chrisvoncsefalvay/vaers-outcomes huggingface dataset:
his is a 74-year-old male with significant past medical history of CAD, hypertension, congestive heart failure, combined diastolic and systolic, ischemic cardiomyopathy status post ICD placement who presented to the hospital chief complaint of progressively worsening dyspnea over the past several days.  The patient recently had a cardiac catheterization on 9/30 and received a stent to the LAD, he was found to have ischemic cardiomyopathy and he had delayed placement of ICD on 10/7.  Patient states he was doing pretty well up until about a weekago when he started develop upper respiratory illness.  He was having a cough, congestion, fevers, chills and poor appetite.  The patient states he was still drinking fluids but he wasn't eating very much.  The patient denied any chest pain, palpitations, lightheadedness or dizziness.  Patient notes he started to get more short of breath over the last several days and he was having more difficulty getting around his house without feeling very short of breath.  Patient has had fevers and chills.  The patient did come to the hospital on October 18 and was sent home as he was not hypoxemic, with the instruction to come back if he got any worse.  He was sent home with azithromycin, albuterol and prednisone.  In the emergency room, the patient was found to be in A. fib with RVR, he was given a dose of IV and oral Cardizem without improvement in his heart rate, blood pressure was stable.  He initially was not hypoxemic he was given 2 L of IV fluids.  He was then started on a Cardizem drip with subsequent improvement of heart rate but then he went to respiratory distress and hypoxemic.  He was titrated up rapidly to a nonrebreather mask.  Chest x-ray did look like Covid.  Pressure still stable, heart rate improving, he is tachypneic but no distress.
red and swelling in my right eye.  I was given steroid eye drops and antiviral medication.
PATIENT DEVELOPED PRURITIC RASH INVOLVING TRUNK, FACE, BUTTOCKS 2 DAYS FOLLOWING VACCINATION.
This spontaneous report as received from a medical assistant refers to a patient of unknown age. On 26-APR-2013 the patient was vaccinated with a dose of VAQTA 50/1.0 U/ML lot # 0628AE, expiration 26-JAN-2015 and a dose of RECOMBIVAX HB lot # reported as 0231AA, expiration 02-NOV-2014 (dose and route unknown for both vaccines). The medical assistant reported that VAQTA and RECOMBIVAX HB had multiple excursions from 20-FEB-2013 to 13-MAY-2013. The lowest temperature the vaccines reached was 24F. The total time of hours for the excursions was 253 hours. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
PATIENT INDICATED SHE FELT DIZZY RIGHT AFTER I FINISHED INJECTED HPV. SUDDENLY PATIENT  PASS OUT, I WAS ABLE TO SAFELY HELP HER AND  ADJESTED BED AS I YELL FOR HELP. MINDTIME I ELEVATE HER FOOT AND BY THIS TIME SHE WAS ALREDY RECOVERING. DR AND ANOTHER NURSE CAME IN AND HELP ME TO ASSES PATIENT. WE KEPT PT FOR ABOUT 20 MINUTES AFTER SHE STATES SHE FEELS  OKAY AND LEAVE CLINIC WITHOUT DISTRESS. PT DIDN'T HER HERSEF.
Severe Headache, Breathing difficulty, back pain and soreness, arm soreness, muscle soreness, irritability, odd taste in mouth.
Td given at primary MD's office (primary MD did not give record). Patient had no knowledge of receiving Td at primary MDs office. PH nurse reviewed past record from PH - last Td was given in 1991. Tdap was given 10/16/07. Primary MDs office notified. Unable to contact patient - left for travel overseas.
At night my arm started hurting. The second day I was tired, fatigued, achy, and I had a headache. They were gone after that. On 11/13/2021, in the evening, I started itching. At night I was really itchy more so I showered and put lotion on. I just started itching more and more. My skin was all red and bumpy and it looked like I had hives. It started spreading everywhere on my body. The itching would really get worse at night. I started taking Benadryl and histamine. It helped a little bit. When I went to the doctor they put me on a low dose prednisone of 2mg 2xday. That wasn't working that much. It worked while taking it, but if I stopped taking it then I would start itching again. I went to see an allergist on 11/23/2021, and they gave me a cortisone shot and put me on medications. They gave me prednisone to take 10mg 3xday for 5 days then 2xday for 5 days and then 1xday for 5 days. I was prescribed and now taking Allegra, Zyrtec, and Pepcid. I am not itching while on the medications, but I am still seeing some spots again.
Achness; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Achness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (Achness). At the time of the report, MYALGIA (Achness) outcome was unknown.            Reporter did not allow further contact
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 56-year-old female patient who received SHINGRIX. On 2nd February 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were reported as follows: For tolerance after 2nd dose, please refer case US2018056944. This case has been also linked to case US2018GSK063531, reported by the same reporter.
The day after I did have the typical fever, chills, and body aches and I did experience a rash on the injection site. After two weeks post shot, there was a swelling in the retina, and the top part of my vision was cut off, branch retina vein occlusion was diagnosed. They dilated my eye and scanned the back of my eye to take a picture of my retina and was treated with Avastin. Symptoms are still present and have not improved and wavy vision. Arm bumps are still present however itchiness has subsided. Previous reaction showed improvement with this treatment method back in September.
This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 08-APR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 infection was not reported. This report was non-serious.
Patient states two days after 2nd moderna vaccines her upper eye lid began to swell and develop a rash like swelling. Pharmacist advised her to make appointment with doctor or visit an urgent care. Patient stated she had appointment. Patient stated no other adverse effects such as blurred vision fever had occured
Tinnitus (severe) and extreme dizziness with nausea. The worst of it was on 3/8/21 and 3/9/21.  I went to ENT doctor on 3/10/21 and was prescribed prednisone for 2weeks. That steroid had very little effect. I am able to function only if I take over the counter motion sickness pills every day. The tinnitus has not diminished but the dizziness is at manageable levels.
expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired doses administered) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses administered). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was provided by the reporter.
Client c/o feeling "lethargic and fatigued" starting the evening of 3/13/03.  States she was talking to her husband and "went out of consciousness" and he had to shake her awake.  Presents this morning feeling tired and is having trouble concentrating. No c/o pain, headache, irritability, mood changes.  States her vision is different and she is seeing colors more vibrant.  Client unable to drive home d/t fatigue so had her husband take her home.  T/C to Dr to inform him of clients condition. He suggests that I call Dr the hospital and inform her of client's condition.  T/C to Dr .  She will call client at home and have her come to the hospital for clinical consult and evaluation.
1:03pm pneumonia vaccine given. 1:05pm epi 0.3mg administered. 1:07pm paged a doctor. 1:09pm emergent ambulance called per Dr. 1:11pm O2 at 2 liters 97% 1:13 pm 98%. 1:14pm emergency arrived, prepared for transport. 6-30-10 142/71 HR-98 98.5 degrees R.A 96% vital signs normal.
about 8 hrs after shot being  administered, started shivering, shaking violently, feverish, nausau, headache, muscle aches and fatigue. slept very little that first night.  got up at 9:30am. exhausted, dizzy and had most of the issues i had the prior day. the next day (today) still had feverish feeling, dizziness, muscle aches and headache.
had Covid twice; had Covid twice; had Covid twice; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 65-year-old patient received BNT162b2 (BNT162B2), on 18Oct2021 as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 20Dec2021, outcome "unknown" and all described as "had Covid twice"; DISEASE RECURRENCE (medically significant) with onset 22Jan2022, outcome "unknown", described as "had Covid twice". Clinical course: The patient stated, "I had my first Pfizer COVID vaccine 18Oct2021. Can the new B variant vaccine be my second dose? I'm 65 and have had COVID twice (20Dec& 22Jan)."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Acute on chronic diastolic heart failure. ED visit to hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
Pt. got varicella vaccine on 6/24/14 at well child check up. She developed fever on 6/30/14 and rash characteristic of chickenpox. Seen at urgent care 7/5/14 and diagnosed with chickenpox.
Patient became dizzy and fainted approx 10 minutes after receiving vaccine.  Lost consciousness for less than 1 minute.  School nurse caught him as he fell.  He received no injuries.
This spontaneous report was received from a physician via an online article and refers to a 12-year-old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date in September 2008, the patient was vaccinated with a third dose of GARDASIL (dose, frequency, route of administration, lot# and expiration date were not provided) for prophylaxis. On an unknown date, reported as after getting her last shot of GARDASIL, the patient began having trouble walking and then her muscles continued to deteriorate. On an unknown date, she used leg braces and a walker at home as her muscles and nerves continued to deteriorate. Patient's symptoms were suspected to be amyotrophic lateral sclerosis (ALS), however, no results of the ALS test were provided so far. The patient received the treatment, however it was stated that none of the treatments given was working. The outcome of the events was reported as not recovered. The relatedness between the events and GARDASIL was not reported. Upon internal review, the event of amyotrophic lateral sclerosis was considered to be medically significant. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1812USA000379: US-009507513-1811USA012613.
Onset noticed about 8 am on 9/13/12. On 9/14/12 reported pain in left upper arm 4 on a scale of 10. Worse when lifting. Area red, puffy, itchy, warm to touch. Denied fever. Area of inflammation marked. 11cm top to bottom x 7cm wide. Dr. aware. Monitor and use warm / cold compress. Completely resolved by 9/19/12.
no adverse effects; improperly stored VARIVAX; Information has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, previously drug reactions, allergies, concurrent conditions and concomitant medication were not reported.      On 17-JUN-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot number R035226 with expiration date in 04-DEC-2020 (strength, anatomical location, dose and route of administration were not provided) for prophylaxis, that was reconstituted with sterile diluent (DILUENT MRK) (strength, dose, lot number, expiration date and route of administration were not provided) (it was not reported if the sterile diluent (DILUENT MRK) used had an excursion).   The varicella virus vaccine live (oka/merck) (VARIVAX) was stored at a temperature range of -9 degrees Celsius (°C) to 8°C (-3°C), for the time frame of 3 hours and 39 minutes. There was no previous temperature excursion and the call was because of a data logger.   No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA008662:
H/o folliculitis and mild eczema; received small pox vaccine left arm 8/4/2011; a wk later started to have itchy rash starting around the vaccine site which continually spread to from left arm to chest/back/right arm; mostly dry itchy scaly rash; seems to be slowly spreading down to his forearm and abdomen; no fevers/cough; has been feeling well o/w.
And red, painful, warm, swollen area around vaccine admin site, extended from shoulder to elbow.
Dizziness briefly when walking after dismissal 15 minutes after her shot.  No near syncope. No other symptoms. Felt better within 5 minutes. VSS stable throughout shot stay.   No orthostasis.   Initial BP - 137/84, Pulse - 84, O2 sat 98%.
Its real itchy/From elbow up all over the chest/Chest is itchy/back isn't so itchy; Got a rash all over the torso around legs and lower arms and face; Low fever 100.6 degrees Fahrenheit; Feeling hurt; Ached all over; Swollen lymph nodes under left arm that lasted for 2 days; Sore arm after booster dose; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling hurt), PAIN (Ached all over), PRURITUS (Its real itchy/From elbow up all over the chest/Chest is itchy/back isn't so itchy), RASH (Got a rash all over the torso around legs and lower arms and face) and PYREXIA (Low fever 100.6 degrees Fahrenheit) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939905, 042L20A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYALGIA (Sore arm after booster dose). On 30-Oct-2021, the patient experienced FEELING ABNORMAL (Feeling hurt), PAIN (Ached all over), PYREXIA (Low fever 100.6 degrees Fahrenheit) and LYMPHADENOPATHY (Swollen lymph nodes under left arm that lasted for 2 days). On 01-Nov-2021, the patient experienced PRURITUS (Its real itchy/From elbow up all over the chest/Chest is itchy/back isn't so itchy) and RASH (Got a rash all over the torso around legs and lower arms and face). At the time of the report, FEELING ABNORMAL (Feeling hurt), PAIN (Ached all over) and PYREXIA (Low fever 100.6 degrees Fahrenheit) outcome was unknown, PRURITUS (Its real itchy/From elbow up all over the chest/Chest is itchy/back isn't so itchy) and RASH (Got a rash all over the torso around legs and lower arms and face) had not resolved and MYALGIA (Sore arm after booster dose) and LYMPHADENOPATHY (Swollen lymph nodes under left arm that lasted for 2 days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Oct-2021, Body temperature: 100.6 (High) 100.6 degrees Fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided Treatment medications were not provided   This case was linked to MOD-2021-374697 (Patient Link).
Vaccine administered after temperature excursion; Vaccine administered after temperature excursion; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Vaccine administered after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Vaccine administered after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion). On 02-Apr-2021, PRODUCT ADMINISTRATION ERROR (Vaccine administered after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) had resolved.        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.   HCP reported on 02Apr2021 that they had power outage on 02Apr2021 and vials were in freezer and refrigerator where temperature dropped to : Frozen Vaccine 47Minutes -13.79 C, Refrigerator 59 Minutes 12 C and effected vials are: Lot no 003B21A, 100 doses, Lot no 027B21A 100 doses, Lot no 030B21A 100 doses and Lot No 02B21A 140 doses. HCP stated that 63 doses were administered to 63 patients.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow up received on 14-MAY-2021 contains No New Information
Headache, muscle soreness, fatigue, dizziness, shivering, large swelling at injection site, sweating, all lasting 4 days
Unknown vaccination information-given at PCP. When seen on today's exam, symptoms have resolved. Large localized reaction per cell phone picture 3-4 cm erythema surrounding injection site.
Received pneumonia shot (PCV23) on 11/10/14. Swollen, painful (L) arm 2 days post injection (L) arm 12 in. in diameter (R) arm 11 inch in diameter.
Severe local reaction with erythema 10-14cms with induration, tenderness and blisters in the center. No systemic effects. Reaction occurred right lateral thigh at the site of ProQuad Lot 0225U Exp 07/25/08
Received smallpox vaccine on left deltoid 6 months ago.  It went through the normal progression to Jennerian scar without any problems.  Approximately one month ago, she noticed several small bumps at the site of the scar.  They have not changed in appearance or number since she first noticed them.
Patient was sitting in chair in exam room after vaccine and fainted, fell forwards and hit face on the floor. She had a few seconds of full-body shaking per parental report. Regained consciousness after less than one minute and was able to answer questions normally. She laid flat on her back and feet were elevated for a few minutes. Allowed sips of water as mental status was normal. An ice pack was applied to the left side of her forehead just above the eye, as this was where she hit her face on the floor and was developing slight swelling. Continued having her lie down for about 15 minutes after the event, then sit for 5 minutes before attempting to walk. Blood pressure was monitored and was normal. Neuro exam normal. Facial swelling resolved after icing. Signs and symptoms of concussion were discussed and patient was discharged home from the clinic.
Swelling in the left shoulder and pain. I used ice, heat and pain medication. It is still swollen.
15 patients were administered the Moderna COVID 19 vaccine after the 30 days use by date.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (15 patients were administered the Moderna COVID 19 vaccine after the 30 days use by date.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (15 patients were administered the Moderna COVID 19 vaccine after the 30 days use by date.). On 08-Oct-2021, EXPIRED PRODUCT ADMINISTERED (15 patients were administered the Moderna COVID 19 vaccine after the 30 days use by date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported. Reporter did not have any information of patients, the vial was initially stored in the refrigerator on 24-Aug-2021, and the vial did not undergo any temperature excursions.
Pt recvd 2 doses of some unk Hep vax & 1 dose of Engerix-B on 9SEP91 & on 16DEC91 immune status was neg; 9SEP91 recvd Engerix-B 16DEC91 titer of less than 10 miu/ML was detected; pt did not convert;