chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a RN concerning an 8 year old female who on 31Jul98 was vaccinated with a first dose of varicella virus vaccine live (lot 625047/1574E) (SC). Subsequently, during week of 18Apr04, the pt developed a full blown case of chicken pox. Unspecified medical attention was sought. The pt recovered. No product quality complaint involved. The RN also reported on two other pt's who had a similar experience after being vaccinated with varicella virus vaccine live (WAES0404USA02308 and 0404USA02309). Additional information has been requested.
Patient reported on 11/09/20 with swelling below the injection site to the below the elbow. Swelling was red and itchy. Was instructed to try over the counter benadryl and topical cortisone to see if symptoms improved and if not seek medical treatment. Patient returned 11/10/20 with improved symptoms and no complaints at this time. Instructed to continue the previously recommended treatment for another day or two and things should improve more. If they do not instructed to seek medical care.
Burning in arm immediately following injection; heaviness/?dead arm? for 36 hours; muscular pain on left side from breast area into front and back chest I left. Swollen lymph nodes and pain around left breast and armpit area, into back shoulder blade, lasting more than 10 days.
mom called 2SEP98 & stated child recv vax 31AUG98 & devel skin rashes 1 day p/vax;rash all over body;will bring child to ER 3SEP98;APAP for sl temp;
Information had been received from a healthcare worker concerning a 17 year old female pt with a sulfonamide allergy who on 8/23/06 was vaccinated IM in left upper arm with a dose of HPV rL1 6 11 16 18 VLP vaccine yeast, lot 653736/089F. There was no concomitant medication. it was reported that 5 days after vaccination, on 8/27/06, the pt developed lymph node swelling in the clavicle area, described as grape size. The pt complained of interference of upper arm movement and felt something was present in the clavicle area. Unspecified blood work was done. On 8/29/06 a CAT scan was performed and lump was described as having 2 smaller and 1 larger lymph nodes involved. On 8/30/06 the pt was scheduled for surgery to have the lymph nodes removed and biopsied. As of the report date, the pt had not recovered. The reporter felt that the lymph node swelling and interference with upper arm movement were other important medical events (OMIC). Additional information has been requested.  10/13/06 Received medical records from hospital which reeal patient seen in ER 8/29/06 for enlarged lymph node left supraclavicular area which was tender to palpation.  Final Dx: lymphadenopathy.  8/31/06 surgical biopsy done of left node & several other lymph nodes were palpated & sent to lab.
The injection site feels itchy, and swollen a week after the injection was given. It is warm to the touch and hurts only a little. The initial soreness was gone 2 days after the shot was given. It was normal and then became sore again.
Information has been received from a health professional concerning a female who was vaccinated with a first, second, and third oral dose of ROTATEQ on 08-OCT-2007, 26-DEC-2007, and 11-FEB-2008, respectively. No problems were reported. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Red knot on right arm (erythematous area 1cmx1.8cm over indurated area 1.8cmx2.3cm). Tender to touch.
5 minute bout of vomiting 11 hours after vaccine given.  Resolved completely, did not recur.
Moderate muscle and joint pain; Moderate muscle and joint pain; Fever; Chills; Minor sore throat; Cough; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 52-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0179), via an unspecified route of administration, administered in Arm Left on 07May2021 09:45 (at the age of 52-year-old) as dose 2, single for covid-19 immunisation. Medical history included drug hypersensitivity (penicillin allergy) from an unknown date and unknown if ongoing. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0162), via an unspecified route of administration, administered in Arm Left on 16Apr2021 11:00 as dose 1, single for covid-19 immunisation. On 10Jun2021, the patient experienced moderate muscle and joint pain, fever, chills, minor sore throat, cough. Reported as onset of symptoms was over a month from date of last vaccine. No known contact with infected persons, working from home, minimal social contact. It was unknown if patient received treatment as a result of events. The outcome of the events were recovering.  No follow-up attempts are possible. No further information is expected.  Follow-up attempts are completed. No further information is expected.
On 7/29/00, pt had acute onset of fever and rash. On 7/30/00, she developed vomiting and was taken to ER. Was in ER for 1 day of observation. Treated with Rocephin.
Patient presented to covid vaccine clinic with father, for Pfizer 1st dose. 5 minutes after receiving the vaccine, patient reported cold sweat, nausea/vomiting, and dizziness/lightheadedness. Patient was brought into nurse clinic. Vitals taken. Initial BP: 101/61, HR: 71, SpO2: 97%. Temp 98.7 F. Pt denied any chest pain, SOB, trouble breathing, abdominal pain, hives, or throat swelling. MD came to bedside and assessed patient. Per MD, likely vasovagal.  No meds given. Pt reported feeling better and was given water/juice. Ambulated around with no issues and was discharged.
The day after 2cnd vaccine, I experienced a severe headache/neckache, severe body aches, fever, chills, dizziness, lethargy.  This was like a fast-moving but fairly severe flu, and lasted only 24 hours.  I used Acetaminophen, and was feeling almost 100% the next day.
6-25-08 in office to report local reaction about 2" in diameter - redness where MMR was given L arm. Pt noticed on 6-19-08 also c/o itching all over. No rash noted - no difficulty breathing - no other symptoms. Advised to see Dr if symptoms cont or get worse.
Initial information received on 27-Jul-2018 regarding an unsolicited non-serious case received from a consumer/non-healthcare professional (market research). This case involves a patient (age in between 50-64 and gender was not reported) who was vaccinated with a dose of FLUZONE HIGH DOSE (batch number, expiry date, route and site of administration were unknown) on an unknown date. The patients medical history and concomitant medication were not reported. It was a case of actual medication error due to inappropriate age at vaccine administration since FLUZONE HIGH DOSE is indicated only for patients aged 65 plus. It was unknown if patient experienced any adverse events following vaccination. 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.
no adverse effect; patient received improperly stored PROQUAD; This spontaneous report was received from a nurse and refers to a 4-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.     On 13-AUG-2019, the patient was vaccinated with one of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live albumin status rHA (PROQUAD) vaccines: lot # R023499, expiration date 13-FEB-2020 or lot # R026722, expiration date 17-MAR-2020 (strength, dose, frequency, route of administration and anatomical location were not reported). The vaccines were reconstituted with properly stored sterile diluent. The nurse stated that the vaccine experienced two temperature excursions on 12-AUG-2019 and on 13-AUG-2019. Neither were reported to the nurse until 06-SEP-2019. Administered dose of vaccine experienced the temperature excursion between minus 14 to minus 10 degrees Celsius, multiple minus 11.91 degrees Celsius for 8 hours. Data logger was involved. There was no previous temperature excursion. No adverse effects were reported.
Had seizures early evening of 10MAR92 & 6AM on 11MAR92; Pt seen each time in ER, t104 & 102; dx febrile seizure;
top of hands swollen; red spots all over body; had a sl fever p/receiving shots on 29NOV94; fever is now gone;
Pt recv vax on 11/24/98; 1 hr post vax pt exp fussiness, spitting up, increased sleeping, night sweating; tx=Pedialyte
A medical assistant reported the occurrence of an injection site reaction in a 6 month old male who received Infanrix. The subject's medical history, concurrent conditions, and concurrent medications were not specified. On 12/12/01, the vaccinee received his first injection of Infanrix without adverse event. On 2/12/02, the vaccinee received an injection of Tripedia without adverse event. On 4/17/02, the vaccinee received an injection of Infanrix (547A2). On 4/19/02, he developed an injection site reaction characterized by a large lump (knot) and redness. He was seen by the physician. The reporter stated that these adverse events were probably related to Infanrix administration. As of 4/22/02, the outcomes of the events were unknown.
Headache; body and joint aches; body and joint aches; chills; extrem tiredness; This is a spontaneous report from a contactable consumer or other non hcp. A 71-year-old female patient received bnt162b2 (BNT162B2, solution for injection, Lot #;FL9265), dose 1 via an unspecified route of administration, administered in Arm Left on 30Jan2021 10:00 as SINGLE DOSE for covid-19 immunisation. Medical history included cardiac disorder from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing, covid-19 from an unknown date and unknown if ongoing. Concomitant medication included pramipexole dihydrochloride (PRAMIPEXOLE DIHYDROCHLORIDE) taken for an unspecified indication, start and stop date were not reported; ezetimibe (EZETIBE) taken for an unspecified indication, start and stop date were not reported; clopidogrel (CLOPIDOGREL) taken for an unspecified indication, start and stop date were not reported. On an unspecified date, the patient experienced headache, body and joint aches, chills, extrem tiredness. The action taken in response to the event for bnt162b2 was not applicable. The outcome of the event was recovering.
Daughter called 30 Min after patient left facility (about 1 hr after vaccine) reporting Left side of her face was numb and tingling but was easing. MD previously approved vaccination. Patient's daughter was instructed to monitor patient and call MD if symptoms worse.
Seriousness criteria other medically significant (OMIC). Initial report received from another manufacturer, report number HQWYE555005MAY, on 4/17/2006. A 16 month old female patient, with a family history of a sister with autism post immunization, had received on 5/18/2000, an intramuscular, second dose injection of IPOL, lot number unknown, an intramuscular, second dose injection of Hib Titer vaccine, lot number unknown and intramuscular, second dose injection of Diphtheria and tetanus toxoids absorbed, purogenated, lot number unknown. Approximately 13 months post vaccination, in June 2001, the patient experienced receptive language and speech delays. By early 2004, the patient was diagnosed with autism. Per the reporter, the patient is receiving therapy to improve her skills. The case was considered medically important by the reporter. At the time of this report, the patients recovery status was unknown. Vaccination, received on 7/18/2000, included intramuscular third dose injection of Hib titer vaccine, lot number unknown, an intramuscular, third dose injection of Diphtheria and tetanus toxoids absorbed purogenated, lot number unknown and an intramuscular first dose injection of Hepatitis B vaccine, lot number unknown. Vaccination received on 10/19/2000 included an intramuscular second dose injection of Hepatitis B vaccine, manufacturer unknown lot number unknown. Vaccination, received on 1/26/2001 included intramuscular injection of Varivax, lot number unknown. Vaccinations received on 5/4/2001 included an intramuscular fourth dose injection of Hib Titer vaccine, lot number 560753A, an intramuscular third dose injection of Hepatitis B vaccine manufacturer unknown, lot number unknown, and intramuscular first dose injection of MMR vaccine lot number unknown.
Immediately after receiving HPV number two patient became lightheaded, nauseated, dizziness, clammy. Remained so x 20 minutes, VSS 102/60, P 68. Dizziness subsided.
Vertigo; lost of weight because of vomiting; lost of weight because of vomiting; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  Clinical course: 48 hours after receiving first vaccination. Patient got a severe vertigo and last time of this whole time it didn't include probably 60 percent so that time patient could function, patient could walk. Patient had been eating, patient had lost of weight because of vomiting. What patient wanted to know was it was now for end of window for vaccination number two. Patient really whether should get it or not? patient's vaccination going to close in 20 minutes. The outcome of events was unknown.  Information about lot/batch number has been requested.
Pt recvd vax & exp microhemangiomas of the legs w/a very sharp demarcation just inferior to inguinal line; progressively had other hemangiomas;
Right thigh entirely involved w/redness and swelling and some edema around the knee but no induration and no tenderness.
Patient stated no pain upon injections.  Tenderness noted about an hour after vaccination.  Within a couple days (1/8/2016) pain was increasingly sore and shoulder not moving freely.  Pain was keeping patient awake and she saw PCP on 1/20/2016 with chief complaint being left shoulder pain with motion.  Chart notes stated pain primarily just distal to acromion with rotation and extension limited.  XR showed normal joint with amorphous calcification superior to the humeral head which could be hydroxyapatite deposition/ calcific tendinitis. Patient saw an orthopedist and 1/26/2016 and pain was significantly better after Medrol dose pak.  She is currently doing physical therapy to improve range of movement.
p/vax pt devel a full case of varicella & then passed on to cousin who devel full case of varicella;
This spontaneous report was received from a pharmacist and refers to a 61-year-old female patient. The patient's concurrent conditions included hepatitis A and hepatitis B. Her concomitant medications included unspecified treatments to treat those diseases. She did not have pertinent medical history, nor known drug reactions or allergies. On 14-JAN-2017, the patient was vaccinated with a dose of ZOSTAVAX intramuscularly (exact dose, lot # and expiry date were not reported). Subsequently, on an unknown date in 2017, the patient experienced redness, soreness and swelling at the injection site. She had no lab diagnostics studies performed and did not receive any treatment for the events. Product quality complaint was not involved. The outcome of the events and causality between the events and ZOSTAVAX vaccination was not provided. Additional information has been requested.
the vaccine has increased his confusion.; This is a spontaneous report from a non-contactable consumer. A 66-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 30Mar2021 at 10:30 (at the age of 66-year-old), as a single dose for COVID-19 immunisation. Medical history included alzheimer's disease and COVID-19. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included unspecified medications for Alzheimers from an unknown date and unknown if ongoing. On 31Mar2021 at 07:00, the patient experienced increased confusion. The patient previously had COVID and patient had experienced same symptoms. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event increased confusion was not recovered at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Flu-like symptoms; Body shaking; Aches; Fever abates then massive sweating.; High Fever; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 24Mar2021 at 14:15 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Other medical history was reported as none. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included paroxetine hydrochloride (PAXIL) from an unknown date for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9266) via an unspecified route of administration in the left arm on 03Mar2021 at 13:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 at 21:00, the patient experienced flu-like symptoms, high fever, body shaking, aches in the last 2 months, fever abated then massive sweating occurred and the duration per event was 4-6 hours. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of flu-like symptoms, high fever, body shaking, aches and included treatment with acetaminophen/ibuprofen. Since the vaccination, the patient had been tested for COVID-19. On 10May2021, the patient underwent lab test which included rapid test and tested negative. The clinical outcome of the events flu-like symptoms, high fever, body shaking, aches and fever abated then massive sweating occurred was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient's first 2 Covid vaccines were Pfizer.  Her first Pfizer shot was 12/18/2020.  Her second Pfizer shot was 01/08/2021.  I did not have her vaccine card in front of me when I administered the 3rd Covid vaccine. Her 3rd vaccine was administered on 09/09/2021.  She was administered Moderna.  All literature states what you start with is what you should stick with.  She has reported no issues or concerns. Main campus noticed the error and brought it to my attention which is why I am just now reporting.
Headache, Myalgia, Fever, Diarrhea, NauseaVomiting, Chills, fatigue, nausea (no vomiting), very ill X2-3 days but then recovered Narrative:
Pt had flu shot at 1023 and then at 1025 she reported to the MA she had "feelings fo tingling, Shortness of Breath, itching and that her back of tongue felt "itch."" No hives noted. She had visible redness to her neck but no swelling and was given two instant icepacks to the back of the neck and to the decolletag. She was immediately rushed to the ER 30 feet away via a wheelchair and placed in Room 18 where she was given the following medications : IM epinephrine X 1 (0.4mg IM 1:1000 injection), Pepcid 20 mg IV push and Benadryl 50 mg IV push and Decadron 10 mg IV push (per ER RN). Patient reported she self medicated later after discharge she self medicated with oral Benadryl with 25mg evening of 10/8/2020, adds for treatment of mild itching she still had. Saturday 10/9/2020 "she felt better and did not need to take additional medications at home." Sunday 10/10/2020 reported no symptoms
Whole-body hurts; Muscles hurt; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Whole-body hurts), MYALGIA (Muscles hurt) and HEADACHE (Headache) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN (Whole-body hurts), MYALGIA (Muscles hurt) and HEADACHE (Headache). At the time of the report, PAIN (Whole-body hurts), MYALGIA (Muscles hurt) and HEADACHE (Headache) outcome was unknown. Not Provided          No relevant concomitant medications were reported. No treatment information was provided by reporter.   Reporter did not allow further contact
This case was reported by a pharmacist and described the occurrence of cough in a pt who received Engerix-B for prophylaxis. In 1/04, the pt received the initial dose of Engerix-B. During the month following vaccination, the pt experienced cough which required medical attention in a doctor's office. The event was unresolved at the time of reporting in 2/04.
Injection site pain, redness, swelling continues today.   Nausea, chills, muscle ache, headache for first 24 hours. Headache continued for  another 16 hours.
Pt reports worsening of psoriasis (reports was clear prior to vaccine)  and GI upset including emesis
Is it normal to get a rash around the breasts after the COVID Vaccine; itchiness; This is a spontaneous report from a Pfizer sponsored program COVAX US Support from contactable consumer (patient). An unspecified age of female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: not reported), via an unspecified route of administration on an unspecified date as a Unknown, single dose for COVID-19 Immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced rash around the breasts after the COVID Vaccine and itchiness. The outcome of the events was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
After taking the first dose of GARDASIL, my daughter discovered two bald patches missing from her head.  She also had a huge rash - the size of an adult hand - on her inner thigh.  After receiving the second dose of GARDASIL she has discovered another patch of hair missing, and two new rashes one on the back of her thigh and one on her elbow.  She is also extremely tired, when riding in the car she hardly keep her head up.  This child is not a sickly individual, and has energy for days before taking this vaccine. Follow-up: Make sure you question the side effects. Everything about this drug was not disclosed before receiving.