chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient stated she was experiencing difficulty breathing, numb face, and chest tightness after her 3rd Moderna vaccination. Pharmacy called paramedics, who examined patient upon arrival. Per paramedics, patient has uncontrolled hypertension due to not taking her medications. Patient stated she just moved to the area and did not have her medicine on her. Paramedics explained to patient that she was not having an allergic reaction to the vaccine, and brought patient to hospital for care.
Influenza seasonal vaccine. Unknown manufacturer. Involuntary muscle spasms and fasciculations throughout body.
This spontaneous report as received from a medical assistant refers to a 6 month old male patient. No information regarding the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 21-DEC-2016 the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # M016238 and expiration date: 07-DEC-2017), (dosing regimen and frequency unknown) orally for prophylaxis (product storage error). The ROTATEQ vaccines were stored between 44 Fahrenheit degrees (F) and 77 F for 45 minutes. There was no previous temperature excursion. There was no previous temperature excursion. The medical assistant also stated that a data logger was involved on 23-OCT-2017 that prompted her to call the company. This is one of the many reports from the same source. Sender's Comments: US-009507513-1710USA012197; US-009507513-1805USA007925; US-009507513-1805USA007926; US-009507513-1805USA007927; US-009507513-1805USA007928.
Extreme swelling, itching, and warmth.  Began 9 day course of Steroids on 10/23/2012 after visiting the Urgent Care.
Flu-ish; Sick-ish; Back ache; Burning in the pelvic area; Bloated; Feeling shaky; Headache; Chills; Nausea; A spontaneous report was received from a consumer concerning a 72-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events flu-ish/ influenza like illness, sick-ish/ sickness, headache, nausea, back ache/back pain, chills, burning in the pelvic area/ pelvic pain, bloated/ abdominal distension, feeling shaky/ nervousness  The patient's medical history included chronic UTI, interstitial cystitis. Allergies included antibiotic allergy No relevant concomitant medications were reported.  On 6 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 028L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient experienced the events flu-ish, sick-ish, headache, nausea, back ache, chills, burning in the pelvic area, Bloated, feeling shaky. No lab data were provided. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events flu-ish, sick-ish, headache, nausea, back ache, chills, burning in the pelvic area, Bloated, feeling shaky was unknown.
Patient received COVID-19 Pfizer-BioNTech vaccine dose 1 on 11/23/2021 and COVID-19 Pfizer-BioNTech vaccine dose 2 on 12/14/2021. Patient received Moderna booster dose (0.25ml) on 08/22/2022.
Patient reported loss of appetite and loss of energy one day after receiving flu shot, and cough two days after receiving flu shot on September 10, 2020
she tested positive for covid; fever/a low grade fever; had congestion; achiness; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age (reported as 42, unit unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 27Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer covid-19 vaccine on Saturday 27Feb2021. She began showing the regular side effects and had congestion, fever and achiness and a low grade fever in 2021. She stated that the fever increased and she tested positive for covid on Tuesday 02Mar2021. She had antigen therapy and wanted to know if it was appropriate for her to get the second dose and what was the timeline. Therapeutic measures were taken as a result of she tested positive for covid. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Pt experienced nausea, vomiting,, and heartburn after vaccination on 4/27.  He awoke on 4/30 with chest pain, intermittent-radiating to his back at times.  His troponin level was elevated, he was admitted for treatment of myopericarditis.  He stayed for 7 days inpatient and was discharged home on 5/7/21.
FAINTED 20 MINUTES AFTER RECEIVING COVID19 VACCINE, SWEATING, UNRESPONSIVE. CALLED 911, EMTs ARRIVED IN LESS ABOUT 6 MINUTES. SHE COMPLETELY REVIVED ON HER OWN, EMT CHECKED HER VITALS, RELEASED HER, SHE WALKED OUT ON HER OWN POWER ALONG WITH HER TWO FRIENDS. CALLED HER AN HOUR LATER AND SHE WAS REPORTED TO BE DOING WELL.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Flushed / Sweating-Mild
Intense shoulder pain, requiring an emergency room visit, a doctor's office visit. Physical therapy, cortisone injection and acupuncture. I still have the pain. I cannot move my arm behind my back.
Patient presented to Hospital by his family for worsening lethargy, SOB, and fatigue.  Patient was admitted with acute on chronic combined CHF.  Patient initially admitted to ICU for BiPAP.  CT PE showing signs of pulmonary edema, pericardial effusion, and pleural effusion.  CT head negative.  EKG negative for acute ST/T ischemic wave changes.  Patient was admitted to hospital services for further management and evaluation of acute hypoxic respiratory failure to acute on chronic combined systolic and diastolic CHF.  Patient then tested positive for Covid 19 on 01/03/2022 and expired on 01/04/2022.
anaphylactic reaction/"full anaphylactic reaction"; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (anaphylactic reaction/"full anaphylactic reaction") in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (almost killed her) in March 2021, Fertility decreased female and Surgery in February 2021. Concurrent medical conditions included Food allergy (Severe food allergies). Concomitant products included LITHIUM ACETATE, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), MESTEROLONE (RESTORE [MESTEROLONE]), DESVENLAFAXINE SUCCINATE MONOHYDRATE (PRISTIQ), TROMETAMOL (TROMETHAMINE), AMLODIPINE BESILATE, ENALAPRIL MALEATE (SINERGEN), PARACETAMOL (TYLENOL) and TIZANIDINE HYDROCHLORIDE (ZANAFLEX) for an unknown indication.    On 30-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced ANAPHYLACTIC REACTION (anaphylactic reaction/"full anaphylactic reaction") (seriousness criteria hospitalization and medically significant). The patient was treated with METHYLPREDNISOLONE SODIUM SUCCINATE (SOLUMEDROL) for Breathing difficult, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; METHYLPREDNISOLONE for Adverse event, at an unspecified dose and frequency and EPINEPHRINE (EPIPEN) for Adverse event, at an unspecified dose and frequency. At the time of the report, ANAPHYLACTIC REACTION (anaphylactic reaction/"full anaphylactic reaction") outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, Heart rate: increased (High) increased.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company comment: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the other events, a causal relationship cannot be excluded.  Anaphylactic reaction is consistent with the product known safety profile.  The event of product dose omission is assessed as not applicable   Most recent FOLLOW-UP information incorporated above includes: On 02-Sep-2021: Significant follow-up appended: New events added, seriousness updated and treatment medications were included.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the other events, a causal relationship cannot be excluded.  Anaphylactic reaction is consistent with the product known safety profile.  The event of product dose omission is assessed as not applicable
Developed a flat rash approximately the size of a hand in the middle of chest. Area itches with perspiration and is still present 3 years later. Shaving area does fade the rash. Has not tried any topical or systemic remedies. Also developed mirgraine headaches. Has the headache approximately 1 time per week. Ibuprofen 400-800mg alleviates headache. (This information was taken via a phone call. Patient was not examined)
Appr 3-4 hrs p/vax PT became irritable; shrill cry for 1.5 hrs; calmed down p/APAP 0.4ml; repeated dose in 4 hrs; no problems since;
pt became fussy & would not take bottle; about 530-6PM mom noticed breathing was shallow & would stop breathing for a few second about 7PM noticed legs (both) were fire engine red & would scream each time was moved; APAP given; taken to ER
Miller - Fisher Syndrome. Respiratory failure.  12/07/2007 MR received for DOS 11/18-29/2007 with DX:  Miller-Fisher Syndrome.  Pt expired on 11/29/2007.  Progress note 11/28/07 states " diagnosis of brain death due to massive intracranial hemorrhage". Pt presented to ER on 11/18/07 with fever and progressive lower extremity weakness and swelling of the R side of face associated with weakness and numbness.  Admission PE (+) for multiple superficial skin ulcers, bilateral conjunctival hemorrhage R>L, L eyelid ptosis, R-sided facial weakness motor function 2/5 in lower extremities and nystagmus. Neuro consult  11/19/07 reports that pt developed double vision, trouble walking, and weakness 2 weeks s/p vaccination.  PE (+) for 3rd and 6th cranial nerve palsy, ataxic gait, and absent DTRs. No respiratory problems at that time. Later that day pt developed agonal respirations and respiratory distress and mental status changes. Dx: Acute Respiratory Failure. Intubation was attempted and pt placed on ventilator.  On 11/22/07 pt developed fever and started on abx. By 11/23/07 pt was unresponsive and developed myoclonic activity.  On 11/29/07 pt was removed from life-support with dx of brain death due to massive intracranial hemorrhage. 12/07/2007 Death summary received as above.  Final DX:  Massive cerebrovascular accident with subarachnoid hemorrhage.  Brain dead with flat EEG and (+) apnea test.  Bactermia with enterococcus faecalis and coagulase-negative staphylococcus.  S/P comatose state.  Miller Fisher Syndrome on admission.  pemphigus vulgaris. S/P respiratory failure.  01/11/2008 Death Cert received.  Immediate COD:  Cerebrovascular Accident-Approximate interval:onset to death-hours.  Ascending Polyneuropathy-onset to death: days.  Pemphigus-onset to death:  years.
Information has been received from a certified medical assistant concerning a 4 year old male patient with a history of contact dermatitis at 18 months of agae who on 28APR2000 was vaccinated in the left arm with a first dose of varicella virus vaccine live (lot no. 632724/0087K). concomitant vaccination in the left leg included a third doe of hepatitis B virus vaccine rHBsAg (yeast) (manufacturer unknown) (Lot 1317K). There was no illness at the time of vaccination. On 27APR2003, the patient developed "typical" chickenpox. The patient presented to the doctor's office with approximately 20 widely disseminated vesicular lesions, but no treatment was required. Subsequently, the patient recovered. Additional information is not expected.
Information has been received from a physician concerning a 16 year old female who on 17-JUL-2008 was vaccinated intramuscularly with the second 0.5 ml dose of GARDASIL vaccine (yeast) (lot no. 658219/0755U). After receiving the second dose the patient fainted in the parking lot of the physician's office. The patient was taken back to the office for observation. Subsequently, on the same day, the patient was recovered. Additional information has been requested. 10/08/08 This is in follow-up to report(s) previously submitted on 8/14/2008. Initial information has been received from a physician and follow-up information was received from a medical assistant concerning a 16 year old female with no known allergies who on 17-JUL-2008 at 11:15 AM was vaccinated intramuscularly with the second 0.5 ml dose of GARDASIL (lot no. 658219/0755U) into the left arm. After receiving the second dose, at 11:45 AM, the patient fainted in the parking lot of the physician's office. The patient was taken back to the office for observation. The patient experienced vasovagal syncope, very lightheaded and low blood pressure. After 15 minutes, the patient was stable but she was tired when she left the office. Subsequently, on the same day, the patient was recovered. Additional information is not expected.
mom stated pt had rash & sl fever for 2 days approx 1 wk p/receiving MMR
It is still going on, off and on. Left side upper chest pain. Axillary and below the nipple line, where my heart is, it seems. It's like a sharp pain. Sometimes, it hurts more when I breathe deeply. It happens every few days and some worse than others. Some days real painful and some days it just feels kind of weird.
pt recvd vax & was crying for 2 1/2 hrs; muscles became rigid & eyes unfocused;
Airways blocked, unable to breathe, rapid and very loud heartbeat, diarrhea weakness and unable to call or get help. Lasted from 9:30 to after 4:30 AM, at which time I either passed out or fell asleep, woke up at 7:00 AM, surprised I had lived through it.
No additional AE's; A pharmacist stated that an improperly stored GARDASIL 9 was administered to a patient.  No additional AE's and no PQC's were reported.; This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.   On 09-OCT-2022, the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection (quantity 1, lot # W006229, expiration date 15-SEP-2024, strength, dose and route were not reported) to prevent human papilloma virus infection (product storage error). No additional adverse event (AE)'s and no product quality complaint (PQC)'s were reported.
Dose given after vials stored in dry ice box ran out of batteries. Temperature therefore unable to be monitored, thus deemed compromised.
Lump at the injection site; red knot; This case was reported by a consumer via call center representative and described the occurrence of injection site lump in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2020, the patient received Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site lump and injection site erythema. On an unknown date, the outcome of the injection site lump and injection site erythema were not recovered/not resolved.   The reporter considered the injection site lump and injection site erythema to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The patient reported that after she received a Shingrix vaccine in December, she had a lump at the injection site. The reporter did not consent to follow-up. No other information was available.
little nausea; This is a spontaneous report from a contactable Other HCP and contactable consumer (patient). A 77-year-old female reported that she received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: not provided), via an unspecified route of administration on 04Feb2021 (at the age of 77 years), as 2ND DOSE, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experience little nausea. The outcome of the event was unknown. No additional information/details provided.  Information on the lot/ batch number has been requested.  Follow-up attempts completed. No further information expected
Telehealth visit on 6/25/2020 localized reaction. Recommended Ice, Motrin. Skin: 1 1/2 - 1 3/4 size of half dollar midly  red/tender, egg shape L. deltoid.
PATIENT'S ARM SWELLED AND TURNED RED THE DAY AFTER THE IMMUNIZATIONS. PATIENT WAS SEEN BY PRIMARY CARE PHYSICIAN 4 DAYS AFTER IMMUNIZATION ADMINISTRATION. PATIENT GIVEN STEROID TO DECREASE SYMPTOMS.
Day of administration, about 8 hours later, patient developed chills, fever of 101, headache and numbness in both hands.
Severe flu-like symptoms next 3 days after shot. Arm severely red and swollen next several days requiring trip to urgent care and treatment with Ibuprofen 800mg.
This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (CHILLS) and HEADACHE (HEADACHE) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. No Medical History information was reported. On 18-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced CHILLS (CHILLS) and HEADACHE (HEADACHE). At the time of the report, CHILLS (CHILLS) and HEADACHE (HEADACHE) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
poss sz activity, shaking of upper/lower extremities, twitching of face, urinary incont, unresponsive to ?'s, disoriented, hives 24-48 hrs post vax;
Pfizer 2/22/21, 3/15/21. Positive on 1/25/22
Patient had a headache and chills the next morning after vaccine was administered. She was very faint and fell the next morning as well. Patient was in bed most of the day. She hit her cheekbone on floor and has a black/blue bruise but did not seek medical attention for it.
Morning after flu vaccine, woke up with terrible pain, Rt upper arm and shoulder - called Dr. - had X-Ray at hospital - took prescription drugs 2 times - had MRI, physical therapy and orthopedic Dr consult.
27 hours after vaccination, a copious, non-stop rhinitis began. I used up an enormous amount of Kleenex, was miserable, and my nose became very sore. The nasal fluid was clear. I had no nasal congestion, no sore throat, no sneezing, no cough, no fever (98.4F all day). I tried 25 mg of diphenhydramine after about an hour of this?zero effect. By 11:30 p.m. I was desperate, and l found a cold & flu nighttime product in my cabinet: each tablet contains 325 mg acetaminophen, 10 mg dextromethorphan HBr, 6.25 mg doxylamine succinate, and 5 mg phenylamine HCl. I took 2 tablets and slept 8 hr uninterrupted. The rhinitis was gone when I woke up.
Developing non stop diarrhea that is now EPI (prev cases reported) No history of Alcholism, Diabetes, Cystic Fibrosis, Pancreatic Cancer or Pancreatic surgery
None: Expired  covid 19 vaccine  ON 10/25/2022: Given on 01/27/2023
This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with 1 dose of GARDASIL 9, for prophylaxis, that was improperly stored by being exposed to light (route of administration, expiration date and lot number were not provided) No adverse effects were reported.
Information has been received from a physician referring to 14 anonymous patients of unknown age and gender. Patients' concurrent conditions, concomitant medication and medical history were not provided. On unknown dates between 12-APR-2015 and 30-JUN-2015, the 14 patients were vaccinated with expired GARDASIL (lot # H016238, expiry date 11-APR-2015, dose and route were not provided). The physician reported that the GARDASIL had previous temperature excursions on unknown dates and was unable to provide the excursion details at this time. No adverse symptoms were reported. The physician called back on 09-JUL-2015 and provided the names of 14 patients administered improperly stored and expired doses of GARDASIL. Physician did not specify what dose in the GARDASIL series was administered to each patient. One of the patients was administered the vaccine on 18-JUN-2015. This is one of several reports received from the same reporter. Additional information has been requested.
Had issue with allergies that was not pronounced before. Was referred to a specialist allergist. (no allergies other than self, out of balance sinus/immune) auto allergic Was given nasal spray: azelastine and Flonase.
On 10/04/2022 I just felt not one hundred percent I had body aches, headache and pain at the injection site. This lasted a day or two after the injection. On 12/14/2022 I was in bed for two days I vomited I had body aches, chills, sore throat, congestion, sinus pressure, fatigue. On 12/17/2022 I tested positive for the COVID-19 virus.
The patient's family member reported that he has been experiencing double vision and trouble seeing far away since 8 a.m. March 25, 2021.
6x6 area, looks like bruise but doesn't hurt like a bruise, red and purpleish-blue; This spontaneous case was reported by a nurse and describes the occurrence of CONTUSION (6x6 area, looks like bruise but doesn't hurt like a bruise, red and purpleish-blue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer. Concomitant products included TRASTUZUMAB (HERCEPTIN) and PERTUZUMAB (PERJETA) for an unknown indication.    On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced CONTUSION (6x6 area, looks like bruise but doesn't hurt like a bruise, red and purpleish-blue). The patient was treated with DIPHENHYDRAMINE at an unspecified dose and frequency and LORATADINE at an unspecified dose and frequency. At the time of the report, CONTUSION (6x6 area, looks like bruise but doesn't hurt like a bruise, red and purpleish-blue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Sender's Comments: Based on the current available information and the temporal association between the use of the prodcut and the start date of the event a causal relationship cannot be excluded.
Patient called to describe a red splotchy rash on left arm. She stated it had grown since yesterday but was not sure if it was warm to the touch.