chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fluzone Quadrivalent High Dose Medication Error as the patients being under the age of 65 at time of vaccination with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via Medical Information (Reference number- 00370469) and transmitted to Sanofi on 24-Nov-2020.  This case involves a 60 year old male patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  On 11-Nov-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number unknown strength standard) at a dose of 0.7 mL via an intramuscular route in an unknown administration site prophylactic vaccination as a medication error as the patient being under the age of 65 at time of vaccination (product administered to patient of inappropriate age and incorrect dose administered).  It was a actual medication error due to Inappropriate age at vaccine administration.   The Nurse Practitioner reported that a staff member administered the incorrect doses due to not paying attention to what was being given and to whom it was being given to and that there is limited information due to the caller not having the information.  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.   There will be no information regarding the batch number for the case.
Case number PHHY2013US020534 is an initial spontaneous report received from a nurse on 30 Sep 2013 with a follow-up received on 25 Feb 2014. This report refers to a 35-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with 0.5 ml intramuscular dose of FLUVIRIN (batch number: 1308401, expiry date: Mar 2014) into her deltoid which was placed in room temperature on 27 Sep 2013. It was reported that the nurse was not there when the shipment arrived and it was placed on desk and hence the vaccine in shipping container was placed in room temperature for 72 hours. No adverse event was reported following the medication error. Follow-up received from a nurse on 25 Feb 2014: Site of vaccination and patient's demographics updated. Date of vaccination amended.
Patient experienced syncope episode after receiving 11 yr. vaccinations in our office. Patient waited in our office for 15 minutes. Upon leaving, patient felt nauseated and vomited x 3. Patient slept well and was fine rest of evening.
Went on a walk on 6/8/21.  Had high heart rate about 178 BPM) the entire time.  After the walk, I could not breath well, the chest hurt, and I lost consciousness.  Went to the ER.
I did not have any adverse effects during the time of taking the vaccine however did develop an auto immune disorder about a month after the vaccine. Severe ulcerative colitis.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021 at 2:30 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Apr-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 32.93.  Concomitant products were not provided.  On 28-APR-2021, Excursion time was 09 AM. temperature was 33 respectively. total doses given for the day was 150, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 19-APR-2021, vial was moved to clinic on 28-APR-2021. 3 vials were sent to clinic. Vaccine BUD date was 19-MAY-2021. On 28-APR-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 33, 10 AM: 36, 11 AM: 40, 12 AM: 41, 1PM: 41, 2 PM: 39, 3 PM: 41 and 4 PM: 40.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
The patient is a 64 y.o. male with history of HTN, HLD, diabetes, schizoaffective disorder, GERD, presented to the Medical Center with generalized weakness found to be COVID positive.    Covid-19 Virus Infection Symptoms present on admission: Fever, weakness.  Date of covid positive test: 12/16/22 Vaccination status: vaccinated Imaging: CXR no acute process. Oxygen requirements on admission:  RA Medical therapy: ID consulted, held off on paxlovid but has strong interaction w/ clozaril and could affect levels; I feel risk outweighs benefit Consultants following:  Anticipated special isolation end date: 12/26   Generalized weakness Frequent falls  Secondary to COVID, possible dehydration, elevated lithium level   Brother reported he was very unsteady and falling at home PT/OT consulted, rec 2-3 days per week Family apprehensive about patient returning home without supervision given that he lives alone, but planning to make some arrangements so that he will have someone with him around the clock at least in the short term     Acute kidney injury, resolved  Baseline Cr 1.1-1.2 Up to 2.3 12/18 despite 1L IVF the day prior, likely dehydration pre-renal UA on admission unrevealing US w/o obstruction  Will DC fluids; encourage PO intake  Normalized day of DC Hold losartan at DC until seen by PCP in follow up  Lithium held, ok to resume at reduced dose at DC  Acute metabolic encephalopathy, fluctuating Unclear baseline mentation, however per brother generally independent w/ some assistance from home nurse Likely due to COVID/dehydration, elevated lithium level  CTH no acute process Reported urinary frequency (this is chronic, may have some DI from chronic lithium use) but UA negative Aox3, no focal deficit Delirium prevention measures, maintain sleep wake cycle  Remains impulsive and forgetful but seems to be close to BL day of DC   Schizoaffective disorder, bipolar type Recently seen by BH day prior to admission Resumed home medications Clozapine, Lithium, ativan.  Lithium level elevated at 1.4-- > 2.9; now improved . Likely related to dehydration.  BH consulted. Resumed clozaril at 400mg nightly (decreased from 450mg nightly)  Lithium held w/ AKI; discussed with doctor - recommend resuming at reduced dose 300mg BID Previously on Invega, last dose in 11/2022. Follow up w/ outpatient prescriber whether this should be continued    Essential hypertension Resume home meds Norvasc, metoprolol.  Losartan held w/ AKI and at DC given BP stable   Diabetes Mellitus Holding home canagliflozin at DC due to dehydration, recent AKI BG well controlled here A1c 5.9%   Abnormal US US renal/bladder 12/19: indeterminate polylocular cyst vs multifocal adjacent simple cysts R kidney Recommend MRI abd vs US at 4-6 mo to ensure stability
This spontaneous report was received from a medical assistant referring to a multiple unspecified patients. There was no information about the patients' concurrent conditions and medical history provided. The patients' concomitant medication included sterile diluent (MERCK) which was properly stored. On an unspecified date in December 2017, the patients' were vaccinated with an improperly stored dose of PROQUAD (dosage, frequency and route of administration were not reported), lot#: N013295 (expiration date: 28-APR-2019), lot#: N012489 (expiration date: 17-OCT-2018) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit (10.6 F) for 15 hours, as recorded by a data logger. The vaccines had not had any previous temperature excursions. There was no adverse effect reported. Lot number N013295 is an invalid lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live. This is one of four reports received from the same source. Sender's Comments: US-009507513-1802USA008842: US-009507513-1802USA008838: US-009507513-1802USA008839: US-009507513-1802USA008841: US-009507513-1802USA008836: US-009507513-1801USA014257: US-009507513-1802USA008837: US-009507513-1802USA008835.
At the time of vaccination it was indicated that this would be a booster dose for this patient. Upon submission of the record to IIS it was determined that the patient had 3 previous doses (2/6/21, 2/26/21 & 3/26/21).  In addition, the booster dose given on 10/25/21 was dosed at 0.5mL in error.  The patient has not experienced any adverse reaction per wellness director.
Chills for 2 hours, severe shreaking, followed by high temperature and sweating along with nausea for another 4 hours from 8:30 pm to approximately 2:30 am.  I thought that if I were in my 80's I would have died.
headache and jaw/tooth pain on left side only evaluated by EMTs Vital signs stable , neuros intact, lungs CTA
Rash over face within 24 hours of administration.  Treated with Benadryl and moisturizers.
The next day after the vaccine I was fine for most of the day, later i started with headaches and body aches and maybe a fever, expected side effects. Sunday 08/15/2021, I woke up with body aches, a sore throat and a runny nose, feeling like i had the flu. Monday 08/16/2021 I was still with these same symptoms. Tuesday 08/17/2021 I started to get a little worse, I woke up with a dry cough and sneezing attacks and mouth sores appeared on the tongue. Wednesday 08/18/2021 it was the same, but the sores started to get worse. Thursday I started to get better.
Pfizer hits harder than Moderna, and this wasn't as bad as 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Pfizer hits harder than Moderna, and this wasn't as bad as 2nd shot) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Day of the vaccine and day after were fine, also flu- life exhaustion for 2-3 days after, and fibromyalgia flared.), Pfizer (Day of the vaccine and day after were fine, also flu- life exhaustion for 2-3 days after and and fibromyalgia flared.). Past adverse reactions to the above products included Fibromyalgia with Pfizer; and Flu like symptoms with PFIZER BIONTECH COVID-19 VACCINE.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Pfizer hits harder than Moderna, and this wasn't as bad as 2nd shot). At the time of the report, IMMUNISATION REACTION (Pfizer hits harder than Moderna, and this wasn't as bad as 2nd shot) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications was reported.  The patient received Pfizer/ flu vaccine 1.5 weeks ago. The day of vaccination and day after were fine. The patient had flu- like exhaustion for 2-3 days after, and fibromyalgia was flared. The patient stated that, Day 4 was like magic was fine and also informed that Pfizer vaccine hits harder than Moderna, but it was not bad as 2nd Pfizer vaccine.  No treatment drug details was reported.
tested positive for COVID; This is a spontaneous report from a contactable consumer (patient herself) via Medical Information team. A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 20Jan2021 (Batch/Lot Number: EL3303) as the 1st dose, single for COVID-19 immunization. Relevant medical history included that the patient was exposed to COVID that same day she got her first dose on 20Jan2021 to an unknown date. There were no concomitant medications. The patient tested positive for COVID on 24Jan2021. Initially, the patient reported that her 80-year-old mother got the first dose of the Pfizer COVID-19 vaccine on 20Jan2021 and was infected the same day and was treated with the antibodies on 27Jan2021. The patient was told that her mother would have to start over again. The patient stated that her mother got the second shot on 29Apr2021 and was asking if this was her mother's second dose or was it necessary to get a third shot. The patient's mother was currently good and was asking if she was protected. The patient further stated that she herself was also exposed that same day, but she did not receive antibodies, so her doctor told her to get the second shot since she did not get antibodies. The patient clarified that she herself tested positive for COVID as well. She had her first dose, but she was younger and knew it would not be as bad for herself, so she did not get antibodies; she just let COVID take its coarse and so the next time when she was supposed to get the second dose she got it. The patient confirmed she also got her first dose on 20Jan2021 and she was also exposed to COVID that same day. The patient tested positive for COVID that Saturday (as reported). They went in and she had a rapid test; her mother did not test positive with the rapid test that day, but her mother tested positive on that Monday (25Jan2021). The patient further reported that she tested positive on 24Jan2021. The patient received her 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 10Feb2021 (Batch/Lot number: EL1283) for COVID-19 immunization. The outcome of the event was unknown.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions or concomitant medications was provided. On 18-MAY-2017, the patient was vaccinated with an improperly stored dose of VARIVAX that underwent a temperature excursion form 6 Fahrenheit degrees to 14 Fahrenheit degrees during 4 hours (lot # M012990 with an expiration date in 14-MAR-2018), for prophylaxis (dose, frequency, route and dose number were not provided) and was diluted with sterile diluent. No adverse effects were reported and no product quality complaint (PQC) was involved. There was no previous temperature excursion and the digital data logger was involved. Additional information has been requested.
no adverse effect; improperly stored PEDVAX HIB were administered/patient received one dose; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 15-APR-2019, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) injection, lot # R027320 with expiration date on 08-JUL-2021 (dose and route of administration were not reported) for prophylaxis. The vaccine underwent the temperature excursion of above 47 (55.4) degrees Fahrenheit for 10 hours 45 minutes and below 36 (34.4) degrees Fahrenheit for 20 minutes. Digital Data Logger was involved in recording of the excursion. No previous temperature excursions were reported. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA012614: US-009507513-1904USA012967: US-009507513-1904USA012968: US-009507513-1904USA012969: US-009507513-1904USA012970: US-009507513-1904USA012971: US-009507513-1904USA012972: US-009507513-1904USA012973: US-009507513-1904USA012974: US-009507513-1904USA012975: US-009507513-1904USA012977: US-009507513-1904USA012978: US-009507513-1904USA012979: US-009507513-1904USA012980: US-009507513-1904USA012981:
skin-chest-abd-lower extremities bilaterally scattered-maculopapular erythematous lesions-across lower abd-some vesicular, non pruritic;
Information has been received from a 22 year old female patient who is allergic to amoxicillin and had human papilloma viral infection.  On 25-APR-2008 she was vaccinated with a first dose of Gardasil.  She reported that approximately twenty minutes after vaccination she began to feel nauseous.  In addition, her vision was adversely affected.  She began to see black dots and then "everything went black" and she had a temporary total loss of vision for ten to fifteen seconds.  She reported that she laid down for ten minutes and she seemed fine after that.  The only other symptom she had been experiencing was abdominal cramping as of 26-APR-2008.  She had a colposcopy of the cervix on the same day she received the injection.  The patient reported to be recovering.  Upon internal review temporary total loss of vision was determined to be an other important medical event.  No further information is available.
Pt experienced fatigue / muscle aches / sore throat / chest tightness starting 6-8 hr after influenza vaccine. Sx's now persisting for 5 days - exam neg - strep screen - neg.
reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (reaction) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (reaction). At the time of the report, VACCINATION COMPLICATION (reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided.  No treatment medications provided.   Reporter did not allow further contact
Sore arm shortly after injection on 09/02/2020. On night of 09/02/2020 experienced:  Patient states she had Fever,  (did not take temperature) headache, body aches, Nausea, pain to back and legs. Fever of 101.1 on morning of 09/03/2020.  Patient took 200mg Ibuprofen on 09/03/2020 and symptoms improved. Offered appointment, she declined. Advised if symptoms return or worsen to seek medical attention.
Cardiac arrest - ED visit and hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
Patient called on 10/15 saying her arm still hurt.  She said that her arm normally hurts for extended period of times after her flu shot.  She said it hurts when she lays down and something if holding phones etc.  I called the MD for her but they wanted her to call the doctor.  I relayed information to pt.
Patient is a 12-year-old male who presents to the ED today (09/08/2021) with chest discomfort, shortness of breath, sore throat, and dizziness.  Patient received his second dose of the Pfizer COVID-19 vaccine on 9/7/2021.  Patient states that he was at school this morning in his math class when he noticed a sore throat and a sharp pain on the right side of his chest.  He also stated that, when he thought about it, he noticed he "was not breathing is much."  He does state he feels a little short of breath.  By way of history, patient did have reactive airway disease when he was around 5 years old, and was seen at the Jewish hospital in Denver.  He he has not had any issues with reactive airway disease since, but does have bronchitis occasionally.  Patient's mother expresses concern of the adverse effects in adolescent males that she had heard about with COVID-19 vaccination, including myocarditis and pericarditis.  Patient was on quarantine for exposure to COVID-19 until August 31, 2021.  He does state that several in his class are currently on quarantine as well.  Patient was diagnosed with multifocal pneumonia.   Patient was seen again on 9/28/2021 with repeat chest xray showing pneumonitis and was treated with steroids.  He was seen again in clinic on 10/18/2021 with ongoing exertional shortness of breath and treated again with prednisone 40 mg daily x 5 days.
30 minutes after PREVNAR vaccine, patient began to develop nausea, sweats and lightheadedness. 2 hours post vaccination, he had a witnessed syncopal spell and was unresponsive for 30 seconds. There was no convulsion, tongue biting, or incontinence. He felt better after he awakened. There was no shortness of breath, chest tightness, tongue swelling, abdominal pain, emesis or diarrhea. There was no local inflammation at the injection site.
Ears started ringing really loud/ aggravating her tinnitus; A spontaneous report was received from a Consumer concerning a 71- year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event ears started ringing really loud(tinnitus).   The patient's medical history was not provided. Concomitant medications reported included, alprazolam, albuterol inhaler, levothyroxine and zetia.  On an unspecified date in JAN 2021, approximately few hours prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 032L20A) via unknown route for prophylaxis of COVID-19 infection.  On an unspecified date in JAN 2021, it was reported that on the same night the mRNA-1273 vaccine got administered, the patient experienced the event "ears started ringing really loud" and since the day it happened off and on. The patient reports "she might be experiencing tinnitus". As per the report, the patient usually takes medication but stopped taking them because she thought they may be aggravating her tinnitus.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event(s) was unknown.  At the time of this report, the event ears started ringing really loud were considered not resolved.