chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received from a nurse on 03 Feb 2011: This patient was vaccinated with MENVEO (batch number M10030) on an unspecified date. Little less than 0.5 mL (not 0.2 mL) of MENVEO vaccine was obtained from the vial after reconstitution. The exact amount was not reported. No other information reported.
Patient informed RN prior to giving seasonal influenza vaccine that he passes out whenever he sees a needle.  Patient was given the seasonal influenza vaccine on 10/8/09, and stated approximately 5 minutes later that he felt dizzy.  Patient was pale, diaphoretic, and had jerking movements in his extremities.  BP 112/64, P56, R16, CBS 97 (after instant glucose po). IV sodium chloride 0.9% at 300 ml/hr was started and patient was sent to an acute care facility for evaluation of possible vasovagal reaction, hypoglycemia, and rule-out seizure.
Her dad had also caught the virus and it may have been where she got the virus from; Her dad had also caught the virus and it may have been where she got the virus from; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Her dad had also caught the virus and it may have been where she got the virus from".  It was reported that the reporter was talking to someone yesterday and they said they felt like "everyone in the world has Covid". Specifically, they mentioned an adolescent girl (Initial "withheld", approximately 16 years old, female, withheld) who had caught coronavirus recently (end of Dec/Jan) that they know, even though her twin had not. Her dad had also caught the virus and it may have been where she got the virus from. There is a strong chance "withheld" is vaccinated, and unknown regarding the dad. Unsure which vaccine and when received and what dosage.  The lot number for bnt162b2 was not provided and will be requested during follow up ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200004461 same reporter/drug/AE, different patient
get sick every time; Initial information received on 20-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional via social media.  This case involves patient (unknown demographics) who get sick every time (illness) while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got sick (malaise)unknown latency following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown.  There will be no information available on the batch number for this case.
Expired dose administered to patient; patient first 2 dose were of pfizer and 3rd dose of moderna; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient first 2 dose were of pfizer and 3rd dose of moderna) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (1sd dose and 2nd dose). Past adverse reactions to the above products included No adverse reaction with Pfizer.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient first 2 dose were of pfizer and 3rd dose of moderna). On 02-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient first 2 dose were of pfizer and 3rd dose of moderna) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: Follow up document contains no new information.
started approx 12:30 am 7/7/2021, low grade fever ~99°F, accompanied with mild malaise, fatigue, sensitivity around injection site. tylenol taken approx 2 hours after vaccination.  advil pm taken around bed time (3am 7/7/2021)   symptoms continued throughout the day with increased tenderness and soreness in arm that received injection. OTC pain medication taken in morning 11:30am. once more at 3pm.  spiked fever began around 10pm cst (22:00, 7/7/2021) of ~101.7°F, moderate to severe muscle aches, general overall feeling of ?unwell?, lethargic.  ~11:30pm pain in left arm began to spread down towards elbow, painful to move or flex muscles in arm out of normal range, stinging sensation.   ~1am 7/8/2021, noticed a rash approx 1.5inches-2.5inches from injection site on arm. arm is hot to touch, rash is inconsistent in size/shape & pattern, slightly raised, swollen, red & splotchy. mimicking the appearance of possible hives. advil pm taken 2am 7/8/2021, along with 25mg benadryl to help soothe rash.
Left Arm upper by deltoid with 3 x 2 1/2 inch red swollen area.
I am 64 years old.  I went through menopause at age 52.  I began getting a period after 12 years.
Pt was given vaccine, walked to the front of the store and got lightheaded. Took BP which had dropped to 80/36. Pt layed down and sipped on soda waited 5 minutes. BP increased to 100/70 pt felt better and left to go to work f/u later that day and felt ok.
Vaccine stored in freezer temperature for too long. We recommended to the patient to get revaccinated.
pt recvd MMR vax & exp numbness from elbow to wrist w/tingling & tightness of inner aspect of lower arm;
Severe debilitating pain in shoulder. Nausea, headache, body aches.
Chills, Body aches, Lightheadedness, Headache, Fatigue, Back pain, Injection site pain; Treated with rest; 24 hours of symptoms
pt's arm became very swollen (not just @ the site of inject); was hot to touch; pt exp a tickling & tightness in throat; temp noc 20OCT-21OCT;
Vaccine administered today 11/22/2017 had expiration date of 10/22/2017. County Health Department was contacted for further instructions. Per Health Department and as previously planned, patient is to have blood work/titer done in one month to check for immunity of mumps. Patient had blood work on 11/17/2017 to check for immunity. Titers indicated had immunity to rubella, rubeola, and varicella but not mumps. Telephone call to patient and made aware the vaccine administered had expired on 10/22/2017, advised that blood work would be ordered for one month to check her status of immunity to mumps. Patient agreed would have blood work done in one month.
Information has been received from a physician and a registered nurse concerning an 18 year old female patient with shoulder injury who on 02-SEP-2008 was vaccinated with the first dose of GARDASIL (lot # 661530/0575X) and on 14-OCT-2009 received the second dose of GARDASIL (663452/0671Y). There was no concomitant therapy. On 15-OCT-2009, the next day after vaccination, the patient complained of headache, fever and general fatigue. The fever went away after about a day. The headache persisted. It was reported that there was stomach discomfort as well. On an unspecified date, the patient ended up being treated at urgent care with IV fluids for dehydration and IV TORADOL for headache. The physician stated that the patient has been out of school for this entire time and unable to drive because of dizziness and light sensitivity to the eyes. On 27-OCT-2009, the patient called to the office because she thought that she was sick with flu like symptoms. The physician also stated that the patient was debilitated and that she was sleeping 8 to 10 hours a day. It was also reported that the patient could not drive or do anymore of her normal activities. This had been ongoing for 2 weeks as of 28-OCT-2009. No laboratory or diagnostic tests were performed. At the time of reporting the patient was on around the clock pain relievers. Upon internal review the patient's experiences were considered to be disabling. Additional information has been requested.
PATIENT HAD SEVERE HEADCHE, NAUSEA, SOB, RAPID HEARTBEAT THE DAY AFTER VACCINE
PERSON AWOKE AT 2:00 AM ON 11/11/2023 THRASHING, INCONTINENT, WEAK AND CONFUSION. PATIENT EXPERIENCING ATONIA IN BILATERAL LOWER EXTREMITIES. PERSON WAS TRANSPORTED TO THE  ER FOR EVALUATION VIA AMBULANCE (UNSURE ON TIME). PERSON WAS TESTED IN THE ER THEN ADMITTED TO THE MED-SURG FLOOR FOR OBSERVATION FROM SYMPTOMATIC VACCINE REACTION. PERSON WAS OBSERVED AT THE HOSPITAL AND DISCHARGED ON 11/12/2023 WITH NORMAL FINDINGS. PERSON HAS DOCTORS APPOINTMENT FOR FOLLOW-UP FROM ER VISIT AND HOSPITAL ADMISSION ON 11/15/2023. PERSON TO CONITUE MONITORING SYMPTOMS AT HOME.
Information has been received from a physician referring to unspecified patients of unknown age and gender. Information about medical history and concurrent conditions were unspecified. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (lot # L005293, expiration date 17-AUG-2016, dose and route were unknown). The PROQUAD (Merck) was stored under -11.8 F for 47 hours and 3 minutes. There was no previous temperature excursion. It was called because of a "data logger". No adverse effect reported. This is one of two reports received from the same source. Additional information has been requested.
Delayed skin reaction- soreness and itching/rash at the injection site, about a week after vaccination.
Had bad headaches, muscle pain, SOB, feels hot inside the body and then it goes away, had chest and arm pain
Expired vaccine was stored and then administered; Dose was given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Expired vaccine was stored and then administered) and EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine was stored and then administered). At the time of the report, PRODUCT STORAGE ERROR (Expired vaccine was stored and then administered) and EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Vaccine was placed in refrigerator on 04-Nov-2021. Vaccine did not undergo any temperature excursion. No adverse events were reported.
I did not have a reaction to the vaccine. On 01/07/2023 I began not feeling well with a sore throat and a cough. I tested positive for COVID-19 on 01/09/2023 with a home test. I contacted a doctor at a clinic via telephone and got the prescription for PAXLOVID and began taking it today.
Hands seize up, I have nerve pain every day.  I have lost my dexterity.
Patient reported itching at several areas within 30 minutes of vaccination.  She was given 25mg of Benedryl.  Symptoms improved and she was released to home.
Initial and follow up information has been received form a receptionist in a physician's office, via a company representative, concerning a 23 year old female student (presumed relative), patient with a history of no reaction on previous exposure to the first and second dose of GARDASIL, who was vaccinated IM on 16-OCT-2007 in the morning, with the third dose, 0.5 ml, of GARDASIL. On 17-OCT-2007 in the morning, the student developed a baseball sized lump with soreness at the injection site. The student did not seek medical attention. At the time of this report, the outcome of the event was unknown On 27-OCT-2007, the patient had recovered from the events. Additional information has been requested.  Additional information is not expected.
Information has been received from a physician regarding his 18 month old niece who on 01-APR-2006 was vaccinated with Vaqta 0.5 mL/25 U intramuscularly. On 08-APR-2006 the patient experienced a rash. On 09-APR-2006 the patient was lethargic. The child's pediatrician was contacted by her parents and they were told to have the child seen in the emergency room. The pediatrician felt the events were unrelated to vaccination. The reporting physician family member felt that lethargy and rash were possibly related to therapy with Vaqta. No further information is available.
Red area around injection site about 3 inches, not swollen, not itchy,  tender to touch
She woke up on the 14th and had some sniffles. I took her to day care, and they called around 3pm and they said she had a fever of 101.7. I went and picked her up, and she was very uncomfortable, warm, and fussy. And she was having a lot of drainage from her nose. I gave her some ibuprofen and made her more comfortable. She slept through the night, and the next morning she still had congestion. It didn?t look like she had any fever that day. She has had some congestion the past few days, and that?s about it.
Rash started on 10/15/02 following injection on 10/14/02 (generalized varicella lake rash). Aveeno bath, calamine lotion, Benadryl
I have a swollen uvula with blood red spot on the side. It is hard to swallow and it burns.  I will call my doctor tomorrow morning.
pt recvd vax & p/3rd dose exp joint pain of the rt elbow, rt wrist & both knees;
Fever, tiredness and local muscle pain. I took Panadol for 48 hours due to the adverse effect.
Pt recvd 3 doses of Engerix-B vax 20FEB91, 19MAR91 & 5SEP91 & it was determined that pt did not convert p/vax series;
Information has been received from a physician concerning a 2-month-old female on 30-Oct-2006 was vaccinated PO with the first 2.0 ml dose of Rotateq. Concomitant vaccinations administered on that same day included a dose of Prevnar, a dose of Pediarix, a dose of PedvaxHib. Other concomitant drug therapy included amoxicillin. The physician reported that on 31-OCT-2006, the patient developed severe diarrhea three times daily. Unspecified medical attention was sought. On 03-NOV-2006, the patient's diarrhea resolved. Additional information has been requested.
Came in for his Janssen COVID-19 vaccine and reported no allergies. Within 5 minutes of vaccination he briefly passed out. He was back up on his feet and reported feeling normal within 30 seconds. About 5 minutes later he began to have slurred speech, excessive perspiration and reported feeling warm. An ambulance was called and arrived within less that 5 minutes and took over care.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 41-year-old female patient (not pregnant) received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 41, in left arm, on Sep 20, 2021, at 15:00, single dose, for COVID-19 immunisation. No medical history or concomitant medications reported. The patient experienced a menstrual disorder (menstrual cycle started night of vaccine), onset Sep 20, 2021, at 19:00, with outcome of unknown. No therapeutic measures taken as a result of menstrual disorder. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. No other medications received by the patient within 2 weeks of vaccination. Prior to vaccination, patient not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
PATIENT PRESENTED TO PHARMACY  2 DAYS AFTER INJECTION TO COMPLAIN ABOUT SORENESS AND REACTION. WHOLE UPPER ARM WAS VERY SWOLLEN FROM ELBOW TO SHOULDER AND SKIN WAS RED AROUND ENTIRE CIRCUMFERENCE OF THE UPPER ARM. SWOLLEN AREA WAS HOT TO THE TOUCH.  PATIENT STATED THAT IT STARTED RIGHT AFTER THE INJECTION BUT THAT IS DOES NOT APPEAR TO BE GETTING WORSE. SHE WILL SEE HER DR IF CONDITION DOES NOT IMPROVE
One week after receiving second dose, my bilateral forearm/hand, bilateral lower leg/foot, and sensory neuropathic cough worsened moderately.  The paroxysmal cough had been mild for the last year not requiring medication.  I had tapered off gabapentin for all symptoms a year ago, but now restarted taking it to control the cough.  This possibly autoimmune neuropathy began 3 years ago after a trip out of country with a few mosquito bites just about 11 days before neuropathy began.  No cause ever identified and it was thought to be either a viral-induced or autoimmune process.  The symptoms slowly abated over the last 3 years until this last 12 days after receiving the second Pfizer vaccine.  Not sure if a relationship, but it is quite a coincidence when the neuropathy had almost resolved for the 6 months beforehand.   The first vaccine dose was uneventful other than a sore arm and chills for a couple days.  The second dose was even less eventful.
According to pt several hrs after injection, the site became red, raised and warm to touch. Area was the size of a 50c piece. Ice applied to area since 11/20/09 area becomes itchy sporadically. Pt scratches area-scabs over heals and then becomes itchy
Covid-19 Vaccine Clinic I was notified by EMT that they had given Benadryl IM to this patient. I went to evaluate patient who was sitting in a quiet corner attended by EMT and  her husband.  BP 150s/104, O2 100% RA Patient reported that about 5 mins after 2nd MOderna vaccine today, she felt  itchy eyes and noticed that her eyes were swollen and she notified EMT on site.  They had given her Benadryl IM.  She reports that she has h/o Anaphylaxis reaction to PCN. 3/12/21 Moderna 1st vaccine- given, patient noted getting          tongue swelling and onsite EMT at BTR gave her Benadryl IM.         Pt observed 30mins,          Doctors note stated pt did not thave throat/tongue swelling           lung exams clear.         He observed her during the episode and checked on her 3hrs later          and pt noted to be felt fine.  She reports that a week later, she had tongue swelling, went to ER  where she was given Epi pen and admitted to ICU for 2 days. No intubation. Sent home on Prednisone taper- dosage unknown but she reports she is still taking  2 tabs daily. She reports she was told by her Hospitalist that she could go ahead  for her 2nd Moderna vaccine dose.  Gen: watery eyes, eyelids slightly swollen, very obese Throat: no tongue swelling, tonsils enlarged touching her palate         Mallampati-Class III Pulm ctab no c,w,r Breathing comfortable, speech coherent, normal CV rrr  About 10 mins of observation by this MD, I had consulted with our other on-site  providers and we all agreed to give her Epi injection due to her prior history and current eye swelling immediately after  vaccine was administered from EMS.  Patient noted she felt shaky but denies sob/chest pain/throat pain/tongue  swelling. She was not coughing.  I accompanied patient to womens restroom for patient to void. EMS officer called EMS who came to pickup patient. Patient requested to be taken to Hospital ER.  During the entire stay, patient denied feeling short of breath/chest pain/throat  swelling.   Treated in ER: IV Decadron/Benadryl/Famotidine and discharged in few hrs with discharge meds: Prednisone taper, Famotidine and Epi pen prescription 4/14/21 Called to checked on patient and she reports took 2 days to settle down to feel normal but no throat swelling or any allergic reactions. States she is feeling well now. She followed up with her PCP (who is not from our facility).
Pt received FLUZONE and PNEUMOVAX on the same arm on1.1.15 and developed redness on the arm on 12.2.15 PM. It was warm to touch and reported this on 12.3.15.
Injection site nodule, patient was prescribed ibuprofen to take every 8hrs prn.
Varicella illness (about 2 dozen lesions) approximately 3 years after vaccine.
Extreme fatigue stared several days after his covid booster.  Then 8 days later he had a sudden cardiac arrest that resulted in death.
Hand on left arm now freezes in place after gripping (holding a fork to cut food) and can't release /relax hand.  1st event lasted about 2 minutes, 2nd event lasted about an hour.  Arm feel weak after and is painful during the experience.
Shingles .... started with lower back pain about 5-7 days afterward first appearance of rash 8 days after vaccine shot
Patient was seen at the treatment center. Patient was receiving covid-19. Patient had gone to the bathroom, and was found in the bathroom floor; had twitching of leg and hands;  After that patient appears to stare off into space repeatedly. Vital arPatient developed seizures after covid vaccine; also had repeated what appears to be absence seizure Vitals stable Called 911 for ER transfere stable
My ears haven?t stopped ringing since I got the vaccine. It?s the first noise I hear in the morning it?s the last noise I hear before I fall asleep and every waking moment between, it?s maddening.  I can?t take it.  It?s anxiety causing and so disruptive I can barely concentrate or sleep, it?s louder than every ambient noise.  While the vac may or perhaps not be the cause, getting the J&J vaccine is the only thing in this timeline that I can pin point.  There have been no other changes in my life that would indicate it came from anywhere else.  What can I do to make it stop.  I can?t imagine living the next 40 years of my life this way, it?s unbearable.  Had I known this may have been a side effect I never would have done it. I lived through the peak of Covid but I don?t know how I?ll live productively with  this plaguing ringing in my ears.  Please suggest a remedy, if you know of one.  Signed, terribly regretful.
Very sore arm started 12/1 Nausea 12/2 Chills, fever, body aches Breakthrough bleeding between period
The reporter is the patient. Other Case identifier(s): US-ABBVIE-22K-163-4506816-00.  An 87-year-old female patient received BNT162b2 (BNT162B2), on 01Apr2022 as dose 4, (booster) single (Batch/Lot number: unknown) at the age of 86 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen since 10Apr2021 (Lot number: 1164825) at 80 mg daily (80 mg, daily(80 mg day 15 citrate free pen, every 1 days)), second regimen (Lot number: 1164825) at 160 mg daily (160 mg, daily( 160 mg day 1 citrate free pen, every 1 days)) and third regimen since Feb2022 (ongoing) (Lot number: 1164825) at 40 mg (40 mg(40 mg citrate free, every 2 weeks)), all subcutaneous for crohn's disease.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Patient was to receive Moderna Bivalent Booster but received the above vaccine in error.  Patient was notified and chose to self monitor for symptoms instead of seeking care.  Patient has reported no adverse events.