chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severe to profound sensorineural hearing loss; cerebrovascular accident; spontaneous movement of the left arm; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 24-JUN-2016, the pt was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (exact dose, dose number, route and site of administration, lot# and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered a sudden onset hearing loss and was diagnosed with severe to profound sensorineural hearing loss. On an unknown date, a few weeks later, the patient was unable to speak and experienced spontaneous movement of the left arm and was diagnosed with cerebrovascular accident. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, the patient's symptoms resulted in physical limitations not present prior to the vaccination. The patient also experienced mental and emotional distress due to resulting physical limitation and seriousness of her condition. As a result of the zoster vaccine live (ZOSTAVAX) use, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX) use, the patient suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was reported as not recovered. The relatedness between the events and zoster vaccine live (ZOSTAVAX) was reported as related.  Upon internal review, the events of sensorineural hearing loss and cerebrovascular accident were considered to be medically significant.  The events of sensorineural hearing loss, spontaneous movement of the left arm and cerebrovascular accident were considered to be disabling.
Erythema 7 cm x 6 cm surrounding the injection site with fevers lasting for 3 days following vaccine administration.
7-8 hours after recieving PENTACEL, patient was in mothers arms smiling and alert when she suddenly fell limp, eyes rolled back and went unresponsive and lifeless. "Hypotonic hyporesponsive reaction" ...after picking up the phone to call 911, she woke up and regained respoveness.
patient received 0.25ml dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ACCIDENTAL UNDERDOSE (patient received 0.25ml dose) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 25-Mar-2021, the patient experienced ACCIDENTAL UNDERDOSE (patient received 0.25ml dose). On 25-Mar-2021, ACCIDENTAL UNDERDOSE (patient received 0.25ml dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This report refers to a case of accidental underdose for mRNA-1273, lot # 017B21A with no associated AEs.   Reporter did not allow further contact; Sender's Comments: This report refers to a case of accidental underdose for mRNA-1273, lot # 017B21A with no associated AEs.
No additional AE reported; Nurse called to report that a dose of PEDV AX HIB expired 7 /9/21 and was administered; Information has been received from a nurse, referring to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 24-AUG-2021, the patient was vaccinated with an expired dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # R027322, expiration date on 09-JUL-2021 (anatomical location and administration route were not reported) for prophylaxis. No adverse effects were reported.
Patient received PREVNAR (13) on 10/3/18 on Left arm and developed redness at the site of injection (Left arm). She also received flu-shot same day on right arm - no reaction occurred.
This was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received SHINGRIX. On 6th March 2018, the patient received SHINGRIX. On 7th March 2018, 1 days after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife. The patient's arm was sore. This case has been linked to case US2018039391, reported by the same reporter.
Mother did not have up to date record with infant so PEDIARIX was given 3 1/2 wks from the previous dose (2nd PEDIARIX given 6/17/08 and 3rd 7/9/08 at her Dr's office).
Patient felt fine after shot.  They were informed to remain in the store for 15 minutes for observation.  They were walking up the aisle and started to feel faint.  Vision went black and patient passed out.   Mom yelled out and laid the patient down on the ground.   911 was called.  Patient quickly came to, feet were elevated and they were resting.   Pulse was checked.  Patient was talking and felt fine but just sad and scared.  After a few minutes she sat up and leaved against the shelves.   At that point emergency personnel arrived and took over.
6 x 7 cm localized reaction from injection site on left thigh from diptheria, tetanus and pertussis vaccine.
Right shoulder pain and limited range of motion at present time (2 weeks since vaccination).  Currently awaiting physical therapy appointment.
expired drug used; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 9-week-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 5N259, expiry date 05-OCT-2023) for prophylaxis.   On 13-OCT-2023, the patient received Pediarix. On 13-OCT-2023, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: expired drug used). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-OCT-2023 The registered nurse reported that an expired dose of Pediarix was administered to a patient which led to expired vaccine used. The reporter to consented to follow up. The vaccine administration facility is the same as primary reporter.
Felt Achy after first primary shot/Felt Achy after  2nd  primary shot; Flu like symptoms after first primary shot/Flu like symptoms after 2nd primary shot; Runny nose after first primary shot/Runny nose after 2nd primary shot; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Felt Achy after first primary shot/Felt Achy after  2nd  primary shot), INFLUENZA LIKE ILLNESS (Flu like symptoms after first primary shot/Flu like symptoms after 2nd primary shot) and RHINORRHOEA (Runny nose after first primary shot/Runny nose after 2nd primary shot) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2022, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced PAIN (Felt Achy after first primary shot/Felt Achy after  2nd  primary shot), INFLUENZA LIKE ILLNESS (Flu like symptoms after first primary shot/Flu like symptoms after 2nd primary shot) and RHINORRHOEA (Runny nose after first primary shot/Runny nose after 2nd primary shot). On 26-Feb-2021, PAIN (Felt Achy after first primary shot/Felt Achy after  2nd  primary shot), INFLUENZA LIKE ILLNESS (Flu like symptoms after first primary shot/Flu like symptoms after 2nd primary shot) and RHINORRHOEA (Runny nose after first primary shot/Runny nose after 2nd primary shot) had resolved.            The concomitant and treatment medication was not reported. The patient had another episode of events achy, flu like symptoms and runny nose after second shot on 23-Mar-2021 and resolved on 26-Mar-2021.   This case was linked to MOD-2021-374714, MOD-2022-660546 (Patient Link).
Expired vaccine was administered; 1 vial of Moderna vaccine out of the Freezer on 23SEP2021 and placed it in the refrigerator. On 28OCT2021 they removed the unpunctured vial from the refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered) and PRODUCT STORAGE ERROR (1 vial of Moderna vaccine out of the Freezer on 23SEP2021 and placed it in the refrigerator. On 28OCT2021 they removed the unpunctured vial from the refrigerator) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered) and PRODUCT STORAGE ERROR (1 vial of Moderna vaccine out of the Freezer on 23SEP2021 and placed it in the refrigerator. On 28OCT2021 they removed the unpunctured vial from the refrigerator). On 28-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered) and PRODUCT STORAGE ERROR (1 vial of Moderna vaccine out of the Freezer on 23SEP2021 and placed it in the refrigerator. On 28OCT2021 they removed the unpunctured vial from the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided No treatment medications were provided.
Fever, chills, sweats, fatigue some loss of smell, no appetite, lasted roughly 28 hours.
Vaccines administered on 7/16/2019. Right arm became red and swollen on 7/17/19 in the evening. Reddness and swelling noted when bathing the child. Minimal pain expressed per father of child. Child active, acting normal. father applied cold compress and administered Tylenol. Father did not take child to the doctor. Arm swelling decreased over 5 days.  Father called today, July 23 at 830 am. Child continues to do well... per father, "arm looks better".  Patient did not experience other signs or symptoms.
This case was reported by a consumer via call center representative and described the occurrence of breathing arrested in a male patient who received ENGERIX B pediatric. On 4th May 2016, the patient received the 1st dose of ENGERIX B pediatric. On 4th May 2016, less than a day after receiving ENGERIX B pediatric, the patient experienced attention impaired. On 5th May 2016, the patient experienced labored breathing. On 8th May 2016, the patient experienced breathing arrested (serious criteria GSK medically significant), seizure (serious criteria GSK medically significant), gaze palsy (serious criteria GSK medically significant), oral discomfort, heart rate decreased and pale skin. In May 2016, the patient experienced sleep apnea and vomiting. ENGERIX B pediatric was interrupted. On 8th May 2016, the outcome of the breathing arrested, seizure, gaze palsy and oral discomfort were recovered/resolved. In May 2016, the outcome of the labored breathing, vomiting and heart rate decreased were recovered/resolved. On an unknown date, the outcome of the sleep apnea was not recovered/not resolved and the outcome of the attention impaired was recovered/resolved and the outcome of the pale skin was unknown. The reporter considered the breathing arrested, gaze palsy, labored breathing, sleep apnea, oral discomfort, vomiting, heart rate decreased and attention impaired to be related to ENGERIX B pediatric. It was unknown if the reporter considered the seizure and pale skin to be related to ENGERIX B pediatric. Additional details were provided as follows: This case was also reported to a doctor. The case was reported by the patient's father. The patient received the vaccine right after the birth. No other vaccines were given that day. The patient after being born, was very attentive and looking around the room. On the same day, in the night, the patient was not as attentive or responding to sounds like earlier in the day. On the next day the patient reacted the same way and was inattentive. On 5th May 2016, 1 day after receiving ENGERIX B pediatric, the patient experienced labored breathing (breathing did not sound normal). To the patient's parents, it sounded like the patient was gasping for air. A doctor and a nurse told the patient's parents that what he thought was abnormal was normal, for a newborn. They did not see that it was a concern. On 7th May 2016, the parents took the patient home. Before checking out, the parents were still concerned about the patient's breathing, but the nurse that checked them out the hospital was not concerned. The parents took the patient home. On 8th May 2016, 4 days after receiving ENGERIX B pediatric, the patient experienced pale skin, mouth tightness, eyes rolled back in the head and stopped breathing. The patient's skin color had changed and was very pale. The father felt that the patient had a seizure. In May 2016, less than a month after receiving ENGERIX B pediatric, the patient experienced sleep apnea and vomiting. The patient's father took the patient to the emergency room since the hospital was close by. This case was linked with US2017GSK003449, for the same reporter.
Two days following vaccination, infant developed severe vomiting and diarrhea, which led caregiver to take her to a local ER, where she was airlifted to the nearest hospital, and she had emergency surgery for intussusception.
THE PATIENT WAS SEEN FOR CHEST PAIN, CHEST PRESSURE, AND SHORT OF BREATHE. THE PATIENT WAS GIVEN A CHEST XRAY AND AN EKG. THEY WERE BOTH CLEAR. THE PATIENT WAS ALSO GIVEN A COVID RAPID TEST WHICH RESULTED AS A NEGATIVE. THE PATIENT WAS THEN RECCOMENDED TO GO TO THE NEAREST EMERGENCY DEPARTMENT TO OBTAIN FURTHER TESTING AND HE REFUSED - SIGNING A AMA.
Left arm swollen (egg size), slightly red, hot to touch, slight ache and slight itch for 3 days.  Symptoms are less and area getting better.  Applied ice, topical treatment, took one Advil.
Sore throat; Nausea; Stomach cramps; Metallic taste; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 37-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 16Sep2021 at 13:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included bowel obstruction (BO). The patient had no known allergies. 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 concomitant medications. On 16Sep2021 at 14:00, the patient experienced sore throat, nausea, stomach cramps, metallic taste, and headache. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had been tested for COVID-19. On 21Sep2021, the patient underwent COVID-19 test via nasal swab and the result was pending. Therapeutic measures were taken as a result of the events which included unspecified treatment. The clinical outcome of the events sore throat, nausea, stomach cramps, metallic taste, and headache were recovering 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.
On day 8 my arm became red from my injection site to just above my elbow. It was itchy and sore and somewhat swollen.  A surgeon friend recommended doxycycline because he thought it was cellulitis.  And I took Benadryl 50mg.  I took Doxy and Benadryl at night and in the AM.  I took the Benadryl 2 hours prior to the Doxy and it was looking less red before I even took the Doxy.  After consulting with my own doctor in the AM, she advised me to stop the doxy and the benadryl and let nature take it's course.  he redness subsided with 4 days and it was much less itchy.  It was still a bit sore but that resolved within a week.  I did not see the doctor in her office.  I sent her a picture of my arm and we talked on the phone.
The patient has a history of advanced dementia. She was brought to the ED by EMS on 3/29/23 with generalized weakness.  A COVID rapid PCR test performed in the ED resulted positive. Ultimately she was admitted 3/29/23 - 3/30/23 with discharge diagnoses including E.coli UTI and COVID-19 infection.  The patient was not hypoxic and did not require any treatment for her COVID-19 infection.
She can't hear at all from her right ear; Her right ear was numb; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS UNILATERAL (She can't hear at all from her right ear) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (Medical history not reported.).    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced DEAFNESS UNILATERAL (She can't hear at all from her right ear) (seriousness criterion medically significant) and HYPOAESTHESIA (Her right ear was numb). At the time of the report, DEAFNESS UNILATERAL (She can't hear at all from her right ear) and HYPOAESTHESIA (Her right ear was numb) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. No relevant concomitant medications were reported.   Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded. Further information has been requested.
Right arm swollen a deltoid, red, warm to touch area 14.5cm x 9.5cm.
decreased fetal movement; decreased fetal heart tones; 34 weeks pregnant; This is a spontaneous report from a contactable pharmacist. This pharmacist reported information for both mother and fetus. This is a fetus report. A fetus patient of an unspecified gender received the first dose of bnt162b2, transplacental on 16Mar2021 (Lot Number: Unknown) as single dose for covid-19 immunisation. The 31-year-old mother received this vaccine via Intramuscular. The patient medical history and concomitant medications were not reported. The mother presented to obstetrician office 2 weeks after covid vaccine with complaints of decreased fetal movement. Mother was taken to emergency c-section due to decreased fetal heart tones in the office. Baby was delivered with apgars of 0 and ultimately fetal demise. Mother was 34 weeks pregnant and had an otherwise uncomplicated pregnancy. The onset date of events decreased fetal movement and decreased fetal heart tones was 30Mar2021. The events were result in Doctor or other healthcare professional office/clinic visit and hospitalization for 3 days. The outcome of the events was fatal. The patient died on an unspecified date in 2021 due to events. It was not reported if an autopsy was performed.  Follow-up (14Apr2021): This follow-up is being submitted to notify that the batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: The reported events are likely due to an intercurrent condition and not related to   BNT162B2 .,Linked Report(s) : US-PFIZER INC-2021359597 Mother case; Reported Cause(s) of Death: 34 weeks pregnant; decreased fetal movement; decreased fetal heart tones
No additional adverse event; 20 years-old patient was administered PROQUAD; This spontaneous report was received from a nurse prescriber referring to a 20 year old patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.     On 12-FEB-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # R030802 (verified to be a valid lot number), expiration date not reported, but upon internal validation established as 22-APR-2020, for prophylaxis.  Other suspect therapies included sterile diluent (STERILE DILUENT). No additional adverse event was reported.