chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional adverse events; on 5/28/2020 a 2 month old patient was administered a properly stored but expired ROTATEQ; This spontaneous report was received from a medical assistant and refers to a 2-month-old male patient. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 28-MAY-2020, the patient was vaccinated with properly stored but expired rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # R022221, expiration date 23-MAY-2020 (exact dose, dose number, dose site and route of administration were not provided) for prophylaxis. No additional adverse events were reported.
Information has been received from a physician concerning a patient who on an unspecified date experienced intussusception 8 months after completing their oral series of ROTATEQ.  The patient was hospitalized but it was unknown for how long or at which hospital.  At the time of reporting, the patient's outcome was unknown.  Additional information has been requested.
Patient received vacc on 6/8/07. Returned to clinic on 6/11/07 to report that the evening at vacc the began having fever, chills, nausea, arm pain. SX resolved by 6/11/07 but right arm still swollen and warm at injection site.
intermittant parathesia in both arm but not related to any dose of the vax; started p/had incident; animal was shot in head & could not be tested; no actual bite exposure; 18OCT93 f/u numbness & tingling @ site radiating to hand;
This spontaneous case, initially received from other health professional on 05-Nov-2018, concerns a 33-year-old, adult, male patient. The patient did not have any medical history. The patient did not receive any concomitant medications. On an unspecified date, the vaccine was left out at room temperature of 70 Fahrenheit for 48 hours (1st temperature excursion). On 05-Nov-2018, the patient was administered AFLURIA QUADRIVALENT (route of administration: intramuscular, anatomical location: left deltoid, dose: 0.5 ml, batch number: YF41608 and expiry date: 30-Jun-2019) which underwent temperature excursion. It was reported that, the patient was not hospitalized for the events. At the time of this report, no adverse events were reported. The reporter assessed the case as serious (medically significant).
Abrupt onset of mildly pruritic rash that worsened over 4 days. Erythematous maculo-papules, no pustules, all at different stages on arm, chest, back, legs.
every year I got the shot, I got really sick; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 06-DEC-2020.  This case involves a patient of unknown age and gender who reported every year I got the shot, I got really sick (Illness), while he/she received vaccine Influenza Vaccine.   The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date, the reporter reported that the patient have a compromised immune system and every year the patient got the shot, the patient got really sick. The patient stopped getting it and haven't been sick with the flu in years!  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.  The reporter assessed the causal relationship with suspect vaccine as related.
Approx. 3 mins post vaccination, pt fell forward from chair and hit the floor with his head and lay unconscious for less than 10 seconds (maybe 5 seconds). Upon shaking by RPh, pt opened his eyes and looked at her and said "I'm okay. I don't know how I got here." He reported no dizziness before or after fainting, and said he felt fine. Paramedics were called, arriving after 15 or 20 minutes, during which pt was alert and oriented.
Severe headaches and bone/joint pain - started about 15 minutes after injection and continues today days at a time then slacks off and reappears
Face numbness, tongue tingling, severe headache, body aches, diarrhea, fever, chills for 4 days now Tylenol and Ibuprofen  Er visit
Redness in injected arm located several inches below the site of injection. Persisted for 4 days and was tender/achy to the touch.
25 years old female called to report an adverse reaction after she received her second P-fizer vaccine on 03/30/2021 @1845. patient reported couple of days later she developed pain in the back of her leg when she walks or stands. patient denies any allergies. patient reported no past medical history. patient reported no current medications. patient was instructed to seek medical attention to get checked.
12/30/21  43 yo female presents with congestion for the past 3 days with body aches. She has not been taking any medications for symptoms. She is here with spouse who also has COVID symptoms. She has not had known sick contacts. She is fully vaccinated for covid without booster. Review of Systems  Constitutional: Positive for fatigue. Negative for chills and fever.  HENT: Positive for congestion. Negative for sore throat.   Respiratory: Positive for cough. Negative for shortness of breath.   Musculoskeletal: Positive for myalgias.  Neurological: Negative for headaches.
Patient received her second Pfizer COVID-19 vaccine on 4/6/21. She developed neutropenia that was found on 4/20/21 (neutrophils 0.8) and resolved by 4/27/21 (neutrophils 4.0). Her chemotherapy was held by 1 week due to neutropenia, but otherwise she did not have any negative effects from this. The timing of the neutropenia did not coincide with her chemotherapy. She received Halaven, 3/15/21, 3/22/21 and 4/6/21. She did not have any issues with neutropenia with her first two doses, nor has she had issues with neutropenia with the doses administered on 4/27/21 and 5/4/21.
Headache, Myalgia, Fever, Diarrhea, axillary lymphadenopathy Narrative: Per nursing report: " states she recieved her 2nd Moderna vaccine on 7/31/2021. She has had diarrhea, headaches, body aches, swollen right axillary lymph node on the same side as injection and fever."
Information has been received from a 56 year old female with no known allergies and no past medical history who in approx. 1997, (4 years ago), was vaccinated with a 1st dose and on 11/1/01, was vaccinated with a 2nd dose of pneumococcal vaccine 23 polyvalent (lot 636158/1456K). Concomitant therapy included Benadryl and (Vicodin Tablets). On 11/2/01, the pt's arm began to swell. It was 14" around and maroon red from the shoulder down to her elbow. The swelling had moved to her elbow joint and was affecting her hand movement. On 11/3/01, the pt went to the ER and was told that she might have been given a contaminated batch. On 11/4/01, the pt returned to the ER and was told that the person who gave her shot had administered the vaccine incorrectly. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complied with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Information has been received from a physician concerning a pt who was vaccainted with Pneumococcal 23v polysaccharide vaccine (lot 651332/1049P). Subsequently the pt developed swelling, redness and painful local reaction and required an antihistamine a few hours after receiving the Pneumococcal 23v polysaccharide vaccination. The pt was hospitalized. At the time of the report, it was unk if the pt recovered. The physician requested a lot check. A lot check of concern has been requested. Additional information has been requested.
Passed out randomly while out with my wife. Felt nauseous, became sweaty, heart rate dropped
An incorrect monovalent mRNA COVID-19 vaccine product was inadvertently administered instead of the bivalent mRNA COVID-19 vaccination.  Pt received 0.3mL of undiluted 5 to <12 yro monovalent Pfizer, dosage equivalent to the adult mcg/mL amount of 12yro+ monovalent Pfizer. Patient had previously completed original Pfizer vaccination series and a bivalent booster dose was intended to be administered instead of a monovalent dose as a booster. Pt was notified and denied any concerns. Pt advised to let his PCP know that he received the monovalent Pfizer as a booster instead of the bivalent and he will be eligible for the bivalent booster 2 months from today's date per CDC recommendations at this time.
This spontaneous report as received from a registered nurse refers to a 5 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 05-SEP-2017, the patient was vaccinated with improperly stored VAQTA (dosing details were not reported) (lot # N017094, expiry date: 31-AUG-2018) for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA007014: US-009507513-1709USA000054.
After receiving influenza vaccine, she reported significant erythema and multiple hives around the injectionsite. No other systemic effects noted.
Chronic migraines for 6 days my armpit swelled up to the point where I couldn?t move it. Throat was sore for 5 days hot flashes continue to persist a week after getting the shot. Chills and fever for 5 days.
Within the first 15 minutes of receiving the vaccine I was was extremely tired.  As time went on, this seemed to subside.  Tiredness has appeared to come and go over the last few days.  Every morning I have woken up with tingling in my left hand, as though there are pins and needles in my left hand.  My left arm feels weaker and feels some numbness when more pressure is placed on it.  I have a bruise that appeared above my left wrist.  I have reached out, as this is my employer and I have not heard back.  Assuming they were closed due to New Year?s Day.
Child got rabies post exposure on sat. On Sunday he started with large amount of hives all over his body. Per his mother-she said she was told they were very severe. She was given antihistamine to ber given to her son x3 days. Child was due on Day 7 (on Wednesday). She called HD beacsue since she lived so far away, she didn't want to get to HD and to be told that the child could not get the vaccine that day. Other than that she had no problems having her son get the vaccine. Mother said child had bad hives, Temp 100.9 and she was giving him Tyenlol. Called to HD FNP. She said to call state DOH. Did so. Was told by DOH she should follow what was said by clinician. Mother brought the child in on Wed. 7/29/2015. Child tolerated vaccine well. It was also stated to try another Rabies vaccine which was done. From Novartis Rabavert to SP Imovax. Called mother several times to see how child did after this past vaccine and she has not returned any calls.
On day 8 after my vaccine, my arm became very sore again, like when I received the vaccine. When I looked at my arm, I had a red welped blotch at the injection site. This spot is also itchy. I have had some pain and itchiness going down my arm as well.  Approximately 20-23  minutes after I received the vaccine, I experienced heart racing and throat constriction. Both of these symptoms went away.  I experienced diarrhea and tiredness the next day (January29).
injection site is red, itchy; injection site is red,red ring /circle size around it about 3" around injection site.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (injection site is red, itchy) and VACCINATION SITE ERYTHEMA (injection site is red,red ring /circle size around it about 3" around injection site.) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (injection site is red, itchy) and VACCINATION SITE ERYTHEMA (injection site is red,red ring /circle size around it about 3" around injection site.). At the time of the report, VACCINATION SITE PRURITUS (injection site is red, itchy) and VACCINATION SITE ERYTHEMA (injection site is red,red ring /circle size around it about 3" around injection site.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported.  No Treatment information was reported.   Reporter did not allow further contact
Transverse Myelitis attack shortly after booster.; This spontaneous case was reported by a patient and describes the occurrence of MYELITIS TRANSVERSE (Transverse Myelitis attack shortly after booster.) in a 38-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7170B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Jan-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced MYELITIS TRANSVERSE (Transverse Myelitis attack shortly after booster.) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 04-May-2023 due to MYELITIS TRANSVERSE. At the time of the report, MYELITIS TRANSVERSE (Transverse Myelitis attack shortly after booster.) had not resolved.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Patient experienced transverse Myelitis attack shortly after booster and was hospitalized on 4/05/2023. He stayed in the hospital for a month and a half. Treatment information was not reported. Company Comment: This is a spontaneous case concerning a 38-year-old male patient with no medical history, who experienced the serious (due to medically significant and hospitalization) unexpected, AESI event of myelitis transverse, which occurred on an unknown date after a dose of mRNA-1273 Bivalent .222 (original and omicron BA.4/BA.5), received as the third dose of COVID-19 vaccination schedule. The outcome of the event was reported as not recovered. It was reported that patient experienced transverse Myelitis attack shortly after booster and was hospitalized. He stayed in the hospital for a month and a half. The benefit-risk relationship of mRNA-1273 Bivalent .222 (original and omicron BA.4/BA.5), is not affected by this report.
30OCT98 severe h/a, dry heaves beginning same day & lasting several hr;no history h/a;
Patient is a 29 year old male Patient identified using 2 identifiers Name and date of birth   S: (situation) : 0753 patient was wheeled to observation by RN manger Verbal report "Pt had a syncope episode after vaccine"   Today covid vaccine Janssen    B: (background) Past Medical History reviewed,   NO KNOWN DRUG ALLERGIES No current medical conditions Takes MVI daily Never had covid   Awake and alert, assisted to gurney by LVN, diaphoretic, appeared pale Able to speak clearly  Any pain- reported tingling to hands bilaterally "I was not looking forward to this shot, do not like needles", stated patient    A: Assessment    Vitals:   10/05/21 0815 10/05/21 0823 10/05/21 0830 10/05/21 0835 BP: 101/62 105/65 109/65 104/64 BP Patient Position: SITTING SITTING SITTING SITTING BP Location: LA-LEFT ARM LA-LEFT ARM LA-LEFT ARM LA-LEFT ARM Cuff Size: Standard Adult     Standard Adult Pulse: 55 53 65 64 Resp:   18 18 18 SpO2: 100%   100% 98% Weight:   155 lb (70.3 kg) 155 lb (70.3 kg) 155 lb (70.3 kg) Height:   6' 2" (1.88 m) 6' 2" (1.88 m) 6' 2" (1.88 m)   Vitals monitored Denies any chest pain or shortness of breath Denies any difficulty swallowing   Patient lying on gurney, legs elevated  Ice pack placed under neck Removed mask Elevated HOB 45 degress 0801 provided with water  Denies any nausea  Patient vitals improving Denies dizziness while HOB elevated Talkative Skin color pink No longer clammy 0815 Tolerated apple juice 0835 standing denies dizziness Last set of vitals Patient verbalized feeling "feel like I did when I walked in now" Instructed patient to stay hydrated, drink plenty of fluid today, reviewed the side effects of vaccine And to report any further side effects to pcp  Patient verbalized understanding All questions answered he has the janssen paper work from CDC   8:59 AM
Oculo-Respiratory Syndrome.  Bright red painful eyes, green discharge from eyes, fever, malaise, shakes, migraine, cough, sore throat, body aches, mild nausea.
0930: Approximately 20 minutes after vaccine, patient reported hives to chest and right arm.  Vaccine administered to left arm.  Patient brought to first aid station.   Allergies: NKDA PMHx: patient denies Medications: Patient denies Patient reports feeling nervous prior to vaccine.  Provider on duty In attendance. VS: SaO2: 98% on RA, b/p: 170/110, HR: 78, RR: 18, Temp: 99.5  0932: Benadryl 50mg Liquid Orally. Pt tolerating water well. 0955: VS Temp: 98.4 B/P: 138/90, HR: 78, RR: 18, O2Sat 98% on RA. Hives present but improved. Continue to monitor for 15 minutes.   1015: Patient cleared by Provider on duty.
I vaccinated client at 05:00 and at 06:15, client returned to me complaining of pain in wrists, ankles and hips. Upon inspection, I noted that her wrist and ankles appeared swollen. She also, complained of feeling achy all over her body. She further complained of feeling very thirsty. I called the manufacturer at 06:30 and was advised to have client be seen by MD.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient was vaccinated with ZOSTAVAX on 20-JUL-2012, via IM route instead of SC route (dose, site of administration and lot # not reported). No adverse effect reported. Follow up information was received from the pharmacist concerning the 66 years old female patient with hypertension and allergy to lisinopril (MARRS 1209USA006456) who on 20-JUL-2012 was vaccinated intramuscularly with the first dose of ZOSTAVAX (lot number reported as 0256AE, dose not reported) and concomitantly with the first dose of BOOSTRIX via subcutaneous route (lot number AC52B85BA, dose not reported). On 21-JUL-2012, the patient experienced redness, pain and a hard lump at subcutaneous site (from BOOSTRIX). On an unknown date the patient recovered. This is one of several reports concerning the same patient (cross-referenced report number 1209USA006456). Additional information has been requested.
Pt has rash left arm, swelling, no fever or vomit. Pt was seen today Doctor 5-22-09.
Admitted with acute heart failure syndrome.  Decongested with IV diuretics and transition to an oral regimen.  Cardiology was consulted and plan for outpatient evaluation with right and left heart catheterization.  Severe tricuspid regurgitation noted with plan for serial assessment outpatient.  Patient was noted to have newly detected atrial fibrillation for which he started on systemic anticoagulation with apixaban.  Plan was for empiric anticoagulation and then outpatient DCCV if needed.  CT imaging concerning for possible bony metastasis.  PSA was obtained and severely elevated.  Urology and oncology were consulted and patient was started on empiric treatment for metastatic prostate cancer.  Plan to follow-up outpatient with oncology and urology including for possible tissue biopsy.
I just did not feel good. I had a severe sore throat. I got the chills and so I slept in a separate bedroom from my husband. I thought I had influenza and the next morning, my throat was even worse, so I took a home Covid test and it was positive. Then, I went to the doctor. Now pop-up site and they confirmed I was Covid positive. Then I went to Urgent Care and was tested for the third time, and it was positive. So, the doctor recommended a Monoclonal Antibody Infusion. Then, I went home and isolated in my room for 4 days and I just slept. I stayed hydrated. I took over the counter Mucinex DM.
Patient received 4th dose 0.5ml vaccine after stating he was immunocompromised instead of receiving 0.25 booster.   Patient has no adverse reactions during 15 minute observation period and left without any complications.
inconsolable, high pitched crying 4 hrs; some swelling and redness @ DTP site; fever 101 for 24 hrs; mom gave APAP; did not consult MD; used cold compresses to inject site;
Acute pain in my left neck and shoulder; Acute pain in my left neck and shoulder; Muscle spasm; I guess where you can lay your hand on the top of your shoulder, it started feeling a little stiff; This is a spontaneous report from a contactable consumer (patient herself). A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution injection; Batch/Lot Number: EN6201), via an unspecified route of administration, administered in Arm Left on 12Feb2021 as dose 1, single for covid-19 immunisation. Medical history included blood pressure and cholesterol from an unknown date to unknown if it is ongoing. Concomitant medications included amlodipine taken for blood pressure, atorvastatin taken for cholesterol and metoprolol succinate. On an unspecified date in Feb2021, patient stated the top of her shoulder, not her arm but where you can lay your hand on the top of your shoulder, it started feeling a little stiff Saturday night. Sunday it was getting stiffer and it was going into her neck and Monday it was to the point where she could not know how to 'adjust' her head off the pillow when she lied down. Tuesday morning she went to the urgent care. Doctor gave some of the medicine but it was not quite affective. Later she clarified that the treatment medications were not working properly it worked when she took it and it was just Tylenol. Tylenol which she just took before but she stopped taking it when she got the vaccine because she read that it was helpful. She was acetaminophen or tylenol and she was taking the arthritis pain extended release tablets. Patient stated that something else that he gave her was tizanidine. It's a muscle relaxer and together they have helped significantly plus he told me to keep ice on it and those 3 things helped. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Vasovagal syncopal reaction - loss of consciousness with amnesia.  No seizure activity, no post ictal period.