chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Ache at injection site; Tingling at injection site; sensation up arm and heart; Tachycardia; Hypertension; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Jan-2021 and was forwarded to Moderna on 14-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Ache at injection site), VACCINATION SITE PARAESTHESIA (Tingling at injection site), FEELING HOT (sensation up arm and heart), TACHYCARDIA (Tachycardia) and HYPERTENSION (Hypertension) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse events reported.). Concurrent medical conditions included No adverse event (No adverse events reported.) and No adverse event (no adverse event reported.).    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (Ache at injection site), VACCINATION SITE PARAESTHESIA (Tingling at injection site), FEELING HOT (sensation up arm and heart), TACHYCARDIA (Tachycardia) and HYPERTENSION (Hypertension). At the time of the report, INJECTION SITE PAIN (Ache at injection site), VACCINATION SITE PARAESTHESIA (Tingling at injection site), FEELING HOT (sensation up arm and heart), TACHYCARDIA (Tachycardia) and HYPERTENSION (Hypertension) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Dec-2020, Blood pressure measurement: 143/74 143/74. On 31-Dec-2020, Heart rate: 94 94. On 31-Dec-2020, Hypertension: 160-180 160- 180. On 31-Dec-2020, Tachycardia: 110-120 110 -120.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medication not provided.  Treatment included emergency department visit.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report was received from a female patient of unknown age regarding herself. On an unknown date in September 2012, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. On an unknown date in September 2012, the patient experienced fever, blisters on her lips. She used to get them (date unspecified), however she was getting more frequently since getting the ZOSTAVAX. The patient did not seek any medical attention. No treatment was given to the patient. It was unspecified if any lab tests were performed. The patient had not recovered from the events at the time of reporting. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Large area of redness, warmth on thigh. Given TYLENOL and used cool compresses.
Patient with history of asthma was given H1N1 Flumist. Within 8 hours of Flumist patient developed wheezing. Was treated by primary care doctor. Treated with aerosol bronchodilatory and other medications. Wheezing resolved in 2 days.
No additional adverse effects reported; improperly stored expired VARIVAX; This spontaneous report was received from a registered nurse and refers to a patient of unknown age. No information was provided regarding the patient's concurrent conditions, concomitant medications and medical history.      On 21-APR-2020 the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) and on 26-APR-2020, was vaccinated with an improperly varicella virus vaccine live (oka/merck)(VARIVAX) with lot # S005077 and expiration date 19-FEB-2021 for prophylaxis (route of administration and dose was not reported).  The administered dose of the vaccine experienced a temperature excursion 50 degrees Fahrenheit on 20-MAR-2020 for 40 minutes.   There was no adverse effect reported.  This call was because of a data logger with no previous temperature excursion.
Irregular menstrual bleeding began almost immediately after receiving first dose of vaccine.  This is a highly uncommon incident for me as I just completed my menstrual 2 weeks ago and it never comes early nor do I experience break through bleeding.
RECEIVED REPORT THAT TWO WEEKS AFTER HIS SECOND DOSE, HE DIED OF A MYOCARDIAL INFARCTION.
This case was reported by a nurse and described the occurrence of injection site cellulitis in a 4 year old female who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. On 5/30/03, the patient received the 5th injection of Infanrix packaged in a prefilled syringe. The injection was made IM into the left deltoid. The patient also received an injection of inactivated poliomyelitis virus vaccine IM into the right deltoid. On 6/1/03, two days post-immunization, the patient developed an injection site reaction and was taken to the local ER. The ER physician made a diagnosis of injection site cellulitis; however, no medication was prescribed. The event resolved after an unspecified period of time. The nurse considered the event to be serious because it jeopardized the patient or required intervention. The nurse considered the event was possibly related to vaccination with Infanrix.
Temperature of 103 degrees, 5 1/2 hours after vaccine. Follow up report received 02/09/2005: states child's fever resolved in a few hours, and fine since.
Sore arm; Nausea; Vomiting; Extreme Headache; Exhaustion/ Tiredness; This is a spontaneous report received from a contactable consumer (the patient). A 29-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: Unknown), dose 2 via an unspecified route of administration on the left arm on 11Mar2021 at 02:15 pm (at the age of 29-year-old) as 2ND DOSE, SINGLE for COVID-19 immunisation. The patient medical history included Hashimoto's thyroiditis, allergy to gluten, dairy, eggs. The patient's concomitant medications included levothyroxine 112mcg, betaine hydrochloride, bromelains, cellulase, pancreatin, papain (DIGESTIVE ENZYMES), VITAMIN C [ASCORBIC ACID], colecalciferol (VITAMIN D) and MULTIVITAMINS [VITAMINS NOS]. The patient past drug history included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: Unknown), dose 1 via an unspecified route of administration in on the left arm at the age of 29-year-old on 17Feb2021 at 05:45 pm for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 12Mar2021, the patient experienced extreme headache that woke her up, nausea with vomiting most of the first day, exhaustion, and sore arm. The patient stated that headache and tiredness continued for 2 days. The patient stated that 5 days out now, the sore arm was mostly gone but was still tired and had a headache that comes and goes. The patient took tylenol as a treatment of these events. The clinical outcome of the events extreme headache that woke me up, exhaustion, nausea, vomiting and tiredness was resolved with sequelae. The outcome of the event sore arm was resolving. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  Information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: updated reporter and patient information and treatment information and Concomitant Therapy, medical history and historical vaccine added, suspect drug details, added, concomitant drug recoding.
4-2-12 Pt. was give 2 injections (Tdap & Yellow fever) and 4 oral typhoid pills. After taking 3 pills of typhoid noted redness and itching on left arm. Had finished all four pills before calling 4-9-12 when arm began hurting. Advised cortisone cream to itching and BENADRYL. Pt. thinks this is due to typhoid pills but being only in area of YF shot that may be source.
This spontaneous report as received from a physician via a field employee refers to a male patient of unknown age. On unknown dates the patient was vaccinated with 2 doses of VARIVAX (merck) (dose, frequency, route and lot# not reported). The patient had a titer level of 91 after receiving this 2 doses of VARIVAX (merck). At the time of reporting, the patient's outcome was unknown. Additional information has been requested.
Patient under the age of 18 received a Moderna booster instead of Comirnaty booster.
pt recv vax 11JUL97 & devel gen rash on 22JUL97;
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 01-AUG-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 24 hours with the lowest recorded temperature of 9 Fahrenheit degree. The total cumulative excursion time of the second time was 24 hours with the lowest recorded temperature of 8.7 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
ABOUT hour after injection started with itchy throat, progressed within 5 to 10 minutes to dry cough, the persistent dry cough, about 20 minutes after symptoms started 1 puff from inhaler, coughing increased to non stop unable to breath, co worker (LVN) called a code, code team arrived within 2 minutes continued trouble breathing, coughing, given 2nd puff from inhaler, put on oxygen transported to emergency room treatment started with breathing treatment, steroids, started experiencing chest pressure, right arm tingling and numbness, face numb and mouth monitored for couple hours, EKG, labs, blood work, x ray's done, then IV's started notified transferring to an adult hospital due to cardiac concerns. Transferred by Ambulance Hospital, triaged labs, EKG, X-Rays, seen by Cardiac Doctor on call advised being admitted for  Anaphylaxis to Moderna injection. Monitored and treatment then released on 04/01/2021. Discharge medications prescribed and advised to follow up with medical doctor.
Covid vaccine given at incorrect interval. Followed up with patient's parent and patient has no adverse reactions and in stable condition.
Report 2001027133-1 describes a sore throat in a 32-year-old female who received an injection of hepatitis B vaccine recombinant (Engerix-B). This report was received from the pt and has not been verified by a physician or other healthcare professional. Medical history and concurrent conditions were not specified. There were no concurrent medications. On 06/30/2001, the pt received an injection of Engerix-B; it was not specified if the pt had received prior injections of Engerix-B. On 09/01/2001, 63 days post-immunization, the pt experienced a sore throat and "feeling that food was coming out of her mouth." The pt was seen by a physician. The events persisted as of 11/14/2001.
Started having pain in right shoulder on 8/13. On 8/15 developed a red rash on right shoulder and arm. Pain increased. Saw MD on 8/15/10, diagnosed herpes zoster, started on Acyclovir 800mg 5x daily. 8/16 Parent reports severe pain and limited mobility of right shoulder/arm.
Within couple of hours of administration, client experienced chills lasting about halfway through the night. She felt okay when she awakened but in the afternoon, she once again had chills lasting about 2-3 hours. 4 days after the administration of injection, she noted hives on her right arm from shoulder to elbow which lasted a few hours. Occasionally arm still itches.
Arm is sore at injection site.  I have a lump and it itches.  Feeling fatigued.
got very sick; had an allergic reaction; Initial information received on 31-Oct-2020 regarding an unsolicited valid non-serious social media case through the agency received from a consumer (Patient).  This case involved adult patient of unknown demographics who got very sick (Illness) and had an allergic reaction (Hypersensitivity), while patient received INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing Rubber sensitivity.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route at unknown administration site for prophylactic vaccination.  On an unknown date, the patient got very sick (Illness) and had an allergic reaction (Hypersensitivity), unknown latency following the administration of INFLUENZA VACCINE.   No relevant laboratory data was reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for both the events at the time of reporting.  There will be no information available on the batch number for this case.
Rheumatoid arthritis flare up; Vaccination site pain; Fatigue; Headache; sore arm; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4214650-00 (Abbvie).  A 47 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 24Mar2021 (Batch/Lot number: unknown) at the age of 46 years as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at weekly (unk, weekly (citrate free, 1 in 1 wk)) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), administration date: 03Mar2021, when the patient was 46 years old, for COVID-19 immunization. The following information was reported: RHEUMATOID ARTHRITIS (non-serious), outcome "not recovered", described as "Rheumatoid arthritis flare up"; VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "Vaccination site pain"; FATIGUE (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "Fatigue"; HEADACHE (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "Headache"; PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "sore arm". The action taken for adalimumab was unknown.  Additional information: The reporter's causality for the events Vaccination site pain, Fatigue, Rheumatoid arthritis flare up, Headache with Pfizer BioNTech Covid-19 Vaccine was Not reportable. The reporter's causality for the event(s) of vaccine caused sore arm, vaccine caused fatigue, minor flare up of rheumatoid arthritis, vaccine caused headache with humira(adalimumab) was no reasonable possibility.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on temporal relationship the possibility of causal association between the reported events Rheumatoid arthritis flare up and other reported events and the suspect drug BNT162B2 cannot be excluded.   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, and Investigators, as appropriate.
Mother reports that child started to break out in lesions Nov. 3rd, one day after vaccines were given. She had them on arms, legs, hands, feet, back and buttock. Developed a fever Thursday that lasted thru Sunday. She had crying bouts that started Saturday, Nov. 4th  from approx. 9PM to 3AM that night Mother contacted her PMP and described what was going on, was advised to treat the symptoms, no respiratory distress was noted and follow up with urgent care in the AM. Child was seen at Urgent Care clinic Sunday Nov. 5th and then by Dr. on Monday Nov. 6th. Dr. diagnosed the condition as chicken pox. I spoke with Mother 11/15/2017 and she reports that patient is much better now and most of the vesicles have crusted over fine and are healed up. The few remaining are on her buttock area that is covered by a diaper and harder to heal. She is open to contact by VAERS if needed for additional information.
migraine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A female patient received bnt162b2 (BNT162B2), administration date 11Apr2021 09:00 (Lot number: EW0150) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Verbatim: The patient took her 1st dose of Pfizer vaccine Lot no.EN6203 in her left arm.), for covid-19 immunization. The following information was reported: MIGRAINE (non-serious) with onset 11Apr2021 15:00, outcome "unknown", described as "migraine". The event "migraine" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The caller stated that after vaccination she having the "throbbing headache and it has not stopped since then. This is not a regular headache; I call it a migraine but I don't know if it's that. It's a chronic, vicious, burning, throbbing headache, it's everyday my whole head cap, eyebrows, I'm a lawyer and it gets worse as the day goes by the weather make worse. I'm at a lost, I had a CAT scan and MRI, I've seen my primary physician, ER doctor, Neurologist and I have follow ups with the Neurologist, I don't suffer from Migraines. I never had COVID. I've heard of people who had the headache/migraine for a long time but these were people who have a history of migraines, which I don't have. This is scary and disheartening. I don't know what to do, is there any assistance hotline for people having a negative effect"? I had the vaccine 6 weeks ago & I have had chronic migraine daily for 6 weeks. I do not suffer migraine. Consumer further stated, "First of all before I answer your question is someone going to help me. I wanted to give you information for you for file. I want to know there is a number at Pfizer that I can speak to someone with scientific knowledge because possibly it is 6 weeks." Consumer stated, "I can't answer your questions because I have headache. It's not easy to understand on the phone."  No follow-up attempts are possible. No further information is expected.
Patient received second dose of Pfizer vaccine.  Vaccine expiration time 0930 on 5/12/2021. Patient received vaccine on 5/12/2021 at 0935. MD made aware.  No harm to patient or adverse reactions.
pt recv vax 1JUN98 & pt had gastroenteritis on 4JUN98 which resolved;gastroenteritis reoccurred on 19JUN98;pt died of SIDS on 20JUN98;
Information has been received from a nurse concerning an unknown number of children who on unspecified dates was vaccinated with hepatitis B virus vaccine (lot # not reported). Subsequently the patients were failing to show antibody levels to hepatitis B after finishing the vaccination series. The practice had 7 offices and nurse reported that they routinely tests for antibody levels and children were not responding. No active cases of hepatitis B to their knowledge. It was unspecified if the patients had sought medical attention. At the time of reporting, the patients' outcomes were unknown. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
PATIENT RECEIVED SECOND DOSE IN SERIES 2 WEEKS AFTER INITIAL DOSE (PRIME DOSE).  PATIENT DID NOT NOTIFY PHARMACY THAT SHE RECEIVED FIRST DOSE 2 WEEKS PRIOR AND PHARMACY DID NOT REALIZE IT EITHER.
Pt given flu shot (told to hang around store for approximately equal to 10 minutes for signs or symptoms of allergic reaction). Patient and her mother returned in five minutes, they said she fainted and bumped her head on the ground. She didn't remember exactly what happened, but I gave her an ice pack and she sat down as help (911) notified. She left before EMS arrived. However, she said she felt fine other than the bump on her head. Later, called (Incident 3:50 PM) 6:50 PM, and spoke w/ pt who said she felt fine.
SLEPT A LOT WHOLE WEEKEND; CHILLS; TIRED; 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, and batch number were not reported) 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 an unspecified date, the patient experienced slept a lot whole weekend, chills, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, slept a lot whole weekend and tired was not reported. This report was non-serious.
Can't 100% say it was b/c of the covid vaccination, as I also got a flu shot at the same time. About 2 hours after getting the shot, my right eye became irritated. It felt like an eyelash was caught underneath the far right side. I was never able to locate an eyelash, and the eye bothered me for the rest of the evening. Almost looked like there was a little fold on the white part of my eye. Fortunately, it's back to normal as of the following morning (right now).
SWOLLEN ANKLES; SWOLLEN FEET; CHILLS; LEFT ARM PAIN THAT FEELS LIKE IT IS IN THE BONE (FROM THE SHOULDER ALL THE WAY TO THE FINGER TIPS); BODY PAIN (HIPS ALL THE WAY DOWN TO BOTH FEET); TOO PAINFUL TO WALK; FEVER; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 42 year old female. 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, intramuscular, and batch number: 211A21A expiry: UNKNOWN) dose was not reported, administered on 08-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-OCT-2021, the patient experienced fatigue. On 09-OCT-2021, the patient experienced body pain (hips all the way down to both feet). On 09-OCT-2021, the patient experienced too painful to walk. On 09-OCT-2021, the patient experienced chills. On 09-OCT-2021, the patient experienced left arm pain that feels like it is in the bone (from the shoulder all the way to the finger tips). On 09-OCT-2021, the patient experienced fever. On 09-OCT-2021, the patient experienced headache. On 10-OCT-2021, the patient experienced swollen ankles. On 10-OCT-2021, the patient experienced swollen feet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body pain (hips all the way down to both feet), too painful to walk, chills, fever, and headache on 10-OCT-2021, and swollen ankles, and swollen feet on 11-OCT-2021, and had not recovered from fatigue, and left arm pain that feels like it is in the bone (from the shoulder all the way to the finger tips). This report was non-serious.