chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administration via Subcutaneous Route; A spontaneous report was received from a nurse concerning a 28-year old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced Subcutaneously Administered vaccine/ incorrect route of product administration.  Concomitant product use was not provided by the reporter.      The patient received their first of two planned doses of mRNA-1273 Batch number not provided.  The patient received their second of two planned doses of mRNA-1273 (Lot number 013L20A) via subcutaneous route  for prophylaxis of COVID-19 infection.    Female Nursing Practitioner called to report Possible vaccine administration via Subcutaneous Route,  on 05FEB2021. The patients have not reported any side effects.   Treatment information was not provided.    The event, Subcutaneously Administered vaccine was considered recovered/resolved on 05 Feb 2021.; Reporter's Comments: This report refers to a case of product administration error for mRNA-1273 (Lot number 013L20A). There were no associated AEs with this event of inappropriate route of vaccination.
Hearing loss in right ear; This literature-study case describes the occurrence of DEAFNESS UNILATERAL (Hearing loss in right ear) in a 51-year-old female patient 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 DEAFNESS UNILATERAL (Hearing loss in right ear) (seriousness criterion medically significant). At the time of the report, DEAFNESS UNILATERAL (Hearing loss in right ear) outcome was unknown. Possible      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered DEAFNESS UNILATERAL (Hearing loss in right ear) to be possibly related.    No concomitant information were reported.  In this case, patient had no prior hearing loss associated issues. The adverse effect was seen in right ear. The days to onset of symptoms was set as between 21 days. Lab test included were the mean pure tone average (PTA) was 52.2 ± 30.6 dB HL for the affected ear, and 21.2 ± 12.5 dB HL for the unaffected ear. The word recognition score (WRS) was 60.6 ± 38% for the affected ear, and 90 ± 23.0% for the unaffected ear. Most of the patients were still undergoing treatment, which may include oral, IT steroids, and/or antivirals. In all cases magnetic resonance imaging of the internal auditory canals was also ordered. The extent of hearing recovery and/or symptom resolution is currently unknown.  Company Comment: This case concerns a 51 year old female with no relevant medical history who experienced serious unexpected event of unilateral deafness on unknown  date after the first dose of Moderna Covid 19 vaccine on unknown date. Rechallenge was not applicable. The benefit-risk relationship is not affected by this report.   This case was linked to MOD-2021-337903, MOD-2021-337994, MOD-2021-337995, MOD-2021-337996, MOD-2021-337997, MOD-2021-337998, MOD-2021-337999, MOD-2021-338000, MOD-2021-338001, MOD-2021-338002, MOD-2021-338003, MOD-2021-338004, MOD-2021-338005, MOD-2021-338007, MOD-2021-338008, MOD-2021-338009, MOD-2021-338010 (Patient Link).; Sender's Comments: This case concerns a 51 year old female with no relevant medical history who experienced serious unexpected event of unilateral deafness on unknown  date after the first dose of Moderna Covid 19 vaccine on unknown date. Rechallenge was not applicable. The benefit-risk relationship is not affected by this report.
After receiving Flu shot pt. broke out in hives inside (L) arm down to (L) wrist with some itching on back. Pt. took BENADRYL and symptoms resolved after 2 hours.
arm pain; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (arm 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 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm pain). At the time of the report, PAIN IN EXTREMITY (arm pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication and treatment information were not reported.
Patient's father filled out paperwork with incorrect date of birth of June 23, 2009 to make him eligible to receive the vaccine. When they came in for second dose and we were searching for GRITS to see the first dose we realized this and when questioned about it the father admitted what he'd done. So patient received first COVID vaccine at age 11.
Information has been received from a physician concerning an approximately 12 year old female who on unspecified date was vaccinated intramuscularly with the second dose of Gardasil (lot # unspecified).  Date of 1st dose of Gardasil was not reported.  Post vaccination the patient experienced pain at the injection site for approximately one month.  The physician reported that the patient did not have this experience after the first dose.  Subsequently, on unspecified date the patient recovered from the pain at the injection site. No further information was provided.  Additional information has been requested.
tenderness at injection site, chills, headache, low fever (99.3), tired.  Lasted less than24 hours.   Took 2 acetaminophen.
Jynneos was administered around 3.5 hours past it's beyond use date; Case reference number US-BN-2022-004859 is a spontaneous case report initially received on 08-Dec-2022 from a pharmacist via  Communications (reference number: USBAV22-2086) and concerns a patient of unspecified age.  The patient's medical history and concomitant medication details were not provided.  On 01-Dec-2022, at 2:44 PM, the patient was vaccinated with a dose of Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: unknown), approximately 3.5 hours past it's beyond use date (01-Dec-2022, 11:15AM), at an unknown dose, administered via an unspecified route of administration, in an unspecified anatomical site location, for smallpox/monkeypox prophylaxis (explicitly coded as 'expired product administered').  At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos vaccination.  Additional information received from Bavarian Nordic on 08-Dec-2022 included the local BN case ID.; Reporter's Comments: A patient of unknown age was vaccinated with a dose of Jynneos vaccine for smallpox/monkeypox prophylaxis approximately 3.5 hours past it's beyond use date, which is considered expired product administered. Expired product administered is listed by convention. It is unknown whether the patient experienced any adverse event. Expired product administered is not related to the suspect product, but to a human action. The case is non-serious.; Sender's Comments: A patient of unknown age was vaccinated with a dose of Jynneos vaccine for smallpox/monkeypox prophylaxis approximately 3.5 hours past it's beyond use date, which is considered expired product administered. Expired product administered is listed by convention. It is unknown whether the patient experienced any adverse event. Expired product administered is not related to the suspect product, but to a human action. The case is non-serious.
This spontaneous report as received from a physician refers to a patient of unknown age and gender who on an unknown date, was vaccinated with GARDASIL (dose, lot # and route not provided). The Physician stated he spoke to his neighbor who is a pediatric neurologist. The physician stated the pediatric neurologist reported he saw one patient who one month post vaccination with GARDASIL developed uncontrolled, strange seizures. The patient sought medical attention and was seen on the physician's office. The outcome of uncontrolled, strange seizures was unknown. The relatedness adverse event was unknown for GARDASIL. Upon internal review uncontrolled, strange seizures was considered to be a medical important event. This is one of several reports from same source. Additional information has been requested.
Went downhill rapidly... Aprox 6 hours after shot was administered I was shaking uncontrollably (freezing sensation) fever 102.6 and commiting. Woke up this morning and felt better but still very much aches and pains and headache
After the second dose of Pfizer vaccine I became very ill. Most of the symptoms were as advertised, nausea, fever, headache etc. The reaction to the fist dose was not as bad, I just went to bed early and after 24 hours felt better. This persisted for more like 48 hours.  I had no reaction to the 3rd dose.
About 5 minutes after receiving vaccine, patient reported to nurse with hives all over face and neck area. Patient denied any difficulty breathing, no swelling of face or lips, no itching reported.
fever (reported by mom as high as 105.2 F). Exam next day 3/2/23 NORMAL
Right below injection site, a red, swollen, hard, feverish, itching site appeared 3 inches long, and 1 inch wide that lasted approximately 2 weeks. Patient put antihistamine cream on it after several days and it went away.
Right Arm became moderately sore at the injection site by the evening of the injection.  Next day, developed flu like symptoms: low grade fever, widespread joint and muscle pain, fatigue and headaches.  Right arm became severely sore with marked weakness, redness and warmth spreading from the right upper deltoid injection site to the elbow.  Bright red hardened welts were present going down the upper arm from the injection site to the elbow.  Over the course of the next 3 days, the symptoms lessened and the right arm redness and pain began to subside.
Hard at site; Raised at site; Sore at site; Pain at site; Redness at site; Hard at site; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of VACCINATION SITE INDURATION (Hard at site), the second episode of VACCINATION SITE INDURATION (Hard at site), VACCINATION SITE PAIN (Pain at site), VACCINATION SITE ERYTHEMA (Redness at site) and VACCINATION SITE SWELLING (Raised at site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chronic fatigue (symptoms worse after the vaccine) in 1990 and Epstein-Barr virus infection in 1990. Concomitant products included SERTRALINE, DOXYCYCLINE and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced the first episode of VACCINATION SITE INDURATION (Hard at site), VACCINATION SITE PAIN (Pain at site) and VACCINATION SITE ERYTHEMA (Redness at site). On 10-Mar-2021, the patient experienced the second episode of VACCINATION SITE INDURATION (Hard at site), VACCINATION SITE SWELLING (Raised at site) and VACCINATION SITE PAIN (Sore at site). On 25-Feb-2021, VACCINATION SITE PAIN (Pain at site) and VACCINATION SITE ERYTHEMA (Redness at site) had resolved. On 14-Mar-2021, last episode of VACCINATION SITE INDURATION (Hard at site), VACCINATION SITE SWELLING (Raised at site) and VACCINATION SITE PAIN (Sore at site) had resolved.            ON 10mar2021, post vaccination, the patient reported that she experienced pain, swelling, redness at the injection site. No treatment medication was reported.       Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow-up information received on 11-May-2021 will be processed with initial report. Follow-up updated patient demographics, concomitant medications, adverse events start/stop dates and outcome. On 14-Jun-2021: No specific follow-up information recorded.
Pt was to receive booster dose (0.25ml) instead, received 0.50ml. Denies any symptoms.
Day after vaccine  Arm was red at injection site & warm had lump where given. Day 7 had episode of feeling faint Day 8 Red area & bump again at inj. site
This spontaneous report was received from a registered nurse who reported that PEDVAXHIB, (lot # not reported), was given to multiple unspecified subjects after the vaccine was exposed to temperatures outside of recommended condition. No adverse events were reported after the vaccine was administered. This is one of several reports from the same reporter source. Additional information has been requested.
Headaches, muscle spasms, diplopia, fatigue, nerve pain that is still present.
Hive x1 at injection site approximately 24 hrs after injection given; treated with Benadryl & cool compress.
Fluvirin .25 was given to this 3 year old.  The vaccine is licensed for 4 years and up.
The day of vaccination developed fever and joint pain 24 hrs later nausea and diarrhea, 48 hrs later  headache and left hand numbness
When recording Lot & expiration date I noticed that vaccine had an expiration date of 7-4-11, I called manufacturer & person stated that this batch was still good. No extra vaccination is needed for patient.
12/19/2017, Tuesday, developed dry cough when went to bed, throat mildly sore in middle of night, next day developed 100.6 fever in afternoon, body aches, cough was persistent but not very productive, still had 100.6 fever next day but by Friday, fever went away but cough didn't and then on Christmas Day, kept coughing and fever went up to 102.9, as of today, all fever is gone but still have persistent dry cough.
Initial information received on 03-Oct-2018 in the united states regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA279741, 2018SA279748, 2018SA279744, 2018SA279745, 2018SA279742, 2018SA279747, 2018SA279740, 2018SA279743 and 2018SA277209 (same reporter). This case involves a 55 years old male patient was vaccinated with a 0.5 ml dose of FLUBLOK QIV lot QFAA1829; expiry date: 30-Jun-2019 via intramuscular route in the left deltoid on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to incorrect product storage. It was reported that the patient did not experience 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
Woke up next day terribly congested, fever, sweat. Worse in the mornings.
Patient claims  axillary and supraclavicular pain, after 48h of 2nd dose vaccination with Pfizer vaccine. That has recovered in 75% since onset of symptoms. Pt claims tenderness in the right neck area, with a non visible but palpable lump the size of  a quarter. Patient took a dose of tylenol 1g which subdued most of the symptoms, and  reports today 1/30/2021 only local tenderness, with no other side effects to report.  Pt also claims feeling of chills, and flu like symptoms 24 hours after the vaccination which subdued with a dose of Tylenol 1g.
Vaccine had a low temp excursion.  Was revaccinated 10/26/2022
C/O anxiety admits to having increased anxiety. Also c/o numbness and tingling to l arm. Sent to ems for further eval.
This is a spontaneous report from a contactable consumer. An 80-year-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on 26Jul2016 at single dose in right shoulder, for immunisation.  On the same date the patient received diphtheria vaccine in left shoulder. Medical history included two previous pneumonia vaccinations on an unknown date. The patient's concomitant medications were not reported.  A couple days after vaccination, the patient started to experience the following symptoms: raised at the injection site, itching all over, scratched until bleed, red patches all over my body (on ankles, the bottom of foot, toes, close to groin). The area around injection site became brown. Also had throat swollen up, felt like had a lump in throat and in between the chest, like if she was choking, but it went away after a while.  Lips and tongue were swollen, eyes were so swollen in the urgent care, they were almost closed shut, can't sleep because the itching. The patient went to see a specialist and her doctor, also showed the arm to the pharmacist. The patient was hospitalized twice since got the injection. The nurse in the urgent care documented that the patient had hives all over the body. They gave topical cortisone cream, anti- itch cream. Patient's doctor prescribed ZYRTEC but it didn t do anything. The outcome of 'felt like had a lump in throat and in between the chest, like if she was choking' was recovered, all other events outcome were unknown.
This spontaneous report was received from a physician and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # M037248 and expiration date 21-FEB-2019 (dose, frequency and route of administration were not reported) for prophylaxis. There were no adverse symptoms reported. Administered doses of vaccine experienced the temperature excursion from 47 to 77 degrees Fahrenheit for 34 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter; Sender's Comments:  US-009507513-1709USA005381: US-009507513-1709USA002048: US-009507513-1709USA005382: US-009507513-1709USA005379:
has received a 3rd dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st and 2nd dose received on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows:  The age at vaccination was not reported.  The patient has received a 3rd dose of Shingrix, which led to extra dose administered. No aware of vaccination Date, Lot Number or Expiry Date of vaccine were provided. All patient identifiers were reported but no other detail was provided when asked. The reporter consent to follow up.
Patient is a 35yof with a PMH of migraines and anemia who presents for first seizure.  Given description of an ictal cry followed by whole body shaking and soreness, it sounds like a GTC.  Seizure was in the setting of sleep deprivation for >30 hours and 2 days after first COVID 19 vaccine.  She has no other history concerning for subclinical seizure activity.
Complaining of his arm hurting; Feeling off yesterday; Feeling a little tired; 16yo son got the booster; Armpit is slightly swollen (same side as; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Complaining of his arm hurting), FEELING ABNORMAL (Feeling off yesterday), FATIGUE (Feeling a little tired), LYMPHADENOPATHY (Armpit is slightly swollen (same side as) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16yo son got the booster) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced LYMPHADENOPATHY (Armpit is slightly swollen (same side as). On 17-Jan-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16yo son got the booster). On 19-Jan-2022, the patient experienced FEELING ABNORMAL (Feeling off yesterday) and FATIGUE (Feeling a little tired). On 20-Jan-2022, the patient experienced PAIN IN EXTREMITY (Complaining of his arm hurting). On 17-Jan-2022, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16yo son got the booster) had resolved. At the time of the report, PAIN IN EXTREMITY (Complaining of his arm hurting) and LYMPHADENOPATHY (Armpit is slightly swollen (same side as) outcome was unknown and FEELING ABNORMAL (Feeling off yesterday) and FATIGUE (Feeling a little tired) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment information was provided The reporter stated that at the time of reporting the patient was feeling much better for the event  a little tired and off
Early menstrual period after 1st shot, at least a week early.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 43-year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 42 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: MENSTRUATION IRREGULAR (non-serious), outcome "unknown", described as "Early menstrual period after 1st shot, at least a week early.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of menstruation irregular.  Additional information: The patient had no covid prior vaccination. Early menstrual period after 1st shot, at least a week early. Very late menstrual period after second shot, about one month late. If covid prior vaccination and if other vaccine in four weeks were reported as no. the patient had been tested for covid post vaccination with method of Nasal Swab and covid test result was Negative.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Painful site Weakness and shaking Tingling sensation in mouth EMS called and recommended transport to the hospital - patient declined
Information has been received from a nurse practitioner referring to a patient of unknown age and gender. The patient's medical history or concurrent condition were not provided. On 23-APR-2015 the patient was vaccinated with the first dose of GARDASIL (injection, strength, lot#, dose were unspecified) intramuscularly. On 07-MAY-2015 the patient was inadvertently administered the second dose of GARDASIL (injection, strength, lot#, dose, were unspecified) intramuscularly (inappropriate schedule of vaccine administered). No adverse effects was reported. Additional information has been requested.
pt recv vax 31MAR95 1145AM APAP given @ home afterwards starting crying (high pitched screaming) rt leg sensitive to touch & movement; cont to scream family MD ofc advised to go to ER;
We will treat this part as a burn, Silvadene cream twice daily until healed/drying. Also recommended nonstick bandages and we gave him several take home with him.  Zyrtec 10 mg daily at bedtime for 2-4 weeks to help with the reaction