chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Feeling "funny" like his breathing was heavier; Weakness; Fatigue; Muscle pain; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATION ABNORMAL (Feeling "funny" like his breathing was heavier), ASTHENIA (Weakness), FATIGUE (Fatigue), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013l20a) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Lactose intolerance and Drug allergy (Simvastatin). Concomitant products included ATORVASTATIN, LISINOPRIL, HYDROCHLOROTHIAZIDE, METFORMIN, LEVOTHYROXINE and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced RESPIRATION ABNORMAL (Feeling "funny" like his breathing was heavier), ASTHENIA (Weakness), FATIGUE (Fatigue), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain). On 08-Feb-2021, RESPIRATION ABNORMAL (Feeling "funny" like his breathing was heavier), ASTHENIA (Weakness), FATIGUE (Fatigue), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2021, Heart rate: fast (High) Fast.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided. Concomitant medication included Vitamins   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: TCR - Consent for FU declined
Fever later in day. Local reaction - red to arm where both shots given. Feels weak, tired, body aches.
On 07/26/2001 the patient developed shortness of breath, anxiety and heart palpitations. The patient had received her HBV earlier, at 4:00 pm. The patient was wheezing and had a dry non-productive cough. The patient had acute airway spasms. The patient was treated with Albuterol aerosol, Pulmicort and Benadryl. On 07/27/2001 the patient was seen again with mild laryngeal edema in addition to the previous symptoms. The patient was treated with Prednisone and Zyrtec. On 08/03/2001 the patient was seen in the ER for postnasal drip and brochospasm with probable allergic rhinitis. On 08/22/2001 the patient reported chest discomfort after eating.
Tinnitus began about one month after second dose. (This form does not allow for dates for all doses. The 1st Pfizer dose was 04/15/2021, the 2nd Pfizer dose was 05/06/2021.)  A 3rd dose was received on 01/26/2022 (again Pfizer; Lot # FL3209). Within approximately 2 weeks of the 3rd dose, the tinnitus seemed to have doubled in volume.
Child was complaining about bumps on legs.  Patient checked leg and notice rash/hives on legs where shot was administered.  On 11/04/10, patient noticed hives has worsen.  Call to make appointment with physician on 11/04/10 and report reaction to physician.  It have been occurring ever since the patient was 4 month.
Severe pain, swelling hard lump and rash on vaccinated arm the day after vaccination.  The rash spread almost down to my elbow also noticed the skin in my entire body felt like a bad sunburn but was not red just felt burned.  Other symptoms were like when I had Covid low grade fever 101 and flu type symptoms, bad headache, pain in ears, jaw, gums and overall body stiffness and pain along with nausea, fatigue, stomach ache and diarrhea.  Also noticed my eyesight was very blurry and on day 2 tiny moving glitter like spots in my vision.  Vision is still very blurry day 5 and seems to have exacerbated Covid symptoms and fatigue I was already dealing with.
Dtap was given instead for Tdap due to miscommunication of another nurse. No effects noted. Contacted agency. They advised pt would not need to received additional vaccination.
Patient contacted me 7/29/13 stating she had broken out in "bumps" that itch and are red, like hives. States she noticed them evening after receiving vaccines earlier that afternoon. States they are on her face. arms chest and right leg and more. Keep developing. She states they are not painful, but just itch. These lasted 2-3 days and she reports they are much better now. 8/1/13 only treated with "CORT AID".
Uncontrollable crying starting 1 hour after shots until 6pm that night.  Right leg sl redness and swelling.
Erythema, edema and warmth at site of injection proximal upper (L) arm.
This medically confirmed report (initial receipt 12-Dec-2014) concerns a 66 year old female patient who had a history of metastatic melanoma to the brain and lung. Concomitant medications included amlodipine, dexamethasone, rosuvastatin, atenolol and hydrochlorothiazide. On an unspecified date, the patient received the influenza vaccine (manufacturer and batch number not reported) prior to receiving the first dose of KEYTRUDA (batch number not specified) for metastatic melanoma and brain metastases on the 19-Nov-2014. The patient was also prescribed sulfamethoxazole/trimethoprim at the time of using KEYTRUDA. After the first dose of KEYTRUDA, the patient experienced unspecified tremors. The sulfamethoxazole/trimethoprim was discontinued on the 26-Nov-2014. The tremors lessened in severity however were still present. The tremors were a result of seizures. The patient was placed on levetiracetam and the tremors resolved. Outcome was recovered. Follow up (31-Dec-2014) Upgrade to serious, patient details and medical history, add event, treatment, and outcome.
No other information reported.; VARlVAX was administered to a patient prior to discovering the temperature excursion; This spontaneous report was received from a nurse practitioner, referring to a 9-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with an improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, 0.5 (ml) by subcutaneous (SQ) route (lot number T022314 which has been verified to be valid, expiration date reported and validated as 30-JUN-2022) (vaccination scheme and anatomical site of injection were not reported) as prophylaxis (product storage error). On 14-MAR-2021 (conflicting information onset date also reported as 15-MAR-2021), the nurse reported a temperature excursion involving their varicella virus vaccine live (Oka/Merck) (VARIVAX) vaccines. The administered dose of the vaccine was stored at a temperature of 31.8 degrees Fahrenheit (F), during a time frame of 5 hours and 30 minutes, as recorded by a digital data logger. There was no previous temperature excursion. No other information was reported (no adverse event).
Received vaccines on 6-29-07. Onset of fever with cough & respiratory symptoms & SOB (inspiratory stidor) after 12-24 hours. 7/26/07-records received from PCP-seen in office 7/5/07-for follow-up after hospitalization for croup. Coughing but is more of a congestive cough. No more fevers. PE unremarkable. Tubes are in place. Assessment:croup improved. Note for 7/9/07- seen for upper respiratory infection fever up to 101 but at office 98.2. Nebulizer treatment. Harsh grade 3/6 systolic murmur heard.
Since I am over 65 this year they gave me the super flu shot. I started feeling sick with chills and fever of 100 about dinner time. I took Tylenol for fever but couldn't sleep all night. My fever spiked to almost 103 at 3 am. Took more Tylenol. Next day I am feeling very weak with slight fever. Still taking Tylenol. My previous regular flu shots I would sometimes feel chills and get slight fever. This super flu shot made me very sick with a dangerously high fever. I was almost ready to go to the hospital. People should be told that the super flu shot can have very bad side effects. I will not get the super flu shot ever again since this is as bad as having the flu. I might take the regular shot next year.
120 when returning to class, school nurse observed patient appearing dizzy, call to RN for assistance, at which time patient was pearly, placed on floor. Briefly lost consciousness. BP 80/50, legs up 911 called. 123 Awake and responsive BP 90/50 P64 R 12 - 128 Awake and responsive BP 104/64 P 72 R 12. Squad arrived. Father arrived; transported child home.
injection given proximal to acromion process resulting in pain , hematoma, and erythema at injection site.  Pain started within an hour of injection; bruising observed the next day after removal of band aide; redness started on day 2 post injection. Ice was applied to injection site reduced redness and swelling.
Pfizer-BioNTech COVID-19 Vaccine EUA  Vomiting and chills about 4 1/2 hours after I got my second dose of the vaccine.
Rash on the injection site about 12x13cm with palpable swelling. +itchiness, red, swelling; had the vaccine pcv 13 1/8/18.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; CHOKING; FELT  BAD; This spontaneous report received from a patient concerned a 59 year old male.. 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, and batch number: 1805018 expiry: UNKNOWN) .5 ml,1 total, administered on 08-MAR-2021 to left arm as prophylactic vaccination.  No concomitant medications were reported. On 24-JUL-2021 patient was felt bad and choking, had symptom coughing, hard to breath, nausea ,diarrhea for the past 5 days.  On 28-JUL-2021 had rapid test  and revealed that he has suspected clinical vaccination failure and suspected covid-19 infection Laboratory data included: SARS-CoV-2 rapid POC test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection, suspected clinical vaccination failure, choking and felt bad was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210760895. This report was associated with product quality complaint:90000187582; Sender's Comments: V0: 20210760417-Covid-19 vaccine ad26.cov2.s -Choking. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. 20210760417-Covid-19 vaccine ad26.cov2.s -Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
The patient developed arm paresthesia a few days after receiving a flu vaccine.  Other symptoms mentioned were tremulousness, anxiety and diaphoresis.  Was seen a couple times at doctor's office then in ER on 10/11/2020, 10/25/2020 and 11/5/2020 for worsening symptoms.  There were some treatments of IVIG in doctor office as well.
Patient reports that vaccine given in right arm was given "very high, almost above the deltoid". She began to experience discomfort at injection site about 30 minutes later.  Discomfort got worse over the next 2 days and 11 days later is still tender to the touch. She experiences pain at injection site when she lays on at night. Patient would like to follow up with an MD.
I had several of the common symptoms, cold chills, headache, mild joint pain, but I also had severe ringing in both ears that reduced to moderate ringing after about an hour and then to an acceptable level about 8 hours later.
Pt given flu inj 9/25/13, called next day stating arm red, warm, also having bad headache. Pt told to ice arm, TYLENOL/ADVIL for headache, brought in on 9/27/13 to be seen by doctor.
Patient's right arm was very red, swollen and uncomfortable for the patient for the last 2 days.
36 hours after Shingrix, noticed eye swelling and itchiness.   At 48 hours, right eyelid 1.2-3/4 swollen shut with redness and itchiness on eyelid & under eye skin. Left eye not quite as swollen but also itchiness.  Looked like I had been punched in the eyes (without the bruising). Left arm vaccine site 3-inch area of rough and pink to red skin. Took Benadryl & Ibuprofen every 4-6 hours. At 72 hours symptoms started lessening but still had skin redness on eyelids and under eye.   Took Benadryl & Ibuprofen but at about 6-8 hours between. At 96 hours still some swelling, redness & itchiness
Pt received the J&J vaccine on Monday 4/12 around 10 am.  Reports onset of diarrhea mon night, frequent episodes.  Then Tuesday 4/13 developed dysuria, fever/chills, headache, nausea, vomiting. Presented to ED 4/14 and admitted to hospital medicine with acute kidney injury.
Patient presented to Clinic with Allergic Reaction Symptoms, including shortness of breath, Chest tightness, and Nausea. Patient states he had gotten the shot roughly 1 hour before coming to Medical. Patient reported to Medical at 1038, where vitals were immediately taken. Patient Vitals were as follows: BP: 148/92 Temp: 98.1 Pulse: 90 R: 20 SPO2%:  100 EMS was called at 1052 and had arrived at 1102. EMS had left with patient at 1106. Patient did report a history of Childhood asthma, no allergies to medications.
Infant vomited after waking up three days post vaccine.  Infant has had slightly runny nose. No fever. Has been extra fussy lately but seems to be better once given Ibuprofin or Tylenol. The vomitting this evening was abrupt but he seems to be doing just fine since.
Could sore arm, where injection was placed. For over 1 week. Could not lift arm, lymph nodes for over 6 days.
Information has been received on 11-DEC-2018 regarding a case in litigation from a lawyer concerning a male patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. On or about 07-NOV-2013, the patient received ZOSTAVAX (lot number, expiration, dose and route unknown) for its intended purpose: the prevention of shingles. As a direct result of ZOSTAVAX, the patient suffered from a shingles outbreak, in addition to chronic pain, rash and lesions to various parts of his body. The patient's shingles outbreak was diagnosed on 14-DEC-2016. As a direct result of ZOSTAVAX, the patient suffered mental and emotional distress due to and continues with physical limitations and seriousness of his condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of ZOSTAVAX, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient paid for ZOSTAVAX for the purpose of preventing shingles. The patient had not received the safe and effective vaccine for which he paid. The patient requests compensatory damages for past, present, and future pain and suffering, medical costs and expenses and lost wages. The patient has incurred significant expenses for medical care and will continue to be economically and emotionally harmed in the future. The outcome of the events was considered to be not recovered. The causality of the events was considered to be related. Shingles outbreak and vaccination failure were considered to be disabling. Additional information has been requested.
Swelling at site w/in 5 mins, slowly subsided over 24hrs intense internal and external itchiness for 48+ hrs, watery eyes, nasal drainage. Dr ordered Benadryl injection and meds (OTC) on 01/27/2005.
pt recv vax lt arm sore 1st day, second day arm sore, swollen & hard @ site took child APAP & did cold packs on arm x 3 days;
FEVER up to 103 F, coughing with mucus and chest pain, making sounds when breathing and having difficulty breathing, voice changed, runny nose.
Later in the day of the vaccine, I noticed dry mouth, tongue and lips.  When I eat or drink, it gets worse and feels like something coats my tongue and mouth.  When it persisted, I searched the internet for dry mouth as a flu shot reaction, but it was not listed on web sites that came up.  This has gone on  continually for almost two weeks now and I have had no other symptoms.  I have nothing else to  relate it to except starting from the flu shot.
Pain on the left upper arm including injection sight. I also developed sensation of fever and chills, malaise for about 2 days.
Patient called our pharmacy on 10/20/2015 at around 2PM to inform us that she experienced a severe allergic reaction that she thinks is due to a flu shot (Fluzone high dose) that she received at our pharmacy on 10/14/2015. She said that she had a rash all over her body including her hands and knuckles. She said that her feet were swollen; that she had lumps on the palm of her hand/feet and underneath her skin. She claimed that this all happened 2 days after receiving the flu shot. I asked her what her Dr thinks this kind of reaction came from and she said that her Dr doesn't know exactly and prescribed for her Medrol dose pak to treat this condition. She also took Benadryl and it didn't help. I questioned her if she took any new drugs before experiencing the rash to see if it was due to a new drug that she may took and she said no. She stated that she only took her regular medications, which cause no problems in the past. I also asked her if she had the flu shot in prior years and she said yes and that she had no problems with the regular flu shots in the past. She informed me that she started her Medrol dose pak on 10/19 and on 10/20 she did not see improvement and asked me what to do. I told her to give it 1 more day and that if she does not see improvement by 10/21 that she should let her Dr know to see what they recommend. It was her first time getting the high dose flu shot so I think she may develop this allergic reaction from receiving the high dose formulation of the flu shot, which is kind of unusual since she had regular flu shots in the past. Pt was complaining that she had to pay a fortune to see several doctors to get this condition treated.
A spontaneous report has been received from a Health Professional concerning 72 year old, Female patient who had been administered Nasal FLUMIST QUADRIVALENT, 0.2 Millilitres, Unknown. FLUMIST QUADRIVALENT started on 23-Dec-2015. It was reported that the patient was given FLUMIST QUADRIVALENT, full adult dose, up each nostril on 23-Dec-2015. It was also reported that the nurse accidentally was given the vaccine that was administered to an adult older than the 49 years old which started during 23-Dec-2015. FLUMIST QUADRIVALENT was discontinued on 23-Dec-2015. The outcome of the event of FLUMIST QUAD administered to a consumer over 49 years and full adult dose given up each nostril was unknown. The report was considered to be non-serious by company physician.
Positive for Covid after vaccine; Lack of drug effect; sniffles for one week; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive for Covid after vaccine), DRUG INEFFECTIVE (Lack of drug effect) and RHINORRHOEA (sniffles for one week) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, the patient experienced COVID-19 (Positive for Covid after vaccine). 17-Aug-2021, the patient experienced DRUG INEFFECTIVE (Lack of drug effect). On an unknown date, the patient experienced RHINORRHOEA (sniffles for one week). At the time of the report, COVID-19 (Positive for Covid after vaccine) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown and RHINORRHOEA (sniffles for one week) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medication was mentioned. No treatment medication was mentioned.; Sender's Comments: This case concerns a 69-years-old, male patient with no medical history, who experienced the unexpected event of Covid-19 with associated non-serious event of rhinorrhoea. Drug ineffective was also considered as an additional event since, the events occurred approximately six months after the second dose of mRNA-1273, Moderna COVID-19 Vaccine. Events were considered non-serious as per the reporter. The rechallenge was considered not applicable. The reporter did not provide a causality assessment. The benefit-risk relationship of mRNA-1273, Moderna COVID-19 Vaccine is not affected by this report.
Prevnar administered 3/5/03. Pt healthy-no s/s of infection at visit. Presented 3/6/03 very pale with pharyngitis. CBC with WBC 18.7, granulocytes 13 (69%), CXR done, Rocephin IM administered. Pt follow-up to clinic 3/7/03, CBC done and WBC 9.2, gran 2.9 (31%).
PRESSURE IN LEFT TEMPLE; NUMB LIPS; FEEL MORE TIRED; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included at the time of this report the patient was healthy, able bodied. The patient was not on prescriptions, had no fever and do not wear glasses. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978) dose was not reported, administered on 31-MAR-2021 10:30 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced pressure in left temple. On 31-MAR-2021, the subject experienced numb lips. On 31-MAR-2021, the subject experienced feel more tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pressure in left temple, numb lips, and feel more tired. This report was non-serious.
The next day after the 2nd dose, around 4pm CST, I believe I may have experienced a cardiac event. Over the course of an hour, chest and back pains along with shortness of breath almost crippled me. I don?t after my PCP who told me to go directly to the ER. I was it able to go because I could not afford the costs.   The pains were like labor contractions and each time hurt more.   I recently had a physical, don?t have any underlying health conditions and don?t take any medications for chronic conditions.  The 2nd day, I experience left pain in my neck, and leg along with reduced chest pains
Suspected vaccination failure; I got the shingles shot and I still got shingles!; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient. The age at vaccination was not reported. The patient received the shingles shot and still got shingles. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown.