chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Almost immediate- headache, nausea, some lightheadedness Day 12: New, sudden, atypical onset of Dupuytren's Disease/Contracture (3 hard nodules and cording on left palm. Very painful, nausea with pain). Not recovered, permanent For approx 7-8 weeks following vaccine- joint pain, muscle aches, ice pick like pain in head, neuropathy (crawling, tingling), mood changes. Largely back to baseline
Very fatigued, general feeling unwell, extremely sore and painful to touch around entire top half of arm, headache
Pt had pneumonia vaccine in her right arm which became warm, red, and very swollen down to forearm.
Narrative: Patient came to walk-in clinic for COVID vaccine. After Janssen vaccine was administered, the nurse discovered information in the chart that he had previously received this vaccine May 2021. The patient denies recollection of this prior dose. The patient was monitored, and no adverse reaction was noted.
swollen neck, severe rash on her legs since Thursday. Tried over the counter Benadryl, cortisone 10. Symptoms haven't resolved till Tuesday 09/17/2019
Stated she started to feel congested, had cough, chill, fever day after vaccine. Took Tylenol and used throat spray. Felt better 4 days later.
Day 3 after shot (Sunday) lymph node in left armpit became swollen and very painful.  Later that same day, roof of mouth started swelling (the entire roof including the upper gums on the inside of mouth).  I also ran a 100.8 fever starting on Day 2 (Saturday) which climbed to 101.8 on Sunday.  Fever was brought to 99.9 with 1000mg of Tylenol.  Dosage would wear off in 4 hours and temp would climb again.  Mouth started swelling during the fever battle.  Today, Day 5 (Tuesday) only symptom I still have is the Roof of Mouth "rash" w/ extreme sensitivity to anything passing by it (hot or cold).
Pt presented on 3/27 with 1-2 days of rash, increased bleeding at site of scabs, and bruising with hematoma, and petechial rash. Platelets <1, and concern for ITP.  Undergoing workup inpatient.
Patient received Flu shot 9am and became very itchy hours later. A rash appeared on arm and neck on side where she got the shot. After taking BENADRYL 50 mg at 12 pm she was brought to the ER in town to get further care. Fine the next day.
Pain down left arm for several days, eventually turned into tingling and numbness - electricity down arm from elbow to fingers, left index finger and tip of left middle finger completely numb for 7 weeks now. Also now noticing left middle toes are numb. Also now noting profuse and continuous pain in left buttock deep muscle.
Patient began running a fever the afternoon she recieved her vaccinations. Mom reports the fever rose to 104 degrees F. rectally by the late evening. She spoke with the physician on call who instructed her to go to the Emergency Room. Patient was seen by ER physician who evaluated patient. Tylenol and ibuprofen was administered in the ER and fever was brought down to 99.4. Patient was discharged home with instructions to continue administering infant Motrin and Tylenol until fever resolved. Patient continued to run a fever of 102-103 degress F. rectally the day after with decreased appetite, increased sleepiness and irritability. Per primary pediatrician, mom to continue with infant motrin and tylenol and use cool baths PRN. Mom instructed to call pediatrician if fever =/>104 degrees, increased lethargy or fever persists.
Noticeable extremity weakness, mainly in the lower extremities. Started 2 weeks after second dose of Pfizer covid vaccine and has been going on ever since.
Potential AE due to doses administered from vials that may have been compromised; Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion; Administered vaccine from vials that may have been compromised; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised). At the time of the report, IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that, the digital data loggers and freezers expired before they were re-calibrated. The reporter was aware in some of the freezers there was a temperature excursion that the data logs showed. The vaccines had never reached a temperature that was considered outside of frozen recommended range. The data loggers had laps where they were not considered calibrated, so they have paper logs to monitor those temperatures. The reporter wanted to know whether need to take any action since the vaccines stored in the freezer without a digital data logger. This was in several different freezers and the vial temperatures never went out of range when they were using the paper log. The beyond used date was reported as 01-Dec-2021 to 15-Dec-2021. Moderna date ordered was reported as 01-Nov-2021 and 15-Nov-2021. No treatment medications were reported.
on may26,2021 woke up early and my right eye could not focus . felt like I had a heavy veil covering it. My husband called my eye doctor and made an appt. for Friday May 29. My eye doctor exam me and told me that I had CRAO, She said I need to see an eye specialist. I saw eye specialist  on monday June 1st. He confirmed th dx. He also recommend that I should report this too you
Pt recvd vax 15MAR94 & pt mom called on 16MAR94 stating arm was very reddened & tender; advised ice q 3-4 hrs for 15-20 intervals & APAP then came in 17MAR93 for a check;
Received the second Shingrix shot on 12/14/19 at about 11AM.  Experienced some pain while the injection was being made but nothing severe.  At about 3PM on 12/14 I experienced severe pain in the left elbow and shoulder.  I tried to raise my left arm to shoulder height but couldn't.  I also had severe pain opening my driver's side car door and fount driving difficult.  Severe pain continued throughout the evening.  I also had difficulty showering since I couldn't lift my left arm.  My wife had to dry my back and assist me with getting dressed.  At the end of the evening she also had to help me to get in bed and pull the covers up.  I usually get up several times during the night to urinate.  Each time I got up was extremely painful and required my wife's  assistance.  When I got up at about 8am, I also needed her assistance as the pain was still appreciably.  Finally at about 10AM on 12/15 the pain in my left elbow and shoulder plus the injection site started to reduce.  After reading the Vaccine Information Sheet I decided to report my Severe adverse reaction.  The form also mentioned that symptoms like mind usually go away in 2-3 days.  I sure hope so.  Never had this before for other vaccines,.
PATIENT HAS THE SKIN RED Y WITH PAIN. SHE DIDN'T REALIZED UNTIL TODAY THAT SHE WAS FEELING PAIN IN THE AREA OF VACCINE ADMINISTRATION.
Pt describes that her arm is painful and hard to move. Not a lit feeling in hand. Her provider is checking for nerve damager and pt has been prescribed gabapentin. Nurse at Dr office states pt received PNEUMOVAX 23 on  6/10/11. Not reported to alert.
Had diarrhea and vomiting for about an hour several times during that hour.  Also complained of feeling ice cold and abdominal pain.
3YO received adult dose; 3YO received adult dose; This case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 3-year-old female patient who received HAV (Havrix adult) (batch number 55M72, expiry date unknown) for prophylaxis.   On 25th January 2023, the patient received the 2nd dose of Havrix adult. On 25th January 2023, unknown after receiving Havrix adult, the patient experienced accidental overdose and adult product administered to child. On an unknown date, the outcome of the accidental overdose and adult product administered to child were unknown.    Additional Information: GSK Receipt Date: 25-JAN-2023 Reporter's Comments: Medical Assistant administered by error to a 3-year-old female patient, Havrix dose adult formulation. Expiration date of the vaccines was no available at the moment of the call. The reporter consented to follow up via email. Additional Supportive Information: The child patient received adult formulation of havrix, which led to accidental overdose and adult product administered to child.
Symptoms started two weeks after getting the vaccine. I was sitting down and got light headed, felt faint, and slightly nauseous. I laid down and these feelings seemed to pass after 30 min.   Later that day I started to feel a strange feeling in my head that is hard to describe. It is a combination of light headedness, slight dizziness, and general head fog. These symptoms have persisted for 7 days now. They were mild to start and have gotten increasingly worse the last 2 days. The symptoms make it hard or impossible to focus on work depending on the severity at the time. I feel these symptoms whether I am sitting down or moving around, although it seems to be most pronounced when I am moving.   Today was the first day I that I had to call in sick to work. I have not yet sought medical treatment, but as symptoms are worsening, this will be my next course of action.   I have found
Information has been received from a healthcare worker (operations manager) referring to unknown number of patients. On unknown dates, the patients were administered improperly stored VAQTA, lot # K012457, expiry date 04-JUN-2017, (route and frequency were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Headache, NauseaVomiting, pain at injection site Narrative:  Other Relevant History:
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 18-SEP-2014, the patient was vaccinated with a dose of ZOSTAVAX 0.65 ml, once, subcutaneous, lot # J004266 expiry date 12-JUL-2014. Concomitant medications were not reported. The pharmacist reported that the patient was administered expired ZOSTAVAX. No adverse event were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Dizziness, Myalgia, Fever, HYPERtension, INJECTION SITE SORENESS Narrative:  Other Relevant History:
swelling & solid red area @ inj site, size of pt's palm, & diarrhea x 4 & nausea;nausea & diarrhea until 4AM;redness gradually decreased & was gone by 10/11/99 AM;
Pfizer covid vacc  Bells palsy right side of face. Ear, eye, nose and mouth all paralyzed happened while waiting for our plane at 5 am 10/8/21 and ems ruled out stroke. Was treated again out of the area for pain and again in my local area exactly 1 month after 2nd shot. No underlyiign conditions. 3 doctors blame vaccine. 10 days later no chamge in facial function and severe pain
vomiting; nausea; sick; This case was reported by a consumer via call center representative and described the occurrence of vomiting in a adult patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine. On an unknown date, less than a day after receiving Influenza vaccine, the patient experienced vomiting, nausea and sickness. On an unknown date, the outcome of the vomiting and nausea were recovered/resolved and the outcome of the sickness was unknown.   It was unknown if the reporter considered the vomiting, nausea and sickness to be related to Influenza vaccine.  Additional details were provided as follows: The age at vaccination was not reported but it could be 60 years or 61 years. Ten years before the reporting date, the patient received Flu shot. The patient felt sick. The patient vomited the day she received it and felt slightly nauseous for a couple of days. The reporter did not consent to follow-up. For tolerance of Shingrix, refer case US2019198490.
10/13  - legs were stiff/sore, went away around 4-5 days. 10/20 - Redness, soreness, swelling around wrists. Left is worse than right.
The first thing I noticed my arm was burning, and right away it was so sore that I could not raise my arm. My joints have been stiffer. I woke up the next day with pain in my lower left back and left hip. It progressed throughout the day. I had to take a muscle relaxer because of the onset of muscle spasms. I couldn't raise my left leg also. I had to go to the ER. Referred me to a spine doctor.
Examined by MD 5-12-09 in Dermatology - note enclosure.
Patient was under the age of 18 when he received both vaccines: 01/28/21 & 02/24/21
Patient received expired dose of deptacel vaccine/No AE; Initial information received on 18-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2020SA046245, 2020SA046248 and 2020SA046250. (same reporter)  This case involves 15 month old male patient who was vaccinated with 0.5 ml expired fourth dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number: C5366AA and expiry date: 07-Feb-2020) via intramuscular route in the left thigh on 14-Feb-2020 for prophylactic vaccination.  Medical history, medical treatment, vaccination and family history were not provided.  On 14-Feb-2020, the patient received concomitant medications included HIB VACCINE CONJ (TET TOX) (ACT-HIB).  It was case of actual medication error due to Expired vaccine used.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
June 5th shot June 6th, sharp (not dull) arm pain, foggy head, eyes,,, feel funny.  June 9 arm getting worse and worse. foggy head, eyes feel strained and different June 11, arm, shoulder neck feels like sharp tiny beads cutting into my arm and traveling up arm, over the trapezius muscle, and through to base of right side of neck. felt like tiny beads of sharp broken glass or metal, slow travel, all different pathways, burning and ?cutting? feeling all ended up in one pinpoint at base of brain, and pushed through like an ice pick. Fell to floor in pain holding my neck. Lasted for less than a minute.  June 12, right arm, hand wrist starts to jerk to the right and left when picking up anything. does not obey my commands. continued foggy head, eyesight straining and slightly dark at times.  June 13th, walking into grocery store, doubled over with chest pain. not able to breathe or move. lasted for less than a minute. continued arm pain and jerking, foggy head, eyesight funny. June 14th, all above continued, chest tighten again, in kitchen, and again walking through house, and again on a walk.  June 17th, chest pains, continued foggy head, scrambled thoughts, eyesight strain, right arm jerkiness and weakness when in use.  August 3rd arm jerkiness a bit better. Foggy head, eyesight, chest pains continued. Aug 4th right leg starts buckling out from under me.  Continued chest pains. Foggy head ect. Aug 5th right leg starts jerkiness and weakness, continued all above. Late Aug/early Sept Insomnia sets in. NOT MENOPAUSE INSOMNIA. Insomnia lasting through night through morning. Not one minute of sleep some of these days. Sept 5 ? 11 ish I mention all these to dr at time,  she said, you might be depressed, Rx for Bupropion 150MG  No change in insomnia, leg jerking, Arm pain, chest pains, foggy head, or eyesight weirdness. Good night 3 hours of sleep with Melatonin, Regular night, no click over to sleep. Watch the light enter through window in the am. No sleep. Sept-ish, Doctor added  Escitalopram 10 mg to help get sleep. No change. Oct 1 ? 8 very little to no sleep Oct 10th am. Electric pulses felt in base of neck. 7 am ? 10 am 2 pulses every 5 ? 7 mins or so. Was recommended a new doc,  at Urgent care.  Oct 11th-Made apt to share these symptoms.  Oct 13 ?  received new Rx for glasses. Oct 18, 19, 20 Diverticulitus in abdomen, Doctor saw me, and I shared with her all other symptoms as well. Got meds to clear up diverticulitus  Oct 27th, new glasses don?t work anymore, eyesight deteriated. Oct 30th Leg a bit better, chest pains and heart pounding out of control when doing little things like gardening or yard work. Insomnia still present, 3 hours sleep gained with melatonin, 8 grams. Foggy head still present, eyesight still weird, arm pain still present. Currant Doctor believes symptoms brought on my Moderna Vaccine. I am out of money to do any more appointments or tests. I no longer excersize heavily for health, for the chest pains come on.
Patient given second dose at another location.  3 days later developed chest pain and shortness of breath with exertion.  Increased troponin and clinical presentation consistent with myocarditis.
Reported to Nurse 9/11/12. States has swelling at bilateral collar bone area, left lymh node enlargement in groin and under left are. Ran low grade fever. She states got antibiotics and CDC on 6/14/12. Had elevated lymph count. States she went to a "med serve place on June 14, 2012." Doctor name nor clinic name given.
Fever of 101.5 degrees Fahrenheit; Felt really sick; Arm was painful; Icky; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was painful), PERSONALITY DISORDER (Icky), ILLNESS (Felt really sick) and PYREXIA (Fever of 101.5 degrees Fahrenheit) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 047A21A) for COVID-19 vaccination.     Concurrent medical conditions included Non-Hodgkin's lymphoma. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), OLMESARTAN MEDOXOMIL (BENICAR), HYDROCHLOROTHIAZIDE, HYDROXYUREA, METOPROLOL, TADALAFIL, ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) and SOLIFENACIN SUCCINATE (VESICARE) for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was painful) and PERSONALITY DISORDER (Icky). On 26-Mar-2021, the patient experienced ILLNESS (Felt really sick). On 31-Mar-2021, the patient experienced PYREXIA (Fever of 101.5 degrees Fahrenheit). At the time of the report, PAIN IN EXTREMITY (Arm was painful), PERSONALITY DISORDER (Icky), ILLNESS (Felt really sick) and PYREXIA (Fever of 101.5 degrees Fahrenheit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication were reported.
I missed my 2nd shot. It's been months; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I missed my 2nd shot. It's been months) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (I missed my 2nd shot. It's been months). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I missed my 2nd shot. It's been months) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Pain, inflammation, reddness, warm to touch at area of injection...55 mm in diameter.  Gave Benadryl 25 mg PO one time
This spontaneous report as received from a physician, via a field employee, refers to a 18 year old male patient. On 21-AUG-2013 the patient was vaccinated with GARDASIL lot # J006587 (dosing information and route were not provided). The patient experienced syncope following the administration of GARDASIL on 21-AUG-2013. The outcome of syncope is unknown. No reporter causality provided. Additional information has been requested.
Headache, NauseaVomiting diarrhea Narrative:  Other Relevant History:
Fatigue, body aches, and mild fever. Onset at 6AM the morning after receiving 2nd dose/booster. Symptoms lasted approximately 18 hours and were managed with standard oral dose of acetaminophen and ibuprofen combination.