chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Legs began to shake/whole body shaking uncontrollably. Minutes later whole body was shaking uncontrollably.; involuntary muscle spasms throughout body butconcentrated in limbs; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12Apr2021 at 11:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as n/a. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021 at 19:30, about 8 hours after receiving the vaccine, the patient noticed his legs began to shake, and minutes later whole body was shaking uncontrollably. This was not shivering from chills but instead intense involuntary muscle spasms throughout body but concentrated in limbs. This lasted for approximately 45 minutes and then ceased. The patient had never experienced anything like this and had not had any neurological issues. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events legs began to shake and minutes later whole body was shaking uncontrollably and intense involuntary muscle spasms throughout body, which lasted for approximately 45 minutes and then ceased was recovered on 12Apr2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Terrible headache, joint pain throughout body, chills, fever, nausea. Huge red mark and pain at injection site. This is the second vaccine. It's even worse than the first.
pt to hospital with increasing fatigue and SOB; states had a recent positive COVID test from; has experienced fever, cough; pt is hypoxic; requiring O2 supplementation; chest x-ray shows COVID pneumonia; given dexamethasone and Lovenox for anticoagulation; DNR; decreasing mental status; pt worsening with an increase in O2 requirements; transitioned to comfort care and pt died in the hospital
no adverse event; Patient was administered a half dose of the Bivalent booster instead of the full dose; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Patient was administered a half dose of the Bivalent booster instead of the full dose) and NO ADVERSE EVENT (no adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 29-Sep-2022, the patient experienced UNDERDOSE (Patient was administered a half dose of the Bivalent booster instead of the full dose). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, UNDERDOSE (Patient was administered a half dose of the Bivalent booster instead of the full dose) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Patient was administered a half dose of the Bivalent booster instead of the full dose).    No concomitant medication information was provided. It was reported that a technician gave 0.25 ml of the Bivalent booster to patient. No treatment drug was reported. This case contains information for the 4th of 5 elderly patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-654604, US-MODERNATX, INC.-MOD-2022-654611, US-MODERNATX, INC.-MOD-2022-654609, US-MODERNATX, INC.-MOD-2022-654608 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654609:Patient 3 US-MODERNATX, INC.-MOD-2022-654611:Patient 5 US-MODERNATX, INC.-MOD-2022-654604:Patient 1 US-MODERNATX, INC.-MOD-2022-654608:Patient 2
sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old male patient received BNT162B2 (Batch/Lot number: unknown, Expiration date: 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: ILLNESS (non-serious), outcome "unknown", described as "sick".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
IN FoR 7th gRade shots 0 acted NeRvouse all quesTions No oN secReening FoRm - seemed. NeRvouse - asked IF WaNTed to LaydowN He Did - seemed FiNe after shoTs - 12 NooN Mom called. Rash oN ToRso - 3pm Rash oN Neck & Race - Did NoT go To ER - over oN Back 8/26/19 815 AM Call To mom FoR Followup - gave Oatmeal Bath a BeNedry. Is DoiNg BeTTeR Now Face PuFFy - ModeRaTe Body Rash. Everything sTaRTed Within 2 hrs after shoT given Mom was going To check with SchooL NuRse & see IF any oTheRs Had same ReacTion- Will check oN Tuesday To call schooL - schooL NuRse - Said No pRoblems From Him & No oTheR children Had any ProbLems
Reaction to pneumo vaccine. Swelling of injection site on right deltoid. Injection site very painful, entire arm hurting. Fever (up to 101.5 degrees), muscle weakness, chills, fatigue, loss of appetite.
Narrative:  64yo male pt with the following info taken from most recent MD note (8/12/21). "Diagnosis: 1. Polycythemia vera, JAK2+ 2. H/o Left common and proximal femoral vein DVT in Feb 2020 HPI: Patient is a 64 year old MALE with past medical history significant for ESRD on dialysis, HIV on HAART, HCV, and hypertension..." Pt dies on 8/27/2021. No information given in regard to his death, no info in pt's chart. Pt had received covid vaccines on 4/6/21 & 5/6/2021. Likely death is not related to the vaccinations given pt's medical history.
Patient developed symptoms that appear like Bell's Palsy on May 17, 2021 and reported to the ED on May 18, 2021. She was treated with a short course of prednisone and Valtrex. Symptoms improved within 2 weeks, but continue to linger about 8 weeks later.
Patient presented at the pharmacy today (8/4/18) with a 3-4 inch diameter red area on her left arm (site of injection of SHINGRIX). She stated she had gotten the SHINGRIX vaccine on 8/1/18 and the redness started soon after her injection. The patient expressed that it was warm to the touch and hurts if bumped or touched. She has been applying ice at intervals with minor relief. I spoke with her about the possibility of cellulitis and instructed her to draw using a marker a ring around the affected area and to take a picture of it for reference. I then explained to her the signs of further infection: the redness not receding or growing larger, radiation streaks appearing, and fever. I instructed her to watch the red spot for getting better and if it has not resolved in 24-48 hours to seek medical attention.
Information has been received from a nurse practitioner concerning a female (age unknown) who on approximately 11-MAY-2007 was vaccinated with a dose of Zostavax (Oka/Merck). In May 2007, the patient experienced ocular shingles "two weeks after receiving vaccine". Unspecified medical attention was sought. No product quality complaint. Follow-up information received indicating that the physician will be doing a "DNA test" to see if the shingles virus this patient has is the "wild" type or the vaccine type. Additional information has been requested. This is in follow-up to report (s) previously submitted on 6/14/2007. Information has been received from a nurse practitioner concerning a 67 year old female with a penicillin allergy and a history of childhood chickenpox who on 16-APR-2007 (previously reported as approx. 11-MaY-2007) was vaccinated with 0.65 ml of ZOSTAVAX (Oka/Merck) (Lot #656609/0015U) in her left deltoid. On 24-MAY-2007 (previously reported as in May 2007), the patient experienced ocular shingles. Unspecified medical attention was sought. No product quality complaint. The patient had no recent exposure to chickenpox or herpes zoster. A rash did not occur at the site of injection or elsewhere within 42 days of the vaccination. The patient was rated a 10 on a scale of 0 (least) to 10 (most). Subsequently, the patient was recovering from ocular shingles. Follow-up information received indicating that the physician will be doing a "DNA test" to see if the shingles virus this patient has is the "wild" type or the vaccine type. The patient was enrolled in the Varicella Zoster Virus Identification program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the Oka/Merck vaccine VZV strain. The sample of the dry scab lesion was collected on 30-MAY-2007. The PCR results for the specimen identified the presence of WT VZV.
Pediatric dose of Hep A inadvertently given to patient.  Birthdate verified with pt and did not calculate pt to be 19 instead of 18.  Pt called per this RN and need for revaccination explained.
Patient stated that she suffers severe anaphylactic response to multiple antibiotics.  Food items as listed previously. Patient denies citrus sensitivity. Patient taken to EMS room at 12:25 PM. Lead RN notified. Benadryl 25 mg po given at 12:20 PM. Patient sat on cot with bottled water while injection of J&J vaccine administered at 12:30 without incident. Patient was closely monitored for adverse symptoms. Patient denies these symptoms at this time. 12:40 PM, patient is texting on phone without any problems breathing or otherwise.
Immunization for yellow fever given at 3PM. Woke up at 4AM, followed by vomiting & diarrhea for 2.5 hours continue malaise throughout day and nausea.
shortness of breath; palpitation; extreme fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 2023, outcome "unknown", described as "extreme fatigue"; PALPITATIONS (non-serious) with onset 2023, outcome "unknown", described as "palpitation"; DYSPNOEA (non-serious) with onset 2023, outcome "unknown", described as "shortness of breath". Additional information: Caller said that he got his COVID 19 vaccine last week since reporting day (02Nov2023) and asking if it's normal to have shortness of breath, palpitation and extreme fatigue.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a Medical Assistant refers to 12 year old patient, gender not reported. On 04-DEC-2014, the patient was vaccinated with GARDASIL, Lot # K008335, expiry 23-JUN-2016, dose unspecified. It was reported that the administered vaccine was subjected to temperature excursion during storage. No adverse event reported. This is one of the several reports from the same reporter. Additional information has been requested.
This case was reported by a other health professional via sales rep and described the occurrence of influenza-like symptoms in a 60-year-old female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms and injection site swelling. On an unknown date, the outcome of the influenza-like symptoms and injection site swelling were unknown. The reporter considered the influenza-like symptoms and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a medical assistant. The age at vaccination was not reported. All questions were asked, field representative provided limited information.
Total body hive reaction the next day.  No other system involvement.  PO benadryl with complete resolution of the rest the following day.
Sore arm after second day as well as sore lymph nodes.  Tylenol and symptoms were gone.  1/25 and 1/26 developed itch on arm that had the injection.  Swollen and somewhat hot.  Applied topical triamcinolone and took a Claritin.  Itch was gone but still swollen.
Initial report was received from a consumer, who was also the patient, on 18 January 2013. A 25-year-old male patient had received an injection of INFLUENZA VACCINE, Sanofi Pasteur, (lot number, route and site of administration not reported) on 16 January 2013 in the emergency room and "had a reaction to it". On 17 January 2013, when the patient woke up, he noticed his thinking was not normal, had no anger, felt like he could not stand up for himself, was depressed and could not cry. His emotions were not right and asked if there was a medication to take the vaccine out of him. He used to hear voices in his head and now he does not and he does not want to be angry. The patient had no illness at the time of vaccination and a medical history of Hepatitis C. Outcome was not recovered. Documents held by sender: None.
Pt recvd 2 doses of Hep B vax 23MAY91 & 20JUN91 & on 4JUL91, 2 wks following 2nd vax exp upper body weakness, arthralgias & myalgias; exp pain rt shoulder which radiated into rt elbow; exp marked degree of limitation;
blood sugar was160; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (blood sugar was160) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic.    On 29-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced BLOOD GLUCOSE INCREASED (blood sugar was160). At the time of the report, BLOOD GLUCOSE INCREASED (blood sugar was160) outcome was unknown. Not Provided          Treatment information not provided. Concomitant medications were not provided.
0945 Client related he is having difficulty breathing and is showing signs of cyanosis within 2 minutes of receipt of 2nd dose Pfizer vaccine. Epinephrine 0.3mg administered per auto inject pen IM to left thigh. Ambulance called. Nursing staff and medics on site. SPO2 55 pulse 133 client has Ventolin inhaler 2 puff administered .0949 BP 76/52. 0952 Sp02 64 Pulse 104. Client relates improved breathing. Audible wheezes. 0956 ambulance arrived Pulse 103 SpO2 76. Client remained conscious and continued to communicate. Client taken by ambulance to Hospital. Wife is with client.
pain around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain around the injection site) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 18-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 VACCINATION SITE PAIN (pain around the injection site). At the time of the report, VACCINATION SITE PAIN (pain around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
ADMINISTERED EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. 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, batch number: 206A21A, expiry: 21-SEP-2021) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-SEP-2021, the patient experienced administered expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from administered expired vaccine. This report was non-serious.
Initial unsolicited report received from a pharmacist on 28 September 2015. This case involves a (68-year-old) female patient who was vaccinated with a [route and dose series not reported] dose of FLUZONE HD (batch number UI448AA, expiry date 20 April 2016 and site of administration were not reported) on 22 September 2015. Patient had denied illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as unknown. Other medical history and concomitant medications were not reported. On 24 September 2015, two days following the vaccination patient had hoarseness, cough, tightness of chest and fever. Patient laboratory investigation and corrective treatment were not reported. The outcome of event was not recovered. List of documents held by sender: none.
Had shingles even with shingrix/Suspected vaccination failure; Shingles 4x (horrible devastating disease); Endless pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Had shingles even with shingrix/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles 4x (horrible devastating disease)) and pain (Verbatim: Endless pain).  The outcome of the vaccination failure was unknown and the outcome of the shingles was recovering/resolving and the outcome of the pain was not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingrix.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingrix.   Additional Information: GSK Receipt date: 04-Mar-2023. This case was reported by a consumer via interactive digital media. The patient stated that his/her heart goes out to all if you.  The patient had horrible devastating disease 4 times and even with the shingrix vaccine. The patient stated that there were no words that could explain the endless pain and he/she just getting over it again. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Several hours post vax, complained of right leg weakness/parenthesis. Referred to ER by family physician, given crutches. Diagnosis: hysterical conversion reaction.
Redness, warmth and pain reported at site of MMR vaccine. Measuring 3 inches x 1.8 inches. Vaccine administered 2 days prior. Site was marked and measured, will continue to monitor. Provider will prescribe KEFLEX tomorrow if not improved. Used Cephalexin QID x 7 days.
Post first and second vax, no untoward effects. Post third vax, he experienced myalgias.
Patient received an expired dose of the Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the Moderna Covid-19 vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medication was not reported. It was reported that the Moderna COVID-19 vaccine provided to the patient was the first, second, third or booster dose.  Furthermore, it stated that the expiration date was always changing and stated that Moderna was not transparent with the information that was provided and wanted more information about stability as stated Moderna obviously had a problem with stability of the vaccine, if not they wouldn't be changing the expiration date all the time.   Reporter did not allow further contact
Narrative: HBPC 64yo male with hx of: PROBLEM LIST: *Malnutrition Obstructive sleep apnea of adult Spasticity Constipation Chronic obstructive lung disease Wound Multiple environmental allergies Seen by palliative care service Amyotrophic lateral sclerosis Abnormal findings on diagnostic imaging Sciatic neuropathy Cyst of pancreas Peripheral vascular disease Prediabetes Chronic low back pain Osteoarthritis of knee Degeneration of lumbar intervertebral dis Essential hypertension Hyperlipidemia Gastroesophageal reflux disease Pt was in HBPC as unable to care for self. Pt's family was waiting nursing home placement. Pt DIED at home on 8/24/21. Pt had received covid vaccines on 2/4/21 & 3/8/21. Likely pt's death is not related to vaccines.
DEVELOPED SWOLLEN LYMPH NODES AND SORENESS ON NECK AND JAW (LEFT SIDE). WENT TO THE ER AND IS FOLLOWING UP WITH MD ON 1/5/21
Initially body aches.  Took temperature at 4:00 pm and it was 101.  Took Tylenol and slept until morning of 3/19.  Have felt fine and no fever on 3/19.