chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nausea, palpitations, Headache, Chills, severe achiness and fatigue, fever,  pain at the injection site and whole injection site arm soreness.
13:10-Patient on gurney in observation after vaccine for hx of nausea/lightheadedness with 1st dose of vaccine x 1.5 days.    PMHx: HTN, Gastroparesis, IBS Meds: Flagyl, Glyburide VS: B/P-148/110, RR 16, SaO2: 96% on RA, CBG: 133 1327 repeat VS: B/P-138/104, RR 16, HR 90, SaO2: 98% on RA Cool cloths to neck and forehead with HOB flat. Slight improvement. Daughter accompanied patient today is able to drive her home. 1415: patient released by Provider on duty and EMS.  Patient educated to follow up if her symptoms should worsen.  Patient communicated understanding at time of discharge home with daughter.
Numbness starting in feet while moving up within the 24 hrs he was numb/weak-unsteady gait, had no reflexes, never had to on ventilator but did have shallow breathing and difficulty swallowing spinal tap confirmed. Tx plasma freeze, IVIG.
Employee felt pressure on the right side of her head and noticed swelling on the right side of her face.
felt dizzy; a light headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "felt dizzy"; HEADACHE (non-serious), outcome "unknown", described as "a light headache".  Additional Information: The reporter had an appointment for her 2nd dose today. She was asking for the time. According to her she felt dizzy and had a light headache. She was asking if this is the cause of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Entire body vibrated internally; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EM9809), via an unspecified route of administration (administered on the left arm) on 12Feb2021 at 02:45 (at the age of 69-years-old) as dose 1, single for COVID-19 immunisation. Medical history included blood pressure from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient has no allergies to medications, food, or other products. Concomitant medications received within two weeks of vaccination included levothyroxine sodium (L THYROXIN), pantoprazole (PANTOPRAZOL), and unspecified blood pressure medications; all taken for an unknown indication, start and stop date were not reported. On 12Feb2021, the patient experienced entire body vibrated internally. It was reported that, after the first vaccination, it was gone in the morning. The event did not result in doctor or other healthcare professional office/clinic visit, 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 event entire body vibrated internally was resolved on an unknown date in Feb2021 but recurred. The patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN6203) via an unspecified route of administration (administered on the left arm) on 05Mar2021 at 15:45 (at the age of 69-years-old) for COVID-19 immunisation and after the administration, the event (entire body vibrated internally) returned. It was reported that the patient had no idea how long it will last.   No follow-up attempts are needed. No further information is expected.  Amendment:  This follow-up report is being submitted to amend previous information: Deleted Relevant Medical History: None", captured "Blood pressure abnormal" as relevant medical history, added "Vaccine Facility Information", concomitant medication "LEVOTHYROXINE" re-coded as "L THYROXIN" and "PANTOPRAZOL" re-coded as "PANTOPRAZOL [PANTOPRAZOLE]", considered stop date of event to Feb2021 per context (considering reported duration "after the 1st vaccine, it was gone in the morning"), and deleted 2nd dose as co-SD (recurring event).   No follow-up attempts are needed. No further information is expected.
No adverse effects reported; Multiple patients were vaccinated with improperly stored VAQTA; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 04-JUN-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), lot # R018935, expiration date 05-SEP-2019, for prophylaxis (dose, route, anatomical site and frequency were not reported). The reporter stated that the vaccine had a temperature excursion of 34.2 F for 4 hours and 54 minutes, which was detected by a data logger. The vaccine had no previous temperature excursion and there were no adverse effects reported.  This is one of several cases from the same reporter.  ; Sender's Comments:  US-009507513-1907USA001174: US-009507513-1907USA004852: US-009507513-1907USA004853: US-009507513-1907USA004854: US-009507513-1907USA004855: US-009507513-1907USA004856: US-009507513-1907USA004857: US-009507513-1907USA004858: US-009507513-1907USA004859: US-009507513-1907USA004860: US-009507513-1907USA004862: US-009507513-1907USA004863: US-009507513-1907USA004864: US-009507513-1907USA004865: US-009507513-1907USA004866: US-009507513-1907USA004867: US-009507513-1907USA004868: US-009507513-1907USA004869: US-009507513-1907USA004870: US-009507513-1907USA004871: US-009507513-1907USA004872: US-009507513-1907USA004873: US-009507513-1907USA004874: US-009507513-1907USA004875: US-009507513-1907USA004876: US-009507513-1907USA004877: US-009507513-1907USA004878: US-009507513-1907USA004879: US-009507513-1907USA004880: US-009507513-1907USA004881: US-009507513-1907USA004882: US-009507513-1907USA004883: US-009507513-1907USA004884: US-009507513-1907USA004885: US-009507513-1907USA004886: US-009507513-1907USA004887: US-009507513-1907USA004888: US-009507513-1907USA004889: US-009507513-1907USA004890:
Vaccine past its expiration date administered to 11 patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED. On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  No Treatment information was reported.    This case was linked to MOD-2021-371236 (Patient Link).
Parent/guardian lied about the child's age on both the first and second dose.  Child was not approved per the guidance.
heart racing lasted 1min on 12OCT97;arm red, swollen, hot & hard;heart racing x 2 lasting 1min each time 13OCt97;pt threw up & had stomach cramps on 13OCt97;called MD office given DPH & hot & cold pads to apply locally on the arm;
2 days of normal soreness after injection on 12/28/2020.  Evening of 1/6/2021, initial redness of injection site with spread thru shoulder down to elbow.  Morning of 1/7/2021, Redness brighter, streaky, swollen knot at injection site about the size of 1/2 dollar.  Warm touch and throbbing.  Contact Employee Health and PCP with pictures and sypmtoms.  Told to ice, pain meds as needed and watch.  Swelling and pain subsided by 1/9/2021, redness and itchy thru 1/10/2021.  All symptoms are gone and ready for dose 2.  I was told by Employee Health and PCP to report.
None called Moderna. no symptoms after vaccination.  Moderna Vaccine was expired on 2/12/23
THE VACCINE ADMINISTERED WAS OUTSIDE OF APPROVED STORAGE & HANDLING INSTRUCTIONS FROM MANUFACTURER.
Rash head to toe-bright. No fever, not toxic. Tx Benadryl.
5 plus days of low grade temp, intermittent flushing, headache, body aches, tiredness . On day 7, left deltoid site became swollen within 2 hours to the size of a small baseball , red, tingling and painful- occupational health ordered covid test as well
Patient received her first COVID vaccine (Pfizer) on 1/4/21 at 1419. She called the clinic on Thursday 1/7 and reported "Since her vaccine she has had body aches, fever, diarrhea." Clinic staff referred her to her PCP.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "TA aneurysm" (unspecified if ongoing), notes: Other medical history: TA aneurysm; "controlled Afib" (unspecified if ongoing), notes: Other medical history: controlled Afib; "known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "known allergies finned fish" (unspecified if ongoing), notes: known allergies finned fish; "Prosthetic Aortic valve" (unspecified if ongoing), notes: Other medical history: Prosthetic Aortic valve (near end of replacement duration). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (Jul2022) Negative, notes: Tested negative after finishing Paxlovid 5 day course. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid from 18Jul2022 to 22Jul2022 for treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Time of assessment 1144. Alert and oriented and Anxious. After sitting for 13 minutes of a 15 minute observation, patient reported feeling his throat tightening. He says it happened 2-3 minutes after receiving his vaccine and sitting down, but it went away. He says it came and went away another time, but this time it stayed. He was able to swallow water and his medication without difficulty.  1144: 129/87, P 89 1156: 139/81, P 87 (reports the feeling of his tightening throat is easing; denies itching to the throat, tongue not swollen, no rash observed) 1210: Reports feeling flushed, BP 139/81, P 83. (he says he's feeling his anxiety rising and says he will take 1/2 Xanax when he leaves) 1215-denies symptoms at this time.   Actions taken:  Vitals sign taken  VAERS form obtained and completed by RN.   Medications administered: Loratadine (Claritin) 10 mg  by mouth. Time: 1147. Administered by RN. Famotidine (Pepcid) 10 mg by mouth. Time: 1147. Administered by RN. Diphenhydramine (Benadryl) 12.5 ml (25 mg) by mouth. Time: 1147. Administered by RN. Pepcid 20 mg given due to that is what is on hand and the pill is not scored, so unable to break in half.   Disposition: Reports no further symptoms of adverse reaction after observation for additional 30 minutes minutes. Discharged home. Instructed to call 911 for trouble breathing, rapid heart rate, dizziness, swelling of tongue or throat. 1215 ambulatory out.
HYPERtension throat tightness, paresthesias in extremities, muscle spasms Narrative: Shortly after receiving the vaccine she felt uneasy and experienced the sensation of throat tightness and numbness and tingling in hands and feet, also some rigidity/clonus in the hands. No rash, no wheezing, O2 sat 99%+. The team at the vaccination clinic checked her vital signs and her systolic BP was elevated to 220's. A rapid response was called and she was taken to the emergency room. In the emergency room, she received a neurology consult and head CT to rule out hypertensive bleeding. The scan was negative. She was given labetalol 10mg IV to lower BP, and also solumedrol 125mg, benadryl 25mg. No epinephrine given. Serum potassium was found to be low as well; given oral potassium repletion. Discharged from ER by noon same day, BP down to 160/79.
Pt rcvd both SHINGRIX (left arm) and PNEUMOVAX 23 (right arm) - patient experienced fever and partial paralysis and severe weakness - said she had to roll on the floor to move - was hospitalized and put on IV antibiotics - right side injection site - recovered.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), PYREXIA (101 Fever) and CHILLS (Chills) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm pain). On 11-Feb-2021, the patient experienced PYREXIA (101 Fever) and CHILLS (Chills). At the time of the report, PAIN IN EXTREMITY (Arm pain), PYREXIA (101 Fever) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, Body temperature: 101.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Tdap administered at 8:15 am pt. sat for 10 minutes, began walking became pale, sweaty, dizzy and fainted. Vitals taken 80/60 pulse 78 and 78/60 p.60. Pt taken to ED and monitored.
Throwing up, sore every where - every joint, headache, LYMPH NODES under arm swollen and so painful, dizzy.
This spontaneous report as received from a doctor of pharmacy refers to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 16-SEP-2013, the patient was vaccinated with ZOSTAVAX (lot # J002777 and expiry date 07-JUN-2014) (dose and route were not reported). No concomitant medication was reported. The call was reported originally on 04-NOV-2013 in which the reporter requested the stability for an improperly stored ZOSTAVAX. At the time of the call it was reported that the ZOSTAVAX was exposed to 15F for an unspecified amount of hours but reported that no doses of ZOSTAVAX were administered. The reporter called back again on 05-NOV-2013, and stated that he thought that the ZOSTAVAX might had been stored improperly since May 2013 and that the temperature of the ZOSTAVAX had ranged between 15F and 20F for an unspecified amount of hours. At that time the reporter was unsure if the ZOSTAVAX was administered but stated that he thought the ZOSTAVAX would had been administered. On further investigation, the pharmacist reported that ZOSTAVAX had been improperly stored since about 10-OCT-2013 reaching a highest of 20F for a total time of 600 hours. It was reported that the patient had no adverse effect. Further investigation stated that the pharmacist had determined that this case might involve approximately 5 different Lots of ZOSTAVAX (details unspecified) stored improperly at temperatures up to 21F. He stated the time frame for the excursions would be as of the day each of the ZOSTAVAX Lots was received at his facility through the date of patient administration, which he believed might had been months, dating back to on an unknown date in May 2013. These involved approximately 40 patients. He had no specific breakdown of time frame as his records didn't indicate when he received each Lot but he was calling further for the data. He also could not identify, at this time, which Lot# was administered on which date. Pharmacist would call back after he had compiled all of the necessary information and would like revaccination recommendations for any excursion that could not be supported. Pharmacist stated there had been no adverse effects noted by any of the patients. The pharmacist faxed a spreadsheet which included the 38 patients names, the date of administration as well as the lot and expiration dates of the ZOSTAVAX which was unsupported an administrated. This is one of several reports from the same source. Additional information has been requested.
Staff from office called 12/23/20 to report that they had seen patient in the office for an adverse reaction to the Shingrix vaccination that patient had received on 12/20/20 at the pharmacy. Per staff, the patient developed symptoms in the middle of the night on 12/20. She woke up feeling dizzy and nauseated, almost as if she was having an episode of vertigo. Staff stated the patient is continuing to have dizzy spells on and off since 12/20. Patient is also having some post-nasal drip according to the office notes. I asked if patient was having an additional symptoms such as pain, discomfort, fever and staff indicated that the patient was not. She simply is feeling dizzy especially when changing positions.
Patient received complete series of Moderna vaccine on 2/26/21 and 3/26/21.  During an outbreak of COVID-19 in a homeless shelter she developed symptoms  on 4/27/2021
It was reported that a 51 year old female patient received a Fluzone SV vaccination  on 11/29/2000. Reportedly on 12/05/2000, the patient developed systemic rash all over her body. The patient was given Xanax, Prednisone and Atarax. The rash was still persisting on 12/07/2000. The patient was diagnosed with fibromyalgia and migraine headaches and mixed tissues symptoms. The nurse stated that she is on lots of pharmaceuticals. From additional information received on 12/08/2000, it was reported the patient developed a rash approximately 48 hours after receiving the flu vaccine, not on 12/05/2000 as previously reported. Rash is pruritic and covers the majority of her body with the exception of her face, hands and feet. The patient is still complaining of symptoms on 12/07/2000. From additional correspondence received on 02/21/2001, it was reported, the patient has been previously diagnosed with fibromyalgia and migraine headaches and mixed tissue symptoms, was not diagnosed as previously reported.
Information has been received from a physician referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On 290-OCT-2015 the patient was vaccinated with a dose of improperly stored ROTATEQ (lot # L008031 with expiration date of 03-AUG-2016; strength, dosage and frequency unspecified) orally. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a patient of unknown age (gender not reported). Nurse reported that an unspecified patient was inadvertently administered PNEUMOVAX 23 (lot#, dose and route unknown) and PREVENAR 13 on the same unspecified date. No adverse effect reported. It was unknown if the patient had sought medical attention. Additional information has been requested.
Nausea and felt weak with chest pains and vomiting 5 min after vaccine given. 12/7/09 ER records received for dates 11/23/09. DX: vomiting. Chief c/o weakness, vomiting 2min after H1N1 vax. Pt states received Hep B dose 3 same day. Pt appeared in no distress. Pt states presently feeling fine.  12/14/09 ER records duplicate of 12/7/09 records received.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 07-JUL-2016, the patient was inadvertently administered with an improperly stored dose of PROQUAD (dose, route of administration, lot# and expiration date were not provided). No adverse effect was reported. Product quality complaint (PQC) was not involved. This is one of the several reports received from the same reporter. Follow-up information was received from the reporting nurse on 15-SEP-2016. The patient was 4-years-old. The immunization status of the patient egg, neomycin, latex and gelatin allergies was reported as "no". The patient was vaccinated with the second dose of PROQUAD in a public health clinic/ hospital and the vaccine was purchased with a public funds. The vaccine status was reported as completed. Additional information is not expected, as scheduled correspondence has been received. The patient demographics, product information and narrative were updated.
Patient  was administered Pfizer COVID-19 Vaccine past 6 hour expiration by nurse.  Patient did not experience any adverse effects.  When the error was noted, the pharmacist on duty contacted State Department of Health Services help desk for assistance.  Was instructed by nurse to re-administer vaccine in alternate arm.  Pharmacy re-issued a new dose and it was administered by nurse on 7/23 21 at 1638.  No adverse effects reported by patient.
Fever 102 for 2 days, 101 for 3rd day , 100 for the fourth day.  Severe headache for 3 days, arm pain for 4 days, joint pain for 3 days, kidney pain for 2 days, chest pressure, fatigue for weeks - still don?t feel normal. heart discomfort occurred a few days after injection, still having the discomfort and  fatigue. Saw doctor today and was referred to cardiologist for evaluation.
While waiting advised 15 min following vaccination pt passed out while in clinic lobby/ waiting area, was taken to treatment room via gurney, and assessed by PCM.
Started running fever 4 hours after vaccine. This morning has red spots that are itchy. Face is swollen and has numb spots. Treatment: Prednisone 20mg Tablet 3 pills a day for 2 days, 2 pills a day for 2 days then 1 pill a day for 2 days.