chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies and past drug reactions/allergies were not reported. On 03-AUG-2017, the patient was vaccinated with a dose of M-M-R II 0.5 ml, subcutaneously, lot # N014485 with expiration date: 10-MAY-2019 (anatomical location was not reported) for prophylaxis; and with a dose of VARIVAX  0.5 ml, lot # N020016 with expiration date: 17-JUL-2019 (route and anatomical location were not reported) for prophylaxis. Other suspect therapies included sterile diluent (MERCK STERILE DILUENT). The reporter stated that on 02-NOV-2017, the patient inadvertently received an extra dose of M-M-R II; and an extra dose of VARIVAX. No adverse effects were reported.
I experienced severe pain at the injection site, which was different than previous vaccines. That started approximately 12 hours following injection. I also experienced low-grade fever and mild flu like symptoms 24 hours following injection. I awoke 36 hours after my injection with severe pain in my left arm pit and breast as well as worsening pain in my left arm at the injection site. I also had pain on the left side of my neck and back. The lymph nodes in my left armpit and breast were enlarged and  painful for 8  days following the booster.
2/28/22 pt brought to ED with increasing SOB and productive cough; poor oral intake; found to be positive for COVID; CXR showed LUL and RLL pneumonia; started on steroids, Remdesivir, ABX; pt had persistent tachycardia, cardiology consulted, medication given; pt decided to not pursue treatment measures; dc'd to home with hospice; pt passed away at home
This lot number expired in the refrigerator on 1/17/2022. It was failed to be taken out of the refrigerator after 1/17/2022 and was given to this patient on 1/24/2022.
Client here for immunization to "catch up" series for immigration purposes. Nurse gave client a second TDaP instead of the needed "TD". 1 misadministration (No event)
Patient was sitting in the chair and a minute or two after administering both vaccines he slouched over and passed out.  He had a difficult time coming around and he was pale and white.  The ambulance was called and patient was taken to the hospital to be checked out.  He was OK and coherent by time the ambulance came.
A Pharmacist was supposed to give Fluarix, however accidentally grabbed and administered Fluzone High Dose Quadrivalent to 13 separate patients on different days with no adverse event; Initial information received on 15-Nov-2020 regarding an unsolicited valid non-serious case received from an other health professional (pharmacy manager) via call center.  This case is linked to cases 2020SA323795, 2020SA323899, 2020SA323872, 2020SA324116, 2020SA323616 and 2020SA323597 (same reporter).  This case involves a 54 year old male patent for whom it was reported that a pharmacist was supposed to give fluarix, however accidentally grabbed and administered influenza quadrival a-b high dose hv vaccine [Fluzone High-Dose Quadrivalent] to 13 separate patients on different days (wrong product administered, latency: same day) on 09-Nov-2020 (batch number: UJ567AB and expiration date: 30-Jun-2021) at a dose of 0.7 ml once via intramuscular route in the left arm for prophylactic vaccination.  Medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  This was an actual medication error case due to the event extra dose administered (latency: unknown).  At the time of reporting, no adverse event was reported.  No laboratory data was reported.  Disclaimer: 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.
Patient received Janssen COVID19 vaccine (LOT#1802068) at approximately 12:00 pm on 3/16/21. During the 15 minute observation period, she expressed "I don't feel good" and endorsed nausea. Shortly thereafter at approximately 12:10 pm, she started to slouch and nearly fainted while sitting in a chair. She did not fall or hit any part of her body. She was easily aroused with a touch on her arm and responded to verbal questions within seconds (less than a minute). She denied trouble breathing or chest pain. She then reported nausea again and was offered a receptacle to vomit in if needed; however, she did not vomit. Patient was encouraged and instructed to sit on the floor to prevent injury in case of fall but she refused stating that she didn't think she would be able to get back up given her preexisting knee problems. Pharmacy staff offered her water, a fan, and opened windows. Her jacket was removed in order to monitor blood pressure/ pulse, which was not abnormal. Patient did not have any trouble breathing, rash, swelling, abdominal cramps, or mental status changes. She was contacted via phone a few hours later for follow up on the incident, at which time she denied any issues and reported feeling well.
Numbness/tingling in both checks, lips, tip of tongue approximately 30  mins after vaccine, improved with Benadryl 50 mg, similar symptoms 4 hours later which again improved with Benadryl
Very high tempurature occured one week after receiving vaccination.  No other symptoms, was not an ear infection or strep throat (was seen by doctor).  Did not have any rashes or other skin occurrences.  The temperature ranged from low grade, to in excess of 105 degrees.
Within 2 hrs of vax, pt started feeling dizzy and developed a fever. He also had abdominal cramping and states he is passing a great deal of gas per rectum. Eyes were dry & itchy and he had a headache. Dry eyes stopped next day, however, other symptoms remain like fatigue.
1st dose March 23rd 2017, 2nd dose on June 28th 2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number 299J9, expiry date 1st July 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 23rd March 2017 in an unknown facility).   On 28th June 2022, the patient received the 2nd dose of Shingrix. On 28th June 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 28-JUN-2022 Reporter's Comments: The pharmacist reported that the patient received second dose late. The reporter did not consent to follow up. Additional Supportive Information: The patient received the second dose later than the recommended interval, which led to lengthening of vaccination schedule. The Vaccine Administration Facility is the same as primary reporter.
2 mins after vaccination, pt experienced anxiety, elevated BP, palpitations.  Pt w/ hx of eclampsia and HTN. Monitored BP until asymptomatic.  Pt stable and released from vaccination site.
8MAR96 approx 830AM as best mom can remember noted fine red rash on trunk w/t101;9MAR96 lips swollen inside out, penis swollen, c/o sore mouth;swelling rt hand, quarter size red areas face & neck, red area also on rt hand;Augmentin started
A non-serious spontaneous report of we gave 14 doses of expired FLUMIST of was received from a health professional concerning an 11-year-old female. Neither the patient's medical history nor concomitant medications were reported. The product expired on 22-Jan-2012. On 27-Jan-2012, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
59 Y female with history of hypothyroidism presenting with fever, cough, and fatigue, admitted for covid pneumonia.   COVID PNA/ AMS/ Fever. Pt p/w fever, cough, fatigue, x1wk, found to be covid+ in ED (7/12), p/w mild leukocytosis, fever 101.4, and elevated inflammatory markers. Pt s/p 2L IVF, and started on decadron 10mg in ED given desaturation to mid 80s w/ ambulation. CXR: w/o acute disease. Pt also p/w  and transient vision loss in setting of high fever (106), suspect symptoms 2/2 fever, no recurrent episode. Per neurology, no indication for further imaging or workup at this time. Given high fever 106 and tremulousness on admission concern for other etiologies of fever. TSH 0.4 wnl. Psych meds initially held given concern for serotonin synd, however given pt improvement w/ <24hrs of holding meds, and no recent dose changes, will restart. Pt w/ 1/2 Bcx + staph simulans, likely contaminant per ID, initially started on vanc (7/13-7/14), will dc. Worsening leukocytosis likely 2/2 known side effect of steroid use. Inflammatory markers downtrending. Overnight pt w/ episode of desaturation to 87% on ambulation to bathroom, this AM satting 94%. decadron 6mg daily for total tx 10d (7/12-); trend inflammatory markers every other day; Lovenox 40mg SQ BID (BMI>40) and hold for Plt <25k, Fibrinogen <100, active bleeding; Hypothyroidism  Last TSH 0.4 on 7/13/21. On PTA levothyroxine 25mcg daily. continue PTA levothyroxine 25mcg daily
"round like sore in mouth"; This spontaneous case was reported by a pharmacist and describes the occurrence of ORAL PAIN ("round like sore in mouth") in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ORAL PAIN ("round like sore in mouth"). At the time of the report, ORAL PAIN ("round like sore in mouth") 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 medication provided.  No treatment medication provided.
1638: Lightheadedness - Reports happening with 1st shot as well. BP 136/60.  HR 53.  Given water.   1651: no symptoms BP 111/86, HR 54 1705: Hands colder than normal 1708: observed for 30 minutes; BP 127/68; HR 53; still cold hands.  off balance, neck pain.  1717: continues to report feeling off and didn't wan tto leave.  moved to chair for more observation and given crackers.  1726: Warming up, felt normal, felt okay to leave. Release home.
Left check numbness, NO tingling noted.   Resolved approximately in about 15 hours with no medical intervention.
Redness from site of injection down to elbow, swelling, knot at site, soreness. Heat in red area. Used Tylenol, clarinex and ice.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 07-NOV-2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) prescribed and/or administered by a pharmacist at a pharmacy for the long-term prevention of shingles and/or zoster-related conditions (dose, route, and lot # not provided). Subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by physician for shingles. As a direct and proximate result of patient's use of zoster vaccine live (ZOSTAVAX), the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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 include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of shingles (herpes zoster) was not recovered. The event was considered to be related to the suspect vaccine.
Case number PHEH2014US019829 is an initial spontaneous report received from a pharmacist on 29 SEP 2014 with a follow up report received from the pharmacist on 28 OCT 2014. This report refers to a 16 years old male patient. His concomitant medication was none. His past vaccination was well tolerated (unspecified vaccine). On 28 SEP 2014, he received initial application of FLUVIRIN 2014/2015 (batch number: 1413501) intramuscularly at a dose of 0.5 ml. It was reported that the patient received FLUVIRIN after excursion below recommended temperature but not frozen. No adverse event was reported following this administration error (incorrect storage of drug).   Follow up report received from the pharmacist on 28 OCT 2014: Updated past vaccination details (unspecified vaccine well tolerated)., vaccination details (initial application) and vaccine does (0.5 ml).
1 shot - By the evening of that day, came home feeling exhausted, headache, took tylenol and slept for 11 hrs.  Next day felt less tired and weak but felt normal again by the following day,  2nd shot - Next day had strong headaches, took 600mg tylenol around the clock for 3-4 days. Symptoms include headaches, motion sickness, exhaustion, difficulty breathing which lasted for 7 days.  After 1st shot, I haven't had my period which is now almost 3 months.  Since my 1st shot, I've been having hot flashes and vaginal dryness.  I was thinking these symptons were due to stress but it doesn't explain vaginal dryness.  So my dr ordered menopause blood test.  My FSH level is at 54mIU/mL.  I just started all these symptons after my 1st vaccine shot and my FSH level is very high already.
Nausea, vomiting, fatigue, low-grade fever (<100 degrees)
Sometimes similar to the feeling she had when she had shingles in the past; She says it feels like period symptoms; This is a spontaneous report received from a contactable consumer  (patient's husband). A 59-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 06Apr2021 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunization. Medical history included shingles. The patient's concomitant medications were not reported. The patient has developed issues on Apr2021, she says it feels like period symptoms and sometimes similar to the feeling she had when she had shingles in the past. They recently read of possible side effects that include the vaccine possibly stimulating previous auto immune issues. Should she get the 2nd shot or visit with physician before receiving? The outcome of the events was unknown.  Information on the lot/batch number has been requested.
First dose of Moderna COVID-19 vaccine given 1/7/21. Second dose of Moderna COVID-19 vaccine given 3/8/21. No adverse effects noted after vaccination. Resident was on hospice care since 2/27/2021 with poor food and fluid intake prior. Admitted to hospice with hypokalemia, failure to thrive.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2022 at 1:55 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 20-Jan-2022 at 1:55 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. On 16-Dec-2021 vial was initially stored in the refrigerator. 5 doses of the Moderna COVID-19 Vaccine were given past the beyond use date of 15-Jan-2022. The vial was still in the fridge and expired. The patient notified of error and that a repeat vaccine was not required. Patient denies any adverse effects. The vial did not undergone any temperature excursions. Treatment information was not provided.
pt rec'd grey cap pfizer vaccine after it was stored i freezer for 22 days- as of now pt is 22 weeks pregnant. will come in at somepoint for replacement dose
Pt notes her menstrual period has gone on for 16 days, which is unusual for pt.  Her period started on 8/9/21 and continues to today (8/25/21).  Pt is worried that this could be r/t her COVID Vaccine that she got on 8/11/21.    Pt's Nexplanon was placed on April of 2021.  It is unclear if this is r/t her recent Nexplanon placement vs other cause.
Moderna COVID-19 Vaccine EUA - Dose 2 Beginning 8 hours after shot (adverse reaction to first dose began 12 hours after shot), headache, fever, chills, fatigue, terrible all-over body aches, joint pain. Within 24 hours, developed rash on arm near injection site, with blisters and itching, followed by all-over body itching - but no rash other than on arm. This made me and my doctor consider that the first dose likely had a lingering similar effect, because from the time of the first dose I had unexplainable body itching with no rash, moving from place to place, in strange places like mons pubis, elbow pits, breasts, palms of hands/feet, scalp, leg creases, ears, eyeballs, neck...for the entire month. It was just resolving when I got the second vaccine, and the itching flared again...again with no rash EXCEPT at vaccine site. We believe I am having not only an immune response to the vaccine but also some kind of allergic reaction.
Toddler received vaccinations on 6/9/06.  Mother took toddler to Dr. on 6/16/06 because of elevated temperature of 104 since 6/14/06.  Mother relates temperature peaked at 106 Friday night and toddler became lethargic with no further fever.  On 6/18/06, was seen in ER at hospital because toddler was "very sleepy" and was told it was due to shots.  Seen on 6/19/06 and was told lab work showed toddler had viral infection.  Had appointment to see Dr. on 6/21/06. 8/9/06 Received medical records from hospital which reveal that patient was in ER on 6/18 for fever & vomiting.  Had started Augmentin on 6/16 for fever & probable OM but patient spilled & vomited most of med.  Recephin IM was prescribed but patient left ER before receiving.  on 6/21 patient was admitted to hospital w/irritability, dectreased appetitie, fever, weakness, photophobia & rash. LP done.& was WNL.  Admitting dx: encephalitis, possibly due to MMR vs viral.  Improved overnight, afebrile, rash fading & was d/c later that day to be w/u as outpatient. 8/15/06 Received medical records from PCP.  Recheck on 6/27 showed patient much improved.  Final dx: encephalopathy, resolved, likely secondary to MMR.
Patient reportedly received COVID vaccine doses on 1/23 and 2/15, but we are unsure of which manufacterer or lot number.  Patient admitted to our hospital on 3/9/2021.  Patient presented with elevated D-dimer with concern for septic shock.  Ultrasound of patient revealed no VTEs.  COVID test on 3/10 resulted POSITIVE.  Patient was going to require vasopressors but patient requested to go on comfort measures only.  Patient ordered comfort measures on 3/10 and pronounced deceased on 3/18.
Did not feel well after vaccine; This is a spontaneous report from a non-contactable consumer. A male patient of an unknown age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patients' medical history and concomitant medications were not reported. On an unknown date, the patient did not feel well after he received the vaccine. The clinical outcome of the event did not feel well after vaccine was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
got redness; This is a spontaneous report from a contactable consumer (patient). A 81-year-old patient of an unspecified gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for immunisation. The patient medical history and concomitant medications were not reported. It was reported that when the patient got the pneumonia shot, the patient also got redness but it run away. The outcome of the event was recovered on unknown date.  Pfizer is a marketing authorization holder of pneumonia shot in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumonia shot has submitted the same report to the regulatory authorities.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I felt drastically more depressed than usual after at least 24 hours received the vaccine. I am not sure whether it is due to the vaccine or any other factors. While I felt very bad these two days, I still consider the symptom to be very slight because no suicidal thoughts or full immobility has occurred.  I cried for almost one day and slept even less than usual (about 1 hour, usually sleep for about 4 hours for 3 months). I was not very mobile.  Two or three years ago, I had same symptoms with similar severity immediately after I took cough syrup from supermarket. Therefore, I suspect there might be some very rare medical interactions going on. To save myself, I tried to talk to people, walked and exercised a bit, and monitoring my thoughts to see if I need to go to the ER. On the second day, the mood was still very down but I feel I can make it to Wednesday for my regular counseling appointment.
trouble sleeping; This spontaneous case was reported by a consumer and describes the occurrence of POOR QUALITY SLEEP (trouble sleeping) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY SLEEP (trouble sleeping). At the time of the report, POOR QUALITY SLEEP (trouble sleeping) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-034892 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: No specific follow-up information recorded.
L arm became red, swollen and painful 36 hrs post Varivax vaccination - dx with cellulitis and treated with Duricef.