chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Increasing  right shoulder pain, muscle pain  over 2-3 weeks Sudden onset of PMR (polymyalgia rheumatica ) one morning Unable to walk, dress myself Hospital ER- steroid IV Under care of Rheumatologist presently On prednisone and methotrexate
This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A patient of an unknown age, gender and race received TRUMENBA (lot R56659, exp.date 31Jan2019) via an unspecified route, at 0.5ml single dose for immunization on  11Jul2017. Relevant medical history and concomitant medication were unknown. On the same date, within 30 minutes of receiving it, the patient experienced all over body aches, pain at injection site, pain radiated down the arm into the hand, radiated up the neck into the chin, numbness facial, panic attack and on unknown date anxiety. The patient had gone to the emergency room. The outcome of the events was unknown.
Pt received COVID vaccine 2/27/21. On 3/3 pt presented to convenient care for hives all over chest. Stated it developed after receiveing vaccine. Stated she had a fever for about 2 hours on 3/2/21. Rash was bilateral UE and under breasts, pink, itchy, not spreading. Used diphenhydramine and cool compresses PTA with mild relief. No history of MRSA or Staph infections. Pt prescribed prednisone 20 mg PO BID x 5 days and discharged.
Body temperature between 100 degrees - 101.5 degrees from 2/23/19 until 3/4/19. Joint and muscle pain; Headache, neck pain from 2/23/19 until 3/6/19.
crying, unconsolable 1 1/2 p/vax; no response to APAP; PE very irritable w/7x0cm erythema on thigh @ site of inject; t99.2;
This spontaneous report received from a pharmacist referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 25-APR-2017, the patient received expired dose of M-M-R II (lot: M032153, expiry date: 22-APR-2017) (dose, frequency, indication not reported) subcutaneously. No adverse effects reported. Additional information has been requested.
I felt slight nausea within 5 minutes of shot and lasted about an hour. At 30 minutes after shot I felt a little better and left the facility. I drove home and about 40 minutes after the shot I started having slight trouble breathing. It felt as if one of my kids was sitting on my chest.  I could still breathe but it was a bit  harder so I took deeper breaths. The trouble breathing  didn?t get worse and only lasted 5 minutes.  I also felt slightly dizzy for a few seconds but that went away. Currently it has been 3 hours and 24 minutes since the shot and I feel completely fine and back to normal. My only complaint is a sore arm.
First a headache within 6-7 hours, and tired. Within  the 8th hour after vaccine a fever came on and headache worsened, arm became sore. Within 2 hours after that (10 hours after vaccine) I was shaking uncontrollably, shivering, and had a fever of 105.  I literally could barely hold thermometer or my cell phone. My arm was too sore to lay on our use to really lift myself to turn in bed. The  fever was down to about 103 in morning but stayed over 102 the entire day following vaccine. The following day, massive diarrhea and fever staying at 100 or so. Today, 3 days after vaccine, I still have a headache, mild, earache,  mildly swollen glands, diarrhea.  And no appetite.  I have eaten very  little since the shot
When I drink Alcohol, I have a hives reaction around my eyes, starting 2 months after my 3rd COVID shot.  Heightened Immune response, i'd guess.  This also happened years ago after a Pneumonia vaccine.
Received only 0.3 ml instead of the full 0.5 ml of the vaccine; Syringe malfunctioned; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of UNDERDOSE (Received only 0.3 ml instead of the full 0.5 ml of the vaccine) and SYRINGE ISSUE (Syringe malfunctioned) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .3 ml. On an unknown date, the patient experienced UNDERDOSE (Received only 0.3 ml instead of the full 0.5 ml of the vaccine) and SYRINGE ISSUE (Syringe malfunctioned). At the time of the report, UNDERDOSE (Received only 0.3 ml instead of the full 0.5 ml of the vaccine) and SYRINGE ISSUE (Syringe malfunctioned) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment medication was not reported.
injection site pain; pain underneath the arm; lymph node; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 19 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Aug2021 (Batch/Lot number: unknown) at the age of 19 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "had Covid", start date: 08Mar2021 (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 18Aug2021, outcome "recovered" (2021), described as "injection site pain"; PAIN IN EXTREMITY (non-serious) with onset 18Aug2021, outcome "recovered" (2021), described as "pain underneath the arm"; LYMPHADENOPATHY (non-serious) with onset 18Aug2021, outcome "recovered" (2021), described as "lymph node". Therapeutic measures were not taken as a result of vaccination site pain, pain in extremity, lymphadenopathy.  Additional Information: 08Mar2021: Patient sick with COVID-19 virus. Patient is on birth control pill. Wants to know if there's any increased risk? Caller did not specify product name. Caller is thinking patient is better protected because of natural immunity and one vaccine than someone with just two vaccines. Small injection site reaction: States following day after the vaccination. Clarified it was pain at the injection site, the day of vaccination. Pain under the arm. The following day after the vaccination. Caller then states she is not sure if patient's reactions were a day after the vaccine.   Follow-up (19Nov2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Patient states a couple days after the 2 vaccines she developed a severe red, rash all over her body.  she states it was very red, itchy, oozing and uncomfortable.  She also stated she was unable to leave the house since it started approx. Oct 18 due to the severity... I could still  observe a severe rash on many areas such as her arm, face, hands etc today.
Pain in left arm, still have it now. Some days cannot move arm. Very painful and weak.
scattered erythema with small papular rash, mild rhinorrhea, treated with monitoring and topical anti-itch cream
Initially, red itchy task on back between shoulder blades. Spread overnight to more of the upper back, as well as nose, face, thighs, and toes.
Early mensuration and started bleeding both times the very next day for a few days and then it stopped; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Apr2021 at 13:00 (at the age of 40-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08May2021 at 12:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included attention deficit hyperactivity disorder (ADHD). The patient had 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-19 vaccine. Concomitant medications included amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate (ADDERALL) 30 mg once a day (1Xday), melatonin (MANUFACTURER UNKNOWN) and unspecified multivitamins; all for unknown indications from an unknown date and unknown if ongoing. On Apr2021, besides the normal side effects both shorts, the patient experienced early mensuration and started bleeding both times the very next day for a few days and then it stopped. The patient was assuming it was from the vaccine and she could not put in both dates but this happened with the first and second vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of events besides the normal side effects both shorts, the patient experienced early mensuration and started bleeding both times. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event early mensuration and started bleeding both times was recovering at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.            .
fever, chills, sore throat, difficulty swallowing, body aches, joint pain, hypertensive, tightness in chest. Went to ER @ Hospital
Within days of receiving my first dose of the Moderna vaccine, I developed a large, mobile, hard lump near my left clavicle. It was visible and I could  move over my clavicle bone. Unsure of what it was I scheduled an e-visit for 1/19/21. I was referred to my PCP and was seen on 1/20/21. I informed the provider that I had recently received the Covid vaccine. The provider originally referred me to dermatology for cyst removal but later called me to recommend an ultrasound of the mass.  I had an ultrasound on 1/26/21 which showed multiple enlarged lymph nodes including the one I had been able to see and move. It was determined to be a reaction to the vaccine and no other treatment was necessary unless it worsened. It has since returned to normal.
Sore arm, fatigue, headache, muscle pain, joint pain, chills, fever all starting during the night.  all next day no appetite, very tired, slept most of the afternoon and evening. Went to bed slept that night, fever gone.  Just very tired the day after.  Two days after almost back to normal.  If booster needed in the future or another shot, I would try another brand.
HEADACHE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of headache was not reported. This report was non-serious.
symptoms started out with "the eyes"/"bloody eyes"; headache; allergies; runny nose; chills; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration on 2021 (lot number was not reported) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 2021, the patient received the Pfizer BioNTech COVID-19 vaccine on Tuesday and has been having side effects and would like to know if she was able to take anything to help treat these side effects. Her symptoms started out "with the eyes" and a headache, and then reported symptoms similar to allergies, stating that she has had a runny nose and "bloody eyes". These symptoms had not stopped since she received her vaccine. She was having chills on 2021. She did not know if these symptoms were going to go away on their own or if she just had to wait them out. She would like to know if it was recommended she take the second dose of the Pfizer BioNTech COVID-19 vaccine based on the side effects that she experienced. The outcome of the events was not recovered.  Information about the lot/batch has been requested.
black diarrhea; joint pain; tiredness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 62-year-old male patient received bnt162b2 (COMIRNATY), administered in arm right (Lot number: FF8841) at the age of 62 years as dose 3, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medications were one 50mg Valcyclovir; one multi-vitamin/ day. Vaccination history included: Comirnaty (product=COVID 19, lot number=EX. EN6205, number=1, vaccine location=left arm), COVID 19, lot number=EX. EL9266, number=2, vaccine location=left arm) for Covid-19 immunisation. The following information was reported: diarrhoea on the 3rd and 4th day following Pfizer 3rd booster; with outcome of recovered with sequel. The event joint pain, tiredness with onset 13Nov2021, outcome "not recovered"". Therapeutic measures were not taken as a result of. Diarrhoea and joint pain, tiredness.  Additional information: The patient had not received any other vaccine within 4 weeks. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Patient was not hospitalized, case was assessed as non-serious,No treatment was taken.  No Follow-up attempts are possible. No further information is expected.
pt recvd vax;devel rxn dx as cellulitis characterized by redness,warmth,induration,pain & swelling from the elbow to the shoulder w/ a four inch diam site of rxn;was tx w/ amoxicillin;
soreness at the injection site; low grade fever; chills; slight headache; fatigue; tingle radiate from the injection site to my finger tips; left hand when held outward was trembling which was the side my injection was given. When I placed both my hands in front of me I visibly see my left hand fingers were trembling but not my right hand.; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 14Apr2021 at 15:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not receive any other medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no known allergies to medications, food or other products. On 14Apr2021 after injection, the patient experienced tingle radiating from the injection site to finger tips. On 14Apr2021 at 17:15, two hours after the injection, the patient experienced left hand when held outward was trembling, when placed both hands in front she could visibly see left hand fingers were trembling but not right hand. The patient also experienced soreness at the injection site, low grade fever, chills, fatigue and slight headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events tingle radiates from the injection site to finger tips, left hand when held outward was trembling, soreness at the injection site, low grade fever, chills, fatigue and slight headache was recovering at the time of this report.    No follow-up attempts are needed. No further information is expected.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 10-APR-2014, a pharmacist administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 24-MAR-2017 and 30-JUN-2017, the patient was treated by a physician for shingles and post herpetic neuralgia. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the zoster vaccine live (ZOSTAVAX), and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
On Saturday, April 27, 2019 I went to Emergency Triage because my painfully, swollen ejection sight needed to be seen as soon as possible by a healthcare provider for advice.  It took approximately 7 days from Thursday, April 25, 2019 day of injection for my pain and swelling to reduce.  However, today Friday, May 10, 2019 my upper left deltoid has no pain or swelling present.
APPROIMATELY 3-5 MINUTES AFTER IM INJECTION OF HPV GARDASIL IN PATIENTS RIGHT ARM, PATIENT STATED THAT SHE FELT LIGHTHEADED. GAVE PATIENT A DRINK OF WATER, PATIENT PASSED OUT TO FLOOR. DOCTOR CAME INTO ASSESS, CLEARED PATIENT TO LEAVE. MOTHER CALLED TO REPORT THAT PATIENT ALMOST PASSED OUT AGAIN AT HOME AND THEN FELL ASLEEP ON COUCH. MD GAVE FOLLOW UP PHONE CALL TO MOTHER AND PATIENT.
Tested positive for covid initially on 10Nov; Tested positive for covid initially on 10Nov; 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 44-year-old female patient (not pregnant) received BNT162b2 (COMIRNATY), on 22May2021 at 08:00 as dose 1, single (Lot number: EW00183), in left arm and on 12Jun2021 at 08:00 as dose 2, single (Lot number: EW0186) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "known allergies: Seasonal" (unspecified if ongoing), notes: known allergies: Seasonal; "Know allergies: Oysters" (unspecified if ongoing), notes: Know allergies: Oysters; "Moderate persistent asthma" (unspecified if ongoing), notes: Other medical history: Moderate persistent asthma; "Obesity" (unspecified if ongoing); "Hypertriglyceridemia" (unspecified if ongoing); "migraine" (unspecified if ongoing); "varicose veins" (unspecified if ongoing); "strabismic amblyopia" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "GERD" (unspecified if ongoing); "HLD" (unspecified if ongoing), notes: Other medical history: HLD. Concomitant medication(s) included: ALYACEN; FENOFIBRATE; OMEPRAZOLE; VITAMIN D NOS. Past drug history included: Erythromycin, reaction(s): "Know allergies: Erythromycin", notes: Know allergies: Erythromycin; Tetracycline, reaction(s): "Know allergies: Tetracycline", notes: Know allergies: Tetracycline; Bactrim, reaction(s): "Know allergies: Bactrim", notes: Know allergies: Bactrim; Wellbutrin, reaction(s): "Know allergies: Wellbutrin", notes: Know allergies: Wellbutrin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Nov2022, outcome "not recovered" and all described as "Tested positive for covid initially on 10Nov". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Nov2022) Positive, notes: Tested positive for covid initially on 10Nov; (18Nov2022) Negative, notes: Tested negative on 18Nov; (22Nov2022) Positive, notes: Tested positive again on 22Nov. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Presented with SOB/weakness; CXR clear;  Labs: D-dimer 2.97, CRP 0.40, Ferritin 181 Tx: with Decadron, Rocephin, Lovenox, Remdesivir, Vit C, Zithromax, Vit D3, Singulair, Zinc; initially on 2 lpm o2, down to room air by d/c
3" X 5" erythematous area mid anterior L thigh with 2 needle puncture marks with slight nodules underneath; very warm to touch.
15-20 minutes, post vax, pt broke out in a rash around mouth with progression to arms. When he awoke the next morning, rash was on legs. Rash was red, fine with itching, not hive-like. Treated by mom with Benadryl. Mom states he is unable to drink juice of any kind, has scalding in diaper area. He has a history of a seizure on 1/01 but not taking any medications. Denies change in diet, soap or detergent. Rash was gone by 4/14/01 but started having respiratory problems on Saturday and went to PMD who told mom breathing problem not related to immunizations.
Patient had a rash the following day but more severe symptoms started 48 hours later. Her face, arms, and feet started to swell, she had a rapid heartbeat, and trouble breathing. Took some Benadryl with no relief. Went to the ER. Was prescribed prednisone. Patient has had a similar reaction with her progesterone injection (same symptoms and required an ER visit).
Respondent's husband received the Comiranty vaccine and then he contracted COVID-19; Respondent's husband received the Comiranty vaccine and then he contracted COVID-19; had a high fever for 5 days; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (COMIRNATY), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Respondent's husband received the Comiranty vaccine and then he contracted COVID-19"; PYREXIA (non-serious), outcome "unknown", described as "had a high fever for 5 days".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The primary report is a nurse. The nurse is reporting a 15-month-old patient was inadvertently administered the second dose of VARIVAX 4 weeks after the first dose of VARIVAX. No adverse effects reported. No further information provided.
Pt vaccinated with Influenza Vaccine developed Guillian Barres Synd progressive numbness & tingling both legs & hands weakness. Unsteady gait.