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 patient's concomitant medications, concurrent conditions or medical history. On or about 22-FEB-2008, the patient was vaccinated with ZOSTAVAX (strength, dose, route, anatomical location, lot number and expiration date were not reported), to obtain permanent prevention and protection against shingles and zoster-related injuries (prophylaxis) as recommended by the healthcare professional. On an unknown date in 2008, the patient experienced shingles (Herpes zoster) and on or about 12-APR-2008, was treated by a healthcare provider at an internal medicine. 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 on unknown dates. The patient had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering (Emotional distress) (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 patient was not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased and the pre-existing unspecified conditions aggravated was unknown. The relatedness between ZOSTAVAX and the aforementioned events was assessed as related by the reporter. The reporter determined all the events to be serious due to disability, life-threatening and medically significant.
This spontaneous report as received from a registered nurse (R.N.) refers to 3 patients of unknown age and gender. Medical history and drug allergies were not specified by the reporter. On unknown dates, the patients received an unspecified number of doses of VARIVAX (Merck) (dose, frequency, route of administration, lot# and expiration date were not reported). Concomitant medication was not specified by the reporter. In approximately 2015 (reported as within the past month), all 3 patients developed shingles. It was not specified if any treatment was given for the adverse event and if the patients sought any medical attention. The outcome of shingles was not specified. Causality assessment between shingles and the therapy with VARIVAX (Merck) was not provided. Product quality complain (PQC) was not involved. Additional information has been requested.
intusseseption 04/24/07-records received from facility for DOS 03/16-03/17/07-DC DX:Intussusception. Admitted for observation after successful reduction of intussesception by air enema. Presented with abdominal pain, bloody stool. Cramping, colicky intermittent. 10 stools in past 24 hours, bloody stools.
I was fine the first week.  Then I noticed the COVID arm thing-swollen, red and sore.  And then I started having issues breathing when I was standing and trying to carry on a conversation with someone.  I have never had breathing issues before when talking.  It would come and go for a few weeks.  I didn't talk to my doctor at that time.  It was after the second dose and I was having lots of issues that I finally saw my primary care doctor.  I had all of the flu like issues-fever, chills, total body aches and the shortness of breath again.  This all started about 12 hours after the second dose.  I was sick for a few days.
Local redness left upper thigh < 10 mins. post immunization with small welt. Welt gone, redness after 30 mins.
Administered Smallpox vaccination on 02/20/04. Pt was interviewed on same date and denied possibility of pregnancy even though marked menstural cycle was abnormal on screening form.  HCG was not performed.  On 03/18/04, HCG was performed upon request from pt.  Results were positive.  Using implantation date calculations show pt to be in 15th week.
100.8 degree fever, sore arm, shoulders, back, opposing arm, legs.  Headache, sick to stomach, congestion, sleeplessness for 48 hours.
Pt reported severe anxiety and syncope when receiving injectable medication and blood draws. Pt was agreeable to receive vaccine and  a plan was made ahead of time to administer to her in her vehicle with the seat laid flat. Upon receiving the vaccine, the pt immediately stated, " I don't feel good" and began to hyperventilate and complaint of tingling in all extremities. Pt then vomited and an EMS crew on standby was notified to evaluate the patient. The patient was eventually transported to the ER due to near syncope and hypotension.
24-48 hrs- Moderate to severe pain in arm Fever 101, joint pain, swollen lymph glands, nausea and diarrhea and general malaise  48-72 hrs. symptoms continued with fever decreasing.  72> hrs. Area just below injection site became swollen, red- an area approx. 6" in diameter.  Other symptoms abated.
I received the vaccine around 11am and did not experience any adverse reactions aside from a sore arm throughout the day.  I went to sleep at 10pm and was awakened at 3am with moderate soreness in my arm and I began to feel feverish and woozy.  About 2 minutes later I could tell that I was going to faint.  The thing I remember was waking up on the floor next to my bed with my wife holding me up.  She said that I started making sudden, loud guttural noises and she was afraid that I had been choking.  She reached over to touch my arm and my body jerked out of bed and I hit the ground.  When I woke up, I realized that I had fainted (I have passed out after a flu shot a couple years ago, but that incident happened about 15 minutes after injection) and my entire body was trembling and sweating profusely.  My wife left the bedroom to get me some water and a cold towel.  I got myself back into bed and passed out again.  The trembling and sweating continued but gradually decreased for about 15 minutes until I felt back to normal.  After I had calmed down, I felt no adverse symptoms and fell back asleep and have felt fine since the incident.
This spontaneous report was received from a consumer (the patient's sister) and refers to a female patient in her early 70's. The patient was not smoking. Her concurrent conditions included chronic obstructive pulmonary disease (COPD) and bad allergies. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route of administration, injection site, lot # and expiration date were not provided). On an unknown date, a few months after the vaccination the patient developed shingles. The patient sought medical attention. The outcome of the event was reported as recovered, on an unknown date (also reported as "a few years"). The relatedness between the event and ZOSTAVAX was not reported. Additional information is not expected because there was no consent to contact with the reporter.
Sick for 11 days after vaccination. sore throat, chills, fatigue, headache, 100 fever for a couple of days
Just thought I'd pass along this info to you about symptoms following getting the flu shot. I know it's been quite awhile, now, but I wasn't interested in paying to get a bunch of tests done, and hoped the symptoms would just clear up. About a half hour after receiving the vaccine, I was in the grocery store, thinking about what I was looking at, and suddenly experienced a very strange feeling in my head that I never felt before, and right after that felt like I was about to pass out. I never felt like that before, either. I grabbed onto something, and waited, and the symptoms mostly left up. Since then, at unexpected times, I have short periods of dizzy lightheadedness. Also, later the same day, I started with a lot of headache and neck stiffness, and in the following days, was tired, weak, and aching. My usual mild sinus symptoms got much worse. Most concerning was the recurrence of symptoms I had as a teenager, (after an mva, with head and neck injuries) mainly irritation and pressure at the base of the skull, and the right eye feeling strained and pulled upward. This was quite disturbing. I know that people who push for getting the flu shot say it's just a coincidence that people get sick following it. But I fully believe that my experience was a direct result of the vaccine. So now, even with the flu epidemic upon us, I see getting the flu shot to be a greater risk than not getting it. I'm told that the vaccine is only effective for a small percentage of the types of flu, anyway. Patient in office to fill out VAERS form re: flu shot. Alerted us to the fact that she missed work 1/16 and 1/17/13 due to sweats, headache, chills. She did not feel better until 1/23/13 and is not sure if it is related to all the other symptoms she has had since November.
Client developed dry cough on 12-30-09. Reported chills and body aches by January 2, 2010. No fever but did feel nauseous. Did not vomit. Continued to feel weak and light headed until 1-5-09. Client did not call her PCP. Feeling better today.
PATIENT WAS GIVEN MODERNA VACCINE AS 2ND DOSE, BUT RECEIVED PFIZER AS 1ST DOSE
Patient had head involuntary movements and muscle contractions in legs and arms. Diagnosis provided was non-epileptic seizures.; This is a spontaneous report from a contactable other HCP (who is also the patient, reported for herself). A 31-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248, expiry date was not provided), via unspecified route of administration, in the right arm, on 14Jan2021 at 10:30 AM (at the age of 31-year-old), as a single dose for COVID-19 immunization. The patient's medical history included chronic migraine, gastritis and arthritis, all were stared from unknown dates and unknown if ongoing. Concomitant medications were not reported. The patient's historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730, expiry date was not provided), via unspecified route of administration, in the left arm, on 23Dec2020 at 05:30 PM, as a single dose for COVID-19 immunization. On an 14Jan2021 at 11:00, Patient had head involuntary movements and muscle contractions in legs and arms. Diagnosis provided was non-epileptic seizures. Patient was hospitalized for the event on an unknown date in 2021. Patient received Kepra treatment for the adverse events. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Patient was not diagnosed with COVID-19 prior to vaccination. Patient had not been tested for COVID-19 since the vaccination. Outcome of the event was recovering.; Sender's Comments: -Based on available  the information in the case report and a plausible temporal relationship, A possible causal relationship between events Seizure  and suspect drug BNT162B2 cannot beexcluded The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
A non-serious spontaneous report of ataxia, dizziness and flu manifested with lethargy, headache and body ache has been received from a consumer concerning a nine-year-old male, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 28-Oct-2011. On 02-Nov-2011, the patient experienced lethargy, headache, bodyache and dizziness with no fever. He has had had some neurological symptoms. Then on 07-Nov-2011, he was diagnosed with ataxia with mild flu like symptoms. The outcome of events ataxia, dizziness and flu was not resolved.
Chills, sweating, pain in right arm, and not feeling himself for a few days.  went to doctor 8/2/21 due to arm pain and not feeling right.
About 15 min after vaccine, going back to work station and felt ringing in my ear (tinnitus) vertigo; headache - went downstairs and drank a lot of water and took my legs up to prevent fainting and i didn't get better. 30 min later - 103/115 BP (Higher than normal -- 96/58or 60); after 12 Pm started having chills, shaking and chest hurt and difficulty breathing. Went ER at 12:55 pm and they did an EKG - not a regular heartbeat; blood work and x-ray. My BP was high - 143/122; I had low potassium; white blood cells higher than normal -10.9 (in mid Nov - only 7.5); They gave me potassium to take. December 30, when I got home at 6:30 - nausea started and I was throwing up two-three  days in a row more than 5 or 6 times a day; weird metallic taste; fever at night; arm pain and swollen under my armpits. (Stayed off work three days.) Went to dr on Jan. 7 - did a follow up appt. and did all the blood work again and everything was back to normal.
Injection site: Pain, redness, soreness, swelling Systemic: Headache, muscle aches, fever, nausea/vomiting, and fatigue. Patient reports that she slept for 2 days. Treatment: MEDROL dosepak.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included arthritis. On 19th February 2019, the patient received the 1st dose of SHINGRIX. In February 2019, 7 days after receiving SHINGRIX, the patient experienced injection site pain and injected limb mobility decreased. In February 2019, the outcome of the injection site pain and injected limb mobility decreased were recovered/resolved. It was unknown if the reporter considered the injection site pain and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient had current ongoing illness of arthritis. The patient received the dose of SHINGRIX and experienced pain at the injection site about a week after the injection. It basically hurts to raise her hand, the patient can raised it but it was painful. The patient's known, how bad that arthritis pain was and this was worse than that. The patient experienced no pain in her arm, when the arm was resting, but had the pain when patient moved her arm. The patient also felt pain, when she press at the injection site. The injection site was not red nor swollen nor lumpy. The patient said that she visited her physician about this pain and physician asked her to call us directly. The patient did not want to provide any details and wanted to stay anonymous. The patient did not gave the consent for follow up.
196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) 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 assessment was provided for UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent).    No concomitant drug information was provided.  It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.  No treatment drug information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live follow-up included narrative updated.
Caller's husband was exposed to someone who tested positive for Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (Caller's husband was exposed to someone who tested positive for Covid-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jul-2021, the patient experienced EXPOSURE TO SARS-COV-2 (Caller's husband was exposed to someone who tested positive for Covid-19). At the time of the report, EXPOSURE TO SARS-COV-2 (Caller's husband was exposed to someone who tested positive for Covid-19) outcome was unknown.            Relevant concomitant medications were not reported.  The treatment information was  not provided.
This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. On 30th August 2018, the patient received the 1st dose of SHINGRIX. On 30th August 2018, several hours after receiving SHINGRIX, the patient experienced fever, general body pain, headache, nausea and appetite lost. On an unknown date, the outcome of the fever, general body pain, headache, nausea and appetite lost were unknown.  It was unknown if the reporter considered the fever, general body pain, headache, nausea and appetite lost to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient's body temperature was recorded as 100 degree F. The patient developed fever, body ache, headache, mild nausea, loss appetite, and not to mention swollen tender arm at the injection site. The patient was asking whether the 2nd injection was recomended in 2 to 6 months, should the patient expect to have less adverse reaction with the second injection or more, and how long should the patient expect the reactions to be lasted.
adverse reaction; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (adverse reaction) in a  patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION COMPLICATION (adverse reaction). At the time of the report, VACCINATION COMPLICATION (adverse reaction) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Follow-Up information received on 10-AUG-2021 included no new information.
SM began feeling chest pain about 4 days following first dose of Pfizer COVID 19 vaccine.  The pain was described as intermittent and sharp in quality.  He felt the pain in the lower left chest which worsened with eating/drinking.  SM was diagnosed with possible pericarditis.
Received 2nd dose of Pfizer COVID-19 vacccine on 1/11/2021.  First dose 12/21/2020 (Lot EK5730, IM left arm).      4/5/2021 developed headache and nasal congestion.  Tested positive for COVID.
"Covid Arm"--Approximate 5-inch by 3-inch rash on right upper arm over area of injection site.  Red and hot to the touch.
pain, warmth, redness, swelling at injection site and about 6" x 4"
Vaccinated as part of nursing home mass vaccination event on 12/18/2020. Staff of nursing home. Tested positive for COVID-19 on 12/21/2020. Ongoing exposure to COVID+ residents at the home. Minimal symptoms.
Information has been received from a physician concerning a female (age not reported) who on an unspecified date, was vaccinated with a second dose of Gardasil. Subsequently the patient became dizzy and had some vomiting. The patient sought unspecified medical attention. At the time of this report, the outcome was unknown. Additional information has been requested.
p/vax pt devel rash to body on 10/11/99;had 3rd dose of rabies on 10/10/99;hx of being bitten by a mouse 10/3/99;
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 36-year-old male patient received BNT162b2 (BNT162B2), on 28Sep2021 at 12:00 as dose 3 (booster), single (Lot number: EW0175) at the age of 35 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CEFALEXIN, start date: 31Mar2022, stop date: 10Apr2022. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19. Clinical Course: Anti viral details, Paxlovid treatment start date was on 18Apr2022, and treatment stop date was on 22Apr2022, adverse event: Sore throat & coughing returned 5 days after taking last dose of Paxlovid. Fatigue returned 4 days after taking last dose of Paxlovid. The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received
Info has been received from an adult female RN who on 3/7/05 was vaccinated with either MMRII or the concomitant suspect therapy Mumps virus vaccine live. On approximately 3/17/05, about 10 days following vaccination, the pt developed headache, neck stiffness, light sensitivity, low-grade fever and joint pain. The pt reported that she sought unspecified medical attention. On approximately 3/20/05, the pt was noted to be recovering from the neck stiffness, light sensitivity, low-grade fever and joint pain as the pt had reported that "most of her symptoms lasted about 4 days only." At the time of this report, the pt had not recovered from the headaches. Additional info has been requested.