chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Have occasional chest pains when sitting up breathing normal.; when take a deeper breath it would be more uncomfortable.; This is a spontaneous report from a contactable healthcare professional. A 19-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the left arm on 03Aug2021 at 12:15 (at the age of 19-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, heart problems as a premature baby and premature baby. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously took azithromycin (MANUFACTURER UNKNOWN) on an unknown date and experienced drug allergy. On 03Aug2021 at 13:30, the patient had occasional chest pains when sat up breathing normal and when taking a deeper breath, it would be more uncomfortable. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events had occasional chest pains when sat up breathing normal and when taking a deeper breath, it would be more uncomfortable was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
enlarged L axillary LN, tender. Had fever 101 night of booster. Woke next AM with LN. fever resolved with aleve. No other sx.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant medications and medical histories reported. On an unknown dates, the patients were vaccinated with an improperly stored doses of PROQUAD (lot# L008355 with expiration date 11-SEP-2016; lot# M0101476 with expiration date 01-SEP-2017; dose, anatomical location and route of administration were not reported). It was also reported that an improperly stored sterile diluent (lot# K023007 with expiration date 24-SEP-2017, lot# L017417 with expiration date 02-FEB-2018, lot# L015432 with expiration date 24-JAN-2018, lot# reported as L03221 with unspecified expiration date; dose and route of administration were not reported) was used. No adverse events were reported. Temperature was 49.3 Fahrenheit degrees (F) on 48 hours, 31.2 F for 16 hours and 16.5 F for 2400 hours. There was no previous temperature excursion and no data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Within 15 minutes my face started to go numb.  I was on a Zoom call for work within one hour of 2nd vaccine.  the person i was meeting with sated and i saw the right side of my face droop.  Speech was slurred and I was struggle to complete a sentence.   I had a fever of 101, and was extremely dizzy for 4-5 days after 2nd vaccine.     i had speech deficits for at least two months after 2nd shot.
A non-serious report of administration of expired FluMist has been received from a nurse concerning a 29-month-old male. This case is submitted in accordance with manufacturer's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. Neither medical history nor concomitant medications were provided. The patient recovered FluMist on 12-Mar-2008. The FluMist had expired on 10-Mar-2008. The reporter stated that she recovered 100 doses of FluMist from the program on 22-Feb-2008 and the vaccine expired on 10-Mar-2008. The clinic did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients. The patient had no adverse events at the time the report was received. Neither as of 18-Apr-2008 when the office was contacted for follow-up information. No adverse events were reported. The event has resolved. It was not reported whether or not FluMist was re-administered. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. Follow-up information received 18-Apr-2008 and incorporated into the narrative: no adverse event occurred. This case is linked to following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006659; MEDI-0006663; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006667; MEDI-0006668; MEDI-0006669; MEDI-0006670; MEDI-0006671; MEDI-0006672;MEDI-0006673; MEDI-0006674; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDI-0006679; MEDI-0006680; MEDI-0006681; MEDI-0006682; MEDI-0006683; MEDI-0006684. The patietn received FLUMIST on 12-Mar-2008.
nodular type of rash or bumps; Nodular rash; warm to the touch; Pain; bumps; arm pain; This case was reported by a physician via sales rep and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, couple of weeks after receiving Shingrix, the patient experienced pain in arm, raised rash, nodular rash, skin warm, pain and rash. On an unknown date, the outcome of the pain in arm, raised rash and nodular rash were recovered/resolved and the outcome of the skin warm, pain and rash were unknown.   It was unknown if the reporter considered the pain in arm, raised rash, nodular rash, skin warm, pain and rash to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The reporter stated that the patient developed arm pain that lasted about 4 days. The patient also had raised nodular type of rash or bumps and they were warm to the touch and slightly sore. The reporter did not confirm any other adverse events from the vaccine. The reporter did not consent to follow up.
CONFIRMED IMMUNOLOGICAL VACCINATION FAILURE; This spontaneous report received from a 62 year old male patient. The patient's height, and weight were not reported. The patient's concurrent conditions included surgery, and past condition included multiple myeloma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070 and expiry: UNKNOWN) dose was not reported,1 total administered on left arm on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 20-APR-2021, COVID-19 antibody test result was negative which confirmed immunological vaccination failure. On same date, he had lab work done and results were unknown. On 20-MAY-2021, COVID-19 antibody test was negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210549805-Covid-19 vaccine ad26.cov2.s- Confirmed immunological vaccination failure . 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: SPECIAL SITUATIONS
felt nauseous; This is a spontaneous report from a non-contactable consumer (patient) received via the Team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration, on 27Feb2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient felt nauseous on 28Feb2021. The patient wanted to know if she could take promethazine. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Am experiencing a very bad headache. Headache has lasted continuously for more than 48 hours. Are times where headache is worse and debilitating and times where it is weaker, but is constant. Also experience short periods of nausea.
This spontaneous report as received from a nurse refers to 5 patients of unknown age. No concomitants were reported. On 20-MAY-2014, the patients were vaccinated with VAQTA INJ, lot K000943, expiration date 26-SEP-2016 (dose, frequency, route of administration and indication were not provided) that was exposed to 8.8C for 10 days. No adverse effects reported. No product quality complaint (PQC) was involved. The outcome of events was unknown. On 02-JUN-2014 a phone call was placed to reporter. The receptionist stated they do not have any one by that name employed at this facility. No further information is available at this time. This report is linked to 1405USA013915 and 1405USA013916 1406USA004906, 1406USA004908, 1406USA004909, 1406USA004913, 1406USA004914, 1406USA004915, 1406USA004863, 1406USA004874, 1406USA004881, 1406USA004891, 1406USA004896, 1406USA004897, 1406USA004900, 1406USA004901, 1406USA004814, 1406USA004830, 1406USA004831, 1406USA004833, 1406USA004835, 1406USA004837, 1405USA013915 by the same reporter.
Arm tenderness same day. On following day, it was swollen and raised and red and hot. Later that afternoon, one of the Hospital facility Dr's took a look and he determined it was a local reaction. He prescribed (an equivalent to Benadryl) Hydroxyvine -25 mg. It helped with the itching.  The symptoms totally resolved by the end of the week (Friday).
Pfizer on 3/17 and 4/7. Positive on 9/15
This same reaction has occurred before:  after receiving covid vaccine, approx 12 hours later, had onset of deep bone aches, but also got a swollen, painful 4th MCP joint of left hand.  This reactive arthritis lasts weeks afterwards and comes and goes.  It hadn't recurred for awhile before she got her booster dose on 1-13-22 which triggered it again.
This 48-year-old received his first anthrax vaccination on 25 January 2003. Within 4 days he felt like he was coming down with a bad cold.  He complained of being a little warm, tired, lightheadedness, and an increase in his cough with large amounts white-creamy phlegm with general "cold- like symptoms" that persisted for approximately two weeks.  Approximately day 7-10, he had three "diarrheal" stools that resolved that afternoon. He describes his lightheadedness as a woozy sensation worse after coughing. One morning while showering, he coughed numerous times with one episode of red-streaked phlegm.  He denies any headaches, shortness of breath, chest pain, musculoskeletal discomforts, lymph node swelling or any fevers.  He called the medical clinic and was advised these cold-flu-like symptoms were probably related to the anthrax vaccination.  He treated his symptoms at home with Robitussin and Motrin without incident and did not pursue further medical care.  He received his 2nd and 3rd anthrax vaccinations without incident.
A non-serious report of hives has been received from a nurse concerning a seven-year-old male. No medical history nor concomitant medications were provided. The patient received FluMist on 08-Nov-2007. In the morning of 09-Nov-2007, the child developed hives and was directed to be taken to the emergency room because the pediatric clinic did not have any appointments available. No outcome for the event was provided by the reporter. No dechallenge or rechallenge occurred. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Vaccine administered  1 day BUD refrigerated. Pfizer contacted and advised dose be repeated. Pt contacted and advised to repeat dose, patient verbalized understanding.
21 day migraine, severe fatigue for 30 days, severe tinnitus which is continuing constantly for over 2 months now.
This spontaneous report as received from a Pharmacy student refers to a male patient of unknown age with pulmonary embolism. On an unknown date when the patient was in his 60's was vaccinated with PNEUMOVAX23, (dose unknown) subcutaneous. The patient's concomitant medications were unknown. On an unknown date in 2013 (about a year ago) the patient experienced pulmonary embolism (life threatening and medically significant). The reporter when asked about the present status stated that he thought the patient was fine. The outcome of pulmonary embolism was reported as resolving (Reporter reported that I think he's fine). The reporter's causality assessment was not provided. Upon internal review the case was considered as medically significant. Additional information is not expected.
Localized swelling, pain and warmth to site. Benadryl 12.5mg every 6 hours. First dose given in office.
AT 12:55 PT REPORTED NAUSEA, DIZZINESS AND FATIGUE.  DECLINED URGENT CARE.  REPORTED THAT SHE JUST WANTED TO GO HOME AND REST.
1:30 Backache, headache, dizziness, generalized discomfort in clinic - call to facility for clarification of side effects, referred to Family Practice - developed stridor, nystagmus - transferred to facility reported at 4:30. Admitted to ICU. Discharged facility 3/9/07. 04/02/07-records received from facility-Fever and altered neurological status. Temp 101.2. Fell at clinic. Fainted. Presented to ER with nystagmus with mainly her gaze toward the right. Not speaking Hyperventilating. Fever a few days ago and had been sick with viral syndrome.  PE pupils equal round reactive to light but she had nystagmus frequently every few seconds and mainly seemed with a right. Required interpreter but she had no spontaneous speech. Carpal pedal spasm.  Summary for DOS 3/7-3/9/07. DC DX:Diseases disorders of nervous system. Convulsions, Tetany, bronchitis, nystagmus, altered mental status, hyperventilation, headache, lumbago, fever.  8/25/08-progress notes received-3/8/07 all symptoms have resolved discharged without any medications.  Continues to experience being a little dizzy when walking.
redness, swelling and itching at site of immunization.  on left arm started in the evening on the day of vaccination.  on right arm started the following day.
Fever of 103.8. ER visit included IV hydration and intramuscular shot of Ibuprofen to reduce fever.  Heart rate noted at 155 upon admittance.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 67-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (7 years ago). Previously administered products included ZOSTAVAX (received in August 2017). On 28th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 28th September 2018, less than a day after receiving SHINGRIX, the patient experienced pain. On an unknown date, the patient experienced erythematous rash. On an unknown date, the outcome of the pain and erythematous rash were unknown. It was unknown if the reporter considered the pain and erythematous rash to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's daughter-in-law. The patient received SHINGRIX on left arm. On the same day of vaccination, the patient experienced pain. On the third day, 3 days after receiving SHINGRIX, the patient noted a rash about an inch below the site of injection. The rash was red and flat in appearance. The area itself was actually traveling downward but the area where it was to begin with was clearing up. Transfered caller to MIS. The healthcare professional had not been made aware, not asked.
This initial spontaneous report was received from a physician referring to a 10 weeks old male infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 17-SEP-2015, at 14:24 hours the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
internal bleeding and hematoma, blood transfusion, vitamin K, left leg turned black and could not be used
Patient admitted for Guillain-Barre syndrome. Only 1 Moderna dose recorded per registry.
Started having cramping stomach aches a week after vaccine. A week later went to my Gastroenterologist, he thought it was just my IBSC acting up but decided to do testing. Had a Colonoscopy and CT Scan. Colonoscopy show a Polyp and doctor removed it. Doctor gave me a prescription for hyoscyamine sulfate. Medication didn't help. Had gotten extremely constipated, doctor increased dosage of LINZESS, but it didn't help either. Tried to reduce my gluten and it helped with my constipation but I still had a lot of cramping. Saw doctor again but hasn't found any diagnosis.
Chest pain, tachycardia - resting pulse 140 -155 went to ER, EKG performed, she was given a potassium pill and told to see a cardiologist.  Cardiologist did ECHO, Holter monitor.  Diagnosed with sinus tachycardia.  Saw a neurologist who diagnosed her with POTS.
Patient had welts/hives show up on his buttock area within 4 days of the vaccine on 11/10/2023. Those cleared up the following day and the reaction then proceeded to move to his scalp and hairline area. He is still reporting itching on and off as off 11/13/2023, Patient is taking benadryl to help lessen the severity of the hives.
Extreme Sluggishness, swollen lymph nodes under arms, swollen armpits, sporadic pimple style rash across entire body.
lips are swollen; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 04Mar2021 as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medication were not reported. In Mar2021 the patient stated her lips are swollen. Reporter stated as, "she had her 1st dose of the Pfizer Covid Vaccine last Thursday and now her lips are swollen". The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot been obtained. No further information is expected.
Red swollen warm to touch rt deltoid area in office today for apt upper arm 8 cm area redness swelling.
Patient received Johnson & Johnson and she reported that she had a fever for 2 days after - she received Pfizer 6/6/22 @ 4:30PM and reported 15 minutes later that she felt like her throat was constricting and getting tighter. She was offered benadryl but patient stated that she has many allergies including a gluten allergy so she did not want to take the benadryl. Epipen was prepared for administration but patient was still conscious and no shortness of breath was noticed so she denied the epipen and requested emergency to be called.
A 75 year old male patient received Pneumovax on 1-12-04. The patient returned on 1-16-04 complaining of redness along with arm swelling and feeling achy the next day after the injection. He was not febrile. On examination the arm with edema and erythema extending to forearm. He was instructed to elevate arm if increased redness and swelling or streaking. He was treated with cephalexin 500 mg four times daily for 10 days to treat the cellulitis.
pt recv vax; w/in 24 hrs, devel gen pruritus & mild erythema w/out hives;
Pt vaccinated with DTP/OPV developed fever 105 in first 24 hrs, decreasing to 104 at 48 hrs and 102-103 at 72hrs.  Excessive irritability for 7 hours.
the vial was initially stored in the refrigerator 21-FEB-2023, BUD 23-MAR-2023 and administration of vaccine 30-MAR-2023; No adverse event; HCP states that a dose was administered inadvertently to a patient today after the 30 day beyond use date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP states that a dose was administered inadvertently to a patient today after the 30 day beyond use date), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator 21-FEB-2023, BUD 23-MAR-2023 and administration of vaccine 30-MAR-2023) and NO ADVERSE EVENT (No adverse event) in a 69-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7173B) for COVID-19 prophylaxis.     Concurrent medical conditions included Immunocompromised.    On 30-Mar-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 30-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP states that a dose was administered inadvertently to a patient today after the 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator 21-FEB-2023, BUD 23-MAR-2023 and administration of vaccine 30-MAR-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP states that a dose was administered inadvertently to a patient today after the 30 day beyond use date), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator 21-FEB-2023, BUD 23-MAR-2023 and administration of vaccine 30-MAR-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (HCP states that a dose was administered inadvertently to a patient today after the 30 day beyond use date) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator 21-FEB-2023, BUD 23-MAR-2023 and administration of vaccine 30-MAR-2023).    No concomitant medication were reported.  HCP stated that a dose of the Moderna COVID-19 bivalent vaccine was administered inadvertently to a patient after the 30 day beyond use date. HCP was looking for viability assessment of this invalid dose that was administered to the patient. Bivalent product (BUD 23-MAR-2023) Vial size was 2.5 mL. The vial was initially stored in the refrigerator on 21-FEB-2023. The vial did not undergo any temperature excursions.  No treatment information was provided by the reporter.