chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Eyes swollen; he vomited; great headaches at night; right side of his face seems to "explode"; Red eye; Right eye "jumps"; backache; body pain; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR HYPERAEMIA (Red eye), MUSCLE TWITCHING (Right eye "jumps"), EYE SWELLING (Eyes swollen), BACK PAIN (backache) and SWELLING FACE (right side of his face seems to "explode") in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, the patient experienced BACK PAIN (backache), MYALGIA (body pain) and FATIGUE (fatigue). On 04-Jun-2021, the patient experienced OCULAR HYPERAEMIA (Red eye) and MUSCLE TWITCHING (Right eye "jumps"). 04-Jun-2021, the patient experienced SWELLING FACE (right side of his face seems to "explode") and HEADACHE (great headaches at night). On 08-Jun-2021, the patient experienced VOMITING (he vomited). On 09-Jun-2021, the patient experienced EYE SWELLING (Eyes swollen). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at a dose of 1 UNK. At the time of the report, OCULAR HYPERAEMIA (Red eye), MUSCLE TWITCHING (Right eye "jumps"), EYE SWELLING (Eyes swollen), BACK PAIN (backache), SWELLING FACE (right side of his face seems to "explode"), MYALGIA (body pain), FATIGUE (fatigue), HEADACHE (great headaches at night) and VOMITING (he vomited) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.
no adverse effects; Improperly stored doses administered; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions/allergies and concomitant medications were not reported.  On 11-JUN-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial, orally (strength and dose were not reported) lot # R033252, expiry date 29-JUN-2020, for prophylaxis. The suspect vaccine was stored in a temperature below 36 Fahrenheit degrees (F) (34 F) for 24 hours. There were no previous temperature excursions. Digital data logger was involved. No adverse effects were reported.  This is one of six reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA003061: US-009507513-1907USA003060: US-009507513-1907USA002834: US-009507513-1907USA003062: US-009507513-1907USA003058:
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 09-JUL-2015, the patient was vaccinated with an improperly stored dose of MMR II lot # K016154 with exp. 24-SEP-2016 (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Presented with non-pruritic urticaria scattered on trunk and arms with right ankle swelling and pain. Mother gave Benadryl 5mL the evening that hives appeared which provided relief. On exam on 8/31/19: wheals scattered on back of leg, abdomen, flank - flat, raised wheals on inner right arm.  erythema of anterior right ankle, no swelling or pain. Ankle erythema may have been secondary to irritation from tight shoes that she wore that day. Spoke to mother on 9/2/19, rash gradually resolved after office visit. No further doses of Benadryl.
I received my first Anthrax shot in November 2007 prior to deploying and following the shot I had a fever with flu like symptoms and my hands and elbows broke out with blisters.  I received the small pox shot at the same time so they were unsure which shot caused the reaction.  I received my second anthrax shot on 23 May 2008 and had a similar reaction.  Almost 24 hours after receiving the shot I started feeling sick with flu like symptoms.  My body was really weak and I had a fever.  Fortunately I had the next day off so I could just lie in bed and rest.  The area around the injection is red and swollen and it is 3 inches in diameter.  Prior to receiving the second shot I told the medics I had an adverse reaction to the first shot, but they wanted me to get another to see how my body would handle it.  I returned to the medics last night and they said they would delay my next shot by one week, but I still needed to continue the cycle.
Left upper arm, swelling, pain, erythema starting within 2 hours of immunization and continuing to worsen for 48 hrs. Also, lymphadenopathy, left axilla - erythema >6" - treated with antihistamine, NSAIDS, ice improved but not completely resolved at 1 week follow-up
Rash on chest and abdomen as well as at injection site.  Treated with Benadryl.
8/10/21 1700-arm hurt, didn't feel well while at work 8/10/21 Late Evening and into the night, did not recall exact time-diaphoretic, Facial swelling, headache Morning 8/11/21-facial swelling still present, but had gone down, feet and hands itching, lethargic. Pt made mother aware of symptoms,  she called clinic at approx. 0930 we had him come into clinic for 1000 appt. Patient was examined and administered a dose of Depo Medrol. 8/12/21 spoke with patients mother 1115. Pt woke mother up early complaining that his "bones hurt". His arm is still swollen, but he had noted a rash starting in different areas all over his body, still complains of hands itching. Mother gave him Tylenol and antihistamine around 0630. Patient did go into work. His mother said he is suppose to check in with her during his lunch.
Vomiting, bloody stool, diagnosed with intussusception on 8/29/2011 which was reduced with a barium enema.  She was hospitalized overnight 8/29 to 8/30 for IV fluids.
Was fine until 5 days later. Then had fever, chills, stuffy head like allergies, tired, achy. Been sick for a week
an expired MMR II was given to a patient; This spontaneous report was received from a registered nurse referring to a 54-year-old patient of unreported gender. The patient's pertinent medical history, concomitant therapies, and previous drug reactions or allergies were not reported.  On 07-DEC-2021, the patient was vaccinated with one dose of expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) for prophylaxis (expired product administered) (lot number S037502 has been verified to be a valid lot number, the expiration date was reported and established as 04-DEC-2021; dose number, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported).   No temperature excursion was reported.
Started as normal pain just from the needle and continued to get worse. By day 3 my upper left arm was not able to have full movement and the pain wakes me up every night and has for nearly 2 months with no end in sight.
14cm x 12cm area of erythema and swelling with pain.  Complaint of joint pain, muscles aches, fever, chills, nausea, diarrhea, and lymphedema of axilla on vaccination arm for several days.  Still having joint pain in various random joints.
hot flash; itchy throat; This is a spontaneous report from a non-contactable pharmacist. A female patient of an unspecified age received first dose of BNT162B2 (COVID-19 mRNA Vaccine BNT162B2), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced a "hot flash" 5 minutes after COVID-19 vaccination and then "itchy throat" 30 minutes after vaccination on an unspecified date. They would liked to know if patient should receive the second dose. She is otherwise fine with all symptoms resolved and never had respiratory distress of any kind. The outcome of the events was recovered on an unknown date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a physician concerning a 21 week old male who on an unknown date and on 20-MAR-2007 was vaccinated PO with his first and second 2.0 ml doses of Rotateq.  On approximately 07-APR-2007 per the physician, "the patient was brought into the office at 5 months old and was lethargic."  On 27-APR-2007 the patient diagnosed with intussusception and was hospitalized (amount of time unknown).  Surgery was performed and the patient had a necrotic bowel therefore the bowel had to be resected.  The patient returned to the office for a follow-up visit and the third dose of Rotateq was administered by a different provider in the office.  Subsequently, the patient recovered.  There was no product quality complaint.  Intussusception was also considered to be an other important medical event (surgery) by the physician.  Additional information has been requested. 4/22/08-record received-Surgical report 4/29/07-Intussusception, ileocolic and ilioiliac due to mesenteric adenitis and possible hypertrophic tire patches, terminal ileum. Exploratory laparotomy with reduction of ileocolic anastomosis and small bowel resection. Seen in ER with 3 day history of URI like symptoms. Lethargic after receiving anti-histamine. Nausea and vomiting. Diminished appetite and urine output. Low grade temperature. Weight loss. Dehydration. Drowsiness secondary to possible antihistamine overdose.
Caught COVID -19 from an unknown source.  Experienced fever, fatigue, sore throat, cough, and headache. Serious symptoms for one week. Unable to work for three weeks. Lingering symptoms (fatigue, cough) continuing at 5 weeks post infection.
No adverse event; patient received a dose of VARIVAX that was improperly stored; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy details were not reported.  On 25-FEB-2020, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S024369, expiry date: 08-JUN-2021) for prophylaxis (product storage error). The vaccine was reconstituted with properly stored sterile diluent. No adverse event was reported. The vaccine was exposed to a temperature of -13.8 Celsius for a time frame of 13 minutes. Previous temperature excursion of 3.4 Celsius for 1 hour 30 minutes was reported. The call was due to digital data logger. No product quality complaint (PQC) was associated with this report.
In January 2022, I began experiencing hip and leg pain and fatigue when walking or standing. It progressed over time and in April 2022, I was unable to walk any significant distance without pain and weakness. May 8, 2022, I was unable to walk and went to the ER where I was diagnosed with a partial blockage of my distal aorta and arterial occlusions in both legs, primarily my right leg.  I was admitted to the hospital where I was put on a heparin IV.  I came dangerously close to losing my right foot. I am now on Xeralto indefinitely and will be having surgery July 26, 2022, to attempt to open up the artery in my right leg.
feeling washed out; complaining of excessive tiredness; complaining of weakness to her leg muscles; uses a walker; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 93-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3247 and expiration date was not reported), first dose via an unspecified route of administration, administered in arm right on 22Jan2021 16:30 (at the age of 93 years) as single for covid-19 immunization. Medical history included High blood pressure, acid reflux from an unknown date and unknown if ongoing. Concomitant medication(s) included calcium, omeprazole, valsartan, vitamin d taken for an unspecified indication, start and stop date were not reported. The patient previously took cleocin [clindamycin hydrochloride] and experienced drug hypersensitivity. Patient got no other vaccine in four weeks. On an unspecified date of 2021 the patient experienced complaining of excessive tiredness, complaining of weakness to her leg muscles, uses a walker while on 25Jan2021 13:00 patient started feeling washed out. Patient did not receive any treatment for Adverse Event. The outcome of the event feeling washed out was not recovered. While outcome of the rest of the events was unknown.   No follow-up attempts are needed. No further information is expected.
After receiving my booster, a week later I was short of breath, a tight feeling in my chest, and my heart felt like it was pounding uncontrollably. It got to the point where I couldn't sleep because the beating of my heart was so loud. I contacted my cardiologist and he stated I had all the symptoms of myocarditis. To get rid of it I was taking 400 mg of ibuprofen 4 times a day for 5 days. My heart rate has been off and have been prescribed metoprolol PRN when symptoms show. I have been struggling and having many of these similar issues as before. I was given a heart monitor for a week and will be seeing my cardiologist this following week to discuss findings.
Patient received a flu shot instead of the Moderna booster that he had made an appointment for. He had already received a flu shot two months before that.
Patient was given Lymerix vaccine (her 3rd shot) at 4:20pm on 6/13/01, she developed chills, shaking all over, heart pounding at 5:50pm.  The reaction stopped 1 1/2 hrs later.
Pfizer-BioNTech COVID-19 Vaccine EUA non-severe allergic reactions- facial rash (7/20/21), right auricular pruritus (7/20/21), right periorbital edema (7/19/21), abdominal pain (7/18/21)
severe bilateral arm and left leg pain, numbness, weakness back pain leukocytosis fever brain edema in region of corpus callosum
This spontaneous report received from a consumer 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) dose not reported, 1 total, start therapy date was not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient fainted after getting the Janssen COVID-19 vaccine. She felt nauseated and sick after.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fainting, nauseated and feeling sick was not reported. This report was serious (Other Medically Important Condition). This event(s) is considered unassessable. The event(s) 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(s).
I ordered this 2 year old child and her twin sister to receive PEDIARIX and some other vaccines. They were a few months behind on immunizations. My nursing assistant mistakenly selected BOOSTRIX instead of PEDIARIX from our vaccine refrigerator and administered the BOOSTRIX. Because of this error both children received an insufficient dose of DIPHTHERIA vaccine and no HEPATITIS B or POLIO vaccine at that visit, thus requiring additional vaccinations. In discussion with the nursing assistant, it became apparent that all other vaccine vials are easily distinguished because each of the plastic caps is a unique color. However, PEDIARIX and BOOSTRIX differ ONLY in the color of a stripe around the neck of the vial. The TOPS of the two vials are exactly the same color, making it more likely for an error in vaccine selection to occur. I believe that the manufacturer of PEDIARIX and BOOSTRIX should change the color of the vaccine vial tops, so that the ENTIRE top of each vial is a unique color, thus reducing considerably the risk of vaccine misidentification by a busy nurse.
Information has been received from a licensed practical nurse concerning a 54 year old female patient (weight 140#, height 65") with allergy to aspirin, penicillin and clopidogrel bisulfate on 06-NOV-2006 at 11:00 am was vaccinated with the initial dose of Pneumovax 23 (lot #651400/0618F), 0.5 ml, IM. Concomitant medication was reported as none. On 06-NOV-2006 (previously reported as 08-NOV-2006 2 days later), the patient called back to report that she experienced painful, red, and hot injection site arm. It was unknown how soon after the vaccination that the reaction started. The nurse reported that the patient had recovered as of 07-NOV-2006 (previously reported as 10-NOV-2006). The nurse requested that a lot check be performed. Additional information has been received from a licensed practical nurse who reported that the patient complained of pain in the left arm, neck and shoulder where the patient had received injection earlier stated severe pain. The nurse reported there was no redness or local swelling, the pulse at the patient's wrist was intact and injection site could not be found. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the agency and was released by the regulatory agency. Additional information is not expected.
particles in some of the syringes; This is a spontaneous report received from a contactable reporter (Pharmacist) from product quality group.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: FJ2602) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIQUID PRODUCT PHYSICAL ISSUE (non-serious), outcome "unknown", described as "particles in some of the syringes".  Additional information: Reportability Determination: This is Medical Device Related. Reportability Determination: This complaint for Prevnar 20v PFS suspension 0.5mlx10 for Particles in two Prevnar 20 syringes that are different lot numbers. is a reportable malfunction. If it were to recur, it could likely cause or contribute to death or serious injury. Product used for treatment. This is a 30-day review 15Nov2022  Amendment: this report is being submitted because case validity has been reassessed.
This spontaneous report was received from a Medical Assistant (C.M.A.) referring to a patient of unknown age and gender. Pertinent medical history, concurrent conditions and concomitant therapies were not reported. On 03-AUG-2016, the patient was vaccinated with M-M-R II lot # K020188, expiration date: 22-OCT-2016 (albumin status unknown) and PROQUAD lot # L009210, expiration date: 17-SEP-2016. Dose, route, frequency and anatomical location were not reported. The Medical Assistant stated that the patient did not experienced adverse effects. There was not a product quality complaint involved. Addition information has been requested.
Got MMR Vaccine on 9/5/17. On 9/13/17 pt because lethargic and had a fever starting at 99.7 degrees. As the day went on fever got higher and higher. On 9/14/17 fever reached 103.7 degrees and Tylenol was given to pt. The fever leveled out between 101.3 degrees and 101.7 degrees. On 9/15/17 pt still had her fever so we contacted the nurse help line and they advised us to bring pt in. At the doctors they advised us that a fever is a known side effect of the MMR Vaccine. On 9/16/17 pt no longer had a fever. On 9/17/17 pt got a rash across her whole body. On 9/18/17 (Today) still has rash across her body.
Difficulty breathing, sharp pains in the center of the chest, and tingling in the throat. Patient was offered ambulance transport and denied due to no insurance, his daughter took him immediately to the ER net door to be seen.
localized cellulitis, pain, swelling, redness warmth to arm, vaccine given too low.  Started on doxy to treat cellulitis.
The needle wasn't on tight and vaccine squirted out on to the patient; He is not sure how much vaccine they received, but estimated that it was less than half a dose; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (The needle wasn't on tight and vaccine squirted out on to the patient) and UNDERDOSE (He is not sure how much vaccine they received, but estimated that it was less than half a dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 00321CA and 033B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DEVICE CONNECTION ISSUE (The needle wasn't on tight and vaccine squirted out on to the patient) and UNDERDOSE (He is not sure how much vaccine they received, but estimated that it was less than half a dose). At the time of the report, DEVICE CONNECTION ISSUE (The needle wasn't on tight and vaccine squirted out on to the patient) and UNDERDOSE (He is not sure how much vaccine they received, but estimated that it was less than half a dose) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.     Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: follow up was received on25-MAY-2021 and contain no significant information
Cc :Chills ,weakness, sweating, anxiousness, low blood pressure and pulse rate intervention: patient was taken to medical tent for observation, and vital signs are as follow: BP86/40  PR62  TEMP 98.7  OXG SAT 96%   Patient was offered water and vital signs were retaken: BP 94/58  PR 62 OXYG SAT 96% Patient was laid Trendelenburg position, BP improved and he felt better. Patient walked back to car in stable a condition
p/vax pt exp low backache, fatigue had flu like sx w/low grade fever & inj site pain & redness;exp severe abd pain w/lt side pain & lt lower back pain;later exp rash & swelling of eyelid;MD call & sent to ER for eval;tx DPH & Medrol;
This report describes the occurrence of photosensitivity in a 6 month old infant who  was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed. This report was received from the subject's parent and has not been verified by a physician or health care professional. The subject's medical history and concurrent medical conditions were not specified. Concurrent medications included Ranitidine (Zantac, GSK). The subject received the injections of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed on 16MAY2002 and 22JULY2002. On that date, the subject also received an injection of combination
Heart rate sped up very much immediately after the injection. I felt ancy & it lasted for a day. I also felt confused, disoriented, out of it.
CNS - chills , fatigue, headache, irritability, malaise, nervousness,, and sleep disturbance. Dermatologic: Dermatitis, centralized varicella, like rash itchy dry skin. Gi:abdominal pain appetite decreased, constipation, myalgia, arthralgia, stiff neck, Pt seen MD and MD suggested VAERS to be filled out.