chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client reported two days after the vaccine he developed a fever. The client stated one week after the vaccine he developed a stiff neck and joint pain that lasted 3 days. The client stated he consulted with his friend who is a doctor who said the client, "almost had a stroke." The client was not formally diagnosed or prescribed any medications for his symptoms. The client denied any tingling, difficulty speaking, walking, or with facial movements. The client stated his friend who is a doctor recommended against receiving the 2nd COVID vaccine Pfizer. The client did not consult with his PCP.
Pt became very ill immediately following vax.Fever,irritability, fatigue,disorientation,& diarrhea.After 4/22/97,pt dvlped severe gastro. sx w/ bouts of diarrhea & constipation; also pt never used language again.Dxed w/ autism in 1998.
Patient returned to Health Department 10/25/2022 reporting a "sore" at site of injection.  Upon inspection, noted a fluid-filled blister approximately 1/4" long and less than 1/8" wide on left deltoid area; a small amount of redness was also noted around the blister.  Patient reported that he had left the bandaid over the injection site intact until the morning of 10/25, when he removed it.  It was then that he noticed the blister.  He denied any itching or pain at the site.  Advised client to loosely cover the area to protect it, and to let the Health Department know if it worsened.  Followed up with patient 10/26/2022 - he reported that the blister "popped" during sleep and a small amount of fluid came out.  He reported that the site is now clean and is healing well.  He denied any further problems.  He was advised to notify the Health Department if he had any further problems.
Pt recv vax on 4/6/99; 3 hr post vax pt exp red/ itchy/ blotchy rash on trunk, back, arms, legs, feet; tx=Benadryl, Atarax, Prednisone
Swollen tense, red left upper arm below injection site to elbow. Started 24 hours after vaccine. Resolved in 3 days.
fluzone qiv t that causes a lot of bubbles when it was inverted to draw out doses, 6 vials have been given to patients with no reported adverse event; Initial information was received on 04-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who reported that influenza quadrival a-b multidose vaccine preserved fluzone qiv t that causes a lot of bubbles when it was inverted to draw out doses, 6 vials have been given to patients with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a unknown dose of suspect influenza quadrival a-b multidose vaccine preserved (lot U890BA, Expiry date : 30-Jun-2024, strength was unknown) via unknown route in unknown administration site for Immunization.  On an unknown date the patient developed a non-serious event of fluzone qiv t that causes a lot of bubbles when it was inverted to draw out doses, 6 vials have been given to patients with no reported adverse event (poor quality product administered) (unknown latency) following the administration of influenza quadrival a-b multidose vaccine preserved.  Reportedly "HCP called to report 50 vials of FLUZONE QIV T that appeared to be bubbly or soapy when it was inverted to draw a dose. Caller mentioned that the syringe was hard to push and that 6 vials have been used. Patient information was not obtained during the call. Caller wanted to know if it was still good to use. Caller mentioned that 6 vials have been given to patients. Patient information was not obtained during the call. Call got disconnected."  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event "poor quality product administered".  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 the 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.
Fever of 102.9, left side chest pain, shortness of breath, chills, physical inability to get out of bed, overall body ache, body pain at a level 8. Light headedness, night sweats, insomnia, headache, inability to move left arm above breast level, numbness in left fingers, sharp pain in right side of chest.
PNEUMOVAX given in L deltoid - whole upper arm red, swollen and painful. Is being treated
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. No pertinent or historical conditions were reported. On unspecified dates starting on or after 21-OCT-2015, the patients were administered an unspecified number of improperly stored doses of RECOMBIVAX HB (lot# L016959, expiration date 12-MAR-2018, strength, dose and route unknown). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Feeling chills; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05May2021 at 13:45 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. The patient has not reported any other health issues. The patient had no known allergies. Concomitant drugs included vitamins (MANUFACTURER UNKNOWN) for unspecified indication from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06May2021 the patient experienced feeling chills and body aches. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The clinical outcome of the events feeling chills and body aches was unknown at the time of report.   No follow-up attempts are possible, information about lot/batch number cannot be obtained.
0.5ml Fluzone TIV Flu given in the Left arm. A few hours after the vaccine was given, mom reports that his whole upper arm, side of neck and left side of chest and back swelled up and became red and itchy.  Mom gave Benadryl and symptoms improved. No shortness of breath or respiratory symptoms noted.
A 30 year old male with a history of 2 or 3 smallpox immunizations during childhood and "no takes" was vaccinated on 11/5/01 (signed in to clinic at 08:45, 19th pt of the day). Past medical history remarkable for 2 previous episodes of cellulitis following fairly minor skin trauma. On day 2, post vax, he developed a fever (99.0F-102.7F per vaccine adverse event card) which persisted until day 12. Also noted malaise, headache and chills. Nurse's note on day 5 describes above, plus "vaccinoid" response. Employee phoned clinic on 11/15/01 complaining of flu-like illness and temperature to 103.7F in the past 24 hours. When seen at the clinic that afternoon, he was noted to have a temperature of 100.6F and tachycardia. A 1.5cm scab c/w primary vaccine response was noted, with 8cm X 10cm area of surrounding erythema and induration. No drainage or lymphangitic streaking were noted. Site was unroofed with sterile needle and small amount of serous drainage was collected on sterile swab (culturette). Bacterial culture showed no growth. Employee was treated for presumed cellulitis with Rocephin, 1gm IM, plus cephalexin 500mg BID. Upon recheck the following AM, pt was afebrile and tachycardic and induration at site had resolved without any change in area of redness. Contact on 11/17/01 and 11/18/01 by phone revealed no further report of fever and continued resolution of soreness and redness. Recheck on 11/19/01 revealed well-scabbed primary reaction without surrounding inflammation. Temperature was 98.2F and pulse was 68. No complaints since that time. Clinical dx: probable cellulitis plus vigorous primary response to vaccine.
Within 2 minutes after COVID vaccine first shot I felt a flushing sensation and began developing heart palpitations. It lasted about 5-8 minutes. I sat down for 15 minutes as required by the clinic for all those getting shots.  After about 8 minutes heart stopped racing and slowly got back to normal.  It did not appear to be caused by anxiety. I did not report it to the clinic staff.  In researching this allergic reaction is likely related to Polyethylene Glycol allergy.  When I got a colonoscopy a few years ago I used colo prep.  Back then my heart was pounding hard the night before and the day of the examination.  I did not know it was a side-effect from the solution.  Doctors could not explain why my heart rate was high but went ahead with the exam. With the current event it appears is the common link between then and the COVID vaccine.
Presented to ED w/SOB; admitted for COVID-19 pna & acute resp failure w/hypoxia; tx w/02, steroids, abx, zinc; dc home w/O2
This spontaneous report as received from a medical assistant refers to a patient of an unknown age and gender. The patient's medical history concurrent conditions and concomitant medications were not reported. On 06-JUN-2016, the patient was vaccinated with an improperly stored dose of PROQUAD lot # M001152 (dose, expiration date and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
chest palpitations; feeling exceptionally tired/fatigue; headache; brain fog; out of breath easily; sweated a lot; Sweeping the floor or wiping the refrigerator was laborious for me; This is a spontaneous report from a contactable consumer (patient). A 29-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0158), dose 1 via an unspecified route of administration, on 07Apr2021 at 04:15 PM (at the age of 29-year-old), in Left arm as dose 1, single for COVID-19 immunization. Medical history included penicillin allergy. Concomitant medication included TYLENOL taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. On 09Apr2021 the patient experienced chest palpitations, feeling exceptionally tired/fatigue, headache, brain fog, out of breath easily, sweated a lot, sweeping the floor or wiping the refrigerator was laborious for me. The patient did not receive any treatment. Outcome of the events was recovered on an unspecified date of 2021.  Follow-up attempts are completed. No further information is expected.
Redness + swelling + irritation on left arm where Shingrix was administered, area approximately 8" diameter. Pt required antibiotics for possible cellulitis. Pt. also experienced general malaise.
Chest pain; itching; because it occurs at night now waking her up; This case was reported by a consumer via call center representative and described the occurrence of chest pain in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included itchy rash (noted 5 to 6 years ago a rash with itching that eventually went away, the cause was unknown.). Previously administered products included Shingrix with an associated reaction of chest pain (received 1st dose in June 2019, refer case US2020AMR076066.).   In August 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced chest pain, pruritus and sleep disturbance. The patient was treated with camphor, levomenthol, phenol (Sarna), non-drug therapy (Ice Pack (No Medication)) and topical steroid nos (Steroid Cream). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the chest pain was recovered/resolved and the outcome of the pruritus and sleep disturbance were not recovered/not resolved.   It was unknown if the reporter considered the chest pain, pruritus and sleep disturbance to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix in the left arm and had chest pain. She stated it was the same location, EKG (Electrocardiogram) was negative again and resolved quickly. She noted with the second dose she also had itching on her back from the neck to her buttocks and in the front from her neck to the top of her legs. She has seen a Dermatologist, who has prescribed steroid cream that helps but the itching returns. She feels the itching was getting worse, because it occurs at night at the time of reporting waking her up. She stated that she gets temporary relief with Sarna and ice packs. This past Saturday night she was in tears with the itching.  The reporter consented to follow up. Emergency room visit required. The caller was open to receiving authorization form, she wanted to think about it and did not provide HCP info with this call. There is discrepancy between the outcome reported in the structured field of database (not recovered) and the outcome reported in the source document (RESOLVED WITH SEQUEL).      Lab Comments: lab test performed on unknown date.
bruise on the forearm; lump under the right armpit; chills (patient had to wear sweat pants); really bad bone pain; arms in a lot of pain radiating towards breast, then underneath armpits; arms in a lot of pain radiating towards breast, then underneath armpits; weak; loss of appetite; really tired; fatigue; nausea; pain in the right shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak), DECREASED APPETITE (loss of appetite), BONE PAIN (really bad bone pain), BREAST PAIN (arms in a lot of pain radiating towards breast, then underneath armpits) and CONTUSION (bruise on the forearm) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02SC21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included ASA for Anticoagulant therapy, LISINOPRIL for Blood pressure management.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced ASTHENIA (weak), DECREASED APPETITE (loss of appetite), FATIGUE (really tired), FATIGUE (fatigue), NAUSEA (nausea) and ARTHRALGIA (pain in the right shoulder). On 08-May-2021, the patient experienced BONE PAIN (really bad bone pain), BREAST PAIN (arms in a lot of pain radiating towards breast, then underneath armpits), CHILLS (chills (patient had to wear sweat pants)) and AXILLARY PAIN (arms in a lot of pain radiating towards breast, then underneath armpits). On 09-May-2021, the patient experienced CONTUSION (bruise on the forearm) and MASS (lump under the right armpit). At the time of the report, ASTHENIA (weak), DECREASED APPETITE (loss of appetite), BONE PAIN (really bad bone pain), BREAST PAIN (arms in a lot of pain radiating towards breast, then underneath armpits), CONTUSION (bruise on the forearm), MASS (lump under the right armpit), CHILLS (chills (patient had to wear sweat pants)), FATIGUE (really tired), FATIGUE (fatigue), NAUSEA (nausea), ARTHRALGIA (pain in the right shoulder) and AXILLARY PAIN (arms in a lot of pain radiating towards breast, then underneath armpits) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, COVID-19: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication included Ibuprofen and Tylenol.
Lisbeth was registered as a Pfizer 5-11 via front desk,  one dose of Pfizer 5-11 was administered by vaccine lead.
This case was reported by a pharmacy via a pharmacy claims management company and described the occurrence of adverse reaction in a male subject of unspecified age who was vaccinated with FLULAVAL TETRA (GlaxoSmithKline). On 6 January 2014 the subject received a dose of FLULAVAL TETRA (unknown details). At an unspecified time after vaccination with FLULAVAL TETRA, the subject experienced adverse reaction. At the time of reporting the outcome of the event was unspecified.
Ringing in ears, dizziness, clogged ears started 7 hrs after vaccine and has not resolved.  Please tell me this will go away and it?s not permanent!!
The evening of the day of vaccination, there developed a red, hard, warm area on the ant/lat R thigh, with pain on palpation and difficulty ambulating.  By 02/07/05, he was walking normally, had no pain to touch, and had a mildly pink and indurated area at site.
ADVERSE EVENTS: "DIZZINESS, FAINTING, NUMBNESS" EMS TRANSPORT
Sudden swelling & redness of the thigh up to knee.  No fluctuation increased redness no pain or fluctuation.
Unusual behavior ( I passed out in a restaurant immediately following us both receiving the vaccine. Her response was totally different than her usual reaction to a stressful situation.). The next day, 02/02/2023, she began shedding hair. Within 3 weeks she had lost all of her body hair, scalp, eyebrows, eyelashes, nose hair,etc.  This has caused her incredible stress and emotional pain. The hair has not yet returned. She has undergone numerous tests and seen several different doctors, as yet to no avail.
Herpes zoster diagnosis in Zostavax recipient. Burning tingling rash on right side of neck. Flu-like symptoms x 3 days. No pain, no blistering. Hx of varicella at age 6. Hx of herpes zoster in fall 2012. Treated with Valtrex.
Pt recvd 2 doses of Engerix-B w/no reaction p/1stdose; w/in 36 hrs of 2nd dose devel hives on chest & abdomen (not very itchy); described as red blotchy areas w/white center; visited private MD;
Pt was given a flu shot for over 36 months and pt is under 36 months. Pt's mother had given him TYLENOL.
only the diluent portion of Pentacel was administered to patient, with no reported adverse event; Initial information regarding an unsolicited valid non-serious case from other health professional via Global Medical Information (GMI) (Reference number- 00667263) and transmitted to Sanofi on 02-Jul-2021 and live follow up received on 06-Jul-2021.  This case involves a 14-months old female patient who only had the diluent portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE INJECTION [PENTACEL] was administered (product preparation error) on 02-Jul-2021 (lot number: U6940BA and expiry date: 21-May-2022) at a dose of 0.5 ml via unknown route in the left thigh for prophylactic vaccination.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  Medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13), ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and HEPATITIS B VACCINE (HEP [HEPATITIS B VACCINE]).  It was a case of an off-label use and active ingredient not added to diluent (latency same day).  At the time of report, no adverse event was reported.  It was unknown if there were lab data/results available.  Disclaimer: 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 the 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.
Right eyelid swollen shut. running and watery eyes very itchy. 3rd still swollen
Client became pale, dizzy, diaphoretic and vomited.  Did NOT lose consciousness.  Client given juice and crackers after event and kept for thirty minutes.  Client was escorted via W/C by RN and sent home with Mom.
This spontaneous report as received from a nurse refers to a patient of unknown age and unknown gender. The medical history and concurrent conditions of the patient were not provided. On 14-JAN-2013 and 22-AUG-2013, the patient was vaccinated with GARDASIL (lot # and expiration date unknown). On 04-DEC-2015, the patient was vaccinated with GARDASIL 9 (lot # and expiration date unknown) and an unspecified image of GARDASIL (unknown if it was GARDASIL or GARDASIL 9). No adverse symptoms reported. Additional information has been requested.
blood oxygen level dropped; chills and shaking; severe coughing; chills and shaking; profound leg weakness; This is a spontaneous report from a contactable consumer (patient). A 98-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Right arm (at age of 98-year-old) on 19Feb2021 at 12:30 PM as a single dose for COVID-19 immunisation, lot number: EL9267. Medical history included normal incident to old age. Patient had no known allergies. It was reported that patient received other medications in two weeks prior to the vaccination, no further details provided. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. On unknown date in Feb2021 at 10:30 PM patient experienced severe coughing, chills and shaking, blood oxygen level dropped, profound leg weakness. Events resulted in Doctor or other healthcare professional office/clinic visit, life threatening illness (immediate risk of death from the event). Patient was treated for the events, hospice was called, oxygen machine was attached. Patient was not tested for Covid post vaccination. Patient was recovering from the events, at the time of the report.
After my 1st dose, I experienced swollen lymph node to my left clavicle. It was over 1 inch  in diameter, it was big and painful and vey irritated.  Today the swollen lymph node is  still present.
Dizziness; Diarrhea; Sore Arm; Headache; Fatigued; Chills; This is a spontaneous report from a contactable healthcare professional.  A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), intramuscular at the left arm on 31Dec2020 13:00 at a single dose for COVID-19 immunization at a hospital.  The patient's medical history and concomitant medications were not reported.  The patient experienced dizziness, diarrhea, sore arm, headache, fatigued, and chills on 01Jan2021. The patient did not received any treatment for the evets. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has been tested for COVID-19 via a blood test in Jan2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks. The patient recovered from the events on an unknown date in Jan2021.