chrisvoncsefalvay/vaers-outcomes huggingface dataset:
NOSE BURNING; STUFFY NOSE ON ONE SIDE; A spontaneous report has been received from a consumer. The report concerns a female patient (age not provided) of unknown ethnic origin.    No medical history was reported. The following demography was reported for the patient's parent: Sex: Unknown    No concomitant products were reported.    On an unknown date, the patient received Flumist (influenza virus vaccine live, intranasal) once/single administration, via nasal route, for an unknown indication.     On an unknown date, the patient experienced nose burning (preferred term: Nasal discomfort) and stuffy nose on one side (preferred term: Nasal congestion).     The outcome of the events of nose burning and stuffy nose on one side was unknown.     The company physician considered events nose burning and stuffy nose on one side to be non-serious.
Pt is doing well, but he was 3 days old when he was accidentally given Hiberix by the medical assistant instead of Engerix-B.
I have a mark on my arm. It is a white outlined mark about a quarter in diameter. The mark where the needle went in is still there. It has not gone away. It has grown about a centimeter more in diameter over the past 2 weeks. I noticed I have been coughing a lot and I have been having to use my inhaler and I have congestion. I don't know if its seasonal allergies or due to the shot. I have had to use my inhaler which I NEVER do. It is Ventolin.
This spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with GARDASIL 9 (lot number, dose, administration route, anatomical site of injection and frequency were not reported). Concomitant therapies were not provided. It was reported that the patient fainted at the physician's office, a while afterwards receiving the vaccination. No product quality complaint (PQC) was involved. At the time of this report, the outcome of syncope was unknown. The reporter did not provide a causality between the reported event and the GARDASIL 9 administration. Additional information has been requested.
pt recv vax 8AUG97 & that evening pt exp swollen tongue, stiff neck, & joint pain;joint pain progressively became worse & pt was adm to hosp on 11AUG97;reporter indicated that pt may have poss meningitis;
Arms sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 7th November 2022, the patient received the 1st dose of Shingles vaccine. In November 2022, less than a week after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 12-NOV-2022 Reporter's Comments:  This case was reported by a consumer via interactive digital media. The patient had first shot on Monday.  His or her arms sore but know what family members went through with shingles.  Two shots required three months apart. Additional Supportive Information: The follow-up could not be possible as no contact details were available.
This spontaneous report as received from a consumer refers to an 82 year old male patient. The patient's medical history and concurrent conditions were not provided. On 15-NOV-2012 the patient was vaccinated with a dose of ZOSTAVAX. Dose, route and lot number were not provided. No concomitant medications were reported. On an unknown date the patient experienced multi-organ failure and cardiac arrest. The outcome of multi-organ failure and cardiac arrest was reported as fatal. The patient died on 13-DEC-2012 at 1515 (military time) in the hospital. The cause of death was reported as cardiac arrest and multi-organ failure, according to the Death Certificate. No reporter causality was provided. Additional information has been requested.
Patient under age 18 was vaccinated with Moderna, which is a vaccine error.  Troubleshooting: Scribe and vaccinator did not validate age;  screeners at the beginning of the process did not ask or turn her away on a Moderna-only day. The ID requirement put in place did not prevent this situation from occurring.  Follow up to be done by DCHHS Physician or delegee will include specific description of next steps for obtaining dose 2.
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications and drug reactions/ allergies were unknown. On an unspecified date in June 2017, the patient was vaccinated with improperly stored doses of PROQUAD (Lot # M007960, expiration date 15-AUG-2017 or Lot # M049122, expiration date 13-JUN-2018) dose, route were unknown for prophylaxis (the nurse reported that since 02-JUN-2017 this patient and 5 more received the improperly stored doses of vaccine). The lot # and expiration date for the properly stored sterile Water diluent used to reconstitute the doses of PROQUAD was not provided. No adverse effects were reported. The temperature excursion was from 6°F to 14°F for 1 hour, no previous temperature excursion was reported, the call was because a data logger. No product quality complaint was involved. This is one of 6 cases received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA011002: US-009507513-1706USA011003: US-009507513-1706USA011000: US-009507513-1706USA010999: US-009507513-1706USA011001.
This spontaneous report as received from a pharmacist via representative refers to a male patient in his 60's (years of age). On an unknown date the patient was vaccinated with ZOSTAVAX for prevention of shingles. Dose, route, lot and expiry date were unknown. On an unknown date, after receiving vaccine, the patient developed an injection site reaction that included pain and swelling. No treatment was given. Patient had called the pharmacy to seek medical attention. One week after injection, the reaction resolved on itself. The outcome was reported as recovered/resolved. Additional information has been requested.
whelp at the injection site; hives; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site wheal in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 05-MAY-2023, the patient received the 2nd dose of Shingrix. On 14-MAY-2023, 9 days after receiving Shingrix, the patient experienced injection site wheal (Verbatim: whelp at the injection site) and hives (Verbatim: hives). The outcome of the injection site wheal and hives were not resolved.   It was unknown if the reporter considered the injection site wheal and hives to be related to Shingrix.     It was unknown if the company considered the injection site wheal and hives to be related to Shingrix.   Additional Information: GSK Receipt Date: 16-MAY-2023 Consumer called and reported that she received dose 9 days after developed a whelp at the injections site and hives. Adverse event was filled. The reporter did not consent to follow up.
client to sbu mvs for 2nd dose pfizer covid 19 vaccine. vaccine administered and client quickly became nauseous and vomitted a small amount of emesis. EMS responded - vss, pulse oximetry wnl no loc. recovered and sent home
Information has been received from a registered nurse concerning an 18 year old female who in July 2008, was vaccinated with the first dose of GARDASIL vaccine (yeast). In July 2008, two hours after vaccination, the patient experienced fever, chills, aches and joint pain. Subsequently, the patient recovered from fever, chills, aches and joint pain. The registered nurse reported that the patient did not seek any treatment  for the symptoms. The symptoms had resolved within 24 hours. Additional information has been requested.
Within 2 hours of receiving the immunization he started having urticaria on the torso are per extremity arms and hands.  Did not have any shortness of breath or difficulty swallowing.  No breathing difficulties.  Immediately took 50 mg of diphenhydramine and took a cold shower symptoms resolved partially came into urgent care around 2:00  p.m. still with some urticaria swelling on the hands and torso.
This spontaneous report was received from a physician and refers to an unspecified number of female patients of unknown age. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On unknown dates, the patients were vaccinated with doses of GARDASIL 9 (lot #, expiration date, exact doses and route of administration were not reported). It was reported that the patients were females over the age of 26 years old. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
10-9-13 received Flu vaccination at work reports immediate flushing, heat throughout body blurred vision past in several minutes also had bilateral numbness 4 and 5 finger and tingling from elbow through finger tips 5 hours later continued with numbness and tingling in hand, fingers.
Returned to clinic 9-9-09 with a red raised vesicles rash in dermatomal distribution on left lower back radiating around to center of lower abdomen. Onset of rash about 9-7-09. Patient denies pain or itching fever or chills. Tx valtrex 1gm TID X 7 days
I was diagnosed with covid 12/1/2020 ended up in hospital 01/03/2021 with low ox level of 83, got it up to 92 by next day, was send home with no ox given steroids, started feeling better and was about 90% by last weekend. got dose one of Moderna vacine on this last Monday, about 7 hours later got a real good cough and had the covid taste in my mouth. Each night since then at night get a real bad cough and fluid in lungs. My blood ox has not been bad, one time as low as 91 but mostly 94 to 98. Is this common to get a real bad cough after vacine?
11.29.21 - late night full body hives that affected sleep - 1st breakout of hives Since then, hives still remain though more controlled with Xyzal. Experimented with other antihistamines such as Benadryl and Zytrec which were not effective. Hydrocortisone cream and calamine lotion/spray only temporary relief. Histamine rich foods exacerbate symptoms and alcohol is a culprit for worsening symptoms. I take nightly Xyzal 5mg to control symptoms and to get a night's sleep but cannot go more than 24 hours without needing to take this antihistamine. I have consulted with 1 dermatologist who did not provide any relief/helpful recommendations. I have also seen 1 allergist who instructed to increase Xyzal dosage up to 4x the dose; however, just doubling the dose of Xyzal leaves me very lethargic and fatigued the next morning so I only take 5 mg.
My entire body, other than my face, chest and tops of my feet felt like I had a sunburn when touched or clothes rubbed against my skin. There was no rash and my skin looked normal.; Chills; Fever; Nausea; Extreme sinus blockage; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 16Apr2021 at 16:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto's thyroiditis, stage 2 kidney disease and high blood pressure. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), losartan (MANUFACTURER UNKNOWN) and dicycloverine (DICYCLOMINE); all from unknown dates for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 23Mar2021 at 16:15 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Apr2021 at 12:00, the patient experienced her entire body, other than her face, chest and tops of her feet felt like she had a sunburn when touched or clothes rubbed against her skin. The patient reported that there was no rash and her skin looked normal. The patient also experienced chills, fever, nausea, extreme sinus blockage and fatigue. The events did not result in doctor or other health care 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 felt like she had a sunburn when touched or clothes rubbed against her skin, chills, fever, nausea, extreme sinus blockage and fatigue were resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
7" round erythemic pruritic, blanchable area, no systemic or respiratory symptoms.
A non-serious spontaneous report of positive for flu has been received from a physician concerning a 42 month old male subsequent to FluMist. This case is 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. The patient's medical history and concomitant medications were not reported. On 10-Oct-2009, the patient received FluMist. On 11-Oct-2009, at night, the patient started to feel bad and experienced symptoms that included fever, decreased appetite, and lethargy. On 12-Oct-2009, a flu test was positive for influenza B and A. No outcome was reported for this even. Required follow up attempts have been performed requested information unable to be obtained.  01-MAR-2010.
pt recv vax 25FEB97 & 10min thereafter exp nausea, inc BP, inc pulse rate, pressure in the head w/visible swelling in the eye area, dizziness & hyperventilated;given epi & sx resolved w/in 10min;
Red raised rash appeared on day 8.  Painful to the touch. Feeling fatigued
Chills. Face/head and arm/fingers feeling fuzzy and cold. Almost like stepping outside in winter in short sleeves. Tiredness but inability to fall asleep outside of normal sleep time. Nauseous.  Dizzy/confused/faint feeling  after moving around.  Had to leave work early 2 days in a row. Might not take 2nd dose because I can't afford to miss work.
feeling weak; tired; This is a spontaneous report received from a contactable physician (also reported as consumer). A male patient of an unspecified age (reported as "over the age of 60") received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced feeling weak and tired a few hours after receiving his second vaccination (unspecified date). The outcome of the events was unknown.  No follow-up attempts are possible. Information about batch/lot number cannot be obtained.
Achey, lethargic, very tired.  I woke up early the morning after with cold chills.  The second day after I woke up having cold sweats.  I feel a lot better the second day, but I?m still feel a little bit drained of energy.
Patient received this Monovalent dose as a COVID booster (3rd dose) instead of the Bivalent dose.
Information has been received from a health professional concerning a patient (33 out of 40) who was vaccinated with Pneumovax 23 (lot number 651406/0620F).  It is unknown if the patient was vaccinated with the influenza virus vaccine (unspecified) on the same day.  Subsequently the patient experienced fever, pain at injection site, redness at injection site, swelling at injection site and red streaks on injection arm.  Subsequently, the patient recovered from fever, pain at injection site, redness at injection site, swelling at injection site and red streaks on injection arm.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot complies with the standards of the agency and was released.  Additional information has been requested.
Patient has an injection site reaction. Arm is noticeably red and swollen around the site of injection. Patient also reports that the spot is itchy. Patient contacted her PCP shortly after noticing the reaction who told her to use hydrocortisone cream.
Pt stated she is having trouble lifting her arm up. She said its painful. No visible inflammation on the arm at all.
Severe left  arm and neck pain. Fever and migraines. Currently having symptoms treating with ibuprofen and acetaminophen. Hot and cold compresses. Health department says no need to see a doctor unless symptoms continue over several days.
36 year old adult given Infanrix instead of Boostrix.; 36 year old adult given Infanrix; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 36-year-old female patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th April 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 28th April 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  GSK Receipt Date: 28-APR-2022 Reporters comment: The adult patient was given Infanrix instead of Boostrix. No other adverse event information was provided at this time by healthcare professional.  Healthcare professional gave permission for safety team to follow up. The reporter consented to follow up. Additional supportive information: The adult patient was given Infanrix instead of Boostrix, which led to wrong vaccine administered and inappropriate age at vaccine administration.
moderate pain at injection site; congested nose; This is a spontaneous report from a non-contactable consumer (patient's husband). A female patient (frontline health care professional)  received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on Dec2020 as a single dose for COVID-19 vaccination. The patient medical history and concomitant medications were not reported.  On Dec2020,  the patient experienced moderate pain at injection site and congested nose. In Dec2020, the pain was mild around the injection site and  her congested nose was now clear. The clinical outcome of the moderate pain at injection was recovering and the outcome of the event congested nose was recovered Dec2020.   No follow-up attempts are possible; information about lot number cannot be obtained.
* felt serum enter my arm, painful immediately / * nothing but mild arm pain until about an hour after the shot/ * entire arm ached all the way to my hand / * became extremely tired within an hour of shot / * neckache, throbbing arm pain, over all achy, VERY tired, slightly dizzy on and off, fuzzy thought processes on and off / * felt feverish but no fever / * eyes felt warm when I closed them/ * slight heart racing the first night  - all of these symptoms lasted about 2 days. Not severe enough to see my doctor or go to a hospital but felt it was important to report the effects.  Even today, 5 days later, my upper arm is still sore and my neck still aches slightly.
Heart palpitations that started possibly day of vaccine, but for sure witihin a couple days.  Unsure of exact date, did not initially think it was related.  However, heart palpitations continued and are still present to this day.  I did recieve a second dose on 2/22/21, and palpitations continued.  I had an ekg completed on 3/9/21which showed sinus rhythm with arrhythmia.  I was sent to have 24 hour holter monitor test.  The results of the holter monitor were Sinus rhythm with average rate of 81 pm ranging from 50-132.  Rare PVC.s Infrequently in bigeminy pattern.  Rare PAC's.  No significant ectopy or arrhythmias.  This holter monitor was completed on a day that felt like symptoms were less frequent.
Child received H1N1 LAIV in AM.  "Headache" (frontal lobe and temples) began the same evening.  No symptoms Sunday but headache, as well as a "stomach ache", resumed Sunday evening, all day and evening Monday.  Better Tuesday but symptoms resumed Tuesday evening.  Mother states that the child has been very tired and uncharacteristically irritable: stomping feet, arching back, slapping sibling, and flailing about.
In right arm at injection site, redness, warmth, pain, and swelling extending distally.
This case was reported by a other health professional and described the occurrence of wrong vaccine administered in a adult female patient who received INFANRIX. On an unknown date, the patient received INFANRIX at an unknown date. On an unknown date, an unknown time after receiving INFANRIX, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown. Additional information received: Adult patient was given INFANRIX vaccine instead of BOOSTRIX.
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Covid-19 vaccine that were given beyond the 30 day use by date; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Covid-19 vaccine that were given beyond the 30 day use by date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2022 at 2:54 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 11-Feb-2022 at 2:54 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Covid-19 vaccine that were given beyond the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Covid-19 vaccine that were given beyond the 30 day use by date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Us Census Ethnicity of patient was reported as Hispanic or Latino of any race. No concomitant medication information provided. It was reported that, vaccine was administered on 11-Feb-2022 at 14:54:00 and it was booster dose. Its 30 days expiry date vaccine went into 2 to 8 °C thaw state on or about to 20-Dec-2021, this vaccine administered until its Mfg date of 04-Apr-2022 No treatment information provided.   This case was linked to MOD-2022-542869.