chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She got her vaccine, had no reaction right away, then probably about 3:00 PM she had slight aching in her upper arm.  She took 2 Tylenol for that.  Then she was OK until later that evening and that's when she got chills, aching, and the headache.  Throughout the night she had the chills most of the night, and at 3:00 AM she fell asleep.  When she got up in the morning she felt much better.  The arm never hurt her at all.  She was very very tired and slept almost all of Sunday afternoon.  She then noticed some pimples popping up and every day there was 1-2 more.  She went to the UC and they told her that she had small vesicular rash noted.  This was most likely related to the shingles vaccine. She got a topical cream called Betamethasone Dipropionate 0.5%.  She used it just about an hour ago and it is supposed to help the itching as it was just awful.  She was told to FU with her doctor.  She did call her doctor and told the receptionist what she had done, and that she went to the UC, and she said that she would relay the message to her doctor.  She has also been taking Benadryl for the itching but has not taken it as she was given this new medication.
Started that night. Woke up about 1 am and had a fever, chills, and muscular soreness throughout my whole body. Spent the following day in bed as I couldn't even get out of bed , my body was that sore. Did not feel better until 2 days later
sore throat; anorexia; feel sick again; Fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), DECREASED APPETITE (anorexia), MALAISE (feel sick again), FATIGUE (Fatigue) and HEADACHE (headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Past drug history reaction- Allergy.).    On 28-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2022, the patient experienced OROPHARYNGEAL PAIN (sore throat), DECREASED APPETITE (anorexia), MALAISE (feel sick again), FATIGUE (Fatigue) and HEADACHE (headache). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 16-Apr-2022 to 20-Apr-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (sore throat), DECREASED APPETITE (anorexia), MALAISE (feel sick again), FATIGUE (Fatigue) and HEADACHE (headache) had not resolved.            Concomitant medication was not reported. Patient got sick after full course of Paxlovid. Patient took Paxlovid for five days, got better immediately and seven days after completing course, felt sick again, worse than initial symptoms of COVID.
PATIENT FEINTED UPON STANDING UP AFTER WAITING 15 MINUTES AFTER HER VACCINATION. SHE WAS CAUGHT BY STAFF BEFORE SHE HIT THE GROUND.  EMS WAS CALLED. SHE REGAINED CONCIOUSNESS AFTER 30 SECONDS. EMS ARRIVED AND CHECKED VITAL SIGNS AND PERFORMED EXAMINATION. PATIENT DECLINED TO BE TAKE TO HOSPITAL.  SHE LEFT ON HER OWN POWER A SHORT TIME LATER
Pt had swollen red area on 11/1/2006 came home from school told mother that arm hurt from other child hitting him but teacher stated that no child hit him.  Mother concluded that mmr and dtap in arm made it swell and turn red and hard. mother gave child benadryl, tylenol, and motrin since 11/01/2006 child also has had a cold x1 week that mother has been treating with otc meds.
Increase joint pain. Bruise noted (R) subluxed shoulder. Death - 4 days later.
temporary loss of smell/taste; temporary loss of smell/taste; This is a spontaneous report from a contactable consumer (patient). A 24-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: ep6955), via an unspecified route of administration, on 26Mar2021 at 11:00 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced temporary loss of smell/taste on 26Mar2021 at 23:00. The events were reported as non-serious. The events occurred 12 hours after vaccination and was reported to have lasted 8 hours. The patient underwent lab tests and procedures which included COVID-19 nasal swab: negative on 27Mar2021. The patient did not receive any treatment as a result of the events. The clinical outcome of temporary loss of smell/taste was recovering.  No follow-up attempts are possible. No further information is expected.
Reaction on the skin started 12th March 2021 until the end of March. I had pain, itching and rash. I had blisters all over my body.
Difficulty breathing, extreme light headed ness, heart palpitations (heart rate jumping from 60 to 105bmp) while sitting eating lunch. Arm is still sore 8 days later, heart still beating hard and faster than usual 8 days later.
Patient is an 85-year-old male with past medical history of myelofibrosis (on hydrea), CKD stage III, who has been fully vaccinated and boosted for COVID. He tested positive for COVID on 1/3/22, with fevers, poor PO intake cough, and shortness of breath. He attempted to get monoclonal antibodies as an outpatient but was unable to get them. He presented to the ED on 1/12/22 and was found to be hypoxic. CXR consistent with COVID pneumonia. He was started on dexamethasone and remdesevir. Due to his fevers, elevated WBC count, as well as elevated procalcitonin, there was concern for superimposed bacterial pneumonia and so he was started on rocephin and doxycycline as well. He was given lovenox for DVT prophylaxis. CRP and D dimer down-trended. He was able to be weaned off oxygen, initially required 2L by nasal cannula but this was weaned off on 1/16/22. He was able to maintain O2 saturaitons in the 90's on room air with ambulation. On 1/16/22, he was feeling well, denied cough, shortness of breath, or fever. He was requesting discharge. His vital signs and lab work remained stable. He was given his final dose of rocephin to complete a 5 day course. He had one more evening dose of PO doxycycline and requested this be sent to his outpatient pharmacy. Dexamethasone and remdesevir were discontinued upon discharge. He was instructed to contact his PCP for a follow up visit. Discharge instructions and medication changes were reviewed with the patient and he expressed understanding. He was discharged in stable condition, with arrangements for home PT.
Injection pain at site; Itching; This non-serious case was reported by a nurse via sales rep and described the occurrence of injection site pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: Injection pain at site) and pruritus (Verbatim: Itching). The outcome of the injection site pain and pruritus were not reported.   It was unknown if the reporter considered the injection site pain and pruritus to be related to Shingrix.     It was unknown if the company considered the injection site pain and pruritus to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR052438   Additional Information: GSK receipt date: 09-Apr-2023 The patient self-reported this case The patient had some itching and injection pain at site. The reporter consent to follow up. For tolerance of 2nd dose, refer case US2023AMR052438. This case was one of 3 cases, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR052438:Same reporter US-GSK-US2023052528:Same reporter
14JAN 3 PM: Received Moderna COVID-19 vaccination. 15JAN 10 PM: Sudden onset severe lower abdominal pain, diarrhea, and chills. Moderate nausea and vomiting. Diarrhea and vomiting ended 16JAN at 1 AM.  16JAN 11 AM: Urgent care visit. Referred to ED to rule out diverticulitis/bowel obstruction. Given IV saline and acetaminophen. Told it was "stomach bug." Diagnoses: vomiting and diarrhea, diverticula of colon. Sent home. 17JAN all morning: Severe lower abdominal pain, diarrhea, and chills. No nausea and vomiting. Returned to ED. Given IV saline, benadry, fentanyl, inject dycyclomine. Diagnoses: general abd pain, body aches, chills. Sent home. 18JAN: abdominal ache with tenderness and diarrhea. 19JAN: recovering.
In November of 2022 I began to have fever in the middle of the night. The following night I had a fever again and a stuffy nose. I was unable to reach my doctor until the next Monday but I tested positive for COVID-19 on a home test.
Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included Alzheimer's disease.    On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm pain). At the time of the report, PAIN IN EXTREMITY (Arm pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment reported was Tylenol.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
2 expired doses of moderna covid-19 vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 expired doses of moderna covid-19 vaccine administered) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (2 expired doses of moderna covid-19 vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2 expired doses of moderna covid-19 vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  HCP states that when they received the shipment a expiration date of 25 May 2022 was entered into the system.. The actual expiration date was 05 May 2022. Vial was stored in freezer and taken out of freezer on 06 May 2022. Vial did not undergo any temperature excursions. Patient was given 1st booster dose. No treatment information were reported.
10 days after the vaccine I developed a chickenpox looking rash on my back. It did and does not itch and is not painful. I went to Dr and he prescribed Valacyclvir  , 1 gramfor 7 days. Today is day 4 of rash and it continues to spread. It now covers all of my back, most of my chest and belly, neck, head and shoulders
On 12/26 starting at 12 AM - Body shaking/shivering and tingling/pinching sensation of skin on arms and legs lasting until 2 AM. Shortly after aforementioned events subsided hallucinations began. Hallucinations of missing body parts of shoulder and knee ( no pain during hallucinations) continued through 4 AM at which time Tylenol was taking due to development of headache. Shortly after tylenol was taken hallucinations of being in several different bodies not of his own were experienced. All hallucinations subsided at 5AM. Headache and fever of 99.6  has continued since 5AM . Family doctor has been contacted , no return call as of yet.
Rapid onset of leg weakness. Transverse myelitis and Guillain-Barre like illness with persistent neuropathy. Doubts it is from vaccine. Is improving. Also diagnosed with Urinary retention and constipation.  Follow up:  Final diagnosis (+) Guillain-Barre Syndrome.  Diagnosis was made by a neurologist.  The patient did not experience any other illnesses within the 4 weeks before onset of GBS.  The patient did however experience severe subluxating joints and uneven gait before the onset of GBS.  The patient never had GBS or a related illness.  The patient has previously been vaccinated with influenza."
HCN heard a "thud" in waiting area of agency who immunization clinic held look in area at client on back on floor. Mother and brother beside her. HCN rushed over and asked her if she knew who she was  and said "yes". She was asked if hurt anywhere and hurt in upper chest and stiff neck and upper back. She stated she did not know where she was then within 10 seconds on back.
The heart dropped below and is on around 12%; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. Medical history included a heart working at 18% since the 90s and on medication. Patient was on the donor list for a new heart. The patient's concomitant medications were not reported. On an unspecified date, the patient's heart dropped below and is on around 12% then they took her off from the donor list. Outcome of the event was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  ACUTE DVT OF UNSPECIFIED VEIN IN PREGNANCY, THIRD TRIMESTER
2 days after receiving the 1st dose of the Pfizer vaccine for COVID-19 I awoke to a loud ringing in my ears. The tinnitus has persisted for over 10 straight days now.
Highest temp measured 102, local rxn @ inject site, high pitched abnormal crying/screaming lasting greater than 4 hrs;
This spontaneous report as received from a certified medical assistant refers to 3 patients of unknown age and gender with no pertinent medical history, drug reactions or allergies reported. On 18-MAY-2015, in the afternoon, 2 of the patients were vaccinated with a dose of GARDASIL lot # K007264, expiration date: 02-MAR-2017 (route and dose were not provided) which was improperly exposed to 19.2 Fahrenheit (F) for 17 minutes in the early morning of the same date. On 28-MAY-2015, in the afternoon, another patient was vaccinated with a dose of GARDASIL lot # K007264, expiration date: 02-MAR-2017 (route and dose were not provided) which was improperly exposed to 31.5  F for 6 hours and 5 minutes in the early morning of the same date. No known adverse effects were reported. This is one of two reports from the same source. Additional information has been requested.
Vaccine administered in left deltoid on Jan 27, 2014. That night patient states that her arm started to hurt, became red, hot and hard. Next day went to the ER and was treated for cellulitis of her left arm with antibiotics. After starting antibiotics arm healed completely and has no concerns at this time.
pt recv vax c/o stinging p/inj;returned to RN about 45min later c/o pain rt side on neck/shoulder & numb like feeling in rt arm & hand;rt had cool to touch & weaker rt grasp then lt hand;rt inj site appears ok;
A report has been received from a Pharmacist concerning subject of unknown gender, who had been receiving nasal FLUMIST Quadrivalent. Single administration. FLUMIST Quadrivalent started on 09-DEC-2014. Pharmacist reports 30 patients received expired FLUMIST Quadrivalent from 9-DEC-2014 to 30-DEC-2014. Pharmacist also states it was due to the European styled expiration date on the product. Individual patient information and specific dates of administration not available at this time. Contact was made for follow up information concerning expired FLUMIST administration. He stated that there were only 3 doses of expired FLUMIST given and it was not 30 patients who received expired FLUMIST Quadrivalent. He told that the nurse checked their inventory and there were 3 doses of expired FLUMIST Quadrivalent administered to the patients and none of them reported any adverse events. FLUMIST Quadrivalent was discontinued on 30-DEC-2014. The outcome of the event expired FLUMIST Quadrivalent administered to 30 patients is unknown. The report was considered to be non-serious. Follow-up of insignificant information received 03-MAR-2015 from pharmacist. Case opened during log step,no new information to add. Narrative updated.
Short lasting Virtigo. Sudden hearing loss in right ear. Loss of tones over 4000hz. Hearing loss has not changed
High fever, chills, shaking and cold feet for 2 days.  Eyelashes started falling out and developed some bumps on inside of right bottom eyelid
rash on face,neck & upper chest. eyes red, burning. watery. slight headache,  lower back pain.  Going away slowing almost gone have not gone back on xeljanz.  seeing  rheumatologist on 4-22
Janssen COVID-19 Vaccine EUA.  Headache, fever (99.5 degree F), fatigue, sore injection site, sore left arm, forgetfulness,
24 hrs following vax pt was lethargic & had dec appetite; also sl temp elevation noted; next day pt vomited x 3 in a 1 1/2 hr period of time; had sl erythema @ inject site LA 10JUL; pt recovered x/sl fatigue noted by mom;
On 4/18/21 the day after receiving my second Pfizer vaccine. I awoke fatigued and with a sore right arm and fever of about 99. The fatigue increased, and then included extreme thirst despite drinking plain water throughout the morning and early afternoon, then I experienced slight nausea, then syncope after attempting to sit for a few moments, after having been resting (in a prone position) around 1 pm.  My husband was unable to revive me - he says my eyes were open but I was not responsive so he called 911. I regained consciousness after receiving saline via IV and then was taken to the ER for follow up testing, then released a few hours later - around 4 pm.  It it likely relevant to know I had passed out from fever brought on by flu during the very harsh flu season a few years before, at the onset of influenza, although vaccinated that year for flu.
Information has been received from a 23 year old female with penicillin, ibuprofen, and Amoxicillin allergy and a history of temporomandibular joint disorder who was vaccinated with GARDASIL in 2007 and in July 2007 after the third dose she went to the emergency room because her jaw locked. The therapy started at "the beginning of 2007". There was no concomitant medication. The consumer reported that she did not stay over night but they gave her anesthesia at the hospital and knocked her jaw back in place. The consumer reported that about four months ago she had her latex gloves on, since she works at a dentist office, and later that night her throat closed up and she went to the emergency room and was there for 6 hours and was given corticosteroids (manufacturer unspecified) and BENADRYL (manufacturer unspecified) and then she was fine. The consumer reported that another time her throat closed up again and at the hospital they gave her an epinephrine (manufacturer unspecified) pen and then she was fine. There were no labs and diagnostic tests performed. This is one of several reports received from the same source. Upon internal review the event of throat tightness treated with an EPI pen was considered to be an other important medical event. No further information is available.
Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Severe, Additional Details: PT FAINTED AFTER FEW MINUTES IN OBSERVATION AREA. LOST CONSCIOUS AND SEEMED TO BE HAVING A SEIZURE, LASTING A FEW SECONDS. SHE REGAINED CONSCIOUSNESS AND STATED SHE HAS HISTORY OF VASOVAGAL RESPONSES/FAINTING. PARAMEDICS WERE CALLED AND UPON ARRIVAL, SHE BEGAN TO HAVE ANOTHER SEIZURE. GIVEN IV FLUIDS/MEDS AND TRANSPORTED OUT OF PHARMACY IN AMBULANCE.
first two shots were Pfizer and third dose as Moderna; first two shots were Pfizer and third dose as Moderna; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first two shots were Pfizer and third dose as Moderna) and INTERCHANGE OF VACCINE PRODUCTS (first two shots were Pfizer and third dose as Moderna) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first two shots were Pfizer and third dose as Moderna) and INTERCHANGE OF VACCINE PRODUCTS (first two shots were Pfizer and third dose as Moderna). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first two shots were Pfizer and third dose as Moderna) had resolved and INTERCHANGE OF VACCINE PRODUCTS (first two shots were Pfizer and third dose as Moderna) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient took his first dose of Pfizer COVID-19 Vaccine on 07-JAN-2021 and second dose on 06-FEB-2021. No concomitant medications were reported. No treatment medications were reported.
After vaccination for couple minutes, patient felt dizziness and fainted and fell.  911 was called and ambulance dispatched to the pharmacy. Before ambulance arrived, breathing is heavy and blood pressure was measured with readings of 92/51.  Patient complaint of dizziness and hot.
Sore Shoulder, could move arm back and forth but unable to lift arm up without using other hand, PCP prescribed Medrol dose pack.
No adverse effects; patients received improperly stored vaccines; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 24-JAN-2019, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0,5 milliliter injection, intramuscularly, lot # R011632, expiration date 02-FEB-2020 (dose, and anatomical location were not reported) for prophylaxis.  The reported vaccines were exposed to the temperature of 35.4 degrees Fahrenheit for 32 hours and 30 minutes. No previous temperature excursions were reported. A digital data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA014098: US-009507513-1905USA014099: US-009507513-1905USA014106: US-009507513-1905USA008566: US-009507513-1905USA014102: US-009507513-1905USA014103: US-009507513-1905USA014104: US-009507513-1905USA014105: US-009507513-1905USA014097: US-009507513-1905USA014096: US-009507513-1905USA014100:
Mild queasiness and fatigue at first (Tuesday). Rash/hives all over my body, especially around neck. No rash at injection site. Very itchy. Small raised red bumps.  Benadryl a few times daily. Aveeno baths nightly. Rash has mostly receded now, but still very itchy.