chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. Patients' concurrent conditions, concomitant medication and medical history were not provided. Since 26-JAN-2015, doses of PEDVAXHIB (lot#, expiry date, dose, route and dose number were not provided), which were exposed to temperatures outside of the recommended range, had been administered to the unspecified patients (dates unspecified). No adverse effect had been observed or reported. This is one of several reports received from the same source. Additional information has been requested.
pt started to complain of itching to his left arm.  pt was noticed to have a couple welps around the injection site and red raised hive on his upper lip
Information has been received from a registered nurse concerning a 26 year old female who on 11/06/01 was vaccinated with the first dose of varicella virus vaccine live. On 11/22/01, the pt noticed six pox marks on her body which were dispersed in different areas and were described as being consistent with chickenpox. The pt also stated that her arm was sore and red at the injection site and reported that she experienced burning at the injection site . At the time of this report, the chickenpox type rash had resolved, however , the injection site pain was still bothering her. The outcome of the injection site erythema and burning was unknown. Unspecified medical attention was sought. Additional information has been requested.
Initially arm was sore for two days and headaches in the morning.  Today, 7 days after the shot,  arm is red and blotchy at injection site.
dose administered to patient was prepared from a vial that had been stored in  freezer -25 C to -15 C for a total of 19 days. maximum allowed time per pfizer temperature excursion table is 17 days.
patient got the Pfizer vaccine and after second dose came down with the covid virus; patient got the Pfizer vaccine and after second dose came down with the covid virus; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), both the first and second dose via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, it was reported that the patient got the "Pfizer vaccine" and after second dose came down with the COVID virus. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on an unspecified date. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on a temporal association and safety profile, a causal relationship between the reported event and suspect drug  bnt162b2 is assessed as possible.
pediatric patient received adult dose; pediatric patient received adult dose; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 1-year-old male patient who received HAV (Havrix 1440 adult) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th May 2022, the patient received the 2nd dose of Havrix 1440 adult and Havrix Pre-Filled Syringe Device. On 19th May 2022, unknown after receiving Havrix 1440 adult and Havrix Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-MAY-2022 Reporter's Comments: The NP (nurse practitioner) reported that an adult dose of Havrix was given to the pediatric patient. The patient were twins. The reporter consented to follow up by postal. Additional supportive information: The use of an adult dose of Havrix to pediatric patient, which led to overdose, adult product administered to child. This case is linked with case US2022081895 reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022081895:Same reporter
Started with uncontrollable shivering cold over the course of several hours, then fever, then became extremely dizzy and fainted.
June 26th- started getting a painful vesicular rash on her left arm- finger- spread up arm to axilla and then to  L scapular area. + axillary lymphadenopathy.  + fever and headache started 6/30/2021. Had a Dr. visit 6/30/2021. Diagnosed with shingles and started on acyclovir. No other areas of rash. No other symptoms. Fever and headache resolved mid day 7/1/2021. Rash on L arm continues- painful.  Also had + rapid strep test that office visit on 6/30/2021- no throat pain- but still placed on antibiotics for strep- penicillin.
DECEASED; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION (DELTA VARIANT); This solicited report received from a consumer: concerned a 51 year old male of unknown race. The patient's weight, height, and medical history were not reported. The patient initiated treatment with 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 in FEB-2021 or MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On SEP-2021, the patient experienced suspected clinical vaccination failure and suspected covid-19 infection (delta variant), and was hospitalized (date unspecified). Patient was released from the hospital and then re-admitted to the hospital. On SEP-2021 Patient was deceased. It was unspecified if autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection (delta variant) and suspected clinical vaccination failure was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and deceased was related, and between covid-19 vaccine ad26.cov2.s, and suspected clinical vaccination failure, and suspected covid-19 infection (delta variant) was not related.  This report was serious (Death, and Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210953828.; Sender's Comments: V0: 20210953961-covid-19 vaccine ad26.cov2.s-deceased. This event(s) is considered related. 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).  20210953961-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. This event(s) is considered not related. 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  20210953961-covid-19 vaccine ad26.cov2.s-suspected covid-19 infection (delta variant). This event(s) is considered not related. The event(s) shows an incompatible temporal relationship.; Reported Cause(s) of Death: DECEASED
Patient felt sharp pain upon administration of shot, then had excessive soreness and bruising. Since pain wasn't improving she made appt. with MD who said shot must've been given in her tendon and now has tendonitis. He predicted she'd feel better in approximately seven days.
Seizure - TM lost consciousness at 1:03p about 3 minutes after receiving vaccine, seizure started seconds after losing consciousness. Transferred to floor, positioned on side, 911 called, VS obtained. Seized again after transferring to floor. TM diaphoretic, cool. VS 116/55, P 51, R 12, O2 97 @ 1:04. Member became responsive at 1:05 but still disoriented. Supportive care and reassurance provided, member became alert to time, person, situation. VS @ 1:09 112/70, P 50, O2 97. Emergency services arrived to assume care at 1:14p. TM transferred to ED via ambulance.
Vertigo 10 days post vaccine. Vertigo lasted 4 days. Another vertigo episode happened June 12th.
Information has been received from a licensed practical nurse concerning a 10 year old male who on 16-May1996 was vaccinated SC in the right thigh with a dose of varicella virus vaccine live.  There was no illness at the time of vaccination.  On 1-Sep-2005, the patient presented with varicella zoster.  It was extensive over the right hip and thigh area to the knee on the same side as the vaccine.  The patient had significant pain one to two days prior to the onset of the rash.  It was a significant vesicular rash with pain which continues to persist on day number three.  The nurse sent for a viral culture for herpes varicella zoster of a lesion on the right inner thigh.  It was unknown if the patient recovered.    Follow up information indicated that the mother of the child "wishes patient would have chicken pox instead of shingles"  She also indicated that she regrets having the varicella vaccine given.  The outcome was reported as recovered the week of 10-Oct-2005.  No additional information is expected.
Patient had anaphylaxis reaction to Pfizer ( LOT#: EW0176, EXP date: AUG2021)first dose. Vaccine administered around 0855, approximately at 0904 patient reported difficulty breathing and reported it to (observer). Observer brought the patient to a patient care room and reported it to the team lead. Patient appeared flushed, Provider noted that the patient was holding her throat. EpiPen 0.3mL (Lot #0FM355 Exp: NOV2021) was administered at 0910 and held in patients left thigh for 10 seconds. Patient reported a burning sensation when Epipen was given. EMS was called at 0913 arrived at 0922. Patient reported lip tingling and chills after EPiPen was administered. Patient developed a horse like cough but was reporting that her ability to breath was getting better. Vital signs taken at 0908 BP: 124/84 HR:82 O2: 98%. Second Vital signs taken at 0920 BP: 124/84 HR:100 O2: 98%. Third set of vitals taken at 0930 BP: 130/88 HR: 102 SPO2: 98%. Patient transported to Hospital at 0932.
Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Visual Changes/Disturbances-Medium
Patient had extreme chills, sweating and teeth chattering. Has had vaccine in the past and never had symptoms like this. It last about 36 hours and patient was unable to sleep.
pain in arm and muscles since date of injection until current date. unable to walk properly. unable to use arms properly.
admitted with a cerebellar stroke; This is a spontaneous report from a contactable physician. A 73-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 27Feb2021 as single dose for COVID-19 immunization. Medical history included ongoing Hypertension, ongoing Diabetes, ongoing Cholesterol, ongoing Chronic UTI, gastrooesophageal reflux disease, depression, diabetic neuropathy, blood pressure abnormal. Concomitant medications includes, atorvastatin taken for blood cholesterol from an unspecified start date and ongoing; omeprazole taken for gastrooesophageal reflux disease from an unspecified start date and ongoing; sertraline taken for depression from an unspecified start date and ongoing; pregabalin taken for diabetic neuropathy from an unspecified start date and ongoing; losartan taken for blood pressure measurement from an unspecified start date to 15Mar2021; captopril, hydrochlorothiazide taken for blood pressure measurement from an unspecified start date to 15Mar2021; glimepiride taken for diabetes mellitus from an unspecified start date to 15Mar2021; cefalexin taken for urinary tract infection from an unspecified start date to 15Mar2021; metformin taken for diabetes mellitus from an unspecified start date to 15Mar2021; dulaglutide taken for diabetes mellitus. It was reported that, they have been holding her blood pressure and diabetes medicine during her admission. On 15Mar2021, patient was admitted with cerebellar stroke. It was reported that, condition has improved slightly and she would most likely discharge to a skilled nursing facility. Patient did not believe that she did receive any other vaccinations on 27Feb2021, but was unsure. On 15mar2021, the patient underwent lab tests and procedures which included angiogram: stroke, magnetic resonance imaging: stroke on 15Mar2021. As therapeutic measures for cerebellar stroke, the patient was put on Aspirin, Plavix and the dose of atorvastatin was increased to 80 mg. The outcome for the event was recovering.  Follow-up activities have been completed and no further information is expected.; Sender's Comments: The event of cerebellar stroke is assessed as possibly related to the suspect vaccine BNT162B2 based on temporal association, but consider also possible contributory effects from patient's medical history and/or concomitant medications.
2-3 days after receiving my 1st covid vaccination, I developed noticeable heart palpitations; visited the clinic again on 3/29/21 and saw Dr.  EKG was normal; wore holter monitor for 48 hours a couple of weeks later; results:  1. This 48 hour holter monitor reveals a predominant rhythm of sinus rhythm at rates of 42-106 bpm. Average heart rate 65 bpm. 2. No ventricular ectopy occurred. 3. Rare supraventricular ectopy occurred as three isolated beats. 4. No significant pauses noted
a lot of diarrhea; can't keep anything down; body aches/body pains; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (a lot of diarrhea), FEELING ABNORMAL (can't keep anything down) and MYALGIA (body aches/body pains) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-May-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, the patient experienced DIARRHOEA (a lot of diarrhea), FEELING ABNORMAL (can't keep anything down) and MYALGIA (body aches/body pains). At the time of the report, DIARRHOEA (a lot of diarrhea), FEELING ABNORMAL (can't keep anything down) and MYALGIA (body aches/body pains) outcome was unknown.        No concomitant medication information was Reported No treatment medication information was Reported Action taken with mRNA-1273 in response to the events was not Applicable.   This case was linked to MOD21-091481 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: follow-up Information recived on 18-JUN-2021 contains non Significant Information; Sender's Comments:  MOD21-091481:
No adverse event; Patients had been administered with the Moderna vaccine (more or less 170 monovalent) which were beyond the 30 days beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients had been administered with the Moderna vaccine (more or less 170 monovalent) which were beyond the 30 days beyond use date) and NO ADVERSE EVENT (No adverse event) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053c21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients had been administered with the Moderna vaccine (more or less 170 monovalent) which were beyond the 30 days beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients had been administered with the Moderna vaccine (more or less 170 monovalent) which were beyond the 30 days beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patients had been administered with the Moderna vaccine (more or less 170 monovalent) which were beyond the 30 days beyond use date).    No concomitant medication was reported.  Pharmacist reported that they have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 monovalent and 20 bivalent) which were beyond the 30 days beyond use date.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Live Significant Follow-up received; Patient information and vaccinations details updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
right ear plugged up constantly pressure in head cannot pop right ear intermittent pain in the right ear balance issues/dizziness/unsteady on feet/feel like a drunk feel like there is a blurriness overall (not cognitive), but like a veil/lack of "clarity" in the head tinnitis in right ear hear blood flowing to my head - like I am listening in on the inside of my body fatigue The second dose of the Moderna vaccine was received at the same location on April 2, 2021. Lot number 025A21A. The lot number for the first dose above may be incorrect as it was handwritten on my card and hard to read... As of the date of completion of this form, there is no definitive diagnosis of the balance/head fullness/ear issue. Follow up with both cardiology and neorology have been scheduled. Audiology testing has been scheduled. Whatever this is (if due to the vaccine) has had a significant negative quality of liffe effect - cannot do a number of the normal activities that I would otherwise do, sometimes interferes with work.
Shingles; Information has been received from a lawyer, referring to a patient of unknown age and gender. Information regrading the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provide. On or about 02-JAN-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot # and expiration date were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, subsequent to vaccination, the patient was treated by healthcare providers for shingles (herpes zoster). As a direct and proximate result of use of the zoster vaccine live (ZOSTAVAX), the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care, 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, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. At the time of the report, the outcome of herpes zoster was reported as not recovered. The lawyer considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).
This spontaneous report was received from a pharmacist referring to a female patient of unknown age.  On 08-AUG-2017, the patient was vaccinated with ZOSTAVAX lot # M038864 and expiration date on 12-DEC-2017 for prophylaxis. The sterile diluent (MRK DILUENT) lot # M042852 and expiration date on 30-MAY-2019 used for reconstitution of the vaccine was properly stored. The doses of ZOSTAVAX were exposed to a temperature excursion of 15 degrees Fahrenheit (°F) to 46°F during a time frame of 1 hour and 45 minutes, which was detected by the data logger. there was not prior temperature excursion and no adverse events were reported.
10 days after injection (09/12/21), BP (normal prior to this and on meds e.g. 121/77), spiked to 157/103, 167/107 x 2 days.  On 09/13/21,  I noted in the late morning a stiffness in ambulation and discovered that my inguinal lymph nodes were very enlarged and hard making flexion  difficult.  Over the next few hours, I noted enlarged cervical lymph nodes and by 5 pm I had very enlarged sub-mandibular lymph nodes making chewing  and tongue movement difficult.  No increase in temperature.  Over the next three days, the lymph node enlargement slowly decreased.  Blood pressure readings also gradually returned to normal.
Pt called back 2-3 hours after leaving from vaccine to report that her lips were tingling and her chin was tingling, and she had some flushing. She stated that she had been monitoring her vitals and that she had no trouble breathing or swelling. Pt stated that she took a Benadryl to treat it.  I told pt that if she was having any difficulty breathing she should call 911 or go to the hospital immediately. She stated that she thought she was past the anaphylactic reaction point, and she did not want to go to the doctor. I informed her that if she begins to have any trouble breathing to call 911 as soon as possible.
Resident expired on 10/09/2022 No s/s leading up to it  No adverse effects after vaccine administration
patient started the next day with hives and since then has had hives of varying degrees all over body, as one site starts to resolve, another comes denies angioedema, dyspnea, or GI issues
Patient 14 years old and received Moderna covid vaccine which is only indicated for 18 and older. No adverse reactions to vaccine.
Day of 2nd vaccine dose 25JAN21 patient reported muscle aches and chills, the day after 2nd vaccine dose 26JAN21 patient reported fever 102.5 and headache, 2 days after 2nd vaccine dose patient reported loss of taste.
I believe it was from the rotavirus. Symptoms started about 2 to 3 days after being vaccinated. My son developed horrible reflux (was already spitting up but now in severe pain) which required ZANTAC. Mucousy, foul smelling stools for approximately 6 weeks after vaccine.
approximately 5 mins after vaccine administration patient felt itching, tickling feeling, and warmth on her abdomen around her naval area.  Patient monitored for full 30 mins. Redness decreasing, itching & tickling resolved by discharge at 1140. MD discussed OTC Benadryl use.
This spontaneous report was received from a medical assistant and refers to a 12 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 18-JAN-2016, the patient received improperly stored GARDASIL 9 (lot number L016429 and expiration date 09-AUG-2017, dose, anatomical location and route of administration were not provided). On 19-MAR-2016, the patient also received improperly stored GARDASIL 9 (lot number L037339 and expiration  date 09-FEB-2018, dose, anatomical location and route of administration were not provided). The vaccine underwent temperature excursion of either plus 1 or minus 1 Celsius degrees for 255.5 total cumulative hours. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.