chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from a physician via other company (Pfizer) on 30 May 2017. Manufacture control number: 2017222696. This case involves a female patient (age not reported) who was vaccinated with a dose of INFLUENZA VACCINE (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had developed allergies to influenza vaccine. The patient's laboratory data and corrective treatment was not reported. The outcome of the event was not reported. List of documents held by sender: none.
vague c/o no feeling in mid back & down rt leg; no feeling & foot limps p/vax; 2nd dose given 19JUN92 no obvious deficit; 23JUN 3rd dose given w/no problems; saliva exposure to a puppy that died;
Patient with Immunocompromised sibling received Rotateq despite recommendations; This spontaneous report was received from a physician via company representative and refers to an infant patient of unknown age and gender. The patient's concurrent conditions, drug reactions or allergies, pertinent medical history and concomitnat therapies were not reported.   On an unknown date, the patient was vaccineted with a dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ), orally (dose, lot # and expiration date were not reported) for prophylaxis.         The patient's family was counseled prior to the infant receiving the vaccination that it was not advisable due to the risk of the immunocompromised sibiling developing rotavirus (Case # 2011USA016850 ). The family went ahead with vaccination of the patient despite recommendations.  .; Sender's Comments:  US-009507513-2011USA016850:
arm swelled up/had arm swelling; little discomfort with the needle; some blood on the band-aid; felt achy in her arm; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program, Pfizer First Connect. A 79-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration in arm in Jan2021 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. The patient reported that when she got the first dose of the vaccine in Jan2021, she felt that the needle went in, she felt a little discomfort with the needle, had some blood on the band-aid, she felt achy in her arm afterwards in Jan2021; and her arm swelled up/had arm swelling on unspecified date. She did not feel anything with the second dose and there was no swelling like the first time. She asked the nurse if it went in for the second dose and the nurse said it did. The patient mentioned that there was nothing that showed like anything went in her arm when she received the second dose. She heard that the second one should feel something going on more than first time. She did not know if she could get another vaccination or what she needed to do.  Outcome of the events was unknown.   Information on the lot/batch number has been requested.
Information has been received from a registered nurse concerning a 5 year old healthy white male with no pre-existing allergies, birth defects, or medical conditions who on 5/5/00 was vaccinated SC in the right thigh with a frist dose of varicella virus vaccine live (lot #632619/1861J). There was no illness at the time of vaccination. On 6/23/04, the patient developed a rash on his face. He presented to the office on 6/24/04 with 20 lesions all over his body. The physician indicated in the chart that this was consistent with chicken pox. No other information was available. Unspecified medical attention was sought. There was no product quality complaint. Follow up information received from a registered nurse indicated that on 6/24/04 the patient developed a scattered rash on his face that was consistent with varicella. The patient was afebrile. Symptomatic relief was noted. The outcome was reported as recovered. There were no relevant diagnostic tests or laboratory results. No further information is expected.
Pain, swelling, heat at injection site the evening of the injection. In addition, fever of 101.2 and headache later that night and through the next morning. Treated with TYLENOL.
nausea, vomiting, diahrea, body aches, low grade temperature, lethargic, yellow cast to my skin transported by EMS to the hospital and was given IV fluids and IV antibiotics Still having liver tests done every two months
Small papules (hives) >40, itchy, red, esp. on trunk 5d after injection
Gastrointestinal issues. Stomach pain and pooping or trying to poop multiple times during the day.
"Patient reports - sluggish / dizzy /nauseated/ vomited today/HA/ fever - temp 102-"
Information has been received from a physician via medical records concerning a 3 day old infant who was born from a 26 year old female patient with no pertinent medical history and no known allergies, who on 28-JUL-2008 was vaccinated intramuscularly with 0.5 ml of the first dose of GARDASIL, the second dose on 22-SEP-2008 and the third dose on 16-DEC-2008 and conceived 1 week later after the third dose. The patient was seen on 18-MAR-2009 at the office and an ultrasound confirmed that the patient's gestation was 15 weeks and 2 days. On 02-SEP-2009, the patient was delivered by normal vaginal delivery at full term; weight 6 lb 1 oz, 20.5 inches, and head circumference 13 cm. On 04-SEP-2009, the patient had a short sublingual frenulum that was clipped. It was reported that on 05-SEP-2009, the patient was seen and the physical examination was normal except for abnormal appearance (jaundice). The physician recommended to watch the jaundice and to expose the patient to sunlight. The patient was diagnosed with neonatal jaundice and newborn feeding problems. On 17-SEP-2009, the patient was seen again in the office and the physical examination was normal except for an yellow drainage from left eye with no hyperemia, external ears and nose were congested, and cough. The patient was placed on erythromycin ointment to treat the eye. The patient was diagnosed with acute dacryocystitis and blocked tear duct/dacrostenosis. The patient was treated with erythromycin ophthalmic ointment, massage and cleaning. On an office visit on 05-OCT-2009, the patient was seen again and the physical examination was normal. The patient's weight was 9 pounds and 5 ounces (34% ile), height was 22.3 inches and head circumference was 36.8cm. Short sublingual frenulum and neonatal jaundice were considered to be congenital anomalies. The mother's experience is captured in WAES 0903USA03210B1. No further information is available.
This spontaneous report as received from a registered nurse refers to a female patient of unknown age. Information regarding drug reactions and allergies and medical history was not reported. In August 2012 (exact date not reported) the patient was vaccinated with the first dose of GARDASIL (dose, route of administration, anatomical location, lot#, expiration date were not reported). Patient received her second GARDASIL in June 2014 (exact date not reported) (dose, route of administration, anatomical location, lot#, expiration date were not reported) and her third injection in August 2014 (exact date not reported) (dose, route of administration, anatomical location, lot#, expiration date were not reported). Concomitant medications were not reported. No adverse effects were reported. Additional information has been requested.
Uncontrolled shaking  Extreme headache Stomach pain  Unable to walk or stand  Nausea  Constant spinning
HEADACH SINCE MON. 1/11/2021,  HAD SORE THROAT, WEAKNESS AND FEELING FLU LIKE.
From telephone call received on 8/9/02, from reporting nurse, it was reported that a 2 month old male infant received a Tripedia vaccination administered on 5/16/02. The pt was admitted to the hospital on 5/20/02 with muscle twitching of both legs and vomiting. He was discharged on 5/21/02, fully resolved.
Information has been received from a registered nurse concerning six patients who were vaccinated with varicella virus vaccine live, 0.5 ml, injection (Oka/Merck) (lot # and route not provided). Subsequently the patients developed chicken pox and had been previously vaccinated. Unspecified medical attention was sought. The patient outcomes were not reported. There was no product quality complaint. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Further information has been received from a school nurse who reported that a male patient was vaccinated with varicella virus vaccine live, on 12-OCT-1995. The nurse reported that the patient developed chickenpox. All of the parents and pediatrician felt the cases were mild with minimal missed time at school (approx 2-3 days out sick). No further information is available. This is one of several reports from the same source.
Narrative:  Covid +, Moderna #2, cough, congestion, diarrhea, weight loss, AKI, sweat, chills, oxygen, remdesivir and dexamethasone. Discharged to home.
Extreme redness and swelling at site of shot, in bullseye pattern about 2.5 to 3 inches across; headache, body aches; weariness.
Information has been received from a female consumer who on 17-JUL-2007 (reported as last Tuesday) was vaccinated with a dose of ZOSTAVAX. on approximately 17-JUL-2007 the patient developed a rash. At the time of this report the patient had not spoken with her physician. No further information was provided. There was no product quality complaint involved. Additional information is not expected.
Pee smells like chemicals; This spontaneous case was reported by a consumer and describes the occurrence of URINE ODOUR ABNORMAL (Pee smells like chemicals) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced URINE ODOUR ABNORMAL (Pee smells like chemicals). At the time of the report, URINE ODOUR ABNORMAL (Pee smells like chemicals) had resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Client was inadvertently given second dose of Moderna vaccine 22 days after dose 1.  Dose 1 was administered on 3/26. RN vaccinator noticed this after administration and brought this to the attention of the attending RN. The client did not experience any adverse reactions while on site during 15 minute observation period.  RN took note from CDC guidance that no repeat of second dose will be necessary if given inadvertently prior to 24 days. Client counseled that she will not need to repeat her second dose.
IMPROPER STORAGE OF VACCINE.  PATIENT DID NOT HAVE ANY ADVERSE REACTIONS.
First dose greater than a year ago; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received greater than a year before reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting patient did not receive the 2nd dose of Shingrix vaccination, which led to incomplete course of vaccination. The reporter stated that 1st dose was greater than year ago and asked do they need to restart the series.
Patient experienced severe itching 25 minutes her Moderna Vaccine.  She developed diffuse redness/rash to her chest.  No shortness or breath of wheezing noted.  She was given 2 tablets of Benadryl and instructed to use her Albuterol inhaler (2 puffs).
Child was given Novartis  this was second H1N1 shot. Previously had Sanofi. Parent advised and refused repeated dose.
Severe abnormal chest pain (diagnosed as enlarged heart); Severe abnormal chest pain (diagnosed as enlarged heart); This is a spontaneous report from a contactable consumer (patient herself).   A 26-year-old non-pregnant female patient received bnt162b2 (formulation: solution for injection; Lot Number: EW0151), dose 1 via an unspecified route of administration administered in left arm on 18Apr2021 at 13:00 (at the age of 26 years) as dose 1, single for covid-19 immunisation. Medical history included allergy to peanuts from an unknown date. The patient's concomitant medications were not reported. The patient previously took bactrim and had allergies. Prior to vaccination, the patient was not diagnosed with COVID-19, since the vaccination, the patient has not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe abnormal chest pain (diagnosed as enlarged heart) on 24Apr2021.Event caused emergency room/department or urgent care. Device Date was 28Jul2021. Therapeutic measures were taken as a result of severe abnormal chest pain (diagnosed as enlarged heart) with imaging. The outcome of the events was recovering.
Hives/itchiness/redness appearing on body. Itchiness continues and hives become larger and more severe when scratched. Hives and itchiness subsided. Began 12/22/2021. Very serve on scalp, neck and ears for first 3 days. Hives continued on entire body after being touched (by skin or clothes). Began taking Zyrtec and applying hydrocortisone PRN 12/27/2021 as suggested by PCP. Zyrtec and cortisone provide relief, but symptoms do not completely subside. Sister and cousin also experiencing same symptoms about 10-12 days after administration of 3rd Moderna dose.
Mixed Series for COVID vaccine.  Patient received  Pfizer for her first shot on 4/6/21 and received Moderna for her 2nd shot on 7/5/21.
Began with very sore arm/shoulder at and around the vaccination site. No noticeable redness or swelling. Took ibuprofen about 10:00 PM just before going to bed for the night. Woke up from sound sleep about 4-4:30 AM. Arm throbbing, head throbbing, muscle aches everywhere. Took more ibuprofen. Restless night, got out of bed about 7:30 AM. Severe muscle aches, headache, nausea, sore arm, (but less severe). Took temperature 101.2 F. Took ibuprofen. Went back to bed. Eventually got up and laid on the sofa. Drank coffee, but still nauseous. Continued ibuprofen every 3-4 hours throughout the day. Able to have a bowl of cereal with milk around noon. Feeling a little better for a short time. Thought maybe I would be able to shower and shop as planned. Took temp. 99.8 F. About 1:00 PM feeling tired, hot and achy, temp back to 101 F. back to sleep. Continued like this all day. Went to sleep for good about 9:30 PM. Woke on 6/29/2018 feeling much improved. Carried out normal activities. A little achy late in the day, temp. 99.2 F. I did not expect this. I am glad I didn't have to work on the day after the vaccine.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose received on 4th August 2018, refer case US2018162430). Concurrent medical conditions included solitary kidney. On 5th September 2018, the patient received the 2nd dose of SHINGRIX. On 5th September 2018, unknown after receiving SHINGRIX, the patient experienced wrong vaccine administered and drug dose administration interval too short. In September 2018, the patient experienced pain in arm and bone pain. Rechallenge with SHINGRIX was positive. On 7th September 2018, the outcome of the pain in arm and bone pain were recovered/resolved. On an unknown date, the outcome of the wrong vaccine administered and drug dose administration interval too short were unknown. It was unknown if the reporter considered the pain in arm and bone pain to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The patient inadvertently received 2nd dose SHINGRIX earlier than recommended when he was supposed to receive Hepatitis B vaccine, which led to shortening of the vaccination schedule and wrong vaccine administered. The patient stated that his bones were hurting and arm was sore after receiving the dose of SHINGRIX. The patient was feeling better at the time of reporting. No further information was reported.
Patient presented to the ED on 4/10/21 and was hospitalized for choledocholithiasis. Then on 5/9/21 he presented to the ED and was subsequently hospitalized for bilateral pulmonary embolism. This was within 6 weeks of receiving COVID vaccination.
Prior asthmatic PT (no h/o asthma for past 3 yrs) c/o wheezing, chest tightness, generalized itching and rash 24 hrs post vax. She c/o'd that Sx's resolved. Used Benadryl.
Flu-like symptoms (body aches, exhaustion, etc) (2 days) Soreness at injection site (4 days) Rash near injection site (4 days)
Nonstop tearing eyes (lasting 2 days), headache (still current), bloody nose(3 days), blurry & double vision(~4 days), light sensitivity (1 week) all without a hx of headaches/migraines in the past
Rapid heart rate; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Rapid heart rate) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (Rapid heart rate). At the time of the report, HEART RATE INCREASED (Rapid heart rate) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: high (High) rapid heart rate.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.
Fever, chills, body aches, muscle and joint pain, nausea, vomiting, diarrhea, trouble concentrating , headache. These symptoms lasted about 30 hours.  Headache, trouble concentrating, pain at injection site have lasted almost 48 hours and continue to exist but have been reduced over time
ERYTHEMA TO UPPER LEFT DELTOID MEASURES 2 INCHES LENGTH AND 2 1/2 WIDTH WITH WARM TO TOUCH, HARD. MOTHER STATED PT HAD FEVER 100.3 AND REDUCED WHEN GAVE MOTRIN.
Mom describes extreme pain in left arm.  Child not willing to lift arm to put coat on.  Mom also states there is a "blotchiness" around the area where immunization was given.  No fever, minimal swelling.  Mom is giving Tylenol and Ibuprofen around the clock.
Information has been received from a registered nurse (RN) concerning a child who was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. The RN reported that the patient subsequently developed a measles-like rash. Unspecified medical attention was sought. At the time of this report. The outcome was unknown. Additional information has been requested.
Patient presented to the hospital with worsening SOB and cough  and noticed to be hypoxic positive infiltrates on COVID-19 infection. Patient was given Remdesivir, decadron, symbicort, and mucinex.
Approx. 10 minutes after rcvg Vx, pt. stood to leave and passed out. Nurses in room placed pt. on exam table laying down. Gave crackers and OJ. Kept pt. for approx 30 min. in office. No other problems, did not fall, no nausea/vomiting.
Fatigue lasting 12 hours.   Debilitating headache lasting 19 hours (in waves)
Pt c/o flushing and "difficulty catching her breath" 10 min after getting vaccinated. EMS/911 was offered but pt refused. She remained in pharmacy a total of 40 minutes after vaccination. The flushing/dyspnea resolved, pt refused BENADRYL or water and 2 other offers to call EMS. RPh checked BP twice: 145/98 P 84. Pt said that is her normal BP.
Patient had severe diarrhea and vomiting started Wednesday Aug. 30th around 7pm, took her in to  Hospital Emergency Room on Friday September 1st, the emergency room doctor stated it was a vaccine reaction and to treat her with pedialyte. On Friday September 8th took her back to her pediatrician for a check up, her diarrhea and vomiting have cleared.
This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On unknown date, it was reported that patient experienced: Pfizer covid vaccine effectiveness is lowered by 36 fold. Outcome of the event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained. No further information is expected.
No additional AE's/PQC's were reported; reporting a temperature excursion for VARIVAX/ have been administered to several patients since the escursion; This spontaneous report has been received from an office manager and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies, and concomitant medications were not reported.  On 18-AUG-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) dose or frequency 1 (units not provided) (route of administration, vaccine scheme, anatomical site of vaccination were not reported; lot number T041685 has been verified to be valid, expiration date reported and established as 10-DEC-2022) as prophylaxis.   The vaccine was exposed to a temperature excursion of 11.3 Fahrenheit degrees (°F) during a time frame of 15 minutes. There was no previous temperature excursion. No adverse events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA006576:
I went to the ER for heavy periods that caused me to bleed for 10 or more days straight. The ER doctor ran tests and asked that I follow up with my PCP. My doctor prescribed Provera to slow down or stop the bleeding. I have been taking the medication but it is not working because it hasn't stopped the bleeding.
A raised red rash was noted the night of the vaccination. It is hard to the touch. Patient reports it does not hurt or itch. It is still there on 4/23.