take a dose of benadryl and reach out to her primary care provider. She reported not other issues.
Body aches and chills (without fever), mild cough (that was not present prior to vaccine), headache
Approximately 10 minutes after vaccine administration patient reported to staff feeling dizzy. Patient had episode of vertigo, diaphoretic and flushed. Patient laid down supine on floor, ice packs applied, knees up. Patient family aware. Patient hypertensive and tachycardic. Patient became unresponsive and EMS called. Symptoms persisted without worsening.
tired; his arm swollen at vaccine site, couldn't lift as high; This is a spontaneous report from a contactable consumer (patient's mother). A 45-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had the Pfizer second dose, got tired, his arm swollen at vaccine site, couldn't lift as high, was gone by the second day. The outcome of the events were resolved on unspecified date.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Itchy body rash, hoarse voice, vomiting, swollen tongue, hives, dizziness; Treatment was to take Benadryl, calling nurses station and visiting urgent care doctor. Body rash had partially subsided with Benadryl and doctor didn't prescribe any meds.
Pt recv vax on 3/16/99; 1 1/2 hr post vax pt exp unconsolable crying x 3-4 hr