chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 15 year old female patient who on 23-JAN-2007 was vaccinated IM with a first dose of Gardasil, lot#654702/0011u. On an unspecified date, the patient received the second dose of Gardasil, lot #656372/0243U. 10 days after the first injection (on 02-FEB-2007) the patient developed fever of 103F. She developed fever of 103F 6 days after her second dose of Gardasil. The patient recovered completely after the first dose and the status was unknown after the second dose. Medical attention was sought. Additional information has been requested.
Chills; fever; fatigue/tiredness; headache; body aches; diarrhea; nausea; This is a spontaneous report from a contactable pharmacist (patient).  A 54-year-old female patient received her first dose of BNT162B2 Lot # EJ1685, via an unspecified route of administration at Arm Left on 30Dec2020 11:00 at single dose for COVID -19 immunization.  Medical history included Hypothyroid. She was not pregnant. There were no known allergies.  Concomitant medication in two weeks included levothyroxine, mometasone furoate (FLONASE), ibuprofen, iron, biotin, and unspecified "B". The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Started 03Jan2021 10:00 AM, the patient experienced chills, fever, fatigue, tiredness, headache, body aches, nausea, diarrhea resulted in [Doctor or other healthcare professional office/clinic visit]. No treatment was received for all events. The patient did not have Covid prior vaccination and Covid was not tested post vaccination.The outcome of all the events was not resolved. The pharmacist considered all the events as non-serious.
2 patient's received expired vaccines; This spontaneous report as received from a nurse referring to two patients of unknown age and gender. Information regarding patients concurrent  conditions, concomitant medications, drug allergies or reactions was not provided.     On 10-NOV-2020, the patients were vaccinated with a expired hepatitis a vaccine, inactivated(VAQTA) for prophylaxis, lot # S032056 which has been verified to be valid for hepatitis a vaccine, inactivated and expiration date 09-NOV-2020 (strength, dose, frequency, and administration route were not provided). The outcome of expired product administered was unknown. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S032056; expirationdate: 09-NOV-2020; deviceage and unit: 0 ; operatorofdevice: Unknown; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
12:45 pm vaccine given on June 28, 2013 1:45 pm symptoms began: itchy eyes, runny nose, photophobia (sens. to bright light) 4:15 symptoms decreased by 70% 6:00 pm symptoms resolved w/o Tx - no hist of UR allergies.
Patient received Moderna COVID vaccine on 2/27/21 (lot # 001A21A), 3/27/21 (lot # 045A21A), and 11/16/21 (lot # 031H21A). On 6/1/22, patient admitted to our inpatient facility with generalized weakness secondary to COVID-19 infection, hyponatremia, and bacteremia secondary to UTI. Patient also tested positive for COVID upon admission as a confirmation. As of today (6/3/22), patient is still admitted in the med/surg unit.
Breakthrough case admission after two vaccines Moderna 1/20/21 Lot# 80777027399;  Moderna 2/1/22 Lot# 012H21B
bulls eye rash on same arm injected; A spontaneous report was received from a 45-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced bull's eye rash on same injected arm/Lyme's disease.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 19 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 02 Feb 2021, 16 days after receiving the vaccine, the patient developed a bull's eye rash on same arm of injection.   On 03 Feb 2021 the patient was diagnosed with lyme's disease. The patient was prescribed a 21-day regiment of doxycycline.   Action taken with mRNA-1273 in response to the events was unknown.   The outcome of event(s), Lyme's disease was unknown.; Reporter's Comments: Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of Lyme's disease is assessed as unlikely related.
Same day of vaccinie at approximately 11:00pm, lymph node in armpit was swollen and patient could not lift arm above head. Mother of child iced and gave ibuprofen. Patient was scheduled to see Doctor on day after vaccine administration. Provider advised to continue with ice and Tylenol and return to clinic if any weakness or unimproved pain in next week or soon if fever or systemic signs of illness appear.
Large area of erythema and induration; almost entire arm (left) from shoulder to elbow. Date of onset-3/14/01.
p/vax that noc mom noticed rash on same leg;saw in MD 6/16/99 5PM;entire rt inner thigh from groin to knee was swollen & red;had temp 100 on 6/15/99;
Pt recvd vax & devel h/a, felt weak & tired; 19DEC92 devel corneal ulcers which persisted; consulted a physician 1 wk prior to christmas who sent pt to an ophthalmologist w/c/o scalp tenderness which began on 30Jan93;also exp pins & needles
Approximately 45 minutes after receiving the vaccine, the patient began to experience severe chills and was shaking uncontrollably.  Shortly thereafter the patient reported the sudden onset of a moderately severe headache. Patient put on additional clothing and got into bed under sheet, blanket and quilt.  Temperature was checked with a scan thermometer. Temperature was 98.8 degrees which is normal for her. Because the patient is diabetic, her blood sugar was checked via finger stick. Blood glucose was 121. One heating pad was placed on torso and one heating pad placed under her feet. Patient was given one 325 mg Tylenol.  After about 30 minutes the chills and shaking lessened. After about an hour, the patient felt normal but tired. About 9 hours later in the middle of the night, the patient woke up with a moderately sever headache. Patient was given one 325 mg Tylenol which seemed to relieve the headache enough for the patient to go back to sleep.
Pt became weak, dizzy, pale and very diaphoretic a few minutes after receiving the vaccine. When further evaluated it was found that he was hypotensive and bradycardic. His blood pressure was initially 77/42 with a pulse of 54 following  the vaccine at 11:21. As patient rested and drank water he was continuously evaluated and his BP increased to 91/53 a few minutes later and then it was up to 111/40 with a pulse of 60 at 11:29. Due to his condition EMS was activated @ 11:27 and they arrived on scene at 11:36 for further evaluation and transport to a higher level of care.
15 minutes post 2nd dose of Moderna COVID Vaccine patient notified nurse that she felt dizzy, nauseated and began to vomit. Pt VS WNL and no other s/sx noted. Patient vomiting intractable and EpiPen 0.3mg autoinjector administered x 1. 911 called and patient transferred to ED for further evaluation and treatment.
onset of sz 2-4 days & ongoing p/vax. Not febrile. No fam hx of sz disorders
Arm Soreness; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date in 2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced arm soreness on an unspecified date in 2021. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Dad states that patient has a 101F fever and sneezing today (8/19/13). Dad did not specify time symptoms occurred.
Pt described having "trouble breathing" approx 10 mins after injection. He reported he walked around & "felt better". Did not call MD.
passed out; felt light-headed; possibly a "light concussion" when fell; a few sore muscles; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), DIZZINESS (felt light-headed), CONCUSSION (possibly a "light concussion" when fell) and MYALGIA (a few sore muscles). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, LOSS OF CONSCIOUSNESS (passed out), DIZZINESS (felt light-headed), CONCUSSION (possibly a "light concussion" when fell) and MYALGIA (a few sore muscles) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) Normal. On an unknown date, Computerised tomogram: normal (normal) normal. On an unknown date, Electrocardiogram: normal (normal) normal. On an unknown date, Magnetic resonance imaging: normal (normal) Normal.         No relevant concomitant medications were reported  Patient reported the nurses at the vaccination facility suggested that  passing out  after vaccination may have been due to not eating enough or maybe anemia.  Patient stated that he was prescribed with strong Advil but  he took over the counter ibuprofen .  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company Comment  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 24May2021 at 12:15 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy and corn allergy. Concomitant medications were not received within two weeks prior to the COVID vaccine. Prior to 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 COVID vaccine. On 24May2021 at 14:15, the patient experienced headache, nausea, dizziness, trouble sleeping, fever, cold sweats, shakiness in hands, pain at injection site, rapid heartbeat, fatigue, coughing, mental fog and light sensitivity. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events headache, nausea, dizziness, trouble falling asleep, fever, cold sweat, shaking of hands, vaccination site pain, heart beats increased, fatigue, coughing, foggy feeling in head and light sensitivity to eye was not recovered at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
the patient developed pain, swelling, and redness around injection site; the patient developed pain, swelling, and redness around injection site; the pain developed pain, swelling, and redness around injection site; altered taste and "food did not taste right"; This spontaneous report has been received from a pharmacist, concerning a 60-year-old female patient. The patient's concurrent conditions included drug allergy to sulfa and penicillin; furthermore, a minor egg allergy. Historical conditions and concomitant medications were not provided.      On 26-AUG-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # S013490 has been verified to be a valid lot number for pneumococcal vaccine, polyvalent (23-valent), expiration date not reported, but upon internal validation established as 06-MAR-2021 (dose, frequency, route and anatomical location were not provided) for prevention of pneumonia.    On 26-AUG-2020, the patient experienced pain, swelling and redness around injection site; furthermore, on the same date, the patient experienced altered taste and "food did not taste right" (taste disorder). The patient did not seek medical attention and did not received any treatment.  The outcome of injection site pain, taste disorder, injection site erythema and injection site swelling was reported as not resolved.  The reporter did not provide a causal relationship between the adverse events and the therapy.  combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: S013490; expirationdate: 06-MAR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Below the bandaid, my arm turned red and warm all the way to the elbow and swelled, particularly my biceps. Very painful. Stayed that way all through Nov 2. It is now Nov. 3 and it is the same, but the redness is not concentrated on the bicep. I have taken ibuprofin and allergy pills.
some skin discoloration; Injection site swelling; injection site pain; This spontaneous report as received from a physician refers to a 15-year-old male patient. There was no information about the patient's medical history, concurrent conditions or concomitant medication.  On 12-FEB-2021,the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)  lot number:16211931 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9); Lot number:16211931 does not match any Company product as confirmed by Lot Verification team, expiration date reported as: 26-JAN-2022) for prophylaxis (dose, and  route were not reported).  It was reported that 2-3 days later, on approximately on 14-FEB-2021 (also reported as on 20-FEB-2021 by the same reporter), he had injection site swelling (Vaccination site swelling) and pain (Vaccination site pain). On 20-FEB-2021, the patient was seen in the office to evaluate injection site swelling. The reporter stated that the site was swollen about 1 cm in diameter, very painful with some skin discoloration, on  20-FEB-2021 (Vaccination site discolouration). No additional adverse event or PQC reported. The patient seek medical attention by office visit. No treatment was given for the events.  The outcome of vaccination site swelling, vaccination site pain  and vaccination site discolouration was not recovered. The causal relationship between the aforementioned event and  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not reported.
Erythema, swelling, warmth and tenderness covering extensive area surrounding the site of injection. Symptoms slight day of injection (6/19/15) and gradually increased until patient sought medical attention on 6/21/15. Patient reports no diagnostic tests were done to confirm infection, but KEFLEX 500mg PO TID x10 days prescribed anyway. I counseled to apply ice.
Received ProQuad 1 and Prevnar 4 on 9/22/06 followed by generalized maculopapular rash 9/23/06.
Roughly 7 hours after receiving vaccine patient complained of difficulty breathing. Per patient's wife/caregiver, patient appeared anxious, skin color appeared abnormal, and pulse was weak and bradycardic (not unusual for patient). Albuterol nebulizer treatment attempted but patient was too anxious to complete. Gave 2 puffs albuterol oral inhaler, and repeated treatment 15 min later followed by a small glass of cola. About 30min later patient calmed, no longer short of breath and pulse strong but face remained flushed. Vitals at 9:20pm included BP 116/47, pulse 67. Following day patient had multiple involuntary diarrheal stools. Symptoms reported to provider 2/8 and noted to be resolved.
On 04/14/2021 this writer received a call from a patient at the Community Clinic re: follow up about a possible adverse reaction that the patient experienced after receiving the second dose of the COVID-19 vaccine on 03/13/2021. Patient stated that the her care giver conveyed that the patient had been experiencing difficulty with lifting her arm since that day the vaccine was administered. The patient has no pain associated with the immobility and it was for that reason that the caregiver did not report the issue until 04/14/2021. This writer to tell the patient and her caregiver to follow up with their PCP should the immobility not improve. This writer also stated that she would report the possible reaction via VAERS. This writer attempted to do so moments ago, but after many reviews of the report, during which all pertinent fields were found to be completed, the system would still not allow the report to be submitted. This writer will attempt report the event at another time
raised, red, very tender, size of fifty cents piece @ inj site, faint red streak to ax, swollen areas in axilla & above clavicle w/sl redness & very tender; c/o nausea, no vomiting, yesterday;
My carpel tunnel symptoms, which had been diagnosed as mild and manages without issue for 20+ years, went out of control and became severe in both hands which ultimately caused me to have bilateral carpel tunnel surgery; My knuckles on my hands enlarged to the point that I could no longer put my wedding ring on (prior to the vaccine, my ring was loose on my ring finger and I worried about it falling off); I had lasik surgery decades ago and NEVER had issues with my eyesight after that.  However, after receiving the vaccine, my ability to see things close up, read a book, read anything on the computer screen, etc. has deteriorated to such a point that I know need strong reading glasses.
On 12/23/2022, we had been on a vacation and their little girl had run a fever with a cough.  She was diagnosed with a viral bronchitis. I ended up having cold symptoms. I had runny nose, coughing, and sinus headaches. This lasted about a month.
Information has been received from a registered nurse concerning a 25 year old female, with drug hypersensitivity to Vistaril and no pertinent medical history, who on 29-JAN-2007 was vaccinated subcutaneously with a 0.5 ml first dose of Gardasil (lot # 657737/0522U). Concomitant therapy included vitamins (unspecified). On an unspecified date the patient was vaccinated subcutaneously with a second dose of Gardasil. On 27-JUN-2007 the patient experienced irritation, burning and redness at injection site. The burning traveled down her arm and there was tingling in her fingers. Medical attention was sought ON 28-JUN-2007 there was still swelling and redness at the arm. The patient was instructed by the office to put ice on affected area. The AE's improved and the patient's irritation, burning and redness at injection site, tingling in her fingers, and swelling and redness at the arm persisted at the time of reporting. Additional information has been requested.
Reported "funny taste in throat." Stated it was "metallic" and occurred five minutes after injection. No unusual foods in the morning prior to vaccination. No food allergies. Upon assessment by onsite MD, patient had mild heaviness in eye and frontal head area that began 15 minutes post-administration of vaccine. Had "wooziness/lightheadedness" 15 min after injection as well that resolved. Chest heaviness in left area that lasted 2 minutes, resolved. Reported some anxiety/nervousness. No history of cardiopulmonary disease. Negative EKG and stress test in 2006 that was conducted due to chest pain after walking. No history of GERD. Denied other signs and symptoms.
generalized red, raised rash, non itching-over trunk, extremities & face;given DPH;
crying for 5hrs p/home from clinic;then slept for 13hrs;mom did awaken to feed during the 13hrs;crying was not high pitched;mom did not report until clinic visit 17JAN96
Rec'd Flu shot on 9/27/2021 at 0730.  Noticed plum-sized, red, hot, firm area on L arm about 2 1/2 inches below the injection site on 9/29/2021 at 1700.  Occupational Health contacted on 9/30/2021, viewed site. Felt it may be cellulitis, and instructed to go to an Urgent/Express Care by end of day 9/30/2021.
This spontaneous report as received from a registered  nurse refers to unspecified patients of unknown age. On an unknown dates the patients was vaccinated with improperly stored GARDASIL (dose and lot # not reported) intramuscular that were exposed to 50F for 55 hours and to 34F for 55 hours. No known adverse effects. Additional information has been requested.
Tightness in chest and difficulty in breathing.  Took several puffs of Ventolin and the difficulty eased up.  still feal breathing difficulty during moderate exercise ( walking the dogs)
muscle aches; headache; did not feel well; pain during injection; fever; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox. Concurrent medical conditions included genital herpes.   On 8th March 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 9 months after receiving Shingrix, the patient experienced muscle pain, headache, feeling unwell, pain during injection and fever. On an unknown date, the outcome of the muscle pain, headache, feeling unwell and pain during injection were resolved with sequelae and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the muscle pain, headache, feeling unwell, pain during injection and fever to be related to Shingrix.  Additional details were reported as follows: The reporter was a patient.  Sometime after receiving the 1st dose of Shingrix, the patient developed severe muscle aches, fever, headache and did not feel well.  The patient could not remember how long the symptoms lasted.  The patient states that he also experienced pain during the injection.  The patient states that the patient had not had the 2nd dose of the vaccine till the time of reporting and it had been almost 8 months since he received the 1st dose.  The patient states that he had not yet received the 2nd dose because of the side effects he experienced with the 1st dose.  The patient was planning to get the 2nd dose soon. Caller had to get off of the phone and get to work, so he did not have time to provide HCP information or any additional details regarding this event.