chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Back pain/painful to stand up and move around; It is painful to stand up and move around.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 75 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "chronic lower back pain" (unspecified if ongoing), notes: back pain isn't associated with the first shot, the caller just has chronic lower back pain. The patient's concomitant medications were not reported. The following information was reported: BACK PAIN (non-serious), outcome "unknown", described as "Back pain/painful to stand up and move around"; DYSKINESIA (non-serious), outcome "unknown", described as "It is painful to stand up and move around.".  Additional information: The caller was concerned because he had back pain right now and was scheduled for second shot today at 13:30. The caller wasn't sure if he should be getting the shot today because of the back pain. The back pain wasn't associated with the first shot, the caller just has chronic lower back pain and his back went out 4 days ago. It was painful to stand up and move around. The caller knows the second dose was a little worse and wants to know if this will effect the lower back. The caller declines to file a safety report as he does not believe that this event is related to the first dose of the vaccine, no further information or details were captured at this time.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Site: Redness at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Fever-Medium, Systemic: Nausea-Medium, Additional Details: pt experienced fever , rash ,and nausea
no adverse effects reported; patient was vaccinated with improperly stored MMR II; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 27-DEC-2018, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) one dose, lot # N023024 with expiration date 23-AUG-2019 (frequency, route and anatomical location were not provided) which was reconstituted with sterile diluent (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported.  The temperature and time frame were unknown by reporter. There was previously temperature excursions and digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011469: US-009507513-1907USA010301: US-009507513-1907USA010302: US-009507513-1907USA010303: US-009507513-1907USA010304: US-009507513-1907USA010305: US-009507513-1907USA010306: US-009507513-1907USA010308: US-009507513-1907USA010309: US-009507513-1907USA010310: US-009507513-1907USA010311: US-009507513-1907USA010312: US-009507513-1907USA010313: US-009507513-1907USA010314: US-009507513-1907USA010315: US-009507513-1907USA010316: US-009507513-1907USA010317: US-009507513-1907USA010318: US-009507513-1907USA010319: US-009507513-1907USA010320: US-009507513-1907USA010321: US-009507513-1907USA010322: US-009507513-1907USA010323: US-009507513-1907USA010324: US-009507513-1907USA010325: US-009507513-1907USA010326: US-009507513-1907USA010327: US-009507513-1907USA010328: US-009507513-1907USA010329: US-009507513-1907USA010330: US-009507513-1907USA010331: US-009507513-1907USA010332: US-009507513-1907USA010333: US-009507513-1907USA010334: US-009507513-1907USA010335: US-009507513-1907USA010336: US-009507513-1907USA010337: US-009507513-1907USA010338: US-009507513-1907USA010339: US-009507513-1907USA010340: US-009507513-1907USA010341: US-009507513-1907USA010342: US-009507513-1907USA010343: US-009507513-1907USA010344: US-009507513-1907USA010345: US-009507513-1907USA010346: US-009507513-1907USA010347: US-009507513-1907USA010348: US-009507513-1907USA010349: US-009507513-1907USA010350: US-009507513-1907USA010351: US-009507513-1907USA010352: US-009507513-1907USA010353: US-009507513-1907USA010354: US-009507513-1907USA010355: US-009507513-1907USA010356: US-009507513-1907USA010357: US-009507513-1907USA010358: US-009507513-1907USA010359: US-009507513-1907USA010360: US-009507513-1907USA010361: US-009507513-1907USA010362: US-009507513-1907USA010363: US-009507513-1907USA010364: US-009507513-1907USA010365: US-009507513-1907USA010366: US-009507513-1907USA010367: US-009507513-1907USA010368: US-009507513-1907USA010369: US-009507513-1907USA010370: US-009507513-1907USA010371: US-009507513-1907USA010372: US-009507513-1907USA010373:
Pain in arm that has continued 45 days after vaccine. Bursitis potentially. Patient has difficulty raising arm and pain when he lifts it too high and crosses his body.
pt presented with a rash aproximately palm sized.  stated started the day after the vaccination and had shrunk in size and intensity over the next few days.  reported as being itchy
reports recvd vax Monday & arm bruised, pain & swelling from shoulder to elbow;now pain radiating down arm;fingers cold & numb; referred pt to ER
After receiving the second dose of the Pfizer vaccine reported fevers and muscle pains; After receiving the second dose of the Pfizer vaccine reported fevers and muscle pains; This is a spontaneous report received from a non-contactable consumer (patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection) via an unspecified route of administration on an unspecified date as 2nd dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient received the second dose of the Pfizer vaccine and experienced fevers and muscle pains on an unspecified date and adverse events was mentioned during a casual conversation. The outcome of events was unknown.  No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained.
Patient had syncopal episode immediately after vaccination.  Patient felt better after resting and was released to home.
Stark coloration differences in both hands, with fingers beyond first knuckle pale yellow and back of hand deep red, looking like images of Raynaud's. Numbness and loss of dexterity in both hands, to the point that it took more than 5 minutes to unbutton one button.  Onset with cold; duration of 30-45 minutes. This was on 3/21/21. On 3/22/21 coloration changes returned with tingling in left hand but normal dexterity. Duration approximately 10 minutes but repeated episodes throughout day. Perhaps entirely unrelated to vaccine -- second vaccine was 3/13/21 and nothing like this happened after first vaccine on 2/13/21.
throat tickling; knee pain; slight back pain; This case was reported by a consumer via call center representative and described the occurrence of throat irritation in a 64-year-old male patient who received Rabies NVS (RabAvert) for prophylaxis.   The patient's past medical history included animal bite. Previously administered products included Rabavert with an associated reaction of arthralgia (1st dose received on unknown, please refer the case US2020146787). Concurrent medical conditions included diabetes. Concomitant products included warfarin, immunoglobulin human normal (Gamma Globulin), paracetamol (Tylenol) and benadryl (nos) (Benadryl).   On an unknown date, the patient received the 2nd dose of RabAvert. On an unknown date, unknown after receiving RabAvert, the patient experienced throat irritation, knee pain and back pain. On an unknown date, the outcome of the throat irritation was recovered/resolved and the outcome of the knee pain and back pain were not recovered/not resolved.   It was unknown if the reporter considered the throat irritation, knee pain and back pain to be related to RabAvert.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter stated with every Rabavert shot he experiences throat tickling which goes away after a day.  The patient experienced ongoing knee pain and ongoing slight back pain.  The reporter consent to follow up. This is 2 of 5 case reported by same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020146787: US-GLAXOSMITHKLINE-US2020AMR148391: US-GLAXOSMITHKLINE-US2020AMR148392: US-GLAXOSMITHKLINE-US2020AMR148393:
pt recv vax & devel inj site rxn characterized by swelling, redness & pain;
1/00 Muscle tightness, achiness in neck and arms (right and left), tingling and numbness in right arm and 1st, 2nd, and 3rd digits. 3/00 blurring and cloudiness of vision in left eye. Tests were conducted 03/15-03/19. 03/22 consulted neurologist. Dx with encephalomyelitis and transverse myelitis. Neurological evaluation is scheduled for 09/00. Annual follow up on 03/05/04: "Pt has not recovered from adverse events.  02/24/04: Contact health center, pt continues to be an employee.  Nurse will contact her. 03/03/04: She is still employed as a lactation consultant.  Pt continues to have tinnitus and occasional numbness and tingling of fingers in right hand.  Neurologist states condition has stabilized but above symptoms will probably continue.
This spontaneous report was received from a healthcare worker during a phone call concerning unspecified patients of unknown age and gender. No concurrent conditions or medical history were reported. On an unknown date, the patients were vaccinated with "the series" of MMR II (dose, route, frequency and anatomical location of administration were not reported). No concomitant therapy was provided. On an unknown date, the patients had low titer levels after completing the series for MMR II. As treatment, the MMR II series were restarted. The event was resolved as titer was within therapeutic range. The outcome of viral titre decreased was reported as recovered on an unknown date. This is one several reports received from the same source. Additional information has been requested.
Tested positive for COVID-19 on 05/24/2021. Mild symptoms including sneezing and runny nose. Received bamlanivimab infusion.
Patient received Shingrix  at local pharmacy on 10/6/19 and on 10/7/19 developed painful rash.  Seen in the office in 10/9/19 and diagnosed with shingles. This was based on clinical presentation which was classic for shingles. Decided to report as odd with timing of this nonlive vaccine.  He denied any recent illnesses.  He is not immunosuppressed.
Thrush(yeast infection in throat and mouth) recurred one month after 3rd vaccine.  Prior incident of thrush occurred on 7/19/21, which was 5 months after 2nd vaccine.  The July 2021 incident caused sore throat and fever (treated with Nystatin after urgent care visit), but after treatment failure led to dehydration and ER visit, then 2-week course of fluconazole.  The September 2021 incident was recognized by us more quickly, we went to urgent care and started 7-day course of fluconazole, which seems to have resolved the problem.
Patient presented to the emergency department on 12/13/09 with 2-3 days of fatigue and lower extremity weakness.  The patient was admitted to the hospital and experienced progressive ascending paralysis with subsequent respiratory distress which required intubation on 12/15/09.  Per the immunology physicians note on 12/17, diagnosis was Acute Inflammatory Demyelinating neuropathy consistent with Guillain-Barre Syndrome.  The patient received a course of five plasmapheresis treatments, followed by one treatment of IVIG.
01/30/09 with diarrhea (day 0 only); variable low grade fever (day 2-10 ); cold-like symptoms (day 2-7): clear runny nose, sneezing, watery eyes; whining/clinging behavior during cold-like symptoms; then moderate-severe measles rash (day 9-12) to face (with puffy eyes), neck, chest, abdomen, back, diaper areas (front and back), and mildly to upper arms and upper legs (lasting ~4 days total).
Patient has been complaining of epigastric supraumbilical pain for the past 2 months and had noted periumbilical subcutaneous palpable lump. Yesterday and today pain has gotten significantly worse, patient was sent to Radiology Office for abdominal CAT scan which showed incarcerated possibly strangulated hernia. Immediately patient was sent to emergency room for further surgical evaluation for treatment. Found to be PCR Positive
8-10 days after VARIVAX local urticaria's occurred near and overlying the site of injection. May be coincidental as she appeared to have popular urticaria's as well - generalized.
POSSIBLE STROKE; BELL'S PALSY; This spontaneous report received from a patient concerned a 46 year old female. The patient's concurrent conditions included cigarette smoker, no alcohol use, penicillin allergy, high blood pressure, and lower back pain from bone loss after menopause, and patient had no drug abuse or illicit drug usage. The patient was previously treated with ibuprofen for drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21a and expiry: 07-AUG-2021) dose was not reported, 1 total, administered on 01-JUN-2021 to left arm for prophylactic vaccination.  Concomitant medications included lisinopril, and oxycodone.  On 27-JUN-2021, The patient had a stroke and patient states that, mouth felt different and went to take a drink and it ran down the mouth, patient's whole right side of face was paralyzed, patient drove to the hospital and patient was scans performed in the emergency room (ER), was given a diagnosis of Bell's Palsy and a referral to a neurologist. The patient was told that a stroke could not be ruled out, and patient was not admitted to hospital and was discharged from emergency room (ER) around 1:30 am on 28-JUN-2021. The patient was contacted primary doctor and a referral for a neurologist was sent and patient was awaiting a call back with appointment information and reports symptoms have not improved including feeling the right side of face being paralyzed and being unable to close right eye. Laboratory data included: Lab test (NR: not provided) Patient willing to provide reports if requested. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stroke and bell's palsy. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210700241-covid-19 vaccine ad26.cov2.s-possible stroke, bell's palsy. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Symptoms were consistent with moderate to severe side effects but lasted longer than they should have. Still had symptoms of swelling, redness and soreness around the injection site. My doctor was not available and went to the emergency room and they prescribed me the antibiotics Keflex.
pt recv vax 26MAR98 & c/o itching @ site w/2cm hardness & 1.5cm redness @ site;noticed 30MAR;
This is a 42-year-old female with an overall unremarkable past medical history seen in clinic for a hospital discharge follow-up.  She states that on 30  March she received first dose of her Covid vaccine.  Just over one week later she developed a red spotty rash across the left arm and left trunk that was itchy.  The rash has persisted until this time.  She has a history of plantar neuromas that have been surgically excised and has persistent left foot pain.  She felt a significant worsening of this so she went to the ER and was given prescription of Celebrex.  3 days after taking the Celebrex she developed symptoms of left-sided facial puffiness underneath the jaw and developed left-sided facial weakness and arm weakness.  Due to appropriate concern for a stroke she presented to the emergency room and was later admitted.  She had a number of CT scans and MRIs all of which were normal.  While she was in the hospital she underwent a number of blood tests which were ultimately negative.  She underwent an echo and after she sat up from having this completed she had a recurrence of the left-sided facial weakness. Neurology evaluated with the following comments, "42 yo female with no significant PMHx with onset of left facial weakness, left upper and lower extremity weakness and paresthesias. No lower extremity weakness on exam today and minimal give-way weakness in multiple muscle groups in the left upper extremity. No pronator drift. Reflexes are symmetric and intact. Sensory is intact in extremities. Left facial weakness is mild with some fluctuating features. No Bell?s phenomenon which is commonly seen with CN VII palsy. Imaging studies are not consistent with ischemic or hemorrhage stroke. Duration of symptoms are not consistent with TIA. MRI without evidence of demyelinating disease process. Low likelihood of migraine. Rash does not appear to be herpetic in nature. Other autoimmune processes are possible given the joint pain and tenderness. No significant edema on exam. Post vaccine response less likely. No ophthalmoplegia or ataxia. Consider facial dystonia."  Upon discharge from the hospital she has waxing and waning left-sided facial weakness.  She admits that it might be provoked the more that she talks or smiles.  Just prior to the patient's weakness episodes she will feel a pressure across the left temple around her ear.  She still has this pinpoint rash across left side of her abdomen and left arm.  There is a focal swelling in the antecubital space of her left arm that has never been characterized. Broad testing negative to this point. Potentially symptoms associated with moderna covid-19 vaccination. As outpatient she has been tested for myasthenia gravis, lyme disease, rheumatoid conditions. Empirically treated with prednisone long taper, acyclovir, and doxycycline all to no substantial benefit. At this time dedicated facial nerve MRI ordered and scheduled, and tertiary workup underway.
Patient became nauseated and vomited. Pale and diaphoretic. Stated didn't get sick until after the MCV4 vaccine was given. Symptoms lasted approximately 15 minutes.
Period has been extra painful with cramps for 3x days, PMSing for 7+ days, and my migraine is worse.    I have been unable to sleep for the last day, and my asthma has been flaring up too.
EAR RINGING; VERTIGO TYPE FEELING; FEELS LITTLE BUMP AT THE INJECTION SITE; EARS FEELS LIKE DRUM RINGING; NO FEELING IN THE ENTIRE LEFT SIDE; A VERY DIFFERENT FEELING ON THE LEFT SIDE FROM THE RIGHT SIDE; LEFT EAR IS HEARING EVERYTHING MUFFLED; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (EAR RINGING), VERTIGO (VERTIGO TYPE FEELING), VACCINATION SITE NODULE (FEELS LITTLE BUMP AT THE INJECTION SITE), TINNITUS (EARS FEELS LIKE DRUM RINGING) and SENSORY DISTURBANCE (NO FEELING IN THE ENTIRE LEFT SIDE) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced TINNITUS (EAR RINGING), VERTIGO (VERTIGO TYPE FEELING), VACCINATION SITE NODULE (FEELS LITTLE BUMP AT THE INJECTION SITE), TINNITUS (EARS FEELS LIKE DRUM RINGING), SENSORY DISTURBANCE (NO FEELING IN THE ENTIRE LEFT SIDE), FEELING ABNORMAL (A VERY DIFFERENT FEELING ON THE LEFT SIDE FROM THE RIGHT SIDE) and HYPOACUSIS (LEFT EAR IS HEARING EVERYTHING MUFFLED). At the time of the report, TINNITUS (EAR RINGING), VERTIGO (VERTIGO TYPE FEELING), VACCINATION SITE NODULE (FEELS LITTLE BUMP AT THE INJECTION SITE), TINNITUS (EARS FEELS LIKE DRUM RINGING), SENSORY DISTURBANCE (NO FEELING IN THE ENTIRE LEFT SIDE), FEELING ABNORMAL (A VERY DIFFERENT FEELING ON THE LEFT SIDE FROM THE RIGHT SIDE) and HYPOACUSIS (LEFT EAR IS HEARING EVERYTHING MUFFLED) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided by the reporter. Treatment information was not provided by the reporter.
There is a hard bump on my left arm and is still there. Also my armpit area is sore like I strained a muscle in there
Patient arrived to clinic to receive a flu vaccine for the 2020-2021 season. Upon arrival to clinic, patient completed flu questionnaire. Patient was then vaccinated with Moderna Covid-19 vaccine by error. Upon realization of incorrect vaccine being administered, staff then vaccinated with correct vaccine (afluria) in opposite arm. Upon speaking with the patient the next day, he reported feeling chills, fever, fatigue continuing throughout the day. States did have a headache on 2/9/2021 that then subsided. Was taking tylenol and theraflu for side effects
After 10 min after vaccine, started to feel lightheaded, dizzy, tongue thick and developed tunnel vision.  B/P 124/88 P 96 SPO2 100 Sent to ED for evaluation
Received immunization 11/8/12 - on 11/11/12 notice 2 inch L x 1/2 inch W square red area surrounding injection site on (L) upper arm - itchiness noted but no swelling or blisters - call agency 11/13/12 - states area decreasing redness - now pink & decrease itchiness - no other symptoms - has not notified family MD.
The day after I had nausea, fever, chills, stomach ache, burning sensation in my legs and hot to the touch...that lasted one hour. The day after these burning sensations went all over my body that lasted two weeks. These last two weeks only the burning sensation is in my legs.  The doctor diagnosed me with Paresthesia, and gave me Gabapentin.
Patient is14 years old and he presented at the clinic and got a vaccine; Sore arm; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient is14 years old and he presented at the clinic and got a vaccine) and VACCINATION SITE PAIN (Sore arm) in a 14-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient is 14 years old and he presented at the clinic and got a vaccine) and VACCINATION SITE PAIN (Sore arm). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient is 14 years old and he presented at the clinic and got a vaccine) had resolved and VACCINATION SITE PAIN (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.
Patient asked on online form and in person if had received a COVID Vaccination before.  Patient stated on the online form and in person that he has NOT received a COVID Vaccination before.  Moderna dose was then administered at 2:23 p.m. At 2:30 pm while patient was still at the pharmacy waiting  the required 15 minutes, I started the state immunization registry for the patient.  Then I discovered patient had already received 2 doses of Moderna Covid-19 vaccination on 03/01/2021 and 03/30/2021. I immediately call the Community Provider line which instructed me to enter the third dose in the registry and complete VAERS form.