chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt. admitted on 04/18/2021; presented with:   "Patient is a 97 yo female with pmhx of HTN, Syncope, HLD, COPD, and TIA that presents with expressive aphasia. Patient was normal on 4/17 and went to bed around midnight. Woke up at 11 AM the next day with difficulty speaking. Also reports lightheadedness and mild blurry vision. No identified aggravating or relieving factors. Had 2nd covid vaccine over 2 weeks ago."    Discharged Home with Skilled Home Care on 4/27/2021.
This spontaneous report as received from a health care worker concerning to unspecified number of patients of unknown age and gender. Patients concurrent conditions and relevant medical history was not reported. On an unknown date, unspecified number of patients were vaccinated with improperly stored RECOMBIVAX HB (lot number, dose and route unspecified). Concomitant medications were not reported. No adverse symptoms were reported. The temperature excursions that were reported for RECOMBIVAX HB was supported excursion with in-house stability data. The outcome of the events was unknown. The causality of the events with RECOMBIVAX HB was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a currently (at the reporting time) 60 years old female patient with no pertinent medical history, drug reactions or allergies. The patient did not take any concomitant medication. On an unknown date the patient was vaccinated with ZOSTAVAX (lot # M042504, expiration date: 30-NOV-2017, dose and route were not provided) for prevention of shingles. The vaccine was reconstituted with sterile diluent (STERILE DILUENT) (lot #, expiration date, dose and route of administration were not reported). On an unknown date, one day after the vaccination, the patient developed redness and itching at the injection site. The itching and redness continued to worsen by day 3 and she sought medical attention. Her practitioner diagnosed her with Streptococcal infection. The patient was treated with amoxicillin + clavulanate potassium (AUGMENTIN) for 7 days and oral diphenhydramine (BENEDRYL)(duration of treatment not provided). She did not have any laboratory test performed. The outcome of streptococcal infection, injection site redness and itching was reported as not recovered. Relatedness between the events and ZOSTAVAX, sterile diluent (STERILE DILUENT) was not reported. The patient did seek medical attention.
achiness; left arm at the injection site very hot; fatigue; red; kind of swollen; Pruritis; Rash; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achiness), VACCINATION SITE WARMTH (left arm at the injection site very hot), FATIGUE (fatigue), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE SWELLING (kind of swollen) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes since 2007, Hypertension since 2013, Asthma, Allergy to chemicals (Allergy to Monosodium glutamate and reaction hives.), Hay fever and Hives. Concomitant products included CHLORTHALIDONE and LOSARTAN for Blood pressure high, GLIMEPIRIDE for Diabetes, METFORMIN for Diabetes mellitus, ATORVASTATIN for Triglycerides high, CLOMIPRAMINE for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (achiness), VACCINATION SITE WARMTH (left arm at the injection site very hot), FATIGUE (fatigue), VACCINATION SITE ERYTHEMA (red), VACCINATION SITE SWELLING (kind of swollen), PRURITUS (Pruritis) and RASH (Rash). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and CORTISONE at an unspecified dose and frequency. At the time of the report, PAIN (achiness), VACCINATION SITE WARMTH (left arm at the injection site very hot), FATIGUE (fatigue), VACCINATION SITE ERYTHEMA (red), VACCINATION SITE SWELLING (kind of swollen), PRURITUS (Pruritis) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details also included anti itch cream. Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Additional information included patient demographics, concomitant medication information and medical history.
Very red, warm and swollen at injection site 2 days post vaccination. Patient says arm the whole  way to neck is tight and painful. Felt like it was going up her arm she got the shot.
This spontaneous report was received from a medical assistant, and refers to two unspecified patients of unknown age and gender. The patients' current conditions, medical history and concomitant medications were not reported. On an unknown date, one patient was vaccinated with improperly stored VARIVAX lot number: M047662 with expiration date: 02-DEC-2018, for prophylaxis (route of administration was not provided). On an unknown date, the other patient was vaccinated with improperly stored PROQUAD lot number: N021727 with expiration date: 06-FEB-2019, for prophylaxis (route of administration was not provided). On unknown dates, the doses of VARIVAX and PROQUAD underwent unspecified temperature excursions for an unspecified time out of the range time frame, which were detected by the data logger. There were multiple unspecified previous temperature excursions reported. No adverse symptoms were reported. Follow-up has been received on 13-FEB-2018 from a medical assistant. The medical assistant reported that on an unspecified date, the patient (name was provided) received a dose of improperly stored PROQUAD reconstituted with properly stored sterile diluent (manufacturer unknown). The second patient received a dose of improperly stored dose of VARIVAX (captured in MARRS # 1801USA001967). The doses of vaccine were stored between 6 degrees Fahrenheit (F) to 14F for 9 hours and 15 minutes. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1801USA001967.
Pt. states that after receiving the 1st dose of Moderna 10/05/2021, started experiencing symptoms 10/06/2021 of pain at injection site, headaches, fever (100.4), feeling of crawling in the face (left), and twitching in the face and left arm. Still continuing to experience symptoms. No noted Primary visit.
Severe flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Severe flu-like symptoms) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Severe flu-like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Severe flu-like symptoms) outcome was unknown.     Concomitant medications were not reported.   Treatment medications were not reported.
Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 03-MAR-2015, the patient was received improperly stored (Oka/Merck) VARIVAX (lot # K007979, exp date 03-JUL-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
bruised; have hit his head because his head was sore; was in lots of pain; sore all over; stiff neck; no appetite; passed out; heard his back crunch when he fell; could not walk; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No past medical history provided.  Concomitant products included MELOXICAM, TRAMADOL, ATORVASTATIN and CURCUMA LONGA (TURMERIC CURCUMIN [CURCUMA LONGA]) for an unknown indication.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021 at 11:12 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-May-2021, the patient experienced GAIT INABILITY (could not walk). On 22-May-2021 at 8:00 AM, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant) and BACK INJURY (heard his back crunch when he fell). On 23-May-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiff neck), DECREASED APPETITE (no appetite), PAIN (was in lots of pain) and MYALGIA (sore all over). On 24-May-2021, the patient experienced CONTUSION (bruised) and HEAD INJURY (have hit his head because his head was sore). At the time of the report, LOSS OF CONSCIOUSNESS (passed out), GAIT INABILITY (could not walk), MUSCULOSKELETAL STIFFNESS (stiff neck), DECREASED APPETITE (no appetite), CONTUSION (bruised), HEAD INJURY (have hit his head because his head was sore), BACK INJURY (heard his back crunch when he fell), PAIN (was in lots of pain) and MYALGIA (sore all over) outcome was unknown.            No treatment information reported.  Additional concomitant medications included cardanol and water tablet.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-182269 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
rapid heart rate (almost always over 100) for entire day after vaccination, exacerbation of existing pains (neck pain, spasm of anal fissure)
Patient stated she wanted to receive her first COVID vaccine. This was missed by the pharmacist on duty and the vaccine was processed as a second booster. Patient was administered Bivalent Pfizer dose as her first dose when she had never received any COVID vaccine prior to the event.
Increased sleep on 10/9. Patient slept most of the day. The following morning (10/10), patient awoke with emesis one time and around 2 PM, patient had ataxic gait that progressed to inability to stand.  Nurse follow up on 10/30/04 states: "anorexia."
Pt.'s Wife states that after receiving the 3rd Booster of Moderna 11/01/2021, started experiencing symptoms 11/02/2021 of sweating, confusion, and difficulty walking (lasting 5 minutes). No noted Primary visit/communications.
Patient felt dizzy. Carefully and safely got patient to the floor in lying position. Called 911. When paramedics arrived patient said she was fine. Patient was able to leave store on her own.
Severe neck & cranial pain.  Treating with 3 Advil 2xday.  Pain diminishes, but does not completely resolve.   Duration has been 4 days so far, after vaccine, & continues with slight lessening of pain.
Vomiting began approx 2 hrs p/receiving HIB/DTP/OPV; stopped p/about 8-10hrs p/pt was given water w/syrup;
Joint pain; sore throat; Hoarseness; This is a spontaneous report from a contactable consumer or other non-HCP (patient's daughter).  A 51-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 17Apr2021 (at the age of 51-years-old) as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number not reported), dose 1 via an unspecified route of administration on 27Apr2021 as dose 1, single for covid-19 immunisation. The patient received the vaccine in Mar2021 or Apr2021. The patient has been experiencing hoarseness/sore throat (voice was horse) which started 3 months ago (in 2021), since then and joint pain a week after her Pfizer shot in Apr2021. The reporter would like more information about the side effects, reclarified the hoarseness and joint pain and asked were these common side effects, and what should be the next steps, treatment. The patient went to the doctor about these issues, and they could not find a solution. This has been ongoing for 3 months, and she was a normally well person, with no health issues. She asked what the next steps for her side effects response were, provided disclaimer that Pfizer does not provide treatment recommendations or clinical interventions.The patient required the physician office visit for the adverse events. The outcome of the events was not recovered.
Severe red streaks; Red blotches on palms of hand; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Severe red streaks) and RASH MACULAR (Red blotches on palms of hand) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Severe red streaks) and RASH MACULAR (Red blotches on palms of hand). On 10-Feb-2021, RASH ERYTHEMATOUS (Severe red streaks) and RASH MACULAR (Red blotches on palms of hand) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
Blood clots; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clots) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Blood clots) (seriousness criteria death, hospitalization and medically significant). The reported cause of death was blood clots. It is unknown if an autopsy was performed.            The concomitant medication was not reported.  A consumer called and stated that his uncle passed away 2 days after receiving Moderna Covis-19 Vaccine.  Reporter stated that his uncle had to go to ICU due to blood clots and died from  it.  No treatment medication information was provided.  This is a case of death of a Male subject who passed away two days after receiving the vaccine. Very limited information regarding the event has been provided at this time. No further information is expected.; Sender's Comments: This is a case of death of a Male subject who passed away two days after receiving the vaccine. Very limited information regarding the event has been provided at this time. No further information is expected.; Reported Cause(s) of Death: blood clots
This spontaneous report as received from a nurse practitioner refers to a 12 years old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 20-JAN-2015, the patient was vaccinated with the dose of GARDASIL lot # K008213 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion (incorrect product storage). No information on patient's concomitant medication was provided. Nurse practitioner confirmed that no adverse events were reported. This is one of several reports from the same reporter. Additional information has been requested.
Patient called pharmacy at 2:30PM on 6/13/21 stating that she was concerned she may be having allergic reaction to Pfizer COVID vaccine administered on 6/11/21. Patient states this AM she has developed a rash at the injection site. She describes the rash as being approx. 1 inch in diameter, raised, red, and hot to the touch. States rash looks similar to a spider bite. Patient denies the presence of a fever as well as facial swelling. Upon further discussion, patient states that shortly after receiving vaccine she experienced some shortness of breath and the sensation that her "throat is closing". She reports the SOB and "throat closing" sensation is still present during pharmacy call today. Patient also states she had a "weird taste in mouth" immediately following vaccine administration. Instructed patient to seek medical attention ASAP as SOB/ "throat closing" symptoms indicate possible allergic reaction to vaccine. Patient expressed understanding and said she would seek medical care.
Severe chills, shaking, heart racing, fever of 102, muscle aches, hoarseness and sore throat, excessive thirst.
Mother noticed inflammed, indurated area at injection site approx. 36 hrs post injection. child showed n o sign of fever or discomfort. Symptoms subsided by afternoon per mother.
Initial unsolicited report received from a nurse on 10-Jul-2018. This case involves a 10-year-old male patient who was vaccinated with a dose of 0.5 ml ADACEL (lot number: U5875AB, expiration date: 14-Feb-2020) via intramuscular in left arm on 18-Jun-2018. The patients past vaccination(s) included ADACEL on 06-OCT-2017, typhoid on 25-JUN-2014 and DAPTACEL with 5 DAPACEL doses. The patients past medical history, medical treatment(s) and family history were not provided. Concomitant medications included 0.5 ml TYPHIM VI intramuscular in right arm for Immunisation. It was an actual medication error due to extra dose administered. It was not reported that patient had any side effects. 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 Directive and Module VI of the 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. List of documents held by sender: none.
26 y/o male developed sub-sternal chest pain on day 13 following smallpox vaccination.  Symptoms were on and off x3 days lasting 20-30 min. and not associated with nausea, diaphoresis, dizziness or SOB.  Presented to cardiology office for evaluations and was referred to the emergency room. Elevated cardiac elevations, no significant EKG changes.  He was give IV nitroglycerin, Asprin and Lovenox.  He was diagnosed with myocarditis secondary to the smallpox vaccine and admitted x 2 days for further observation and treatment.
Systemic: Chills-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Additional Details: Patient received first dose of Pfizer vaccine by pharmacist with no issues/complaints. During the 15min observation period, patient noted she was dizzy and requested some water. Pharmacist immediately brought her back into the vaccination room to sit down and observe closer, at which point she slumped back in chair, tensed up & did not respond to verbal cues. EMS was called, and patient began vomiting upon coming to.
Pt reported not feeling well, so sat on mother's lap on floor. Pt said she was going to throw up which did not happen. She stopped responding to questions and briefly slumped forward. We continued to talk with her and once she was responsive again (just a couple of seconds) an ice pack was applied to her neck and she was offered water. Within 5 - 10 minutes she was standing and reported that she could walk on her own.
In May I had an unusually heavy menstrual cycle with excessive bleeding. In June the same thing happened. In July the same thing happened in addition to my cycle starting again for second time in July and it was very heavy. I seen gynecologist in July, and she sent me to do an ultrasound to see if I had fibroids causing the excessive bleeding but everything came back normal. Everything she has done has come back normal and she has no justification as to why. She did give me from my 2nd cycle in July some Provera which is a hormone medicine to stop the bleeding and that did work, and she said that means body is responding to it, but she has no idea what the cause is. Everything else is normal. I had gone to my medical doctor in May for routine checkup and he said my blood was very low (7.6) and I was iron deficient, and I ended up having to get an iron infusion. I did have to go to hospital because I was lethargic. In July when I had excessive bleeding again, I went to a hematologist and again my blood was at 7.6 and I had to get two iron infusions and he took a lot of blood work as well. PCP doctor, phone number.
10/7/09 After receiving Pneumonia shot in right upper arm - became swollen, red and hurt for 3 days later - large bruise remains to this date of 10/19 - Two days after getting shot - my chest felt very tight, with deep coughing to this day - ran temp of 100 for 2 days - mouth and nose itched for several days. Received Rx of Zithromycin for 5 days, cough medicine. Still have congestion and cough on this date. This was first pneumonia shot I had - never any problems w/ flu shots.
Patient let us know he has passed out from time to time for various reasons (spinning motion, certain foods, vaccines) but that he had had vaccines and done well with them in the recent past.  We administered the moderna shot and had him remain on the bench in front of the pharmacy.  Another patient alerted us to him fainting and I, the pharmacist, ran out there asap with epi pen and benadryl.  He was awake and sitting up when I got to him.   He was coherent and answered my questions.  He remained in the pharmacy area for about 30 minutes while we watched him and his ride came.
Very, very minimal spotting for period- basically didn't get a period for the last 2 months.
12/01/22 @ 0130- woke up with fever of 103.0, extreme shivering, & body aches. Shivering lasted 3+ hours. Took 1000mg of Tylenol 0600-fever of 100.0, shivering , body aches & pain in left arm below site. 1000- no fever, body aches w/ extreme bilateral hip pain, joints on elbows, knees & ankles lasting until 12/2/22.  12/02/22 @ 0900 extreme left arm pain, felt like in the bone, red rash about 1.5 inches below injection site started. Red rash about 3 inches in length & 1.5 inches wide. Rash lasted until 12/05/22. no blisters but raised like hives. 12/05/22- rash is gone but now tingling  & pain started on lower left forearm. still continuing on 12/7/22.