chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After receiving the 2nd Covid Vaccine- When going up the stairs in the garage to get to my vehicle I had a sudden inability to breathe and had to stop on the first landing to catch my breath. After 5 minutes or more I started back up the stairs at a very slow pace to make it to the 3rd level. Prior to the vaccine, I took the stairs every day with no problems. To date, exertion causes shortness of breath. Xrays showed hyperinflated lungs. Also getting a cardiac workup. I also started getting blisters on the hands and feet intermittently. I also now have a myopathy for no apparent reason with leg weakness and muscle pain.
Unknown which vaccine was given.  Only selected Pfizer because VAERs wouldn't let me proceed. Was not given at hospital.  Given somewhere else.  Cardiologist believes that that pericardial effusion (admitted here for that) may have been due to COVID vaccine given 2 weeks prior to admission, even though patient has advanced age and significant cardiac history
Pt developed "achy" fingers and toes approximately 2 days after the injection, had difficulty holding a pencil, took ASA and received some relief. Pt continued ASA for the next 2 days with 75% improvement of symptoms. States fingers are less swollen today (4/10/00).
One week after the patient received the second dose of the COVID-19 Pfizer vaccine, he started experiencing episodes of seizure-like activity, dizziness, and syncope. He experienced these symptoms on day 9 after receiving the vaccine, and continued experiencing episodes on day 10 when he presented to the emergency department. He was diagnosed with high-grade second degree heart block, requiring the implantation of the pacemaker and a 6 day hospitalization with time in the pediatric intensive care unit. The patient is improving clinically is currently still in a deconditioned state however is recovering from the new diagnosis and recent procedure.
Bruise, lumpy swelling, soreness surrounding injection site. Soreness increased with movement of arm.
Dose Number: 1:Pfizer / Dose Number: 1:Janssen; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Oct2021 as dose 2 (booster), single (Lot number: PE3590) at the age of 59 years, in right arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (COVID-19 VACCINE JANSSEN), on 30Mar2021 as dose 1, single (Lot number: 1805018), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Neutropenia" (unspecified if ongoing). There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Dose Number: 1:Pfizer / Dose Number: 1:Janssen"; DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive for COVID again; Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a healthcare worker refers to an adolescent male patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 08-AUG-2014 (at the age of 16 years old), the patient was vaccinated with his first dose in series of GARDASIL (dose, route of administration, lot # and expiration date were not reported). On 14-SEP-2015 (at the age of 17 years old), he was administered his second dose in series with GARDASIL 9 (dose, route of administration, lot # and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
Developed symptoms of cough, fever, sore throat, and diarrhea on 08/31/2021
I had a sore arm for a couple of days. On 01/16/2023 I had a sore right side, and I had a rash. As each day progressed the rash moved on and I had pain. I saw my doctor on 01/19/2023 and it was confirmed that the rash was shingles. I was given the prescription Valacyclovir and that helped with my symptoms.
No adverse event; On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 067H22A) for COVID-19 prophylaxis.     It was unknown if the patient had acute illnesses at the time of vaccination and up to one month before. It was unknown if the patient had chronic or long-standing health conditions.     On 10-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 10-May-2023, the patient experienced UNDERDOSE (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine).    This case was for 2nd (wife) patient out of 27 patients. Patients was an over the age of 65 years.  Concomitant medications were not reported.  It was unknown if the patient was taking any prescriptions, over-the-counter medications, dietary supplements, or herbal remedies at time of vaccination or at the time of the adverse event.  The vaccine was administered in the deltoid site. On 11-May-2023 26 patients were contacted, on 12-May-2023 18 patients received an additional 0.25ml, 2 patients made appointments to receive the following week and 1 declined to receive the additional 0.25ml dose. A husband and wife pair stated that they would go to the clinic to receive the additional dose but gave no specifics and one patient was mailed a letter as he was not able to be reached by phone.   Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-723833 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723833:Master case
patient received vaccine and immediately passed out and hit the floor. he woke up soon after and we gave him some water and crackers and he felt better. we called the ambulance and they came and checked him out and he was fine so he and his mom went home. he walked out on his own and was fine. no issue at the injection site, etc. i think he just passed out from nerves and not eating all day.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 16-APR-2018 and 18-JUN-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ (strength were unknown) (lot# N024295 and expiration date 24-MAR-2019; lot# N028258 and expiration date 30-MAY-2019) orally for prophylaxis, respectively. The MERCK STERILE DILUENT (lot# and expiration date were unknown) was properly stored. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments:  US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
Not able to walk with assistance, wobbly, upper extremity shaky and tremors. Put in physical therapy for 3 months.
Chills, fatigue, headache, muscle aches (Tylenol every 6 hours for 2 days)  Symptoms relieved after 36 hours.  Peaked at 20-30 hours post shot
Initial and follow up information has been received from a physician and a licensed visiting nurse through the Pregnancy Registry for GARDASIL concerning an 18 year old female, with no previous pregnancies and no reported medical history who on 02-MAY-2007 was vaccinated intramuscularly with the first dose of GARDASIL (Lot # and site not provided). On 27-JUN-2007, the patient was vaccinated intramuscularly with the second dose of GARDASIL (Lot # and site not provided). Subsequently, it was reported that the patient was pregnant (LMP = 10-JUL-2007). On 31-AUG-2007, the patient had an ultrasound to confirm gestational age and the results were normal. Concomitant medications during pregnancy were prenatal vitamins (unspecified) and TYLENOL. On 10-APR-2008, the patient gave birth to a normal baby girl (8 lbs 10oz; 21.5 inches in length, and head circumference 13 inches). The infant's apgar scores were 9 and 9. There were no complications during pregnancy, or labor and delivery, and the infant had no congenital anomalies. Follow-up information indicated that the infant was seen on 14-APR-2008 and there was a concern that her feet were "turned in." The infant was assessed with bilateral feet inversion most likely from inutero positioning. The plan was to observe the infant over the next couple months and it was reported that it may take 6 to 12 months to fully correct. A orthopedic referral, evaluation, and possible splinting for this problem were all considered. The physician reported that there were no congenital anomalies. However, upon internal review bilateral feet inversion was considered to be a minor congenital anomaly. Additional information is not expected. Medical records are available upon request.
Dose 1 given  2/8/2021 Pfizer lot #EN6201 Patient was hospitalized and died at Medical Center from Covid 19
Day after vaccination: sore arm, tingling all day in arm and fingers, light headedness and occasional dizziness. Second day after vaccination: sore left arm.
Woke up 3 am to body aches and chills. Took Tylenol at 10 am after finding out I had a temp of 100.4. Checked temp again after taking Tylenol at 1130 am and temp was 101.2. Severe body aches continue.
Dizziness, Headache, Myalgia, Arthralgia, NauseaVomiting, congestion, chills, fatigue, injection site pain/arm pain Narrative:  Other Relevant History:
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 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Nov-2021 at 12:43 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Nov-2021 at 12:43 PM, 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 65.68 for dose administered on 03-NOV-2021.  No concomitant medications were reported.  Batch number 035C21A underwent temperature excursion on 03-NOV-2021 with temperature 35 degrees Fahrenheit at 10:00 AM. This vial was moved to fridge on 10-MAY-2021 and beyond use date for the vial was reported as 05-NOV-2021. Product moved to clinic on 03-NOV-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.   This case was linked to MOD-2022-566976 (Patient Link).
I took the nurse visit for a Shingrix vaccine from a coworker and when I went to document it after giving the shot I noticed it was the patient's 4th dose when it is only a 2 dose series.
This is a spontaneous repot from a contactable consumer (patient's wife). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were unknown), on 19Mar2021 as DOSE 1, SINGLE for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was vomiting black substance, having a black stool, fever, feeling dizzy and weak. Symptoms started on 22Mar2021. Asking if black stool and vomiting black substance was part of side effects of the vaccine and if he will be eligible for the 2nd dose. The outcome of the events was unknown.  No follow-up attempts are Possible. Information about lot/batch number cannot been obtained.
Pt received Pfizer Bivalent 6m-4yr dose instead of Pfizer Bivalent 5-11 yr dose. RN discussed error with pt's parents and offered to revaccinate with Pfizer Bivalent 5-11 yr old dose today- they declined and stated they would like to reschedule to receive this dose. Error reported to clinic manager and incident report filled out. Pt waited 10 min. post Covid-19 vaccination in clinic with no complications.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 05Oct2022 at 13:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (18Dec2022) Positive, notes: Retested positive for COVID 3 days after finishing Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: No known allergies. Received Paxlovid treatment for COVID-19 (start date:10Dec2022 and stop date:14Dec2022). Retested positive for COVID 3 days after finishing Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Client had syncopal episode after vaccine, fell, and hit his head on floor. Due to signs and symptoms of concussion, he was transported via EMS to hospital
Information has been received regarding a case in litigation regarding a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history. In 2016, the patient was vaccinated with a dose of ZOSTAVAX, (dose, route, anatomical location, lot number and expiration date were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries as recommended by the healthcare professional. On unknown date, the patient experienced shingles (herpes zoster) and in approximately 2016, the patient was treated for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX (vaccination failure) and suffered serious physical, emotional, and economic damages (emotional distress), as a result of patient's injuries. The patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffered (pain); 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 included 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 (condition aggravated); lost wages; loss of earnings capacity; and other losses and damages. At the time of the report, the outcome of herpes zoster, pain, condition aggravated, and vaccination failure was unknown. The patient had not recovered from the pain and the emotional distress. The reporter considered herpes zoster, pain, condition aggravated emotional distress and vaccination failure to be related to ZOSTAVAX. The reporter considered the events to be disabling, life-threatening and medically significant.
On April 05/2022 received booster and my adverse event started on the same day within 20 minutes) dizziness, headache, nauseas, rash, right arm tremor. I was in my PCP's office  that day and she call the ambulance I was sent to the ER. They kept me there and monitored me there. They gave me medications and after 8 hours they let me go home. They did neurological exams. Medication for nausea. I still have headache and dizziness and still seeking care for it.
This spontaneous report was received from a physician via a company representative concerning an approximately a 63 year old female patient. On 02-FEB-2010, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. On 14-OCT-2013, after the vaccination, the patient developed a moderate case of shingles to the front of the body that stops at the midline was unknown. The relatedness for a moderate case of shingles to the front of the body that stops at the midline was unknown for ZOSTAVAX. Additional information has been requested.
Nine days later, injection site is raised, red, firm, and itchy. Previously it was just noticeable, now it is worse. Raised area is 3 inches in diameter.
Patient was administered the vaccine subcutaneously; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Patient was administered the vaccine subcutaneously) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 21-Apr-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Patient was administered the vaccine subcutaneously). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Patient was administered the vaccine subcutaneously) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments.   No relevant concomitant medications were provided. No treatment information was provided.
Had shingles vaccine 12/10/09, broke out in hives on legs, arms, stomach and hands on 12/26/09. Was given MEDROL at emergency room at hospital for 7 days. Took about 2 weeks for hives to be completely gone. Had high blood pressure 200/100 and fast heart beat from meds and the vaccine.
This spontaneous report has been received from a medical assistant referring to a 14 year old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. In 2017 (reported as someday during 31-JUL-2017 to 22-AUG-2017), the patient was vaccinated with ROTATEQ lot # M041768, expiration date 25-JUN-2018, orally (dose unknown) and LIQUID PEDVAXHIB lot # N003701, expiration date 01-NOV-2019 (dose and route unknown) for prophylaxis. The vaccines were exposed to temperature excursion of 34.6 degree Fahrenheit (F) to 34.9 F for 255 hours from 31-JUL-2017 to 22-AUG-2017. Data logger involved. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA010748:
Pt stated on 7/2/05 left arm was red, hot, swollen the size of a baseball, tender to touch and itches. Instructed to use hydrocortisone cream and apply ice.
Patient came back in saying arm turned black/blue (like a bruise) and was extremely sore, she iced it and took Tylenol OTC but could barely get out of bed she stated
A report was received form a health care professional on 23OCT2003 concerning a vaccinee less than 4 years of age who received Fluvirin on 22OCT2003. On 22OCT2003 the vaccinee received Fluvirin wen less than 4 years of age. The reporter did not know whether or not the vaccinee exhibited any signs or symptoms of an adverse reaction. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
At noon on Wednesday 1/8 patient noticed a number of GI upset side effects, possibly even a stiff neck. Patient then reported severe tremors from 5-6:30PM but woke up half way through the night feeling totally normal and well
Fever of 102, severe body aches, severe fatigue, severe dizziness, severe headache, and shortness of breath.
C/O redness, pain and itching at injection site immediately after inj. Denies generalized itching, SOB. No hives or rash noted. Placed ice pack at site and monitored x 1 hr. Redness improved but itching cont. Called parent to pick up per child's request. Parent advised to monitor and consider OTC BENADRYL.