chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concomitant therapy and concurrent condition were not provided. On unknown dates, the unspecified patients were vaccinated with unspecified doses of GARDASIL 9 (dose, lot number and expiration date were unknown) following a temperature excursion for prophylaxis. No adverse effects were reported. Follow up information was received on 29-DEC-2016. All telephone attempts to obtain follow-up information have been unsuccessful. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA001061: US-009507513-1611USA001062: US-009507513-1611USA001063: US-009507513-1611USA001064: US-009507513-1611USA001065: US-009507513-1611USA001066: MERCK 1610USA011064:Mfr number.
Body aches; headache; tender around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches), HEADACHE (headache) and VACCINATION SITE PAIN (tender around the injection site) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced MYALGIA (Body aches), HEADACHE (headache) and VACCINATION SITE PAIN (tender around the injection site). The patient was treated with PARACETAMOL (TYLENOL) in March 2021 for Headache, Myalgia and Vaccination site tenderness, at a dose of 1000 mg once a day. On 19-Mar-2021, MYALGIA (Body aches), HEADACHE (headache) and VACCINATION SITE PAIN (tender around the injection site) had resolved. Not Provided          No relevant concomitant medication was reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Event outcome was updated.
very sore/sore bones; her muscles "oh my God!", every step she took she had to hold to a piece of furniture, she had no strength at all/very weak; fever over 102°F/fever 102.4°F; chills; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (very sore/sore bones), ASTHENIA (her muscles "oh my God!", every step she took she had to hold to a piece of furniture, she had no strength at all/very weak), PYREXIA (fever over 102°F/fever 102.4°F) and CHILLS (chills) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 01-Dec-2020. Concurrent medical conditions included Breast cancer, Bladder cancer and Bone loss. Concomitant products included MULTIVITAMINS [VITAMINS NOS], AMLODIPINE, ANASTROZOLE, TRAMADOL, ACETYLSALICYLIC ACID (ASPIRIN 81), CALCIUM and ALENDRONATE SODIUM (FOSAMAX) for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced ASTHENIA (her muscles "oh my God!", every step she took she had to hold to a piece of furniture, she had no strength at all/very weak), PYREXIA (fever over 102°F/fever 102.4°F) and CHILLS (chills). On 28-Feb-2021, the patient experienced BONE PAIN (very sore/sore bones). The patient was treated with PARACETAMOL (TYLENOL) for Fever chills, at an unspecified dose and frequency. On 28-Feb-2021, BONE PAIN (very sore/sore bones), ASTHENIA (her muscles "oh my God!", every step she took she had to hold to a piece of furniture, she had no strength at all/very weak), PYREXIA (fever over 102°F/fever 102.4°F) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Dec-2020, COVID-19: positive (Positive) Positive. On 27-Feb-2021, Body temperature: 102 (High) 102°F. On 28-Feb-2021, Body temperature: 102.4 (High) 102.4°F.     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.   Concomitant medication included BCG treatment for bladder cancer. Patient reported that since they had coronavirus it took over their lives, for two weeks they had all the symptoms and then she used nebulizer medicine. They had cough and headaches. Then after a week and a half they felt stronger and better. From that moment the fatigue was just consuming their lives.
It was reported that a 54 year female received Fluzone SV 98-99 USP vaccine on 10/16/1998. Reportedly sometime after the vaccination the pt experienced a large red area at the site of injection. The pt also experienced a 3-cm lump and pain at the injection site left deltoid to elbow.
Patient complained about having a fast heart rate. He asked if someone could check it as he had concerns. Patient was checked..
Patient was given PPSV 23 shot at approximately 12pm. She began grocery shopping and developed pain in her lower back - the pain shot across from the left to the right in her lower back, making it hard to move. The she had pain shooting across the upper part of her chest from the left to the right side. The pain lasted approximately 2 minutes. The patient went to the bathroom to catch her breath, and the pain resolved about 5 minutes later. She went home, and was feeling very lethargic. She does not normally take naps but had to take a nap because she was so tired. The lethargy lasted until approximately 4pm the next day, She did not feel like herself again until Friday
Patient said she started experiencing dizziness/lightheadedness about 20 minutes after receiving the vaccine
VEIN BURST IN LEG; This spontaneous report received from a patient concerned a 71 year old white female. The patient's height, and weight were not reported. The patient's past medical history included: 2 bowel surgeries/resection and 3 heart stents and concurrent conditions included: heart problem, bladder problem and allergies. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of administration, batch number and expiry not reported) dose was not reported, 1 total administered on 07-MAR-2021 on right arm for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s  (Dose number in series 1). The patient additionally received booster of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of administration not reported, batch number: 211D21A and expiry: 10-JUL-2022) dose was not reported, 1 total administered at right arm on 29-OCT-2021 for prophylactic vaccination.  Concomitant medications included acetylsalicylic acid for drug used for unknown indication, amlodipine for drug used for unknown indication, metoprolol tartrate for drug used for unknown indication, potassium for drug used for unknown indication, rosuvastatin for drug used for unknown indication, and glyceryl trinitrate for heart problem. The patient also takes bladder medication. On an unspecified date in DEC-2021, about one and half months after the booster dose, the patient started having a vein issue (a vein burst in her right leg, on the outer side of her leg, behind the kneecap), in late November or early December (Dose number in series 2). The patient went to the emergency room on a weekend. She underwent an ultrasound to make sure it was not a blood clot passing and the results were fine. She was told to relax, take it easy, and to prop up her feet. When she sat for too long the vein did hurt and she had to get up and move. Once the vein burst, the pain went away. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vein burst in leg was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20220404440-Covid-19 vaccine ad26.CoV-2.s-Vein burst in leg. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Slightly fatigued, bad taste/tingling in mouth and throat.  No sign or symptom of distress, respirations even and unlabored. skin pink warm and dry.  Monitored for further problems then released.
Child was given Dtap, IPV injection. Within 10 minutes, developed hive, facial swelling, eye swelling, lip swelling.
within 15 min of receiving Covid-19 Moderna vaccine pt  C/O:  chest pain and heart palpitations.  Vitals 100/60 P: 80 Regular.   Learned later from family member that patient was taken to hospital and admitted.
Vaccine was accidentally drawn up from an undiluted vial, so patient received 0.2ml of vaccine without diluent added.  Patient had a headache the evening he received the vaccine, but then headache resolved.  No other significant side effects reported.
have had shingles and the shots\ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had Shingles shots about five years ago and had shingles. The patient asked he/she could had Shingles shots again. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Flu symptoms began almost immediately, and lasted for two months.  Rash similar to shingles virus rash erupted after two months and abated after 10 more days.   A second dose was administered in February 2023, and the same symptoms have arisen immediately after the shot
Information was received from a nurse regarding a female colleague of unknown age. On approximately 10-OCT-2013, the patient was vaccinated with ZOSTAVAX, subcutaneous. It was reported that the patient received an unspecified flu vaccine "close to" her vaccination with ZOSTAVAX, it was not confirmed if the vaccine were given on the same day. ON approximately 10-OCT-2013, the patient experienced a "well above average" local reaction that lasted several days. The reaction included significant swelling and redness. No further information was provided. Additional information has been requested.
Initial information received on 18-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 18 months old patient who experienced received an expired dose, while he/she received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. On 18-Jul-2018, the patient received a 0.5 ml single dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5390AA (expiry date: 17-Jul-2018) via intramuscular route in the right thigh. It was a case of actual medication error due to expired vaccine used. It was unknown if 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.
No additional AE reported; a dose of PNEUMOVAX 23 was inadvertently administered after the labeled expiration date; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.   On 05-APR-2022, the patient was inadvertently administered an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # T022294, expiration date 26-MAR-2022; strength, dose, route of administration and anatomical location were not reported) for prophylaxis (expired product administered). The vaccine did not experience any temperature excursions. No additional adverse event (AE) or product quality complaint (PQC) was reported.
The patient was giving an expired vaccine on the day of  01/24/2022. Varicella  T002847 Expiration date 01/23/2022
Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Medium, Additional Details: pt got flu and moderna booster. felt nausiated and vomited. sat down to be monitored for 30 mins and condition would not go away. emergency services called. pt vomited again when ems arrived and was taken to the hospital. on later check in pt was still in hospital, doing well bit still vomiting
Experienced light fever; Left arm pit is still swollen and puffy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (159558). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 21Apr2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer) for COVID-19 Immunization. The following information was reported: SWELLING (non-serious) with onset Apr2022, outcome "not recovered", described as "Left arm pit is still swollen and puffy"; PYREXIA (non-serious) with onset 22Apr2022, outcome "recovered" (2022), described as "Experienced light fever". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The caller received the booster dose Pfizer COVID 19 Vaccine on Thursday, 21Apr2022, The caller experienced a light fever on Friday, 22Apr2022. The light fever went away. The caller's left arm pit is still swollen and puffy. The caller is assuming the left arm pit being swollen and puffy is a lymph node. The caller read on the Pfizer website that it would take 24-48 hours for the swollen armpit to go away. However, the caller's left armpit is still swollen. The caller would like advice or to know when the left armpit swelling will go away?.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
By May 12, 2021 I was at urgent care with extreme hand pain. The urgent care was unable to find out the cause of the pain and told me to follow up with a specialist on May 14th, 2021 who told me it was most likely trigger finger and sent me for physical therapy and later did injections.    By June I also started experiencing unknown skin conditions. I ended up having a biopsy on August 25th, 2021 after condition continued to get worse.
Dizziness, Headache, indigestion, tingling mouth, burping, she reported "heavier to swallow" Narrative:
Client reported itchy and tingling sensation to upper outer aspect of both thigh 5 minutes after receiving the injection. Hives present to upper outer aspect of both tights by 10-31-09. Received topical steroid cream from own PCP.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: ER8734), on 21Apr2021 as dose 2, single (Lot number: EW0169), in right arm and on 20Dec2021 at 17:00 as dose 3 (booster), single (Lot number: FE3594) at the age of 39 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "Known Allergies: Penicillin" (unspecified if ongoing), notes: Known Allergies: Penicillin. Concomitant medication(s) included: SERTRALINE, start date: 01Apr2021, stop date: 20May2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10May2022, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10May2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  clinical course: Started Paxlovid on day I test positive for COVID. Had runny nose, cough, moderate body aches/chills. Symptoms immediately improved. Terrible, soapy taste in mouth during treatment with paxlovid; intensified as the 5 days went on but stopped as soon as I stopped treatment. Test negative for COVID on day 5. Now on day 10/11, I have significant nasal congestion, headache & mucus, with slight headache.  No follow-up attempts are possible. No further information is expected.
my son received his 2nd dose earlier than the recommended window; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (my son received his 2nd dose earlier than the recommended window) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 029L20A) for COVID-19 immunisation.     No medical history provided.  Concomitant products included ATENOLOL, ACETYLSALICYLIC ACID (BABY ASPIRIN), VENLAFAXINE HYDROCHLORIDE (EFFEXOR) and BUSPIRONE HYDROCHLORIDE (BUSPAR) for an unknown indication.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (my son received his 2nd dose earlier than the recommended window). On 29-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (my son received his 2nd dose earlier than the recommended window) had resolved.
approx 18 hrs p/vax pt noted to have welts & hives covering every part of body; pt was afebrile & in no resp distress but was very irritable; tx w/DPH & rash cleared over 24 hrs;
Patient came in forn a well child check and I was advised to give the patient vaccines. When I checked the container in the fridge that holds tha vaccines I could not find a box of tdap vaccines for children. Another MA that I work with was there because i asked her to confirm that I had the correct vaccines and she stated that she had used the last tdap vaccine and had not put a new box in the vaccine container. She then handed me a new box of tdap vaccines which we both looked at and thought that it was the appropriate vaccine. I gave the vaccine to the patient in the left thigh. I tried calling the company of the vaccine but they were closed. I also tried calling the patient's guardian and left a message asking them to call the office. There were no immediate adverse reactions noted after I gave the vaccine.
The following day I had a low grade fever including chills; I had a low grade fever; Fatigue; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (The following day I had a low grade fever including chills), PYREXIA (I had a low grade fever) and FATIGUE (Fatigue) 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 30-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Oct-2021, the patient experienced CHILLS (The following day I had a low grade fever including chills), PYREXIA (I had a low grade fever) and FATIGUE (Fatigue). On 01-Nov-2021, CHILLS (The following day I had a low grade fever including chills), PYREXIA (I had a low grade fever) and FATIGUE (Fatigue) had resolved.            No concomitant medications reported by reporter No treatment medications provided by the reporter.
Patient presents to the emergency department with cough, body aches from being fatigue, shortness of breath, flank pain, chest pain, a score throat, left ear pain, dizziness, and loss of taste or smell.
improper dose of Menveo on 08/09/2023 reconstituted with sterile diluent.; improper dose of Menveo on 08/09/2023 reconstituted with sterile diluent.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA769A, expiry date 31-JAN-2024) for prophylaxis.   On 09-AUG-2023, the patient received Menveo. On 09-AUG-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: improper dose of Menveo on 08/09/2023 reconstituted with sterile diluent.) and inappropriate dose of vaccine administered (Verbatim: improper dose of Menveo on 08/09/2023 reconstituted with sterile diluent.). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date 16 August 2023: The medical assistant reporting having administered an improper dose of Menveo on 9 August 2023 reconstituted with sterile diluent. The reporter consented to follow up.  The Vaccine Administration Facility was the same as primary reporter. The patient administered an improper dose of Menveo reconstituted with sterile diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
1 month after vaccine administration presented with 4cm left thigh in diameter mass at inoculation site that was expanding. no fever 1cm of induration. Started on Keflex later changed to Clinda on follow up. After 1 week started to have exadated discharge. On follow up noted to be 1cm in diameter. Will follow up with Surgeon due to vessel seen on ultrasound
Pt presented for routine primary care visit 3/30 and reported swelling of right lower leg starting 2 weeks prior. Ultrasound positive for DVT.