chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Note: Not sure  which shot(s) caused problem; date and batch number is given for 2nd shot. 1st shot was given on 3/12/21 with batch number BN6199  or EN6199 (can't read properly)   Persistent pain (4+ months) in left shoulder. Aggravated by exercise. Tenderness when joint is poked. Past injuries to both shoulders years earlier but pain only in left shoulder (vaccination site).
Approximately 12 hours after the vaccine, I had a high fever (103.5 degrees), started shaking uncontrollably, was disoriented, fatigued and very weak which lasted for another 16 hours until I went to the ER.
24 hrs post vaccine injection fever of 102F, baseball size redness, swelling of R thigh. Treated with Augmentin for possible cellulitis.
The vaccine caused my menstrual period to start very early. This happened after the first dose as well. My period is tremendously regular, so this was quite odd.
Fever; Chills; Ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date 07Jan2022 (Lot number: PL03198) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 08Jan2022, outcome "unknown", described as "Fever"; CHILLS (non-serious) with onset 08Jan2022, outcome "unknown", described as "Chills"; PAIN (non-serious) with onset 08Jan2022, outcome "unknown", described as "Ache". No follow-up attempts are possible. No further information is expected.
1/13/21 woke at 4am with neck pain 1/14 Pain worse, could not move neck, radiated on both sides of neck to back of head, saw doctor, was given a muscle relaxant, pain worsened, went to ER was given valium and sent home 1/15 called doctor, was given hydrocodone, increased pain, went to ER due to pain, was hospitalized 1/19 discharged from hospital, off work till 2/3/2021 per PCP
Initial unsolicited report received from a company representative on 03 December 2016. This case involves a 74-years-old female patient who was vaccinated with a dose of FLUZONE HD (batch number-UI728AB, expiration date-03 June 2017) via intramuscular route of administration in left deltoid (dose and dose in series and dose was not reported) on 15 November 2016. Illness at time of vaccination was reported as none and patient had allergies to actinal, quinolone, red dye and patient had medical history of asthma, Gastro esophageal Reflux Disease (GERD) (Reported as GURD). Concomitant medications were not reported. On 15 November 2016, same day by the evening following the vaccination, the patient had experienced rigor, aches, confusion, and palpitations. Relevant laboratory data was reported as none. Corrective treatment was not reported. On an unspecified date (within 24 hours) patient was recovered from the events. List of documents held by sender: none.
Anterior side of both thighs from hip to above knee there are raised pin point size rash. Started 1/30. Has improved some with use of hydrocortisone, no other problems.
67 yo female with Hx of breast cancer, remote bilateral THA, DVT/PE on xarelto, OCD, DM2, morbid obesity presented following a fall causing femur fracture    Right periprosthetic proximal femur fracture with non union  - s/p revision right total hip arthroplasty, repair proximal femur nonunion with bone graft substitute 8/8 - post operative and pain management and peri operative antibiotics per orthopedics   Acute on chronic anemia - now stable - suspected mostly post operative blood loss. No active bleeding noted. - baseline Hb around 11, decreased to around 8 post operatively, now stable around 7.5   Hx of DVT/PE - per patient, approximately one year ago. Per her report, anticoagulation lifelong. On outpatient rivaroxiban - currently on prophylactic enoxaparin. Resume home rivaroxiban 10mg daily Would continue rivaroxiban indefinately given she was previously on this prior to admission   DM2 - hold home metformin, likely can resume at discharge - HbA1c 6.7% this admission - basal, SSI/IIT. Diabetic diet. Goal blood glucose 140-180. Will not need insulin at discharge, only metformin given above HbA1c    AKI - resolved - noted post operatively   Constipation - postoperative, narcotic associated, immobility  - cont bowel regimen, daily Miralax. May require enema or suppository   COVID 19 infection, asymptomatic - positive test 8/2/22 - evaluated by ID at WBH GP: no further treatment needed   HTN  - resume metoprolol   Right breast skin ulcer: 2/2 self inflicted injury/skin picking due to pt's OCD  - no signs of infection, dry dressing if needed   OCD Mood disorder - cont home buspirone, clonazepam, fluoxetine, risperidone    Hypovitaminosis D - vitamin D supplementation   Hx of breast cancer >20 years ago S/P mastectomy/chemo and radiation  Morbid obesity :  weight loss GERD : resume omeprazole      Stable for discharge to ECF from medical standpoint
Administered unnecessary vaccines to child. 1) Proquad in right leg SC. 2) Hep A in left leg IM. No reaction to vaccines while in office x 1 hour.
Site: Pain at Injection Site-Severe, Additional Details: severe arm pain that extended to arm, back, neck, shoulder. patient cannot lift/raise arm. the pain and unable to lift arm still ongoing
Severe muscle pains, cold hands, acne, nausea, loss of appetite, headache, sleepiness, mucus was clear, now yellow and orange
Chest pain with exertion beginning night of Sunday (4/25). Increased chest pain with exertion through Monday morning and afternoon. Went to ER to get checked Monday evening. Admitted due to elevated troponins. Stayed in hospital for 2 nights. During stay had echocardiogram and heart cath done due to troponins continuing to elevate. These showed clear and ruled out anything serious like a blockage. Discharged Wednesday afternoon to rest at home with MRI scheduled for Friday morning.  Appointment with cardiologist Monday after the MRI and given the diagnosis of myopericarditis. Still resting at home and avoiding strenuous activity to recover fully.
I had surgery for spinal stenosis on 07/09/2020, including a decompression and fusion at L4/L5.  I reported the following symptoms, which I attribute to the COVID-19 vaccination, to my spine surgeon.  I had my second dose of the Pfizer COVID-19 vaccine on Monday, March 29th at 5:45 PM.   Lower back pain in the general area of my surgery (07/09/2020) woke me up from sleep around 4:30 AM Tuesday (03/30/2021) morning.  Being woken up from sleep had never happened previously - not before surgery, following surgery, ever.  I recall the pain being a dull throbbing ache, nothing sharp.   I recall being generally pain free Tuesday during the day and went for a mile and half walk Tuesday evening and hit  about 20 40-yard (or less pitch shots) Tuesday evening.   I woke up Wednesday at my usual 6:45 AM.  Although I don't recall being in pain getting out of bed, I do remember being in excruciating pain the remainder of the day.  It hurt to walk (landing either foot) and the only position that I had any relief was sitting at work.  The pain was frequent, sharp, and up to a 6 on a scale of 1 to 10.  I felt exhausted and feel asleep at 7:30 PM Wednesday night.   I was in significantly less pain Thursday, although it was still uncomfortable rising from a seated position and bending at the waist (to assume a putting position in the office) caused pain to the extent that I chose not to fully bend.  Thursday night was generally OK but there was one point, while seated on a couch, where I felt a sharp stabbing pain in the general area of my surgery.  I tried to change positions to alleviate the pain, but it persisted for 30 seconds before finally subsiding.  The pain felt like I was being stabbed and it was a 8 or 9 on a 1 to 10 scale.   Friday was a repeat of Thursday.  Generally, I have very little pain except when I stand from a seated position (1 or 2 on a 10 point scale) or bend slightly at the waist (3 or 4).  The pain is dull but the pain from bending does prevent me from bending comfortably.   All of this pain is new this week since Monday.  This past weekend I worked in the yard, including some heavy lifting and digging.   Is there any chance this is a side effect of the vaccine?  Should I schedule an office visit to evaluate the pain?  NOTE:  I was generally symptom free by Saturday, 04/03/2021 and totally symptom free by 04/05/2021.
pt recv vax & 1wk p/vax pt devel papular acrodermatitis (Gianotti-Crosti synd);pt recovered from sx;
Was dx'd with "unatic skin rash" by MD on 1/31/01. Was treated with a steroidal antihistamine IV in the hip. Was told that 1% of Hep-B vaccinees experience this reaction. Had a rash on both arms, legs, trunk and back, all within 2-3 days of vaccine. Had severe itching with rash. Complained of slight dryness of skin on elbows and hips possibly prior to vaccine. No complaints of reaction to prior Hep-B vaccine.
Adverse events include consistent, daily episodes of irregular ventricular tachycardia ranging, from 115-180 worsened with physical activity such as walking through the home from one room to the next. 2-3 episodes of true SVT were documented on the heart monitor that was worn for 30 days. The events started within 3 months of receiving the vaccination and continue to present time with little to no successful medical intervention. Symptoms of the tachycardia include but are not limited to, tremors, heavy perspiring, moderate to severe fatigue, nausea and vomiting, significant weight loss (30 lbs in 2.5 weeks), weakness/loss of muscle tone.    Other adverse events to note after receiving vaccination, unexplained facial swelling and bruising of the left eye.
Feeling very tired and sleeping more that usual. Very large reaction on the injection site. Large patch of bluish bruise like color on the injection site.
After vaccination pt. fainted. Pt. layed on floor for a few minutes then felt okay.
Pt passed out after getting the shot. When pt recovered after 5 mins,she started vomiting and was really shaken
Patient had vaccine administered on 12/15/17. Patient showed up at pharmacy on 12/22/17 and stated that since Wednesday 12/20/17 the area around the vaccine site had become slightly inflamed and had spread down the bicep of the left arm. Patient stated that the rash had begun to subside since 12/21/17, and was not itching. He claimed to have not other problems,  I told patient to use diphenhydramine, if needed. I told patient to call his MD as soon as possible, to make him aware of this reaction. We also called the MD and are awaiting a return call. We also faxed a note to the physician. I spoke to the patient in thevening of 12/22/17, and he stated that the rash was improving, and he had no ill effects.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 01-AUG-2014, the patient was vaccinated with a dose of ZOSTAVAX (dose number was not reported), 0.65 ml, subcutaneous. Co-suspect and concomitant therapies were not reported. The pharmacist reports that on 01-AUG-2014 a dose of ZOSTAVAX that underwent a temperature excursion was administered to five patients. (MARRS 1408USA006489, 1408USA006490, 1408USA006491, 1408USA006492 and 1408USA001809). This case is one (1) of five (5) reports from the same source. Additional information has been requested.
Redness, edema, warmth in (L) upper arm. Improving with only Ibuprofen. Started about 1 wk after Tdap administered.
This spontaneous case, initially received from other health professional (pharmacist) on 18-Sep-2018, concerns a 55-year-old, adult male patient. The patient received FLUCELVAX QIVc last year (historical drug) and had experienced a little pain. On 18-Sep-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252656 and expiry date: 31-May-2019). As soon as the pharmacist administered the vaccine, the patient suddenly developed swelling and some redness at the site of the injection (coded as immediate post-injection reaction). The pharmacist applied ice at the site of injection. It was reported that the events did not worsened, and the swelling went down a little bit. The patient was observed for 15 minutes while applying ice and was advised by the pharmacist to continue to use ice after leaving the pharmacy. At the time of this report, the patient had recovered from the events. The reporter assessed this case as non-serious. Follow-up received from the pharmacist on 15-Oct-2018: The pharmacist reported that the patient had recovered from the event, hence the outcome of the event (immediate post-injection reaction) was changed from not recovered to recovered in the event tab. It was also reported that the patient started recovering from the events on the same day of vaccination. Narrative was amended accordingly.
pt recv vax 25MAY95 & pt devel less than 50 lesions & did not feel  bad;It was noted that there were many other cases in daycare;
About 2-3 minutes after vaccination the child complained of headache and became pale and diaphoretic.  She was sitting in chair with a nurse beside her.  She did pass out for about 10 seconds.  No injury.  Cool cloths applied to forehead and neck.  Feet elevated.  Mother was present along with 2 nurses.  Patient was also given a coke to drink once she was alert.  Patient was monitored for 20 minutes and released home in stable condition with her mother.
Hives from neck to thighs front and back, predominantly on stomach/torso area -lasted about 2.5 weeks, treated with Cortizone-10 cream, anti-itch spray, and generic antihistamine Swollen and dry upper lip (almost like a sunburn) - lasted about 3 days, untreated went away on its own Fatigue and headache for the day after vaccine, treated with tension headache pills, went away on its own
24 hrs after UMM placed erythema, tenderness and warmth occurred- 9cm X 6 cm oral paten, resolving after 2 more days. At visit 5 days later paten of  non- raised pink skin 6X 5cm, Now NT
Pt. was scheduled to receive 2nd dose of Pfizer but was given Moderna in error.
Patient was brought to the ED by EMS on 7/19 for weakness. She was initially mildly hypoxic and was temporarily placed on 2L O2 and eventually was able to be weaned off.  A COVID PCR test was done which was positive. She was discharged at that time, however returned to the ED on 7/20 with shortness of breath, weakness, and lethargy. EMS brought her into the ED, and prior to the ED EMS found her to have O2 sat of 88% and so she was placed on supplemental oxygen.  Patient was admitted to the hospital from 7/20-8/4 for COVID-19 infection and acute hypoxic/hypercapnic respiratory failure, along with other health concerns. Ultimately patient was discharged on 8/4 with discharge diagnoses of permanent atrial fibrillation, hypertension, nonischemic cardiomyopathy, hyperlipidemia, and acute respiratory failure with hypoxia and hypercapnia. At discharge, provider noted patient use oxygen as needed for comfort. Patient was fully vaccinated and had received two boosters. This meets criteria for vaccine breakthrough case review.
Resident with nausea, vomiting, confusion, increased blood sugars, falling, tremor. Out to ED and transferred to hospital. Found to have an MI and a brain abscess.
pt recv vax;exp cold sx i.e. cough,runny nose & fever;tenderness at inject site esp lt arm;to MD;dx w/ sinus infect;ATB given;better but lt arm still red;4may had grand mal sz,lasting approx 3 mins;to er;nl exam;MD unsure if sz from immun
Patient received vaccine after published expiration date.  Moderna Company analyzed vacccine and advised lot 007B21A maintained activity necessary to protect against Covid 19  on date of administration. Also patient did not call in to complain of adverse event.  This is an administrative error without adverse event.
A physician reported via a company representative that a child(age and gender unspecified) received a second dose of prevnar on an unspecified date. Approximately 6 weeks post vax, the pt was hospitalized for bacteremia, The infecting organism was unspecified. Follow up info received on 05/18/2001 from the reporting physician revealed that the 8 month old male had a history of hypoplastic left heart syndrome with Norwood and Glenn shunt procedures. He received the 2nd dose of Prevnar on 03/05/2001. On 04/15/2001, the child presented with a history of high fever and shocky appearance. A blood culture revealed the presence of type 3 pneumococci and a diagnosis of ambulatory bacteremia with bacterial sepsis was made. The child was treated with intravenous ceftriaxone and he was since recovered.  FOLLOW-UP INFORMATION received on 10/12/01 from the reporting physician revealed the child had a history of cardiac murmur and a sustained oxygen saturation in the 70 % range. Upon the child's hosptial admission, respiratory syncytical virus was also detacted The remainder of the physical examination was normal except for clubbing and cyanosis of the child's extremties. The child received treatment with three courses of antibiotics. NOTE: Upon receipt of this information, this report has once again been classified as a 15-day expedited report
First Injection, March 7, 2021, no side effects. Second Injection, March 28, 2021, 3 days of swelling, tenderness, warmth and redness at injection site (March 29-31). April 1, tingling sensation developed in ball of right foot. April 2, began experiencing soreness and weakness in both thighs, dizziness, and pain and weakness in left shoulder and arm, spoke to doctor on call Saturday afternoon, April 3, who shared probable result of vaccine.  Soreness and weakness in both thighs subsided by Monday, April 5. Dizziness and left arm weakness and pain has increased extending to the little finger, ring finger and middle finger of left hand. Tingling continues on ball of right foot. Had dizziness evaluated, Wednesday, April 7, and told related to covid vaccination. Completing blood work on Monday, April 12, and have follow-up appointments with primary care physician, Wednesday, April 14, and Neurologist on Thursday, April 15.
Injection site reaction left shoulder (redness, warmth, swelling) treated with Benadryl.
1 week after my second dose I start developing hair loss, specifically alopecia Areta; 1 week after my second dose I start developing hair loss, specifically alopecia Areta; This is a spontaneous report received from a contactable 28-year-old female nurse reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: El1284, dose number=2) via an unspecified route of administration on 06Jan2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. She received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: Ej1685, dose number=1) via an unspecified route of administration on 18Dec2020 10:30 AM at single dose for Covid-19 immunization. As per the adverse event description, one week after her second dose on 15Jan2021, she started developing hair loss, specifically alopecia Areta resulted in doctor or other healthcare professional office/clinic visit. She took unspecified steroid injections to scalp. The outcome of events was not recovered.  No follow-up attempts are possible. No further information was provided.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. It was reported that on July 2009 the patient received the first dose of GARDASIL (route, dosage and lot number unknown) for prophylaxis. On September 2009 the patient received the 2nd dose (route, dosage and lot number unknown) for prophylaxis. On 04-JUN-2013 (reported as today) the patient was going to receive the 3rd dose (route, dosage and lot number unknown) for prophylaxis. No adverse event was reported. Additional information has been requested.
Received dose of Moderna vaccine beyond 30-day use by date; Received  dose of Moderna vaccine beyond  30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received  dose of Moderna vaccine beyond  30-day use by date) and PRODUCT STORAGE ERROR (Received dose of Moderna vaccine beyond 30-day use by date) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received  dose of Moderna vaccine beyond  30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received dose of Moderna vaccine beyond 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received  dose of Moderna vaccine beyond  30-day use by date) and PRODUCT STORAGE ERROR (Received dose of Moderna vaccine beyond 30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vials were placed in refrigerator on 05-Jan-2022.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Mar-2022: Follow-up received: no new information was added.
Pt recv vax on unspecified date; on unspecified date pt exp rx of injection site of redness, warmth, swelling &pain; pain to her shoulder &neck.  Pt imp in 5 days.
As soon as the shot was given my daughter said she felt sick at her stomach. We waited about 10 mintues while the doctor prepared the necessary papers for my daughter to turn in at school. This immunization was her 7th grade shots. As we were walking out of the clinic we might have got 20 feet when she completely passed out, which caused her to hit the right side of her face on the floor. I got the receptions attention and she helped me get my daughter back to the clinic. She started sweating profusely and had no color what so ever. The physician got her a bottle of water and wet towels to hold off her face and brow. After about another 10 minutes she regained some of her color and felt well enough to walk to my car. Wednesday after she got home everything she showed me arm that was swollen.
This spontaneous report was received from a physician via a company representative concerning a currently 20-year-old female patient. The patient's sibling: twin sister. The patient's other concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On an unknown date, the patient received the third dose of GARDASIL 9 intramuscularly (dose, lot number and expiration date were not reported) for prevention of human papillomavirus. On the same day, the patient also received a shot of TRUMENBA (dose, route of administration, lot number and expiration date were not reported). On an unknown date, the patient fainted. The patient sought medical attention by seeing the physician. The product quality complaint was not involved. At the time of the report, the outcome of the event was recovered. The causal relationship between the event and GARDASIL 9 was not reported. The patient's twin sister who also fainted after GARDASIL 9 administration (captured in MARRS# 1706USA002769). This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA002769.