chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2010. A 60-year-old female patient received an intramuscular left deltoid injection of Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative (lot number UT068HH, not a valid sanofi pasteur lot number) and ZOSTAVAX (Merck, lot number 0961Y) on 11 March 2010. The patient had a history of migraine, chronic fatigue syndrome, fibromyalgia, insomnia, recurrent urinary tract infections, right knee arthroplasty (2008), hysterectomy (20 years ago), and vaginal reconstruction (3 years ago). Drug allergies included Sulfa, BACTRIM, Codeine, Erythromycin, CIPRO, and DILAUDID. Concomitant medications included ATIVAN, CALAN-CR, HIPREX, NEXIUM, TOPAMAX, and Trazodone. The patient denied any previous events following receipt of vaccines, and denied acute illness at the time of vaccination. On 12 March 2010, one day post-vaccination, the patient presented to the emergency room with fever (reported as 103 degrees), severe pain in both legs, generalized weakness, and body aches. The pain was initially in the right knee, but quickly spread to her hands, back, shoulders, groin, knees, and neck. It was described as 10/10, acute, and sharp. She also complained of some nausea, and a headache beginning 11 March 2010. She was treated in the emergency room with Morphine with partial relief. Physical exam was essentially negative. Diagnostic data showed an elevated C-reactive protein (21.3). She was admitted to the hospital with a diagnosis of fever, myalgia, and arthralgia, which the physician noted was "due to vaccination yesterday". On 13 March 2010 the patient underwent an orthopedic consult, during which 45ml of fluid was aspirated from a right knee effusion. The patient was started on ANCEF due to the cloudiness of the fluid; however, subsequent cultures revealed no growth x 2 days, and antibiotics were discontinued. She was also started on "round-the-clock" MOTRIN. During hospitalization she was noted to have mild anemia and mild hypokalemia; potassium was replaced during hospitalization. Her blood pressure was also low, and CALAN dosage was decreased. On 15 March 2010 she was discharged from the hospital, and at that time it was noted that she was "doing better and her joint aches and pains are also resolved".
Intradermal injection given to left forearm but did not wheal. Repeat subcutaneous injection given to the back of left arm successfully.
Pt recv vax on 12/17/98; on 12/19/98 pt exp wheezing, hives, swollen hands, knees, ankles, face x 1.5 wk, pneumonia; tx=bronchodilators, steroids, Amoxicillin
2/26/21  Red, tender spot appeared on Palmar surface of index finger of right hand  2/27/21 Awoke with multiple round red spots,  up to 1/2 inch in diameter on both legs, but not on ankles or feet.  A few on abdomen at the waist.   Also now on both hands at multiple sites.  Treatment is hydrocortisone cream.
Sudden onset of vomiting, ached all over.Took Tylenol. Fine on Saturday.
Information has been received from a physician concerning a 60 year old female with no pertinent medical history and no drug reactions or allergies who in approximately October 2010 (reported as about 3 months ago) was vaccinated IM with a dose of PNEUMOVAX 23 (lot number not provided). There was no concomitant medication. The patient was still experiencing shoulder pain. Patient complained of lateral shoulder pain over the deltoid region and decrease in range of motion. Tendonitis was diagnosed as well. Magnetic resonance imaging (MRI) was performed (result not provided). EMG was done and result came out normal. The patient sought unspecified medical attention and was treated with corticosteroid injection. At time of the report, the patient's outcome was unknown. Additional information has been requested.
Symptoms x 1 day 1/2 - fever of 102, (L) arm swelling, erythema, & severe pain loss of mobility. E.R. treatment - IV ABTs, VALIUM, TORADOL, KEFLEX, bed rest.
No treatments as of yet started taking Benadryl for safety reasons as soon as Benadryl wears off not this back and throat have an appointment to see my primary doctor on Tuesday the 13th 2021
Muscle Pain, abdominal pain, diarrhea, pain in the hands and fingers. Headache, joint pain, veins were bulging up in her legs.
He flew back hard on the exam table his eyes rolled to the back of his head and all 4 limbs moved in a seizure action.  He was unresponsive. I?m not sure what the brand of the vaccines are.
pt recv vax SEP95 & w/in 1 wk pt exp a vaginal yeast infect;
Approximately one month after receiving injection, started feeling fatigue.  At approximately two months after, had flu like symptoms which led to severe headaches and pain in neck, temple and jaw and vision problems.  My jaw then became too painful to open and close.    Was subsequently diagnosed with Giant Cell Arteritis for which I am currently and continually receiving treatment.
Did not get the second dose; Hallucinations; Headache; Malaise; Dry heaves; This case was reported by a consumer via call center representative and described the occurrence of hallucination in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number XN443, expiry date 15th May 2022) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles.   On 24th June 2020 10:00, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On 24th June 2020, 2 hrs after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced hallucination (serious criteria GSK medically significant), headache, malaise and dry heaves. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the hallucination, headache, malaise and dry heaves were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the hallucination, headache, malaise and dry heaves to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient states she had the Shingrix dose and by noon she experienced headache, malaise, dry heaves, and hallucinations. The patient feels that she was possibly given too large of Shingrix dose and it appeared to be much greater than 0.5 ml in the syringe she was given that day. The patient states she did not get and has no plans to get the Shingrix 2nd dose, which led to incomplete course of vaccination. The reporter consented to follow up.
Approximately 9 days after COVID19 vaccine 2nd booster (Moderna), was awakened with sharp pain deep at injection site. Over course of next few weeks, pain persisted and spread down triceps to elbow, forearm. Tingling experienced in lowest two fingers, and significant weakness noted in lower left arm. At time of injection, I recoiled as it seemed needle hit nerve.  Two days after injection, had ACDF surgery C3-C7 - resulting in elimination of pain from neck/shoulder/left arm to same digits. Returning pain after injection only from deltoid and below, with addition of weakness not experienced previously.
Itchiness at various sites in body with a rash, later nausea and headache, fever fatigue, then extreme itchiness on hands, especially between fingers , on palms and backs of hands
Pfizer-BioNTech COVID 19 vaccine EUA-  7.5 hours after vaccine severe chills for 4 hours. Severe muscle aches for 22.5 hours.
Chills, overheated, fatigue, nausea, dizziness, body aches
WCC done on 4/15/09 at which time vaccines administered according to CDC recommended schedule.  Parents report that on 4/16/09 patient developed pale lips, pale skin of face and had episode of "holding breath/not breathing" then when child caught breath cried like in pain.  Parents brought patient to ER for evaluation, patient had Temp of 99.8 rectally and an SpO2 of 100% on room air, and determined to be fine. ER doctor advised parents to follow up with babies PCP.  Patient seen in office on 4/17/09 and determined to be fine by Dr.
This spontaneous report as received from a physician via a company representative, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 04-JAN-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB "10Pk 10mcg/1mL SD LLok Cap AD", lot # L001441 with expiration date 17-AUG-2016 (route of administration and anatomical location were not reported). There were no concomitant therapies and adverse effects reported. No product quality complaint was involved. On an unspecified date, the RECOMBIVAX HB had six temperature excursion of 29 F (-1.6 Celsius Degrees) for 256 hours, 33 F (0.5 Celsius Degrees) for 168 hours, 34 F (1.1 Celsius Degrees) for 88 hours, 32 F (0 Celsius Degrees) for 288 hours, 31 F (-0.5 Celsius Degrees) for 368 hours and 30 F (-1.1 Celsius Degrees) for 264 hours, respectively. The vaccine status was reported as "in excursion". The vaccine storage criteria and type of excursion were reported as "Refrigerator (R)". This is one of several cases from the same reporter. Additional information has been requested.
First dose and second dose did not match manuracturers. First dose was Moderna vaccine Lot #001A21A given on 02/23/2021 at same facility. Second dose was Pfizer vaccine given 03/23/2021.
pt recvd MMR vax on 8MAY91 immed p/vax devel redness, swelling & inc temp @ inject site; pt was kept for observationn & released upon recovery; subsequent visits showed no adverse reaction due to vax; no further details were provided;
Long term muscle aches; Fatigue; This case was reported by a other health professional via sales rep and described the occurrence of muscle pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced muscle pain and fatigue. On an unknown date, the outcome of the muscle pain and fatigue were not recovered/not resolved.   It was unknown if the reporter considered the muscle pain and fatigue to be related to Shingrix.     Additional Information: GSK Receipt Date: 08-SEP-2022  Reporter's Comment: The patient had complained that after post completion of Shingrix, she had long term muscle aches and fatigue for longer than 6 months. The reporter did not agreed to follow up from GSK. The consent to follow-up was denied. Additional supportive information: This case has been linked with the case US2022AMR129912 reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR129912:Same reporter
pt recvd vax; 26jul95 devel thigh, ankle, groin & neck papules, similar to a follicular rash 1-2 mm in size;whitish head on few lesions; generalized rash
PT is complaining of swollen, red arm at the site of injection.  As well as severe soreness.
This case was reported by a nurse and described a patient who did not respond to immunization with hepatitis B vaccine recombinant (Engerix B) immunization series. The subjects medical history, concurrent conditions, and concurrent medication were not reported. On unspecified dates, the patient received three doses of Engerix B. Subsequently, on an unspecified date after immunization with Engerix B, a hepatitis B surface antibody titer indicated that the patient was a non responder. The nurse considered the event to be possibly related to vaccination with Engerix B.
In the night 12 hours after injections high temp 101 degrees. Vomited next morning x 1. No local reaction other than soreness at injection site (L)>(R) mother reported at 10 am. Instructed to treat fever, clear liquids advance as tolerated. Mom calls again at 1:15 pm 6-29-10 to report fever now 100.2 degrees but has headache (moderate) "doesn't feel well at all". Instructed to use TYLENOL or ADVIL for fever + headache-which they did not treat earlier as instructed. 5:00 pm (TC) no fever after 2 TYLENOL no headache up and around-just tired. 6-30-10 (TC) all symptoms gone. Normal state of health.
Hypertensive crisis; headaches; bruising; visual changes; slowing of optic nerve; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 21-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Apr2022 as dose 1, single (Lot number: FK9894) at the age of 21 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "If covid prior vaccination: Yes" (unspecified if ongoing). No known allergies. The patient took concomitant medications. Other medications in two weeks included birth control. No other vaccine in four weeks. The following information was reported: HYPERTENSIVE CRISIS (hospitalization, life threatening) with onset Apr2022, outcome "recovered with sequelae"; CONTUSION (non-serious) with onset Apr2022, outcome "recovered with sequelae", described as "bruising"; HEADACHE (non-serious) with onset Apr2022, outcome "recovered with sequelae", described as "headaches"; OPTIC NERVE DISORDER (non-serious) with onset Apr2022, outcome "recovered with sequelae", described as "slowing of optic nerve"; VISUAL IMPAIRMENT (non-serious) with onset Apr2022, outcome "recovered with sequelae", described as "visual changes". The patient was hospitalized for hypertensive crisis (hospitalization duration: 8 day(s)). The events "hypertensive crisis", "headaches", "bruising", "visual changes" and "slowing of optic nerve" required emergency room visit. Therapeutic measures were taken as a result of hypertensive crisis, headache, contusion, visual impairment, optic nerve disorder which included Potassium drip, anti-hypertensive meds. Clinical courses is as follows:  The patient received BNT162b2 (BNT162B2), on 11May2022 as dose 2, single (Lot number: FK9894) intramuscular for covid-19 immunisation. The patient  experienced hypertensive crisis, requiring emergency hospitalization with 5 days in Intensive Care Unit. headaches, bruising, visual changes, slowing of optic nerve. Covid wasn't tested post vaccination.
Pt developed cluster of vesicles at site of vaccine approximately 10 days post vax. Soon after developed fever as well. Pts sibling had same reaction with varicella vaccine.
Pt recvd Engerix-B & devel chills, t102, diarrhea & abdo noc cramps; tx water & APAP;
Had a huge blood clot come out of my nose after a nose bleed. I do not get nose bleeds so this was very strange. Took me 15 minutes to get it to stop bleeding.
Positive COVID Test; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive COVID Test) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes since 2010.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced COVID-19 (Positive COVID Test). The patient was treated with PARACETAMOL (TYLENOL) for COVID-19, at a dose of 1 dosage form. At the time of the report, COVID-19 (Positive COVID Test) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2020, SARS-CoV-2 test: negati ve (Negative) negative. On 19-Jan-2021, SARS-CoV-2 test: positive (Positive) positive. On 30-Jan-2021, SARS-CoV-2 test: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient had symptoms cough, headache, Muscle aches and nasal congestion.  No relevant concomitant medications were reported.   No Treatment information was provided   This case was linked to MOD-2021-275500.   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Follow up information received included medical history, laboratory details, treatment drug and clinical information.; Sender's Comments: Very limited information regarding the event has been provided at this time.  Further information is not expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), on 12Apr2021 at 07:00 as dose 1, single (Lot number: EW0158), on 03May2021 at 07:00 as dose 2, single (Lot number: EW0173), in right arm and on 21Nov2021 at 12:00 as dose 3 (booster), single (Lot number: FJ1620) at the age of 36 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Sleep apnoea" (unspecified if ongoing). Concomitant medication(s) included: ADDERALL; LEXAPRO, stop date: 30Sep2022; BUPROPION, stop date: 30Sep2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Oct2022) Negative; (04Oct2022) Negative; (07Oct2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Muscle pain, dizziness, nausea, vomiting, stomach pain, sweating
states that since his vaccine, his muscles are weak and he has a HA.  Claims chills, fatigue and dry cough  Temp 100.4, BP 151/68 HR 84 EKG indicated atrial flutter and low QRS voltage in the prechordial leads.
shingles; This is a non-serious spontaneous report from a contactable Consumer. This 65-year-old female Consumer reported for herself. A 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: ER534, but she is not sure if it is an R), dose 2 via an unspecified route of administration, administered in Arm Right on 21Mar2021 (at the age of 65-years-old) as a single dose for covid-19 immunization. The patient medical history was not reported. There were no concomitant medications. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EN6198), dose 1 via an unspecified route of administration, administered in Arm Right on 26Feb2021 (at the age of 65-years-old) as a single dose for covid-19 immunization. The patient had no other vaccine within four weeks. The patient developed shingles about a month ago, and has questions about the booster shot. She was on antibiotics now, but will be done before scheduled for the booster shot. She was wondering when she would be able to take the booster since she will be 66 next month and will qualify for it. Shingles: came down with it about 4 weeks ago. She was not breaking out anymore, but still experiencing pain. It has improved somewhat. It was in her eyes and she was having problems with eyes, ears, and facial pain. She was better than she was. No emergency room visited, but visited physician office- She has been seen by a couple of doctor's. No further information provided. Outcome of the event was unknown.  The lot number for, BNT162B2, was not provided and will be requested during follow up.
Shot administered on 6/14/16. Customer complained on 6/16/16 of a "2 inch welt and swelling and redness" at injection site. Local pain also reported.
had a blood clot in the leg; This spontaneous case was reported by a patient family member or friend and describes the occurrence of THROMBOSIS (had a blood clot in the leg) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (had a blood clot in the leg) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (had a blood clot in the leg) outcome was unknown.            Concomitant medication information was not provided.   Treatment information was not provided. Company Comment This spontaneous case concerns an unknown-years-old patient, with no medical history reported who experienced the expected seriousness criterion medically significant AESI of Thrombosis unknown days after  a  dose of  mRNA-1273 vaccine.  The benefit-risk relationship of mrna-1273 bivalent vaccine is not affected by this report. Events seriousness was assessed based on medical judgement.   This case was linked to US-MODERNATX, INC.-MOD-2022-680935, US-MODERNATX, INC.-MOD-2022-681158 (E2B Linked Report).; Sender's Comments: Company Comment This spontaneous case concerns an unknown-years-old patient, with no medical history reported who experienced the expected seriousness criterion medically significant AESI of Thrombosis unknown days after  a  dose of  mRNA-1273 vaccine.  The benefit-risk relationship of mrna-1273 bivalent vaccine is not affected by this report. Events seriousness was assessed based on medical judgement. US-MODERNATX, INC.-MOD-2022-680935:Stepdad's case, same reporter US-MODERNATX, INC.-MOD-2022-681158:husband's case, same reporter
Patient c/o of vertigo after receiving his Moderna Booster at 1459, after 15 minutes of observation pt asked to talk to RN. Initial VS were taken BP 107/65, HR 72, SPO2 98%, after 30 min of obs. pt vitals trended up at 150/52. Called RRT at 1548, 1549 RRT announced on loud speaker, RRT came to assess pt. After assessing pt and pt confirm vertigo diminished, feeling better, and able to walk, pt was dc with daughter.
the symptoms as "having Covid all over again"; the symptoms as "having Covid all over again"; headache; nausea; severe joint and body pain; body pain; coughing; fever; This is a spontaneous report from a contactable other healthcare professional (HCP) reporting for herself. A female patient of an unspecified age received  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. Medical history included covid-19 from an unknown date. The patient's concomitant medications were not reported. The patient just got the Covid vaccine and was experiencing side effects. She described the symptoms as "having Covid all over again", mentioned headache, nausea, severe joint and body pain, coughing and fever on an unknown date. Want to see how long these side effects last. The outcome of the events was unknown. Information regarding lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded. Further information like confirmative virus genome /nucleic acid detection is needed for meaningful medical assessment.
A few hours after shot was received extreme chills with no fever.  This last approx 12 hours.  In addition  intense burning feeling on the palms of both hands.  Very intense to the point I required an ice pack on the palms of my hands.  This lasted approx 20 hours.  The left hand still experiences this "tingling"  throughout each day since the vaccine.  The burning is no longer intense, but has left a "numbing" and at times a slight burning feeling
Patient was given the 5-11 monovalent formulation instead of the 6mo-4yr formulation
She received immunizations and was fine. Riding home with Mom talking/laughing. Approx 20 minutes after injections she started slurring speech, not responsive, passed out and started drooling. Mom called office and was sent to Hospital ER. By the time she got to ER was acting more normal. Exam normal at time.
pt recvd vax & mom states t102.4, turned blue, jerking motions of head & hands, then vomited dose of children's advil; pt heard crying in background; brought to office by medics; seen by MD adm to hosp for observation due to febrile sz;
fever approx 103 followed by sz 18 hrs following vax;taken to ER dx'd febrile convuls pt has hx of febrile convuls; had repeat sx on 18AUG95 w/fever; spoke w/MD 1SEP95 dx'd OM & febrile convulsions