chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within 3 hours of vaccine - grand mal seizure which resulted in bruised sternum, ribs and forehead. Bit both sides of my tongue and broke out a tooth. Convulsed for over 3 minutes with no memory of event. Husband found me on our kitchen floor. Had to have head MRI and X-rays at medical center. Another episode occurred April 18, 2014 at approx. 6:30 pm. This was not as severe in nature, lasting less than 2 minutes. Loss of consciousness and convulsions. I was in my recliner so therefore I did not hall or suffer injury. Had episode number 3 on 6-19-14 at approx 10:30 am. Was cooking and my husband caught me before I hit the floor. I hit the refrigerator door and cut my lip and chipped a tooth. Lasted approx. 40-45 seconds. July 11th 2014 at 7:45 pm while eating dinner. My husband said he held me in my chair and loss of consciousness for 20-25 seconds and body jerking. I have no memory of the episode. Loss bladder control.
1 day p/vax pt seen by MD for fever of 101 & erythema extending from the inj site to the wrist & over the trapezius area;
Approximately 6 hours vaccine, patient developed symptoms of rigors, chills, uncontrolled shaking of her arms. Around 12 hours after vaccination, patient tried getting out of bed and was briefly unresponsive per son.    presented to ED, awaken and alert, fever (101 F) and question syncope, BP 105/54, HR 75.
A few hours after vaccine began getting itchy all over and slight numbness on left side. Went to ER and was given benadryl. The next morning 3/22 I woke up with hair feeling in my throat and heart palpitations. Went back er BP and treated with hydrolyzed hcl, Famotadine, lorazepam and Prednisone. By the evening 911 was called and I was taken back to er BP for heart rate of 150 +, light headed and nausea. I was treated with clonazepam and discharged that night. On today 3/26 I am still experiencing fast heart rate and taking atarax as needed.
High pitched screaming 24 hrs. Swollen tender leg 1 wk. Fever 102. 1st DTP. No family hx available.
First dose of Moderna vaccine administered to patient on 28-Apr-2021 and second dose administered on 06-May-2021; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of Moderna vaccine administered to patient on 28-Apr-2021 and second dose administered on 06-May-2021) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A and 026B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (tested positive, no hospitalization) on 06-Jan-2021. Concurrent medical conditions included Drug allergy (Lisinopril allergy), Allergy to NSAIDs and Drug allergy (allergy to Statins).   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 06-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of Moderna vaccine administered to patient on 28-Apr-2021 and second dose administered on 06-May-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of Moderna vaccine administered to patient on 28-Apr-2021 and second dose administered on 06-May-2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was reported.
Hib component mixed with Sterile Water as diluent. Dtap/IPV not given
Arm was sore, red, swollen & itched quite a bit. There was a large lump where the injection was given.  This lasted for 4-5 days.  The evening of the 28th every bone in my body ached severly overnight, by the 29th my entire body was just sore from the muscle aches
exactly 2 weeks after 1st dose started getting what i call "brain Zaps" . Weird sharp pain in the right side of my  head. On july 26 ,2021 major headaches started.(its been almost a month, and I still have daily-but 2 days-of  headaches). July 27th i went to eye dr thinking it may be something with eyes. dr said my eyes were perfect , no inflamation at all..July 29th i had second dose of vaccine. July 30 I saw my primay dr for headaches. prescribed Excedrine 1 per day. Had CT scan on Aug 4th.Aug 9th was diagnosed with brain lesions.  tomorrow Aug 18 going for MRI of brain.
Five to seven minutes after injection felt dizziness, chest tightness, flash, pressure in eyes, nausea.  Blood pressure was measured by a medical technician,  first measurement 178/92 mmHg,  ten minutes later systolic 147, after another 10 minutes 141 mm Hg.  Was no treatment offered  at that time, had a choice to be escorted to an emergency department, or leave.  Left with BP 141/75 mmHg, took  Benicar 20 mg at 11am. At 2 pm BP was 136/72 mmHg,  at 4 pm 104/72 mmHg. The rest of the day had a light headache .
sore arm (not unbearable); This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from medical information team.  A male patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "sore arm (not unbearable)". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101018905 same patient/vaccine, different AE and dose
PATIENT SAID AFTER FIRST SHOT, GOT ITCHY RASH AT INJECTION SITE THAT WENT AWAY IN A DAY OR SO.  WITHIN 10 MINUTES OF 2ND SHOT ARM STARTED TO "ITCH REALLY BAD" AT INJECTION SITE.  ADVISED PATIENT TO FILL OUT AGENCY REPORT AND USE HYDROCORTISONE CREAM AND CONTACT DOCTOR IF DID NOT GO AWAY OR HAD OTHER SYMPTOMS. PATIENT WAS STILL IN WAITING AREA AND DID NOT HAVE ANY OTHER SYMPTOMS.
Did not get the second dose of Moderna; 16 year old received the Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received the Moderna COVID-19 vaccine) and INCOMPLETE COURSE OF VACCINATION (Did not get the second dose of Moderna) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received the Moderna COVID-19 vaccine). On an unknown date, the patient experienced INCOMPLETE COURSE OF VACCINATION (Did not get the second dose of Moderna). On 25-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received the Moderna COVID-19 vaccine) had resolved. At the time of the report, INCOMPLETE COURSE OF VACCINATION (Did not get the second dose of Moderna) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No treatment medication were given. No relevant concomitant medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Updated reporter information, patient information, suspect product details and event start date.
4/07/2022...Day after injection...Severe muscular soreness and slight lethargy 4/08/2022...2:00 am...Severe night sweats
Vaginal Herpes; painful; Cyst; This spontaneous case was reported by a consumer and describes the occurrence of CYST (Cyst), VAGINAL INFECTION (Vaginal Herpes) and PAIN (painful) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) for COVID-19 vaccination.     The patient's past medical history included Herpes infection (she had herpes sore in the past but never vaginal herpes.). Concurrent medical conditions included Drug allergy (Steroid allergy) and Sjogren's syndrome.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced VAGINAL INFECTION (Vaginal Herpes). In November 2021, the patient experienced CYST (Cyst) and PAIN (painful). At the time of the report, CYST (Cyst) and VAGINAL INFECTION (Vaginal Herpes) had not resolved and PAIN (painful) outcome was unknown.            The patient developed cyst which burst with sticky fluid in it and smell bad.first HCP visited and said it is not sure could be shingles. the patient think virus opened up her system and she was attacked     No concomitant medications were reported   No treatment information was provided
Chills, fever, muscle aches, weakness, fatigue, nausea lasted 24 hours, then fatigued for another 12 hours. Recovered completely within 36 hours. Arm red, sore and swollen for 36 hours
A report has been received from a Health Professional concerning a 4 year old, male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT (Intranasal) started on an unknown date. The nurse reported, that they inadvertently gave expired FLUMIST QUADRIVALENT to the patient which started on 21-Jan-2014. The outcome of the event of expired FLUMIST QUADRIVALENT administered is unknown. The report was considered to be non-serious by the reporter.
patient received Pfizer dose on 05/18/2021 and it was approved for his age group in June 2021.
Information has been rec'd from a pharmacist concerning a 31 yr old female who on approximately 1/12/01 was vaccinated with rubella virus vaccine live (second generation) Concomitant therapy included ethimyl estradiol/norgestres (Triphasil) Subsequently on approximately 1/12/01 the pt experienced allergic eczema. The pt was placed on therapy with methylprednisolone (Medrol dose pack). In follow-up the physician's office reported that they did not know what this is about and did not report this adverse event. No further information is expected.
At 3am the following morning, I woke with every muscle hurting and my head hurting and nausea and no appetite.  I was very fatigued throughout the day with chills and muscle aches continuing.  In the afternoon around 3pm on 3/6 (same day) I had a temp of 100.4.  Fatigue all day long which prohibited my normal daily activities.  I took Tylenol (2000mg) throughout the day to alleviate the muscle aches and reduce headache.  This morning 3/7/21 I am still fatigued however much better with very slight muscle aches.  I do however now have a rash around my neck and up and down the sides of my torso. As I am writing this, I still have my rash.
his eyes are swollen for a month now after getting the booster; double bags under his eyes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization complete; manufacturer unknown), for COVID-19 immunization. The following information was reported: EYE SWELLING (non-serious) ,outcome "not recovered", described as "his eyes are swollen for a month now after getting the booster"; PERIORBITAL SWELLING (non-serious), outcome "not recovered", described as "double bags under his eyes".  Additional information: The next day after receiving the injection, he woke up and there were double bags under his eyes, which is not normal, and they have not gone away. He doesn't remember the date he received the injection, but states that it's been about a month. The reporter is seeking information covid 19 booster confirms most recent bivalent for adult vaccine, wondering if double bags under his eyes for a month is a usual symptoms. It was reported that starting the next morning when he got out of bed it was within 12 hours of vaccination. The patient has taken very good care of eyes, no crows feet, avoided sun and use lotion. This has not gone away in almost a month.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Around 4:45 pm - Difficulty breathing, I couldn't seem to take a deep breath, and also little faint - lasted about 15 minutes - no treatment, because I was driving home from work during the time.  It was scary to the point of me almost pulling over to the side and pressing my ONSTAR button for assistance, but I let my windows down and kept on driving.
Patient stated that she was tachycardic the night of her vaccine and then dizzy the next morning. She stated that she was dizzy but that she does suffer from vertigo already. She said these symptoms lasted about a week. On the 1/14/21 she was tachycardic, dizzy, weak and she had a raised red rash distal to the site of injection. She went to urgent care and was diagnosed with cellulitis and prescribed an antibiotic. On 1/17/21 she went back to urgent care since the rash had migrated and appeared patchier than cellulitis. Her doctor said that he did not believe it to be cellulitis at this time and prescribed her a steroid cream.
pt devel erythematous papule over the site of DTP inject 3 days p/vax; by next day pt had urticaria over entire body; no temp, irritability;
Redness swelling and minor discomfort to right thigh. Rx. diphenhydramine 12.5mg/5ml.
5 minutes after vaccination he stood up, climbed down from exam table and had a syncopal episode, falling forward and striking his left temple. He recovered consciousness quickly, rested, no concussion or other serious injury resulted.
Soreness; Patient got COVID-19 after 1st dose of vaccine; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness), COVID-19 (Patient got COVID-19 after 1st dose of vaccine) and FATIGUE (Fatigue) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced PAIN IN EXTREMITY (Soreness), COVID-19 (Patient got COVID-19 after 1st dose of vaccine) and FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (Soreness), COVID-19 (Patient got COVID-19 after 1st dose of vaccine) and FATIGUE (Fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
I had my first dose of Moderna, went for wellness checkup between vaccinations - 4-20-21. My platelet and hemocrit levels were extremely high. I was referred to see a hematologist 5/11, and he performed a bone marrow test 5/19 and ultrasound of the spleen 6/11. Visited another hematologist 6/17 and had blood work done, which reinforced the original blood results. It may not be related to my vaccination, but the possibility of blood clots made me wonder. So I am sending this form.
first shot her arm was swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (first shot her arm was swollen) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 016C21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD and Degenerative disc disease.   On 23-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (first shot her arm was swollen). At the time of the report, PERIPHERAL SWELLING (first shot her arm was swollen) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       She stated that she wishes she didn't get the vaccine. Patient had many other comorbidities at baseline including degenerative disc disease.  No concomitant medication details were provided. No treatment medication details were provided.   This case was linked to MOD-2022-452853 (Patient Link).
Case number PHEH2014US016777 is an initial spontaneous report received from a pharmacist on 19 Aug 2014 with a follow up information received from a pharmacist on 30 Sep 2014. This case refers to a 51 year old female patient. Past medical history was not reported and concomitant medication included spironolactone 100 mg oral once daily. She had annual flu shot and her vaccination history included administration of FLUVIRIN (batch number: not reported) which was well tolerated. She was vaccinated with FLUVIRIN (batch number: 145204, expiry date: Mar 2015) intramuscularly at a dose of 0.5 ml on 19 Aug 2014 at 11:18 am. Reporter stated that, at another store they administered FLUVIRIN prefilled syringe to her without first shaking it. No adverse reaction was reported following this administration error. Follow up information received from a pharmacist on 30 Sep 2014: Updated concomitant medication, vaccination history, expiry date, dose and time of vaccination.
Abdominal Pain started 11/28/17 evening and resolved w/in a couple of hours. 11/29/17 pt reporting fatigue, overall body aches, headache, multiple joint pains. Pt is afebrile. Home treatment recommended.
Information  has been received from a registered nurse concerning a 39 month old male with no pertinent medical history and no known drug allergies who on 10Jun02 was vaccinated IM with a first dose of varicella virus vaccine live (lot 640492/0202M). There was no illness at the time of vaccination. There was no concomitant medication. On 03Sep04 the pt developed a rash which later became full blown vesicles. He was seen in the office on 07Sep04 with a small number, about 2 dozen, of vesicles on his arms and legs. He was treated with diphenhydramine hydrochloride (Benadryl). Unspecified medical attention was sought. There was no product quality complaint. Follow up information indicated that the pt had a mild varicella. She was prescribed diphenhydramine hydrochloride (Benadryl as needed). No additional information is expected.
12hr p/vax pt devel pain & swelling @ the inj site;later that day devel a fever of 99.9, h/a & myalgia in calves, back & neck;2 days post vax fever rose to 101.3;devel n/v;
Herpes outbreak on my lip(Haven?t had one for over 15 years) Also, red itchy spots on my torso, right side skin on upper ribs
Pain in upper and lower left arm, lasting three days. Headaches, eye irritation bilateral, burning, dry. Eye migraine four days after vaccination lasting two hours. Fatigue lasting 10 days.
Rash on back, face, arms, abdomen and legs 2 days after flu shot.
The symptoms started 12 hours after the shot, with chills, fatigue,  severe muscle aches, headache, fever reaching 101 F,  felt like was beaten up. Urine color was brown .Got a bit better after 30 hours, but temp didn?t go below 98.6 F. then After 48 hours notice rash on chest, 2 hours later the rash extended to neck, then to back and face. The fever got up to 101 again. Only to get better after injection with Benadryl and cortisone . 72 h later, rash better, but still there on chest with petechiae.
Inconsolable crying x 2 days following 2nd DTaP. Irritability gradually resolved over course of 1 week. Prior to this vaccine, he was vocalizing a lot. Vocalizing stopped x 3 weeks. Now returned to normal.
Migraine- 24 hours Fever- 36 hours Fatigue Headache
4/17/2021; Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening .  During the observation period, she experienced an adverse reaction with the following symptoms:  complained of scratchy throat. Assessment: Time of assessment 1752. Alert and oriented and Anxious. VAERS form obtained and completed by RN; 1752- BP- 129/84, P- 74, O2- 99%, recheck at 1804- BP- 122/90, P- 65, O2- 98%; Medications administered: Diphenhydramine (Benadryl) 25 mg capsule, by mouth. Time: 1750. Administered by RN.; Disposition: Reports no further symptoms of adverse reaction after observation for 45 minutes. Discharged home. The Patient was provided with Vaccine Information Sheet and instruction to access the V-Safe system.; Immunizations Administered; COVID-19 Vaccine 4/17/2021  5:14 PM 0.3 mL 12/11/2020 Intramuscular; Lot: ER8729; NDC: 59267-1000-2
pt c/o of arm pain radiating down from injection site to rest of lower right arm. Pt states vaccine administration site was "too low". No issue of arm pain with other shoulder. Pt states using lidocaine patch below injection site , and also taking generic Norco to relieve arm/shoulder pain. Pt vaccine on 8/10/23, pain reported on 8/14/23.
Tingling lips and tongue; tingling body sensation in skin; hives; rash; shortness of breath; dizziness; This is a spontaneous report from a contactable consumer (patient).  A 34-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation solution for injection; Lot number: EN6201), via an unspecified route of administration, on 03Mar2021 11:00 (at age of 34-year-old) as single in Arm Left for covid-19 immunization. The patient's medical history included allergies to coconut sunflower, and cats and dogs. No covid prior vaccination and has not tested covid post vaccination. The patients concomitant medications included quetiapine (SEROQUEL) and diphenhydramine hydrochloride (CETIRIZINE). On 06Mar2021 16:00, the patient experienced tingling lips and tongue, tingling body sensation in skin, hives, rash, shortness of breath, and dizziness. The outcome of all events were not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report was received from a nurse and refers to an unspecified number of pediatric patients. No information regarding the patients' pertinent medical history, concomitant medication and drug reaction or allergies was reported. On unknown dates, the patients were vaccinated with the complete three-dose series of RECOMBIVAX HB (strength, dose, route of administration, lot # and expiration date were not provided). On unknown dates (also reported as "over the years"), the patients were nonresponders (did not have detectable antibody levels). The outcome of the event was not reported. The relatedness of the event was not reported. The relatedness between the event and RECOMBIVAX HB was not reported. This is one of several reports received from the same source. Additional information has been requested.
Itching around mid-section, temperature of 101 degrees F, rash on chest/back/torso.  Took Benadryl & symptoms resolved by 1/27/22