chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Medication Administration Error. Patient received 0.25 mL of Moderna bivalent vaccine instead of 0.5 mL at office visit. When the error was discovered, the patient was contacted and returened to the clinic later in the day to receive an additional 0.25 mL for a full dose.
Vaccine beyond use date was 24-Mar-2023 , Dose was administered on 29-Mar-2023; No adverse event; Inadvertently administered an expired dose (beyond the BUD) of the monovalent vaccine to a patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Inadvertently administered an expired dose (beyond the BUD) of the monovalent vaccine to a patient), PRODUCT STORAGE ERROR (Vaccine beyond use date was 24-Mar-2023 , Dose was administered on 29-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 063B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 29-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Inadvertently administered an expired dose (beyond the BUD) of the monovalent vaccine to a patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine beyond use date was 24-Mar-2023 , Dose was administered on 29-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Inadvertently administered an expired dose (beyond the BUD) of the monovalent vaccine to a patient), PRODUCT STORAGE ERROR (Vaccine beyond use date was 24-Mar-2023 , Dose was administered on 29-Mar-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Inadvertently administered an expired dose (beyond the BUD) of the monovalent vaccine to a patient) and PRODUCT STORAGE ERROR (Vaccine beyond use date was 24-Mar-2023 , Dose was administered on 29-Mar-2023).    No concomitant medications were reported.  It was unknown whether the dose was the patient 1st or 2nd dose.  No treatment information was provided.
Patient called this morning (9/28/15) to state that his left arm where he received both the Pneumovax and Adacel was red, raised, and painful to the touch and had been as such since the evening of 9/25/15.
Body aches, fever, pain at injection site all over night. Intense dizziness and fainted once in morning
? Received 3rd Rabies vaccination at approximately 4:30 pm 8/30/21 ? Started experiencing symptoms 10-15 minutes post-vaccination  Pounding headache Red and hot face Red and itchy hands ? Arrived home approximately 5 minutes after onset of symptoms and symptoms had worsened Hives began appearing on abdomen, face, and arms Hand irritation began to worsen Eyes partially swollen Ear canal felt as though they were closing (difficulty hearing and pressure in both ears) ? Arrived at emergency room at approximately 5:20 pm Hives were more severe and no improvement of other symptoms Experienced syncope during venipuncture and IV placement and a few other times after IV placement ? Experienced several moments of low blood pressure ? Unsure if anxiety v. allergic reaction related o Received fluids, diphenhydramine, famotidine, and steroid (unsure what type) all via IV o Symptoms mostly resolved within 30 minutes of treatment o Prescribed 3 days of Prednisone, 5 day of Famotidine, and 5 days of Diphenhydramine
myalgia/painful shots in her body; painful shots in her head; painful shots in her arm; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (myalgia/painful shots in her body), HEADACHE (painful shots in her head) and VACCINATION SITE PAIN (painful shots in her arm) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (myalgia/painful shots in her body), HEADACHE (painful shots in her head) and VACCINATION SITE PAIN (painful shots in her arm). At the time of the report, MYALGIA (myalgia/painful shots in her body), HEADACHE (painful shots in her head) and VACCINATION SITE PAIN (painful shots in her arm) had resolved.      No concomitant medications were reported.  The vaccine side affects that lasted 5 hours.  Patient was expecting the same things with booster vaccine.  No treatment medications were reported.
the fetus stopped growing at seven weeks; seven weeks pregnant mother received a dose of FLUBLOK QUADRIVALENT vaccine at seven week and  fetus stopped growing from same week with no adverse event; Initial information was received on 16-Nov-2020 regarding an unsolicited valid serious case from a consumer or non-health care professional.  This case involves fetus who was stopped growing at seven weeks (foetal growth restriction) as 32-year-old pregnant mother received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] at seven weeks with no side effect (maternal exposure during pregnancy).  Data regarding this pregnancy were received prospectively.   Event occurred at between 7-10 weeks of pregnancy.  The date of last menstrual period and estimated due date was not reported.   Patient (fetus) condition at the time of vaccination to mother was not reported.   On 10-Oct-2020, the patient was exposed to a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [lot number and expiry date not reported] via transplacental route via mother who was vaccinated via unknown route at left deltoid for prophylactic vaccination.  On an unknown date, the patient (fetus) stopped growing (foetal growth restriction) (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. This event was assessed as medically significant.  This was a case of Maternal exposure during pregnancy, first trimester.   It was reported, at 10 weeks, patient's mother had an ultrasound scan and the physician said that the fetus had stopped growing at 7 weeks. The physician stated that he could not tell what had caused it.  It was not reported if the patient received any corrective treatment.  At the time of reporting event outcome was unknown for foetal growth restriction and event outcome was not applicable for maternal exposure during pregnancy.   Pregnancy outcome for mother was unknown at the time of report.  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.  Information on the batch number was requested.; Sender's Comments: This case involves fetus for whom  foetal growth restriction with maternal exposure during pregnancy was reported after mother's vaccination with FLUBLOK QIV. The time to onset is unknown. At 10-week patient's mother had an ultrasound and confirmed that the fetus had stop growing at 7 weeks. However, fetus condition at the time of vaccination and other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Pt dad thinks pt has vasovagal syncope. Pt passed out immediately after getting vaccinated and vomited when regained consciousness.  Pt turned white in the face and fell forward in chair when he fainted and after vomiting pt continued to go in and out of consciousness. Took about 10-15 minutes of placing feet on another chair and raising hands over head but pt color returned and he felt much better.
17 hours after vaccine, developed gradually worsening fatigue, myalgias, arthralgias, chills, sweats, malaise, and fever up to 103. Sxs peaked at approx 24 hrs post vaccine administration, resolving nearly completely by the following morning.   Would have reported via v-safe but had no info to access the app.
12 days out from vaccine, re-local reaction with itching and erythema and raised about 4 inch large at injection site.  No pain, on day 13 with brusing in the center as well and itching.  Fatigue worse both of these days, no fever.  Benadryl oral taken and helped itching, but did not change the size or erythema of rash at local injection site
patient received a dose of Ipol on 18th of November that had expired on the 9th of November 2020, No AE; Initial information received on 20-Nov-2020 regarding an unsolicited valid non-serious case from a physician.  This case involves a 11 years old male patient who was administered with 0.5 ml expired first dose of IPV POLIOMYELITIS VACCINE (INACTIVATED) (VERO)  [IPOL] (lot number- P1E701M and expiration date: 09-Nov-2020) via intramuscular route in right deltoid for prophylactic vaccination on 18th of November 2020 (Expired product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  This was an actual medication error due to expired vaccine used [latency was same day].  No laboratory data reported.  At the time of reporting, no adverse event was reported to the patient.  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 vaccine at approx 7:38pm, immediately experienced a syncopal episode. She was placed in a wheel chair, brought to an observation area, placed on a cot with feet elevated. Patients color began to return, and she was answering all questions appropriately. Initial BP 90/52, HR 47. Patient began to feel better, sat up and drank 1 bottle of water, repeat BP 92/64 HR 67 then 115/72, HR 63. Patient stood and walked feeling back to baseline released home with father in stable condition.
swollen, red, painful tongue with sores lasting for 18 hours followed by sore throat and ear pressure
46 year male patient received the havrix pediatric dose inadvertently on 24-August-2022; 46 year male patient received the havrix pediatric dose inadvertently on 24-August-2022; This case was reported by a pharmacist via call center representative and described the occurrence of adult use of a child product in a 46-year-old male patient who received HAV (Havrix 720) (batch number EP47E, expiry date 6th February 2023) for prophylaxis.   On 24th August 2022, the patient received the 1st dose of Havrix 720. On 24th August 2022, unknown after receiving Havrix 720, the patient experienced adult use of a child product and accidental underdose. On an unknown date, the outcome of the adult use of a child product and accidental underdose were unknown.   Additional Information: GSK receipt date: 25-AUG-2022 Reporter's comment: The pharmacist reported that a 46 year old patient had received the Havrix pediatric dose inadvertently on 24th August 2022. The reporter had consent to follow-up. Additional supportive information: The adult patient received the Havrix pediatric dose inadvertently, which led to adult use of a child product and accidental underdose.
601 doses were given after expiration date; 601 doses were given after expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (601 doses were given after expiration date) and PRODUCT STORAGE ERROR (601 doses were given after expiration date) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (601 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (601 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (601 doses were given after expiration date) and PRODUCT STORAGE ERROR (601 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided. The vial was placed in the refrigerator on 29-Oct-2021. No treatment medications was provided.
Narrative: patient broke out into hives the evening after getting COVID-19 vaccine. Patient's girlfriend stated that this happens to patient sometimes, off and on. Patient did not get his second dose of the vaccine. Patient was in hospice care due to appendix cancer and passed away on 02/24/2021.
Patient reports slight tightness in throat radiating to chest. Symptoms resolved spontaneously within the hour.
This spontaneous report was received from a female patient of unknown age and refers to herself. In approximately March 2014 (reported as a month ago) the patient was vaccinated with a dose of ZOSTAVAX 1 time injection under the skin (dose, route, lot number not reported). On an unspecified date in 2014 the patient broke out with "herpes on the corner of her mouth". The outcome of broke out with "herpes on the corner of her mouth" was unknown. The relatedness between "herpes on the corner of her mouth" and ZOSTAVAX was not reported. Additional information is not expected.
This spontaneous report as received from a registered nurse refers to a male patient of unknown age. The patient was received three doses  of (Merck) VARIVAX, 0.5ml. First dose was given sometimes in September-2005, the second dose was given in May-2010 and the third dose was given on 16-JUL-2012. First dose and second dose had been given subcutaneously. Third dose had been intramuscularly. No lot number was provided. The nurse reported that the patient was younger than 12 months of age when he received first dose. The patient was given first dose for post-exposure prophylaxis because he was exposed to varicella. No symptoms was reported, The outcome of patient was unknown. Whether the patient sought medical attention was unspecified. Additional information has been requested.
03/01/2021: Positive pregnancy test 03/31/2021: 8 weeks gestation based on LMP; US showed fetus measuring 6w1d, fetal heartbeat 81 04/07/2021: 9 weeks gestation based on LMP; US showed fetus measuring 6w1d, no fetal heart tones 04/09/2021: D&C performed for missed abortion
Employee received flu vaccine at 2:10 10/11/2002. Took Albutrol. Adverse effect at 2:25pm. SOB and tightness throat, hoarseness, diaphoresis, headache. Health Service called MD called .02 Benadryl 50 mg IM. to Er IV's prednisone IV, Pepcid, Albutrol, Benadyl RX. Discharged with Prednisone dose pack. See her MD 10/14/2002 received second dose pack. Antibiotics and inhaler continued
t105 pt taken to ER, crying nonstop, refused to eat; returned to MD 25MAy93; t103 & ear infection then dx; rx Cefcil;
Second dose was given at 16th day following first dose - 1 day before 4 day grace period
one patient received one dose of Varivax following a temperature excurision; no adverse effects were reported; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.  On an unknown date, the patient was vaccinated with a one dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # R029517, expiration date 14-OCT-2020, subcutaneously (dose and anatomical location were not provided) for prophylaxis or R029519, expiration date 14-OCT-2020 subcutaneously (dose and anatomical location were not provided) for prophylaxis. The lot number and expiration date of the dose that patient received could not be determined by the reporter, so both lots affected by the temperature excursion were reported. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 36 degrees Fahrenheit for 18 hours and 5 minutes (multiple excursions). There was no previous temperature excursion. Data logger was involved.  The outcome of product storage error and no adverse event was unknown.
Extremely heavy bleeding during menstrual cycle, unlike any heavy cycle in the past. Lasted 2-3 days.
Hives devel Sat 14DEC91 1st noticed around 0700; became worse during course of day; p/MD contacted by phone DPH initiated @ 7PM 14DEC91; hives worse Sunday 15DEC91; pt given more DPH hives cleared Monday morning;
the roots of her teeth hurt; top of her head hurts when she touches her hair it radiates to all the teeth at the same time; Fever; This spontaneous case was reported by a consumer and describes the occurrence of TOOTHACHE (the roots of her teeth hurt), PAIN (top of her head hurts when she touches her hair it radiates to all the teeth at the same time) and PYREXIA (Fever) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Fever). On 02-Mar-2021, the patient experienced TOOTHACHE (the roots of her teeth hurt) and PAIN (top of her head hurts when she touches her hair it radiates to all the teeth at the same time). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 03-Mar-2021, PYREXIA (Fever) had resolved. At the time of the report, TOOTHACHE (the roots of her teeth hurt) and PAIN (top of her head hurts when she touches her hair it radiates to all the teeth at the same time) had not resolved.            Action taken with mRNA-1273 in response to the event was not applicable. Patient had a question that the pain at the root of her teeth is a side effect from  the vaccine. no concomitant medications are provided.
This spontaneous prospective pregnancy report was received from a nurse and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 11-FEB-2019, the patient was vaccinated with GARDASIL 9 (strength and dose were not reported) lot # R017251, expiration date 04-MAY-2021, intramusculary for prophylaxis. Later, it was discovered that the patient was 12 weeks and 6 days pregnant as of 13-FEB-2019. The patient's last menstrual period (LMP) was 15-NOV-2018 and estimated delivery date (EDD) was 22-AUG-2019. The pregnancy outcome was pending. No adverse effect were reported.
18-19 hours after vaccination, pt experienced chest pain, dizziness, hot flash while at rest.  She was not anxious.  She was in between classes of teaching virtually
Severe dizziness, severe vomiting, diarrhea for about one hour.  Then slept until 2:00am. Woke up and felt OK.
lot of pain in her bilateral armpits; This is a spontaneous report from a contactable consumer.   A 35-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date were not reported), via unspecified route of administration on an unknown date as single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Previously patient took first dose of bnt162b2 PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date were not reported), via unspecified route of administration on an unknown date as single dose for COVID-19 immunization. The reporter stated that the (patient mother), patient received her second dose of the Pfizer Covid vaccine 7 weeks ago and had been experiencing a lot of pain in her bilateral armpits. Reporter wanting to know if this was normal? Reporter wants to know if her daughter should wait a certain time period before getting a mammogram? She was concerned that the pain in her armpits could cause a false reading. The outcome of event was unknown.  No follow-up attempts are possible. No further information is expected.
A lot of head pain 2 months persistent after the vaccine, now I have it on the left side of my head with dizziness and involuntary movements, chest pain left side, currently and it does not go away
COVID ARM large swollen rash around injection site; COVID ARM large swollen rash around injection site; Dose 1: 12May2021; Dose 2: 26May2021; This is a spontaneous report from contactable consumer, the patient. A 63-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EP7534) via an unspecified route of administration in the arm left on 26May2021 at 12:00 as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included doxycycline (ORACEA) since an unknown date taken within two weeks of vaccination for an unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EP6955) via an unspecified route of administration in the left arm on 12May2021 at 12:00 as a single dose for COVID-19 immunisation. The patient had no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 29May2021, the patient experienced "COVID ARM" large swollen rash around injection site. The patient did not receive any treatment for the event. The event had not resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event "COVID ARM" large swollen rash around injection site was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected
Bump showed up 2 centimeters above injection site 3 minutes after injection was given. After 5 minutes, throat started to feel itchy. 7mL of BENADRYL was given and a cold pack was placed over bump and injection site. After 15 minutes of observation, symptoms has gone away and bump has gone down.