chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Per client telephone call:   3 days after injection, pink area developed about 4 inches down from injection site on left arm. Went away after a few days. Now area has returned to left arm and is itchy- returned 3/3/2021. Encouraged to consult with PCP prior to second dose scheduled 3/22/2021
In the evening Pt started to have pain in her left deltoid muscle where TD was given the same day with pain radiating into left trapezius and left neck muscle group. Pain continued. The next day and was seen back in clinic given Toradol 60 mg, IM and extra strength Tylenol for pain and hot pack neck.
09/27/2005 patient presented to clinic 5 1/2 weeks after receiving immunisation with indentation in left thigh near knee possibly related to MMR given SQ Left thigh on 08/19/2005. No temperature, pain or swelling at injection site indentation removed from injection site onset unknown.
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion) ) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion) ). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion) ) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication were reported. No treatment information were provided. No adverse reactions were reported by the patient. This case was linked to MOD-2022-501575 (Patient Link).
Hives face and upper trunk no swelling face, throat, hands, neck no SOB. Treated with ZYRTEC 10 mg. Still intermittent episodes of hives.
pt recv vax 4APR96 & w/in 24hr exp sz;the frequency of the sz inc over 7-10 days & pt was hospitalized;pt is being medicated w/Dilantin, Phenobarbital, & Depakote;
Developed Atrial Flutter.; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm on 01Mar2021 (Batch/Lot number was not reported) (at the age of 71-year-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient has not been diagnosed with covid-19 prior to vaccination and has not been tested for covid-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Medical history included high blood pressure and acid stomach (waiting for consultation with cardiologist). The patient had no known allergies. Concomitant medications included omeprazole magnesium (PRILOSEC [OMEPRAZOLE MAGNESIUM]) and amlodipine besilate (NORVASC). On 10Jun2021 16:00, the patient developed atrial flutter. The patient never had this problem prior to covid-19 vaccine. The event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care visit. The patient underwent lab tests and procedures which included echocardiogram: unknown results and heart monitor: unknown results. Therapeutic measures were taken as a result of the event which also includes echocardiogram and heart monitor. The patient had not yet recovered from the event. Information on the lot/batch number has been requested.
Pt cried non-stop for  at least 3 hrs w/o stopping; had fever not measured; pt given APAP every 4 hrs;
Received 5-11 year old dose. Should have received >12 year old dose.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 78-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jul2021 at 12:00 as dose 1, single (Lot number: EW0191), in left arm, on 14Dec2021 at 12:00 as dose 2, single (Lot number: 33130BA), in left arm and on 16Jul2022 at 12:00 as dose 3 (booster), single (Lot number: FJ4991) at the age of 78 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "occasional high blood pressure" (unspecified if ongoing), notes: Takes Olmesartan Medoximil 10 mg PRN. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid (Lot number: GG0133) from 20Feb2023 to an unknown date in Feb2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300081211 Same patient, different product and event;
This "adverse event" was reported directly to Public Health 6 months after it occurred. The patients husband was concerned about vaccines being "mandated". Patient is a 77yo F with an extensive medical history who presented on 03/18/21 with c/o chest pain and SOB for 2 days. She had been taking lasix for CHF, but hadn't taken a dose in several days. She was admitted, given multiple labs and tests.  She was given several doses of Lasix, and improved significantly. She was diagnosed with an exacerbation of CHF, and released to home the next day. Her husband who made the report stated I received a call.  He wanted to make a report warning about the side effects of the Pfizer vaccine.  He received his last dosage of the vaccine in February, and he and his wife had severe complications due to the vaccine.  He stated that he had blood clots in his brain and lungs, and his wife has been hospitalized five times since their last dosage.  He disclosed that he was 81 years old, and believes that not everyone should not be mandated to take the vaccine. This is the only hospital record that he provided (his wife's).
Allergic type rxn-redness vesiculation surrounding inject sit of rt deltoid, minimal inc temp to the skin; pt put on DPH x 2 wks;
Patient came to pharmacy one day after vaccine administration showing right arm with inflammation and red. It was counseled to visit her doctor.
Pt states day after shot arm felt like someone punched it. By the 2nd day she couldn't move it. Decreased ROM of left shoulder with abduction to about 20 degees. Frozen shoulder, shoulder pain. Pain has stopped, but still can't move shoulder. She's the third person who's complained of a shore shoulder with a frozen shoulder due to the vaccine. The other two were vaccinated elsewhere.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 immunisation.     No Medical History information was reported.    On 20-Mar-2021 at 9:08 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 9:08 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 58.38.  Concomitant products were not provided.  On 20-Mar-2021 Excursion time was reported at 09 am and 10 am with temperature as 34 and 37 degrees Fahrenheit respectively , total doses given for the day was 184, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Mar-2021, vial was moved to clinic on 20-Mar-2021. 19 vials were sent to clinic. Vaccine BUD date was 08-Apr-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration.  Temperature recordings were taken using a temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
This spontaneous report was received from a nurse practitioner regarding to a 60 year old female patient. The patient's pertinent medical history and drug reactions/allergies were none. On 01-APR-2015, the patient was vaccinated with a dose of ZOSTAVAX (lot# K023621 and expiry date: 19-FEB-2016) intramuscularly in the hip because of her age and family history of shingles. Concomitant therapies included estradiol and unspecified estrogen cream. On an unspecified date in April 2015 (reported as around the end of April), the patient noticed changes in area around the injection site. The patient sought medical attention and visited doctor's office on 13-JUL-2015 and presented with muscle and tissue atrophy at injection site. The outcome of changes in area around the injection site/muscle and tissue atrophy at injection site was reported as not recovered/not resolved. The causality of the events was not reported. Additional information has been requested.
Left shoulder pain and pain in neck lower left side. Mobility limited by 20%. Discomfort disrupts sleep. Taking ibuprofen with little affect.
pt recv vax & exp red, raised area @ the inj site;pt reported that the area was approx the size of a dime w/divided w/a hard lump & swelling;dx w/ringworm;
Patient is 19 days short of 12 years of age.  No adverse reaction occurred.  Parent informed to bring daughter in on 8/6/2021 for booster.
Generalized weakness in the left arm, burning in upper left arm at the joint, weakness and inability to grasp in the left hand, and numbness in both left and right big toes.
During a flu vaccine clinic for employees of Health Behavioral Services at the Treatment Center, this employee was inadvertently given expired influenza vaccine.  The vaccine administered was for the 2021-2022 season and expired on 6/30/2022.  The employee was made aware of the this mistake, did not present with any adverse clinical reaction, and will be administered the influenza vaccine for the 2022-2023 season as soon as clinically appropriate.
Pt recvd Engerix-B on 05JUL91 & on 07JUL91 & exp hives; tx DPH; sx resolved;
Flu vaccine given at 2:15 pm. By 4:15 pm, pt. reports throat "scratchy/itchy", eyes, "red & itchy" feeling of congestion. No respiratory distress. All symptoms resolved by 9:00 pm. No fever. No vomiting.
Her friend broke out into hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Her friend broke out into hives) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history provided by the reporter.     On 01-Jan-1900, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Her friend broke out into hives). The patient was treated with PREDNISONE for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (Her friend broke out into hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.   Reporter did not allow further contact
Onset of headache over forehead area and feeling tired. Sx progressed into evening and temp of 100.7 - took 400mg ibuprofen. Morning woke up w/ bad headache 7/10 & temp 100.1. 400mg ibuprofen. Headache lasted all day and temp fluctuated btwn 99.9 and 101.2. Third day 8/10: still continued headache upon waking. Took 200 mg ibuprofen, temp 99.7. Sx continuing to persist through this posting.
43-year-old female with a history of a motor vehicle accident in 2004 that created neck pain and led to discovery of a Chiari I malformation, which was later decompressed in 2005. She was stable for years without significant complaints but in January 2021 after receiving Covid vaccine, she developed a list of neurological symptoms that to date are not improving.    She is still reporting neck pain, migraine, and some burning sensation in her right arm plus other symptoms that include:  Intermittent vision disturbance "wavy vision" Feels that her equilibrium is off.  Feels off balance Pressure in the back oh her head Feels weak mostly on her left side. Feels that her head is heavy. Intermittent burning in right upper extremity Intermittent numbness and tingling in hands and feet. Muscle twitching in left leg and left arm Involuntary movements.   She has been off work since 01/04/2021 when she visited me with worsening symptoms for a few weeks. She worked as health unit coordinator at Providence. Received Pfizer Covid vaccine on 12/20/21 and 01/10/21.    She has been evaluated by neurology and neurosurgery. Had imaging or brain and spine, but no findings that specialist believe would explain her symptoms.   Most recently, she has been evaluated and treated by physiatry A and diagnosed with cervical dystonia for which she is getting Botox injections. Last injection on 08/13/2021 and she was advised to return in 3 months. She states that since the shot, she feels the neck is more unstable, getting severe headaches when bending over, pain is type sharp in the back of neck, right shoulder pain is worse. All the prior neurological symptoms remain unchanged.   Per last physiatry note: If not adequate for the upper occipital area, we will consider referral for an anesthetic medial branch block. Patient states that she has her next appointment schedule with physiatry in 12/2021
I almost immediately experienced dizziness and nausea. I figured it was from not really eating breakfast before. The dizziness and nausea continued to the point where I messaged my doctor through the patient portal a week later. She suggested I try meclizine, and if that didn't help to call for an appointment. The meclizine seemed to stop the nausea, dizziness, and at this point also sweating. Then a week after having relief, I had a dentist appointment. Being tipped back in the chair set it all off again. My doctor ordered bloodwork, and my thyroid had swung very hyper. I am currently awaiting an appointment with endocrinology. My Hashi's had been well controlled on medication for several years to this point.
Suspected myocarditis. Developed chest pain and exertional dyspnea about 48 hours after vaccination. Gen 5 troponin, CRP elevated. Normal ECG.
Local reaction last year and needed oral steroids. This year he had local reaction, larger than last year, pretreated with benadryl . Fever for 1.5 days, body aches
A 12-year-old patient received the wrong dose of Pfizer vaccine (patient underdosed). Instead of receiving the adult Pfizer-BioNT dose, patient received  Pfizer-BioNT COVID-19 tris (5 to 11-year-old) VAC (PF)10 mcg/0.2mL IM susp (EUA). Parents notified of underdosing and declined the recommended additional immediate vaccination with Pfizer adult dose. Parents plan to have their child receive the second vaccine in 21 days.
Initial information received on 17-Dec-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 62 years old female patient who experienced stiffness in her thumbs when, sharp pain in her hand/ her feet are bothering, heart problem and mobility and pain issues, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history included Arthritis. The patient's past vaccination(s) included flu vaccine with reports having flu shots in previous years with no problems. The patient's past medical treatment(s) and family history were not provided. In October 2017, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious stiffness in her thumbs, heart problem, sharp pain in her hand/ her feet are bothering and mobility and pain issues 24-hours following the administration of INFLUENZA QUADRIVAL A-B VACCINE. It was reported that the patient had a sharp pain in her hand and that is "too coincidental", her feet are bothering and there is a stiffness in her thumbs when she does too many things with her hands periodically. She also reports multiple mobility and pain issues, a heart problem, calling EMS, taking prednisone. (Other relevant tests included on unknown date in Jan 2017 she was positive for rheumatoid factor.) Final diagnosis was mobility and pain issues, heart problem, sharp pain in her hand/ her feet are bothering and stiffness in her thumbs when. The patient was treated with PREDNISONE. The patient outcome is reported as Unknown for sharp pain in her hand/ her feet are bothering, as Unknown for stiffness in her thumbs when, as Unknown for heart problem and as Unknown for mobility and pain issues. List of documents held by sender: none.
After the first booster, he was itching just on his back; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old male patient received BNT162b2 (BNT162B2), on 25Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EL9262; Anatomical location: left arm), administration date: 02Feb2021, when the patient was 76-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE; Lot number: EM9810; Anatomical location: left arm), administration date: 21Feb2021, when the patient was 76-year-old, for COVID-19 immunization. The following information was reported: PRURITUS (non-serious) with onset 2021, outcome "recovered" (2021), described as "After the first booster, he was itching just on his back". Therapeutic measures were taken as a result of pruritus.  Additional information: After the first booster, he was itching just on his back and was given gaba and the itching phased off towards end of year. Lot:  is what is written on the card. Hard to read the writing. All of his vaccines were Pfizer vaccines, and they were all given in his left arm at the (withheld). Did not receive any other vaccines that same day. The patient saw  the allergist the first time it happened with the first booster. Allergist said no, its not an allergic reaction and prescribed the gaba at first. Allergist thought it was a neurological issue.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200416811 same patient, same event different dose (dose 2);US-PFIZER INC-202201387218 same patient, same event different dose (second booster);US-PFIZER INC-202201387232 same patient, same event different dose (LOE);US-PFIZER INC-202201387233 same reporter, different patient, different event;
Initial information received on 28-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional (patient himself) via Acroda Affiliate Biogen (RCT-11092018-235603). This case involves a 62 years old male patient who experienced runny nose, sniffling symptoms, while he received vaccine INFLUENZA VACCINE and while treated with AMPYRA and TECFIDERA. The patient's past medical history included Gait disturbance. The patient's past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included BACLOFEN for Product used for unknown indication. On an unknown date, the patient started taking AMPYRA dosage unknown route unknown (with an unknown batch number) for Gait disturbance and TECFIDERA 240 mg BID oral (with an unknown batch number) for Multiple sclerosis. On 08-Nov-2018, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date, dose, dose in series were not reported) via unknown route in unknown administration site. The patient developed a non-serious runny nose, sniffling symptoms following the first dose intake and following the last dose intake of FAMPRIDINE and following the first dose intake and following the last dose intake of DIMETHYL FUMARATE. The patient developed a non-serious runny nose, sniffling symptoms following the administration of INFLUENZA VACCINE. It was also reported as the patient had a flu shot yesterday (from date of initial report) and that is why the patient had the symptoms. No additional information was provided. Other relevant tests included no lab test was reported. Final diagnosis was runny nose, sniffling symptoms. AMPYRA and TECFIDERA actions taken were unknown. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Not Recovered / Not Resolved on an unknown date for runny nose, sniffling symptoms. The reporter (patient) did not assess the causal relationship between AMPYRA and runny nose; sniffling symptoms. Documents held by the sender: none.
After 30 minute observation after vaccination per protocol for anaphylaxis history, patient left unit at 5:55pm and as she was leaving facility she reported symptoms to staff of "high blood pressure", "faintness", dizziness, lightheaded, weakness per patient--patient was assessed by EMS on site and BG was 86, BP elevated at 161/76. After further observation but no significant progression or improvement of symptoms she agreed to be transported to ED at 6:30pm.. No medications given on site, juice and crackers provided for low BG and report of missing meal,