chrisvoncsefalvay/vaers-outcomes huggingface dataset:
got really sick; bad headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got really sick), HEADACHE (bad headache) and NAUSEA (nausea) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (got really sick), HEADACHE (bad headache) and NAUSEA (nausea). At the time of the report, ILLNESS (got really sick), HEADACHE (bad headache) and NAUSEA (nausea) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.    This case was linked to MOD-2021-370027, MOD-2021-370043 (Patient Link).
Systemic: Fainting / Unresponsive-Mild, Additional Details: Pt was sitting during observation period got dizzy and  blacked out. She fell off of the chair and we helped her back up and gave her candy, water, and continued to observe her for another 20 minutes. She stated she got a bump on her head and gave her an ice pack to decrease swelling. I called her a day later to make sure she was fine and she said she is ok.
I didn't have any symptoms. My husband was positive, so I kept checking. I completed an at home COVID-19 test on February 16, 2023, and it was positive. I contacted my provider and he prescribed PAXLOVID. A few days after testing positive I felt achy in the afternoon and wanted to sleep. 3 weeks later I developed chest pain and pressure 3 weeks later and I am still attempting to figure out what's going on. They completed multiple EKG's and lab work to see what was going on in the emergency room. My primary doctor ordered a stress test, and the results were abnormal. From there I was referred to a heart hospital which I went to yesterday. They completed an EKG, Lab work, and an Echocardiogram. I am not certain what the results are yet. I am scheduled to have an angiogram done on Monday.  I was told that the bottom part of my heart is not getting enough blood. I was 81mg aspirin and the doctor prescribed atorvastatin. Yesterday they prescribed 3 additional medications. Isosorbide, metoprolol, and nitroglycerine. Since I just started to take the medication, it is too soon to determine whether it is working.
16 TO 17 HRS AFTER VACCINES GIVEN PATIENT DEVELOPED FEVERS, MYALGIS, STIFF NECK, & HEADACHE. PATIENT TREATED SYMPTOMATICALLY AND SYMPTOMS RESOLVED IN 48 HRS.
Generalized arm soreness turned into severe right arm/shoulder pain with limited arm movement.  Prescription provided for Medrol pack (steroids) dues to severed arm/shoulder inflammation.
A report was received from a health care professional on 11/1/02, concerning a male vaccinee older than 60 years who experienced soreness and erythema at the injection site one day after receiving 0.5ml of Fluvirin intramuscularly on 10/25/02. On 26/02, the vaccinee experienced soreness and erythema (5"x4") at the injection site the morning after receiving Fluvirin on 10/25/02. the vaccinee has recovered at the time of the report. The vaccinee received Fluvirin last year without any adverse symptoms. There was insufficient information to determine the reporter's causality assessment. Update (1) 12/18/02: A report was received indicating that the vaccinee was a 62 year old female. The vaccinee also experienced chills and fever which began on 10/19/02 and lasted 1 week. The chills and fever have resolved. There was insufficient information to determine the reporter's causality assessment. Cross reference with: PJP200200672 and PJP200200674.
She presented on 11/6/03 with what appears to be clinical chicken pox which started on 11/5/03 (very mild case).
Information has been received from immunization coordinator concerning a child patient whose mother on unspecified date was vaccinated with 1 dose of GARDASIL, (lot number, dose and site of administration not reported) while pregnant. The child now had autism. At the time of the report the patient's outcome was unknown. Upon internal review, autism was determined to be an other important medical event. The mother's experience has been captured in WAES # 1107USA00366. Additional information has been requested.
Information has been received from a licensed practical nurse concerning a patient who, at 2 months of age, was vaccinated with a first oral dose of Rotateq (human bovine). On 29 Nov 2006, at 6 months of age, the patient was vaccinated with a second oral dose of Rotateq (human bovine). It was reported that no adverse experience was related to the event. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Little toe on left foot became inflamed and slightly swollen. Condition persisted from 9/3/2021 to date. Over last 2 weeks of January 2022 toe developed a blue/purple/red hue, the toe swelled and became increasingly painful to the touch on the PAD side of the toe. The skin began to blister and slough off and the pain level increased significantly as the swelling continued. The situation persisted and an ulcer approximately 3-5mm developed on the toe pad and displayed signs of infection. A topical antibiotic was applied and a prescription of Cephalexin 500mg x 3 times daily regime started on 01/29/2022 with some initial success in reducing the infection. The ulcer has scabbed over and the pain has subsided in part.
The first shot caused soreness in my arm where the injection was made; a rash on both inner thighs/rash on the left side of my face; This is a spontaneous report from a contactable consumer or other non hcp. A 72-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 15Feb2021 14:00 (Batch/Lot Number: EN6201) as 1st dose, single dose for covid-19 immunisation. Medical history included high blood pressure, cholesterol, diverticulosis (it is not active at this time). Concomitant medication included AMLODIPINE and ROSUVASTATIN. The patient was not tested positive prior vaccination. The patient did not have covid prior vaccination. The patient did not have known allergies. The patient experienced the first shot caused soreness in my arm where the injection was made and a rash on both inner thighs/rash on the left side of my face. It was reported that, the first shot caused soreness in patient arm where the injection was made, which went away after about three days. After about 10 days, patient developed a rash on both inner thighs. It cleared up in about 3 days. Patient also had a rash on the left side of my face about the same time. Patient took prescription medicine for high blood pressure and cholesterol. Patient had diverticulosis, but it was not active at this time. No treatment was received. The outcome for the event first shot caused soreness in my arm where the injection was made was recovered on unknown date while for the other event was unknown.  No follow up attempts are possible. No further information is expected.
pt recvd vax & exp rash to cheeks & upper back & swelling to eyes & lips; tongue w/o swelling; airway open; talking; responsive;pt sent home.
Child developed fever less than 24 h after vaccines with temperature max greater than or equal to 104 degrees F. Area of induration and erythema (L) lower ant. thigh c/w influenza site. 48h after vaccine Tmax 103-104 with increase in induration, erythema and exquisite tenderness non fluctuant. CBC D/P, Blood Cx done. Leukocytosis with WBC 21,000. B Cx - neg. Treated with PO Clindamycin at 25mg/kg/d. Resolving & afebrile after 48-72h medication.
10-12 hours post vax, the pt developed fevers, nausea, body aches, headaches, and fatigue.
Had Temp. for 1 week ranging from 99 to 101degrees. Then when temp broke developed red spots on face and over body. It did go away, but does return if she gets hot. Went to Dr. was told it may be 5th disease.
This spontaneous report as received from a nurse refers to 2 patients of unknown age and gender. The patients' medical history was not reported. On 13-SEP-2016, the patients were vaccinated with improperly stored doses of VARIVAX lot # L041204, expiration date 20-OCT-2017 (dose, route and site of administration were not reported). No adverse effects were reported. Additional information has been requested.
Case number PHEH2016US024015, is a spontaneous report initially received from pharmacist on 15 Sep 2016. This case refers to 67 years old female patient. Medical history and concomitant medication were not reported. The patient was vaccinated with a single dose of FLUVIRIN (batch number: 168723, expiry date: not reported) at a dose of 0.5 ml, intramuscularly on 13 Sep 2016. On the same day after vaccination, the patient was dizzy. The patient did not state when the dizziness began only stated since she got the shot. On an unknown date, the patient again felt dizziness. The outcome of the event was reported as unknown. The seriousness and causality of the event were not reported. Follow up information was received from a pharmacist on 15 Sep 2016: Event (patient is dizzy) verbatim and coding were updated.
Feeling crappy; Lungs are pretty bad; Migraine for 3-4 days/migraine was off the charts; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling crappy), LUNG DISORDER (Lungs are pretty bad) and MIGRAINE (Migraine for 3-4 days/migraine was off the charts) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure management.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Feeling crappy), LUNG DISORDER (Lungs are pretty bad) and MIGRAINE (Migraine for 3-4 days/migraine was off the charts). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Feeling crappy) and LUNG DISORDER (Lungs are pretty bad) outcome was unknown and MIGRAINE (Migraine for 3-4 days/migraine was off the charts) had resolved.            Concomitant Medications were blood pressure medication.  No Treatment Medications were provided.  Consumer called to report they received their first dose of the Moderna COVID-19 vaccine 2-3 months ago. Patient did not know if he was feeling this way from the vaccine, or if it was COVID.
Welts, urticaria rash starting under arms 2 hours after flu mist given. It spread to inner thighs, hairline and wrists the same evening. The next day rash spread to breasts. Visited doctor 12/3/04 and placed on Benadryl and Zertec. Still has rash on breasts as of 12/7/04 symmetrical rashes.
This spontaneous report as received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 07-JUN-2011, patient received improperly stored (Oka/Merck) VARIVAX dose 2, from batch/lot # 1564Z (expiry date, dose, units, route and anatomical location were not specified) (incorrect product storage). Concomitant medication were not reported. No adverse effect were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was sufficient data to provided 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from the office manager referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication. On 07-FEB-2019 the patient was inadvertently administered M-M-R II (rHA) lot number R025335 and expiration date of 06-APR-2020 and lot number R001659 with expiration date of 17-JAN-2020 for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported). No adverse effects were reported. The vaccine was exposed to a temperature excursion of 60°F for 60 minutes while the sterile water diluent did not undergo a temperature excursion. There was no previous temperature excursion. A "data logger" was involved. Sender's Comments: US-009507513-1902USA007818: US-009507513-1902USA011925: US-009507513-1902USA011924: US-009507513-1902USA011927: US-009507513-1902USA011923.
5/9/05 Received Menactra vaccine left arm. Started c/o arm itching 5/10/05 3:00PM. Took shower that night and arm swelled to the size of a baseball at injection site. Tx: Claritin, Triamcinolone cream.
Flu; Initial information received on 03-Dec-2020 regarding an unsolicited valid non-serious case from a non-health care professional (patient) via social media.  This case involves involves an adult patient with an unknown demographics, who got flu (influenza), while being vaccinated with INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE(produced by unknown manufacturer) (batch number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date (latency: unknown) after starting the suspect vaccine therapy, the patient got flu (influenza) the very next day. The patient would never again do it.  No laboratory data was reported.  It was not reported if the patient received any corrective treatment. At the time of reporting, outcome of the event was unknown.  There will be no information available regarding batch number in this case.
This spontaneous report as received from a licensed practical nurse (LPN) regarding unspecified patients of unknown demographics. All patient information including concurrent condition, medical history and past drug history were unknown. On an unknown date, the patient was vaccinated with LIQUID PEDVAXHIB, lot number- K015463, expiration date- 09-JUL-2017. No concurrent condition was reported. On an unknown dates, the HIB was exposed to temperatures up to 11.6 degrees Celsius for a total of 63 hours and were given to an unknown number of patients. The outcome of receiving the HIB vaccine that had undergone a temperature excursion was unknown. Additional information has been requested.
Feeling abnormal; Tiredness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling abnormal) and FATIGUE (Tiredness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Feeling abnormal) and FATIGUE (Tiredness). At the time of the report, FEELING ABNORMAL (Feeling abnormal) and FATIGUE (Tiredness) outcome was unknown.
Patient complaining of numbness going from the left arm at injection site to the neck. Zyrtec given 10 mg po. After 10 minutes, patient reported feeling better. VS taken at 1255: 159/73 P 55;  O2 94% ; Second set of vitals at 143/69 P 55, O2 95% on RA. Patient stable, able to ambulate without any problems. Patient discharged from vaccine center to home. Numbness resolved before departure.
On Sunday afternoon noticed redness and itch on inside of arm, from elbow to just below armpit. Also has edema on inside elbow.
04/28/2021 I felt dizzy, after a few days I felt my legs and feet tingly, a few days more and I felt euphoric then depressed, after that I was okay. I might have had some tingling, but nothing too bad. 2 days before May 20th, 2021, I started feeling nervous then I went to ER, due to feeling lack of oxygen , I was  disoriented, dizzy, fainting type of dizzy. I could not breathe, I laid down and I could not breathe and my hands were tingling, then it went away at ER, but then it came back. After that my feet were tingly for days on and then my eyes were twitching, this was 4 days after the ER, 1 week, now I am recovered. I still have some abdominal pain.
Patient was given the VIS for HPV, the provider talked with her for 30 minutes,  CMA asked her the VIS related questions at 10:14am and injected her #1 HPV (Gardasil) at 10:16am. She stated she felt find and okay to get up and walk around 10:18am. She was walked to the lobby to check in for labs. As she went to check in for labs at the front desk, she fainted and hit her head. EMS was called, she was evaluated by providers and RN in clinic until EMS arrived.  She was discharged then passed out again i the car and was taken for second Evalutation.
Feeling of mild swelling of her tongue and eyes, associated with mild itching in her throat. No SOB, No chest tightness, no pain/discomfort with swallowing, no hives, itching. History of allergic reaction to mushroom (anaphylaxis), PCN & shellfish (Hives). Pt stated benadryl usually helps with her allergies. Benadryl administered and pt observed. Time extended for close monitoring. V/S 120/93, Pulse 64, Sat 99% No hoarseness, redness/swelling of the tongue noted. Pt was re-assed and stated "I feel fine now. I think I can drive home now, I live about 5-10 minutes from here".  Patient WAS ADVISED TO GO TO THE NEAREST ER OR CALL HER PCP IF SYMPTOMS PERIST OR GET WORSE
Right leg swelling, right arm ached and I had a headache on my right side, nausea and chills, and felt very tired. I went to the hospital and got an IV, I had 186 blood pressure. I was there for 9 hours. My blood pressure went down to 176/100 and left to go  home. I did not receive any medication for leg and arm pain but did get a shot for the pain. I was referred to a primary doctor.
Painful lymph node left armpit; Swollen, painful lymph node left armpit; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Er8730), via an unspecified route of administration in the left arm on 24Mar2021 at 13:15 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included osteoarthritis, moderate sleep apnoea and seasonal pollen allergies. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included meloxicam 15mg (MANUFACTURER UNKNOWN) and pravastatin 50mg (MANUFACTURER UNKNOWN) for unknown indications from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205), via an unspecified route of administration in the left arm on 04Mar2021 at 09:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 25Mar2021 at 21:00, the patient had swollen, painful lymph node left armpit and this had persisted longer than other symptoms. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events swollen, painful lymph node left armpit. The clinical outcomes of the events swollen, painful lymph node left armpit were unknown at the time of the report.   No follow-up attempts are needed. No further information is expected.
On 01/03/2022 at 9:45 AM a 16 year old female client received 3 vaccines (Influenza, Hep A, MenACWY). Before vaccination, nurse verified that the client had no pre-existing conditions and no history of reactions to vaccines. Before vaccination, nurse also verified that the client had eaten breakfast before coming to the clinic. Immediately after receiving the vaccines, the client reported to nurse and Nurse, that she was feeling dizzy. The client was offered juice, water, and an ice pack to place on the back of her neck. Her vitals were taken at this time (9:45 AM) B/P: 74/39, HR: 62, RR: 18, A&Ox4. Client was lowered to lay down on a mat on the floor as a fall precaution. She responded to all questions from the nurses during this time. At 9:53 AM her second reading of vitals were taken and read: B/P: 97/67, HR: 76, RR: 13, A&Ox4. Client reported that she was "feeling better" and had "no dizziness". She denied any other symptoms. Client continued to be monitored by nurses. Her aunt/caregiver was brought into the clinic room and was updated on the client's status. Additional vitals were taken at10:03 AM. These vitals were as follows: B/P: 99/69, HR: 73, RR: 16, A&Ox4. Patient denied any symptoms at this time. At 10:20 AM vitals were: B/P: 86/55, HR: 70, RR: 18, A&Ox4. Patient denied any symptoms at this time. At 10:30 AM vitals were: B/P: 90/70 (manual), HR: 72, RR: 16, A&Ox4. At 10:32 AM client denied any signs or symptoms. Remaining vaccines were not administered, and nurse advised for client to return another day to receive vaccines. Client and aunt were educated by nurse for client to hydrate, eat, rest, and to seek medical attention if any signs or symptoms return or develop. Client left clinic at 10:33 AM, ambulating independently.
Patient came into vaccine clinic this afternoon to receive booster shot. A few minutes after receiving the shot, the patient began to complain of coughing and "her tongue swelling". RN laid patient down. Assessed mouth, mouth was not swollen or red. Able to drink bottle of water.  VS were all normal on RA.  RN called MD. Dr. verbally ordered 20 mg of PO zyrtec and to keep patient for 20 minutes to ensure she was feeling ok.   The patient refused Zyrtec at first, RN was able to convince pt to take it after a few minutes. At 1355 pt took 20 mg of PO zyrtec per MD order.   RN messaged PCP, and notified of patient condition, MD aware and will be seeing patient after 1430 today.    At 1415, RN re took VS, VS remained normal on RA, messaged MD, MD ok for patient to leave vaccine clinic
This spontaneous report was received from a nurse and refers to a 34-year-old female patient. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 06-NOV-2018, the patient was vaccinated with a child dose of PROQUAD (albumin status: rHA) lot # R006217, expiration date 28-AUG-2019 (exact dose, dose # and route of administration were not report) for prophylaxis. No adverse effects were reported.
Burning at injection site - Start: 5 mins after injection, End: 7 mins after injection Sore arm - Start: 2 hrs after injection, End: Evening of 1/6/21 Night sweats - Night of 1/4/21 (moderate-severe), Night of 1/5/21 (mild)