chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At first I started some body aches of feeling uncomfortable & I thought it was from sitting on bleachers, so I asked for a chair & started getting hot was sitting in the chair started getting super hot so they told me to take off my coat and my extra sweatshirt and so I had on short sleeves and my legs were cold my arms were cold but I was sweating I did not have a temperature. They notice my face was flashlight took my blood pressure and it was super high then they put the oxygen thing on my fingers and we all watched it drop 97 96 90 by 94 and then they asked by heading inhaler they sent my aid to get the inhaler and Benadryl out of the car. They were calling in the ambulance guys from outside because i started getting tight and unable to breath and was coughing. Then I take my inhaler my oxygen levels started to come back and they noticed my Benadryl was expired and they gave me liquid Benadryl a child dosage and then I started getting better eventually I went back to my office let me my classroom and fell immediately asleep for one hour. So it was not antiflactic but i sis atart to have trouble breathing
A few days after my second vaccine it felt like pins sticking my body. Mostly legs and at times arms. Still ongoing and taking medication.
Hair loss; Fever; Chills; Headache; Pain at injection site; Lethargy; Back pain; no apettite; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY, BACK PAIN, DECREASED APPETITE, ALOPECIA, and PYREXIA in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 055E21A and 056D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 PCR test positive on 02-Aug-2020.   On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Sep-2021, the patient experienced LETHARGY, BACK PAIN, DECREASED APPETITE, PYREXIA, CHILLS, HEADACHE, and VACCINATION SITE PAIN. On 10-Sep-2021, the patient experienced ALOPECIA. On 12-Sep-2021, LETHARGY, BACK PAIN, DECREASED APPETITE, PYREXIA, CHILLS, HEADACHE, and VACCINATION SITE PAIN had resolved. At the time of the report, ALOPECIA outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) on 02-Aug-2020, SARS-CoV-2 test positive PCR test.         No concomitant medications were reported. No treatment medications were reported.
Severe pain throughout entire body. Head to toe. Unable to be still. Tylenol did not help. Chills, fever. Difficulty walking due to pain.  Symptoms began to subside Saturday morning, and I was back to normal by Sunday morning.
3 hours after receiving vaccine started having pain to lymph nodes, then progressed to all joints including ribs, long bones. Today 9 days after vaccine was given, toes, lymph's and hips are still warm to touch and painful.
This spontaneous report was received from a consumer (patient father) refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with GARDASIL (dose, route and frequency were no reported). On an unknown date, the patient underwent a Pap smear test and tested positive for HPV. It was reported that it was unknown whether the patient completed all three shots of GARDASIL. The patient sought medical attention and saw the doctor. It was reported that currently the patient was tested positive for HPV and presently no active symptoms. The outcome of the event was unknown. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
Patient's daughter states worsening dementia and bladder control. Patient can normally care for herself, but peed her pants more than once between 3/13 and 3/15. Unable to remember to take her medications by herself. Unable to cook for herself. Seems to be letting up as time has passed. Patient's daughter is taking her to see her primary care provider.
Got the vaccine,gave me shigles/Suspected vaccination failure; Shingles/gave me shingles; 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: 24-Jan-2023 Reporter's comment: The case was received form the patient via interactive digital  media. The patient got the vaccine and gave him/her shingles. 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.
Patient is 14 years old and was administered a Pfizer Booster.   Patient and mother were informed of the error.  Both patient and mother were not concerned.
8.0 x 7.0 cm red warm rash on right deltoid area on 05/12/2005
PER ED Provider notes: Patient is an 85-year old male who presents to the emergency department. States that he has had increased weakness throughout the week. He lowered himself to the ground today and has been crawling around his apartment on his hands and knees. He states that he got the 2 shot series it sounds like on Thursday. He got the 2nd part of the shingrix vaccine for shingles. He said after that he felt great. He went to the gym and did a vigorous workout. He denies any chest pain. No shortness of breath. No syncope. No presyncopal symptoms. Has had no recent fevers , chills. No nausea, vomiting, or diarrhea. Denies any coughs or colds. He has tried nothing for this prior to arrival to the emergency room and denies any other concerns or complaints today.
Pneumonia shot given in the R upper arm 11/11 Slight swelling, severe pain, and fever 11/12 Bruise and cystitis  start 11/13 Cystitis becomes larger and blister forms  at site of bruise. Given Doxycyclene by  Dr. 11/14 Visit to ER, seen by Dr., given Keflex 11/15 Blister breaks, eschar becomes visible surrounded by red, infected tissue. Given  AMOXICILLIN-CLAV by Dr. 11/22 Seen by Doctor at Wound Care.  Examination confirms eschar diagnosis. No action taken. 11/25 Seen by Doctor at Wound Care.  Examination of eschar. No action taken. 12/02 Seen by Doctor at Wound Care.  Surgical removal of eschar and debridement of wound. 12/09 Seen by Doctor at Wound Care.  Debridement of wound. 12/16 Seen by Doctor at Wound Care.  Debridement of wound. 12/26 Seen by Doctor at Wound Care.  Debridement of wound. 12/31 Will continue to see Doctor at Wound Care until wound heals.
Day 1: Left arm turned a little purple, like small blood vessels visible. The next day the arm was already with a normal skin tone  Day 5: itching all over the body, I had a virtual medical consultation with a teledoc doctor, I recommended 2 benedryl at night and prednisone 20mg every 24 hours orally for 7 days. I only took the benadryl because the pharmacy did not have prednisone available. I stopped taking the supplements I was taking (Fit 9 and Goli gummies)  Day 7: woke up with a rash on the arms and neck, itching all over the body, red ears, a feeling of heat in the head. Take a prednisone 20mg at 4:30 pm. The symptoms remained the same. I had a virtual consultation with another teledoc doctor, we reviewed my routine, my diet, the components of the supplements that I have been consuming in the last 3 weeks (Fit 9 and Goli gummies) and came to the conclusion that the symptoms that I am presenting are Side effects of the vaccine, and recommend taking Allegra or Benadryl at night and continuing the Prednisone for 6 more days. Said if I do not see / feel improvement in the next 48 hours, the doctor suggests that I visit an emergency room for a check-up in person.
Information has been received from a 61 year old female who on 19-JUN-2007 was vaccinated with a dose of ZOSTAVAX (657767/0740C). Concomitant therapy included tetanus toxoid, CYMBALTA and WELLBUTRIN. The patient reported that on 21-JUN-2007, she developed "half a dozen: mosquito type lesions on her torso. One of the lesions was itchy on 21-JUN-2007 and another lesion, which was the size of a small eraser was pale pink with a white middle. No fluid was leaking from the lesions. no diagnostic test were undertaken. Unspecified medical attention was sought. At the time of the report the patient had not recovered. There was no product quality complaint. A lot check was requested. A review of the initial release testing for the lot number in question was found to conform to specifications. The lot complies with the standards of the agency and was released. Additional information has been requested. This is in follow-up to report (s) previously submitted on 9/24/2007.  Information has been received from a 61 year old female who on 19-JUN-2007 was vaccinated with a dose of ZOSTAVAX (Merck) (657767/0740U).  Concomitant therapy included tetanus toxoid, CYMBALTA and WELLBUTRIN.  The patient reported that on 21-JUN-2007, she developed "half a dozen" mosquito type lesions on her torso.  One of the lesions was itchy on 21-JUN-2007 and another lesion, which was the size of a small eraser was pale pink with a white middle.  No fluid was leaking from the lesions.  No diagnostic tests were undertaken.  Unspecified medical attention was sought.  At the time of the report the patient had not recovered.  There was no product quality complaint.  In follow-up, it was reported that the vaccine was given at a different facility.  A lot check was requested.  A review of the initial release testing for the lot number in question was found to conform to specifications.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  No further information was available.
patient received two doses of Fluzone High-Dose Quadrivalent within a few days of one another/no AE; patient received Fluzone High-Dose Quadrivalent instead of Tetanus vaccine on her previous visit/no AE; Initial information regarding an unsolicited valid non-serious case was received from an other health professional (clinic supervisor) via Medical Information (Reference number- 00309537) and transmitted to Sanofi on 09-Oct-2020.  This case involves a 66-year-old female patient who accidentally received second dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] instead of TETANUS TOXOID [TETANUS VACCINE] within a few days of one another from her first dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT]. [wrong vaccine administered and extra dose administered].  Medical history, medical treatment, vaccination and family history were not provided. It was reported that, patient received no other vaccine as concomitant medication.   On 28-Sep-2020, the patient received a 0.7 mL first dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot not and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.   On 05-Oct-2020, patient was intended to receive TETANUS TOXOID [TETANUS VACCINE], but accidentally received 0.7 mL second dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [Lot number: UJ516AA, expiry date: 30-Jun-2021] via intramuscular route at the left arm for prophylactic vaccination.   It was a case of actual medication error due to extra dose administered and wrong product administered. (latency on the same day of vaccination)  It was reported that, patient thought she got a TETANUS TOXOID [TETANUS VACCINE] on her previous visit and not realizing she got the INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE instead, then the patient thought, that she still needed get her flu vaccine, and went back to the clinic with asking for and receiving the INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE again. It was reported that, patient did not receive the Tetanus shot yet.    Product used: Used  First time product used: Yes  Still using product: No  At the time of reporting, patient had no adverse event.  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.
I had a sore arm after receiving the vaccine.  I tested positive for COVID-19 in 11/2022. I did not contact my doctor and just self-isolated and took over the counter medication. In 01/2023, I have been getting lightheaded when I stand up. I have been referred to a cardiologist.
Shingles/herpes zoster infection on lip. Rx: Valacyclovir 1 gm TID x 7 days.
Patients received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.
High temp of 99° - 103° for 3 days... left arm very swollen & inflamed... Swelling Non responsive to ice packs. Right arm swelling went down after icing. Blood pressure elevated & headaches. Dr. Suggested TYLNEOL for fever, it worked after 3 days. Left arm still very sore & swollen.
This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Moderna product on 01/22/2021 and 02/19/2021. They tested positive twice on 10/03/2021. They were also admitted to a Hospital during that time. I do not have admit/discharge dates available to me. The individual experienced complications of Acute Hypoxemic Respiratory failure according to the death certificate. They died on 10/23/2021.
unusually high number of covid infections in fully vaccinated employees; unusually high number of covid infections in fully vaccinated employees; This is a spontaneous report from a contactable physician. This physician reported similar events for 11 patients. This is the second of 11 reports. A patient of unspecified age and gender received the first dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on 17Dec2020 (lot number EH9899) and in Jan2021 (lot number unknown), respectively, both via an unspecified route of administration (age at vaccination unknown), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The physician stated they were seeing an unusually high number of COVID infections in fully vaccinated employees, with second dose plus two weeks, plus well over two weeks. All of whom received Pfizer and all of whom received their first dose from the same lot. The physician stated they may need some kind of investigation here, because they are seeing high viral loads in these individuals and symptoms. It is not right. All eleven individuals received their first dose from the same lot: EH9899. They did the standard dosage with the standard vanishing needle. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. The case will be reevaluated should additional information become available.,Linked Report(s) : US-PFIZER INC-2021446068 same reporter/ vaccine/ event, different patients;US-PFIZER INC-2021446063 same reporter/ vaccine/ event, different patients;US-PFIZER INC-2021446064 same reporter/ vaccine/ event, different patients;US-PFIZER INC-2021446065 same reporter/ vaccine/ event, different patients;US-PFIZER INC-2021446067 same reporter/ vaccine/ event, different patients;US-PFIZER INC-2021446066 same reporter/ vaccine/ event, different patients;US-PFIZER INC-2021446070 same reporter/ vaccine/ event, different patients;US-PFIZER INC-2021446069 same reporter/ vaccine/ event, different patients;US-PFIZER INC-2021446062 same reporter/ vaccine/ event, different patients;US-PFIZER INC-2021392224 same reporter/ vaccine/ event, different patients
Fever; Body ache; Muscle ache; Sweating; Chills; Arm hurt; Felt sluggish; A spontaneous report was received from a consumer concerning a 49 year-old male patient who experienced arm hurt, felt sluggish, fever, body ache, muscle ache, sweating, and chills.  The patient's medical history was reported as COVID in March 2020 and concomitant product use was not provided by the reporter.  On 28-Dec-2020, about four hours prior to onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 28-Dec-2020 the patient developed arm pain and felt sluggish.  On an unknown date the patient developed a fever, body ache, muscle ache, sweating and chills.  The events were treated with Tylenol.    Action taken with mRNA-1273 in response to the events was not provided/unknown.  The outcome of the events were unknown/not reported.   The reporter did not provide causality for the events.; Reporter'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.
Patient presented at a Covid-19 vaccine event at local store this morning requesting a Pfizer booster. She filled out appropriate paperwork and there were no contraindications noted. Only after patient left and I was reviewing paperwork did I notice the dates of her initial doses of 09/01/2021 and 10/31/2021 and I had given her booster dose sooner than 5 months from completing her primary series. She was still at the facility, so I called patient to come back to the room at 0655. She returned at 0840. I explained that she had received the booster too early and while there is no danger to her I encouraged her to stay aware of any adverse reactions. She said she understood and returned to work.
Night of vaccine patient reports feeling lightheaded and her lips were tingling.  Her arm was red.  The next day her arm turned black and her eyes were swollen shut.
Vaccine administered on Sun 11/25/12. Patient contacted pharmacy at 8 am on 11/27/12 to say she had a red, round area around vaccination site about the size of a silver dollar.
Patient reported sever lethargy, leg pain/ leg heaviness, severe headache. Took several naps during the day after.  The next day, patient woke up feeling fine.
This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 51-year-old female patient who received SHINGRIX for prophylaxis. On 22nd September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 23rd September 2018, 1 days after receiving SHINGRIX, the patient experienced feeling unwell, tiredness, chills and fever. On an unknown date, the outcome of the feeling unwell, tiredness, chills and fever were recovered/resolved. It was unknown if the reporter considered the feeling unwell, tiredness, chills and fever to be related to SHINGRIX. Additional details were provided as follows: The patient received the vaccine at 5:30 PM and she awoke the next morning and she spent the first half of the day in bed and did not feel great. The patients side effects resolved later that day. The reporter gave consent to follow up.
End of March 2021, reported in April to my neurologist for migraines that were coming on and their severity. I had low grade cells and had to have a procedure done in April. Several months later I had told my physician that I was beginning to have bleeding past my typical cycle. It continued to get worse and finally just today 03/22/2022, I visited my physician and my bleeding had gotten to the point where I am bleeding for almost 23 days out of the month, I am now going to get uterine ultrasound and biopsy suggested by my doctor. Before doctor thought it may have been perimenopausal symptoms however she is now ruling that out.
Administered the Janssen vaccine to a 14 year old.    Patient presented to the pharmacy with his Mom and sister.  The Mom requested Janssen vaccines for all of them.  The patient appeared to be an adult.  Pharmacist confirmed that all 3 wanted the Janssen vaccine as we also had Moderna in stock.  Mom filled out the forms for all 3 but age was not verified until after the vaccine was administered.  Mom was notified about the error and it is not currently recommend repeating with another vaccine at this time.  Pediatricians office has been notified as well.
Feeling of congestion and Hearing buzzing or hissing sound in right ear.  We are about to visit ENT and got the appointment on 12/3/2021.
Patient calls to report headache, nausea, sharp pains in joints, left arm is swollen at injection site and hurts, she was not feverish this morning, but feels feverish now (1330pm), and anxiety
I personally know 9 people who died from your vaccination; This is a spontaneous report from a non-contactable consumer reporting same event under the same suspect product for 9 patients. This is one of 9 reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Reporter stated, "I personally know 9 people who died from your vaccination. You reported 16,000 people have died in the US, even the people who work for the company speaking on this." It was unknown if autopsy was done. The outcome of the event was fatal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101145863 Same reporter/drug/event, different patient.; Reported Cause(s) of Death: died from your vaccination