chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Menveo reconstituted with sterile water; Menveo reconstituted with sterile water; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number SKBAMVA721A) for prophylaxis.   On 03-AUG-2023, the patient received Menveo. On 03-AUG-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Menveo reconstituted with sterile water) and inappropriate dose of vaccine administered (Verbatim: Menveo reconstituted with sterile water). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: Receipt date: 9-Aug-2023 A nurse wished to know how to proceed. Information about vaccine, event and patient were given. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow-up. The patient received a dose of Menveo reconstituted with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Sore arm and back pain starting 4 hours after injection , chills and abdominal cramping 11 hours after vaccination administered  Sore arm - lasted 4 days Back pain - lasted 2 days Chills and abdominal cramping lasted 2 hours
The patient was less than 18 years of age at the time of vaccination. There were no known adverse effects.
Immediate formation of nickel-sized induration and erythemic rash about size of tennis ball at injection site, induration swelled to about size of quarter within 5 mins. Ice applied. Pt observed for about 15 mins. No systemic reaction observed. Pt returned to work.
red mark at injection site; blotchy hives around injection site that are itchy at times; lymph nodes by her shoulder and armpit/outer breast area are swollen, tough; lymph nodes by her shoulder and armpit/outer breast area are sore; bumps on her shoulder area, neck and arm; A spontaneous report was received from a consumer concerning a 25 year old, female patient who received Moderna's COVID-19 vaccine and experienced bumps on her left shoulder area, neck and arm, red mark at the injection site, blotchy hives at the injection site, swollen, tough, and sore lymph nodes by her shoulder and armpit/outer breast.   The patient's medical history was not provided. Concomitant medications reported included ethinyl estradiol/norgestimate.    On 22 Dec 2020, the patient received her first of two planned doses of mRNA-1273 (039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 27 Dec 2020, the patient noticed bums on her left shoulder area, neck and left arm. The bumps worsed on 30 Dec 2020. On 31 Dec 2020, the patient reported a red mark at the injection site and blotchy hives around the area that are itchy at times. She also has lymph nodes by her shoulder and armpit/ outer breast area that are swollen, tough and sore. Treatment for the event included paracetamol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events was unknown/not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Local allergic reaction. Redness (diffuse but no induration) developed the evening vaccine was given in left arm. Local warmth and pain but she stated no induration. Erythema extended below injection site to above elbow. No SOB or other symptoms other than fatigue on evening of injection. Seasonal allergy rhinitis and watery eyes. No wheezing.
Pt recieved vaccine noticed pain when vaccine was injected into Left deltoid. within 1 hour pain moved up into the shoulder area.  Injection site red and almost rashy like noticed the next day- size of a quarter. At 1030am on Friday became nausea and vomited at about 1100am.  Run to pharmacy to pick up meds and spoke with pharmacist who questioned whether she had the high dose vaccine.  Pt went home feeling fatigued. Feverish, and arm/shoulder aching pt felt bad and stayed in bed rest of the day.  Arm was still sore Sunday 10/7/12 and today - tender to touch on Monday. Noticed more arthritic pain across shoulders and neck still as of today.
Patient describes stronger than normal pain, described as nerve pain. Says entire arm is sore and tingling
devel pain w/in a few hrs of inject; area became hard & red; was on ATB & intermittently & ran t100; had mass excised on 27JUN95 (cyst); no growth from culture done fluid cyst;
Patient came into the pharmacy on 10/31/2015 to pick up some other prescriptions. While here, she said she received her flu shot here, which was on 10/24/2015.  On the night of the day after she was immunized (10/25/2015), she said she developed a burning rash.  The patient said this occurred shortly after taking niacin that she ordered on the internet. She has taken niacin in the past without any problems, but this tablet was from a different manufacturer than previous tablets she used.  The rash began on her ankles and spread to her legs.  Then she said it started on her wrists/hands and spread up her arms (worst at her forearm) and around her armpits.  She said she felt severe pain, as though she had shingles.  She did not know if it was from the niacin or the flu shot.
Started with swelling and redness, over night area turned purple. Was very swollen and uncomfortable. Bruising extended down arm from injection site and some bruising still remains today 04/25/2016.
Headache, body aches, chills, fever 99.5, fatigue. Also began menstruating 24 hours after receiving the vaccine and I have not had a period in 6 months and 10 months before that.
Pt recvd 1st dose of Engerix-B & 6-8 hrs p/inject exp flu like sx, stiff neck, h/a, lymphadenopathy of axilla & groin, low grade temp 99.6, chills & achiness; tx ES APAP w/mod relief; sx subsided p/48 hrs;
Painful area left thigh around injection site 4cm in diameter area of erythema treated on 11/5/14 at emergency room with rx AUGMENTIN. Followed up at MD office 11/11/14 with provider and symptoms resolved.
Flu shot 1 - 10:30A - 11 AM. 530 - 6PM Nasal congestion, mild N, chest tightness, wheezing mild - reminded him of Asthma that he had up until age 30. Tx with hot tea & ASA. Said wheezing lasted about 2 hr. Otherwise sx lasted not > 1 1/2 da.
Rash on back, same side as injection, 6 hours post vaccination. Rash is red and itchy
Flu-like symptoms starting same day last 4 days or so, numbness also starting same day and lasting up to 8 days.
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Shakiness-Medium, Systemic: Weakness-Severe, Additional Details: note: pt stated no allergies on form and when asked verbally by immunizer.  at the 7 minute mark he began to exhibit weakness and started falling off his chair. seemed like he was going to pass out. his breathing seemed labored. we position pt on floor, rph admin epipen to left outer thigh. 911 called. ems responded. pt felt better after epipen. bp, hr normal. pt taken to er by ems
tinnitus or ringings in her ears; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 81-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 81 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunization. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "tinnitus or ringings in her ears". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient said that 2 days after receiving the 2nd dose of the Pfizer-BioNTech Covid-19 Vaccine, she experienced tinnitus or ringing in her ears. She said they have been ringing ever since after that. She also mentioned that she heard that some people have also reported ringing in the ears after getting the vaccine. Consumer wants to know if this is a common reaction to the vaccine, and what she should do about it. She said she already consulted an ear specialist, and had a hearing test.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
reports that a mild headache started at 0923am BP=112/80, P = 64, R=16.  reports decreased headache.  Dischared with fathr with instruction to F/U with PCP
CLIENT STATES ON THE EVE OF 12/11/15 SHE DEVELOPED A FEVER OF 99.8-100.8 WHICH LASTED IN TO MONDAY (12/14). MONDAY AM SHE NOTICED HER RT. ARM WAS RED, HOT AND SWOLLEN AND ALSO ITCHY. DENIES ANY PROBLEM WITH MOVEMENT OTHER THAN DISCOMFORT. WAS SEEN BY MD MONDAY NIGHT AND DIAGNOSED WITH CELLULITIS AND PRESCRIBED BACTRIM AND KEFLEX. TODAY (12/16) SHE STATES IT IS IMPROVING.
Entire left thigh is extremely swollen, red, warm to the touch, and child is struggling to walk. When she attempts to walk she has to be on top toes on her left foot. Pain and swelling is interfering with sleep.
At 1230, patient reported numbness in left palm to EMT. Patient denied itchiness, rashes, and hives. Patient reported taking Advil before her vaccine to prevent side effects. Patient moved to gravity chair. At 1235, EMT assessed vital signs: blood pressure 102/70 mmHg, pulse 73 beats/minute, and SpO2 98%. Patient given water and advised to wait for further observation. At 1245 EMT reassessed vital signs: blood pressure 112/80 mmHg, pulse 67 beats/minute, and SpO2 98%. Patient stated her left palm felt "less numb". At 1300, EMT reassessed vital signs: blood pressure 106/72 mmHg, pulse 68 beats/minute, and SpO2 98%. Patient reported less numbness in her left palm. At 1301, RN  educated patient to not take medications before vaccination, signs/symptoms of when to seek emergency care, to sign up on v-safe, and to follow up with primary care provider. At approximately 1305, patient left facility with unlabored respirations and steady gait.
Approximately 3 days after this vaccine I experienced extreme swelling. My hand swelled two four times their normal size and I was unable to make a fist. The pain was excruciating. I have never felt pain so bad and I have had RA for almost 30 years. I also noticed that I was having pain in joints that weren't usually affected by my RA such as my wrist elbows and ankles. I took Advil, vicodin, and increased prednisone, along with Immersing my hands in very hot water or moist heating pads. The Tissue swelling of my hands started to subside the end of June. However my knuckles remained extremely large and severe pain continued. I was started on enbrel injections and diclofenic ointment. which helped to decrease the pain somewhat. (Diclofenic tablets DC'd). Continuing to have chronic increase pain I was placed on hydroxychloroquine. To this date the effects are still evident, as if my RA was accelerated. My knuckles are twice the size they were and I have additional pain continuing in the wrist, ankles and elbows. Prior to the vaccination my pain was pretty well maintained, (never completely gone but acceptable), with occasional flare ups which needed a little additional medication (Motrin) or therapy. Since the vaccination on April 28th 2021, my pain is worse on a daily basis, often keeping me from sleeping. The flare-ups have been so bad that I have to increase my prednisone, use motrin, vicodin, topical ointments and heat.
Described by patient over phone - evaled in ER. Delayed arm redness/swelling. Resolving 1-2 weeks later.
Information has been received from a physician concerning a 2-6 month old patient who was vaccinated with the first dose of Rotateq. Concomitant vaccines administered on that same day included "other vaccines". The patient subsequently became irritable. Unspecified medical attention was sought. The patient's symptoms subsequently resolved on their own after a short period of time. It was unknown if the patient completed the series. This is one of several reports received from the same source. Additional information has been requested.
Patient was administered a Pfizer Bivalent COVID booster dose instead of a Pfizer Monovalent Primary Series Dose. Patient waited in office for 15 minutes after administration with no adverse reactions or side effects during that time.
STROKE; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total, administered for covid-19 prophylaxis. The batch number was not reported. Per procedure no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced stroke. It was reported that " You gave me a stroke. Why". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221217662-Stroke. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
A spontaneous report was received from a consumer, concerning a female patient of an unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced chills, fatigue, achy/pain, couldn't get warm/feeling cold and passed out/loss of consciousness.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event were not reported.  On 28-Jan-2021, the patient received first of two planned doses of mRNA-1273 (Lot number: 02RL20A) intramuscularly for prophylaxis of COVID-19 infection. She had had no reaction with her first vaccine dose.  On 25-Feb-2021, the patient received her second of two planned doses of mRNA-1273 (Lot number: 02YM20A) intramuscularly for prophylaxis of COVID-19 infection.  On 26-Feb-2021, the patient felt achy. About 2 weeks later, the patient experienced chills, fatigue, aches and couldn't get warm. On an unknown date, the patient blacked out /passed out and found herself on the floor when she got up to go to the bathroom. The patient weighed only 97-100 lbs. The event blacked out/loss of consciousness was considered as serious (medically significant).  Treatment information was unknown.  Action taken with mRNA-1273 was not applicable since the patient received both the doses of the vaccine.  The outcome of the events chills, fatigue, achy/pain, couldn't get warm/ feeling cold and passed out/loss of consciousness were considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
12/24/16 BELCHING, RUNNY NOSE, DIFFICULTY BREATHING, RASH, REDNESS NECK AND CHEST AREA. 12/31/16 SENSITIVE TO COLD, TINGLING OF HANDS, FEET, ARMS, CRAWLING SENSATION BACK AND SCALP, FATIGUE. SEEN GP 4 TIMES AND NEUROLOGIST 2 TIMES. AS OF 2/10/17 NECK PAIN, TINGLING SENSATION ARMS AND LEGS WORSEN, WITH NEW SYMPTOMS OF BURNING SENSATION. PAIN IN HANDS, FEET, AND MUSCLE ACHES AND GENERALIZED FATIGUE.
No adverse event; Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 12-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster).    Concomitant medications were not reported. No treatment information was provided by the reporter. This case contains information for the 6th adult patients out of 15 adult patients described by the reporter.
No adverse event; Drew up a dose of the vaccine from the vial with the blue cap instead of the red cap and inadvertently administered; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Drew up a dose of the vaccine from the vial with the blue cap instead of the red cap and inadvertently administered) and NO ADVERSE EVENT (No adverse event) in a 39-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 018C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Feb-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 16-Feb-2023,  after starting , the patient experienced WRONG PRODUCT ADMINISTERED (Drew up a dose of the vaccine from the vial with the blue cap instead of the red cap and inadvertently administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Drew up a dose of the vaccine from the vial with the blue cap instead of the red cap and inadvertently administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Drew up a dose of the vaccine from the vial with the blue cap instead of the red cap and inadvertently administered).    Concomitant medication was not provided.   Nurse stated that drew up a dose of the vaccine from the vial with the blue cap instead of the red cap and inadvertently administered it to a 39 year old patient, it was the vial with the blue cap and a label which states (For booster dose only).   Treatment information was not provided.   Reporter did not allow further contact
This spontaneous report was received from a physician via company representative and refers to a 70-72 year old female patient. No pertinent medical history reported. Approximately in 2007 (reported as 6 to 7 years ago) the patient was vaccinated with ZOSTAVAX (dose and route unknown). No concomitant medications reported. The physician reported that the patient experienced the worst case of shingles that she had seen after receiving ZOSTAVAX (disability). The patient sought unspecified medical attention. The outcome of shingle was unknown. The causality was not reported for shingles. No product quality complaint involved. The reporting physician considered the event to be serious due to significant disability/incapacity. This case is also related to 1411USA002638 due to same reporter. Additional information has been requested.
07/11/02 4:30pm, mother reported that child developed a rash on the face after receiving four vacicnes today. Crying and irritable, afebrile, no difficulty in breathing, color good, denies other illness-to monitor temp and administer Tylenol q 4-6 hours. Given instructions to notify MD. 07/12/02 9am rash has decreased-still irritable, refusing formula-not eating a normal dose (has taken 6-7cm in past 12 hrs) will call family MD this am. 07/15/02 called client left message. 07/18/02 spoke with mother and she stated that she contacted MD but an office visit was not required. Pt rash began to fade on 07/12 and he began eating normally later that day. Will document an office records and perhaps received vaccines separately at next dose to determine if vaccines caused this reaction. No residual problem noted at this time.
Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Additional Details: approximately 10 minutes after dose patient blood pressure dropped, eyes dilated, clammy. sweating. First responders came, pt did not leave with them but was going to hospital to \"get checked out\".
PAIN, SWELLING, ERYTHEMA AT INJECTION SITE, LYMPH TO LEFT AXILLA SWOLLEN Narrative:
This medically confirmed report (initial receipt 12-NOV-2010) concerns a 3 year old male patient with no pertinent medical history or concomitant medications. On an unspecified date, approximately one week prior to reporting, the patient received a dose of AFLURIA. The patient was subsequently admitted to hospital for evaluation and treatment of suspected toxic sinovitis. Lab diagnostics studies performed included unspecified x-rays, throat culture, erythrocyte sedimentation rate, lumbar puncture and complete blood count. The patient's symptoms resolved with rest. The event outcome was recovered. The patient made a full recovery.
pt had a temp of 103 & cont crying for 3 to 4 hrs;
Pt did not eat much for supper. It was bath time for the patient and pt was very, weak, limp and starry eyed during this. Pt kept complaining of her one arm, a  limp feeling. Pt was going to have a snack afer bath time and pt wet herself and then passed out. Pt did have a fever and was given a fever reducer for that. Pt was taken to ER for evaluation and pt "snapped out of it and was fine for her ER visit."  Pt did carry a fever through out the weekend and was kept home from preschool one day just to make sure she was still doing ok.
VACCINE THAT WAS GIVEN TO PATIENT IS PASS OUT OF EXCURSION TIME TABLE OF VIABILITY. DOSE THAT WAS GIVEN IS WITHDRAWN FROM A VIAL THAT WAS 1ST PUNCTURED ON 06/16/2021 9:30 AM. VACCINE WAS GIVEN 26HOURS OUT EXCURSION TIME TABLE.
redness/swelling at injection site approximately 0.5-1in below injection for next 2-3 days patient reports day of symptoms included body aches/headache which resolved after 2 hour nap
the morning p/vax pt rt hand & wrists were swollen; no temp, no pain; swelling went down by the afternoon;
This spontaneous report as received from a Healthcare worker refers to unknown number of patients of unknown age and gender. Approximately in 2013 the patients were vaccinated with MMR II (manufacturer unknown) (lot # and expiration date unspecified) (dose, route and anatomical location unspecified) for prophylaxis. The Healthcare worker reported that an unknown number of patients received doses of MMR II (manufacturer unknown) that were exposed to temperatures of 53F for 68 hours beginning on 29-MAR-2013, and then exposed to temperatures of 52F for 68 hours beginning on 12-APR-2013. All doses were administered after 29-MAR-2013. No adverse effect reported. This is one of two reports from the same source (MARRS 1306USA001249). Additional information has been requested.
p/recv vax pt exp wheal & flare react w/urticaria @ inj site;no fever or other rash;