chrisvoncsefalvay/vaers-outcomes huggingface dataset:
02/12/2021, 9.15 pm Chills so intense that I was shaking uncontrollably. Then intense headache later on that night, 3.30 am 02/13.2021, Got out of bed to take some tylenol, so weak I passed out, twice in the bathroom.  I have no memory of passing out. My husband called 911 and I was taken by ambulance to the local hospital. Vital signs remained good through out. Large bump on my for-head and brushing on my chin as a result of passing out.
By checking my pulse, I discovered irregular heartbeat; my chest felt funny; was unable to work the next day; tired; fever; Achey; chills; no appetite; throbbing headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Sep2021 11:00 (Lot number: EW0168) at the age of 41 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "hypothyroid" (unspecified if ongoing), notes: other medical history: hypothyroid; "penicillin allergy" (unspecified if ongoing), notes: known allergies: penicillin. Concomitant medication(s) included: NP THYROID. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0168, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 23Aug2021, when the patient was 41 years old, for Covid-19 immunization. The following information was reported: HEART RATE IRREGULAR (non-serious) with onset 16Sep2021, outcome "recovered" (18Sep2021), described as "By checking my pulse, I discovered irregular heartbeat"; FATIGUE (non-serious) with onset 15Sep2021 21:00, outcome "recovering", described as "tired"; PYREXIA (non-serious) with onset 15Sep2021 21:00, outcome "recovering", described as "fever"; PAIN (non-serious) with onset 15Sep2021 21:00, outcome "recovering", described as "Achey"; CHILLS (non-serious) with onset 15Sep2021 21:00, outcome "recovering", described as "chills"; DECREASED APPETITE (non-serious) with onset 15Sep2021 21:00, outcome "recovering", described as "no appetite"; HEADACHE (non-serious) with onset 15Sep2021 21:00, outcome "recovering", described as "throbbing headache"; CHEST DISCOMFORT (non-serious) with onset 16Sep2021, outcome "recovering", described as "my chest felt funny"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 16Sep2021, outcome "recovering", described as "was unable to work the next day". Therapeutic measures were not taken as a result of heart rate irregular, fatigue, pyrexia, pain, chills, decreased appetite, headache, chest discomfort, loss of personal independence in daily activities.  Additional Information: Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient received multi vitamin and NP Thyroid medications within 2 weeks of vaccination. There were no prolongation for the reported events. The patient did not receive any treatment. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination.   No follow-up attempts are possible. No further information is expected.
Patient had flu-like symptoms including sore throat, fever, and cough. Symptoms lasted two days and were self resolving.
I had serve pain in my left knee cap. This knee has replaced.  I had serve pain and stiffness.  It was hard to walk at times.  I went to the doctor about this.  They did an x-ray and they are getting ready to do a MRI on the 23rd of November.
I had a rash all over, it started at injection site and spread. It looked like a viral rash. Within 3-4 days it went away. I took antihistamines.
03/12/21 at approx 8 pm I began to have uncontrollable tremors/seizure in both arms, both legs and head. Numbness/weakness in all fingertips and both legs to above the knees. The symptoms continued to increase and at 11:30 pm I was taken to ER. Was transported by ambulance to Hospital. Was admitted to the ICU. Lumbar puncture was done on 03/13/21 to rule out Guillain Barre. Neurologist determined it was a neurological reaction to the COVID vaccine shot. Was released from the hospital 03/15/21. Legs continue to be numb/weak, but I am able to walk carefully unassisted.
DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute on chronic respiratory failure with hypoxia  [J96.21] Chronic obstructive pulmonary disease, unspecified COPD type  [J44.9] COVID [U07.1] COVID-19 [U07.1]   HOSPITAL COURSE: HOSPITAL COURSE: Patient is a 70 y/o male with history of COPD, ILD and amiodarone toxicity, chronic oxygen use, DM, HTN and PAF. He presented to the ER on 1/2/2023 with increased dyspnea on exertion and hypoxia with exertion. He is on 3L NC at baseline and on arrival to the ER was requiring up to 6L NC. He tested positive for COVID at home on 12/24 and completed a course of Paxlovid outpatient on 1/1.    In the ER he had CT that showed no PE, mild diffuse ground glass opacities superimposed upon pulmonary fibrosis which could be related to atypical pneumonia. He had slightly elevated WBC and normal BNP. His other labs were fairly unremarkable. He was admitted to the hospitalist team due to his increased oxygen needs. He was started on decadron in the ER. After admission his pulmonologist was contacted who recommended treatment with solumedrol 1mg/kg while hospitalized and transition to prednisone 60 mg daily at discharge. The patient's oxygen needs returned to baseline quickly. He has close follow up with pulmonology next week. He will be discharged home on daily prednisone 60 mg with a slow taper until he can follow up with his pulmonologist. He was also encouraged to follow up with his PCP after discharge. The patient verbalized understanding of these instructions and discharged home in stable condition.     CONSULTANTS: Care management Pulmonology    INPATIENT PROCEDURES: None     BP 117/63  | Pulse 78  | Temp 36.5 °C (Oral)  | Resp 18  | Ht 1.702 m  | Wt 125.1 kg  | SpO2 90%  | BMI 43.20 kg/m²    Physical Exam Constitutional:      General: He is not in acute distress.    Appearance: He is obese. He is not diaphoretic.  HENT:     Head: Normocephalic and atraumatic.  Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.     Pulses: Normal pulses.     Heart sounds: Normal heart sounds.  Pulmonary:     Breath sounds: Normal breath sounds.     Comments: Mild tachypnea after walking around Abdominal:     Tenderness: There is no abdominal tenderness.  Musculoskeletal:     Right lower leg: No edema.     Left lower leg: No edema.  Skin:    General: Skin is warm and dry.  Neurological:     Mental Status: He is alert and oriented to person, place, and time.  Psychiatric:        Mood and Affect: Mood normal.        Behavior: Behavior normal.
no adverse effect; administered improperly stored vaccine; This spontaneous report was received from a medical assistant referring to refers to a 2-month-old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On 09-OCT-2019, the patient was inadvertently administered improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # R026541 with expiration date: 11-JUL-2020) (strength, exact dose, route of administration and anatomical location were not reported) for prophylaxis. Administered dose of vaccine experienced a temperature excursion of 51.62 degrees Fahrenheit for 10 hours. It was reported that digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. There were no adverse effects reported. No product quality complaint (PQC) was involved.  This is one of the several reports received from the same reporter.
Pt  was taken to the ER by ambulance from his home in full code sometime after leaving the clinic following his 2nd dose of his COVID vaccine. He did wait his 15 min in the clinic after receiving the vaccine and reported no side effects at that time. Report of the incident was called into the  primary care provider the next morning. Pt has been transfered to a higher care facility
Fast heart rate (120 bpm) was noted during visit to neighborhood Urgent Care for routine covid test. EKG perfomed there confirmed arrhythmia/tachycardia  and I was advised to go to the ER immediately.  I went to the ER at (PRIVACY), where EKG confirmed atrial flutter/tachycardia. Eliquis blood thinner was prescribed and followup visit was scheduled before my release that evening.  At followup vist on March 19, ablation was recommended and scheduled for March 31.  Ablation performed on 3/31 was successful, but Atrial Fltter/Tachycardia resurfaced in mid-August, 2021 and a second ablation was performed on September 15, 2021 which was successful.
Once my period started, (somewhat on schedule) I had terrible period cramps. Worse than I've ever had before. I very rarely get cramps at all, and these were certainly the worse I've ever had. Pain was bad enough to prevent my ability to work and to some extent move at times. This is not something I have ever experienced before. Reporting because I have heard anecdotally from  close friends about changes in their periods after the vaccine as well. I had not heard of this until after I was already done with my period, so it wasn't something I was expecting  or in my opinion not placebo related since I did not hear about possible period-related side effects until afterwards.
Initial misuse report received from a healthcare professional on 17 JULY 2013. ADACEL. ADACDEL was administered to a 15 month old patient. No adverse event was reported. Documents held by sender: None.
1 hour after vaccine administration developed chest pain, fatigue, SOB. "Like hit by a train" Recommended rest, Benadryl prn
the patient is not exhibiting any adverse symptoms.; Caller is a nurse practitioner reporting that a patient received a dose of MMR II on 29JAN2021 after having had a previous admistration l 1SEP2020.; Information has been received from a nurse practitioner, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 11-SEP-2020, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (anatomical location, administration route, lot # and expiration date were not reported) for prophylaxis.  Later, on 29-JAN-2021, the patient was vaccinated with an additional dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # S037502 and expiration date on 20-NOV-2021 (anatomical location and administration route were not reported) for prophylaxis.  Per caller, the patient was not exhibiting any adverse symptoms.
Started with headache then chills and muscle ache was. Fever of 103. With MOTRIN fever broke and muscle aches better by 9am 10/17/18 but not feeling 100 percent.
PT called call center 4/28/2021. Verified pt with 2 identifiers. Pt denies emergency s/sx. Pt reports he got 1st vaccine Pfizer 4/14/2021 and ili symptoms; sore throat, nasal congestion, left back(pressure pain but not chest pain or SOB per pt) and both legs pain(weakness but pt is able to walk around in his house without difficulties per pt) since Sunday evening 4/25/20201. Pt said his temperature 99F at noon 4/28/21. Pt is taking tylenol, lozenges and resting a lot and it's helpful. Pt scheduled at 8:45 am 4/29/2021 @ urgent care for evaluation. Pt is educated covid vaccine side effect and flu. Pt agreed and verbalized understanding.
Rash, UrticariaPruritus, Pain and swelling into right axillary region. Narrative: Was started on antibiotics by her PCP.
Incorrect Moderna covid 19 vaccine strength  of vaccine given on April 28, 2023.  I called mom over the phone and requested she bring in child to vaccinate with correct dose.  Parent brought in child to vaccinate with correct Moderna vial vaccine and dose.
High fever, pounding headaches, heart racing, weak, muscle aches, soreness to touch of skin. Lasted 1 week. Took - Tylenol extra strength for fever - Darvocet for pain.
Patient had redness and swelling at the injection site and further redness roughly six inches down the right arm. The flu shot given on her left arm caused no reaction.
pt was seen by MD 7SEP96 p/vax 5SEP96;mom reports inc temp of 103 x 2 days;cried on & off x 2 days;reports inconsolable crying during MD visit;reports pt acted alot differenct w/shots than other children;MD exempted pt from pertussis;
extreme headache; nauseous; threw up; fatique; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (extreme headache), NAUSEA (nauseous), VOMITING (threw up) and FATIGUE (fatique) 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 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced HEADACHE (extreme headache), NAUSEA (nauseous), VOMITING (threw up) and FATIGUE (fatique). On 24-Mar-2021, HEADACHE (extreme headache), NAUSEA (nauseous) and VOMITING (threw up) outcome was unknown. At the time of the report, FATIGUE (fatique) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.
Patient administered 0.3ml of Pfizer vaccine that was diluted with only 0.8ml diluant.
headache; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (father) reported that a female patient (daughter) of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number, Expiry date: Unknown), dose 1 via an unspecified route of administration on 16Jun2021 as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine includes first dose of bnt162b2 for covid-19 immunisation. It was reported that the patient is currently experiencing headache, and asked what over-the counter medication can he give for this? Outcome of the event was unknown.   Follow up attempts completed. No further information expected.
Patient suffered from chills fever (99.8 degrees F) for 2 days after receiving the Flu + Pneumonia shot. Pt also experience joint + muscle pain, nausea, + localize pain + swelling near injection sites shots were given in the same arm @ the same time 1 inch apart.
Information has been received from a 58 year old male patient with diabetes mellitus referring to himself. The patient was diagnosed with shingles in approximately 2010 (reported as "over 5 years ago"). In approximately March 2015 (reported as "about two months ago"), the patient was vaccinated with a dose of ZOSTAVAX (lot number, dose and route were unknown). Concomitant therapies included metformin and losartan potassium (manufacture unknown). Recently on an unknown date in 2015, the patient was mowing the grass and he experienced sunburn, that felt just as bad or worse than the shingles he had 5 years ago. He was not sure if it was the shingles again. His skin was burning and felt like it was on fire from the waist up. The patient did not experience a rash or redness. He sought unspecified medical attention. Penicillin and levofloxacin were given for the events. The outcome and causality of the events was unknown. Additional information has been requested.
Left-sided facial weakness c/w Bell's Palsy, starting 2 weeks after vaccination. Treated with prednisolone, acyclovir.
4pm started having chest pains took blood pressure it was 191/101 pulse was 118 went to the ER
vaccines were exposed to 0.7 C for 25 hours and 24 minutes/ NO AE; Initial information received on 25-Jan-2021 regarding an unsolicited valid non-serious case received from a other health professional via call-center.  This case involve a INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE], DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL], DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL], MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA], IPV (VERO) [IPOL], DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (batch number and expiry date not reported) which was exposed to 0.7 Celsius for 25 hours and 24 minutes (product storage error) excursion occurred in December-2020. Also one year patient administered post exposed 0.5 mL FLUZONE (batch number: UJ477AA and expiry date: 30-Jun-2021) via an intramuscular route at an unknown administration site on 06-Jan-2021 for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to product storage error temperature too low.  It was reported that 11 doses of Fluzone quadrivalent were administered post excursion.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available for DAPTACEL, ADACEL, IPOL, MENACTRA and PENTACEL on the batch number for this case.
Hi, I actually not sure if the couse of my problem was couse by the Vaccine given to me on January 17 2021. At the time of the injection given to me I was pregnant don't know how long because I just had found out about it. I took the injection because I wanted to be safe for the health of my baby and my family..am just curious about the side effect of this covi19 vaccine. On January 19 I started seen some spot of blood at first I thought it was nothing to worried about but then around 8am I that day I saw that I was bleeding more and more not a crazy bleeding but I ended  up at the emergency room on January 19 around 3:45pm. To find out that I was having a miscarriage..so now I don't know if this was couse by the injection or not. Am just worried that these is a side effect of this injection and nobody knows about it.  Please reply  me back I want to know more I already have both covi19 vaccine.
Pain in shoulder increasing over days following vaccination.  Saw a provider on 10/04/2022.  X-rays.  Diagnosis SIRVA.  Continuing pain and Physical therapy started.
This spontaneous report as received from a 60 year old female patient referring herself. The patient's drug allergies and pertinent medical history was none. On 27-AUG-2014 the patient was vaccinated with ZOSTAVAX (dose/frequency: Unspecified). Concomitant therapies included LOPRESSOR, LIPITOR and LOVAZA. On 08-SEP-2014, the patient developed chicken pox. The patient sought medical attention, the patient reported the event to her physician and the patient was treated with calamine, camphor, CALDRYL lotion. Lab diagnostics performed were none. The outcome chicken pox was reported as recovered on an unknown date in 2014. The causality of the chicken pox was not reported. No product complaint was reported for ZOSTAVAX. Additional information is not expected.
Deep vein thrombosis in popliteal vein of lower right extremity (unspecified chronicity).
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Information regarding their pertinent medical history, concurrent conditions and drug reactions/ allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored VARIVAX (which had the possible lot numbers and expiration dates: M027342 and 01-JUN-2018; M024683 and 18-MAY-2018; M006722 and 18-FEB-2018; M027885 and 03-JUN-2018; M024678 and 18-MAY-2018; or M027886 and 03-JUN-2018; however, the dose, dosage number, and anatomical location were unknown), subcutaneously, for prophylaxis. No concomitant therapies were reported. The stated vaccine experienced a temperature excursion of -13 °C for a time frame of 9 minutes. No previous temperature excursions had occurred and this call had not been made because of a data logger. Despite being vaccinated with such an improperly stored vaccine, no adverse effects were reported. Additional information has been requested.
Patient developed specks of blood in her stools along with what appeared to be abdominal pain. starting on 03/10/2023 and was seen in the office again. It persisted through 03/13/23 where she was referred to be evaluated in the ER.  Her parents reported she had a  normal work up and her symptoms resolved on 03/14/23.
Within four hours after vaccinated developed redness, erythema, induration, swelling, pain extending 5-6 inches around and below injection site. Very Painful injection site and surrounding area.  Unable to sleep. Headache, myalgia, fatigue, abnormal weakness and lack of engery. Asthenia.
Hoarse sounding cough, raspy voice. No treatment. Lasted 24 hours
*eyelid area on both sides of face felt tingly/numb for about 20 minutes which started about 40 minutes after the shot was administered. *42 hours after administration of vaccine, I woke up with a metalic taste in my mouth which has laste for 6 hours
Lt deltoid area swollen, warm to touch, swelling and redness measures approx 4 1/2 inches x 3. Instructed to continue fever med and cold compresses and massage. Mom said she would  bring him to Dr if necessary. 8/25/06 11:05am spoke with mom, he's better, went to Dr.
Information has been received from a medical assistant concerning multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. On unknown dates in October 2016 (reported as "at the beginning of October 2016"), the patients were vaccinated with doses of improperly stored PROQUAD (lot # L045675 with expiration date 09-MAY-2017; dose and route were unknown). The vaccines were exposed under temperature of 14 degrees Fahrenheit for a short amount. The previous temperature excursions started at the beginning of October 2016. Data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.