chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician, concerning a 1 day old Caucasian male infant (a normal 9 lb 0.2 oz, male infant with no abnormalities or anomalies), who on 10-DEC-2007 was vaccinated with the first dose of RECOMBIVAX HB (manufacturer not specified).  On 21-DEC-2007 the infant was seen for a 2 week check up, and had a nonspecific rash.  On 08-JAN-2008 the infant was seen for a 4 week check up with no findings noted, and was vaccinated with the second dose of RECOMBIVAX HB (manufacturer no specified).  On 21-JAN-2008, the infant, whose brother had an upper respiratory infection (URI) was seen by the physician; his mother expressed concern about his wheezing, and reported "cough, rhinorrhea, congestion for 3 days."  There was no fever.  The physician assessed an upper respiratory infection, and prescribed treatment with a cool mist machine for coughing and saline nasal suction.  On 11-FEB-2008, the infant was seen by the physician for a 2 month check up.  At this visit, the infant was vaccinated with the first dose of ROTATEQ, the first dose of DTAP (manufacturer not specified), the first doe of IPOL (manufacturer not specified), the first dose of PEDVAXHIB (manufacturer not specified), and the first dose of PREVNAR (manufacturer not specified).  On 03-MAR-2008, the infant was seen by the physician, who noted the infant's brother had conjunctivitis; the infant was diagnosed with blepharo conjunctivitis (symptom onset documented as 2 days prior to visit), and thrush.  Treatment included nystatin and sulfacefamide 1.0 % ophthalmic drops.  The outcome of the individual events was not specified.  Additional information is not expected.
Post vaccination, patient began to experience itching of face, neck, L arm and eventually back and legs.  BP initially 146/101, 5 minute re-check - 156/96, HR 105.  Benadryl 50mg PO administered.  BP continued to remain elevated.  itching improved within 30 minutes.  Remained at clinic.  BP still elevated but instructed on importance of calling MD when she got home.  Telephone call to patient today.  she reports fever of 100, dry heaves, weakness chills and can't get out of bed.  She stated BP was better when she got home at 140/80.  States she feels like she has the flu.  Instructed again on necessity to call MD today for further guidance for follow up or testing.  Will follow-up with patient on 2/19/21.Unsure if she will require an MD visit at this time.
severe hearing loss in my right ear; roaring in my head; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), in Oct2021 as dose number unknown (booster), single (Lot number: ff2590) for covid-19 immunisation. The patient's relevant medical history included: "Sleep apnea" (unspecified if ongoing); "COPD" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Drug allergy". Vaccination history included: Covid-19 vaccine (DOSE NUMBER: UNKNOWN, MANUFACTURER: UNKNOWN), for COVID-19 immunisation. Other medication in 2weeks: Unknown. The following information was reported: TINNITUS (non-serious) with onset 21Oct2021 at 22:00, outcome "not recovered", described as "roaring in my head"; DEAFNESS (medically significant) with onset 21Oct2021 at 22:00, outcome "not recovered", described as "severe hearing loss in my right ear". It was unknown if therapeutic measures were taken as a result of deafness, tinnitus. Adverse event: After receiving the pfizer booster in Oct2021 I developed roaring in my head and severe hearing loss in my right ear. This was confirmed by 2 ENT specialists. Treatment for adverse event reported as unknown.
09:50 Pt complaint of headache and she did not eat breakfast and was not sure if she took her BP 140/60, SO2 98%, HR 80, RR 20,  10:03 Pt reports H/A has gone.  Feels fine 10:09  Instructed to eat breakfast and make sure has taken HTN medication prior to next dose BP 110/70, RR 16, HR 79, SO2: 99%
almost 24 hrs later I felt Nauseous,  dizzy, and felt funny.  I was running a fever 04:30-5 cold /hot cold sweat terrible fever, real weak , out of it Didn't leave my bed for 2 days straight lasted about 4 days didn't feel normal again until about Tues/Wed
Within 5 min of receiving DTaP vaccine child developed hard, hot red lump on arm with red welts were vaccine had dropped out onto skin. Child complained of itching and pain. The following day knot had progressed to large, reddish purple, hot lump approximately 3 inches in diameter. Within 4 days of administration, redness eps had faded to dull purple and heat had subsided. Child developed runny nose and deep coughing by day 4 after immunization.
Chills; Fever; Diarrhea; Coughing which kept me from lying down to sleep; Fatigue; Coughing which kept me from lying down to sleep; Feeling faint; My upper arm was completely black & blue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  An 82-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Immunosuppressed" (unspecified if ongoing), notes: I am 82, immunosuppressed. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (1st booster; unknown manufacturer), for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 14Nov2022, outcome "not recovered"; COUGH (non-serious), INSOMNIA (non-serious) all with onset 14Nov2022, outcome "not recovered" and all described as "Coughing which kept me from lying down to sleep"; DIARRHOEA (non-serious) with onset 14Nov2022, outcome "not recovered", described as "Diarrhea"; FATIGUE (non-serious) with onset 14Nov2022, outcome "not recovered"; DIZZINESS (non-serious) with onset 14Nov2022, outcome "not recovered", described as "Feeling faint"; PYREXIA (non-serious) with onset 14Nov2022, outcome "not recovered", described as "Fever"; VACCINATION SITE BRUISING (non-serious) with onset Nov2022, outcome "not recovered", described as "My upper arm was completely black & blue". Additional information: The patient received the 2nd Pfizer booster on Saturday, 12Nov2022. The patient is 82, immunosuppressed, a retired nuclear engineer. The upper arm was completely black & blue. Starting the following Monday, had chills, fever, diarrhea, coughing which kept him/her from lying down to sleep, fatigue, feeling faint. As of today, 17Nov2022, the symptoms have not receded. The patient was sending this email just to advise Pfizer of the outcome of this booster for him/her. Had he/she been aware of the reaction, he/she would not have received it.  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.
Information has been received from a registered nurse concerning a 23 year old female patient with no pertinent medical history and no known drug allergies who on 24-DEC-2008 was vaccinated with the first IM dose of GARDASIL vaccine (lot# 0947X). Concomitant therapy included calcium (unspecified), vitamins (unspecified) and DESOGEN. On 24-DEC-2008 the patient experienced felt dizzy 3 minutes and lay down. The patient became frail and unresponsive for 20-30 seconds. her pupils were equal, dilated and reactive to light. Her blood pressure was 100/50, pulse was 52, and had shallow breathing. About 2-3 minutes after being responsive, the patient fell back into a state of unresponsiveness and was difficult to arouse, This lasted for a few minutes and then she became fully alert. The emergency medical services were called and the patient was given juice boxes and bagel. EKG was normal and blood sugar after the food intake was 112. On 24-DEC-2008 the patient recovered from the adverse events. Additional information has been requested.
2-3 days post flu shot devel red, rash-like swelling starting @ site of shot  & slowly progressed to chest, arms & legs;denies h/a, fever or diff breathing;MD put on Pred
Fever to 105 x 3 days w/irritability; Mom did not notify clinic until 18mo check up;
Saturday I had a sore arm. Felt burning, itching, hot on skin of upper left arm. Felt a large lump. Two days later felt another burning, hot itching bump a few inches down. Felt swollen. From 24 hours of the vaccine both arms were numb and tingly.
Headache, general malaise, cellulitis, eye pain, severe pain at injection site and all of left arm, fever, arthralgia, rash.
At injection site: soreness, redness, hot to the touch, swollen/knot about the size of a lemon, itching. These symptoms were present the morning after the injection.
Information has been received from a consumer, via a company representative, regarding the consumer's 19 year old daughter (also the niece of the representative), with no pertinent medical history, who on 10-JAN-2008 was vaccinated with the first dose of Gardasil (lot # not reported).  There was no concomitant medication.  Approximately 10 or 15 minutes after the vaccination, the consumer's daughter experienced nausea, swelling of the tongue, and her ears "felt steaming in heat."  She also fainted.  The mother reported that her daughter's blood pressure also dropped (value not provided).  Her daughter was given "a large dose" of diphenhydramine (BENADRYL), and the swelling of the tongue "subsided."  At the time of this report, the outcome of the events was unknown.  No further information is available.
My husband had tested positive for COVID-19, I was his caregiver. I started having sinus issues, sinus drip, runny nose, a fever, I lost my sense of smell for three weeks. I suspected I was getting COVID-19; I took a home COVID-19 test that came back positive. The next day I went to Urgent Care to confirm that my home test was correct. The PCR Rapid COVID-19 test, it also came. The nurse practioner and I discussed my symptoms, that were, I really am not in the high-risk category aside from my age. We both agreed that it would not hurt for me to not take the antiviral medication. I am starting to feel more like me, my sense of smell is coming back, my energy is finally back. It did take m six or seven weeks to get my energy level back to where it was before I had COVID-19.
This spontaneous case reported by a patient, describes the occurrence of feeling abnormal, insomnia (cannot get enough sleep), myalgia (body ache), headache(s) and fatigue (tired) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Aug 29, 2022, patient received the third (booster) dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the first and second dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On Aug 29, 2022, patient experienced feeling abnormal, insomnia (cannot get enough sleep), myalgia (body ache), headache(s) and fatigue (tired). At the time of the report, feeling abnormal, insomnia (cannot get enough sleep), myalgia (body ache), headache(s) and fatigue (tired) outcome: unknown. No concomitant medication or treatment information reported. This case linked to MOD-2022-637949 (patient link).
She tested positive for SARS-CoV-2; She tested positive for SARS-CoV-2; This is a literature report for the following literature source(s): Pediatric Nephrology, 2022; pgs:1-2, DOI:10.1007/s00467-022-05712-0.  A 14-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "kidney failure secondary to Henoch-Shonlein Purpura nephritis" (unspecified if ongoing); "living related kidney transplantation at 12 years of age" (unspecified if ongoing); "kidney failure secondary to Henoch-Shonlein Purpura nephritis" (unspecified if ongoing). Concomitant medication(s) included: PREDNISONE oral taken for immunosuppression; TACROLIMUS oral taken for immunosuppression. The following information was reported: DRUG INEFFECTIVE (medically significant), 6 months after the suspect product(s) administration, outcome "recovered", COVID-19 (medically significant), outcome "recovered" and all described as "She tested positive for SARS-CoV-2". The patient underwent the following laboratory tests and procedures: Blood creatinine: 0.9 mg/dl; 1.1 mg/dl; 0.9 mg/dl, notes: back at her baseline; Body temperature: 102.3 Fahrenheit; Electrocardiogram: QTc prolongation; Epstein-Barr virus test: 520, notes: copies/ml; tacrolimus: 4.8 ng/ml; 54 ng/ml, notes: supratherapeutic; 49 ng/ml, notes: A repeat tacrolimus level 1 and  3 days later showed a decline  (54 h following last tacrolimus dose); 13 ng/ml, notes: (103 h following last tacrolimus dose); 9.5 ng/ml, notes: upon re-check 3 days later; 6.1 ng/ml, notes: 4 days following the dose change; SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Very red; swollen after 3 days; painful after 3 days; This case was reported by a consumer via call center representative and described the occurrence of erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 3 days after receiving Shingrix, the patient experienced erythema, swelling and pain. The patient was treated with paracetamol (Tylenol), antihistamine and non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the erythema, swelling and pain were unknown.   It was unknown if the reporter considered the erythema, swelling and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient asked recommendation on how to treat negative reaction to Shingrix and had very red, swollen and painful after 3 days and taken tylenol, an antihistamine and applying ice.
pt recv vax 20NOV96 & mom brought pt in 21NOV96;mom stated that observed red patches on both thighs & child c/o soreness & itching; 1 1/2" was @ inj site;rest of the 1" in diameter;all spots, red, raised & warm to touch;APAP, DPH;
On 12/19/2021 in the evening, I started to have headaches that subsequently worsened over the next days. From 12/23 on, they were around the clock for several days, unresponsive to acute medications (triptans, tylenol) and I was bedbound. At the end of december 2021, there were a few headache free days. In January 2022, headahces became daily and severe 10/10 again, I increased Depakote to 500 mg daily without any relief. Ubrelvy for acute migraines without any relief. Started accupuncture with some relief. MRI and blood work as below. Started prednisone taper on 1/21 60-60-40-40-20-20, which decreased headches a lot, but after taper was over, headaches bounced back to 10/10 within 2 days; I went to ER and I was hospitalized for one day and given Decadron and longer steroid taper started from 60 mg x 3 days, 10 mg decrease every 3 days. Also started Nurtec 75 mg very other day for migraines. Botox prior authorization was started in January and approved in February and injected 2/23. After steroid taper was over, headahces were better and within 10 days after Botox injections, additional improvement was seen.  As no other trigger was seen, this exacerbation of well controlled daily headaches 9 days after Covid booster shot seems mist likely association.  Note that I had Moderna inital primary series in January and February 2021; however I had quite severe Grade 3 reactogenicity event after 2nd dose wih nausea, vomiting, fever, arthralgia, headaches; so decided to have Pfizer booster. Typically I have some degree of reactogenicity events after certain vaccines, including Shingrix and influenza.  Headaches have been ongoing since July 2019, but well controlled on 125 mg of Depakote. I had concussion in 2018 with 4 months of pot concussive headaches that resolved after 4 months.
Administered into subcutaneous tissue of arm right arm with edema, redness, pain. Fever not relieved with TYLENOL, ibuprofen. Back of right arm. Duration 4 days.
Patient stated 6 days later still running a fever (not as high as previous day after vaccination), and also upper arm swollen, red, and hot.
1515 - Extreme weakness throughout entire body...felt like I was going to pass out...felt like my body was heavy like a brick and had a difficult time moving myself.  Went to the ED department at ~1530 and had cardiac monitoring, head CT, blood work and electrolytes drawn.  All came back within normal limits. Began to feel stronger ~ 1930 .  Released from ED ~ 2130 feeling much stronger but extremely weak.
This spontaneous report was received from a pharmacist concerning an unknown number of patient, of an unknown gender and age. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with a dose of M-M-R II (dose, dose number, lot number, expiration date and route were not reported. Co-suspect and concomitant therapies were not reported. Pharmacist reported that, on an unknown date, an unspecified number of patients received improperly stored M-M-R II. No symptoms reported.  This is one (1) of 3 (three) reports from the same source (MARRS1408USA009356, 1408USA13073 and 1408USA013074). Additional information has been requested.
Patient had cellulitis 24 hrs after vaccine administra. About 6 cm distal to the injection site.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Oct2022 at 11:00 as dose 4 (booster), single (Lot number: GJ6665) at the age of 71 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6203), in right arm, on 18Mar2021 as dose 2, single (Lot number: ER8727), in right arm and on 01Oct2021 as dose 3 (booster), single (Lot number: FF2589), in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Ceftin, reaction(s): "Known allergies: ceftin", notes: Known allergies: ceftin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovered" (06Jan2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 including Paxlovid.  No follow-up attempts are possible. No further information is expected.
Light tingling/numbness on Right side down to hands and toes, then through whole body. Began feeling light-headed briefly. Narrative:  Patient sat through most of anticipated monitoring time without incident, the reported tingling and numbness developing on the right side which fairly quickly expanded to entire body. Reported mild light-headedness. Continued to monitor closely without other intervention required. Patient stood up, reported feeling better and resolution of symptoms with that movement. Continued to monitor a few more minutes. Patient left area symptom-free at 12:00 with teaching of appropriate calls to make or where to return to should she be further symptomatic.
It was reported that a 68 year old male received Fluzone SV '99-'00 on 10/13/99. On the same day, the pt states that he was "pale, weak and had hives on the left forearm". The pt was evaluated by his physician and treated with Benadryl. No further information is available at this time. Follow up #1 06/14/02: During internal auditing of all files, it was deemed necessary to amend the report by updating the Adverse Event coding (added pallor and asthenia) (deleted injection site reaction).
This spontaneous report as received from a medical assistant refers to a unknown number of patients of unknown age and genders who on unspecified date were vaccinated with RECOMBIVAX HB (Doses, lots # and routes not provided). Other suspect therapies included on unspecified date, VAQTA (Doses, lots # and routes not provided). No concomitant medications were reported. The medical assistant stated that an unknown number of patients have received improperly stored RECOMBIVAX HB and VAQTA. No adverse event reported. Additional information has been requested.
Localized reaction to immunization. (R) thigh - 12cm area erythema with edema, tender to touch. Second area (R) thigh 4cm area erythema with mild edema. (L) thigh: 5cm area erythema with edema tender. No edema of airway. Lungs clear.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021 at 4:46 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 16-Nov-2021, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided. Excursion duration was 1 month reported by reporter.   This case was linked to MOD-2021-402935 (Patient Link).
Fatigue and nausea starting around 1:30pm on day of shot, fever (100.7F) in the evening, night sweats, ear pain, muscle aches, severe joint pain in all joints (or so it seemed).  It was painful to get out of bed or sit down/stand up.  This lasted until about 9:30pm on 2/13/2021 and then I felt fine until Monday, 2/15/2021, when I had a severe headache all day (may have been a migraine, but Rizatriptan did not relieve pain and it usually clears it up within an hour),  We had no power on Monday 2/15 and it was extremely cold inside our house - probably less than 55F degrees with no heat.  By Tuesday, we still had no power, but the headache was gone and I felt okay.  I feel like I have had more joint pain since the shot and it's become difficult to breathe in the face masks since I took the shots.  I feel like I can't get enough air.
30 hours after injection had severe vertigo and nausea for 15 minutes. Took meclizine and went to bed. Had dizziness and balance issues for 1.5 months before seeing primary care physician and ENT for the dizziness. Had balance test (VNG) with abnormal results. Went to ER and had CAT scan, EKG and bloodworm with normal results. Had MRI and saw neurologist. Began vestibular rehabilitation therapy on May 7, 2021. Vestibular rehabilitation physical therapy is helping.