chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Suspected vaccination failure/Got the shot in 2017, I came down with shingles in 2021; Shingles in 2021 were in my mouth; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 26-June-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had received a shingles shot in 2017 and came down with shingles in 2021 and they were in his/her mouth. The patient stated that worst thing ever. The patient stated that he/she would never have a vaccine for anything again. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
fatigue, headache, shivering, nausea, vomiting, fever, myalgia
Information has been received from a physician concerning a female patient who was vaccinated IM with a third 0.5 ml dose of GARDASIL.  Subsequently the patient experienced abnormal Pap test.  At the time of this report, the patient was recovering.  No product quality complaint was involved.  Additional information has been requested.
Muscle joint pain, rash, trouble breathing, swelling,  vomit, diarrhea.
The pt broke out in a rash over trunk with a temp of 101. Was seen in ER with no findings.
Severe headache this morning and all today.  We went to the pediatrician and they performed neurological tests because of the blood clots that were reported.  She was sent home and alerted to go to ER if any other symptoms develop
No additional AE reported.; PROQUAD was administered after a temperature excursion; This spontaneous report has been received from an "HBP" responsible for vaccines concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.  On 18-JUL-2022, the vaccine of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) had a previous temperature excursion of 6 degrees Fahrenheit (F) up to 14 F (10F) for 1 hour and 8 minutes and 0 seconds, and another temperature excursion on an unspecified date of 6 F up to 14 F (9.1 F) for 1 hour and 6 minutes and 0 seconds.    On 07-SEP-2022, the patient was vaccinated with an improperly storage dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) administered as prophylaxis, lot number W017570 with expiration date 29-NOV-2023 (dosage frequency and route of administration were not provided). The previously mentioned vaccine underwent a temperature excursion of 5.7 F for 30 minutes and 0 seconds. No additional adverse event were reported (No adverse event).
Vaccine was erroneously injected too high on arm approximately one fingerbreadth below acromion so it was not placed in the deltoid muscle as intended. Therefore the immune response will not be optimal and shoulder injury could develop.
patient presented to pulmonology office with significant shortness of breath and bilateral extremity swelling. Found to be COVID+ and have a DVT. Currently undergoing inpatient treatment.
Woke up with a fever of 101.9 on 12/29/20 at 0500
pt stated had mucosal membrane rash, w/arthralgias;pt referred to hlth dept;pt called back & referred to own MD;
Pain in right arm and shoulder into neck and back.  Loss of motion of right arm. Massage (March 2022), chiropractic care (April 2022), physical therapy (June-July 2022).
Adverse event - I had some chills (even though I was wearing a heavy sweatshirt) and low grade fever (99).   Treatment - I took some Tylenol and went to bed a bit early.  I wore the heavy sweatshirt to bed and threw on an extra blanket.  Outcome - By morning (5am), I was fine.
second dose: blood pressure has been a little high; right eye was affected somehow; second shot: swelling of left arm; second shot: headache; second shot :could not eat for three days; second shot: had normal aches and pains; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 (Lot number: ER8732) at the age of 66 years as dose 2, single. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: Pain(non-serious) with onset 24Mar2021, outcome "recovered" (25Mar2021), described as "second shot: had normal aches and pains"; Peripheral Swelling(non-serious) with onset 14Apr2021, outcome "recovered" (17Apr2021), described as "second shot: swelling of left arm"; Headache(non-serious) with onset 14Apr2021, outcome "recovered" (17Apr2021), described as "second shot: headache"; Decreased appetite(non-serious) with onset 14Apr2021, outcome "recovered" (17Apr2021), described as "second shot :could not eat for three days"; Blood pressure increased (non-serious) with onset 17Apr2021, outcome "not recovered", described as "second dose: blood pressure has been a little high"; Eye disorder(non-serious) with onset 16Apr2021, outcome "not recovered", described as "right eye was affected somehow". Relevant laboratory tests and procedures are available in the appropriate section.  Follow-up (23Dec2021): Follow-up attempts are completed. No further information is expected.  Additional Information:Why was the patient taking Covid vaccine (Verbatim): trying to follow what they thought would be the best thing in the Covid situation Physician details: Stated that she went to the Health Department. Stated there was no doctor. Occupation/specialty, consent to contact, address, phone number and email address not provided.Treatment: Stated that she took Tylenol and cold compress for swelling of left arm. Stated that she went to the doctor and is monitoring her blood pressure.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101767816 Same patient and drug, different event separated in time
Improperly stored PROQUAD was administered to patient; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug allergies or reactions or concomitant medications was not provided.  On 27-OCT-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), for prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location were not reported; lot number S021326 verified to be valid with expiration date of 05-JAN-2021). The administered dose of the vaccine experienced a temperature excursion at an unknown temperature and timeframe. It was unknown by the reporter if there were previous temperature excursion.
Developed redness and induration at injection site and dx of cellulitis, also developed blanching maculopapular rash on trunk that spread to face and body, had subjective fever for 2-3 days, injection site redness resolved with course of cephalexin.
Employee received a flucelvax vaccine and began to wheeze. Had shortness of breath and immediately used her inhaler. She was fine afterwards.
Patient inappropriately received adult dose Pfizer at a vaccination clinic. The patient, who is currently 11 years and 11 months old, should have received the pediatric dose of Pfizer. The date of birth was incorrectly added to the patient's chart at registration and was not confirmed prior to the vaccination being provided. The patient's mother was present for the vaccination. The error was discovered while the patient and his mother were still at the vaccination station. The error was discussed with the patient and his mother, and they both understood to look for adverse events and to call with any symptoms.   We reached out to the patient's mother on 1/13. She stated the patient was feeling fatigued, had a headache and chills. She was instructed to encourage fluids and to contact us with new or worsening symptoms. She was also told to seek emergency care for severe symptoms.
Patient has 1 day of urticaria rash (5 days after vaccines given), no other symptoms. No respiratory issues. No new exposures, seen in ED on 7/23, given BENADRYL and prednisone, worsening rash on 7/24 and seen in office. Directed to continue BENADRYL and prednisone.
Pt dizzy, brought head forward, placed in laying positive, developed shaking of arms, legs, pallor, momentarily, monitored one hour, no lip or throat sensation, no tingling or weakness. Discharged home after eating/drinking, monitored.
could not wake pt up all day; pt vomited & slept all day; pt was limp all day; did not eat all day; may have had fever;
Patient is getting her second dose of Moderna vaccine Per CDC guideline. Even if she is 16 years old.
COVID symptoms began 5/11/22, positive at home, rapid test on 5/12/22. Sypmtoms included fatigue, dull headache, slight fever (although not the entire time), some cough, running nose
Hot to touch; Likely less than full dose injected; Leaked onto skin; Not injected into muscle; Red patch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot to touch), ACCIDENTAL UNDERDOSE (Likely less than full dose injected), VACCINATION SITE DISCHARGE (Leaked onto skin), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Not injected into muscle) and VACCINATION SITE ERYTHEMA (Red patch) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2022, the patient experienced VACCINATION SITE WARMTH (Hot to touch), ACCIDENTAL UNDERDOSE (Likely less than full dose injected), VACCINATION SITE DISCHARGE (Leaked onto skin), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Not injected into muscle) and VACCINATION SITE ERYTHEMA (Red patch). On 18-Jan-2022, ACCIDENTAL UNDERDOSE (Likely less than full dose injected), VACCINATION SITE DISCHARGE (Leaked onto skin) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Not injected into muscle) had resolved. At the time of the report, VACCINATION SITE WARMTH (Hot to touch) had not resolved and VACCINATION SITE ERYTHEMA (Red patch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient reported that ice pad application helped little. Concomitant information was not reported. Treatment information was not reported.
Injection site pain and ecchymosis, pain, swelling , redness.  Symptomatically treated with anthistamine and ibuprofen.
Pt received Covid vaccine, was told you wait 15 minutes to be monitored. While waiting, he was adjusting his sweatshirt and was flailing with the sleeves and hood. It was witnessed that his face became red, he started to convulse and fell to the ground while pulling on the handle of his shopping cart. He was able to sit up on his own; at which time 911 was dispatched.  Paramedics arrived quickly and assessed patients blood pressure and condition.  They cleared him and they left at 11:40am.  Pt was escorted to his truck by staff pharmacist and left before noon.
Vomiting, chills, metallic taste in mouth, diarrhea, loss of appetite, coughing, soreness, difficulty sleeping, tiredness
Temperatures exceeding 102 Body aches and chills Muscle pain / weakness Headaches  Large red skin bump
blood pressure has been going up and down; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE FLUCTUATION (blood pressure has been going up and down) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced BLOOD PRESSURE FLUCTUATION (blood pressure has been going up and down). At the time of the report, BLOOD PRESSURE FLUCTUATION (blood pressure has been going up and down) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient's parents noticed the onset of hair loss starting 6/14/21, and report no other symptoms. The hair loss is on-going as of today.  The patient?s father reports a history of 2 prior episodes of similar hair loss, the first occurring in July/August of 2020 (approximately 85% total hair loss) and the 2nd episode occurring in December 2020 (with approximately 40% total hair loss).  During those 2 prior episodes, the patient was evaluated by her pediatrician and a pediatric dermatologist. A diagnosis of alopecia (of likely auto-immune etiology) was made and topical steroids were prescribed.
Case was symptomatic upon case investigation on 8/2/21. Symptoms included fever, subjective fever, chills, rigors, runny nose, sore throat, olfactory disorders, headache, cough and congestion. Tested positive on 7/31/21 for Covid 19.
Cold sweat, chills during late night trying to sleep. Got up to bathroom, felt dizzy and fainted. I was passed-out 30 sec to 2 minutes. Symptoms resolved after taking Tylenol 500mg.
Several hours after vaccine, pt was tired and lethargic. Next morning left upper arm /shoulder swollen and warm to the touch. 08/19/16 mom called and reported that swelling and warmth was gone and pt was back to himself.
Had tingling/pain in right side of head 4 days after vaccine. Resolved in approximately one month. No treatment.
Left arm tingling after vaccination that did not go away after 30min. Evaluated by EMS. ST elevation in screening lead 2, 12 lead performed but revealed only enlarged QRS, no ST change. No resp distress, no chest pain, given aspiring by EMS and transferred to hospital for continued monitoring and observation.
Day 1: 103F temperature, chills, headache, exhaustion Days 2-4: normal temperature, fatigue, headaches, difficulty sleeping
Pt returned back to the clinic about 25 minutes after recieving her vaccine complaining of left leg pain that was throbbing and radiating down the back of her leg down to her calf  and that her right arm was going to sleep and fingers tingling. Pt denied any chest pain, difficulty breathing or tingling of lower extremity. I assess the patient first by checking Blood pressure in right arm which was 110/67. Pulses in bilaterall lower extremities were hard to palpate but were equally 1+ in PT and DP locations. I instructed patient to call a family member to come and pick her up after confirming she was stable enough at this time. Family came to pick her up and took her belongings where i had already gave them an update over the phone that she would be coming over to be assessed. I walked patient to front door and assisted her into the car. She went to ER down the road to be assessed.
Suspected VITT treated with bivalirudin 0.08 mg/kg/hr, IVIG, hemoptysis, cough,  chest pain
Red circular rash 8 days after injection. Description of rash: Perfectly round red rash aproximate size of a golf ball below the injection site. Rash is now encompassing the entire front of my upper left arm.
Pain at injection site; Bleeding/ Period after vaccine, I had severe cramping, clotting and bleeding; Severe cramping/ Period after vaccine, I had severe cramping, clotting and bleeding; Clotting/ Period after vaccine, I had severe cramping, clotting and bleeding; This is a spontaneous report received from a contactable reporter (other healthcare professional). The reporter is the patient.  A 24-year-old female patient (not pregnant) received the second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in the left arm on 22Dec2021 (batch/lot number: unknown) at the age of 24 years old, as DOSE 2, SINGLE for COVID-19 immunization. Relevant medical history included: "Fibromyalgia" (unspecified if ongoing) and "Insomnia" (unspecified if ongoing). Patient has no known allergies and had no history of COVID-19 prior to vaccination. Concomitant medications included: GABAPENTIN, CYMBALTA, and TRAZODONE. Patient did not receive other vaccines in four weeks. Vaccination history included: Bnt162b2 (first dose (batch/lot number: unknown), administered in the left arm as DOSE 1, SINGLE), administration date: 29Nov2021, when the patient was 24 years old, for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 22Dec2021, outcome "recovering" described as "Pain at injection site"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset 22Dec2021, outcome "recovering" described as "Bleeding/ Period after vaccine, I had severe cramping, clotting and bleeding"; DYSMENORRHOEA (non-serious) with onset 22Dec2021, outcome "recovering" described as "Severe cramping/ Period after vaccine, I had severe cramping, clotting and bleeding"; MENSTRUAL DISORDER (non-serious) with onset 22Dec2021, outcome "recovering" described as "Clotting/ Period after vaccine, I had severe cramping, clotting and bleeding." Therapeutic measures were not taken as a result of vaccination site pain, heavy menstrual bleeding, dysmenorrhoea, and menstrual disorder. The patient was not tested for COVID-19 post vaccination.  The batch/lot number for bnt162b2 was not provided and will be requested during follow up.
After Menactra administered in R deltoid Pt head dropped to the R and his eyes looked crossed - pt was sweating profusely (911 was called) immediately. Pt tapped on shoulder and asked if OK and he "come to" and said Yes I' OK. Pt was breathing fine. Heart racing and still sweating. Pt walked out with EMS.
Painful and red when she got home so she applied ice off and on and then at about 6/7pm she broke out she then was extremely itchy and came up with hives that were painful she then took an antihistamine which helped but as soon as it wore off it would come back as well as Cortizone Cream, Ibuprofen and Bengay for relief it finally seemed to go away as of today 6/24/2019.
Within 12 hours of the vaccine the patient started having heart palpitations.  She has never had a palpitations before the vaccine.  She bas had over 100.  She loses her breath and occasionally has heart pain.
Pt had reddened area to right thigh from inj site to below knee. Rash was approximately 8 in in duration. No further tx was necessary
patient was administed a second dose of the seasonal flu vaccines (Fluad). He did not report any adverse effects and left saying no foul not harm.
Reported onset of cough, sore throat, fever, weakness on 10/23/03, states symptoms are somewhat better today (10/24), but remains weak with lingering cough.
Diffuse rash over body. Went to Dr office and they could find no reason for rash so they said it "may be shot?? Pt back to doctor office 9/29/03 states patient is fine no problem
15 x 10 cm area of erythema & warmth over deltoid, lt;onset occurred on the fifth day following inj;
June 17, 2004-Developed 5 fluid filled, red, raised areas on left side of abdomen, wrapped around waist area to back June 20, 2004 Temp. 101.6F
Lingering soreness in my arm up to my neck now; Diarrhea; Fever; Tested positive for Covid; Felt like i got cold; sore arm at moderate level of pain; Chills; Cramps in my feet; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Jan-2021 and was forwarded to Moderna on 15-Jan-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (sore arm at moderate level of pain), CHILLS (Chills), MUSCLE SPASMS (Cramps in my feet), NECK PAIN (Lingering soreness in my arm up to my neck now) and NASOPHARYNGITIS (Felt like i got cold) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE and ESTRADIOL.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore arm at moderate level of pain), CHILLS (Chills) and MUSCLE SPASMS (Cramps in my feet). On 10-Jan-2021, the patient experienced NASOPHARYNGITIS (Felt like i got cold). On 11-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), PYREXIA (Fever) and SARS-COV-2 TEST POSITIVE (Tested positive for Covid). On an unknown date, the patient experienced NECK PAIN (Lingering soreness in my arm up to my neck now). On 06-Jan-2021, CHILLS (Chills) and MUSCLE SPASMS (Cramps in my feet) had resolved. On 07-Jan-2021, VACCINATION SITE PAIN (sore arm at moderate level of pain) outcome was unknown. At the time of the report, NECK PAIN (Lingering soreness in my arm up to my neck now), NASOPHARYNGITIS (Felt like i got cold), DIARRHOEA (Diarrhea), PYREXIA (Fever) and SARS-COV-2 TEST POSITIVE (Tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2021, SARS-CoV-2 test: positive 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 included over the counter advil and Tylenol.
Rash and itchiness at injection site. Very mild. Resolved in a few days.