chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe Itching over rash sites; Rash over scalp,neck and ears; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Severe Itching over rash sites) and RASH (Rash over scalp,neck and ears) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023V20A and 047A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced RASH PRURITIC (Severe Itching over rash sites) and RASH (Rash over scalp,neck and ears). At the time of the report, RASH PRURITIC (Severe Itching over rash sites) and RASH (Rash over scalp,neck and ears) outcome was unknown.            Treatment information not provided. No concomitant information was reported.   This case was linked to MOD-2021-103111 (Patient Link).
Pt rec. expired vaccine. Staff state they read the expiration date although it did not register at the time. Staff state when they were entering vaccine into the state website and it gave them the caution sign is when they recognized they gave expired dose.
Pharmacist states patient received 1st dose 6Apr2021; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Pharmacist states patient received 1st dose 6Apr2021) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) unknown. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Pharmacist states patient received 1st dose 6Apr2021). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Pharmacist states patient received 1st dose 6Apr2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Fallow up received and contains no new information
The patient even had anaphylaxis to the COVID (Corona Virus Disease 2019) vaccine; This is a spontaneous report received from contactable reporter (Consumer or other non HCP).  A 62 year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). Concomitant medication included: ENBREL taken for rheumatoid arthritis. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "The patient even had anaphylaxis to the COVID (Corona Virus Disease 2019) vaccine". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Nov2020) positive, notes: the patient contracted COVID-19 (Corona Virus Disease 2019). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a medical assistant concerning a 71 year old female with osteopenia and drug hypersensitivity to Paxil who on 14-MAY-2007 was vaccinated with a dose of Pneumovax 23 (lot #655152/0889F) IM in the right arm. Concomitant therapy included estrogens, Premarin, calcium (unspecified), and aspirin. On 14-MAY-2007, the patient experienced redness of the medical aspect of right upper arm and a swollen right axillary lymph node. The reaction is under the arm not at the injection site. The patient sought medical attention. The pateint did not have a fever. The pateint did not report any difficulties with movement of her right arm. The pateint was treated with Ceftin. At the time of reporting, the patient was recovering. No additional information was available at the time of reporting. Additional information has been requested.
Increased lethargy,body aches,chills,the injection site was tender and swolen
The day of my second covid vaccin, I was having my periods. I was feeling well. The day after in the morning my arm was really sore, I had strong nauseas and my period start to be very heavy and very painfull.  I was so so tired.  I had to say, after my first vaccine 4/01/21 , I just had my arm sore the day after, but I got my period during during almost 4 weeks. Then start one day before the second  vaccin...  I took ibuprofen and vogalen ( anti vomitid). I was feeling better sunday. Then the symptoms started again on monday 3 of may.
This spontaneous report as received from a other health professional refers to a 50 year old female patient. The patient's vaccination history included measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (manufacturer unknown). On an unknown date the patient was vaccinated with PROQUAD from lot N021725 expiry date 06-FEB-2019 for prophylaxis.  Concomitant therapies included sterile diluent. No adverse effects reported. No further details provided.
PATIENT EXPERIENCING SEVERE ITCHINESS OVER GENERALIZED BODY, MORESO ON TORSO, HANDS AND FEET. PATIENT ALSO EXPERIENCING LEFT ARM PAIN AND WEAKNESS EVEN WITH VACCINATION TO THE RIGHT DELTOID.
Within 24 hours post vax, pts thigh looked swollen.  The infant was seen by a physician who noted that the left thigh was .25 inches larger than the right thigh, on 7/2/99. No previous measurements had been taken for comparison.
18 hours after injection, fever, acute pain, in joints and muscles,  migraines, paresthesia, pain in extremities. Continued 4 day. Felt somewhat better, drove to buy groceries (I live alone), experience actor diplopia with mental confusion (drove wrong side down familiar 1 way street), acute paresthesia. Day of reporting symptoms have improved but are not close to resolved. Can't drive, move about w/o risk of falls. Hoping to recover fully, but still experiencing symptoms 10 days post vaccine. Oddly, had NO reaction at all to first two doses, not even minor symptoms
Parents report that infant lost muscle tone and became less active after receiving his 2 month vaccines.  Pt was subsequently admitted to the hospital with RSV- intubated and had chest tube for pneumothorax- after recovering from this illness was still profoundly hypoptonic- undergoing evaluation by neurology currently.  2/26/08 Reviewed hospital medical records. FINAL DX: respiratory failure, RSV pneumonia; dysphagia; severe hypotonia, etiology uncertain; right pneumothorax w/chest tube placement; small VSD & ASD w/slight right ventricular dilation. HPI: patient experienced 3 day history of nasal congestion, constant nonproductive coughing & difficulty breathing.  D/C from outlying ER on 1/14/08 w/dx viral URI.  No improvement & seen by PCP where RSV tested (+).  Admitted 1/14/-2/06/2008 w/RSV bronchiolitis.  Exam revealed fever, weakness, URI s/s & mild respiratory distress w/exp wheezing & intercostal retractions.  Condition worsened. Transferred to PICU, intubated & chest tube placed for pneumothorax.  Developed pneumonia.  Tx w/IV antibiotics, nebs, chest PT & improved.  Extubated w/o difficulty.  Had continued significant profound hypotonia w/DTRs WNL & very diminished ability to clear his oropharyngeal secretions.  Tx w/diuretic & improved.  Consults by surgery, pulmonogy, cardio, neuro, genetics, speech tx D/C to home on apnea monitor & feeding tube w/neuro, cardio & surgery (for muscle biopsy) outpatient f/u.    2/29/08 Reviewed pcp med records & vax records RO lot # corrected in database.  Records indicate patient well w/normal strength & tone on 11/26/07.  Next office vs 1/14/08 s/p ER for nasal congestion, rhinitis, wheezing, deep wet cough, heavy rapid breathing, lethargic.  Dx w/viral illness, RSV & flu neg.  In office dx w/bronchiolitis & referred to ER for admission.  Returned to office 2/12/08 f/u hospital stay.  On apnea monitor & using lasix as needed to control oral secretions.  Seen by home health nurse 3x/wk.  Scheduled for muscle biopsy same day & followed in feeding clinic & cardiac clinic for dilated RV W/2 holes.  Exam revealed mild nasal congestion.  Doing well overall.  Returned to office 2/19/08.  Had been seen by neuro for EMG.  Muscle biopsy on hold until complete recovery from RSV.  Exam revealed puffy hands/feet & hypotonic throughout w/decreased hand grip strength right hand. Lasix dosing increased.  Returned to office 2/25/08 for difficulty breathing w/grunting & rapid breathing.  Tx w/home nebs & was to have feeding tube replaced next day.  Suspected aspiration & referred to ER if worsened. 1/20/2010 Patient has been diagnosed with Congenital muscular dysncopay.
She couldn't move her arm [and had pain and numbness in that arm]; [She couldn't move her arm and] had pain [and numbness] in that arm; [She couldn't move her arm and had pain and] numbness in that arm; The same day of the vaccine she developed swelling at the injection site; This non-serious spontaneous case, initially received from other non-health care professional on 11-Apr-2018, concerning a 64-year-old, adult, female patient.  The patient's current condition included diabetes (since an unspecified date).  On 09-Jan-2018, the patient was administered with Afluria (TIV) Thiomersal (influenza vaccine, dose: reported as 1 dose, batch number: 15049211A (reported as 150492110), expiry date: 30-Jun-2018, route of administration and anatomical location: not reported) for influenza prophylaxis.  On the same day, after the vaccination, the patient developed swelling at the injection site. She couldn't move her arm and had pain and numbness in that arm. On an unspecified date, the patient visited her HCP (health care professional) for treatment.  As of 23-Mar-2018, the patient had not recovered from the events.  The reporter did not provide the seriousness assessment.  Update received on 22-Oct-2018: Significant case correction (IRD: 11-Apr-2018): The suspect product coding was changed from Afluria (TIV) to Afluria (TIV) Thiomersal in the product tab. Narrative was amended accordingly.; Reporter's Comments: This 64-year-old, adult, female patient with concurrent condition of diabetes was administered with influenza vaccine. On the same day after the vaccination with Afluria (TIV) Thiomersal, the patient developed injection site swelling, her mobility decreased (couldn't move her arm), pain in arm and numbness of upper extremities. Considering the close temporal relationship between the vaccination and biological nature of the events, the events are assessed as related to the influenza vaccine.
blood pressure issues; sodium level that dropped to 126; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 28Feb2021 08:30 (Batch/Lot number: EN6198) at the age of 62 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing). There were no concomitant medications. The following information was reported: BLOOD SODIUM DECREASED (non-serious) with onset 02Mar2021 13:40, outcome "not recovered", described as "sodium level that dropped to 126"; BLOOD PRESSURE ABNORMAL (non-serious), outcome "unknown", described as "blood pressure issues". The events "sodium level that dropped to 126" and "blood pressure issues" 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 blood sodium decreased, blood pressure abnormal.  Additional information: It was reported that the doctor wanted the patient to go to ER because her sodium level had dropped to 126. It was also reported that the patient has a follow up for her blood pressure and had to get blood work done. The patient stated that she felt fine and she read on the paper what the side effects were and didn't know if it had to do with her sodium with her blood pressure issues. The events did not result in an emergency room visit. The patient has no prior vaccinations within 4 weeks. The patient has no family medical history relevant to adverse events.  No follow-up attempts are possible. No further information is expected.
DIZZINESS; NAUSEA; FEVER; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's past medical history included vertigo, and autonomic dysfunction, and concurrent conditions included sulfa allergy, iodine allergy, perennial allergy, and food allergy, and other pre-existing medical conditions included history of vertigo and automatic dysfunction and allergic to sulfa, iodine, perennial and food. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced dizziness. On 06-APR-2021, the subject experienced nausea. On 06-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, and fever on 07-APR-2021, and was recovering from nausea. This report was non-serious.
no adverse event; multiple patients were vaccinated with an improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 28-MAY-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally (LOT# R034700, expiry date 16-JUN-2020) for prophylaxis. The vaccine was exposed to a temperature of 34.2 Fahrenheit degrees (F) for 4 hours and 54 minutes. Digital data logger was involved. There were no previous temperature excursions. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA000862: US-009507513-1907USA000882: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000892: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000895: US-009507513-1907USA000896: US-009507513-1907USA000897: US-009507513-1907USA000898: US-009507513-1907USA000899: US-009507513-1907USA000900: US-009507513-1907USA000901: US-009507513-1907USA000902: US-009507513-1907USA000903: US-009507513-1907USA000904: US-009507513-1907USA000905: US-009507513-1907USA000906: US-009507513-1907USA000907: US-009507513-1907USA000908: US-009507513-1907USA000909: US-009507513-1907USA000910: US-009507513-1907USA000911: US-009507513-1907USA000912: US-009507513-1907USA000913: US-009507513-1907USA000914: US-009507513-1907USA000915: US-009507513-1907USA000916: US-009507513-1907USA000917: US-009507513-1907USA000918: US-009507513-1907USA000920: US-009507513-1907USA000921: US-009507513-1907USA000922: US-009507513-1907USA000923: US-009507513-1907USA000924: US-009507513-1907USA000925: US-009507513-1907USA000926: US-009507513-1907USA000927: US-009507513-1907USA000928: US-009507513-1907USA000929: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000936: US-009507513-1907USA000937: US-009507513-1907USA000938: US-009507513-1906USA011674:
sitting in chair - fell out, mom picked pt up couldn't hold head up, seemed not to get any air; lips cyanotic, pulse 82, w/in 1 min pulse 120, crying;
Fatigue; Body aches; Fever; Chills; Nausea; vomiting; This is a spontaneous report from a non-contactable healthcare professional, the patient.  A 29-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 20Feb2021 at 08:45 (at the age of 29-year-old) as a single dose for COVID-19 immunization. Medical history included constipation predominant irritable bowel syndrome (IBS-C). The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication included ethinylestradiol/ norgestimate (PREVIFEM). The patient previously received the first dose of BNT162b2 on 24Jan2021 at 14:30 (at the age of 29-years old) in the left arm for COVID-19 immunization. On 20Feb2021 20:30, the patient experienced fatigue, body aches, fever, chills, nausea and vomiting. No treatment was received for the adverse events. The clinical outcomes of the fatigue, body aches, fever, chills, nausea and vomiting were resolving.    No follow-up attempts are possible; information about batch/lot number cannot be obtained.
Upper arm at injection site very red from elbow to shoulder, no pain, minimal edema. After a few days it resolved. Also c/o liquid stool for 3 days after vaccination.
fatigue, fever (100.2), exhaustion, body aches, headache over about 24 hours
Could not move her arm for three days; Arm was hot; Covid arm; Her arm was extremely itchy for a week; Hives on it for a week; Arm was swollen; Arm was red; Pain in arm; Chills; Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), LIMB DISCOMFORT (Could not move her arm for three days), VACCINATION SITE WARMTH (Arm was hot), VACCINATION SITE REACTION (Covid arm) and VACCINATION SITE PRURITUS (Her arm was extremely itchy for a week) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 821a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL for an unknown indication.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced DIZZINESS (Dizzy) and CHILLS (Chills). On 02-Apr-2021, the patient experienced LIMB DISCOMFORT (Could not move her arm for three days), VACCINATION SITE WARMTH (Arm was hot), VACCINATION SITE REACTION (Covid arm), VACCINATION SITE PRURITUS (Her arm was extremely itchy for a week), VACCINATION SITE URTICARIA (Hives on it for a week), VACCINATION SITE SWELLING (Arm was swollen), VACCINATION SITE ERYTHEMA (Arm was red) and VACCINATION SITE PAIN (Pain in arm). At the time of the report, DIZZINESS (Dizzy), LIMB DISCOMFORT (Could not move her arm for three days), VACCINATION SITE WARMTH (Arm was hot), VACCINATION SITE REACTION (Covid arm), VACCINATION SITE SWELLING (Arm was swollen), VACCINATION SITE ERYTHEMA (Arm was red), VACCINATION SITE PAIN (Pain in arm) and CHILLS (Chills) outcome was unknown and VACCINATION SITE PRURITUS (Her arm was extremely itchy for a week) and VACCINATION SITE URTICARIA (Hives on it for a week) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient concomitant drug also included an unknown statin. No treatment medication details was reported.
LEFT UPPER ARM RED AND SWOLLEN FROM SHOULDER TO 1/2 WAY DOWN TO ELBOW. NO TEMP. ADVISED TO NOTIFY PHYSICIAN IF SIZE INCREASES AND TO APPLY COLD COMPRESS TO SITE. PEDIATRIC TYLENOL FOR PAIN IF NEEDED.
Breakthrough case admission after 3 vaccines Pfizer 3/11/21 lot# EN6207;  Pfizer 4/1/21 Lot#Er8732;  Pfizer 10/19/21 lot# 320308D
-- after vaccination, the next day (05-14-2019), mother noted redness and swelling in left lateral thigh. Nurse believes this is where the varicella vaccine was given. Over the next two days, the swelling and redness worsened to perhaps 6-7 inches diameter. Mild discomfort only, no fever.  Benadryl and topical steroid given.
Patient says she feels like someone is stabbing her nerve endings 24/7.  She said it started immediately after receiving the vaccination and has not eased up.
Initial information received on 13-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer/non HCP (office staff). This case is linked to case 2018SA260284 (same reporter). This case involves a 17 years old male patient received vaccine FLUBLOK QIV. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ADACEL for Immunization; and GARDASIL for Immunization. On 04-Sep-2018, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot 2FAA1802 via unknown route and site of administration. It was a case of actual medication error due to inappropriate age at vaccination. It was not reported that any adverse event occurred or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Information has been received from a physician assistant (P.A.) concerning a 16 year old female patient with not pertinent medical history or allergies, who on 28-JUL-2010 was vaccinated with VARIVAX (Merck) (Lot # 664691/0732Y Exp date 21-MAY-2011). There were no concomitant medications. The P.A. reported that a week after she received the first vaccine dose, on 04-AUG-2010, the patient experienced a large red, swollen area of erythema, 5.3cm x 6 cm on the right arm at the injection site. The patient was treated with BENADRYL by mouth and BENADRYL cream applied topically. Then, in the past few days, on an unspecified date, the patient developed 5 lesions that looked like chicken pox on her neck and arm with clear, itchy blisters. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. Follow up information has been received from the physician assistant concerning the 16 year old female patient with no illness at time of vaccination and no known drug allergy who on 28-JUL-2010 was vaccinated with the first dose of VARIVAX (Merck) (Lot # 664691/0732Y) SC at right arm. On 29-JUL-2010 the patient initially developed erythema and edema at injection site. One week later, on approximately 04-AUG-2010 the patient not only had the erythema increased but developed 5 lesions which appeared as chickenpox. The patient recovered on 13-AUG-2010. One month later, on approximately 28-AUG-2010 varicella IgG test titers were negative. This is one of several reports received from the same source. Additional information is not expected.