chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist referring to three patients of unknown age and gender. Concurrent or medical conditions were not reported. On unknown dates, the patients were vaccinated with PNEUMOVAX 23 (lot # L003188, expiration date 06-JUL-2016) (dose, strength, frequency were not reported). Secondary suspects and concomitant therapies were not reported. The pharmacist reported that upon administration of PNEUMOVAX 23 to the patients, they experienced injection site reaction described as swollen, red and raised area with blisters. No treatment was received for the events. It was reported that the patients sought medical attention by telling the pharmacist about the events. The outcome of events was not reported. The reporting pharmacist required a lot check of PNEUMOVAX 23. The events did not require intervention to prevent serious criteria, did not produce significant disability or incapacity, did not require hospitalization and were not life threatening for the patients. No product quality complaint was reported. Follow-up information has been received during phone call on 26-MAY-2015. The physician was unavailable at the time of the call. The call was transferred to the nurses' station where a voice mail was left requesting patient identification and a returned phone call. Follow-up information was received on 17-JUN-2015 from a physician's office via a registered nurse. The nurse reported that there were four patients who received a dose of PNEUMOVAX (lot # K008419, previously reported as lot # L003188 with events for three patients) and upon follow up physician the lot number was corrected to K008409 and information was provided for four patients. This is concerning a 66 year old female who on 08-APR-2015 at 2:33 PM received dose of PNEUMOVAX 23 in the left deltoid muscle. This was her first dose. There were no previous illnesses at time of vaccine administration and allergies there were none known. On 08-APR-2015 the patient experienced pain, swelling, redness and heat at the injection site. The patient recovered on an unknown date. No other information was provided. The event of injection site vesicles was removed as physician did not report this reaction on questionnaire. Additional information is not expected. Narrative was updated. New cases created for 3 additional patients (MARRS # 1506USA012350, 1506USA012351, 1506USA012352, source case 1504USA009855).
Received a COVID-19 vaccine dose from a vial which have been punctured more than 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a COVID-19 vaccine dose from a vial which have been punctured more than 12 hours) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jun-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 25-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a COVID-19 vaccine dose from a vial which have been punctured more than 12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received a COVID-19 vaccine dose from a vial which have been punctured more than 12 hours) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.
(1) Approximately one month after vaccine, swelling in the muscle behind my left leg. I went to my Primary Care doctor, he examined my leg and immediately sent me to hospital ER because he was concerned that it might be a blood clot. They performed an ultrasound, but the results were negative and showed no signs of any blood clots. (2) Approximately three weeks after vaccine, I developed stiffness on the left side of my body in my arm, thigh and hip area. The stiffness was intense, uncomfortable and bothersome enough for me to take Tylenol for the pain the next 5 days and it lasted for about a week.
Patient age 16 received Moderna vaccine at Store.  Age limit for Moderna is 18.
Moderna COVID-19 Vaccine   Day #7: Developed chills and fever (~100-101) in the evening at around 6.30 pm with night sweats. Fever subsided in the early morning hours (around 4 AM). Day #8: Similar to day #7. Day#9: Some  redness at the site of injection in the morning, with developing large wheal in the arm with some itching.
moderate reaction; red bad rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (moderate reaction) and INJECTION SITE RASH (red bad rash at injection site) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (moderate reaction) and INJECTION SITE RASH (red bad rash at injection site). At the time of the report, ADVERSE REACTION (moderate reaction) and INJECTION SITE RASH (red bad rash at injection site) had not resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-020908 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-020908:Crosslinked (First dose)
SOB, body aches, coughing. hypoxic resp failure secondary to COVID pneumonia. not candidate for remdisiver (outside of window). Dexamethasone, O2, IV fluids; 6 min walk study , no O2 requirement
Nausea and vomiting . Started 3 days after first dose and became severe after second dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Apr2021 13:15 (Lot number: Ew0164) at the age of 29 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing); "gastritis" (unspecified if ongoing). Concomitant medication(s) included: ALPRAZOLAM. Past drug history included: Clyndamicin, reaction(s): "known allergies: Clyndamicin", notes: known allergies: Clyndamicin. Vaccination history included: Bnt162b2 (COVID vaccine details: , Product: COVID 19, brand: Pfizer, Lot number: ER8732, Lot unknown: False, Administration date: 31Mar2021, Administration time: 01:00 PM, Vaccine location: left arm, Dose number: 1), administration date: 31Mar2021, when the patient was 29 years old, for covid-19 immunisation, reaction(s): "Nausea", "vomiting". The following information was reported: CONDITION AGGRAVATED (non-serious) with onset Apr2021, outcome "unknown", described as "Nausea and vomiting . Started 3 days after first dose and became severe after second dose". Therapeutic measures were not taken as a result of condition aggravated.
Information has been received from an office manager in a physician's office, concerning an unspecified number of female patients, who on unspecified dates were vaccinated IM with the first dose of Gardasil (lot #'s not provided).  Concomitant therapy for some patients included Menactra and/or diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unspecified).  The reporter stated that following the vaccination with Gardasil, "90%" of the patients complained of upper arm pain and tingling in their fingers, and "about 10%" of the patients "pass out in the office."  The patients sought unspecified medical attention.  At the time of this report, the outcome of the events were unknown.  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.
Whole arm ached down to wrist within 5 minutes of shot. Eyes tearing and scratchy feeling. 7:30 pm that evening sudden spike of temperature to 103.8 and bad chills. Starting vomiting every 10 to 15 minutes hour after hour . This did not stop . Could not keep even a mouthful of water down.Very dizzy and weak feeling. Husband said I seemed disoriented. After 8 hours of this not improving went to ER about 3;30am 4/25; Blood draw, chest X-ray, IV fluid and  odansetron through IV. This relieved the nausea. They gave something for fever also. My blood pressure was low for me.  Released after several hours. Recovered at home
Patient received 2nd covid-19 vaccine yesterday. Patient's wife called stating around 8:30pm yesterday he started to experience shaking, chills, and a fever of 100.6. Today he is feeling painful/sore all over his body and has a temperature of 99.1. He states he is still experiencing episodes of shaking that come and go throughout the day.  He is helping manage fever and pain with Tylenol and taking it easy. They will call back with more updates if anything progresses.
That night after receiving the vaccine, while trying to go to sleep I began to have chills and was experiencing shivering in my upper body although the ambient temperature was 78 degrees. My legs were still warm though and my teeth were chattering and making noise until I began to tighten my muscles and move my arms and upper body at which point the chattering stopped but when I would stop the movements, the chattering would return. My temperature is normally low, but it was a bit high so I took a Tylenol and was able to go to sleep. I've also been experiencing shoulder pain.
Pt recvd vax 7JAN93 & 6 hrs p/playing 4 hrs of intensive squash pt exp sudden onset of nausea, h/a, sweating & fever; pt was treated w/Ibuprofen;
Patient received Td injection on 09/18/06 and on 09/20/06 patient visited a nurse with a bilateral pitting edema/swelling of legs, redness, warmth and pain at the injection site. Patient also reported that her menses arrived 2 weeks early. Patient was given ice packs and Advil. Patient did not experience an adverse reaction when she was previously vaccinated with Td. Follow up obtained on 09/25/06: Patient had a bilateral 1+ pedal edema. Patient was previously healthy and had never had edema in the past. edema improved if feet were kept up, but returned when the patient was standing or keeping feet down. On 09/22/06 edema subsided and was not a problem anymore. Patient was treated with Benadryl and Advil. Local reaction improved as well. Patient still had some itchiness and was somewhat sore at the site, but the RN considered it much improved.
Temp excursion  went below freezing (20 F for 20 minutes / Pediarix was administered to a patient; This case was reported by a other health professional via call center representative and described the occurrence of product storage error in a 7-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number AZ472, expiry date 28th November 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe (batch number Unknown, expiry date unknown) for prophylaxis.   On 14th April 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced product storage error. On an unknown date, the outcome of the product storage error was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The reporter was a medical assistant. The reporter mentioned the temperature excursion went below freezing (20 degree F for 20 minutes) for across vaccines that happened on 12th April 2021 which was not known till the time of reporting. On 14th April 2021, the patient received Pediarix dose, which was kept below temperature 20 degree F, which led to product storage error. The reporter consented to follow up
she got sick with COVID after the last booster.; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (she got sick with COVID after the last booster.) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (she got sick with COVID after the last booster.). At the time of the report, COVID-19 (she got sick with COVID after the last booster.) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The patient had 1 initial vaccine and 3 boosters. No treatment medication was reported.   Reporter did not allow further contact
Information has been received from a Licensed Practical Nurse concerning 4 month old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies or concurrent conditions were not reported. On 22-NOV-2016, the patient was vaccinated with an improperly stored dose of PEDVAXHIB for prophylaxis (lot number L051123 with an expiration date of 13-OCT-2018) (dose, frequency, route of administration and anatomical location were not reported). Other suspect and concomitant medications were not provided. There was no adverse effect reported. The doses of the vaccine experienced a temperature excursion of 1 degree Celsius (C) for a time frame of 48 hours. A digital data logger was involved. There were no previous temperature excursions. Furthermore, no product quality complaint was involved. No other suspect or concomitant therapies were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA013756.
Patient had urticaria and rash to face following first vaccination which responded to diphenhydramine. Patient today - pretreated with 25 mg of diphenhydramine and albuterol inhaler 30 minutes prior to vaccination.  Patient given vaccine at 1:06.  At about 1:20, patient complained of rash to face and patient was monitored.  By 1:35, rash was extending to arms and back and patient began coughing.  BP 162/110.  Patient given solumedrol 125 mg IM at 1352.  Ambulance called and sent patient to emergency room for monitoring .
Information has been received from a health professional concerning a 6 month old female who on 05-FEB-2007 was vaccinated with a first dose of Rotateq (Lot# 656102/1165F). No symptoms were reported. No product quality complaint was involved. No other information was provided. Additional information has been requested. This is in follow-up to report (s) previously submitted on 6/14/2007.  Information has been received from a certified medical assistant (CMA) concerning a 6-month-old female with no medical history who on 05-FEB-2007, at 1112, was vaccinated PO with the first dose of ROTATEQ (Lot # 656102/1165F).  There was no illness at the time of vaccination.  No laboratory/diagnostic tests were performed as medical attention was not sought.  There were no symptoms/adverse experience reported.  Additional information is not expected.
BUD 9/2/2022 PATIENT RECEIVED VACCINE ON 9/12/2022
Adult patient received a pediatric dose; Adult patient received a pediatric dose; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 68-year-old female patient who received HAV (Havrix 720) (batch number EP473, expiry date 6th February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Havrix 720 and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix 720 and Havrix Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product 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: 14-Feb-2023: Reporter comment: A nurse reported that the adult patient received a pediatric dose of Havrix.  The reporter consented to follow up. Additional supportive information : The adult patient received a pediatric dose of Havrix, which led to underdose and adult use of a child product.
Swollen and pain in gland under right ear and throat.  Approx 7 days
Patient developed flu like symptoms as well as a red discoloration/rash on neck and both forearms.
Breakthrough COVID infection. Admission to local Health clinic on 10/21/2022 for evaluation of weakness and leg pain. Positive COVID test collected 10/28/2022 after patient intubated for airway protection.
Information has been received from a pharmacist via a company representative referring to unknown number unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates the patients were vaccinated with doses of ZOSTAVAX subcutaneous injection (dose, route, site of administration, lot # and expiration date were not reported) for "shingles". On unknown dates the unspecified patients experienced "red spots" to form on the body, not related to shingles or injection site redness (rash papular); which was reported by the pharmacist reading information from unknown source on unknown date that ZOSTAVAX could cause "red spots" to form on the body. The outcome of the event was unknown. It was reported that the pharmacist was reading the information from unknown media source and no specific patients were mentioned in it. Additional information has been requested.
double pneumonia in the both lungs, fully vaccinated and still got a  Delta variant; double pneumonia in the both lungs, fully vaccinated and still got a  Delta variant; This is a spontaneous report received from a contactable reporter (Consumer) reporting for friend from medical information team.  A female patient received COVID-19 VACCINE (COVID-19 VACCINE - MANUFACTURER UNKNOWN) (Batch/Lot number: unknown) as dose 2, single and (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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "double pneumonia in the both lungs, fully vaccinated and still got a  Delta variant". It was reported not sure which vaccine was given. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: Delta variant.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101590157 same reporter/drug/event, different patient;US-PFIZER INC-202101590157 same reporter/drug/event, different patient
Flushing, lightheaded, sinus cleared 5 minutes after shot, extreme fatigue 2 hours after. Pain, harness, redness at injection site 6 hours after shot. Fatigue, sleepiness, floatiness , headache, palpitations, neck pain, right ear pain, 2 ulcers on left tonsil, sinus pressure lasted 3 days. Right lung/back pain upon exertion. Constipation 5 days without bm. Fatigue and palpitations linger.
Patient states her joint pains were markedly worse the day after her vaccine dose, including new pain in the knees. Of note is that her rheumatoid arthritis has been worsening for the past 2 months since she stopped taking Xeljanz 3 months ago. (Her rheumatologist closed his practice and she was unable to establish with new one till 4/9/2021. Exam then showed now inflammatory changes in joints. Exam today by me also showed no inflammatory in joints, including knees. Labs ordered on 4/9 are just being drawn today.
Patient states she felt a "dry/tight throat" pretty quickly after shot was given. Patient drank gatorade and water and ate a protein bar without difficulty. Vital signs normal. After 30 minutes post vaccination pt. stated she was feeling good enough to leave, maybe some improvement in throat, experiencing no additional symptoms. Denied/refused calling 911 for additional evaluation.
Pt stated she felt her tongue was swelling. VSS BP 146/87  p88 r16 O2 sats 99% room air.  Seen by Dr, pt instructed to take antihistamine. Pt discharged to home. Instructed to take antihistamine prior to next dose
Itching / in different areas of his body; soars all over in different areas of his body; This case was reported by a consumer via interactive digital media and described the occurrence of pruritus in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine, the patient experienced pruritus and pain. On an unknown date, the outcome of the pruritus and pain were unknown.   It was unknown if the reporter considered the pruritus and pain to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the wife of patient. The age at vaccination was not reported. The patient received Shingles vaccine a year ago and experienced itching and soars all over in different areas of his body. The reporter asked that can you still getting shingles dr don't know all he did was it.
RN arrived at the patient's home where he resides with his mother who also is his caretaker and guardian. The patient's mother stated to the RN the patient is a non-verbal special needs and aligns with an 8-year-old build. RN confirmed patient's size. The mother insisted the patient is supposed to receive a pediatric dose because of his weight and size (under 100 pounds and 5ft tall). The RN administered the pediatric dose to the 47-year-old patient, which resulted in violation of proper protocol and procedure. Patient screened and contacted management on next steps. The RN stayed the 15 min observation period and confirmed he had no adverse reaction.
Case number PHEH2014US001903 is an initial spontaneous report from a nurse received on 23 Jan 2014 with a follow-up received on 27 Jan 2014 and 25 Feb 2014. This report refers to a 3-year-old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 13462P, expiry date: May 2014) intramuscularly into right deltoid at a dose of 0.5 ml on 20 Jan 2014 at 16:28. No adverse event was reported following this maladministration. Follow up received from nurse on 27 Jan 2014: Updated patient demographics, FLUVIRIN dose, batch number and expiry date. Changed report type from other to spontaneous report. Follow up received from health care professional on 25 Feb 2014: Site and time of vaccination updated. Reporter details updated.
Site: Itching at Injection Site-Medium, Additional Details: patient states a "little warmth ", dizziness, and feeling itchy but no other side effects . she waited about 30 mins plus and contacted family friend. nurse gave bottle water and we shared we would check on her in evening. also, recommended if any further concerns to contact ER or physician