chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Felt very sick; Headache; Vomiting; Nausea; chills; 99 degree fever; Couldnt move; Dizziness; Dry heaving; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Couldnt move), DIZZINESS (Dizziness), RETCHING (Dry heaving), ILLNESS (Felt very sick) and HEADACHE (Headache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020, Asthma and Hospitalisation (hospitalized in the past).    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced MOBILITY DECREASED (Couldnt move), DIZZINESS (Dizziness), RETCHING (Dry heaving), HEADACHE (Headache), VOMITING (Vomiting), NAUSEA (Nausea), CHILLS (chills) and PYREXIA (99 degree fever). On an unknown date, the patient experienced ILLNESS (Felt very sick). At the time of the report, MOBILITY DECREASED (Couldnt move), DIZZINESS (Dizziness), RETCHING (Dry heaving), ILLNESS (Felt very sick), HEADACHE (Headache), VOMITING (Vomiting), NAUSEA (Nausea), CHILLS (chills) and PYREXIA (99 degree fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Body temperature: 99 (High) 99 degree.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated that received her first dose of the Moderna covid-19 vaccine on march 24th after which didn't feel well. She experienced severe vomiting, chills and felt very sick. She stated she was given zofran by her doctor. Currently she is outside the dosing window for the second dose and wants to know if she can still received the second dose, and if not what is the efficacy of her just receiving one dose? Her doctor recommended she does not get the second dose due to extensive vomiting she experienced.  concomitant product include an inhaler  Treatment medication include Anti-nausea medication   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Added event , lab data and concomitant product information
I was called into the room and notified that 4 minutes after he received his HPV vaccine, he became sweaty, dizzy, and fainted.  His airway, breathing, and circulation were intact.  He was oriented to person, place, and time but had initial blood pressure of 74/45 that improved after 15 minutes of lying down to 105/65.
PATIENT STATED THAT IN HIS RIGHT ARM HE HAD SHARP PAIN AT THE SIGHT OF THE INJECTION AND IS CURRENTLY HAVING SOME PAIN.  HE STATED HE HAD SOME NUMBNESS OR TINGLING IN HIS RIGHT HAND AND CURRENTLY HAS LIMITED MOBILITY AND NOT ABLE TO COMPLETELY LIFT HIS RIGHT ARM WITHOUT ASSISTANCE.  PATIENT STATES THIS HAS BEEN ONGOING SINCE 1/7/2015 AND HAS NOT RESOLVED.
~4 weeks after the 2nd dose of Pfizer, patient presented to the hospital with chest pain; had pericardial effusion. Initially improved but then had decompensation, prolonged hospitalization. Diagnosed with hemophagocytic lymphohistocytosis (HLH) and ultimately died.
Patient was identified at the clinical station to have increased risks for vaccination reactions based on history, Vaccination administered, 30 minute patient watch assigned. About 12 minutes into observation, patient began to complain of tightness in throat and difficulty swallowing. Patient was without any signs of rash, no itch, no swelling, No observed SOB.  Just described a sensation of "Throat Closing".  Lungs clear, no wheeze or rhonchi, no change in pulses or capillary refill.  Placed on pulse oximetry - initial reading of 97% room air, HR 94. No initial blood pressure taken. During assemment, patient with slight anxiety due to feeling of throat tightness, no changes in SOB, no tripoding, no changes in color, no stridor or wheeze. Patient treated with 50mg Benadryl IM (With consult of Dr. - Present at Clinic. EMS on scene with additional treatment and care to Emergency Department.  Time of transfer, patient's awake x3, no chest pain, no verbalized SOB, no difficulty swallowing, no hives, no rash. Remians with the throat sensation of tightness.
pentacel, ipol, fluzone quadrivalent mdv and prefilled syringes, menactra, adacel, and daptacel at 0.7C for 25 hours and 24 minutes/no AE; Initial information received on 25-Jan-2021 regarding an unsolicited valid non-serious case received from an other health professional.   This case involves a 3 years old male patient for whom reported temperature excursion of unknown cause at 0.7 Celsius for 25 hours and 24 minutes (Product storage error), while he received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], ,MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA], IPV (VERO) [IPOL], DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination and INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] [lot UJ477AA and expiry date: 30-Jun-2021] via an intramuscular route at an unknown administration site for prophylactic vaccination on Dec-2021.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   It was a case of actual medication error due to product storage error temperature too low. [Latency: at the same time of vaccination].  Details of laboratory data not reported.  It was reported that, caller reported opened Ipol Multi dose vials and opened Fluzone quadrivalent MDVs. Caller reporting excursion occurring in Dece-2020. Caller reported 11 doses of Fluzone quadrivalent MDVs were administered post excursion. Caller with question on viability of administered vaccines.   It was not reported if the patient received a corrective treatment.  At the time of report, no adverse event was reported.  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.  There will be no information available on the batch number for this case.
After First dose of vaccine on 2-3-21, approximately 10 days later I noticed sensitivity to gums/teeth. Gums would bleed with brushing teeth.  Days later I noticed sores/blisters inside mouth.  Also had swelling. After Second dose of vaccine on 3-3-21, during the evening I experienced chills and cold sweats.  I felt very tired the morning and continued with chills and cold sweats.  The gum/teeth sensitivity, bleeding of gums, sores/blisters inside mouth and blisters on lower lip continued.  Blisters inside mouth and on lip were oozing.  I saw doctor and prescribed Acyclovir 400mg and Prednisone 10mg.
Initial pregnancy report received from healthcare professional on 06 January 2014. A 25-year-old female patient, whose medical history and concomitant medications were not reported, had received intramuscular first dose of ADACEL, batch number: C4424AA (anatomical site of administration was not reported) on 06 January 2014. The patient's last menstrual period was not reported and the expected date of delivery is 21 February 2014. The patient did not experience any adverse event. List of documents held by the sender: none.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider (physician) recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 18-OCT-2012, a pharmacist at a pharmacy administered the ZOSTAVAX (lot number, dosage and route of administration not provided) to the patient. On or about 07-OCT-2016, the patient was treated by a physician at a physician's office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages as a result of shingles and other zoster-related injuries. The outcome of the events was considered to be not recovered. Causality assessment considered events to be related to the use of ZOSTAVAX. Additional information has been requested.
Patient became light-headed and very briefly lost consciousness a few minutes after receiving the vaccine.  She was immediately lowered to the floor and feet were elevated.  She quickly opened her eyes but was still disoriented for another minute.  We checked her blood pressure shortly after this and it was 100/61, pulse 60.  She was diaphoretic.   After her feet were elevated, she became oriented and reported she was beginning to feel better.  She stayed laying down for about another 5 minutes or so then sat in a chair for another 15 minutes or so.  At this point, she reported feeling better and left with her husband.  She refused any further blood pressure checks.
Per pt., 2 days after injection, noticed 2 red areas which were "quarter size", warm to the touch with bruising. Next day, stated 2 areas combined to form one large swollen, red area and still warm to touch. Today, 10/4/11, area measured at 50 mm - redness noted and warm to touch. Pt. denies any other sx's - NP requested adverse event report be documented. Per NP - localized skin reaction; call if any other sx's. Once again provided copy of common side effects, etc. In retrospect, noticed vaccine given in incorrect route; given as SQ instead of IM.
dose while they had active shingles; Fatigued; achy; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles.   On 21st January 2022, the patient received the 2nd dose of Shingrix. In January 2022, less than a week after receiving Shingrix, the patient experienced fatigue and pain. On 21st January 2022, the patient experienced off label use. On an unknown date, the outcome of the fatigue and pain were not recovered/not resolved and the outcome of the off label use was unknown.   It was unknown if the reporter considered the fatigue and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 79 or 80 years. The reporter called on behalf of a neighbor. Neighbor was the patient. The patient received a second dose of Shingrix while he had an active case of shingles., which led to off label use. The patient was feeling fatigued and achy.  The reporter provided very limited information, did not provide consent to follow-up with HCP (health care professional). Therefore, HCP contact information was not collected. Also the reporter did not provide initials and date of birth of the patient, lot/exp date, dose, route of administration, and an email address of acknowledgment letter and also no contact information either of herself. The reporter did not consent to follow-up.
HCP calling to report a TE for GARDASIL 9, product administered after the excursion.; No additional AEs. No PQCs.; This spontaneous report has been received from a medical assistant regarding a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drugs reactions or allergies, and concomitant medications were not reported.   On 05-APR-2023, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (lot number: W010661, expiration date reported as 19-OCT-2024), administered for prophylaxis (strength, dose, and route of administration were not provided) after it was exposure to a temperature excursion (product storage error). The temperature excursion was of 61.7 Fahrenheit degrees for 4 hours 39 minutes. It was reported that there was not a previous temperature exclusion. No additional adverse event was reported.
pt c/o  itching and dizziness about 10 minutes after receiving vaccine. light rash to upper back and neck noted. given 25mg Benadryl po.  pt released after 1 hour of observation
Headaches, sore throat, hoarse, nasal drainage, sinus drainage, coughing, lots of coughing, chest aches, wheezing
Resident received a third administration of the maderna covid vaccine,  related too a previous date of administration documentation issue.  NO s/s of distress noted  and resident denies any adverse effects.
CELLULITIS - ARM DOUBLING IN SIZE BY 5 HOURS AFTER VACCINE, TRAVELED TO MIDFOREARM BY 48 HOURS, AND TO WRIST BY 3RD DAY
Patient received the 2-dose Moderna COVID-19 Vaccines on 1/27/2021 and 2/24/2021. This patient subsequently tested positive for COVID-19 on 3/10/2021. She received a COVID test due to admission into the hospital after a stroke.   She does have a history of COVID-19. She tested positive on December 7, 2020. Her 90-day window after her initial positive test ended on March 7, 2021, three days prior to her positive test after vaccination. Her note does not reveal any COVID-related symptoms. However, the adverse event is her positive COVID test result post-vaccination and 90-day window.
Fine systemic papular rash sparing anterior trunk beginning near injection site approx. 24 hours after influenza vaccine.
(L) arm redness, hard bump - 5 days post vaccine. 3 X 1 1/2".
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown. 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 medication information provided. No treatment medication information provided.
This spontaneous report was received from a nurse refers to an unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot # L022262, the expiration date: 05-NOV-2016, lot# L033707, the expiration date 18-MAY-2017 (dose and route were not reported). Other suspect therapies include M-M-R II lot # K015374, the expiration date: 18-SEP-2016 (dose and route were not reported). There was no concomitant medication provided. The temperature excursion was reported as 10 degrees C with a time frame of 13:20 hours, however it was not registered by the data logger. It was also stated that there was no previous temperature excursion reported. This is one of two reports received from the same reporter. Additional information has been requested.
Made patient sleepy; Injection site left arm soreness; This spontaneous case was reported by a patient family member or friend and describes the occurrence of SOMNOLENCE (Made patient sleepy) and VACCINATION SITE PAIN (Injection site left arm soreness) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046L21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 31-Mar-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2022, the patient experienced SOMNOLENCE (Made patient sleepy) and VACCINATION SITE PAIN (Injection site left arm soreness). At the time of the report, SOMNOLENCE (Made patient sleepy) and VACCINATION SITE PAIN (Injection site left arm soreness) outcome was unknown.     No concomitant drug was reported. No treatment drug was reported.   This case was linked to MOD-2022-660901 (Patient Link).
threw up for hours; This case was reported by a consumer via interactive digital media and described the occurrence of vomiting in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on an unknown date and it was fine).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 2 days after receiving Shingles vaccine, the patient experienced vomiting. On an unknown date, the outcome of the vomiting was recovered/resolved.   It was unknown if the reporter considered the vomiting to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the 2nd shot and after that it was fine for the first day and the second day it threw up for hours. No further details provided. This case has been linked with US2021AMR101848, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR101848:same reporter (reporter´s case)
Headache, Myalgia, Fever,  fever, headache, chills, and mild rhinitis 24 hours later, missed worked today d/t symptoms
Rheumatoid arthritis; This is a literature report for the following literature source(s): Private. A 61-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto thyroiditis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), 7 days after the suspect product(s) administration, outcome "recovering". The patient underwent the following laboratory tests and procedures: Antibody test: negative; Antinuclear antibody: negative; C-reactive protein: 3.7 mg/dl; Hepatitis B virus test: negative; Hepatitis C virus test: negative; HIV test: negative; classsification criteria for rheumatoid arthritis.: met the 2010 ACR, notes: classification; remarkable for synovitis, notes: at the bilateral wrists and second to fourth MCP joints; Red blood cell sedimentation rate: 41, notes: Unit:mm/h; Rheumatoid factor (0-13.9): 16 IU/ml; SARS-CoV-2 test: negative; X-ray limb: negative, notes: for erosive changes; negative, notes: for erosive changes. Therapeutic measures were taken as a result of rheumatoid arthritis.  Clinical course: The patient was presented to rheumatology with 4 months of symmetric polyarthritis involving the wrists and MCP joints in the setting of prolonged morning stiffness. Symptom onset occurred 1 week after completing the Pfizer-BioNTech vaccination series. The patient had a history of Hashimoto thyroiditis, no history COVID infection, and no family history of autoimmune disease. The patient never received immunosuppression in the past, and no medication changes were made at the time of vaccination. Examination was remarkable for synovitis at the bilateral wrists and second to fourth MCP joints. The patient met the 2010 ACR classification criteria for rheumatoid arthritis. She was treated initially with a prednisone taper and achieved clinical remission on oral methotrexate.; Sender's Comments: Based on the temporal relation, the association between the event of rheumatoid arthritis and the suspect product cannot be completely ruled out.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Started to scream while feeding instead of eating normally. Then started to lose weight from not feeding despite all attempts to get him to eat.
body aches; Shivers; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), CHILLS (Shivers), HEADACHE (Headache) and PYREXIA (Fever) in a 70-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: J&J (First Primary J&J dose, Lot# & Exp. Date: unknown) on 17-Mar-2021, J&J (2nd Primary J&J dose and Lot# & Exp. Date: unknown) on 28-Oct-2021. Past adverse reactions to the above products included No adverse event with J&J and J&J.   On 16-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-May-2023, received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (body aches), CHILLS (Shivers), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, PAIN (body aches), CHILLS (Shivers), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Previously administered vaccine included for Moderna COVID-19 vaccine (Shot #3 and First Monovalent Booster dose with Lot no. 058A22A & Exp. Date unknown on 17-Jun-2022.  No concomitant medication was reported.  Reporter stated that she had her Spikevax vaccination at the same time as her husband. Her arm was okay. Inadvertently she reported that with previous vaccines, she only had shivers, headache and body aches. She would usually get shivers.  No treatment information was provided.   This case was linked to MOD-2023-742520 (Patient Link).