chrisvoncsefalvay/vaers-outcomes huggingface dataset:
TINNITUS THROUGH THE ROOF; 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 not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 23-NOV-2021, the patient experienced tinnitus through the roof. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tinnitus through the roof was not reported. This report was non-serious.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # M000442, expiration date 31-MAR-2018 (dose and route of administration were not reported). There was no adverse event reported. This is one of several reports received from the same source. Additional information has been requested.
Patient first received J&J vaccine 3/3/21 then received Pfizer dose in December 2021. Two days after receiving vaccine, patient reported dyspnea.  She reported that she now gets short of breath with minimal activity such as going to the bathroom. She was found to have atrial fibrillation with rapid ventricular rate. She was hospitalized and chemically cardioverted.
eye lids are swollen and very itchygetting Worsen; eye lids are swollen and very itchygetting Worsen; eye lids are swollen and very itchygetting Worsen; This is a spontaneous report from a contactable Pharmacist reported that.  A 51- years old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 23Feb2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization (Age at vaccination 50 years). The patient medical history was not reported Concomitant medication(s) included loratadine (CLARITINE strength 10mg once a day) taken for an unspecified indication. The patient is reported that he has had a reaction that is lasted several months, stating this is been longer than 6 months and it's gotten worse. He is stating that his eye lids are swollen and very itchy and getting Worsen on an unspecified date. Well, they are exactly worsened in the last probably 2 months, it was like pretty mild all way up from February all way up to April or May and then started getting Worsen, worsen and now it's swollen every day. No treatment was reported. The event outcome was Unknown.
Dose 2 Pfizer @ 10:30 AM Thursday, March 11.  Event: Friday, March 12, 6:00 AM excruciating total left leg shooting pain with no relief or ability to ambulate. Saturday, March 13; friend took me to the Hospital ER upon my request. The non- stop pain was intolerable! I wanted X-Rays because I thought something somehow was broken. There was no fall or any accident of any kind. The X-Rays revealed strong arthritis & sent me home w crutches & an Ace bandage wrap. Recommended ice &/or heat, otc Tylenol or naproxen, which I did all day. Sunday, March 14, I was 80% improved. I attribute this strong reaction as triggered out of the blue by the 2nd Pfizer dose!
About an 1.5 hours after receiving the vaccine, I started feeling dizzy and would randomly start leaning/falling over at random. It felt as if the ground wasn't even and my sense of balance has been affected since I received the vaccine. Along with this came a loud ringing in my ears that persists to today. I have difficulty hearing certain frequencies because of the loud ring sound. I have notified my provider of these issues from the vaccine and have not received a response yet as to what to expect and if treatment is available.
48 HOURS AFTER RECEIVING INJECTION NOTED SWELLING, WARM TO TOUCH AND REDNESS ON RIGHT THIGH FROM APPROXIMATELY UPPER THIGH TO KNEE - LOW GRADE FEVER 100.-101., AND DIFFICULTY WALKING DUE TO SWELLING. ON 12/26/19, SWELLING AND REDNESS DECREASED, TEMP 99. BUT WALKING BETTER.
Within 10-15 minutes after receiving vaccine I got burning itchy eyes, nausea & metallic taste in mouth
Office drew up all doses from a vial and discarded without a double check. They used a sticky note with the bivalent NDC, lot and expiration to enter data into EMR. At some point they realized that some days they had pulled a vial of monovalent and administered instead of the intended bivalent booster.
Rapid onset of hard shaking chills and rapid breathing 24/min. Fever. Temp 102.7. Responded to Tylenol. Low grade fever next day of 99.9 with weakness and fatigue. 2nd day resolved. No nausea/vomiting.
Patient reported noticing swelling and redness to right deltoid starting Saturday 01/23/2021. Area is warm to touch when patient returned to clinic 01/25/2021. Pt denies any pain, fever, or chills.
pt recv vax NOV96 & devel an inj site rxn w/redness, swelling & itching;the affected area is about the size of BP cuff (4" x 10");this case reported by MD;cross reference w/DER0010150960093/99, DER0010150960101/102;
Pt fell dizzy an faint ~5 min after injection. Offered cold water, glucose tablet, ice pack for symptomatic support. paramedics  on scene to evaluate safety of patient before departure
Severe body aches, very tired. Started right after I came home from grocery shopping. Slept for 4 hours then woke up in severe pain from head to toe.  Got up off the couch, went to bed. Then at 3am on Sunday morning, I could take no more. Got up and took a warm bath with Epsom salt, that seemed to help the aches and pains subside.  I literally did not get out of bed on Sunday 01/10/21 til  noon.  Today, Monday 1/11/21, I'm still pretty achy, no fever, but just really want to lay down.  I did take advil during all this but it did not touch the pain.
The pt experienced redness, swelling at the injection site on the left arm with occasional pain and soreness.
Serum (varicella) exposed to low temps not meeting requirement, making serum invalid for use.  Difficulty to track family after moving from state but was able to finally encourage father to revaccinate child.
TOOK FOUR UNREFRIGERATED DOSES OF VIVOTIF; TOOK VIVOTIF RIGHT AFTER EATING; This spontaneous case report (PVX2019-1607) was received from a caregiver on 20-Jun-2019. It describes a male consumer who "took four unrefrigerated doses of Vivotif" and also he "took Vivotif right after eating". He was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took all four unrefrigerated doses of Vivotif. He also took Vivotif right after eating. He had a planned trip.  Action taken with Vivotif was not applicable.  The clinical outcome of the events was unknown.  Company's Comment: The causality of the event "took four unrefrigerated doses of Vivotif" and also he "took Vivotif right after eating" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took four unrefrigerated doses of Vivotif" and also he "took Vivotif right after eating" was considered as not applicable.
Information has been received from a licensed practical nurse concerning approximately 14 patients who was vaccinated with Gardasil (yeast). Subsequently the patients experienced injection site reaction including pain. The reactions resolved "after a couple of days". Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested.
pt recv vax 7MAR95 & 30mins later exp burning pain on the rt side of neck & discomfort;applied icepack to neck w/minimal relief;4 1/2 hrs later still uncomfortable;tx w/Aleve & DPH;
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2013, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose, route and site of administration were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries. On an unknown date, after and despite being inoculated with the ZOSTAVAX, the patient was diagnosed with shingles and/or other zoster-related injuries and suffered serious physical, emotional and economic damages as a result of patient's injuries. On or about 28-DEC-2016, the patient was treated for shingles. The reporter considered adverse events to be related to ZOSTAVAX. As a direct and proximate result of the ZOSTAVAX, the patient had and would continue 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 including 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. By the time of the report, the patient did not recover from shingles as the patient suffer for ongoing injuries. The outcome of vaccination failure was unknown. The events were considered to be related to ZOSTAVAX.
patient received Janssen vaccine  and was under age 18.  Patient did well no issues post vaccination
Patient received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter stated that the expired vaccine was administered to 36 patients and wanted to know if the dose administered was good or if they would need to re vaccinate. On 08-Nov-2021, the vial was initially stored in the refrigerator and the vial did not undergo any temperature excursions.  No concomitant drugs were reported. No treatment drugs were reported.   This case was linked to MODERNATX, INC.-MOD-2021-383189 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: Follow up includes patient and dose information. On 12-Nov-2021: Follow up received contains NNI.; Sender's Comments: MODERNATX, INC.-MOD-2021-383189:master case
Information has been received from a 25 year old female consumer with no pertinent medical history, drug reaction/allergies or concomitant medication use, who on approximately 08-NOV-2007, "3 weeks ago", was vaccinated intramuscularly (site not reported) with the 1st 0.5mL dose of Gardasil vaccine (lot # not reported). The patient reported that post vaccination (1 to - days after being vaccinated), she experienced bronchi spasms, neck and joint pain, abdominal pain, disorientation and hematuria. The patient stated she has gone to the emergency room 2 times and had EKG, MRI and several blood test performed, they have not been able to pinpoint any problems. At the time of this report the patient had not recovered. Additional information has been requested.
Information has been received from a RN concerning a 13 year old white male who was vaccinated with a dose of varicella virus vaccine live. On 11/26/03 the pt had multiple scattered macules and pustules on the face and trunk. A MD's visit was required and the pt was treated with calamine and given symptomatic care. No diagnostic tests were performed. Subsequently, the pt recovered.  Additional information is not expected.
no adverse event; an expired MMR-II was in advertently administered to twins; This spontaneous report as received from a medical assistant refers to a twin patient of an unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions, were not provided. On 07-SEP-2022, the patient was inadvertently vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live ((M-M-R II) rHA (dose and route not reported) (lot number T029549 expiration date reported as 01-SEP-2022, but upon internal validation established as 10-SEP-2022) (conflicting information). Concomitant therapies included  sterile diluent.; Sender's Comments:  US-009507513-2209USA003202:
tired; aches and pain; This spontaneous pregnancy case was reported by a consumer and describes the occurrence of FATIGUE (tired) and MYALGIA (aches and pain) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included High cholesterol. Concomitant products included ATORVASTATIN for High cholesterol.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 26-Feb-2021, the patient experienced FATIGUE (tired) and MYALGIA (aches and pain). On 27-Feb-2021, FATIGUE (tired) and MYALGIA (aches and pain) had resolved. Not Provided          No treatment medications was  provided by the reporter. No concomitant medications was reported by the reporter. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-019237 (Patient Link).   Reporter did not allow further contact
15-20min p/vax c/o throat feeling numb;unable to swallow, SOB, flushed (had similar rxn to cortisone inj);
Fever of 103 down to 101 by taking Tylenol q 4 hrs; Started w/diarrhea tonight, also has nausea; On 2APR91 vomited x 1 on awakening, vomited more in afternoon w/cont diarrhea;
Pt received the adult Pfizer vaccine on 1/18/2022 and this vial was unfrozen on 12/17/2021 at 12pm.  The vaccine was good for 31 days according to Pfizer help line but vaccine was given on day 32., it was given 1 day after expired.
This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A male patient of an unspecified age and race received pneumococcal PREVNAR 13 at 0.5 ml single and FLU VACCINE, both via an unspecified route of administration, on an unspecified date, for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Since an unknown date the patient developed a reaction as it looked like larger than normal rash, swelling and pain at the site of injection. Events outcome was unknown.
5-10 min. after receiving vaccine, felt my energy level completely drop--stayed down all evening and most of next day/next evening...still exhausted the following day, but not as bad.
This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A patient of unspecified age, ethnicity and gender received TRUMENBA (lot number requested) via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had soreness, swelling and redness at the injection site. The outcome of the events was unknown. The following information on the batch number has been requested.
Sitting on exam table for vaccination. Sitting on chair for faint, eyes closed and jerky movements. Not aware of previous history of faint. No med. history. Total episode 3-5 minutes.
Approximately 4 minutes after administration of vaccine, patient fainted and was caught by parent and gently laid on ground.  Patient was monitored by pharmacist  until paramedics arrived.  Patient woke up quickly and was in good spirits and left the store on her own after being monitored by paramedics.  Followed up with parent the next day and she was doing well with no adverse effects except for a mild sore arm.
Patient was sitting for 15 min observation, patient was feeling dizzy, was diaphoretic and pale. Blood pressure and vitals taken  Initial: BP: 60/32, HR: 63, SpO2: 98% on room air. Patient transferred to gurney. Next set of vitals:  BP: 79/36, HR: 52, SpO2: 96% on Room Air, Temp: 96.4 F tympanic, RR 16. MD stat called. Patient was assessed by MD. PEr mD, Vitals taken, BP: 103/62 (75), HR: 76, SpO2: 99% on Room Air, RR: 16. observe patient and vitals, no need for hospitalization or clinic visit at this time.  Patient completed observation of 30 minutes total, Patient alert and orientedx4, Vital signs stable, accompanied by mother. BP: 109/65, HR: 80, SpO2: 99% on Room air
Feeling cold, dizzy, muscle surrounding injection site was in pain but no swelling. Measured body temperature and got a 101.7 F underarm. Fever lasted for about 30 hours.
3 weeks after taking the vaccine i started to have left leg numbness and a burning feeling when showering, when the cold water would hit my left leg i had a burning sensation.  Following that i also experienced walking and balance issues, dropping on the left side of my face.  Hearing issues.  Fatigue.  Tingling or numbness feeling on the arms and legs.  Stomach issues.
Difficulty breathing, swelling of throat, cough, warmth in chest, dry mouth, chills, violent shaking
BREAKTHROUGH COVID INFECTION. TESTED POSITIVE ON 08/25/2021. PATIENT FULLY VACCINATED ON 02/06/2021.
Numbness in hands & feet, BP up 157/89 cold, but sweating & clammy, confusion, restlessness call doctor on call around 10 pm.
No additional AEs; incorrect product storage; This spontaneous report has been received from a licensed practical nurse and an office manager referring to a 5 months old (also reported as 6 months old) male patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported.    On 22-APR-2021, the patient was vaccinated with the second dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 2 ml, orally (strength not provided, lot number 1691302 has been verified to be a valid lot number, expiration date reported as 28-SEP-2021, but upon internal validation established as 23-JAN-2022) as prophylaxis; with the second dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (dose and strength not provided; lot number T001206 has been verified to be a valid lot number, expiration date reported as 03-JUN-2022) intramuscularly (IM) on left anterolateral thigh (LAT) as prophylaxis; with the second dose of pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) (indication, strength and dose were not provided, lot number LY4777, expiration date reported as 22-AUG-2022) IM at right anterolateral thigh (RAT); with the second dose of diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (PEDIARIX) (indication, strength and dose were not provided, lot number 23YL4, expiration date reported as 04-APR-2022) IM at LAT; and with hib vaccine conj (tet tox) (HIBERIX) (indication, strength, dose, route of administration, lot numbers and dates of expiration were not provided). All vaccines underwent temperature excursion of 35.2 Fahrenheit (F) for 480 hours and 0 minutes (product storage error). It was reported that there were no previous temperature excursions. The digital data logger was involved in recording excursion details. No additional adverse events (AEs) were reported.
Unable to sleep well / can't get a full night's sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INSOMNIA (non-serious) with onset 26Mar2021, outcome "not recovered", described as "Unable to sleep well / can't get a full night's sleep".  Additional Information: The reporter (patient's wife) mentioned that the patient had been experiencing the same symptom she had.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021338094 same report/drug/AE, different patient;US-PFIZER INC-2021355282 same report/drug/AE, different patient
This spontaneous report as received from a physician via company representative refers to a male patient of unknown age. There was no information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies reported. On 12-FEB-2016, the patient was vaccinated with the first dose of PNEUMOVAX 23 injection (lot # I024132, expiration date, anatomical location and route of administration were not reported) 0.5 ml, one time injection. On 13-FEB-2016, the patient experienced a high fever, loss of appetite and he did not have the strength to walk. On the same day, he went to an unspecified hospital for unspecified treatment. The patient was at the hospital for an unspecified amount of time. On 17-FEB-2016, he saw the reporting physician and had unspecified treatment. The outcome of the events was not reported. The patient sought medical attention by contacting the physician. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has not been requested.
Varicella vaccine breakthrough diagnosed by Dr in our office on 5-1-09. Had VARIVAX X 2. Sibling also has varicella.