chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mom reported "heavy breathing at 8 pm 10/26/09 that continued next day.  Took child to ER at Hospital where he was admitted with dx of bronchiolitis.  10/30/09:  ED Records received for date of service 10/27/09.  DX:  RAD, Bronchiolitis.   Assessment:  Presented to the ED with fever, decreased air movement, retractions and use of accessory muscles of respiration as well as cough and runny nose.  The child was fussy, crying and irritable. Nebulizer treatment was given.  Prescribed Pediapred and Xoponex. Admitted to the hospital.  ICD 9 Codes:  786.2, 490. 11/10/09 Medical records received for dates 10/27/09. DX: Viral bronchiolitis. Chief c/o shortness of breath. Presents to ER with 24hrs of SOB, fever, runny nose, cough, diarrhea. Assessment: O2 sat 94% room air, mild respiratory distress, bilat rhonchi with faint wheeze, tachycardia. Pt. received flumist 24hrs prior to onset of sx. Pt. admitted. Upon d/c pt condition as good.
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Consulted with the local Dept. of Public Health and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Local healthcare service is working on a compliance improvement plan and has been reinstated vaccination privileges.
Right after receiving the vaccine, I felt light headed and dizzy; this continued for several days;  about five days after receiving the shot, I felt pressure in my ears and had slight ringing in my right ear, on the evening of 4/8/21, my lips started to feel numb; the following day, the side of my face begin to feel numb and this sensation now comes and goes; I continue to feel light headed and dizzy and have sporadic episodes of tightness or pain in areas such as my legs, thighs, neck, chest, and back
Day one - moderate pain and swelling at injection. Day 2 - injection site ache, mild diffuse aches, nasal congestion. Day 6 - brief vertigo. Day10- recurrent vertigo, brief but lingers though the day. Day11 - worsening persistent vertigo with persistent lateral nystagmus Nausea and vomiting. Seen acutely by ENT physician and diagnosed with vestibular neuritis after negative head CT scan.
Pt stated that the next day after receiving vaccine she had headaches and a pain that radiated down from the head to left side of arm to injection site. Headaches were lasting until reporting date.
Headache; four days, mild and occasional hives; two days, burning and redness of eyes; five days, pain swelling and burning of injection site to include the majority of the upper arm; five days, occasional nausea; three days.
This spontaneous report received from a health care professional via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: disabled, and other pre-existing medical conditions included: The patient was a Registered Nurse by profession. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced allergic to the covid vaccine. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of allergic to the covid vaccine was not reported. This report was non-serious.
Day 1- fever and chills Starting day 1-72 hrs : swollen, sore, tight bump at injection site, with a fever in bump.   72+ hrs: same symptoms but bump decreased in size a little bit.
pt recv vax & devel an inj site rxn;this is 1 of 5 pt from this facility to have an adverse exp p/vax w/lot# 4978216;
A nurse reported that a 3 year old male received an injection of Prevnar on 8/25/00. Immediately, post vax, he developed an injection site reaction characterized by redness and swelling. He was treated with diphenhydramine. This is 1 of 5 pts from this facility who had an adverse experience following receipt of Prevnar lot 471654.
There are no side effects as of call.; HCP calls to report MMR II administered to a woman who is pregnant.  Patient is 4-6 weeks pregnant.  There are no side effects as of call.  See request case. Urgent Callback Request case.; This spontaneous prospective pregnancy report was received from a physician and refers to a 26-year-old female patient.  The patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies were unknown by the reporter.  On an unreported date in 2023 (reported as 4-6 weeks pregnant), the patient became pregnant and the last menstrual period (LMP) was calculated on an unknown date in May 2023.   On 23-JUN-2023, the 4-6 weeks pregnant patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, one time, administered intramuscularly for prophylaxis (strength, anatomical location, lot number, and expiry date were not provided) (exposure during pregnancy).  The pregnancy outcome was not reported at the time of the report (outcome pending) therefore, the fetal outcome was unknown.  It was reported that there were no side effects (no adverse event).
heavy, heavy menstrual cycle bleeding; major bleeding; severe muscle pains; Lethargy; just slept it off; felt completely run down/just felt horrible; This is a spontaneous report from a contactable consumer reporting for herself (patient). A female consumer of an unknown age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: unknown, expiration date: unknown), via an unspecified route administered in right arm on 16Apr2021 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history was reported as none and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no history of adverse events with any previous vaccines. No additional Vaccines Administered on Same Date of the Pfizer Suspect. Patient reported she has gotten both Covid vaccines with the first one on 16April2021 and the second one on 07July2021. She waited to get the second one because she had side effects after she took the first dose. On an unspecified date in 2021, the patient had heavy, heavy menstrual cycle bleeding after the first shot. In the interim, that was why she waited. Also, after the first dose and major bleeding, which is very unusual for her, she had severe muscle pains and lethargy that occurred for 3 weeks afterwards. So, she just slept it off, but felt completely run down. States it also happened again after the second dose. The heavy menstrual bleeding started the second or third week on a Monday and 2 weeks later she started her cycle and called into work. After the second vaccine it happened again. The lethargy and muscle pains and feeling completely run down started the Thursday 3 weeks after the first shot, and she just felt horrible for 4-5 days. The menstrual cycle cleared and then after her second vaccine it started all again. The lethargy and severe muscle pains did improve. The outcome of the events heavy, heavy menstrual cycle bleeding; major bleeding, just slept it off, felt completely run down/just felt horrible was not recovered and outcome of severe muscle pains and lethargy was recovering.  Follow-up attempts completed, information on batch/lot number cannot be obtained.
I didn't have any issues until 10 days later. My arm was red, bumpy, hard, swollen and it itched. I talked to a friend of mine that was a nurse and she told me I should go to the ER. I called the clinic and they set up a appt. He said that he thinks it's a case of cellulitis, so he put me on doxycycline in case that's what it was. I took the medication and was fine from there.
Redness, swelling at injection site, very itchy, from a few hours after injection till date.
Fever 101, aches, awful headaches, nausea, threw up 5 times, very tired, fatigue.  Lasted 4 days.  Headaches have not gone away since my first symptoms of Covid on December 24, 2020
Fever Chills Muscle aches Headache  Fatigue Difficulty breathing Chest pain
Patient began to seize (shake uncontrollably and eyes were rolling into the back of head).
Swelling, redness, hot to touch, itching on right arm. Visited urgent care Sunday 6 August. Prescribed Amoxicillin and Prednisone. Patient reports symptoms have improved.
Fever 99.5, body aches, extreme tiredness, injection site pain and swelling, itching at injection site  36 hours+-
Headache, took Tylenol. Was better by morning  Diarrhea, has lasted 2 days so far.
TINGLING DOWN LEFT ARM; DISCOMFORT SKAKING; BLURRED VISION; DIFFICULTY BREATHING; SHINGLES SWOLLEN SPLEEN.
Pt received DTAP right thigh upper 5cc and IPV lower IM 5cc. on 03/29/04.  Father of child states child had redness, warm to touch, itchy upper thigh on Tuesday 03/30/04 AM.  Father of child came to our office on 04/01/04 to have pt evaluated.
tingling lips, thick tongue approx 7 minutes after administration of vaccine, lasted 1 minute Employee had tingling of her lips and felt like a thick tongue. She states it lasted 1 minute.
Pt. showed me the injection site. It looked as if she had scraped it against a wall and it was healing already on the outer parts. There was severe blistering. There was a huge fluid bubble next to the bandage that was applied after the injection.
Fatigue, headache, lethargic, severe chills, body aches, pain at injection site, itching at injection site, fever between 100 degrees F to 102 degrees F. Treatment was Tylenol every 4 hours
Heart palpitations, tightness in chest by heart,  sharp pain on heart, extreme fatigue
Patient received Pfizer vaccine (1st dose)/ Patient received Moderna vaccine (2nd dose); This spontaneous case was reported by an other health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Patient received Pfizer vaccine (1st dose)/ Patient received Moderna vaccine (2nd dose)) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jul-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Patient received Pfizer vaccine (1st dose)/ Patient received Moderna vaccine (2nd dose)). On 03-Jul-2021, INTERCHANGE OF VACCINE PRODUCTS (Patient received Pfizer vaccine (1st dose)/ Patient received Moderna vaccine (2nd dose)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant Medications were provided. No Treatment Medications were provided. Patient received Pfizer vaccine on 03JUL2021.
30 seconds after I received my first shot I immediately felt dizzy and weak in the arms and legs.  This continued for the 15 minute waiting period.  The remainder of that day I slept in between dizzy spells.  The next day, and ever since, I have had a headache, lightheadedness, and bouts of dizzy spells that almost make me fall over.  today is day 7 of these effects.  I have had no other notable reactions to the dose (fatigue, swelling, aches etc,)
After my second shot had bad shivers 24 hours after the shot  10 days later started to feel severe pain in my left-hand joints, very hard to make a fist. Not nearly as bad on my right hand. its been 3-4 days since I started feeling the pain. Feels I guess what arthritis would feel like, but I don't have that until maybe now??
A non-serious spontaneous report of "FLUMIST got into patient's eye" was received from a health professional concerning a seven-year-old male. Neither the patient's past medical history nor the concomitant medications were reported. The patient received FLUMIST on 02-Dec-2010. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved. Additional information was received on 01-Mar-2011: Reporter confirmed that the patient did not experience any adverse events.
I experienced severe nerve pain in both arms and in my legs the night after having the injection.  The pain felt like the leg pain that I had in my legs prior to having  back surgery in 2018.  I have NEVER had this type of pain in my arms  and had not had this degree of pain in my legs since my surgery.  The pain woke me up around 2:00 am.  I took a couple extra gabopentin which helped settle it down.  I also had similar, but not as severe pain my my arms and legs after my first pfizer shot  on  2/25.  The pain also woke me up the night after the shot but it went away quickly.  I thought it was coincidence  The increased leg and arm pain lasted for 4-5 weeks.  I increased my gabopentin from 4 tabs daily to 6-8 daily and had to keep up this level of med for at least a month.  I am still having an increase in leg pain and will see my Dr when I return to the USA  in 2 weeks  I did not talk to my Dr. about this as I felt they were already busy enough and as long as I took the extra gabopentin it was bearable
Severe fatigue, headache, nausea dizziness, throat tightness, fever all started within 12 hours. Severe headache Knife like remained for 3-4 weeks.  Mild to moderate daily headaches continue.
arm wasn't as sore; Second dose given on day 24; fever, temperature didn't get as high; headache; chills; fatigue, tiredness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm wasn't as sore), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given on day 24), PYREXIA (fever, temperature didn't get as high), HEADACHE (headache) and CHILLS (chills) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (experienced loss of taste, loss of smell and a fever of 100.4) in September 2020. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given on day 24). On an unknown date, the patient experienced VACCINATION SITE PAIN (arm wasn't as sore), PYREXIA (fever, temperature didn't get as high), HEADACHE (headache), CHILLS (chills) and FATIGUE (fatigue, tiredness). On 07-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given on day 24) had resolved. At the time of the report, VACCINATION SITE PAIN (arm wasn't as sore) outcome was unknown and PYREXIA (fever, temperature didn't get as high), HEADACHE (headache), CHILLS (chills) and FATIGUE (fatigue, tiredness) had resolved.            Concomitant medication include  Blood Pressure Medication and statin medication.  No Treatment medication was provided.   This case was linked to MOD-2021-022930 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up received 25-May-2021 which includes Outcome of the events was updated to recovered On 31-Jul-2021: Follow-up received on 31-jul-2021 in which Reporter Address was  added. Medical history, Concomitant medication and new events were added.
Case number PHEH2014US024960, is an initial spontaneous report refers to a 17-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 03 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration. No further information was provided.
Father called to report that patient was taken by her mother to an urgent care or ER and seen for cellulitis with fever on 5/22/16. The area of concern was near injection site on left deltoid. Antibiotics were given and today she is fine.
Pediatric patient received adult dose; Pediatric patient received adult dose; 1st dose: 06-MAR-2021; 2nd dose: 19-JUL-2021; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 2-year-old patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B adult) (batch number 4pg49) for prophylaxis.   Previously administered products included Engerix B (1st dose received on 06th March 2021).   On 19-JUL-2021, the patient received the 2nd dose of Engerix B. On an unknown date, the patient received the 3rd dose of Engerix B adult. On 19-JUL-2021, an unknown time after receiving Engerix B and not applicable after receiving Engerix B adult, the patient experienced drug dose administration interval too long (Verbatim: 1st dose: 06-MAR-2021; 2nd dose: 19-JUL-2021). On an unknown date, the patient experienced overdose (Verbatim: Pediatric patient received adult dose) and adult product administered to child (Verbatim: Pediatric patient received adult dose). The outcome of the drug dose administration interval too long, overdose and adult product administered to child were unknown.   Additional Information: GSK Receipt Date: 05-MAY-2023 The reporter was pharmacist administrative assistant. The reporter reported that the pediatric patient was accidentally received an adult dose of Engerix-B vaccine. The reporter stated that they provided incomplete information about the patient and previous vaccinations and they accepted to be transferred to the second line. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up. The patient received 2nd dose of Engerix B late than recommended time frame, which led to lengthening of vaccination schedule. The pediatric patient was administered a adult dose of Engerix B , which led to overdose and adult use of a child product.
guillain barre; has to use a wheelchair and walker; This case was reported by a consumer via media and described the occurrence of guillain barre syndrome in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced guillain barre syndrome (serious criteria GSK medically significant) and mobility decreased. On an unknown date, the outcome of the guillain barre syndrome and mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the guillain barre syndrome and mobility decreased to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient's friend. The age at vaccination was not reported. The patient got the shingles vaccine and now has Guillain barre. The patient had to use a wheelchair and walker to get around. The reporter stated that they have a class action lawsuit against the makers of the shingles vaccine.
Initial information received on 24-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an 23-years female patient who experienced injection site leaking, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history was not provided. No concomitant medication was received. On 24-Sep-2018, the patient received a 0.5 ml single first dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UI980AB in the right arm. On an unknown date, following the administration of INFLUENZA QUADRIVAL A-B VACCINE, the injection site was leaking clear fluid (injection site extravasation). The injection site was not swollen, red or anything. She couldnt even see where she got the shot. The patient stated that there was slight seepage at the site. The injection site was not infected. Her patients got panicked over getting these vaccines. Pharmacist believed that this was just normal 'body function. (Other relevant tests included no lab data.) Final diagnosis was injection site leaking. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for injection site leaking.
Information has been received from a registered medical assistant referring to a 2 year old male patient. The patient's pertinent medical history and drug reactions/allergies were not reported. On 16-OCT-2015 the patient was vaccinated with GARDASIL 9 (lot # L013429 with expiration date 21-JUL-2017, 0.5 ml, intramuscularly). The patient's parents has not reported that their sone had experienced any adverse effects. Additional information has been requested.
Headaches; Bad rash on stomach and back for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Bad rash on stomach and back for 2 days) and HEADACHE (Headaches) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (Bad rash on stomach and back for 2 days) and HEADACHE (Headaches). At the time of the report, RASH (Bad rash on stomach and back for 2 days) and HEADACHE (Headaches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided. Treatment information was not provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Events outcome updated from unknown to recovered/resolved.
This spontaneous report as received from a pharmacist via a field representative refers to an unknown age and gender patient. Pertinent medical history, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route and lot number were not reported). Concomitant medication was not reported. In 2013, reported as "a few weeks ago", the patient developed shingles. It was reported that the patient sought unspecified medical attention. The outcome of patient developing shingles a few weeks ago was unknown. Causality was not reported. Additional information has been requested.