chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt received anthrax vaccine #4 on 16 May, 2008, pt presented adverse reaction on 19 May, 2008. Site: posterior aspect of left arm appears erythematous and was tender to palpation, arm was not weak showed full range of motion left arm was edematous.
Bad rash all over body. Itching, swelling, redness. Lasting 3 weeks. Then Dr visit. Prescribed Claritin, Prednisone for 1 week.
Patient reports pain and normal post reaction following day but then progressed to joint pain in both shoulders as well as knees. Denies pain in hips. Still has pain at injection site a week after injection.
Severe outbreak of hives covering my whole body. swollen eyes, ears, arms ,legs and penis . Treatment including prednisone  and Benadryl. These treatments exacerbated the symptoms. Advised to go to the hospital and given prescription for epinephrin. Once home conditions became more severe and administered the epi-pen to my thigh for fear of shock. During the next month and to present ,some of my symptoms still persist such as some itching, scalp excema and spotty hives.
This spontaneous report concerning a currently 10 years old female patient was received from a nurse practitioner. No concurrent conditions and medical history were provided. On an unknown date in January 2016, reported as approximately six months ago, the patient was vaccinated with the first dose of GARDASIL 9, one dose (lot number and expiration date were not provided), by intramuscular route. There were no concomitant medications reported. On an unknown date in 2016, the patient experienced Crohn's disease. The reporter stated that, since the patient's first dose of GARDASIL 9, she was started a treatment with REMICADE for her Crohn's disease and she was responded well to it. No product quality complain was involved. At the time of reporting, the outcome of the event of inflammatory bowel disease was unknown. The causality between the event of inflammatory bowel disease and GARDASIL 9 was not assessed. Upon internal review, the event of inflammatory bowel disease was considered medically significant. Additional information has been requested.
Patient complained about left arm and leg numbness. Patient states she cant feel pressure on left leg when she gets up.
administered the adjuvant portion of Arexvy without reconstituting; administered the adjuvant portion of Arexvy without reconstituting; This non-serious case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a 78-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 08-SEP-2023, the patient received Arexvy. On 08-SEP-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: administered the adjuvant portion of Arexvy without reconstituting) and inappropriate dose of vaccine administered (Verbatim: administered the adjuvant portion of Arexvy without reconstituting).  The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 13-Sept-2023 and 14-Sept-2023 The case was received from nurse of the department of health. The Vaccine Administration Facility was the same as Primary Reporter. Any follow up should go to the health care professional in details above, or the field representative. The patient was administered the adjuvant portion of Arexvy without reconstituting it with the antigen portion of the vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
a nurse has administered Fluzone Quadrivalent to an elderly patient instead of Flublok with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a healthcare professional via Medical Information (MI) (Reference number- 00410287) on 29-Dec-2020.  This case involves a 73-year-old male patient who had administered INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] instead of QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] by nurse on 21-Dec-2020 (lot UT7035LA, expiration date: 30-Jun-2021) via intramuscular route in the left deltoid for prophylactic vaccination (wrong product administered).  The patient's medical history, past medical treatment(s), vaccination(s), Concomitant medication and family history were not provided.  This was an actual medication error case due to the event wrong product administered (latency: on the same day).  At the time of reporting, no adverse event was reported.  Disclaimer: this suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
Psychiatric illness; Patient received another shot after 14days of her 1st dose; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of MENTAL DISORDER (Psychiatric illness) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. O  n 03-Mar-2021, the patient experienced MENTAL DISORDER (Psychiatric illness) (seriousness criterion hospitalization). On 18-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received another shot after 14days of her 1st dose). The patient was hospitalized from 03-Mar-2021 to 23-Mar-2021 due to MENTAL DISORDER. On 23-Mar-2021, MENTAL DISORDER (Psychiatric illness) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received another shot after 14days of her 1st dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Started to feel some pain on the right knee; felt a pain in his right knee that is "getting worse".; He also have difficulty of going upstairs.; He could not sleep on that side; Pain on the arm; This is a spontaneous report from a contactable consumer. A 45-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0158, Expiry Date: unknown), via an unspecified route of administration on arm left on 02Jul2021 11:06 (age at vaccination: 45 years) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history included ongoing Low vitamin D (Onset Date: 2 or 3 months ago) Vitamin D level was very low on last blood work. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) and additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as none. Prior Vaccinations (within 4 weeks) was reported as none. Family Medical History Relevant to Adverse events was reported as none. The patient Concomitant medications included colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for Very low vitamin D from an unspecified date in 2021 . Historical Vaccines included MMR and DTap on an unspecified date in Aug2019 and experienced dizziness and passed out. On 02Jul2021, the patient experienced Pain on the arm. On 04Jul2021, the patient experienced He could not sleep on that side. On 05Jul2021 in the morning, the patient experienced Started to feel some pain on the right knee and felt a pain in his right knee that is "getting worse", He also have difficulty of going upstairs. It was reported that he had the pain on his arm 12 hours after he had the vaccine at 11:00. He felt the pain that night at 22:00 or 23:00. The pain started 02 Jul and it was painful until the second day. It lasted about 3 days and then it was gone. It was not painful and he could use his hand. First caller stated that the pain went away on 04Jul2021, but he said that it was not completely gone when he slept on that hand. He felt some pain. He could not sleep on that side. Caller stated that on 05Jul2021, he could sleep on that arm and the pain was completely gone. He stated that on 05Jul2021, he woke up that day and felt some pain on his knee. It started fair. By the end of the day, it was more painful than it was that morning. It was getting worse every day. Caller woke up about 04:00 with some pain 06Jul2021. It is getting worse day by day. The lab test included Vitamin D: low on an unspecified date in 2021. It was reported that he did not do any treatment. Caller heard from one friend that he would feel like influenza, joint pain and fatigue. The only thing caller noticed after the first dose was the arm pain and then the knee pain 3 days after. The outcome of Pain on the arm was resolved on 05Jul2021. The outcome of He could not sleep on that side was resolved on an unspecified date in 2021, while outcome of other events was not resolved.  Follow-Up (27Jul2021): Follow-up attempts are completed. No further information is expected.
Patient came into clinic for her second dose of Pfizer. Patient revealed to Lead Nurse that she felt dizziness in  the observation area after her first dose, but she did not report it to the EMTs. Patient reported she went home and continued to feel dizziness. Patient did not take "anything" for dizziness. Patient reported dizziness went away on its own a few hours after she got home.
No adverse events reported. Given FLUMIST nasal vaccine 2009-2010 approximately 3pm 2/21/09. On 4:45pm 2/22/09 patient doing great! (per husband). Greater than or equal to age 49.
On 3/28/2021 at approximately 2PM in the afternoon I developed a severe headache and fatigue with photosensitivity. I self medicated with Tylenol X1 and Excedrin X1 without relief. At approximately 5 PM I developed severe nausea. I was not able to take anything by mouth (food or liquids). Treatment involved sitting up in bed in a dark room with a cold compress and ice pack on my head. The headache resolved at approximately 9PM that evening. The nausea resolved at approximately 2:30 AM on 3/29/2021.
Our son has had regular recurrence of diarrhea since late 2009 (2-3X per week).  The vaccine was administered on 12/1/2009.  We don't have an exact date as to when the diarrhea began. For the past two months, we have been exploring other medical intervention to determine the cause, and it has recently occurred to us that he received the H1N1 vaccination during the same season.  We have no idea if there is a connection between his diarrhea and the H1N1 vaccination, but felt it was worth reporting.  If there are others who have had similar reactions, we would like to be contacted.
pt recvd vax 28SEP95 & 7OCT95 pt exp soreness @ inj site that lasted until 8OCT95;9OCT95 pt exp sore throat, fever, adenopathy, stiff neck & otitis;f/u the pt's MD reported that no further info was available as the pt did not contact ofc;
I got my Flu shot around 3 in the afternoon on Sept 16th, and was in our local ER bleeding from my lung that night.   Doc's at hospital (was shipped via ambulance from our local hospital) came in next day telling me my WHITE BLOOD CELL COUNT WAS LOW AND CONCERNED THEM (I highlighted in Red the first 'reaction' shown in the box below)...So for a short 'window of time' after the Flu shot (approx. 24 hours all told), these things happened. Thrombocytopenia (abnormally low platelet count, which can result in abnormal bleeding) My note:  this is what happened to me after getting Flu shot earlier in the day...I had a LOW white cell count that concerned Docs the following day!  And was bleeding from my left lung!  One of the Serious adverse events in your package insert. I definitely will never get another Flu shot of any kind for any reason.  I was NOT informed that the shot I was getting was 4 times the amount of flu bug as the regular shots...I feel like a guinea pig being used for experimentation without my knowledge or consent!  Apparently the injection set my white cells on the attack due to your products invasion, and I could not produce them fast enough, resulting in the LOW cell count, resulting in the bleeding...
Most all speech immediately stopped for several months, and then trouble forming words he used to be able to say.  The constant ?mama dada? stopped immediately.  He became reclusive/ antisocial at church, which was brought up to me by a teacher just a few days after the vaccine.   Then his anger, outbursts, and frustrations became increasingly worse.  He gets very upset when he can?t communicate or say words correctly, when I know he knows ?what? he is trying to say, but can?t form the words.  There is nothing wrong with his hearing (checked at least 3 times, and the last time from an ENT office), and no lip-tie/ tongue tie.  Something in that vaccine damaged his brain.
PT WAS VACCINATED WITH SECOND MODERNA DOSE ON 02/16/2021 .  DR  CALLED ME TO INFORM OF PT ADVERSE EVENT.  PT PRESENTED TO DR WITH SWELLING IN LEFT LOWER LEG. DR ORDERED VENUS DOPLAR SHOWING A LARGE BLOOD CLOT FROM PT'S GROIN TO HER CALF MUSCLE.  DUE TO NO PREVIOUS HX OF CLOTTING OR BLOOD DISORDERS NOR FAMILY HX AND PROXIMITY TO VACCINATION, DR BELIEVES VACCINE CAUSED THE CLOT.  DR PLACED PATIENT ON ELIQUIS.  DR WISHES TO BE CONTACTED IF FURTHER DETAIL IS NEEDED.
Information has been received from a physician concerning approximately 50 patients of unknown age and gender. Between the dates of 04-JAN-2015 to 17-JAN-2015, these patients were vaccinated with improperly stored GARDASIL (lot#, route and dose not provided). No adverse effect was reported. The physician stated he was considering revaccinating the patients. Additional information is not expected as the physician did not allow to be contacted.
Raised itchy area the night of vaccine, progressing to swollen left arm 3-4 inches in diameter, seen by Dr. who stated local reaction to vaccine - no infection.
Fever of 103 on 12/30/2020, Continued fever on 12/31/2020 and then Complex febrile seizure with right facial droop and limited movement of right upper extremity. Symptoms lasted less than 48 hours
I was very wobbly walking and the morning after the vaccine (Pfizer Booster shot and regular Flu Shot) and my wife had to assist me to get to the bathroom.  As I finished urinating, I could not stay standing and didn't fall but went down to the floor by the toilet and could not get up.  I could not even crawl to get out of the bathroom. I had extreme fatigue caused by trying to get up.  It was like all my strength was gone.  I called for my wife and she assisted me to crawl out of the bathroom but only made it to the door.  After resting awhile (15 minutes), with much difficulty, my wife assisted me to get up into a rolling desk chair.  I stayed in the chair for a few hours after she rolled me to my desk where I could do some work at the computer but it was really hard to sit up.  After this time, I was able to stand and walk very carefully to my regular easy chair.  I stayed there the rest of the day.  The rest helped and I was able to walk but it was pretty unsteady.  I went to bed about 10pm and when I woke up, I felt much better and could walk but I tired easily. Each day after this incident things have gotten better and better.
Patient received Pediatric Pfizer 0.3ml dose diluted in 1.8ml of Sodium Chloride (normal saline).
This RN did a flu clinic on 10/12/2023 for the nursing faculty. Today, this RN just received the following email from a faculty member that was administered the flu vaccine from this RN:   "Hi reporter,  I got a flu shot on Oct. 12th at flu clinic. Since then, I've had unusual right shoulder pain in the joint area, rating it at 6/10 in intensity. The pain hasn't subsided, and I've taken IBU twice daily for almost two weeks. My healthcare provider suspects a possible shoulder injury from the vaccine (SIRVA). I have an appointment on Thursday, Oct. 26th, at 1:15  and I'll have more information after that evaluation. I've also switched my primary provider and never set up a portal. I request a copy of my flu vaccination record for my work requirements. Thanks for your assistance.   Best regards,  Patient  -- EdD, MSN, RN, AMB-BC"  The vaccine was kept within appropriate temperature before administration, and appropriate needle length of 1" was used for vaccination of this individual. This RN has given hundreds of vaccines over her 6 year career, and always takes care to palpate the Acromion Process, properly sanitize the vaccination site with alcohol, and to vaccinate about an inch below the Acromion Process (depending on patient's anatomy). This RN has never had a complaint like this. This RN encouraged the patient to seek further medical care to determine the cause of his shoulder pain and provided him a copy of his influenza vaccine that he will be able to pick up at the front desk of the clinic per his request.
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 029620A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 16-Feb-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown. Not Provided          Reporter did not allow further contact
My arm has hurt at the injection site since I got the shot. A sharp pain run down my arm almost to my elbow.
severe Headache; fever (ranged between 99-101); chills; sore arm; This is a spontaneous report from a contactable consumer or other non-health care professional reporting for herself.  A 40-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN5318, expiration date: not reported), via an unspecified route of administration, in right arm on 12Feb2021 09:00 (at the age of 40-year-old) as DOSE 2, SINGLE for COVID-19 immunization. The patients medical history included asthma and migraine. The patients known allergies included Latex, doxycyline, tree nuts and penicillin. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN5318, expiration date: not reported) via an unspecified route of administration in left arm on 26Jan2021 08:00 as DOSE 1, SINGLE for COVID-19 immunization. Patient was not tested to covid post vaccination and was does not had covid prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient concomitant medications included Trazadone, cetirizine hydrochloride (ZYRTEC), ibuprofen (ADVIL), PARACETAMOL (TYLENOL) and Multivit. On 18Feb2021 23:30 , the patient experienced severe Headache, fever (ranged between 99-101), chills, sore arm. Patient had not received any treatment for the events reported. The outcome of all the events was recovered on unspecified date in 2021.  Follow-up attempts completed. No further information expected.
Underlying asthma that had been relatively dormant got activated exacerbated 2 days following vaccination. Was not using inhaler medication for asthma prior to vaccination and now requires at least daily inhaler medication.
Patient reported having chest tightness/ trouble breathing 9 days after vaccination, went to ED and was diagnosed with Pulmonary Embolism.
Throwing up every 10-15 minutes; This is a spontaneous report received from a contactable consumer (patients mother). An 18-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Caller reported that a couple of days ago both she and her daughter received the first covid vaccine dose. She reported that as of last night all through the night her daughter has been constantly throwing up every 10-15 minutes. Outcome of event was unknown.  No follow-up attempts are possible; Information related to batch/Lot number could not be requested.
Case number PHEH2016US010864, is an initial spontaneous report received from a nurse on 29 Apr 2016. This report refers to a 66 years old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514701) at a dose of 0.5 ml intramuscularly on 21 Oct 2015. On 02 Dec 2015, the patient was diagnosed with polymyalgia rheumatica. It was reported as the symptoms (unspecified) started in the week of Thanksgiving. The outcome of the event was reported as unknown. The seriousness and causality of the event was not reported. Seriousness assessment of the event polymyalgia rheumatica was upgraded based on Novartis Important Medical Events list. The reporter declined follow up be sent as she did not have any more information to provide in regards to the events reported, hence considered as lost to follow up.
Fever, chills, nausea and vomiting, weakness, and soreness at injection site.
8 days after vaccine I started getting swelling, redness, tenderness and itchiness at injection site. Also severe diarrhea but unsure if that is related.
Large, splotchy, swollen red bump at injection site. Hard and painful to the touch. Used ice to try and calm swelling.
Onset of symptoms started on 7-22-2021 with fever, feeling feverish, chills, muscle aches, sore throat, cough, shortness of breath, headache, fatigue, loss of taste and smell.
04/11/21 stroke event --unable to speak and not consistent with actions, CT 04/11/21 L MCA infarct no midline shift
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) 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 05-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 05-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Pharmacy received vaccine on 28 May 2021 On 27 Jun 2021 the vaccine was used and was refrigerated. Then the product used by twenty patients and most were of second dose and few were first dose. No relevant concomitant medications were reported. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Additional information received in which reporter details were added. Event start date is added. On 26-Aug-2021: The TCR form received in which fax details were provided.