chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse practitioner refers to 18 patients who might have been vaccinated with doses of RECOMBIVAX HB (Lot # H011183, expiration date 31-JAN-2015) that were exposed to 31F for accumulative of 1 hour and 30 minutes between 04-OCT-2013 and 10-OCT-2013. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
swelling of the underside of the right arm; redness of the underside of the right arm; tenderness of the underside of the right arm; soreness when lifting the right arm; Information has been received from a physician via a field employee referring to a 66 year old female patient. The patient's concomitant medication and drug allergies were not reported. History vaccine included pneumococcal 13v conj vaccine (crm197)(PREVNAR 13) on 15-MAR-2018 and the patient had no adverse reaction following administration of pneumococcal 13v conj vaccine (crm197)(PREVNAR 13).     On 20-MAR-2019, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # R033343, expiration date 03-AUG-2020; route, strength, dose and frequency were not reported) in the right deltoid for prophylaxis.   On 22-MAR-2019, the patient returned to the office with swelling, redness, tenderness of the underside of the right arm and soreness when lifting the right arm.      The outcome of the events was unknown. The causality between the events and Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23) was not reported.
No additional AEs; the improperly stored vaccine was administered on 08/19/22; This spontaneous report was received from a nurse and refers to a patient of unknown gender and age. The patient's concurrent conditions, medical history and concomitant therapies were not provided.   On 19-AUG-2022, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) syringe,  lot # T029522, expiration date 13-MAR-2023 (dose, route of administration and anatomical location were not provided) for prophylaxis (product storage error). The suspect vaccine was stored at a temperature of -39.8 Fahrenheit (F) for 3 hours and 27 minutes. There was no previous temperature excursion. No adverse events were reported (no adverse event).
no adverse event; The patient was inadvertently administered a dose of VARIVAX that had been improperly stored; This spontaneous report was received from a practice manager concerning a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was not provided.  On 10-MAR-2020, the patient was inadvertently administered a dose of varicella virus vaccine live (oka/merck) (VARIVAX), lot number S021322, expiration date 09-JUL-2021 for prophylaxis (dosage schedule, anatomical location and route of administration were not reported) (product storage error). The vaccine was reconstituted with properly stored diluent MRK (lot number and expiration date were not reported).  The administered dose of the vaccine experienced a temperature excursion of (-8.3C) for 24 minutes, as recorded by a data logger. No previous temperature excursion was reported. There was no adverse effect reported.; Sender's Comments:  US-009507513-2003USA005878:
Pt got injection on 8/21/13. She mentioned she had an excruciating itch in the middle of her back for a few days. No rash ws seen by husband. One day, use a back scratcher felt a pain and itch went away.
Patient has major take to smallpox vaccination with multiple autoinoculation sites (x6) around original site.
At 1651, patient was in recovery area and sustained a period of syncope lasting roughly 10-15 seconds. Patient awoke slightly disoriented and diaphoretic. Symptoms resolved in 30 minutes
A report has been received from a Physician concerning multiple subject of unknown gender, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on 08-DEC-2014.It was reported that patients received FLUMIST Quadrivalent that was subjected to a temperature excursion above and below the recommended storage temperature range. The outcome of the event of multiple patients received FLUMIST Quadrivalent exposed to temperatures above and below the recommended temperature range was unknown. The report was considered to be non-serious.
Left upper arm pain, swelling, redness for 24 hours treated with rest, ice, NSAIDs, BENADRYL OTC.
Progress Notes Nurse Practitioner Patient is a 65 y.o. male  Date:  4/20/2022 CC: Chief Complaint Patient presents with ? Generalized Body Aches      ASSESSMENT AND PLAN 1. Arthralgia after vaccination -     predniSONE (DELTASONE) 2.5 MG tablet; Take 1 tablet by mouth Daily for 90 days Please take dose between 5 to 10 mg that mitigates symptoms..  Dispense: 90 tablet; Refill: 3 -     predniSONE (DELTASONE) 10 mg tablet; Take 1 tablet by mouth Daily for 90 days Please take dose between 5 to 10 mg that mitigates symptoms..  Dispense: 90 tablet; Refill: 3 -     predniSONE (DELTASONE) 5 mg tablet; Take 1 tablet by mouth Daily for 90 days Please take dose between 5 to 10 mg that mitigates symptoms..  Dispense: 90 tablet; Refill: 3   2. History of autoimmune disorder -     predniSONE (DELTASONE) 2.5 MG tablet; Take 1 tablet by mouth Daily for 90 days Please take dose between 5 to 10 mg that mitigates symptoms..  Dispense: 90 tablet; Refill: 3 -     predniSONE (DELTASONE) 10 mg tablet; Take 1 tablet by mouth Daily for 90 days Please take dose between 5 to 10 mg that mitigates symptoms..  Dispense: 90 tablet; Refill: 3 -     predniSONE (DELTASONE) 5 mg tablet; Take 1 tablet by mouth Daily for 90 days Please take dose between 5 to 10 mg that mitigates symptoms..  Dispense: 90 tablet; Refill: 3   Patient currently taking 10 mg daily to control symptoms. Recently ran out of medications and was hopeful he would not need to resume, but generalized arthralgias and myalgias returned.  He would like to trial 7.5 mg daily.  He would also be interested in trying 7.5 mg and 10 mg regimen every other day; medication ordered in various dosage amounts to allow for patient to trial dosing regimens.  Unable to be seen by rheumatology until Jan '23.  Will continue to monitor for exacerbations.
Body aches; Lymph node swelling under left arm; headache; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the arm left on 03May2021 at 10:45 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension. Concomitant medications included losartan (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04May2021 at 02:00, one day after vaccination, the patient experienced body aches, lymph node swelling under left arm and headache. The clinical outcome of the events body aches, lymph node swelling under left arm and headache was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Flushed. BP 110/58 (pulse 78). O2 sat 98%.
administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not reported. Number of doses administered was 102 doses. The vial did not undergo any temperature excursions. Treatment medications was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up contains non significant information.
the patient came out with a severe case of eczema.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 76 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 31Jan2021 (Lot number: EL9262) at the age of 76 years as dose 1, single and administered in arm right, administration date 21Feb2021 (Lot number: EL9266) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Heart condition" (unspecified if ongoing). Concomitant medication(s) included: ENTRESTO taken for cardiac disorder (ongoing); FUROSEMIDE taken for cardiac disorder (ongoing). The following information was reported: ECZEMA (non-serious) with onset Mar2021, outcome "not recovered", described as "the patient came out with a severe case of eczema.". The event "the patient came out with a severe case of eczema." was evaluated at the physician office visit.  Additional information: The patient began concomitant medications two and a half years ago. Relevant Family Medical History was none. Relevant Tests was none. The patient received first dose about 1300 or 1400 and second dose about 1100. The patient did not receive any other vaccines within 4 weeks of vaccination. The patient did not experience any AR following prior vaccinations. It was reported that severe case of eczema was worsened.  No follow-up attempts are possible. No further information is expected.
My arm was sore; I got a knot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (My arm was sore) and VACCINATION SITE NODULE (I got a knot) in a 63-year-old male patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced PAIN IN EXTREMITY (My arm was sore) and VACCINATION SITE NODULE (I got a knot). At the time of the report, PAIN IN EXTREMITY (My arm was sore) and VACCINATION SITE NODULE (I got a knot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were reported. Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Followup information received on 28 Jun 2021 and updated the outcome of the event.
Site of DTAP injection became red, swollen, and tender to touch. Left thigh measured 12" and right thigh measured 11" on 8/31/00.
I started to feel a sharp pain in my left arm when I moved my arm in certain positions. I was thinking I strained or pulled something and was giving it time to heal. This went on for a month and did not resolve itself with stretching. I went to see a chiropractor on May 19, 2021 visited twice a week for eight weeks. Doctor diagnosed me with AC joint issue. There was little or no improvement. Please note that I also visit a massage therapist every 3-4 weeks and have done so for over 10 years. Between the two of them I was still not seeing any results. I then went to Dr. who is an osteopathic doctor who diagnosed me with frozen shoulder. I had two sessions with him with minimal improvement. I continued to do all the exercises the doctors prescribed. I bought a handheld electric self massager to use on my shoulder, arm and back area and use it 3-4 times daily. This provides some relief but still no improvement in mobility or pain when I move my arm in certain positions as of 8/8/2021.
09/02/22 presents to ED for "fatigue". PMHx of "CP,  SPC, DM, nephrolithiasis"
I am in menopause, with my last period in April of 2021. My only menopausal symptom was frequent hot flashes. The hot flashes stopped immediately with the bivalent booster in September, 2022.  Shortly thereafter, I began having strong premenstrual symptoms (swollen and tender breasts, bloating, clear vaginal discharge, headaches, feeling of malaise). These symptoms were more severe than I used to experience prior to menopause. After three and a half weeks of hormonal symptoms, I had a period. I am now on my third menstrual cycle since the vaccine. I still have not had another hot flash.
Information has been received from a physician concerning an 18 year old female with no pertinent medical history or drug reactions/allergies, who on 10-AUG-2006 was vaccinated intramuscularly with HPV rLi 6 11 16 18 VLP vaccine (yeast) (0.5 ml) (lot#653650/0702F).  Concomitant therapy included ethinyl estradiol/norgestimate (TRINESSA).  On 10-AUG-2006 the patient experienced multiple episodes of vomiting.  Unspecified medical attention was sought.  Subsequently, the patient recovered from the vomiting within 48 hours.  Additional information has been requested.
patient said 4 to 5 days after the vaccine, she went to the hospital and had blood clots in the lungs and legs. she said she's ok now and dr told her to get her second vaccine today.  she is now on Eliquis.
Red, raised, hot, peeling, almost had a scald effect. Rt arm. 6" long area. Itchiness.
This spontaneous report as received from a pharmacy technician refers to a female patient of unknown age who was being hospitalized since an unspecified date for pancreatitis. The patient did not have drug reactions/allergies. On 11-APR-2014, the patient was vaccinated with PNEUMOVAX 23 (lot # J010332, lot number 14-JAN-2015) (dose and route were not reported) during the hospitalization in her upper arm. Concomitant medical history was not reported. In approximately April 2014, the patient experienced a streak going down the arm in which she was administered PNEUMOVAX 23. The patient was diagnosed with cellulitis. It was unspecified by pharmacy technician whether hospitalization was prolonged by cellulitis. The outcome of the event was unknown. Additional information has been requested.
Patient received the vaccine on 9/18/21 and had nothing to report at that time in regards to adverse events or side effects. About a week after receiving the vaccine he noticed a small bump and bruising in the location of where he received the vaccine. It is not painful, hot, and there is no discomfort according to the patient. The bruising started dark purple in that one spot and has slowly started to dissipate along with the bump decreasing in size.
Noted swelling/erythema of right thigh severe that improved after 48-+2 hours post injection , no systemic signs, no fever.
2 days after vaccination patient developed fatigue, anger, irritability, tremors, balance issues, trouble with fine motor skills, slurred speech, burning in chest, tinnitus
No additional adverse event reported; 21 year old patient given RECOMBIVAX HB Dialysis Formulation in error; This spontaneous report as received from a pharmacist refers to a 21-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 02-APR-2021, the patient was vaccinated with the first dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) dialysis formulation in error, lot # T020448, expiration date 13-APR-2023 (exact dose, route of administration and anatomical location were not reported) for prophylaxis. No additional adverse event was reported.
BREAKTHROUGH CASE : Pt. states that after receiving the 3rd dose of Moderna 08/16/2021 (Prior 1st and 2nd dose given) Covid + 12/27/2021
No Adverse event; had an administration error for a pediatric patient who was supposed to receive a Moderna bivalent booster dose but received the monovalent Moderna booster dose instead.; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (had an administration error for a pediatric patient who was supposed to receive a Moderna bivalent booster dose but received the monovalent Moderna booster dose instead.) and NO ADVERSE EVENT (No Adverse event) in an 11-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018C22A) for COVID-19 prophylaxis.     There was no parental vaccine exposure.  Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 1), PFIZER BIONTECH COVID-19 VACCINE (Booster) and PFIZER BIONTECH COVID-19 VACCINE (Dose 2). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 03-Dec-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Dec-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (had an administration error for a pediatric patient who was supposed to receive a Moderna bivalent booster dose but received the monovalent Moderna booster dose instead.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (had an administration error for a pediatric patient who was supposed to receive a Moderna bivalent booster dose but received the monovalent Moderna booster dose instead.) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (had an administration error for a pediatric patient who was supposed to receive a Moderna bivalent booster dose but received the monovalent Moderna booster dose instead.).    Concomitant product use was not provided by the reporter. Care Team HCP stated that they had an administration error for a pediatric patient who was supposed to receive a Moderna bivalent booster dose but received the monovalent Moderna booster dose instead. The incorrect product was administered on 3-DEC-2022 from Moderna monovalent (0.25 mL dose) lot # 018C22A, expiration date: 9JAN2023. The patient has previously received 2 primary doses and 1 booster dose of the Pfizer COVID-19 vaccine. No adverse reactions have been reported by the patient at this time. No treatment information was provided.
tension headache; soreness in her arm; feeling tired; This is a spontaneous report received from a contactable consumer (patient herself). A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  Caller mentioned that she was allergic to metronidazole (FLAGYL) but didn't say what kind of reaction she had before. Patient stated that she received her 1st dose of the Pfizer Covid Vaccine yesterday and in the afternoon she experienced some side effects such as soreness in her arm, feeling tired, and tension headache. She said that she was now feeling fine except for the headache which she still had until now. She didn't experience any other AE aside from the ones she mentioned. Patient wanted to know if she can take BC Powder for her headache since it was the only thing she has and was already advised during vaccination not to take it until she's completed her vaccine doses. Outcome of tension headache was not recovered, and outcome of other events was recovered on an unspecified date.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Injected subcutaneous instead of intramuscular. Patient developed red itchy area unclear at this time how soon. She called on 5/15/2018 12:49 stating circular, red, itchy area. Patient seen Dr. on 5/16/2018 placed on doxycycline hyclate 100 MG. Doxycycline hyclate 100 MG and prednisone 10 mg three times daily. Prednisone 10 MG Take one tab po tid.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 28-DEC-2012 the patient was vaccinated with a first dose of GARDASIL (intramuscularly, dose, lot#, expiration date not reported). On 07-MAR-2013 the patient was vaccinated with a second dose of GARDASIL and will receive the third dose on 17-APR-2014. No adverse effects were reported. Additional information has been requested.
This case was reported by a healthcare professional who was also the subject and described the occurrence of twitch in an adult male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On 16 August 2010 the subject received 2nd dose of ENGERIX B (unknown). On 16 August 2010 the subject received 2nd dose of ENGERIX B (unknown). On 16 August 2010, less than one day after vaccination with ENGERIX B, the subject experienced "twitches in joints". On 17 August 2010, one day after vaccination with ENGERIX B, the subject experienced complete loss of mobility in his right arm, edema and "heated area" in joint. On 18 August 2010, two days after vaccination with ENGERIX B, the subject experienced inability to focus. On 20 August 2010, four days after vaccination with ENGERIX B, the subject experienced pain which spread to his left knee. The healthcare professional considered the events were disabling. At the time of reporting the events were unresolved. The healthcare professional considered the events were possibly related to vaccination with ENGERIX B.
15MAY redness & welts around inject site; temp 16MAY pt to immediate care approx 1PM; t100 rash, swelling local rxn around inject site 3x6 cm w/annal border, inc warmth; rx DPH; referred to family MD; resolved approx 4 days/mom;
HEADACHE; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced headache, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and fever was not reported. This report was non-serious.
Sore arm; This is a spontaneous report from a Pfizer Sponsored Program from a contactable consumer (patient's husband). A 65-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not available), via an unspecified route of administration, in left arm on 08Apr2021 at 12:30 or 13:00 (at the age of 65-years-old) as a single dose for COVID-19 immunization. The patient's medical history was reported as none. The patient's concomitant medications were not reported. No other vaccine was given in four weeks. The patient experienced sore arm on 09Apr2021. The patient did not receive any treatment for the event. The outcome of the event was not recovered.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Patient is a new patient. Patient reports left arm numbness and weakness after receiving 2nd dose of COVID-19 at a different facility on 7/3/21