chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse referred to unspecified number of patients of unknown ages and genders. On unspecified dates in 2014, doses of ROTATEQ (Lot# and expired date unspecified) and other vaccines (captured in MARRS#1409USA008509, 1409USA008512, 1409USA006676, 1409USA008510, 1409USA008511, 1409USA008514) were administered to unspecified patients (doses, frequency and route unspecified), after exposed to temperatures of 10 C degree for 37.5 hours/temperature excursions with other vaccines on 08-AUG-2014, 13-AUG-2014 and 28-AUG-2014. No adverse effect has been reported. This is of the several reports from the same source. Additional information has been requested.
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe
Redness, swelling and hot to touch (6.5 x 4.5 cm).
10/16/13 at 3:55PM patient called and talked with a nurse:  Patient had flu and PPSV23 vaccines on 10/14/13, developed swelling in arm Monday evening and increased swelling and redness on Tuesday.  States that today that entire arm is red and it feels like my arm is going to fall off.  Also has nausea and vomiting today.  Recommended to go to the ER/Urgent Care and schedule a follow-up visit (here) for later this week; patient voiced understanding and transferred to scheduler for appointment. At 8:58AM patient returned my call and said he did go to Urgent Care.  Was informed by them that it was just a fluke with the injections to the muscle - might have flinched when got the injection.  He said it resolved in 4-5 days and completely normal in 7-8 days. He said symptoms started that evening (14th) and definitely the next day. Note:  Patient no showed follow-up appointment with us and there is no documentation that he went to the ER/Urgent Care anytime that week.
Lump in right arm where she got the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Lump in right arm where she got the shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer stage IV and Lymphedema (lymphedema in left arm).    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, the patient experienced VACCINATION SITE MASS (Lump in right arm where she got the shot). At the time of the report, VACCINATION SITE MASS (Lump in right arm where she got the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment details were provided.
Chills; fever; muscle aches; rash on injection arm local to injection site (left deltoid). Chills; fever; muscle aches lasted for approximately 24 hours. Rash did not appear until 48 hours after injection. Still present at the time this form was completed.
Patient notified pharmacy on 10/4/17 of a sore and throbbing left arm at site of injection and radiating down arm.
Information has been received from a physician concerning a male patient "in his 60's" who on an unspecified date, was vaccinated with a dose of PNEUMOVAX 23 (Lot No. not reported) in his right arm. About 10 hours after vaccination the patient had symptoms of 101.5 degree fever, chills and rapid breathing. The injection site had swelling and redness. The patient also received a dose of ZOSTAVAX (Merck) (Lot No. not reported) on the same day as PNEUMOVAX 23 but in his left arm. The injection site area of the ZOSTAVAX (Merck) was sore. On an unspecified date, white count was 16,000. The patient sought medical attention at office visit. At the time of the report, the patient had not recovered from the events. Additional information has been requested.
Fevers to 102, erythema, pain at site within 24 hours.  Treated with Benadryl and Motrin.
Administered first & second dose vax following second dose legs felt heavy & ached fr the mid-thigh down; inc in severity for 3 days tx Naproxen; Also extreme fatigue & sneezing;
Patient had two separate incidents within 6 weeks of receiving COVID vaccination where he presented to ED and was subsequently hospitalized. The first incident occurred on 3/26/21, the second on 4/5/21.
The next day after receiving the vaccine, I felt tired, and my arm hurt for a day. On 07/17/2022, I started developing sores (like canker sores) in my mouth. They started on my tongue, check, under my tongue and on my gums. I have been to two primary care physicians, my dentist, an ENT doctor and I have an appointment on 01/16/2022 to see a rheumatologist. In late August 2022, my lymph nodes started swelling and hurt in my neck. I have lost 30 pounds because I cannot eat. For the November holiday, I was able to eat but the following Monday, the sores came back for about three days. As of today, I'm having a good week without any sores. My appointment with the rheumatologist is to check for an autoimmune disease. The November holiday I was able to eat. The following Monday I had mouth sores are worse.
Chills,nausea,headache, fever,body aches,dizziness,diarrhea and tiredness
The patient had not completed her primary series.  The bivalent Moderna Covid Vaccine was given instead of the monovalent. No adverse events reported at this time.
Vaccine was initially stored in the refrigerator on 15-Jul-2022 and administered on 19-Aug-2022; No adverse event; Received expired 2nd booster dose after 30 day beyond use expiry date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired 2nd booster dose after 30 day beyond use expiry date), PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 15-Jul-2022 and administered on 19-Aug-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired 2nd booster dose after 30 day beyond use expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 15-Jul-2022 and administered on 19-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired 2nd booster dose after 30 day beyond use expiry date), PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 15-Jul-2022 and administered on 19-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received expired 2nd booster dose after 30 day beyond use expiry date) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 15-Jul-2022 and administered on 19-Aug-2022).    Concomitant medications details were not reported by the reporter. Patient received the second booster dose. Reportedly 4 doses and 3 vials were initially stored in the refrigerator on 15-Jul-2022. Two patients received Moderna COVID-19 Vaccine on 19-AUG-2022. The vials had not undergone any temperature excursions. Treatment details were not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-631699 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-631699:Adult patient 1
Day 1: Symptoms began with dizziness when getting up from a reclined position. Day 2: Mild vertigo symptoms began to appear throughout the day. Location of shot on upper arm began to itch; rash appeared. Itching worsened.  Day 3: (Today) Feeling vertigo with head movements. Rash area is larger and red -- about the 3" diameter.
Passed out/ Status post syncopal episode; Double vision; Diagnosis of static vision; Hypothyroid; Diarrhea; Injection site pain; Headache; A spontaneous report was received from a healthcare professional concerning a 48-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hypothyroidism, passed out/status post syncopal episode, diarrhea, injection site pain, headache, static vision/double vision.  The patient's medical history was not provided.  Concomitant medication history was not provided.  The patient received their first of two planned doses of mRNA-1273 (batch number: unknown) on 24 DEC 2020.  On 21 JAN 2021, the patient received their second of two planned doses of mRNA-1273 (batch number:  028L20A) intramuscularly for prophylaxis of COVID-19 infection.  The patient developed injection site pain and diarrhea after the second dose. She continued to have the headache from the first dose that was administered. On 03 FEB 2021, the patient experienced double vision and dizziness while driving to work. The patient passed out at work and was admitted to the hospital. A CT of the brain showed no acute findings and her CT angiography was normal. The patient was discharged in less than 24 hours with the diagnosis of static vision, hypothyroid and status post syncopal episode.    Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event passed out/status post syncopal episode and static vision/double vision were resolved. The outcome of the events hypothyroidism, diarrhea, injection site pain, and headache were unknown.; Reporter's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.; Sender's Comments:  MOD21-024368:Crosslinked: Same reporter MOD21-024340:Crosslinked: Same reporter MOD21-024343:Crosslinked: Same reporter MOD210-24360:Crosslinked: Same reporter MOD21-024387:Crosslinked: Same reporter MOD21-024396:Crosslinked: Same reporter MOD21-024411:Crosslinked: Same reporter
Resident found unresponsive without pulse, respirations at 04:30 CPR performed, expired at 04:52 by Rescue
COVID Vaccine Breakthrough Case  J&J Dose 5/4/21 (201A21A COVID Positive 11/21/21  11/21/21: Patient is a 59 year old male presented to ED via EMS from a facility with reports of shortness of breath.  The patient has felt unwell for the past 3 days.  He has had body aches, productive, wheezes, shortness of breath and decreased appetite and oral intake.  He was recently started on a course Azithromycin and albuterol but has not had no improvements in his symptoms.  He developed increased shortness of breath today and is reported to ED for further evaluation.  He denies any abdominal pain, nausea vomiting or diarrhea.  He does endorse some chest tightness especially with inspiration.  He was COVID vaccinated with Johnson and Johnson approximately 6 months ago.  He has a past medical history significant for hypertension, morbid obesity, type 2 diabetes mellitus, asthma and coronary artery disease status post stenting & CABG.  On arrival to ED patient was febrile 101.2 saturating at 95% on 2 L NC.  Laboratory findings were significant for hyponatremia 132. Hypomagnesemia 1.2.  Lactic acidosis 4.9. ProBNP 491. Anemia 11.4.  Hyperglycemia 196. Rapid COVID positive. Chest x-ray showed cardiomegaly and pulmonary vascular congestion.  Patchy bibasilar airspace disease could represent atelectasis versus infiltrates. Levaquin was initiated in ED.  Patient received DuoNeb treatment and Solu-Medrol, as well as acetaminophen in ER.  IV hydration was given with NS 0.9% 2 L bolus.  11/30/21:  Patient is a 59 year old male presented to EDwith reports of shortness of breath.  The patient has felt unwell for the past 3 days.  He has had body aches, productive, wheezes, shortness of breath and decreased appetite and oral intake.  He was recently started on a course Azithromycin and albuterol but has not had no improvements in his symptoms.  He developed increased shortness of breath today and is reported to ED for further evaluation.  He denies any abdominal pain, nausea vomiting or diarrhea.  He does endorse some chest tightness especially with inspiration.  He was COVID vaccinated with Johnson and Johnson approximately 6 months ago.  He has a past medical history significant for hypertension, morbid obesity, type 2 diabetes mellitus, asthma and coronary artery disease status post stenting & CABG.  On arrival to ED patient was febrile 101.2 saturating at 95% on 2 L NC.  Laboratory findings were significant for hyponatremia 132. Hypomagnesemia 1.2.  Lactic acidosis 4.9. ProBNP 491. Anemia 11.4.  Hyperglycemia 196. Rapid COVID positive. Chest x-ray showed cardiomegaly and pulmonary vascular congestion.  Patchy bibasilar airspace disease could represent atelectasis versus infiltrates. Levaquin was initiated in ED.  Patient received DuoNeb treatment and Solu-Medrol, as well as acetaminophen in ER.  IV hydration was given with NS 0.9% 2 L bolus.  The patient was treated for acute hypoxemic respiratory failure due to COVID-19 infection and symptoms have improved  Patient will be discharged to original facility and he will continue his home medications.  We recommend him to see his primary care provider in 3-5 days
Presented with low b/p; hyponatremia; + covid in ED; Ferritin 1676; CRP & D-dimer normal; CXR ? atypical infection vs edema; No supplemental O2 needed; Tx: Zithromax, Rocephin
Client received just NS instead of Pfizer COVID vaccine. Client was notified and recommended to return for a correct dose. Client returned on 04/24/2021 and received a correctly mixed dose of Pfizer vaccine. Lot number ER8736, intramuscular, in right deltoid.
3 days post vax devel vomiting, diarrhea, & low-grade fever which resolved in 1-2 days; 20NOV90 recvd 2nd dose of vax & 3 days later developed vomiting, fever, & achiness, which resolved after 3 days; @ time of report still some achiness;
worsening left shoulder/upper arm pain since shot, can't lift above head without severe pain, severe pain with lifting or moving
Erythema and swelling at shot site. Tenderness and warmth also. No fever. The redness was darker at the site. The redness abated. 5cm induration at time of this report.
9/4/19 1PM SORE THROAT DEVELOPED.  9/4/19 11PM BODY ACHES OCCURRED.  9/5/19 2AM BODY CHILLS WITH JOINT ACHES AND FEVER OF 102F WERE RECORDED.  9/5/19 9AM FEVER OF 100 WITH JOINT ACHES AND BODY ACHES AND NASAL PRESSURE.  DECREASE IN APPETITE.  9/6/19 9AM BODY TEMP WAS 99 WITH CONTINUED JOINT PAIN. 9/7/19 FEVER WAS ABSENT AND NO BODY PAIN BUT SORE THROAT WORSENING.  WENT TO SEE URGENT CARE ON 9/7 11AM AND GIVEN AMOXICILLIN FOR POSSIBLE STREP THROAT INFECTION
Severe Fever. Fever and shivering. Sharp pain in body. Testicular pain. Headache. Weakness.
Patient was accidentally given 0.3 mL of normal saline instead of a mixed Pfizer vaccine. Patient reported no problems associated with injection. She returned to the pharmacy the next day and received a mixed dose of the vaccine.
High fever, 103/4 consistently ,vomiting, chills, diarrhea, aches, weakness, joint inflammation, neck pain, unable to lie flat without shortness breath, chest pain/tightness,
had a TIA; This spontaneous case was reported by an other health care professional and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (had a TIA) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included EPINEPHRINE (EPIPEN) for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jul-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (had a TIA) (seriousness criterion medically significant). On 06-Jul-2021, TRANSIENT ISCHAEMIC ATTACK (had a TIA) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication were reported.  Patient does not want to get the booster since this happened to her.  Company comment:  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
MASSIVE FEVER; This spontaneous report received from a patient concerned a female of unspecified age.  The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported.(dose number in series 1) The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s first dose the patient experienced massive fever. (dose number in series 1)  On an unspecified date the patient received covid-19 vaccine ad26.cov2.s booster dose. (dose number in series 2) The patient had no side effects with covid-19 vaccine ad26.cov2.s booster dose and experienced nothing.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The outcome of massive fever was not reported.  This report was non-serious.
I started shaking uncontrollably and shivering that lasted about 3 hours. I could not stop shivering, even though the house with much warmer than usual. I had shooting pain all over, especially in my shoulders.  I could not move, or even reach for my water glass,  without extreme pain. It felt like nerve pain, muscle and joint pain. I am very active, strong and healthy.  When I walked to go to bed I was in so much pain that I could not stop moaning and saying Oh my god, oh my god, (that?s not like me ? I have a high tolerance for pain and consider myself stoic) and I was shaking so hard I thought I was going to have a seizure or something. I was very tired and slept through the night. This morning I feel like I have the flu ? headache, body aches, fatigue. Thank you.
My entire arm and hand was tingling and numb. I had face tingling and also my tongue and lip. My throat also feels tight and is hurting. I also had a headache.
Prolonged arm soreness. Excessively sore for several days. Slightly sore for several weeks. Very localized soreness still persists as of date of reporting. Itchy rash in about .5" radius around the injection site appeared about 4 weeks after injection and persisted for 2 weeks. No treatment other than rest and drinking fluids.
GBS is reported in pt who recvd flu vax; 27OCT93 devel numbness & weakness in legs & tingling in hands; pt lost ability to ambulate; pt adm to hosp 31OCT93 to 8NOV93 w/dx of GBS;
Woke up the next morning 8.4.21 and could not pick up my head. Neck was stif and stuck to the right side. Right arm is where my shot was given. Took roughly 3 days to be able to pick up my head fully without pain. Arm and neck was in pain when trying to pick up my head.
This spontaneous report as received from a doctor of pharmacy refers to a patient who was vaccinated with an improperly storage dose of ZOSTAVAX (lot # 672609/1733AA, expiration date 04-FEB-2013, dose not reported) on 12-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. The doctor of pharmacy reported that one of the facilities that he was in charge of was recording the temperature of the storage unit of ZOSTAVAX as -5F. He reports that they recently discovered that the actual temperature of the storage unit was -5C. He did not know if the patient had experienced any adverse effects. This is one of several reports received from the same source. This report is cross referenced with the following MARRS #: 1209USA002918, 1210USA006055, 1210USA006056, 1210USA006057, 1210USA006058, 1210USA006059, 1210USA006060, 1210USA006061, 1210USA006062,1210USA006063, 1210USA006064, 1210USA006065, 1210USA006066, 1210USA006067, 1210USA006068, 1210USA006069, 1210USA006070, 1210USA006071, 1210USA006072, 1210USA006074. Additional information is not expected.
multiple temprature excursion with no adverse event; Initial information received on 29-Apr-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old and unknown gender patient who experienced multiple temprature excursion with no adverse event while receiving vaccine diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 30-Mar-2022, the patient received a  dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine suspension for injection (strength and formulation: unknown) (lot UJ578AAA, Expiration Date:09-Oct-2022) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date it was reported multiple temprature excursion with no adverse event (intercepted product storage error) (unknown latency).  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event multiple temprature excursion with no adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.