chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concurrent conditions, medical history, or concomitant medications. In 2015, a pharmacist at a pharmacy administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). In 2015, the patient was treated by a physician at the physician's office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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 including 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; lost wages; loss of earnings capacity; and other losses and damages.  The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Presented with rash , red macules, with papules and scabs in center on 12/27/04. Exposed at school. Treated symptomatically at Doctor's visit
vision problems; This case was reported by a consumer via call center representative and described the occurrence of abnormal vision in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2021, the patient received Shingrix. In October 2021, less than 2 weeks after receiving Shingrix, the patient experienced abnormal vision. On an unknown date, the outcome of the abnormal vision was not recovered/not resolved.   It was unknown if the reporter considered the abnormal vision to be related to Shingrix.   Additional details were reported as follows: The case was reported by the patient. Age at vaccination was not reported. The patient received the Shingrix vaccine a week or so ago from the date of reporting.  The patient was concerned about vision problems. The patient inquired what type of health care professional she should see to address her concern. Referred her to optometrist or ophthalmologist.  The patient was provided with medical advice disclaimer.  The reporter did not consent to follow-up. No additional details were provided by reporter.
13Jul89 pt vax w/ hepta B;  exp hot, flushing attack w/o sweating.  BP rose to 160/110.
Right after giving the DTaP w/in 5-10 mins in the upper right thigh sight got red - size of a quarter. PT was given 1.5 tsp of Benadryl. Gave Polio vax in same leg. M? said she had a past reaction to polio, but no reaction to polio yesterday.
received the peds dose for dose 1 of the series although he was already 12 years of age
low grade fever same day adverse event 100 most of day-rapid increase 9PM febrile convuls; APAP had been administered all day prior to sz; t104;
Patient had high dose flu vaccine and presented to ER non-responsive less than 2 days later. Date of vaccine 10-8-2014. Date of death 10-10-2014. Patient had underlying COPD and CHF but he was stable when I saw him 10-8-2014.
No adverse effects reported by patient. Vaccine was from a vial used the day before in the fridge and was outside of the 12 hour window.
Wheezing, urticarial rash that developed about 6 hrs p/being given trivalent influenza vax;
Pt received bivalent booster dose 6 weeks after last COVID vaccine.  Per pt report, had been over one year since last COVID vaccine.  Registry unavailable at time of vaccination because it was administered at an outreach event.
Received second dose of Moderna vaccine and should have received second dose of Pfizer vaccine; A spontaneous report  was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) but the patient received second dose of Moderna vaccine and should have received second dose of Pfizer vaccine.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.     On an unknown date, the patient received their first of two planned doses of Pfizer COVID-19 vaccine for prophylaxis of COVID-19 infection.   On 12 Jan 2021, the patient received their second of two planned doses of COVID-19 vaccine, but was administered Moderna's  mRNA-1273 vaccine instead of Pfizer's.    Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.  The event, patient received second dose of Moderna vaccine and should have received second dose of Pfizer vaccine, was considered resolved on 12 Jan 2021.; Reporter's Comments: This report refers to a case of Wrong product administered for mRNA-1273, lot #
Fever; Body aches; Tremors; This spontaneous case was reported by a patient and describes the occurrence of TREMOR (Tremors), PYREXIA (Fever) and MYALGIA (Body aches) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced TREMOR (Tremors). On an unknown date, the patient experienced PYREXIA (Fever) and MYALGIA (Body aches). At the time of the report, TREMOR (Tremors), PYREXIA (Fever) and MYALGIA (Body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, Body temperature: 101.9 (Inconclusive) 101.9. On 13-Jan-2021, SARS-CoV-2 test positive: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant details were reported by the reporter. No treatment details were reported by the reporter.; Sender's Comments: Based on biological implausibility the event of COVID-19 test positive is assessed as unlikely related to mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the events of (Pyrexia, Myalgia, Tremor), a causal relationship cannot be excluded.
This spontaneous report as received from a pharmacist refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. On 17-MAR-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 injection (lot # L031459 with expiry date: 30-APR-2017; strength, dose, route and site of administration were unspecified). The administered vaccine underwent the temperature excursion of 70 degree Fahrenheit during 1 month. It was not the case of a "data logger". No concomitant medications were reported. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Patient with initial COVID positive test on 08/18/21.  She had mild symptoms which  continued to worsen including cough and shortness of breath.  Admitted through ED on 08/28/21 for COVID pneumonia with hypoxia at 87%.  HFNC at 75% needed.  Patient discharged home with 3-4 L of supplemental oxygen.
Itchy and swollen rash at injection site began the evening of the eighth day after receiving the shot.
ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 53 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included developmentally disabled. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1802068 expiry: 25-MAY-2021) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-JUN-2021, the subject experienced administration of expired vaccine. The action taken with covid-19 vaccine  was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This report was associated with product quality complaint: 90000181533.
I received the first dose of vaccine on 12/17/20 with no symptoms initially other than soreness at injection site.  4-5 days post vaccine I began to have mild sinus drainage, headaches,  and backaches that I attributed to allergies, stress, and sinus issues.  On the evening of 12/23/20, I had lost my sense of smell completely and had diminished taste.  I was tested for COVID-19 around 0830 the next morning on 12/24/20 and was positive for the virus.  That day and the 7-8 days that followed I was extremely fatigued with muscle aches.  I continued to participate in the V-safe surveys and made note that I was having these symptoms likely because I was positive for COVID-19 (as of 12/24/20).  The CDC called and I relayed this information to them and it was decided that a report was not necessary.  After my second dose of vaccine on 01/07/21, I received another call from the CDC and it was recommended that I do file a report so data could be collected on those who have tested positive for COVID-19 after the initial vaccine.  I had no significant symptoms after my second vaccine and have presumably fully recovered from the virus to date.
TSH levels were very elevated/TSH level thyroid are off the chart, they are like double; Tired and aching a lot; Tired and aching a lot; Sick for about a week; This is a spontaneous report from a contactable consumer or other non hcp (Patient).   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 2 via an unspecified route of administration on 05Apr2021 (Batch/Lot Number: ER8737; Expiration Date: 31Jul2021) as 2nd dose, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 on 08Mar2021 (Batch/Lot Number: EN6206). On an unspecified date in Apr2021 the patient felt tired and experienced aching a lot and sick for about a week. Patient was happy with the vaccination and on 26May2021 patient got blood report, and patient's TSH level thyroid was off the chart, they were like double, they were like 8, as patients TSH levels were very elevated, and all the other tests was perfect but patient's TSH was doubled and last TSH was done a year and half ago that was normal. The patient underwent lab tests which included blood thyroid stimulating hormone: normal on unknown date, blood thyroid stimulating hormone: 8.0 and it was elevated, Thyroxine and triiodothyronine: Perfect on 26May2021. Reporter could not specify the seriousness of events. The outcome of the events Tired and Aching a lot, Sick for about a week was recovered on an unspecified date in Apr2021, and the other event TSH level thyroid are off the chart, they are like double was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Other symptoms; Caller said she had Covid; No appetite; Poundind and stabbing headache; Very fatigued; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Other symptoms), COVID-19 (Caller said she had Covid), DECREASED APPETITE (No appetite), HEADACHE (Poundind and stabbing headache) and FATIGUE (Very fatigued) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020.   On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Other symptoms), COVID-19 (Caller said she had Covid), DECREASED APPETITE (No appetite), HEADACHE (Poundind and stabbing headache), FATIGUE (Very fatigued) and NAUSEA (Nausea). At the time of the report, VACCINATION COMPLICATION (Other symptoms), COVID-19 (Caller said she had Covid), DECREASED APPETITE (No appetite), HEADACHE (Poundind and stabbing headache), FATIGUE (Very fatigued) and NAUSEA (Nausea) outcome was unknown.            Concomitant medication list was not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.    Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: New event was added.
Headache one hour after vaccination, numbness left arm & leg 2:30 PM evaluation by ED physician  No treatment
Patient received the wrong formulary for covid vaccine. Patient received the orange cap 5-11 vaccine when patient is only 4 years old. Spoke to parent, patient has no adverse reactions. eating and playing happy.
weakness in left elbow and shoulder; Experienced a 5 inch rash/red circle on arm that itches; Experienced a 5 inch rash/red circle on arm that itches; Patient claims her kidneys felt tight and swollen; Elbow discomfort; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness in left elbow and shoulder), RASH ERYTHEMATOUS (Experienced a 5 inch rash/red circle on arm that itches), RASH PRURITIC (Experienced a 5 inch rash/red circle on arm that itches), RENAL DISORDER (Patient claims her kidneys felt tight and swollen) and ARTHRALGIA (Elbow discomfort) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypoglycemic episode (borderline hypoglycemic), Pollen allergy and Allergy to chemicals (Fluoride allergy).   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weakness in left elbow and shoulder), RASH ERYTHEMATOUS (Experienced a 5 inch rash/red circle on arm that itches), RASH PRURITIC (Experienced a 5 inch rash/red circle on arm that itches), RENAL DISORDER (Patient claims her kidneys felt tight and swollen), ARTHRALGIA (Elbow discomfort) and FATIGUE (fatigue). At the time of the report, ASTHENIA (weakness in left elbow and shoulder) and ARTHRALGIA (Elbow discomfort) had not resolved and RASH ERYTHEMATOUS (Experienced a 5 inch rash/red circle on arm that itches), RASH PRURITIC (Experienced a 5 inch rash/red circle on arm that itches), RENAL DISORDER (Patient claims her kidneys felt tight and swollen) and FATIGUE (fatigue) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The patient reported that they experienced a 5 inch rash/red circle on arm that itched as well as fatigue and weakness in left elbow and shoulder. The patient also claimed that their kidneys felt tight and swollen. It was reported that the symptoms were resolving over time, but elbow discomfort was still present.  No treatment information was provided.
Beginning at 10pm on 4/11/21, I felt tenderness and slight swelling of the lymph node in my left armpit.  I still felt this the next morning when I woke up. Later in the day on 4/12/21 (around 4:30pm) I noticed that the area near the injection site on my arm was itchy, lumpy, and a little warm, but I did not look at it until later in the evening (around 7pm).  At that time I saw that I had a large welt approximately 4 inches in diameter on my arm. It is now 9pm and all symptoms continue.
NAUSEA; DIZZY; FREEZING COLD; her face was sheet white; FAINT; ARM PAIN / injection site pain; injection site pain; This case was reported by a nurse via call center representative and described the occurrence of faint in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABX796AZ, expiry date 30th September 2020) for prophylaxis.   On 20th March 2020 02:30, the patient received the 1st dose of Bexsero. On 20th March 2020, 5 hrs 30 min after receiving Bexsero, the patient experienced pain in arm and injected limb mobility decreased. On 20th March 2020 08:00, the patient experienced faint (serious criteria GSK medically significant), nausea, dizziness, feeling cold and skin discoloration. On 21st March 2020, the outcome of the faint, nausea, dizziness, feeling cold, skin discoloration and injected limb mobility decreased were recovered/resolved. On an unknown date, the outcome of the pain in arm was recovering/resolving.   It was unknown if the reporter considered the faint, pain in arm, nausea, dizziness, feeling cold, skin discoloration and injected limb mobility decreased to be related to Bexsero.  Additional details were reported as follows: This case was reported by the patient's mother, who was nurse. At 2:30 PM, the patient received a dose of Bexsero on the left arm. The injection site arm pain was immediate and had not completely resolved. At approximately 8:00 PM the day of the vaccination, all other symptoms were presented and lasted throughout the night. The patient's mother reported that her face was sheet white and she was freezing, nauseous and very faint.  The patient also couldn't move her arm that night. The symptoms with the exception of the arm pain, resolved the next day. The reporter consented to follow up.
pt recvd vax 11SEP92 c/o lt leg & lt knee pain; 12SEP92 inc swelling lt knee; t102; taken to MD & hospitalized;
tested positive with Covid-19 on friday; This is Spontaneous report from a Pfizer Sponsored Program. A contactable male consumer (patient) of an unspecified age received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration on 04Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On Friday 09Apr2021, the patient underwent lab tests and procedures which included sars-cov-2 test and tested positive with Covid-19 (non-serious). It was reported that patient asked what he needs to do with his 2nd dose which is scheduled on 25Apr2021. The outcome of the event was unknown. The action taken in response to the event for bnt162b2 was not applicable.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pregnant woman comes for the Moderna vaccine; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnant woman comes for the Moderna vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (pregnant woman comes for the Moderna vaccine). At the time of the report, EXPOSURE DURING PREGNANCY (pregnant woman comes for the Moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPOSURE DURING PREGNANCY (pregnant woman comes for the Moderna vaccine) to be not applicable.    No concomitant medications were reported. No laboratory details were  provided. No treatment medications were reported.
REDNESS ABOUT 15CM IN DIAMETER AT SITE AND A BIT BACK AND DOWN FROM INJECTION SITE ALSO INFLAMMED AND HOT AT SITE PT WENT TO DERMATOLOGIST 2/9/21 AND RECEIVED HYDROCORTISONE 2.5%
Within the first day, before I went to bed, my entire body was itching. I had itches everywhere. Within 6 hours of the vaccine. That's not unusual for me. I've had an itching problem after every COVID-19 vaccine that goes away in about 2 weeks. When I got up the next morning, I had a bad urinary tract infection. I'm already wearing a catheter bag and it was clogging the nozzle into the bag. Prior to that, we had the urinary tract well under control and now here we are two weeks later, still having the same problem. I cannot get rid of the urinary tract infection. Before the vaccine issues on the second dose of Moderna, I've never had a urinary tract infection in my life, and now I'm wearing a catheter bag. No headaches, no soreness, nothing else. Everything is related to nerves. The clinical trials have proven that the vaccine can create havoc with the myelin sheath on your nerves as well as COVID-19 itself. I've never tested positive for COVID-19. I cannot do anything anymore. I can't walk around with a urine bag off my hip. This has ruined my life.
pneumonia shot given while patient at osu. site where shot given hot red painfull and very swollen. Growing bigger every day. On 3rd day body aches more painfull. Breathing more difficult. Headache unable to go away. Went to urgent care.
Pt reported feeling extremely dizzy, hot, and arm started to hurt almost immediately.   Gave patient cool compress on the back of the neck and had pt sit down, started to feel better after about 15 minutes
Itchy rash on underside of forearm, used Benadryl and hydrocortisone cream. Went a way after 5 days.
Mr Omere was COVID positive on 5/12/2020, and subsequently had several negative tests. Received his first dose of the Moderna vaccine on 2/11/2021. Had a routine covid test as part of his job requirements on 2/19/2021, and tested positive. He was asymptomatic. He has since completed his isolation period.
Redness and itching 2 days after administration. 8/23 - Administered. 8/25 - Noticed redness and itching. 8/31 - Reported to pharmacy seems to be getting better.
Began episodes of crying long and hard, inconsolable. Episodes began on 8/16/08 through 8/19/08.
When I received the vaccine (Saturday) I was dizzy and my arm went numb immediately but after waiting 15 minutes I felt fine and everything was okay. The next morning (Sunday) I woke up with a fever, chills, sweats, and fatigue that lasted until about 24 hours after I received the vaccine. The following day (Monday) I felt completely fine and had no adverse symptoms or side effects. Tuesday was fine as well until about 2pm after I ate lunch, during a meeting my arm went numb as well as my legs and I had trouble concentrating and could not hold a conversation. Went home and slept until Wednesday morning. Today, Wednesday, I am still not feeling normal and am having trouble concentrating at work, low light seems to help. No numbness today but still feel dazed and not able to focus
weeks from the 2nd dose, I have been experiencing extreme fatigue, chest pain or pressure, and shortness of breath
About 5-10 minutes following first vaccine I started to feel ?funny? my throat felt a little swollen and lips started tingling. I then started to feel hot and sweaty. This lasted about 20-30 minutes then I felt ok to leave. I did get sharp pains in my muscle from shoulder to neck on and off the rest of the day along with waves of nausea and  being very tired. No medications were given.
Site: Pain at Injection Site-Medium, Additional Details: patient had a swollen under arm, around her arm pit.
bilateral forearm and shoulder rash, back, torso, and hip included. rash is red, raised, but not itchy nor painful. No known allergy to anything in past besides those ADRs to sertraline or topiramate