chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diagnosed with cellulitus; Itchy at injection site; Hard at injection site; Red at injection site; Swelling at injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CELLULITIS (Diagnosed with cellulitus) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included LORAZEPAM for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced CELLULITIS (Diagnosed with cellulitus) (seriousness criterion medically significant), VACCINATION SITE PRURITUS (Itchy at injection site), VACCINATION SITE INDURATION (Hard at injection site), VACCINATION SITE ERYTHEMA (Red at injection site) and VACCINATION SITE SWELLING (Swelling at injection site). At the time of the report, CELLULITIS (Diagnosed with cellulitus), VACCINATION SITE PRURITUS (Itchy at injection site), VACCINATION SITE INDURATION (Hard at injection site), VACCINATION SITE ERYTHEMA (Red at injection site) and VACCINATION SITE SWELLING (Swelling at injection site) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported included lorazepam and unspecified blood pressure medication.  This case concerns a 74-year-old female with a serious unexpected event of cellulitis, and nonserious unexpected vaccination site pruritus, vaccination site induration, vaccination site erythema, vaccination site swelling. Event onset 9 days after mRNA-1273. Event resolving. Based on 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: This case concerns a 74-year-old female with a serious unexpected event of cellulitis, and nonserious unexpected vaccination site pruritus, vaccination site induration, vaccination site erythema, vaccination site swelling. Event onset 9 days after mRNA-1273. Event resolving. Based on 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.
Patient 18 month old was given an adult dose of Hep A, instead of pediatrics. Vaccine was given by medical assistant  which reports he verified vaccine with provider. Contacted mother and let her know about the vaccine error administration. She discussed incident, limited on research, mother can expect minimal side effects, which may include increased risk of localized reaction or fever, associated with excessive local or systemic dose of antigen or vaccine constituents. Mother was given precautions and advised can walk into clinic with any questions or concerns. Mother verbalized understanding, no additional questions.   Vaccine error was found when medical assistant was billing medication. Reviewed adult vaccines are in separate shelves than pediatric and will verify prior to administering.
site was raised & swollen in a 3x3 area wk p/vax; pt c/o pain & tenderness @ site also h/a, dizziness occurred p/inject 1-2 hrs or so;
It began with chills to the point of physically shivering, my skin became extremely sensitive to touch.  I went to bed and woke up a few hours later with an all-over rash that was painful to touch, a temperature of 101.3 degrees Fahrenheit and a headache.  Went back to bed, woke up around 9 am.  Rash was almost gone, temperature was down to 98.8 degrees Fahrenheit.  By 5 pm my rash was gone, my headache much better but still there, my temperature still at 98.8 degrees Fahrenheit and I noticed my left arm was sore.
The MA gave the patient two Hep B vaccines. Patients parent informed. 1 multi dose and 1 single dose "above listed" No reactions reported.
PERIPHERAL NEUROPATHY 2/4/2022 LOWER GI HEMORRHAGE PULMONARY EMBOLISM, UNSPECIFIED. 3/3/2022 LOWER GI HEMORRHAGE ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 3/3/2022 LOWER GI HEMORRHAGE HYPOXIA 1/22/2022 LOWER GI HEMORRHAGE PERIPHERAL NEUROPATHY 2/4/2022 HYPOXIA PULMONARY EMBOLISM, UNSPECIFIED. 3/3/2022 HYPOXIA ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 3/3/2022 HYPOXIA HYPOXIA 1/22/2022 HYPOXIA
About an hour after the vaccination, I experienced a rash and itching around the site of the injection. The rash & itching lasted a total of 7 days after the injection.
p/ pt recv vax 2 days later devel cough, & then presented to MD w/outbreak of approx 28 bumps on back, shoulders & legs.
pt recv vax & exp muscle weakness, pain @ inj site, fatigue, flu like sx, n&d; The pharmacist reported that two other pt recv the first shot of vax from the same vial & they exp the same sx;They were assigned WAES96090110 & 96090111
Started feeling warm at 8:00pm (3 hours after vaccination), TYLENOL 5ml was given at 8:10pm. Shortly after, was in mom's arms, looking at her, when his arms and legs began to shake. Family called 911. Estimated episode lasted between 5 and 10 minutes. Squad arrived 4 minutes after call and patient was no longer seizing. Family reports patient was unresponsive immediately after shaking stopped, then began crying, and has been sleepy since. Arrived at Hospital ED at 8:31pm. Ibuprofen 148mg was given at 9:27pm, and patient was discharged at 10:48pm.
Severe itching; large rash; Initial information was received on 07-Jan-2020 regarding an unsolicited valid non-serious case received from consumer/Non-Healthcare Professional.  This case involves a female patient who experienced severe itching(pruritus) and large rash(rash), while she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Medical history, concomitant therapy, medical treatment, vaccination and family history were not provided.   On an unknown date, the patient received dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA1944) via an unknown route at an unknown administration site.  On an unknown date, the patient developed non-serious severe itching (Pruritus) and large rash(Rash) Unknown latency following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Detail of laboratory data were not reported.  Final diagnosis were pruritus and rash.  It was not reported if the patient received any corrective treatment.  On unknown date, the outcome of the events had reported as unknown.
Patient woke up around 2 AM having chills, ran fever, muscle pain, injection site is sore, and hard to lift arm up.
I started feeling the pain on my arm where it was swollen from my elbow to the top of the arm. The next day I got a lumps on the top pf under the arm and another of the top of the shoulder. Still have my lumps.
6/26 84-year-old man with a past medical history significant for solitary kidney, GERD, hypertension and prostate cancer who presents to hospital due to intractable nausea
discomfort in my right ear and under my right collar bone; swollen lymph nodes on side contralateral to injection; Ear infection/10 days after the first vaccine, I started to feel discomfort in my right ear./ This was the opposite side of vaccine injection. Felt like an ear infection.; soar throat; runny nose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EAR INFECTION (Ear infection/10 days after the first vaccine, I started to feel discomfort in my right ear./ This was the opposite side of vaccine injection. Felt like an ear infection.), OROPHARYNGEAL PAIN (soar throat), RHINORRHOEA (runny nose), DISCOMFORT (discomfort in my right ear and under my right collar bone) and LYMPHADENOPATHY (swollen lymph nodes on side contralateral to injection) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     NO Medical History Information was reported.  Concomitant products included LISINOPRIL from 05-May-1988 to an unknown date for Blood pressure high.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced EAR INFECTION (Ear infection/10 days after the first vaccine, I started to feel discomfort in my right ear./ This was the opposite side of vaccine injection. Felt like an ear infection.), OROPHARYNGEAL PAIN (soar throat), RHINORRHOEA (runny nose) and LYMPHADENOPATHY (swollen lymph nodes on side contralateral to injection). On an unknown date, the patient experienced DISCOMFORT (discomfort in my right ear and under my right collar bone). The patient was treated with IBUPROFEN from 22-Feb-2021 to 27-Feb-2021 for Adverse event, at a dose of 200 mg as required and AMOXICILLIN ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, EAR INFECTION (Ear infection/10 days after the first vaccine, I started to feel discomfort in my right ear./ This was the opposite side of vaccine injection. Felt like an ear infection.), OROPHARYNGEAL PAIN (soar throat), RHINORRHOEA (runny nose), DISCOMFORT (discomfort in my right ear and under my right collar bone) and LYMPHADENOPATHY (swollen lymph nodes on side contralateral to injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient went to his Otolaryngologist on 22-Feb-2021 for the reported events.  Doctor advised to take anti inflammatory for any swollen glands or lymph nodes.  Patient tested for wax buildup, inflammation in throat  and speech test all with negative results.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Added patient demographics , Concomitant medication, treatment medication and a new event, discomfort.
Woke up on 5OCT91 skin beneath chin beet red, quickly spread to red blotchy spots all over body; Skin felt warm, but no temp; ears also became swollen, red & hot; Red areas on body had appearance of burns according to mom;
Breakthrough case admission after 3 vaccines Moderna 2/23/21 Lot# 023M20A;  MOderna 3/23/21 Lot# 030A21A;  Moderna 12/8/21 Lot# 045J21A
Information not available.  Patient died at home.  Covid 19 listed as a cause of death on the death certificate.
Fever up to 38.8 x 2 days, maculopapular rash on trunk x 6d cadescing on face, spreading to legs.
Pain at injection site.  Dizziness & shivers.  Slight fever.  Fatigue
A little weak; Feeling weird; Tired; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (A little weak), MALAISE (Feeling weird) and FATIGUE (Tired) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced ASTHENIA (A little weak), MALAISE (Feeling weird) and FATIGUE (Tired). At the time of the report, ASTHENIA (A little weak), MALAISE (Feeling weird) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Rash, swelling, red hot, fever, Primary care doctor sent her emergency room in hospital Dr gave her cephalexin, VICODIN, and MEDROL
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 31-DEC-2015 the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX (dosing details were not reported) lot # L029467 with an expiry date of 06-AUG-2017. No concomitant medications were reported. No adverse symptoms were reported. There was no product quality complaint. This is one of the two reports received from the same reporter. Additional information is not expected as the reporter did not wish further contact.
Patient received vaccines around 12:30 and 3 hours later called stating child's face was numb & looked swollen. Advised to go to ER ASAP possible allergic reaction. Mom gave BENADRYL & went to ER. He was given Prednisone medication.
Child developed signs of respiratory distress, turned cyanotic, rolling of eyeballs, lethargy and stopped breathing X 1 minute. Mom called EMS. At this time, child resumed breathing. Taken to ER.
Experienced redness on anterior chest and forearm. Went out to car to look in mirror. Presented back for evaluation around 12:05 PM.   A&Ox3. Redness noticeable on upper anterior chest and left forearm. Denies of SOB, CP, lightheadedness/dizzinesss. Only a mild diffuse headache. Denies of reactive symptoms after #1 dose.   25 mg Benadryl given from Pharmacy and bottle of water. After 10 mins, redness improved. No new additional symptoms or worsening. Recommended additional 15 mins of monitoring.
Describes palpitations that developed immediately after the vaccination. Ended up going to the ED a few days later. Nothing seen in the ED and has had follow up with cardiology with Holter monitor placed. Cardiologist not convinced that this is cardiac in nature. Patient concerned and has diagnosis from I believe neurology for autonomic neuropathy. Not clear how diagnosed and how related to vaccine from records.
Moderna vaccine (NDC--80777-0273-99, lot # 048C21A) was received on 7/16/2021 and placed under refrigerated temperature.  3 vials were transferred to store where 20 doses were administered beyond use date.
Serious aches and pains all over her entire body; Second dose administered less than 21 days after the first dose administered; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) reported that a female patient of an unspecified age received bnt162b2 (lot number and expiry date were not provided), with first dose on 19Dec2020 and second dose on 05Jan2021, both via an unspecified route of administration at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Second dose administered less than 21 days after the first dose administered. The patient experienced serious aches and pains all over her entire body on an unspecified date. The outcome of event was unknown.  Information about lot/batch number has been requested.
This case was reported by a physician via call center representative and described the occurrence of injection site hyperpigmentation in a 4-week-old male patient who received HIBERIX (batch number 2S27K, expiry date 17th September 2017). On 9th March 2017, the patient received the 1st dose of HIBERIX .5 ml. On 9th March 2017, immediately after receiving HIBERIX, the patient experienced injection site hyperpigmentation. On an unknown date, the outcome of the injection site hyperpigmentation was unknown. It was unknown if the reporter considered the injection site hyperpigmentation to be related to HIBERIX. Additional details were provided as follows: The patient had a black dot being left at the injection site of HIBERIX and had not faded by the date of the next dose. On 12th May 2017, the patient received 2nd dose of HIBERIX 0.5 ml (Batch number: 4294M, Expiry date 20th January 2018). On 13th July 2017, the patient received 3rd dose of HIBERIX 0.5ml (Batch number: 4B745, Expiry date: 23 February 2018). This was purely cosmetic and no additional adverse events were reported. This was one of the two cases reported by the same reporter.
Sharp pain as soon as needle was injected, high upon right arm. Was told I had a muscle spasm, when I thought she hit a nerve. She said arm would be sore for several days. I had severe pain, loss of motion that is still causing issues today. Saw a family doctor in October 2018. Doctor gave me muscle relaxer and some range of motion exercises. Continued to have severe pain when moving my arm Could not take off shirt alone, could not raise arm high at all and any moving of my arm caused sharp pain. Saw doctor again in November and started Physical therapy in December. Range of motion did get better and pain was/is not as bad now but I still have some pain and range of motion is still limited.
I started feeling bad on 05/17/2022 and I thought I had some allergy problems and then I started feeling worst so I went to urgent care and that's when I tested positive on 05/24/2022. I told them what I had been taken and they said that I had waited to long, so they didn't give me any meds. The doctor just said to continue what I was doing. My symptoms was mild. I felt really bad. I had a running nose, congestion, cough and I really feel like I had the mildest case ever. It just felt like I had a really bad head cold.
Patient came in for a sick visit follow up. Provider ordered the Flu vaccine for Patient. Our new  Medical Assistant grabbed the PEDIARIX vaccine by accident and administered it. Provider, FNP was notified immediately and entered the room and spoke to mom of what occurred. Signs and symptoms were discussed by provider and myself to mom. Mom was also assured that this will not occurred again in the future. Mom verbalized understanding.
This patient came in for a routine well visit. Vaccines were given approximately 15 minutes later the child was still crying and her right leg was noted to be very swollen and red from the thigh area to near the top of the knee area. The patient was extremely fussy. Provider notified. Monitored the patient, no other signs and symptoms at this time.
Pain at injection site arm almost immediately after vaccination.  Severe joint pain (similar to pain experienced with chikungunya) in wrists, elbows, knees, and ankles started during the night after vaccination.
"Patient with 3 COVID vaccines, but not up to date, who admitted to hospital with complications of COVID and positive PCR test.  Provider d/c note:  ""Patient is a 77 year-old male with a history of DM2 on an insulin pump, HTN, and dyslipidemia who presented to the ED on 9/13/22 with a 2-3 day history of worsening weakness, nasal congestion, cough, and fever. History is obtained from the patient and his daughter, who report that he last felt well about 3 days prior to admission, when he developed nasal congestion. The next day he noted weakness which progressively became worse until he could not get out of his chair, prompting him to call EMS. On admission he endorsed frontal HA and nausea without vomiting. No chest pain, diarrhea, abdominal pain, new back pain (stable back pain from osteoarthritis), dysuria, or hematuria. He was in a motorcycle accident at the end of July which resulted in a fracture to his left foot and a large abrasion over his left shin. He has been following with ortho and undergone 2 courses of antibiotics and reports that the fracture has healed, but his daughter noticed increasing redness of his left foot over the 2 days prior to admission. After he was admitted to the floor he had 2 episodes of emesis and fecal incontinence. Required increased O2 up to 6L NC. ABG revealed hypoxia and hypocapnia. No significant change on CXR. He was treated with IV antibiotics and steroids and he elected to discontinue his insulin pump while inpatient. His blood glucose was managed with accuchecks and insulin. He was seen by the physical therapy team who assessed that he was ready for discharge. He experienced a run of 19 v tach. An echocardiogram was ordered which showed no acute abnormalities. His magnesium was just below the normal range, and was repleted with IV supplementation. His clinical status improved and he was deemed stable for discharge on 9/18/2022.
Worsening of POTS (postural orthostatic tachycardia) symptoms; worsening of ME/CFS symptoms: 1) profound, debilitating fatigue, 2) post-exertion malaise, 3) unrefreshing sleep, 4) orthostatic intolerance, 5)cognitive dysfunction. ME/CFS feels like being sick every day--like having the flu every day (body aches, feeling ill, brain fog)--have all worsened significantly since the booster dose of Moderna vaccine.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2022 at 16:00 as dose 4 (booster), single (Lot number: FT5407) at the age of 48 years, in right arm for covid-19 immunisation; COVID-19 Vaccine - Manufacturer Unknown, as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Mitralvalve Prolapse" (unspecified if ongoing); "Mitralvalve Regurgitation" (unspecified if ongoing); "First Degree Heart Block" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION, start date: 03Jan2022, stop date: 20Apr2022; DAYQUIL, start date: 18Apr2022, stop date: 20Apr2022; SUDAFED [GUAIFENESIN;PSEUDOEPHEDRINE HYDROCHLORIDE], start date: 18Apr2022, stop date: 20Apr2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19. Clinical course: The patient had chest pain and upper abdominal pain started within 30 minutes of first dose. Still happening 9 hours later. Nasty taste in her mouth. She had no known allergies.  No follow-up attempts are possible. No further information is expected.
Pain, redness, swelling, and heat at injection site (left deltoid). Chills, fatigue, and hot flashes.
Headache, Myalgia, Arthralgia, Fever, Fatigue/ Chills Narrative:  Other Relevant History:
She had sudden onset respiratory distress/tachycardia on two occasions:  05/05/2023 and 05/07/2023.  She expired on 05/09/2023.  Her death certificate was completed as respiratory failure, but it was told by the mortician and that had marked, excessive blood clots within her vascular system at the time of embalming.  It is now highly suspected that death was due to thromboembolism secondary to blood coagulopathy - due to the COVID vaccines.
Initial misuse report received from a healthcare professional on 20 February 2014. A patient (no information was provided regarding the patient) had received a dose of FLUZONE HD vaccine exposure during pregnancy and no adverse event was reported. I.e. inappropriate age at vaccine administration. List of documents held by sender: none.
As soon as I got the shot in my left arm, my left thumb went numb.  The feeling went away after 10-15 minutes. Over the course of the week my thumb got more and more swollen and harder to move. Very hard to bend, and started to throb when it rained. I would best describe it as arthritis. My left thumb is twice the size of my other thumb. Swelling goes down in the afternoon and is worse in the morning. I didn?t previously have any kind of injury to my left thumb.
Possible allergic reaction to PPSV given 5-12-10.  Had pain and tingling on left side of body.  Was instructed to go to ER 5/14/10.  Was given MEDROL dose pack and told to follow up w/PCP.  Seen by PA-C 5-17-10 and told to discontinue steroid.  Prescribed Doxycycline 100 BID X 7d.  Referred to Neuro.
PATIENT PRESENTED TODAY, 12/18/19, COMPLAINING ABOUT PROLONG MUSCLE FATIGUE AND SORENESS POST VACCINATION.  PATIENT STATED THAT PAIN AND FATIGUE STARTED WITHIN 48 HOURS OF INJECTION OF FLU SHOT IN LEFT ARM.  SYMPTOMS HAVE IMPROVED FOR PATIENT BUT HAVE NOT RESOLVED COMPLETELY AS OF TODAY.
I woke up with a loud buzzing sound in my ears. Almost sounds electronic. It is not painful but extremely noticeable and distracting.