chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Student brought to the school nurse office one day after vaccination by his mother, stated that he has a rash from the vaccine. Student had one small red, raised on left neck behind left ear and right forehead.
Within 6 days or less arm painful, swollen, spreading erythema developed cellulitis.
One side of vaccination record provided before vaccination.  2nd side of vaccination record provided after vaccination,  which, when entered, make vaccination administered that day invalid.  Hep A too short interval Men too young for 2nd dose
Patient was given 0.25mcg Moderna Bivalent Booster not 0.5mcg, patient was given the wrong dose.
Case number PHEH2015US004131, is an initial spontaneous report from a medical assistant received on 27 Feb 2015. This report refers to a 2 years old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch numbers: U5036CA, U5018AA, U5I173AB, UI1207AB and 14511P) intramuscularly at a dose of 0.5 ml on 08 Feb 2015, which reached 31 degree Fahrenheit for two hours. No adverse event reported following this administration error.
Information has been received from a registered nurse (R.N) concerning a female patient who on 20-APR-2011, was vaccinated in error with a dose of PNEUMOVAX 23, intradermal (lot number not reported) instead of a tuberculin skin test. On 20-APR-2011, the patient developed itching at the site and the area was "raised about the size of a nickle". Mistake caught when she returned for the reading. The patient sought called office. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
No additional AE or PQC reported.; administration of improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a 15-month-old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 28-AUG-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # T002848, expiration date: 23-JAN-2022 (dose and route of administration were not reported) for prophylaxis. The vaccine was reconstituted with sterile diluent (STERILE DILUENT).  It was reported that the dose of the product administered to the patient was not stored properly for the time frame of 50 minutes in the temperature between 6 degrees Fahrenheit (F) and 14 F (10.56 F), with a previous temperature excursion for 30 minutes between 6 F and 14 F (8.47 F). Digital Data Logger was involved.  There was no additional adverse event reported. The outcome of medication error was unknown.
About 30 minutes after receiving vaccine severe pain in head started unrelieved by normal migraine medications which have always worked 100% of the time. Saw my PCP once. Was seen in the emergency department twice. Was on home IV DHE therapy. Admitted the to hospital for 48 hours. Had a lumbar puncture which revealed intracranial hypertension.
Complained of dizziness and chills and complained of upset stomach.  Treatment BENADRYL 50mg PO. 6/6/08-records received-ER report for DOS 5/19/08-Assessment:Allergic reaction. C/O feeling hot and cold, dizzy, weakness all over, some nausea. Other kids in school started feeling same symptoms. Stable during entire ER visit.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 02-AUG-2016, the patient was vaccinated with an improperly stored dose of VARIVAX, (Concentration, dose and route were not reported), lot # M005972, expiration date: 02-FEB-2018. The administered dose of VARIVAX underwent temperature excursion at 26 Fahrenheit degrees, for 6 hours. No previous temperature excursions were reported. The temperature excursions were detected by a data logger. Patient's concomitant medication was not reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
"Spacey for 36 hrs", fever 101.0, parents gave Ibuprofen, being not herself for 1 1/2 days (making moaning sounds, listless, "out of it"), crying, excessive.
Starting 06/03/2022, I developed a bad headache, body aches and nasal drainage. I never ran a temperature but felt extremely wiped out. I barely got out of bed that weekend and on 06/05/2022 I took an at home test which was positive. That same day I went to the pharmacy to get a PCR test just to confirm and on Monday the results came back as positive. I called my doctor the next day (06/07/2022) and he prescribed Paxlovid, albuterol and a z-pack which I started that day. Thursday 06/09/2022 I was starting to feel a little better. I continued the medication and finished it as prescribed. By Sunday 06/12/2022 all of my symptoms but fatigue had resolved. I tested myself on 06/13/2022 at home and it was negative. The fatigue continued into the next week and progressively got better. I am back to normal as of today.
Pt called hospital call center on 10/5/21 401pm reporting dizziness, chills, cough, vomiting and SOB  in AM but she feels better now. Pt also complains of chest pressure and pain but also states feeling better. Onset of symptoms started on 10/5/21. Advised pt to go to ED immediately or call 911, pt verbalized understanding but states she wants to monitor herself a little more but understands the importance of going to ED.
Approximately 25 days post vaccination, patient (I) started to feel burning sensations in the right upper half of my body - areas affected were the back shoulder and chest.  Approximately 4 days later, a rash appeared on my back shoulder and under arm areas. The burning sensation continued and the area was sensitive to touch.   A telehealth doctor visit was done and I was diagnosed with Zoster without complications and I was prescribed valacyclovir for 7 days.
I am sick to my stomach; little dizzy; feel sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: ABDOMINAL DISCOMFORT (non-serious), 3 days after the suspect product(s) administration, outcome "unknown", described as "I am sick to my stomach"; DIZZINESS (non-serious), 3 days after the suspect product(s) administration, outcome "unknown", described as "little dizzy"; MALAISE (non-serious), 3 days after the suspect product(s) administration, outcome "unknown", described as "feel sick".  Additional information: It was reported as patient was sick to His/her stomach and little dizzy, feel sick. Patient was not sure, just know Prevnar was looking online, got my shot on Thursday Pneumonia vaccine (Prevnar) and here 3 days later and patient was sick to my stomach and little dizzy, feel sick.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
lt arm w/ 22x26cm area of induration, erythema @ site of anthrax immun given 2 days prior;
Information has been received from a consumer concerning her son with down's syndrome, transient leukemia, unbalanced atrioventricular canal defect, coarctation of the aorta and kung disease who was vaccinated with the first dose of ATTENUVAX. Other suspect therapies included MERUVAX II and MUMPSVAX. It was reported by the patient's mother that "I was fortunate enough to have my son's first shots available to me as individual injections. He had reactions to two of the three and became quite ill. Imagine if the two would have been in one injection. My son is medically fragile with a  seizure cardiac defect and lung issues." The patient's outcome was not reported. No further information is available.
Developed red, blotchy, mildly itchy rash to anterior and posterior neck on the morning of 12/25/2020 (rec'd vax afternoon of 12/23/2020). The rash progressed throughout the day; extending to anterior torso down to waist, right arm, and upper back. Took 25mg benadryl tablet. Rash began improving the next afternoon (12/26/2020) and completely resolved by morning of 12/28/2020.
Roughly 1 hr after receiving hepatitis a (#1) and TRUMENBA (#1), pt had severe headache (>10/10), shivering and moaning. Referred to ER, waited at ER. Was never seen. Headache improved, shaking stopped, eating/drinking w/o difficulty. No lingering symptoms day after.
I started having chills at 3pm At 10pm that night, I developed a fever, continued chills, body aches, fatigue, and nausea
Mild urticarial rash on (B) arms - seen 8/4/12. Reported finger swelling/itch but nl exam 8/4/12.
Shingles noted on 2/18/02. Treated with Acyclovir X 7 days. Lesions resolved. No post-herpetic neuralgia.
Client was vaccinated with Yellow Fever Vaccine which may have been reconstituted with  0.7 mL sterile diluent provided by Merck and meant for Merck live virus reconstitution, rather than 0.6 mL Sodium Chloride solution provided by Sanofi Pasteur specifically for YF-Vax.
Depo Provera 150mg IM R deltoid, Hepatitis B 1.0ml in L deltoid, client c/o feeling lightheaded after receiving injections instructed her to put head between legs, cool pack to forehead and neck and she was given something to drink, lightheadedness resolved and she stated she felt ok when she left clinic, instructed her to get something to eat and she verbalized understanding. Clients mother telephoned into clinic stating that client had called her and told her my arm is hot and I have red streaks going up my neck, advised client's mother that client needs to go to the emergency dept now. Advised clients mother that client can call the national vaccine injury compensation program and get help paying for hospital visit, clients mother verbalized understanding and stated she would tell relay my instructions to her, I telephoned clients cell phone and it is not a working number, I will file a VAERS form and check with Emergency dept to see if client went or not. I telephoned hospital emergency dept and spoke with a RN and she verified that client was seen by MD and discharged home.
a red rash with a severe itch element.  Rash turns into red welts (akin to mosquito bite), upon scratching.  The welts and rash subside, then pop up on other parts of the body.  The rash has been on face, head, neck, shoulders, both arms, chest, waist, thighs, behind the knees. Patient has been to dermatologist twice for consultation, and another 3 day visit for an allergy test.
8 days after vaccine my left upper arm became inflamed, red, hot, swollen, tender and at times itchy.    It continued to spread over the next 3 days.  I went to an urgent care and saw who put me on an antibiotic due to the continued worsening of the arm and how hot it was to the touch.  It continued to spread from my shoulder to my elbow.  ( i have pictures if you need). It lasted 8 days before it began to recede.  3 weeks  later, you can still see the remnants of the red rash. I also went to my Dr to be looked at.
Extremely fatigue; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (Extremely fatigue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Extremely fatigue). At the time of the report, FATIGUE (Extremely fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and Treatment medications were not provided by reporter.
Headache; fever up to 101.5; Body aches (could barely get out of bed; chills; lump under my right armpit; knot and swollen at injection site
Information has been received from a registered nurse concerning a patient who on approximately 21-JUL-2008 was vaccinated with a second dose of VARIVAX vaccine (Oka) (route and administration site not reported). Concomitant therapy included other vaccines (unspecified) which were not administered at the same site. Within hours of the shots the patient experienced an injection site reaction and swelling at the injection site. The swelling worsened the day after the vaccination. Additional information has been requested. This is one of several reports from the same source.
Extreme heart palpitations, none experienced for years before. Woke up shaking so badly I thought there was an earthquake, realized it was my heartbeat.
Since received flu shot, has had a headache, felt crummy, and lost voice for approx. a week.  Laryngitis resolved on 10-25-12, but now, mouth and throat is numb feeling.
Developed acute shingles on trunk on right back-- associated with pain, rash, burning. My partner has had 2 cases of shingles not long after her pts received Covid vaccines as well- she did report this
Tenderness and induration without erythema at injection site that wrapped around outer arm, under axilla and produced tender axillary lymphadenopathy . This occurred within 24 hours of vaccination and is still present 84 hrs after vaccination.
Pt states she has a 'hive' 1" x 2", 1.5" below injection site. The hive appeared 4-5 days post injection. It is sore. No fever, dizziness, SOB reported.
Menstrual period lasting at least double what is normal for my body.  Light flow - but has now lasted over 10 days.   Nipples are extremely itchy.  No redness or rash
Post vaccination it was noted that the vaccine expired on 8/21/2023.  Supervisor notified, vaccine pulled from stock, clinic physician notified and consulted, parent notified.
Patient reports that she had a Shingles Vaccination.  Within a day, she experienced suprapubic pain.  Then her diverticulosis got worse.  She was hospitalized for 5 days and treated for diverticulitis. 9/25/09 Medical records received for DOS 8/12/09 to 8/16/09.  Seen in ER for dysuria, LLQ pain, nausea. Assessment: decreased bowel sounds, low grade fever. D/C DX: Diverticulitis, Abscess intestine,  ICD9 codes 582.11, 569.5.
On the evening of 1/6 patient started to develop flu like symptoms that continued through the morning of 1/7. Patient then begin to develop swelling in the left armpit/axillary region. As of 1/8 swelling was the size of an orange or grapefruit and described as being "almost like subcutaneous swelling." As of 1/8 the swelling could be seen through his shirt and looked like hypertrophy. Patient has taken photos for documentation.
Within 20 minutes of injection my left jaw experienced such pain as if I was kicked in the jaw by a horse.  Within another 15 minutes I had severe chest pain. I returned it to the hospital pharmacy and told them of my symptoms.  ?Well they do say there could be muscle pain? Unacceptable answer
pt recv vax 27JAN97 & 27JAN97 pt devel a low-grade fever;
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. The pharmacist reported that in one of their clinics, on 05-JUL-2018, the patient was inadvertently administered with a dose of ROTATEQ orally, lot # M046008 (exact dose was not reported), which expired on 29-JUN-2018. No adverse effects were reported.
Assessed client on 12/20/12 at 12 noon when he came to show nurse his left arm. Client received pneumococcal vaccine 12/18/12 in left arm. Redness measures 20cm length x 17cm width. No wheezing, throat swelling etc... Client denies itching. Advised BENADRYL.
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Concurrent conditions and medical history of the patients were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored RECOMBIVAX HB (lot#, expiration date, dose and route unspecified). Other suspect and concomitant therapies were not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Case previously recorded as MA2009-4576. Case report received from a physician, via Novartis Medical Communication, on 17 NOV 2009. Patient (gender unknown) under 3 year-old was vaccinated with S-OIV FLUVIRIN (batch no. unknown) i.m., on 13 NOV 2009. No adverse event was reported. MedCom reference no.: NA09-008308.
Information has been received from a registered nurse concerning a 25 year old female patient with mentally challenged, trisomy 9, blindness, osteoporosis, scoliosis, allergy to KEFLEX, SEPTRA, amoxicillin, CECLOR, DEMEROL, kidney stones and "nebutol", and a history of delayed puberty, who on 30-AUG-1996 was vaccinated with a first dose of VARIVAX (Merck) (route and Lot # not reported). On 19-OCT-2006, the patient was vaccinated with a second dose of VARIVAX (Merck) (route and Lot # not reported). Concomitant therapy included DIURIL, LORABID, DULCOLAX, BENEFIBER, NEXIUM, FLAGYL and KLONOPIN. The nurse reported that on 03-DEC-2010 the patient developed chicken pox, "about two weeks", after the patient's mother developed shingles. The patient presented with a severe case of the lesions which were also present in her vagina. A fever of 101.6 was reported. The rash was described as painful, blistering and very itchy. The patient was treated with BENADRYL, AVENO oatmeal baths and as needed TYLENOL for pain. There were no Lab diagnosis/studies performed. The patient sought unspecified medical attention. At the time of the report, the patient was recovering. Additional information has been requested.
Information has been received from a healthcare worker referring to a female patient of unknown age. Information about medical history, concurrent condition and concomitant medication was not reported. On an unspecified date in 2013 the patient was vaccinated with the first dose of GARDASIL (strength, dosage, frequency and route unspecified) and would "now" like to continue the vaccine series (exact date unspecified)(inappropriate schedule of vaccine administered). Additional information has ben requested.
This spontaneous report as received from a physician via company representative, and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 28-APR-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mLVls 10SDV" with lot number J009689 with expiration date of 29-JAN-2015 (route of administration was unknown), which was stored at 34 Fahrenheit (F) Degrees (1.111111111 Celsius)for a total of 144 hours and also at 33 Fahrenheit (F) Degrees (0.555555556 Celsius)for a total of 72 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effect were reported nor product quality complaint was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Initial unsolicited report received from an other health professional on 31-Jul-2018. This case involves a 56-years-old male patient who was vaccinated with a dose of 0.5 ml IPOL lot number not reported via unknown route in the left deltoid instead of 0.5 ml dose of TYPHOID VI POLYSACCHARIDE VACCINE lot PIA171M. The patient's past vaccination(s) included TYPHOID. The patient's past medical history, medical treatment(s) and family history were not provided. It was an actual medication error due to wrong vaccine administered. It was reported that the patient with no allergic reaction was observed. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 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.
Mild flu symptoms, including fever, chills, fatigue, then severe depression lasting a few days. Shooting, sharp pains in my arms and face for several days afterwards.
chills, full-body pain, nausea, dry cough, severe headache, temperature of 103-104f 20 hours after injection. vomiting, extreme fatigue and weakness and light sensitive.   Nausea subsided after taking Zofran (glad we had that on hand).  Ate crackers and drank Liquid IV hydrating packets the rest of the day.  Chicken noodle soup later at night.  Two days after injection, temperature has dropped to 99f, body pain, fatigue.  Injection site is still very tender.
Rash around neck / Have rash all body; Itchy all body; This is a spontaneous report from a contactable consumer (patient). A 12-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0180), via an unspecified route of administration, administered in left arm on 29Jun2021 at 10:45 AM (vaccinated at the age of 12 years) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included atopic dermatitis from an unknown date and unknown if ongoing, allergic to apple and cedar tree, birth, Alder, Prennial Rye, sweet Varnal, Timochygrass. Concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. The patient was not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. After taking the vaccine 11 am, on 29Jun2021 at 04:00 PM, patient got rash around neck around 4pm and all body except face around 12am -1am and took Benadryl to sleep. On next day, patient was still itchy all body and took Benadryl again to sleep. After the next day, patient went to ExerUrgent care and got steroids prescription creams. However, after 4 days now, patient still have not to get better and have rash all body. Therapeutic measures were taken as a result of the events with prescription steroids cream and Benadryl cream. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. The report was non serious. Outcome of the events was not resolved.
Caller has fever; This is a spontaneous report received from a Pfizer Sponsored Program from a contactable consumer (patient herself).  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. It was reported that the caller has appointment for today it is their 2nd dose it is scheduled for late evening. Caller has fever in the last seven days (unspecified date in Apr2021) that lasted 2 days hasn't had fever after. Caller wanted to know if it was safe to have 2nd vaccine. Read ISI. Faxed AE due to fever after 1st vaccine. The outcome of the event was recovered on an unknown date in 2021 (duration: 2 days).  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
A week after the vaccine: chest pain, rapid heart beat, high resting heart rate (lying down makes it go normal rate, sitting elevates it to 80-90bpms, and any standing position causes it to rise 100-110 bpm and stay there, fatigue, and brain fog