chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a 49 year old female registered nurse with lupus, degenerative joint disease, gastroesophageal reflux disease and thalassemia who on 11MAR2003 at 1:00 PM was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine, IM in the left deltoid. There was no illness at the time of vaccination. On 11MAR2003 at 9:00 PM the patient developed acute swelling (to left upper arm: triple in size), severe pain, tenderness, unable to move/ rotate at shoulder, increased warmth and redness at the injection site. It was reported that "her arm became so swollen that she had trouble wearing her lab jacket. The arm looked so bad that she thought at first that she had cellulitis." It was reported that "narcotic pain medication was required" and Advil for swelling. Her signs and symptoms reportedly lasted 3-4 days and the pt recovered. It was noted that the pt had an adverse event following a prior unspecified vaccination at 49 years of age. There were no relevant diagnostic laboratory tests performed. There was no product quality complaint involved. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of fatigue in a adult male patient who received SHINGRIX for prophylaxis. On 22nd April 2018 18:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, less than a day after receiving SHINGRIX, the patient experienced fatigue, flu symptoms, fever, sickness, pain and daytime sleepiness. On an unknown date, the outcome of the fatigue, flu symptoms, fever and sickness were recovered/resolved and the outcome of the pain and daytime sleepiness were unknown. It was unknown if the reporter considered the fatigue, flu symptoms, fever, sickness, pain and daytime sleepiness to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on left arm. The patient reported that he received his first dose of SHINGRIX on 22nd April 2018 and that night he started to felt fatigued. He felt sick like he was coming down with the flu and he had a temperature with aches. He fall asleep for 7 hours during the middle of the day because of the fatigue he was experiencing. He claims that his symptoms started that Friday night and into the next day and the following day and then all of his symptoms resolved on Sunday. He claims that he received the vaccine around 6:00 PM at night. The patient reported that he received the vaccine on 22nd April 2018 which was a Sunday, however, he specifically stated that his symptoms started on Friday night and into the next day and the following day which contradicts his initial vaccination date. The reporter did not realize during phone conversation that 22nd April 2018 was a Sunday when he reported the information.
Site: Pain at Injection Site-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Headache-Medium, Systemic: Hypotension-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Seizure-Severe, Systemic: Tachycardia-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Medium, Additional Details: Patient was given COVID vaccine and moved to another chair to be observed. Upon sitting in other chair, he almost immediately went stiff, began convulsing, and then went unconscious. Patient came to, 911 was called, and patient was transported to ER.
Had symptoms of the flu and felt the same. Fever, chills, muscle aches, headache, diarrhea, vomiting. Had these symptoms for approx 36 hours. What I'm most concerned about is that after these symptoms disappeared I was left with somewhat muffled hearing.
Patient bleed and area around site began to swell and become hard. Advised patient to keep an eye on it and apply ice and use NSAIDS.
It was so long ago but I'm reporting now because I just recently learned that, even though we told the Dr. (she was wonderful), that doesn't necessarily mean it was reported to the CDC. That shocked me. We've since moved and have a new pediatrician. On the day he received the DTaP (which Nurse though was most likely the culprit of his reaction) Patient also received HepB, HIB, & PCV7. Within 20-30 minutes patient's demeanor was entirely changed. His eyes became wide, his legs and arms stiff and straightened in his car seat. He became minimally responsive in affect and appeared to be in a state of shock. Patient was highly articulate and expressive at this age and it was disturbing to see him identifiably altered. He appeared to be unable to respond to my initiated interactions of any kind--again, it looked like a serious state of shock. When we arrived home approximately 20 minutes later, patient began wailing. Though a very content, carefree child, he was virtually inconsolable for approximately 24 hours without many interruptions. He alternated between loud wailing to exhausted crying. He cried almost the entire night with very brief periods of dozing before waking alarmed again and wailing. It was incredibly disconcerting and disturbing. Patient ran a slight fever during this time as well which concerned us much less than the other reaction. If I remember correctly we called the pediatrician's office the next day and he was seen either one or two days after the vaccine. By the time he was seen in the office again, his crying had tapered significantly though he was still very upset off and on. It was a horrifying two days and we both feared he could have been permanently damaged. Thankfully, we observed no long term side effects and his behavior was basically normalized within several days.
muscles felt like they were on fire for the first three weeks/muscle burn; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program . The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 22Apr2021 15:00 (Lot number: ER-8735) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TYLENOL taken for prophylaxis, start date: 22Apr2021, stop date: 23Apr2021. Past drug history included: Tylenol, start date: 21Mar2021, stop date: 22Mar2021, notes: Reduce after effects. Vaccination history included: Bnt162b2 (Dose:1, Time: 13:00, Anatomical Site of injection: Left Arm, Route of administration: intramuscular, Batch/lot number: EN6203), administration date: 21Mar2021, for COVID-19 immunization, reaction(s): "heart beat sky rocketed", "had chest pains (1st two hours after the shot)", "pain in the shot site". The following information was reported: MYALGIA (non-serious) with onset 22Apr2021 17:00, outcome "not recovered", described as "muscles felt like they were on fire for the first three weeks/muscle burn". No follow-up attempts are possible. No further information is expected.
Information has been received from a registered nurse referring to 2 patients of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 17-AUG-2015, the patients were vaccinated with ZOSTAVAX (0.65 ml, Lot#L011529, expiration date: 03-JUL-2016), which were improperly stored for 14 days (Incorrect product storage). The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a registered nurse concerning a 32 month old white female patient with no pre-existing allergies or medical conditions, who on 03-NOV-2005 was vaccinated with a first dose of varicella virus vaccine live. The patient was not ill at the time of vaccination. On 25-JUL-2005 the patient developed 50 plus multiple lesions in various stages on her trunk and arms. She was treated with calamine (+) camphor (+) pramoxine hydrochloride (AVEENO), diphenhydramine hydrochloride (BENADRYL) and mineral oil (LUBRIDERM Lotion). There were no laboratory tests performed. The patient did not have adverse events following prior vaccination. The patient recovered. No additional information is expected.
Patient was given 4 months vaccinations at the pediatricians office and later went down for a nap. When the patient woke up she presented with oscillating rhythmic jerking. Parents took patient to Hospital, where they ran test and later said she had a myoclonic seizure disorder. They prescribed vitamins and seizure medications (KEPPRA and ONFI). After her one week hospital stay patient came home where her jerks got worse and presented more like seizures. Patient was weaned off of seizure medications and when she was 9 months old she had a 5 plus minute seizure. Patient was taken to the hospital where more tests were run and she was put back on KEPPRA. Once back at home seizures looked more like the jerks from before and Patient started therapy. Patient was then taken to another Hospital for a second opinion. At hospital the neurologist stated that she did not have a seizure disorder after looking at an EEG their hospital performed. The neurologist also did an MRI that stated that her ventricles appeared bright asking the parents if mother had a normal pregnancy, if patient lost oxygen at any point, or if patient had a cardiac event. Mother had a normal pregnancy and the patient did not lose oxygen or have a cardiac event to the parents or doctors knowledge.
Headache, Fatigue, Nausea, intermittent tinnitus, feeling "off",  appetite off, taste off,  lasted several months, never worse than a 3 or 4 out of 10, typically mild, but lingering, even now seem more sensitive in the stomach.
Patient was administered a child vaccine dose 0.2mL verses and adult dose 0.3mL  which is age appropriate requires it for Covid vaccine. Pt's mother was notify at the time of the event by the Provider Dr. and myself, CMA. Pt's mother aware and verbalized understanding. Pt's mother was advice okay to proceed to give 2nd dose as scheduled by our quality control staff. Pt's mother aware and verbalized understanding.
This case was reported by a health professional and described an injection site reaction in a 45 year old pt who received hep B vaccine recombinatn (Engerix B) for prophylaxis. On 7/24/03, the pt received an injection of Engerix B (5371A4). On 7/25/03, one day post-immunization, the pt developed an injection site reaction characterized by a "red, itchy spot." The pt was seen by the physician. The reporter stated that the injection site reaction was "perhaps from the bandage."
Mother called on 9/17/2009 left message stating "child broke out in red rash head to toe and bowels swollen after receiving vaccines on 9/16/2009."  Mother says child would not eat and was crying and hurting to stomach approx. 8 pm on 9/16/09 so she took him to ER and they found the rash on his body and told her his bowels were swollen.  ER did not give any treatment to this patient.
Starting approx 5 days ago pt states that she has a constant ammonia smell that nobody else can smell.  Does not smell if holds nose or breaths through mouth.
Loud tinnitus, roaring high pitched - started about 4 hours after first dose.  Continues 3/20 and is continuous. Haven?t found anything to help.  Had fever and chills for 18 hours. Fatigue unrelenting for 3 days.
Severe redness & irritation at site of injection, swelling from shoulder to elbow, heat noticed, about 15 cm. temp of 101.4 - severe headache, malaise.
Pt called on 9/22/03 and told us that on 9/18/03 his tongue swelled up and he could hardly talk. It resolved without him seeking medical attention.
Two days after vaccination, patient returned to the pharmacy displaying a large, raised, red area, encircling the injection site. I instructed her to take diphenhydramine to counteract what appeared to be an allergic reaction. Pt returned again on 1/18/16 with a prescription for LEVAQUIN and Prednisone. The reacting area had increased and spread to her elbow.
Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Fever - 101, swelling and redness at injection site (L) thigh. No treatment was required.
A large rash developed on left arm at the site of vaccine six days later (01/06/2021) following first dose of Moderna Covid-19 Vaccine (12/31/2020). The rash was warm to the touch, itchy, inflamed and pink. Hydrocortisone was initially applied to the rash on day one and day two. No improvement had been noted with hydrocortisone. The rash resolved about seven days later (01/13/2021).
The day after my vaccine I experienced Fatigue, headaches, most like having a mild flu. The worst symptoms I had was nothing could get rid of the headache, water, caffeine, Aleve etc. did not help. Some sinus issues however nothing terrible. I had a mild fever as well. The day after I woke up feeling fine. I came down with covid-19 symptoms showing around April 27th 2022. I didn't get to urgent care until May 2nd. I was experiencing immense fatigue, night sweats, chills, etc. It lasted a few days and then I was able to get to Urgent care after wards when I began to feel better. No prescription given. I am still experiencing some brain fog and fatigue, as well as sinus irritation that is mild.
warm to the touch; had a smooth red rash the size of a quarter (or maybe two quarters); is a smooth red; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (warm to the touch), INJECTION SITE RASH (had a smooth red rash the size of a quarter (or maybe two quarters)) and INJECTION SITE ERYTHEMA (is a smooth red) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025520/2A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ROSUVASTATIN and TAMSULOSIN for an unknown indication.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced INJECTION SITE WARMTH (warm to the touch), INJECTION SITE RASH (had a smooth red rash the size of a quarter (or maybe two quarters)) and INJECTION SITE ERYTHEMA (is a smooth red). At the time of the report, INJECTION SITE WARMTH (warm to the touch), INJECTION SITE RASH (had a smooth red rash the size of a quarter (or maybe two quarters)) and INJECTION SITE ERYTHEMA (is a smooth red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment information provided.
Patient received her 1st GARDASIL injection on 12/12/13. She had an immediate headache and lightheadedness. Pt was hypertensive (134/100) -> BP decreased to 112/84 in 15 minutes.
She was positive to Covid-19; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiry date: not reported), via an unspecified route of administration on 27Apr2021 as a dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, the caller called to say that received the vaccine last Tuesday on 27Apr2021 and on the same day, she got the PCR test. She was positive to Covid-19. She wanted to know whether she could proceed to get her second dose on 18May2021 or does she need to wait for 90 days. On 27Apr2021, the patient underwent lab tests and procedures which included PCR test, resulted as positive. The outcome of the event was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
w/in 3 mins of immun pt collapsed & had a mild sz, dilated pupils, legs & arms jerking, head rocking-lasted less than 30 seconds then came to feels tired;
Around 10am today I started having chest tightness and pain, some shortness of breath. It was constant and every time I got up to walk around my BPM (on my Fitbit) went up to about 120. I am normally around  70 and even when sitting still it was 80-95. I went to urgent care around 1 and saw Dr. They checked my blood pressure several times and it was between 118-126/84 (normal for me is about 105/70).  They did a PCR test for COVID but later called to tell me the sample was mislabeled. In the meantime I went to a rapid testing site and got an antigen test that was negative.  Dr opinion was that the reaction was most likely an immune response to the vaccine.  He said I should go in if symptoms last longer than 1-2 more days or if they get worse.  They said I could repeat the PCR test if I needed to be seen again but felt pretty confident about the antigen test results. I am still having the same symptoms tonight, the same severity.  I have no other symptoms of COVID and did not have any other vaccine side effects besides expected/mild ones. I had  a little shortness of breath last night before bed but the chest pain didn?t start until today. I?ve gotten all scheduled vaccines throughout my life plus some for travel and have never had a reaction. I have never had anything like this chest pain and have no history of heart issues.
A non-serious spontaneous report of stuffy nose and sneezing has been received from a registered nurse concerning herself, a 48-year-old female subsequent to FLUMIST. The patient's medical history and concomitant medication were not provided. The patient received a total of one dose of FLUMIST on 18-Sep-2009. The patient experienced stuffy nose and sneezing on 20-Sep-2009. The outcome of the events was unknown.
A 3 inch by 5 inch itchy rash has appeared around the injection site. Itching began last night (4/19/2021) 8 days after receiving the vaccine. I noticed the rash the next morning (4/20/2021).
24 hours after vaccination patient developed generalized burning and electric pains. This is similar to symptoms that were previously diagnosed as small fiber neuropathy, which had resolved 9 yrs prior to vaccination.  01/04/2010 PCP medical records received. Service dates 9/24/09 to 12/30/09. Assessment: Small fiber neuropathy. Patient has resumption of long dormant neuropathy. Physical therapy. Pain everywhere. Distraction, sleeping poorly, eating poorly, activities of daily life impaired. Biofeedback / Relaxation program. Neurology consult. Epigastric abdominal pain after NSAIDs.
severe ongoing complications related to the Covid vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION COMPLICATION (non-serious), outcome "unknown", described as "severe ongoing complications related to the Covid vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
not feeling well; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient wasn't feeling well on 07Apr2021.  The outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Client was given dose of adult vaccine instead of pediatric dosage. Mother advised and will be assessing for adverse reaction signs/symptoms.
One (1) day after vaccination in the left deltoid, the patient had diffuse erythema and swelling over much of the deltoid area. Antibiotics started 11/06, by 11/07 her skin had raised edge consistent with erysipelas . Swelling f the deltoid and erythema decreased by 11/09.
none Narrative:  1st dose was Pfizer manufacturer given on 1/22/21 at 16:09 hours. 2nd dose given by nurse was Moderna manufacturer on 2/17/21 at 15:45 hours. No reaction to date, only manufacturer difference.
tingling in fingers/ 3 fingers of right hand; numb/only 3 fingers of right hand; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in fingers/ 3 fingers of right hand) and HYPOAESTHESIA (numb/only 3 fingers of right hand) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In September 2021, the patient experienced PARAESTHESIA (tingling in fingers/ 3 fingers of right hand) and HYPOAESTHESIA (numb/only 3 fingers of right hand). At the time of the report, PARAESTHESIA (tingling in fingers/ 3 fingers of right hand) and HYPOAESTHESIA (numb/only 3 fingers of right hand) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported  No treatment information was provided
Patient called clinic stating that he had an adverse reaction to the pneumococcal 13 valent vaccination. Patient felt dizzy and had blurry vision for 4 days post immunization. This resolved after 4 days. He also states that he later developed bronchitis. Patient states that he went to the hospital 11/5/19 due to this and trouble urinating. States that he was diagnosed with atrial fibrillation. (Flu vaccine administered 10/15/19 - unknown manufacturer and lot. Was given at another private physician's office) BlurredVision & Dizziness
Chills, nausea, 100 degree 10 hours after vaccine. Arm pain less than  an hour to initiate
no additional AE; a nurse reconsituted VARIVAX with monactra instead of the sterile diluent and she administered it to a patient; a nurse reconsituted VARIVAX with monactra instead of the sterile diluent and she administered it to a patient; This spontaneous report was received from a nurse and refers to a male patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 27-JAN-2021, the patient was vaccinated with an improperly reconstituted dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneously (exact dose, anatomical location, lot # and expiration date were not provided) for prophylaxis (product preparation error). A nurse reconstituted the vaccine with meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) (reported as monactra) instead of the sterile diluent (wrong product administrated). There was no adverse event (AE) reported.