chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE/PQC reported.; Inbound call from pharmacist calling to report temperature excursion for MMR-II that was administered to a patient.  Product was evaluated and found to be supported.  Confirmed that no symptomatic AE's were reported.  Reporter declined to provide fu; This spontaneous report was received from Pharmacist and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient started therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, 0.5 milliliter, lot #W017555, expiration date: 24-DEC-2023, administered for prophylaxis (strength, and route of administration were not provided).  On 09-JUN-2023, there was inbound call from pharmacist calling to report temperature excursion for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)that was administered to a patient. Product was evaluated and found to be supported. Temperature excursion was 50 F for 1 hour. Confirmed that no symptomatic AE's were reported. Reporter declined to provide full patient demographics and only provided  initials. HCP declined correspondence regarding this AE. No additional AE/PQC reported.  Lot Number W017555 is valid for V205C and albumin status is rHA.
Tiredness, headache, chills, nausea, and feeling unwell.; Tiredness, headache, chills, nausea, and feeling unwell.; Tiredness, headache, chills, nausea, and feeling unwell.; Tiredness, headache, chills, nausea, and feeling unwell.; Tiredness, headache, chills, nausea, and feeling unwell.; This is a spontaneous report from a contactable other healthcare professional, the patient. A 27-year old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), via intramuscular route of administration in the right arm on 30Dec2020 at 12:30 PM (at the age of 27 years-old) as a single dose for COVID-19 vaccination. There was no relevant medical history. The patient did not have any allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 31Dec2020, the patient experienced tiredness, headache, chills, nausea, and feeling unwell. The report was reported as non-serious. The patient was not  treated for tiredness, headache, chills, nausea, and feeling unwell. The clinical outcome of tiredness, headache, chills, nausea, and feeling unwell was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are Possible; Information about batch number cannot be obtained. No further information is expected
Could not sleep night of Injection; day after injection- massive headache, fever & chills, fatigue- all subsided within 24hrs
Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced VOMITING (Vomiting). At the time of the report, VOMITING (Vomiting) had resolved.            Relevant concomitant medications were not reported.  On an unknown date, patient experienced vomiting and it got resolved.  Treatment information was not provided.  It was unknown if patient was enrolled in a COVID-19 vaccine Trial.  The reporter's causality for the event of vomiting with HUMIRA was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Initial misuse report received from a healthcare professional on 22 March 2013. A patient had received ADACEL vaccine in December 2012 and then received another dose on 22 March 2013. No information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
Numbness in extremities, paralysis full body. Pneumonia left lung. Now diagnosed with Guillain-Barre syndrome, due to reaction to covid-19 vaccine
This spontaneous report as received from a X-ray technician refers to a patient of unknown age and gender. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On an unknown date, the patient might have received improperly stored dose of ZOSTAVAX 19400 Plaque-Forming Units (PFU) or improperly stored dose of M-M-R II, or improperly stored dose of PNEUMOVAX 23, or improperly stored GARDASIL 9, or improperly stored dose of PEDVAXHIB or improperly stored dose of VARIVAX (dose, anatomical location, lot#, expiry date and route of administration were not reported). No adverse effect reported. M-M-R II, PNEUMOVAX 23, GARDASIL 9 and PEDVAXHIB were stored in the temperature greater than 46 Fahrenheit degrees but less than 77 Fahrenheit degrees for 53 hours. ZOSTAVAX and VARIVAX were stored in the temperature greater than 5 Fahrenheit degrees but less tan 14 Fahrenheit degrees for 2 hours 30 minutes. There was no previous temperature excursions. Digital data loggers were involved. Additional information has been requested.
Very large, red, swollen and hot area with pain, 2 days, post vax. Treated with ice, Benadryl and Motrin.
pt recv 1st dose varivax in 6/95 & in 3/98 pt devel mild rash on his back, less than 30 bumps, area was itchy for 2 days
SOTROAT, JAW PAIN AND EAR PAIN  3 DAYS POST VACCINATION
Rash with hives, swelling, itching on both arms, neck, chest, face, hands, and right thigh. Itching lungs, some difficulty breathing. Cold symptoms -- sore throat, runny/clogged nose and sinuses, coughing up dark-yellow phlegm. Cold symptoms improved after approx 4 days. Rash worsened and itching lungs developed. On 10/02/12 emergency room physician prescribed 50 mg Prednisone daily for 7 days. Patient began first dose 10/2, today.
High grade fever 6 hours  Low grade fever 6+hours  Sever hives all over body Swelling of face and neck  Took Benadryl for the hives
-high fever102+ -painful and swollen left arm -severely painful and swollen left breast -pain radiating down left side and hip -painful swollen joints all over -CRPS flare -headache-migraine -exhaustion
Approximately 1 hour after receiving her vaccination, patient began feeling "nauseated, lightheaded, and fatigued."  She did not lose consciousness and was able to ambulate normally while in the medical clinic.
Persistent, inconsolable screaming/crying for 2 1/2-3 hours within 48 hours.
This infant had scattered red papules, some vesicular, some excoriated on the chest, back, face, and ears.
Pt recvd 3 doses of Engerix-B vax & it was determined that pt did not seroconvert; 4th & 5th doses of Engerix-B were administered;
heaviness in her chest and bones; heaviness in her chest and bones; hot flashes; has not slept in four days; her whole body swelled up; This is a spontaneous report from a Non-contactable consumer. This consumer reported similar event for 2 patient (Herself and her Brother-in-law). This is First of 2 report.   A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation solution for injection; Batch/Lot Number: not reported), via an unspecified route of administration on 04Mar2021, as single for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that she took the first dose of the Pfizer Covid 19 vaccine six days ago and stated she knew what her experience was. On an unspecified date in Mar2021, she had heaviness in her chest and bones; she had hot flashes and had not slept in four days and her whole body swelled up. She also wanted to ask if the vaccine would be ok for her husband who had polymyalgia (PMR) because she knew how the vaccine made her feel. The patient was very angry that agent could not provide her HCP information. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021277081 same reporter/drug/AE, different patients
Arm Soreness; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Arm Soreness) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for Covid-19 Vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced LIMB DISCOMFORT (Arm Soreness). On 30-Jan-2021, LIMB DISCOMFORT (Arm Soreness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
Got my second does of Moderna vaccines  20 hours after. My heart rate rise to 130bpm and  rhythm become Irregularly. Added Metoprolol from 25 to 50. Hart rate around 100bpm(my usually  heart rate is 55 to 60bpm) It already last 48 hours.
Patient vasovagal reaction on his way out of the immunizations room, he fell forward and hit left side of head on wall and then was caught by other service member and myself, he was helped to the grown, laying flat on back, pillow provided. Patient was unconcious for about 3 seconds. Patient was A&O  X3 after coming to. States this has only happened once in his past. Patient denies eating lunch today. Patient left laying for about 5 minutes, VSS. Moved to sitting position. Patients states feeling fine. Water and snack Provided. Employeee notified and in room assessing. Patient notified to report to ER if he notices visual distturbances or severe HA, patient verbalized understanding.
The day after the immunization developed redness, swelling, warmth. Positive mild itch and mild pain. No shortness of breath or cough. Has normal range of motion. Area is about 8 cm diameter, oval shape, left upper arm, includes the injection site. Given ZYRTEC.
Metallic taste in mouth; Red, itchy rash on her chest, neck area; Red rash on her chest, neck area; Mouth felt weird (tongue and throat); Itchy rash on the vaccination site; Felt fatigue; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), DYSGEUSIA (Metallic taste in mouth), RASH PRURITIC (Red, itchy rash on her chest, neck area), RASH ERYTHEMATOUS (Red rash on her chest, neck area) and FEELING ABNORMAL (Mouth felt weird (tongue and throat)) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stroke. Concomitant products included CLOBETASOL PROPIONATE (CLOBETASOL 0.05%) for Psoriasis, FOLIC ACID, METHOTREXATE SODIUM, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), SIMVASTATIN, MONTELUKAST SODIUM (SINGULAIR), LISINOPRIL, DULOXETINE HYDROCHLORIDE (CYMBALTA), LORATADINE (CLARITIN [LORATADINE]), OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) and BETAMETHASONE DIPROPIONATE, CALCIPOTRIOL (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) for an unknown indication.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Felt fatigue). On 10-Apr-2021, the patient experienced DYSGEUSIA (Metallic taste in mouth), RASH PRURITIC (Red, itchy rash on her chest, neck area), RASH ERYTHEMATOUS (Red rash on her chest, neck area), FEELING ABNORMAL (Mouth felt weird (tongue and throat)) and VACCINATION SITE RASH (Itchy rash on the vaccination site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 10-Apr-2021, DYSGEUSIA (Metallic taste in mouth) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm), RASH PRURITIC (Red, itchy rash on her chest, neck area), RASH ERYTHEMATOUS (Red rash on her chest, neck area), FEELING ABNORMAL (Mouth felt weird (tongue and throat)), VACCINATION SITE RASH (Itchy rash on the vaccination site) and FATIGUE (Felt fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Patient became pale and had one episode of emesis in the office. Gave her juice and crackers and within 10min patient had improved and started feeling better.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. No known allergies. There were no concomitant medications. No other medication in 2weeks.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Indication: COVID 19 Treatment; (03Jul2022) Positive, notes: positive test 5 days after completion of 5 day Paxlovid course. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Reoccurrence of covid symptoms and positive test 5 days after completion of 5-day Paxlovid course. Anti-viral product Paxlovid, treatment start date was 23Jun2022 and treatment stop date was 28Jun2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Lots of swelling, lots of pain, 103+ fever, fatigue, neck pain. Eye pain, chills and nauesa.
Tested positive for Covid 19 after receiving 3 doses of the Pfizer Covid 19 Vaccine; Tested positive for Covid 19 after receiving 3 doses of the Pfizer Covid 19 Vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Tested positive for Covid 19 after receiving 3 doses of the Pfizer Covid 19 Vaccine". It was reported that patient was 90 percent good and eat the same thing and have been married for over 40 years. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive for Covid 19 after receiving 3 doses of the Pfizer Covid 19 Vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201014623 Same reporter, different patient/ drug/ AE;
Chest infection; Cold; A spontaneous report was received from a 67 year old female patient, who received Moderna's COVID-19 vaccine and experienced chest infection/ lower respiratory tract infection and cold/ nasopharyngitis.  The patient's medical history was not provided. Concomitant product use was not provided.  On 22 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number unknown) via unknown route for COVID-19 infection prophylaxis.  On an unspecified date, after vaccination, when patient was due for second dose on 22 Mar 2021, she experienced chest infection and cold. Hence second dose was delayed. No treatment information was provided.  The outcomes of the events, chest infection and cold were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
to ER with  syncope and found in the floor, generalized weakness, h/o neck mass she had declined intervention for in the past.  found to be + covid .  Admitted  7-22-22  dehydration,  weakness, hypotension.  Developed afib RVR, hematemesis( not a surgical candidate due to comorbidities), acute kidney injury,    Covid pneumonia.   Treated with rocephin, doxy, remdesivir and also decadron.   Had reduced  cardiac EF.   Patient was DNR status and expired 8-3-22
had both new vaccines and still got shingles!/ 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 self-reported by the patient. The age at vaccination was not reported. The patient had both newshingles vaccines and still got shingles of lesser version. This case was considered as suspected vaccination failure as details regarding, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
This spontaneous report as received from a other health professional refers to a patient of unknown age and gender. On 10-MAR-2014 the patient was vaccinated with GARDASIL (lot number, dose and frequency not provided), intramuscular. The patient received the vaccine which was exposed to 49 degrees F for 1 hour. No known adverse effects. Additional information has been requested.
her face was swollen; This is a spontaneous report from a contactable consumer. A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EN6199, Expiration date was not reported), via an unspecified route of administration on 09Mar2021 (at the age of 47-years-old) as dose 1, single for COVID-19 immunisation. Medical history included leukaemia from Feb2016, stem cell transplant from Aug2017 and blood clot from an unknown date. Concomitant medications included rivaroxaban (XARELTO) taken for thrombosis and unspecified oral chemo, start and stop date were not reported. The patient experienced her face was swollen on 10Mar2021. It was further reported that the patient got the COVID vaccine yesterday. She was pretty okay yesterday and today she woke up and her face was swollen, and it was still swollen. The reporter was concerned that it could get worse with the patient's throat closing up since she was a cancer patient, had stem cell transplant 3 and a half years ago and takes oral chemo. The reporter clarified that the patient's throat was not closing up but that was a concern of his that he was afraid it could progress to that. The patient took BENDARYL at 11 something and her face was still swollen. The reporter was trying to see if there was anything he could do to help or if this was a normal thing, they have heard of people having. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Treated for cellulitis and hematoma on right deltoid region. Treated with antibiotic. Had previous pneumovax in 1996.
This spontaneous report was received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of M-M-R II (lot # M034387, expiry date 19-JUL-2018, lot # M029229 expiry date 06-AUG-2018  lot # M022408 expiry date 02-MAY-2018) for prophylaxis since 15-MAR-2017. The reporter did not have access to the lot# and expiration dates of the diluent that was used to reconstitute the M-M-R II. No adverse events were reported. Temperature of 47 degree Fahrenheit to 77 degree Fahrenheit and time frame was 6.5 hours. There was no previous temperature excursion. It was stated that it was because of data logger.  This is one of the several reports received from the same reporter. Additional information has been requested.
Patient developed heart palpitations and racing heart 3 days after receiving her vaccination, 10/8/23.  Patient has had these symptoms in the past so unsure if related to vaccination.