chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report was received on 04 September 2012 via a search of the scientific literature. The following is verbatim per the report: "Background: Annually, over 2 million are administered influenza vaccinations. As of the 2010-2011 influenza season, the safety of the influenza vaccine was actively monitored nationally. Possible associations between potential adverse events of interest and influenza vaccination were evaluated at the end of the influenza season. Objectives: The goal of this study was to determine the safety of the 2010-2011 influenza vaccinations in the population treated. Methods: Integrated automated databases were used to identify patients who were diagnosed with Guillain-Barre Syndrome (GBS), idiopathic thrombocytopenic purpura (ITP), and Bell's palsy from 10/1/10 to 3/31/11 as identified by ICD-9 code. The influenza vaccination status for these patients was determined using the Immunization Package database in addition to the integrated automated and prescription databases. Adverse event rates in the risk period (within 1-42 days) were compared to rates in the non-risk period (43 days or after) in terms of incidence rate ratios (IRR) using the self controlled case series method. Only vaccinated cases were included. Seasonality was included to account for possible fluctuation of disease occurrence over the calendar time. Results: Approximately 2.1 million received the influenza vaccines (including 42,375 high-dose vaccines) from 10/1/10 to 3/31/11. A total of 38 GBS, 81 ITP, and 575 Bell's palsy post-vaccinated cases were identified. No significant risks for GBS (IRR = 2.07 and 95% CIs =0.59-7.24), ITP (IRR = 0.71, 95% CIs = 0.32-1.59), and Bell's palsy (IRR = 0.90, 95% CIs = 0.67-1.22) were observed for patients who received the regular dose influenza vaccines. Similarly, no significant increased risk for Bell's palsy (IRR = 1.13, 95% CIs = 0.21-6.02) was observed for patients who received high-dose influenza vaccines. There were no GBS and ITP cases after high dose vaccines. Conclusions: There was no evidence of increased risks of GBS, ITP, and Bell's palsy following 2010-2011 influenza vaccinations in the population treated in the health care system." The reporter for this case is the same as for case number 2012-08441. Documents held by sender: None.
Tachycardia to 120s; Palpitations; This is a spontaneous report from a contactable physician (patient). A 35-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685), via an unspecified route of administration on the left arm on 19Dec2020 16:45 at a single dose for COVID-19 immunization. The patient's medical history included hypertriglyceridemia. There were no concomitant medications. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 19Dec2020, the patient experienced tachycardia to 120s and palpitations. No treatment was received for the events. The patient underwent lab tests and procedures which included heart rate was 120s on 19Dec2020. Outcome of the events not recovered. The events were considered non-serious.
02/12/22 presents to ED for "fall". PMHx of "chronic back pain"
This spontaneous report was received from a pharmacist, concerning a 69 years old female patient with unspecified dental problems. There was no medical history reported and the patient did not have any drug reaction or allergy. The concomitant therapies included acetaminophen (+) oxycodone (PERCOCET). On 12-FEB-2017, the patient was vaccinated with an intramuscular dose of PNEUMOVAX23 (dose, frequency, lot # and expiration date were not reported) for increased risk of pneumococcal disease due to age and then, she experienced soreness, stiffness, swelling and erythema from the shoulder to the elbow beginning at an unspecified time after receiving the vaccine. The patient sought medical attention by contacting the primary reporter. The outcome of the adverse events was reported as not recovered at the time of reporting. No product quality complaint (PQC) was involved.  The causality between the mentioned adverse events and PNEUMOVAX23 was unknown. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA006019: US-009507513-1706USA005964: US-009507513-1702USA006102:
Cause of death not documented.  The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Significant comorbidities include HTN, hyperlipidemia, COPD, GERD, prolonged QT interval, and history of polypectomy.
A spontaneous report has been received from Health Professional, with follow up from another Health Professional, concerning a 9 years old male patient. No information regarding relevant medical history, concomitant disease or concomitant medication was provided. On 24-Aug-2013, the patient was receiving FLUMIST (Intranasal). The reporter stated that three patients received FLUMIST and then get the flu on 07-Nov-2013. The patient recovered from the event of flu on an unspecified date. The reporter considered the event of flu to be non-serious. Summary of follow-up information received by AstraZeneca/MedImmune from Health Professional on 25-Nov-2013: date of birth, two new reporters, patient initials drug start date, onset date, lot number added; outcome changed to recovered.
her second shot was pretty sick for 2 or 3 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the parent.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (1st dose, Manufacturer: Unknown), for COVID-19 Immunization. The following information was reported: ILLNESS (non-serious), outcome "recovered", described as "her second shot was pretty sick for 2 or 3 days".  Additional information: Patients second shot was pretty sick for 2 or 3 days so mother guess it effects everybody differently.  The follow-up was being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
I went into the doctors for a pre-physical exam for an operation I was going to have on my foot. I was perfectly healthy. I do not have a spleen so the nurse practitioner said I needed these shots. She gave me the ones above. I am not sure of the name of the Meningocacal shots. It says Serogroup B Meiningococal Vaccine (MenB). She said there were three in the series and she would just give me two. The pneumon shot was also given at the same time. I woke up on May 12th and was completely deaf in my left ear.  This is the only thing that could have made this happen. I had no cold at the time.
Subjective fever, chills, headache, lightheadedness, one episode of emesis a few hours after administration today. His father, also a Physician, contacted our office and tells me his son is feeling better after episode of emesis.
Gave pt a Covid booster vaccine that had been opened more than 12Hrs before administration. Vaccine  Opened documenation stated 10/05/2022 13:45 Exp- 10/06/2022 1945. My mistake was that i  just verified exp date and time and not opened time and date. Did review this information with Pt pcp and he reviewed the vaccine information and information stated vaccine was good refrigirated for 10 weeks room temperature 12 hrs. Unable to find information for vaccine stability once opened. He stated vaccine should be ok. Manager was also notiifed vial was discarded
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2015, a pharmacist administered ZOSTAVAX, (lot# and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. In 2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
First 3 days: brain fog slurred speech tingling in face, arms, fingers high fever nausea inability to walk pressure in head - headache -front of head teeth / jaw tight/tingling scratchy throat inability to sleep  Next 7 days: fingers tight - difficulty writing exhaustion nausea tightness in limbs facial tension heaviness
it was on my face and eye; shingles on eye; it was on my face and eye. Got 2 Vaccines/suspected vaccination failure; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles (serious criteria hospitalization) and ophthalmic herpes zoster (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the vaccination failure, shingles and ophthalmic herpes zoster were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and ophthalmic herpes zoster to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had Shingles and was admitted into the hospital because it was on face and eye. The patient further specified that the patient got 2 vaccines so far. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
This felt as bad as having COVID.; fever Saturday night that reached 105F),/"Yeah. Bye brain cells; mistakenly give me the Moderna booster and then gave me a primary dose 30 minutes after; mistakenly give me the Moderna booster and then gave me a primary dose 30 minutes after; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (This felt as bad as having COVID.), PYREXIA (fever Saturday night that reached 105F),/"Yeah. Bye brain cells), ACCIDENTAL OVERDOSE (mistakenly give me the Moderna booster and then gave me a primary dose 30 minutes after) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (mistakenly give me the Moderna booster and then gave me a primary dose 30 minutes after) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Dec-2021 at 10:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Dec-2021 at 11:20 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Dec-2021, the patient experienced FEELING ABNORMAL (This felt as bad as having COVID.), PYREXIA (fever Saturday night that reached 105F),/"Yeah. Bye brain cells), ACCIDENTAL OVERDOSE (mistakenly give me the Moderna booster and then gave me a primary dose 30 minutes after) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (mistakenly give me the Moderna booster and then gave me a primary dose 30 minutes after). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at a dose of 4 dosage form once. On 18-Dec-2021, ACCIDENTAL OVERDOSE (mistakenly give me the Moderna booster and then gave me a primary dose 30 minutes after) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (mistakenly give me the Moderna booster and then gave me a primary dose 30 minutes after) had resolved. At the time of the report, FEELING ABNORMAL (This felt as bad as having COVID.) and PYREXIA (fever Saturday night that reached 105F),/"Yeah. Bye brain cells) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Dec-2021, Body temperature: 105f (High) 105F fever.         No concomitant medications were reported.  Patient went to get his first dose of the Moderna vaccine (069H21A) and there was a bunch of confusion at the pharmacy. They initially thought he was there to get the Pfizer vaccine, but the patient corrected them. The patient stated that they mistakenly give him the Moderna booster and then gave him a primary dose 30 minutes after. He was on his butt entire weekend.
Pt stated that her L arm started to get very warm and swell 10/14/19 afternoon.  Pt stated that she tried  hot packs  to help with the swelling and tenderness but it did not help, started to use Ice packs.  Husband wanted her to go Monday night to the ER due to swelling of arm.  Tues arm was swollen up into the shoulder area and down to the elbow  and all the way around her arm.  Pt continues to Ice  arm. Wed  pt called and wanted to be seen. swelling had gone  down  but not away still in area above elbow. site was red and warm to the touch.   Pt was tx with Triamcinolone Acetonide Cream BID for 7 days
Welts on the left arm and extreme tenderness in the armpits started 11AM Friday peaked at 4 and 10om Friday. By 4pm 9/16 reaction is gone.
warm to the touch around IS; Itch; redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to the touch around IS), VACCINATION SITE PRURITUS (Itch) and VACCINATION SITE ERYTHEMA (redness) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (warm to the touch around IS), VACCINATION SITE PRURITUS (Itch) and VACCINATION SITE ERYTHEMA (redness). At the time of the report, VACCINATION SITE WARMTH (warm to the touch around IS), VACCINATION SITE PRURITUS (Itch) and VACCINATION SITE ERYTHEMA (redness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
Pt received vaccine in left deltoid. A raised area localized reaction occurred. Approximately the size of 10 cm x 9 cm x 2 cm (ht). Pt denied SOB, or difficulty swallowing. Pt advised to take Benadryl if itching persists. Call clinic if any problems develop.
Sore armpit for 7 days.  Severe headache, onset 8 days after.
Tenderness and inflammation at sight; Tenderness and inflammation at sight; This is a spontaneous report from a contactable nurse via Pfizer sales representative. A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient medical history and concomitant medications were not reported. The patient experienced tenderness and inflammation at sight on an unspecified date. The outcome of the events was unknown.  The information on the lot/batch number has been requested.
Moderna COVID-19 Vaccine EUA: Five months after COVID-19 vaccination patient presented to emergency department with nausea, vomiting, and diarrhea. Hospitalized for c diff infection and hyponatremia and found to be COVID-19 positive. Patient improved with antibiotics and IV fluids and maintained oxygenation on room air. Discharged medically stable.
Developed a rash over neck, back arms and spreading.; This is a spontaneous report from a contactable consumer. An 80-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 06Feb2021 12:00 (Batch/Lot number: FL9265) at single dose for covid-19 immunisation. Medical history included none. The concomitant medications were not reported. The patient reported, developed a rash over neck, back arms and spreading on 08Feb2021 on doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken with Triamcinolone 0.1% Cream for the event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19 was unknown; Since the vaccination, the patient not been tested for COVID-19. The outcome of event was not recovered.  No follow-up attempts are possible. No further information is expected.
Rash broke out on upper stomach, right buttock, back and forearms. Rash started as itchy spot and later progressed to hives. Rash on stomach developed blisters and filled in as a red circular rash. Skin is very sensitive. Rash is currently ongoing.
Patient came in today and reported that she had flu like symptoms the day after she received the vaccine but felt better about three days latter. She reported the fatigue never went away since the day after she received the vaccine. She reported that today when she woke up, her left arm which she received the vaccine on was very painful and she cant move it. She reported that the arm is progressively getting worse. She was advised to massage the arm, warm compress, Tylenol or go to the urgent care if she doesn't get better.
Liquid benadryl given at 11:59am following reports of itching of nose and eyes. Changes in voice or breathing which pt contributes to allergic reaction. 2nd benadryl given at 12:10pm, itchiness began to decrease, some itching at vaccination site. 12:30pm, pt reports increase in itchiness on head. Pt left at 12:46pm still reporting itching on head
Myalgia & Fever Narrative: Per supervisor report, "flu-like symptoms" is the only information provided
Right moderate stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Right moderate stroke) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol and Depression.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In June 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jul-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Right moderate stroke) (seriousness criterion medically significant). The patient was treated with Physical therapy for Cerebrovascular accident. At the time of the report, CEREBROVASCULAR ACCIDENT (Right moderate stroke) outcome was unknown.            The patient received second dose in June. Concomitant medications Includes medication for cholesterol and for depression. The patient was receiving physical therapy and there were sequels in the left arm and leg. No treatment medications were provided.  Company Comment: Based on current available information and patient's advanced age and medical history of cholesterol as plausible confounders for the event, causality is assessed as unlikely related to mRNA-1273.; Sender's Comments: Based on current available information and patient's advanced age and medical history of cholesterol as plausible confounders for the event, causality is assessed as unlikely related to mRNA-1273.
Pt. complained that his arm is red and swollen and showed me his arm which looks red and swolled. He went to his MD. MD states he has cellulitis and Tx pt with cephalexin.
pt recv vax 5AUG96 @ 12PM & 3PM pt devel fever;APAP or other fever med given;approx 5PM pt had a sz;mom took pt to ER dx w/febrile sz;pt recovered fully from incident;
Severe itchiness - hives & rash like bumps started in groin & crotch area "spread over time to stomach, legs & arms including wrists and back & buttocks areas, also chest & waist. Medication prescribed. Note: 1) had case of shingles in or about year 1983. Recovered with no ill effects in about 6 weeks - no medication except calamine lotion. Note: 2) Itching often begins after sharp pinprick sensation in that spot.
Feeling of impending doom Throat tightening Tongue swelling Increased heart rate  Increase in blood pressure Dry mouth and throat Dizziness
>35 days between doses; really fatigued after second dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>35 days between doses) and FATIGUE (really fatigued after second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>35 days between doses) and FATIGUE (really fatigued after second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>35 days between doses) and FATIGUE (really fatigued after second dose) outcome was unknown.            NO CONCOMINANT AND TREATMENT MEDICATOPN WERE REPORTED
Early evening of 5/20/2021 large red rash appeared bilaterally on calves, with spreading of rash  overnight of 5/20 to 5/21/21 to the front  of right leg.  Affected areass hot to touch with minimal itching.       No exposure to possible irritants.   It should be noted that patient had also started on tricor  4/20/2021.      The rash is a known symptom of both the covid vaccine and tricor therapy in some cases.   Blood tests ordered (cbc, complete metabolic panel and liver enzymes) but results not yet available.  PCP has seen similar rashes in other patients after covid vaccine so recommended filing the report to vaers out of an abundance of caution.