chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presented on 2/11/14 with complaints of pain in left shoulder increased erythema that migrates to her elbow. Denies fever, fatigue or malaise. Pt stated she had no problem at time of injection but developed symptoms and they were worst they had been today 2/11/14.
Parasthesias starting immediately after vaccination and lasting greater than 4 hours after administration. Parathesias were mobile and seemed to move throughout body in different locations. Eventually, this led to transient hand tremors.
A serious report of urinary tract infection and bacteremia has been received from a study investigator concerning a 44-month-old male participating in a post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. On 01-Dec-2008, the subject received FLUMIST. The subject was admitted to the hospital for urinary tract infection and bacteremia on 19-Dec-2008. The length of stay was two days. The outcome of the events was not reported. The investigator assessed the causality for the events to FLUMIST as not related. The severity of the events was moderate. The sponsor also assessed the causality for the events as not related to FLUMIST.
pt recvd vax around MN awoke crying, t105, arm was red & swollen had recvd motrin @ bedtime repeated @ MN; cool packs applied to reduce fever; temp stayed down p/6AM; taken to MD 9NOV94
This spontaneous report as received from a registered nurse refers to an unknown number of patients. Approximately in JUNE-2014 (reported as between 15-JUN-2014 and 25-JUN-2014) the patients were inadvertently administered with VARIVAX (Lot # expiry date not reported) dose not reported, that had been improperly stored. No adverse effects reported. No product quality complaint reported. The outcome of the event is unknown. Additional information has been requested.
On 5/14/00, the pt developed sores around the injection site. The pt had been taking antibiotic Keflex orally for the sores but the sores did not improve. On 5/17/00, she began experiencing nausea and vomiting, a fever of 101. Treatment of the fever and nausea/vomiting was unknown.
COVID-19 treatment; COVID-19 treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in May2022 as dose 4 (booster), single (Lot number: FN9992) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Chronic colitis" (unspecified if ongoing); "recovered breast cancer" (unspecified if ongoing), notes: other medical history: recovered breast cancer; "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Jul2022) Negative, notes: I tested negative daily 25Jul -29Jul; (26Jul2022) Negative, notes: I tested negative daily 25Jul -29Jul; (27Jul2022) Negative, notes: I tested negative daily 25Jul -29Jul; (28Jul2022) Negative, notes: I tested negative daily 25Jul -29Jul; (29Jul2022) Negative, notes: I tested negative daily 25Jul -29Jul; (30Jul2022) Positive, notes: tested positive 30Jul; (unspecified date) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received vaccine. The patient received other medication in 2weeks.  No follow-up attempts are possible. No information is necessary.
Initial and follow up information has been received from a physician, via a company representative, concerning a 21 year old female patient, who on 20-JUL-2007, at 11:35 AM was vaccinated IM in to left deltoid with the first dose of Gardasil lot # 658094/0524U. On 20-JUL-2007, following the vaccination, the patient experienced syncope, as she "fainted and hit her head." In follow up it was reported that the patient left room to check out and passed out hitting head on floor. The physician and several people heard the sound. The physician immediately ran to assess patient. Cool wash rag applied to patient's forehead and blood pressure was checked which was stable. On 20-JUL-2007, at 11:40 AM blood pressure was 120/82 and heart rate was 78. At 11:45 B/P was 118/76 and pulse was 72. at 11:50 AM the B/P was 120/74 and pulse was 76. The physician evaluated patient's head. At the time of this report, she had recovered from the events (duration and date not specified). Additional information is not expected.
RN who gave med gave a more concentrated dose of mixing 0.8 ml of saline to Pfizer vial instead of 1.8 ml of saline to vial. One dose was given IM at a more concentrated dose.
On 10/21 Pt c/o pain and limited ROM to arm where Tdap was administered. Evaluated by physician who states pt has synovitis to shoulder on 10/25.
This spontaneous report was received from a nurse and refers to a 5 year old female patient. No information regarding medical history, concurrent conditions and concomitant therapies was provided. The patient was vaccinated on 03-JUN-2013 (first dose) and on 23-SEP-2013 (second dose), with VARIVAX injection, 1 DF (reported as one dose) (route of administration, lot numbers and expiration dates were not reported) for prophylaxis (reported as routine vaccination). Other suspect therapies included sterile diluent (MERCK), used to reconstitute the suspected vaccines (dose, route of administration, lot number and expiration date were not provided). On an unknown date, the patient was vaccinated with first dose of M-M-R II injection, (dose, frequency, route of administration, lot # and expiration date were unspecified) for prophylaxis. On unknown date in September 2017, the patient came to county health department for kindergarten shots. Before the vaccines were administered, the mother of the patient asked about the rash on patient's leg. It was reported that the symptoms started on 10-SEP-2017 (reported as 10-SEP-2017 or 11-SEP-2017). The patient was referred to medical office and was diagnosed with varicella (also reported as chicken pox) by her primary care physician (name unspecified) on 13-SEP-2017. The patient's mother wanted the patient to get the second dose of measles, mumps and rubella vaccine. The reporter wanted to verify time frame to give another live vaccine with recent varicella infection. The outcome of varicella was reported as not recovered. The relatedness between chicken pox and VARIVAX, sterile diluent (MERCK) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) was reported as unknown. On 20-SEP-2017, the patient's mom called and wanted patient to get second measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) vaccine. The reporter wanted to verify time frame to give another live vaccine with a recent varicella infection. The patient sought for medical attention (reported as physician appointment). No information regarding given treatment was provided. No Product Quality Concern (PQC) was involved. No additional information was available.
Progress Notes  COVID VACCINE CLINIC  Subjective Patient is a 46 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination.    She denied any history of previous adverse reactions to vaccines.   She was given the Moderna vaccination in the right deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience increased  breathing rate following right shoulder/clavicle pain.  She denied rash, hives, welts, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling.   This provider was notified of patient reaction and she was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality  and respiratory distress with increased work of breathing.         ALLERGY REVIEW OF SYSTEMS:  Patient complains of shortness of breath ( most likely from mild anxiety) and muscle aches       Previous Reactions: none    Objective    Vitals Vitals:   01/07/21 1136 01/07/21 1146 BP: (!) 140/92 129/70 BP Location: Right arm Right arm Patient Position: Sitting Sitting Cuff Size: Regular Adult Regular Adult Pulse: 88 76 Resp: 14 12 SpO2: 100% 100%     Physical Exam Vitals signs reviewed.  Constitutional:      General: She is not in acute distress.    Appearance: Normal appearance. She is well-developed. She is not diaphoretic.  HENT:     Head: Normocephalic and atraumatic.     Right Ear: Hearing and external ear normal.     Left Ear: Hearing and external ear normal.     Nose: Nose normal.  Eyes:     General: No scleral icterus.       Right eye: No discharge.        Left eye: No discharge.     Conjunctiva/sclera: Conjunctivae normal.  Neck:     Musculoskeletal: Normal range of motion and neck supple. No neck rigidity or muscular tenderness.  Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.     Heart sounds: Normal heart sounds. No murmur. No friction rub. No gallop.   Pulmonary:     Effort: Pulmonary effort is normal. No respiratory distress.     Breath sounds: Normal breath sounds. No wheezing or rales.  Chest:     Chest wall: Tenderness ( right mid clavicle) present.  Musculoskeletal: Normal range of motion.  Skin:    General: Skin is warm and dry.  Neurological:     Mental Status: She is alert and oriented to person, place, and time.     Sensory: No sensory deficit.     Gait: Gait normal.  Psychiatric:        Behavior: Behavior normal.        Thought Content: Thought content normal.        Judgment: Judgment normal.         Assessment/Plan  Treatment included: avoidance measures and talking with the patient.. Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP.   Patient was thought to have a mild muscle spasm from the injection that may have cause a mild anxiety attack.  Patient was fully cooperative the whole time and appreciative for team of medical staff.  Patient's symptoms quickly resolved and she was able to leave without assistance.  Patient declined assistance to her car.
Had temp 101, rash and achy morning after vaccine. Fainted. Taken to hospital. 8/11/05 AM. 8/12/05. Doing much better.
upper lip edema; roof of mouth irritation and burning; gum irritation and burning; nose irritation and burning TRX: Benadryl 25mg  X1 then Benadryl 50mg TID x 5 days  Patient improved
This spontaneous report was received from a registered nurse via physician and medical assistant regarding a patient of unknown age and gender. The patient's medical history, current conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of ROTATEQ lot # M040267 with unknown expiry date, (strength, dose and route of administration were not reported) for prophylaxis. The vaccine was exposed to 31 Fahrenheit degree (F) or colder (25F) for 1 hour 53 minutes and 47 Fahrenheit degree (F) to 77 Fahrenheit degree (F) (49F) for 3 hours 59 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects reported. There was no product quality complaint (PQC) involved. This is one of the several reports received from same reporter. Sender's Comments: US-009507513-1708USA003308: US-009507513-1709USA011730: US-009507513-1709USA011731: US-009507513-1709USA011732: US-009507513-1709USA011733: US-009507513-1709USA011734: US-009507513-1709USA011735: US-009507513-1709USA011736: US-009507513-1708USA003070.
Narrative: COVID infection following COVID vaccine series 01/29 COVID vaccine dose #1 02/19 COVID vaccine dose #2 10/12 COVID vaccine dose #3 10/20 c/o Headache, Loss of taste or smell, COVID test positive 10/21 c/o Rhinorrhea, reports exposed to grandson that lives w/ him and is COVID positive 10/22 declines daily calls
This case was reported by a healthcare professional and described the occurrence of not responding to therapy in an adult female subject who was vaccinated with Engerix B vaccine (manufacturer unknown) for prophylaxis.  On unspecified dates the subject received unspecified doses of a complete Engerix B vaccine series (manufacturer unknown).  At an unspecified time after completing vaccination a Engerix B vaccine series, the subject was found to have lack of seroconversion.  The reporter noted that the subject had to have the series as a medical student, but was not sure which series the subject received.  At the time of reporting the outcome of the event was unspecified.  The healthcare professional considered the event was probably related to vaccination with Engerix B.  Follow-up information received later the same day of initial reporting indicated the dates of receipt of Engerix B.  The dates were 21 August 2003, 29 March 2003 and 28 February 2003.  A titer taken on 20 April 2007 indicated that the subject was not seroprotected following receipt of the Engerix B three dose series completed four years ago.  Follow-up information received on 14 May 2007 indicated that the reporter had limited information on this case as the subject was a student that requested a hepatitis titer as a requirement for continuing on at another school.  The subject has been lost to follow-up.  It was reported that the subject was 22 years old at the time the titer was performed.
Patient reported she felt dizzy- after approx. 5 minutes from receiving the covid vaccine. Patient laid down on the exam table. Patient was given a cool towel for her forehead. Dr. came in to see patient.  Patient reports she doesn't feel as bad as with the first vaccine. Patient reports dizziness improved after another 10 minutes. Patient left the office after approx. 20-25 minutes.
I have mobility issues, So the whole left arm and my body wasn't able to perform a function; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient received BNT162b2 (BNT162B2), on 03Dec2021 as dose 1, single (Lot number: FJ1620) at the age of 32 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: MOVEMENT DISORDER (non-serious), outcome "unknown", described as "I have mobility issues, So the whole left arm and my body wasn't able to perform a function". Therapeutic measures were not taken as a result of movement disorder.  Additional information: It was reported that the patient had no medical conditions. The patient did not undergo any lab tests and had no prior vaccinations. The patient receive regular medications, most are vitamins. The patient did not receive any treatment for the event.
Pt has received flu shot annually without incident. Received Fluzone HD this year. Woke up next morning with oval shaped area 3 inches by 5 inches that was red, swollen and felt hot. Reaction diminished quickly with time over the course of the day but was still present in the PM.
Nausea, slight headache  EXTREME ITCHING HIVE ON BACK CHEST, NECK, CHEST ,EARS AND HEAD. COMPLETE FATIGUE, NO APPETITE  Difficulty breathing
Pt reports that she received her first dose of Pfizer Covid vaccine on 01/21/2021. She reports that on Saturday 01/23/2021, she was doing yoga and started to develop severe dizziness and the room "kept spinning." Pt reports that this morning she woke up out of a dead sleep and started to experience that severe dizziness, and states that she could not even "walk a straight line." She states that she has been very unsteady on her feet. She states that her whole body felt "shaky."  All symptoms have resolved.
pt states that he woke up the next morning with bruising between ring and pinkie finger on palm of right hand. Hand did have bruising about 1 inch in diameter on the palm between 4th and 5th fingers
Administered expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) in a 33-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  Reporter stated that the vaccines were stored in freezer and they took out one to two vials and placed in fridge each day as needed.
Initial report received from a healthcare professional on 05 November 2013. A 17-year-old patient received FLUZONE ID. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
No adverse Reaction In November 2022 our Immunization program did our every-other-year audits in Both our offices. It was discovered at that time, that some covid vaccines were administered outside of the 10 week expiration date (which is calculated from the date the vaccines were received from the state.)
I've been pretty sick since 9 o'clock last night; From head to toe, my body just hurts to no end; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I've been pretty sick since 9 o'clock last night) and MYALGIA (From head to toe, my body just hurts to no end) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced ILLNESS (I've been pretty sick since 9 o'clock last night) and MYALGIA (From head to toe, my body just hurts to no end). At the time of the report, ILLNESS (I've been pretty sick since 9 o'clock last night) and MYALGIA (From head to toe, my body just hurts to no end) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2021, Blood pressure measurement: 132/86 (High) 132/86  units not provided.. On 08-Feb-2021, Body temperature: 96.7 96.7 units not provided.. On 08-Feb-2021, Heart rate: 82 82  units not provided..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
115PM pt recvd vax & was given IM lt deltoid; pt immed exp sudden warm to inj site radiating to rt hand & a fullness feeling; flat reddened area @ inj site;intermittent ice pack applied to site;DPH given;
Severe stomach pains. Diarrhea. Vomitting. Got 2nd vaccine Phfizer WM4335 IM LA Dose 2. Persistant cough, trouble breathing, inflammed lungs. Now on antiboitics, steriod, inhaler. Has scheduled an appointment radiologist for lung x-ray. Now taking emergency state leave from job. Vaccine was mandated by job, no medical or religious exception.
pt recv vax;fever;flu like sz;devel allergies;sneezing, coughing, asthma attack x 1;
Increasing site soreness, increasing muscle soreness which is increasing in area involved, increasing warmth in muscle area, intermittent nausea, low grade fever (up to 100.9 F).
pt recv vax 18OCT96 & 19OCT96 pt devel t105.5;20OCT96 pt was seen in clinic w/fever of 102;pt dx w/viral pharyngitis;tx w/Ibuprofen;
Tinnitus/intense ringing in ears, no treatment. Has occurred approximately twice per day since 4/23/21. No previous history of this.
Fever, lethargy, loss of appetite, large (6+ inches in circumference)swollen area on arm at injection site, accompanied by swelling, heat, pain and inability to move arm.  Area was very hard, and hot to the touch.
afib; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "rheumatoid arthritis" (ongoing). Concomitant medication(s) included: XELJANZ XR taken for rheumatoid arthritis, start date: 01Dec2021 (ongoing). Past drug history included: Humira, reaction(s): "bruising all over her body", notes: second injection of humira she woke up with bruising all over her body and md immediately discontinued medication.; Humira, notes: First injection. Vaccination history included: Covid-19 vaccine (Dose:01), for COVID-19 Immunization. The following information was reported: ATRIAL FIBRILLATION (medically significant), outcome "not recovered", described as "afib". The patient underwent the following laboratory tests and procedures: pain assessment: 6, notes: i have pain all over but it has only been two weeks. my pain level is a 6.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
patient did not bring his immunization card to get his booster and we were unable to pull the information of his first two vaccines at time.  Patient stated he got his last dose more than 6 months before but when he brought his card to get vaccine information added, it showed it had not been 6 months since 2 nd dose.  Patient got first two doses of Pfizer Covid vaccine on 6-14-21 and 7-7-21 and got Moderna booster on 11-30-21.
Oval shape, hot, red 8cm x 5 1/2cm, hard raised (#mm) mass to right delt
high fever for 3-4 days, up to 104.2 to ER x 3, to ER on 1st noc, 2nd day & 3rd day, pp gave meds that finally brought fever down to nl;
Patient self palpated right breast mass in August 2021. Previously healthy. Now diagnosed with right breast invasive ductal carcinoma , gr 2, with assoc dicis
Janssen COVID-19 Vaccine EUA headache (8/10), chills, muscle pain, fever, nausea, dizziness, weakness, fatigue
On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was Cardinal refrigerated packaging tote to maintain a temperature of 36 F - 46 F. However, that is not approved for COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.