chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient called on 9/8 to report that her arm was sore, had pain, and she had pain down her back. Followed-up with patient on 9/11/23 to see if the pain had subsided, but she said she is a little better but still wanted us to report it because the initial pain was severe.
Patient noticed soreness, difficulty of movement (raising arm above shoulder) approximately 1 week after flu shot.
High fever starting on day 7, lasting 5 days. Full body rash, including face and scalp.
Vaccine is Pfizer-BioNTech COVID-19 Vaccine EAU  Approximately 2 hours after injection small lump and discomfort. By the next morning, warmth, further discomfort, further swelling. Today is day 6 after the injection and I still have a lump with slight tenderness. Itch to the area started on day 3, intermittent and "manageable". Largest spread of redness and firmness was from day 2-4 that was approximately 3.5 inches from top to bottom and 3 inches wide. Today, on day 6, it is down to a little less than 1 inch from top to bottom and a little under 1.5 inches from side to side. It is tender if pushed on, but no longer tender to touch.  Intermittent rigors (severe shaking with chills) occurred on both evenings of nights day of injection and day 2.  Minor low back pain with only posterior upper bilateral leg discomfort occurred on day 2. Minor frontal headache occurred twice and resolved with Tylenol both times, on eve of days 2 and 3. PCP made aware of side effects.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. During 2015 (specific date not provided), the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about May 2016, the patient was treated at a clinic and was diagnosed with severe herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
Symptoms were fairly mild. I had some nasal drainage and a slight sore throat. I had a little bit of a cough that went with that, and I had no fever. I was really tired, but that's all I really had for the symptoms. I was prescribed PAXLOVID. I only tested positive for 7 days. I first tested positive on 02/21/2023.
pt recv vax;2nd day p/ vax lt arm swollen;9x9cm darkened, hardened, hot area in deltoid region;2x2cm blistered  area in the ctr of this;progressively worsening;referred to er due to time of day & week end approaching;
Shots were given around 3:30pm. Around 11:30pm my daughter had a seizure. She has no history of seizures and is otherwise very healthy. Her lips turned blue, slight shaking, stared off into nothing, didn't know her name at first, was confused for about 30 mins before she was herself again.  She was taken to the hospital via ambulance. Then transfered to a hospital for more testing. All tests came back normal. We still had no diagnosis when we went home.
site reaction, low fever, chills, headache, body pain, malaise lasting 48 hrs.
Pt had the KINRIX vaccine on 3/19/2012. On 3/20/12 she started to have redness and swelling, by 3/22/12 the redness was 3 1/2" x 3 1/2" on left thigh.
1 of 2 pts vaxed from the same lot who exp adverse event following immun; pt vax 26APR94 had a high fever 104; presented in office 27APR AM w/vomiting; rx'd w/APAP & Advil; no local react present; No illness @ time of immun;
Patient complained of itchiness to site, area was hot to the touch and had a red bump. symptoms started the same day of vaccine a couple of hours later. she is an employee and was sent to a different healthcare professional  office to seek medical attention.
Received Moderna vaccines on 2/5, 3/6, 11/16/21 COVID-19 positive by PCR on  1/4/22 admitted to hospital on 1/4/22 for weakness, diarrhea
No additional AE reported; an expired PROQUAD was inadvertently administered to a patient; This spontaneous report was received from a licensed practical nurse and nurse supervisor and refers to a 4-year-old male patient. The patient's concurrent conditions, concomitant medication and medical history were not provided.  On 08-MAR-2022, the patient was inadvertently vaccinated with an expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA)) (PROQUAD) first dose, 0.5 ml, administered subcutaneously (SQ) into left arm, lot # 030481, expiration date 07-MAR-2022 for prophylaxis (Expired product administered). It was reported that nurse received order for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) from provider, pulled vaccine from box, checked lot number, expiration date, obtained consent from patient, and administered vaccine. Upon returning to chart vaccine registered nurse realized that the date was 08-MAR-2022 and not 07-MAR-2022. 07-MAR was the expiration date on the bottle and she thought that was the date for the day. Upon noticing her mistake she called the nursing supervisor. The nursing supervisor contacted manufacturer and provider, per manufacturer potency still viable one day after expiration. The nursing supervisor contacted the patient's mother and made her aware of the situation, and the patient's mother agreed no revaccination needed. No additional adverse event was reported (No adverse event).
This spontaneous report was received from a medical assistant regarding a 11 year old patient of unknown gender. The patient's medical history, concurrent conditions were not reported. On 21-APR-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot # L004014, expiry date 04-MAR-2017) dosing details and route unknown. Concomitant medications were not reported. It was reported that the vaccine administered was subjected to first temperature excursion of 47 degrees F for a time frame of 48 hours from 04-APR-2016 to 06-APR-2016. It was also subjected to second temperature excursion of 48 hours from 19-APR-2016 to 21-APR-2016. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of several reports received from the same reporter. Additional information has been requested.
3/14/03 Left pupil largely dilated.  Instructed to see an ophthalmologist.  Dr. instilled drops into left eye and then left eye pupil became constricted more than the right eye. Developed a headache an hour after she noted left pupil dilation.   3/15/03 Left pupil equal to right pupil, stated they were normal size.
Very red face; Droopy eyes; Achy; Tired; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Very red face), EYELID PTOSIS (Droopy eyes), PAIN (Achy) and FATIGUE (Tired) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included No adverse event.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced ERYTHEMA (Very red face), EYELID PTOSIS (Droopy eyes), PAIN (Achy) and FATIGUE (Tired). At the time of the report, ERYTHEMA (Very red face), EYELID PTOSIS (Droopy eyes), PAIN (Achy) and FATIGUE (Tired) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was reported.  Action taken with mRNA-1273 in response to the events was not applicable.
c/o nausea about 1 hr p/receiving 1st Hep B vax; the next day had bodyaches, fever, chills, nausea (no vomiting); the 3rd day pt cont w/same sx;
Well circumscibed, 4x4.5 cm erythematous lesion area around site, induration in small area. Pt complained of redness and pain immediately after injection and evaluated by myself 48 hours afterward.
Beginning about 48 hours after shot, I became nausea, vomiting, severe diarrhea, headache, body aches and exhaustion until Tuesday February 16  (5 days post vaccine).
Received flu shot 10/18/10 in AM. Left arm was sore. When took a shower 10/20/10 at approximately 1630 crossed arms and felt Left upper arm was warm to touch. Looked in mirror, arm red, swollen, and has welts around the entire arm. 10/21/10, hot to touch, red and swollen. He reported reaction to his HR dept., they gave him number to call. Referred to physician was told not an infection. To use BENADRYL cream & ice. Is a questionable reaction.
11NOV98 child was fussy & screamed a lot during the day, no elevated temp that mom could recall;12NOV98 1230AM child started w/jerky motions, eye locked & then breathing stopped;EMS called;pt lost breath & choked;got stiff;
Initial symptoms began approximately 10 hours post injection. First symptoms were joint pain and skin sensitivity.  Dizziness began around 11 hours post injection.  The following day, 10/5/22, I called into work. I was so dizzy that I could not drive. On returning work, an RN took my blood pressure and it was noted to be 160/98. I am not hypertensive. I just had a physical within the last two months with a normal BP.
rash w/reddened, raised areas over entire body; pt very fussy lt thigh w/lump @ site of inject mom givening APAP; feels hot;
15-20 mins p/vax vomited x 1; 30 mins p/vomited x 3; 70 mins p/rash, crying, pulling @ ear; 90 mins p/seen by MD @ ER & treated for allergic react to immun given DPH & Pediapred; mom reports pt OK some swelling of lips;
This case was reported by a consumer and described the occurrence of hives in an adult female subject who was vaccinated with DTAP (manufacturer unspecified) (non-gsk). A physician or other health care professional has not verified this report. On an unspecified date, between the mid 1970s and 2000, the subject received unspecified dose of DTAP (unknown) or unspecified dose of Tetanus vaccine (Non-GSK) (unknown). Between the mid 1970s and 2000m at an unspecified time after vaccination with DTAP or Tetanus vaccine (Non-GSK) (unknown), the subject experienced major hives and shortness of breath. The subject received either a TDAP or tetanus shot between the mid 1970s and the year 2000 and experienced adverse events or major hives and shortness of breath. The subject was given a shot (unk injection) at the physician office after administration that relieved her symptoms. She does not know the exact facility that the vaccine was administered. At the time of reporting the hives and shortness of breath were resolved.
Approximately 2 1/2 hrs after received FLUZONE HIGH DOSE. Patient felt shortness of breath. Took himself to the ER and received oxygen and observation and was discharged by attending ER physician. With order to take diphenhydramine three times a day for 2-3 days.
Systemic: Fainting / Unresponsive-Medium, Additional Details: patient passed out from getting shot. he stated he always does due to anxiety with needles. he was up and feeling fine after a couple of minutes
PASSED OUT; HEART PALPITATION; SENSATION ON HEAD LIKE FLASH OF LIGHT; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, weight and medical history were not reported. The patient was not pregnant at the time of reporting. The patient does not have diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: 25-MAY-2021) dose was not reported, 1 total, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date in JUN-2021, the patient experienced heart palpitation and passed out. It was reported that the patient heard her heart beat very fast. The patient went to emergency room (ER) and they sent her home. The patient had couple more episodes. The patient also reported that while sleeping she felt the sensation on head like flash of light. The patient's palpitation comes and goes, she feels palpitation then sensation of passing out. The patient went to ER again and she mentioned that they said nothing was wrong. In JUN-2021, electrocardiogram (EKG) performed was not normal. ER recommended the patient to go to heart doctor once she has insurance. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from passed out, and heart palpitation, and the outcome of sensation on head like flash of light was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210666494-covid-19 vaccine ad26.cov2.s-passed out. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Pt. stated "my head feels funny".   Blood pressure was high.  @ 9:58 am 188/90, @ 10:02 - 176/84.  consulted with APRN on call & was informed to monitor BP & observe pt. for 20 more minutes.  AT 10:10, BP was 180/88, @ 10:20 - 190/98.  Pt continued expressing head feeling funny & stated she had a mini stroke in February 2020.   Nurse again consulted with APRN & was informed to offer to call an ambulance for pt.  Patient initially refused ambulance, but eventually decided  to accept.  Ambulance was called & transported pt. to hospital at 10:45 am.
She got covid-19 infection; She got covid  19 infection; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single 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) with onset Aug2021, outcome "unknown", described as "she got covid-19 infection"; SUSPECTED COVID-19 (medically significant) with onset Aug2021, outcome "unknown", described as "she got covid  19 infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Aug2021) infection.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt given Adacel vs Td. Pt wasn't age appropriate for Pertussis.
Fever, nausea/vomiting, chills, headache, muscle/joint pain, weakness beginning AM of 11/5/15; Advil, Tylenol, and Benadryl taken; rest and hydration; had to call out of work that night; did not begin feeling better until Saturday 11/7/15.
Fever, aches, chills, headache, vomiting, cough, congestion, lowered O2 level
Patient's daughter came to the pharmacy today and said patient died of a heart attack.  Patient thought that she was sick from the vaccine.  Did not get help until five days after
pt woke up 2AM shaking very hard all over but had no fever;vomiting started 2hr later & cont until 6Pm that evening every 2hr;the shaking occurred from 2-6AM;pt was unable to eat until p/31MAY98 & was very tired;
Pt fainted and fell over the side of the arm chair about 10 minutes post vaccination. He hit is head on the floor. He bit his tongue and was bleeding from the mouth. Pt was dizzy and confused. This was not resolving so 911 was called by the Pharmacy. Fire/Rescue arrived and did assessment. Upon trying to stand, pt fainted again. EMT advised pt be checked out in the ambulance due to consistent presentation of fainting. Pt left with EMT.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored GARDASIL 9 with lot number M003659 and expiration date of 20-SEP-2017 (strength, route of administration, anatomical location and dose were unknown), which were stored at a maximum of 60 Fahrenheit degrees (degrees F) for 24 hours and a minimum of 29.3 degrees F for 1.5 hours (14 cycles below 32 degrees F). There was a previous temperature excursion described as below 32 degrees F off and on for a week, several occasions stated as 50 minutes, 45 minutes, 40 minutes, 55 minutes, 1 hour and 15 minutes, 50 minutes, 35 minutes, 35 minutes, 1 hour and 35 minutes, 2 hours and 15 minutes, 45 minutes, 30 minutes and 55 minutes. The temperature excursions were detected by a data logger. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Extreme fatigue, swollen and extremely itchy vaccine site and toes, pain under arms, pain under breast bone.
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
The first COVID-19 infection was around 10/20/2022. I had a sinus infection and I felt like I was having trouble thinking properly and concentrating. I started feeling bad a week before that, and I went to the outpatient clinic and diagnosed it as COVID-19 as well as a sinus infection. I was sent to the ER and she said I was sicker than I thought I was. They gave me antibiotics and I started to feel better over the next week or so. I then had an injection treatment for my prostate cancer a few days later on 11/15/2022. I was feeling better but I was still having trouble concentrating and getting things done. I was feeling weak so I was being careful moving around the house. Walking and getting up and down. The body was weak and mind had difficulty concentrating. I never had a fever. On Christmas Eve, my wife was diagnosed with COVID-19. We were quiet over the Christmas holidays, and I was starting to feel worse again. I ended up in the ER because my chest was congested. They gave me the same antibiotic and there was some improvement and it got a little better. I then went to an osteopath for treatment for my previous accident, and at that stage he gave me a different antibiotic which was levofloxacin on 02/10/2023 and that helped dramatically. It took about 3 weeks for me to start feeling better again. I started to get myself back on track, and I wasn't sure how much was related to getting COVID-19 and having prostate cancer. All the COVID-19 tests at home had indicated that they were negative, but when I went to the doctor/ER, they were positive. The reason why I have such a problem with my prostate cancer is also because the CDC guidelines said not to test people over 72 years old. My PSA was at 147, and if I was tested earlier, I believe it could have been handled better without problems. People do not age at the same rate and so to set a date on that is ridiculous.
About two weeks after first shot, I got shingles. It could be unrelated, but since I'm young, perfectly healthy, not abnormally stressed, and haven't ever had singles before, I thought there might be a chance it is related. I've seen online other young people who are saying that they got shingles after the first shot of Moderna or Pfizer.  Maybe it was just a coincidence, but I figured it was worth reporting. It is overall a pretty mild case because I got on the antiviral drugs pretty quickly. Wondering if I should still get my second shot on schedule or wait until my shingles is all cleared. I have asked my doctor and am awaiting a response. I first noticed the symptoms on Saturday (3/20) exactly two weeks after my first shot.
As per phone conversation w/ grandmother on 6/12/09. Patient had swelling to left arm w/blisters (<50). w/fever. Intended to seek medical attention w/PMD.
After 2 days my arm had swelled up, with a slight head ache, day 3 arm very hard and swollen by mid day the itching was very strong. I had takin ibuprofen and benadryl
3/3 @ 2200 mild headache and fatigue started.  3/4 @ 0800 woke up with fever, headache, body aches, fatigue (continued throughout whole day).  1800: same symptoms plus chills and skin sensitivity.  3/5 @ 0900 symptoms resolved except fatigue and headache. 1700 mild headache resolved.   No medications taken.
Sudden, severe tightness in chest while standing still in kitchen lasting less than a minute, followed by lightheadedness for about 5 minutes. Went to Urgent Care (see below). The chest pain was determined to not be a serious concern and I returned home to normal activity.
Had 2 periods in October which is unusual; "My" cycle has been thrown off; Experiencing painful periods with heavy flow; Experiencing painful periods with heavy flow; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180) via an unspecified route of administration in the left arm on an unknown date in Aug2021 at 17:15 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroid, endometriosis and polycystic ovarian syndrome (PCOS). It was unknown whether the patient had any allergies. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7484) via an unspecified route of administration in the left arm on an unknown date in Aug2021 at 17:15 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. On 05Sep2021 at 06:00, the patient's cycle has been thrown off and she experienced painful periods with heavy flow. On unknown dates in Oct2021, she also had 2 periods which was unusual. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events cycle has been thrown off, painful periods with heavy flow and had 2 periods which was unusual were not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.