chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 01-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves 09 months old patient (gender not reported) who was vaccinated with 0.5 ml expired dose of ACT-HIB (Batch number: UI787AA, expiration date: 11-May-2018, site was not reported) via intramuscular route on 01-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included FLUZONE QUADRIVALENT for Immunisation. It was an actual medication error due to expired vaccine used. It was unknown if patient had adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
The patient experienced itchiness around the injection site and on 01/17/2001 developed 10 lesions over the entire body. The patient sought unspecified medical attention. Additional information has been requested. Per F/U 6/17/02: The pt has a novacaine allergy, irregular menses and keratitis and a history of dry skin, tendinitis and lipoma. On 1/2/01, the pt was vaccinated with the 1st dose of varicella (0.5ml) (lot 635490/1142K) in the left deltoid, IM. Concomitant therapy included 1 dose of DPT in the right deltoid, IM (0.5ml) (lot 343AA) and unspecified eye drops for keratitis and prenatal vitamins. On 1/4/01, the pt reported at 16:10, right arm tender, no increasing warmth but increasing redness around the injection site of 1". Pt also reported that she thought she had a low-grade temperature. The pt was instructed to use ice packs. On 1/17/01, the pt broke out in about 10 lesions all over her body, they were "pinhead to grapefruit size", very itchy and no drainage noted. The pt called the physician's office on 1/18/01 and noted she was afebrile until "today" (temp of 99.1F). The pt was told to use OTC Benadryl as instructed. It was noted on 1/20/01 that the symptoms "sounds like chickenpox". It was also reported that on 1/25/00, the pt was tested for varicella, IgG titer was absent. On the day of vaccination, the pt was given a urine pregnancy test which was negative. Her last menstrual period was some 6 weeks prior; the pt was typically late. Additional info has been requested.
One hour after receiving flu vaccine, pt. developed generalized hives, dizziness and was pale. Pt. was taken to ER, given BENADRYL.
Patient reports a week after receiving the high dose flu vaccine his arm started hurting. Reported this is the second week of pain.
Approx 10 min after vacc., pt c/o feeling nauseated and seeing colors and couldn't talk right. Also c/o headache.  He had a speling test, was unable to write. This rxn lasted 15 mins, during which pt vomited.
Headaches started in the left side of my head but did not cease.  MRI on May 3rd revealed brain lesion, MRI C-Spine May 8 - Clear, MRI T-Spine, MRAngio, Chest Xray May 14th Clear, Lumbar Puncture May 20th - Elevated Protein - Headaches continued, Repeart Brain MRI
Symptoms: Extreme cold and shaking from cold. No fever. Was taken by ambulance to ER. They used heated blankets to warm me up and gave me a shot of Motrin. Symptoms began approximately 11 hours after shot was given. After returning home and sleeping, currently have a headache and muscle aches.
Heart Angina; Vertigo; Dizziness; Achy Muscles; Tired; Queasy; Stomach Uneasy; mild headache; woozy; booster dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 63 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Nov2021 02:45 (Lot number: FF2590) at the age of 63 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing). There were no concomitant medications. Past drug history included: No, reaction(s): "Allergy". Vaccination history included: Pfizer (DOSE 2, SINGLE, Batch/Lot No: ER8727, Location of injection: Arm Right, Vaccine Administration Time: 02:15 AM), administration date: 29May2021, when the patient was 62 years old, for Covid-19 immunization; Pfizer (DOSE 1, SINGLE, Batch/Lot No: EN6199, Location of injection: Arm Left, Vaccine Administration Time: 02:00 AM), administration date: 05Mar2021, when the patient was 62 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 11Nov2021, outcome "recovering", described as "booster dose"; ANGINA PECTORIS (non-serious) with onset 23Nov2021 10:00, outcome "recovering", described as "Heart Angina"; VERTIGO (non-serious) with onset 23Nov2021 10:00, outcome "recovering", described as "Vertigo"; DIZZINESS (non-serious) with onset 23Nov2021 10:00, outcome "recovering", described as "Dizziness"; MYALGIA (non-serious) with onset 23Nov2021 10:00, outcome "recovering", described as "Achy Muscles"; FATIGUE (non-serious) with onset 23Nov2021 10:00, outcome "recovering", described as "Tired"; NAUSEA (non-serious) with onset 23Nov2021 10:00, outcome "recovering", described as "Queasy"; ABDOMINAL DISCOMFORT (non-serious) with onset 23Nov2021 10:00, outcome "recovering", described as "Stomach Uneasy"; HEADACHE (non-serious) with onset 23Nov2021 10:00, outcome "recovering", described as "mild headache"; DIZZINESS (non-serious) with onset 23Nov2021 10:00, outcome "recovering", described as "woozy". Therapeutic measures were not taken as a result of immunisation, angina pectoris, vertigo, dizziness, myalgia, fatigue, nausea, abdominal discomfort, headache, dizziness.
Swelling at itching at the shot site within one hour, red circle warm to touch expanded throughout the day. Lasted at the injection site 4 days without getting worse. Within 2 days, mild itching throughout all parts of body. Severe itching on scalp. Day 5, noticed bumps on scalp - hot and itching. That night at 2am, entire body covered with large welts - bilateral in  many places (same spot on each arm, same spots on hips, buttocks) and smaller ones throughout entire body. Took BENADRYL, woke up to the hives subsided but head swollen and extreme pressure in back of neck, forehead protruding, eyes extremely swollen and distorted, one eye off center. Went to ER immediately, had Brain scan to be sure swelling/pressure not caused by bleeding in the brain. Scan results normal. Treated with BENADRYL and MOTRIN - Diagnosis - Allergic Reaction. Followed up with my own Dr the next day, prescribed prednisone 10 mg a day for 5 days, then drop to 5 mg a day. Diagnosis - allergic to recent Flu vaccination and advised not to have any in the future.
diabetic; He didn't eat much last night and didn't eat this morning.; temperature was 100.3.; Nausea; feeling dizzy; Rash; face real red; shaky and jittery; shaky and jittery; This is a spontaneous report from a contactable consumer. A 92-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EW0167), via an unspecified route of administration in left arm on 29Apr2021 at 14:30 (at the age of 92-years-old) as unknown, single dose for COVID-19 immunization. Medical history included patient first diagnosed as pneumonia, reporter was unsure pulmonary lung infection and pneumonia are the same and treated 3-4 weeks ago for a pulmonary lung infection and type 2 diabetes mellitus. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer Suspect. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. No adverse event prior vaccinations. Patient did not perform any relevant test. Patient took a lot of medications after being in rehab but concomitant medication was not reported. Vaccine was not administered at (Privacy)Facility. On 30Apr2021, the patient experienced nausea, feeling dizzy, temperature, developed rash, red face and shaky and jittery. Patient had been bringing up stuff from lungs some of the stuff bothers and makes patient nauseated, didn't eat much last night and this morning. Patient was diabetic so she thought it might be related to a sugar thing. Patient won't drink any water and temperature was 100.3. She put a cold towel on face and it came to normal color and face was real red before, on 30Apr2021. Diabetic on an unspecified date. Reporter asks would that condition aggravate the side effects of the vaccine. Patient did not visit to physician office and emergency room. The patient underwent lab tests and procedures which included body temperature: 100.3 on 30Apr2021. The outcome of the event nausea was recovered and rest of the events are unknown.   Follow-up attempts completed. No further information expected.
I was dizzy and could not keep my balance or walk.  I was having chest pains and felt a heavy feeling in my chest.  My husband took me to the ER. They ran blood work and did a CT Scan and chest x-ay.  I told the ER that I had the covid vaccination the Tuesday prior but they said I would have already had symptoms.  They didn't ask which vaccination.  They said they thought I had vertigo and gave me Antivert.   They said I should follow up with an ENT, Cardiologist and Gastroenterologist.  When I went for the follow-u p with a Cardiologist, they scheduled a stress test (May 21st) and an Echocardiogram ( May 11th).  The Gastro doctor wants a endoscopic and colonoscopy but wont schedule until I have clearance from the Cardiologist.
Beginning 01/04/2009 I have experienced the following symptoms: -chest pain -shortness of breath -nausea -pain radiating down legs and arms -joint pain -frequent heart burn -frequent burning when urinating/ UTI -tired all the time -painful superficial lump/ clot -poor circulation in legs -no period for over 9 months (not pregnant)
This spontaneous report as received from a pharmacist via a company representative referring to himself, a male patient of unknown age. Patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication were not reported. On an unknown date, it was reported that the patient developed blistering bumps on his finger the day after administering ZOSTAVAX (dosage regimen, route of administration, lot # and expiry date unspecified) to a patient. It was reported that the patient had worn gloves during the administration. The patient was diagnosed with herpes virus infection on his finger after consulting with an unspecified physician. It was reported that the lesions resolved in 3 weeks without requiring medical treatment. Outcome of herpes virus infection was recovered. Causality assessment was not provided by the reporter. No product quality complaint (PQC) was involved. No further information was provided. Additional information has been requested.
Patient's sister (who lives out of state) called 10-4-14 to report a 3 inch "blotch" near injection site. No fever, itching, SOB on this date (24 hrs after admin). Sister called back 10-8-14 to report rash better but itching and warm. I advised sister on 10-4 to take patient to her Dr, which she did not do.
Sore throat, severe muscle/body aches, fatigue, weakness, lack of energy--continued so appointment with MD 12/2/13--several lab tests performed--Zithromax taken without resolution of symptoms; throat culture negative for strep; ANA screen, sed rate, Lymes test, TSH, BNP all done--negative; CBC done which showed a low WBC count, Low Bands, Low Segs and elevated LYMPHS; MONO test negative. Throat continues to be slightly sore and red as of 1/11/14. Continue with off and on muscle/body aches.
This spontaneous report as received from a physician refers to a 18 month old patient with no medical history reported. On an unknown date the patient may have been administered a dose of GARDASIL (dose 0,5 ml, intramuscular), instead of the intended dose of PEDVAXHIB. Lot number of vaccine administered was not provided and identified by the physician as GARDASIL. Physician stated that this may have not occurred and may have been a documentation error. No adverse events were reported. Additional information has been requested.
Inflammation; Deformation; severe pain; This is a spontaneous report from a contactable consumer (patient).   A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; ), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE and dose 2 via an unspecified route of administration, administered in left arm on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included liver disorder (liver) and Known allergies (yes). There were no concomitant medications. Patient not administered other vaccine in four weeks. The patient experienced Inflammation, deformation, and severe pain for more than 2 months after vaccinations on an unspecified date. Patient went to emergency room and physician room for visit. Patient not had Covid prior vaccination. Patient was tested Covid post vaccination. The patient underwent lab tests and procedures which included sars-cov-2 test and result was unknown. The patient received Colchicine for the treatment of events. The outcome of the events was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Within 5 min of immunizaiton, patient began complaining of strange feeling in throat, like it was hard to swallow, and then that her tongue felt enlarged/swollen.  A doctor was summoned and at the same time, patient complained of feeling light-headed and faint.  Patient was reclined and legs elevated.  Doctor examined and noted airway was patent with no signs of respiratory distress.  Pulse ox 100%, B/P 90/48, Pulse 55. (Patient stated she runs 4-5 miles/day and her pulse is usually in the 60's.  Doctor recommended transport to ER by ambulance.  Patient refused.  At 12:10 PM patient called her mother to come pick her up.  Continued to c/o light-headedness.  B/P 110/86.  Stated her throat and tongue were feeling "better".  At 12:30 PM she tried sitting up, took sips of water without difficulty and asked for something with sugar in it.  Stated she had worked all night and came straight from work to appointment.  Very tired and had last eaten at 8:00 AM (only applesauce).  Apple juice given. Tolerated well.  At 12:45, her mother arrived.  Mother stated she would take patient to ER.  At 12:55 PM patient's B/P 110-84, patient still complaining of slight light-headedness, but stated her throat and tongue feel better.  Patient released with her mother.
Nose bleed; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: PAA165969), via an unspecified route of administration in right arm, on 26Feb2021 at 03:15 PM (15:15) (at the age of 60 years), as dose 1, single, for COVID-19 immunization. The patient's medical history included breast cancer from 1995 to 2014 and allergies to teagarden. The patient's concomitant medications included escitalopram oxalate (LEXAPRO) and omeprazole. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. On 02Mar2021 at 01:45 PM (13:45), the patient experienced nose bleed. The patient never has had a nose bleed before. No treatment was administered for the event. The patient has not been tested for COVID-19 post vaccination. The patient recovered from the event on 02Mar2021 (unspecified time).  No follow-up attempts are possible. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of nausea in a 55-year-old female patient who received SHINGRIX for prophylaxis. On 6th August 2018 19:30, the patient received the 1st dose of SHINGRIX. On 7th August 2018, 1 days after receiving SHINGRIX, the patient experienced chills, tremor, injection site swelling, muscle pain, headache, fever, sweating, injection site muscle pain, sleepiness and performance status decreased. In August 2018, the patient experienced nausea, dry mouth and dizziness. The patient was treated with non-drug therapy (Cold Compresses). On an unknown date, the outcome of the nausea, dry mouth, chills, injection site swelling, muscle pain, headache, fever, sweating, injection site muscle pain, dizziness and sleepiness were recovering/resolving and the outcome of the tremor was recovered/resolved and the outcome of the performance status decreased was unknown. It was unknown if the reporter considered the nausea, dry mouth, chills, tremor, injection site swelling, muscle pain, headache, fever, sweating, injection site muscle pain, dizziness, sleepiness and performance status decreased to be related to SHINGRIX. Additional details were provided as follows: The patient had no chronic illness. The patient received the vaccination at 7:30 PM on left deltoid. The next morning about 8 AM, she felt nauseated, dizzy and had a dry mouth. The patient also had chills, and was shaking and trembling uncontrollably. The patient could not stay awake and slept for 10 to 12 hours. The patient could not function and her large muscles were aching. The patient still had a dry mouth but was no longer shaking. The patient never had an experience like this before. It was reported 10 hours in (unspecified), she woke up with a terrible headache. The patient had barely eaten some toast and ginger ale and was afraid to take Ibuprofen right away. Around 12 hours in (unspecified), she had a fever and was hot. The patient applied cold compresses and the fever broke and she began sweating and it seemed to relieve her symptoms. The patient had a mild local injection site muscle ache and a tiny amount of swelling.
Left arm has a round red patch a little larger than a half dollar size at this time. Slightly raised around edges. This site is down to the right of injection site. Slight arm soreness.
22May90 pt vax; w/in 30-45 min devel swelling of eyelids, moderatly severe dyspnea, & sensation of throat closing.  Given oxygen & Epi w/ improvement for respiratory sx.  In ER tx w/ pred & DPH. Periorbital edema persisted, resp. sx resolvd
Patient received a flu shot 10/26/11 in the AM at her place of work by H.D nurse. School nurse called H.D when patient came to her c/o eyes being blood shot red, nausea, indigestion, pain in back between shoulder blades.
2 hours after receiving vaccine, child experienced swelling at injection site.  Next morning injection site/upper arm swollen, rock hard to touch, hot to touch, painful to move.  Child taken to ER.  Given Benadryl and Prednisone dose pack.
After the second dose, like 2 days later I was running a fever and I was really exhausted for a week. I had a virtual visit with my doctor probably on 05/10/2021. They told me to get a COVID-19 test because they were convinced, I had COVID-19. By the time I got the results my fever was already gone but I continued to be tired. I recently had a checkup like 2 weeks ago, I am pretty sure it was on 10/22/2021, they did blood work and I had high blood pressure, which I have never had before, and my blood sugar was high too. Also, I have been more tired than usual ever since I got that vaccine. They did not prescribe any medications, but I have a follow up next week because my blood pressure is still high.
Headache, Fever highest recorded at 101.7 F,  severe chills, nausea. Started at 8:30p on 2/3 and continued until 6p 2/4. Used 650 mg acetaminophen q8h and 400mg Ibuprofen q6h, hot compress for headache, and increased fluid intake. Developed red splotches on skin near injection site on 2/5
5 days post 2nd shot severe to debilitating headache; 80% or greater bowel movements are all liquid stool, no accompanying abdominal discomfort ..    after the 5 days daily headaches of low level, OTC meds usually work or I just live with it.
Pfizer-BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 2/6/2021 and 2/27/2021. Patient stated he received a third COVID vaccine around the 1st of September 2021 but unable to verify with documentation. Patient presented to ED on 9/9/2021 for hypoxia. Hospitalized for COVID pneumonia. Dexamethasone, levofloxacin, zosyn, vancomycin, and remdesivir were administered. Patient continued to decompensate throughout hospitalization. Patient was transitioned to comfort care on 9/20/2021 and expired at 1734 on 9/20/2021.
Pfizer's COVID vaccine on 16Jan2021 with his second dose scheduled 06Feb2021. Caller stated he had taken the COVID test on 02Feb2021 and tested positive for COVID 19 an hour ago; This is a spontaneous report from a contactable consumer (patient). A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown) via an unspecified route of administration on 16Jan2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had second dose scheduled on 06Feb2021. Patient had taken the COVID test on 02Feb2021 and tested positive for COVID 19 an hour ago. He had family members that just came out of quarantine 3 days ago and he got tested when his family members just came out of quarantine. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Covid Arm- approximate 3 inch rash at injection site. Resolved on it's own in 2 to 3 days. No treatment needed
Shingles; Developed 2 small red blisters on left side of her cheek and buttock, progressing to the left side of body; Rash about 7-8" long starts on left buttock and follows her back; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles), BLISTER (Developed 2 small red blisters on left side of her cheek and buttock, progressing to the left side of body) and RASH (Rash about 7-8" long starts on left buttock and follows her back) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISDEXAMFETAMINE MESILATE (VYVANSE) and LEVONORGESTREL (MIRENA) for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 03-Mar-2021, the patient experienced HERPES ZOSTER (Shingles) and BLISTER (Developed 2 small red blisters on left side of her cheek and buttock, progressing to the left side of body). In March 2021, the patient experienced RASH (Rash about 7-8" long starts on left buttock and follows her back). At the time of the report, HERPES ZOSTER (Shingles), BLISTER (Developed 2 small red blisters on left side of her cheek and buttock, progressing to the left side of body) and RASH (Rash about 7-8" long starts on left buttock and follows her back) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       She indicated she has a reddish color with blisters in a straight line or string that starts on her butt cheecks and follows back as well. On 08-Mar-2021, the patient went to see her physician. On 10-Mar-2021, her physician diagnosed her with shingles. Treatment included doxycycline, triamcinolone, valacyclovir and gabapentin.
low grade fever 24hr p/vax;varicella rash over body starting 3 days past vax;dx as varicella by MD;