chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient accidentally received expired dose of MENACTRA vaccine with no reported AE; Initial information received on 11-Oct-2021 regarding an unsolicited valid non-serious case from a other health professional Medical Information (Reference number- 00807259).  This case involves a patient (unknown demographics) who was accidentally vaccinated with the expired dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (expired product administered).  The patient's medical history, medical treatment, vaccination and family history were not provided.  On 08-Oct-2021, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6745AB and expiry date: 06-Oct-2021) (Frequency: once) via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency on same day).  It was reported "Caller reported accidentally administering a MENACTRA vaccine on 08OCT2021 to a patient that expired on 06OCT2021 (2 days expired vaccine). Caller is asking about the efficacy of this vaccine and where to go from here".   At time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 21-Jun-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment details were provided.
28 doses(booster) were given to patients out of 20 dose vials/Vaccine underdose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (28 doses(booster) were given to patients out of 20 dose vials/Vaccine underdose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (28 doses(booster) were given to patients out of 20 dose vials/Vaccine underdose). At the time of the report, ACCIDENTAL UNDERDOSE (28 doses(booster) were given to patients out of 20 dose vials/Vaccine underdose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medication was provided.  No treatment  was provided.  No adverse event experienced by the patient.   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Follow-up received on 19-NOV-2021.Contains event information added in I narrative.
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 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 11:14 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 11:14 AM, 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 39.78 years  Concomitant products were not provided.  On 15-Apr-2021, Excursion time was 09 AM, the temperature was 34, total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-May-2021.  Vial was stored on cooler 1, on 15-Apr-2021, Excursion duration at 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM : 44, 3 PM: 44, 4 PM: 42 and 5 PM : 42.  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 Fisherbrand 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 on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Patient given 0.3 mL of undiluted PEDS bivalent pfizer instead of intended 0.3 mL of adult bivalent
her husband's gums are bleeding; This is a spontaneous report from a Pfizer sponsored program support received from a contactable consumer (patient's wife).  A male patient of an unknown age received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number: not reported) dose 1 via an unknown route of administration on 23Apr2021 as dose 1, single for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unknown date, the patient experienced her husband's gums are bleeding. It was unknown whether the Reporter a Healthcare Professional (HCP) or prescribing HCP. The reporter's contact information available to you or a sub-contracted party was unknown. It was reported that patient was scheduled to return on 14 May for the second dose. The outcome of the event was reported as unknown.   No follow-up attempts were possible; information about lot/batch number cannot be obtained.
patient had swelling and redness in a circular shape around the injection site. It was warm to the touch. patient experienced vomiting and back pain several days after vaccination. Patient reported feeling very ill after getting the vaccine as well.
4 cm erythema at site of vaccination (R deltoid), appearing 1 day after immunization and evaluated 2 days after immunization.  Otherwise well.
Faint body rash - erythema, extensive, near confluent macular-papular rash on all extremities including face.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 3-decade-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015f21a) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2022, 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.   Patient was in her thirties, one partial date of births 21 September.  No concomitant medication was reported.   The treatment information was unknown.   This case was linked to MOD-2022-480631 (Patient Link).
Patient was given second dose, but vaccinator reported much of the dose coming out. Patient was given another dose as per recommendation.
Bruising and blisters around injection, feet swollen, unable to walk or talk since 8/23/2021
My symptoms began on with a cough and low-grade fever.  I spoke to the doctor on January 23, 2023, Monday, and now I had a runny nose and slight headache.  I was prescribed an antiviral and began taking it that day.  I had fatigue through the entire infection and took two naps a day.  I tested positive for 3 weeks.  I still have a bit a fatigue and notice this while swimming.
Information has been received from a consumer concerning her now 9 year old son who at 6 year old (approximately in 2006) was vaccinated with a dose of MMR II (LOT# not reported). Concomitant therapy included: diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid booster, RECOMBIVAX HB, VARIVAX and other unspecified vaccines. The patient experienced a rash after he received the MMR II and on an unspecified date the patient woke up with had difficulty walking and the mother had to "carry the patient to the car". The patient was seen by physician and recovered on an unspecified date. No further information is available.
Four hours after receiving the vaccine noticed that voice was lower and had a wet cough, "breathing was noisy. and noticeable" States breathing was not difficult but it felt like, "my chest was not right." About 12 hours later back to breathing normally. Tongue looks like all taste buds are gone on one section of tongue. Color is different than rest of tongue. Noticed metal taste on tongue on  02/11/2021 two days after vaccine. Food does not taste the same. Continues to have these concerns. 02/15/2021 chest was "pinkish, lacy redness." This was gone by 02/15/2021
The next morning after the vaccine I had significant pain in my arm where the injection was and my arm continued to be sore for 2 months. It would keep me up at night. My chest was also sore and I had extreme fatigue, swollen lymph nodes through shoulder and armpit. I started doing acupuncture and massage to help with the pain.
One day after vaccine 2nd shot - lightheartedness, slight dizziness, headache, head felt heavy and buzzing in ears (tinnitus).  The tinnitus has continued  and has not stopped along with heaviness on head.  This is affecting my daily activities.  Headache  around three times. After one week after vaccine shot, abdomen area is very bloated and is still continuing.  Also on May 5th, my right ear has sharp pains and that alerted me to see the ENT.  This is continuing on and off.
A non-serious, spontaneous report of administered expired product was received from a nurse concerning a four-year-old female, subsequent to FLUMIST. The patient received FLUMIST on 20-Feb-2009 which expired on 15-Feb-2009. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up received 31-Mar-2009: added product complaint investigation results.
Not sure if vaccination related: moderate pain (like a pulled or strained muscle) on my right shoulder and neck dissipated over 2 or 3 days but migrated to my left shoulder and neck, then to my neck and left arm today (March 11). Not aware of anything to cause the pain (lifting heavy objects, etc). Due for second shot on Monday, March15).
arm started burning underneath her arm as days went by the burning started get worse and have a dull headache
My daughter was given the Gardasil shot this year, she has stopped her period completely and has not recovered it. She had the last shot in October of 2011 and still no period so I got concerned and took her two different Dr.'s. My daughter has has two ultrasounds and a pap smear to see what is going on. I have her going to an actual OB/GYN and having her seen and see if there is a way to force her period other than medicines, we already have tried that. My daughter had healthy periods and was regular till she received the shot and I am upset and concerned because it wasn't written as a side affect. I have did research online and my daughter is not the only one, there are a number of females that has experienced the same thing and are also concerned.
Patient came to the pharmacy today to show us her arm after she had called her doctor to let him know about the reaction to the flu shot.  Her doctor told her to come to the pharmacy to let us know and he told her to take Benadryl.  Her arm was red, itchy, swollen, and she stated that it had a burning sensation.
Patient is a 87 y.o. female admitted to the hospital on 12/21/2022 for acute respiratory failure with hypoxia secondary to COVID.    Discharge Diagnosis and Associated Hospital Course   Acute Respiratory Failure with Hypoxia COVID-19 - tested positive on Monday, 12/19 but the test was reportedly at her request - CXR clear - she is vaccinated, but they are unsure of when her most recent booster was given - Patient not a candidate for Paxlovid as she is onTikosyn  - completed decadron course and stable on RA    Paroxysmal A.fib - rate controlled - maintained on tikosyn - not on AC due to fall risk   R leg Wound - due to accidental trauma from wheelchair recently.  - continue local wound care.    Chronic Encephalopathy -on 12/22; Patient with comments related to death during encounter, asking about "if you can make me die sooner". -son had stated that the patient has had phases for years transiently of making comments of this nature such as wanting to ensure she passes away on a weekend to not inconvenience her children in interfering with their work -No behavioral medicine consultation needed at this time, recommend continued redirection and therapeutic listening. -yesterday and today patient did not make any similar comments, denies SI/HI   Hypertension - BP mildly elevated - continue home losartan   Chronic Pain - continue home gabapentin, robaxin, and PRN tramadol   GERD - continue PPI   Anxiety - continue celexa, dose decreased per pharmacy recommendation
Information has been received from a registered nurse concerning a 12 year old male who on 12-JUN-1996 was vaccinated with a dose of Varivax. On 15-MAY-2006 the patient developed a breakthrough case of varicella. It was reported that the patient had 50+ lesions on his trunk and extremities. The patient was seen in the physician's office but he received no treatment and he was not hospitalized. At the time of the report the patient was recovering. There was no product quality complaint involved. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to multiple (unspecified how many) unidentified patients of unknown ages and genders. No information about the patients' medical history, concomitant medications, concurrent conditions or drug reactions and allergies was provided. On an unknown dates, the patients were vaccinated with incorrectly stored doses of PEDVAXHIB (lot number: M020100, expiry date 07-MAR-2019, dose and route of administration were not reported). No adverse effects were reported. Digital Data Logger was involved, the storage temperature was reported as 48.52 degrees Fahrenheit in a 20-minute timeframe, on an unknown date. No previous temperature excursion was reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA013978: US-009507513-1612USA008794.
Pt had an arthritis attack. His thumb has had visits to hand surgeon and injection of cortisone. He has pains in his neck and knee. Visited rheumatologist and given medications.
8 hours post vax, the pt experienced swelling, redness, and heat on the under side of the arm, away from the injection site. Unspecified medical attention was sought.
lt thigh red, swollen, hot to touch;good ROM;lt thigh 13minc rt thigh 12in;med given;recheck in AM;cold pack to area;APAP PRN;7MAR97 same s/s area getting sl larger adm to hosp;dec ROM;
high fever 38 hrs p/vax 3 hrs of extreme irritability 24 hrs p/dose;
There was a little bit of a stuffy nose and maybe 2 days of a mild fever. Fatigue was felt for about 3 days and was fully recovered after 5 days.
CONSISTENT PAIN WHILE WAKING RESTING IN RIGHT CALF MUSCLE; This spontaneous report received from a consumer concerned a 44 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included dairy allergy, wheat allergy, and gluten allergy, and other pre-existing medical conditions included the patient had give birth 4 times with healthy delivery. The patient never got a clot before, not overweight. The patient was not pregnant at the time of report. The patient was non-smoker and alcohol user. The patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1802072 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 17-MAR-2021, the patient experienced consistent pain (pain to touch ) while waking and resting in right calf muscle. She did not take anything for that pain. The patient had no swelling. She had normal temperature. On 13-APR-2021, the patient went to MD for D-dimer to be measured because her physician recommended to do so since she was going to have a long flight on 14-APR-2021. The physician had a concern for having a blood clot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from consistent pain while waking resting in right calf muscle on 23-MAR-2021. This report was non serious..
Child at grandmother's house on 4-26-07.  In morning, grandmother noted fever (reached 101 degrees), child tired, somewhat lethargic.  That evening mother noticed left arm swollen, hot and red.  4-27-07 child still running 99.8 degree fever, arm swollen 3" x 3 1/4" red, hot.  Dr tx with Benadryl.  Line drawn around redness.  Redness increased to 8 1/4" x 7" width.  Dr. prescribed steroid clantin.  If not better will see doctor again.  (1 previous dose of MMR and 1 previous dose vanvax was received by patient)
Narrative:  PATIENT WAS VACCINATED IN TIMELY MANNER 1/24/21 AND 2/18/21. PATIENT CALLED EMS 10/4 REPORTING A WORSENING COUGH AND DIFFICULTY BREATHING. HE WAS FOUND TO BE SATTING IN UPPER 80S TO 90S--PATIENT WAS PUT ON O2 AND TRANSPORTED TO HOSPITAL. PT HOSPITALIZED FOR HYPOXIA, COVID PNEUMONIA, AND POSSIBLE COPD EXACERBATION.
On 4/30/2021 4:15pm. patient came to COVID-19 clinic held by Pharmacy.  Patient did not bring vaccination card, but stated to door staff, check-in staff, pharmacy technician, and pharmacist/pharmacy manager that she received the 1st dose of Moderna 4 weeks prior.  Patient was asked multiple times if she received Moderna Dose 1 and was adamant that she had received the Moderna dose.  Pharmacist administered Moderna Dose 2 for patient.  Patient left clinic after 15 min of observation . Around 5-10 minutes after leaving, patient returned to the clinic stating she made a mistake.  Patient stated she actually received Pfizer dose back on 4/9/2021 instead of Moderna on 4/2/2021.  Pharmacist went to CDC website for guidance and it was advised that patient not receive an additional Pfizer shot and that she would be considered fully vaccinated.  Pharmacist and clinic staff asked patient to stay for observation  for 15-30 minutes.  Patient agreed, but staff stated patient ended up leaving right away.  Patient was called 3 hours later at 7:30pm and was doing fine with no side effects.
Information was received from a pharmacist who reported that during a discussion regarding ZOSTAVAX, a consumer stated that her physician mentioned to her that one of his patients had been administered ZOSTAVAX on an unspecified date and had subsequently developed "the worse case of shingles ever". No further information was provided. Additional information was requested.
Pfizer-BioNTech COVID-19 Vaccine: patient presented to emergency department 22 days after first immunization and one day after second immunization with right leg swelling for three days.  Vital signs within normal ranges except heart rate 107 beats per minute. No cough or shortness of breath. Reports family history of deep vein thrombosis (DVT) and pulmonary embolism. Diagnosed with  right leg DVT, prescribed anticoagulation, referred to  outpatient follow-up, and discharged to home.
patient said there was leakage after the dose was given, a clear liquid; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single), for COVID-19 immunisation. The following information was reported: VACCINATION SITE EXTRAVASATION (non-serious), described as "patient said there was leakage after the dose was given, a clear liquid". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
20 min after vaccine administration, pt. had a 30 sec generalized tonic clonic seizure with a post-ictal phase. All vitals stable. Seizure subsided w/o intervention. Then a 2nd sz 10 min later, again lasting 30 sec. Transferred to ED.
Patient was given vaccine and then minutes later began to lose consciousness and became very weak. 911 was called and EMT's attended to patient.
POST VACCINATION- DURING MONITERING PERIOD BECAME NAUSEAUS, WITH "DRY HEAVES"-- EMS AT SITE ADVISED TRANSPORTATION TO  HOSPITAL FOR EVALUATION.  EMS FOLLOWUP TO ER AT HOSPITAL- CLIENT DISCHARGED WITH NO TREATMENT
Pt had swelling, itching, erythema of entire upper arm from shoulder to wrist, post vax. She had blistering and was feverish and achy. Rx'd with Medrol dose pack. She is recovering, as of 9/29/00, but still has some redness.