chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A patient received an expired Adacel vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Global Medical Information (Reference number- 00672539) and transmitted to Sanofi on 07-Jul-2021.  This case involves a 33-year-old male patient who received an expired DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 07-Jul-2021, the patient received 0.5 mL dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U6378AA and expiry date: 04-Jul-2021) via an intramuscular route in the right deltoid for prophylactic vaccination (expired product administered).  It was reported that "Caller states that she gave an Adacel vaccine to a male patient because the patient stepped on a nail. She states that over the weekend the expired vaccines were not pulled out due to the holiday and she did not pay attention to the expiration date before vaccinating the patient. The nurse states that the patient did not experience any other AE's (adverse event) as a result of this. Pasteur AE Reporting."   There were no lab data/results available.  It was a case of actual medication error due to expired vaccine used (latency same day).  At time of reporting, no adverse events were 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 the 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.
Vaccine that administered beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 28-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient's age was reported as 37 years and 10 months. No concomitant medication was provided. It was reported that vaccine was administered beyond use date to the patients. There was no adverse reaction noted or reported regarding these administrations. Vaccine NDC code- 80777-0273-99 No treatment medication was provided.
Information has been received from a certified medical assistant (C.M.A.) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 25-FEB-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # K014798 (expiration date 12-MAR-2016, dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
COVID Disease after Bivalent Booster; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID Disease after Bivalent Booster) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In November 2022, the patient experienced COVID-19 (COVID Disease after Bivalent Booster). At the time of the report, COVID-19 (COVID Disease after Bivalent Booster) outcome was unknown.            No concomitant medication was reported.  No treatment medication was reported.   This case was linked to MOD-2022-673958 (Patient Link).   Reporter did not allow further contact
Pt c/o of abd pain, fever and chills. Pt was admitted to hospital told due to flu vaccine. Mom states at discharge told had pneumonia and given ATB, steroids and albuterol for treatment. Doing good 10/11/13 per mom.
The patient refers that after first dose 0n 6/22/21 she had difficulty in walking.  After 2nd dose on 7/20 she was leaning to the side while walking. On 6/16/22 she had 4th dose and she presented abdominal pain the same day.  When she woke up in the morning of 6/17 she noticed vaginal bleeding that has continue until now but in less amount (spotting).
Called health system call center to report the following symptoms post vaccination:  fatigue, pain at site of injection. Takes ibuprofen PRN which helps somewhat. Patient was scheduled for visit with urgent care for 5/4/21
This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. On 04-MAY-2017, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot# M000442, expiration date: 31-MAR-2018, dose, route of administration and anatomical location were not reported). Administered dose of vaccine experienced the temperature excursion of 48 Fahrenheit degrees for 30 minutes. Data logger was not involved. There were no previous excursions reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA001661: US-009507513-1704USA000587: US-009507513-1704USA001660:
Never run fevers -but ran 102.5 for 24 hrs. Then 99.5 second day. Nausea, diarrhea , headache. Red area at vaccine site.Slept for 16 hrs. Had no reaction to first dose
Swelling at site of injection lasting > 3 days & Mild Erythema. Local reaction, red cellulitis; no systemic reaction.
Date removed from freezer 8/9/22 . Thaw expiration date 9/8/22 @1100. Dose administered 9/9/22. Doses administered after 30 day thaw expiration. Moderna was contacted for assessment of vaccine activity for both doses. Based on the assessment vaccine maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration per Moderna. No adverse reaction reported
Initial and follow up information has been received from a physician and by telephone call from the healthcare professional concerning a 22 year old female patient with family history of rheumatoid arthritis and autoimmune disease who on 03-APR-2008 was vaccinated IM with a dose of GARDASIL (lot # not available).  The physician reported that the patient experienced serum sickness, full body rash, and severe arthritis and joint pain.  She was taken to the emergency room and was admitted to the hospital.  In follow up telephone call the health care professional reported that on 04-APR-2008 patient developed fatigue, temperature of 102, weakness, near syncope episode at work, blanchable rash all over body, very achy joints hands, knees and ankles, and had trouble walking.  She went to the emergency room (E.R.) on 04-APR-2008 and was sent home.  On 05-APR-2008, she went to the ER and was told she had chicken pox and was sent home.  On 08-APR-2008 the patient went to the ER and was sent home.  On 09-APR-2008 the patient was admitted to the hospital.  The patient's final diagnosis was reactive arthritis, possible reaction to GARDASIL, urticaria associated with reactive arthritis, abnormal liver function test (LFT's) possibly related to fatty liver or polycystic ovary syndrome or possibly related to reactive arthritis.  Her hepatitis A, hepatitis B and hepatitis C, Lyme, Rocky Mountain fever, serum antinuclear antibodies (ANA), serum antineutrophil cytoplasmic antibody (ANCA) test was normal.  Her Rheumatoid factor tests were all normal and her sed rate was slightly elevated.  Serum C Reactive protein test was 29.9.  The patient was treated with intravenous (IV) steroids and improved.  She was in the hospital for four days.  On 21-APR-2008, the patient was seen in the office and it was noted that she was "remarkably better".  Skin rash was resolved, ache in joints/stiffness still there especially after sleeping.  Fever was gone.  The patient was recovering.  Additional information has been requested.  06/04/2008 MR received from DOS 4/09-11/2008 with D/C DX: Reactive Arthritis: Possible reaction to Gardasil vaccine (symptoms began 3 days after the injection and peaked at ~7-8 days after the injection). Urticaria associated with Reactive Arthritis.  Abnormal LFTs: possibly related to fatty liver or polycystic ovary syndrome or reactive arthritis.  Hx of polycystic ovarain syndrome-on Provera for menses. Pt presented with c/o fatigue, fever, a near syncopal episode, weakness, joint pain, macular rash and difficulty walking x 6-7 days.  PE (+) for mouth ulcerations, abdominal tenderness, macular erythematous rash and marked swelling of the PIP, DIP and MTP joints of the hands and ankles, with associated tenderness. Swelling also noted at wrists with tenderness and limited ROM. (+) warmth of the joints.  LFTs markedly abnormal. Txd with Solumedrol then Medrol dosepack with partial resolution of sx.
Pt vaccinated with DTP developed atrophy of skin & subcutaneous tissue at the site of injection.
Rash - neck and face, itching & irritation. Positive erythema. Positive warmth. Negative vesicles.
This case was reported by a pharmacist and described the occurrence of injection site redness in a 35-year-old female subject who was vaccinated with FLULAVAL. In November 2008 the subject received a dose of FLULAVAL at 0.5 ml. Shortly after vaccinations with FLULAVAL, the subject experienced injection site redness and chills. At the time of reporting the events were resolved.
High Blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (High Blood pressure) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History Information was reported.  Concurrent medical conditions included Lactose intolerance, Gluten intolerance, Allergy to metals, Allergy to antibiotic (Allergic to Bactrim.) and Drug allergy (Allergic to Macrobid.). Concomitant products included IRBESARTAN and VERAPAMIL for an unknown indication.    On 23-Feb-2021 at 10:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced HYPERTENSION (High Blood pressure). On 24-Feb-2021, HYPERTENSION (High Blood pressure) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, Blood pressure measurement: 188 (High) 188.     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 Treatment information for the event was provided.   This case was linked to MOD-2021-259147 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: NON-SIGNIFICANT FU On 16-Jul-2021: Follow-up information received on 17 Jul 2021: second reporter information added and checked medically confirm and Other Relevant History and lab data result added and anatomical location of suspect drug, vaccine facility information concomitant drugs added.
Donor called from home and reported a fever of , chills and body aches.  Donor reported calling Dr's office and nurse gave instructions to take Tylenol every 4 hours for fever and to only come in if fever was 104 F. Instructed donor to not over dose and take Tylenol and Ibuprofen alternating every 2 hours for a short time. If fever hasn't gone down to report to PMD.
Inconsolable crying/screaming starting about 5 hours after vaccines given. Inconsolable crying/screaming lasted 3 hours the first night of oct 30th. Also baby became clammy and diaphoretic. Another episode of inconsolable crying lasting about 2 hours the following evening, and again the evening after that. Treatment included soothing baby, keeping her cool by undressing her, and administering Tylenol 2.5ml as needed. Right thigh was also red and swollen, very sore to the touch. Symptoms seemed to subside within 3 days and baby seemed back to normal after about 5 days after vaccine administration.
PC from dad on 2JAN92 stated pt had swollen leg from inject recvd 31DEC91; Advised to take pt to MD; 3JAN92 dad stated MD was called & told da no tx necessary since pt had not temp elevation. Pt is OK today.
nausea, headaches, muscle stiffness, joint pain, swollen lymph nodes, swelling of face, neck and throat, dizziness, fatigue  took benadryl 2 tablets every 4-6 hours for 7 days since 3/23/21 and now still taking benadryl occasionally (when needed )started 4/02/21 for swelling of face, neck and throat. Swollen lymph nodes are still present but no other symptoms.
contracted covid after receiving the 1st vaccine dose; contracted covid after receiving the 1st vaccine dose; This is spontaneous report from a contactable nurse. This nurse reported similar events for 6 patients. This is 4th of 6 reports.   An unknown age and gender patient received first dose of BNT162B2 (Pfizer BioNTech Covid 19 vaccine) on 22Dec2020 at single dose for covid-19 immunization. Medical history and concomitant drug were not reported. It was reported that patient contracted COVID after receiving the 1st vaccine dose. Outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 22Dec2020, and contracted COVID on an unspecified date.  No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection.  Further information like COVID infection date needed for a full meaningful medical assessment.,Linked Report(s) : US-PFIZER INC-2021035078 same reporter/product/event, different patient
watery stool diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHEA (watery stool diarrhea) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHEA (watery stool diarrhea). At the time of the report, DIARRHEA (watery stool diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.  No treatment medications were pro
Flu like illness-aches, fever, diarrhea. Swelling, redness, tenderness to injection site.
Patient developed hives on trunk and limbs 2 hours after the injection.  He started trying to clear his throat so mom took him to the ER.
Got fever and sweats that evening. Went to ER. Sore throat with a questionable viral infection.
Started in the morning with injection site swelling . itching and inflamed. Intense headache and nauseous & upset stomach. Lasted all day (approximately 11 hours) Used ice bag on arm and head.  Took an Advil. Finally subsided in the evening. Swelling went down on my arm by next day but stayed red for 2 days.
Suspect COVID breakthrough case Was found to have a hemoglobin of 6.7 on routine lab work- sent to the hospital by PCP.   Subsequent COVID finding.  Developed sudden chest pain and EKG identified STEMI and was taken to catheterization lab where he was noted to have complete occlusion of the proximal LAD..  Stenting was attempted but he went in V fibrillation and expired.
This spontaneous report as from a consumer via social media who obtained the information from a third source launched a campaign against the HPV vaccine and released the video shown at last week's briefing, who reported that a 20 years old female on an unknown date was vaccinated with a dose of GARDASIL (dose, route, lot number and expiration date not reported). The patient stated that her parents never told about the adverse events that could occur after receiving GARDASIL. The patient reported that before receiving GARDASIL, she played soccer and softball. On an unknown date, after receiving GARDASIL she "could not walk". At the time of the report, the patient's outcome was unknown. It was stated that it was not a coincidence that the patient could not walk. Upon internal review "could not walk" was considered to be disabling. This is one of several reports received from the same source. No further information is available.
Patient developed itching and rash over several areas of her body. Took CLARITIN at the time of reaction and BENADRYL in the evening. Contacted her physician's office also but was not seen. Spoke with patient in am the next day and rash was resolved except for area around injection site. Patient has had flu vaccines before without any event.
This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, since 01-MAR-2015, the patients were vaccinated with improperly stored doses of GARDASIL 9, (dosing details and lot# not reported). No adverse effects were reported. The vaccine was exposed to high temperature of 10.3 degree Celsius for a cumulative time frame of 731 hours from 24-NOV-2015 through 26-OCT-2016. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Devel "goose egg" size swelling at site of inject. Tiredness, nausea, malaise w/in 8 hrs after. Then erythema, warm to touch at 20-48 hrs after. Right deltoid.
Spike in sugars; This spontaneous case was reported by a consumer and describes the occurrence of HYPERGLYCAEMIA (Spike in sugars) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced HYPERGLYCAEMIA (Spike in sugars). At the time of the report, HYPERGLYCAEMIA (Spike in sugars) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Blood glucose: high (High) Sugar level spiked.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient ate greens as treatment.
Patient presented to office with erythemous patch on left arm  5 cm x 10 cm, 2cm below vaccine injection site
After one day of vaccaination, the area near the  area of  vaccainated begin to swell and pain  a lot especially for the whole muscles in the arm.  It is still a little bit itch in the skin. After one week of vaccination, the skin of the same area begins to  appear small red blocks and begins more itch in the skin.
Fever; Chills; little bit Tachycardia; Headache; soreness at injection site; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), TACHYCARDIA (little bit Tachycardia), HEADACHE (Headache) and VACCINATION SITE PAIN (soreness at injection site) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills), TACHYCARDIA (little bit Tachycardia), HEADACHE (Headache), VACCINATION SITE PAIN (soreness at injection site) and FATIGUE (fatigue). At the time of the report, PYREXIA (Fever), CHILLS (Chills), TACHYCARDIA (little bit Tachycardia), HEADACHE (Headache), VACCINATION SITE PAIN (soreness at injection site) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant information  provided. Treatment included Advil
On 6/11/2021, patient presented to the Emergency Department complaining of chest pain that started initially in the evening of 6/10, which had initially self-resolved, but has since recurred, now also with shortness of breath.  Troponin was significantly elevated on presentation at 16.3, and 12-lead EKG showed an abnormal rhythm concerning for STEMI vs perimyocarditis.  After negative cardiac/embolic work-up in cath lab & CT imaging, myocarditis was felt to be the most likely cause of this patient's symptoms.  On the following day, patient was noted to have brief bursts of Vtach, for which metoprolol was initiated.  The patient was subsequently discharged home in stable condition on 6/13/2021.
Short bursts of V-Tach. (Ventricular Tachycardia) Skipped heart beats, racing hear rate, dizziness, nausea, jitters in chest and arms
Injection site pain; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Injection site pain), CHILLS ( chills) and HEADACHE (headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Osteoarthritis. Concomitant products included VITAMIN D [VITAMIN D NOS] for Osteoarthritis, LEVOTHYROXINE SODIUM (SYNTHYROID) for an unknown indication.    On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced INJECTION SITE PAIN (Injection site pain), CHILLS ( chills) and HEADACHE (headache). At the time of the report, INJECTION SITE PAIN (Injection site pain), CHILLS ( chills) and HEADACHE (headache) outcome was unknown.            No treatment medication were provided. Action taken for Moderna  COVID-19 Vaccine was not applicable.
Sore arm at sight of injection  Nausea Headache  Body aches Weakness  Panic attacks
p/vax pt devel inj site swelling & inj site erythema the size of a large first, general malaise, & stiffness of rt arm for tow to three days;pt recovered;
Heart pain immediately after the shot which lasted ~6 hours (9:15 am to ~4 pm).  Nex day, 3/24/2021, right arm pain and red spots on the chest.
Redness (3 inch diameter), swelling, warmth, and pain at injection site.