chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm; a really bad rash; really bad chills; the knot on her arm is about the size of a tennis ball; headache; coughing; sneezing; and extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), RASH (a really bad rash), CHILLS (really bad chills), NODULE (the knot on her arm is about the size of a tennis ball) and HEADACHE (headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (She had Corona virus in November and was hospitalized.) in November 2020. Concurrent medical conditions included Haemoglobin low. Concomitant products included WARFARIN and PREDNISONE for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), RASH (a really bad rash), CHILLS (really bad chills), NODULE (the knot on her arm is about the size of a tennis ball), HEADACHE (headache), COUGH (coughing), SNEEZING (sneezing) and FATIGUE (and extremely tired). At the time of the report, PAIN IN EXTREMITY (sore arm), RASH (a really bad rash), CHILLS (really bad chills), NODULE (the knot on her arm is about the size of a tennis ball), HEADACHE (headache), COUGH (coughing), SNEEZING (sneezing) and FATIGUE (and extremely tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, COVID-19: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications provided were cortisone cream and warm compress.
right sided pneumonia; having difficulty breathing; cyanotic; coughing; sounded congested; A spontaneous report was received from a nurse concerning a 92-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced right sided pneumonia, difficulty breathing, cyanotic, cough and sounded congested.  The patient's medical history, as provided by the reporter included Alzheimer's, hypertension, arteriosclerotic heart disease, hyperlipidemia, benign prostatic hyperplasia, prostate cancer, covid-19, allergy to aricept and exelon. The concomitant medications reported included atorvastatin, tamsulosin hydrochloride, paracetamol, macrogol 3350, furosemide and ipratropium bromide/salbutamol sulfate for unspecified indications.  On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 26 Jan 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 039k208) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 08 Jan 2021, the patient was on droplet isolation due to possible exposure of Covid 19 and received duoneb treatments for chronic nonproductive cough. The patient also received honey consistency fluids.  On 19 Jan 2021, the patient's droplet precautions were discontinued.  On 26 Jan 2021, after receiving the vaccine, the patient experienced difficulty breathing, cyanotic, cough and sounded congested following which the patient was repositioned. The  lab findings included oxygen saturation at 78 percent on room air, so oxygen was applied at 2L which increased oxygen saturation at 88 percent, so oxygen was increased to 4L and oxygen saturation increased to 95percent, body temperature at 103.1 degree Fahrenheit, blood pressure 188/110 mmHg, respiratory rate at 28 breaths per minute, pulse rate at 128 heartbeat per minute. The patient was then sent to the Hospital emergency room (ER) where he was diagnosed with right sided pneumonia.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome for the events, right sided pneumonia, difficulty breathing, cyanotic, cough and sounded congested was unknown.; Reporter's Comments: This case concerns a 92-year-old, male patient. The patient's medical history od Alzheimer's, hypertension, arteriosclerotic heart disease, prostate cancer, covid-19, on duoneb treatments for chronic nonproductive cough remains as contributing factors. Very limited information regarding this event  has been provided at this time.  Further information has been requested.
5 days, post vax, left upper arm became swollen, red, warm and painful. Area of redness 36mm X 48mm.
This spontaneous report as received from a physician refers to a baby of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with (wistar ra 27-3) M-M-R II (lot # and expiry date not reported) (dosing details were not reported) that was reconstituted with sterile diluent, intramuscularly for prophylaxis. The reporter stated that the vaccine started subcutaneously but the bay was kicking and some of the dose may have been intramuscular (incorrect route of drug administration). No adverse effects reported. No product quality complaint involved.
No additional adverse events reported; Nurse reporting a dose of Improperly stored VARIVAX has been administered to a patient; This spontaneous report as received from registered nurse refers to a 13-month-old patient of unknown gender. The patient's pertinent medical history, concomitant medications, past drug reactions or allergies were not reported.  On 24-JAN-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml dose, lot # U020244, expiration date 28-JUN-2023 (route of administration and anatomical location were not reported) for prophylaxis (product storage error). The temperature excursion was from 6 Fahrenheit degree up to 14 (13.8) Fahrenheit degree for 1 hour 45 minutes and 14 Fahrenheit degree up to 46 (14.4) Fahrenheit degree for 25 minutes. No previous temperature excursions were reported. No additional adverse events reported (no adverse event).
Information has been received from a nurse practitioner, concerning a 15 year old male patient, with no pertinent medical history, drug reactions or allergies, who on 17-NOV-2010 was vaccinated with his first dose of GARDASIL (lot #, dose and route not reported), on 10-JAN-2011 was vaccinated with his second dose of GARDASIL (lot #, dose and route not reported), and on 23-MAY-2011 was vaccinated with his third dose of GARDASIL (lot #, dose and route not reported). No concomitant medications were reported. Nurse practitioner reported that on approximately 24-NOV-2010, the patient developed swollen glands in his neck, joint pain and fatigue beginning after his first vaccination with GARDASIL, within one or two weeks of first vaccination. Physical therapy and MOTRIN was given as treatment for the events. Unspecified X-rays were performed (results not provided). The patient sought unspecified medical attention. At the time of the report, the patient's outcome was not recovered. Additional information has been requested.
Fever about 100 degrees F; chills; headache; nausea; This case was reported by a consumer and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, chills, headache and nausea. On an unknown date, the outcome of the fever, chills, headache and nausea were unknown.   It was unknown if the reporter considered the fever, chills, headache and nausea to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received both doses of Shingrix vaccine and experinced fever of 100 degrees.      Lab Comments: On an unknown date, the lab test was perform
No reaction at this time. Pt received Moderna COVID vaccine at 21-day interval instead of required 28-day interval (7 days early)
Given with flu shot, resulting in death within 13 days. Patient complained not feeling well after receiving vaccination.
Patient received VARIVAX on 7/26/1996. Patient was examined on 10/18/06. He had shingles in the left T/O dermatome.
Itchiness, rash, swelling, redness at injection site x 1 week post vaccination. Circular lesion, papule, approximately 5cmx4cm at largest. Improving but still present x 5 days (as of today).
At aprroximately 1030, began having heart palpatations, chest pain, and shortness of breath. She contacted her primary care provider who advised her to go to the Emergency Room since this was just a little over an hour since she received the vaccine. At the emergency room, they gave her IV fluids, pepcid, and benadryl. She was released home at 1430.
I received the vaccine at a clinic unknown to me.  I talked to my primary clinic about my symptoms and they thought that I probably was given the shot at the wrong site (either in the joint or bursa or the bone or a tendon) instead of in my deltoid muscle, based on my description of symptoms.  I had strangely severe arm pain (more severe than the many shots I've had before) almost immediately, and the pain got worse over time.  About five days later, symptoms had lessened so that I could use my arm some without pain.  Then I lifted weights using my arm, and the following day the severe pain to my right arm was back.  I am afraid that the injection won't be fully effective if it was erroneously put into my joint instead of muscle.  Please try to make sure this doesn't happen again to someone else.  Thanks!
health ruined; can't work or read a computer screen; ear thumping; vertigo; can't eat; extremely dizzy / dizziness; 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 VACCINATION COMPLICATION (health ruined), VISUAL IMPAIRMENT (can't work or read a computer screen), EAR DISCOMFORT (ear thumping), VERTIGO (vertigo) and FEEDING DISORDER (can't eat) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 VACCINATION COMPLICATION (health ruined), VISUAL IMPAIRMENT (can't work or read a computer screen), EAR DISCOMFORT (ear thumping), VERTIGO (vertigo), FEEDING DISORDER (can't eat) and DIZZINESS (extremely dizzy / dizziness). At the time of the report, VACCINATION COMPLICATION (health ruined), VISUAL IMPAIRMENT (can't work or read a computer screen), EAR DISCOMFORT (ear thumping), VERTIGO (vertigo), FEEDING DISORDER (can't eat) and DIZZINESS (extremely dizzy / dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter. No treatment details were provided.
Expired vaccine was stored at room temperature; No Adverse Event; Patient was administered vaccine past the expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered vaccine past the expiration), PRODUCT STORAGE ERROR (Expired vaccine was stored at room temperature) and NO ADVERSE EVENT (No Adverse Event) 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)) (batch no. 052D22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Dec-2022, 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 29-Dec-2022 at 8:30 AM,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered vaccine past the expiration). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine was stored at room temperature). an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered vaccine past the expiration), PRODUCT STORAGE ERROR (Expired vaccine was stored at room temperature) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient was administered vaccine past the expiration) and PRODUCT STORAGE ERROR (Expired vaccine was stored at room temperature).    No concomitant medications were reported.   The patient was administered vaccine past the expiration. Dose administered more than 12 hours post puncture. The size of the vial was reported as 2.5 ml. The vial was initially stored in refrigerator on 20-Dec-2022 and was punctured on 28-Dec-2022 11:20 AM and was administered on 29-Dec-2022 at 08:30. The vial was stored at room temperature post puncture. The vial did not undergo any temperature excursion. The vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) for 18 hours.  No treatment details were reported.   Reporter did not allow further contact
10 day after I suddenly got freezing cold, then achy joints and muscles, nausea, slight diarrhea, fever up to 101, thirsty,. This lasted 12 hours then I was ok except I got a red, itchy,stinging, strawberry rash all over my torso lasting 18 hours more. UCSF had me come in the next morning for a PCR test which was COVID negative. My kids and partner did not get sick so I knew it was not the flu.
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. No relevant medical history of the patient was reported. On 27-JAN-2015 the patient was vaccinated with an expired dose of MMR II (albumin status was unknown) (lot # H014988, expiry date 10-AUG-2014) 0.5 ml, subcutaneous. There were no concomitant medications reported. The patient experienced no adverse effects. There was no product quality complaint involved. The outcome was unknown. Additional information has been requested.
Dizziness started approximately 30 minutes after injection, weakness approximately within two hours along with extremely tiredness.  Muscle pain in left leg started approximately 24 hours after injection.
Swelling and soreness at injection site. Swelling and tenderness in underarm area/lymph nodes
Pt admitted to hospital with Takotsubo cardiomyopathy, with LV EF decreased to 35% 2 weeks after her dose of the Moderna Vaccine.  Elevated serum cardiac markers (troponin I to ~ 10)
Rash, fever, chest pain, - started 10/16/14 around 9 am.
chills; weakness; This is a spontaneous report from a non-contactable consumer (patient). A 70-year-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) lot number and expiry date unknown, via unspecified route of administration on Jan2021 at single dose for Covid-19 immunization. Medical history included covid prior vaccination. The patient's concomitant medications were not reported. In Jan2021, the patient experienced chills, weakness. The patient has not been tested since the vaccination. The patient did not receive treatment due to the events. The outcome of the events was recovered. The reporter considered the events non-serious; did not results in death, not life threatening, did not cause/prolong hospitalization, not disabling/incapacitating, no congenital anomaly/birth defect.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient received vaccine and was waiting out her 15 minutes. Right at her 15 minute mark, patient states she felt itchy all over. Vital signs were taken. BP 98/71. States her head felt like it was in a haze. Skin was red and flushed. After a minute or 2, stated her throat felt itchy and tight. Clinical assistance code called over the PA system. Patient was taken to the ER via wheelchair for further evaluation and monitoring. In the ER, was given diphenhydramine 25 mg, famotidine 20 mg, and methylprednisolone 4 mg all PO. Following medication administration and monitoring, patient states her symptoms had subsided and she was feeling better, so she was released from the ER.
Patient was vaccinated at a non-approved age (Moderna is indicated for 18 years and older) on January 18, 2021.
She stated she felt upper lip tingling and a headache. She said she did not feel itchy or had any difficulty breathing. I took vital signs: HR: 64, BP 128/92, O2: 100%. Observed for additional 15 minutes. She stated that she felt better and decided to go home. I recommend that she check in with her health care provider if symptoms come back or worsen.
7.17.21: patient diagnosed with COVID-19 3 days prior, presents to ED with worsening "flu like symptoms" over past 2 weeks including fatigue, malaise, generalized body aches, dyspnea, dry cough, and CP, and hallucinations over last 24 hrs. Patient was previously vaccinated with COVID-19 J&J vaccine on 4/6/21. Diagnosed with: COVID-19 pneumonia, acute resp distress with hypoxia, poorly controlled DM. received remdesivir. 7/22/21: discharged
Patient traveled abroad and as she was getting on the plane to return, she noticed a tickling in her throat. Afterwards, she became sick with Covid. She tested herself for Covid and it was positive both times. She went to see the doctor and was prescribed a z-pak and benzonatate. However, she wasn't hospitalized. Called to pharmacy to confirm if she was given correct updated vaccine (she did) and complain that the vaccine didn't work. Was reminded that the vaccine helps to prevent hospitalization and death
After the vaccine, I started feeling sluggish and tired and got a real bad headache. And I decided to go to bed. The headache lasted all night and part of the next day. No fever. I was tired the next day and then I was okay. About a week later, on the 17th, I noticed heart palpitations. I called my doctor to ask if I should come in. She thought I should come in if it lasted a few more days. I had the palpitations about four days and then they went away.
This spontaneous report was received from a health care worker (certified medical assistant) refers to patients of unknown age and gender. The patients medical history and concurrent conditions were not specified. The reporter stated that, multiple unspecified patients received improperly stored doses of M-M-R II (lot # L012479, expiry date 10-APR-2017, dose, strength, dose number, vaccination site and route not provided) on unspecified dates. Concomitant medications were not specified. Additionally 32 doses of M-M-R II were administered to these patients on unspecified dates. No adverse effects were reported. The vaccines were exposed to temperature of 50.03 F for a time period of 48 hours. There as no previous temperature excursions. No additional information was provided. Product quality complaint (PQC) was not reported. This is one of two reports received from the same reporter. Additional information has been requested.
Soreness at injection site-started 4 hours after injection, lasted about 36 hours Fatigue- started next morning 9am. Lasted off and on about 48 hours Hot flashes- started about 6 hours after injection. Totally random times lasting 5 minutes to 30 minutes each without fever over the next 84-96 hours Headache- 48 hours after injection. Off and on over next 48 hours Irritability- started 30 minutes after injection. Has been 105.5 hours and is still occurring.
Information has been received from a health care worker concerning a female patient in her late 60's who on 9/28/04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (647359/0740N). Concomitant therapy included influenza virus vaccine (unspecified), it was unknown when the flu shot was given. On 9/30/04, the patient developed lymph node swelling and fever. It was noted that one patient had gone to the emergency room. It was also noted that the patient was hospitalized. The outcome was not recovered. The reporter also mentioned 4 other female patients who were also vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (647359/0740N) and developed similar reactions. No product quality complaint was involved. Lymph node swelling and fever were considered to be immediately life threatening and disabling. Additional information has been requested.  Follow up on 10/18/04 states: "Information has been received from a health care worker concerning a female pt in her late 60's who on 09/28/04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (647359/0740N). Suspect concomitant therapy included influenza virus vaccine (Fluzone), in the same arm, which was administered on the same day. On 09/29/04 the pt developed lymph node swelling and fever.  The pt was seen in the ER. It was noted that the pt was hospitalized. At the time of the report, the pt had not recovered. The reporter expressed concern with Lot 0740N.  Lymph node swelling and fever were considered to be immediately life-threatening and disabling. Additional information has been requested." Follow up 03/03/05: Patient has not recovered from the adverse event(s).
presents with mom's concern about vaccine reaction. Child was vaccinated at 10:30 this morning and at 11:30 she started to have fever and feel ill. She has had rapid heart rate, breathing fast and now nausea. Mom gave 3/4 tab of tylenol but child does not want to take it.  Mother reported patient slept and woke the next morning with no symptoms
The pt complained of pain and itching at the injection site on the left deltoid. The site was red and warm circle around injection site that was 20mm in width. No complaint of fever, chills and no drainage at site.
Case number PHEH2014US003594, is an initial spontaneous report from a pharmacist received on 20 FEB 2014. This report refers to a 15-year-old female patient. Past medical history and concomitant medications were not reported. She was inadvertently vaccinated with FLUCELVAX 2013/2014 (batch number: 006031A) intramuscularly on 23 NOV 2013. It was reported that she did not experience any adverse reactions due to the maladministration (inappropriate age at vaccine administration).  Following an internal review on AUG 2014, a significant correction was done for the information received on 20 FEB 2014. The BPI labeling of the event " inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Swelling and redness around injection sites. No itchiness. Hurts upon palpitation.