chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feel tired/more tired; mind felt foggy; feel achy throughout body; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247), via an unspecified route of administration (at the age of 52-years-old) on 01Feb2021 12:30 at a single dose in left arm for COVID-19 immunization. Medical history included none from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took Bactrim and clarithromycin and experienced allergies. The patient experienced feel tired/more tired, mind felt foggy, feel achy throughout body all on 01Feb2021 14:30 with outcome of recovering. The patient reported that "Approximately 1 hr (as reported) after receiving the vaccine, I started to feel tired, and my mind felt foggy. A few hours later, I began to feel achy throughout body and more tired. Next morning continued to feel achy but not as tired." No treatment received for the events. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events were assessed as non-serious.
After giving PNEUMOVAX 23 patient swelled at injection site. Swelling went down with 3 minutes of injection. Patient waiting around for 15 minutes said was ok. Called patient next day to see how was and she said a little sore but ok. Patient called about 10 days later to inform arm was still sore and painful to the touch. But no swelling or redness. Patient was informed to contact md to have looked at.
emergency room after motor vehicle accident and mental status changes.  Patient denies any injury but remained disoriented.  Patient does not recall what happened.  Patient work-up in ER essentially negative but this morning he is COVID-19 test came positive.  Patient is slightly hypoxic.  Patient admitted for management.  Patient denies chest pain shortness of breath cough congestion abdominal pain nausea vomiting diarrhea and answer question appropriately
On 4/2/21, experienced facial swelling.  on 4/2/2021 and continuing to present, experienced whole body hives.  On 5/4/2021 and continuing to present, experienced facial swelling.
every cell in my body ached, fever, dizziness, extreme pressure headaches, couldn't move/walk much, shivered in bed night of injection, couldn't eat, tried to drink, nausea, blurred vision, extreme fatigue, couldn't stand loud noises/tv, couldn't read, felt like every cell in my body was fighting to live. Aleve helped the second nigh but not the first.
Myalgia & Diarrhea Narrative:  Went to ER on 12/24/2020 for Body Aches and diarrhea.
Received MenB vaccine in L deltoid than 1-2 days later had continued soreness at site and decreased rom of left shoulder. Good ROM, but pain with movement of Left shoulder. No redness at site
Pt developed every joint aching, weakness in the knees, generalized muscle stiffness, malaise, and an injection site reaction characterized by redness and swelling.
Information has been received from a physician for the pregnancy registry for GARDASIL concerning a 14 year old female who on 03-JAN-2008 was vaccinated with GARDASIL (lot number unspecified). Concomitant therapy included prenatal vitamins (unspecified). The patient's LMP is reported as 10-Dec-2007. An ultrasound was performed on 29-Apr-2008. Follow up information was received from a healthcare professional who reported that the patient did deliver a baby by cesarean section in September 2008. Upon internal review, cesarean section was considered to be an other important medical event. Additional information has been requested.
This spontaneous report was received from a nurse regarding multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with an improperly stored doses of PROQUAD (Merck) (dose and route were not reported, lot # L030586, expiry date: 10-FEB-2017). There was no adverse effects reported. This is one of the several reports from the same source. Lot number L030586 has been verified to be a valid lot number for PROQUAD (Merck). Follow up information was received on 12-FEB-2016, from health professional regarding a 4 year old male patient. On 09-NOV-2015, the patient was vaccinated with a dose of PROQUAD (Merck). This is one of several reports received from the same reporter. Additional information has been requested.
Generalized urticaria 8-10 hrs after immunizations. Seen by ER DR & treated with steroid IM injection, oral steroid & Benadryl. I saw the child on 1/20/00, she had 1 small erythema on R/upper extremity. (urticaria)
Mental Health distress, amplification of mood disorder, rage similar to what patient had when received Prednisone in the past, similar to adrenal crisis of past, noticeably amplified after Moderna first injection.  Not enough information is available about affects of Moderna Covid-19 vaccine on underlying mental health conditions, so am reporting in hopes others can find help and validation if they experience the same kind of acute amplification of mental health symptoms.  Patient had to seek professional mental health care and was unable to perform complex intellectual tasks--had to cancel an important legal meeting due to impairment.  This is not typical for patient, became acute following 1st vaccine of Moderna.
Painful swelling under arm that was vaccinated. About the size of a tennis ball. Feels fluid filled
Big Red swollen spot on arm, was hot and is now just start to go away after almost 3 weeks
Red spots over entire body.  Feeling like joints being hammered on by an ice pick.  Tingling in hands and legs.  Side effects lasted roughly 24 hours then stopped completely.
58-year-old female presents to the office for symptoms of possible allergic reaction. Patient reports that yesterday around 1230 patient had Pfizer Covid vaccine which is her first dose patient reported that she had her first dose 6 months ago however was not able to do a second dose so they had to repeat the first dose yesterday. Patient reports after2 hrs of having her vaccination, she started to experience fatigue and body aches. Fatigue and body aches continue to persist this morning however approximately around 1045-11 AM today, patient started to have tingling sensation on her upper lip and also redness on her face. Patient denies any difficulty breathing or swallowing there is no hives. Patient denies any allergic reaction towards administration of Covid 6 months ago. pt is allergic towards solu-medrol and penicillin. pt took ibuprofen earlier today for bodyaches
Primary Breakout of HSX2 genital herpes. HSX2 infection was previously undetected and has been dormant for 25+ years. Breakout began approximately 2 weeks post-vaccination and progressed for 3 weeks. Herpes simplex was not initially considered a possible diagnosis as I have remained fully monogamous for 25 years. Post-vaccine was the primary breakout and caused significant emotional distress as well as marital complications resulting from an STD diagnosis. It is unclear whether subsequent breakouts will occur after this primary breakout.
This spontaneous report as received from a Medical Assistant refers to an adult patient of unknown age and gender who on 10-APR-2015 was vaccinated with an improperly stored dose of GARDASIL lot # K006960 (exp date, dose and route of administration not provided). According to the reporter the vaccine dose administered underwent a temperature excursion for 72 hours. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received. Product and narrative were updated.
received complete Hep-b series/ tested lowHep-B antibodies./received 1 / dose /still low; received complete Hep-b series/ tested lowHep-B antibodies./received 1 / dose /still low; This case was reported by a nurse via call center representative and described the occurrence of therapeutic response decreased in a 28-year-old male patient who received Hepatitis B vaccine for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Hepatitis B vaccine. In July 2021, the patient received Engerix B. On an unknown date, more than 2 years after receiving Hepatitis B vaccine and not applicable after receiving Engerix B, the patient experienced therapeutic response decreased and therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased and therapeutic response decreased were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received complete hepatitis B series and was tested low hepatitis B antibody which led to therapeutic response decreased. The patient received Hepatitis B series as a child and now the patient is entering dental school. The patient was scheduled to receive a second booster dose. The health care professional had no further information on the subject and did not agree nor denied for consented to follow up.   Follow up information was received by nurse on 30th August 2021: Upon follow up the classification was changed to FU NO - permission denied.
Non-stop crying, fever, red skin, won't sleep, won't eat as much, fussiness.
Rash & UrticariaPruritus Narrative:  Developed rash a/w redness/mild itching at injection site on day 7. Described area as the size of a well circumscribed nickel, which resolved within a few days. No warm to touch or indurated. No hives, other areas or swelling or sloughing. No therapies applied to tried, no other adverse events noted.
Woke up on 8-18-16 with fever and fussiness. Mom brought her in to Hospital urgent care, treated with TYLENOL and had physical exam and sent home.
large red patches of swelling & warm to touch @ lt deltoid site per MD dx cellulitis;
Headache; Chills; Sore eyes; Fatigue; Tinnitus in my right ear; This is a spontaneous report from a contactable consumer, patient. A 56-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534), via an unspecified route of administration in the left arm on 26Mar2021 at 08:15 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine. Concomitant medications included vitamins (MANUFACTURER UNKNOWN), temazepam (MANUFACTURER UNKNOWN), hormonal replacement therapy (MANUFACTURER UNKNOWN), non-steroidal anti-inflammatory (MANUFACTURER UNKNOWN); all for unknown indications from an unknown date. The patient previously received naproxen (MANUFACTURER UNKNOWN) on unknown date for unspecified indications and experienced drug allergy and sulfa drugs on unknown date for unspecified indication and experienced sulfonamide allergy. Prior to vaccination, the patient was not diagnosed with Covid-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Mar2021 at 20:00, about 12 hours after the shot, the patient experienced headache, chills, sore eyes, fatigue, and tinnitus in the right ear which all lasted about 36 hours. Then patient was left with just the tinnitus for about 24 hours. Then she woke with the headache, sore eyes, and continued tinnitus. It's Tuesday evening, and she received the shot last Friday morning. she still had these symptoms. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events headache, chills, sore eyes, fatigue, and tinnitus were not recovered at the time of report.   No follow-up attempts are needed. No further information is expected.
Twitch around eye, now developed to generalized muscle twitching. Now 2mo since x2 post exposure doses 3-4 days after doses had flu-like symptoms characterized by fever, headache.  Had pre-exposure series in 1985.
Fever for about 36 hours. Chills. Sweats. Body aches. Headache. Fatigue. Sore arm.   Ibuprofen taken every 6 hours until fever broke.
A physician's office manager reported that a 25 year old female inadvertently received an intradermal injection of Tetanus and Diphtheria Toxoids Adsorbed, Purogenated on 05/07/2001. On 05/09/2001, the pt developed an injection site reaction characterized by a swollen area "the size of a grapegruit," a "dime sized blister," inflammation, and itching. The physician prescribed application of Lidex cream.
pt to ED via EMS after a fall at home; found supine; family guessing she has been there x 3 days; no evidence of fx; CT of brain showed no intracranial hemorrhage; pt had a sore throat and diarrhea earlier in the week; found to be positive for COVID; no O2 supplementation needed; echocardiogram shows 20% Ejection Fraction; cardiology consulted but cardiac catherization not done due to COVID positive; DNR/Comfort Care; pt passed away in the hospital
On Sunday both of my children, went to bed feeling fine. Patient woke up during the night with pain in his throat, coughing, ear pain and a fever. During the day on Monday, Patient's sibling developed a dry cough and then they both tested positive for COVID on a home test which led me to contact our pediatrician.
Pt. experienced vasovagal syncope upon leaving the Center. A security guard on duty assisted.  Pt. recovered from the episode after 15 minutes of sitting. The doctor was consulted and recommended pt. rest the remainder of the day.
expired ADACEL vaccine being administered with no reported adverse event; Initial information received on 02-Dec-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age male patient who had administered with expired DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (ADACEL) with no reported adverse event   The patient's past vaccination(s) included TDAP with Caller states that it has been more than 10 years since the patient received a Tdap vaccine. The patient's past medical history, medical treatment(s) and family history were not provided.   On 30-Nov-2022, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE Suspension for injection lot U6855AA via intramuscular route in Left Arm, Dosage text  0.5 ml (milliliter) 1X  (Total) , expiry date: 25-NOV-2022 ( strength, : unknown) for Immunisation  On 30-NOV-2022 the patient who had administered ADACEL with expired with no reported adverse event (expired product administered) (latency : same day)  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event   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 the 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.
Patient reports after vaccination developed marble sized bump at vaccination site that is tender to touch, pain has been improving but bump size remains stable per patient. Patient on vacation at time adverse event reported and advised to visit local urgent care. Patient may seek office/clinic visit upon return from vacation.
1 hr p/vax pt devel palpitations & dizziness; 4 hr after vax, was seen by MD. Heart rate 116 beats/min. BP 130/90 mmHg. Given oral Benadryl. As of 10/10/97 heart rate is still greater than 100.
I was sitting after I got the shot and I started to feel a little off. I felt light headed and wish I would have drank more water before I received the vaccine. I was kind of okay, sitting there waiting, but then I started feeling a weird sensation from the top of my head to the tip of my toes. My skin felt like it was tingling. While I was sitting there I was thinking that I was experiencing anxiety. I received a phone call from my sister that distracted me from my feelings and I felt okay. When I started to leave, I felt light headed and disoriented. I thought I may have been dehydrated. I went to the car and my lips felt like they were swollen, but were physically not. I started feeling like there were pins and needles in my skin. I started to itch in the back of my throat and started experiencing breathing complications. I sat in the parking garage for 40 minutes and debated if I wanted to go back. It was a long walk from my car to the vaccination area. I had my service dog with me and decided to go home. The itchiness went away and I started feeling better for about 24 hours. The next day, I ended up in the ER. I was given Benadryl and in 10 minutes I was fine. Over the next couple of weeks, I started experiencing random heart palpitations. It felt like my heart would skip and jump from time to time. I have not seen anyone yet in regards to my heart. I have had multiple ocular migraines. I still get them now and then after receiving the vaccine. It affects my vision for up to 20 min to an hour after the headache. Bright lights and too much time on my phone and computer causes a problem for my vision.
Fingernail showed black and blue spots; This is a spontaneous report from a contactable healthcare professional, the patient. A 61-year-old patient of unknown gender, received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: UNKNOWN) in the left arm on 14Mar2021 at 12:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was reported as none and the patient was allergic to epinephrine. Prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 16Mar2021, 2 days after vaccination, the patient experienced fingernail discoloration, where 3 of the fingernails showed black and blue spots. No therapeutic measures were taken as a result of the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event fingernail discoloration was not recovered at the time of this report.   Information about lot/batch number cannot be obtained. No further information is expected.
headache; aches and pains; chills; is experiencing swelling in her left hand; having trouble moving L arm; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), PAIN (aches and pains), CHILLS (chills), SWELLING (is experiencing swelling in her left hand) and LIMB DISCOMFORT (having trouble moving L arm) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-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 (headache), PAIN (aches and pains), CHILLS (chills), SWELLING (is experiencing swelling in her left hand) and LIMB DISCOMFORT (having trouble moving L arm). At the time of the report, HEADACHE (headache), PAIN (aches and pains), CHILLS (chills), SWELLING (is experiencing swelling in her left hand) and LIMB DISCOMFORT (having trouble moving L arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
I walk 3 miles a day. I came home from work and walked to the store; I felt a pain. The bone in my right thigh shot through a large pain throughout my leg.  The pain was so intense.  I called my doctor the very next day! he was concerned and immediately sent me to an orthro doctor. There they gave me an MRI and CAT. I was diagnosed as having torn GLTEUS-Medius and a torn tendon in my hip all on my right side.  I am currently just finishing my last physical therapy Tuesday. I will see the Orthopedic in few weeks. I can only walk half of my three miles.
11/21/22 presents to EC ED for "shortness of breath". PMHx of "factor V and CAD"
On day 8 a small itchy  rash appeared . The itch mostly subsided within a few hours. Rash remains 6 hours later.
pneumonia; suffered varicella type rash located throughout his body, facial swelling, difficulty swallowing and was diagnosed with autoimmune urticaria, dermatitis, cryoglobulinemia and vasculitis; suffered varicella type rash located throughout his body, facial swelling, difficulty swallowing and was diagnosed with autoimmune urticaria, dermatitis, cryoglobulinemia and vasculitis; suffered varicella type rash located throughout his body, facial swelling, difficulty swallowing and was diagnosed with autoimmune urticaria, dermatitis, cryoglobulinemia and vasculitis; suffered varicella type rash located throughout his body, facial swelling, difficulty swallowing and was diagnosed with autoimmune urticaria, dermatitis, cryoglobulinemia and vasculitis; atherosclerosis of aorta; chronic obstructive pulmonary disease; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  On or around 27-JUN-2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), patient suffered varicella type rash located throughout his body, facial swelling, difficulty swallowing and was diagnosed with autoimmune urticaria, dermatitis, cryoglobulinemia and vasculitis. Patient also suffered and was diagnosed with pneumonia, atherosclerosis of aorta and chronic obstructive pulmonary disease.  As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient's symptoms have resulted in physical limitations not present prior to using the vaccine. Patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of using zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Company's wrongful conduct, patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  All events were considered to be disabling.  Upon internal review, cryoglobulinaemia and pneumonia were considered to be medically significant.
Pt recvd flu vax & devel a knot, & redness @ the inject site, & a fever;