chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Immediate swelling and redness and warm are (injection site) became itchy - Pt blood pressure normal at 116/82, called pt's immediately.
got shingles from vaccine/suspected vaccination failure; got shingles from vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, 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 Shingrix.  Additional details were provided as follows: The case was reported by patient's husband. The age at vaccination was not reported. The patient experienced shingles after receiving Shingrix. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset for the event confirmation at the time of reporting were unknown. This is 1 of the 4 cases reported by the same reporter.
Myalgia, Fever, Rash, HYPERtension, Tachycardia, Chills/Fatigue/Swollen Glands/ Ear Ache/ slight numbness on face Narrative:
VERTIGO; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced vertigo. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vertigo was not reported. This report was non-serious. This case, from the same reporter is linked to 20220316156.
Patient inadvertently received expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number Z9MZ2, expiry date 31st December 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th January 2022, the patient received the 2nd dose of Kinrix (intramuscular) and Kinrix Pre-Filled Syringe Device. On 26th January 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient inadvertently received expired dose of Kinrix in the left thigh, which led to expired vaccine used. No further information reported. The reporter consented to follow-up.
Breakthrough COVID-19 case with symptom onset 8/20/2021: Fever, Aches, Shortness of breath/difficulty breathing, Cough. Hospitalized 8/20/2021-8/27/2021. From HCW: Respiratory Distress. Per pt, he got "stuck in bed, couldn't sit up for 3 hours". Pt found semi-responsive by EMS, initially satting 40s RA, mid-80s NRB, heard wet lung sounds. No known Covid exposure, recently vaccinated. Hx sleep apnea, lymphedema. No other aggravating or alleviating factors. Symptoms are described as mild to moderate in intensity, severity, quality, and character.  Nurse's notes have been requested, obtained, and reviewed. I agree with their assessment. The patient presents with shortness of breath with hypoxia.  The patient is a very morbidly obese male with a history of sleep apnea and significant lymphedema to the left lower extremity.  The patient denies using Lasix.  The patient does seem to have a dry oral mucosa and feels thirsty.  Patient denies any history of congestive heart failure.  The patient was found semi responsive by EMS with an O2 saturation in the 40s but increased to the upper 80s on 100% non-rebreather mask. Death 8/27/2021. From Vital Records: place of death: HOSPITAL-INPATIENT, MEMORIAL MEDICAL CENTER; certified, PRONOUNCING AND CERTIFYING PHYSICIAN; occ/ind: DIRECTOR, SCHOOL BOARD DIRECTOR . Per vital records, COD ICD Codes include: U071, A419, J80, J969, N288 ; Other Significant Conditions include: None listed
Body ache and headache; Body ache and headache; This is a spontaneous report from a contactable Nurse. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient experienced body ache and headache (non-serious) on 31Dec2020. She has no fever. The patient asked, "I'm concerned about my side effects. Should I get tested for COVID-19?" The outcome of the events was unknown.  Information on the lot/batch number has been requested.
ADMINISTERED INJECTION ON 11/15/08.  PT CALLED ON 11/30 SAYING BOTH HE & HIS WIFE HAVE EXPERIENCED SEVERE PAIN/SORENESS IN RIGHT UPPER ARM. HE FEARS THAT THE SHOT WAS GIVEN IN WRONG PLACE (HIGH-TOP OF SHOULDER)& THAT THE PAIN CONTINUES TO WORSEN. PT STATED THAT IBUPROFEN & SPORTS CREAM ARE NOT HELPING. ON 12/1/08, I RETURNED HIS CALL & TOLD HIM TO SEE A DOCTOR. ON 12/2, PT TOLD ME HE HAD SEEN HIS DOCTOR & WAS GIVEN AN ORAL CORTICOSTEROID FOR 1 WEEK. DOCTOR SPECULATED THAT THE JOINT OR BURSA SACK MAY HAVE BEEN HIT.  (HIS WIFE DID NOT SEE A DOCTOR. HE STATED THAT SHE CANNOT TAKE A CORTICOSTEROID BECAUSE OF A CURRENT HEALTH CONDITION). ON 12/17, PATIENT SAYS HE HAD COMPLETED THE CORTICOSTEROID. PAIN SUBSIDED WHILE ON MED,BUT NOW HAS RETURNED. HIS WIFE IS SOMEWHAT BETTER.  THE DOCTOR HAS TOLD PATIENT THAT HE SHOULD HAVE AN MRI.  PATIENT SAYS HE WILL DO THIS AFTER THE HOLIDAYS ARE OVER.
On the same day of the shot, at bedtime I started shriveling and couldn?t stop along with a very bad headache. Took Tylenol and fluids.
Information has been received from a registered nurse concerning a 13 year old female who on an unspecified date was vaccinated with a dose of Zostavax (Oka/Merck) instead of Varivax (Oka/Merck) (MSD).  No adverse reactions were reported.  Medical attention was not sought.  No further information was provided.  There was no product quality complaint involved.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 9/24/2007.  Follow up information was received from the nurse who stated it was a case of the nurse picking up the wrong vaccine and not double checking the label to make sure she had the right vaccine.  The nurse reported that the patient is a healthy young lady with no contraindications and fortunately did not experience any untoward effects.  Additional information has been requested.
Developed a fever at 0400, had a fever of 102.5 throughout the day. Tried to control fever with 1.875ML of Ibuprofen every 5 hours. Child had chills and sweats, very little appetite for food or liquids, but did eat and drink some. At 9PM the child's fever spiked to 105.00F. Child was transported to Hospital, where he was given Ibuprofen and Acetaminophen every three hours to control fever. Rectal temp at hospital was 104.5 and lowered to 100 with meds. 6/06/2018-Child was taken to primary care doctor the following day for a follow-up. As of 6/09/2018 child is not as energetic, appetite hasn't recovered and seems to have a slight difficulty with balance/coordination.
This client came to clinic and requested/received a first Pfizer dose. Upon entry of the dose in the immunization registry, it was discovered this client received a Janssen vaccination on 03/18/2021. The client was called. A voicemail was left requesting a call back.
5 weeks after second Moderna vaccine I woke up with significant lip swelling on 3/3/21.  Have completed a medrol dose pack and prednisone 5 day tapered dose. Lips are still bumpy and swollen.
After dose 2, extreme fatigue and muscle ache ongoing since the day after. Also, nausea for about a week after the second dose.
diagnosed with COVID-19; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (diagnosed with COVID-19) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced COVID-19 (diagnosed with COVID-19). At the time of the report, COVID-19 (diagnosed with COVID-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, SARS-CoV-2 test: positive (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.   No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Extreme soreness and tenderness at injection site. Headache, body aches, joint aches, chills. Only treatment to far is Ibuprofen.
A 16 year old male patient inadvertently received a pediatric Pfizer dose, lot number Fk5618, dosage amount 0.2 ml instead of the adult dose of Pfizer  vaccine.   Once it was realized that the pediatric dose 0.2 ml was given, the patient was then given 0.1 ml  of the adult Pfizer vaccine with lot number 33130BA.   Patient remained in clinic for observation for 15-20 minutes and displayed no adverse symptoms.
Wide area around the injection side got swollen after exactly 7days. It was very painful and the surface was hard now it is better but redness is still there.
I am so Sick; Hurts (Everything in Body); Fever 102 F; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I am so Sick), PAIN (Hurts (Everything in Body)), PYREXIA (Fever 102 F) and HEADACHE (Headache) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced ILLNESS (I am so Sick), PAIN (Hurts (Everything in Body)), PYREXIA (Fever 102 F) and HEADACHE (Headache). At the time of the report, ILLNESS (I am so Sick), PAIN (Hurts (Everything in Body)), PYREXIA (Fever 102 F) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Feb-2021, Pyrexia: 102 (Inconclusive) 102 Fahrenheit.
Swelling in throat, fever > 102 degrees F, hepateptosis, malaise, vomiting.
This solicited report, was received from the patient's mother, referring to a 14 year old female patient as part of the market research program. The patient had no concurrent conditions or medical history. She was otherwise healthy. In spring 2015, the patient was vaccinated with the first dose of GARDASIL 9 (70mg, lot # and anatomical location were not reported). On an unspecified date on 2015, the patient was vaccinated with the second dose of GARDASIL 9 (lot # and anatomical location were not reported). It was reported that the patient only received 2 out of the 3 recommended doses of the vaccine (Drug use for unapproved schedule). The series of vaccination stopped in Summer 2015. Additional information is not expected since there is no consent to contact the reporter nor the doctor.
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. No Medical History information was reported. On 07-Jan-2021 at 11:21 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 11:21 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The age of patient was provided as 76.54 years. Concomitant products were not provided. Excursion time was 09:00 AM and 2 PM, temperature was 34 and 35 respectively, total doses given for the day was 98, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 05-Jan-2021, vial was moved to clinic on 08-Jan-2021. 2 vials were sent to clinic. Vaccine BUD date was 04-Feb-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
slight thrombocytopenia; This spontaneous case was reported by a physician and describes the occurrence of THROMBOCYTOPENIA (slight thrombocytopenia) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOCYTOPENIA (slight thrombocytopenia) (seriousness criterion medically significant). At the time of the report, THROMBOCYTOPENIA (slight thrombocytopenia) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.  Company comment-This spontaneous case concerns a patient of unspecified age and gender with no medical history reported, who experienced the unexpected serious (medically significant) AESI of Thrombocytopenia which occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date and onset date of event was not disclosed. Patient had slight thrombocytopenia after administration with Moderna Covid-19 vaccine. Outcome of the event was not known at the time of report. No further information on risk factors, concurrent illness, detailed clinical course, investigations results, treatment of the event and details pertaining to the doses was available in the report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a patient of unspecified age and gender with no medical history reported, who experienced the unexpected serious (medically significant) AESI of Thrombocytopenia which occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date and onset date of event was not disclosed. Patient had slight thrombocytopenia after administration with Moderna Covid-19 vaccine. Outcome of the event was not known at the time of report. No further information on risk factors, concurrent illness, detailed clinical course, investigations results, treatment of the event and details pertaining to the doses was available in the report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per medical judgement.
Patient states she had nausea and a lot of gastrointestinal symptoms about 32 hours after vaccination and vomited once.  She also states that she has a welt at the administration site, red and hot to the touch, also 24 hour after the vaccine and still currently.  She also had a low grade fever about 24 hours after the vaccine, never over 101 degrees F and is now back to normal.
EE reports fever of 100.3, achy,  muscle and joint pain, and HA. Treatment with Tylenol with no improvement. She will continue to monitor.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 16-JAN-2015, the patient received the ZOSTAVAX (lot number, dosage and route of administration not provided), for its intended purpose the prevention of shingles. On 02-OCT-2016, the patient suffered from a shingles outbreak, in addition to chronic pain, rash and lesions to various parts of his body as a direct result of the ZOSTAVAX. As a direct result of ZOSTAVAX vaccine, the patient suffered mental and emotional distress due to resulting physical limitations and seriousness of his condition. The patient has suffered serious, progressive, permanent, and incurable injuries, as well as conscious pain and suffering, mental and emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred medical expenses and other economic harm as a direct result of ZOSTAVAX use. The outcome of the event was unknown. Causality assessment was related. The event of shingles outbreak was considered disabling. Additional information has been requested.
10 hours after flu shot c/o "severe headache, severe joint aches, swollen glands in neck, entire back of neck very painful, intense temperature" for 2 days. No reaction at all last year per patient.
This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown gender and unknown age. On an unknown date the unspecified patients were vaccinated with improperly stored VAQTA. No adverse effects were reported. No product quality complaint (PQC) was reported for VAQTA. This is one of the several reports from the same reporter. Additional information has been requested.
pt recvd vax & around 8PM a/pt sent to sleep around 130-2 pt woke up w/fever 105; mom contacted MD around 10AM next morning & was told pt had a react to DTP & was never to receive DTP again; pt irritable;
08/25/22 presents to ED for "palpitations and chest pressue". PMHx of "WPW, HTN, anxiety, GERD"
After HPV vaccine on dec 13 2022, developed progressive shoulder joint pain despite ibuprofen, found to have tendonitis. also experiencing intermittent dizziness, flutter/palpations.
Chest pain/pressure; heart-related (left side of chest). Still ongoing; I feel it a few times a week. It lasts several minutes; usually fades away in 15 minutes.
pt recvd vax & pt was fussy; @ 6PM pt began crying, & was fed p/that & vomited used warm compresses; rt leg was red, warm & swollen 4-5AM raised 1/2 cm, lt leg warm, red & sl swelling; 2 cm was given APA @ 615PM; alert, smiling, neck supple
Swollen lymph node in left side of throat. Formed swollen lump that lingered for two weeks. No pain, just concern and made doctors appointment for examination.
Information has been received from a physician concerning a female who was vaccinated with a dose of GARDASIL. The patient had not gotten her period since she received the vaccination and the patient thought that it was because of vaccination. Medical attention was sought. The patient was placed on birth control pills (manufacturer unspecified) to regulate her menstrual cycle. The patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Shooting pain in hips, body aches, fever, diarrhea, headache, chills, large red circle around vaccination site and warm and hard to the touch
Per Dr. Vaccine clinic note 41 yo female received 2nd dose Moderna complains of  Dizziness, light headed,   And chest pressure Pt with chronic pain. She states the discomfort in chest is  Something she has not experienced before.  No nausea Rated 5/10,  Some diaphoresis   Denies hx of cad                    - dm                    - smoking   Medications reviewed   140/80   Hr 84 heent -neck  Lungs clear to a and p Cor rrr Ab soft  Ext no    Assessment Chest pain  Chronic pain    Will transport to ER for further evaluation  EMS here to transport Report given to triage nurse at kaiser ssc"
Vaccine was diluted with incorrect diluent solution. Patient did not experienced any symptoms or side effects. Patient was called to advised of need to repeat dose. Has appointment scheduled to repeat dose on 04/16/2020.
Started after about 2 months after my third dose have chest pain. Also various roving joint pain, in my one knee and ankle and wrist. This is similar to what I had when I had an outbreak of Sarcoidosis, except not as severe. I am referring to the joint pain. I am hoping this goes away or I will visit my Doctor.
I tested positive for COVID-19 on 05/29/2022 with symptoms of runny nose, congestion, cough, chills, fever, and I mistook my symptoms for allergies. I am on a cruise and was tested by the ships doctor when I sought treatment for what I had assumed were allergies. I was given acetaminophen, dextrin, chlothinyzine, and phenylephrine combined cold medication. I was not offered monoclonal antibodies or Paxlovid. My symptoms have improved slightly, but I am still feeling ill at this point.
He received the vaccines on 4/27/20. A few hours after getting his vaccines he developed pain in his left arm. He received Bexsero in this arm.   The pain is in the upper 1/3 of his arm up to the shoulder joint.  He does not have pain in his lower arm. He had mild swelling and redness on his left arm around the injection site for two days but this has improved.  He has not had fever.  He has taken ibuprofen and naproxen for pain which helps some.  Pain is mostly constant but will resolve if he is very still.  He has been unable to lift his arm above the level of his chest in any direction.  Passive range of motion also causes severe pain.  He will see orthopedics on 5/5/20. Further evaluation and treatment recommendations per orthopedics.
1/13/2021 Pfizer Covid Vaccine 2/3/2021 Pfizer Covid Vaccine 8/3/2021 ill 8/4/2021 PCR test positive for Covid 8/11/2021 potential to return to work
(URI) Upper Respiratory Infection; fever; Body aches; Nasal Congestion; cough; sore throat. Fever 101 degrees. Tx: (1) IV Bolus then maintenance fluids. (2) CBC BMP (Complete Blood Count) (Basic Metabolic Panel). (3) Flu Swab and Throat Culture. Vaccine Failure.