chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This writer administered Hep -B dose to patient on 11/1/2022  then realized after when documenting in system that it was  pediatric dose 10 mcg/0.5 ml and not adult dose .  Call placed to nurse to inform. She confirmed no adverse effect but dosing is 1/2 of adult dose so patient needs to return to a clinic that has adult dosing for Hep B vaccine .  No waiting time required between dosing required per nurse.     This writer called pt.  and his wife who translated as patient is speaking informing them this writer administered  pediatric dose in error instead of adult dose of Hep B.   gave wife phone number to clinic to make appointment for adult dose administration of Hep B.  Also reiterated information from nurse no waiting time between doses required and that it is fine to receive adult dose in addition to the pediatric dose received 11/1/2022.  wife verbalized understanding and will make appointment today.
pt recvd vax 8NOV93  630PM devel fever & SOB; fever cont for 2 days; SOB subsided w/in short while; 9NOV93 woke up in AM w/purplish rash on face & still w/fever;
mild anemia or blood disorder; mild anemia or blood disorder; This spontaneous case was reported by a consumer and describes the occurrence of ANAEMIA (mild anemia or blood disorder) and BLOOD DISORDER (mild anemia or blood disorder) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANAEMIA (mild anemia or blood disorder) and BLOOD DISORDER (mild anemia or blood disorder). At the time of the report, ANAEMIA (mild anemia or blood disorder) and BLOOD DISORDER (mild anemia or blood disorder) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Full blood count: normal (normal) The test was done twice, in Dec 2020 and also in Mar/Apr 2021 and was normal..         The patients cardiologist ordered a complete blood test in Dec-2021 and it was found to be normal. The test was repeated in Mar-2021/Apr-2021 and another one was done last week.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.    Reporter did not allow further contact
2 days after injection left arm swelled, was red and hot 3 1/2 by 4" long by next day, Dec 1 redness had progressed to whole upper arm, shoulder to elbow and hot and painful.
Patient states injection site (left deltoid) abruptly turned red, warm, swollen, and itchy on 1/3/21 around 2:00 pm. Patient took Benadryl before bed on 1/3/21 and woke up this morning with no relief.
Information has been received from the Merck pregnancy registry for GARDASIL from a physician concerning a 21 year old female who on 05-DEC-2007 was vaccinated with her first dose of 0.5 ml GARDASIL (Lot #659437/1266U) intramuscularly and the patient was pregnant. There was no concomitant medication. LMP was 13-NOV-2007 and on 18-DEC-2007 a pregnancy test was performed and results were positive. The physician reported that the patient became pregnant after her first dose of GARDASIL. No other symptoms were reported. Followup phone call information was obtained from a physician who reported that the patient had not continued in his care and may have terminated the pregnancy. No further information was available. Upon internal review elective termination was considered to be an other important medical event. Additional information has been requested.
during the first shot I experienced a bad taste in my mouth approximately 30 minutes after, upon brushing my teeth my gums bleed.  Which I did not realize the connection at that time.   Second shot I experienced the same bad taste and rinsing my mouth when I returned home, noticing that my gums were bleeding.  They have continued to have a very slow rate of bleeding, however, it can be noticed when rinsing my mouth and taste remains.
Burning lips, throat tickle, 4 inch red patch raised snd located approximately 2 inches below injection site, itchiness all over body.  12 hours after injection
Pfizer-BioNTech COVID-19 Vaccine EUA      Approximately 1 week after receiving my second vaccination, my hair starting falling out and is still falling out at an alarming rate
Blood pressure raised almost immediately and stayed up. She went to PCP and found out her thyroid function had decreased. Her daily medications have been adjusted to compensate.
I can't say for sure but it appears I got Shingles as the result of the shot.
Vaccine approved for adults 18 years and older. Patient was not 18 at the time of vaccination.
A report has been received from a Health Professional concerning a 6 year old, Male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST started on 22-Oct-2013. The patient experienced BLOODY NOSE ON LEFT SIDE and WEREN'T ABLE TO FINISH THE DOSE which started on 22-Oct-2013. The patient recovered from the event of BLOODY NOSE ON LEFT SIDE on an unspecified date and the outcome of the event of WEREN'T ABLE TO FINISH THE DOSE is unknown. The report was considered to be non-serious. Summary of follow up information received by AstraZeneca/MedImmune on 24-Oct-2013 from Health Professional: Form completed date added. Outcome of the event bloody nose on left side changed from unknown to recovered. Corrected report 16-Nov-2013: Dosing regimen updated.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2013, a health care provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On 19-JAN-2016, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Headache, sweats. Swelling at sight of shot and underarm after 3 days.
Parent reported within one hour of getting flu vaccine, developed raised, red, itchy rash and in the following hour, the rash was worse.
vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 16Jul2022; No adverse event; Administered the vaccine to 346 patients after the 30 day by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 16Jul2022) and NO ADVERSE EVENT (No adverse event) in a 43-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 16Jul2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 16Jul2022) 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 (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 16Jul2022).    No concomitant medications were reported.  The patient received half dose. The vial did not undergo any temperature excursions. No treatment details were reported.
Rash on face, got progressively worse for several days and is now getting better. Still present, using aquifer without much change.
After taking the flu vaccine, I started experiencing spontaneous pneumothorax. I have had no history on this condition before.
Mother reported child has had fever ranging up to 102.  Was seen at hospital several times since 10/15/2014 and mother reports child was diagnosed with "strep infection", "ear infection" and "fifths disease".  Mother child improving and has only had fever once in last 5 days.
Extremely thirsty; Arm swollen; Headache; Nose, eyebrow and cheek reddish in color; fever; This spontaneous case was reported by a consumer and describes the occurrence of DEHYDRATION (Extremely thirsty), PERIPHERAL SWELLING (Arm swollen), HEADACHE (Headache), ERYTHEMA (Nose, eyebrow and cheek reddish in color) and PYREXIA (fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced DEHYDRATION (Extremely thirsty), PERIPHERAL SWELLING (Arm swollen), HEADACHE (Headache), ERYTHEMA (Nose, eyebrow and cheek reddish in color) and PYREXIA (fever). At the time of the report, DEHYDRATION (Extremely thirsty), PERIPHERAL SWELLING (Arm swollen), HEADACHE (Headache), ERYTHEMA (Nose, eyebrow and cheek reddish in color) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no treatment nor concomitant medication provided
pt recv vax;1 hr later,sleeping,awoke crying;mom gave apap;started shaking & grunting,tremors;became mottled;irregular resp rhythm;episode lasted 15 min;ran fever;T 102.9;pt fine but cranky & congested;
This case was reported by a other health professional and described the occurrence of incorrect product storage in a male patient who received HAVRIX pediatric (batch number AHAVB642CA, expiry date 14th December 2014). On an unknown date, the patient received HAVRIX pediatric. On an unknown date, an unknown time after receiving HAVRIX pediatric, the patient experienced incorrect product storage. On an unknown date, the outcome of the incorrect product storage was unknown. It was unknown if the reporter considered the incorrect product storage to be related to HAVRIX pediatric.
Rednees on skin started Tuesday 09-22-09.  Pt was given the vaccine on 09-21-09.  Red splotchy area approximately 4 inches in diameter around injection site.
Patient reported to and was treated at local ER. Pt complained of shortness of breath and chest pain following Flumist administration. Symptoms started shortly after inhalation of Flumist and continued to progress. Local ER evaluated as dehydration and brochospasm secondary to Flumist. Treated with nebulizers and steroids and released.
Headache; tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (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), for COVID-19 immunisation.  The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Headache"; FATIGUE (non-serious), outcome "unknown", described as "tired".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
it was rpt from sales representative that p/pt recv vax pt subsequently devel diarrhea; no further info available
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 10:02 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 10:02 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 66.93 for dose administered on 11-Jan-2021. No concomitant medications were reported.  Batch number 041L20A administered on 11-Jan-2021 underwent temperature excursion with temperature of 35 degrees Fahrenheit at 02:00 PM. This vial was moved to fridge on 08-Jan-2021 and beyond use date for the vial was reported as 07-Feb-2021. Product moved to clinic on 11-Jan-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.
On Friday, 12/3/2021, Pt(DOB: 6/25/1963) came to the ECC Covid-19 vaccination site for her Moderna Covid-19 booster dose. During administration of vaccine, RN inserted needle in client's arm and immediately vaccine spilled from the syringe from not being tightly secured. No vaccine was given to the client at this time. RN explained to client what happened and client verbally agreed to receiving her Moderna Covid-19 booster dose with a new syringe. Client was vaccinated with  Moderna (Lot #: 035C21A) at 1:15 PM in her left deltoid. Client denied any underlying medical conditions or allergic reactions and was to be a 15 minute observation. Client was also educated by RN on signs and symptoms of adverse reactions and when to go to the ED/call MD. Client experienced no adverse reaction while waiting in Observation Area and left vaccination site with a steady gait at approximately 1:35 PM.
Suspected vaccination failure; Flu; Rib cage hurts; Body aches; Drained; Sinus pain; Head pain; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 67-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent 2018-2019 season at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza, rib pain, general body pain, sinus pain, headache and exhaustion. On an unknown date, the outcome of the vaccination failure, influenza, rib pain, general body pain and exhaustion were unknown and the outcome of the sinus pain and headache were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, influenza, rib pain, general body pain, sinus pain, headache and exhaustion to be related to Influenza vaccine Quadrivalent 2018-2019 season.  Additional details were provided as follows as follows: The age at vaccination was not reported. The patient received unknown flu vaccine in 2018. On 4th March 2019, the patient went to emergrncy room because of rib cage pain, the patient also had body ache, sinus pain and excrutiating pain in head. The patient was daignosed with flu like symptoms in emergency room. It took 2 weeks to resolve all the symptoms and patient felt drained during this 2 weeks. The reporter did not consent to follow-up. This case is linked to case US2019073161, reported due to same patient.
Information has been received from a certified medical assistant (C.M.A.) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 26-FEB-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # K014798 (expiration date 12-MAR-2016, dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
Face started tingling; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Face started tingling) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (Face started tingling). At the time of the report, PARAESTHESIA (Face started tingling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Allergy reaction; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (174934). The reporter is the patient.  A 79-year-old female patient received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20) (Batch/Lot number: unknown) as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "Allergy reaction".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe body aches, headache, joint pain, 103.2 fever, nausea
weight loss; Back pain; Neck pain; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT DECREASED (weight loss), BACK PAIN (Back pain) and NECK PAIN (Neck pain) 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 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WEIGHT DECREASED (weight loss), BACK PAIN (Back pain) and NECK PAIN (Neck pain). At the time of the report, WEIGHT DECREASED (weight loss), BACK PAIN (Back pain) and NECK PAIN (Neck pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Pain for a couple days; Hard to get up; All muscles hurt; Received second dose almost 8 weeks after first dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain for a couple days), MOBILITY DECREASED (Hard to get up), MYALGIA (All muscles hurt) and INTENTIONAL PRODUCT USE ISSUE (Received second dose almost 8 weeks after first dose) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939676) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient had COVID in August 2020.) and Pericarditis (Patient has a past history of Pericarditis that happened 4 years ago during an autoimmune attack.). Concurrent medical conditions included ADD, Thyroid disorder, Ulcerative colitis, Blood sugar decreased and Blood pressure abnormal (Patient's blood pressure has been going up and down.). Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for ADD, HYDROXYCHLOROQUINE for Blood sugar decreased, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder, MESALAZINE (LIALDA) for Ulcerative colitis.    On 11-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jul-2021, the patient experienced PAIN (Pain for a couple days), MOBILITY DECREASED (Hard to get up), MYALGIA (All muscles hurt) and INTENTIONAL PRODUCT USE ISSUE (Received second dose almost 8 weeks after first dose). On 03-Sep-2021, INTENTIONAL PRODUCT USE ISSUE (Received second dose almost 8 weeks after first dose) had resolved. At the time of the report, PAIN (Pain for a couple days), MOBILITY DECREASED (Hard to get up) and MYALGIA (All muscles hurt) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was reported. Patient had COVID 19 in August 2020. Since then, her blood pressure has been going up and down, so patient takes some drug that helps BP remain constant.   This case was linked to MOD-2021-316301 (Patient Link).