chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm of the injection got warm, itchy, swollen and there's a puffy area; arm of the injection got warm, itchy, swollen and there's a puffy area; arm of the injection got warm, itchy, swollen and there's a puffy area; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (arm of the injection got warm, itchy, swollen and there's a puffy area), VACCINATION SITE PRURITUS (arm of the injection got warm, itchy, swollen and there's a puffy area) and VACCINATION SITE SWELLING (arm of the injection got warm, itchy, swollen and there's a puffy area) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced VACCINATION SITE WARMTH (arm of the injection got warm, itchy, swollen and there's a puffy area), VACCINATION SITE PRURITUS (arm of the injection got warm, itchy, swollen and there's a puffy area) and VACCINATION SITE SWELLING (arm of the injection got warm, itchy, swollen and there's a puffy area). At the time of the report, VACCINATION SITE WARMTH (arm of the injection got warm, itchy, swollen and there's a puffy area), VACCINATION SITE PRURITUS (arm of the injection got warm, itchy, swollen and there's a puffy area) and VACCINATION SITE SWELLING (arm of the injection got warm, itchy, swollen and there's a puffy area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Moderna Dose 1 5/5/21 (lot NA) Moderna Does 2 6/1/21 (lot NA) COVID Positive 2/19/22  2/19/22: Pt, is 71-year-old female past medical history significant for coronary artery disease, hypertension, hypothyroidism, Parkinson's disease, tremor, GERD, anxiety/depression, schizoaffective disorder, and bipolar disorder.   Patient was admitted after she was admitted for COVID pneumonia and stayed for 4-5 day after she presented with fatigue and was found to have low pulse ox of 80%.  Patient was admitted for 5 days and completed antiviral medication with remdesivir and Decadron.  Patient had CT of the chest with no pulmonary emboli at that time   Currently she still feels short of breath but denies any chest pain fever chills or rigors  3/7/22:  I have been reviewing the chart and the long complicated clinical course.  The specialists and family had agreed with comfort measures, the patient expected to not survive after extubation, but has been hanging on with poor responsiveness and no signs of improvement.  Will approach the family about hospice therapy and possible discharge to a hospice facility. UDPATE I have just been informed that the patient passed away at 08.46 pm.
He had normal - tired, kind of sicky feeling when he woke up on Thursday. At 07:00pm, he had pain behind his right knee. I told him to drink more water and I gave him some Tylenol. I told him to keep me posted as to how he felt. The next morning, he said he hadn't slept all night - he had a dull pain that didn't go away when he moved. It traveled up his upper leg and up to his right hip. Moving and stretching didn't make it go away. Constant dull pain. I took him to ER. It took 36 -48 hours before it faded. He didn't wake up with it on Saturday.
Information has been received from an office manager concerning a 55 year old male who on 22-OCT-2008, "Wednesday of last week", was vaccinated into the arm with the first dose of PNEUMOVAX vaccine. Concomitant therapy on the same day included influenza virus vaccine (unspecified) given in a different arm. Right after getting the vaccine, the patient experienced swelling of the arm from the forearm up that lasted about 3 days. The patient recovered on 25-OCT-2008, Saturday. No lab tests were performed. The patient did not seek medical attention. Additional information has been requested.
When came in for 2nd set of shots stated may have had reaction to 1st set of shots.  States that @ 4:00 pm day of shots started crying. Described it as "high pitched screech"  Crying was off and on, not non stop.  Was eating normally. Crying stopped completely about 8:30 pm. Slept that night in normal pattern.  The next day he was "fussy" but no long term crying. Denied fever, limpness, paleness, convulsion or reddness or swelling at injection site. Did not call doctor.
I had only a sore arm with shot 1. The second, caused issues 6 hours later, giving me severe chills and fever.  Loss of appetite, Sensitive to bright light, Pain behind eyes, I felt dizzy & felt  like I had the flu. Over a 3 day period, it subsided. On the 4th of April I was still dizzy/ lightheaded/ Had vertigo? As of today, 4/16/21 after seeing my GP, I still have this problem along with a very sore stiff neck. The shot and this problem may be unrelated, but it started during the worst of the side effects.
felt a little sore in his arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 66 year-old male patient received bnt162b2 (BNT162B2), administration date 09Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "felt a little sore in his arm".  Additional information: The patient only felt a little sore in his arm. He did not see where the needle came from when he received his vaccine and would like to know how it was supposed to be stored and how were they storing it at the location he received my vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I had diarrhea, numbness in my face, high blood pressure. 9 days of symptoms. The symptoms started a few days after.
she has broken out with hives and red dots all over her body; she has broken out with hives and red dots all over her body; she feels "plastered"; her tongue turned green and got swollen; her tongue turned green and got swollen; she can eat nor swallow anything, she almost chocked with a pill the size of her "pinky" nail (she had to stop taking medications because of this, she also can not eat); she can eat nor swallow anything, she almost chocked with a pill the size of her "pinky" nail (she had to stop taking medications because of this, she also can not eat); she constantly feels like she has to pee but then she does not do it; patient mentioned that "every whole" in her body is "going loco" as she is constantly sneezing; diarrhea; has secretions on her throat (spitting); This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY), administration date Sep2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Liver failure" (unspecified if ongoing); "Kidney failure" (unspecified if ongoing); "No Immune system" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization, reaction(s): "Soreness in her shoulder", "Soreness in her neck bone". The following information was reported: URTICARIA (non-serious), MACULE (non-serious) all with onset 2021, outcome "unknown" and all described as "she has broken out with hives and red dots all over her body"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "she feels "plastered""; TONGUE DISCOLOURATION (non-serious), SWOLLEN TONGUE (non-serious) all with onset 2021, outcome "unknown" and all described as "her tongue turned green and got swollen"; EATING DISORDER (non-serious), DYSPHAGIA (non-serious) all with onset 2021, outcome "unknown" and all described as "she can eat nor swallow anything, she almost chocked with a pill the size of her "pinky" nail (she had to stop taking medications because of this, she also can not eat)"; POLLAKIURIA (non-serious) with onset 2021, outcome "unknown", described as "she constantly feels like she has to pee but then she does not do it"; SNEEZING (non-serious) with onset 2021, outcome "unknown", described as "patient mentioned that "every whole" in her body is "going loco" as she is constantly sneezing"; DIARRHOEA (non-serious) with onset 2021, outcome "unknown", described as "diarrhea"; OROPHARYNGEAL DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "has secretions on her throat (spitting)".  Additional information: She defined her experience was overwhelming. Patient stated that the vaccine did not work on people who were "already ill". She stated to be ok after she received the vaccine but now she regrets taking the shot, she took the shot to "avoid accidental contamination"  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Woke up with 101F fever, almost passed out. After lying down for 15 mins on the floor with elevated legs and drinking water, I was able to relocate back to bed. Fever continued to stay between 101-103F all day, while I was mostly sleeping. Temperature came down to 100.5 towards the evening. All fine the next day, except for the expected soreness at the injection site, which continued.
patient was given wrong dose of vaccine. no reaction as of 12:20pm on 7/1/21.
High fever 104.7 F 15 weeks after the vaccine. Treated with antibiotics and saline solution. Fever subsided within a week.  Symptoms were high fever, chills, involuntary muscle contractions. suspected kidney infection.
shortness of breath, fever 101.2, generalized body aches in joints, resting heart palpitations,
liquid from the vaccine running down arm / liquid leaked from vaccine needle; liquid from the vaccine running down arm / liquid leaked from vaccine needle; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (liquid from the vaccine running down arm / liquid leaked from vaccine needle) and DEVICE CONNECTION ISSUE (liquid from the vaccine running down arm / liquid leaked from vaccine needle) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 14-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Feb-2022, the patient experienced ACCIDENTAL UNDERDOSE (liquid from the vaccine running down arm / liquid leaked from vaccine needle) and DEVICE CONNECTION ISSUE (liquid from the vaccine running down arm / liquid leaked from vaccine needle). At the time of the report, ACCIDENTAL UNDERDOSE (liquid from the vaccine running down arm / liquid leaked from vaccine needle) and DEVICE CONNECTION ISSUE (liquid from the vaccine running down arm / liquid leaked from vaccine needle) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Pharmacist took the needle out of the patient's arm and said the liquid from the vaccine came running down out of the arm down the chair. Also, pharmacist stuck the needle in, and its like it dripped all the way down the patient's elbow and down to the chair. Pharmacist was not sure how much came out, but said it seems like a lot came out. The patient had not experienced any symptoms. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Feb-2022: Upon internal Review on 17-Feb-2022, significant correction was made to update event verbatim. On 16-Feb-2022: Followup received contains no new information
This is a spontaneous report from a contactable Physician via Pfizer sales Representative. This Physician reported similar events for 3 patients. This is 3rd of 3 reports. A patient of unspecified age, ethnicity and gender received PREVNAR 13 via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced lightheadedness/dizziness on an unspecified date with outcome of recovered, weakness on an unspecified date with outcome of recovered. Event was described as lightheadedness, dizziness and weakness lasting 2-3 minutes after injection, resolved by lying down, given fluids and glucose tablet. Sender's Comments: Linked Report(s): US-PFIZER INC-2017379704 different patient, same product, same event; US-PFIZER INC-2017379977 different patient, same product, same event.
Headache, Arthralgia, Fever, CoughWheeze, Syncope, FATIGUE, CHILLS, PAIN/SWELLING TO INJ SITE, SORETHROAT
G62.1 ALCOHOL INDUCED NEUROPATHY 2/2/2023 TRAUMATIC SUBDURAL HEMORRHAGE W/LOC UNS DUR INIT
Five minutes post vax, pt became pale and complained of stomach ache. Pulse remained steady. Pt somewhat tired and "out of it" afterwards but never lost consciousness. Pt complained of feeling faint and hot. Vasovagal reaction to immunizations. In Feb 2001 pt received Hep A, Hep B and varicella immunizations, first dose for each in series. Post vax he became pale and lost consciousness, questionable seizure.
Had initial pain at injection site however about one week later I experienced Intense aching pain from left side of chest to fingers on left hand.  This pain extended through my entire arm for several hours during the first event.  This aching returned several times over the following two weeks.  Each time extending through my entire arm and into the left side of my chest.
Information has been received from a 63 year old female consumer with no known allergies or pertinent medical history who on "last Friday" (28-MAR-2008) was vaccinated with a first 0.65 mL dose of zoster vaccine live (Oka/Merck) (lot # 658325/1429U) "in her lower arm between her wrist and elbow." There was no concomitant medication. Subsequently, right after receiving the vaccination she developed a red and inflamed injection site. Medical attention was not sought and there were no lab studies performed. At the time of the report the patient was recovering. There was no product quality complaint involved. Follow-up information from the patient indicated that the vaccination was ordered by her regular physician and administered by a physician friend after she picked it up from the pharmacy. It was noted that the vaccination was administered into her lower forearm. At the time of the report the patient's status was unknown. The patient also reported that she had no adverse reaction. Additional information is not expected.
Body aches, chills, slight temp, headache, felt really lousy. Took 1000mg of Tylenol extra strength every four fours during the day
Rash on the right side of her chest; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on the right side of her chest) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012C20I) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (Rash on the right side of her chest). The patient was treated with CORTISONE at an unspecified dose and frequency. At the time of the report, RASH (Rash on the right side of her chest) outcome was unknown. Not Provided      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.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Rash is consistent with the product known safety
Box of DTaP placed with Tdap. Pt given DTaP instead of Tdap. No adverse reactions.
I tested positive for COVID-19 on February 28th, 2023. I experienced fever, coughing, severe sore throat, body aches & congestion.
Fever, abdominal pain, lightheadedness, multiple syncopal episodes. Found to be septic in Emergency Department work up.
Red itchy circle 2 inches below injection site 8 days after vaccine. Looks like "covid arm".
I am experiencing sharp pain in my chest while inhaling. I have asthma but it is very mild and never causes me pain. EKG and chest X-ray were clear. The doctor said it is possible that the vaccine has triggered asthma flare ups.  I am also experiencing worsened never pain. I have been suffering for a year with a bulging disc that presses on my sciatic nerve. I experience very bad lower back pain, pain in my hip and down my leg. Since getting the vaccine I feel that my pain is worse.
Report A0359813A describes fibromyalgia in a female vaccine of unspecified age who received Lyme disease vaccine recombinant Ospa (Lymerix). This report was received as part of litigation proceedings and has not been verified by a physician or other healthcare professional.  Medical history, concurrent conditions and concurrent medications were not provided. The vaccinee reportedly received Lymerix; the number of injections administered was not reported. In a Statement of Injuries, her attorney alleged that the vaccinee "experiences joint pain in her hands, shoulder, neck and back and throughout her entire body".  She also experiences muscle pain throughout her body. In addition, she suffers from fatigue and insomnia. She also experience pain when applies any pressure to her skin. She has been diagnosed with severe fibromyalgia syndrome. She also suffers from degenerative osteoarthritis. In addition she suffers from bilateral upper quarter myofacial syndrome with prominent clinical activity of trapezius and scalene which produces a supraclavicular thoracic outlet syndrome. Time to onset following immunization, treatment and outcomes of the alleged events were not reported.  The adverse event "osteoarthritis" does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per the June 28, 2000 letter.
Initial unsolicited case received from a nurse on 05 Jun 2018. This case involves an eleven years old patient (gender not reported) who was vaccinated with a dose of ADACEL and was given another dose yesterday in error instead of HPV VACCINE (Batch number, expiry date, dose, dose in series, route and site of administration was not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. It was of actual medication error due to Wrong vaccine administered and Extra dose administered. No adverse event was reported. 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 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. List of documents held by sender: none.
Patient stated that he felt faint and started to sweat profusely, got very pale in color.  as soon as he received his vaccine.  This was approximately 1140.  I then laid him back in the drivers seat, put a cold wet cloth on his neck and forehead.  Initial vital signs were: 97% 02, 60 pulse and 116/62 BP.  He states that he has high blood pressure.  Pressures taken every 5 minutes, 98%, 65 pulse 102/68 pulse, 1152: 118/70, 98, 71.  1156: 118/78, 98,81 1158: 124/84, 99%, 72
6-7 hours after receiving, I got a headache, and became very tired & achey all over. I took ibuprofen & acetaminophen and felt reasonably better for a few hours. Then later that night (12-18 hours after vaccine) I became much sicker and was unable to sleep. I had a low fever, upset stomach, severe chills (couldn't stop shaking/shivering for over an hour) body aches, and an extremely bad headache. I continued to use ibuprofen and acetaminophen but even combined they weren't nearly enough to relieve my symptoms. Late into the night around 3-4am (15-16 hours after vaccine) nausea became the worst side effect, surpassing the headache. I eventually vomited around 4am, after which point the symptoms became more bearable and I managed to sleep a couple hours. Thursday/Friday (two days after vaccine) I still felt very weak, achey, and tired and had to call out of work both days. I was never again in the severe discomfort I experienced Wednesday night/Thursday morning, but I still felt a little tired, achey, and mildly sour stomach on days 3 &4 (Saturday/Sunday). Monday morning I felt similarly tired & achey, but I do feel essentially back to normal Monday night.
Site: Pain at Injection Site-Medium, Systemic: Joint Pain-Medium, Additional Details: Pt made an appointment with Clinic after receiving vaccine 12/21/2022. He reported right arm pain which had persisted since receiving the vaccine 12/21/2022. He requested an immediate solution for his discomfort since he had already scheduled an evaluation with his PCP for that same week. Once advised that no immediate solution could be guaranteed, he left the clinic to follow up with his PCP.
Information has been received from a healthcare worker referring to a 24 year old female patient with unspecified drug reaction to CECLOR and VICKS NYQUIL. There was no pertinent medical history reported. 08-MAY-2015 the patient was vaccinated with the first dose of VARIVAX (Merck) (lot  #K005181, expired date 10-APR-2016, dose was unknown) subcutaneously. On 10-JUL-2015, the patient received the second dose of VARIVAX (Merck) (lot # K005181, expired date 10-APR-2016, dose was unknown) subcutaneously which was improperly stored along with TWINRIX. Concomitant medication included JUNEL FE. On 11-JUL-2015, one day after receiving the vaccinations, the patient experienced injection site itching and swelling, and the injection site was "hot to the touch". The patient did not seek medical attention. No lab test was performed and no treatment was given to the patient. The outcome of the events and causality were not provided. Additional information has been requested.
This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional information was reported as follows: The age group was not reported, but was captured as adult as per the vaccine indication. The reporter received the adverse event reporting, that was received by her from a healthcare provider. The reporter stated that the healthcare professional stated that, SHINGRIX vaccine hurts. The healthcare professional had not mentioned any specific patient or any other details.
Information has been received from a physician concerning a 12 month old white female with cold symptoms (no fever) and no other medical history or allergies who on 28 Sep 2006 was vaccinated with a first dose in the left upper leg of Proquad (lot#654040/0661F). On 06 Oct 2006 the patient broke out with pox. The patient was seen by the physician on 10 Oct 2006. No laboratory diagnostic tests were performed. Additional information has been requested.