chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Got vaccinated still got shingles/ suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got vaccinated still got shingles/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 18-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received Shingles vaccine and still experienced mild case of shingles. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Patient c/o itchiness after taking 3rd oral typhoid capsule, no rash noted at that time.  After taking 4 dose on 9/9/09, again became itchy & noticed rash "small red bumps" on right foot and then left foot and ankle.  On 9/5 rash continued up legs.  Pt notified MD on 9/8 -> advised to take BENEDRYL 25 mg PO as needed.  9/14/09 -  Has slight itchiness at times, but resolving.
This spontaneous report was received from a 50 years old male patient, as part of a marketing research program. The current condition included pneumonia. On an unknown date the patient was vaccinated with pneumococcal vaccine (manufacturer unknown). On an unknown date the patient 'got sick' (malaise). The outcome of the event and the causality was unknown. Additional information is not expected.
This is a spontaneous report from a non-contactable nurse who reported on behalf of the daughter. A female patient of an unspecified age and race received the first dose of TRUMENBA on an unspecified date at single dose for immunisation. The patient was going to a University where there was an outbreak of meningococcal disease. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient developed a papule at the site of injection 1 week after vaccination with unknown outcome. The reporter wanted to know if this is a contraindication to administering the next dose. No follow up attempts possible. No further information expected.
When I woke on 12/24 I had hives on Legs, Torso, Stomach, Arms. Took a benadryl but by that evening could not function. 12/25 By Christmas day my hives was everywhere on my body and tried to stay home. 12/26 Went to see a doctor thru urgent care telehealth and was advised if got worse go to hospital but try to stay home and take benadryl with rest. By 12/31 I experienced headache and nasal congestion and I went to get a COVID test at home. It come back positive and started to quarantine at home. Went to urgent care 2 days later for an official check and have not heard back from them yet.
1. Dec. 30, 2020- Headaches for about 24hrs after 1st COVID-19 injection, treated w/ 500 mg of Ibuprofen at 1:00 am, reduced/eliminated headaches by Dec. 31, 2020 3:00 p.m.   2. Jan. 01, 2021- Woke up/laying down when the dizziness/room spinning began lasting about 10 seconds. Dizzy/spinning episodes continued from 01/01/2021-01/05/2021 (decreasing in episodes on 01/04/2021- 01/05/2021). The dizzy/spinning episodes would happen randomly when I first woke up, through out the day/night, about 6-7 times a day, and lasting  about 10 seconds. A few times I felt like I would faint. Treated with rest, sleep, drinking water, and took off work for 1 week due to the danger of driving or going outside the home.  3. I would randomly wake up with hot sweats and nausea from 01/01/2021-04/01/2021, treated by drinking water, and resting.  4. I experienced the general feeling of being unwell, fatigue, and foggy mind that lasted about a week after the 1st COVID-19 vaccination. Treated with rest and was off work for 1 week.
A spontaneous report had been received from health professional concerning a 5 year old, male patient. No information was provided regarding medical history and concomitant medications and concurrent disease of the patient. Five year old patient was administered the full dose of FLUMIST, (intranasal) (0.2 ml) in one nostril by the clinic nurse. Incorrect administration. The outcome of the incorrect administration was unknown. The company physician considered the incorrect administration to be non-serious. The reporter considered that there was no causal relationship between incorrect administration and FLUMIST and company physician agreed with the reporter's assessment of causality.
Enlarged left sided supra clavicular lymph nodes noted 2/6/2021. Hypertensive crisis on 2/11/2021 with blood pressure 202/101 and palpitations with heart rate 113.
Discharge Provider: MD Primary Care Provider at Discharge: DO Admission Date: 8/17/2022 Discharge Date: 8/23/22      HOSPITAL COURSE: The patient is a 43 y.o. female who was admitted for acute pancreatitis and sepsis secondary to Covid 19 infection.    Patient developed fevers and shortness of breath on 8/9/22 and tested positive for COVID on 8/11.  On 8/13 pt developed vomiting and generalized abdominal pain. Symptoms continued to worsen and she presented to ED on 8/17 where she was noted to have tachycardia and leukocytosis. Lipase was >3000 and CT a/p showed inflammation and edema of the pancreas. She was initially treated with IV pain medicine and kept NPO. CT with steroid prep was obtained (pt had allergy to contrast) and ruled out PE. Her pain gradually improved and she was transitioned to oral pain medications. She did have some diarrhea during admission which could have been due to Covid or pancreatitis. Pt was also newly diagnosed with diabetes this admission, A1c 7.1. She was not started on metformin due to acute pancreatitis. Prior to discharge she was tolerating soft diet and pain was well controlled on oral medications. She was medically and vitally stable for discharge.
Fever to 103.5.  Localized swelling and redness at injection site.  Macular rash on trunk.
Vomiting Sickness. Fever. Shaking chills. Muscle pains. Headache. General decline. Lack of appetite. It was as if I had the Virus again. The virus hit me last September. Symptoms lasted 24 hours.
low grade fever 1wk p/vax;by 31OCT98 had mild gait instability which progressed hosp  6NOV98 @ hosp;dec reflexes, weakness of extremities, painful tingling;dx GBS has had 5 plasma exchange;
This spontaneous report was received from a medical assistant concerning multiple unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history were not provided. It was reported that, on unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 Lot #: M023169, expiration date: 13-JUN-2018 (strength, dose and route not provided), which had a temperature excursion of 1.9 Celsius Degrees for 17 minutes. It was reported that the temperature excursion was detected with a data logger and that the vaccines had no prior excursions. There were no concomitant medications and adverse effects reported. No product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested.
Menstrual Cycle Changes immediately following vaccine. The day after receiving the vaccine my period came early. it was extremely heavy the very first day and dibilitating and uncontrollable. The next 3 days I had absolutely no bleeding. 4 days post vaccine I started bleeding again lightly and have been bleeding ever since. I am now 8 days post vaccine still bleeding lightly.  My normal menstruation occurs every 28 days and lasts 3 days. My menstrual cycle has not changed or become irregular in any way in over 10 years.
At 2:00am on 4/26/07 patient woke up with a severe sore throat. She experienced chills and pain in lower extremities(legs). She did not take temp so unsure if she had fever. When she woke up later in am she felt like she had the flu. She experienced dizziness, headache and weakness in her legs. Called Dr. on 4/28/07 because she was not getting any better. Dr. could not see her that day so patient made an appointment for Mon 4/30/07. At that point in time, still had some weakness in her legs and patient still felt very bad. Dr. proceeded to do a strep culture on her. The strep culture came back negitive. Patient still complaining of slight headache as of today,but most of the other symptoms have subsided. Patients denies of ever having symptoms like this prior to a vaccination. Patient states that in 2003 she was given a Tetnus-Diptheria only, and the only side effect she had was a sore arm.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 23-DEC-2010 the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine 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 or about 11-NOV-2014, the patient was treated by a physician for a blistering vesicular outbreak, that was diagnosed as herpes zoster dermatitis. 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 direct and proximate result of these malfunctions, 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.
Report 2001018011-1 describes pain at the injection site in a pt who rec'd hepatitis B vaccine (Engerix-B). Medical history, concurrent conditions, and concurrent medications were not specified. The pt had no illness at time of immunization. On 11/1/99, 02/02/01 (R deltoid), and 7/13/01 (IM, L deltoid) , the pt rec'd her first, second, and third 20mcq dose of Engerix-B, respectively. Within hrs after receiving her third injection of Engerix-B, the pt experienced pain at the injection site, and numbness and tingling of her left ring and fifth fingers. These events persisted on 7/16/01, and she reported them to her manager. At that time, she also complained of swelling and warmth at the injection site, headaches, and pain in her neck and back. The pt was sent to the ER for evaluation on 7/20/01. The ER physician prescribed a rapidly-tapering course of methylprednisolone (Medro DosePak). On 8/2/01, the injection site warmth had resolved. The pt continued to complain of cramping in the fingers and neck pain. She was referred to an orthopedic surgeon. The most recent information was rec'd  on11/8/01. The pt was under care of 2 physicians. She was initially treated with dexropropoxphene acetaminophen (Darvocet N) and an unspecified muscle relaxant. The pain persisted, and she was treated with gabapentin (Neurontin) the dosage was initially 100mg daily and was increased to the current dosage of 400 mg 3 times daily. The pt does not feel she is improving and states she has pain all the time at the injection site. The pain radiated underneath the mid arm and on down to the little and ring finger. The outcome of the other events were not specified. The pt was cleared for light duty, but could not lift anything heavier than 5 pounds. As a result, she worked part-time and her job duties were changed. Because it resulted in job restrictions, the pain at the injection site is considered to be incapacitating. Therefore, this report has been reclassified as serious.
Within 3 to 5 min of vaccine I turned fire red, was sweaty and hot for 20 to 30 minutes. Took Benadryl and it calmed down.
Fainted approx. 20 hours after receiving dual vaccines of Bivalent booster and flu shot.  Prior to fainting felt dizzy, and lightheaded.  Fell straight back and hit head on the floor.  Remained "unconscious for about 5-7 seconds gasping for air.  Took about 1 hour for them to not feel dizzy/nauseous etc.
PATIENT CALLED DESCRIBING HAVING A MIGRAINE HEADACHE WITH LIGHT SENSITIVITY, AND NAUSEA.  SHE ALSO STATES THAT NO OTC MEDICATIONS HELPED WITH ALLEVIATING THE PAIN AT ALL
Post menopausal - no bleeding for one year - woke up morning after shot to spotting - been going on now for months.  Getting tests done.
rashes on chest/ rashes on abdomen/ rashes on back/rashes on neck; Headache; chills; had a fever of 99.7; legs hurting,arms hurting; back hurting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (legs hurting,arms hurting), BACK PAIN (back hurting), RASH (rashes on chest/ rashes on abdomen/ rashes on back/rashes on neck), HEADACHE (Headache) and CHILLS (chills) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sulfonamide allergy. Concomitant products included PROBIOTICS NOS for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (legs hurting,arms hurting), BACK PAIN (back hurting), HEADACHE (Headache), CHILLS (chills) and PYREXIA (had a fever of 99.7). On 13-Mar-2021, the patient experienced RASH (rashes on chest/ rashes on abdomen/ rashes on back/rashes on neck). The patient was treated with PARACETAMOL (TYLENOL) on 12-Mar-2021 for Adverse event, at a dose of UNK dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 13-Mar-2021 for Adverse event, at a dose of UNK dosage form. On 13-Mar-2021, PAIN IN EXTREMITY (legs hurting,arms hurting), BACK PAIN (back hurting), HEADACHE (Headache), CHILLS (chills) and PYREXIA (had a fever of 99.7) had resolved. On 14-Mar-2021, RASH (rashes on chest/ rashes on abdomen/ rashes on back/rashes on neck) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Body temperature: 99.7 (High) 99.7,Fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Narrative:  Patient received two doses of covid vaccine while on hospice for HCC. Death appeared progressive of disease. No further details of death noted. Reported per network guidance.
HSV BREAKOUT (SMALL LESIONS STARTED TO DEVELOP RIGHT POSTERIOR LOWER AND BACK OF JAW, FEVER, EXTREME FATIGUE, BODY ACHE, FEELING NAUSEOUS); PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included hsv1, and concurrent conditions included spondylytis, and rheumatoid arthritis, and other pre-existing medical conditions included patient had a strep test, which was negative. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-MAR-2021 10:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAR-2021, treatment medications included: naproxen, and valaciclovir hydrochloride. On 06-MAR-2021, the subject experienced pain at injection site. Laboratory data included: Body temperature (NR: not provided) 102 F. On 11-MAR-2021, the subject experienced hsv breakout (small lesions started to develop right posterior lower and back of jaw, fever, extreme fatigue, body ache, feeling nauseous). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain at injection site on 10-MAR-2021, and the outcome of hsv breakout (small lesions started to develop right posterior lower and back of jaw, fever, extreme fatigue, body ache, feeling nauseous) was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required per standard procedure as the case is assessed as non-serious.
A non-serious spontaneous report of administration of expired product was received from a registered nurse concerning a 38-month-old male who received FLUMIST. The patient is one of 16 pediatric patients who was administered expired product with six patients receiving the vaccine on 31-Dec-2008, three on 02-Jan-2009, six on 05-Jan-2009 and one on 06-Jan-2009. Neither the patient's medical history nor concomitant medications were reported. The patient received the FLUMIST on 31-Dec-2008, which expired on 30-Dec-2008. All the expired FLUMIST vaccines were part of the 300 units with same lot# delivered to the pediatric clinic on 21-Oct-2008. All the vaccines were kept in one refrigeration equipment in the clinic and only immunization nurses who work on rotation give the vaccines. The clinic did an inventory of the FLUMIST vaccines on 06-Jan-2009 and it was discovered on that day that expired FLUMIST were given to the 16 patients. There was no adverse event associated with this medication error as of 15-Jan-2009; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case in submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Additional information received on 15-Jan-2009 and incorporated into the narrative: patient's demographics and outcome of adverse event.
This case was reported by a physician via sales rep and described the occurrence of sleepiness in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced sleepiness and malaise. On an unknown date, the outcome of the sleepiness and malaise were unknown. It was unknown if the reporter considered the sleepiness and malaise to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported however; the patient was in his 70s. The patient experienced sleepiness and malaise for 24 hours. This case has been linked to the case US2018GSK198461, reported by same reporter. The reporter agreed to be contacted for follow up.
Information has been received from a 60 year old female office manager who on 12-JAN-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (lot # 669263/1361Z). Later on 12-JAN-2011 the patient experienced redness, soreness, warmth and a knot at the site of injection site that lasted 2 weeks. She did not receive treatment. She did not develop a rash. At the time of reporting, the patient's outcome was unknown. Additional information has been requested.
On October 12 one hour after the shot, I developed severe pain in my legs and lumbar spine. I had hives on both of my arms. Itching from head to toe. I am still having severe pain in my spine and legs. I called my primary care doctor to ask if I should get the second shot.   He said wait until the symptons go away. I went to an orthopedic doctor also, who said it could be an inflammatory reaction. At this point, I still have severe pain in my back and legs causing difficulty walking.
She had the covid vaccine 7/17/21 Moderna. 022C21A.She started to feel bad around 7/30/2021, with elevated BP, increased nerve pain, drooping face, severe headache, and muscle pain. After her last visit she took claritin on 8/2/21, then on 8/3/21 when she took her lyrica and had really weird flare of her neurologic symptoms. She stopped the claritin and continued to be tired and achy. Then she started with a fever as well as more severe nerve pain, her neck went into spasm. She had chills and her body felt like it was on fire. She had radiating electrical like pain down her neck and back. She also had fever 99.7 and 100.7 starting August 3rd. The fever continued until now. She also had periods of severe tremors which made it impossible to use the computer. The headache is ongoing but improving slightly. She did see her regular doctors yesterday, he was at a loss.
Sore are pain can't left above head can't lay on it hurts bad with dot where shot was given.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 10-FEB-2015 the patient was inadvertently vaccinated with ZOSTAVAX (dose and frequency were not reported) (lot # J011333 and expiry date: 13-DEC-2014) which passed expiry date. No adverse effects were reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one of the two reports received from the same reporter. Additional information has been requested.
pt recv vax 18AUG97 130PM in rt deltoid area began to swell 19AUG97 in PM; pt c/o arm warm to touch & burning;area about the site of an orange;referred to MD for further eval;
Information has been received from a physician concerning a female who was vaccinated intramuscularly with a 0.5 ml first dose of Gardasil.  Subsequently shortly after injection the patient developed a rash.  Unspecified medical attention was sought.  At the time of the report the patient's outcome was unknown.  Additional information has been requested.
Pt was on mother's lap feeding with a bottle and then started jerking and shaking his head a little bit, shaking a foot and eyes rolled back into his head.
Flu like symptoms; Inflammation; Chills; A spontaneous report (United states) was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills, flu like symptoms and inflammation.  The patient's medical was not provided. No relevant concomitant medications were reported.  On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced chills, flu like symptoms and inflammation.  Treatment for the event included Benadryl.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events chills, flu like symptoms and inflammation was not reported.; Reporter's Comments: This case concerns a female of unknown age who experienced nonserious unexpected events of influenza-like illness and inflammation along with and a nonserious expected event of chills.  The events occurred with unknown latency after the first dose of mRNA-1273. Treatment included Benadryl. Event outcome not reported. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Received shots stood up for 5 min after receiving Hep B #3 ambulated across room and passed out while conversing with mother. Assisted to floor per nurse, leg rolled to side lying position, unresponsive approx. 3 min. Sat up and began talking asking what happened.