chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Screamed approx 9hrs, began about 12hrs p/vax; fussy, poor appetite the next 24hrs, then back to normal activity;
CLIENT IMMEDIATELY REPORTED A TINGLING SENSATION AND SWELLING  ON PARTS OF HER TONGUE
Patient reports feeling warm sensation and tenderness to injection site area 4 hours after administration by MOA.  The area proceeded to become painful and formed an area of enduration.  Assessed today 12/8 site is approximately  4x4 inches erythema, area feels hot and enduration of most area of redness; after administration site gave her  depomedrol at 9am.   Dr. evaluated her at 2:30 and was given Rx for keflex 500mg TID for 7 days and topical steroid.  She was also administered 1gram of rocephin IM at 3PM Observed for reactions to antibiotic, no reaction after 15 minutes of observation
Bright red, splotchy, flat, blanchable rash limited only to the breasts. Mildly itchy. Self limiting and lasts only a few days before resolving. Initially occurring the day after Moderna #2 and Moderna #3 injection. Same exact breast rash has occurred 3 times the day after viral gastroenteritis illness - negative home COVID test. Breast rash 5 times total, with Moderna twice and with GI illness 3 times.
SHE GETS A SHARP PAIN IN DIFFERENT AREAS OF HER BODY VERY SHARP LIKE A NEEDLE  IN HER LOWER JAW AND THE ARM HER SHOT WAS IN AND HER FOOT AND HER LEG DIFFERENT TIMES OF THE DAY 5 TIMES IT HAPPEN TODAY
Shingles after receiving both Shingrix/Suspected vaccination failure; Shingles 1st outbreak/the second case of shingles was diagnosed yesterday on 13-Feb-2023; This case was reported by a other health professional via call center representative and described the occurrence of vaccination failure in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 24th September 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 23rd June 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 14-Feb-2023 Reporter's Comments: The reporter reported two cases of shingles in a patient who came to their clinic.  The reporter reported that the patient said she had a case of shingles after receiving both Shingrix vaccines in unknown deltoid, but did not know the date of the first outbreak of shingles.  On 13th February 2023, the patient was diagnosed with second case of shingles, by her supervising health care professional.  The shingles was on the right side of the patients back. The reporter consented to follow up.  Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory confirmation of shingles were not provided.
caller states the pt lost hearing in his right ear.  pt went to his audiologist and his test shows his hearing is 0-5 percent hearing loss.  He was referred to Doctor and his appt is in 2 weeks.  He is on high dose of prednisone taper meds.
This spontaneous report was received from a registered nurse referring to a 17 year old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 21-OCT-2015, the patient was vaccinated with the first dose of GARDASIL 9 (strength, dose, route, lot # and expiration date were not reported). Two months after, on 21-DEC-2015, the patient received the second dose of GARDASIL 9 (strength, dose, route, lot # and expiration date were not reported). A third dose of GARDASIL 9 (strength, dose, route, lot # and expiration date were not reported), was administered on 14-APR-2016.  On 05-FEB-2018, the patient was vaccinated with a fourth dose of GARDASIL 9 lot # N017686, expiration date on 02-FEB-2020 (strength, dose and route were not reported). All vaccines were administered for prophylaxis. No adverse effects were reported.
This spontaneous report was received from a 75 year old male patient regarding himself. Patient had no drug reactions or allergies. On 04-JAN-2013, the patient was vaccinated with a dose of PNEUMOVAX23 (lot # H015780, expiry: 11-JUN-2014, route and dose not reported). No concomitant medications were reported. On 14-JAN-2013, the patient experienced some adverse experiences. The patient's baseline temperature was normally 97.6 degrees F. However, after receiving PNEUMOVAX23, his temperature moved up to 98.6 degrees F with frequent daily spikes to 99.2 degrees F. In addition, the patient has constant fatigue and feels very lightheaded. No treatment was received. Patient sought medical attention (unspecified). No laboratory diagnostic tests were performed. The patient also reported that in 2003 he had received the pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) before, but was not sure about the manufacturer or name of the product. The outcome of the events were reported as not recovered. The relatedness of the events with PNEUMOVAX23 was unknown. This is one of 2 reports received from the same source. Additional information is not expected.
Patient was given DTaP at age 7 years. No reaction to vaccine has been documented.
Expired vaccine given.  Vaccine Expired on 5/26/21. 1 Dose given on 6/5/2021
This spontaneous report as received from a physician via a company representative refers to a 15 year old female patient. Patient was not pregnant. The patient had no pertinent medical history. Drug reactions/allergies were none. On 26-JUL-2013 the patient was vaccinated with GARDASIL, intramuscular (dose, dosage, lot not reported). Concomitant therapies included YAZ. On an unknown date of August-2013 the patient experienced headache, nausea, heart palpitations, dizziness and trouble with balance after receiving the vaccine. The patient has had difficulty standing (disability) and trouble walking (disability) and because of this has been out of school for 2 months. The patient saw the physician and sought medical attention. It was also reported that the patient will not continue with the series. The outcomes of the reported events were unknown at the time of the report. The events difficulty standing and trouble walking were considered to be serious due to disability. Additional information has been requested.
presenting today for worsening shortness of breath.  She has a history of sleep apnea with COPD overlap using CPAP at night with supplemental oxygen.  She was diagnosed with COVID approximately 5-6 days ago by home tests after having multiple sick contacts
This spontaneous report as received from a Registered Nurse refers to an unspecified number of patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date, the unspecified number of patients were vaccinated with GARDASIL (dose, route of administration, lot # and expiration date not reported). The patients received a dose of GARDASIL that was stored improperly. There was no adverse effects reported. Additional information is not expected. This is one of several reports received from the same reporter.
Itchy rash that started on right shoulder of injection site. The site was fevered and the rash was itchy and hurt to touch. The rash spread down the chest to the abdomen. The further away from the site the rash got, the less itchy and painful it was. The rash was gone the next day.
Noticed swelling around site and around arm 2 days after getting vaccinated. Swelling began moving down to elbow area, also had some tenderness and redness. Started to get better 11/16/03, 11/17/03. Advised warm soaks and call if no better 48 hours. Tylenol/Advil prn.
Chest tightness in the center of my chest, hard to breathe, shortness of breath, and severe nausea and headache.
Immediately experienced a headache and sore arm at the injection site. Within 12 hours experienced chills. The chills lasted for a day and a half as well as body aches were present the next day and lasted for a day and a half.
Significant Hematochezia. Discussed with a GI specialist. Sent to emergency room for evaluation and treatment.
Moderna vaccine was administered outside of facility - reported by patient ? NO LOT NUMBER WERE SUPPLIED --------------------------------------------------------------------------------------------------------- J96.00 ACUTE RESPIRATORY FAILURE 12/21/2021 ASTHMA, UNSPECIFIED
Patient said the morning after the vaccine she was having body aches and the next day a rash and swelling developed on the arm below the site of injection.
Redness, swelling on left arm deltoid area. Pain two days- Tylenol - ice to effected area.
her daughter had it worse; This is a spontaneous report from a contactable consumer (parent). A female patient of an unspecified age received bnt162b2 (BNT162B2, solution for injection, Lot number was not reported, NDC number was not provided) dose number unknown via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medication was not reported. Investigation assessment was not provided. On an unspecified date the patient experienced her daughter had it worse. Reporter reported that she had her first Pfizer COVID-19 vaccine shot and was ready to get her second shot, but she got the COVID. She said that she had her appointment for on the second then on the first she tested positive. Caller said something about her husband and daughter two days later and a week after. Unable to clarify with caller due to poor sound quality and caller speaking over call handler. She said her question is can she get the second dose of the vaccine still and how soon she can get it. She said her husband is 84 and she was 70 and they had very mild symptoms, so she thought the vaccine helped them, which her daughter had it worse. Caller said she had been on the phone three hours now and she was tired. She said she was afraid to provide further information on this call since she did not know if it was Pfizer. Address: Caller began to provide address then declined to clarify street name, documented as provided. Caller declined to complete a report. No further details captured, reported, or documented at this time. The clinical outcome of the event was reported as unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Symptoms began on 05/19/2022 with lots of mucus. I tested positive with a home test on 05/20/2022. I had been exposed on a Thursday 05/12/2022. On 05/20/2022 I woke up and my lungs were filled with mucus, and I knew I was sick. Despite my lung being full of mucus my Pulse Ox was 97. I tested positive that morning and spoke to my doctor and she prescribed an anti-viral which I started that night. Through the course of the infection. I did not feel good, I was tired and I had no energy, I was literally in bed for 5 days.
pt recv vax & mom states pt fussy for 1-2 days;mom felt this was d/t sore legs;10 days post vax pt had 5 grand mal sz according to mom;t100;pt taken to ER, tx w/valium;mom stated many test were done but no abnormalities were found;
Vaccine administered about 3PM.  About 11PM got out of bed and experienced vertigo which occurred several more times during the night.  Since I had experienced labryntitis in the late 1980's, I was cautious with my movements until Friday, the 11th when I sought help at the Health Center.  I received a prescription for MECLIZINE 25MGM TAB,(1/2) and DIAZEPAM 5MG TAB (1/4)for my trip home. When back in Reno 10/14, I experienced explosive diarrhea and vomiting for about 5 hours.  In a few days with no other symptoms I gradually returned to normal. On this day, 10/21 I have residual symptoms.
Fever 37.5C, fatigue, headache, swollen lymph nodes, back of the neck pain, stomach ache, pale complexion. Missed school, stayed in bed at home until symptoms resolved.
After the 2nd dosage I had antibody testing done and was negative for antibodies; This a spontaneous report from a contactable consumer. A male patient of an unspecified age received first and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.  After the 2nd dosage patient had antibody testing done and was negative for antibodies. This was 2.5 weeks after 2nd dosage. Outcome of event was unknown.   Information about Lot/Batch number is requested.
Ten days after receiving the Moderna booster shot, I developed hives across my entire face and body. I visited an ER on 12/18/2021 to seek treatment. 6 weeks after the booster, I am still struggling with full-body hives which are affecting my everyday life.
received covid positive diagnosis on 09/01/21 and was released to return to work on 09/08/21 , received first covid vaccine Pfizer  on 09/08/21 around 2 pm or so, I think, about 4 hours or so later, got excrutiating headache and started vomiting, vomited off and on  through Friday 09/10/21 , Friday night around 9 pm or so , was still vomiting / dry heaving at this point, was taken by ambulance to the ER at Hospital and was give Zofran  in the ambulance en route and then was given IV fluids and Reglan and  steroid and Tramadol through the IV after about 4 hours in ER, vomiting subsided .
Patient woke up in the night with chills and was shaking uncontrollably.  She also had intense muscle aches in her limbs and a very sharp headache.  These symptoms lasted for about an hour and then I was able to get her to calm down and fall asleep.  When she woke in the morning, she still had soreness in her limbs.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Oct2023 at 09:00 as dose 1, single (Batch/Lot number: unknown) at the age of 39 years, in left leg for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 30Oct2023 to 04Nov2023.  Additional information: No Known allergies. No Other medical history.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a pharmacist concerning an adult male pt who two to four weeks ago on an unspecified date in Sept 2005, was vaccinated SC with a 0.5mL dose of varicella virus vaccine live. On 14Oct05 he presented to his physician with was seems to be Bell's palsy. No other information was available regarding the adverse event or the pt's outcome. There was no product quality complaint reported. The pt sought unspecified medical attention. Additional information has been requested.
Swelling and aching of right elbow. Seen at emergency center, noted small laceration below elbow. Dx - R/O MRSA in wound re-poss source of swelling.
Initial report received from a health care professional in the USA on 15, March 2007. A 17 year old female patient developed joint and muscle pain, diarrhea and an erythematous papular full body rash, within 12 hours after she received Menactra (lot # U2002AC) intramuscularly in the deltoid on 05, February 2007. She was seen and evaluated by a doctor on 14, March 2007. Stool cultures and CBC were completed, the results were not available. At the time of the report, the symptoms still persist and the patient was not recovered. This case has the same reporter as case 2007-00798. Follow up information received on 22 June 2007 from a health care professional. Illness at the time of vaccinaiton included myalgia, pharyngitis, cough and headaches. The patient had also been exposed to viral meningitis. She did not follow up for the CBC and stool cultures. In return visits on 09 February 2007, 17 March 2007, and 21 May 2007 (all for pharyngitis), the patient did not complain of symptom due to the immunization. However, in a conversation with the patient's mother on 05 June 2007, the patient stated that "she still has joint pain in her knees and rash off and on." This case has th esame reporter as 2007-00708.
Rt elbow joint-extreme pain. Started 2 hrs after Moderna 2nd vaccine. It has been 4 days and pain has not resolved nor responded to Aleve (2). Very similar to arthritis joint pain when arthritis is exacerbated.
This spontaneous report was received from a Nurse practitioner refers to a 4 month old patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 22-FEB-2019 (also reported as 21-FEB-2019) the patient was vaccinated with PNEUMOVAX 23 lot # R021045, 0.5 milliliter, intramuscular in the right thigh for prophylaxis accidentally instead of PREVNAR 13. The outcome of the events were reported as recovered.
The pt developed an onset of headache, photophobia and eyelid twitching about 5-6 hours, post vax. No history of similar symptoms.
Turned pale within 10 minutes after injection. Continued on + off X 3 hours crying. Redness at site. Returned to office. Sent to ER to evaluate and monitor.
Post injection raised spot on L upper arm measuring aprox. 10cm.  Hot to touch, painful. no range of motion difficulties, 3 days post. small raised area approx 5 cm. swelling going away
pt recv vax & was found to be pregnant (LMP 15DEC95);pt had a miscarriage;there were no complications assoc w/miscarriage, according to pt;
After receiving vaccines patient began vomiting at 1036, blood pressure taken at the time 67/42 HR 66. Had the patient lay down with legs up in a chair, at 1040 had the patient sit up, patient states he is "feeling better". BP 83/56 HR 85 at 1047 patient ambulated back to chair BP 104/73 HR 77. Patient is sitting up eating crackers and drinking coke at this time. Patient ambulated out of clinic with his grandmother.
HPI: Patient reports mild substernal nonradiating, non-positional chest discomfort/pain and dizziness that started 10 minutes after receiving 2nd dose of Pfizer (at 11:30 AM). Denies worsening of pain with upper extremity movement or when presses on it. Reports she has never had these symptoms before and did fine with first dose.    Pt denies swelling of the face, throat tightness, difficulty swallowing, itching of the skin, SOB, or CP. Pt denies n/v, HA, changes in vision, slurred speech, n/t/weakness in extremities. Patient reports h/o hypothyroidism, depression, migraines, and duodenitis. She takes Synthroid QD, Effexor QD, Sumatriptan PRN, and unspecified antacid or PPI PRN (no flares > 6 months). H/o facial/body swelling w/ PCN and Vancomycin (last reaction 11/2018 during labor). Denies h/o COVID-19 infection.   Exam: GEN: Alert and oriented x 4, in NAD HEAD: NCAT EYES: PERRL, EOMI ENT: Ears normal, Nose normal, OP normal, no evidence of angioedema NECK: Supple, without LAD.  CV: RRR, no m/r/g PULM: Clear to auscultation bilaterally, no accessory muscle use ABD: deferred SKIN: vaccine site at left deltoid without edema, erythema, bleeding, or discharge. No rashes, skin warm and dry MSK: FROM, MS 5/5 NEURO: Alert and oriented x 4, CN 2-12 grossly intact, no facial droop, normal speech, NVID, strength 5/5 in bilateral UE, no ataxia, gait steady   Clinical Impression/Field Tx: Suspicion for anaphylaxis low due to no face/lips/eye swelling, no SOB or difficulty swallowing, and no rash/itching of the skin. No hemodynamic instability seen as patient?s vital signs were WNL. Patient given water and grape Jolly Rancher sucker at and felt 40-50% better (in regards to chest pain and dizziness) at 12:15 PM. EMS called due to concerns about chest pain and arrived at 12:16 PM.    Medications administered: None   Disposition:  Following over 30 minutes of observation, patient?s symptoms improved. Patient evaluated by EMS in ambulance - EKG and further exam normal. Per EMS, patient left AMA - husband drove her home in their car. Pt was advised to drink plenty of water, eat a substantial meal, and take it easy for the rest of the day. She was also instructed to visit the ER if she felt SOB, swelling of the face/lips/eyes, throat tightness, difficulty swallowing, itching of the skin, vision changes, onset of severe headache, or any other concerning symptoms. Pt indicated understanding of instructions.
suspect vaccination failure; I got both shots and I've had shingles six times since; This case was reported by a consumer via interactive digital media (Facebook) and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and 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 and Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient herself/himself. The age at vaccination was not reported. The patient stated that he/she received the both shots and had shingles six times since. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Did not mix DTaP-IPV component  with Hib component pf Pentacel. Only DTaP-IPV was given of the Pentacel dose. Hib was given separately.
Axillary pain and swollen nodes, afebrile.  Patient took ibuprofen. Pain is moderate and patient was told to contact physician if no improvement or worsening condition within 72 hours.