chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Nov2021 as dose 3 (booster), single (Lot number: F63527) at the age of 33 years, as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CRYSELLE. Past drug history included: Penicillin, reaction(s): "Allergy".  The following information was reported: DISEASE RECURRENCE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I never tested negative but the positive line was very faint at this point.  Additional information: I finished my final dose of Paxlovid on Sunday, 03Jul, and my symptoms had mostly cleared up by Wednesday 06Jul. I never tested negative, but the positive line was very faint at this point. However, on Friday 08Jul I started to feel fatigued again, and on 09Jul I was coughing a lot again, was very fatigued, and congested.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever 101.5 - beginning 9 hours after vaccination lasted for about 5 hours. Headache / sinus - Beginning about 10 hours after vaccination lasted for about 8 hours Achy muscles, stiffness swelling - Beginning about 12 hours after vaccination and continuing into the morning.
0911 Received TIV 0925 c/o dizziness & headache. No resp diff. T 98.3 BP 100/72 AP-96. 0936 ate 1/2 cracker & sip water 0950 c/o (L) leg pain. 1100 to ER c/o (L) arm & (L) leg pain. MD was told (L) jaw was drooping but not seen by MD. Very fatigued. BENADRYL (po) given & started talking more. Given oral Penicillin for sinusitis. Discharged home.
blisters at the injection site; blisters around her nose and below her chin; fatigue; redness; This case was reported by a consumer via call center representative and described the occurrence of injection site blisters in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number 5S43T, expiry date 5th March 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 9th November 2019).   On 31st January 2020, the patient received the 2nd dose of Shingrix. On 2nd February 2020, 2 days after receiving Shingrix, the patient experienced injection site blisters and blister. In February 2020, the patient experienced fatigue and erythema. On an unknown date, the outcome of the injection site blisters, blister, fatigue and erythema were unknown.   It was unknown if the reporter considered the injection site blisters, blister, fatigue and erythema to be related to Shingrix.  Additional details were reported as follows: The patient experienced blisters at the injection site as well as around her nose and below her chin after receiving 2nd dose of Shingrix. The patient also experienced fatigue and erythema. The patient was not seen her physician or pharmacist, but spoken with her pharmacist. Consent to follow up was provided.
Patient accidentally given Td vaccine that had expired January 22nd of 2023. Patient's last vaccine was 6-7 years ago.
Information has been received from a physician concerning a 21 or 22 years old female with unknown medical history, who on 04-APR-2008 was vaccinated (route unknown) with a second dose of GARDASIL (Lot # 655604/0052X). The date and lot number of the first vaccination were not reported. The physician reported that the patient was "stuck" twice with two different prefilled syringes, because the first syringe did not function properly and did not release the vaccine. The patient reported arm pain to the physician. No laboratory diagnostic studies were performed. The patient sought unspecified medical attention at the physician's office. Subsequently, on an unspecified date the patient recovered. This is one of several reports from the same source. Additional information has been requested.
Onset of severe dizziness and vertigo, experiencing it all day from onset at 10:30am this morning and experiencing nausea from dizziness and vertigo. My balance is off and deep unstable on my feet.
A 15-year-old female, who had no history of syncope, fainted in school the day after the third COVID-19 vaccine booster. She was also given a flu shot at the same time.
Mom states pt started w/fever Friday night; Went up to 103.8 was given APAP & cool bath & came down; no fever Saturday; Also exp vomiting, c/o local reaction redness & swelling;
Information has been received from a nurse concerning a female who on an unspecified date was vaccinated IM with a first 0.5 ml dose of GARDASIL (lot # not provided). Subsequently the patient experienced "breaking out in hives" after receiving her first dose of GARDASIL. The healthcare professionals said they had decided not to continue the series of treatment for the patient. The patient sought unspecified medical attention. At the time of reporting, the patient's status was not provided. Additional information has been requested.
Patient states arm had gradually become more numb since injection. Numbness has gradually moved down to fingers. Soreness at injection site still persists.
Very red, warm and swollen at injection site.  affected area was 3 inch in diameter. Very strong headache that hurt so much that it impacted sleep.  Body aches and chills.  Significant fatigue and mental tiredness and fog. All of the above except fatigue, mental tiredness and fogginess subsided by end of 3rd day.  Today is the 5th day and I still feel slightly fatigued and unmotivated to be active (I normally workout and exercise daily).  I also still feel mentally tired and foggy. The first vaccination wasn't as bad.  I had a sore arm at the site of the vaccination, tender to touch but no redness.  I didn't get a headache or body aches or chills.  I just felt very fatigued and mentally tired for about 4 days.  The brain fog lasted about 7-10 days.
Nausea; Fever; Chills; Headache; hard time concentrating due side effects; This non-serious case was reported by a consumer via patient support programs and described the occurrence of nausea in a 55-year-old female patient who received Herpes zoster (Shingrix) for vaccination.   On 28-FEB-2023, the patient received Shingrix. On 01-MAR-2023, 1 days after receiving Shingrix, the patient experienced nausea (Verbatim: Nausea), fever (Verbatim: Fever), chills (Verbatim: Chills) and headache (Verbatim: Headache). In MAR-2023, the patient experienced attention concentration difficulty (Verbatim: hard time concentrating due side effects). The outcome of the nausea, fever, chills and headache were not recovered/not resolved and the outcome of the attention concentration difficulty was not reported.   It was not reported if the reporter considered the nausea, fever, chills, headache and attention concentration difficulty to be related to Shingrix.     It was not reported if the company considered the nausea, fever, chills, headache and attention concentration difficulty to be related to Shingrix.   Additional Information: GSK Receipt date: 01-Mar-2023. This case was reported by a consumer via patient support programs. This report was submitted via the reporting system. Patient stated she was having a hard time concentrating due to the side effects nausea, fever, chills and headache. The reporter denied consent to follow up.
Patient called out reporting that he had fainted/blacked out while sitting in chair across from the pharmacy counter. The patient was sitting with legs were stretched out and his head was laying back on a shelf that was immediately behind the chair he was in.  I immediately went out to converse with the patient. I called for someone to bring him a cool drink and gave him a cool compress for his forehead. He pulled his mask down below is nose to breathe more freely. While he was drinking the pineapple drink I asked if this had ever happened before while receiving a vaccine or during a blood draw. He said never as an adult but as a child he did have fainting spells. When asked if he had eaten at all during the morning or afternoon he reported he had not but had only drank water and coffee. After about 10-15 minutes he started to feel better. I asked if I could call someone to drive him home, he said he was fine and when he went to get up to go he reported that his arms were tingling. I asked his permission to call 911 so he could be evaluated in the ER. He agreed. 911 was dispatched. Paramedics took his blood pressure and found his diastolic pressure to be 100. He was asked if he had been diagnosed with HTN or if he was taking any medications to treat it. He denied. They suggested that he be taken to the ER to which he declined to go. The paramedics escorted him out of the store at approximately 2:15pm.
Initial unsolicited report received from a pharmacist on 06-Jul-2018. This case involves a 62-year-old male patient who was vaccinated once with a 0.5 ml dose of TENIVAC (batch number: US856AA, expiry date: 26-Jan-2020) via intramuscular in the left arm instead of TDAP (batch number, expiry date, route and site of administration were unknown) on 06-Jul-2018. The patient's medical history and concomitant medication were not reported. It was a case of actual medication error due to wrong vaccine administered. It was not reported whether the patient experience any adverse events or not. The reporter enquired about administration of TDAP to the patient. 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
About 11 hours after my 2nd dose that night of injection I had a fever, chills-I self treated and recovered. Nothing required doctor's care. Within 24 hrs symptoms resolved  A few months later I developed kidney stones. I went and saw Dr. and had surgery in mid-January. Only prescribed pain medication after surgery. I never have Kidney stones before and I did have this after the shot but not sure if it's related or note.
Severe sepsis causing acute hypoxic and hypercapnic resp failure, AKI, acute encephalopathy due to pneumonia and CF exacerbation; treated and discharged. ED visit 10 days later for C-Diff diarrhea. Treated and released. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
Patient contracted COVID after being fully vaccinated.  No booster runny nose, chills, body aches, fatigue, cough, headache, shortness of breath with exertion.
Rash on her face got really bad; Swelling of her whole face after the second dose; Redness on her whole face after the second dose; Itching on her whole face after the second dose; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), SWELLING FACE (Swelling of her whole face after the second dose), ERYTHEMA (Redness on her whole face after the second dose), PRURITUS (Itching on her whole face after the second dose) and RASH (Rash on her face got really bad) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced FATIGUE (Fatigue). On 19-Mar-2021, the patient experienced SWELLING FACE (Swelling of her whole face after the second dose), ERYTHEMA (Redness on her whole face after the second dose) and PRURITUS (Itching on her whole face after the second dose). On 20-Mar-2021, the patient experienced RASH (Rash on her face got really bad). At the time of the report, FATIGUE (Fatigue), SWELLING FACE (Swelling of her whole face after the second dose), ERYTHEMA (Redness on her whole face after the second dose), PRURITUS (Itching on her whole face after the second dose) and RASH (Rash on her face got really bad) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable    This case was linked to MOD21-061327, MOD-2021-062562 (Patient Link).
Itchy, red, warm to touch, 2 lumps on left arm.   Aware approx 6pm. Lasted 24 hrs Both ankle areas itchy.  Started 02/09/2021 through 02/12/2021
pt recv vax 28FEB97 & approx 3-4 days post vax pt devel a rash;approx 10 days later pt began twitching & became frequent on 15MAR97;pt to ER EEG done;it was determined that twitching not d/t sz but indicative of vax-induced encephalopathy;
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 15-May-2021.    On 24-Nov-2021 at 12:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Nov-2021 at 12:30 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 24-Nov-2021 at 12:30 PM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-May-2021, SARS-CoV-2 test: positive (Positive) Positive, Rapid test.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided. It was reported that expired moderna vaccine given to 7 patients and moderna vial was moved from freezer to refrigerator on 24 Nov 2021 the same day the dose was administered.
crying began late afternoon p/immun given; pt not eating, not sleeping, rubbing ear; examined on day 2 12MAY93 nl ear found;
This was the 2nd dose of H1N1 vac. It was given at 9:30 a.m. Parent called school at 1 p.m. stating that the child was complaining of nausea, vomiting and diarrhea.
moderate pain in the left deltoid where he received the immunization / tender to the touch; limits his ability to raise his arm without pain / where he received the immunization; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 62 year-old male patient received bnt162b2 (BNT162B2), administered in deltoid left (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "moderate pain in the left deltoid where he received the immunization / tender to the touch"; VACCINATION SITE MOVEMENT IMPAIRMENT (non-serious), outcome "not recovered", described as "limits his ability to raise his arm without pain / where he received the immunization".  Additional information: It was reported that the patient was healthy and received his first dose of vaccine two weeks ago (from the time of the report). The patient continues to experience the events. It was reported that his left deltoid was not red or swollen.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
23 Hours after the injection,  a mild muscular pain started  on the mid left arm , within minutes  it became  evident on the entire  left arm and it extended  across from to right  shoulder arm.  The pain included a burning sensation, being extremely intense  (using the standard pain scale  I was  way over 10)  At first it appear to be a heart attack.  I never had any cardiac  issues.  The pain lasted  approximately 30 minutes.  Second event started on Sunday, 7 at 10 : AM  same location, and intensity.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional information were reported as follows: The age at vaccination was not reported. The patient was the caller's husband. The patient received SHINGRIX and experienced injection site pain that hurt when the area was touched. The pain went away in a few days. For tolerance of 2nd dose of SHINGRIX, refer case US2019GSK066313. The patient did not consent to follow-up.
Slurred speech noted by patient, mom, teachers and peers.  Lasted until evening when went to sleep.  Awoke fine the next day.
Fever to 102 within 24 hours, maculopapular rash on thigh around site of injection, swelling of thigh around site of injection. Rash resolved with po BENADRYL.
Within a few hours she began to experience slight muscle pain; She also suffered from extreme chills; she continued to have some muscle pain and a headache; This is a spontaneous report from a Non-Contactable consumer. This (age: 32; unit: unknown) female consumer reported. A female patient of an unspecified age received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 27Jan2021 (Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On27Jan2021, the patient experienced, she received the second dose of the vaccine on Wednesday. Within a few hours she began to experience slight muscle pain, but within a few hours the pain became very acute. She also suffered from extreme chills. The next day Thursday, 28Jan2021, she continued to have some muscle pain and a headache. On 29Jan2021, the outcome of event was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Moderate pain in the arm that received the injection. Redness, swelling, warm to touch and itchy at injection site. Fatigue, muscle pain, achy all over and nausea.
red rush around where the injection site was, it is a little painful, but not itchy; red rush around where the injection site was, it is a little painful, but not itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red rush around where the injection site was, it is a little painful, but not itchy) and VACCINATION SITE PAIN (red rush around where the injection site was, it is a little painful, but not itchy) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (The patient takes nasal spray for allergy). Concomitant products included GABAPENTIN, LEVOTHYROXINE SODIUM (SYNTHROID), VITAMIN D3 and KALLIDINOGENASE (SOMAX) for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (red rush around where the injection site was, it is a little painful, but not itchy) and VACCINATION SITE PAIN (red rush around where the injection site was, it is a little painful, but not itchy). At the time of the report, VACCINATION SITE ERYTHEMA (red rush around where the injection site was, it is a little painful, but not itchy) and VACCINATION SITE PAIN (red rush around where the injection site was, it is a little painful, but not itchy) outcome was unknown. associated with second dose of vaccine      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications included antidepressants and nasal spray for allergy. The patient did not receive any treatment medications.
Seizure occurred 8 days after vaccine. Rash occurred 10 days after vaccine.
Patient here on 10/1/21 to receive booster covid 19 Pfizer vaccine. Shortly after vaccine patient began to to experience lightheadedness, wheezing, cough, throat tightness and scattered rash-like around chest and arm area. Staff notified and was taken back to private exam room, patient mentioned that at time of feeling these symptoms, patient administered self provided Xopenex inhaler.   Patient responsive and conscious, alerts and oriented, skin dry, no severe distress noted. Initial vital signs:@11:15am BP-142/87, Pulse-112 Resp-19, O2-98%RA. ; 25mg of Liquid Oral Diphenhydramine was given. Patient stated began to feel feel better, symptoms were beginning to subside, and roughly 20-25 minutes after 25mg of Liquid Oral Diphenhydramine was given patient reported symptoms were returning and worsening. At this time vitals were reassessed  BP-126/79, Pulse-117 Resp-18, O2-98%RA, no severe distress noted. Epinephrine 0.3mg was administered to right vastus lateralis with EpiPen, patient remained alert an oriented at all times. EMS was called to transport to higher level of care via ambulance.
Positive for COVID-19/breakthrough infection; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive for COVID-19/breakthrough infection) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020F21A, 044A21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Positive for COVID-19/breakthrough infection). At the time of the report, COVID-19 (Positive for COVID-19/breakthrough infection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive for COVID-19 in the morning.         No concomitant medication was reported. The treatment information was not reported.  Company comment: This is a spontaneous case concerning a 62-year-old male  patient with no medical history reported, who experienced non serious, unexpected events of COVID-19 (AESI). The event occurred 1 month 24 days after the third dose of mRNA-1273 vaccine. Clinical course and treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 62-year-old male  patient with no medical history reported, who experienced non serious, unexpected events of COVID-19 (AESI). The event occurred 1 month 24 days after the third dose of mRNA-1273 vaccine. Clinical course and treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.