chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diarrhea; Arm hurts; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and PAIN IN EXTREMITY (Arm hurts) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included APIXABAN (ELIQUIS) for Anticoagulant therapy.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced DIARRHOEA (Diarrhea) and PAIN IN EXTREMITY (Arm hurts). At the time of the report, DIARRHOEA (Diarrhea) and PAIN IN EXTREMITY (Arm hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment was not provided.
Dry cough, itchy throat, wheezing, SOB, heaviness in chest, headache. Resolved about two hours later after taking Benadryl and aleve.
Initial Complaint of Constipation, admitted for altered mental status, respiratory failure, HTN, hypothyroidism. Information pulled from Report
After about 7 hours of receiving the vaccine I started to shiver. My body felt extremely cold even though I was in 75 degree temperature indoors. I started getting goosebumps. That lasted for about 9 hours throughout the night. I also experienced nausea for about 30 minutes at 8:45 pm. I felt like I was going to pass out within that time period too. My head was also hurting throughout the night. My body was aching through the night as well. The only reason I am not sure if I had a fever is because I did not have a thermometer. My arm was sore for 3 days and I was also sweating throughout the first night.
CHICKENPOX RASH, ITCHY. GREATER THAN 10 LESIONS.
Sore arm; She had a reaction; Rash/ rash is about size of half dollar on right arm/ rash size is now size of a nickel; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), INJECTION SITE REACTION (She had a reaction) and RASH (Rash/ rash is about size of half dollar on right arm/ rash size is now size of a nickel) in a 77-year-old female patient 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received 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 PAIN IN EXTREMITY (Sore arm), INJECTION SITE REACTION (She had a reaction) and RASH (Rash/ rash is about size of half dollar on right arm/ rash size is now size of a nickel). At the time of the report, PAIN IN EXTREMITY (Sore arm) and INJECTION SITE REACTION (She had a reaction) outcome was unknown and RASH (Rash/ rash is about size of half dollar on right arm/ rash size is now size of a nickel) was resolving.            No Concomitant and Treatment medications were provided.  Patient stated that she was concerned that vaccine was not injected properly into the muscle.   This case was linked to MOD-2021-395969 (Patient Link).   Reporter did not allow further contact
Chest tightness, throat closing up, nasal congestion, difficulty breathing, redness on face (especially nose & cheeks).
Received my 2nd dose of the Pfizer vaccination on April 20, 2021. About two hour after receiving my vaccine, my period began,  was gushing and clots.  I also had cramping.
The vaccine was administered 6 days too early by the vaccinator. The first dose was given on 1.6.22 and the second dose was given on 1.21.22. No adverse symPtoms were observed. Patient was observed for 45 minutes. Vital signs at 1648 BP 98/72, 98bPm, 100 % 16resPirations. Parents were instructed to seek emergency medical services for any signs or symPtoms and to call their Pediatrician immediately for monitoring.
Numerous attempts were made between 08/22 - 08/24/07 to reach mother, unsuccessful (pay-as-go phone not accepting calls). TC to clinic 08/24/07 for review - child was not admitted to hospital. He was treated in ER only (transferred to clinic from hospital with fever and seizure). No further problems reported R/C to this incident. Treated for unrelated Febrile episode/seizure 2". Sent home that morning with mother. Spoke with nurse at hospital also and she had the same understanding from clinic - r/o seizure 2 hours imms - seizure 2 hours febrile episode.  3/19/08  Reviewed ER medical records of 8/21/2007. FINAL ER Dx: Seizure disorder Records reveal patient experienced seizure activity during sleep with shaking, foaming at the mouth, incoherent, eyes rolled back, urinary incontinence.  Post ictal in ER.  Transferred to higher level of care. 4/4/08 Reviewed 2nd ER medical records of 8/21/2007. FINAL DX: new onset seizure. Records reveal patient experienced s/s as noted at previous ER.  Patient very sleepy.  Discussed w/neuro
No adverse event; Patient received her first vaccine on 23-Jul-2021/ 2nd dose on 09-Mar-2023; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received her first vaccine on 23-Jul-2021/ 2nd dose on 09-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a 35-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On 23-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Mar-2023, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received her first vaccine on 23-Jul-2021/ 2nd dose on 09-Mar-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received her first vaccine on 23-Jul-2021/ 2nd dose on 09-Mar-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received her first vaccine on 23-Jul-2021/ 2nd dose on 09-Mar-2023).    No concomitant medications were reported.  The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The patient was traveling in May-2023.  The patient did not have any reactions.  No treatment medications were reported.
Hospitalized for COVID 19 pneumonia, Temp 38.3, productive cough, weakness and myalgias x 48 hours. Dexamethasone, Remdesivir.
daughter called at 325pm and said patient had some numbness and tingling in lower lip with a little swelling of lower lip recom. 25mg Benadryl and will call them later tonight
Client mother reports 10/26/2023 child's right arm has swelling, redness, and heat at injection site that began day after vaccine administration10/24/2023. Reports stabbing pain beneath swelling to elbow of right arm.  Reports swelling is not bigger than a softball and no pain at swelling portion of arm. Declines drainage from injection site.  Reports child can move arm more today than 10/25/2023. Mother disclosed that child fainted in shower 10/25/2023.  Instructed to apply cold compress and use Ibuprofen as directed for swelling. Notify pediatrician of event for further eval.  Mother reports pediatrician instructed to follow with Ibuprofen and heat compress.  No further testing.
This spontaneous report as received from a registered nurse refers to a 61 year old female patient. Patient's current conditions included type 2 diabetes, hypertension, hypothyroidism, fibromyalgia, dysthymic disorder, hyperlipidemia and osteoarthritis. Patient had no drug reactions/allergies. On n13-AUG-2014 the patient was vaccinated with ZOSTAVAX lot # J016259, expiry date 27-FEB-2015, (dose and frequency unknown), subcutaneous for vaccination. Concomitant therapies included metformin, HYZAAR, WELLBUTRIN, CYMBALTA, ZOCOR, NORCO, TESSALON PERLES, FLEXERIL, ATIVAN. The reporter stated that since receipt of the ZOSTAVAX, on 13-AUG-2014, the patient had complained of an injection site reaction, described as red, warm to touch, growing in size, tender and causing her pain on the right side of her body. Patient sought medical attention-the reporter stated that when the patient came to the office on 15-AUG-2014, the nurse practitioner noted redness, warmth and swelling at the site which was getting worse and diagnosed the patient as having an allergic reaction to the ZOSTAVAX. No laboratory studies were performed. The nurse practitioner treated the patient with a prescription for halobetasol (topical) and prednisone. The outcome of allergic reaction was not recovered/not resolved. Reporter's causality assessment was not provided. Product quality complaint was not involved. Additional information has been requested.
During a primary care appointment on 1/13/20, the patient informed his PCP that he had a "severe reaction on the palms of both hands after taking the first Shingrix injection" so did not want to receive the second injection. He did not notify PCP of this reaction until that time.
This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (an immunocompromised patient who received a half dose (0.25ml) for their third vaccine dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Immunocompromised. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (an immunocompromised patient who received a half dose (0.25ml) for their third vaccine dose). At the time of the report, ACCIDENTAL UNDERDOSE (an immunocompromised patient who received a half dose (0.25ml) for their third vaccine dose) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment information was reported.
received expired dose past manufacturer expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired dose past manufacturer expiration date) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired dose past manufacturer expiration date). On 10-Nov-2021, EXPIRED PRODUCT ADMINISTERED (received expired dose past manufacturer expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was provided. No concomitant medication was provided.
patient felt anxious. Patient can not explain it. Patient's pulse was not beating right.; patient felt anxious. Patient can not explain it. Patient's pulse was not beating right.; This is a spontaneous report from a contactable consumer (patients mother). The report is cross referenced to report ID: #. Report 3 of 3.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date reporter called about the Pfizer covid vaccine. Reporter called to report her side effects after the first dose of the covid vaccine and was wondering if her side effects were normal. It was reported that after receiving the first dose of Pfizer covid vaccine, patient felt anxious. Patient cannot explain it. Patient's pulse was not beating right. The feeling went away for patient after a couple of days. Reporter declined to complete a safety report about patient. Reporter did not say much about patient. Reporter does not know when patient received the covid vaccine. Reporter does not know anything other than patient told her that she had the same feeling. Unable to clarify details provided or gather additional information. No further information or patient information provided. The outcome of event pulse abnormal was unknown and for anxiety the outcome was resolved on an unspecified date.   Follow-up needed, Information on the lot/batch number has been requested.
Upon injection, felt immediate soreness at injection site (left arm, near shoulder). Had also felt soreness after first shot in series, which went away. Ten weeks after the second shot, I still feel considerable soreness at the injection site, which sometimes increases from general soreness to mild pain. A specific example is a general difficulty sleeping on my left side, which will wake me with pain and often cause mild pain for the remainder of the day.
Patient had just received flu vaccine to left deltoid and within minutes (<5 min) had redness/rash, itching  and swelling  near injection site. She felt her heart racing and some dizziness. Denied shortness of breath of chest discomfort initially. The rash/redness/itching started to travel up to her chest/neck area and down her left arm.  She was wheelchaired to the ER for immediate intervention. Upon arrival to ER triage area, she did report some tightness in her chest and started to feel some throat discomfort, but denied shortness of breath or difficulty breathing.  In ER:  Temp 98 degrees, HR 82, RR 18, pulse ox 99% on room air, BP 139/82 She was given Decadron 10mg IV push, Pepcid 20mg IV push & Benadryl 50mg IV push.   Upon re-evaluation, chest tightness, chest wall pain & redness to left arm was resolving.  On discharge from ER, she was given Rx for Prednisone x 7days and instructed to follow-up with PCP.
Acute onset esotropia, left cranial nerve 6 palsy. Normal MRI and lumbar puncture with normal CSF studies. No other symptoms. Being monitored.
Guillain Barre Syndrome. Admitted 9/17/11 - 10/7/11 (hospitalization) then ventilator SNF  then req SNF till 12/8/11.
sore arm; swelling at injection site; it was hard; horrible headache, from shoulder to base of neck to other shoulder; Felt really tired; feeling really cold; woke up shaking; A spontaneous report was received from a Consumer concerning a 70  Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced , sore arm, shaking and feeling really cold, headache from shoulder to base of neck to other shoulder, tired, swelling at injection site and it was hard.               The patient's medical history included Blood pressure and high cholesterol. The concomitant medications taken by the patient, for unspecified indications, levothyroxine, metoprolol, Torvavastin, omeprazole and baby aspirin.  On 15 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch: 011J20A) intramuscularly in the upper left arm for prophylaxis of COVID-19 infection.  On 15 Jan 2021, the patient experienced sore arm, horrible headache from shoulder to base of neck to the shoulder, shaking and feeling really cold, swelling at the injection site. Patient treated with Tylenol. Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the event(s) (sore arm, headaches, swelling at injection site, shaking and feeling cold, injection site pain) was unknown.
Patient is fully vaccinate. 64y.o. female with a past medical history of A-fib, Depression, GERD, IBS, CVA, HTN,  presenting for rapid heart rate. She states an EKG was performed and she was found to be in A-fib with RVR and asked to come to the ED. She admits to experiencing shortness of breath at rest and on exertion, but states this has been occurring for over a year. she did have palpitations one night. At that time, she had 5 episodes of emesis along with dizziness and lightheadedness. She took an Aspirin and her symptoms resolved. Patient states she does have chronic, intermittent, non-radiating sharp chest pain that is located on the left side. She also has chronic abdominal pain. She is vaccinated, but was diagnosed with COVID on 12/11/21. Admits to subjective fever, having a headache, but denies diarrhea. In the ED, patient was hypertensive and tachycardic. EKG showed A-fib with RVR, and she was started on Cardizem. Initial troponin was 0.04, second troponin was 0.02. WBC 15.1, potassium was 3.2 and replaced. Creatinine was elevated to 1.75 (baseline 1.3-1.4). CXR demonstrated interstitial coarsening which could reflect chronic inflammatory changes or atypical viral infection such as COVID. COVID treatment:  patient does not require supplemental oxygen so not decadron, no need for Lovenox.  Continue with Xaralto at home. Patient discharged.
Top layer of skin has peeled off and underneath the skin is red and swollen and warm. Has been diagnosed as a 2nd degree burn at the sight of injection.
Vaccine administered subcutaneously instead of intramuscularly; A spontaneous report was received from a nurse concerning a 68 year-old, female who received Moderna's COVID-19 Vaccine (mRNA-1273) and the vaccine was administered subcutaneously instead of intramuscularly.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 03-Feb-2021, the patient received their first of two planned doses of mRNA-1273 subcutaneously for prophylaxis of COVID-19 infection.  On 03-Feb-2021, the patient's daughter, who was also a nurse, reported that the patient received her vaccine subcutaneously instead of intramuscularly.  Action taken with mRNA-1273 in response to the event was not reported.   The event, vaccine was administered subcutaneously instead of intramuscularly, was resolved on 03-Feb-2021.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273 (lot # unknown) with no associated AEs reported.`
Stevens-Johnson syndrome.  Oral ulcers began 2d after vaccines; fever & decreased appetite also.  Seen in office 4d after vacs; sloughing oral mucosa & urethra, admit to hosp. Patient was complaining of cough with brown sputum at time of immunization; no eval or Rx undertaken.  Swollen, macerated, scabbed and yellow crusted lips-bleeding.  Erythematous macules on arms.  Dry skin around eyes. 12/20/07-records received with report for DOS 11/5-11/21/07-DC DX: Steven-Johnson syndrome with severe mucositis. Admitted with 4 day HX of swelling of eyes and face and 3 days HX of progressively worsening mouth ulcers. For previous week had non-productive cough and on morning of admission productive with green sputum. PE: swelling and sloughing of lips, greenish dischrage from right eye.DRESS.
Patient states unable to move arm after injection, c/o severe pain left deltoid since day before, area tender to touch, hurts to move arm, states pain radiates to left scapular area. Reddess, warmth and swelling at injection site.
Intense headaches for 1 month after second shot that have still continued semi-consistently in the 9 months after vaccination; Seems to have re-ignited the post concussion syndrome, diagnosed with after a head injury 4 years ago / Headaches are in similar spot; Seems to have re-ignited the post concussion syndrome, diagnosed with after a head injury 4 years ago / Headaches are in similar spot; Lingering brain fog; Confusion; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 34-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 at 12:00 (Lot number: ER8732) at the age of 34 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Post concussion syndrome" (unspecified if ongoing), notes: "Post concussion syndrome" was diagnosed after a head injury 4 years ago and "Head injury" (unspecified if ongoing), notes: "Post concussion syndrome" was diagnosed after a head injury 4 years ago. Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EN6203; Anatomical site: Left arm; Administration time: 12:00; Route of administration: Unspecified), administration date: 03Mar2021, when the patient was 33 years old, for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset 25Mar2021 at 14:00, outcome "not recovered", described as "Intense headaches for 1 month after second shot that have still continued semi-consistently in the 9 months after vaccination"; POST CONCUSSION SYNDROME (non-serious) with onset 25Mar2021 at 14:00, outcome "not recovered" and DISEASE RECURRENCE (non-serious) with onset 25Mar2021 at 14:00, outcome "not recovered", both described as "Seems to have re-ignited the post concussion syndrome, diagnosed with after a head injury 4 years ago / Headaches are in similar spot"; FEELING ABNORMAL (non-serious) with onset 25Mar2021 at 14:00, outcome "not recovered", described as "Lingering brain fog"; CONFUSIONAL STATE (non-serious) with onset 25Mar2021 at 14:00, outcome "not recovered", described as "Confusion". The events "Intense headaches for 1 month after second shot that have still continued semi-consistently in the 9 months after vaccination", "Seems to have re-ignited the post concussion syndrome, diagnosed with after a head injury 4 years ago / Headaches are in similar spot", "Lingering brain fog" and "Confusion" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, post concussion syndrome, disease recurrence, feeling abnormal and confusional state.  Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 and the results were unknown.
Post vax, left thigh became swollen and red. Parents treated at home with acetaminophen and ibuprofen. Arrived at ER at 21:00. ER nurse documented leg swollen from hip to knee, warm to touch and red. Pt able to walk with limp. Dx'd with allergic reaction and given Benadryl and sent home. Did not return to ER.
I don't know if this is a side effect or not, but my left hamstring  and fcalf muscles have been extremely painful since 2 days after shot.   Still hurting.
Approximately a week after the second injection I developed heart palpitations that started off very infrequent and gradually became almost constant over the next 9 months or so.  I saw my dr and had an ekg and wore a holtee monitor that showed PVC?s.   I never had anything like this prior to getting the vaccination.  When I got covid twice in Dec and then in jan the palpitations worsened.
FEVER FOR 4 DAYS, 5 DAYS POST VACCINATION ASSOCIATED WITH REDNESS SLIGHT INDURATION ON SITE OF INJECTION, LEFT THIGH. FOLLOWED BY MACULOPAPULAR ERUPTION ON FACE TRUNK WHEN FEVER ABATED.