chrisvoncsefalvay/vaers-outcomes huggingface dataset:
zoster related pneumonia; other zoster-related conditions; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 07-SEP-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and/or zoster-related conditions (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). At the time of vaccination, the patient relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through the patient's healthcare provider that zoster vaccine live (ZOSTAVAX) was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effects, which induced the patient to be vaccinated Alternatively, on or about 07-SEP-2016, the patient's healthcare providers included but not limited to a healthcare provider, relied on the warning label affixed to the zoster vaccine live (ZOSTAVAX) vaccine, believed that it was effective in preventing shingles on a long-term or permanent basis that it did not carry any significant risks of adverse effects. On an unknown date, reported as subsequent to the inoculation, the patient was treated for zoster related pneumonia and other zoster-related conditions. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffered ongoing injuries, including but not limited to: mental and physical pain and suffering; 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 include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of varicella zoster pneumonia and ill-defined disorder were not recovered. The reporter considered varicella zoster pneumonia and ill-defined disorder to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, varicella zoster pneumonia was determined to be a medically significant event.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. Patient's concurrent condition and medical history were not provided. On an unknown date, the patient previously received a dose of M-M-R II (lot#, expiration date, dose and route not reported). On an unknown date the patient had negative titers for mumps vaccine. The outcome of the event was not recovered. Additional information is not expected as the physician asked not to be contacted.
This spontaneous prospective pregnancy report as received from a nurse refers to a female patient of unknown age. The patient had no medical history. On 25-NOV-2013 the patient was vaccinated with M-M-R II lot number J002934 and expiry date 15-MAR-2013, 0.5 ml, subcutaneous, as required for unspecified enrollment. Other suspect therapies included a single 0.5 mL dose of VARIVAX (merck) (Lot number J006161 and expiration date 20-MAY-2015) on the same day. Both vaccines were administered via the subcutaneous route. Concomitant medications were none. On the day of report, the patient stated that she took an at home pregnancy test a couple of days after her appointment on 25-NOV-2013, and the test came back positive. The patient stated that she had not yet been seen by her unspecified obstetrician and gynecologist (OBGYN). The nurse stated that according to the paperwork the patient filled out during her 25-NOV-2013 office visit, the patient's last menstrual period was on 24-NOV-2013. The estimated date of delivery (EDD) was of 31-AUG-2014. No treatment was given. The pregnancy outcome was pending. Additional information has been requested.
Patient said that he experienced extreme dizziness. When he stood up he had a headache and could not walk. Patient stated that his hand locked up and it was painful to move. He went to bed and when he woke up he was fine.  Patient stated that this happened 44 days after taking the vaccination. Patient stated that he started this was a one time occurrence  and that it happened around 8pm.
This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported. On 11-DEC-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 10 PK-0.5 ml SD-PFS LLokwTip, lot # L002310, expiration date 08-JUL-2016, (route and anatomical location of administration were unspecified) which was improperly stored in refrigerator to a temperature excursion of 1.1 Celsius degrees for 208 hours. The lowest temperature recorded was: 34 Fahrenheit degrees. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Ongoing nausea.  Visit to doctor.  Ruled out many things through blood tests.  Still unsure of cause.  Going to GI in two weeks.  Taking anti-acid but with no visible end of nausea.
Chills; naseaus; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and NAUSEA (naseaus) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills) and NAUSEA (naseaus).        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Within a few seconds of the Gardasil vaccination, she had a seizure.  Nurses turned her on her side and symptoms resolved in about 1 minute.
Adm pneumo 10/08/06 called this am red around site and red below marked at 9 am and spread DX cellulitis.
Within one week of second dose vaccine, blue/pink colored "hematoma-looking" 'bruise' underneath the skin about an inch long and an inch wide appear on the same arm as the vaccine location. Painful to lay on, hurt when using the arm. Over the next week, site became red, elevated, hot, and painful (like it was on fire).
Warm, reddened area noted covering left deltoid. Child has no complaints of pain. Parents concerned.
This spontaneous report as received from a registered nurse refers to a female patient of age in 80s (years) with drug reactions/allergies to sulfite. On an unknown date the patient was vaccinated with pneumococcal vaccine (manufacturer unknown). On an unknown date (report as at an unspecified time in the past), the patient immediately began to feel bad after receiving a pneumococcal vaccine (manufacturer unspecified). Benadryl was given as treatment for the event. The patient reported to the nurse that it took her a week to recover. Reporter's causality assessment was not provided. Additional information is not expected.
6 hours after injection, swelling around inject site, pain of deltoid. Next day: Mild chills, slight nausea, malaise, mild headache at 32 hours after injection, lasting 2 hours till went to bed. Woke up next morning tired, mild headache.
Left arm swollen from deltoid 23cm to below elbow 19.5cm. Right arm normal size deltoid 17cm, elbow 17.5cm. Went to hospital ER on 7/31/03. Doctor on call instructed them to use warm cloths, take Benadryl and Tylenol. Not to get any more shots in deltoid away. Use gluteal area. Arm warm to touch but soft. Client has equal and good grip in both hands.
2 minute seizure in early morning, self resolving after 2 minutes. Now back to normal self. Normal exam.
This case was reported by a healthcare professional (physician assistant) and described the occurrence of anaphylaxis in a 10-week-old male subject who was vaccinated with Dtap (GlaxoSmithKline), Hepatitis B, ROTARIX, Hib, PREVNAR (non-gsk) and IPV (non-gsk). Concurrent medical conditions included premature birth (infant). On 17 August 2013 the subject received unspecified dose of Dtap (unknown, "leg" (unknown thigh)), unspecified dose of Hepatitis B (unknown), unspecified dose of ROTARIX (oral), unspecified dose of Hib (unknown), unspecified dose of PREVNAR (unknown), unspecified dose of IPV (Non-GSK) (unknown). On 17 August 2013, less than one day after vaccination with Dtap, Hib, Hepatitis B, IPV (Non-GSK), PREVNAR and ROTARIX, the subject experienced anaphylaxis, hive and fever. The subject also developed throat swelling, the reporter stated it was unclear when it started. The subject was hospitalised and the healthcare professional considered the events were disabling, life threatening and clinically significant (or requiring intervention). Immunization series with DTap was delayed. At the time of reporting the events were resolved. The healthcare professional considered the events were probably related to vaccination with Dtap, Hepatitis B, ROTARIX, Hib, PREVNAR and IPV (Non-GSK).
Started breaking out in spots.  Saw my primary care, rheumatologist, allergist, dermatologist.  No one can identify why I have these spots and they are still breaking out.  Tried different things to stop it but it continues 7 months later.  Had my booster shot on 9/23/2021.
After my dose, I began experiencing a severe migraine headache so I contacted my PCP who suggested I go to the emergency room. At the ER, they gave me a CT scan to make sure I wasn't experiencing a stroke or aneurism. They then gave me migraine medication and gave me fluids to help reduce the migraine pain and prescribed me migraine medication to take at home for the next week and if the migraines were to return after being discharged.
Patient received first dose of Pfizer Covid 19 vaccine on 03/12/21 in am and by 8pm same day, she was experiencing numbness and tingling  in left arm, from acromian process to hand/fingers.  She also report pain in arm, especially at night which wakens her. she is able to relieve the pain by stretching and extending left arm above her head.  She has received second dose of Pfizer Covid 19 vaccine on 03/30/21 in right deltoid and has not experienced these symptoms. The symptoms reported in left upper extremity continue through today. 04/30/21.
A 5 year old patient received a dose of the Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) booster for 6 months to 5 years  following the completion of primary vaccination with Pfizer COVID-19 Vaccine.  ?
Client says he first noticed symptoms on 12/22/03, which consisted of red blisters all over his body, fever of 102 F, and a sore throat.  As of 01/02/04, client says symptoms were subsiding.  It is important to mention that client states his wife had the disease of shingles prior to pt receiving the varicella vaccination.
chest pain; suspicious of myocarditis; This is a spontaneous report. A non-contactable female consumer (patient's mother). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) Dose 2 via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  On an unspecified date, the patient experienced chest pain and suspicious of myocarditis (medically significant). The patient got second dose (of bnt162b2) and got chest pain and went to ER who were suspicious of myocarditis. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a registered nurse and refers to a 12 months old patient of unknown gender. No medical history, concurrent conditions and concomitant therapies were reported. On 03-JUN-2015, the patient was vaccinated with improperly stored dose of VARIVAX (Merck) lot # K021933, expiration date 10-NOV-2016, dose 0.5 ml, subcutaneously (anatomical location was not reported). No adverse effects were reported. This is one of several reprots received from the same reporter. Additional information is not expected.
Pt devel redness, soreness & an infect p/recvd Td vax; No additional info is available regarding this event;
Patient complained of headache, nausea, dizziness, and burning sensation on upper lips 10-15 minutes post-injection.
excessive sleepiness, severe stomach pain, diarrhea, vomitting, decreased appetite, lethargy, sore arm
I was diagnosed with SVT Tachycardia on February 11, 2023 my symptoms were heart pounding, irregular heart rate. I was prescribed metoprolol for my symptoms.
Lightheaded immediately after vaccinated. Continued to be light headed throughout the rest of the day. Dizzy. High anxiety. Symptoms have not gone away and it was been 4 full days since vaccination.
fatigue; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), CHILLS (chills) and HEADACHE (headache) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigue), CHILLS (chills) and HEADACHE (headache). At the time of the report, FATIGUE (fatigue), CHILLS (chills) and HEADACHE (headache) had not resolved.            Treatment medication was not provided.  Concomitant medication was not provided.   Reporter did not allow further contact
Phone call from patient stating a possible reaction to shingles vaccine. Three days after arm had swelling, huge welt, itchy, painful, no fever, lasted for a few days.
Worst headache I've ever had the day after (even surpassed any migraine I've ever had). And three weeks later suddenly had to sleep all night and all day for a week, like I had mono. No appetite, total lethargy, stomach pain. went to my chiropractor today who I saw the day before the first shot, and she said my lymph system was completely clogged and "stuck".  And I continue to have bad headaches every day, a couple times a day, when I haven't had headaches in years and have been very healthy.
Initial information regarding an unsolicited valid serious case received on 26-Sep-2018 from a consumer. This case involves a 68 years old female patient who experienced she almost died, she got flu, sick as a dog, high fever, she had three seizures, while she received vaccine FLUBLOK QIV. The patients past medical history included Food allergy (eggs). The patients past medical treatment(s), vaccination(s) and family history were not provided. On an unknown date in Sep-2017, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via intramuscular route in the left arm. On an unknown date, the patient developed a serious she almost died (apparent death), following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. This event was assessed as life-threatening. It was reported that she was down for approximately 6 weeks. On an unknown date, the patient developed a serious three seizures (seizure), following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. This event was assessed as medically significant. On 15-Jan-2018, the patient developed a non-serious she got flu (influenza like illness), following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. On an unknown date, the patient developed a non-serious sick as a dog (malaise), high fever (pyrexia) and she had three seizures (seizure), following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. Other relevant tests included no lab data. Final diagnosis was she got flu, she had three seizures, high fever, sick as a dog and (Life-threatening) she almost died. It was not reported if the patient received a corrective treatment. The outcome of the events was not reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.; Sender's Comments: This case involves a 68 years old patient who presented with seizures, flu, high fever and near death experience post vaccination with FLUBLOK QIV. Time to onset is unknown. Additional information regarding patient's medical history, condition at the time of vaccination, lab tests and etiological work up ruling out other etiologies is necessary to assess the causal relationship with respect to the vaccine. Based upon reported information the role of the vaccine cannot be assessed.
Severe chills including in spine, severe left arm pain despite using Tylenol/Advil, fever of 100.6 that does not come low with Advil/Tylenol Ongoing
I woke up at 2 am with hives all over my upper body and head. Granted this is the booster shot I took after I got my JNJ shot
Patient admitted to referring hospital on 5/18/2021 for fatigue and SOB, found to have pulmonary embolism (CT with central pulmonary emboli with right heart strain),  alteplase was given at referring hospital and was admitted to ICU for continued monitoring.    Venous duplex done also revealed bilateral DVTs.  Patient was doing well after fibrinolytic with heparin anticoagulation, but had sudden decompensation on 5/21 (hypotension and respiratory failure requiring intubation).  Transferred to current institution for ECMO evaluation due to severe cardiopulmonary compromise.  Patient deemed not ECMO candidate based on co-morbid conditions based on CT findings.  He underwent mechanical thrombectomy with improvement.  He was continued on heparin infusion, then had sudden decrease in platelet on 5/25 with worsening cardiopulmonary status.  HITT was suspected and heparin was transitioned to argatroban.  Results of heparin induced platelet antibodies (PF4 ELISA assay) and Serotonin Release assay was negative.  Repeat imaging revealed increase clot burden and therefore patient underwent catheter directed thrombolysis followed by aspiration suction thrombectomy.  Due to high clinical suspicion of HITT, repeat heparin induced platelet and SRA sent and pending at the time of report. Of note, patient still in hospital at the time of this report
When i first got the shot I didn't think it was bad at all I actually hardly  felt the needle. around 5 o'clock I started feeling ill and then i started about quarter to 6 I started getting cold and shaking bad but it wasn't like a seizure. So really severe chills. When i got home i got under heated blanket then I started getting itchy and noticed hives all over body. then I started getting blisters on palms of my hands and they were like water blisters. I was uncontrollably itchy. I started looking up online  what to do and asked friends and family and started taking Benadryl.  I had to take it for 4-4.5 days so then the hives finally went away but I was still itchy. I've just been very very exhausted and been having to push myself to get up. I had anxiety about getting  the vaccine but I decided to get it. I still don't feel like myself, I don't have much of an appetite but not losing weight because I've been forcing myself to eat. I'm taking vitamins and praying I feel better but I just don't feel like myself. I don't have as much energy and exhaustion is the big thing. My joints started hurting really bad.
Systemic: Abdominal Pain-Mild, Systemic: Buring of the ear-Medium, Systemic: Nausea-Severe, Systemic: Vomiting-Mild, Additional Details: Patient's original BP was 139/84 pulse 94 and second reading was 101/65 pulse 76.
In August 2021 I began to have vaginal bleeding for 5 days like a menstrual cycle, but I am post-menopausal. This was 4 months after dose 2. I had dose 3 in December 2021. I went to the gynecologist/doctor in January of 2022. They found a lump in my breast. I had to have a biopsy of my uterus. I was forced to have a full hysterectomy on March 4, 2022.
3 days and night non stop bad headach, neckach, shoulders, back, lower hips, and arm site of injection.
Approximately 10 minutes after vaccination developed increased heart rate, dizziness, and shakiness.
Post vax, the pt developed rashes on 10/28/01, starting on face and then on 10/29/01, rashes worsens to erythema multiforme. Seen at ER for rash and Rx'd with Pediazole.
LUPUS FLARING; This spontaneous report received from a patient via a company representative concerned a 42 year old female.  The patient's height, and weight were not reported. The patient's concurrent conditions included lupus, adrenal problems, non alcohol user, and non smoker. The patient had no known allergies and no history of drug abuse or illicit. The patient was not pregnant at the time of reporting.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, 1 in total administered at left arm on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the patient was sick for 3 weeks already and could not even get out of bed and recently had lupus flaring and adrenal issues. The patient was experienced canker sores in mouth, pain in left upper chest, diarrhea, left arm pain, bad headaches and extreme fatigue. The patient could not keep on getting pains all up and down her left side. She went to hospital twice with various tests which includes computed tomography scan, Electrocardiography, Magnetic resonance imaging, and White blood all results were normal. The patient was seeking guidance on why the adverse event are lasting so long and was concerned that she might die from after taking the vaccine shot.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lupus flaring. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 : 20210453759-covid-19 vaccine ad26.cov2.s-Lupus flaring. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
Bivalent Pfizer covid 19 vaccine was inadvertently given early. No symptoms reported. No treatment necessary.
I woke up Friday with chills; I couldn't stop shivering and shaking. I had a tremendous headache. I didn't feel right, and these symptoms were going on all day. I took medicine I usually take for headaches, and it didn't do anything. Headache was nonstop from Friday to today. I called my neurologist yesterday and they were able to get me in and give me a shot in a bottom to calm everything down to help me. I got a Toradol shot in my bottom. I would have gone to ER if I couldn't have gotten to my doctor for the shot. This migraine was not responding to migraines. But it didn't respond to the Toradol shot, and I finally got relief.  I will know tomorrow if it's totally gone. The chills and shaking stopped on Saturday.