chrisvoncsefalvay/vaers-outcomes huggingface dataset:
next day it was bad; limping but can "walk it off"; sore arm; leg started bothering him; from his knee to ankle when he bends it; headache; Had same pain about 10 days before; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PAIN IN EXTREMITY (leg started bothering him), MOOD ALTERED (next day it was bad), GAIT DISTURBANCE (limping but can "walk it off") and PAIN (Had same pain about 10 days before) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypertension. Concomitant products included ALPRAZOLAM for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced PAIN (Had same pain about 10 days before). On 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), PAIN IN EXTREMITY (leg started bothering him), ARTHRALGIA (from his knee to ankle when he bends it) and HEADACHE (headache). On 20-Feb-2021, the patient experienced MOOD ALTERED (next day it was bad) and GAIT DISTURBANCE (limping but can "walk it off"). At the time of the report, PAIN IN EXTREMITY (sore arm), PAIN IN EXTREMITY (leg started bothering him), MOOD ALTERED (next day it was bad), GAIT DISTURBANCE (limping but can "walk it off"), PAIN (Had same pain about 10 days before), ARTHRALGIA (from his knee to ankle when he bends it) and HEADACHE (headache) outcome was unknown.             Treatment information was not provided.
Severe watery diarrhea and abdominal pain occurring 3-5 days after vaccination. This continued at same level for 1-3 weeks. GI symptoms have progressed since with continuing abdominal pain, diarrhea, constipation, nausea, vomiting and heartburn. Abnormal stools, yellow and/or pale, diarrhea, loose stools and infrequent blood in stools.
Flu shot was to be administered and accidentally a Moderna Bivalent Booster was given in R-arm instead. Flu shot was administered in L-arm . I have been vaccinated and boosted w/2 boosters w/Pfizer and my last booster of Pfizer was last friday .
Urticaria at site of injection (2 Hive wheel formation spreading to entire body (Immunization given at Rt thigh subcutaneous site) Less than 24 hours after Imm. child covered in hive wheel formation No oral mucosal involvement Tx with long acting antihistamine-No vesicular form of rash No difficulty breathing
I received my second vaccine on 9-14-21 and started having chest pains two days later, on 9-16-21. I went into Hospital and was diagnosed with a pulmonary embolism. Bloodwork, X-ray, ultrasound and a CT scan was used to confirm the diagnosis.
Increased heart rate; This case was reported by a consumer via interactive digital media and described the occurrence of heart rate increased in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced heart rate increased. On an unknown date, the outcome of the heart rate increased was not recovered/not resolved.   It was unknown if the reporter considered the heart rate increased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had heart rate increased. The reporter asked as a side effect of the shingrix injection how long did the increased heart rate last.
Left Arm became very sore.  Left Bicep had deep ache and spasm. I developed a large painful knot under the skin.  As time went on the are immediately at injection site got red and inflamed. By Thursday the redness transversed the width of my arm. Friday a large red ring began to go around injection site and the center began to be less red and then appeared blanched.  The Ring was maybe 4" x 8" which got more inflamed through Saturday. By Sunday the ring was still there, but less inflamed.  I did not take any medication except Tylenol starting on Thursday at 10:00 AM as I developed 102.8 fever until Friday morning.  I did experience Headache and chills, but I considered that minor compared to my arm and the local reaction that occurred. I did not go  to Doctor, but rather waited to inform medical staff at my employer, as I am a healthcare worker.
pt recv 2nd dose of vax 24NOV97 & same day approx 6hr post vax pt devel a fine, pinpoint rash all over body, primarily on legs & trunk;pt was eval by pediatrician who felt the rash may have been r/t component of varicella vax;tx DPH;
Patient was suddenly unable to walk without falling at 1:00 PM on 2/10. Was taken to emergency room. Was then admitted to hospital. Received CT of head and Xray of hips and legs in ER. Had MRI of head and Lumbar puncture, both under sedation. Also received physical therapy while in hospital. Was diagnosed with Acute Cerebella Ataxia. Symptoms improved in 48 hours, and resolved within 1 week.
pt recvd 2 doses of Engerix-B & 6 days p/2nd dose exp delayed hypersensitivity rash, itching, SOB, angioneurotic edema; pt was dx w/serum sickness secondary to Engerix-B; pt was taken to hosp exp 2 syncopal episodes along the way;
This spontaneous report was received from a nurse regarding an approximately 67 year old female patient. There was no information  on pertinent medical history and drug reactions or allergies. On 29-OCT-2014, the patient was vaccinated with ZOSTAVAX, product lot # J007208, expiry date: 20-SEP-2014, dose 0.65 ml (milliliter), subcutaneously in the right arm, which expired on 20-SEP-2014. No adverse effects were reported. There was no product quality involved. The outcome of the event was unknown. Additional information has been requested.
Noticed hair loss and hand swelling between March-August 2021. On August 9, 2021, I had an overwhelming sensation that I was going to faint while walking, I also had stomach pain and diarrhea. In the following week, I was taken to the Emergency Department 4 times; my heart felt like it was racing, I got extremely lightheaded, I could not walk straight, I needed to hold on to something sturdy within my range to hold myself up, felt like I was dying. Doctors performed EKG, routine blood work and results were normal so they did not know what was wrong with me and would just give me IV fluid and discharge me.
I received the vaccine on 2/6/21. I felt like I was going to get a cold on 2/7/21 and was unconcerned. By 2/8/21 I had tightness in my chest and feared it might turn quickly to pneumonia but had no nasal drainage or fever. I only had a tightness in my chest. By 2/10/21, I was actually scared and had an appointment at an urgent care. They did chest xrays and an EKG. My BP was up but no signs of a cold or pneumonia. I was told to keep a close eye and reach out to my Rheumatologist. By 2/12/21 I was struggling to swallow and felt like I had a baseball in my esophagus. I suspected a flare up of Barretts. My Rheumatologist was unsure what to do and sent me to my gastroenterologist. My Gastroenterologist did an EGD on me on 2/18. By this time I was struggling to eat food and only drinking fluid. Cold and Hot water were painful. I could only have "warm" fluid. My gastro said that my esophagus was tight and had comparison data from a previous EGD to look at. I was given Nitroglycerin to try a few days later because it was not resolving. This helped and told him I was having spasms. So I was started on Diltiazem twice daily and Omeprazole. We tried 4 times a day at first and moved to long acting Diltiazem and that works better. This keeps the pain at bay for the most part and I only have slight flare ups if I am delayed taking it or if I forget one or the other. I am still unable to eat all foods-chips are painful and irritate my esophagus and cause me to have pain for a few hours every time I try. I continue to have a cough that came with this pain and have coughing spasms periodically and unexpectedly on a regular basis. I still have no cold symptoms but a nasty cough. The next step is Ph Testing and motility testing because the doctors have expected this to calm and it hasn't and the cough is impacting my sleep. Date for test is not known yet. I have not had the 2nd vaccine.
Information was received from an unspecified source regarding a patient, demographics unknown, who on an unknown date, was vaccinated with VARIVAX (Merck) lot # J003221, expiration date 15-MAR-2015, which had been improperly stored. The outcome of the improperly stored vaccination is unknown. Follow up information was received from a nurse indicating that the patient had been revaccinated. No symptoms reported. Additional information is not expected.
mom states had temp 2 days before which went away the day of vax;p/shot low grade temp returned & devel fine rash on face body & arms;irritable & missed up sleep pattern;no scratching or c/o itching;rash raised on face;
Chills, body aches, and headache that lasted about 24 hours after symptoms first started at 3 pm which was approximately 8 hours after receiving the vaccine.
Within 15-25 mins after receiving Hep B vaccine in right deltoid muscle, the pt developed erythema and edema. Her neck was red and she described chest tightness. She stated "her mind went blank." She did not become pale, SOB, she was alert and oriented. Ice was applied to injection site. She declined offer to go to ER or go see her physician. The erythema and edema had resolved by 05/15/2002.
Pain; Really bad feeling in chest; not able to do anything physical till now; Heart issues; With the Pfizer vaccine I got sick for 7-10 days; Flu symptoms; felt like I had a flu; Coughing; Fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2023NVX-US-000001010.  A 57-year-old female patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Lot number: ER2613) at the age of 57 years for covid-19 immunisation. The patient's relevant medical history included: "Illness" (ongoing); "Lung disorder" (ongoing). The patient's concomitant medications were not reported. The following information was reported: COUGH (non-serious) with onset Mar2021, outcome "unknown", described as "Coughing"; PYREXIA (non-serious) with onset Mar2021, outcome "unknown", described as "Fever"; INFLUENZA (non-serious) with onset Mar2021, outcome "unknown", described as "Flu symptoms; felt like I had a flu"; CARDIAC DISORDER (non-serious) with onset Mar2021, outcome "unknown", described as "Heart issues"; CHEST DISCOMFORT (non-serious) with onset Mar2021, outcome "unknown", described as "Really bad feeling in chest; not able to do anything physical till now"; ILLNESS (non-serious) with onset Mar2021, outcome "unknown", described as "With the Pfizer vaccine I got sick for 7-10 days"; PAIN (non-serious), outcome "unknown".  Additional information: The individual reported Pfizer BioNTech COVID-19 vaccine as the suspect product for the events of Illness, Influenza, Cough, Pyrexia, Pain, Chest discomfort, and Cardiac disorder and Moderna Covid-19 Vaccine as the suspect product for the events Pyrexia, Illness, Vaccination site pain, and Influenza.
Pain below the injection site, swelling. Issue with PNEUMOVAX 23 site only.
got the flu from flu needle; aching so much and so painful; unusual feeling in muscles after taking the flu needle; Initial information regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (consumer) via Social media on 12-Nov-2020.  This case was linked to case 2020SA322867 (Case for Wife).  This case involved a male patient of an unknown age got the flu from flu needle (Illness), and experienced unusual feeling in the muscle (Muscle discomfort) and was aching and was so painful (Pain), after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by an unknown manufacturer lot number not reported via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (unknown latency), the patient got the flu from flu needle (Illness) and unusual feeling in the muscle (Muscle discomfort) and was aching so painful (Pain).  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome of the events was unknown.  There will be no information available on the batch number for this case.
anaphylaxis; throat swelling; This is a spontaneous report from a contactable physician. A 50-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunization.  Medical history included hypertension, lipids (as reported) and asthma. The patient was known allergies: codeine, iodine, shellfish, latex, and cefatrizine propyleneglycolate (CEFTIN). Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in hospital. The patient experienced anaphylaxis and throat swelling on 22Dec2020 with outcome of recovered in Dec2020.  The events were reported as non-serious. The events resulted in Emergency room/department or urgent care. Treatment of epinephrine, steroids, antihistamines, observation was received for the events.    Information on lot/batch number has been requested.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis and throat swelling cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  The underlying predisposing condition of allergies to multiple materials may put the patient at high risk of anaphylactic reactions.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Information has been received from a registered nurse concerning a female who on 11-JUL-2008 was vaccinated with the first dose of GARDASIL.  Subsequently the patient developed an injection site reaction.  The patient developed arm soreness and injection site reaction.  The patient developed arm soreness and hardened raised area the size of a walnut (also reported as a "hard lump") at the injection site. At the time of the report, the patient was recovering from the symptoms. The vaccine was provided at the patient's primary care physician's office, not at this clinic. No further information is available.  This is a consolidation of two reports concerning the same patient.  It has been determined that WAES # 0807USA04078 is a duplicate of WAES # 0807USA04026. Therefore, WAES # 0807USA04078 is being dleted from our files and the reportd consolidated into WAES # 0807USA04026.
severe worsening of underlying autoimmune disease (ankylosing spondylitis) w/in 24hr p/vax;no change in treatment;
ERYTHEMA, EDEMA, WARMTH RADIATING TO FOREARM FOR 3 DAYS AFTER SHOT. PT NOTED TO HAVE IMPROVEMENT AT THE INJECTION SITE, BUT CONTINUED TO HAVE EDEMA, ERYTHEMA, WARMTH DISTALLY. HAD FULLNESS FEELING IN ELBOW
This spontaneous report received from a pharmacy intern referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. The intern reported that on 01-JUN-2017, an expired dose of PNEUMOVAX 23 (unknown lot, expiration 10-MAY-2017) was administered (expired product administered). No adverse effects reported. Additional information has been requested.
Information has been received from a 69 year old female patient concerning herself. The patient has sulfonamide allergy and was still hospitalized for an unspecified reason when on 03-NOV-2008 was vaccinated with PNEUMOVAX 23 (Lot#), 0.5ml (unspecified route). Concomitant therapy included analgesic (unspecified names and manufacturers) and omega-3 marine triglycerides. The consumer reported that about three or four hours after receiving the vaccine, she could not lift, move, put weight on her arm and was in a lot of pain. The consumer also reported that she had a fever and it felt like she had paralysis. The patient reported that this experience lasted for two days, but she is still experiencing pain in her shoulder and some pain in her fingers. The patient sought unspecified medical attention. Upon internal review paralysis was determined to be an other important medical event. Additional information has been requested.
No fevers, indurated, erythematous, warm, irregular lesions, RX cephalexin 250 mg x 10 days.
patient had reaction from her first dose moderna vaccine on 07/31 FEW MINUTES AFTER THE SHOT. she had a fainting feeling but recovered soon.
Mom died of a Brain Stem stroke; This is a spontaneous report from a contactable consumer (who reported for the mother). An 88-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the left arm on 03Mar2021 at 11:30 (at the age of 88-year-old) (Lot Number: EN6198) as single dose for COVID-19 immunisation. The patient was not tested for COVID-19 after vaccination. Relevant medical history included COVID-19 prior of vaccination. Concomitant medication included atorvastatin (LIPITOR) taken for an unspecified indication, start and stop date were not reported. On 09Mar2021 at 09:45, the patient experienced a brain stem stroke; the event required emergency room visit, the patient was hospitalized on 09Mar2021 and the event was considered serious also as life-threatening and causing disability. The patient received unspecified corrective treatments. The patient died due to brain stem stroke on 11Mar2021. An autopsy was not performed.; Reported Cause(s) of Death: Brain stem stroke
This subject is a seven month old female, who died while enrolled in Comparative post-marketing safety study of DAPTACEL administered with other recommended vaccines according to the US standard of care, at 2, 4, and 6 months of age in infants and as a booster to toddlers. The subject received two doses of the study vaccine. The last dose prior to the event was given on 1/22/04. On 2/4/04 the subject died. The subject suffered from Walker-Warburg Syndrome and expired due to respiratory arrest and cardiac failure. No autopsy was performed. The death was reported by the investigator as unrelated to the study vaccine.
"got the shot at 8pm - started at 0400 itching all over benadryl helps - but still itchy- calling about the itchiness"
Itchy, red rash on upper arm that increased in size from the size of an egg to covering most of my upper arm (about the size of my hand).  It was a little warm to the touch.   Doctor prescribed  Triamcinolone Acetonide Cream and advised me to apply ice to the area.
102 fever, chills, muscle ache, headache, flu like symptoms and slept for 18 hours.
Asymptomatic positive test for SARS CoV 2 virus after surgical mask and face shielded healthcare workplace exposure to unvaccinated, Covid positive symptomatic patient.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 16-year-old female patient who received HAVRIX 1440 adult. On 25th April 2016, the patient received the 1st dose of HAVRIX 1440 adult 1 ml. In April 2016, less than a week after receiving HAVRIX 1440 adult, the patient experienced injection site pain. On 25th April 2016, the patient experienced inappropriate age at vaccine administration and accidental overdose. On an unknown date, the outcome of the injection site pain, inappropriate age at vaccine administration and accidental overdose were unknown. It was unknown if the reporter considered the injection site pain to be related to HAVRIX 1440 adult. Additional details were provided as follows: The patient accidentally received an adult HAVRIX vaccine at the age 16 year old, which led to inappropriate age at vaccine administration and accidental overdose. The patient had also experienced some pain at the injection site. The reporter did not know the actual date of birth, lot, expiration date at the time of reporting, as she was calling from home.
About half hour after vaccine had a headache woke up with a  100 temp fever. The next morning fever went away. The night of 12/18 my temp was 102. temp, lost  taste/smell  and felt fatigue. On 12/19 I went to get a Covid Test results positive. The week of 12/21 started to feel better and then on 12/26 OT started dropping. I had to miss 5 days of work.
patient was administered FluMist without incident. After that he was watching his father and brother get the injection and he passed out.  He was standing and he hit his chin on the edge of the table.  He was only blacked out for a few seconds but 911 was called due to hitting his chin in the table. When he awoke he said he was dizzy and head was throbbing. He was A&Ox3 and responding to questions.  Father stated he has very high anxiety and history of panic attacks.   5:10pm BP=160/92 , P=96.  5:20pm BP=168/106 P=66. No meds were given.  EMT's arrived and assessed. Blood sugar=92. Pt went to ED for evaluation and was diagnosed as vasovagal and his chin was fine, no further injury.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 24-JAN-2018, the patient was vaccinated with improperly stored M-M-R-II (lot # N010495, expiry date: 31-MAR-2019) reconstituted with improperly stored sterile diluent, lot # M014034, expiry date: 20-NOV-2018. The vaccine was exposed to a temperature of 9 Cº to 25 Cº (8.3Cº) for 1 hour 17 min, on 06-JAN-2018, 9 Cº to 25 Cº (11.5Cº) for 1 hour 59 min on 11-JAN-2018, 9 Cº to 25 Cº (15.6Cº) for 1 hour 33 min on 17-JAN-2018, 9 Cº to 25 Cº (11.9Cº) for 1 hour 2 min on 23-JAN-2018 and 9 Cº to 25 Cº (12.1Cº) for 1 hour on 30-JAN-2018. There was no previous temperature excursion. The call was because of a data logger. No adverse effects reported. The outcome of the event was unknown. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA004616: US-009507513-1802USA004629: US-009507513-1802USA004629: US-009507513-1802USA004636: US-009507513-1802USA004641: US-009507513-1802USA004647: US-009507513-1802USA004652: 1802USA004654: Original Case : 1802USA002182 US-009507513-1802USA004654: US-009507513-1802USA004658: US-009507513-1802USA004663: US-009507513-1802USA004671: US-009507513-1802USA002182: US-009507513-1802USA004692.