chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extensive pruritic rash on arms, legs abdomen Started immediately and has lasted into April.
All over body itching requiring 5 days antihistamines, syncope lightheaded leading to faint
antibiotic for skin condition; This is a spontaneous report from a contactable male consumer (patient) via Pfizer-sponsored program. A male patient of unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number not reported), via an unspecified route on an unspecified date in Jan2021, as a 1st Dose, Single Dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient stated that he received his 1st dose last week, today he was prescribed an antibiotic for skin condition and wanted to know if it was advisable to wait to finish the 2nd dose before taking the antibiotic. The outcome of the event was Unknown.    Follow-up attempts are completed. Information on the lot/batch number has been requested.
Left arm extremity sore, sore knees, fever, fever blisters, extremely sleepy, extreme fatigue, annoying headache, glossy eyes, blurred vision, aching bones all over,   I exercised  mildly by walking after 2pm on Thursday shot by visiting memorial park and shopping.   At 2am on Friday I awoke to headache and achy bones   I took Tylenol 2 tablets and felt okay but at 9 am was feeling worse. And extremely sleepy.  Took some dose of Tylenol and slept for 5 hours   straight. Drank ginger ale for mild nausea.  No appetite until Saturday.   Felt good all day but achy at night.  Especially knees.
Initial unsolicited report received from a nurse on 20 October 2015. This case is linked with 2015SA169848, 2015SA169857, 2015SA169859 and 2015SA169870. This case involves a female patient (age not reported) who was vaccinated with a dose of FLUZONE QIV (single dose) (batch number: U5321BA, expiration date: 30 June 2016, dose, dose number, route and site of administration were not reported) on 13 October 2015. The patient's medical history and concomitant medication were not reported. On an unspecified date, following the vaccination, the patient had developed rash and localized reaction. Laboratory investigation and corrective treatment were not reported. The outcome of the events was not reported. Follow up information received from nurse on 30 December 2015. The patient's age was reported as 64 years at the time of event. Patient had medical history of menopause, hypertension, vitamin D deficiency, diabetes mellitus type 2, gastroesophageal reflux disease. The patient had tiredness, light headed, heart pounding and racing when she had not taken the ZIAC for two days in October 2014. Patient had sinus pressure, drainage and cough in March 2015. Patient also had history of left otitis media with effusion on unknown date. Allergies to drugs, food or chemical were reported as none. Patient reported that diabetes was under control. Patient did not have any reaction to previous vaccinations. Family history reported that patient's mother had diabetes and sister and father had cancer and nephew had diabetes and cancer. Concomitant medication included ZIAC 10-6.25 mg tablet advised to take 0.5 tablet by mouth daily, dispersion, Rfl:, PRINIVIL 20 mg tablet advised to take 1 tablet by mouth daily, dispersion: 30 tablets Rfl:5, GLUCOPHAGE 500 mg tablet advised take 1 tablet by mouth daily with breakfast, dispersion Rfl:, PREMARIN 0.9 mg tablet advised to take 1 tablet by mouth every day, dispersion:30 tablet Rfl: 11, ZANTAC 150 mg tablet advised to take 1 tablet by mouth 2 times daily, dispersion: 60 tablets Rfl:, 5 Blood-glucose meter (RELION PRIME), for use with twice daily glucose testing Dx:250.00, dispersion: 1 each, Rfl:0, Blood sugar diagnostic (RELION PRIME) strip, for twice daily glucose testing Dx:250.00 Dispersion:100 strip, Rfl:1, Cholecalciferol, vitamin D3,(VITAMIN D3) 5,000 unit oral tablets advised to take 1 tablet by mouth daily, dispersion 100 tablet Rfl:0, OS-CAL-500 plus D 500 mg(1250 mg)-200 unit oral tablet advised to take 2 tabs by mouth daily,Dispersion, rfl, centrum and biotin. Patient was given 0.5 ml of FLUZONE QIV intramuscularly in left deltoid. On 13 October 2015, same day following vaccination patient experienced left frontoanterior pain, left frontoanterior edema, minimal and was warm to touch and red. Laboratory investigations and corrective treatments were not reported. Follow up information received from nurse on 20 May 2016. No additional information has been provided. List of documents held by sender: none.
Swollen right arm, swollen lymph nodes in armpits (both side), sore and stiff right arm, fatigue
Description: Joint pain reported by pt. Symptom: Joint Pain, multiple joints Comment: 719.49
Patient describes onset of stiffness and soreness in right neck with 99 degree temperature. (Vaccine administered left deltoid). Continued soreness in right neck 1/24/2010.  Increased to throbbing and pulsating sensation in right neck, unrelieved by Ibupro.  Seen at Urgent Care Center on 1/28/2010 for swollen glands, antibiotics prescribed. Seen at Emergency Room for fever of 103-104 degrees and continued pain and swelling in neck.
Administerd vaccine that was not stored in recommended temprature; A report was received from a health care professional concerning a 46-year old patient participating in the mRNA-1273 Emergency Use Program who was administered vaccine that was not stored in recommended temperature.  The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient received their first of two planned doses of mRNA-1273 (Lot 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection on 21 Dec 2020. On the same day, the nurse noticed administered vaccine was not stored in recommended temperature. Temperature reading of -21.6 and -20.9 ranges were in Fahrenheit instead of Celsius as the freezer reading was set to Fahrenheit. The nurse called to inquire whether the vaccine is usable. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered vaccine that was not stored in recommended temperature, was unknown.   The reporter did not provide an assessment for the event of administered vaccine that was not stored in recommended temperature.; Reporter's Comments: This case concerns a 46-year-old patient who received their first of two planned doses of mRNA-1273 (Lot 011J20A), reporting Product storage error without any associated adverse events.
Sore injection site; Fatigue; Tightness in chest; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient 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 in Aug2021 at 18:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within two weeks of vaccination. On an unknown date in Aug2021 at 03:00, the patient experienced sore injection site, fatigue and tightness in chest. The events did not result in a visit to the doctors or other healthcare professional office/clinic, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore injection site, fatigue and tightness in chest were not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Client received his vaccination during a drive though clinic. Immediately after receiving his vaccine he developed lightheadedness and dizziness. Client did not experience syncope. A paramedic was on site and assessed client at 1250. Client did not require medical intervention . He was offered water and his dizziness was resolved by 1300. HR was 72 . Client was able to drive out of the parking lot by 1305.
HPV vaccine used for hands warts; This literature marketed report has been received from the authors of the published article, titled as stated above concerning a 50 year old male patient. The patient's pertinent medical history included therapy with liquid nitrogen, curettage and topical fluoracil (reported as 5-FU). The patient's current conditions and concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) for hands warts (product use in unapproved indication) (strength, dose, frequency, route of administration, lot number and expiration date were not reported).   The authors informed that on an unspecified date, the patient died due to natural causes.   A copy of the published article is attached as further documentation of the patient's experience.   This is one of several reports received from the same literature.  Sender's Comments:  US-009507513-1912USA001729:
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hyperventilation-Medium, Systemic: Nausea-Medium, Systemic: Visual Changes/Disturbances-Mild, Systemic: Vomiting-Medium, Systemic: Weakness-Medium
Body aches after 2nd dose; Felt bad after the 2nd dose; Chills after 2nd dose; Fatigue after 2nd dose; May have had a fever after the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches after 2nd dose), FEELING ABNORMAL (Felt bad after the 2nd dose), CHILLS (Chills after 2nd dose), FATIGUE (Fatigue after 2nd dose) and PYREXIA (May have had a fever after the 2nd dose) in a 20-year-old female patient 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Body aches after 2nd dose), FEELING ABNORMAL (Felt bad after the 2nd dose), CHILLS (Chills after 2nd dose), FATIGUE (Fatigue after 2nd dose) and PYREXIA (May have had a fever after the 2nd dose). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Body aches after 2nd dose), FEELING ABNORMAL (Felt bad after the 2nd dose), CHILLS (Chills after 2nd dose), FATIGUE (Fatigue after 2nd dose) and PYREXIA (May have had a fever after the 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Noted in patient's visit summary, after administration of the vaccines, patient was witnessed by his mother and the MA to "Seize" while sitting up on patient bed, and then collapsed off bed to the floor. He was reported to hit his left shoulder and head on the ground. He then regained consciousness. Pt states that he just remembers getting the injection and then waking up on the floor. No post-ictal period. no confusion. Bruise noted on left parietal scalp, no laceration. Glucose checked in clinic and is within normal limits. patient was given juice, water, and crackers. He was observed for 45 minutes before discharge. mother was counseled about strict ED precautions.
This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with PNEUMOVAX23. The dose number, dose, lot number and expiry date were not reported. On an unknown date the patient experienced pneumococcal disease (hospitalization and life threatening). The patient was hospitalized for an unknown amount of time and hooked up to a ventilator. The reporter considered the event to be life threatening. The reporter stated that PNEUMOVAX23 is not working, the drug is like a placebo. The outcome of pneumococcal disease is unknown. This case was linked to case 1307USA002815, based on the same reporter. Additional information has been requested.
This spontaneous report received from a patient concerned multiple patients. No medical history, concurrent conditions or concomitant medications reported. The patient received the COVID-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch/lot# unknown/not reported), start therapy date not reported, for immunization. Per procedure no follow-up will be requested for this case. On an unspecified date, patients contracted COVID-19, with outcome of recovered. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable.
Initial misuse report received from a healthcare professional on 29 May 2013. It was reported that a female patient had received YF vaccine 21 days after receiving varicella vaccine. No adverse event was reported. List of documents held by sender: none.
05/03/2021 Paresthesias both feet, weakness lower extremities. Increased heart rate. Shortness of breath when recumbent. Ataxia.  05/07/2021 Paresthesias both hand, fasciulations,  tremors   05/21/2021 Evaluation by neurologist, Dr. Diagnosis
p/vax pt T104; pt taken to ER;has not been taking much po since evening;given some motrin;pt ingesting po fluids w/o problem;disch to f/u w/regular MD; tx: plenty fluids & tylenol for fever;impression: viral syndrome
Severe fever, throbbing headache, dizziness, mild hallucinations. Started about 9 hours after vaccination, fever diminished after about 2 hours. Other symptoms lasted most of the night.
No additional AE reported; 9 Month Old Patient was administered GARDASIL 9 by Unknown Healthcare Professional on 12/30/2022; This spontaneous report has been received from a Healthcare Business Professional who was in charge of vaccine storage/stability, concerning a 9-month-old patient of unknown gender.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 30-DEC-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, lot number, expiration date, route of administration, and anatomical location were not provided) as prophylaxis (Product administered to patient of inappropriate age).  No additional adverse events (AEs) were reported. No further information was provided.
mom states about 1 1/2 hrs pp/vax pt eyes rolled up into head & was very tired;
Redness w/ in 2 hours after vaccination, w/ in 24 hours larger area of redness and swelling 5"x4", movement away from injection site.  Tender to touch.  Burning sensation.  Arthus reaction.
Noted wheal like blanching below injection site on right thigh; area around injection site turned bright red; benedryl given per Provider request
Low grade temp chills muscle aches sore arm and lacey rash on chest for about 36 hours. Onset was about 14 hours after injection
Tinnitus right ear-moderately to severe - still going on sometimes very loud and unbearable. No treatment for it.  Swollen, aching joints in knees and back- moderate at first lasting 7 days- mild as of today but still there. Tylenol.  Covid arm- Moderate for 7 days, redness, pain, swelling, itching. Today it is mild red and itchy day 8. Benadryl, Tylenol  Fatigue- Moderate for 7 days. Mild as of today.  Most concerning is the Tinnitus.
01-28-2021  Hard to breath, wheezing and hyperventilating, finger, lips, and toes turned blue, severe headache and ringing tinnitus, fever up to 102, about 2in diameter red spot below injection site. All over body/muscle soreness and irritability to being touched by anything. Unable to sleep at all  Took ibuprofen  naproxen , benedryl   01-29-2021  Breathing returned to normal, fever 100-99 for entire day and all over body/muscle soreness and irritability to being touched by anything and red spot remains Took ibuprofen , naproxen , benedryl   1-30-2021 Fever gone, soreness mostly gone, red spot remains
Information has been received from a registered nurse through the manufacturer pregnancy registry concerning a 26 year old female patient, with a "history of asthma in 1999," who on 30-NOV-2006 was vaccinated with the first dose, 0.5ml, of Gardasil. The nurse stated that the patient reported she was "5 weeks pregnant" on 30-JAN-2007. Pregnancy was confirmed via pregnancy test (not specified). The approximate date of conception was 26-DEC-2006, with an estimated due date of 02-OCT-2007. On 22-FEB-2007, at approximately 8 weeks of pregnancy, the patient "had a miscarriage." The patient went to the emergency room (ER) on 22-FEB-2007 due to the miscarriage, but she was not admitted. On 23-FEB-2007, the patient had a dilatation & curettage (D & C) performed. The nurse reported that the patient "was not seen in the physician office for her pregnancy," and added that she "had recovered from the events" (date not specified). Upon internal review, miscarriage was determined to be an other important medical event. Additional information has been requested.
Metallic Taste in Mouth; Sweating; Vertigo; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 40-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Brand: Pfizer), dose 1 via an unspecified route of administration in Arm Left on 29Mar2021 16:30 (Lot number and expiry date was not reported) as single dose for covid-19 immunisation.  Medical history included hypersensitivity from an unknown date and unknown if ongoing Allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. Prior to vaccination, was the patient diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 29Mar2021 16:45, the patient experienced metallic taste in mouth, sweating and vertigo. Therapeutic measures were not taken as a result of adverse event. The outcome of the event was recovered on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Information has been received from a RN concerning a 37 year old female with an allergy to PCN, erythromycin, Biaxin, and a possible allergy to Motrin who on 05/21/04 was vaccinated with pneumococcal 23v polysaccharide vaccine.  On 05/21/04 the pt developed a local reaction of redness and swelling of left tricep. "By next day", on 05/22/04, the pt developed severe malaise, severe headache, chills, body aches, fever of 102.5, speech difficulty and confusion. The physician prescribed prednisone (1 1/2 20mg tablets twice daily and then decreased dose to one 20mg tablet twice daily for 4 days after).  The pt had a follow up visit at the doctor's office and was improving. No product quality complaint involved. Additional information has been requested. Follow-up information received. The patient recovered.  No further information is expected.
Pt presented to clinic 7 days post vaccination complaining of symptoms at injection site that developed 5 days post vaccination. Noted erythema, edema, tenderness gradually increasing in size until clinic visit. PE - 13 cm x 9.5 cm circular, indurated, erythematous lesion on (R) deltoid. Tx: (1) Rocephin 1 mg IM x 1, (2) Clindamycin 400 mg qd x 10 d, (3) Benadryl PRN.
got the shots and still got/Suspected Vaccination failure; one of the worse pain I vert had; and still gotand still got; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 70-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got the shots and still got/Suspected Vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: and still gotand still got) and pain (Verbatim: one of the worse pain I vert had). The outcome of the vaccination failure was unknown and the outcome of the shingles was resolved (duration 3 months) and the outcome of the pain was not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 25-MAR-2023 The case was received from the patient  interactive digital media. The patient stated that his/her was really bad got the shots an still got at 70 which lasted for three months and it was one of the worst pain, he/she ever had. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Diagnosed with Acute Lymphoblastic Leukemia (ALL) on 12/31/2009.
NO ADVERSE REACTIONS REPORTED OR DOCUMENTED FROM TIME OF VACCINE ADMINISTRATION TO DATE OF DEATH
Patient complained of  about 5 minutes of her bicep twitching . It started about 2:25 pm subsided approximately 2:33 pm. No other complaints. BP 125/88, P-100 and RR 20. Feels well enough to leave.
Body aches (particularly in all joints), crushing headache with intermittent nausea; Body aches (particularly in all joints), crushing headache with intermittent nausea; Body aches (particularly in all joints), crushing headache with intermittent nausea; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 36-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Apr2021 13:45 (Lot number: EP-6955) at the age of 36 years as dose 2, single and administered in arm left, administration date 10Mar2021 10:00 (Lot number: EL-3247) as dose 1, single for covid-19 immunization.   The patient's relevant medical history was not reported. Concomitant medication(s) included: fluoxetine and multivitamin [vitamins nos].  The following information was reported: PAIN (non-serious), HEADACHE (non-serious), NAUSEA (non-serious) all with onset 02Apr2021 02:30, outcome "recovered" and all described as "Body aches (particularly in all joints), crushing headache with intermittent nausea". Therapeutic measures were taken as a result of pain, headache.  No follow-up attempts are possible. No further information is expected.  Additional information: the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for covid-19 since the vaccination. The patient received treatment for the adverse events with Ibuprofen. The patient had allergies to medications, food, or other products.
Erythematous round lesions with central scabs c/w varicella on trunk and 4 extremities face, scalp one lesion above BV area and on left thigh have upper erythematous margin. No d/c concerning of early cellulitis treated with Augmentin.
Four to five pt rec'd 3 engerix-B shots; Had a needlestick & when titers were checked none of the patients had titers;
31OCT91 site soreness, sl achey (no fever); 1NOV91 more achiness, extreme sensitivity to cold, achey joints; 2NOV91 general aching, joint aches-back, knees, ankles, awakened w/h/a; 4NOV91 fatigue & congestion of throat & chest (no cough);