chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Suspected vaccination failure; After I got the shot about six months later I got the shingles again; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 6 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient had shingles in past and when that cleared up and went away the patient received the Shingles vaccine. About 6 months after the vaccination the patient experienced shingles again. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting.
pt recv vax 30SEP98 & pt exp a severe allergic rxn & was immed hosp for one day;the reporter felt that the child immune system may have been compromised as a result of mom's cocaine addiction;
Headache, Fever, CoughWheeze, Diarrhea, COVID-19 positive PCR on 5/26/21 Narrative:
8/11/22: Received first shot 8/12-14/22: Headache  8/14-15/22: Headache and Muscle Aches/Soreness 8/16/22: Hives appeared on the abdominal area, arms, and thighs  8/17/22: 50 mg prednisone prescribed for allergic reaction (hives) to allergy shots 8/18-23/22: Taking Double OTC Daily Dose of Zyrtec in the AM, and 50 mg Benadryl in the evenings 8/24/22: 10-20mg daily of Hydroxyzine HCl as needed for itchiness, continuing to take Zyrtec and Benedryl to manage symptoms  Presently, hive location moves around my body, up or down my arms, up or down my thighs and legs, and moves around my stomach area.   They are not concentrated in one spot. I do not have any hives at the injection site.
Fatigue for 2 and half days. Increased blurred vision while driving and watching television.  Tender at injection site.
My period used to be 3-5 days max.  Since I received the vaccine my menstrual cycle is at least 2 weeks, extremely heavy bleeds and terrible cramping.
I have had periodic stabbing pain in the injection site on and off since the shot.  I mentioned it today to a nurse when I got my flu shot and she said I should report it.  Kind of late now, but, finding it odd that this happened.
On 11/23/2022, I woke up with GI issues. I was experiencing diarrhea throughout the day. That is very unlike me. On 11/26/2022, I started to show symptoms of a sore throat, headache and congestion. Within 24 hours, I developed a fever and a cough. I also experienced the skin on my lips started to become sore and the skin peeled off. It was like a really bad case of chapped lips. It hurt really badly. I contacted my physician and they prescribed Paxlovid. On 12/1/2022, I lost my sense of smell. I continued with GI issues while taking the medication. It cleared up once the medication was complete.
Patient received vaccines on 4/23/22.  On the evening of 4/24/22 patient claimed to have radiating pain in left arm from wrist to shoulder and chest paint.  Went to ER twice and both times EKG and bloodwork all came back normal.  Patient is still experiencing  arm pain and chest pain.
This spontaneous report was received from a pharmacist regarding to an unspecified number of patients of unknown age and gender with no pertinent medical history reported. The pharmacist reported that on unspecified dates the medical center he works for, may have possibly administered to an unspecified number of patients an improperly stored M-M-R II (lot number and expiration date not reported) (dose and route not specified). No other suspect therapies or concomitant medications were reported. The pharmacist stated he was not sure, he also stated that he did not know if the information he had was correct or not. No symptoms were reported. Additional information is not expected.
11/15/21 presents to ED "via EMS for COVID pneumonia, hypoxia". PMHx of "Asthma and PCOS".
Minor pain in upper left arm most of the time and excruciating pain with certain movements or pressure on upper arm.
On 09/09/2021 I had my vaccination. On 08/09/2022 I started to experience COVID 19 symptoms. I had low grade fever and upper respiratory congestion. I tested COVID-19 positive with an home test.  I got the infusion for COVID-19 on 08/10/2022 at the Hospital. I tested COVID-19 negative on 08/14/2022.
Covid Vaccine Booster dose administered after reconstituted vaccine had expired. Vaccine drawn up on 11/16/21 at 0925 expired at 1525 after 6 hours. Administered the vaccine at 1722. No signs/symptoms of adverse reaction at this time. Patient notified on 11/17/21 at 0804. Will contact the manufacturer for recommendations.
Pt developed 3 hives on skin - face, back, leg. No other signs/symptoms. Attempted to give Benadryl but parents never picked-up medication.
Was dizzy that evening after injection.  Very fatigued next morning and still fatigued and sore at injection site. These side effects are not bad, just thought I should report.  I was very nervous about getting this shot due to my sensitivity to medicines and other allergies,  so these side effects are better than I was expecting.
Amnesia and altered mental status lasting 2 days.Amnesia occured shortly after administration.
After receiving vaccine, patient felt dizziness, vertigo, checked BP and it showed high about 170/100 and pulse at 100, called 911 for help.
I fell asleep soon after vaccination was administered. When I awoke I felt very ill and confused. The fatigue was severe and I felt very weak. I experienced great difficulty with any type of physical functioning. My heart felt as though it was beating in an irregular manner and beating much harder than normal. I had developed a very productive cough as well. It is difficult to describe because I can remember very little of the following couple or few days after being vaccinated. I was completely out-of-it. However, I did notice my blood sugar levels were very high (400-500;s) when remembered to test. Everything I tried to accomplish was with great effort. The very first time I tried to climb a few (4) stairs, I was rendered completely out of breath. Something, which had never happened to me prior to the Vaccine. Soon thereafter, while visiting other specialists, I could tell by the looks on their faces and their announcements about my obvious "heart murmur" that it had become worse. (I had a very slight heart murmur prior to the vaccine, but for the most part was found to be undetectable.) I am also having problems with my Short-short term memory since the vaccine was administered. An Echocardiogram was ordered by my doctor, however it appears it was not a very good study. I have a follow-up appointment with a cardiologist on May 12, 2017. I have never before had a problem with a vaccine. I receive the extra strength flu vaccine very year, and have had also been vaccinated with the Tetanus vaccine and regular Pneumonia vaccine without incident. Testing and treatment in progress.
1/16 complaints of headache, nausea and fatigue and chills, no fever.  1/17 complaint of headache and fatigue  No symptoms Monday, and able to work
Redness and swelling of upper arm slowly developed over the next three days resulting in visit to urgent care center on 11/31/2009.  Diagnosis: cellulitis of upper arm.
twinge of a headache; mild swelling at injection site; pink at injection site; I feel a little unsettled; Fatigue; A spontaneous report was received from a 81 year old female patient, who received  Moderna's covid 19 vaccine (mRNA-1273) and experienced a twinge of a headache, mild swelling at injection site , injection site pink, little unsettled and fatigue.  The patient's medical history was not provided. Concomitant medications were reported.    On 17 Jan 2021 prior to the onset of event, the patient received first of two planned doses of mRNA-1273 (Batch NO:041LZ0A ) injection for prophylaxis of covid 19 infection.  On 17 Jan the patient experienced a twinge of a headache, mild swelling at injection site , injection site pink, little unsettled and fatigue .  No treatment information provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  Outcome of the event, a twinge of a headache, mild swelling at injection site , injection site pink, little unsettled and fatigue, not provided.
History provided by the patient and mother. Patient is a 13-year-old male with no sickened PMH who presents with complaints of fever, left shoulder pain and rash. Patient received HPV vaccination one week ago on Monday (7/21/14) into the left deltoid and shoulder. He had some localized pain and soreness in her shoulder following injection. Over the weekend he began to feel ill with slight fever and developed a rash on Sunday. He began having red areas with small bumps mostly to left upper extremity. This continued to worsen with more areas of rash across the upper back and left side and abdomen. Patient has been taking Benadryl send ibuprofen for his rash and symptoms without significant improvement. Ibuprofen has helped with this shoulder soreness. Denies any other aggravating or alleviating factors. Denies similar symptoms previously.
headache; fever; nauseous; chills; still feeling sweaty; feeling too shaky to drive; shortness of breath; This spontaneous case was reported by a patient and describes the occurrence of HYPERHIDROSIS (still feeling sweaty), NERVOUSNESS (feeling too shaky to drive), DYSPNOEA (shortness of breath), HEADACHE (headache) and NAUSEA (nauseous) in a 76-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 205E23A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No previous heart conditions.  Previously administered products included for Product used for unknown indication: Flu in September 2023 and RSV in September 2023. Past adverse reactions to the above products included No adverse event with Flu; and No adverse reaction with RSV. Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included TOFACITINIB CITRATE (XELJANZ) for Rheumatoid arthritis, SERTRALINE for an unknown indication.    On 29-Sep-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. In 2023, the patient experienced HYPERHIDROSIS (still feeling sweaty), NERVOUSNESS (feeling too shaky to drive), DYSPNOEA (shortness of breath), NAUSEA (nauseous) and CHILLS (chills). On 30-Sep-2023, after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced HEADACHE (headache) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (still feeling sweaty) had not resolved, NERVOUSNESS (feeling too shaky to drive), DYSPNOEA (shortness of breath), HEADACHE (headache), NAUSEA (nauseous) and CHILLS (chills) outcome was unknown and PYREXIA (fever) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Sep-2023, Body temperature: fever of 100 and something. On 09-Oct-2023, Body temperature: At morning it was 100.4 and after taking Tylenol and it was 99.3.     For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   On 03-Mar-2021, patient received dose 1 of Moderna. On 31-Mar-2021, patient received dose 2 of Moderna. On 09-Nov-2021, patient received dose 3 of Moderna. On 12-Apr-2022, patient received dose 4 of Pfizer. On 11-Nov-2022, patient received dose 5 of Moderna.  The day after receiving the Spikevax vaccine, patient woke up with a headache and fever of 100 and something. Patient had no reaction to the previous ones. A few days later, she was nauseous after waking up and still had a fever. Every day she wakes up in the morning with an elevated fever. On 09-Oct-2023, it was 100.4, after taking Tylenol it was 99.3. After taking Tylenol it goes down during the day, but she still was feeling sweaty. She was initially concerned about having a fever in the middle of the night because she had chills. Fever was going down. Patient was feeling too shaky to drive and also seems to have shortness of breath. She was hardly ever nauseous but read that it could be a side effect and thought it could something she ate.
Dizziness  starting early  AM and progressing to virtigo and nausea with vomiting around 3 pm in the afternoon.  Bed rest until 1/21. and able to get out of bed around 8 AM.  Ate a small breakfast and returned to bed rest until later in the morning.  Vertigo is still evident but not as severe.  Vertigo is still present at 4 pm on 1/21 but able to move around slowly with assistance. Vertigo continues at the time of this report.
Patient is fully vaccinated. COVID + on 1/7/2022 at ED visit. 13-year-old female who presents to the ED complaining of 2 days of headache, cough, subjective fever, general malaise, nausea, dizziness, lightheadedness. Denies loss of consciousness. No chest pain. No abdominal pain and constipation or diarrhea. No leg pain or swelling, denies history of DVT/PE. She does have a history of diabetes. Positive for shortness of breath and cough and fatigue. BP (!) 148/72  | Pulse (!) 130  | Temp 99.4 °F (37.4 °C) (Oral)  | Resp 18  | SpO2 100% CXR: no acute process. She was given an IV fluid bolus, Toradol, Zofran.  Discharged from ED
Received Dtap 6/10/05 during well child exam. Fever, subsequent seizure lasting minutes on 6/13/05. No focus of infection on exam.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2014, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unknown date in 2015, the patient was treated at an urgent care for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
lightheaded, dizzy, she laid on the stretcher for 10 min and felt much better left asymptomatic
Gave mRna Covid 19 Moderna vaccine booster after 8/31/22 instead of Bivalent booster
This spontaneous report as received from a consumer refers to her 6 months old son with no pertinent medical history, drug reactions or allergies. On 07-APR-2014 the patient was vaccinated with a dose of MMR II (route, dose, lot# and expiry date not reported). Concomitant therapy included reflux medication (unspecified). The reporter stated that her son was administered vaccinations intended for a twelve-month-old, instead of a six-month-old children. The consumer reported that the physician stated that the patient would need to be re-vaccinated at the appropriate age for the twelve-month-old vaccines. The consumer stated that three vaccines were administered, but could only identify one as MMR II. The consumer was concerned about any potential problems with additional vaccinations. No adverse symptoms were reported. The patient did not take any medication for treatment. Lab diagnostic studies were not performed. The patient did not seek medical attention. Additional information is not expected.
A nurse reported a female pt received an injection of Flu Shield '00-'01 on 11/16/00 and subsequently developed an injection site reaction characterized by swelling. The pt also developed a pin-point rash on her chest. The pt "felt the reaction was due to  the bandaid as she said it went away when she took the bandaid off".
About a week and a half later I began to notice soreness in the shoulder joint.  It continued and was then met with stiffness in the joint.  Stiffness and soreness continued through December and January.  By the end of January I was unable to lift my left arm over my head.  By February I ceased my yoga practice as I could no longer utilize my left arm.  In March my shoulder was so painful I often used a sling to keep the joint still.  I contacted my doctor in March and began the process of being referred to a shoulder specialist.  April 7, 2020 I had a telemedicine call with Dr. about my shoulder.  It is about to time me out; so I will send.
Acute onset of fever, chills, lethargy, slurred speech and hallucinations. Take to ED and observed/admitted/followed over 24 hours. Noted elevated WBC and CRP. Negative head CT. Given antibiotics, e.g. Rocephin and fluids. Cleared completely within 24 hours. and discharged. No further symptoms.
Right deltoid area was swollen and tender to palpation . The patient had limited movement at right shoulder due to pain in deltoid area. She is unable to perform her job. 5 days of prednisone was given as an empirical trial.
A non-serious event of expired product administered was received from a nurse concerning a four-year-old male coincident with FluMist therapy.  This case is submitted in accordance with MedImmune post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.  No medical or drug history was provided.  FluMist was administered on 10-Jan-2008.  The FluMist expired ten days earlier on 31-Dec-2007.  Follow-up twelve days later revealed that the patient experienced no ill effects post exposure to the expired FluMist.  No additional dosing is indicated.  The reporter did not provide a causality assessment.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
I just feel face getting hot and I had shortness of breathe. I had my blood pressure taken and it was over 200. And once at 204/192. It continued to climb throughout the day. I was given medication to bring it down quickly. Now on from time to time, my blood pressure rises for no reason. I have seen a cardiologist since and he has me taking a extreme regimen to control the spurts of rising blood pressure. it has been helping a bit, so far I am doing pretty go. I have never had this issue before, now I have to take it medication exactly right all the time.
I have not had a minstral cycle since 2015 but after taking the second Pfizer dose Im experiencing minstral cramps and spotting.; I have not had a minstral cycle since 2015 but after taking the second Pfizer dose Im experiencing minstral cramps and spotting.; This is a spontaneous report received from a contactable consumer or other non-health care professional.  A 54-year-old non-pregnant female patient received bnt162b2 (COMIRNATY, formulation: solution for injection, Batch/Lot Number: EW0161), via an unspecified route of administration on 01May2021 as dose 1, single and received bnt162b2 (COMIRNATY, formulation: solution for injection, Batch/Lot Number: EW0176), via an unspecified route of administration on an unspecified date, as dose 2, single for COVID-19 immunisation. The patient's medical history included none. No past drug events. No known allergies. Concomitant medication(s) were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination. The patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27May2021, the patient experinced I have not had a menstral cycle since 2015 but after taking the second Pfizer dose I am experiencing menstral cramps and spotting. All the events were non-serious. The outcome of all the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Chill; shingles; Loss of taste; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chill), VACCINATION SITE PAIN (Soreness), HERPES ZOSTER (shingles) and AGEUSIA (Loss of taste) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concomitant products included LOSARTAN, ATORVASTATIN, METFORMIN and VITAMINS NOS for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PAIN (Soreness). On 05-Feb-2021, the patient experienced CHILLS (Chill), HERPES ZOSTER (shingles) and AGEUSIA (Loss of taste). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 06-Feb-2021, VACCINATION SITE PAIN (Soreness) had resolved. At the time of the report, CHILLS (Chill) and AGEUSIA (Loss of taste) had not resolved and HERPES ZOSTER (shingles) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Patient was vaccinated on 4/31/21, on the morning of 5/1/21 she has shooting pain up her neck and down her arm on the left side, and is unable to move her arm like normal. Site of vaccination is sore and looks high on her arm. Going to take Tylenol and ice today, and follow up with her PCP if it does not resolve by Monday. Declines to seek treatment today, 5/1/21.
On the afternoon of 8/8/21 at approx. 2pm, I had a change in my vision of my left eye.  There had been no trauma and no strenuous activity.  The change in vision came and went over the next few days and then remained constant.  At that time, I had lost approximately 75%-85% of my vision in my left eye.
Moderna COVID-19 Vaccine EUA 14 hrs after dose 2, fever, chills, aches, 20 min AFIB.  Back to sinus rhythm after 20 min on its own.  14 hrs after adverse effect started, fever normal, aches gone.  Arm red, somewhat swollen.  6 hrs later, arm redder from injection site entire front of biceps down to elbow.  Lump at bottom of biceps and enraged lymph node in armpit.  25 hours after noticing COVID arm, swelling down, lump on bicep gone and redness subsiding. Feeling good
On the night of March  18th, around 2am on the Friday morning, I woke up with a vicious headache -- a steady pressure and pain in my whole head. By far the worst headache I've ever had. I sat in the shower for about 40 mins trying to get it to go away, it didn't. I took a Tylenol when I got out of the shower which I immediately vomited up . After a while I was drained enough that I was able to go back to sleep. Headaches continued for more than a week, though not as awful (I was more or less functional). On March 26th I requested an appt and was seen right away.
Patient developed Covid-19 symptoms, to include cough, diarrhea, fatigue and myalgia; symptom onset date was 8-8-2021. Admitted into the hospital, Hospital, on 8-16-21; release date was 8-19-21.