chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The reporter stated that unknown number of doses of PROQUAD (Merck) (dose and route of administration was unknown) that had been exposed to 18 degrees F for 14 hours were administered. Pertinent medical history and concomitant medications were unspecified by the reporter. No adverse effect reported. The outcome of the events was unkonwn. No other information was available. This is one of several reports received from the same source. Additional information has been requested.
Tremors in both hands and jaw; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Tremors in both hands and jaw) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 048A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient experienced TREMOR (Tremors in both hands and jaw). At the time of the report, TREMOR (Tremors in both hands and jaw) had not resolved.            No Concomitant medications were reported.  No Treatment information was reported.
Pt vaccinated with Pneumovax 23 developed a red, hot swollen arm w/lymphangitis & swollen glands. Treated with Ceftriazone sodium (Rocephin).
Notes: 3 day history of swelling of right hand, right arm after receiving flu vaccine. Reassuring clinical examination.  Of note, brother has a much more significant swelling of his arm and hand after vaccination.  Given history of emesis and severe swelling in brother, will give Rx for epipen today Pt has received flulaval in recent years without problems will give trial of benadryl. watch for worsening swelling, rash, worsening emesis or diarrha
I developed severe Bell's palsy affecting the left side of my face on 11/17/2021. I was seen in the emergency room at local Hospital on 11/18/2021, and was admitted under Observation status. An MRI of the brain, CT angiogram of the head and neck, and Echocardiogram were all normal. I was diagnosed with Bell's palsy, and was treated with a course of prednisone, Valtrex (although there were no signs of Herpes zoster) and doxycycline (just in case I had Lyme disease--however, there were no obvious signs of Lyme disease, and my Lyme antibody test was negative in the emergency room). I still have significant weakness on the left side of my face. There has been some improvement around my mouth region, but no improvement in the muscles involved in closing my left eye or wrinkling my forehead.
Started with sore arm during the night and in the morning body felt achy but no fever or chills. Intestinal discomfort began at 1:00 PM 1/31/21. Diahrrea has not started but intestinal pain is similar.
Menorrhagia beginning one month after second dose of Moderna vaccine.   Heavy/large menstrual clots.  Period lasted 6-7 days for the third month in a row.  Period soak a super + tampon and leak through a pad 4-5 times per hour.
directly following the shot a bump and sharp muscular pain was at the injection site preventing full movement of my left arm, with every movement sending a sharp pain through upper left arm/left shoulder. Two days after the shot a fever and pounding headache developed that lasted for hours but subsided with the use of Tylenol, the medics attributed this fever and headache to the anthrax shot as I did not have any other symptoms that would have explained the fever and headache.
Patient stated she felt her tongue was feeling numb and also her arm.she also stated she felt sightly dizzness,noticed her lips were blue upon arrival. 12:15pm;upon arrival patient was taking her own po benadryl 50ml .assisted patient to back via wheelchair .checked bp.sats,o2 sats and respirations. During those moment,snack was provided,assessment done every 10 mins,Patient denies any sob or wheezing at the moment.vs Patient stated she was having a headache but didn't want to take anything for it. provided some gatorade to drink and noticed the color of the skin return back to normal. 1:05pm ; pt stated she felt better after eating the snack and drinking gatorade ,assisted her to walk around to make sure she felt comfortable which she did but complain of since dizziness,still refused for EMS to be called,she sat for total of 35 mins . 1:10pm: pt was wheelchair to her car accompanied with husband and education was provided on calling 911 if symptoms is not improved and also to notify her pcp.
This spontaneous report was received from a medical assistant and refers to a 4 year old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 22-AUG-2017, the patient was vaccinated with improperly stored PROQUAD injection (lot # N010247 with expiration date on 25-SEP-2018, dose, anatomical location and route not reported) for prophylaxis, reconstituted with properly stored sterile diluent (manufacturer unknown). The administered vaccine experienced a temperature excursion of 6 degree Fahrenheit to 14 degree Fahrenheit for 18 hours. There was no previous temperature excursion and the call was not because of a data logger. No adverse effects were reported. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA000870: US-009507513-1709USA001401: US-009507513-1710USA009268: US-009507513-1710USA009269: US-009507513-1710USA009270:
every 4 months or 6 months the patient got; This case was reported by a consumer and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional case details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had the case every 4 months or 6 months.  This time the physician gave an oral medicine. No contact details were reported. The case had been linked with US2021AMR233779 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR233779:1st outbreak
Had a stroke the day after receiving the vaccine; This is a spontaneous report from a contactable consumer (patient's daughter/son). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported), via an unspecified route of administration, on an unspecified date, at dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, after the day of vaccination, the patient had a stroke. The outcome of the event was unknown.    The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Pt reported swelling of lymph nodes and pain in collar bone area said she had same reaction last year she received AFLURIA both times.
Patient received vaccination in Administration Clinic. Post vaccination patient complained of feeling very warm with  throat fullness. No other symptoms reported. Patient positioned self by window and felt need to remove mask. Proceed out called. ED team responded and patient evaluated by MD Patient remained in clinic under observation until symptoms resolved.
3/5: Had hematoma on the tongue, inside mouth, gums and over the body 3/6 am: platelets was 3, diagnosed as ITP, given steroids + platelets transfusion, platelets to 33 right after 3/7: platelets dropped to 8 in the morning, and then started steroids and 2nd platelets transfusion and IVIG, checked after, platelets 54, but random glucose 285, given 3 units insulin 3/8: platelets remained at 54, given steroids and 2nd IVIG 3/9 am checked platelets at 84, discharged
Itching in belly and above my chest; Slight rash like on my stomach and over my chest; This is a spontaneous report from a contactable consumer (patient) or other non HCP.   A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 24Mar2021 at 17:00 as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were not provided. on 25Mar2021, patient experienced slight rash like on my stomach and over my chest, itching in belly and above my chest. patient had little bit itching in belly and above his chest that was about a day or two and that was minimal. The outcome of the event slight rash like on his stomach and over my chest was reported as unknown and outcome of events itching in belly and above my chest was recovered on an unspecified date.  No follow-up attempts are needed. Information out batch/lot number cannot be obtained.
This spontaneous report as received from a health worker concerning an unknown number of patients, of an unknown gender and age. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with a dose of ROTATEQ (dose, strength, lot number, expiration date and route were not reported). The healthcare worker reported that an improperly stored ROTATEQ, "may" have been administered. The reporter stated that the ROTATEQ, were exposed to a temperature as low as 26F for a total of 238 hours over multiple excursions which started on 06-MAY-2014. No adverse effect reported. These case is one (1) of four (4) reports from the same reporter (MARRS 1405USA009827, 1405USA013153, 1405USA013154, 1405USA013155). Additional information has been requested.
This spontaneous report as received from a medical assistant refers to a 2 month old patient of unknown gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On 26-SEP-2016, the patient was vaccinated with VAQTA, strength 25/0.5 (unit unknown), (dose 0.5 ml, once, lot # M015290 and expiry date 20-SEP-2017) via intramuscular route. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Atrial Fibrillation acted up; Hot in my injection site arm; Itching in my injection site arm; Hives in my injection site arm; Swelling in my injection site arm; Pain in my injection site arm; Red in my injection site arm; A spontaneous report was received from a consumer concerning herself, an 84-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced atrial fibrillation acted up/atrial fibrillation, hives/urticaria, pain/injection site pain, red/injection site erythema, itching/injection site pruritus, swelling/injection site swelling, hot sensation/injection site warmth.   The patient's medical history was not reported. Relevant concomitant medications were included losartan, furosemide, warfarin, thyroid, diltiazem, carvedilol, lorazepam.  On 05 Feb 2021, the patient received the first of two planned doses of mRNA-1273 (Lot number: 031L20A) intramuscularly for prophylaxis of COVID-19 infection and patient had no reactions to that vaccination.  On 05 Mar 2021, prior to the onset of event, the patient received the second of two planned doses of mRNA-1273 (Batch number: 048A21A) intramuscularly in the left arm deltoid for prophylaxis of COVID-19 infection.   On 10 Mar 2021, the patient experienced atrial fibrillation acted up which was considered medically significant and hives, pain, red, itching, swelling and hot sensation in the injection site. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of the events atrial fibrillation acted up, hives, pain, red, itching, swelling and hot sensation in the injection site were unknown, at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Three months after the COVID-19 vaccine had a dizzy spell. Went to the emergency room and after testing they found that my sodium levels were low and I was probably dehydrated. About 6 weeks later had another similar dizzy spell and went to the emergency room again, testing showed that I had Anemia as well as low sodium levels. Had an Endoscopy test and testing showed that I had internal bleeding, probably due to taking blood thinners. Also started having Afib, doctor put in a Left Atrial Appendage Closure in an outpatient clinic. Still has Afib.
This case was reported by a healthcare professional and described the occurrence of headache in a 59-year-old female subject who was vaccinated with Engerix B for prophylaxis. Concurrent vaccination included tetanus toxoid vaccine and yellow fever vaccine both given on 31 August 2007. Concurrent medications included Nexium. On 31 August 2007 the subject received 1st dose of Engerix B at 20 mcg. On 2 September 2007, 2 days after vaccination with Engerix B, the subject experienced headache which resolved after a few days. On 15 September 2007, the subject developed swollen glands and lower energy level. She was seen by her physician and told that her liver was swollen. At the time of reporting, swollen glands, low energy level and the swollen liver were unresolved. Causality was not reported.
SYMPTOMS  swollen and noticeably raised bump over injection site itchy red rash radiating around injection site (wasn't raised or bumpy though)  TIME AND COURSE swelling appeared within 12 hours; lasted about 3 days rash appeared within 36 hours; lasted about 5 days  TREATMENT ibuprofen 2x day for 4 days, starting day after injection  anti-itch cream 1x day for 2 days starting day 5 after injection (didn't help rash)
Facial numbness; extremely dizzy for 2 weeks; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left (Lot number: 30145BA) at the age of 41 years as dose 1, single for covid-19 immunization. Relevant medical history included: "anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "Back/ gastro issues" (unspecified if ongoing); "Known allergies: PCN" (unspecified if ongoing). Concomitant medication(s) included: EFFEXOR; BUSPAR; XANAX; VIT D [COLECALCIFEROL]; COLACE; SENNA+; PREVACID; PEPCID AC. Past drug history included: Iodine, reaction(s): "Allergies: iodine". The following information was reported: HYPOAESTHESIA (non-serious) with onset 27Sep2021, outcome "recovering", described as "Facial numbness"; DIZZINESS (non-serious) with onset 27Sep2021, outcome "recovering", described as "extremely dizzy for 2 weeks". The events "facial numbness" and "extremely dizzy for 2 weeks" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of hypoaesthesia, dizziness.  Additional information: Patient not had other vaccine in four weeks and no prior Covid vaccination. Patient had not Covid tested post vaccination. Patient provided information to HCP regarding the adverse event(s) after the fact. The reporting Nurse considered the Pfizer product did not have a casual effect to the adverse event.  Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with PEDVAXHIB (dose and route unknown) (lot# reported as J000358, exp date 21-OCT-2015). It was reported that the vaccine was improperly stored vaccine (start date unknown). The outcome and action taken not provided. Additional information has been requested.
I have been experienceing pressure, discomfort, tightness in the chest since the second vaccination.  I passed out with extreme vertigo and my vitals dropped right after the second shot, then went to the hospital, and I was sick for 5 days afterwards.  I have had ongoing issues with irregularly high blood pressure and heavy palpitations, feeling very dizzy, shaking, and periodic severe discomfort.
Pt recvd 1 dose of Engerix-B devel low grade temp, malaise, eyes hurt, felt tired 7 nauseated 24 hrs post inject;
product=COVID 19 Treatment, brand=Paxlovid/vaccine brand=Pfizer / BioNTech.; product=COVID 19 Treatment, brand=Paxlovid/vaccine brand=Pfizer / BioNTech.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 20Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 years for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "IBS" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02Jun2022 at 08:00, outcome "recovering" and all described as "product=COVID 19 Treatment, brand=Paxlovid/vaccine brand=Pfizer / BioNTech.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jun2022) Negative, notes: testing negative day 8; (02Jun2022) Positive, notes: Testing positive on day 9; (05Jun2022) Positive, notes: Now on day 12 and still testing positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Round red lesion around injection site, raised, hard to the touch; appeared on the morning after the second dose (none after first dose) and is not itchy or too painful. Sore. Taking Tylenol every few hours and no other body aches or rashes other some tiredness
employee reports LOC for approx. 10-15seconds witnessed by family member who states her eyes rolled back and she began to drool. she has a history of passing out when not feeling well or vaccine.  Eval in ED, treated with benadryl IV and fluids. D/c home.
chills; fever; sleep for 1 hour then wake up; tired; weak; feels like i have the flu; This is a spontaneous report from a non-contactable consumer (patient). A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number was not reported) via an unspecified route of administration, administered in left arm on 05Mar2021at 16:15 (age at vaccination was 54-year-old), as dose 1, single for COVID-19 immunization. The patient's medical history included high blood pressure. Concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks. Prior to vaccination, the patient has not been diagnosed with COVID-19 and post vaccination, the patient has not been tested for COVID-19. The facility type where COVID-19 vaccine was administered was reported as Pharmacy or Drug Store. On 05Mar2021 at 23:15 (7 hours after vaccine), the patient experienced chills, fever and he would sleep for 1 hour then wake up. On 05Mar2021, he experienced being tired, weak, and feels like he have the flu. It was reported that it was 4 days later and the patient still felt the same. No therapeutic measures were taken as a result of the events. Outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Extreme stabbing, at times crushing  bone pain that has lasted for over 2 1/2 weeks. Most prevalent in hands, feet, and elbows.
Spontaneous report received on 21MAY2015 from a physician. An approximately 30 year old female with a history of seasonal / environmental allergies and migraines received her 3rd dose of BioThrax (Lot FAV374) in approximately JAN2015. Of note, after dose 1 and 2, she experienced a migraine which the reporter attributed to her previous "sensitivity to migraines". After the third dose of BioThrax, she again experienced a migraine, and over the course of two days, she developed flu like symptoms, muscle aches, fatigue, nasal stuffiness and itchy eyes. The symptoms subsequently resolved.
Client reports 2 days after receiving first dose of vaccine c/o fatigue, nausea, headache, mild dizziness, and "cloudy head."  reports lasts off and on x19 days. Denies SOB, Chest pain, numbness or tingling, denies reduced mobility, denies rash. Client reports did not see a physician. Reports drinking water and eating helped symptoms. Client at  site today for second dose, reports all symptoms resolved, no symptoms today. Sent information to team., give 2nd dose today, observe for 30 min. Educated client to f/u with is symptoms last longer than 1 week.
Brain zaps/Electric shock feeling; Constant, intense headaches with light sensitivity.; light sensitivity; Muscle weakness and trembling.; Pressure in head.; Nausea; Full body tremors; Fully body chills and shuddering; extreme Fatigue.; Disassociation.; Heavy period a week early.; Tinnitus.; It impacts her ability to function normally.; This is a spontaneous report from a contactable consumer (patient). A 26-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 09Apr2021 11:00 (Batch/Lot Number: ER8734) as single dose for COVID-19 immunisation. Medical history included Anxiety, herniated disc. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included trazodone (TRAZODONE); fluoxetine hydrochloride (PROZAC) taken for an unspecified indication, start and stop date were not reported; birth control. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since 12Apr2021, the patient experienced events: Constant, intense headaches with light sensitivity. Muscle weakness and trembling. Brain zaps. Pressure in head. Nausea. Full body tremors. Fully body chills and shuddering, lasting over an hour at a time. Extreme fatigue. Disassociation. Heavy period a week early. Tinnitus. It's been 2 months and the patient still had muscle weakness and electric shock feelings in most of her body, particularly upper body. It impacts her ability to function normally. Tinnitus had worsened and was now constant. Adverse event result to Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient received treatment. Treatments for AE reported as Fluids, Cat of brain, bloodwork. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was not recovered.
On day 6 swelling and discomfort began in the area of ??the vaccine. Cold compress treatment. At day 7 the swelling continued. At day 8, the swelling radiated to the hands, reaching the thumb and forefinger. Treatment with acetaminophen and cold compresses. Gradual improvement. Days 9 and 10 swelling only in the area of ??the vaccine. Days 11 and 12 sporadic sensation of palpitations and involuntary movements in the area of ??the vaccine.
pt recv vax 17OCT96 & w/in 24 hr gen muscle ache,  fever up to 102;pt exp muscle pain & weakness & macular facial rash;adm to hosp secondary to poor swallowing & swallory eval-aspiration;
Beginning in day after receiving 2nd vaccine: Systemic inflammation, severe joint pain, abdominal pain, digestive/intestinal issues (ranging from constipation to diarhea and excessive gas), loud ringing in the ears (tinnitis)