chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2014US023467 is an initial spontaneous report from a nurse received on 20 Nov 2014 and with a follow-up from a nurse received on 26 Dec 2014. this report refers to a male patient of an unknown age. Concurrent condition included allergies to hydrocodone. The patient had tolerated vaccines (no further details provided) well in the past. On 20 Nov 2014, the patient received an intramuscular dose of expired FLUVIRIN (batch number: 13474P, expiry date: May 2014) at a dose of 0.5 ml into right deltoid in error. No adverse event reported following this medication error (expired vaccine used). Follow-up from a nurse received on 26 Dec 2014: Patient's demographics (weight and height), vaccine details (dose and site) and concurrent condition were updated.
This spontaneous report as received from a health professional refers to a 4 year old patient. On 27-MAY-2014 the patient was vaccinated with (Oka/Merck) VARVIAX (lot # J009728, expiration date 07-AUG-2014, dose and route not reported) and M-M-R II (lot # J003785, expiration date 27-MAY-2015, dose and route not reported) which were stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
13cmx7cm red, hot, tender left thigh. Treatment cold compresses, Tylenol.
Started with dizziness, then nausea, tingling sensation, lump in throat. Then racing heart and heart palpitations. Blood pressure dangerously high. Then extreme tiredness and passed out. Then ambulance was called
Fever, chills, headache, sore arm, swollen arm, lethargy, sensitive and sore skin. These began within 6 hours of the shot and were debilitating for 48 hours. Severe for 49-72 hours and then fever broke and other symptoms gradually subsided over next 48 hours.  At some (unknown) time after the vaccine, I developed viral pericarditis. In addition to the above, this manifested in chest pain (no difficulty breathing) which radiated from what felt like the lungs, through my windpipe, into a sore throat, jaw muscles hurting, inner ear and neck soreness. These symptoms lasted after all had subsided and didn?t disappear until 14 days after the 2nd vaccine.
32-year-old female without any known past medical history presents with an acute onset of bilateral arm weakness and pain.  She reports around 10 PM she was caring for her children when she suddenly started having acute onset upper back and shoulder discomfort which radiated into the arms resulting in significant distal arm weakness bilaterally.  She has some paresthesias and loss of sensation associated with such.  Subsequently she also noticed that her symptoms radiating into her legs and she had difficulty ambulating and standing.  She reported some twitching of her legs during a CT scan that was performed as well.  Patient is otherwise healthy does not take any medications for any chronic medical issues.  She has had gestational diabetes with her pregnancy in 2011, without any subsequent diagnosis of diabetes.  She also had a traumatic motor vehicle collision in November 2020 with some residual chronic low back pain is resolved.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient. who had been intended to be administered a TB test, was inadvertently administered 0.1 PNEUMOVAX23(lot number reported as H011780, expiration date 16-FEB-2014) intradermally on 27-NOV-2012 due to nursing error. No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
woke with her right arm feeling like it was on fire and prickly; woke with her right arm feeling like it was on fire and prickly/it hurt really bad/hands hurt; This is a spontaneous report from a contactable consumer (patient) reported for herself. This 87-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch#/Lot#: EK9231) on right arm at single dose on 13Jan2021 for COVID-19 immunisation. Her right arm had a history of going to sleep. Her arm had been going to sleep for less than a year. She thought she may have a pinched nerve. There was no concomitant medication or investigation assessment. Patient got first covid shot a week ago and she didn't know if this was a side effect or not. She got this shot in her right arm. Last night she woke up an 3am and her right arm had gone to sleep but felt like it was on fire and prickly and hurt really bad on 19Jan2021 at 03:00. She got up and shook it and couldn't get it to go away. She was sitting up over an hour and it did lessen somewhat but then started back up. She was scheduled to get her second shot and decided she would get it in her other arm. Patient stated her hands hurt and she was unsure of how long she could stay on the phone. Reporter seriousness for woke with her right arm hurting really bad was unspecified. The outcome of event was unknown.
Information has been received from a Licensed Practical Nurse referring to an unspecified number of patients of unknown age and gender. Information about medical history, concurrent condition and concomitant medication. On unknown dates the patients were vaccinated with doses of improperly stored GARDASIL 9 (lot # L000610 with expiration date 21-JAN-2017; strength, dosage, frequency and route unspecified). No symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt claimed that he faints after shots. Pt felt lightheaded immediately after vaccination. Had pt lie on the floor with feet elevated up on the chair. Gave pt ice pack to use on forehead. Pt felt better with 5-10 minutes.
Vaccine was - FLUZONE HIGH DOSE. I became ill - flu symptoms - breathing - SOB - fever
Pt received vaccine, pt was c/o chest pain @ 1050. Requested PAR to call rapid response team, pt started to be unresponsive and requested PAR assistance to assisst pt to the floor. Rapid response team arrive @ 1051, pt place on Oxygen 2 lpm. EMS contacted, pt had 4 seizure episodes 1st was @ 1053 with 20 sec duration, 2nd @ 1056 with 46 sec duration, 3rd @ 1100 with 30 sec duration, 4th with @ 1107 lasted 20 sec. EMS arrive @ 1102 and left with pt @ 1110, pt referred to ED.
A few hours after receiving the vaccine my arm started to become sore. On 01/28/2021 my arm started to become pink and very itchy. The next couple of days it remained very itchy, started light pink and got pinker never got really red color. On Sunday 31st in the morning it looked normal but later in the day it got pink again. Yesterday and today it is fine besides it is itchy. I have not been scratching it.  One day I put some Benadryl cream on it one time.
Pharmacy contacted 10/11 - Pt reported "4 or 5" blisters along arm and reported "sick at stomach" - Also reported blisters on palm of right hand and his armpit.
Severe tenonosis of left achilles. Very red, swollen 2x normal size. Unable to bear weight and walk. Prescribed steroid for 5 days and anti-inflammatory for 60. Wasn't helping much. Around day 40 looked up physical therapy for achilles tendinosis and have been following for 40 days. Helps, but have to complete daily to avoid pain.
Patient initially speaking, some tremorous activity in the hands, breathing fine, good heart rate, lungs clear to auscultation, was placed in supine position, legs elevated, offered apple juice.  Response to vaccines and exam initially consistent with vasovagal response, he was left with nursing staff for monitoring  Several minutes later called back to the room, patient complaining of throat tightening  On entering the room, patient was still supine, he was looking at the ceiling, closing his eyes, would not speak, was guarding when touching his throat, and it looked like there was some right side throat swelling perhaps, he then sat up, attempted to throw up, and did not, lay back down, again could not speak, holding his throat  Subsequently epinephrine was obtained, this was not injected, as the patient then sat up, was a little combative towards receiving epinephrine, spit out some phlegm, and was more interactive  He was still complaining of seeing stars, and seeingg "trucks"  At this point his oxygen remains 97 to 100%, pulse between 67 and 82, he was monitored for 5 to 10 minutes, given 25 mg of Benadryl, EMS was canceled, he was taken to his car via wheelchair, and mom is taking to the emergency room for further observation  ED expect entered by nursing staff
I was exhausted because we had been doing a ton of stuff week after Easter. Friday / Sat tired. Sunday extremely hoarse and started coughing. Monday coughing a lot and achy, no fever, but felt like the flu. I'm still so tired, almost indescribably tired and it's not like me and it's been 3 weeks.
Fatigue; Headache; Fever; Chills; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 03May2021 at 16:45 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. The patient medical history was reported as none. Patient did not receive any medications in the past. Patient did not receive any medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not 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 four weeks prior to the COVID vaccine. On 04May2021, the patient experienced fatigue, headache, fever and chills. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fatigue, headache, fever and chills were unknown at the time of report.   No follow-up attempts are needed. No further information is expected.
pain, redness, and swelling at the injection site; pain, redness, and swelling at the injection site; swelling at the injection site; fever; muscle pain,; tiredness; upset stomach; GI problem is the worst; This case was reported by a consumer and described the occurrence of injection site pain in a 65-year-old patient who received Herpes zoster (shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site swelling, fever, muscle pain, tiredness, upset stomach and gastrointestinal disorder. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, fever, muscle pain, tiredness, upset stomach and gastrointestinal disorder were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, fever, muscle pain, tiredness, upset stomach and gastrointestinal disorder to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient had most common side effects after vaccination. The patient experinced pain, redness, and swelling at the injection site, muscle pain, tiredness, fever, and upset stomach. According to patient gastrointestinal problem was worst but also had other events.
This spontaneous report as received from a certified medical assistant refers to 3 unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with doses of VARIVAX (Merck) (route not reported) that were improperly stored. There were two lots involved (lot # K003420 exp date 06-MAR-2016) stability not supported and (lot # K007783 exp date 28-MAY-2016) which stability was supported. No adverse experiences were reported. Additional information has been requested.
Rash on left leg-photo attached physician thinks it is contact dermatitis-we do not think so.
CHILD GIVEN ORANGE CAP 5-11YO PFIZER INSTEAD OF MAROON CAP 6MO-4
She has had a fever of 102 the arm is bright red and warm to the touch. She has been fatigued and has body aches. Feels like the flu but she states that it is not the flu it started exactly 24 hours after she got the shot. Injection site redness & swelling measuring approximately 5 inches In diameter. Recommendations: A large local reaction. Supportive home care for site swelling, redness and pains.  Fever can happen with vaccine reaction also. Control signs and symptoms. Treat fever. Appointment next week if worsening signs and symptoms from here.
PATIENT INDICATES PAIN IN THE LEFT ARM AND SWOLLEN AREA. SHE WENT TO THE DOCTOR AND WAS DIAGNOSED WITH CELLULITIS. SHE IS CURRENTLY TAKING CIPROFLOXACIN 750MG.
Swollen eyes; Puffy eyes; flushed eyes; Low-grade fever; Body ache; felt tired and fatigued; This case was reported by a consumer via call center representative and described the occurrence of eye swelling in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th September 2021, the patient received the 1st dose of Shingrix (intramuscular). On 9th September 2021, 1 days after receiving Shingrix, the patient experienced eye swelling, puffy eyes, eye red, low grade fever, general body pain and tiredness. On an unknown date, the outcome of the eye swelling, puffy eyes, eye red, low grade fever, general body pain and tiredness were recovered/resolved.   It was unknown if the reporter considered the eye swelling, puffy eyes, eye red, low grade fever, general body pain and tiredness to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient himself/herself. The patient received Shingrix in the right deltoid. Next day of vaccination, he felt tired and fatigued, and had body ache, low-grade fever, swollen/puffy and flushed eyes (involved both eyes). These symptoms were resolved after 24 hours, in September 2021. The lot number and expiry date were not reported. The reporter gave a consent to follow-up with health care professional.
Fever, aches, chills, sweats, racing pulse, swollen ears, vomiting. Fever and aches continuing to the next day. Unable to sleep due to pain and getting up several times at night to vomit.
Vomiting; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 12 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17May2021 17:30 (Lot number: EW0187) at the age of 12 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: VOMITING (non-serious) with onset 18May2021 19:00, outcome "recovering", described as "Vomiting". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vomiting.  Additional Information: It was reported that there was no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Information has been received from a registered pharmacist regarding an 81 year old female patient. The patient's medical history, drug reactions or allergies were not provided. The pharmacist stated that a physician told her that on 07-MAY-2013, the patient was vaccinated with an expired dose of ZOSTAVAX (dose and route was not provided) (lot # 669187/1543Z, expiration date 06-FEB-2012). No adverse effect reported at this time. Additional information is not expected.
Parent-please describe: 11/20/08- noticed red rash on left thigh, appeared larger (1/2 dollar) next day, itchy. Began to fade by 11/23/08.
This spontaneous report was received from a Registered Nurse concerning a multiple unspecified patients of unknown age and genders. The patients' concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose, route, lot number and expiration date were not reported) for prophylaxis. The temperature involved, time frame and previous temperature excursion were unknown by the reporter. A data logger was involved. No adverse effects were reported. Additional information has been requested.
Fever of 101 started approximately 24 hours after injection. Severe nausea and vomiting starting approximately 96 hours after injection. Fever of 101 faded 10 days after injection.
This spontaneous report was received from a registered nurse concerning an unspecified number of patients of an unknown gender and age. Medical history and current conditions were not reported. On an unknown date, the unspecified patients were vaccinated with doses of ZOSTAVAX (dose, dose number and route were not reported), (lot # K003598, expiration date 13-MAR-2015), which were improperly stored. The nurse stated that since the time of administration of the vaccinations there had been no reports of adverse events and the office would be contacting the patients who received the vaccinations to return to the office for revaccination. The nurse did not provide specific patient identification information. This is one of three reports received from the same reporter. Additional information has been requested.
Arm hurts when moving, lifting, or pressure. Area around injection site is warm and has a deep burning sensation.
phone and spoon also adhere to his arm/I have a friend who got the vaccine in March, she has the same problem on both arms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date Mar2021 (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: LIMB DISCOMFORT (non-serious), outcome "unknown", described as "phone and spoon also adhere to his arm/I have a friend who got the vaccine in March, she has the same problem on both arms".  Additional information: Reporter had a friend who got the vaccine in march, she had same problem on both arms.  Follow-up attempts completed. No further information is expected.
I had a little cough a couple of days before that but I had been to 3 events in the ballroom which had a lot of people and we were at the tables. Mild sore throat on and of Wed-Friday, feeling dry throat. Saturday 17th that morning I felt everything starting to come on I had eaten scrambled eggs and thought that was why. I had diarreah but I have a problem with this on and off anyway. Took temperature that afternoon and 98.2, normally I'm 97.2 so it was up a bit for me.  Cold symptoms, cough with wheeze which i never had before, runny nose, slight headache, very tired -- it just all came on in a couple of hours but it was mild. I went to the Urgent care center on Sunday and got COVID tested.  I was given an inhaler and cough medicine.  This lasted 3-4 days in the most. It was very mild. The highest my temp went to 99.9.
Patient is shown as having received the covid-19 vaccine on  4/9/21, 4/30/21 and on 5/15/21.  [This is a 69-year-old female with multiple medical problems who came in with fever , cough, and myalgias x3 days. She also had loss of taste, nausea, diarrhea, h/a,and dizziness.,  Her husband was found to have Covid.  Vitals admission show temperature 99.9, O2 saturation 94% but went down into the 80% with walking, heart rate 103, blood pressure 143/81. She has had the covid vaccine but takes Embrel.
I didn't have any issues until 2 months after my vaccine and didn't associate it as an issue with the vaccine. But I began to have persistent heart burn and around 06/15/2022 my doctor prescribed a prescription strength PRILOSEC which has completely resolved the issue so far.
This AE does not have to do with a patient, but a malfunction in equipment causing a vial of vaccine to be wasted. 1.8 mL of 0.9% sodium chloride solution was drawn up into into a 3 mL syringe with 21 G needle (REF:309574, Lot: 0225188). There was no leakage at this time from the syringe shaft.  When the plunger was pressed to inject the saline into a vial of Pfizer Covid 19- vaccine (Lot: EM9810, Exp 6/2021) the pressure caused some of the saline to leak through a crack that had not been noticed previously in the shaft. As a result, only some of the  saline made it into the vial, rendering it unusable.
EXTREMELY TIRED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 06-MAY-2021, the subject experienced extremely tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of extremely tired was not reported. This report was non-serious.
passed the 6 month mark; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter asked was Shingrix recommended for patient with no known history of chicken pox.  The reported stated that the patient had passed the 6-month mark for second dose of Shingrix and till the time of reporting, the patient did not receive 2nd dose, which led to incomplete course of vaccination. The reporter asked when should second be administered or should series be restarted. The consent to follow up was granted. No further details provided via web form.
Malaise and dizziness an hour after vaccination. Fatigue and chills 10 hours after Body aches, legs and back 13-14 hours after Fever (101 F) 24 hours after vaccination