chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hearing loss; Shingles; Information has been received from a lawyer regarding a case in litigation, referring to a female pt of unknown age. Information regarding the pt's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. In or about 2015, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (route of administration, strength, dose, lot # and expiration date were not provided) by a healthcare provider at a pharmacy for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, the pt was treated at a physician office for shingles and hearing loss. As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, had and would continued to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, included but not limited to medical losses and costs which included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. At the time of the report, the outcome of deafness and herpes zoster was considered as not recovered. The lawyer considered herpes zoster and deafness to be related to zoster vaccine Live (ZOSTAVAX).     Upon internal review, deafness was determined to be medically significant.
Flu-like symptoms, fever, body aches, fatigue. I have stayed in bed since yesterday and taking Nyquil.
26dec96 pt was found laying on floor w/ hands & feet shaking; was taken to SFMC- hosp was aware of previous vax having been given.  All tests were negative & inconclusive. Hosp indicated was probable febrile sz.
patient reported dizziness immediately after shot. reported he had not ate or drank that day. patient was given water and orange juice and sat down for 15-20 minutes. he denied any other symptoms, and chose to leave the pharmacy against medical advice to stay a bit longer. denied any further help.
Sore arm; little bit tired; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FATIGUE (little bit tired) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included VALSARTAN, HYDRALAZINE, HYDROCHLOROTHIAZIDE and ATENOLOL for an unknown indication.    On 14-Feb-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 PAIN IN EXTREMITY (Sore arm) and FATIGUE (little bit tired). At the time of the report, PAIN IN EXTREMITY (Sore arm) and FATIGUE (little bit tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment information was reported.  Patient stated that she takes unspecified medication for hypertension twice a day and also checks her blood pressure first thing in the morning and she stated that the blood pressure is typically less 120/70.   This case was linked to MOD-2021-361949, MOD-2021-361984 (Patient Link).
Rash on right arm from QUADRACEL and or PROQUAD. Developed fever 2 days ago after receiving QUADRACEL and PROQUAD on 11/8/18. Fever was 103. Seen in ED and diagnosed with strep throat. Presribed amoxicillin. This morning mom noted rash on the upper arm where he received vaccines. Patient complains that the area is itchy. No fever since starting amoxicillin. No other rash noted.
No adverse event; First dose on 7-Feb-21 and second dose on 27-Feb-21; This spontaneous case was reported by an other health care professional and describes the occurrence of NO ADVERSE EVENT (No adverse event) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 7-Feb-21 and second dose on 27-Feb-21) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 7-Feb-21 and second dose on 27-Feb-21). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, NO ADVERSE EVENT (No adverse event) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 7-Feb-21 and second dose on 27-Feb-21) 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 assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 7-Feb-21 and second dose on 27-Feb-21).    No concomitant medications was reported.  The reporter informed that, no adverse event was known.  No treatment drug details was reported.   This case was linked to MOD-2022-620425, MOD-2022-608992 (Patient Link).
Vial was first punctured on 15-Nov-2022 around 2:30 pm and was administered on 16-Nov-2022; No adverse event; administered with vaccine from a vial punctured for more than 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with vaccine from a vial punctured for more than 12 hours), PRODUCT STORAGE ERROR (Vial was first punctured on 15-Nov-2022 around 2:30 pm and was administered on 16-Nov-2022) and NO ADVERSE EVENT (No adverse event) in a 77-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 16-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with vaccine from a vial punctured for more than 12 hours). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was first punctured on 15-Nov-2022 around 2:30 pm and was administered on 16-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with vaccine from a vial punctured for more than 12 hours), PRODUCT STORAGE ERROR (Vial was first punctured on 15-Nov-2022 around 2:30 pm and was administered on 16-Nov-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (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 with vaccine from a vial punctured for more than 12 hours) and PRODUCT STORAGE ERROR (Vial was first punctured on 15-Nov-2022 around 2:30 pm and was administered on 16-Nov-2022).    Concomitant drugs were not reported. It was reported that the bivalent vial of 2.5 ml was initially stored in refrigerator on 09-Nov-2022 and post puncture was stored in room temperature for 20 hours. The vial was first punctured on 15-Nov-2022 around 2:30 pm and was administered on 16-Nov-2022 1 dose at 11:00 am and 2 doses at 01:00 pm. The vial did not underwent any temperature excursion. Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-674355 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-674355:same reporter
COPD w/exacerbation;resp distress;expired 15NOV98 @ hosp;adm to hosp 14NOV98;
Mom and her 10-year-old daughter came to get a Pfizer adult booster and a Pedi Pfizer first dose. I got both mom and daughter in the IMZ room. I went in there to give the pediatric dose first, however; after a little back and forth with the daughter, mom decided to get her shot first. Now I have two shots in the room. Another back and forth on who wants to go first occurred, and daughter insisted that mom should go first. At this time, I accidently gave mom the Pedi Pfizer dose. As soon as I did it, I realized that I made the error, went out and draw another Pedi dose and administer it to the daughter. Mom received a second shot of the full adult Pfizer dose per Pfizer recommendations.
I have been experiencing tinnitus and potential hearing lose in right ear. When I first noticed it, I had a numbness by my right ear which subsided but three weeks later, I still have a ringing in my ear which I have never had issues with my ears and I am nervous to get the second dose. There are multiple reports of this very thing on website and it is concerning.
Patient is under 18 y.o and was administered moderna vaccine. Patient reports sore arm with first dose, no other compliants.
weak pulse,changes in body temperature,clammy sweat, pale skin I called emergency services the emt firefighter came they checked her vitals  her color returned and she was doing better but still shaky Mom wanted her to be checked out the emt took her to hospital
Information has been received from a healthcare worker concerning a patient (gender and age not reported) who in April 2007 ("with in the last two weeks"), was vaccinated with a dose of Pneumovax 23 (Lot# 655592/1175F).  Subsequently, the patient reported to the office that the injection site was red and swollen within two days after receiving vaccination.  The patient was told to take ADVIL for the reaction.  It was also reported that the patient was scheduled for examination in the office but never kept the appointment.  At the time of the report, the patient's recovery status was unknown.  The reporter felt that the patient's experiences were related to therapy with Pneumovax 23.  The reporter has requested a lot check.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  The lot met the requirements of the agency and was released.  Additional information has been requested.
Syncope 1-2 minutes after vaccine was given. Pt abruptly fell backwards from standing position, hit head on wall behind him and then down to ground. Patient did not lose consciousness. Pt was immediately able to tell us who and where he was. Normal mental status with dizziness, nausea and light sensitivity. Not able to sit up on his own without feeling worse- 911 was then called.
POSSIBLY TOOK VIVOTIF WITHIN 3 DAYS OF ANTIBIOTIC; This spontaneous case (PVX2019-879) was received from a caregiver on 15-Apr-2019. It describes a 17-year-old adolescent male consumer who "possibly took Vivotif within 3 days of antibiotic". The consumer was receiving oral Vivotif (one capsule every other day) for typhoid prophylaxis and oral minocycline extended release (90 mg) for acne.  Case report: The consumer took last dose of minocycline on either 11-Apr-2019 or 12-Apr-2019 and then he took his first dose of Vivotif on 15-Apr-2019.   Action taken with Vivotif and minocycline was not applicable.  The clinical outcome of the event "possibly took Vivotif within 3 days of antibiotic" was unknown.   Company's Comment: The causality of the event "possibly took Vivotif within 3 days of antibiotic" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "possibly took Vivotif within 3 days of antibiotic" was considered as not applicable.
Warm around injection site; Redness around injection site; knotty area around injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site warmth in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injection site warmth, injection site erythema and injection site lump. On an unknown date, the outcome of the injection site warmth, injection site erythema and injection site lump were unknown.   It was unknown if the reporter considered the injection site warmth, injection site erythema and injection site lump to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not applicable for this report. The age group was captured as adult as per Shingrix indication.  The reporter reported some patients had told him they had a warm, red, knotty area around Shingrix injection site. The reporter provided specific details other than what was stated at time of initial report.  No other details, including patients or products was available. The reporter did not consent to follow up. This case has been linked with US2019153979, reported by same reporter.
pt recv vax & devel cellulitis;pt hosp & treated w/IV ATB;
High dose Quadrivalent administered to individual less than 65 years of age. Call placed to individual 3 days following injection to inform of error. She denies any sign or symptoms of concern; no adverse reaction reported as result of error.
Dose 1: Severe fatigue, severe headache, joint aches, nausea lasting 72 hours.  Dose 2: Temporary loss of smell and taste within 5 minutes after injection. Smell and taste returned a couple hours later. Metallic taste in mouth  for duration of symptoms. Severe fatigue, strong headaches, nausea, diarrhea, numbness in both arms and left side of body, strong joint pain. Most extreme symptoms lasting approximately 60 hours, overall symptoms lasting 96+ hours, nearly ~108 hours  in total.
About 2 minutes after the shot I walked out of the doctors office and into the lobby, and all of a sudden I lost all energy in my body. Literally, I felt as though if I were to take one more step I would collapse. I did not have the energy to put my hand up and ask the clerk for help, and she was only a few feet away. Not knowing what else to do, I laid down on the floor in the lobby and tried to sleep. Probably soon after a medical assistant brought me back into the office and gave me some water. She said I looked "clammy" and I felt a cold sweat. After I drank the water I laid down on one of the beds in the small offices. I have not gone back to get the other two shots. I am a 19 year old female.
Potential AE due to doses administered from vials that may have been compromised; Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion; Administered vaccine from vials that may have been compromised; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised). At the time of the report, IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  Moderna vaccine was ordered on 01-Nov-2021 and 15-Nov-2021.  The beyond use date of the vaccine was reported as 01-Dec-2021 to 15-Dec-2021.  The reporter reported that they had a group of 13 pharmacies that had administered the Moderna vaccine. Their digital data loggers and freezers expired before they were re-calibrated. They were aware that in some of the freezers there was a temperature excursion that their data logs showed.  They wanted to reach out to see if the vaccines had been compromised. The vaccines had never reached a temperature that was considered outside of frozen recommended range. The data loggers had laps where they were not considered calibrated, so they had paper logs to monitor those temperatures.  The reporter asked whether they need to take any action in relation to the doses administered since the vaccines were stored in an unapproved freezer without a digital data logger. This was in several different freezers and the vial temperatures never went out of range when they were using the paper log.  No treatment information was provided.
chest pain; lower abdominal pain; lost his taste, a part of it has come back but not completely; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary immunization complete; , Dose number unknown), for Covid-19 Immunization. The following information was reported: CHEST PAIN (non-serious), outcome "unknown"; ABDOMINAL PAIN LOWER (non-serious), outcome "unknown", described as "lower abdominal pain"; AGEUSIA (non-serious), outcome "recovering", described as "lost his taste, a part of it has come back but not completely". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient was asking any advice on how to help with pain, mentioned he is experiencing chest pain and lower abdominal pain. Patient was made aware by agent that will not be able to do medical advice. While the call is being transferred, patient mentioned that he has taken test for COVID Sunday it came back negative. He also mentioned that he lost his taste, a part of it has come back but not completely; and he experienced this "a week after". After providing response, patient stated that his next appointment will be in Jun and the emergency room is packed with COVID patients, which makes him afraid of going. Patient mentioned that it was the "Pfizer plus BioNTech vaccine, the updated booster" he got. He only experienced this with the "Pfizer plus BioNTech booster" and not with previous "Pfizer vaccines" he had, stating maybe because the booster has "BioNTech" combination. The patient was advised to seek medical attention right away if you have any of the following symptoms after receiving the vaccine: Chest pain.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Patient was given the gray top vaccine for 12 and older instead of the orange top 5 to 11
Sore arm-no treatment; appendicitis pain set in w/in 48 hrs-underwent a laparoscopic  appendectomy w/in 72 hrs. following vaccination.
itching; rash with hives on left arm, shoulder chest and up her neck on left side; This is a spontaneous report from a contactable Nurse (reported for herself). A 68-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 28Feb2021 (at the age of 68-years-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 01Mar2021, the reporter reported that, she experienced itching, and a rash with hives on left arm, shoulder chest and up her neck on left side. She applied hydrocortisone cream and took Benadryl. The next morning used the hydrocortisone cream again after her shower since the rash came back. The reporter requesting to take the second vaccine. Her doctor said it was up to her but to take Zyrtec the day before and the day of the second dose. Therapeutic measures were taken as a result of events included treatment with Hydrocortisone cream and Benadryl. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Severe left upper arm/ shoulder pain..limited mobility.  Saw orthopod.....Medrol dose pack x 2 with some relief.  Off of steroids and severe pain returned.  Following up with orthopedic for frozen shoulder.
Father called 6/25 to cancel appts for August/08 and states baby died of SIDS. 8/29/09 Autopsy report also states: apparently found unresponsive at home in car seat which had been placed in crib;no evidence of acute traumatic injury; post mortem studies all negative. 8/29 Autopsy states COD: no anatomic cause./
LIP SWELLING; GENERALIZED ITCHING; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUN-2021, the subject experienced generalized itching. On 10-JUN-2021, the subject experienced lip swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from generalized itching, and lip swelling. This report was non-serious.
A sore, what generally is called a cold sore, appeared on patient's lip. she applied Orabase and it disappeared in a few days. Within a week another appeared and a third is about to appear. Since these cold sores are herpes related and so is the Zostavax we are wondering if they are related to the vaccination.
Pt said a few days after she has received the PREVNAR vaccination, she happened to look at her right arm and noticed that her upper arm around the injection site was red and warm to the touch. No pruritus reported. She had also received an influenza vaccination on the same day, but that was on the left deltoid.