chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had a fainting episode while checking out of the office. Fell backward, had tonic-clonic movements and came to immediately when he was placed on his side. Very pale on exam, heart and lungs normal sounds. Responsive but sluggish. HR 51, O2 99%, BP 60/50, T 98.4, glucose 104. Gave juice, watched and waited, color began to come back. Repeat vitals at 5-10 minute HR 105, O2 98%, BP 63/45. Continued to monitor in the office. BP at 11:25 78/40, HR 103, 99%. Able to sit up and walk around the office without problem. Discussed likely vasovagal episode with mom, will discuss vaccines in the future, possibly separate them or keep him in observation afterward.
Patient had localized redness and some inflammation about 4 to 6 inches around injection site. Patient first noticed this on 1/20/2019 when he wakes up around 9am. Patient was advised to go see his primary physician as precaution and also to verify his ongoing rash on his face since March 2018 prior to SHINGRIX immunization. Dr. confirmed the adverse localized redness at his left around the injection site. Dr. also diagnosed the rash on the face to be an ongoing shingles rash that has been first documented back in March 2018. Provider prescribed antiviral treatment for the shingles rash on the face. Patient was counseled to continue to monitor localized adverse effects.
After approx 10 mins of monitoring after injection in exam room, patient reported tingling and pain in his fingers and joints of both hands. Provider was alerted and patient was examined. recommended to stay an extra 15 minutes for monitoring. Patient was monitored for an extra 15 mins before being assessed again by MA and let go after determining he was fit to leave.
48 hours after vaccination, mother noticed edema and erythema at the vaccination site (left leg). No fever.
Systemic: Seizure-Severe, Additional Details: patient was administed covid 19 pfizer vaccine. after 3 minutes, she started to convulse. she came to after about 1 minute, but was very out of it. 911 was called and she was brought to hospital.
Epilepsy; Seizures; ADHD; Allergic to the Pertussis portion; This case was reported by a consumer via interactive digital media and described the occurrence of epilepsy in a infant patient who received DTPa (DTPa vaccine) for prophylaxis.   Previously administered products included DTPa vaccine (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of DTPa vaccine. On an unknown date, less than a year after receiving DTPa vaccine, the patient experienced epilepsy (serious criteria GSK medically significant), grand mal seizure (serious criteria GSK medically significant), attention deficit hyperactivity disorder and drug allergy. On an unknown date, the outcome of the epilepsy, grand mal seizure, attention deficit hyperactivity disorder and drug allergy were unknown.   It was unknown if the reporter considered the epilepsy, grand mal seizure, attention deficit hyperactivity disorder and drug allergy to be related to DTPa vaccine.  Additional details were reported as follows:  The age at vaccination was not reported. The patient stated that he/she received vaccine 3 times at 1st year of life. The patient experienced epilepsy with grand mal seizure, Attention deficit hyperactivity disorder. The patient stated that he/he heard Tdap was much safer than the DPT shot from old time.The patient was allergic to the Pertussis portion.  The patient still willing to do what he/she must for his/her children though. For tolerance of 1st and 3rd dose refer case US2020AMR228374 and US2020AMR228497 respectively.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR228374:1st dose, same reporter US-GLAXOSMITHKLINE-US2020AMR228497:3rd dose, same reporter
Had DTaP, Hep A, MMR. L deltoid area swollen and red-had DTaP (Daptacel) #5 and hep A #1 on this side. R deltoid area received MMR #2 dose.
swollen and has a diameter of 2-3 inches; itchy; arm is red; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen and has a diameter of 2-3 inches), PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (arm is red) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939905) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced PERIPHERAL SWELLING (swollen and has a diameter of 2-3 inches), PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (arm is red). At the time of the report, PERIPHERAL SWELLING (swollen and has a diameter of 2-3 inches), PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (arm is red) outcome was unknown.            No concomitant medication were given. Patient stated that no treatment was done
Chronic fatigue syndrome; Their immune system overreacted; Felt sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2022NVX-US-000003221 (Novavax).  A female patient received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown) and in Feb2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHRONIC FATIGUE SYNDROME (non-serious), outcome "recovered"; IMMUNE SYSTEM DISORDER (non-serious), outcome "recovered", described as "Their immune system overreacted"; MALAISE (non-serious), outcome "recovered", described as "Felt sick".  Additional information: The patient got what doctors called Chronic fatigue syndrome. It was reported that immune system overreacted, and the patient felt sick. All that went on for 2 months. The lot number was reported as EL1283.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Approximately 5-10 seconds post immunization, pt became pale, limp, lost consciouness, and appeared to be convulsing. Pt. was grabbed by nurse to prevent him from falling from the exam table.  He reponded immediately, asking "What Happened?"  He denied remembering anything after the immunizations.  The clinic physian examined the patient and determined that the episode was a vasovagal response to the Immunizations, instead of an allergy.  Patient's mother reports that his father has experienced the same symptoms several times following injections, injury, etc.  Patient recovered fully from the incident without pharmacologic intervention.  Blood Pressure post incident:  110/60 supine,  120/70 sitting, 120/80 standing.
Her white count is extremely high and she was told to go to the hospital; developed rash all over her body two weeks ago; She is filled with red welt/ rash which has become red ,dark purple and blistery.; The doctor diagnosed her with vasculitis after running some blood work.; She is filled with red welt/ rash which has become red ,dark purple and blistery.; This is a spontaneous report from a contactable consumer or other non hcp. A 64-years-old female patient (reporter's mother) received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 06May2021 (at the age of 64-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history reported as Urticaria after the first dose of vaccination and concomitant medications were not reported. The patient previously received first dose received (BNT162B2, Solution for injection, Batch/Lot number was not reported) via unspecified route of administration as DOSE 1, SINGLE for covid-19 immunisation. After the second dose of the vaccine which was 06May2021. She developed rash all over her body two weeks ago (on an unspecified date). She is filled with red welt/ rash which has become red ,dark purple and blistery (on an unspecified date). The doctor diagnosed her with vasculitis after running some blood work (on an unspecified date). Her white count was extremely high and she was told to go to the hospital (on an unspecified date). She had no other issue prior to the vaccine. She sated that she had seen on the internet million of such report related to the vaccine. But she could not think of anything else but the vaccine that might have caused her to feel that way. Caller wants to know if this side effect had been reported with the vaccine. The patient underwent lab tests and procedures which included blood test: unknown on diagnosed her with vasculitis after running some blood work, white blood cell count extremely high on an unspecified date. The outcome of the was unknown.  Information about lot/batch number has been requested.
Numbness and extreme weakness in arm, heart palpitations, shortness of breath, shakiness, dizziness, cold fingertips, cold sweating extremities.
Fever, myalgia, fatigue, HA, L axillary pain. Treated with ice and NSAID's, Tylenol. Missed 2 days of work.
Pt recv vax on 11/11/98; on same day pt exp red/painful vax site
9/18/2018 I went to my primary care physician for a flu shot. I received the injectable form without preservatives. Today my heart has been racing off and on and I have had diarrhea since this evening. I have been lightheaded, chest pains, and nauseous as well as having a throbbing sensation in the spine. Had a fever come on earlier that was low grade around 99 and profuse overheating and sweating regardless of external environment temperatures. Shortness of breath and mild confusion and inability to concentrate more so than normal. Unable to drink more than a small sip of water and unable to eat or it upsets the GI issues. Have had a weird sulfur or egg like taste in my mouth today since I woke up. As of 3:25am 9/20/18 the issue still continues.
She also reported that her neighbor had her first shot recently and complained of temporary wrist pain in the inject arm as well; This is a spontaneous report from a contactable Consumer (patient herself). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration on an unspecified date s dose 1, single for Covid-19 immunisation. Patients medical history and concomitant medications were not reported. it was unknown whether patient had any known allergies. the patient was not pregnant at the time of vaccination. Facility type vaccine was public health clinic/veterans administration facility. No other vaccine in four weeks was administered. It was unknown whether any medications patient took in two weeks. On an unspecified date, patient experienced soreness at injection site and achy feeling in left wrist. She also reported that her neighbor had her first shot recently and complained of temporary wrist pain in the inject arm as well. "Feels like just before your hand goes to sleep". She also stated another neighbor had the injection previously and was "very" bruised in the injection site "looks like I was beat up". No treatment was given for the adverse event. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The outcome of event was unknown.   Follow-up (11May2021): Follow-up attempts completed. No further information expected.
sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th July 2021, the patient received Shingrix. On 6th July 2021, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient's wife. The age at vaccination was not reported. The patient received Shingrix vaccine a day before reporting date and experienced sore arm. The lot number, expiry date and birth date was not reported. The reporter did not consent to follow up. This case was linked with case US2021148603, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021148603:Same reporter
mild flu; lethargy; cloudy in head; couldn't sleep; sweats; disoriented; joint pain; tiredness; chills; achy; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (mild flu), LETHARGY (lethargy), FEELING ABNORMAL (cloudy in head), INSOMNIA (couldn't sleep) and HYPERHIDROSIS (sweats) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA (mild flu), LETHARGY (lethargy), FEELING ABNORMAL (cloudy in head), INSOMNIA (couldn't sleep), HYPERHIDROSIS (sweats), DISORIENTATION (disoriented), ARTHRALGIA (joint pain), FATIGUE (tiredness), CHILLS (chills) and MYALGIA (achy). At the time of the report, INFLUENZA (mild flu), LETHARGY (lethargy), FEELING ABNORMAL (cloudy in head), INSOMNIA (couldn't sleep), HYPERHIDROSIS (sweats), DISORIENTATION (disoriented), ARTHRALGIA (joint pain), FATIGUE (tiredness), CHILLS (chills) and MYALGIA (achy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-067231 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-067231:crosslinked with dose 1
Developed immediate headache following injection of initial vaccine. Came to ED on 1/19/21 for same symptom and blurred vision in left eye. Given IV fluids, benadryl, reglan, toradol and decadron. Head CT done with no acute changes. DC home.
Two weeks after my booster, after feeling better. I had a return of all of the symptoms I typically get right after vaccination. That would last sometimes 4-5 days. And I cycled for probably 6 weeks in and out of that state. I did talk to my doctor through that email process and he stated that he felt that it was vaccination related because of the similarity of symptoms. That all resolved probably within 2 months and I cycled in and out of that 4 times. Often with a week or two in between. A couple weeks ago, I developed vertigo. Paradoxical vertigo, when my head shifts left or right, I get a sense of the room spinning. I'm not sure if this is vaccine related, but I've never experienced it before. When I talked to my doctor and he said it was vaccine related, he stated that he was seeing some clients who have had symptoms lasting weeks and not days from the vaccine. Cycling of symptoms: Body aches, extreme fatigue, the chills. Recovered from vaccination related symptoms, not recovered from the vertigo.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown ages and genders. There was no information about the patients' pertinent medical history, drug reactions or allergies and concomitant therapies provided. On unspecified dates, the patients were vaccinated with improperly stored doses of M-M-R II (albumin status, exact dose, dose number, route of administration, lot # and expiration date were not reported), for prophylaxis. The vaccines were reconstituted with properly stored sterile diluent (lot # and expiration date were not reported). No adverse effects were reported. The administered doses of M-M-R II experienced a temperature excursion between -58 and 46 (21 Fahrenheit) Fahrenheit degrees for 1 hour. Digital data logger was used to capture the temperature excursion. Previous temperature excursions occurred, but no details were provided. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA008478: US-009507513-1709USA008477: US-009507513-1709USA004743:
pt cried inconsolably & constantly for 1 hr on the evening of the day pt recvd vax; ER visit; no fever; no focal abn on exam;
diarrhea, began day before, possibly day of,  final dose. Low grade headache upon waking, usually gone within 2 hours untreated.
pt called to report slight swelling, redness, and itching at injection site that started 3 days after getting immunization.  she didn't have any reaction after the first dose.
headache for 4 hours now; normal pain in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (normal pain in the injection site) and HEADACHE (headache for 4 hours now) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017BZ1A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine (TENSION MIGRAINE). Concomitant products included ORPHENADRINE CITRATE (NORFLEX [ORPHENADRINE CITRATE]) for Muscle relaxant.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced VACCINATION SITE PAIN (normal pain in the injection site). On 08-Apr-2021, the patient experienced HEADACHE (headache for 4 hours now). At the time of the report, VACCINATION SITE PAIN (normal pain in the injection site) and HEADACHE (headache for 4 hours now) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication include Tylenol for headache.
In left arm- red swollen pain warm itchy Sat. Symptoms- headaches coughing chills muscle pain joint pain tiredness nausea vomiting night sweats Medicine took - ibuprofen for pain n headache and pedialyte and saltines for nausea and drank lots of water Sunday I was feeling better ate some soup and more pedialyte my arm pain redness swelling was still there but not as bad I could move my arm easier Monday I was all back to normal!
Clinic called to report and described: 7 x 8.5 cm area of erythema, extra warmth and induration present. Treatment: antibiotic and Tylenol for comfort.
Patient stated she felt generalized pain above the waist, nausea, headache, tired, sore joints.
Child Given vaccine that may have had temperature excursion (Data Logger Failure) with Stable Fridge temps Before & After. DOH determined the vaccine to Be At Risk & Advised Reporting & Revaccinations. Child Had No ill Effects thus FAR
Refridgeration excursions identified; No adverse event; Poor quality product administered; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered), PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event) in a 44-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Sep-2022 at 3:50 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 15-Sep-2022 at 3:50 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered), PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) and PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified).    No concomitant medications were reported.   Dose 4 vaccine administered through deltoid.  It was reported that refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department and made aware of the situation. No adverse reactions reported for any of these patients.  The Nurse reports a temperature excursion that has occurred in a refrigerator at her clinic containing both monovalent and bivalent Moderna Covid-19 vaccines. The Moderna and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients.   The Nurse was now calling about Moderna Monovalent and Bivalent vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022.   No information was available on that patients at this time.   It was unknown that the patient ever been diagnosed with/ tested positive for COVID-19.  The patient had received moderna vaccine doses 1, 2, and 3 intramuscularly and at the deltoid site of the body.  No treatment medications were reported.
a feeling in my body of tiredness/ fatigue; a tremor in right hand and body; positive for ANA titer; weight loss; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received bnt162b2 (Pfizer-BioNTech Covid-19 vaccine), dose 2 via an unspecified route of administration on 02Sep2021 (Batch/Lot Number: FE 3592) as DOSE 2, SINGLE, at age of 34-year-old of vaccination, for covid-19 immunisation. The patient previously received first dose of BNT162b2 on 12Aug2021 (lot number EW 0181) at 34-year-old of vaccination for Covid-19 immunization and experienced metallic taste in mouth. Medical history included attention deficit hyperactivity disorder (ADHD), obsessive-compulsive disorder (OCD), gastrooesophageal reflux disease (GERD). The patient had no known drug allergies. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), omeprazole, all taken for an unspecified indication, start and stop date were not reported. The patient experienced a feeling in my body of tiredness, a tremor in right hand and body, positive for ANA titer, weight loss, all on 23Sep2021 with outcome of not recovered. The events resulted in disability or permanent damage. Clinical course was as follows: after second injection, the patient had a feeling in her body of tiredness, fatigue and developed a tremor in right hand and body which still had not subsided, positive ANA titer, weight loss. She had seen two specialists and no new diagnosis had been made. The patient had multiple doctor visits and lab work, and received treatment for the events. The patient underwent lab tests and procedures which included antinuclear antibody: positive on 23Sep2021, investigation: unknown results on, weight: loss on 23Sep2021.  No follow-up attempts are possible. No further information is expected.