chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Dose administered >12 hours post puncture; 1st  dose was given on 05Dec2022 and 2nd done was 12Jan2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st  dose was given on 05Dec2022 and 2nd done was 12Jan2023) and NO ADVERSE EVENT (No adverse event) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS1417B and AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 05-Dec-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 12-Jan-2023, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 12-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st  dose was given on 05Dec2022 and 2nd done was 12Jan2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st  dose was given on 05Dec2022 and 2nd done was 12Jan2023) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered &gt;12 hours post puncture) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st  dose was given on 05Dec2022 and 2nd done was 12Jan2023).    No concomitant medication was reported. No treatment medication was reported.
Pt was given .25 dosage from Lot 102127P1 4 year and older vial.
4 month old inadvertently given dose of Ipol and Pentacel; Initial information received on 09-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 4 months old female patient who received vaccines IPV (VERO) [IPOL] and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and reported that experienced 4 month old inadvertently given dose of Ipol and Pentacel.  The patient's past vaccination(s) included PEDIARIX. The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13).  On 09-Jul-2019, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ102AA and expiry date: 19-Sep-2020 via intramuscular route in the left thigh.  On 09-Jul-2019, the patient received a dose of suspect IPV (VERO) lot UJ102AA and Expiry date: 19-Sep-2020 via intramuscular route in the left thigh.  It was a case of actual medication error due to extra dose administered.  It was unknown if the patient had any adverse event.  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.   List of documents held by sender: none.
Rash around vaccinated area and redness. As per pt felt warm. Mother return to clinic on 7-26-07, and receive instructions and treatment for conditions.
At 5:30 PM, March 2nd I began severe chills, shaking, and teeth chattering.  My hands were shaking, whole body trembling.  Then around 10 PM I began perspiring.  Very uncomfortable for the night.  This morning I feel okay, a little tired.
I experienced an increase in volume of my tinnitus perception in my left ear. My head feels stuffy and I am slightly dizzy. These symptoms have caused insomnia, nausea, rapid weight-loss, and panic attacks. Treatment has been Flonase daily, anti-inflammatory diet, no caffeine, drinking lots of water, and resting.
Information has been received from a consumer concerning her 21 year old daughter who was vaccinated with the first dose of GARDASIL (lot #, route and site of administration not reported). The patient experienced 36 hours of diarrhea after vaccination with GARDASIL. This is one of several reports from the same source. No further information is available.
Narrative: Pt stated he got depressed after his 2nd covid dose, but since then, his mood is good and back to baseline. Lasted one day. Pt denied SI/HI.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 30-JAN-2015 the patient was vaccinated with VARIVAX (Merck) (0.5 ml, subcutaneously) that underwent two temperature excursions. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
I had tingling in the right side , opposite arm of the injection. I felt it  from the forarm  to my hand and the top of my foot.
Swollen arm; red arm; arm hot to the touch; Metal taste; Bruise arm; sore arm; knot at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metal taste), CONTUSION (Bruise arm), PAIN IN EXTREMITY (sore arm), VACCINATION SITE NODULE (knot at the injection site) and PERIPHERAL SWELLING (Swollen arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included HYDROCHLOROTHIAZIDE, ATENOLOL, LEVOTHYROXINE, METFORMIN and ESTRADIOL for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced DYSGEUSIA (Metal taste), CONTUSION (Bruise arm), PAIN IN EXTREMITY (sore arm) and VACCINATION SITE NODULE (knot at the injection site). On 16-Mar-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm), ERYTHEMA (red arm) and FEELING HOT (arm hot to the touch). On 08-Mar-2021, DYSGEUSIA (Metal taste), CONTUSION (Bruise arm), PAIN IN EXTREMITY (sore arm) and VACCINATION SITE NODULE (knot at the injection site) had resolved. At the time of the report, PERIPHERAL SWELLING (Swollen arm), ERYTHEMA (red arm) and FEELING HOT (arm hot to the touch) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided
CHILLS X24 HRS; FEVER X8HRS ON AND OFF; SMOOTH, RAISED, WARM TO TOUCH RASH XTHIS MORINING; TUESDAY NIGHT SENSITIVITY TO TOUCH WORSENED OVERNIGHT GONE BY MORNING. IBUPROFEN STARTED FROM START OF PAIN OF ARM 2PM TO ABOUT 7PM (600MG TOTAL). PATIENT WAS SEEN IN OFFICE TODAY 04/15/18 @11:40 AM PT REASSURED NO TREATMENT NEEDED.
day 8 after 1st vaccine developed extensive red itchy rash over all parts of body; not centralized to shot arm!!! saw my phyician yesterday and received steroid shot and told to take benadryl Today is worse with heavier rash and rash over most of body; have a prescription for prednisone and a prescription cream for itching
four hours after vaccination severe pain in left shoulder and elbow joints , shivering and trembling, fainting then taken to ER for treatment
Patient developed Shingles 3 days after vaccination.  Patient had no prior history of Shingles, was not ill, had not been ill for atleast 3 months prior to vaccination and did not have a history or reason for a low WBC or other immunilogical problems.
Patient reported severe body aches, fever, headache (pressure behind eyes), wheezing, and sinus congestion. Patient stated the symptoms lasted about 2 weeks. Spoke with Dr. on his next office visit and the doctor suggested he not receive the 2nd dose of SHINGRIX. Patient's symptoms have resolved and reported his event to the pharmacist during a phone conversation on 8/1/18. Patient requested his adverse event be reported to VAERS.
arm felt "frozen" after received PNEUMOVAX 23/ arm immobility.; This spontaneous report was received from a consumer via a pharmacist and refers to a 50 year old male patient. No information regarding the patient's medical history, concurrent conditions or allergies/drug reactions was provided. The patient did not have concomitant medications.   On 01-DEC-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) which had a lot # T028093 with expiration date on 24-APR-2022, given intramuscularly (dosage,  as prevention of pneumococcal disease.   On 02-DEC-2020, the patient's arm felt "frozen" after vaccination. It was described it as arm immobility(monoplegia). At the time of reporting, the outcome of monoplegia was reported as not recovered. The causality assessment between monoplegia with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not provided.  Upon internal review, monoplegia was considered a medically significant event. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T028093; expirationdate: 24-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
pain in left arm / feeling the needle is poking on arm; got thinner and lost weight after vaccination; high blood pressure; chest pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in left arm / feeling the needle is poking on arm), WEIGHT DECREASED (got thinner and lost weight after vaccination), HYPERTENSION (high blood pressure) and CHEST PAIN (chest pain) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included LISINOPRIL for Chest pain, HYDROCODONE and GABAPENTIN for Pain, METFORMIN and SIMVASTATIN for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in left arm / feeling the needle is poking on arm), WEIGHT DECREASED (got thinner and lost weight after vaccination), HYPERTENSION (high blood pressure) and CHEST PAIN (chest pain). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (pain in left arm / feeling the needle is poking on arm) had not resolved and WEIGHT DECREASED (got thinner and lost weight after vaccination), HYPERTENSION (high blood pressure) and CHEST PAIN (chest pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reported that patient also used hot and cold compress and some ointment, not otherwise specified.     Reporter did not allow further contact
Severe headache, 4/15/2021 took Aleve and bedrest. Headache is gone but body aches began 4/16/2021 took Aleve and bedrest. Body aches are gone but rash on inner forearms began 4/17/2021 taking Benedryl and using cortisone ointment. I still have rash, continuing with Benedryl and cortisone ointment,  called to report symptoms. They said to call my physician if it doesn't clear up by tomorrow.
I had a reaction at the injection site. My arm swelled and had a rash that lasted 2 weeks. I had flu like symptoms of fever and aches for 4 days.
Given after 30 days in refrigerator. Was given after being in fridge for 34 days.
20 minutes after receiving vaccine - eyelids began to swell and become urticaria within 2 hrs - eyelids red, puff, very itchy. Pt took 2 AC PEPCID - response was decreased swelling, redness and itching. 10/19/12 pt seen at employee health, slight swelling and redness of lids remains. Lids itchy.
Nausea; Dull persisting headache; Right arm (not the injection arm- but opposite arm) could not be lifted; Fatigue; Fogginess (almost like an overdose reaction where I could not process thoughts); Sinus pressure; Chills; Mild fever; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the arm left on 21Apr2021 at 08:00 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received an unspecified medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Apr2021, the patient experienced fogginess (almost like an overdose reaction where the patient could not process thoughts), sinus pressure, right arm (not the injection arm- but opposite arm) could not be lifted, nausea, dull persisting headache, fatigue, chills and mild fever. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fogginess (almost like an overdose reaction where the patient could not process thoughts), sinus pressure, right arm (not the injection arm- but opposite arm) could not be lifted, nausea, dull persisting headache, fatigue, chills and mild fever was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Presents to the ED c/o shortness of breath which started earlier today and ramped up significantly this evening. The patient was exposed to a family member roughly 5 days ago who was diagnosed with COVID. Now most of the family is becoming symptomatic from the COVID infection. The patient tested positive for COVID 2 days ago. She states she was asymptomatic at that point. She reports no cough and no fever. Shortness of breath has become severe. Paramedics report room air oxygen saturation was 59%. They have had her on a nonrebreather mask and have administered an albuterol nebulized treatment but her oxygen saturations have remained in the upper 70s and lower 80s.
Client had clonic/tonic seizures x2 within one minute of receiving the COVID-19 vaccine, first dose.  Within 3-4 minutes of the seizure activity, client was awake, alert, oriented x3.  Client was placed on a stretcher by paramedics and transferred via a stretcher to the observation area.   Client remained awake, alert, oriented x3.  No incontinence noted.  Client was transferred to the hospital by the paramedics to the hospital within 10-15 minutes after seizure activity.  No other family members were present with client.
expired Dapacel vaccine was administered to the patient, No AE; Initial information was received on 02-Mar-2020 regarding an unsolicited valid non-serious case from a nurse.  This case is linked to cases 2020SA058732 and 2020SA058733.  This case involves a 22 months old male patient who was vaccinated with 0.5 ml fourth dose of expired vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number: C5611BA and expiry date: 07-Feb-2020) via intramuscular route in the left arm on 17-Feb-2020 for prophylactic vaccination (PT Expired product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccination included INFLUENZA VACCINE INACT SPLIT VIRION 4V (FLUZONE QUADRIVALENT).  It was actual medication error due to expired vaccine used.  At the time of report 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 holders 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.
Experiencing painful low back pain and cramping in conjunction to "my" menstrual cycle.; Experiencing painful low back pain and cramping in conjunction to "my" menstrual cycle.; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 26Aug2021 at 13:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and known allergies were reported as none. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medications within two weeks of vaccination. On 01Sep2021 at 12:00, the patient experienced painful low back pain and cramping in conjunction to her menstrual cycle. The patient reported that nothing other than the vaccine had changed and there was no added stress, exercise, medication, just the vaccine. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events painful low back pain and cramping in conjunction to menstrual cycle were not resolved at the time of this report.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Itching; developed a rash / on the torso, back shoulders and lower abdomen; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine (received many years before reporting). Concomitant products included hmg coa reductase inhibitors (nos) (Statins).   On 30th November 2020, the patient received the 1st dose of Shingrix. In January 2021, between 2 and 4 weeks after receiving Shingrix, the patient experienced rash. On an unknown date, the patient experienced pruritus. On an unknown date, the outcome of the pruritus was not recovered/not resolved and the outcome of the rash was recovering/resolving.   It was unknown if the reporter considered the pruritus and rash to be related to Shingrix.  Additional information was provided as follows: The case was reported by patient himself. The patient developed a rash 2 to 3 weeks after the vaccine in the areas where others get the shingles rash. The patient inquired that could it be Shingles or a statin rash. The patient reported that the rash was located on the torso, back shoulders and lower abdomen. Patient reported itching. Patient stated the rash had improved but he still had it. Lot and expiration date not available. Patient did not have HCP phone number. The reporter consented to follow up. Note: Discrepancy in product start date, reported as 30th December 2020 in structure field, however reported as 30th November 2020 in narrative.
Admission Date: 5/5/2023 Discharge Date: 5/7/2023  PRESENTING PROBLEM:  History of fourth degree perineal laceration History of maternal fourth degree perineal laceration, currently pregnant Status post cesarean delivery PROCEDURES PERFORMED: CESAREAN SECTION, PRIMARY, N/A - Abdomen   HOSPITAL COURSE: Patient is a 32 y.o. female G3P2012 underwent an uncomplicated cesarean delivery and was discharged home in stable condition.  Delivery complicated by PPH, EBL 2392 Postnatal Depression Scale Total: 2   DELIVERY TYPE: C-Section    ESTIMATED DUE DATE: Estimated Date of Delivery: 5/12/23 GESTATIONAL AGE AT DELIVERY: 39w0d  G3P2012 DELIVERY PROVIDER:   ASSISTING PROVIDER(S):     Delivery Blood Loss  05/05/23 0906 - 05/06/23 0934     QBL Calculator (mL) Hospital Encounter 2392 mL   Total   2392 ml       FINDINGS: NEWBORN STATUS: Living  NEWBORN SEX:  boy      Delivery Date/Time:  5/5/23  9:34 AM           WEIGHT: 3.07 kg  APGAR:  1 minutes 5 minutes 10 minutes  8  9        RESCUSITATION: None  PLACENTA REMOVAL: Spontaneous  CORD VESSELS: 3 Vessels  ANALGESIA METHOD: Spinal
A report has been received from a Licensed Practical Nurse via Merck concerning an adult patient of unknown gender. The patient's medical history, concurrent diseases and concomitant medications were not reported. On an unspecified date, the patient started receiving a treatment with nasal FLUMIST. The dosage, frequency and indication of use of this medication were not provided. The nurse reported, that the patient was diagnosed with multiple sclerosis several weeks after receiving FLUMIST. At the time of reporting the action taken with FLUMIST and the outcome of the event were unknown. According to the reporter the event of multiple sclerosis was considered to be serious and the serious criterion for the report was as follows: important medical event.
Large inflamed area around the 2 injection sites, warm, swollen (entire thigh)
20 minutes after receiving the vaccine the patient began to describe feeling of malaise, fast heart beat and shallow breathing.  Patient became visibly flushed and began sweating.  Patient then complained of a bad headache.  The patient's blood pressure was measured at 180/110.  After lying down for a period of time the patient asked to have an ambulance called.  The patient's father was called and informed of the incident at the patient's request.  The patient then left with emt's when they arrived shortly after calling.
Immediate pain in right arm from elbow to shoulder sometimes difficult to write sometimes difficult turning steering wheel. 11 weeks-no improvement.
Initial report was received on 07 February 2014 from a non healthcare professional. An adult female had received a 0.5 ml dose of FLUZONE, lot number UH892AA (route, site and date of administration not reported) and four hours later, was admitted to the ER with a very swollen throat and mouth, increased heart rate, difficulty breathing and red eyes. The symptoms resolved around 11 PM and then the patient developed body chills. According to the report, the patient had never been diagnosed with an egg allergy. No further information was provided at the time of the report. Documents held by sender: none.
Left deltoid area red, inflamed, edematous and warm to touch. Started on AUGMENTIN for 10 days.