chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recvd vax; fever of 102 x 2 days; general muscle aching x 2-3 days; n; lethargy x 4-5 days; anorexia;
No additional AE reported; an adult patient was administered a pediatric dose of RECOMBIV AX HB (0.5ml)/patient returned within 4 hours for additional dose (0.5ml); This spontaneous report was received from a physician and an unspecified reporter from the physician's office and refers to a 28-year-old (discrepant information, the patients date of birth also reported as 09-SEP-2021) female patient. There was no information regarding their medical history, concurrent conditions or concomitant therapies provided.  On 22-NOV-2021, the patient was vaccinated by a healthcare professional at a private doctor's office with a pediatric dose of hepatitis B vaccine (recombinant) (RECOMBIVAX HB) 0.5 ml intramuscularly, first dose, expiration date reported as 12-NOV-2022 (serial number (SN) and TTIN # reported as 102895422330, 00300004981001, respectively) (route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis (incorrect dose administered). On the same date, she was recalled to the facility and returned within 4 hours for additional 0.5 ml dose of the vaccine (expiration date reported as 12-NOV-2022, serial number (SN) and TTIN # reported as 102895422330, 00300004981001; route of administration, anatomical location, lot # and expiration date were not provided). The patient tolerated the vaccinations well without compliant, no adverse event (AE) was reported. No prescription drug treatment was required for the experience.
Patient was inadvertently given two doses of Moderna COVID-19 vaccine.   Event was discussed with patient was monitored for 30 minutes, remained stable.  Instructed to notify her PCP and monitor for any symptoms/side effects.  Patient was informed of error.  Clinic will follow up with patient today and tomorrow.
Received Prevnar vaccine in right arm, by Sunday morning I was breaking out in hives. Raging hives. OTC hydro cortisone cream. RX Medrol pak.
first shot caused white blood cells to drop by 50% and then they came back up and then after the second dose the white blood cells dropped by 25%.; This is a spontaneous report from a contactable consumer from a Pfizer sponsored program with Regulatory Authority Support. A patient of unspecified age and gender received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single; dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced first shot caused white blood cells to drop by 50% and then they came back up and then after the second dose the white blood cells dropped by 25%. The patient underwent lab tests and procedures which included white blood cell: drop by 50%, white blood cell: dropped by 25%. The outcome of events was unknown.  This follow-up is 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.
Pt had significant abdominal pain/fussiness.  MOC reported blood in stool - went to ED where stool heme negative and AXR not c/w intussusception.
Cancer; This serious case was reported by a nurse via call center representative and described the occurrence of cancer in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In SEP-2020, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced cancer (Verbatim: Cancer) (serious criteria GSK medically significant). The patient was treated with chemotherapy, nos (Chemotherapy Compound (Unknown)). The outcome of the cancer was unknown.   It was unknown if the reporter considered the cancer to be related to Shingrix.     It was unknown if the company considered the cancer to be related to Shingrix.   Additional Information: GSK receipt date: 12-JUN-2023 and 13-JUN-2023 The nurse reported that a patient received full on schedule dosing Shingrix series in September 2020. Health care professional (HCP) was unsure of whether patient would be undergoing chemotherapy or went through chemotherapy, but doctor wanted to revaccinate patient with Shingrix. HCP was unsure of why patient would be/went through chemotherapy. HCP stated patient had already gone through chemotherapy. The reporter consented to follow up.
This spontaneous report was received from a medical assistant regarding a 5 month old patient of unknown gender. The patient's medical history, concurrent conditions were not reported. On 06-APR-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L029618, expiry date 20-MAY-2017) dosing details and route unknown. Concomitant medications were not reported. It was reported that the vaccine administered was subjected to temperature excursion of 48 degrees F for a time frame of 11 hours and 10 minutes. No adverse effects were reported. Product quality complaint (PQC) was not filed. Additional information has been requested.
pt recv vax 6JAN95 2PM;9PM devel fever 105R & periods of crying;given APAP which would bring temp down a little but p/4 hr temp back to 105;took to hosp;given APAP;
Patient initially had normally expected side effects from the vaccine. Next day - he had a sore arm. 2 days after - he was achy with low grade fever.  3 days after - he woke up feeling better, but that evening started to develop multiple canker sores in his mouth. By the next morning (4 days after his vaccine) he had 8-10 canker sores in his mouth. He has no history of canker sores, and there was no injury to his mouth that caused this.
showed signs of a vaginal yeast infection; along with bleeding (menstrual period was not due); This is a spontaneous report from a contactable consumer, the patient. A 20-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the left arm on 13May2021 at 10:30 (at the age of 20-year-old) as a single dose for COVID-19 immunisation. Medical history included covid-19. The patient had no known allergies to medication, food or other products. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and spironolactone (MANUFACTURER UNKNOWN) all started on unknown dates and for unspecified indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the left arm on 13April2021 at 11:00 (at the age of 20-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient was not pregnant. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14May2021 at 00:00 the day after her vaccine, the patient experienced signs of a vaginal yeast infection along with bleeding. The patient menstrual period was not due. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with fluconazole started on unknown date. The clinical outcome of the events signs of a vaginal yeast infection and bleeding was recovering at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
patient developed Bell's palsy after adminsitration of Menactra, Adacel and Varivax
Vertigo, dizziness, unsteady walking-admission to hospital and given medication-released next morning with prescription
Cramping in legs, pain in muscles and joints, weakness, dizziness, nausea, lightheaded, flushing.
Three days after the vaccine the last digit of my middle finger on the hand the side of the shot was given on became numb, purplish and VERY tender.  You couldn't even touch the tip of my finger.  The condition was not long term but came and went with no apparent time lapses.  During this time I could not get a pulse/ox reading on any of my 10 fingers.  The tenderness is slowly dissipating and after 9 days I was able to get a pulse/ox reading on both my little fingers but no others.  Today I was able to get a reading on my vaccine arm ring finger and the tenderness has much less.  The ends of my fingers still turn purple but with a little massage they return to pink.
Patient reports feeling tightness in chest immediately after vaccine on 5/26/21, and 2 days later experienced feeling an internal burning sensation without a fever. Patient went to emergency room on 5/26/21 and was discharged with no conclusive diagnosis.
pt recv vax & reported noticed lt side neck tender, swollen;325AM awakened w/severe pain, side of neck-painful to touch;pt also exp elevated temp;
Patient fainted after receiving vaccination for HPV. Mother was with patient. Patient fell on floor lying with back and head down. Patient states she has no pain to back of head or neck and able to state her name and date and place where she's at. No change in Level of consciousness. No complaints of dizziness or vomiting. No bump, swelling, or bruising noted to back of head and neck. Assisted patient to room and checked VS. Pt was stable/asymptomatic when leaving the office with no complaint of dizziness, N/V. PT on exam neurologically intact. Evaluated by PAC.
Short breath; Red Arm; Itchy Injection Site; Swollen Injection Site (Shoulder to elbow); Headache; Tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Short breath), ERYTHEMA (Red Arm), VACCINATION SITE PRURITUS (Itchy Injection Site), VACCINATION SITE SWELLING (Swollen Injection Site (Shoulder to elbow)) and HEADACHE (Headache) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes, Hypertension and Vertigo.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced DYSPNOEA (Short breath), ERYTHEMA (Red Arm), VACCINATION SITE PRURITUS (Itchy Injection Site), VACCINATION SITE SWELLING (Swollen Injection Site (Shoulder to elbow)), HEADACHE (Headache) and FATIGUE (Tired). On 25-Apr-2021, DYSPNOEA (Short breath), ERYTHEMA (Red Arm), VACCINATION SITE PRURITUS (Itchy Injection Site), VACCINATION SITE SWELLING (Swollen Injection Site (Shoulder to elbow)), HEADACHE (Headache) and FATIGUE (Tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information was provided.
About 1 day after immunization customer complained of extreme soreness and loss of motion in vaccinated arm.
*Arm so sore, that I can barely lift it, & can't sleep on it Began2/3/21) *Headache since 6:am *nausea(Began after breakfast)
Body aches from head to toe  for 2 days. Ended 11:30 am on Sunday. Shot given 9:30 am Friday.
PATIENT CLAIMED THAT 16-17 HOURS AFTER THE VACCINE (THE NEXT DAY) SHE FAINTED, BLACKED OUT AND PASSED OUT ON THE BACKYARD FLOOR WITHOUT NOTICING. AND AFTER SHE WOKE UP, SHE FELT UNSTABLE FOR ANOTHER 6H UNTIL SHE GOT BETTER AND BACK TO HER NORMAL SELF. HER DOCTOR WANTED US TO REPORT THE POTENTIAL SIDE EFFECTS OF PFIZER VACCINE AND DOCUMENTED IT.
Chief Complaint   covid since last friday, getting more SOB, was 88% RA  History of Present Illness     Patient is a 58-year-old male with a history of ADHD, Depression, sleep apnea on CPAP, hypertension, hypercholesterolemia, and type 2 diabetes presenting for concerns of shortness of breath after being diagnosed with Covid.  Patient first started having symptoms 10 days ago with fevers, diarrhea, and malaise.  He tested positive for Covid 8 days ago, despite being vaccinated with the Pfizer vaccine in February.  He states that he has been getting progressively more short of breath, to the point where he is having to take breaks while going upstairs to his bedroom.  He called EMS to the scene, who state that when they arrived that he was saturating 88% on room air, so he was placed on a nonrebreather.  Patient states that his fevers have stopped and the biggest issue that he is having is his shortness of breath.  He does endorse some intermittent swelling in his lower extremities, which he takes furosemide for. Furthermore, patient started crying thrice during the interview, seemed depressed but had no thoughts of hurting himself. He denies any history of heart failure or heart attacks.  He also denies any chest pain. Chest Xray was done in the ED and it showed severe diffuse bilateral lung consolidation, consistent with Covid 19 pneumonia.
2 days following the Influenza vaccine my son developed a fever of 105 degrees F, lethargy, severe headache, loss of all previously acquired language, verbal and motor tics.  He has diagnosed with post vaccination encephalopathy recently and is still not recovered.
About 6 days after vaccine, had a large 3 cm hives on upper arms, back, and chest which was very itchy. About 3 months after, I went to the dermatologist. I was prescribed hydrocortisone cream and anti-itch medicine. On follow up, they stated it could be from the vaccine. Also had booster. Since then she has always had an itchy spot which is still persistent. It does look like it does have some fluid in the hives.
Patient stats right arm has had constant pain since receiving immunization on 9/26/19 and the pain is worse in the morning upon waking. Pain has progressed to causing stomach discomfort in the past week. No local reactions or indications the immunization was not given in proper injection site.
Soreness at injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448) via an unspecified route of administration in the left arm on 08Sep2021 at 10:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 08Sep2021, approximately 6 hours later, the patient experienced soreness at injection site which lasted for 2 to 3 days. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event soreness at injection site was resolved on an unknown date in Sep2021.  No follow-up attempts are possible. No further information is expected.
Shortly after vaccination, patient developed nausea, vomiting and diarrhea that have persisted for 5 days. She also has a bilateral rash on arms.  She has taken diphenhydramine 25mg periodically but reports that has not relieved the problem. I told her at this point, she should seek treatment at her primary doctor to evaluate need for a steroid, potentially.
General malaise began day 1 followed by fever > 102 degrees F / Headache/ myalgnas & chest discomfort all day 7-22-09 - Took Ibuprofen 600 mg PO - better after - Mon will call us 7-23-09 for update.
4th dose given in error as consent form documentation listed as 1st dose , facility administrator notified once identified, stated resident showing no signs of an adverse reaction
Patient was scheduled to receive the Covid 19 Bivalent Booster but received in error the covid 19 monovalent primary series vaccine.
Sudden onset of chills, shivering to the point of knees nearly buckling. Was able to get in bed independently. Continued most of night. Totally recovered by 9 am next morning
Information has been received from a licensed practical nurse concerning a 16-week-old female with no medical history, who on 28-SEP-2007, at 10:30, was vaccinated PO with the first dose of RotaTeq vaccine (Lot #656707/0410U). There was no illness at the time of vaccination. The patient was seen in the physician's office. No adverse event was reported.  No further information is available.
Within three months, left arm which is the injection site, was struggling to lift up much at all, left hand went tingly, once Nurse came saw that I had an increased pulse. When medics came through as increased pulse and increased blood pressure. Was cleared after about 15 minutes. The next day was decently sleepy with a decent headache. Then was fine.
This case was reported by a consumer via call center representative and described the occurrence of forehead swelling in a 62-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (about 3 to 4 years ago). In February 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, 2 days after receiving SHINGRIX, the patient experienced forehead swelling. On an unknown date, the outcome of the forehead swelling was not recovered/not resolved. It was unknown if the reporter considered the forehead swelling to be related to SHINGRIX. Additional details were provided as follows: The caller stated that he received SHINGRIX in early February and about 2 days afterwards he had swelling of his forehead and cheeks. He stated it was just very slight but he noticed it, there was no pain. He stated that he did report it to his physician but the physician stated he could not tell there was swelling and offered no treatment recommendations. The patient stated the swelling was still present at the same degree, he had his 2nd SHINGRIX shot three days ago even though the swelling was still present but has not had any increase or worsening since receiving the 2nd dose. The reporter did not consent to follow-up. The health care professional declined to provided information and follow up.
CoVid like symptoms including fever to 102; chills, fatigue, muscle cramps, body pain and headache lasting 48 hours
Immediate area around injection site was sore "like any shot" per patient, beginning on the evening of administration.  States she woke up Sunday morning (11/01/2015), removed Band-Aid from site, and noticed a small blister at injection site. Upper arm, neck, and scapula on right side began to get achy and sore.  Blister increased in size, and pain got worse until 11/03/2015, when symptoms began to subside.
This spontaneous report was received from a back office lead and refers to a 34-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 12-FEB-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # L035881, expiration date: 26-JUN-2017, 1 ml, intramuscularly, in left deltoid (a dose number was not provided). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Approximately 2 weeks after second dose of modern vaccine, I started having armpit pain and groin pain in my lymph nodes. It continued daily for 4 months until I sought medical care from my regular family practice nurse practitioner. She had to prescribe steroids to calm my immune system to get rid of the pain and swelling. My immune system went into overdrive because of the second dose of the shot. It threw my entire body out of balance.
staff administered DTaP-IPV portion only of Pentacel/no AE; Initial information received on 01-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 5 months old patient who was administered Dtap-IPV portion only of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE SHANTHA) for Immunisation; and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation.  On 01-Nov-2019, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot U6216AB via intramuscular route in the left vastus lateralis.  It was a case of actual  medication error due to Inappropriate reconstitution technique.  It was unknown if patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This is a spontaneous report based on the information received by Pfizer from Merck & Co., Inc., other manufacturer report number 00821766. A contactable medical assistant reported for a female patient of an unspecified age and race who received a dose of TRUMENBA (S56026, expiration 28Feb2019) and a dose of MENACTRA (U5848AA, expiration 01Mar2019) both in the left arm on 04May2018, for immunization. The patient passed out at the pharmacy and an ambulance was called on 04May2018. Medical assistant reported the patient went via ambulance to the emergency room. Medical assistant reported the patient had lab studies that included urinalysis, urinalysis for pregnancy, BMP and CBC, with results that showed glucose of 124, platelets 101 and neutrophils 8.9. Medical assistant reported the patient was observed in the emergency room and discharged on the same date. No additional information was provided. No follow-up attempts are possible. No further information is expected. Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
This spontaneous report as received from a registered nurse refers to a 44 year old female patient. Her relevant medical history and past drug history were unknown. On 30-AUG-2013, in the morning, the patient received a dose of GARDASIL, 0.5 ml, once (lot number, expiration date, indication, route and site of administration were not reported). Concomitant medications were unknown. On 30-AUG-2013, in the afternoon, the patient drank a glass of wine after having received the GARDASIL in the morning and was not feeling well. It was unknown if any laboratory testing were performed. As of 30-AUG-2013, she only received GARDASIL once and it was unknown if she continued to not feel well.  The nurse did not feel the event was related to receiving GARDASIL and drinking wine. Additional information has been requested.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose:12/15/21,pfizer,Lot#EH9899 2nd dose:01/04/21 Pfizer,Lot# EK9231 Diagnosed covid positive:02/04/21 Exposure:unknown Symptoms:Muscle aches,cough,Runny nose.
Fussy, irritable, not eating or drinking; APAP w/codeine elixir;
pt recvd vax;devel an inject site rxn consisting of erythema & induration of 2-3: in diam;