chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a healthcare student refers to a 2 year old female patient without pertinent medical history and with hypersensitivity to amoxicillin. On 09-FEB-2015, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX, (strength, dose, frequency and anatomical location were not reported), subcutaneous, (lot number reported as K007781; expiration date: 28-MAY-2016). Other suspect therapies included a dose of M-M-R II, (strength, dose, frequency and anatomical location were not reported), subcutaneous injection, (lot number reported as J013316; expiration date: 22-OCT-2015) and INFANRIX (GlaxoSmithKline), (strength, dose, frequency, route, anatomical location and indication were not reported). There were no concomitant therapies. On 15-FEB-2015, the patient experienced rash maculo-papular on an unspecified area of her body which was continuing to evolve and was currently on her face, trunk, diaper area and legs. On 16-FEB-2015, the patient experienced body temperature increased with a maximum of temperature of 39.7 degrees C (103.5 degrees Fahrenheit) on 18-FEB-2015. Patient continued to have an elevate temperature. On 19-FEB-2015, the patient sought medical attention through office visit and an unspecified lab studies were prescribed but the results were not available. It was reported that no treatment was given for the adverse events. The outcome of body temperature increased and rash maculo-papular was reported as not recovered/not resolved. The relatedness between body temperature increase and rash maculo-papular and therapy with (Oka/Merck) VARIVAX, M-M-R II and INFANRIX (GlaxoSmithKline) was not reported. Additional information has been requested.
Sensitive skin on left side of torso, front and back. Barely noticeable at first, but it got progressively worse. Within a day, I noticed a small rash and increasing pain. On the morning of the third day, 11/17/13, I went to see my doctor.
Leg where shot was given turned deep purple.  Entire leg.  I took her to her ped and to a dermatologist, neither could pinpoint why her leg was purple. I did not think about her shot, since it had been a week prior, but then my other daughter's arm did it in a smaller scale.
Patient states that she was told by pharmacy to be seen by doctor due to having a possible allergic reaction to shingrix 2nd dose.  Patient states that on Saturday 12/21/2019 she started having a rash under her left upper arm that was puritic in nature.  She states it then started under her right upper arm that was then followed by swelling in both arms and hands and both feet.  Patient had macular erythematous puritic rash to bilateral upper arms and 1+ pitting edema to bilateral feet.  Non-pitting edema to  bilateral hands, arms and chin.  Patient was prescribed Medrol dose pack for 6 days for this reaction.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received 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 injection site pain, injection site swelling, lymphadenopathy cervical, ear pain, chills, fever, heart pounding, headache, blurred vision and intramuscular formulation administered by other route. The patient was treated with prednisone, sudafed (nos) (Sudafed) and antibiotics nos (Antibiotics (Brand Names Not Known)). On an unknown date, the outcome of the injection site pain, lymphadenopathy cervical and ear pain were not recovered/not resolved and the outcome of the injection site swelling, chills, fever, heart pounding, headache and blurred vision were recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site pain, injection site swelling, lymphadenopathy cervical, ear pain, chills, fever, heart pounding, headache and blurred vision to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but the age group was captured adult as per vaccine indication. The patient reports her first dose of Shingrix administered was inadvertently injected into the soft tissue of her arm as opposed to the muscle, which led to incorrect route of administered. The patient developed injection site pain and swelling, gland swelling in left side of neck along with ear pain and swelling, chills, fever of 101 for 5 days, heart pounding, headaches and blurry vision. The patient was seen by her nurse practitioner who treated her with antibiotics, prednisone and Sudafed. At the time of this report all symptoms resolved aside from injection site tenderness, neck gland swelling and ear pain. Lab Comments: lab test performed on an unknown date.
Case number PHEH2015US020302 is an initial spontaneous report received from a nurse on 08 Oct 2015. This report refers to a 63 year old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml intramuscularly on 07 Oct 2015. The nurse reported that the patient was administered FLUVIRIN multi dose vial (MDV) that was in out of temperature range at 47 degree Fahrenheit. The case was reported as non-serious. No adverse events were reported following the maladministration.
My child cannot walk he cannot hold nothing he cannot stand he cannot crawl he cannot turn over he cannot do nothing for his self now it this short messed up his nerve system he cannot do nothing nothing he has to wear bib you have to feed him he cannot do nothing nothing what this shot did to my baby oh my God
Itching, no rash; This is a spontaneous report from a contactable consumer. An unspecified aged adult female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown, if the patient received any other vaccine within four weeks prior to the COVID-19 vaccine. On an unknown date, the patient experienced itching, no rash. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. It was unknown whether any therapeutic measures were taken as a result of the event. The clinical outcome of the event itching, no rash was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
minor issues of fever and chills; minor issues of fever and chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: In February he was diagnosed with COVID-19; "Breathing issues" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CHILLS (non-serious), PYREXIA (non-serious) all with onset 2021, outcome "recovered" (2021) and all described as "minor issues of fever and chills".  Additional information: I have a consumer on the line that is calling to report an adverse event and in Feb he was diagnosed with COVID-19 and he was having breathing issues with having the COVID and in Apr he received the Pfizer COVID -19 vaccine and he had minor issues of fever and chills he said it didn't last very long but he said that having the vaccine alleviated the breathing issue that he was having from having COVID and then two nights ago he received the booster dose and he said that he has the swollen lymph node that is about the size half a lemon."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv varicella vax in 4/96 & in 3/98 pt devel five lesions described as chickenpox w/fever of 100 for 2 days, treated w/motrin & benadryl
No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 11-SEP-2020, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB), 1 injection, lot # S022584, expiration date: 31-OCT-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursion of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022584; expirationdate: 31-OCT-2021; deviceage and unit: 0; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
arm hurts and is very unbearable; hard to drive; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurts and is very unbearable) and MOBILITY DECREASED (hard to drive) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm hurts and is very unbearable) and MOBILITY DECREASED (hard to drive). At the time of the report, PAIN IN EXTREMITY (arm hurts and is very unbearable) and MOBILITY DECREASED (hard to drive) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient complained about still having side effects from the Moderna vaccine and wanted to be involved in the program for compensation.  No concomitant medications were reported  No treatment information was provided
DEVELOPED 3 DAYS OF ABD PAIN WITH N/V, ANOREXIA & FEVER. ADMIT 9/19, APPENDICITIS. TO OR FOR REMOVAL
pt apparently devel encelopathy post vax; not known until 9AUG94;
PMH Unknown, Medications Unknown, Allergies: NKA 1min post vaccination pt reported flushing/sweating, vomiting, dizziness. Patient observed pale, skin clammy to touch. Patient transferred to observation room via wheelchair. Patient vomitted 1x, clear liquid. Pt reports similar adverse effects after first dose.  Pt denies reporting adverse effects prior to 2nd dose vacciantion.   Vitals: @12:10 BP 118/77, HR 86, RR 18, 02 98% -- > @12:20 113/73, 73, 16, 100%. Juice and cracker snack provided. Patient reports relief of adverse symptoms. Patient gait is steady, directed to return to POD4. Patient stable at discharge (12:35)
Cellulitis; fever; rash on my Buttocks; shingles; I am so sick; This case was reported by a consumer via call center representative and described the occurrence of cellulitis in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix with an associated reaction of pain in extremity (1st dose received on 6th April 2020, refer case US2020113036).   On 6th June 2020, the patient received the 2nd dose of Shingrix. In June 2020, 8 days after receiving Shingrix, the patient experienced cellulitis (serious criteria GSK medically significant), fever, rash, shingles and sickness. The patient was treated with antibiotics nos and antivirals nos. On an unknown date, the outcome of the cellulitis and sickness were unknown and the outcome of the fever and rash were not recovered/not resolved and the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the cellulitis, fever, rash, shingles and sickness to be related to Shingrix.  Additional case details were reported as follows: The patient reported case for herself. On 14th June 2020, patient went to urgent care clinic because of a fever and a rash on buttocks and was diagnosed with Cellulitis. The patient was prescribed with an antibiotic. The patient returned to the clinic on 18th June 2020 because the fever and rash were worse and was told that she had shingles. The patient was prescribed an antiviral. The patient did not believed on them. The patient told that, they must warn patients that they could get shingles immediately after getting the vaccine. The patient had to stop taking all her medications for 2 weeks while taking both antibiotics and antivirals. The patient was wished that she was dead, and was so sick. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020113036:Same patient, 1st dose
107.6 fever. Vomiting.  Gradually came down to 102.5 within 3 hours.  Treated with 2 liters IV hydration with vitamin C and Glutathione.  Fever now gone but can?t keep good down.
Child came into the clinic with guardian to have 2nd dose administered. Vaccine card was given to RN who then passed the card to the scribe and RN did not verify DOB.  Scribe then located patient in the adult clinic. Once verified that patient was in the system, RN gave pediatric dose but was not informed that patient was listed to received adult dose and not pediatric dose.  Patient stayed in the observation area for 15 min and no adverse reactions noted and left with guardian.
Vaccine was given to under aged patient. Patient was 16 years of age at the time.
Sore arm, headache, fatigue.  Headache stopped 12 hours after vaccine. Fatigue stopped after 26 hours. Sore arm stopped after 30 hours.
22yo male who presents with history of repair of vascular ring in May 2021 chest pain in setting of ~ 2 weeks of vomiting/diarrhea.  Emesis multiple times a day, nonbloody, occasionally green, and watery diarrhea, nonbloody. Fevers for past week, over past 4 days have been steady at 102.  3 days ago he received his maternal booster for Covid.  Yesterday, he noticed chest discomfort which is persistent and worsening today so presents for evaluation.  States that there is a sharp and intense pain with deep inspiration.  He does not feel significantly short of breath.   He denies cigarette use, marijuana, vaping.  Occasional alcohol use. Past medical history: Vascular ring repair with rotational esophagoplasty and tracheal pexy  Eosinophilic esophagitis  Note question of cortisol abnormality but not fully evaluated, no known adrenal insufifciency  Meds: Prozac, Protonix, dicyclomine  Social: From Texas, college student here at Tufts, triple major, works with preschool students with multiple illnesses in the classroom, none known to be Covid  Per verbal conversation with cardiology, patient bedside echo was normal. CT pending. On my reassessment, patient is endorsing dizziness that started before going to CT and has continued since. He describes it as the "room spinning". He states it has somewhat improved but is still there and is worse with changes in position like when he got into the wheel chair. He also endorses bifrontal pressure like headache for 3 days that have been constant with some nausea. He denies any vision changes, numbness or tingling. No neck stiffness. Still endorsing chest pain worse on the right. On my exam, patient has some initial unsteadiness while getting out of bed to ambulate but was able to tandem walk, toe and heel walk without any gait instability. He was also noted to have soft blood pressures in the mid 90s systolic.   Plan for 1 additional liter of IVF, Toradol, GI cocktail and Reglan. Will await CT, if negative and patient sx improved with improvement in BP, will DC with GI and Internal Medicine follow up. If continued dizziness, will TBW Cardiology for any additional recs.  2nd reassessment:Patient CT read as negative for PE.  Patient notes improvement in all his symptoms post fluids, Reglan, Toradol and GI cocktail. Endorsing no longer dizzy. BP improved to 108 systolic which is his initial baseline. Patient ok to DC at this time. No further cardiology consult needed. Patient given FU to GI and internal Medicine at Lahey clinic. Also given return precautions.  Final Diagnosis  1. Chest pain R07.9 2. Headache R51.9 3. Dizziness R42
Chills; Joint Pain; MILD FEVER; Muscle Aches; Fatigue; Headaches; INJECTION SITE SORENESS; INJECTION SITE SWELLING; This spontaneous report received from a patient concerned a 50 year old of unspecified sex. The patient's height, and weight were not reported. The patient's past medical history included liver transplants, and concurrent conditions included Crohn's disease, osteopenia, hyperparathyroidism, and sluggish kidneys. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 13:30 for prophylactic vaccination. Concomitant medications included vedolizumab for Crohn's disease, tramadol for Crohn's disease pain, levothyroxine sodium for hyperparathyroidism, azathioprine for immunosuppressant, and tacrolimus for immunosuppressant.  On 06-MAR-2021, the subject experienced chills. On 06-MAR-2021, the subject experienced joint pain. On 06-MAR-2021, the subject experienced mild fever. On 06-MAR-2021, the subject experienced muscle aches. On 06-MAR-2021, the subject experienced fatigue. On 06-MAR-2021, the subject experienced headaches. On 06-MAR-2021, the subject experienced injection site soreness. On 06-MAR-2021, the subject experienced injection site swelling. Laboratory data included: Body temperature (NR: not provided) 99.8 F. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, joint pain, mild fever, muscle aches, headaches, injection site soreness, and injection site swelling on 10-MAR-2021, and fatigue on MAR-2021. This report was non-serious.
Case received primary vaccine series in January 2021, and died of Covid in October 2021 Case was a resident of a long-term care facility. He tested positive for Covid, and died the same day before he could be taken to the hospital. The facility was experiencing an outbreak at the time.
Retinal migraine unlike other migraines patient has experienced. Patient present to urgent care clinic, received Sumatriptan 100 mg PO in clinic. Patient discharged home.
heart palpitations, chest pain, elevated heart rate, burning sensation under the skin, muscle spasms, migraines, pins and needles sensation in arms and legs,
Swollen eyelids, swollen ears, swollen face, rash in neck, back and chest.  Red and very itchy  papules distributed all over the neck and trunk.
she started having itching and rashes; itching and rashes/affected different parts of her face; She got a swollen chin; swollen eyelids, swollen lips and trouble swallowing with her throat.; swollen eyelids, swollen lips and trouble swallowing with her throat.; swollen eyelids, swollen lips and trouble swallowing with her throat.; This is a spontaneous report from a contactable consumer (patient) via a Pfizer.   A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an un-specified route of administration on 21Apr2021, dose 1 via an unspecified route of administration on 24Mar2021 as a signle dose for COVID-19 immunisation. Medical history included pruritus and rash (started having itching and rashes like the first time she took the vaccine). The patient's concomitant medications were not reported.   The patient received the second dose on Wednesday afternoon (21APR2021) and was fine but over-night she started having itching and rashes like the first time she took the vaccine. The onset of the symptoms was twelve hours after the dose and they affected different parts of her face. She got a swollen chin as well but after Wednesday she felt fine. She then woke up this morning with itchiness again as well as swollen eyelids, swollen lips and trouble swallowing with her throat. Therapeutic measures were taken, patient took two Benadryl to ease the symptoms. She would like to know also what we recommend for her to do regarding her symptoms. The clinical outcome of the events was unknown.   Were any unaddressed medical questions referred or forwarded to Medical Information: Yes  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt received vaccine on 1/25/12. Reported adverse effect on 1/27/12 at 2:40 PM. Injection side reported as hard, itchy & slightly inflamed. Pt reports slight hardening of past 24H.
Patient had no adverse event.  We are reporting that the patient received one booster dose of the Pfizer pediatric vaccine that was 10 days past the beyond use date. That is the vaccine had been in our refrigerator for 80 days instead of 70 days.
Slight fever. Redness and swelling at injection site. Arm soreness  and tenderness in upper arm.
About 10 minutes in splotchy skin and all over itching with a tight throat. Urgent care doctor assessed her and treated with Benadryl. Assessed again approximately 10 minutes later then   had her transferred over to urgent care for epinephrine shot and prednisone .  She started having relief  about 15 minutes after.
Never had any issues with knees, about knees hurt, swollen  after 2 nd shot  toes  hurt along with knees.    Felt swollen and painful. Maybe joint pain.    today is 8/30/.21 a lot better today.
Received treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 at 13:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 20Aug2020 at 17:00 as dose 1, single (Lot number: 7006320001), in left arm, on 17Sep2020 at 09:00 as dose 2, single (Lot number: 7006320004), in left arm, on 17Sep2021 at 10:00 as dose 3 (booster), single (Lot number: 8522500102), in left arm and on 13May2022 at 10:00 as dose 4 (booster), single (Lot number: 038A22A), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Oct2022 at 13:00, outcome "recovered"; DRUG INEFFECTIVE (medically significant), outcome "recovered", described as "Received treatment of COVID-19"; COVID-19 (medically significant), outcome "recovered", described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.