chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sleeping a lot; he was tested positive for covid; he was tested positive for covid; experiencing mild congestion in the head/congested in his head; sense of smell is pretty much  gone; decided since his throat was scratchy; congestion in his ears; Exhaustion/ Fatigue; This is a spontaneous report from a contactable consumer (patient). A 55 year old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 19Mar2021 (Batch/Lot Number: ER2613) as SINGLE DOSE for covid-19 immunisation, age at vaccination 55 years old. Medical history included Diabetic from 2013 (Diabetes is fairly under control. He has no super high readings. His diet is better); blood pressure (blood pressure abnormal) from 2013; ongoing overweight (obviously he is overweight) from an unknown date; and heart (disorder) from an unspecified date. Concomitant medications included metformin taken for an unspecified indication; lisinopril for blood pressure (abnormal); and lovastatin for heart (disorder), start and stop dates were not reported. Patient is taking an unspecified over the counter multivitamin. There were no other recent vaccinations or started any new medications. The patient is due for the second dose on 9April2021, but he tested positive for COVID-19 on 01Apr2021 with a PCR test described as oral saliva test. Patient was negative on a rapid test on an unspecified date. Patient wanted to know if he could reschedule the shot and when is it recommended. The patient had a coworker who tested positive, he decided since his throat was scratchy that maybe he had got it, then two more employees had gotten COVID-19 so he got a rapid test that was negative. On Mar2021, he stated he stayed home because he was experiencing mild congested in his head/congested in his head, which it still actually was, and he lost sense of smell completely. He was really tired, sleeping a lot, had congestion in his ears, and he can't smell anything. Patient had no fever, and his lungs were clear (unspecified date), so he commented it was deceiving since he feels fine like he can do whatever he wants, then he gets exhausted and sleeps. He stated he can't work for a whole week. He stated he is assuming his first dose of the shot is helping with it. Patient stated he is doing well, he has it (COVID-19), but he feels pretty good. Outcome of congested in his head was not recovered, while unknown for the other events.
Patient hospitalized on 4/12/2021 for Atherosclerosis of artery of extremity with rest pain. Patient presented to the ED and was subsequently hospitalized on 5/3/2021 for  Closed fracture of right hip. These visits are within 6 weeks of receiving COVID vaccination.
Pt. states she noticed a "brown spot" on arm when she removed the bandaide 4 hours after GARDASIL injection. Area started itching 2-3 days later and has not stopped- (has been scratching). Redness at site started 2 weeks later and then started having pain radiating out 4 inches diameter around site- minor swelling noted. No treatment done. Reported on 12/2/08 to CCHD- Instructed to see PMD immediately.
Patient received vaccine and responded "oh that was easy", got up from the chair, and walked away from the clinic area  then fell to the floor. RPH on duty did not see the first fall. Patient was responsive, talking, and laughing (at times) during  the event. RPH on duty asked patient if she was okay while she was still lying on the floor. The patient responded by saying  I'm okay.  The patient then stood up and proceeded to walk toward the pharmacy lobby but then fell to the floor a second time. The RPH on duty called 911, passed the call over to the pharmacy tech to complete the call,  then placed a cold cloth (paper towel ) across the patient's forehead. Emergency Medical Technicians arrived on the scene within minutes. Patient maintained consciousness and was responsive throughout the event. Patient  was evaluated by EMT personnel and eventually left the store via wheelchair accompanied by EMT personnel and parent.
No adverse event - vaccine error. Patient was told he needed PNEUMOVAX 23 by a pharmacist after checking MCIR. MCIR confirmed patient had previously had two PREVNAR 13 vaccines (2nd was unnecessary and should have been PNEUMOVAX 23). Patient came in for vaccination, and the RPh on duty states that the patient told her he had never had a pneumonia shot. Patient was given a 3rd PREVNAR 13 vaccine, instead of PNEUMOVAX 23.
Part of the vaccine splashed on face; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ACCIDENTAL UNDERDOSE (Part of the vaccine splashed on face) 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 04-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 ml. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, the patient experienced ACCIDENTAL UNDERDOSE (Part of the vaccine splashed on face). At the time of the report, ACCIDENTAL UNDERDOSE (Part of the vaccine splashed on face) outcome was unknown.            No Concomitant medications were provided No Treatment information provided
Received 3 dose vaccine on 5/3/22. Within first 24 hours experienced some discomfort and pain in back and neck. Some nausea an upset stomach. By 5/6/22 I went to ER. Over the next 11 days the pain became excruciating and paralysis started to set in on my extremities. In total I made 6-7 attempts to get help from multiple ERs, Urgent car, Orthopedic Care before finally being admitted to ER on 5/17/22. Diagnosis, many Epidural Abscess of cervical thoracic and  lumbar spine. Sepsis. Septic shock. MSSA. Spinal Cord Compression. DDD. Osteomyelitis. And others problems . Was rushed to emergency surgery had multiple disc removed. Cages pins screws placed. Spinal decompression. ICU 2 weeks. Extended Hospital stay and rehabilitation. Recurrent condition and symptoms led to more stays. Life long injuries. Morbidities Mortalities
Itching, redness, swelling bumpy about 1 hr after shot given. Patient states she wants to "Rip" her arm off it itches so bad.
Bilateral numbness, sensitivity, tingling, weakness in hands beginning 10 minutes after vaccine-not resolving 4 days post vaccine. 12/04/09 Hospital records received for DOS 11/4-11/5/09.  Pt. with c/o weakness of lower extremities.  Neurology consult to r/o MS vs. anxiety.  Reflexes absent in upper and lower extremities with glove and stocking sensory reduction in upper and lower extremities. Motor system showed distal weakness is upper and lower extremities. LP:elevated spinal fluid protein. DX: Possible Guillian Barre secondary to H1N1 vaccine.
Patient's mother reports that redness and swelling on injection site began shortly after leaving the office 06/25/2018. Mother reports that it doubled in size the following day. Mother denies any fever, N/V, or diarrhea. Presented to the office on 06/27/2018 to have patient seen for the above symptoms. After assessment by CRNP, it was determined patient had a localized reaction at the injection site of the above stated vaccines. Patient was prescribed steroids and mother instructed to give BENADRYL PO PRN and OTC ibuprofen or acetaminophen per package instructions as needed for pain or fever. Mother educated concerning what symptoms should prompt them to present to the ER immediately. Mother instructed to return patient to clinic if problem not improving or worsening, despite treatment given.
1. Severe body aches, pain all over body; fever for 24 hours 2. Soreness in left armpit, starting approximately two days after the injection and lasting approximately 5-7 days.
pt recv vax;stiffness in shoulders & neck;back pain;pain & swelling in lt knee;muscle pain in back,neck & shoulders;exp unexplained weight gain;tx w/ meds;devel lump on lt heel;tx by chiropractor;md does not feel sx related to vax;
Dose 1 given on 26Aug2021 and Dose 2 on 9Sep2021 which is less that 19 days; My mensural cycle began 9/29/21 and has not stopped as of today 10/7/21 and I am worried.; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Sep2021 at 18:45 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Aug2021 at 18:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. On 29Sep2021, the patient experienced menstrual cycle which began and had not stopped as of the day of report, 07Oct2021, and was worried. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event menstrual cycle began on 29Sep2021 and had not stopped as of the day of report, 07Oct2021 was not resolved at the time of this report.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
administrated to a child earlier than recommended in the prescribing information, with no reported adverse event; Initial information received on 11-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 13 months and 20 days old female patient  to whom  HIB (PRP/T) VACCINE [ACT-HIB] was administrated to a child earlier than recommended in the prescribing information, with no reported adverse event.  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) and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Prophylactic vaccination.  On 11-Oct-2022, the patient received a 0.5 ml (dose 4) of suspect HIB (PRP/T) VACCINE, powder and solvent for solution for injection (lot UJ648ABA; expiry date; 16-Mar-2023) via intramuscular route in the left thigh for Immunization to a child earlier than recommended in the prescribing information, with no reported adverse event  (product administered to patient of inappropriate age).  Action taken : not applicable.  Outcome: Unknown.   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.
24 hrs after injection: lip swelling, nausea, red injection site. 48 hrs after injection: larger area of redness with central bullous lesions. Treated for 1 1/2 week with SILVADENE cream. Cultures (viral bacterial) taken from bullous lesions - Results: Negative viral and bacterial cultures. KEFLEX 100 mg bid X 10d started.
This spontaneous report was received from a nurse refers to a 01-year-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 16-SEP-2017, the patient was vaccinated with improperly stored  M-M-R II (dosing details were not reported) (lot # M045401, expiry date: 14-NOV-2018) for prophylaxis. The lot of M-M-R II were reconstituted with properly stored sterile diluent (MRK). No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054: Original Case: 1709USA000054.
Soreness in deltoid muscle began approx. 24 hours post vaccination, also had difficulty lifting arm. Symptoms worse at night, continued for approx. 1 month. No redness/warmth/swelling or drainage at injection site.
Expired vaccines given to 4 patient's during 1/20-1/22015. An employee working during immunization clinic saw vaccine was expired and I was immediately notified and removed vaccines from refrigerator. The 4 patient's were notified and were later revaccinated. I also contacted our VFC rep and was provided with the necessary information.
felt sore, hot and cold along with fatigue; felt sore, hot and cold along with fatigue; felt sore, hot and cold along with fatigue; This is a spontaneous report from a non-contactable consumer reporting for herself. A female patient of an unspecified age received  bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on an unspecified date at single dose  for Covid-19 immunisation .  The patient medical history and  concomitant medications were not reported.  The patient  felt sore, hot and cold along with fatigue on an unspecified date with outcome of unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt had shot on 9/26 around 6:30pm, they waited for 15 minutes no reaction, after go home, 1 hr later pt felt pain on the back around neck & shoulder area, rash appears on the arm & feels hard. Pt did not put anything on. Came to Rx on 9/28, the rash is still there but better, pain is almost gone, give ice pack to put on. When verify on 10/5 pt  is OK.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 04Apr2022 at 12:00 as dose 4 (booster), single (Lot number: FK9895) at the age of 64 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 included: "rheumatoid artritis" (unspecified if ongoing), notes: rheumatoid artritis; "known allergies: penicilline" (unspecified if ongoing), notes: known allergies: penicilline. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: in total for 3 weeks; (20Jul2022) Negative, notes: after 3 days from the end of the treatment. Therapeutic measures were taken as a result of covid-19. Paxlovid was given as anti viral therapy from 13Jul2022 to 17Jul2022.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 07-DEC-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot#  M044718 and expiration date 07-MAY-2018) for prophylaxis (Incorrect product storage). The Merck Sterile Diluent was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709; US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001956; US-009507513-1810USA001957; US-009507513-1810USA001959.
Patient just after vaccination stated tachycardia, throat itchy with throat clearing but states has seasonal allergies. Felt dizzy. States she feels this way after all vaccines states "has a reaction." BP was 140/82 which is around her "norm", heart rate 90-100 bom, and SPO2 @ 98% on room air
Flublok vaccine subcutaneously instead of in the muscle / no AE; improper needle size, 25g 5/8th inches / no AE; Initial information received on 01-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case is linked to case 2019SA307055.  This case involves two female patient who received dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot QFAA1910 via subcutaneous route in the deltoid nos on 30-Oct-2019.  The patient past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other vaccine was given.   It was an actual medication error due to Inappropriate route of vaccination and Incorrect needle gauge used.  At a time of reporting No AE symptoms reported.  It was reported that some patients received the Flublok vaccine subcutaneously instead of in the muscle and improper needle size, 25g 5/8th inches.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Information has been received from a registered nurse concerning a 13 year old female who on 12-DEC-2006 was vaccinated with her second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently the patient experienced pain down her arm one month after receiving her second dose.  The patient's pain down her arm persisted.  Additional information has been requested.
Shortness of breath; bone pain; Back pain; Sores in mouth; Headache; Pain in elbow; Fatigue; overall arm pain; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), BONE PAIN (bone pain), BACK PAIN (Back pain), STOMATITIS (Sores in mouth) and PAIN IN EXTREMITY (overall arm pain) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hashimoto's thyroiditis. Concurrent medical conditions included Shellfish allergy (Allergic to scallops and mollusks).   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (overall arm pain). On 02-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSPNOEA (Shortness of breath), BONE PAIN (bone pain), BACK PAIN (Back pain), STOMATITIS (Sores in mouth), HEADACHE (Headache), ARTHRALGIA (Pain in elbow) and FATIGUE (Fatigue). At the time of the report, DYSPNOEA (Shortness of breath), BONE PAIN (bone pain), BACK PAIN (Back pain), STOMATITIS (Sores in mouth), PAIN IN EXTREMITY (overall arm pain), HEADACHE (Headache), ARTHRALGIA (Pain in elbow) and FATIGUE (Fatigue) outcome was unknown.            Per reporter, the patient received a COVID test and awaiting result. No concomitant medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-070003 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-070003:
Initial misuse report received from a healthcare professional on 20 January 2014 and at the agency on 21 March 2014. A patient over 14 years of age of unknown gender had received FLUZONE 0.25 ml instead of 0.5 ml. The patient received incorrect dose of FLUZONE. No adverse event was reported. The list of documents held by sender: None.
it felt like my head would pop off at one point; hearing muffled; left ear was clogged and ringing; This is a spontaneous report from a contactable consumer. A 60-year-old non-pregnant female patient received dose of bnt162b2 (PFIZER BIONTECH COVID mRNA VACCINE, solution for injection, Lot Number: EN6205), via an unspecified route of administration, administered in arm Left on 27Feb2021 at 12:00 as SINGLE DOSE for covid-19 immunization. Medical history included Acid Reflux and known allergies to Bananas. The patient had no other vaccine in four weeks. Concomitant medication(s) in two weeks included rabeprazole (RABEPRAZOLE) taken 20 mg dose for an unspecified indication, start and stop date were not reported.The patient reported that about 28 hours after the vaccination her left ear was clogged and ringing and then both ears were clogged, and it felt like her head would pop off at one point. The patient was literally thought that she was going deaf. This had never happened to her before. It has gotten better at about 34 hours in, but left ear still feels clogged and hearing muffled. On 28Feb2021 at 16:00, the patient experienced hearing muffled and it felt like my head would pop off at one point and left ear was clogged and ringing. The patient not had covid prior vaccination; not tested covid post vaccination. The patient did not receive any treatment for the events. The outcome of the events is recovering.   No follow-up attempts are possible. No further information is expected.