chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 16 1/2 year old female who "2 weeks prior to adverse event" (in December 2006), was vaccinated with her first dose of varicella virus vaccine live (Oka/Merck). There was no medical history or concomitant medication reported. In January 2007, the patient experienced early morning tremors. The patient had no tremors during day or when seen at the office. The patient received unspecified medical attention. Laboratory evaluation was performed in February 2007 which included a normal thyroid hormone test, normal complete metabolic profile, normal complete blood count, a negative mononucleosis test, and a normal erythrocyte sedimentation rate. The patient's outcome was reported as not recovered. There was no product quality complaint involved. Additional information has been requested.
Received the injection around 5p on Wed, 03/03/21. About 12 noon on Thurs, 03/04, starting shaking in my arms and upper torso. Took my temperature and was only 1 degree lower than normal. Uncomfortable headache, could barely walk to my bed or get into it. By Friday morning, 03/05/2020, much better. No need to go to the ER or need of an Epinephrine injection.
2nd shot tiny soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) (Lot number: , LN-S PF) at the age of 80 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID]. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation, reaction(s): "No adverse effect- not even any redness". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "2nd shot tiny soreness". Additional information: Time at vaccination for the 2nd dose was reported at 08:30 AM. The patient wanted to know if taking 81 mg aspirin and that if having a "Crest" would preclude her from getting the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Immediate pain-unlike all shots previous continued all day. 2nd day 1/2 pain but lasted all day-learned it was double dose-which I would not have agreed to. Everything ok until late November when I awoke it felt like the 2nd day of vaccination all day. March 2018-sharp pain when I reached to get water. Mid March-pain when I reached for towel. Next few days felt pain occasionally. Month of April-almost daily discomfort-not acute pain. Early May-sore-could not brush teeth for 3 minutes. Mid May-pain where I could not read newspaper. Pain persisting so called Dr to make appt-1st available date was in 90 days-this was May 24. May 30th felt so bad went to pharmacy to see if they could suggest relief. They referred me to Dept of Human Resources and asked that I notify them of adverse effect-delayed. Early June tried calling Dr several times but after about 12 minutes wait, phone could go dead. By noon had difficulty carrying groceries with rt arm. Mid June-started improving but still occasional pain and discomfort. Finally got to see my Dr on August 21. When I mentioned flu shot problem-he said no such thing-it only hurts for few days, after injection and if I'm having any kind of problems it is a rotator cuff problem and he would need an X-ray to determine course of treatment-since I was no longer having acute pain I declined.
Started my period 11 days early. Also felt extreme fatigue, body aches, and chills
No additional adverse effects; The nurse stated that on 20-AUG-2020, a dose of expired but properly stored PROQUAD was administered to a female patient; This spontaneous report has been received from a registered nurse concerning a 7 years-old female patient. The patient's concomitant therapies included sterile diluent (MERCK STERILE DILUENT).The patient's concurrent conditions, historical drugs and medical history were not reported.        On 20-AUG-2020,  the patient was  inadvertently vaccinated with one dose of expired  measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (rHA) subcutaneous injection, Lot # S005074, expiration date 18-AUG-2020 for prophylaxis(patient route of administration was not reported). The  measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) was reported to had been properly stored and it was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT).No additional adverse effects were reported.
almost one week after the vaccine the patient noticed extreme itchiness that couldn't be treated with over the counters.  It is all over and only lasts 1-2 hours every evening.
No adverse effect reported.; a patient received improperly stored PROQUAD on 11/1/2019; This spontaneous report was received from a nurse referring a patient of unknown age and gender. Information about pertinent medical history, drug reactions/allergies and concomitant therapies was not provided.    On 01-NOV-2019, the patient received improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # S021617 and expiration date 09-FEB-2021; strength, dose, frequency and route were not reported) for prophylaxis (product storage error). The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was reconstituted with properly stored diluent. No adverse effect was reported. The vaccine underwent temperature between -14 degrees Celsius to -10 degrees Celsius (-11.7 Celsius) for a duration of 2 hours 35 minutes. There was no previous temperature excursion and the call was because of data logger.
Administered vaccine that was stored at temperature between -80 degree Fahrenheit to -84 degree Fahrenheit; Administered vaccine that was stored at temperature between -80 degree Fahrenheit to -84 degree Fahrenheit; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree Fahrenheit to -84 degree Fahrenheit) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree Fahrenheit to -84 degree Fahrenheit) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021 at 3:53 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Oct-2021 at 3:53 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree Fahrenheit to -84 degree Fahrenheit). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree Fahrenheit to -84 degree Fahrenheit). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree Fahrenheit to -84 degree Fahrenheit) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree Fahrenheit to -84 degree Fahrenheit) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided.  It was reported that the vaccine was at frozen storage condition at the time of the temperature excursion. Excursion duration was 1 month.  On 19-Nov-2021, the Moderna COVID-19 vaccine vial went from the super cold freezer to the refrigerator. The vaccine was returned to the freezer/refrigerator/ultra cold freezer, or maintained at room temperature.  No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No previous temperature excursion issues had happened.  The patient was given doses from a vial that were stored in an ultracold freezer which is colder than they should have been.   This case was linked to MOD-2021-402935 (Patient Link).
Increased heart rate (100 beats per minute); Face was red; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Face was red) and HEART RATE INCREASED (Increased heart rate (100 beats per minute)) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026190A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced ERYTHEMA (Face was red). On 15-Jan-2021, the patient experienced HEART RATE INCREASED (Increased heart rate (100 beats per minute)). On 14-Jan-2021, ERYTHEMA (Face was red) had resolved. On 15-Jan-2021, HEART RATE INCREASED (Increased heart rate (100 beats per minute)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medications details not reported by the reporter. Treatment details not reported by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. The pharmacist reported that on 09-SEP-2014 a patient was administered a dose of ZOSTAVAX, 0.65 ml, subcutaneously (lot number not reported), that was improperly stored. No adverse events were reported. Additional information has been requested.
This spontaneous report was received from a medical assistant refers to a patient of unknown gender and age. Information regarding the patient's pertinent medical history, drug reactions/allergies and concomitant medications were not provided. On 30-AUG-2016, the patient was inadvertently vaccinated with a second dose of ZOSTAVAX (lot # M010486, expiry date: 25-MAY-2017) via subcutaneous route. Medical assistant reported that the patient received their first dose of ZOSTAVAX (lot # L011529, expiry date: 30-JUL-2016) on 30-JUN-2015. No adverse effect was reported. Additional information has been requested.
Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not provided. On unknown dates the patients were vaccinated with RECOMBIVAX HB (lot#, expiration date, dose and route not reported), which were improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
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 a health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 immunisation.     No Medical History information was reported.   On 28-Feb-2021 at 3:32 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 3:43 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (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 58.45 for dose administered on 28-Feb-2021 at 03:32 and 58.52 for dose administered on 28-Mar-2021.  No concomitant medications were reported.  Batch number 019B21A underwent temperature excursion on 28-Mar-2021 with temperature 35 degrees Fahrenheit from 10:00 AM. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 27-Mar-2021.Batch number 014M20A underwent temperature excursion on 28-Feb-2021 with temperature 27 and 26 degrees Fahrenheit from 09:00 AM to 01:00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 27-Feb-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).
This spontaneous report as received from a physician, as part of a marketing research program, refers to an 11 year old female patient. Patient's current conditions and pertinent medical history were not provided. In around 2010 the patient was vaccinated with her first dose of GARDASIL (lot#, dose and route were unspecified). Concomitant therapies included MENACTRA and Tdap, which were given at the same time as GARDASIL. Within a few days the patient became partially blind; this was diagnosed as autoimmune in nature. The patient was seen by ophthalmologists. Diagnostic tests information was unknown. Her vision resolved within a few weeks, but it was a scary few weeks. The physician believed it was probably a coincidence (i.e., not caused by the vaccines), but could not be certain. Because the physician couldn't be certain she preferred now not to give GARDASIL and MENACTRA at the same time. Upon internal review, the event of autoimmune partial blindness was considered to be medical significant. Additional information has been requested.
About 5 or 6 hours after the shot: chills, low temp at first ( 94.6) then 100.9, aches (generalized,), nuchal rigidity, severe headache, fatigue, vomiting; hive at injection site with marked deltoid tenderness
Same Day  - increased temp. Day 1 - Body aches, headaches. 2 - Rash face and arms - body aches and headaches. 3 - rash improving, sl temp. Body aches and headaches. 4 - Sl. rash on face. Symptoms appreciated be going away.
pt recv vax cried cont from the time the inj was given;mom called approx 4PM & was advised to take pt to ER since the APAP & comfort measures wasn't working;
Patient received the shot and started feeling dizzy approximately one minute after. Dizziness worsened and nausea developed over the next few minutes. Patient laid he head in-between his knees and then passed out, Patient was unconscious for approximately 3 seconds.  Patient was then helped onto a cot and his vital signs were taken. BP 150/90, HR 77, O2 98%, RR 18. Patient was advised to wait until all symptoms have subsided and at least 30 minutes have passed before leaving. Patient left with significant other driving.
This case was reported by a nurse via call center representative and described the occurrence of neck pain (with radiation) in a 30-year-old female patient who received ENGERIX B (batch number K35HY, expiry date 14th April 2018). On 22nd August 2016, the patient received ENGERIX B. In August 2016, less than a week after receiving ENGERIX B, the patient experienced neck pain (with radiation) and headache. On an unknown date, the outcome of the neck pain (with radiation) and headache were unknown. It was unknown if the reporter considered the neck (with radiation) and headache to be related to ENGERIX B. Additional details were provided as follows: The nurse reported the patient (an employee) received ENGERIX B vaccine in her right arm. On 25th August 2016, when the patient came back for work, she was experiencing pain radiating in her neck and it was causing her to have a headache. The reporter's call was transferred to Medical information for additional information and questions were asked by the reporter on behalf of patient.
swelling, redness, itching at injection site, headache, fever and hoarseness and weakness.    Shingles Vaccine
When I got the vaccine, I had an ocular migraine come on almost immediately, within 1 minute, with visual field disturbance. It lasted about 5 hours. Starting a day and a half or two days later, I began to have dramatic digestive symptoms that were familiar as an exacerbation of IBD/Ulcerative Colitis. I've been struggling with them since. Saw GI Specialist, who recommended following the FODMAP diet. Very restrictive and no relief. I have abdominal bloating and pain all through my digestive tract, rectal pain, explosive/uncontrollable/urgent BMs, and anal bleeding, worse than I have experienced.  When I recieved the 2nd dose, the symptoms intensified for a period of approximately three weeks.
The pt's right arm swelled up, very hard / hot. Nose started to run, increased mucous, temp unknown.
Redness, swelling, warmth in 24 hrs after injection, RX; 2cc (8mg) Decadron, Time course rechecked 11/07/02, Resolved
Received 2nd vaccination on Monday and on Friday I broke out in Shingles on the back of my lower left thigh.; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 59-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0177 and expiration date was not reported), second dose via an unspecified route of administration, administered in arm Left on 24Apr2021(at the age of 59 years) as dose 2 single for covid-19 immunisation. Patient medical history included back surgeries, depression from an unknown date and unknown if ongoing along with known allergies to Latex, cipro, iodine, doxycylicine, codeine, sulfa, levaquin paper tape causing drug hypersensitivity. Patient concomitant medication(s) included plantago ovata (METAMUCIL), alprazolam, citalopram taken for an unspecified indication, start and stop date were not reported. Patient historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number and expiration date was not reported), first dose via an unspecified route of administration, administered on an unspecified date dose 1 single for covid-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination and since the vaccination. On 28May2021 at 15:45 on Friday patient broke out in shingles on the back of his lower left thigh leading to emergency room. Already had those vaccinations 2 years ago. Patient received valacyclovir for the treatment of adverse event. The outcome of the event was not recovered.        Follow-up attempts are completed. No further information is expected.
SX started 15 minutes after flu shot, SOB, wheezing and stridor. Sensation of throat closing, swelling, and SOB with associated wheezing and stridor
Right arm began itching on 3/15/2021 in morning.  Felt  very warm to touch, then raised red area about the size of a hand.  The itching is intermittent and has reduced significantly.  The red also faded after using ice on 3/18/2021.  Today I noticed my arm has a more red area about the size and length of two fingers. And a few tiny white raised  spots in the red area.  This seems brighter than the original red raised area in the beginning, although it is smaller in size.  I was signed up with COVID program, but it stopped sending me texts to check in after 7 days and I was unable to report.  I have since signed back up to try to report through the program
I noticed a constant high pitched humming, or what I consider tinnitus in both ears after the 2nd shot which has not lessened since getting the shot.  I am a runner and during my runs my ears would 'pop' or it seemed like wax build up was somehow 'releasing' pressure but the ringing was still consistent.  I tried chewing gum but that did not help and I have not contacted my doctor.  I have begun taking Flavanoid vitamins to see if it will help.  After 1 week it has not that I can tell but note that the same 'popping' has occurred now several times of normal activity but I cannot conclude the tinnitus is resolving.  I am concerned I will have permanent hearing loss.
This is a spontaneous report from a contactable physician assistant communicated to a sales representative. A female patient (age unknown) received a dose of PREVNAR13 in the quadriceps, along with a dose of VARIVAX, both on 25FEB2012. Relevant medical history, concomitant medications and past product history were not provided. On 25FEB2012, following administration of the vaccinations, the patient developed a lump on the quadriceps. The outcome of the event was unknown. Follow-up (03MAY2012) Follow-up attempts completed. No further information expected.
1) while taking 2 naproxin sodium every 12 hours: reasonably high fever (101-103F) with headache and skin sensitivity for two days, followed by low fever (99-100F) with headache for another day, and no fever with headache a fourth day 2) moderate localized pain in the muscle at the injection site - continuing into the 6th day
****I want to note that I am submitting on behave of my mother who passed away yesterday. The medical examiner has declined 2x for an autopsy to be done.  My mother was healthy and was absolutely fine besides the rash (dr diagnosed her with cellulitis week of March 14). I do not agree with the rule of death being  ?natural causes? neither does her doctor.
Patient's chart notes state that several days after administration of 2nd booster, the patient developed more shortness of breath and atrial fibrillation with rapid ventricular response.
Left arm pain, vomiting, Sickle Cell Crisis. Was admitted 7/10 thru 7/12 to hospital for pain management and IV fluids and bloodwork.
Information has been received from a 54 year old female who reported itching at the injection site after being administered with ZOSTAVAX in the left tricep on 22-NOV-2014 around 6pm. She noticed itching late at night on Sunday (23-NOV-2014). On the morning of 24-NOV-2014, the patient said she woke up and looked into the mirror and noticed a large red welt at the injection site. She explained that it is swollen and it hurts to touch. Patient said that it still itches at the injection site as well. The patient said she is not having any other symptoms. Concomitant medication included SYNTHROID. Pertinent medical history included thyroid cancer. No additional adverse event information was provided. Additional information had been requested.