chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician referring to a 1 year old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 07-MAR-2013, the patient received a dose of VARIVAX lot number reported as H014073 (dose, route of administration and expiration date were not provided) for prophylaxis. On an unspecified date in March 2013, reported as within 24 hours after vaccination, the patient developed a black and blue area around the injection site and 1 to 2 days later, the patient had a red bumpy rash from his shoulder to wrist on the side of the injection. On an unknown date, the patient was seen by another physician and since the patient was afebrile no treatment was given for the adverse events. The patient did not experience significant disability nor incapacity, life threatening nor intervention to prevent serious criteria, he was not hospitalized. It was unknown by the reporter whether there was an overdose. The patient did not die. On 14-FEB-2017, the patient had a Varicella immunoglobulin G (IgG) drawn and the results showed no immunity (blood immunoglobulin G abnormal). On an unknown date, the patient took weeks to get better and was recovered from injection site rash and injection site bruising by the reporting time. The outcome of blood immunoglobulin G abnormal was unknown. The causal relationship between the events and VARIVAX was not reported. Additional information has been requested.
Information has been received from a medical assistant concerning a 13 year old female with no pertinent medical history and no known drug allergies who on 31-JUL-2009 was vaccinated intramuscularly with the first 0.5 mL dose of VAQTA (LOT# 663913/0206Y) and on 28-SEP-2010 was vaccinated intramuscularly (IM) with the second 0.5 mL dose of dose of VAQTA (LOT# 668749/0988Z). There was no concomitant medication. On 28-SEP-2010 that evening after receiving her second dose of VAQTA the patient experienced stomach cramping. She was experiencing irritable bowel like symptom such as diarrhea after eating. On 01-OCT-2010 the patient experienced tingling in her tongue for 20 minutes The complete blood cell count "CBC" was tested for possible nut allergy. Unspecified medical attention was sought. At this time of reporting, the patient has not recovered. Follow-up information has been received from the medical assistant concerning the 13 year old female student with no illness at time of vaccination who on 29-SEP-2010 (previous reported as on 28-SEP-2010 that evening) after receiving VAQTA (IM left arm, LOT# 668749/0988Z) experienced abdominal pain. The patient put on calcium carbonate (+) famotidine (+) magnesium hydroxide daily. Food radioallergosorbent test (RAST) nut allergies done which was all negative. Ultrasound of gallbladder was pending. Complete blood cell count was within normal range. At the time of this report, the patient was still having some symptoms. Follow-up information has been received from the medical assistant who reported that the patient was no longer having abdominal pain as of 11-NOV-2010. No further information is available.
Pt received 2 month vaccines on 10/15/18. On 10/16/18 mom gave TYLENOL. She states child experienced brief seconds of a color change and a question of a breathing pause. Went to ER. Child was in no distress at the ER.
Painful upper extremity, unable to move arm in any direction and is unable to apply any pressure without pain.
Dizziness, Numbness of tongue and lightheadedness. 50mg PO Benadril. Monitored for 30 minutes. All symptoms resolved. No further intervention required. Patiient released to home with spouse.
The night I got my vaccine, I started to experience muscle twitching in my left leg.  This was a month ago and I experience muscle twitching daily all around my body - leg, buttocks, feet, eye, face.  I went to my doctor about this and got blood work done and all my labs were normal.  My doctor suggested I see a Neurologist if the twitching doesn't stop.  I have never experienced muscle twitching before the vaccine.
Thursday and Friday my arm was red and sore and over the weekend on Monday I have terrible pains in the lungs I called the nurse and she said to go to the hospital. I have a pressure of 102 with terrible pain. They thought I was having a heart attack and they did an electro, echo cardiogram. They did a Ct scan and they found I have clots in the lungs.  They admitted me into the hospital and stayed for 2 night and then on 3/11 they sent me home and they gave me a Blood thinner (take it twice a day).
She's been complaining about discomfort in her arm for a few days but yesterday I noticed that the arm was swelling.
Information has been received from a healthcare worker concerning a 12 month old female who on 04-JAN-2008 was vaccinated with her first dose of Rotateq.  Concomitant vaccinations administered on that same day included a dose of Varivax (MSD) and a dose of PREVNAR.  Medical attention was sought in the physician's office.  There was no product quality complaint.  Additional information has been requested.
From time vaccine administered, after two days, I began to run a high fever 104 degrees.  Had general flu like symptoms, ached all over.  After one day fever left but am still experiencing general fatigue & persistent cough.
Hives over entire body.; dose_number=3; prev dose brand=Moderna; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 10Dec2021 09:30 (Lot number: FJ1620) at the age of 26 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "covid" (unspecified if ongoing), notes: if covid prior vaccination Yes. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, administration date 18Nov2021. Vaccination history included: Moderna (Dose Number: 1, Batch/Lot No: 039K20A), administration date: 29Dec2020, when the patient was 25 years old, for COVID-19 Immunization; Moderna (Dose Number: 2, Batch/Lot No: 027L20A), administration date: 28Jan2021, when the patient was 25 years old, for COVID-19 Immunization.  The following information was reported: URTICARIA (medically significant) with onset 12Dec2021 12:00, outcome "not recovered", described as "Hives over entire body."; IMMUNISATION (non-serious) with onset 10Dec2021 09:30, outcome "unknown", described as "dose_number=3"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 10Dec2021 09:30, outcome "unknown", described as "prev dose brand=Moderna". The event "hives over entire body." was evaluated at the emergency room visit. Therapeutic measures were taken as a result of urticaria.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and 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.
Shingles outbreak on left side of head/face (V1 area)  It began with a pressure headache behind my left eye, about 3 days after my first vaccine shot in March 2021.  The headache has been completely constant since that date (today is September 20). After a week, I began to experience an outbreak of bumps on my nose. About 4 days after the bumps began appearing and spreading, I was unable to open my left eye. I went to an urgent care facility, where the doctor diagnosed me with shingles, attributing it to possible stress. At the time, I didn't think to attribute it to the vaccine shot, so the doctor was not aware of my recent vaccination.
This spontaneous report as received from a pharmacist refers to a 64 year old female patient. No information on her medical history, concurrent conditions or concomitant drugs was provided. On 06-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX subcutaneously in the right upper arm, lot # K000330, expiration date 06-MAR-2015. In October 2014 (reported as "either 07-OCT-2014 or 08-OCT-2014), the patient experienced itching all the time and welts around the vaccination site, when she touched the welts it would itch. The welts and a rash were also on her right upper thigh and have gone over to her left hip area, the middle of her belly button, under the left breast, and on her back on the left side of her body. Reportedly, the patient was feeling well except for the itchiness. It was unknown if there was any laboratory data. The outcome of the adverse events was unknown at the time of the report. Relatedness between use of the ZOSTAVAX and the adverse events was unknown. Additional information has been requested.
Arm is swollen, red area more than 5 inches wide and three inches high, hot to the touch
The nurse reported that the patient received a dose of MMR II that was reconstituted with expired diluent; The nurse reported that the patient received a dose of MMR II that was reconstituted with expired diluent; This spontaneous report was received from a licensed practical nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.   On 12-AUG-2020, the patient was vaccinated with a dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (rHA) (M-M-R II) injection (lot number S018595 which has been verified to be valid, expiration date reported and validated as 17-JUN-2021) (dosage, vaccination scheme, frequency, route of administration and anatomical site of injection were not reported), as prophylaxis. The vaccine was reconstituted with expired sterile diluent (DILUENT MRK) (lot number N029293 which has been verified to be valid, expiration date reported and validated as 25-APR-2020) (expired product administered and product preparation error).
Pt developed varicella. Symptoms started on 02/06/06, included fever, malaise, rash.
Very bad gastrointestinal gurgling. Strong need to use the bathroom. Very lose stools.  Going to the bathroom several times per day since March 10, 2021. This is not usual.
they were sick; Reason for case deletion: As per reported information, it was not clear after which shot of shingles vaccine patient had experienced the event. Therefore, one case was kept valid one without dose number as case of record (US2023AMR038711) and deleted the other case (US2023AMR038745) as case created in error.; Sender's Comments:  US-GSK-US2023AMR038711:same reporter US-GSK-US2023AMR038711:same reporter
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Migraine since an unknown date.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. On 06-Feb-2021, HEADACHE (Headache) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported
Influenza vaccine FLUARIX quadrivalent syringes, NDC 58160-901-52, 2014/2015 formulation inadvertently returned to stock and administered to 1 or 2 patients. Boxes of 2014/2015 and 2015/2016 vaccine differ only by the year in the upper right corner of the labeling.
Numbness down her left arm; Pressure in her left side of the chest.; Weird sensation that she has never had before.; Pain at the site; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness down her left arm), CHEST DISCOMFORT (Pressure in her left side of the chest.), SENSORY DISTURBANCE (Weird sensation that she has never had before.) and VACCINATION SITE PAIN (Pain at the site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain at the site). On 26-Mar-2021, the patient experienced HYPOAESTHESIA (Numbness down her left arm), CHEST DISCOMFORT (Pressure in her left side of the chest.) and SENSORY DISTURBANCE (Weird sensation that she has never had before.). At the time of the report, HYPOAESTHESIA (Numbness down her left arm), CHEST DISCOMFORT (Pressure in her left side of the chest.), SENSORY DISTURBANCE (Weird sensation that she has never had before.) and VACCINATION SITE PAIN (Pain at the site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided.
This spontaneous report was received from a pharmacist, via a company representative, and refers to a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 14-NOV-2017, the patient was vaccinated with a dose of ZOSTAVAX lot # M040146, for prophylaxis (strength, dose, route, frequency and expiration date were not reported). On an unknown date in November 2017, the patient got a "big rash on his arm towards the elbow, the size of a softball with welts". The patient followed up with his primary physician who prescribed an unspecified cream and a possible steroid injection (unknown date). The outcome of urticarial rash was unknown. The causality between urticarial rash and ZOSTAVAX was not reported.
This spontaneous report was received from a pharmacist regarding an approximately 71 year old female patient. The patient has reaction/allergy to latex. The patient was not immunosuppressed. On 01-OCT-2014 the patient was vaccinated with ZOSTAVAX (19400 plaque forming units, lot # K007986, expiry 03-SEP-2015, dose 0.65 ml) subcutaneously in the right deltoid. Concomitant therapies included prednisone. On an unknown date in October 2014 after the vaccination, the patient exhibited rash on her trunk region, including her breasts and her navel area. The patient also experienced pain bilaterally in her axilla region. The pharmacist did not provide a detailed description of the patient's rash, and he could not describe the quality of the patient's pain. He does not know when the symptoms began. He states that she has not consulted her physician and no treatment has been administered for the symptoms. No intervention was done to prevent serious criteria as the event was not serious. The outcome of the events was reported as not recovered. The causality of the events to suspect therapy was not specified by the reporter. Additional information has been requested.
Patient complained of constant pain from injection site even months following injection. Patient states she visited a physician who told her it may be from the vaccination in which a nerve was affected.
Mom noted swelling/inflammation "greater than expected" approx 24 hours after vaccinations given. Mom phoned clinic and was advised by RN "to use ice packs and give Tylenol". Following day (6/11) says swelling was worse, child complained of itching, so brought in to clinic. Right upper arm reddened, swollen from elbow to shoulder. Advised to change to Ibuprofen every 6-8 hours and po Benadryl for itch and cold, moist packs. Improved considerably with 24 hours of this Tx, per Mom's phone report.
Dizziness; Nausea; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced dizziness and nausea. On an unknown date, the outcome of the dizziness and nausea were unknown.   It was unknown if the reporter considered the dizziness and nausea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced dizziness and nausea with Shingrix vaccine. The patient did not provide any demographic information and disconnected the call prior to any questions being asked in regards to the adverse event.
Rash and warm on injection site down to elbow. 2 red streaks. Treated with amox.
Diarrhea;Case reference number MOD-2021-008851 is a spontaneous case report sent by a Other Health Professional on 17-JAN-2021, which refers to a Female aged 51 Years .  On   the patient started taking Moderna COVID-19 Vaccine for COVID-19 vaccination. Some  6 days later,  the patient developed Diarrhea.  No treatment was undertaken for the event.  The action taken for Moderna COVID-19 Vaccine was  Unknown. The Other Health Professional did not declare any relatedness between Diarrhea and Moderna COVID-19 Vaccine.    Narrative (for narratives and signal review) Brief 3 line summary of above for ADR listing: Report Source- Other Health Professional,  Age- 51 Years,  Sex- Female,  Suspect Drug- Moderna COVID-19 Vaccine,  Treatment-    Diagnosis\Outcome- Diarrhea - Recovered/Resolved.
got really sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got really sick) in a  patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (got really sick). At the time of the report, ILLNESS (got really sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient received booster shot on Friday, September 10. The patient got really sick, much worse than with the previous two shots, and on the second day, woke with really swollen lymph nodes in neck.  No concomitant medications were reported. No treatment medications were provided.   This case was linked to MOD-2021-319590, MOD-2021-319591 (Patient Link).
All the neck and arm and chest area hurts; Arm is more swollen, hard and hurts; Headache; Shivering went awat 10 mins later and felt asleep/chills and was Shivering; Swollen Nodule on the Clavicle; On a scale of Pain at the injection site from 1 to 10 it was a 3 to 4; Arm and Shoulder was hurting; Arm is still swollen over there at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (All the neck and arm and chest area hurts), LIMB DISCOMFORT (Arm is more swollen, hard and hurts), APPLICATION SITE PAIN (On a scale of Pain at the injection site from 1 to 10 it was a 3 to 4), LYMPHADENOPATHY (Swollen Nodule on the Clavicle) and ARTHRALGIA (Arm and Shoulder was hurting) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced ARTHRALGIA (Arm and Shoulder was hurting) and VACCINATION SITE SWELLING (Arm is still swollen over there at the injection site). On 18-Aug-2021, the patient experienced APPLICATION SITE PAIN (On a scale of Pain at the injection site from 1 to 10 it was a 3 to 4). On 26-Aug-2021, the patient experienced LYMPHADENOPATHY (Swollen Nodule on the Clavicle). On an unknown date, the patient experienced CHEST PAIN (All the neck and arm and chest area hurts), LIMB DISCOMFORT (Arm is more swollen, hard and hurts), HEADACHE (Headache) and CHILLS (Shivering went awat 10 mins later and felt asleep/chills and was Shivering). At the time of the report, CHEST PAIN (All the neck and arm and chest area hurts), LIMB DISCOMFORT (Arm is more swollen, hard and hurts), APPLICATION SITE PAIN (On a scale of Pain at the injection site from 1 to 10 it was a 3 to 4), LYMPHADENOPATHY (Swollen Nodule on the Clavicle), ARTHRALGIA (Arm and Shoulder was hurting), HEADACHE (Headache) and CHILLS (Shivering went awat 10 mins later and felt asleep/chills and was Shivering) outcome was unknown and VACCINATION SITE SWELLING (Arm is still swollen over there at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.   Treatment information was not  provided.
5:50 PM after 15 min observation, pt left facility but was experiencing nausea and dizziness when she got to the car. Patient accompanied by sister (ROI and permission from mom on file). RN assessed patient and documented vital signs, WNL. Presented to Dr. Transported patient via wheelchair back inside clinic for further observation. Patient complained of left sided chest pain 10/10. Presented to Dr. Provider assessed patient and requested EMS. 2nd set of vital signs documented. Patient states intermittent chest pain. Mother arrived and EMS arrived. Dr. gave report to EMS. Mother and patient left via EMS transport to hospital.
Heart palpitations.  I had some prior to the  boostershot. They were minor  before and would go away when changing position. I don't know if the minor ones started after the first and second shot or not.  Waking up in the middle night with the heart palpitations and severe shaking with nerves jumping in my arms, legs, stomach, back.  The nerve jumping felt like twitches.  It takes about 3 minutes for the twitching to stop, but the palpitations last longer.  Mainly happening at night with a few happening during the day.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 21-AUG-2018, the patient was vaccinated with a improperly stored M-M-R II lot # N023146, expiration date: 24-AUG-2019 (exact dose, route and site of administration were not reported) for prophylaxis. The vaccine was diluted with an improperly stored sterile diluent lot# N030026 (also reported as #030026), expiration date: 04-JUN-2020. The vaccine and sterile diluent were exposed to temperature in the range of 9 Celsius degrees to 25 Celsius degrees for 13 days. Temperature excursion was not detected by a data logger. There was no previous temperature excursion. The medical assistant declined evaluation of improperly stored administered vaccines. No adverse events were reported. This is one of three reports from the same reporter.; Sender's Comments: US-009507513-1809USA001804: US-009507513-1808USA011459: