chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse via a sales representative and described the occurrence of injection site pain in a subject of unspecified age and gender who was vaccinated with influreza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. On an unspecified date on or prior to 17, January 2007, the subject received unspecified dose of Fluarix (0.5 ml, unknown, right arm). On an unspecified date after vaccination with Fluarix, the subject experienced injection site pain, joint stiffness and unable to raise arm. At the time of reporting the outcome of the events was specified.
muscle pain; my arm stayed sore almost up to I got the second one; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77 year-old female patient received bnt162b2 (BNT162B2), administration date 09Mar2021 (Lot number: EN6208) at the age of 77 years as dose 1, 0.3 ml single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYALGIA (non-serious) with onset 10Mar2021, outcome "unknown", described as "muscle pain"; PAIN IN EXTREMITY (non-serious) with onset 10Mar2021, outcome "not recovered", described as "my arm stayed sore almost up to I got the second one". The events "muscle pain" and "my arm stayed sore almost up to I got the second one" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of myalgia, pain in extremity.  Additional Information: Patient stated that arm stayed sore for a really long time and patient got the second one, it was 10Mar2021 and patient arm stayed sore almost up to patient got the second one on the 29Mar2021 and patient have had muscle pain every-since then. patient went to see patient primary, in like patient muscle at the top of patient arm and patient cannot hold it right, patient arm and it was excruciating pain, it was like my muscle be coming apart like a real sever muscle pain in patient arm that patient got both the shots in and then patient told her primary about it in Apr2021, and patient says well do exercises of the arm. Patient have been doing exercises and patient got into an exercise program and it hurts so bad that patient had to go to the emergency room and tell them about never had this, muscle pain in her arm before and it came after patient had the Covid shot and patient would just like to report that patient do not know if anybody else has experienced this but patient have been having a lot of pain in that arm and patient was unable to actually use it as a regular arm because of the limitation of the pain when patient practically experienced it. It is really not sore. It just hurts with movements, and it cramps, and it just has pain going through if patient move it a certain way and it is in the muscle on the upside, where that injection at. No follow-up attempts are possible. No further information is expected.
Pt had a fever of 103.8 on 7-17-15 and a seizure in the early morning on 7-18-15. Full body rash.
patient has syncope episode s/p administration.  Patient has numbness of nose and  mouth beginning 2 days s/p vaccine  10/14/2008 Reviewed PCP office records of 9/29- FINAL DX: numbness of skin, vaccine adverse reaction Records reveal patient came into office w/numbness of nose & lips x 4 days starting 2 days s/p #2 HPV vaccine.  Stated that had immediate syncope s/p #1 HPV vaccine received 6/30/08.  Referred to neuro but no records available.
Rash on inner arms where the crease is, lasted the first couple days after the vaccinations and a rash on lower neck towards the chest, lasted almost two weeks. Took BENADRYL and used cortizone cream
Injection site red , is tender to touch, area swelling to 6-7 cm diameter. Pt given Keflex 250 mg.
swelling/of the injected arm/ 'considerable'/ arm swollen up to 20 inches; redness/of the injected arm; This case was reported by a nurse via call center representative and described the occurrence of extensive swelling of vaccinated limb in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb and erythema of extremities. On an unknown date, the outcome of the extensive swelling of vaccinated limb and erythema of extremities were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The case was reported by family nurse practitioner. The age at vaccination was not reported. The reporter did not have full demographic details to provide. The patient experienced redness and swelling of the injected arm the next day after the dose of Shingrix. The swelling was described as 'considerable' with the arm swollen up to 20 inches. The reporter did not have lot number or expiration date details of Shingrix. No resolution date was provided. The reporter consented to follow up via email.
I woke up at 2 am feeling sick. As soon as I got out of bed I passed out. It took about 10 minutes for me to become conscious again. I was shaking, hot and cold, slight fever and it sounded like I was underwater. Everything was spinning. I took Tylenol for body aches and keep the fever down. I was sweating a lot. I was better by noon that same day.
Body aching, fatigue, and mild stomach ache lasting about 24 hours. Low back pain lasting about 48 hours.
pARENT CALLED ON 10/10/2008 STATING PATIENT NOT EATING WELL AND SLEEPING ALOT. ON 10/11/2008 PATIENT HAD SEIZURE AND TAKEN TO HOSPITAL.  10/23/08-records received for DOS 10/11-10/17/08-presented with fever and seizure activity on 10/9/08, increased somnolence and decreased feeding and decreased urine output. Unable to perform LP. 1/27/2010 Patient under care of neurologist for seizures and hydrocephalus.
Almost about 1 week after getting second shot of covid-19 vaccine I started feeling weird on right side of my body. Swollen right side of my body specially facial area, which got worse over the period of time. Now main symptoms i am having are  tender facial muscles , hoarseness, loss of voice and blurry vision on right side. Symptoms got worse last week.
11 days following my first dose, I have developed a 2" by 3" rash on my left arm (at the site of the injection) that is red with a hard nodule present.  Increased skin temperature, erythema and site soreness along with tingling into my 4th and 5th digits.  General feeling of malaise as well.  No previous rash, redness or swelling.
Per the EUA, any adverse event or vaccine administration error is to be reported: Syringe hub broke during Pfizer Covid  vaccination of patient. Medication splashed out of broken hub. Attempted to conatct Pfizer and CDC and were on hold for 90 minutes without response.  ID doctor was consulted and was advised to give another dose of vaccine per CDC guidelines. Vaccine was administered
Pt experienced generalized, progressive urticaria and swelling to a severe degree of feet and hands.
49 year old female c/o nausea following vaccine administration. Brought to first aid area. V/S: Temp 97.2, HR 78, BP 138/87, Resp 16. No s/s of acute distress noted. Pt. denied SOB, difficulty swallowing, rash, or itching. Pt. kept in first aid for 25 minutes and then denied any further nausea or symptoms. Pt. left clinic with spouse and was advised to follow up with PCP or emergency medical services if further adverse reactions occur.
I had soreness started right after the vaccine. That lasted a few weeks. I was tired as well. I have joint pain. My hips, shoulder, knees I am having pain. I am having trouble sleeping as well. I still am having joint pain as of now.
Fussiness started 4/16/12. Projectile vomiting started 4/17/12  through 4/20/12. Low grade fever throughout 4/17/12 - 4/20/12. 99' ax -> 99.9 ax.
This spontaneous report as received from a Nurse regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 29-JAN-2018 the patient was vaccinated with improperly stored PROQUAD lot # N020620, expiration date: 23-AUG-2019, dose 1 for prophylaxis. Concomitant therapies included sterile diluent. The vaccine had temperature excursion of -14 degree C to -10 degree C for 10 hours 15 minutes. Previous temperature excursion of -14 degree C to -10 degree C for 127 Hours and 45 Minutes. The call was due to the digital data logger. No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA002332: Original Case: 1810USA001739; US-009507513-1810USA002333: Original Case: 1810USA001739; US-009507513-1810USA002335: Original Case: 1810USA001739; US-009507513-1810USA002336: Original Case: 1810USA001739; US-009507513-1810USA002337: Original Case: 1810USA001739; US-009507513-1810USA002338: Original Case: 1810USA001739; US-009507513-1810USA002331: Original Case: 1810USA001739; US-009507513-1810USA002330: Original Case: 1810USA001739; US-009507513-1810USA002329: Original Case: 1810USA001739; US-009507513-1810USA002334: Original Case: 1810USA001739.
the skin around my eyes was red and dry, forehead red and dry; the skin around my eyes was red and dry, forehead red and dry; face slightly red with raised red bumps on cheeks; face slightly red with raised red bumps on cheeks; my right arm it was itchy; This is a spontaneous report from a contactable consumer (patient). A 78-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot #: EN6502) via an unspecified route of administration on 22Mar2021 at 13:00 (at the age of 78-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included sinus, breast cancer, high cholesterol, GERD, asthma, ocular rosacea and dermatomyositis (diagnosed after an allergic reaction 10 years ago with yellow dye 5 while on a low dose Aspirin regimen), all from unspecified dates and unspecified if ongoing. The patient had known allergies to penicillin, brimonidine tartrate (LUMIFY), cefaclor (CECLOR), aspirin and yellow dye #5, all from unspecified dates and unspecified if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications (received within 2 weeks of vaccination) included pitavastatin calcium (LIVALO), mometasone furoate (ASMANEX), budesonide (NASOCORT), ascorbic acid/tocopheryl acetate/xantofyl/zeaxanthin/zinc (AREDS), montelukast sodium (SINGULAIR) and azelastine hydrochloride (AZELA), all taken for unspecified indications on unspecified dates. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot #: EN6198) via an unspecified route of administration on 01Mar2021 at 13:00 (at the age of 78-years-old) as a single dose in the right arm for COVID-19 immunization and experienced felt like when you get contrast dye with a CT. On 22Mar2021 at 20:00 the patient experienced the skin around my eyes was red and dry, forehead red and dry, face slightly red with raised red bumps on cheeks and my right arm it was itchy. The events were reported as non-serious. The clinical course was reported as follows: On the evening of the second shot, the skin around my eyes was red and dry, forehead red and dry and face slightly red with raised red bumps on cheeks. The patient took Benadryl (also reported that treatment was not received for the events). Under my right arm it was itchy for two days. The clinical outcomes of the events the skin around my eyes was red and dry, forehead red and dry and face slightly red with raised red bumps on cheeks were recovered/resolved on an unspecified date and my right arm it was itchy was recovered/resolved on 24Mar2021. Since the vaccination, the patient had not been tested for COVID-19.
"Rash" around injection site, headache, nausea, itching around site of injection and area hot to the touch. "Rash" -> erythema, induration, warmth.
redness & swelling over 5 inch square area of upper right arm, warm, no fever or itching.
This case was reported by a consumer and described the occurrence of fever in a 55-year-old male patient who received Flu vaccine. Co-suspect products included ADVAIR Diskus inhalation powder (batch number 3ZP4760, expiry date unknown) for chronic obstructive pulmonary disease. The patient's past medical history included pneumonia (born with pneumonia). Concurrent medical conditions included hypertension (has had it for 5-10 years) and anemia (since he was a little boy). Concomitant products included Albuterol, ipratropium and trazodone. In October 2014, the patient received Flu vaccine. In 2013, the patient started ADVAIR Diskus (inhaled) 1 puff(s) (see dose text). On an unknown date, the dose was changed to an unknown dose and frequency. In October 2014, an unknown time after receiving Flu vaccine and ADVAIR Diskus, the patient experienced breath sounds. On 29th October 2014, the patient experienced fever, bronchitis and difficulty breathing. ADVAIR Diskus was continued with no change. On an unknown date, the outcome of the fever, bronchitis, difficulty breathing and breath sounds were unknown. The reporter considered the fever, bronchitis, difficulty breathing and breath sounds to be unlikely related to Flu vaccine and ADVAIR Diskus. Additional information: the caller reports that her partner has taken ADVAIR Diskus for about a year and a half. She reports that he takes one puff twice a day of the ADVAIR Diskus. The caller reports that her partner received a flu shot last week on Wednesday or Tuesday of last week. She reports that he started to develop a fever on 29 October 2014. He also had bronchitis like symptoms since then. She reports that he has had difficulty breathing and has been making gurgling sounds since then. She reports that her partner usually gets bronchitis about this time every year. She also reports that they are going to the doctor right now to see what is wrong with him.
Gagging/wretching, hives, swollen face, dizzy, "throat closing up", loud dry heaves.
Dx:Pericarditis Combination of sharp and dull pain similar to episode in 04/2018 s/s: Dyspnea with lying down or orthopnea, palpitations, acute chest pain or pressure Alternative diagnosis ofr the patietn's s/s other than myocarditis are MI, PE. Alternatice etiology for cause for the patient's myocarditis: History of pericarditis in 04/2018 similar symptoms to this time.  Due to the past history, I feel this is not a pertinent case to include in our overall data, but if so we will need to review the hospitalization records from 05/20/2021.   06/11/2021:   Further review of records from ED visit 5/20, follow up and labs, I feel this patient should not be included due to past medical history of pericarditis.
Diagnosed with Frozen Shoulder. Symptoms include shoulder pain radiating down arm and decreased range of motion.
Immediate injection reaction of 10cm X 15cm area of heat and swelling to SC administration. No chest or pulmonary complaints. (Urticarial redness and swelling).
Intense Nausea and vomiting; Intense Nausea and vomiting; Dose 1 administration date 06May2021/dose 2 administration date 06May2021; This is a spontaneous report from a contactable consumer (patient). This 24-year-old male patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0158) via an unspecified route of administration on 06May2021 at 10:15 (as reported) and dose 2 of BNT162B2 (lot number EW0175) via an unspecified route of administration on 06May2021 at 10:30 (as reported) as single doses in the left arm for COVID-19 immunization. Medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included aripiprazole (ABILIFY) from an unknown date for an unknown indication. On 07May2021 at 04:30, the patient experienced intense nausea and vomiting, threw up several times in several hours, and trouble holding food down. The patient received treatment with left over ondansetron (ZOFRAN). The outcome of nausea and vomiting was recovered. The outcome of dose 1 and dose 2 on 06May2021 was unknown. It was also reported that since the vaccination the patient had not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.
4-20-07 - onset "bruising" dx: ITP. 4-25-08 - GUILLAIN-BARRE Syndrome - hosp 32 days.  4/1/09  MR received for 4 DOS- 11/27-29/07 with DX:  Thrombocytopenia, 12/3-9/07 with DX: ITP, 12/14-19/07 with dx ITP and 4/25-5/27/2008 with D/C DX:  Guillain-Barre Syndrome which is slightly improved. Pt initially presented  to PCP's office for c/o bruising on hands and buttocks and blood blisters in the mouth.  Platelet count found to be 7K and pt referred for admission. Reports recent dizziness and near syncope. Tx with platelet transfusions and steroids with platelet count 47K by d/c. Readmitted 12/3/07 for dropping platelet count (5K) with bruising and bleeding. Started on IVIG with count up to 128K by 12/8/07. D/C to f/u as outpt.  Pt returned 4/25/08 with c/o diffuse weakness, decreased grip strength. Reflexes were initially intact but lost in several days with progressive weakness. Tx with IVIG and steroids with little improvement, then plasmapheresis. Recovery was very slow and pt d/c to rehab 5/27/08.
within an hour after getting vaccine severe headache started. continued thoughtout rest of day. by evening my left eye swollen red couldn't see out of it, severe headache, severe body aches, chills, low grade fevers off and on extreme fatigue, unable to get out of bed without being dizzy and nausea
Headache, body ache, runny nose, tired. In bed for 2 days and out of sorts for another 2 days.
AFib; Jaw and tooth pain; Jaw and tooth pain; Rapid heartbeat/Rapid pulse; Extreme weakness; Irregular heartbeat; blood pressure was 142/80; A spontaneous report was received from a consumer concerning a 92-years-old, male patient who experienced AFib (atrial fibrillation), rapid heartbeat/rapid pulse, extreme weakness, irregular heartbeat, blood pressure was 142/80, jaw and tooth pain.   The patient's medical history was not provided.  Products known to have been used by the patient, within two weeks prior to the event, included levothyroxine sodium, metoprolol tartrate, pravastatin, fexofenadine, vitamin D, acetylsalicylic acid, fluticasone propionate and latanoprost.   On 04 Feb 2021, approximately prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 [Lot number 004M20A] intramuscularly in the for prophylaxis of COVID-19 infection.   On 04 Feb 2021, the patient woke up that night with jaw and tooth pain. He later experienced rapid heartbeat, extreme weakness, irregular heartbeat, rapid pulse and AFib (atrial fibrillation) which was confirmed by his primary care physician (PCP) on 06 Feb 2021. On 08 Feb 2021, patient repoted his blood pressure was 142/80. Treatment for the event included metoprolol IV.   Action taken with mRNA-1273 in response to the events was not provided.  The events rapid heartbeat/rapid pulse and extreme weakness were considered recovered/resolved or on 08 Feb 2021 and the outcome of the events AFib (atrial fibrillation), irregular heartbeat, blood pressure was 142/80, jaw and tooth pain were unknown.; Reporter's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested. Company assessed the events to be unlikely related to company product.
pt recv 3 doses of vax plus 1 booster & testing indicated the pt was antibody neg but antigen positive;
got the flu/ suspected vaccination failure; got the flu; never so sick in my life; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   On an unknown date, the patient received the 1st dose of Influenza vaccine Quadrivalent 2019-2020 season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza and sickness. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza and sickness were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, influenza and sickness to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were reported as follows: The patient's demographics were not reported. The patient never had the flu for 40 years. The patient got first flu shot this year and had flu. The patient stated that he/she was never so sick in life and still recuperating since 5 months. The patient stated that he/she would never get the flu shot again. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
rashes appearing on the left upper arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rashes appearing on the left upper arm) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced RASH (rashes appearing on the left upper arm). At the time of the report, RASH (rashes appearing on the left upper arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use included unspecified blood thinners. No treatment information was provided. Action taken with mRNA-1273 in response to the event was unknown