chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physicians assistant concerning a 72 year old male with polycythaemia (stable in past 5 years), no allergies, and folliculitis of the face and neck. On 11/29/2005 the patient was hospitalized for a change in mental status and a seizure. It is part of the hospitals protocol to offer a patient the vaccine if they have not had one. The patient had never had one so that same day he was vaccinated intramuscularly with a first 0.5 ml dose of Pneumococcal 23v polysaccharide vaccine. Concomitant therapy included a dose of influenza virus vaccine unspecified given approximately 11/15/05, phenytoin Dilantin, clopidogrel bisulfate Plavix, aspirin and doxycycline for folliculitis. On 11/30/05 the patient developed swelling and redness at the injection site. He was discharged from the hospital. On 12/1/05 he was seen in the ER with increasing symptoms. On 12/5/05 he was seen in the office with cellulitis of the right arm, distal to the injection site to the fingers. A CBC with differential and Protime time were pending. Therapy with aspirin and clopidogrel bisulfate Plavix were discontinued. A Doppler study of the right arm was negative for a deep vein thrombosis. On 12/8/05 the patient was scheduled to be seen by a neurologist for his seizure. The reporter felt that the cellulitis was disabling because he had still not recovered and was unable to use the arm due to the pain and swelling. He was scheduled to be seen in the office for a follow up visit. Cellulitis of right arm was considered to be an other important medical event (OMIC). Additional information has been requested.
Migraine headache and then constant headaches daily since March 17th.  Some more severe than others but always there. Doctor visits, CT scan, blood work. Neurologist appointment next week.
This spontaneous report was received from the Vaccine Coordinator referring to a 15 month year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 14-DEC-2017, the patient was vaccinated with an improperly stored dose of VARIVAX with one of these lot #'s reported M017292, expiration date on 07-APR-2018; lot # N017701, expiration date on 09-JUN-2019 or with lot # N019127, expiration date on 22-JUN-2019 (Strength, route, dose, frequency, and anatomical location were unknown) for prophylaxis. There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 7.52 F degrees Fahrenheit for 24 hour, and had a previous temperature excursion of 5.5 F degrees Fahrenheit for 1 hour. There was a digital data logger involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA008693.
1 hour and a half after shot I started with fatigue and it lasted for 2 days. 2 hours after the shot my left breast started hurting, got very sensitive, and shape changed. This lasted for 8 days.
Information has been received from a pharmacist concerning an adult male who in 2003 was vaccinated with a dose of varicella virus vaccine live. The pharmacist reported that the patient did not have the second vaccination. A titer in approximately May 2004 was negative. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested/
Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. On 04-AUG-2016 a dose of improperly stored M-M-R II (lot# L032044, rHA, expiration date 24-AUG-2017) was given to the patient. No adverse effects reported. The temperature excursion was 48 degree Fahrenheit for 24 hours, data logger was used. There was no prior excursion. The temperature was back in range at the time of reporting. This is one of several reports received from the same source. Additional information is not expected as there is no consent to contact the physician.
Systemic: metallic taste in mouth -Mild, Systemic: Flushed / Sweating-Mild, Additional Details: patient states that she has metallic taste in her mouth post observation of 30 minutes -- patient states she still has it upon leaving
Similar to the "black box" warning for Levaquin which I have had with previous Levaquin dose: L arm tendon pain lasting 3 weeks with limited ROM; L knee tendon pain, lasting 4 weeks
Awoke early morning to  body aches, muscle pain and soreness at injection sight.  Ended up in bed for the entire day with complete fatigue, body aches, loss of appetite and muscle pain. Used acetaminophen on 4/2 at 10a, 4p and again at 10p. Awoke the next morning feeling better but had a terrible headache and some fatigue through the morning and early afternoon. Remained in bed for most of the morning and early afternoon. Appetite did not resume until early evening on 4/3. Again used Acetaminophen on 4/3 at 4a and 10a.
Information has been received from a registered nurse concerning a 46 month old male with no past medical history or illness at the time of vaccination and no known allergies who on 10/30/1997 was vaccinated with the first dose of varicella vaccine administered IM in the right thigh. It was reported that on 03/09/2001, the child experienced a "full-blown" case of chicken pox, according to the pt's mother. He was seen in the clinic. It was reported that on 03/15/2001, he recovered. Upon follow-up, it was reported, on 08/07/2001, that the correct lot number was not available. No further info is available.
Step mother reports patient awoke with right arm swollen and pruritic. Described the swelling on the arm was half the size of a baseball on posterior of arm. Area was warm to touch and very sensitive. Benadryl and Ibuprofen helping. Patient could not tolerate cool packs to area. Clothing also intolerable. The swelling has reduced but the inflammation is now encircling the arm and skin remains sensitive.
Tired after their booster dose; This spontaneous case was reported by a physician and describes the occurrence of FATIGUE (Tired after their booster dose) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 007M20A and 002B) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Tired after their booster dose). At the time of the report, FATIGUE (Tired after their booster dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment was reported by the reporter.   This case was linked to MOD-2021-406064 (Patient Link).
Reports she had hives on her neck and trunk 2 days after vaccine which has not completely resolved but is improving. She states it is "itchy". She has no history of hives. She denies any fever.
Tingle in tips in both finger and toes in both; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingle in tips in both finger and toes in both) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination.     Concurrent medical conditions included Heart disorder. Concomitant products included FLECAINIDE for Heart disorder, COLECALCIFEROL (VIT D3) for an unknown indication.    On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021, the patient experienced PARAESTHESIA (Tingle in tips in both finger and toes in both). On 20-Aug-2021, PARAESTHESIA (Tingle in tips in both finger and toes in both) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment information was provided.   This case was linked to MOD-2021-324280 (Patient Link).
legs felt  like weights stomach hurt headache for 3 days congested fever chills congestion  went into chest
Within 1 minute of receiving the shot, I had the equivalent of an adrenaline reaction (rapid heart rate, shaking). This resolved within 5 minutes of sitting. No SOB or lightheadedness. No treatment necessary. (Never occured with a vaccine before.)  The next morning, I had chest tightness over the left side of my chest that lasted for 3 days and resolved on its own.  Following this, I had PVCs (which I don't normally have) for about 4-5 days, worse with activity (exercise, walking the dog, etc) and eating.  This also resolved on its own.  I informed my PCP office (the NP), but did not need to come in or postpone the second dose.
felt like her arm was broken, still can't really use left arm; waves of pain like restless leg syndrome; it was given in the incorrect place on her arm; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (felt like her arm was broken, still can't really use left arm), VACCINATION SITE PAIN (waves of pain like restless leg syndrome) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (it was given in the incorrect place on her arm) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No medical history was reported.     On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced LIMB DISCOMFORT (felt like her arm was broken, still can't really use left arm), VACCINATION SITE PAIN (waves of pain like restless leg syndrome) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (it was given in the incorrect place on her arm). On 05-Apr-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (it was given in the incorrect place on her arm) had resolved. At the time of the report, LIMB DISCOMFORT (felt like her arm was broken, still can't really use left arm) and VACCINATION SITE PAIN (waves of pain like restless leg syndrome) outcome was unknown.            No concomitant medication history was reported.  The patient had an antibody test done and it was negative.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Treatment of the events included unspecified steroids.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
No additional AEs; Vaccines were administered IM (instead of SQ); This spontaneous report was received from a medical assistant and refers to a. patient of an unknown age and gender.  The patient's medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies were not reported.  On 16-AUG-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) at a dose of 0.5 ml, lot #U006596, expiration date: 01-MAR-2023, administered intramuscularly instead of subcutaneous (Incorrect route of product administration) as prophylaxis. The outcome of the event was not provided. It was mentioned that the vaccine was stored within recommended range of temperature and that no additional adverse event occurred.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2208USA008668: US-009507513-2208USA008503: US-009507513-2208USA008558: US-009507513-2208USA010122: US-009507513-2208USA008497:
This spontaneous report was received from a pharmacist and refers to a 35 years old female patient. The patient's concurrent conditions included allergy to penicillin and sulfa drugs. Concomitant therapies included fluoxetine hydrochloride (PROZAC), simvastatin (ZOCOR) and omeprazole (PRILOSEC). On 17-APR-2017, the patient was vaccinated with a dose of PNEUMOVAX23 (dose, lot # and expiration date were not reported) intramuscularly for asthma. In April 2017 after receiving the vaccine, the patient experienced pain going down the side to the ribs (musculoskeletal chest pain) and pain on the inside of the arm (pain in extremity). The patient received an unspecified treatment for the event. The patient sought medical attention by contacting her pharmacist but no laboratory diagnostic studies were performed. At the time of this report, the patient had not recovered from the event. The causality between the events and PNEUMOVAX23 was not provided. Additional information has been requested.
MODERNA COVID 19 Vaccine EUA Patient got the vaccine and was waiting the 15 minutes after during which he went to stand up and fainted. The pharmacy technician called the pharmacist immediately and when pharmacist arrived patient was alert and talking. He states that he always faints after he gets IVs placed or shots in his back. He states that this is normal and happens whenever he gets shots. EMT was called as a precaution because he hit his head as he fainted. Patient was okay and taken by the EMT to get evaluated.
High heart rates ranges from around 100 to over 150 bpm for around 5 days. Begins around 10 hours after second shot of Pfizer Covid-19 Vaccine. After that there is long-lasting low fever (around 37 to 38.5 degree celsius) for more than 2 weeks.
Pt noted briefly passing out for less than 15 seconds after final vaccine administration but cam to quickly.  Pt noted pale and requested water.  Pt baseline vitals all WNL.  BP taken after episode noted WNL @ 107/64.  Pt observation continued another 15 minutes and Pt regained color.  Pt denied HA, dizziness, nausea.  Pt stated feeling much better after observation and final BP taken also WNL @ 117/77.  Pt exited with parents, ambulating without difficulty.
12/20 COVID swab, result: detected 12/20 SARS-COV-2 Variant Sequencing: pending 12/19 pt cc: cough, headache, dyspnea, fever, myalgias, rhinorrhea, sore throat, wheezing exposure: unknown 12/12 FIBRINOGEN: 394 12/21 DDIMER: 1.44
Right deltoid erythema, swelling, induration 7in x 7in  diameter
REDNESS, SWELLING, WARM TO TOUCH. PAIN THAT RADIATES DOWN ARM
I had a rash that was all over her body that would flip to different parts of the body at various times on my legs, tops of hands, elbows, chest, stomach and buttocks. My arm was very red following the shot and very hot.  I had rashes before hand and took the shingles vaccine and the rashes became much worse nothing would clear it up. The vaccine I took was Shingrix. I was advised not to get second shingles shot by my doctor.  I had hives with both Moderna vaccines. The rashes were so bad I could not sleep the only thing that really helped was ice. The rash is still on my left leg currently. It is improving but still here.
COVID 19 VACCINE WAS GIVEN TO HIM ON 5/10/2021 AND WE FIGURED OUT HIS AGE WAS TOO YOUNG TO GET THE VACCINE AT THE MOMENT. WE CHECKED HIS STATUS NOW, HE IS OKAY.
In order of progression:   - numbness/tingling in hands  - double/blurry vision  - affected speech, loss of some tongue/pallet mobility  - partial paralysis of face  - headache  - loss of functioning in throat (unable to swallow)  - loss of bowel control  - loss of reflex (especially in upper body)  - not able to open eyes  - respiratory arrest
This spontaneous report was received from a vaccine professional and referred to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. From 01-FEB-2017 to 28-FEB-2017, those patients were vaccinated with improperly stored doses of VARIVAX lot # M037008, expiration date: 25-AUG-2018, for prophylaxis (dose, route of administration were not reported). The time frame for the improper storage amounted 120 hours in the temperature of 70 degrees Fahrenheit. No previous temperature excursion was reported. It was not a case of a data logger. No adverse effects were reported. The product quality complaint was not involved. Additional information has been requested.
ADVERSE EVENT: PATIENT STARTED FEELING LIGHT HEADED AND TINGLING SENSATION IN THE FEET, HE WAS FEELING DIZZY AND STARTED PASSING OUT. HE WAS NOT ABLE TO COMMUNICATE. TREATMENT: PATIENT WAS ASKED TO LEAN BACK, RELAX AND TAKE DEEP BREATHS, CALLED AMBULANCE IN THE MEAN TIME. SLOWLY HE STARTED FEELING BETTER BY THE TIME AMBULANCE WAS HERE. HIS BLOOD PRESSURE MEASURED 110/60. HE REFUSED TO GO TO HOSPITAL AND HE SAID HE WAS FEELING FINE AND BETTER. MOM TRIED TO CONTACT PCP AND INFORM.
16 weeks pregnant; due 4/28/22.  Approx 4 minutes after injection, felt as though throat was closing.  911 called and taken to Hospital for evaluation and treatment. Monitored only at hospital and fetal monitoring at hospital. Discharged home.
Papular rash Pruritic rash Redness From initial information received on 10/28/2003 from a health care professional regarding an adverse event occurring in the U.S.A., it was reported that a 64 year old female patient received a dose of FLUZONE SV '2003-'2004 USP,  lot number U1123AA, administered intra-muscularly in the left deltoid on 10/21/2003 at 12:15 PM. Within 2 hours of receiving the vaccination, the patient developed an itching rash. There was no swelling or breathing difficulty. The following day at 10:56 AM, the rash pruritic, scattered, raised and red. It was described as papular with a reddish border (about 20 papules in total). The affected areas were the upper body, arms, chest and back. There was no typical hives or urticaria. The patient was treated with benadryl and caladryl lotion for itching. The patient has had influenza shots in the past with no previous reactions. She has had similar rashes in the past, but only from oral medications including penicillin, sulfa and morphine and these were described as "blotches further apart - hives". Reportedly, the patient recovered from these events.
Pt recv vax on 11/16/98; on 11/17/98 pt exp LA soreness; tx=Tylenol/ Ibuprofen
Product use in unapproved indication; Product use in unapproved population; Literature Report:    Information has been received from the authors of a published literature article, titled as stated above, regarding a 58-year-old male post Left Ventricular Assist Device (LVAD) with hoarseness post implant related to intubation injury. He received a heart transplant in February 2022, with persisting hoarseness 3 months after surgery. A laryngoscopy was done which noted bulky papilloma with central vascularization on medial surface of bilateral arytenoids, left vocal fold, and vallecula. Ear Nose & Throat (ENT) recommended that the patient be given the HPV vaccine (manufacturer unknown) to prevent recurrence and regrowth (Product use in unapproved indication, Product use issue)  A copy of the published article is attached as further documentation of the patient's experience.
patient reported developing  body wide rash without itching - referred patient to physician for examination and consultation - currently listed patient as allergic to shingrx
Hives, itchy throat, wheezing, anaphylaxis symptoms. Given epi-pen at home, has other life threatening allergies, taken to ED by family after epi-pen administered.
I could get up to stand My Body Slammed me back down  I couldn't Talk, no one could understand me I had a Toilet full of Blood Not sure if any of this has to do with my Kidneys or the Booster
Patient came in day after having vaccine (11/08/2017) for consultation with the pharmacist about redness around and under the arm of the injection site. The patient went to the doctor on 11/09/2017 to have the swelling and redness checked out. The doctor recommended that he start an antibiotic if it did not get any better by the next day. The rash started to subside.
Patient was given 0.9mL of Pfizer Covid 19 vaccine- staff then discarded rest of the vial.   Wrong dose was not discovered until hours later.  Patient did fine during 15 minute wait time and was doing fine when called after event was discovered.   Reported no signs or symptoms relating to the covid vaccine.
This spontaneous report was received from a registered nurse via physician and medical assistant regarding a patient of unknown age and gender. The patient's medical history, current conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of ROTATEQ lot # M038724 with unknown expiry date, (strength, dose and route of administration were not reported) for prophylaxis. The vaccine was exposed to 31 Fahrenheit degree (F) or colder (25F) for 1 hour 53 minutes and 47 Fahrenheit degree (F) to 77 Fahrenheit degree (F) (49F) for 3 hours 59 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects reported. There was no product quality complaint (PQC) involved. This is one of the several reports received from same reporter. Sender's Comments: US-009507513-1708USA003308: US-009507513-1709USA011730: US-009507513-1709USA011731: US-009507513-1709USA011732: US-009507513-1709USA011734: US-009507513-1709USA011735: US-009507513-1709USA011736: US-009507513-1709USA011737: US-009507513-1708USA003070.
Suspected delayed vasovagal reaction. Patient was post 15 minute observation period. He had left vaccine clinic accompanied by family. Family went to get car while leaving patient in lobby of the clinic. Patient became light headed and dizzy and fell, did hit his head. He has a history of vasovagal reactions and reports this has happened to him before.
pt passed out after injection, placed on cot to lay down, v/s were monitored.
I had a lower back pain. It was hurting while I sat or when I was standing. I was having a hard time at work. The doctor had told me that she had the same side effects from the booster. I didn't go to work yesterday or today. I was given a muscle relaxer Cyclobenzaprine once a night and a prescription strength ibuprofen. I apply ice and heat. It has improved from yesterday but not 100 percent.
Patient was 21 yrs old at time of vaccination.  After administration of the vaccine he became lightheaded and nauseated shortly after. He had one episode of vomiting. Vitals stable. Applied cold compress. Pt started feeling better after resting for awhile. His mother works at  came to check on him. He was then released with a friend. Pt refused to be taken out in a wheelchair
Pain injection site since day of vaccination, still have pain.  Slight fever and chills, body aches, fatigue for 12 hours.
Pt reports that about 10 minutes after her vaccine she started to have increase heart rate and chills. Pt reported to observation personnel, who then called this RN. Pts vitals after being brought to the cart: BP:158/88 SPO2: 100% HR:113 Water was given to pt.   1040-Pt now stating she is feeling better.   2nd set of vitals: BP:130/76 Spo2:100 HR:74   Last set of vitals  BP: 123/74 Spo2: 100 HR: 68     Pt states she is feeling better and OK to go home. Reminded to keep up with fluids.