chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administered with an expired vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine). On 28-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.
I started having side effects one week after 3rd dose of Moderna; 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 VACCINATION COMPLICATION (I started having side effects one week after 3rd dose of Moderna) 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 an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (I started having side effects one week after 3rd dose of Moderna). At the time of the report, VACCINATION COMPLICATION (I started having side effects one week after 3rd dose of Moderna) outcome was unknown.            Concomitant medications were not reported.  Treatment medications were not reported.  Patient took immunosuppressive drugs.
This case was reported by a healthcare professional and described the occurrence of injection site hemorrhage in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date in October 2010, the subject received unspecified dose of FLULAVAL (details unknown) and experienced injection site bleeding and vaccine underdose. The healthcare professional reported that the subject bled from the injection site due to defective needle and subject being on blood thinner, COUMADIN and aspirin. She believed that a portion or most of the dose came out. She refused to provide any further information. At the time of reporting the outcome of the injection site bleeding was unspecified.
Arm pain, red, warm to touch 3/12/19 swelling ER given BENADRYL, ice on area 3/14/19 PCP visit sore throat, body aches, ear pain, congestion, fever - checked for flu (-) given prednisone, AUGMENTIN.
Developed a cystic type lesion, palpable, moveable, hard, subcutaneous about 2 cm X 1.5 cm on left arm according to Mother. Had induration the first few days after the injection and tenderness but developed a mass one month or two later. No general reaction or other problems. The adverse event (permanent induration or vesicle cyst) appeared gradually over a period of time and became eveident apprx. 1 or 2 after the shot. NOTE: To the best of mt knowledge the concerns of the mother are what to do with the cyst that is palpable and vesible and the cost of recovering it also if the vaccination provided are protection to the child. To the first concern, I believe it can be surgically removed by surgeon (we don't do surgery). I believe it should not be a certificated or difficult procedure, but pt is uninsecured. To the concern, it was the second MMR if are doubt can be repeated (the shot) or do lab levels (impractica). I provided above information with the only purpose of give as much information as possible, to contribute to the understanding of the event.
3hs after vaccination she felt lots of itching, diffused all over her body; 1 hive, very small on her neck; A spontaneous report was received from a nurse concerning a 31 years old, female patient who experienced itching all over and hive on her neck.   The patient's medical history was not provided.  Products known to have been used by the patient, within two weeks prior to the event, Concomitant product use was not provided by the reporter.   On 31-Dec-2020, approximately 3 hours prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 026L20A ) intramuscularly for prophylaxis of COVID-19 infection.   The patient experienced itching all over the body and hive on neck since 31-Dec-2020.Treatment for the event included [List all drug and non-drug therapies administered to treat the event] OR Treatment information was not provided/unknown.   Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.  The event(s), itching all over and hive on neck, were considered recovered/resolved on 02-Jan-2021.
Sore arm from injection; Chills; body aches; Tired; Headache; Seasonal allergy symptoms after receiving vaccine injections; think the nurse pulled it out a little too soon, felt wet on my arm, and it was not saline colored; This is a spontaneous report from a Pfizer Sponsored Program Corporate (Pfizer) Social Media Platforms and Pfizer clinical trail Advocate stimulated report. A contactable consumer (patient) reported that: A 37-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm on an unspecified date in Oct2020 as a single dose for COVID-19 immunisation. Medical history included bad sinus from an unknown date (reported as a few weeks ago). The patient's concomitant medications were not reported. On an unspecified date, the patient experienced sore arm from injection, chills, body aches, tired, headache, seasonal allergy symptoms after receiving vaccine injections, think the nurse pulled it out a little too soon, felt wet on my arm, and it was not saline colored. The patient reported that she was a trial participant and experienced possible sore arm from injection, was tired and had a few hours of body aches and chills. She further reported that then it was all good. Patient reported that she received the live vaccine, the staff who administrated injections missed taking some vitals like they missed a pregnancy test before one injection. Patient also reported experiencing seasonal allergy symptoms after receiving vaccine injections: and enquired like "we've been playing is it allergies or is it COVID." The outcome of events sore arm from injection, body aches, chills, tired was recovered on an unspecified date and the outcome of rest all other events was unknown.   Information about Lot/Batch number was requested
HYPOTENSION 11/6/2022 -- RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
The day after I received the first  dose I had vaginal bleeding ahead of my expected period which was not due until 2 weeks.  The bleeding lasted 2 weeks.  After the second dose I again have vaginal bleeding.  It still has not gone away.
This patient may have received less than the standard 0.5mL dose. The vaccinator who administered the vaccine to this patient obtained over the expected 11 doses from a single vial. This was noted on reconciliation of vials and consents. Patient informed (or attempts are being made to contact them to inform them). Plan on second dose as scheduled as per guidance from CDC and Moderna.
Mom states pt was taken to ER @ 4PM for inc t103.8 w/APAP; no seizure activity noted;
After receiving the second dose of the COVID vaccine I had an intense reaction of very deep and intense  bone pain. Over the weeks following I developed increased fatigue and shortness of breathe. I began to struggle with using the stairs, and found I overall had less energy.  Before the vaccine I had worked on the 6th floor and would regularly take the stairs to my unit, and lived in a 3rd floor apartment without an elevator and would regularly use the stairs. After the vaccine, using the stairs was noticeably difficult and my overall fatigue was worse.  I sought out help from my primary care physician who suggested anti-depressants for the fatigue, which set off horrible heart palpitations, so she referred me to cardiology and psychiatry.  My endocrinologist is the doctor who thought that the vaccine triggered a dysautonomic reaction in my body and that I developed POTS from the vaccine.  It took awhile to find a specialist who could order the appropriate testing to get diagnosed. I finally had a tilt table test on 8/8/2023 which confirmed the diagnosis of POTS.
No additional AE were reported; received improperly stored vaccines; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 31-MAR-2022, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 1 dose, lot #U026217, expiration date: 02-NOV-2023 (strength, exact dose, site and route of administration were not provided) for prophylaxis (Product storage error). On an unknown date, before the administration, vaccine underwent temperature excursion at 34.3 degrees Fahrenheit (F) for 55 minutes. No previous excursions were reported. No adverse events were reported (No adverse event).  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2204USA001816:
low-grade fever; Injection site tenderness; Chills; Feeling unwell; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age (reported as in her middle of 20s) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration, on 06Jan2021, as dose 1, single, for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced low-grade fever, injection site tenderness, chills, feeling unwell on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PERIPHERAL NEUROPATHY (MAINLY TINGLING AND SLIGHT LOSS OF SENSATION) IN BOTH FEET; VERY STRESSED; This spontaneous report received from a patient concerned a 54 year old female.  The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was not diabetic and never had diabetic. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 212A21A expiry: unknown) dose was not reported, administered 01 total to right arm on 24-SEP-2021 at 08:00 hours for prophylactic vaccination. No concomitant medications were reported. Patient reported that after 7 days of vaccination, on 30-SEP-2021, it appeared to her that she experienced peripheral neuropathy (mainly tingling and slight loss of sensation) in both feet. The onset was sudden at the 7 day mark after receiving the vaccine and the side effects continue, they were not getting any better. The patient stated that her podiatrist was the one that suspects peripheral neuropathy and referred her to the neurologist, the appointment to see the Neurologist was on 29-OCT-2021. The patient also stated that she had never experienced anything like this before. On an unspecified date in SEP-2021, the patient reported that she was very stressed. The patient also visited to physician office for the event peripheral neuropathy (mainly tingling and slight loss of sensation) in both feet. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from peripheral neuropathy (mainly tingling and slight loss of sensation) in both feet, and the outcome of very stressed was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211020241-covid-19 vaccine ad26.cov2.s -peripheral neuropathy. This event(s) is considered unassessable. 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).
Developed fist sized area of swelling and redness. Treated with IM BENADRYL and PO BENADRYL for home and cool packs.
Dry cough; headache; body aches; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Dry cough), HEADACHE (headache) and MYALGIA (body aches) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 002B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COUGH (Dry cough), HEADACHE (headache) and MYALGIA (body aches). The patient was treated with IBUPROFEN at a dose of 1 dosage form and SUMATRIPTAN (IMITREX [SUMATRIPTAN]) at a dose of 1 dosage form. At the time of the report, COUGH (Dry cough), HEADACHE (headache) and MYALGIA (body aches) outcome was unknown. Not Provided          There were no concomitant medications provided.
COVID-19  Chills  Nasal congestion PND (post-nasal drip) Acute nonintractable headache, unspecified headache type Diarrhea  05/06/2021 03:54 PM EDT Phone (Outgoing)     COVID 19 MAB Infusion Navigator Initial Patient Assessment   Ordering Prescriber has completed required FDA EUA elements.    COVID-19 Positive Result Date (and on chart/file):05/06/2021   Start of Symptoms Date: 04/29/2021  Meets Criteria:   ANY AGE: ? Body mass index (BMI) ?35 ? Chronic kidney disease ? Diabetes ? Immunosuppressive disease AGE SPECIFIC: ? ? 65 years of age       ? ?55 years of age AND had Cardiovascular Disease OR Hypertension OR COPD/other chronic respiratory disease   Reviewed present symptoms with patient.     Congestion, diarrhea   Purpose of Infusion Assessment: Can you tell me why you are receiving this infusion? Reviewed by Physician   1. Date/Time of Infusion: 5/7/21 @12:00. Location of Infusion:      Come to unlisted address.  Park in the parking lot next to the Medical Office Building, and while in your car, contact the Infusion Center to register over the phone from your vehicle.  Once you are registered, you will be directed to the entrance and a nurse will be down to meet and assist you to the suite and infusion room.   2. Confirmed that patient has spoken with his PCP/Referring Physician, patient is in agreement to the MAB infusion and acknowledges understanding and denies any additional questions at this time.   3. Confirmed that the demographics in the chart are correct including phone numbers, address and health insurance.   4. Patient will utilize a thermometer and pulse ox. Explained to patient about collecting temperature and pulse ox  daily for 10 days. If applicable, patient will receive any additional assistance with their website access & use by the infusion clinic clinical team.   5. Patient will receive a ride to the appointment if needed. Patient first emergency contact and decision maker is  unlisted.   6. SDOH ASSESSED.   Key Reminders: You will want to eat or drink like you normally would prior to coming for your infusion. You can also take your medications as you would normally do, unless your physician has told you specifically not to take something.
Uncontrollable movements began with foot moving and full body shakes 3 hours after the shot was given. Shakes progressively moved throuhgout body to every part, including face and throat movement. Went to ER a total of 4 times, no answers for the condition were given any visit. Primary care doctor prescibed muscle relaxers and benzos while I waited for a Neurologoist. Also tried acupuncture, to help during this time. Had a huge welt on my arm for a month. Was diagnosed with Functional Neurological Disorder December 9, 2022. Still going to acupuncture, functional medicine doctors to help symptoms. Still dealing with ongoing symptoms as of June 2023. (pharmacy report states both the flu and COVID shot were adminstered in left arm, but they were not. One was in left and one was in right. COVID was left and flu was right.)
Cellulitis developed at injection site within 2 hours. Responded well to Clindamycin HCL and Benadryl. Pt received 2 day hospital admission. DC DX: Allergic reaction-pneumovax. Fever. Vomiting/Dehydration PMH: Positive for allergy for penicillin, clindamycin.
ITCHY ON THE ARM WHERE GOT SHOT; This spontaneous report received from a patient. The patient's weight, height, and medical history were not reported. The patient received Covid-19 Vaccine AD26.COV2.S (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) 0.5 ml, administered on 06-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 07-Mar-2021, the patient experienced itchy on the arm where she got shot. The action taken with Covid-19 Vaccine AD26.COV2.S was not applicable. The patient recovered from itchy on the arm where got shot on 08-Mar-2021. This report was non-serious.
received their 4th dose of acthib 3 months early on 8feb2022; would not be due for their 4th and final dose until 12 months of age with no reported adverse event; Initial information received on 09-Feb-2022 regarding an unsolicited valid non-serious case received from a health professional.  This case involves a 9 months old female patient who received their 4th dose of acthib 3 months early on 8feb2022; would not be due for their 4th and final dose until 12 months of age with no reported adverse event, after receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].     The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Prophylactic vaccination; MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Prophylactic vaccination; and HEPATITIS A VACCINE (HEPATITIS A) for Prophylactic vaccination.  On 08-Feb-2022, the patient received dose 4 of suspect HIB (PRP/T) VACCINE (strength, dose, formulation: unknown) with lot UJ456AA via unknown route in the left thigh as immunization.  It was reported that patient received their 4th dose of acthib 3 months early on 8-Feb-2022; patient received their 3rd dose on 22-Nov-2021 at 6 months of age and would not be due for their 4th and final dose until 12 months of age (inappropriate schedule of product administration) following the administration of HIB (PRP/T) VACCINE. No adverse event was reported.  Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was not applicable.  It was not reported if the patient received a corrective treatment for the event   At time of reporting, the outcome was Unknown for the event      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.
Information has been received from a healthcare worker concerning a 13 year old female who on 28-MAY-2008 was vaccinated subcutaneously with a dose of ZOSTAVAX (Merck) instead of her second dose of VARIVAX (Merck). This was related to staff error and not product confusion. No adverse effect reported. The healthcare worker also reported the same events for patient's brother (refer to WAES# 0805USA06014). Additional information has been requested.
Patient received vaccines (MMR, VZV, DTaP, Flu) and then had fever x3 days. He has also been "not himself". He's having tantrums all day long and even daycare sent him home due to tantrums. He's difficult to console. He's not sleeping well at night. No regression in language or other milestones.
101 fever for 12 hours. Chronic headache that has not resolved to date, ongoing chills since vaccination, unresolved insomnia, intestinal discomfort, and intermittent shortness of breath.
I woke up early did housework I got sleepy layed on the couch an hour later I wloke up with  a bad pain and called EMS.  I was taken to the Hospital and was there  from  13JAN2023 to 17JAN2023.
year old vaccinated female was admitted for sepsis  From pneumonia. She also had Covid-19 infection. She did not receive Remdesivir due to liver disease. She received antibiotics. Blood cultures were (-). She improved clinically. She will be transferred back today in stable condition.
This spontaneous report was received from a healthcare worker (medical assistant) and refers to a 4 weeks old white female patient. The patient had no pre-existing allergies, birth defects, medical conditions or illness at the time of vaccination. The patient's other pertinent medical history was not reported. On 03-FEB-2016 at 10:50, the patient was inadvertently vaccinated with the first dose of VAQTA 25/0.5 ml, lot number L032749, in right thigh (dose, route of administration and expiration date were not provided). The patient's concomitant medications were not reported. At the time of reporting (reported as so far), the patient experienced no adverse events. No product quality complaint was involved. No lab diagnostic studies were performed. This is one of two reports received from the same reporter. Additional information is not expected as all scheduled correspondence was received.
Anaphylactic like reaction started with dizziness sweating increased heart rate wheezing in and out of consciousness. administered 0.3 of epinephrine, O2 via NC at 3L. called EMS. EMS arrived with in 10 minutes and administered additional 0.5 of Epinephrine and transported patient to the ER