chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Red welts; Face was red; Head ache either the front or the back of her head; had hot spot all over her face (cheeks, ears) about 102 F; Lips felt numb; Flush; Numbness in the left side of the face; Brain frog; Hot spot all over her face (cheeks, ears); Numbness in the left side of body hip and buttock/Went numb from elbow to wrist; Face was hot to touch; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (Lips felt numb), FLUSHING (Flush), HYPOAESTHESIA (Numbness in the left side of the face), COLD-STIMULUS HEADACHE (Brain frog) and RASH MACULAR (Hot spot all over her face (cheeks, ears)) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hashimoto's disease since an unknown date, Polycystic ovarian syndrome since an unknown date, Psoriatic arthritis since an unknown date and Hypothyroidism since an unknown date.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced HYPOAESTHESIA ORAL (Lips felt numb), FLUSHING (Flush), HYPOAESTHESIA (Numbness in the left side of the face), COLD-STIMULUS HEADACHE (Brain frog), RASH MACULAR (Hot spot all over her face (cheeks, ears)), HYPOAESTHESIA (Numbness in the left side of body hip and buttock/Went numb from elbow to wrist), HOT FLUSH (Face was hot to touch), ERYTHEMA (Face was red), HEADACHE (Head ache either the front or the back of her head) and PYREXIA (had hot spot all over her face (cheeks, ears) about 102 F). On 21-Jan-2021, the patient experienced URTICARIA (Red welts). At the time of the report, HYPOAESTHESIA ORAL (Lips felt numb), FLUSHING (Flush), HYPOAESTHESIA (Numbness in the left side of the face), COLD-STIMULUS HEADACHE (Brain frog), RASH MACULAR (Hot spot all over her face (cheeks, ears)), HYPOAESTHESIA (Numbness in the left side of body hip and buttock/Went numb from elbow to wrist), HOT FLUSH (Face was hot to touch), URTICARIA (Red welts), ERYTHEMA (Face was red), HEADACHE (Head ache either the front or the back of her head) and PYREXIA (had hot spot all over her face (cheeks, ears) about 102 F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, Body temperature: 102 (High) Fahrenheit. In 2021, SARS-CoV-2 test: negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.
After vaccination on 11/24/21 I felt very tired and fatigue also very dizzy came home and stood on bed rest for 2 days on the 3rd day started to feel a lil worse with body chills and heavy sweating and diarrhea on the 4th day 11/28/21 around 7:45 pm I got up to use ice he restroom while still feeling body aches stomach pain and dizziness and chills all over my body while trying to get up from using my he restroom I just remember calling a relative because I felt very weak from my legs and I was told I blacked out and threw up also and after coming back to my conscious I was very pale and transported to the er where I was admitted do to something abnormal in my heart I was in the hospital 6 days where they constantly took blood out every 4 hours and did X-rays and ultrasounds also a stress test for my heart and also a colonoscopy and telenoscopy due to the stomach pain and gastritis I suffer from after coming home I visited my primary care dr 12/8/21 and was told the hospital reports said I suffered from a mild heart attack causing my blood to thin and my heart work 2x as faster
Used only 0.8 ml of diluent to prepare the vial. No adverse reaction on the patient after 30 minutes observationb
This unsolicited case was received from a literature on 16-Jun-2015. This case is linked to cases: 2015SA089691 and 2015SA082627 (same literature). Abstract: Although naturally occurring smallpox virus was officially declared eradicated in 1980, concern for biological warfare prompted the Government in 2002 to recommend smallpox vaccination for select individuals. Vaccinia, the smallpox vaccine virus, is administered into the skin, typically on the upper arm, where the virus remains viable and infectious until the scab falls off and the epidermis is fully intact - typically 2-4 weeks. Adverse events following smallpox vaccination may occur in the vaccinee, in individuals who have contact with the vaccinee (i.e., secondary transmission), or in individuals who have contact with the vaccinee's contact (i.e., tertiary transmission). In June 2014, two cases of inadvertent inoculation of vaccinia and one case of a non-viral reaction following vaccination occurred. This includes the first reported case of shaving as the likely source of autoinoculation after contact transmission. This paper describes the diagnosis and treatment of these cases, the outbreak investigation, and steps taken to prevent future transmission. A male patient (age not reported) who was unvaccinated and exposed to vaccinia virus via contact transmission with a patient, who was vaccinated with ACAM2000 (lot number: VV04-003-A, manufacturer: Sanofi Pasteur Biologics Co., route was not reported) on an unspecified date. Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination. The medical history and concomitant medications were not reported. On an unspecified date, the patient developed four crusted papules on the left upper arm and he reported to the clinic on 13-Jun-2014. The first papule appeared 5 days after he had received a tattoo at the same location. He noted that his roommate, who was vaccinated three weeks prior with smallpox vaccine had not kept his vaccination site covered at all times and had mistakenly used the patient's towel. He was referred for a dermatologic evaluation, which included a biopsy and wound culture. On an unspecified date, there was a contact transmission of vaccinia and inadvertent inoculation. The patient developed granulomatous inflammation which was typical of a tattoo reaction and necrotic keratinocytes which was suggestive of an infectious process. Polymerase Chain Reaction (PCR) suggested non-variola orthopox DNA which was consistent with the diagnosis of contact transmission of the vaccinia. At the time of this report, the outcome of the event was unknown. Documents held by sender: yes.
A non-serious spontaneous report of administration to a child under 2 years of age was received from a registered nurse/health professional concerning a 21-month-old male child. Neither relevant medical history nor concomitant medications have been reported for this patient. On 05-Nov-2009, the patient received H1N1, Intranasal, for an unknown indication. The patient also received a dose of H1N1 inactivated on 12-Jan-2010 and another dose of H1N1 inactivated on 09-Feb-2010. There was no adverse event associated with this medication error therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
SERIOUSNESS CRITERIA OTHER: IMPORTANT MEDICAL EVENT. Initial unsolicited report received from a pharmacist on 03-Nov-2017. This case involves a 68 year old female patient who was vaccinated with a 0.5 ml once dose of FLUZONE HIGH-DOSE (Batch number- UI883AB) in deltoid left and PREVENAR 13 (batch number and site not reported) (expiry date and dose in series not reported for both the vaccines) intramuscularly on 26-Oct-2017. The patient's medical history was not reported. Concomitant medications was not reported. On an unspecified date (also reported as today), following the vaccination, the patient diagnosed with a cellulitis the site is red and the size of a baseball it's in the lower deltoid area and down no swelling at site visualized, not palpated by reporter. Lab data were not reported. She was given BACTRIM and Prednisone as corrective treatment to taper but she didn't tell when she would be going back for a recheck. The outcome of the event was not recovered. Upon internal review the company decided to consider the case as serious due to Important Medical Events: cellulitis and redness. List of documents held by sender: none. Sender's Comments: The patient experienced cellulitis and the site was red post vaccination with FLUZONE HD and PREVENAR 13. Time to onset was not reported. Patient's medical history was not reported. Cellulitis could be due to alternate infectious etiologies. Since the site of vaccination was not specified as vaccination site it could not be concluded if it was due to improper aseptic technique at the time of vaccination. Additional information regarding patient's medical condition at the time of vaccination, site of event should be requested. Based upon reported information the role of one vaccine cannot be assessed.
redness, lump, itchiness, heat, raised lump at injection site on left arm
About 27 hours after the shot I started feeling weak and had chills. When I got home my I had a fever of 100.4 and I had body aches and a headache. I took Advil for the fever and it came down and chills and body aches went away, but started to come back again late that same evening. I took more Advil and went to bed around 11 pm that night. When I woke up the next morning all the symptoms except the head ache and fatigue, which both got better later that day.
The evening of the shot I woke up with pain in my legs near my hips which lasted for a day. On 04/12/2021 my left leg was swollen and painful. I was already taking blood thinner. I went to the Emergency Room the next day and they found a blood clot in my leg. The Thrombosis was behind my left knee. My leg was swollen from the knee down and my ankle was very swollen. My Eliquis dosage has been increased from 2.5mg to 5mg twice daily. I did not have a repeat sonogram but my leg is no longer swollen.
a lot of pain in my arm; I only had fever throughtout the day; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 03-JUL-2023, the patient received Shingles vaccine. In JUL-2023, an unknown time after receiving Shingles vaccine, the patient experienced fever (Verbatim: I only had fever throughtout the day) and pain in arm (Verbatim: a lot of pain in my arm). In JUL-2023, the outcome of the fever was resolved (duration 1 day) and the outcome of the pain in arm was resolved.   It was unknown if the reporter considered the fever and pain in arm to be related to Shingles vaccine.  It was unknown if the company considered the fever and pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 11-JUL-2023 This case was reported by a patient via interactive digital media. The patient only had a fever throughout the day but it was just one day, a lot of pain in his/her arm but it was gone away now.
Developed a rash around the injection site within several hours of receiving shot. Rash looked similar to her eruption the previous year. Within 2 days the pruritic rash erupted over her entire body surface except for palms and soles of the feet. She was treated by primary care but has no documentation of the type. At one point, the lesions revealed fungal elements on culture. She used Lotrimin as well as cortisone cream. The rash subsided in 2 weeks everywhere but her legs and the antecubital fossa. The condition was active from March 2000 through February 2002.
This spontaneous report as received from a healthcare worker refers to a 4 month old patient of unknown gender. On 29-JAN-2014 the patient was vaccinated with a dose of M-M-R II. No adverse effect was reported. Follow up information had been received from a physician 4 month old female patient. The patient do not have any previous medical history and illness during vaccination. On 29-JAN-2014, the patient was vaccinated with a dose of M-M-R II (lot number not specified) for an unknown indication. The 4 month year child was given vaccine mistakenly. It was an inappropriate age to have the vaccine administered. No adverse event was reported. Additional information has been requested.
DIZZINESS; FELL; HURT HIMSELF; SOME DAMAGE TO HIS KIDNEYS IN THE PROCESS (BLOOD CLOT); SOME DAMAGE TO HIS KIDNEYS IN THE PROCESS (BLOOD CLOT); CONFIRMED COVID-19 POSITIVE; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 15-MAR-2021, the patient became ill with COVID like symptoms, and got tested for COVID on 22-Mar-2021 and received results that he was COVID positive on 25-Mar-2021 and was running high temperatures (fevers over 103), On 27-MAR-2021, the patient became dizzy, fell and hurt himself, was rushed to the hospital and was admitted same day. He did some damage to his kidneys in the process. On 25-MAR-2021, Laboratory data included: COVID-19 virus test positive (NR: not provided) Positive. On 25-MAR-2021, Laboratory data included: Body temperature (NR: not provided) Over 103. Laboratory data included: Oxygen consumption decreased (NR: not provided) 87.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 positive, dizziness, fell, injury to kidney, hurt himself and blood clot was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition) This report was associated with product quality complaint : 90000174591.; Sender's Comments: V0: 20210355610- Covid-19 Vaccine Ad26.Cov2.S-Confirmed Covid-19 Positive. This event is considered Unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. 20210355610- Covid-19 Vaccine Ad26.Cov2.S - Dizziness, Fell, Hurt himself, Some damage to his kidneys in the process (blood clot). This events are considered Unassessable. The events have a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Left cheek, eye socket and nose felt numbness and tingling and slight swelling of left side of face.  It started around 10:30 am and most of the numbness and tingling eased up by 3:30 pm, except for numbness in eye socket and tingling in nose. Pain in left arm and woozy feeling most of the day, pain in left collar bone and down left shoulder blade and left breast. The pain has been consistent  but not extreme.   I have used Tylenol so the pain is bearable.
shingles; tiredness; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (had vaccine 16 years ago).   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced shingles and tiredness. The patient was treated with medication unknown (Pill (Medication Unknown)). On an unknown date, the outcome of the shingles was recovering/resolving and the outcome of the tiredness was not recovered/not resolved.   It was unknown if the reporter considered the shingles and tiredness to be related to Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient for himself/herself. The age at vaccination was not reported. The patient had new vaccine which was better and was diagnosed within 72 hours of onset. The patient was taking pills for 7 days (3x/ day) and was fortunate to escaped the blisters. The patient was just getting over shingles. Still the patient was not over the tiredness. The patient was glad to had the vaccine. The patient stated vaccines worked. The follow up could not be possible as no contact details were available.
Patient developed redness and swelling of L arm at/around injection site starting the afternoon following flu shot. Swelling, erythema, and induration has increased since. Prescribed ZYRTEC and ZANTAC 10/21/14. ORAPRED to start 10/22/14. Loose stool 10/20/14; nausea on the morning of 10/21/14.
38y.o. female who presents to the local HCF with a complaint of Seizure. She had a witnessed tonic-clonic seizure. Seizure lasted approximately 1 minute per report she obtained from bystanders.. Patient reports a fall associated with a seizure in which she fell onto her buttocks. Patient reports no history of prior seizures. She is uncertain of any inciting event that could've caused the seizure. She did experience a shoulder dislocation. Treatment with methocarbamol and prednisone.  Discharged to home.
swelling of spleen and liver; swelling of spleen and liver; Fever followed by unremitting abdominal pain; Fever followed by unremitting abdominal pain; This is a spontaneous report from a contactable Other HCP. A 33-year-old male Other HCP reported that he receive second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL8982), intramuscular at single dose into the left arm on 18Jan2021 at 10:45 am for COVID-19 immunization. The patient had received the first dose of vaccine (Lot number ElC9231) on 28Dec2020 at 11:30 am intramuscular into the left arm. Medical history was none. Concomitant drugs were none. On 20Jan2021 the patient experienced fever followed by unremitting abdominal pain that led to hospital admission for pain management and diagnostic imaging that revealed swelling of spleen and liver. Proton pump inhibitor via IV. Opioid IV in ER. the patient was hospitalized for 3 days. Unremarkable patient history prior to this even for GI and cardio. Non smoker non alcohol user. First ever hospitalization as an adult. On 21Jan2021 the patient had a negative Nasal Swab test for covid. The outcome of the event was recovering.; Sender's Comments: Based on the compatible temporal association and in absence of strong confounding factors, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the events fever, abdominal pain and swelling of spleen and liver.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
red area-egg size w/tiny bumps in center w/c/o itching @ inj site
arm was sore; turned red at the injection site; This spontaneous report was received from a 73 year-old-female patient reporting on herself. The patient had no pertinent medical history. Her drug reaction or allergies included enalapril. She took regular medications (unspecified) daily.    On 02-MAR-2022, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) route of administration reported as "injection", in the arm (dose, lot # and expiry date were not specified) for prophylaxis (also reported as "pneumonia").  On the same date (reported as "that night"), her arm was sore and turned red at the injection site. The patient did not seek medical attention and did not receive any treatment due to the events.    The outcome of "arm was sore" was not reported. The outcome of "turned red at the injection site" was not recovered (reported as "was still red"). The causality assessment between the event and the suspect vaccine was not provided.
Approximately 2 weeks after the vaccination, I went to my PCP thinking I had allergies due to a dry hacking cough. I have tried OTC cough medication and nothing was helping. My PCP advised to continue taking OTC cough medication. So after a week, it did not help so I discontinued taking the medication. I still have the cough to this day. Also, 2 weeks after the vaccination, I started having a ringing in my ears which was tinnitus. It was very loud. I went to a hearing doctor and I was prescribed hearing aids which do not help. The ringing is constant and never goes away which still continues to this day.
Received varicella 11/07/2000 without complication.  11/23/2003 began with rash which was evaluated 11/24/2003 and thought to be varicella.
My daughter had the first pfizer vaccine on 7-29-21, and the second one on 8-19-21.  She started having pain in her left calf.  This pain has been constant and chronic since September. It restricts her movements, and she is unable to run, hike, or other physical activities.
Serum sickness secondary to Hep B #2: redness & swelling to both ankles, R > L; started on 2/26/13. OV on 3/4/13 with some improvement now.
Lost balance in a 40%; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 634592236) via an unspecified route of administration in the left arm on 15Apr2021 at 10:45 (at the age of 46-year-old) as dose 1, single for COVID-19 immunisation. Patient also received the first dose of unspecified vaccine(Lot Number:Fw0169) via an unspecified route of administration on 15Apr2021. Medical history included none. The patient did not receive any other vaccines within two weeks prior to the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 15Apr2021 at 12:00 the patient experienced Loss of balance in a 40 percent not enough to fall but patient felt like the ground was moving every time when he bend down. It was very noticeable at first and fade out with the time. It was reported that patient was going take the second dose now, hopefully it was not going to be worse. The clinical outcome of the event Lost balance in a 40% was recovered with sequelae.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Amendment of patient information and narrative data.
Pt received Hep B vaccine on 09-08-2014, 1st dose. Pt received a second dose of Hep B on 09/26/2014.
Shoulder pain that moved up to clavicle area then resulted in a rapidly growing lump possibly the virchows node, waiting for an appointment
Patient stated he developed hives on legs, lower back and gluteus after receiving influenza vaccine.  He was seen by his primary care provider two days after vaccination and was prescribed diphenhydramine and prednisone taper with instructions to report to ER if rash worsened or if he developed problems with breathing.
Pt given Influenza mist instead of H1N1 mist. Had previously received the seasonal mist.