chrisvoncsefalvay/vaers-outcomes huggingface dataset:
We were in the middle of a rush of vaccines. I inadvertently gave the patient the J & J vaccine instead of her second dose Pfizer. I called the patient to notify her of my error.  She was understandably upset. I asked her reasoning for not wanting the J & J and it was due to the risk of blood clots. I asked her if she had a history of blood clots to which she denied.
Resident passed away in her sleep. No s/s of adverse events leading up to the residents death. Resident was previously declining- MD stated the vaccine had nothing to do with the death.
Presented to clinic on 11/6/18 with paleness of 1-2 months duration. He had been having cold symptoms for about 4-5 days with low grade fevers. The paleness was not noticed or believed to have started before his visit with me on 9/18/18. He was found to have hepatosplenomegaly on exam that day and initial CBC showed very low counts. He was immediately sent to our Hospital and diagnosed with acute lymphoblastic leukemia. He is currently being treated with chemotherapy through one of our tertiary care centers - Hospitals and Clinics.
Severe Swollen Rash and Hives painful burning sensation that began on vaccinated arm and spread to both arms and rear end.
Rash L arm, hand and a little on R arm. BENADRYL melt-a-away given. Rash resolved quickly.
Information has been received from a consumer concerning her currently 8 year old son who in 1995 was vaccinated with a first dose of MMR (second generation) (lot # not reported). Soon after vaccination, the patient experienced having night terrors and he broke out in a fever. In addition, it was reported that the patient had been throwing his body into his crib and the walls. The patient woke one night with a high pitched scream and with uncontrollable fear. The patient also had screaming episodes and has had episodes of acting as a rabid dog like in the movies. The reporter stated that her son's behavior has definitely changed since receiving the vaccine. It was reported that even today, the patient easily flies off the handle and it was reported that these episodes could go on for a half an hour. No further information was provided. It was reported that the patient had not recovered. Upon internal review, night terrors, high pitched scream and screaming episodes, uncontrollable fear, behavior that has changed-throwing body into crib and walls, acting as a rabid dog and easily flies off the handle were determined to be other important medical events (OMIC). No further information is available.
pt recv vax 29SEP96 & 7OCT96 pt devel chickenpox;pt devel several lesions on foot & stomach & on one on face;
Client reported a mild CVA 2 weeks to the day from receiving the vaccine. She has received 4 covid vaccines 1/4/2021, 02/04/2021, 10/22/2021, 06/09/2022. All these where Moderna . The one on 11/29/2022 was the Pfizer Bivalent. Client was at the local Hospital and has not risk factors other than age.
stated she developed an extensive rash/redness around the injection site. She stated this did not occur right after receiving the vaccination, it developed a few days later. Initially the area was warm to touch but that has subsided. The redness/rash has subsided slightly but has not gone away completely yet.
13 minutes after the injection, experienced an intense whole body hot flushing, increased perspiration which lasted 2-3 mins then resolved. Headache. Then felt "odd", BP was 92/47. drank 8 ounces fluid, BP slightly increased then dropped again. Felt very faint chest pain, about 8-9 deep & sharp, but resolved quickly. Returned to work. Next day at 32 hours exactly, arm injection site felt slightly achy , return of off feeling. Headaches off and on.  On day 3 fatigue began, and intense injection site sharp pains which woke me at night although not apparent in day.   Over next several days, intense site pain continued to wake me in middle of night, very painful.  On day 7, began to feel better, but then woke that night with extremely intense pain at site. Today is day 8, I found 2 red swollen, thickened and hard, pear shaped areas 4cm x 10cm; smaller one at site and a second larger area below that, area red and warm to touch indicating a cellulitis was developing.  Call to primary doctor and CDC, instructed to complete this. Now concerned about whether to obtain vaccine #2.
Mom states pt recieved IZ`S and next day painful, swelling, warm, red, erythematous 11x15.5 to left lateral thigh.pt was Tx`d with keflex 250mg/5ml 3 ml PO QID X 7days. Pt was given an appointment to return on 10.22.2005 for follow up.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The medical history and drug reactions/allergies of the patients were not reported. On unspecified dates since 11-SEP-2015, the unspecified patients were vaccinated with improperly stored doses of VARIVAX (Merck) lot # K002924, expiration date 25-FEB-2017 (dose, frequency and route were not reported). No concomitant medications were reported. No adverse effects had been reported. No product quality complaint was involved. Additional information has been requested.
Patients wife called states she think patient is having an allergic reaction to the pneumococcal injection that was administered yesterday. States yesterday when they got home patient was complaining of pain in his arm. During the night pain got a lot worse couldn't get to sleep. Arm started swelling couldn't left arm, tingly feeling down arm. They tried a heating pad and Tylenol. Advised patient to go to instacare. States they will wait until later this afternoon after he is off of work to see how he is feeling. Called patient left detailed message. Please call patient and tell him that he can take 25mg Benadryl and that should help if its an allergic reaction.  Tell them to avoid heat and that ice may be better to reduce inflammation. Patients wife called states she think patient is having an allergic reaction to the pneumococcal injection that was administered yesterday. States yesterday when they got home patient was complaining of pain in his arm. During the night pain got a lot worse couldn't get to sleep. Arm started swelling couldn't left arm, tingly feeling down arm. They tried a heating pad and Tylenol. Advised patient to go to instacare. States they will wait until later this afternoon after he is off of work to see how he is feeling. Noted. Treated with Keflex for suspected soft tissue infection at PNEUMOVAX injection site.
Patient received two doses of Pfizer COVID-19 for primary series and one dose of Moderna COVID-19 booster. Patient was diagnosed with CML a few months later and is now immunocompromised.
Hospitalization for shortness of breath from COVID-19 on dates 8/31/22- 9/6/22.  Treated with dexamethasone, baricitinib, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
This spontaneous report was received from a registered nurse refers to an unspecified number of male patients greater than 15 years old. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patients were vaccinated with GARDASIL 9, injection, (dose, route of administration, anatomical location, lot number and expiration date were not reported). There were not concomitant medications provided. The reporter stated that the boys were vaccinated with GARDASIL 9 "because the CDC says that boys older than 15 years can receive the vaccine". No adverse symptoms were reported. There was no product quality issue involved. Additional information is not expected since the reporter did not want to be contacted.
Really bad headache since March 15. That's when I got the second shot. First one, no issues.  I have just taken over the counter Tylenol.
Upper arm erythematous, warm pruritia.  Temperature 99.4 orally.
day p/vax pt exp firm red, warm area induration, upper right leg no pain but tender w/some papules noted, itching. given benadryl.
chills/Body shivers; low grade fever of about 99.3-99.5 F/constant mild fever of 99.5 to 99.8 degrees; Feeling cold; constant trembling; lethargic episode; was a little off last night; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Feeling cold), TREMOR (constant trembling), LETHARGY (lethargic episode), MALAISE (was a little off last night) and CHILLS (chills/Body shivers) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes since 2001. Concomitant products included METFORMIN, AMLODIPINE and LEVOTHYROXINE SODIUM (LEVOTHYROXIN) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced FEELING COLD (Feeling cold), TREMOR (constant trembling), LETHARGY (lethargic episode) and MALAISE (was a little off last night). On 05-Mar-2021, the patient experienced CHILLS (chills/Body shivers) and PYREXIA (low grade fever of about 99.3-99.5 F/constant mild fever of 99.5 to 99.8 degrees). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING COLD (Feeling cold), TREMOR (constant trembling), LETHARGY (lethargic episode), MALAISE (was a little off last night), CHILLS (chills/Body shivers) and PYREXIA (low grade fever of about 99.3-99.5 F/constant mild fever of 99.5 to 99.8 degrees) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Body temperature: 99.3-99.5 (High) 99.3-99.5 degree Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had a period of discomfort for 24 hours.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Patient Demographics were added.Concomitant medication (metformin, Levothyroxine)were added.Events Body Shivers,Constant trembling,Feeling cold.were added. Outcome of the events Events lethargic episode,low grade fever of about 99.3-99.5 F/constant mild fever of 99.5 to 99.8 degrees,was a little off last night got resolved.
Within 10-15 minutes he acutely started bubbling saliva out of his mouth as if he had acute throat swelling. Face very red. Lethargic and mucousy cough. Pulse ox 91%. Watched him in my office for 3 hours. Pulse ox improved to 99% and ate bottle well here.
Headache, Diarrhea, site soreness Narrative:  Other Relevant History:
A report has been received from a Health Professional concerning a 10 year old, female subject, who had been receiving FLUMIST. FLUMIST started on an unknown date. The patient experienced mild runny nose, mild sore throat which started on 06-Nov-2013. The outcome of the event of runny nose, sore throat, and watery eyes is unknown. The report was considered to be non-serious.
Expose to grandmother with shingles 1 week ago. Rash developed on arms, face, trunk and extremities. Has numerous lesions. To use Benadryl and Calamine lotion.
chills; body aches; runny nose; This is a spontaneous report from a contactable consumer (patient himself). A male patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced chills, body aches and runny nose on an unspecified date. All events were reported as non-serious. Outcome of events were unknown.   Information on the lot/batch number has been requested.
Patient is an employee, after getting her shot, she returned to the sales floor and was talking to a customer (in front of aisle 10&11, pharmacy is in front of aisle 16). patient passed-out and fell backwards from standing position and have hit her head on her fall. Patient regained consciousness, when was helped up but again passed-out. Front end managers brought the patient to the covid waiting area room and was supported on a sitting position. Pharmacist administer ammonia inhalant and patient regained consciousness and was responsive. Patients BP was 108/70mmHg. Patient was transferred on  the floor to raise legs, while waiting for 911 response. Patient was transported by fire department to ER for testing.
Heavy period following the first dose, and missed period with high fsh jumping from 7 to 30 after second dose!!!! Other women are reporting the same effects.
FLU VACCINE (I had to check unknown vaccine as I do not know the manufacturer and because of digital form limits)  I received the flu vaccine by injection into my right arm. The next morning I work with severe pain and limited right arm movement at the shoulder.  Severe pain on attempting to move arm 9+ on a 10 scale.  I call clinic who administered it at the office.  I called several times but was always transferred to leave a message.  I did but did not get called back.  So after another week of limited movement and severe pain.  I called Clinic and Mr. to address the pain and limited movement.  The vaccine was given high and to the back of arm.  As she injected whe met resistance and then laced two hands on syringe and pushed in the plugner again. I saw Mr. on 10-07-2022.  I got on a wait list for a radiograph.  I continue to have pain and limited movement.  It felt sharp, aching, like wanting to move away from shoulder...a tearing feeling...
patient was given double dose of FLUZONE HD with no reported adverse event; Initial information was regarding an unsolicited valid non serious case was received from a pharmacist via Medical Information (Reference number- 00853740) and transmitted to Sanofi on 11-Nov-2021.  This case involves a 67-year-old male patient who received double dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (extra dose administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 11-Nov-2021, the patient received a 0.75 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ772AC, expiry date: 30-Jun-2022) via intramuscular route in the right deltoid for prophylactic vaccination.  It was an actual medication error due to extra dose administered. (latency: same day).  It was reported "He would like to find out about likely side effects and next steps."  At time of reporting, no adverse event reported.   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 the 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.
pt recv vax & devel rash @ inj site;the rash resolved spontaneously p/3 days;this is 1 of 3 pt from this site to devel rxn;
Dizziness, feeling disconnected, off.  Happened immediately. Felt better the next day but have had the same feeling since the 3rd day.  This is day seven.
Pt recvd 2 doses of Engerix-B & following doses had diarrhea & cramping;
pt recvd vax 3SEP92 & was subsequently found to be pregnant; during pregnancy devel a UTI & was treated w/Septra; pt also devel preterm labor; 2JUN93 @ 40 wks gestational age pt delivered an 8lb 4 oz female;
Entire deltoid muscle swollen and firm, warm to touch.  Not red though.  Patient reports it is itchy, and a little painful.
I became aware after appointment at Hospital vaccine clinic on 2/2/2021 that injection was not given in the deltoid. I saw my PCP on 2/5/2021 who confirmed that the shot ( which was too posterior and too far down from the shoulder)was administered next to the muscle or barely at the edge of the muscle. At this point I am waiting for Hospital to respond to my inquiries for a replacement shot in the proper location.
Dizziness, Headache, Myalgia, Fever, swelling and pain at injection site.  Narrative:  Per nursing report: "2nd dose of COVID 19 vaccine on 2/1/22. Report similar problems with the first vaccine. Hx of breast lumpectomy on right and states that she received the 2nd vaccine in the same arm on the left. Employee report a fever (100.1), redness and swelling in left arm, dizziness, body aches, and headaches."
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 03-APR-2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 06-AUG-2016, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Narrative: Patient was hospitalized for GI bleed after receiving the COVID-19 vaccine. Also developed gynecomastia, which was confirmed via mammogram.
Patient did not have any adverse events.  Patient was administered the wrong dose (received 1ml instead of 0.5ml).
She got her vaccine, she had no problems.  About 45 minutes later it became a little bit sore.  Then it started with the terrible chills about a little after 1:00 PM.  She went to that to high fever of over 100, high blood pressure, and then she started with whole body tremors to where she wanted some hot tea, but she was not able to drink it because of the tremors.  It did subside, she checked her BP as she warmed up and she could feel that she was getting warmer.  It went very hot for many hours, then her body was burning up to skin and still had the chills.  She also had no appetite, tried to eat something, but not able to.  No vomiting, and she believes when she put lighter pajamas and had a fan on that she started cooling down and feeling better.  Her BP was 127/74, and it was then 95 pulse oximetry and heart rate was about 85, and he resting is normally 62.  This morning it was around 70, and feels it is close to normal now.  She feels right now a little bit of flu-like symptoms.  She has no dizziness, no tremor and all that is gone.  Nothing at the arm site, just a tiny bit sore.   She was hydrating with water, and started urinating a lot and then went to sleep and had no problems with her bladder or urine during the night.    She did not call her doctor, but if it continued to get worse then she would have called 9-1-1.  It did concern her as she has been minimally reactive to other things.  She felt she was hypothermic due to the chills.    She is feeling better, but still not up to her normal.    When she got the shot she weighed 117#, and is 5'5# and wonders if she got too high of a dose.
HEADACHE, NUMBNESS RIGHT FACE, RIGHT HAND, RIGHT FOOT `` `12/22/2009 PCP and Neuro consult notes, patient with c/o's headache, tunnel vision, numbness hands/feet, rt sided facial numbness
In about 10 minutes got home and all of a sudden fell -- like if someone hit her -- was not feeling dizzy at all before. Episodes, 4 to 5, happened in the next couple of days.
Patient stated she had chills, weakness, and a sore arm for 3 days after receiving the vaccine.
BIG RED SWOLLEN ARM, ITCHING, PATIENT CAN NOT LIFTED UP ARM. DOCTOR PRESCRIBED ANTIBIOTIC, ANTIHISTAMINE, ICE PACK FOR TREATMENTS.
Nausea and vomiting, fatigue, complains of chest tightness, headaches, sore throat. Has had clay colored stools (? asthma now). Still complains of chest tightness and trouble breathing.
Information has been received from a physician concerning an approximately 20 year old female who in approximately September 2008 "a couple months ago"  was vaccinated intramuscularly with the first dose of GARDASIL and experienced "small bump"  at the injection site that lasted for 3-4 days.  On 01-NOV-2008 "17 days ago" the patient was vaccinated with the second dose of GARDASIL and experienced a similar bump for 2 weeks.  After 2 weeks, it got larger and painful and it was "hot".  At the time of reporting, the patient still has "a little bump" that "hurts a little bit when I touch it".  The patient sought unspecified medical attention and had blood work performed.  The result was not reported.  Additional information has been requested.
This study case was received from the investigator on 22 May 2012. A 24-year-old male subject received the following vaccinations on 13 February 2012: an injection of ACAM2000 (lot number not reported), TYPHIM VI, sanofi pasteur SA (lot number not reported), ANTHRAX (manufacturer and lot number not reported). On 26 February 2012, the subject had an abnormal ECG. Results from the subject's troponin I results were not available. On 26 February 2012, the subject was diagnosed with unspecified disease of pericardium. The subject had no significant medical history. The outcome was not reported. Additional information will be requested. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Vaccinated arm became swollen, red area of redness and swelling included chest and back muscles that continued down arm to elbow.
Swollen lymph in left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (Swollen lymph in left arm) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (Swollen lymph in left arm). On 09-Apr-2021, VACCINATION SITE LYMPHADENOPATHY (Swollen lymph in left arm) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.  Patient received her second dose of mRNA-1273 and had no adverse events.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Event outcome was updated as resolved and suspect drug dosage details were updated.The reporter declined consent for further follow up.
? 1st dose Pfizer on 04/09/21, 2nd on 05/03/21. Patient was only 13yrs old at the time of first dose.   No adverse effects to report, just patients age at the time of their first dose.