chrisvoncsefalvay/vaers-outcomes huggingface dataset:
felt fine yesterday,started experiencing side effects,the side effects come and go; left arm is "very warm"; dizziness,lightheadedness; fatigue; feels terrible; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (felt fine yesterday,started experiencing side effects,the side effects come and go), SKIN WARM (left arm is "very warm"), DIZZINESS (dizziness,lightheadedness), FEELING ABNORMAL (feels terrible) and FATIGUE (fatigue) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced FEELING ABNORMAL (feels terrible). On an unknown date, the patient experienced VACCINATION COMPLICATION (felt fine yesterday,started experiencing side effects,the side effects come and go), SKIN WARM (left arm is "very warm"), DIZZINESS (dizziness,lightheadedness) and FATIGUE (fatigue). At the time of the report, VACCINATION COMPLICATION (felt fine yesterday,started experiencing side effects,the side effects come and go), SKIN WARM (left arm is "very warm"), DIZZINESS (dizziness,lightheadedness), FEELING ABNORMAL (feels terrible) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       VACCINATION COMPLICATION (felt fine yesterday, started experiencing side effects,t he side effects come and go.  felt fine yesterday was on 30/Mar/2021.
After inj pt walked and stood by the door pt brother had anH1N1 inj too after disposing of the 2nd inj in shurps container. Pt fainted Pt slid to the left and hit his head on the door knob. Pt was very weak and pail pt was helped to a chair in the room, then helped to a wheel chair, then helped to a bed where his feet were elevated and a cold compress was put on his head and he layed down for 20 min.
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 02-JUL-2015, the patient was vaccinated with the third dose of improperly stored oral, ROTATEQ (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Fever, fatigue, headache; joint/muscle pain that has been ongoing for over 30 days. Treatment: patient was advised to continue Tylenol/Motrin PRN and hydrate/rest. Outcome: Fever, fatigue, headache subsided, but joint/muscle pain persisted-patient given exemption by MD, Acting Medical Director and advised to have an MMR titer drawn to see if there was any immunity retained.
This spontaneous report was received from a physician via medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 07-JUL-2016, the patient received the second dose of GARDASIL (lot# reported as M005714, expiration date: 03-OCT-2017, dose, route of administration and injection site were not provided) one week earlier. No adverse reactions were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
itchiness on the palms of his hands; rash developing on his neck and chest/rash around his waist.; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness on the palms of his hands) and RASH (rash developing on his neck and chest/rash around his waist.) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced PRURITUS (itchiness on the palms of his hands). 27-Feb-2021, the patient experienced RASH (rash developing on his neck and chest/rash around his waist.). At the time of the report, PRURITUS (itchiness on the palms of his hands) and RASH (rash developing on his neck and chest/rash around his waist.) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  Reporter stated that the patient takes lots of medications but someone takes care of them for him. Patient self treated the events using cortisone cream with mild relief but  stated that itchiness comes back.
Patient received pfizer vaccine on 1/27/21, 2/17/21, and 11/2/21. Presented to ER on 4/19/22 and tested positive for COVID19.presents to ED from an independent living facility with fever and cough.  Afebrile while in the ED.  She is hypertensive.  Daughter is providing much of the history given history of severe dementia.  Patient is noted to have a mild leukocytosis and a lactic acid elevation likely more so in response to volume depletion as does not appear septic.  She has a UTI and tested +ive for COVID.  She has been fully vaccinated and boosted against COVID.  CXR is unremarkable.  She remains on RA.  She again is hemodynamically stable.  She will be admitted at this time for further management.  Received ceftriaxone and doxy.  Discharged on 4/21/22 on cephalexin.
Patient notified me this morning that his clavicle (on the same side as injection) is "very swollen." Patient was advised to follow up with his PCP and report event through V-Safe.
Information has been received from a 62 year old female patient with high cholesterol and a history of thyroid disorder and no drug reactions/allergies who on 20-DEC-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (lot number unknown). Concomitant therapy included LEVOXYL, simvastatin (manufacturer unknown), calcium (unspecified), estrogens (unspecified) (reported as hormone replacement), ubidecarenone (reported as coQ10), vitamins (unspecified) (reported as "multivitamin") and omega-3 marine triglycerides (reported as fish oil). On 26-DEC-2010 the patient had broken out in one blister on abdomen. The patient wanted to know how long she needed to stay away from her grandchildren once she received ZOSTAVAX (Merck) shot and also how she should treat the blister on her abdomen. Laboratory test blood work was performed, no results provided. The patient did not seek medical attention. There was no treatment given for the adverse event. The patient's blister on abdomen persisted. Additional information has been requested.
Anaphylaxis (dyspnea, stridor, drooling, tongue swelling); This is a spontaneous report from a non-contactable other Health Care Professional. A 74-year-old female patient received second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, Solution for injection, lot Number: EN6204 and expiry date was not provided) and received first dose of BNT162B2: both were via an unspecified route of administration, on an unknown date, as SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, during her 30 minute waiting period after the injection, the patient began to experience hoarse voice. She denied rash, difficulty breathing, difficulty swallowing, dizziness, facial swelling, lip swelling and tongue swelling. Patient complained of chest tightness (she later developed chest tightness when she was in the bay prior to epi-pen administration). Patient denies chills, fever, malaise/fatigue, facial swelling, cough, shortness of breath, wheezing, rash, hives, eczema, itching of skin and abdominal pain. The patient experienced anaphylaxis (dyspnea, stridor, drooling, tongue swelling) with early onset of presumed anaphylaxis that responded well to epi-pen. Patient sent to ED for closer observation/treatment by ambulance. Treatment was good, she started to have return of symptoms when AMR was leaving with her. The outcome of the events was reported as unknown.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile and close temporal association, the event of Anaphylactic reaction is assessed as related to the suspect vaccine BNT162B2.
Axillary swelling or tenderness; Axillary swelling or tenderness; Headache; Chills; Muscle ache; Pain at the injection site; This is a spontaneous report from a non-contactable consumer or other non HCP (patient). A 47-year-old non pregnant female patient received bnt162b2 (BNT162B2, formulation; Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 09Feb2021 14:00 (Batch/Lot number was not reported) as DOSE 2, SINGLE (at the age of 47-year-old) for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The medical history was none and no known allergies. Concomitant medications included fish oil (OMEGA 3 [FISH OIL]) and zinc (ZINC) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccine included the patient received first dose of bnt162b2 (dose number: 1, administration time: 10:00 AM, vaccine location: Left arm) for covid-19 immunisation on 16Jan2020. The patient experienced pain at the injection site, axillary swelling or tenderness, headache, chills and muscle ache on 10Feb2021 at 04:00. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events was reported as recovering.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
5yo MALE pt received his 1st pfizer dose on 07/01/22 and his 2nd Pfizer dose on 07/22/22. Based on his age, his booster dose was supposed to be due in 5 months, Dec 2022.  However, Pt received booster dose today, 09/16/2022, 3 months too soon.  Infectious MD was notified.  Per Dr. : I do not anticipate problems but the patient should monitor for the same signs and symptoms that they would after the regular dose, and contact their PCP with any concerns. The PCP will reach out to pediatric MD if there are further questions. Contacted pt's mom, states that pt is doing well so far with no side effects or symptoms from booster dose.
1st day: Nausea and vomiting; diarrhea; fatigue; chills; rash approx 3x4x2 cm triangle, erythematous, non-raised, painful, circumscribed, hot to touch and hard to palpation 2nd day: Rash, approx 4x5 cm rectangle, erythematous, painful, non-raised, circumscribed, hot to touch and less hard to palpation 3rd day: Rash, approx 3x4 rectangle, improved since prior day, less erythematous , less painful,and less hard, occasionally itchy 4th day:  Noncircumscribed erythema on the upper R arm, still warm to touch, itchy (today)  Treatment: Benadryl 25-50 mg q8-hours
Pt vaccinated with DTP/MMR/OPV experienced generalized convulsion with temp of 105F 3 1/2 - 4 hrs after immunizations.
MOM CALLED THIS MORNING STATING REDNESS-BURNING & ITCHING AT BOTH INJECTION SITES. STARTED THE DAY AFTER VACCINES WERE GIVEN. MOM MEASURED RIGHT THIGH 3"X3" AND LEFT THIGH 4"X3" REDNESS.
Information has been received from a medical assistant referring to 5 unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored ZOSTAVAX (lot # M039453 expiration date: M039453; dosage, frequency and route unspecified) for prophylaxis and sterile diluent (lot and expiration date unknown). No adverse effects were reported. Temperature was 6 degree F to 14 degree F. Time frame was 30 minutes. Previous temperature excursion was reported as VARIVAX 15 degree F to 46 degree F for2 hour. This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1707USA010585:
Few months afterwards, onset of optic neuritis then developed progressive neurological symptoms consistent with multiple sclerosis. Progressed to point ot. now completely describedly. Doc 212572, states that they have no way of obtaining the missing infos.
This spontaneous prospective pregnancy report was received from a physician, concerning a 22 year old female patient with irregular periods. The patient had no known drug reactions/allergies. On 01-MAY-2013 and 19-JUL-2013, the patient was vaccinated with a first and second dose of GARDASIL, 0.5 ml IM, left arm; respectively. On 11-NOV-2013, the patient received the third dose of GARDASIL, 0.5 ml IM, Lot # H019206, expiration date on 03-APR-2015, left arm. It was reported that the patient who was recently vaccinated with her third dose of GARDASIL was pregnant (LMP: 15-OCT-2013; EDD: 22-JUL-2014). The patient had thought she was putting on weight so she took a urine home pregnancy test and it was positive. The patient went to the physician's office to confirm the pregnancy. At the time of the report, the patient's outcome and the relatedness between the suspect therapy and event were unknown. Additional information is not expected.
Large, red welt at site of injection that showed up 24-48 hours after injection. Lasted for about one week and then turned into a bruise.  Dizziness and vertigo that started about 5 days after injection. Lasted for at least 2-3 days so far.
Associate received both doses of Pfizer vaccine. First dose on 01/05/2021. Patient then reported symptoms of congestion and cough on 02/23/2021 with a positive COVID test on 03/04/2021.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient. A 59 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Sep2021 (Lot number: 301308A) at the age of 59 years as dose 2, single for Covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose: 15Aug2021 at 11:30, Lot: FO8448 or FD8448, then states it is FD8448, Dosage text: unknown dose, injection in left upper arm), administration date: 15Aug2021, when the patient was 59 years old, for Covid-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 06Sep2021, outcome "recovering", described as "swollen lymph nodes to her left side/lymph nodes that she noticed swollen is more on her left side, on her neck". Therapeutic measures were not taken as a result of lymphadenopathy. Additional information: The reporter stated that she was a teacher, and saw the news about people dying. Has second dose of Covid-19 vaccine on 05Sep2021. After the vaccine she has experienced swollen lymph nodes. She went to the doctor and was told that it was a possible side effect from the vaccine. First dose was more towards the outside of her upper arm and the second dose was more towards the inner side of her left arm. She does not know if it is a coincidence the lymph nodes that she noticed swollen is more on her left side, on her neck. She is curious why is it on that side, is it a coincidence that she noticed the swollen lymph nodes are on the same side she was given the injection. Vaccination Facility Type was pharmacy. Patient had not administered vaccine at military facility. Patient went to an urgent care. No follow-up attempts are possible. No further information is expected.
received pediarix instead of infanrix inadvertently; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 15-month-old patient who received DTPa-HBV-IPV (Pediarix) (batch number 4N2PM, expiry date 28-MAR-2025) for prophylaxis.   On an unknown date, the patient received Pediarix (right thigh). On an unknown date, an unknown time after receiving Pediarix, the patient experienced wrong vaccine administered (Verbatim: received pediarix instead of infanrix inadvertently). The outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 6-Jun-2023 The reporter consented to follow-up. The patient received a dose of Pediarix instead of Infanrix inadvertently, which led to wrong vaccine administered.
Five days after had extreme vertigo on getting up. Nausea too. Still am very dizzy and can't move too fast. Have called my dr. Waiting to hear back.
Day of vaccine: I noticed about an hour after receiving vaccine that a couple areas on tongue felt like it had been burned (like it would feel if it had been burned on hot food or hot coffee). This lasted for a few hours.  Two days after receiving vaccine: slight, very subtle tingling spots over body in morning. In afternoon, some slight tingling on right side of lips and area just above lips.
Vaccine administered from a vial punctured more than 18 hours ago; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered from a vial punctured more than 18 hours ago) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered from a vial punctured more than 18 hours ago). On 11-Mar-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered from a vial punctured more than 18 hours ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
(I am the patient's husband). My wife had an office visit at the Hospital and Clinic facility on 28 December 2016. During that visit she was given a vaccine called Pneumococcal Conj Vaccine 13 Valent IM. Later, around 4PM, (28 December) she experienced chills and feverish feeling, and pain at the vaccine location (left arm). Later, we noticed her face was flushed. Around 10PM on 28 December, we noticed a rash developing on the front of her thighs. At this time we went to the Emergency Department. The diagnosis included vaccination reaction and cellulitis. She was prescribed Clindamycin for the cellulitis. We noticed the rash getting worse on 31 Dec, and went to the Urgent Care at the same facility. She was prescribed prednisone and instructed to report to the emergency room if conditions worsened. We are currently watching her rash condition.
Initial report received from a consumer on 14 November 2013. A female patient whose age at the time of event, medical history and concomitant medication were not reported, had received a dose 2 of FLUZONE (lot number: unknown, route was not reported) in the right deltoid on an unspecified date in 2012. The patient had received dose 1 of FLUZONE (lot number, route was not reported) in the left deltoid on an unspecified date in 2011. On an unspecified date, the patient had got flu with 3x1 inch nodule, hard lump and pain in left deltoid. Laboratory investigation was and corrective treatments were not reported. On an unspecified date, the patient had recovered from events. Documents held by sender: none. Follow-up received from a health care professional on 27 January 2014. The age of the patient was reported as 57 years. It was reported that the patient had received the vaccine in winter 2012, in the right and left upper arm. The event was recovered on its own. The patient does not have any laboratory details, corrective treatment and medical history.
grandma reported pt had temp of 104 & crying; stated pt leg red swollen above knee & did not move leg-cried if a blanket touched the leg;
Recalled Lot  Product was administered; Recalled Lot  Product administered; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B pediatric) (batch number CP23D, expiry date unknown) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-May-2022 Reporter's Comments: The vaccine coordinator reported a dose of Engerix-B from recalled Lot Product was administered to patients. The patients were administered this lot number but no adverse event reported. The reporter inquired what information should they send to patient regarding Engerix recall from back in October 2021. The reporter did not consent to follow-up. Additional Supportive Information: The patient received engerix B from recalled Lot which led to recalled drug administered and drug dispensing error. This is one of 10 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR085028:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085026:Same Reporter US-GLAXOSMITHKLINE-US2022084603:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085025:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085027:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085030:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085031:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085032:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085033:Same Reporter
Patient received #1 dose of Pfizer vaccine today 6/29/2021 at 1:47 pm.  Patient spent 15 minutes in observation room without exhibiting any signs or symptoms of any adverse reaction.  Patient left observation room with parent and siblings and entered elevator near the check in desk of the clinic.  Patient found laying in elevator on floor after staff arrived due to mother calling for help.  Parent reports that patient passed out and fell to ground.  Patient was conscious.  Patient taken to observation room via wheelchair once determined that patient was fully awake.  911 called.   Vital signs obtained at 2:10 pm BP 98/42 P 77 O2 Sat 100%   .  Patient transported to hospital with parent via 911 for further observation.
01-13-2021 C/o syncope and collapse Body aches- Transported per EMS. to ER. Sometime around 10:00 am. Arrival ER . 10:39
HA generalized joint pain, pain behind eyes, sensitivity to light, increased nasal secretions, chest tightness, generalized fatigue SX last 2 1/2 days. Began evening of vaccine. Missed 5 hours of work on 10/12/06.