chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Delirium; Severe fever 102+; Aches; chills; Restlessness; Headache; Weakness; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration administered in arm right on 14Apr2021 09:30 AM (Lot Number: EW0158) at vaccination age of 44 years old as single dose for covid-19 immunisation.  Medical history included hypertension, high cholesterol, Cephalosporin allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications within 2 weeks of vaccination included atorvastatin calcium (LIPITOR) taken for blood cholesterol increased; tadalafil (CIALIS). The patient previously took 1st dose of   BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot: EN6206) via an unspecified route of administration administrated in Left arm on 24Mar2021 at time of 09:45 AM at vaccination age of 44 years old as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe fever, 102+, aches, chills, delirium, restlessness, headache, weakness on 14Apr2021 at time of 11:00 PM. No treatment received for the adverse event. The patient underwent lab tests and procedures which included body temperature: greater than 102 fahrenheit on 14Apr2021.  The outcome of events was recovering. Since the vaccination, the patient had not been tested for COVID-19.
Hospitalized 10/23/2021; COVID-19 positive 10/23/2021; fully vaccinated  Discharge Provider: MD Primary Care Provider at Discharge: MD Admission Date: 10/23/2021 Discharge Date: 10/26/2021   DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: COVID-19 [U07.1]   Patient is a wonderful 102 y.o. female with PMH of diabetes mellitus type 2, atrial fibrillation, hypertension, hyperlipidemia, CKD 3 who presented to the Emergency Department on 10/23 via EMS with increasing fatigue and lethargy secondary to covid19 infection.     Patient's VS were largely normal on presentation, labs initially were otherwise at baseline for patient and she didn't require oxygen.  CT head didn't show acute process.  Echo was obtained and showed normal LV function with possibly mildly reduced RV function.  Patient remained clinically stable and on room air however Cr uptrended and BP was low so lisinopril was held and fluid were given.  Patient continued to clinically do well and creatinine decreased on f/u check though Na was down to 129 (has been low at least since April) with both AKI and hyponatremia most likely being from poor PO intake.  Patient was seen by PT/OT who recommended SAR however patient and family opted for home care.  Patient was discharged with lisinopril held and she should avoid NSAIDs entirely going forward.  She will need close PCP f/u with repeat BMP to monitor sodium and creatinine.  Should sodium fail to improve would recommend obtaining urine sodium and osm to assess for SIADH.    Of note, patient had blood cultures obtained on presentation and on day before DC 1/2 cultures showed globicatella species; patient clinically did well off antibiotics with clinical improvement and this was felt most likely to be a contaminant.  ID (not officially consulted) did review case and recommended repeat BC which were obtained before DC but did not feel patient needed to stay in hospital for results with plan for either PCP to f/u on results if negative or hospital will reach out if cultures result as positive
SECONDARY BACTERIAL INFECTION IN NECK; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age, sex, race and ethnic origin. 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 not reported, batch number: unknown, expiry date: UNKNOWN) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced secondary bacterial infection in neck, suspected clinical vaccination failure, and suspected covid-19 infection. It was reported that, "I caught covid from someone who had vaccine and all booster shots. I contracted it from him. Covid caused a secondary bacterial infection in my neck which I had to go through two operations while under the effects of covid. No doubt covid caused my secondary bacterial infection. I am lucky to still be alive and if the vaccine worked all that would have never happened."  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection, secondary bacterial infection in neck and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000217483. This case, from the same reporter is linked to 20220234118.; Sender's Comments: V0: 20220234819-COVID-19 VACCINE AD26.COV2.S- secondary bacterial infection in neck. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable. 20220234819-COVID-19 VACCINE AD26.COV2.S- suspected clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
I''ve passed out several times; Headaches; leg pain; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 17Sep2021 14:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included known allergies: Sulfur. Patient did not have COVID prior vaccination. There were no concomitant medications. Patient passed out several times and patient had not been sick nor taken any medicine. Patient also experienced headaches and leg pain. Adverse events start date was 20Sep2021. Treatment for the events was unknown. Nasal Swab on 17Sep2021 was negative. Outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Pain, / in the arm (site of injection); swollen / in the arm (site of injection); redness in the arm (site of injection); general discomfort.; This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced injection site pain, injection site swelling, injection site erythema and general discomfort. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema and general discomfort were unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema and general discomfort to be related to Bexsero.  Additional details were reported as follows: The age at vaccination was not reported. Nurse informed that after the vaccination of patient with Bexsero, the patient experienced pain, swollen, redness in the arm (site of injection) and general discomfort. The reporter consented to follow up. This case is 1 of the 13 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR209822:same reporter US-GLAXOSMITHKLINE-US2020208660:same reporter US-GLAXOSMITHKLINE-US2020AMR210161:same reporter US-GLAXOSMITHKLINE-US2020AMR210162:same reporter US-GLAXOSMITHKLINE-US2020AMR210163:same reporter US-GLAXOSMITHKLINE-US2020AMR210164:same reporter US-GLAXOSMITHKLINE-US2020AMR210165:same reporter US-GLAXOSMITHKLINE-US2020AMR210160:same reporter US-GLAXOSMITHKLINE-US2020AMR210159:same reporter US-GLAXOSMITHKLINE-US2020AMR210166:same reporter US-GLAXOSMITHKLINE-US2020AMR210156:same reporter US-GLAXOSMITHKLINE-US2020AMR210158:same reporter
Achy pain in left shoulder. Injection site was high on the arm. Achiness comes and goes. The site of pain is a couple of inches below the injection site. I have this pain numerous times a day for up to an hour. It hurts to lift my arm.
Pt was seen for a well 15 month checkup on 2/20/01. She had mild wheezing and was afebrile. She was given MMR, Varivax and Prevnar #2. She was treated with albuterol syrup and Zithromax. She had a cardiopulmonary arrest on 2/23/01. Is there a correlation between mild wheezing, any of the vaccines, the medications used and sudden death? Pt had unexplained cardiopulmonary arrest and expired. Autopsy also states bruise right side of forehead, congestion, pulmonary edema. Cause of death given as acute bronchitis.
allergy; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (allergy). At the time of the report, HYPERSENSITIVITY (allergy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Upon in internal review on 21 May 2021, the age was corrected to unknown age.  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.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 19-Feb-2021: Upon internal review on 27 May 2021, it was discovered that the patient age was incorrectly captured as 121 years and DOB mentioned in source document was 01-Jan-1900, which was a error. The patient age and narrative has been updated to unknown age with reports re-submission and significant amendment is performed for the correction.; 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.
Information has been received from a registered nurse concerning a 67 year old female with chronic obstructive pulmonary disease, sodium pentothal allergy, sulfonamide allergy and codeine allergy who on 07-JAN-2008 was vaccinated subcutaneously with a single dose of ZOSTAVAX (Merck) (lot # 656861/0329U). Concomitant therapy included SPIRIVA, ADVAIR and albuterol. In February 2010, the patient was diagnosed with shingles. The patient called the office on 17-FEB-2010 to report she was hospitalized. The patient was discharged and was prescribed acyclovir, hydrocodone and alprazolam. The patient was seen in the office on 13-APR-2010 and was noted to be recovering. Additional information has been requested.
Received phone call from county human resources dept that pt called his family MD on 9/27/06 PM and told his MD he has a rash all over and was very itchy. Pt instructed by MD to take Benadryl which cleared the rash.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 12-FEB-2015, the patient was vaccinated with a dose of ZOSTAVAX (administration route and lot number were not provided) which expired on 29-AUG-2014. No concomitant medication was reported, neither was any adverse effect. Additional information has been requested.
Client fainted at the checkout counter. Her mother laid her to the floor. She regained conscious immediately without intervention. Client was pale, diaphoretic, hyperventilation.
Had the vaccine but still got shingles/ suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had the vaccine but still got shingles/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was resolving.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 31-MAR-2023 This case was reported by patient's relative via  interactive digital media. The reporter reported that his or her mother received Shingles vaccine and experienced shingles right now. The reporter also reported that it had been 3 weeks and shingles are just started to heal. The reporter reported that it was the worst thing ever she had. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory details were unknown at a time of reporting. The follow-up could not be possible as the as no contact details were available.
Breakthrough COVID-19 case with symptom onset 9/20/2021: Aches, Shortness of breath/difficulty breathing. Hospitalized 9/20/2021 for unknown duration
pt recvd 1st dose of Hep B on 17SEP91; 2 wks p/vax pt devel a blanching of skin & a circular hypopigmented lesions approx 3 cm in diameter @ inject site; pt recovered;
This spontaneous report was received from a registered nurse referring to a 12 year old male patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 02-OCT-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored (incorrect product storage). This is one of several reports received from the same source.; Sender's Comments:  US-009507513-1709USA008666:
Approximately 22 hours post  vaccine injection, I felt like I was going to pass out. I got hot, sweaty, ringing in both ears, and tunnel vision. I had to lay down for an unknown amount of time until the feeling passed.
Information has been received from a physician concerning a 19 year old female who became sexually active at 16.5 years old and had a normal PAP December 2006. In December 2006 the patient had her first dose of GARDASIL (therapy route, site unknown), second January 2007, and her third March 2007. In August 2008 the patient had an abnormal PAP for high risk HPV. In October 2008 she had a colposcopy (results not provided). At the time of report, the patient was not recovered. Additional information has been requested.
On 9/20/2021 I drew up a dose of Janssen Covid-19 vaccination. This was the first dose drawn from the vial. I did not check the expiration date of the vial. I gave the syringe to my coworker, RN,  who administered the vaccine to the staff member. Later that morning another coworker came in and told us that the vaccine had expired on 9/19/2021. I then called Janssen for further guidance. I was told to alert VAERS and follow local jurisdiction guidelines.
10-29-11: Severe aching in lower extremity joints. 10-30-11: Achy, cold chills, small bump appeared on (R) arm - filled with clear fluid. That evening, noticed these bumps on lower extremities. 10-31-11: More bumps appeared (no itching). Severe pain in ankles, knees - all over. No appetite. MD visit to walk in clinic - not treatment. 11-1-11: Could hardly walk due to pain. Lower extremities swollen, red, MD visit.
Pt. felt mouth numb and had a headache in observation line.  Paramedic assessed her until pt. symptoms subsided.  Paramedics released her to leave.
expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired doses administered) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses administered). On 07-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On December 6, 2021, Lot 012H21B vials were placed in refrigerator. No concomitant medications were given. No treatment information were given.   This case was linked to MOD-2022-449479 (Patient Link).
COVID-19; This spontaneous report received from a consumer concerned an adult female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported, per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced covid-19. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 was not reported. This report was non-serious.
On 8/10/98 pt recv vax and 3 mins later exp hives at injection site, then on face and arms.  Pt tx=Benadryl.  Allergist consulted; pt observed for 1 hour; hives dissipated.  Pt sleepy, color good.
lump is on the arm; arm soreness near injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (lump is on the arm) and VACCINATION SITE PAIN (arm soreness near injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced VACCINATION SITE MASS (lump is on the arm) and VACCINATION SITE PAIN (arm soreness near injection site). On 07-May-2021, VACCINATION SITE MASS (lump is on the arm) had not resolved. At the time of the report, VACCINATION SITE PAIN (arm soreness near injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.   Reporter did not allow further contact
Severe muscle soreness in hamstrings, inner thighs and lower back. Is now also in spine, neck, shoulders, knees and feet also pelvic area.
pt reported sever itching, rash, swelling, SOB, facial numbness 2 days p/vax;seen by MD given pred, atarix for sx;
chills/fever, severe vomiting (couldn't even keep water down for 2 days), headache, body aches, loss of balance  Due to being a "brittle" type 1 diabetic I am reluctant to get the second shot. (Fear of dying)
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Jun2021 as dose number unknown, single (Batch/Lot number: unknown), in left arm and in Aug2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "Known allergies: Avocados" (unspecified if ongoing). There were no concomitant medications, reported as no other medication in 2weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of suspected covid-19 started on 22Apr2022 and stopped on unspecified date in Apr2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Daughter stated that her father didn't feel well a few hours after vaccine. Reported fever (for total of 6 days), vomiting, shortness of breath, muscle pain, and couldn't urinate. After a few day they took him to hospital where he was admitted into ICU for 1 week
Bruising at injection site-bluish/purple in color. Nausea with severe headaches.
FEVER 101 F FOR 4 DAYS THEN RASH, ITCHY & RAISED BUMPS
The next day she started vomiting, stomach pain, diarrhea. This lasted for about 12 hours. She was just eating ice chips to stay hydrated.
ringing in ears; sinus infection; runny nose and ears were blocked a little; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ringing in ears), SINUSITIS (sinus infection) and RHINORRHOEA (runny nose and ears were blocked a little) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included Sinus infection.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced TINNITUS (ringing in ears), SINUSITIS (sinus infection) and RHINORRHOEA (runny nose and ears were blocked a little). At the time of the report, TINNITUS (ringing in ears), SINUSITIS (sinus infection) and RHINORRHOEA (runny nose and ears were blocked a little) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported. Upon follow up information received on 16 JUL 2021, reported stated that after received the first dose of Moderna vaccine patient experienced ringing in the left ear and hesitant to get the second dose. They have been seen a specialist but it did not help the patient, and that after a year they were getting better.   Most recent FOLLOW-UP information incorporated above includes: On 02-Mar-2021: Narrative was updated.
Broke out in a rash, which was itchy and moved around my body in different locations starting on my upper arms, then breast, then ears, then lower legs then abdomen. It occurred two days after the vaccination around 8;20 pm (Monday, 22 March 2021). I had never experienced this before. I occasionally get a skin rash but this is not very often . I had eaten anything different or used a new soap or cream. The next day I took Benadryl and a cortisone ointment to calm the itch. I did not have any pain or water. when it dod not want to steel and was moving around my body, I visited the clinic. The doctor prescribed an antibiotic called Cephalexin