chrisvoncsefalvay/vaers-outcomes huggingface dataset:
09-year-old female patient experienced sore arm the day after receiving the COVID vaccine (booster); This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 9-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "09-year-old female patient experienced sore arm the day after receiving the COVID vaccine (booster)".  Additional information: Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt rcvd a 0.2 mL volume injection of Moderna vaccine (blue cap for 6 months-5years) when it should have been 0.25 mL. Clinic noticed error, notified parents of patients, advised of current ACIP/CDC recommendation for this error, and changed clinic practice to prevent future errors.
Following injection on 9/10/07 had severe continuous headaches(occipital) and nausea for 2.5 weeks, also during that period I experienced a spontaneous scleral hemorrhage along with increased BP.  Fever started with frequent vomiting and generalized muscular aches on 9/26.  On 9/28 rash then developed mainly with torso involvement and now has spread over body - non- pruritic raised red non-vesicular? headache and elevated BP has subsided with the onset of rash.
I awoke to severe pain in my shoulder and could not lift my arm.  The pain persisted throughout the evening despite taking Advil so much that I was unable to find a comfortable sleeping position.  No change this morning.  I am unable to lift my arm and am not able to do normal household chores or work efficiently. I am a computer administrator and can't even lift my arm to type on the keyboard.  The pain feels like a deep bone bruise. I hope this goes away soon because I am completely debilitated in my left arm.  I've never had pain like this before from any injection ever!
2009 INFLUENZA A H1N1, live, attenuated by Medimmune Lot 500757P Exp. 1-25-10 was administered to child with history of VSD/pacemaker.
On 8/6/21 patient woke up with large, warm, painful hives covering the injection site and surrounding area.  She said they also started to itch and continued to improve over the course of the day.  She came into the pharmacy the next day and her arm showed significant improvement with small areas red that were hard, slightly painful and itchy.  I recommended treating with oral antihistamines and otc pain relievers if needed.  She had not reached out to her primary care provider yet, but would if her arm didn't continue to improve.
Adverse effect of other vaccines and biological substances, initial encounter on 2020-12-31.
This spontaneous report was received from a healthcare worker concerning an unspecified number of patients of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown date, the unspecified patients were vaccinated with improperly stored doses of PEDVAXHIB (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). No adverse effects reported. Concomitant therapies were not reported. This is one of several reports received from the same reporter. Additional information has been requested.
The infant has prolonged crying. He received his immunization shot about 10 AM, crying began at 12:30 PM. The infant still crying when back to the office at 4:50 PM.
This case was reported by a pharmacist via call center representative and described the occurrence of leg pain in a 73-year-old female patient who received Shingrix (batch number C523T, expiry date 4th July 2020) for prophylaxis. On 2nd July 2018, the patient received Shingrix (intramuscular). On 5th July 2018, 3 days after receiving Shingrix, the patient experienced leg pain. On an unknown date, the outcome of the leg pain was not recovered/not resolved. It was unknown if the reporter considered the leg pain to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix in right arm. The healthcare professional confirmed lot number as C523T, but they were initially unsure due to handwritten information being unclear.
Pt became dizzy and passed out a few seconds after the HPV vaccine was administered IM into her RA. Pt was monitored for 15 mins after passing out. I checked her blood pressure and it was at 106/68 She had no other side effects to  report. Patient was released home to mom.
Fatigue, Body aches, loss of appetite, 100 degree fever for a short time. indigestion, nausea for about 3 days Fatal Heart attack 2/28/2021
Mother stated generalized Rash in AM-denies SOB. Instructed Tx BENADRYL and/or MD or ER if worse. Called mother 3-2-09 AM-she stated went to ER last night. Rash-increased-more like hives-and had Temp increase 101. Tx Steroids and BENADRYL. If still present after steroids, will go to family MD.
2:00 shot administered, burning sensation as vaccine was injected, waited 15 minutes, left facility 2:20 headache started 3:00 Headaches and body aches 4:00 arms and hands tingling, they went completely numb, I could not lift them, they were paralyzed. Migraine, body aches, severe fatigue, could not lift my head off the pillow, sore arm, chills, heart palpitations, dizzy, brain fog. Severe conditions continued all night.  Heart palpitations continued to increase throughout the night.   Day 2: Heart palpitations, migraine, brain fog, chills, muscle aches,  Day 3, 4, 5,- migraine, brain fog, heart palpitations on and off, brain fog, sore body and chills.  Day 6  continued symptoms. heart palpitations stopped, other symptoms continue Day 7- went to hospital. severe migraine that still continued even with medication, body aches, fatigue. Drs said the first 72 hours was the vaccine, the next 4 days they assumed it was an infection and treated me for cellulitis at injection site.  Day 8- headache continued until day 11 I still suffer from brain fog and its now SEPTEMBER!! This vaccine almost killed me.  I am so scared to get another!
Patient reported that she had "muscle pain in the chest", and she went to the ER.  ER did tests and nothing was abnormal.
Received Hib titer, the next day child was admit to hosp. /w Haemophilus Influenza type b meningitis. Details are not currently available but apparently child is immuno compromised.
CLIENT PRESENTED 10 MIN. AFTER INJECTION AND C/O SOB, FEELING HOT, SHAKEY, AND DIZZY. VS 4:15PM HR 90, RR 16, BP 164/82, O2 SAT 97%.   CLIENT CONTINUED WITH ABOVE SX'S AND RN NOTED FACIAL FLUSHING AND SCLERA  OU APPEARING BLOOD SHOT AND CLIENT C/O R ARM NUMBNESS.  VS 4:20PM HR 90, RR 16, BP 154/84, O2 SAT 98%.  4:40PM HR 92, RR 16, BP 156/82 02 SAT 98%.  4:40PM HR 96, RR 30, BP 136/86, 02SAT 99%.  CLIENT WAS TRANSFERRED VIA AMBULANCE TO MEDICAL CENTER.  F/U CALL TO CLIENT 6/15/2021.  CLIENT STATES HE FELT DIZZY FOR ONE HOUR AFTER ARRIVING IN ER.  HE REPORTS BEING MONITORED UNTIL 10:00PM AT WHICH TIME HE WAS RELEASED AND FELT BACK TO NORMAL.
high fever; body aches; chills; ringing in his ears; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (high fever), MYALGIA (body aches), CHILLS (chills) and TINNITUS (ringing in his ears) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced PYREXIA (high fever), MYALGIA (body aches), CHILLS (chills) and TINNITUS (ringing in his ears). At the time of the report, PYREXIA (high fever), MYALGIA (body aches), CHILLS (chills) and TINNITUS (ringing in his ears) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications include lipo-flavonoid vitamins   This case was linked to US-MODERNATX, INC.-MOD-2021-102931 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-102931:
Case number PHEH2012US014290 is an initial spontaneous report received from a nurse on 16 Jul 2012: This report refers to a 19-year-old male patient. He was given only the CYW-135 liquid component of MENVEO vaccine (batch number: M11073) without being constituted with MenA, intramuscularly on 14 Jul 2012. No other adverse reaction was reported following this administration error.
INFLAMMATION OF EYE LIDS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821288 expiry: UNKNOWN) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the patient experienced inflammation of eye lids. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from inflammation of eye lids. This report was non-serious.
Initial report received on 19 October 2006 from a health care professional.  Approximately five to six patient had received a deltoid injection of Fluzone SV 2006-2007, lot number U2193AA, on 18 October 2006.  Immediately post-immunization, a black dot appeared at the injection site.  The administration products used included a 3ml, BD syringe (#309585) with a 23 gauge, one inch needle (#305902).  Per the reporter, following their own testing, the silicone on the needle was suspected as the cause.  Outcome for these patients was reported as unknown.  Follow-up information received on 21 November 2006.  The patients (no individual patient identification provided) did not have any illness at the time of vaccination.  The vaccine was purchased with private funds.  Follow-up information received on 11 December 2006 from a health care professional.  The case was reviewed, and there was no additional information at this time.
ADMINISTERED MODERNA VACCINE TO A 16 YEAR OLD. THIS SHOULD BE FILED UNDER OFF-LABEL USE PER CDC, IF SOMEONE  16 OR 17  YEARS OLD IS GIVEN MODERNA.
T78.40XA ALLERGIC DISORDER, INIT 4/26/2023 BILAT ACUTE IRIDOCYCLITIS T78.40XA ALLERGIC DISORDER, INIT 4/26/2023 ASTHMA, UNSPECIFIED
Patient reports red, swollen, very sore arm which is hard at the injection site and limited range of motion in the arm (i.e. can't lift above her head.)  Patient reports it is still ongoing as of 12/14/21, 4 days after the immunization.
On 2/25/07 at about 3am febrile seizure lasting about 15 seconds. Paramedics on scene. Went to emergency room and released.
Information has been received from a pharmacist concerning a 47 yr old Native American woman with hypertension,Type 2 diabetes mellitus and low back pain and no other known medical history who on 01/16/2002, at 0900 was vaccinated IM in the left deltoid with a second dose of pneumococcal vaccine 23 polyvalent (lot number 641116/1160L) also reported as 1106L-invalid. It was reported that the pt experienced a quick onset of swelling, redness, pain, and warmth at the injection site. The pt returned to the clinic on 01/17/2002 for a precription for pain and was advised to use a cold pack occasionally to the site. The pt returned again to the clinic on 01/21/2002 and the symptoms had resolved. Another pt (WAES0201USA02698) had a similar experience with vaccination with the same lot. The reporter "questioned the stability" of the lot. The records of testing prior to release of this lot been checked by GMP Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and research and was released.
About 7 hours after the shot, nausea, fever, chills, fatigue, and headache were all present along with minor injection site soreness. These symptoms lasted through the night and were still present the following evening. The chills were no longer present by midnight and the fever was starting to break.  An pain in the foot also started at the same time and continues to exist as of this report.
Initial effects were soreness and redness. However, a couple of weeks later I experienced shortness of breath, anxiety, and a racing heart. This lasted for about an hour after which things calmed down. I have not had a repeated incident.
i experienced cold sweats and an unwell feeling shortly after injection. I passed out at the vaccination site and was taken by ambulance to the medical center yesterday, april 21st around  356pm.
Fatugue started right after the vaccine; then she had arm pain same day; headache next morning Narrative:
Bells Palsy.  Patient also got it with second vaccination but did not think it was the vaccine but then realized it is the vaccine after getting it again after the third dose
I got a ringing in my ear, I was diagnosed with Tinnitus on April 9th. They did a hearing test and ruled out any other problems with my ears. There wasn't anything that could be done about it. I took vitamin supplements online, I took them for about 3 months. It doesn't feel like they helped, but it did help improve from one COVID-19 shot to the second vaccine. Its a constant ringing, and high pitch sound. I was told by my doctor that there's nothing that can be done about it. I thought it was related to my antibiotic but it didn't seem to be that.
hearing loss; vision loss; herpes zoster; Information has been received from a lawyer regarding a case in litigation, concerning a female patient (pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not reported.   On 02-NOV-2017, the pt was inoculated with zoster vaccine live (ZOSTAVAX) at a pharmacy, for routine health maintenance and for its intended purpose of prevention of shingles (herpes zoster) (dose, route of administration, anatomical location, lot number and expiration date were not reported).   In approximately April 2018 ("within approximately 5 months of vaccination"), the pt experienced severe outbreaks of shingles and vision and hearing loss, requiring extensive medical treatment, which significantly affected the pt's daily life. It was reported that the pt suffered sustained severe, serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury, due to physical limitations and seriousness of her condition. Moreover, he has suffered economic losses due to her inability to work and incurred damages, including medical expenses, the loss of accumulations and other economic and non-economic damages. These injuries continued by the time of this report and were considered to be caused by zoster vaccine live (ZOSTAVAX).   Upon internal review, hearing loss and vision loss were considered to be medically significant events. Moreover, the reported events were considered to be disabling.
On day 14, after my second shot I starting getting a rash; some discomfort on my lower back; Went to an urgent care, where they diagnosed me with shingles.; This is a spontaneous report from a contactable consumer or other non hcp.   A 36-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 15Mar2021 11:00 (Batch/Lot Number: EN6208) as DOSE 2, single for covid-19 immunisation (at the age of 36-year-old). The patient medical history and concomitant medications was not reported. The patient had not experienced covid prior vaccination. The patient had tested covid post vaccination on 31Mar2021 and result was negative. Covid test type post vaccination was Nasal Swab. On 29Mar2021 the patient experienced event described as "on day 14, after my second shot I starting getting a rash, some discomfort on my lower back, went to an urgent care, where they diagnosed me with shingles". Therapeutic measures were taken as a result of the events. The outcome for all the events was recovered on an unspecified date 2021.  No follow-up attempts are possible. No further information is expected
This spontaneous report was received from a Medical Assistant concerning to multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history or concurrent conditions were not provided. On an unknown dates the patients were vaccinated with an unspecified doses of improperly stored MMR II, lot # K002816, expiration date: 26-FEB-2015 (routes, anatomical locations and doses were not reported). Co-suspect therapies or concomitant medications were not provided. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 19-JUL-2013, the patient was vaccinated with an expired PNEUMOVAX23 (lot number 672057/1417AA, expiration date: 22-JUN-2013)(dose and route were not reported). No concomitant medications were reported. No adverse effect reported. Additional information has been requested.
Erythema multiforme; glomerulonephritis or kidney inflammation; nephrotic syndrome; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA MULTIFORME (Erythema multiforme), GLOMERULONEPHRITIS (glomerulonephritis or kidney inflammation) and NEPHROTIC SYNDROME (nephrotic syndrome) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA MULTIFORME (Erythema multiforme) (seriousness criterion medically significant), GLOMERULONEPHRITIS (glomerulonephritis or kidney inflammation) (seriousness criterion medically significant) and NEPHROTIC SYNDROME (nephrotic syndrome) (seriousness criterion medically significant). At the time of the report, ERYTHEMA MULTIFORME (Erythema multiforme), GLOMERULONEPHRITIS (glomerulonephritis or kidney inflammation) and NEPHROTIC SYNDROME (nephrotic syndrome) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided and no treatment information was provided.  Very limited information regarding these events have been provided at this time. No further information is expected.; Sender's Comments: Very limited information regarding these events have been provided at this time. No further information is expected.
Patient stated that she was been having Dizziness since 8/14/2021. She stated that she received loose stool and extreme fatigue. She is also experiencing nausea and no apatite.
A non-serious spontaneous report of a 56-year-old got H1N1 was received from a nurse concerning a 56-year old male. On 29-Oct-2009, the patient received single dose H1N1, Intranasal. There is no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
everytime I get the flu shot I get sick for about 3 days; Initial information received on 27-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional via social media.   This case involves patient (unknown demographics) for whom it was reported everytime I get the flu shot I get sick for about 3 days (illness) while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got sick for about 3 days every time after taking flu shot (illness)  unknown latency following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown.  There will be no information available on the batch number for this case.
This case was reported by a nurse and described the occurrence of pain in a 55-year-old female patient who received SHINGRIX (batch number CH2X7, expiry date 25th April 2020) for prophylaxis. On 14th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 15th February 2018, 1 days after receiving SHINGRIX, the patient experienced pain, erythema, fever and chills. The patient was treated with Antibiotics (Brand Names Not Known)). On 24th February 2018, the outcome of the pain, erythema, fever and chills were recovered/resolved. The reporter considered the pain, erythema, fever and chills to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the licensed nurse. The physician had ordered antibiotics for cellulitis.
Slight fever, restlessness, pain in both legs, right greater than left. No injection site reaction noted. Bilateral strength intact. No PCP. Referred to clinic.
Started to have body chill, bad headache, weakness, Sore throat, ear ache, body ache, all symptoms of flu. Was really bad for 5-6 day. Still sick with bad head ache and sinus inflammation. Taking antibiotic Penicillin for sinus inflammation for 5 days and Sudafed. This is second time flu shot in my life. First time was 10 year ago and had the same effects. Don't think that this is coincidence. Not planning to do any flu shot in future.
Information has been received from a healthcare worker (medical assistant) referring to an unspecified number of patients of unknown age and gender. The patients' medical history or concurrent condition were not provided. On unknown dates the patients received improperly stored doses of VAQTA (strength, lot#, expiration date, dose and route were unspecified). No concomitant therapy was provided. No adverse effect was reported. This is one of the several reports that received from the same source. Additional information has been requested.
This spontaneous report was received from a medical assistant referring to a 38 year old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 24-MAY-2017, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 with lot # N003997 and expiration date 20-OCT-2018 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect or product quality complaint reported. No excursion details had been determined at the time of the report. There was a data logger involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA011654.