chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax 8AUG97 & next day on 8AUG97 pt exp moderate non-pitting edema from the ankles to the feet;pt presented positive pulses & negative coolness;pt taking ketoprofen intermittently for rheumatoid arthritis;
Information has been received from a 59 year old female registered nurse with latex allergy, unspecified pain medication allergy and penicillin allergy who at "end of September or beginning of October" 2008 was vaccinated with PNEUMOVAX 23. Concomitant therapy included ASMANEX, albuterol (manufacturer unspecified) and VALIUM. "Immediately after receiving vaccine" the patient had burning, swelling, redness and rash at the injection site. The patient had unbearable arm pain and her arm was put in a sling. An X-ray was done and edema at the injection site was found. The patient had lost partial use of arm. The patient also hurt her back because of the complications from the vaccine and had rapid heart beat problems. The patient had sought medical attention. At the time of reporting the patient's adverse effect persisted. A product quality complaint was not involved.  Follow-up information has been received from the registered nurse who stated that as soon as the PNEUMOVAX 23 was given she started to the registered nurse that the injection site was burning. The patient reported that "the serum going in was like acid". Since that time the patient had experienced shooting pain and down the nerve. The patient reported that "the pain was severe and had persisted since the injection increasing in intensity". The patient reported weakness in the right arm and at this time the patient was wheelchair bound. The patient reported "yesterday (13-MAY-2009) she noticed mottling of the right arm and tremors of the arm. There was interstitial fluid leaking from the injection site still today." At the time of reporting the patient's right hand was swelling. The patient stated that she was having sleep deprivation due to the pain. The patient also stated that she was having right sided facial drooping and drooling. The patient was told that "a stroke could not ruled out." Although the patient could verify whether or not she had had a stroke, she had undergone an MRI of the arm, ultrasound of the arm and X-ray. On 12-MAY-2009 the patient stated that "she had a nerve test performed that she could not complete because the pain was too much to bear." Upon internal review, stroke was determined to be an other important medical event. Additional information has been requested.
Shat was administered by a nurse at the Elementary/Middle School.  Shot was given.  Child was sent back to class.  Child ate lunch and returned to school nurse complaining of dizziness and chest pain.  Pulse 106, blood pressure 98/60.  Respirations non-labored at 34 per minute.  C/o's some nausea.  Denies numbness, tingling, itching, no rash or hives noted.  Child laid down with cool compress.  Approximately 15 minutes late pulse 82, respiration 28 per minute.  Still c/o's some dizziness and but feels some better.  Father notified by school nurse and is coming to pick up child.
Febrile seizure on 12/20/13 at 0330 AM.
Bright red rash on vaccine site, turned dark and has a permanent dark spot now.  Changes in menstrual cycle, had my period right after the shot and then had it again  a few days later. I then had my period two weeks later for just a few days and I have had severe menstrual cramps the last few days
During a drive-thru Covid-19 vaccination clinic, this 12 year old incidentally received the Moderna vaccine which is only EUA approved for individuals 18 years and older.
The patient died of a stroke  5 days after receiving the COVID-19, he was very old and it is unknown what other medical conditions they he had.
DRAWN: 1256  GIVEN: 1326  REACTION= COUGHING VIGORISLY @1340; EPI 0.3MG GIVEN 1345 RT DELTOID I.M., CONTINUED MONITORING FOR ANOTHER 20 MIN BY STAFF.
This was 9 months after his last booster of Moderna Covid-19 vaccine, he got Covid-19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (This was 9 months after his last booster of Moderna Covid-19 vaccine, he got Covid-19) in a 93-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Aortic surgery (Aortic repair). Concurrent medical conditions included Stroke (He's on Eliquis.). Concomitant products included APIXABAN (ELIQUIS) for Stroke.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (This was 9 months after his last booster of Moderna Covid-19 vaccine, he got Covid-19). At the time of the report, COVID-19 (This was 9 months after his last booster of Moderna Covid-19 vaccine, he got Covid-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.         The AE reported caused patient to seek medical care. Patient took primary regimen with full doses on unknown dates and also first booster on unknown date. Batch numbers were not known. There were no events reported with these three doses of Moderna. It was unknown if the patient experienced a similar event in the past.  It was unknown if the patient received any other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Treatment information was not reported. Company comment: This is a spontaneous case concerning a 93-year-old male patient, with no relevant medical history, who experienced the unexpected and non-serious AESI of COVID-19 after his last booster of mRNA-1273. Patient got full doses of mRNA-1273 vaccine on unknown dates (primary schedule and 2 booster doses); hence, latency could not properly assess. No information disclosed about lab tests or treatments received. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.    Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning a 93-year-old male patient, with no relevant medical history, who experienced the unexpected and non-serious AESI of COVID-19 after his last booster of mRNA-1273. Patient got full doses of mRNA-1273 vaccine on unknown dates (primary schedule and 2 booster doses); hence, latency could not properly assess. No information disclosed about lab tests or treatments received. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.
Call from Pt C/O reaction to Pneumovax immunization given yesterday. Right deltoid was sore, red and a little swollen this morning. Soreness redness continues along with increased swelling thoughout the day. Dr. informed. Pt directed to her local ED for evaluation. Pt agrees to this plan.
Increased coughing.  I must clear my throat much more frequently than before due to congestion. I have increased phlegm.  It is only just very annoying.
06/25/2021 - noticed swelling in arm 06/26/2021 - went to urgent care for swelling and was diagnosed with a blood clot.
Rash appeared 4/12/14 on back and by ears, spread over body on 4/13/14 - not itchy, acted normal. Fever up to 102.7 Friday and Sat. (4/12-4/13/14). Likely viral exanthem, but had MMR and Varicella immun. on 4/4/14.
Patient developed a large hive on his right arm after about 36hours just under the area where he received the vaccine, then developed full body hives, lip swelling, fever and cough/congestion in the next few days
On April 9th, 2021, I developed body inflammation and especially in the lower abdomen.  I waited it for about a month until I had to contact my OBGYN,  in early June 2021, because I started to feel pain in my  lower abdomen and I noticed that a hernia was developing as well and swelling in my lymph nodes in my groin area.  Dr. did an ultrasound of my uterus and ovaries to check for swelling,  and the results came back normal urine test to check if I had a urine infection but that was negative.  My general  practitioner, ordered me an MRI for August 11, 2021, to check the swelling in my abdomen.
Took 1 shot of Cortozione on the 3-19-13, then started me on Synvisc One, 5 shots given, Legs swelled up so big with the last 2 shots, had to walk on a walker for 2 weeks, knees swelled as big as cantalopes, I hurt in both legs all the time, both knees stay very, very cold, have to wear knee warmers all the time, to get them to warm up, constantly stay cold and in pain, have suffered every day since having these injections, something that was supposed to help my knees, but ended up me having to wear braces on both knees because of these shots, wearing braces for support for the knees, the shots didnt help me at all only damaged my knees further.
Temp 102, chills, dry heaves, arm very sore w/in 2-3 hours, myalgia w/in 7 hours. 2nd and 3rd day fatigue only.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE HYPOXIA 4/1/2022 -- RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Fever started on July 5th, lasted for 3 days 101-103 F. Fever came down and rash started on face and trunk Maculopapular rash. Parents came today to the office to be seen, child stable. Diagnosis to MMR vaccine or viral illness, viral exanthem.
Fever, swollen, hives, painful, redness, soreness, poor appetite, fussiness, tiredness. Leg still red, and swollen.
breakthrough case of COVID; breakthrough case of COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "breakthrough case of COVID". Additional information: The patient had breakthrough case of COVID after being vaccinated the Pfizer vaccine, wanted to know if there is an antidote for the vaccine because he stated that it is really hurting him. The reporter considered the event as non-serious.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300092557 same reporter/drug, different patient/event;
Injection site became warm to the touch, red, and a little swollen. And itchy. Our daughter scratched it because it felt itchy. We are day 5 since the shot. Small welts that appear hive like are on her left forearm. It was still warm to the touch and itchy, red, slightly swollen, and bumps/welts on  11/13/2021    Hydrocortisone was applied 11/13/2021 at approx 8:30am. Itching subsided.  She woke up 11/14/2021  at. 6:30am with an itchy arm. It is not warm to the touch. And feels a bit smoother. Hydrocortisone was applied.
shingles; Pain in the abdomen; Rash; This spontaneous case was reported by a nurse and describes the occurrence of HERPES ZOSTER (shingles), ABDOMINAL PAIN UPPER (Pain in the abdomen) and RASH (Rash) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced HERPES ZOSTER (shingles), ABDOMINAL PAIN UPPER (Pain in the abdomen) and RASH (Rash). At the time of the report, HERPES ZOSTER (shingles), ABDOMINAL PAIN UPPER (Pain in the abdomen) and RASH (Rash) outcome was unknown. Not Provided      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.   No concomitant medication use was provided by the reporter.  The patient reported treatment of shingles was with acyclovir since an unknown start date.
pt recv vax & devel an inj site rxn characterized by swelling & induration which extended from shoulder to elbow;this is 1 of 6 pt from this facility to devel an inj site rxn p/vax;
Information has been received from a physician concerning a 14 month old patient who in approximately September 2004, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). In 2004 the patient experienced a varicella zoster like rash in the abdominal area. The patient was sent to a dermatologist to determine the source of the rash. No product quality complaint was involved. No other information was provided.
Information has been received from a nurse practitioner concerning a 14 year old female with "high risk human papillomavirus", and a history of genital warts who on 28-APR-2008 was vaccinated with her first dose of GARDASIL vaccine (yeast) (Lot # 654885/1424F, site and route not reported). Concomitant therapy included "DOXY" (not otherwise specified). On 28-MAY-2008, also reported as "2 weeks before 11-JUN-2008", "the patient had trouble walking because of stiff legs and had trouble opening her jaw". When the patient relaxed on her bed, the symptoms went away, but when she started to walk again, the symptoms came back. The patient went to the emergency room and was released (not further specified). The patient outcome was not reported. No further information was provided. Additional information has been requested. Follow-up information. On an unspecified date, the patient presented to the clinic with ataxis and difficulty speaking. The patient was sent to the emergency room. The nurse practitioner stated the reaction "wasnt related to the vaccine". "The patient had taken her mother's psychiatric medication, ABILIFY and drank some bleach." The patient received activated charcoal, recovered and discharged. When asked if this was a suicide attempt, the nurse practitioner stated "It was just a bunch of kids being kids." The patient took the medication and drank bleach with "a bunch of friends". There was "no adverse reaction to the vaccine". No additional information was provided. Additional information is not available.
Given VARIVAX immunization 4/23/08.  5 days after administration, felt tingling sensation, red, running on skin and fever low grade.  Symptoms worsened - sent to E.R.  Treated Naproxin and Tylenol.
Possible SIRVA Got flu shot on 10/29 Noted a bit of the normal soreness right away, nothing out of the ordinary. That pain faded off but about a week later, started noticing issues with certain motions. Pain with abduction and posterior rotation. Adduction causes pain as well. Able to lift the arm up over his head - causes a little pain but not as much. Pain is in the whole upper arm.  Hand strength is normal. No sensory issues.  No fevers or chills or any other problems. Has never had trouble with a flu shot before.  Denies any systemic symptoms then or now (no fever, no chills). No swelling of the upper arm. No truama.
arm pain; This is a spontaneous report from a contactable pharmacist (patient himself). A 35-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EK5730) intramuscularly on 22Dec2020 04:30 PM at single dose in left arm for COVID-19 immunization at Hospital. Medical history included ulcerative colitis, ADHD (Attention deficit hyperactivity disorder), prediabetes and high cholesterol. Allergies to medications, food, or other products were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included mesalazine (LIALDA), methylphenidate hydrochloride (CONCERTA), cetirizine hydrochloride (ZYRTEC), vitamin d, citalopram, atorvastatin. The patient experienced arm pain on unknown date. No treatment received for the adverse event. Since the vaccination, the patient had not been tested for COVID-19. The outcome of event was recovered on unknown date.  No follow-up attempts are possible. No further information is expected.
Patient present to the emergency room on 6/24/2021 for right arm redness, swelling and pain. Was told to follow up with PCP and no treatment was started at the time.  Mom presented to the PCP office on 6/25/2021, the redness had spread, it was reported the child had a fever of 101 the night before, afebrile at time of office visit, affected area of arm was hot to touch, painful and with mild swelling. Discussed post vaccine fever and local reaction as this was the site of DTaP but due to warmth and mild spreading, treated for cellulitis with Clindamycin three times a day for ten days.  Spoke to mom today, 6/29/2021 who reports the arm is without redness, swelling or pain and the child is continuing the Clindamycin treatment.
mother reporting pts are was "really red" swelling, itching and bruising the day after vaccines were given (06/30), was seen at an Urgent care over the weekend. we called 07/05 for fup and symptoms were improving, only w/little redness and itching, still w/some bruising to side of arm
This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L208A) for COVID-19 vaccination. No Medical History information was reported. On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) outcome was unknown.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment includes hydrocodone for pain. No concomitant drugs are provided.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested. Received consumer call: I notice 4:30 in the morning I fell a little dizzy, I got my shot 4 days ago - (January 14). I am taking hydrocodone for pain. They said that I will get this side effects few minutes after vaccination but I had this after 4 days I received the vaccine, is this normal? Vaccinated at remote site a warehouse; Lot Number: 013L208A Consented for follow-up at anytime 18Jan2021.
Severe pain in left arm/Soreness in left arm; Swelling in left arm; Left arm turned black, then blue and now purple; hot; Doctor thinks tendon was torn; chills; fatigue; Vaccination provider did not let patient sit down, pulled the jacket little bit down and quickly ran the; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Severe pain in left arm/Soreness in left arm), PERIPHERAL SWELLING (Swelling in left arm), SKIN DISCOLOURATION (Left arm turned black, then blue and now purple), FEELING HOT (hot) and TENDON RUPTURE (Doctor thinks tendon was torn) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE REACTION (Vaccination provider did not let patient sit down, pulled the jacket little bit down and quickly ran the). On an unknown date, the patient experienced VACCINATION SITE PAIN (Severe pain in left arm/Soreness in left arm), PERIPHERAL SWELLING (Swelling in left arm), SKIN DISCOLOURATION (Left arm turned black, then blue and now purple), FEELING HOT (hot), TENDON RUPTURE (Doctor thinks tendon was torn), CHILLS (chills) and FATIGUE (fatigue). At the time of the report, VACCINATION SITE PAIN (Severe pain in left arm/Soreness in left arm), PERIPHERAL SWELLING (Swelling in left arm), SKIN DISCOLOURATION (Left arm turned black, then blue and now purple), FEELING HOT (hot), TENDON RUPTURE (Doctor thinks tendon was torn), VACCINATION SITE REACTION (Vaccination provider did not let patient sit down, pulled the jacket little bit down and quickly ran the), CHILLS (chills) and FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment details were reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow up report received on 05 Aug 2021, Updated outcome for the events.
feeling a bit under the weather; Initial information received on 01-Nov-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.   This case involves an unknown age/gender patient who experienced feeling a bit under the weather after receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose 3 of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (strength, dose, formulation, route,lot number not reported) in unknown administration site for Immunization.  On an unknown date the patient developed a non-serious event feeling a bit under the weather (malaise) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Action taken: not applicable  It was not reported if the patient received a corrective treatment for the event (malaise).  At time of reporting, the outcome was Unknown for the event.
Full exam 1/16/14. Resolving pharyngitis - rapid strep negative. Returned 1/17/14 for vaccines. 1/18/14 Rash began on shoulder, then progressed through trunk and extremities. 1/19/14 Culture positive for strep - began Omnicef. 1/20/14 diarrhea x 1. 1/23/14 Evaluated by MD in another country - Dx E. Multiforme. No response to trial dose of BENADRYL.
Received vaccine Feb 4th, Feb 5th I had the regular side effects of pain in injection site, fever, headache.  Feb 6th I woke up tp tingling in my left arm. I got up and went into the bathroom and tried to pick something up and my shot arm would not move. It was like a dead limb. When I realized my arm was not moving I looked at it and tried to wiggle my fingers. Nothing worked. After about 5 minutes it started to move again slowly. It felt very leaden and tingly through out the day. On the 7th I tried shaving my legs in the shower. I had trouble getting my shot arm to follow my thoughts. It would go several inches from where I was directing it.  Still feels off. Tingling  comes and goes.
Information has been received from a registered nurse, concerning a 23 year old female patient, with no known allergies and no significant medical history, who was vaccinated (date unspecified) with the third dose, 0.5ml, IM, of Gardasil, two months after the second dose. There was no concomitant medication. Following the vaccination (duration of time not specified), she developed hand swelling, and a rash that developed on her arms. At the time of this report, the patient had recovered (date unspecified). Additional information has been requested. Initial and follow up information has been received from a registered nurse, concerning a 22 year old female patient, with no known allergies and no significant medical history, who on 22-JAN-2007, was vaccinated with the second dose of GARDASIL vaccine (lot # 653937/0637F). Following the vaccination on 01-FEB-2007, she developed hand swelling, and a rash on both hands. At the time of this report, the patient was vaccinated with the third dose, 0.5 ml, IM of GARDASIL vaccine, two months after the second dose. No further information is expected.