chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient sat in waiting area chair after receiving vaccine. I was notified by another customer that something appeared wrong with the patient. I went to the patient and found him unconscious and unresponsive. I told the technician to call 911 for EMS and I proceeded to remove the Epinephrine emergency pen from the emergency bag. The patient regained consciousness, I did not administer the epinephrine emergency pen. I remained with the patient. The patient complained of feeling hot, nausea and tired. Patient also appeared confused. Patient's head was cold to the touch. EMS  arrived and took the patient's vital signs. The patient's awareness  and tiredness appeared to vary from feeling fine and alert to confusion.  After about 15 minutes with EMS the patient choose to go with EMS to the Hospital Emergency room for observation. The patient walked about 15 steps then chose to go on the gurney with EMS.
Irregular menstrual cycle; First month heavy and lasted two weeks; Second cycle light and lasted 3 days; Spotting; Mild cramping; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the right arm on 05Apr2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FP7533) via an unspecified route of administration in the right leg on an unknown date (also reported on 05Apr2021 at 12:00) as a single dose for COVID-19 immunisation. On 14Jun2021, the patient experienced irregular menstrual cycle, for first month it was heavy and had lasted for two weeks. The patient's second cycle was light and lasted for 3 days. On an unknown date in 2021, the patient experienced spotting and mild cramping. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had been tested for COVID-19. On an unknown date, the patient underwent COVID-19 test via nasal swab and the result was unknown. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the event first month heavy and lasted two weeks was resolved on 28Jun2021 while that of second cycle light and lasted 3 days was resolved on an unknown date in 2021. The clinical outcome of the events spotting, mild cramping and irregular menstrual cycle were not resolved at the time of this report.
Painless bruise about the size of a dime. I still have it two weeks later.
CLIENT COMPLAINING OF PAIN AT INJECTION SITE, LEFT UPPER ARM.  REDNESS AND SIGNIFICANT SWELLING TO LEFT UPPER ARM.  DX WITH CELLULITIS PER DR.  ROCEPHIN 500 MG IM GIVEN WITH ORDERS FOR NEXT DAY FOLLOWUP WITH LOCAL ER.
This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (could not sleep for 2 days), VACCINATION SITE MOVEMENT IMPAIRMENT (Could not lift left arm for 2 days) and VACCINATION SITE PAIN (Left arm hurt extremely bad for 2 days) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Pulmonary embolism and Arthritis.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced INSOMNIA (could not sleep for 2 days), VACCINATION SITE MOVEMENT IMPAIRMENT (Could not lift left arm for 2 days) and VACCINATION SITE PAIN (Left arm hurt extremely bad for 2 days). In February 2021, INSOMNIA (could not sleep for 2 days), VACCINATION SITE MOVEMENT IMPAIRMENT (Could not lift left arm for 2 days) and VACCINATION SITE PAIN (Left arm hurt extremely bad for 2 days) had resolved.            Concomitant medications were not provided. Treatment information was not provided.   This case was linked to MOD-2021-351016, MOD-2021-351023 (Patient Link).
Narrative: Per advice line documentation on December 7, 2021, A 60yo male called with complains of noticing flat rectangular red spotson his stomach, chest and back x 2 -3 days and not sure if he was bitten by a thick since he returned from (Privacy) on 11/13 or a reaction to Moderna vaccine received on 11/15. The patient was advised to go to urgent care for evaluation and management. the following day the patient called and reported he went to urgent care received a steroid pill and was prescribed a topical cream but the symptoms have worsened. Physician requested patient be contacted by the nurse for a possible antibiotic reaction the patient was recently started on and to stop taking it. Prescription for methylprednisolone was ordered and the patient was asked to come for evaluation, The patient presented to the clinic on December 10,2021 and communicated he had completed the doxycycline therapy stated on November 29, 2021 for Chlamydia. Further test were ordered to rule out DRESS vs other possible infections. The physician recommended to finish oral steroids as ordered and use of topical triamcinolone. December 16, 2021 - all lab test results were normal and patient also reported rash had stopped spreading. The Physician reported a possible ADR reaction to Moderna Covid vaccine vs Doxycycline
She always has allergies but this seems to be more serious; little more sick than usual; This is a spontaneous report from a contactable consumer. This consumer reported for a patient  that a 13-years-old female patient received bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, batch/lot number: unspecified), via an unspecified route of administration on unspecified date as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. She had allergy (not specified).  about seven days ago and he has Covid 19 right now, tomorrow my  was supposed to get her Pfizer shot (It was not clarified whether the shot was first or second shot) and I was wondering should I take her and have her do the quick overnight Covid test first to see if she has the Covid thing and also can you take the Covid vaccination if you were already sick. She seems to be little more sick than usual. She always has allergies, but this seems to be more serious. The outcome of the events was unknown.Follow-up (21May2021): This follow-up contains no new medically significant information.  Follow-up (21May2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported for a patient that: COVID 19 exposure between doses of the Pfizer Covid Vaccine. No follow-up attempts are possible; information about lot batch number cannot be obtained.
Patient developed bilateral cervical lymphadenopathy on 4/21. She was started on Augmentin 4/23 without improvement. At time of my exam on 4/27/21 she had a large right fixed submandibular neck mass. CBC 4/27/21 showed mild monocytosis, and US 4/27/21 showed bilateral hypoechoic LNs (R>L with largest node adjacent to R submandibular gland 3.2cm in size) concerning for systemic abnormality such as lymphoma or metastatic disease. Patient was switched to clindamycin on 4/27/21, but developed drug rash, so was ultimately treated with 10-day course of Augmentin and Bactrim with complete resolution of lymphadenopathy when next examined 5/6/21.
heavy heart burn; fever; fatigue; sore throat on left side lasting four days (sore throat, 2 days longer); This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3247, Expiration date: Unknown), via an unspecified route of administration, administered in right arm on 09Feb2021 at 08:30 am (at the age of 74-year-old) as dose 2, single for COVID-19 immunisation at other facility. No other vaccines were received in four weeks. The patient did not have Covid prior vaccination. No medical history was reported. No known allergies were reported. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL1283, Expiration date: Unknown), via an unspecified route of administration, administered in arm left on 22Jan2021 at 07:00 PM (at the age of 74-year-old) as dose 1, single for COVID-19 immunisation at another facility. Concomitant medications included amlodipine, meteprolol and atorvastatin (LIPITOR). On 18Feb2021 at 11:00pm, at 9 days after the second dose, the patient experienced: initially heavy heart burn, followed by fever, fatigue and very sore throat on left side lasting four days (sore throat, 2 days longer). Tested for COVID (3 times) and strep throat (2 times) all negative. On 20Feb2021, the patient underwent covid test post vaccination with covid test type nasal swab: negative, covid test post vaccination for strep throat: negative. No treatment was received for the events. Outcome of the events was recovered with lasting effects (recovered with sequel).
Started experiencing Numbness in my left side of my face; Slow speech; This is a spontaneous report from a contactable consumer (Patient). A 36-years-old female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 36-years-old, intramuscular, administered in Arm Right on 20Apr2021 (Lot Number: ER8731) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. patient received first dose of bnt162b2, at the age of 36-years-old, on 29Mar2021 4:00 PM for covid-19 immunisation. Patient went in for second dose of the COVID shot yesterday, The Pfizer COVID shot and the first 15 minutes she was fine. After she left (withheld), after about 20 minutes, she started experiencing numbness in left side of face and slightly slow speech and she was still actually experiencing the numbness in face. She didn't have numbness in face before getting the shot. Treatment for events was No. Events outcome were not recovered.  No follow-up attempts are needed. No further information is expected.
15-20 minutes after vaccine pain in chest on left side near heart, sharp for 10-15 sec and than tingling constant dull pain, sharp pain happened multiple times since the injection.  Went to ER on advice from physician, had multiple tests including blood work, EKG,  CT angiogram d-dimer high, did not show heart issues but it did show minimal basilar atelectasis.  Currently still having pain and started incentive spirometer.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. On an unknown dates in 2014 (reported as "between 06-SEP-2014 and 18-DEC-2014"), unspecified number of patients were vaccinated with a dose of GARDASIL (lot number, expiry date, dose, frequency, route were not reported) that underwent multiple temperature excursions. It was unknown if any of those doses were supported. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Severe swelling in upper R arm, redness, very warm feeling as described by patient, pt felt weak and dizzy as if she were going to faint.
Initial small rash, size of about 2" x 2" south of injection site, increased rash area over the day to eventually a 3-1/2" x 5" area with a very small raised "dot" kind of near the middle of the initial rash appearance.  Mild headache began around 9:30 pm. the same day.  Increased headache next morning and a feeling of being not quite right.  Mid-afternoon, around 3 pm, felt tired, and really overall sick feeling, but no temperature ? not exactly nausea, but just feeling very tired, sleepy and sick with no appetite. Shooting pains in bottom of feet started in the evening around 6:30 pm,  also aches in right leg bone and both arms.
A non-serious, spontaneous report of pruritic generalized rash has been received from a physician concerning her nine-year old daughter subsequent to FLUMIST. Neither medical history nor concomitant medications were reported for the patient. The patient received FLUMIST on an unknown date in 2010. Approximately 7-10 days after receipt of FLUMIST, the patient developed an intensely pruritic generalized rash covering her whole upper body, arms and neck. The rash quickly began spreading and was unresponsive to diphenhydramine and oatmeal baths. She was taken to the pediatrician who tested her for strep throat, which was negative. The patient was referred to a dermatologist who stated the rash appeared post-viral. The rash was unresponsive to treatment at the time of reporting. The outcome of pruritic generalized rash was not resolved.
Pt presented with epigastric pain, and uncontrolled hypertension and tested positive for covid asymptomatic, pt discharged home.
Extreme pain (increase in chronic right leg/hip pain), pain much worse after 3rd HPV vaccination (1st and 2nd may have been related to increase in pain over previous months also), hospitalized 9 days after 3rd vaccination, also hospitalized in 7/2012 for 6-7 days with pain, pt now diagnosed w/ undifferentiated connective tissue disease (possibly Lupus) and responding to Plaquenil. Vaccine dates: 9/8/11, 11/10/11, 6/12/12.
This spontaneous report has been received from a registered nurse, concerning a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On 16-OCT-2018, the patient was vaccinated with expired doses of VARIVAX lot # M038856 with expiration date 14-SEP-2018  and M-M-R II (Albumin status rHA) lot # L027591 with expiration date 23-JUL-2017 (doses, frequencies, routes were not provided) for prophylaxis which were reconstituted with sterile diluent, lot number reported as M041688 with expiration date 12-JUN-2019. No adverse effects were reported.
I started feeling dizzy; This spontaneous case was reported by a pharmacist and describes the occurrence of DIZZINESS (I started feeling dizzy) 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.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced DIZZINESS (I started feeling dizzy). At the time of the report, DIZZINESS (I started feeling dizzy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had booster at 5pm yesterday and about an hour ago patient started feeling dizzy. No concomitant medications were mentioned. No treatment details were reported.
Caller reports that a 70 year old female patient developed a circular erythema at the injection site 10 days after immunization with VAXNUVANCE.; This spontaneous report was received from a nurse practitioner via company representative concerning a 70-year-old female patient. The patient's medical history, concurrent conditions, concomitant medications, and previous drugs reactions or allergies were not reported.  On an unspecified day, the patient was vaccinated with pneumococcal 15v conj vaccine (CRM197) (VAXNUVANCE) (dosage regimen, lot number, expiration date, route of administration, and anatomical location were not reported) administered as prophylaxis.  Afterwards, she developed a circular erythema at the injection site (vaccination site erythema) 10 days after the immunization. No additional information was reported. At the reporting time, the outcome of the event was not provided.  The causality assessment between the event of vaccination site erythema and pneumococcal 15v conj vaccine (CRM197) (VAXNUVANCE) was unknown.
Information has been received from a pharmacist concerning a 70-year-old female with no pertinent medical history or allergies, who on 23-NOV-2007 was vaccinated subcutaneously with a dose of Zostavax (Oka/Merck). There was no concomitant medication. Subsequently, on an unknown date, the patient developed "red spots" (hive like) all over her body, skin burning sensation, nausea and dysphagia. Medical attention was sought via the telephone. No laboratory or diagnostic studies were performed. The outcome is reported as not recovered. There was no product quality complaint involved. It is not known if the physician would be interested in VZV analysis. Upon internal review, dysphagia was considered an other important medical event. Additional information has been requested.
Soreness in her arm after the second vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Jan2021 (Lot number: EL1283) at the age of 57 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot no: EH9899), administration date: 16Dec2020, for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Soreness in her arm after the second vaccine".  Additional information: It felt like someone punched her. Then, her Booster dose was given on 23Dec2021 with lot number 33BOBA, and was given in her left arm and was given at 10 am. All three vaccines were given in her left arm.  No follow-up attempts are possible. No further information is expected.
Vaccines given 6/25/18. Mother reported high fever of 104.5 degrees F. Gave TYLENOL suppository fever went down. Reported patient was lethargic and fever of 100.2 degrees F on 6/26/18.
Patient was given injection with no issues; spent a few minutes post injection speaking to patient about the potential side effects. Encouraged him to stay hydrated and to utilize Tylenol if fever, pain, or aches. Patient was alert and oriented when he left the vaccination room. After sanitizing the room for the next member, preparing the next member's shot, came out of the room to announce the next member and found the original patient face down on the floor of the warehouse. Witnesses stated he had fell to his knees from a sitting position and then hit his head on the floor with no more then 2 minutes going by (most likely less then 1 minute). Had the patient lay on the ground with legs elevated while he came to. Offered patient water and ice pack. Patient was able to call his parents, which I stayed by his side, until they arrived.
Headache that last two days.  Severe chills that started day three and have continued for nine days.  Nausea, diarrhea, abdominal pain, body aches, increased joint pain, increased inflammation, and increased fatigue that started day two and has  continued for nine days.
Aches in the body/Body aches; Had to crawl into the bed; Weak; Side effects were worse than getting the flu; Did not feel like eating; Chills; Headaches; Fatigue/Hard to get up and go to the bathroom/Still worn out; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Aches in the body/Body aches), FORMICATION (Had to crawl into the bed), ASTHENIA (Weak), INFLUENZA (Side effects were worse than getting the flu) and DECREASED APPETITE (Did not feel like eating) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 041C21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     Concomitant products included ATORVASTATIN, IRON and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-May-2021, the patient experienced MYALGIA (Aches in the body/Body aches), FORMICATION (Had to crawl into the bed), ASTHENIA (Weak), INFLUENZA (Side effects were worse than getting the flu), DECREASED APPETITE (Did not feel like eating), CHILLS (Chills), HEADACHE (Headaches) and FATIGUE (Fatigue/Hard to get up and go to the bathroom/Still worn out). At the time of the report, MYALGIA (Aches in the body/Body aches), FORMICATION (Had to crawl into the bed), ASTHENIA (Weak), INFLUENZA (Side effects were worse than getting the flu), DECREASED APPETITE (Did not feel like eating), CHILLS (Chills), HEADACHE (Headaches) and FATIGUE (Fatigue/Hard to get up and go to the bathroom/Still worn out) outcome was unknown.            No treatment medications were provided.  Action taken in response to mRNA-1273 was considered to be not applicable.
flu-like symptoms; itchy; rash; very hot to touch; injection site was very red; injection site to the elbow is very red; arm was sore at the inject site; headache; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), PRURITUS (itchy), RASH (rash), FEELING HOT (very hot to touch) and VACCINATION SITE ERYTHEMA (injection site was very red) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METFORMIN, AMLODIPINE, LISINOPRIL, TAMSULOSIN, LEVOTHYROXINE, FINASTERIDE, ATORVASTATIN and DOXYCYCLINE for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), PRURITUS (itchy), RASH (rash), FEELING HOT (very hot to touch), VACCINATION SITE ERYTHEMA (injection site was very red), ERYTHEMA (injection site to the elbow is very red), VACCINATION SITE SWELLING (arm was sore at the inject site) and HEADACHE (headache). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), PRURITUS (itchy), RASH (rash), FEELING HOT (very hot to touch), VACCINATION SITE ERYTHEMA (injection site was very red), ERYTHEMA (injection site to the elbow is very red), VACCINATION SITE SWELLING (arm was sore at the inject site) and HEADACHE (headache) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided by reporter.   Action taken with the drug in response to the events was not applicable.   This case was linked to MOD-2021-029591 (Patient Link).
CLIENT WAS INADVERTENTLY GIVEN PFIZER FOR AGE 5-11 YRS OLD NO ADVERSE EVENTS NOTED WHILE IN CLINIC. I CALLED CLIENTS FATHER 24 HOURS LATER, NO ADVERSE REACTIONS NOTED