chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a adult female patient who received HAVRIX 1440 adult. In November 2017, the patient received the 1st dose of HAVRIX 1440 adult (intramuscular) .5 ml. On an unknown date, less than a year after receiving HAVRIX 1440 adult, the patient experienced pain in arm and injected limb mobility decreased. HAVRIX 1440 adult was discontinued. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the injected limb mobility decreased was unknown. The reporter considered the pain in arm and injected limb mobility decreased to be related to HAVRIX 1440 adult. Additional details were provided as follows: The age at vaccination was not reported. There was a Hepatitis A break out at the facility, so the patient was required to get the vaccine. The reporter was also a healthcare provider but her title was unknown. The reporter herself was the patient. The reporter (patient) did not know the exact date of vaccination but knows it was in November of 2017. It was given in her upper deltoid but unknown if it was on the right or left. She experienced pain at the injection site for 3 weeks. She was unable to raise her arm and was still experiencing soreness. She has elected not to receive the 2nd dose.
By night got fever, was tired felt sleep. Had loss of appetite but no nausea/vomit/diarrhea. Lost 5 pounds in 1 week. Chills, sore joints, body aches and very bad cough. Called doctor after 72 hours and was told not to worry about it unless temperature spikes. Took guaifenesin for cough, helped somewhat, worse at night. Would cough for 10 minutes straight when lay down so it interfered with sleep. Cough not productive except once it was yellowish indicating infection. Still have a little cough last night. Fever everyday 100 degrees - 101 degrees until today. Fever gets wore on evening 99.7 degrees.
Headache, Myalgia, chills, soreness at injection site Narrative:  Per nursing report: "2nd dose of Moderna yesterday about 3:30 pm. C/o last night [2/1] about 9pm started having headache, chills and about 3am this morning started having cold sweats and body aches. States feels like the flu. C/o left arm pain and swelling to site of injection. Temp this morning 101.3."
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns an 67 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not provided. Administration of company suspect drug(s): On 19-Sep-2016 the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number: WT54306. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 19-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursions identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. On 04-Oct-2016, the remaining 42 doses of lot number WT54306 were discarded. The patients will be contacted for revaccination.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider(s) recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On 26-MAR-2009, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On 27-MAR-2016, the patient was treated by a physician at a hospital for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs 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 (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Causality assessment considered events to be related to the use of ZOSTAVAX. Additional information has been requested.
Administered Menveo vaccine at ~ 11:50 am. Told patient and her mother to walk around the store for a little bit to make sure she was okay. After 5 minutes of walking, mother ran back to the counter and asked for help, stating her daughter had passed out. When I saw the daughter, the patient was starting to sit up and did not realize what had happened. I asked her if she was okay breathing, which she stated yes. She then said she was just feeling faint and the color from her face was gone, so I gave the patient water. I took the patient's blood pressure a couple minutes later, and it was 69/54. I asked the patient if she had eaten before the vaccination and she said no. I gave the patient a snack and waited for a few minutes to take her blood pressure again. After she had eaten, her blood pressure rose to 106/69. The color was coming back to her face. Her mother had stated she was very anxious prior to receiving the vaccine. I told her to wait a few more minutes, and I would take her blood pressure one more time. The patient sat for another 10 minutes, I returned to take another blood pressure reading, and it was around 100/69. The patient said she was fine and the patient and her mother had left the store. I told the mother if it happens again, to go to the emergency room. I called back around 1:45pm to check on the patient, and the mother had stated that she gave the patient a full meal, and that she would check her blood pressure again at home to make sure she was ok.
This AM, client developed redness and slight and swelling in L upper outer arm in general area where Td was administered 1 wk ago. Area noticeably warm to touch. No pain, pruritis according to client. Involves 2" diameter area on upper deltoid and 2" x 3" area directly below that. Advised considering OTC anti-histamine but need to see MD if not resolved by tomorrow.
Patient stated that within the first 10 min of receiving the vaccination her heart started racing and her air way started to close up. Patient has had trouble breathing and problems with airways. Patient was admitted to the hospital right away,
This spontaneous report received from a nurse referred to unspecified patients. The patients' medical history, concurrent conditions and concomitant medications were not reported. The nurse reported that doses of improperly stored vaccines GARDASIL 9 (lot 030380 expiry date: 01-FEB-2019) were administered to unspecified patients. No adverse effects were reported. The vaccines was stored at 47.49 F for 1 hour. There was no any previous excursions. The call was because of a data logger. This is one of the two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA005927.
Patient is a 68y.o. year old male PMHx hypertension, type 2 diabetes who presents for fever, non-productive cough, and elevated blood pressures. Patient notes his symptoms started approximately eight days ago. Temperature at home: 99.0-102.0F. He also endorses occasional lightheadness, myalgias, occasional diarrhea, generalized, abdominal pain, rhinorrhea, and sore throat. Denies sick contacts. COVID-19 vaccine: Moderna 2/27/2021 and 3/27/2021. He has not yet received a booster vaccine. Patient currently denies vomiting, chest pain, shortness breath, constipation, dysuria, hematuria, visual changes, dizziness, dysuria, hematuria, melena. He works as a truck driver for a steel company and travels around southern Michigan. No recent travel. Patient does admit to being prescribed Amoxicillin 500mg PO BID x 15 days for an "gum infection" by his brother who is a physician. Patient started taking these medications on 10/19/2021. Patient frequently travels. Last time he abroad was seven years ago. No exposure to TB that he is aware of.    ED/Hospital Course: Vitals on arrival: 149/70, HR: 99, RR: 18, temple and 98.3, SPO2: 94% on room air. Patient has not required any supplemental oxygen to keep his Sp02 >94%. Patient has remained afebrile. Labs remarkable for WBC: 5.4 with neutropenia, hyperglycemia, elevated CR: 3.13, unknown baseline, and hypocalcemia. Patient admits to feeling improved since admission. He has received multiple duo-neb treatments.  Following assessment patient was admitted to address nephrotic syndrome, electrolyte imbalance and acute kidney injury
Information has been received from a registered nurse concerning her 17 year old daughter with an allergy to antibiotics and no other pertinent medical history, who on 22-APR-2008 was vaccinated with a 0.5 mL first dose of GARDASIL intramuscularly.  On 20-JUN-2008 the patient received the second dose of GARDASIL.  Concomitant therapy included hormone contraceptives (manufacturer unspecified).  On 22-SEP-2008 the patient experienced headache, dizziness, nausea, fatigue, chest pain and stomach pains.  The patient had her first CT Scan of the abdomen and blood work that were negative.  On 09-OCT-2008 the patient had another CT Scan of the abdomen and the pelvis due to increased pain; the results were negative.  On 22-OCT-2008 the patient received the third dose of GARDASIL.  Then on 03-NOV-2008, the patient had an upper GI that was negative.  On 04-NOV-2008 the patient had gastric emptying studies that were negative.  On 05-NOV-2008 the patient had X-rays and blood work that were negative.  The mother reported that her daughter was now "incapacitated", sleeping most of the day and was unable to get out the bed.  The pain in the patient's stomach and chest had persisted and continued to worsen.  The mother stated that "she continues to go down every day".  The patient had been out of school for the past week and was not able to participate in after school activities (the patient was a cheerleader).  At the time of this report, the patient had not recovered.  The patient's headache, dizziness, nausea, fatigue, "sleeping most of the day/unable to get out of bed", "out of school for the past week and not able to participate in after school activities", "continues to go down every day", chest pain and stomach pains were considered to be disabling.  Additional information has been requested.
Client states fatigue symptoms post 2nd hep B vaccination then arthritic symptoms post few months. Feels as if she is slowly getting better, never sought medical attention for this.
Information has been received from a physician concerning a 49 year old male with asthma and allergic rhinitis who on 06-NOV-2008 was vaccinated with PNEUMOVAX 23 (lot number 661577/1161X) intramuscularly in the right arm. On 06-NOV-2008 the patient developed tenderness, swelling and pain at the injection site after receiving the dose of PNEUMOVAX 23. The pain became severe and stemmed from the shoulder up through the neck. The patient recovered after stopping therapy. Follow up information was received from the physician. The physician stated that on 06-NOV-2008 post vaccination the patient developed erythema, warmth and pain at the injection site. On 08-NOV-2008 the pain stemmed from shoulder through the neck. The patient was treated with MEDROL and VICODIN. On 14-NOV-2008 the patient's symptoms and signs resolved. There were no additional diagnostic tests. The physician felt the patient's injection site pain, erythema, warmth, and pain from shoulder through the neck were other important medical events. Additional information is not expected.
Facial hives Eye lid swelling Symptoms began at 630pm 2 25 mg tablets (50mg total) taken orally at 7pm Symptoms resolved within 4 hours
Patient was admitted to the hospital after falling and injuring her back 2 days prior.  She also c/o pharyngitiis, cough and weakness and poor appetite for 4-5 days.  She was given the SARS-CoV-2, NAAT nasopharyngeal which returned detected.  Pt. is being hospitalized for Covid 19.  She received both Pfizer vaccines
Injection of Td administered left deltoid, once at home noticed arm very red, itchy, swollen (approx 1cm) and painful 4/10. Red bumpy rash and itch lasted for approx one month, area covering 3"x3" approx. Did not impair use of/mobility of left arm.
Patient passed out momentarily. She was sitting and fell back in chair and had convulsions. Eyes remained slightly open, breathing not affected in any way. Patient was awake, alert and responsive within a minute. 911 called and patient taken to hospital.
This spontaneous report as received from a nurse via field representative refers to a 5 year old (reported as age 5) female patient. The patient was a 1.5 pound preemie, had past history of respiratory problems and had taken multiple steroids over her lifetime and details of her vaccination history were in a company registry. On 31-JAN-2012 the patient was vaccinated with VARIVAX (Merck) dose 2 for vaccination in the nurse's office. Dose and route were not reported. Lot number was 669271/1605Z and expiry date (reported as 1605Z). The date of first dose was not reported. From an unknown date in 2013 approximately (reported as currently), the patient had developed chicken pox, diagnosis confirmed on 18-NOV-2013. The patient ha 100 pox, itching and no fever. The outcome of events was not resolved. Medical attention was sought by visit to clinic. Nurse stated that she thought it was unique that both children had chickenpox reported one day apart that were administered in January 2012, in different facilities. Both children had small, multiples of chicken pox. No treatment was prescribed. This is 1 of 2 reports from the same reporter. Additional information has been requested.
This spontaneous report as received from a certified medical assistant refers to a 1 year old patient. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with (Oka/Merck) VARIVAX unknown route and strength (lot # K015970 with expiration date 23-SEP-2016 or lot # K021847 with expiration date 03-NOV-2016 or lot # L001335 with expiration date of 13-JAN-2017) which were exposed to temperatures outside of the recommended range. There was no adverse event reported. The reporter could not break out which specific lot number of vaccine was administered to the patient. This is one of the several reports received from the same reporter. Additional information has been requested.
Patient reported a rash on both arms 3 days after receiving Shingrix. Patient states that the rash is "definitely caused by Shingrix."
COVID arm - red welt (3.5" diameter) developed on injection site 1 week (April 19) after shot (April 12)
rash and skin lesions on her abdomen, back, arms and legs; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the pt's past medical history, concurrent conditions, or concomitant medication. On or around 17-SEP-2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, dosage, vaccination site and route of administration were not provided) for routine adult health maintenance and for its intended purpose: the prevention of shingles. Shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered an abrupt and sudden onset of rash and skin lesions on her abdomen, back, arms and legs. She continued to suffer from rash outbreaks throughout her body at the reporting time. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The pt also experienced mental and emotional distress due to resulting physical limitations and the seriousness of her condition. As a result of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, she suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt have suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered. The events were considered to be related to zoster vaccine live (ZOSTAVAX).  The event of abrupt and sudden onset of rash and skin lesions on her abdomen, back, arms and legs was considered to be disabling.  Additional information has been requested.
Sleepy; Red bump the next day; Chills; Body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Oct2021 10:30 (Lot number: FF2593) at the age of 52 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, administration time: 08:00 AM, Lot number: ERS739, Vaccine location: Right arm), administration date: 25Mar2021, when the patient was 51 years old, for Covid-19 immunization; Bnt162b2 (Dose 2, administration time: 08:00 AM, Lot number: EW0158, Vaccine location: Right arm), administration date: 15Apr2021, when the patient was 51 years old, for Covid-19 immunization. The following information was reported: SOMNOLENCE (non-serious) with onset 24Oct2021 07:00, outcome "recovering", described as "Sleepy"; SKIN DISORDER (non-serious) with onset 24Oct2021 07:00, outcome "recovering", described as "Red bump the next day"; CHILLS (non-serious) with onset 24Oct2021 07:00, outcome "recovering", described as "Chills"; PAIN (non-serious) with onset 24Oct2021 07:00, outcome "recovering", described as "Body aches". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of somnolence, skin disorder, chills, pain.  Additional Information: The patient had no known allergies. The patient did not received any other vaccines within 4 weeks prior to the covid 19 vaccine. The patient had not been diagnosed with COVID-19 prior to vaccination and had been tested post the vaccination. The patient underwent a unknown lab test for Covid-19 (Nasal Swab) resulted in Negative. No other medication in two weeks. No other medical history.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a physician and licensed practical nurse refers to a 8 years old male patient (student) with strabismus (since 2009), no illness at the time of vaccination and no known drug allergies (NKDA) and Hep B positive mother. On 12-JUL-2012 at 16:00 PM, the patient was revaccinated with the fourth dose of RECOMBIVAX HB 5 mcg, (reported as 'pediatric dose", given intramuscularly in left arm)(lot# 671326/1522A, exp, date not reported) due to decreased (low) titers. No concomitant medications were reported. The patient did not visit the emergency room or doctor. At the time of report, the patient's outcome was unknown. Vaccine information statement (VIS) was given. The relatedness for the patient's event was not reported for RECOMBIVAX HB. It was also reported that the patient was given GARDASIL in error on 12-JUL-2012(MARRS # 1207USA005280). Additional information has been requested.
Pain and large red swelling. Pain lasted, gradually diminishing, for three days; soreness lasted another three days. Redness lasted five days.
a few mins after the vaccine, i got a bad taste in my mouth and my jaw felt different and a mild headache. 2 hours later i feel a slight numbness in the left side of my face. and there is mild swelling.
Information has been received from a physician concerning a 23 year old female patient who on unspecified dates was vaccinated a three 0.5 ml dose series of with GARDASIL. The patient recently came back to the office and tested positive for HPV. At the time of the report, the patient's status was unknown. Additional information has been requested.
VERTIGO; This spontaneous report received from a patient 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 was not reported, administered on 26-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021 18:00, the subject experienced vertigo. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vertigo was not reported. This report was non-serious.; Sender's Comments: V0-Medical assessment comment is not required as per standard procedure as case assessed as non-serious.