chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A physician reported that a pediatric heart transplant pt with acute cellular rejection, received 1st dose of Prevnar on 12/5/01 during a routine cardiac catheterization while under general anesthesia. The Prevnar administration was "immediately" followed by a dose of morphine sulfate (ESI Lederle). Approx. 30-60 seconds, post vax, the pt developed hypotension and "very pronounced" and "unusual" ST segment changes that resolved after approx. 5 minutes, without treatment. The attending cardiologist suspected administration of morphine sulfate and other unspecified anesthetic agents combined with the pt's lack of "proper" cardiac innervation and circulatory compensatory feedback as a cause of the events. The reporter noted that the pt's acute cellular rejection may have contributed to the ST segment changes. The reporter indicated that the events were "unlikely to be related" to Prevnar administration. Hypotension and ST segment changes were considered to be "Other Important Medical Events". Follow-up information received from the physician on 2/01/2002 identified the patient as a 6-year-old male. The physician idicated that the ST segment changes in lead V2 normalized after the patient's blood pressure normalized. The reportered noted that the patient's acute cellular rejection (3A) was determined by the results of an endomyocardial biopsy performed on 12/06/2001. The reportered considered the events to be life-threatening.
After receiving the influenza vaccine, patient began to feel progressively more fatigued, as well as to feel subjective fevers, chills, headache, nausea, and muscle aches, prompting an ER visit on 11/29. He was found to have elevated CK to 1015 and was admitted for rhabdomyolysis. Of note, he has a history of prior elevations of CK and has required workup for a myopathy/myositis of unknown etiology.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 29-AUG-2017 the patient was vaccinated with VAQTA lot # N012324 for prophylaxis. Other suspect therapies included ROTATEQ, PEDVAXHIB and M-M-R II (rHA). Concomitant therapies included sterile diluent. On 29-AUG-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage to be not related to M-M-R II, ROTATEQ, PEDVAXHIB and VAQTA. The reporter considered no adverse event to be not related to ROTATEQ, M-M-R II, PEDVAXHIB and VAQTA. Sender's Comments: US-009507513-1708USA012838: US-009507513-1708USA013542: US-009507513-1708USA013545: US-009507513-1708USA013547: US-009507513-1708USA013548: US-009507513-1708USA013549: US-009507513-1708USA013550: US-009507513-1708USA013551: US-009507513-1708USA013552: US-009507513-1708USA013538: US-009507513-1708USA013537: US-009507513-1708USA013539: US-009507513-1708USA013540: US-009507513-1708USA013541: US-009507513-1708USA013543: US-009507513-1708USA013544.
Incorrect product storage; no adverse event; This spontaneous report has been received from a medical assistant concerning a patient of unknown age and gender.  The patient's concurrent conditions, medical history, drug/allergy reactions, and concomitant therapies, were not reported.  It was reported by the medical assistant that on an unknown date, the administration of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # T032316 with expiration date on 22-SEP-2022) as prophylaxis. The temperature was -12.7 degree Celsius. Time frame: 0 hours, 13 minutes, 0 seconds. There was no previous temperature excursion and the call was not because of "data logger". No additional adverse events were reported, further details were not provided.
45 mins past vaccination experiencing shortness of breath, chest tightness/lump in throat feeling squeezing/heart palpitations. not wanting to move around at all due to chest discomfort.  heartbeat over 100 bpm resting shortness of breath relieved with inhaler went home and went to bed, chest tightness and palpitations through the night, along with chills/aches/  injection site pain and elevated temp 99.8 F persisted through evening and improved next day @ 98.4 F  urgent care visit, feeling better, vitals in normal range, suggested EKG/ER to be sure no heart issues went to GP for EKG 3/10, EKG normal, vitals good
pt recv vax & exp rash which burned on the top of feet which spread to trunk & breast, then to neck; also exp aching; recovered in 4-5 days;
TONGUE HURTS TO CHEW AND EAT; This spontaneous report received from a patient concerned a 72 year old male. The patient's height, and weight were not reported. The patient's past medical history included hip replacement surgery on right side, and concurrent conditions included smoker, and non alcoholic, and other pre-existing medical conditions included the patient had no known allergies, and drug abuse or illicit use. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, and batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. Concomitant medications included gabapentin for post hip replacement pain, and methadone for post hip replacement pain. On 16-MAY-2021, the subject experienced tongue hurts to chew and eat. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from tongue hurts to chew and eat. This report was non-serious.
rash itched; Broke out into a rash the circumference of a tennis ball around the vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (rash itched) and VACCINATION SITE RASH (Broke out into a rash the circumference of a tennis ball around the vaccination site) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced RASH PRURITIC (rash itched) and VACCINATION SITE RASH (Broke out into a rash the circumference of a tennis ball around the vaccination site). On 17-Feb-2021, RASH PRURITIC (rash itched) and VACCINATION SITE RASH (Broke out into a rash the circumference of a tennis ball around the vaccination site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: contact information updated
Patient called and stated at 1 am he woke up with chills all over his body, then broke out in a fever which lasted about an hour. When fever broke he was extremely tired. He was in bed the next day because he was exhausted.
Symptoms of brachial neuritis on side of injection. 11/13/07-office notes for DOS 10/25/06-received-DX: allergic rhinitis.  11/14/07-records received for DOS 10/26-11/1/07-office notes-presented on 10/26/07 with pain left arm, shooting pain shoulder to elbow, elbow to 5th finger. Dull pain. No swelling, warm, or tenderness. No weakness. DX: brachial neuritis secondary to vaccination. 11/1/07-brachial neuritis resolved.
Immediately after receiving MenQuadfi patient stated, she felt sick and dizzy.  Afterwards she stated she felt her eyes "go black" for a couple of seconds. She did not faint but did vomit. After recovering she did receive Tdap in lying position. She had no issues directly after vaccine and rested for 10 minutes. While out at the desk she started feeling dizzy and had another feeling of her eyes "going black". She did not faint. She rested for about 15 minutes and was able to leave the clinic with no issue.
Throat swelling/closing feeling, outcome is anxiety, will take hydroxyzine. Feeling of throat swelling, throat closing
Severe pain at injection site and all through upper arm, headache, body aches, nausea, exhaustion, and fever.
No Adverse event. On 11/03/2021 the Vaccine Refrig data logger showed a temperature excursion occurred on 10/29/2021 at 10:48 a.m. of +50.7 (F). The timeframe documented is 13 mins with n 5 min alarm notification totaling 18 min. The vaccine providers were not aware that the vaccine needed to be used within a 24 hour timeframe of the excursion prior to discussion with the health department on 11/3/2021. A clinic was scheduled for Moderna Booster doses at a School for their employees for 11/1/2021. This clinic did occur with the Moderna Vaccine with Lot # 076C21A between the hours of 3:00-5:00 p.m. A total of 16 people received Moderna Booster shots 0.25ml.  The vaccine provider learned on 11/3/2021 in conversations with the health department that due to the excursion, the vaccine should be discarded if not used within 24 hours of the temperature excursion. With the instructional education provided via the health department, all remaining doses of Moderna with Lot# 076C21A was wasted.
Mother stated child's Left arm very red, swollen and tender to touch. Stated child never complianed until mother touched his arm.
These symptoms started at various times and have gotten progressively worse...seizures (especially when tired or stressed), migraine headaches, IBS, tingling in hands, joint aches, endometriosis, tiredness, temper outbursts, severe menstual cramps, excessive menstrual bleeding, 2 exploratory surgeries to determine cause of abdominal pain, sensitivity to light and temperature differences.
1st dose 3/22/2021 mild sore arm fatigue. 2nd dose 4/19/21 mild sore arm fatigue. Booster dose (3rd) 10/20/21 extremely sore arm, difficulty/pain with range of motion, sleepless nights extreme pain. Used ice, heat, moist heat, non narcotic pain medication, lidocaine patch and icy hot all of which give very mild symptomatic relief.
Information has been received from nurse concerning a 21 year old female patient who on 22-NOV-2010 was vaccinated with the first dose of GARDASIL (Lot #, expire date and route not reported). An hour and 15 minutes after receiving the first dose of GARDASIL, the patient went to the emergency room with severe pain in her leg and the patient was treated with ibuprofen. Patient still had leg pain. Patient also started experiencing low back pain as well, and later, armpit pain. At the time of the report, the outcome of low back and armpit pain were unknown. No further information is available.
swelling and soreness on the injection site; swelling and soreness on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (swelling and soreness on the injection site) and INJECTION SITE PAIN (swelling and soreness on the injection site) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced INJECTION SITE SWELLING (swelling and soreness on the injection site) and INJECTION SITE PAIN (swelling and soreness on the injection site). At the time of the report, INJECTION SITE SWELLING (swelling and soreness on the injection site) and INJECTION SITE PAIN (swelling and soreness on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Symptoms: fever, nausea, vomiting, fatigue, aches, flu-like symptoms. Time Course: 2 days.
Large lump (granuloma) at DTap injection site.  Patient had similar reaction after ~4 month booster for DTap.
24hr p/vax twenty five cent size red hard area-sterile abscess;4 days later seen by MD &ATB given;
rash on chest; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on chest) and VOMITING (vomiting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No medical history information provided.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and METOPROLOL for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced RASH (rash on chest) and VOMITING (vomiting). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 08-Mar-2021, RASH (rash on chest) and VOMITING (vomiting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This spontaneous report was received from a nurse regarding a 1-year patient of an unknown gender. The patient's concurrent conditions and medical history were not provided. On 14-JAN-2019, the patient was vaccinated with an improperly stored of VARIVAX (route of administration, indication and dose were not reported) for prophylaxis (lots # and expiration dates: R018777, 07-JUL-2020; R017641, 20-JUN-2020; R013563, 13-MAY-2020), however, it was unknown which specific lots the patient received. The sterile diluent used to reconstitute the vaccines was stored properly. No adverse effects were reported. The vaccines were exposure to a temperature excursion of 9°C to 25°C (9.2°C) during 2 hours which was called by a data logger. There was not previous temperature excursion. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA005742: US-009507513-1901USA005741: US-009507513-1901USA005740: US-009507513-1901USA005739: US-009507513-1901USA005573.
right sided facial numbness that started same night of vaccination about 8-9 hours after, lethargy that started right away
This case was reported by a consumer via call center representative and described the occurrence of fever in a adult patient who received SHINGRIX for prophylaxis. On 13th December 2018, the patient received the 2nd dose of SHINGRIX. On 14th December 2018, 1 days after receiving SHINGRIX, the patient experienced weakness generalized, feels awful, tiredness and general body pain. In December 2018, the patient experienced fever, chills and muscle pain. On an unknown date, the outcome of the fever, chills, muscle pain, weakness generalized, feels awful, tiredness and general body pain were unknown. It was unknown if the reporter considered the fever, chills, muscle pain, weakness generalized, feels awful, tiredness and general body pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had fever, chills and muscle aches all night. On the day of reporting, the patient had sore all over and was extremely tired. The patient asked how long they could expect to feel this way.
8/26/21 10:00 PM - tired 10:10 - Chills, go to bed 10:30 - 98.6 11:00 - 100.5 11:25 - 101.7 11:30 Chills stopped 8/27/21 12:00 AM  - 102.7  1:30 - 102.3 4:15 - 101.1 Daytime ~100.8 sleeping most of the day 6:15 PM - 102.2 8/28/21 12:15 AM - 102.8 muscle and joint aching begins 3:15 100.9 7:30 100.3 8:15 liquid diarrhea 10:30 - 99.8 11:00 - 99.5 11:30 last episode of diarrhea 3:15 PM - 98.4 10:45 normal 97.7 temperature 8/29/21 Normal BM - all symptoms subsided
Patient received DTaP #4 and Prevnar #4 on January 2, 2007 and DTap #5 and Prevnar #5 on February 7, 2007.  After vaccines, patient had fever over night of 101, pain at injection site, very mild edema. no erythema or echymosis
After the vaccine I started to feel burning pain in my right shoulder. It will radiate down my arm. It will travel up my neck and cause major headaches. I have tried over the counter pain relivers, ice, heat and nothing will help. I will also stretch and massage with no relief. It has caused so much pain I cannot sleep. I went to the doctor because my right lymph node is extremely swollen and tender. She believes it is an adverse reaction to the vaccine.
Swelling of the throat, swelling of the eyes, redness of the eyes, swelling of the face lips tongue & inside of mouth.
Information has been received from a consumer concerning her approximately 17 month old female daughter with a history of "had a high fever" to unknown vaccine by unspecified manufacturer and "hand-foot-mouth night of vaccination to unspecified vaccine or manufacturer but different than the one in which she experienced a high fever" and who experienced sickness, measles, fussiness, fever, and rash while on therapy with measles virus vaccine live (WAES # 0907USA01311) who in the spring of 2008, was vaccinated with a dose of rubella virus vaccine live (Wistar RA 27/3) (dose and lot # not reported). There was no concomitant medication. Subsequently, the patient had an immediate reaction. The specific reaction was not remembered but the consumer did remember it was not as a severe reaction as the one after vaccination with measles virus vaccine live (MSD). The consumer was unsure if her daughter went into the office with this reaction or if the medical attention was over the phone. No lab diagnostics studies were performed. On unspecified date, the patient recovered.
got covid in september, 6 months later, still struggling to breathe, struggle with appetite, anxiety
Pt experienced nausea within 4 minutes of vaccination. Pt denied itchiness or hives.  Symptoms quickly progressed to difficulty swallowing, redness, and notable upper airway swelling. Pt given Epi 0.3 mg IM and taken to ER via wheelchair.
pt cried inconsolably p/vax;crying started 2hrs p/vax & persisted through the noc despite APAP;cont into next 2 days;parents report small fever as well, but did not take temp;
Information was received via Pfizer from a nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On an unknown date, the patient was vaccinated with PNEUMOVAX23 (lot#, expiration date, concentration, route and frequency were unknown) for prophylaxis. On an unknown date, the patient had allergic reaction to PNEUMOVAX23. The outcome of allergic reaction was unknown, and the causality between PNEUMOVAX23 and allergic reaction was reported as related. Additional information is not expected, because the reporter declined to provide further demographics.
Information has been received from a registered nurse at OB/GYN office concerning a 27 year old female who on 10-FEB-2009 was vaccinated with a third dose of GARDASIL.  There was no concomitant medication.  As of 28-APR-2009, the patient was pregnancy.  Her last menstrual period was in February 2009.  It was ultrasound that confirmed the pregnancy and her due date was estimated to be 08-DEC-2009.  The GARDASIL vaccine was not given at reporter's office.  And the OB/GYN will be following her during the pregnancy.  The patient was seen in the office.  Follow up information was received from a registered nurse via initial pregnancy questionnaire.  It was reported the 27 year old female patient with no medical history or concurrent conditions had no previous pregnancies.  Concomitant therapy included prenatal vitamin.  The date of the patient's last menstrual period was 03-MAR-2009, the estimated conception date was 17-MAR-2009, and the estimated delivery date was 08-DEC-2009.  The ultrasound was performed to confirm viability on 22-APR-2009 and the result was the fetus was 7 weeks and 1 day.  Pregnancy and the estimated due date were confirmed.  Follow-up information was received from a physician via outcome pregnancy questionnaire concerning the patient who on 25-NOV-2009, 38 weeks after LMP, delivered a 6 pounds 6 ounces normal female baby.  The Apgar score was 8.1/9.5.  It was reported that the patient experienced maternal preeclampsia during pregnancy (date unspecified).  On an unspecified date during the pregnancy the patient had an ultrasound which was normal and the estimated gestational age (EGA) was reported to be 18 6/7 weeks.  The outcome of the patient was not reported.  Follow-up information was received from a medical record concerning the patient with a history of ear tubes at age 21 who on 25-NOV-2009, at 00:06 am delivered a 2900 g (also reported as 2798 g or 6 pounds 6 and 1/4 ounces) normal female baby.  The patient was induced and delivered the baby vaginally.  She also had an epidural.  The Apgar score was 8/9 (previously reported as 8.1/9.5).  The baby's head perimeter was 13 and 1/4 inches and her chest perimeter was 12 and 1/4 inches.  At 20 weeks pregnancy the patient experienced bleeding.  The outcome was not reported.  Additional information is not expected.
Felt like her throat was closing up. Water was offered and 15 minutes later she reported that she felt better.
temperature of 100.7, chills, headache on the first night.  temperature of 101.1, sweating, and headache on the second night.
This spontaneous report as received from pharmacist via company representative refers to a currently 3 week old female patient. In an approximately June 2013, reported as within 2 weeks of date of birth (also reported as within the past week) the patient was vaccinated with a dose of PNEUMOVAX23 (0.5 ml, once). The patient received an injection of PNEUMOVAX23 within the past two (2) weeks of date of birth. In approximately June 2013 (reported as "within the past week") the patient was kept in the hospital for an unspecified period of time after receiving the vaccine, however no adverse effect was reported. Patient sought medical attention. The action taken and the patient's outcome were not reported. The relatedness between PNEUMOVAX23 the patient's event was not reported. Additional information has been requested.