chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant regarding a 48 year old female patient. No information was provided regarding the patient's medical, drug and allergy history, concomitant medications or concurrent conditions. On 10-MAR-2018, the patient was vaccinated with a dose of (WISTAR RA 27/3) M-M-R-II (recombinant Human albumin rHA) subcutaneously, lot number N0091969, expiry date: 20-MAR-2019 for prophylaxis as a requirement to work with children (dosage was unknown). Later the same month, a MMRII titer was done and did not show an antibody for measles (Measles antibody negative). It was reported that the patient sought medical attention and received treatment. The action taken with Measles antibody negative was unknown. The outcome of the event Measles antibody negative and the causal relationship between the event and therapy with (WISTAR RA 27/3) M-M-R-II were not reported.
LF Deltoid region red, hyperemic, tender to touch, size 4.5"x3" (margins non elevated). Ice, MOTRIN, BENADRYL-Call update (x3 dy)
is not in good health; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 85 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood thinner" (unspecified if ongoing), notes: He's on Coumadin a blood thinner. Concomitant medication(s) included: COUMADIN taken for anticoagulant therapy. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "is not in good health".  Additional information: Reporter explained she was calling on behalf of her 85-year-old father whose second dose of the Pfizer-BioNTech COVID-19 vaccine was scheduled this Friday. She added her father was not in good health and had a nose surgery scheduled this Wednesday on 10Mar2021. Reporter stated her dad was having nose surgery on 10Mar2021 and was going to receive his 2nd Pfizer vaccine 12Mar2021. His surgery was scheduled 2 days before his second dose. She asked if the surgery interfere with the vaccine's effectiveness. Reporter asked if the surgery cause my father to have different/worst side effects to the Pfizer-BioNTech COVID-19 vaccine. He's on Coumadin a blood thinner.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a medical assistant regarding a 6 month old patient of unknown gender. The patient's medical history, concurrent conditions were not reported. On 08-APR-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L008059, expiry date 18-DEC-2016) dosing details and route unknown. Concomitant medications were not reported. It was reported that the vaccine administered was subjected to temperature excursion of 48 degree F for a time frame of 11 hours and 10 minutes. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter. Additional information has been requested.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 27-OCT-2011, the patient was administered with a dose of VARIVAX (merck) (Lot # 1730Z, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Night one bad headache chills and diarrhea lasted 48 hours.  After that, horrible headache, fevers to 101 and chills since but got worse Wednesday and has been worsening incrementally since.  No more nausea, diarrhea.  Developed cough on Wednesday and has persisted and has gotten worse as of today (9/16).   Unable to focus. Urgent care felt maybe sinus infection so put on Augmentin for 7 days on 9/15
Did not feel her best; Started running a fever yesterday (or potentially day before); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 14-year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 24Dec2021, outcome "unknown", described as "Started running a fever yesterday (or potentially day before)"; MALAISE (non-serious), outcome "unknown", described as "Did not feel her best". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional information: Lot unknown reason: Not available/provided to reporter at the time of report completion. Adverse event: Started running a fever yesterday (or potentially day before). Had at home covid test and it came back negative, and a doctor gave them Tamiflu. (Note that based on recent experience, the at-home tests can give false negatives) Unsure vaccinate status, which one, dosage received. Adverse event treatment included Tamiflu. Follow up to previous report regarding running fever and negative at-home covid test. We do believe patient was vaccinated, but not sure which and how many doses and when. Previously, we were not totally sure of vaccine status. Believe does have a vaccine card. Covid test post vaccination: covid test date was Dec2021, covid test result was negative. Was made aware yesterday that individual was vaccinated. Recounted a story where name went to a camp after Thanksgiving and did not feel her best. This was after covid exposure over the Thanksgiving weekend. Never heard if they were tested for covid. Do not know vaccine, dosage, when dosed, but is at least partially vaccinated. Have submitted other recent AEs for name. 14YO female.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Rashes in the right rib, Dermatologist identified it as Shingles.
This case was reported by a healthcare professional and described the occurrence of local reaction at injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLUARIX in an unknown deltoid. Within one day of vaccination, the subject experienced a local reaction at the injection site with injection site redness and injection site  pain. Drowsiness was also reported. At the time of reporting the outcome of the events was unspecified. The nurse reported that 7 employees of the nursing home received FLUARIX and experienced a local reaction site reaction within one day from vaccination. The local reactions ranged from local redness and pain at the injection site to left arm pain which radiated to the chest in one subject and left arm pain which radiated down the arm in another subject. No additional information was provided at the time of reporting. Linked case numbers included A0809349A, A0809357A, A0809358A and A0809360A through A0809362A.
pt recv vax;was pregnant;meds during pregnancy:prenatal vitamins & amoxicillin due to urinary tract infect;24may94,pt's baby exp fetal distress because baby was too large to be delivered vaginally;had c-section & @ 40 wk delivered nl new bo
The patient received the adult dose of Pfizer-BioNtech vaccine instead of the pediatric dose.  Upon interview with patient's mother (16 hours post injection) the only adverse reaction was a sore arm.
1/2 of booster dose was given. Pt was given 0.25 ml of vaccine when label on bottle states the booster dose for this vial is 0.5 ml
pt says she got elevated blood glucose as a result of this vaccine. The day prior to this she received a fluzone (u7453ab, exp 06/30.2021) and this was given instead of the shingrix which she asked for. This was her second flu shot given
I developed a dry cough, it wakes me up in the middle of the night, today my left elbow is sore and aches, I just recently had my period 2 weeks ago and have been very regular and I started my period again this morning and there are more than usual small blood clots.
Headache, Myalgia, lips felt funny, chills, injection site pain radiating to left breast area Narrative:  Other Relevant History:
Student presented with swollen red arms day after vaccination was given. Student states his sister hit him in arm after vaccine given. Swelling and redness decreased on 10/29/202.
Initial and follow up information has been received from a Registered Nurse (R.N.) concerning a 26 year old female patient who on 14-AUG-2007 was vaccinated with a first dose of Gardasil lot #658222/0927U. Concomitant therapy included ethinyl estradiol (+) Levonorgestrel (SEASONALE). On 14-AUG-2007, within one month of vaccination patient developed injection site soreness, and then passed out for about one minute. She was dizzy and nauseated. She was transported to the Emergency Room via ambulance. In follow up the nurse reported that after patient received her Gardasil injection she turned her back and about 30 seconds later she turned around and the patient's head had dropped down and she was very stiff, not limp but stiff. She passed out. She was taken to the emergency room (ER) where she vomited. She had a computed axial tomography (CAT) scan which was normal, although she had a hematoma on her head. The nurse said that she did not fall while in the office or anytime before hand that she knew about so she was not sure where that came from. She had an electrocardiogram (EKG) which was borderline abnormal, and she was recommended to follow up with her primary care physician about the EKG. The primary care physician was aware of the patient's cardiology problem. The patient's glucose was 126, prothrombin time (PT) 13.0, red blood cell count (RBC) 4.05, everything else was right on the normal border. She was discharged from the ER that same day. Her discharge diagnosis was vasovagal syncope. The nurse's office was not able to contact the patient since then and was not sure if patient had recovered. The nurse reported that she did not know whether the event was from her Gardasil vaccination, since the event occurred about 30 seconds after her vaccination. The reporter indicated that the patient's adverse events injection site soreness, passing out, being dizzy and nauseated were disabling. She also believed transporting patient to the emergency room (ER) via ambulance was an intervention to prevent a serious criteria and it was reported as an other medical event. Additional information has been requested.
Immunizations received at 1 yr well check on 1st birthday. Developed a twitch/tic consisting of cocking her head to the right and shrugging her shoulder twice wo the chin. Continued for approx 6 weeks. No sensorium changes, no post event drowsiness, resolved as quickly as it began. Exam 04/26/02 normal except tic. Referred to a neurologist but it resolved prior to appt. Did fall down one step on 04/24/02 priior to onset of tic.
Developed body aches, fever, nausea and emesis within 6 hours post vaccination with #2 in Anthrax Series. Symptoms lasted approx. 12 hours with residual lethargy and mild nausea the following day. Fully recovered.
Patient is a 86 y.o. female patient of a MD with history of recently diagnosed with COVID-pneumonia, diabetes mellitus type 2 requiring insulin, anemia, hypertension presented to a local Hospital with mechanical fall hence the admission..   Mechanical fall No loss of consciousness or head injury. CT head shows no acute intracranial abnormality No history of syncope/near syncope Imaging showed no acute fracture/subluxation Evaluated by PT/OT, DC to SNF   Diabetes mellitus type 2. Continue home regimen after discharge   Lab Results Component Value Date   HGBA1C 7.3 (H) 03/29/2023    COVID-19 positive test (COVID-19)  Community-acquired pneumonia Patient recently started on Paxlovid And requiring 2 L of nasal cannula oxygen Started on dexamethasone and Levaquin Elevated procalcitonin We will continue dexamethasone x10 days,  Levaquin 750 mg every 48 hour Mucinex, as needed bronchodilators She is currently requiring on and off 2 L nasal cannula oxygen No evidence of respiratory distress, no accessory muscle We will DC to SNF with follow-up with PCP Data positive test 3/26//2023 Treatment: Was on Paxlovid, currently on steroids and Levaquin Estimated discontinuation of isolation 4/05/2023 AKI Baseline likely stage III CKD, with SCR~1.0 Was admitted with SCR 1.39, improved with IV fluids  Lactic acidosis?resolved Reported to be 2.2>1.3   Decubitus ulcer POA Wound care consulted
Dehydration was considered medically important (OMIC). A nurse reported that a 39 year old male received Flumist and developed a fever, aches, pains, cough, dehydration, sore throat, headaches and nausea. The pt was reportedly healthy. Indication for Flumist was immunization. Product was administrated on 12/18/03. Dose regimen was 0.5mL. Concomitant medications were not reported. On 12/21/03, the pt, while staying at a ski resort, developed upper respiratory tract infection (URI) symptoms including fever, aches, pains, cough, dehydration, sore throat, headaches and nausea. Treatment at a local medical facility included "IV fluids for a few hours" for the dehydration and ibuprofen for the aches and pains. The reporter stated that the pt had to be "shipped" home because he was so sick. Follow up: information from the nurse revealed that the patient was seen at the clinic one time for URI symptoms. A nurse reported that a 39-year old male received Flumist and developed a fever, aches and pains, dehydration, sore throat, headaches, nausea, cough and upper respiratory tract infection symptoms. The patient received a dose on 18DEC2003.
This case was reported by a physician via sales rep and described the occurrence of injection site rash in a adult patient who received SHINGRIX. In May 2018, the patient received SHINGRIX. In May 2018, less than a week after receiving SHINGRIX, the patient experienced injection site rash. The patient was treated with Antihistamines. On an unknown date, the outcome of the injection site rash was unknown. It was unknown if the reporter considered the injection site rash to be related to SHINGRIX. Additional information were received as follows: The age at vaccination was not reported. The patient received a dose of SHINGRIX earlier in the week of reporting date and came on the day of reporting to visit physician with a large rash on half of her arm. The patient was prescribed with steroids and antihistamines. The reporter was agreed for follow up.
On Friday May the 14th I vaccinated one patient for the Janssen vaccine in the morning. I placed the vial in refrigerator for further vaccinations and at the end of the shift i forgot to discard the vial. Monday morning (05/14/2021) I returned to the pharmacy and i had patients for the Janssen vaccine, as i was about to send my report of the day of Monday (05/17/2021) i realized that i had more vaccines than i should, coming to the realization that i accidentally administered 5 doses pf the janssen vaccine form the vial of Friday(05/14/2021). patients from Monday(05/17/2021) they all waited their 15 minutes and there was no reaction and no  fever at the moment. the patients left pharmacy without any complaints.
tingling in my arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in my arm) 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 26-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, the patient experienced PARAESTHESIA (tingling in my arm). At the time of the report, PARAESTHESIA (tingling in my arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information was not reported. Treatment information was not reported.
Left arm pit accompanied by pain and discomfort.; Left arm pit accompanied by pain and discomfort.; Severe swelling of the lymph node; Fever of 37.9; Severe pain in left arm; This is a spontaneous report received from a non-contactable consumer (patient). A 46-year-old non-pregnant female patient received BNT162B2 (COVID-19 VACCINE-MANUFACTURER UNKNOWN; Lot Number: ew0151), via an unspecified route of administration in the arm left on 01Apr2021 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 prior to vaccination on an unspecified date. The patient had history of known allergies to nickel. Concomitant medications included vitamin D (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN) and ibuprofen (ADVIL); all from an unknown dates taken for unknown indications. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced left arm pit accompanied by pain and discomfort on 02Apr2021, at  16:00 with outcome of recovering, severe swelling of the lymph node on 02Apr2021, at 16:00 with outcome of recovering, fever of 37.9 on 02Apr2021, at 16:00 with outcome of recovered on 04Apr2021, severe pain in left arm on 02Apr2021, at 16:00 with outcome of recovering. Details were as follows: on 02Apr2021 at 16:00, 24 hours following the injection, the patient experienced fever of 37.9 which lasted for almost two days. Severe pain in the left arm. Severe swelling of the lymph node in the left arm pit accompanied by pain and discomfort were noted. The lymph was visibly swollen 4 days after the injection. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of the left arm pit accompanied by pain and discomfort, severe swelling of the lymph node and severe pain in left arm was recovering; fever of 37.9 recovered on 04Apr2021.   Pfizer is a marketing authorization holder of BNT162B2 in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of BNT162B2 has submitted the same report to the regulatory authorities.  No follow-up attempts are possible. No further information is expected.
Within 24-hours I experienced stabbing pain in the Uterus/Abdominal area. It lasted approximately several hours. Dull pain lasted 24 hours. I then missed my period for 2 months. Since then I have been experiencing cramps when I get my period. I have never, in the history of my 34 years gotten cramps and my period is very regular. Missing a period is not normal for me and cramping is not normal. There was my menstrual cycle for the 34 years prior to my second shot and my menstrual cycle now. It has returned in regularity but I now have low grade cramping.
4:15 pm- 10 minutes after injection pt reports feeling dizzy, cold, and throat dryness.  Pt denies short of breath, chest pain or swallowing difficulties. 4:20 pm Pt evaluated by EMS. BP 140/108, P 95, O2 sat 100% 4:25 pm BP 142/99, P 94, O2 sat 100 %. pt reports feeling better and declined transport to ED
1min post vaccination, pt had a syncopal episode.  Pt was noted to be pale. Vitals: @17:32 BP 108/80, HR 66, SpO2 98% -- > @17:55 110/80 Pt stable and released from the vaccination site.  Janssen Booster after Moderna Primary Series
pt recvd vax & 2hrs post vax exp severe vomiting & abd cramping which have resolved;addl 2hrs post vax exp malaise & nausea;sx resolved w/in 7 days;no further problems;
Generalized hives 2 hours after vaccination for Flu. Itchy. Patient taken to medical center ED. Patient given BENADRYL, prednisone and famotidine. Pt improved after treatment. Parents advised to continue treatment for 3-4 days.
Local tenderness and muscle aches within a couple of hours of injection. Fever and headache.
On 5/31 patient developed acute abdominal pain and n/v.  Evaluated 6/2 in hospital with fevers and dark urine, found to have elevated LFTs including bilis.  Ultimately rehospitalized 6/6-6/13 for FUO, jaundice, transaminitis, fatigue.  Also had conjunctivitis.  No heart/lung issues. Had eosinophilia to 1000s. Ultimately required liver biopsy which showed hepatic congestion as if had cholangitis (but did not) and eosinophils.  Ultimately discharged when LFTs and CBC stabilized.
extreme dry mouth (thirst), shivers (lasted 40 minutes), headache, body aches; all adverse events ended by 24 hours post-vaccine; dry mouth/thirst is not listed as a possible side effect on any discovered literature
As stated by mother, face, upper part of chest and upper part of back area became very red in color. Area around eyes became swollen. Treated at hospital with "a pink syrup". Rx given to mother to fill. Mother did not know the name of the medication and did not return to the pharmacy for the Rx because she "did not have money to pay for it". Signs and symptoms were gone by evening.
Severe muscle pain and weakness; treated with steroids with little relief; MRI done 11/26/2013 seeing specialist 12/05/2013.
Intermittent days of dizziness, off-balance and nausea upon waking. Tension in head.
myocardial infarction leading to death.  Impossible to know causality, but completing this out of an abundance of caution.
This spontaneous report was received from a Registered nurse regarding a 14 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 31-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Within an hour of receiving Flu Mist vaccine yesterday, patient had a high fever (104) with shaking (chills?). We gave him Tylenol at 4:45, 8:15, and 4:15am. He had the high fever for 12-15 hours. It seems to have broken now, and he seems to be feeling better. Additional symptoms included general discomfort, shaking, runny nose, glassy eyes. All symptoms have now subsided.
Received Pfizer vaccines on 4/15/21, 5/10/21. Tested positive for COVID19 by PCR on 7/15/21, symptom onset date of 7/13/21; known exposure to COVID-19, symptoms of New headache, New muscle aches, New cough, New sore throat