chrisvoncsefalvay/vaers-outcomes huggingface dataset:
everything smells like manure; urine smells terrible; very tired; This spontaneous case was reported by a consumer and describes the occurrence of PAROSMIA (everything smells like manure), URINE ODOUR ABNORMAL (urine smells terrible) and FATIGUE (very tired) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027a21a) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAROSMIA (everything smells like manure), URINE ODOUR ABNORMAL (urine smells terrible) and FATIGUE (very tired). At the time of the report, PAROSMIA (everything smells like manure), URINE ODOUR ABNORMAL (urine smells terrible) and FATIGUE (very tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment and concomitant drug information were provided
Within I hour, hurt to open eyes, eye tissues swollen; could not read or watch tv; migraine ; thirsty; muscles and joints hurt all over body; nauseous ; L deltoid extremely sore(worse than a tetanus shot); deltoid swollen, could not lay on arm, felt sick like a flu; felt weak; nauseous; little strength ; HR and BP increased
Confusion; Very Sick; no energy; High Fever over 103; Fatigue; Vomiting; This spontaneous case was reported by a non-health professional and describes the occurrence of CONFUSIONAL STATE (Confusion), ILLNESS (Very Sick), ASTHENIA (no energy), PYREXIA (High Fever over 103) and FATIGUE (Fatigue) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Encephalopathy on 16-Sep-2019, Drug overdose on 16-Sep-2019, Drug overdose on 15-Sep-2019 and MRI brain abnormal on 21-Sep-2019. Concurrent medical conditions included Bipolar disorder since 21-Sep-2019. Concomitant products included QUETIAPINE FUMARATE (SEROQUEL), CLONIDINE HYDROCHLORIDE (CATAPRES [CLONIDINE HYDROCHLORIDE]), SALBUTAMOL SULFATE (VENTOLIN HFA) and NALOXONE HYDROCHLORIDE (NARCAN) for an unknown indication.    On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CONFUSIONAL STATE (Confusion), ILLNESS (Very Sick), ASTHENIA (no energy), PYREXIA (High Fever over 103), FATIGUE (Fatigue) and VOMITING (Vomiting). At the time of the report, CONFUSIONAL STATE (Confusion), ILLNESS (Very Sick), ASTHENIA (no energy), PYREXIA (High Fever over 103), FATIGUE (Fatigue) and VOMITING (Vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 High fever. On an unknown date, SARS-CoV-2 test: Negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment medication information was provided.   This case was linked to MOD-2022-599461 (Patient Link).
Moderate rash, red with raised white white spots, starting around midsection 2 hours after shot. Symptom abated with 5mg Children's Benadryl, persisted into next day at time of this report with rash presenting in various places all over body. No respiratory distress.
Pt. began having SOB shortly after vaccination. The pt. reported having difficulty breathing and 0.3mg epi SQ was administered by on site medic team. The patient had 95-100% 02 sat and left in stable condition with a reported 135/80 BP with 110 HR.
Pt devel severe pain, erythema, & induration @ inject site p/receiving Typhoid vax;
extreme joint and muscle aches (ankles,elbows,hips,lower back,calves were the worst)/aches and joint pain continued but less intense, arches of feet to fingers, hips and lower back were most prominent; extreme joint and muscle aches (ankles,elbows,hips,lower back,calves were the worst)/aches and joint pain continued but less intense, arches of feet to fingers, hips and lower back were most prominent; extreme joint and muscle aches (ankles,elbows,hips,lower back,calves were the worst)/aches and joint pain continued but less intense, arches of feet to fingers, hips and lower back were most prominent; fever/low grade fever; nausea; gas which lead to vomiting; gas which lead to vomiting; extreme joint and muscle aches even after 1gm of Tylenol (ankles, elbows, hips, lower back, calves were the worst)/ lower back pain; chest similar to what one would experience during hyperventilation; tingling feeling in hands/fingers, lips; tingling feeling in hands/fingers, lips; headache; Slept most of the day evening; This is a spontaneous report from a contactable nurse (reported for herself). A 37-year-old female patient (not pregnant) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration on 08Jan2021 10:15 at single dose at right arm for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication received in two weeks included lisdexamfetamine mesilate (VYVANSE) in two weeks (did not take on vaccine days). The patient previously received the first dose of bnt162b2 (lot number: EJ1685) on 18Dec2020 10:00 at single dose at right arm for COVID-19 immunization. No other vaccine in four weeks. On 09Jan2021 12:00, 12hrs after injection extreme joint and muscle aches even after 1gm of Tylenol (ankles, elbows, hips, lower back, calves were the worst), fever, nausea/gas which lead to vomiting (even after 25mg phenergan) and headache this last 6hrs. The aches and joint pain continued but less intense, arches of feet to fingers, hips and lower back were most prominent. Tylenol did not relieve symptoms, but was able to sleep. Slept most of the day evening in Jan2021. 48/60hrs after injection the lower back pain remains intense as well as low grade fever (Jan2021). Also have a tingling feeling in hands/fingers, lips, chest similar to what one would experience during hyperventilation on 09Jan2021 12:00. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The patient didn't have Covid prior vaccination and didn't have Covid tested post vaccination. The outcome of Arthralgia and Pain in extremity was recovering, of Pyrexia and Low back pain was not recovered, of the other events was unknown.
Individual was given standard dose of Moderna instead of booster dose.  After it was identified of the incident occurring, the individual was directly notified of the situation and received guidance on what to expect/look out for the next 48-72 hours.  Current questions/concerns answered.  Individual instructed to continue to monitor side effects and if something additional or more serious occurs, they should go seek medical attention. Patient was given a contact at the clinic to reach out to if there were any additional questions/concerns or felt the need to be evaluated.
Pt reports pain and weakness on the left arm starting the day after immunization. Pain level of 8 out of 10. No relief with TYLENOL.
This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Apr2021 at 10:45 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 00:00, the patient experienced headache, pain in arm and increased tinnitus. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of headache, pain in arm and increased tinnitus were recovering at the time of reporting.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient reported to pharmacy on Monday 10/25/21 stating that, that morning she noticed discoloration of her lips (more brown that normal).  She states she does not ever wear any type of make-up or put anything on her lips that would cause this.  She states that she thinks it may be a result of the vaccine but that this did not occur for her first two doses.  She states it does not hurt.  She has made her doctor aware.
Starting 12/31/22 in the morning with minor cough, tiredness and a feeling in my chest. I tested myself and got positive. Then I saw an ENT around 22MAR2023 I felt dizzy and weak on my arms and thought I was having a heart attack. He took my blood pressure and EKG was good. 24MAR23 you felt dizzy more frequently when I move my eyes or head around and it was persisted as I am moving around. I am going to see my doctor again soon.
11/18/2021 AM :Pain, itching, redness and swelling at injection site. Headache, muscle aches, malaise, low grade temp, nausea. PM: Pain, redness and swelling at injection site extending to left shoulder, supraclavicular, ROM difficult. Headache, muscle aches, malaise, low grade temp, nausea, emesis. Notified nurse manager/FHS. Treatment: OTC Motrin, Tylenol, rest, elevate, ice pack or warm compress prn 11/19/2021 -11/21/2021 AM/PM  Pain, redness and swelling at injection site. Increased pain and swelling left: shoulder, neck, and armpit. Significant swelling left supraclavicular. Treatment: OTC Motrin, Tylenol, rest, elevate, ice pack or warm compress prn 11/22/2021 AM/PM  Continued Pain itching and tenderness, area firm, decreasing redness and swelling at injection site. Increased pain and swelling left: shoulder, neck, and armpit. Significant swelling left supraclavicular. Limited ROM left shoulder. Headache, malaise. Treatment: OTC Motrin, Tylenol, rest, elevate, ice pack or warm compress as needed.
This is a spontaneous report from a non-contactable consumer (Pfizer employee). A patient of unspecified age, ethnicity and gender received a single dose of PREVNAR, via an unspecified route of administration, on an unspecified date for immunization. The patient medical history and concomitant medications were not reported. The patient's arm was swollen significantly on an unspecified date. The clinical outcome of arm was swollen significantly was not reported. No follow up attempts possible. No further information expected.
5 cm x 3 cm erythematous, swollen area to left, posterior, upper arm. States area is itchy. Taking BENADRYL and applying topical cortisone cream 4 times/day.
Employee reported "tongue thickness"  and dry mouth. Employee was taken to ED for evaluation and treatment.
Headache; a tender lump suddenly appeared either at the injection site; rash; left arm was slightly sore; This is a spontaneous report received from a contactable consumer (Patient) via a program.  A 48-years-old female patient received bnt162b2 (COMIRNATY, PFIZER BIONTEC MRNA COVID-19 VACCINE, solution for injection, Batch No. not reported/Lot Number: EW0175) via an unspecified route, administered in left arm on 22Apr2021 at 10:00 AM (Age at vaccination 48 years old) as dose 2, single for covid-19 immunization. The patient medical history reported as none and concomitant medications was not reported. Family Medical History Relevant to AE were reported as none. Patient has received prior Vaccinations included Pfizer dose 1 within 4 weeks. AE(s) following prior vaccinations were reported as none. The historical vaccine included bnt162b2 (COMIRNATY, PFIZER BIONTEC MRNA COVID-19 VACCINE, solution for injection, Batch No. not reported/Lot Number: EP6955) via an unspecified route, administered on 30Mar2021 at 10:00 AM in left arm as dose 1, single for covid-19 immunization. Patient would like to discuss a delayed reaction to 2nd Pfizer vaccine. It was reported that, patient received second Pfizer COVID shot two weeks ago. On 22Apr2021 the day of vaccination, Patient experienced with his left arm was slightly sore and on 05May2021, at 12:00, the patient experienced a tender lump suddenly appeared either at the injection site or very close to it, patient found some information regarding delayed cutaneous sensitivity, but it seems to be related more to a rash appearing about a week out and on 06May2021, with headache. AE did not require a visit to Emergency Room and Physician Office. The reporter wanted to know whether or not this might be vaccine related. No Investigation assessment was reported. Relevant Tests were reported none. Treatment taken reported as None. The outcome of the event left arm was slightly sore was recovered on 24Apr2021, tender lump in her left arm close to where she was vaccinated, headache was not recovered, and rash was unknown.  Follow-up attempts are completed. No further information is expected.
Client was given expired vaccine but it was not know until after the family left and the nurse was charting the vaccine administration. No signs or symptoms were noted in the office. Family was  later notified of incident  approx 45 minutes later and child remained symptom free.  Office physician was notified.
Headache; A spontaneous report was received from a consumer concerning a adult female patient of unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unspecified date, the patient received their first of two planned doses of mRNA-1273 (unknown batch number) for prophylaxis of COVID-19 infection.  On 25 Jan 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (unknown batch number) in intramuscular, for prophylaxis of COVID-19 infection.  On 27 Jan 2021, the patient experienced the event headache.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event headache was unknown.; Reporter's Comments: Based on the information provided and the established safety profile of mRNA-1273 vaccine, a causal association between the event of headache and the product use cannot be excluded.
Chills, Fever , intense nausea, head ache  , general. pain over whole body. starting with a head ache around 9 pm, took ibuprofen . intense  nausea following around 11 pm.  Chills and fever started around 7 am tool Tylenol and more ibuprofen
This spontaneous report as received from an administrator refers to a patient of unknown age. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 16-OCT-2018, the patient was administered a dose of PROQUAD (lot # R006216, expiry date: 28-AUG-2019) following a temperature excursion for prophylaxis. Dosing details and route of administration were unknown for the vaccine. The sterile diluent used for reconstitution did not have a temperature excursion. No adverse effect reported. The temperature excursion occurred at 68 degrees Fahrenheit (F) for a time frame of 43 hours. No previous temperature excursions occurred. There was a data logger involved. No product quality complaint was involved. Sender's Comments: US-009507513-1810USA012914: US-009507513-1810USA013008.
yellowing; swelling; pain; This case was reported by a pharmacist via call center representative and described the occurrence of yellow skin in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 74A7L, expiry date 22nd October 2021) for prophylaxis.   On 30th July 2019, the patient received the 1st dose of Shingrix (intramuscular). In July 2019, less than a day after receiving Shingrix, the patient experienced yellow skin, swelling and pain. On 1st August 2019, the outcome of the yellow skin, swelling and pain were recovered/resolved.   It was unknown if the reporter considered the yellow skin, swelling and pain to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that a patient experienced yellowing, swelling and pain under her armpit after receiving Shingrix.  The patient did not have any symptoms in her arm. The symptoms started within 24 hours of receiving Shingrix and proceeded to resolve within 24 hours. The patient did see her doctor about the symptoms. The patient did receive her 2nd dose on 24th October 2019 and has not reported any adverse events. Emergency room visit required.
Monday morning, I was feeling tired and had a really bad head cold. I thought I was getting a sinus cold and congestion because I could feel sinus pressure. I rested all of Monday in bed because of my body chills and slight diarrhea. The next day, I developed a fever and cough. I stayed up all night coughing. I took an at-home COVID-19 on 03/21/2023 which came back positive. So I called my doctor, informed him of my status, and was prescribed Paxlovid. I was told to stop taking Atorvastatin when beginning my prescription and take Mucinex with the prescription. I also used a neti pot to help with my congestion. By day 3 of my prescription, I began feeling better. By day 5 of yesterday, I'm up to 85% full recovery and still making improvements.
Patient had redness/rash beginning the morning after injection. Patient was seen by Dr. and there was concern for erysipelas. Patient was treated conservatively with Amoxicillin 500mg TID x 7 days.
Sudden Cardiac Arrest, needed to be defibrillated twice. Life support for 2 days. No previous health issues. Hospital stay for 7 days. ICD implanted.
Moderna COVID-19 Vaccine. Headache and nausea onset 12 hours after vaccine was given. Chills/body aches and fever were present 18 hours after injection. Fever remained between 101.2 and 102.4, with a spike of 103.4 on 1/14/2021. Headache and nausea lasted approximately 24 hours, while fever and chills/body aches lasted for 5 days after vaccine was administered. An Emergency Room visit to Hospital was made on 1/15/2021 into 1/16/2021 for these symptoms since they had lasted over 48 hours. Negative on all tests, with elevated inflammation levels. X-ray and CT scan of chest revealed no pneumonia or blood clots.
Information has been received from a physician concerning a 24 month old female who on 23-MAY-2008 was vaccinated with her first dose of 0.5 mL VARIVAX (Oka/Merck) (Lot 660217/0167X) injection (site not reported).  On 06-NOV-2008 the patient experienced minor case of chicken pox.  The patient recovered "within the last week or two."  Unspecified medical attention was sought.  There was no product quality complaint.  No further information is expected.
Patient experienced swelling of injection site and upper arm. Significant redness of the area soreness of arm, and a large bruise, and fever/chills. Patient treated reaction with BENADRYL and all symptoms resolved within a few days.
was called to waiting room because it appeared the patient was having a seizure.  When reached the patient, she was slumped over in her chair, diaphoretic, and pale.  She was initally responsive and reporting feelng "shaky".  Patient briefly became unresponsive which promped 911 EMS call.  While waiting for EMS, pt blood pressure taken (88/66) as well was pulse (55).  Patient regained consciousnesses about a minute after becoming unresponsive.  Smelling salts administered and cold rag placed on back of patient's neck.  Once EMS arrived, they removed patient via stretcher from the clinic and were encouraging her to seek treatment in the ER.  Unsure if patient was actually taken to ER or UC since she was removed from the facility.
18NOV92 pt recvd 1 dose of Engerix-B; 19NOV91 c/o joint pain, neuritis in legs & eyes hurt; vax was discontinued;
Admitted to hospital 3/13 with encephalopathy for monitoring.  Discharged 3/14.  At the beginning of ED visit, Patient did not know her daughter's name. She was unable to lift her legs at home when daughter tried to help patient to dress. At ED patient was given Tylenol and fluid. Patient now recognizes her daughter and was able to get up to the bathroom with only minor assistance. During encounter, patient is awake and able to follow directions. Patient is not oriented to time, though she know she is in the hospital. Patient states that she had COVID this morning and that is the reason why she was in the hospital. Daughter at bedside helped history. Patient received 2nd Moderna COVID 19 vaccination yesterday. Daughter called but patient did not respond at noon. daughter went over to see the patient. Patient could not finish the sentence to questions. Patient could not get her dressed up by herself. Patient went to bathroom for urination but she wiped the toilet, and folded the towel. But she did not do what she was there for. Also she could not life her legs to get helped to get dressed to come to the hospital. Now patient is able to shuffle to the toilet. Now she is able to answer her name and birthday. But still patient looks confused and not her baseline. Patient has difficulty remembering her medications. Patient does remember her children's name and home address. Patient lives alone at home and daughter wishes patient to be monitored as she has not recovered completely.  Hospital Course/Treatment Rendered 78/F, CC : altered mental status PMHx Endometrioid adenocarcinoma stage IA, grade 2, status post hysterectomy and BSO on 04/06/2015. Diabetes type 2. HTN. HLD. Altered mental status, Encephalopathy, metabolic, likely related to COVID 19 vaccination. Neuro status as well as hemodynamics been monitored. Fall precaution. PT/OT was consulted for home safety evaluation as patient lives alone. Neurology, Dr. was consulted. Patient refused lumber puncture in ED. CT chest - no pneumonia or Pulmonary embolism. UA - ketone positive and dehydrated but no UTI. In the morning of 3/14/2021, patient has improved and mental status back to baseline. PT deemed patient able to go home safe. Uncontrolled hypertension at ED. Gentle hydration as patient has dehydration(urine specific gravity 1.026) and continue antihypertensives such as losartan. SBP 145-165mmHg, Asymptomatic. Will continue home medication. High D-dimer. CTA chest - excluded DVT. Venous duplex US of Both Lower extremity in AM done and no evidence of DVT. Type 2 Diabetes Mellitus. continue to monitor blood glucose and continue glipizide. controlled with blood glucose 188-135.
14JUN96  8-10AM pt recv vax;15JUN96 evening fever 102R started APAP;16JUN96 t103 R & rash everywhere similar to rash in JAN but less;17JUN96 sores in mouth-took to urgent care-MD thought it is pertussis rxn;19JUN96 blisters on toes to MD;
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history, drug reactions, allergies and concurrent conditions were not reported. On unknown day in June 2016, (reported as "one day this week on an unspecified date") the patient was vaccinated with a one dose of improperly stored VARIVAX lot # L046888, expiration date: 23-NOV-2017, (route of administration, anatomical location and dose were not reported). Concomitant therapies were not reported. No adverse effects were reported. Additional information has been requested.