chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pfizer monovalent was given beyond 72 days from the time the vaccine was transferred by original box of Pfizer to the pharmacy refrigerator.
Pt. was a home care hospice patient w/ a terminal diagnosis of CHF. Was in usual state of health on 10/08/2015. Son reports that patient began to rapidly decline over the next few days, ultimately dying on 10/15/15. RN reports no local reaction to vaccine. PMH significant for: DM II; cardiomyopathy; glaucoma; hypothyroidism; osteoporosis; renal insufficiency.
About 7 hours after my vaccine, I started experiencing chills and body aches. 9 hours after the vaccine, I felt as if I?d taken cold medicine. I was slow to react, felt ?foggy?, I had trouble recalling words and the names of household objects I was staring at, my movements weren?t coordinated and I dropped a few things. During the night, I was tired but had trouble sleeping. The body aches worsened and really concentrated in my joints, especially my spine. I stayed either in bed or on the couch the whole day following my vaccine but my heart rate (as read by my smart watch) would go from the 70?s to as high as 129 just from sitting up higher in bed. My normal resting heart rate is in the upper 50?s/lower 60?s and I don?t see 120+ unless I?m working out for at least 20 minutes. I didn?t take Tylenol or Motrin until 7 PM on April 19th (I took 800mg of Motrin) about 34 hours after my vaccine. I had a low grade fever and my head ached so bad all my teeth were throbbing before I took the  Motrin. I started to feel better within a hour of taking Motrin and was fine from then on. I only took Motrin the one time.
Case number PHEH2015US020305 is an initial spontaneous report from a nurse received on 08 Oct 2015. This report refers to a 59 years old female patient. Medical history and concomitant medications were not reported. The patient received FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml intramuscular on 07 Oct 2015. It was reported that the patient received FLUVIRIN MDV that was out of temperature range at 47 F before administration. No adverse event was reported following this medication error (incorrect storage of drug).
UNABLE PUT TWO THOUGHT TOGETHER; SUSPECTED COVID-19 INFECTION; MUSCULOSKELETAL SYSTEM PROBLEM; FALLS; PATIENT TALKING WAS VERY BIZARRE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: autoimmune problem. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 1 total administered, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, patient had covid (suspected covid-19 infection) and it was really bad. She had more falls and it affected her musculoskeletal system (musculoskeletal system problem). She was unable to put 2 thoughts together and her talking was very bizarre. There was no syntax, no subject and her son noticed this. She states that the vaccine and covid causing problems to her musculoskeletal systems. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection, musculoskeletal system problem, unable put two thought together, falls and patient talking was very bizarre was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230742693-unable put two thought together. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the Causality is considered indeterminate. The company causality is considered unassessable.
I went in for a routine stress test and the physicians noticed that there was an irregular rhythm. They stopped the procedure and performed an EKG to check if there was still an irregular rhythm. I went back the next morning, and my heart was back in rhythm. They wanted to put me on Eliquis, but it was too expensive. I am now taking Warfarin. I will be transferring back to Eliquis starting next week. I am going to have an ECG performed 01/03/2023. I will be wearing a patch monitor for three days and sending the results in, prior to the ECG.
Pt recvd 1st dose of Heb B vax on 5APR91 due to needle stick & w/in 24 hrs of vax devel rash & arthralgia which subsided in approx 4 days;
Fever of 100; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th October 2020, the patient received Shingrix. On 16th October 2020, 1 days after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.   Additional details were provided as follows: The age at vaccination was not reported. Age group of patient was captured as adult as per indication of product. The patient received Shingrix vaccine yesterday from the day of reporting and had a fever of 100 Degree Fahrenheit on the day of reporting.
Since receiving Covid vaccine, had 3 weeks of menstrual bleeding, more heavier, more painful cramps.
Dec 13, 2020- Arm from shoulder to elbow became red, swollen, hot and painful for over a week. Tender for several weeks.   Tinnitus began in right ear early Jan 2021, still continues with only slight decrease in intensity.  Mild/moderate hearing loss (high and low tones) developed in right ear, and still continues. Received Moderna vaccine on Jan 27 and Feb 22, 2021 Brief period of decreased pressure and lower intensity tinnitus on Jan 31. Vestibular attack  on March 11, 2021, presently treated with Betahistine Dihydrochloride.
No adverse event; on unspecified date an unspecified number of patients were administered improperly stored PEDVAXHIB, ROTATEQ, and VAQTA; This spontaneous report was received from a medical assistant referring to a 11-weeks-old female patient. The patient's medical history, concurrent condition and concomitant medication were unknown.  On 06-NOV-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial of lot # S004398 with expiration date 31-OCT-2020 (strength, dose, dose number and route of administration were unknown) for prophylaxis (product storage error).   On an unknown date, the vaccine was stored at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (9.3 Celsius (C)) for 23 minutes. Previous temperature excursion was at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (8.7 C) for 36 minutes, 47 degrees Fahrenheit/9 degrees Celsius (8.9 C) for 15 minutes and 47 degrees Fahrenheit/9 degrees Celsius (9 C) for 12 minutes. Digital data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA012749:
administered an expired dose of daptacel to one of their patient with no reported adverse event; Initial information was received on 23-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 1 years old female patient who was administered an expired dose of diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 23-Jun-2023, the patient received a 0.5 ml, once dose of suspect diphtheria-15/tetanus/5 AC pertussis vaccine (Suspension for injection) (lot number, expiry date: unknown) Strength: standard via unknown route in unknown administration site for Immunization. The information on the batch number will not be available.  On an unknown date the patient was administered an expired dose of daptacel with no reported adverse event (expired product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Miscarriage 2 weeks after receiving the first dose (March 1, 2021). Baby had a heart beat, then slowly died.  Ultra Sound Showing Fetal Bradycardia on 2/26/21.
Site: Bruising at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient came to the pharmacy 11/7/2022, and explained to me that intern advised pt. to roll up her sleeve to administer her flu shot. The next day her arm was swollen, and had significant bruising from a photo she brought to my attention. I told her a mild to moderate rash is rare but not uncommon with any vaccine, and it may have been due to either the administration of the flu shot or just by chance. She said she'd contact me later this week if any concerns.
Information has been received from a nurse concerning an adult female who on 29-AUG-2008 was vaccinated with a booster dose of MMR II. On 10-SEP-2008, 12 days after receiving MMR II, she developed a high fever and rash on her torso. The vaccine was a booster because the woman works around unvaccinated infants and had a low measles titer. It is reported that the women has not recovered. She sought medical attention with an appointment with her physician. No product quality complaint involved. Additional information has been requested.
Macular rash to chest and L arm night after receiving vaccine rash resolved next day, residual soreness-soft swelling L arm.
My 6 year old received the flu shot and varicella vaccine after being repeatedly reminded by his public school that he had to have it to continue attending. Since receiving those vaccines (approx 7 weeks ago) he has been experiencing daily headaches, had 4 migraines causing vomiting and severe pain and contracted tonsillitis. Something is wrong with these vaccines when they make kids live in constant pain!
Extreme redness and heat at injection site. Complaint of fever and chills. RPh advised pt. to apply cold compress at injection site, TYLENOL and BENADRYL. Referred to PCP. PCP notified via RPh 7/6/18.
Pain; Itching; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Pain) and pruritus (Verbatim: Itching). The outcome of the pain and pruritus were resolved.   It was unknown if the reporter considered the pain and pruritus to be related to Shingles vaccine.     It was unknown if the company considered the pain and pruritus to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 21-MAR-2023 This case was reported by patient via interactive digital media. The patient thankfully had the shots. The second shot caused pain a few days but then it started itching on the inside. It was gone now. Follow up was not possible, as no contact details were available.
Febrile 102.5 degrees F. C/o headache. No rash.
Received vaccine, went to observation area, sat down, 2 minutes later felt very flushed, hot, skin became red, and almost fainted.  Similar to vasovagal experience without nausea at that time.  Staff took me to nursing station, and I felt better within 10 minutes of laying down on ice pack, drinking water.  Stayed there for an hour and got  a ride home in case.  Blood pressure was very elevated afterwards for several hours.
Decreased alcohol tolerance (one glass of wine was like I drank three) Nausea (nearly vomited several hours after being home)
Symptoms:  Brief, acute, localized, rolling pain in descending colon beginning upper section just below ribcage on left side of abdomen.  Successive days, 7 in total, pain proceeded along descending colon, continuing as brief and localized to a small section at a time, ending in sigmoid colon on day 7.  Treatment: None. As pain was intense but brief, I just waited it out. Time Course: 7 days Outcome:  As far as I can tell, I am now symptom free with no other adverse effects.
This case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in unspecified number of patients who received FLUARIX Quadrivalent. On an unknown date, the patients received FLUARIX Quadrivalent at an unknown dose. On an unknown date, an unknown time after receiving FLUARIX Quadrivalent, the patients experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to FLUARIX Quadrivalent. Additional details were provided as follows: A director of the pharmacy reported to GlaxoSmithKline's sales representative via email. The reporter heard from staff that there were unspecified number of patients, who experienced sore arms after flu vaccination this past flu season. It was reported that nearly 100 percent of the sore arms were from GlaxoSmithKline vaccine. The reporter noted that she was reporting the case to the sales representative just so that he knew. No other information or specifics were communicated.
15 days post vacc, pt developed rash, fever, pruritus and severe musculoskeletal pain, late c/o cough, continued musculoskeletal pain despite treatment.
developed a large lump in the right armpit; developed a large lump in the right armpit; After my second booster, I have noticed it has gotten larger; dose administration date=17Feb2023; dose vaccine location=Right leg; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Feb2023 at 13:00 as dose number unknown (booster), single (Lot number: GL0446) at the age of 61 years, in right leg for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (First booster dose, COVID 19 Pfizer, lot number: FO7139, administration time: 01:00 PM, vaccine location: Right arm), administration date: 22Aug2022, when the patient was 60-year-old, for COVID-19 immunization, reaction(s): "have developed a large lump in the right armpit. first noticed it after my first booster."; Covid-19 vaccine (Primary Immunization series completed; unknown manufacturer), for COVID-19 immunization. The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 17Feb2023 at 13:00, outcome "unknown", described as "dose administration date=17Feb2023; dose vaccine location=Right leg"; AXILLARY MASS (non-serious), outcome "unknown", described as "developed a large lump in the right armpit"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "developed a large lump in the right armpit; After my second booster, I have noticed it has gotten larger".  Additional information: Patient was not pregnant at the time of vaccination.  Facility type vaccine was Doctor's office/urgent care. No other vaccine in four weeks. Patient developed a large lump in the right armpit. First noticed it after first booster, event started on 29Aug2022 02:30 PM (no treatment received and not recovered). After second booster, noticed it had gotten larger. No covid prior vaccination and covid not tested post vaccination. No known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300088529 Same patient, different drug and different event.;
Got shot on 9/14 (Tuesday) and began feeling burning sensation in lower abdomen and upper legs that evening.  Rash began in same area over the weekend 9/25, 9/26.  Went to MD Monday 9/27 and was told it was shingles and prescribed Valtrex.
i still feel weird; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (i still feel weird) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 18-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (i still feel weird). At the time of the report, FEELING ABNORMAL (i still feel weird) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Haematocrit: high (High) High.         The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.  Patient had to have blood thinned because of high hematocrit levels.  No Relevant concomitant medications was reported.  Treatment information was not provided.
Received 2nd dose of Pfizer COVID vaccine 2/6/2021.  On 3/29/2021 patient developed fever, chills, body aches, diarrhea, headache, and rhinorrhea.  Positive for COVID.
Patient inadvertently received a dose of 2023-2024 COVID-19 vaccine sooner than recommended. Patient received Moderna Bivalent on 08/30/2023
Redness, swelly, pain day 9 after vaccination Patient received Moderna vaccine on 01/12/2021. Initially, she had mild soreness followed by mild headache for which she took Tylenol. However, on day 9 she developed increased pain with redness and warmth. She reports the redness has improved but is persistent. The pain was worse last night. She has applied cortisone on it and took antihistamine. The intense itching has improved. She denies any fevers, shortness of breath, mouth swelling or lip swelling.
I took Pfizer civic vaccine and since got brand new never before had. Tinnitus. Bad ringing in the ears!,,
I woke up the day after the vaccine feeling very tired and I felt like I had the flu.  I was vomiting and had diarrhea. I have been sick with these same symptoms since then and I am 6 day's past the vaccination. My second vaccination dose was on the 21st of may. My first dose was on the 7th of May and I was extremely sore with the first dose but, I did not have any of these other symptoms. I have autoimmune diseases and have been told by a couple different doctor's that several other people with autoimmune diseases are reporting the same things.
Rash appeared on both shoulders, elbows, trunk and forehead. Blood pressure and heart rate stayed stable. Patient took 2 cap of 25 mg BENADRYL. Rash subsided in 30 minutes, post meds.
Red itchy raised spot on my left arm below where injection was given. Started to enlarge after 8 days but showed up the day after.
pt recvd vax;2days later localized redness, swelling & pain to lt thigh; no fever or allergic rxn; localized not generalized SOB;
From faxed correspondence received from vaccine provider it was stated that a 27 y.o. female PT received an Imovax Rabies vaccination on 7/6/01. Reportedly the next evening the PT developed an itchy red rash "like small hives" over arms and anterior trunk. PT denies systemic manifestations, feels generally well. She reportedly recovered from this experience. From add'l correspondence received on 9/6/01, it was reported, "Reviewed, no add'l info. at this time - 8/31/01" This case is closed.
Severe pain in the arm that received the shot for 2 days, tiredness, diarrhea, problems to fall asleep and wakening up at night, back pain.
Chills; Fever; sore arm; generalized bone pain; Booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Nov2021 (Lot number: FG3527) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (non-serious) with onset 20Nov2021, outcome "unknown", described as "Booster"; CHILLS (non-serious) with onset 21Nov2021, outcome "recovering", described as "Chills"; PYREXIA (non-serious) with onset 21Nov2021, outcome "recovering", described as "Fever"; PAIN IN EXTREMITY (non-serious) with onset 21Nov2021, outcome "recovering", described as "sore arm"; BONE PAIN (non-serious) with onset 21Nov2021, outcome "recovering", described as "generalized bone pain". Therapeutic measures were taken as a result of chills, pyrexia, pain in extremity, bone pain.  Additional information: Treatment was given as Theraflu and Tylenol. Upon follow-up on 23Nov2021: This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation of below mentioned query. The response included Thanks for reporting to safety. There were two queries about the report are the patient withheld (myself), RN provided on the reporter email. But as per reporter email address, it seems that not consistent with initials CPD. Please help us to provide correct name of patient. And then start of AE Sunday Nov21 was provided the in reporter email. This adverse event start date, which was not always equal to the awareness date. The awareness date was reporter as 21Nov2021 for the adverse events. It was reported as Pfizer US Drug safety unit recently received the attached report submitted by reporter via withheld. This awareness date where reporter became aware of the occurrence of the reported events. If reporter were the patient in the case, the awareness date would be that reporter became aware were experiencing the reported events. This awareness date represents that Pfizer receipt date of the report and reflects the earliest date that any Pfizer colleague learned of the adverse event. It was reported that do not consent further FU.  No follow-up attempts are possible. No further information is expected.
Menstrual cycle began much sooner than expected, was extremely heavy.  PMS symptoms were much more severe than normal to include tender breast, cramping, fatigue and hunger.
red face and arm below the injection site, nausea, ache in muscles, extreme fatigue, general feeling of malaise
Vertigo and Nausea (along with regulary covid vaccine symptoms which all went away within two days). I still have vertigo and nausea after two weeks post second covid vaccine.
increased lower back pain and inflammation started hours after the vaccine was given. 2 days later pain is increased and am now going to take steroids and pain pills to control the pain