chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Her lymph node under her right armpit became the size of the boiled egg; could not let my arm down; Nurse injected the vaccine on the backside of the arm; 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 62 year-old female patient received bnt162b2 (BNT162B2), administration date 08May2021 09:00 (Lot number: EW0173) at the age of 62 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: IBUPROFEN. The following information was reported: INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset 08May2021, outcome "unknown", described as "Nurse injected the vaccine on the backside of the arm"; LYMPHADENOPATHY (non-serious) with onset 09May2021, outcome "unknown", described as "Her lymph node under her right armpit became the size of the boiled egg; could not let my arm down". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient also received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT no.: EW0173, Expiry date: unknown), administered intramuscular in right arm on 08Jun2021 at 09:00 as dose 2, single for covid-19 immunisation and experienced some type of discomfort between the shoulder blades she mentioned that it was all like the foot was pushing in between them and it got worse and later on the discomfort eased but still present. And, to add to that she mentioned that last night she felt chills. Felt achy my body aches and earlier had pressure and her lower back, rib, back and chest area it felt like pressure feel like somebody was hitting in her back and it was gone a while now but yesterday it was terrible it was so painful. Her other sisters do not take the Pfizer they took the Moderna.  No follow-up attempts are possible. No further information is expected.
Activation of Varicella-Zoster virus and development of herpes zoster approximately four weeks after vaccine.
Pt stood up and felt dizzy & light headed. Felt anxious & felt heart racing. Sat patient back in chair told her to take some deep breaths. Took pulse & BP 66, 100/74. Waited 5 min took BP 96/70 (which she said was normal for her) took pulse 10 min later 60 bpm. Pt stated she has a history of anxiety & has not taken her medication. She felt she was just having some anxiety from the shot & from discussion of side effects. Pt stopped back 45 minutes later and she said she felt fine.
Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. patient had acute right ACA stroke.
Immediate: sweating, rise in temp.  30 min-hour: swelling bilaterally in extremities, slight swelling in face
Pt came in today for 2nd dose of Hep A with c/o "L" arm  hurting after 1st shot. Unable to lift above shoulder aches hurts when she sleeps on it. Doesn't remember when it started to hurt after 1st shot just realized it was bothering her
Patient received her second dose of Moderna COVID 19 vaccine, she was fine immediately after receiving the dose. I asked her to sit in the pharmacy area for observation post administration. Approximately 10 minutes later the patient turned pale and appeared to faint, she fell off the chair and hit her head on the floor. First aid was administered and the patient quickly woke up. 911 was called and the patient left the store under her own power with EMS.
Large red area site of injection 6cm by 6cm, hot to touch, patient was put on ZITHROMAX for treatment.
Severe headaches, extremely exhausted, body aches, chills, hot flash type events, nausea
This spontaneous report was received from a nurse concerning to a 4 months old patient of unknown gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 22-JUN-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # K023534, expiration date: 22-MAY-2016) (strength and dose were unspecified), the route was defaulted to oral. No concomitant medications were reported. No adverse effect had been observed or reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
devel fever 102.9, rhinitis 10 days p/vax;devel papular rash the next day that started on trunk, spread to extremities;over 150 lesions w/severe pruritus;clinically c/w varicella but no vesicles only papules;
I was alone.  I have little memory of the early a.m. hours after the vaccination.  I wasn't cold but was trembling so I thought the bones in the roof of my mouth were cracking.  It took me hours to get up and get to the kitchen to get tylenol which was impossible with the trembling.  I had a 100.8 fever, though the thermometer didn't really stay in my mouth.  I was extremely short of breath.  All of my nail beds were blue.  I honestly don't remember all details of that round of after effects other than that I could barely walk.  The next afternoon when I sort of came-to I noted I'd used 22 inhalations on my albuteral inhaler the hours I was in bed, I don't remember using it.  I had the zaps all day and the next night.  I woke with a migraine early am the next morning to the point of almost vomiting, I've not vomited in 15 years.  I don't get migrains but for a few back in my 20's.  I had some SOB and headache on and off and dizziness persists.  there is more, but my greatest concern is the SOB and clear oxygen issue I had with the blue nail beds.  I believe I wasn't thinking nor remembering due to that. Had my adult aged kids been here I suspect they'd have called me an ambulance.  I wish they had been as I remember being terrified not being able to get up, but I just kept trying to sleep a bit more.  There needs to be a MUCH better check system here for people.  Maybe even suggested not to be alone the night after the vaccination (either dose really).  I've never seen my nailbeds so blue in my life.  I've seen it on a friend once years ago, she was bleeding internally.   Headaches continue.  Oh and food does not taste right yet.  It took 2 days for anything to taste normal, but many things still don't.
Fever, aches, abdominal pain, minor day nose bleed, afternoon migraines
rash; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   The reporter considered the rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 19-OCT-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient thought he/she had a rash from the Shingrix vaccination. Additional supportive information: The follow-up would not possible as no contact details were available.
Information regarding PREVNAR was received from a healthcare professional regarding a patient who experienced extreme pain when PREVNAR was administered.  The patient received a dose on an unspecified date.  The patient experienced extreme pain when PREVNAR was administered.  The physician commented that he wondered if the pain has something to do with the PH of the vaccine.  The patient's outcome was unknown. 07/02/2009 Additional information indicated the patient recovered. Manufacturer's Comment: The reporter was unable to specify the number of patients who experienced this event. Additional reports will be generated when identifying information is provided. No additional information was available at the time of this report.
Approx 20-25 minutes after receiving MMR, Varicella and Hep A vaccines, infant developed hives to neck, chest, upper back. Hives responded to BENADRYL.
Violent elevated red rash with much itching started several hours after.  Treated self with Benadryl po and hydrocortisone cream
This spontaneous case reported by a consumer, describes the occurrence of diarrhea and headache in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Jan 24, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jan 24, 2021, patient experienced diarrhea and headache. At the time of the report, diarrhea and headache outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medications or treatment information provided. This case linked to MOD-2021-017362, MOD-2021-018737 (patient link).
5/23/chest discomfort. Hiked pain going uphill.  went to Clinic care.  They did ekg -negaitve. Dx me as Costa Chondritis and rx prednisone 6 -1st day to 1- 6th day Pain abated somewhat at first by 6th day could not sleep from the pain. Admitted into hospital 5/31 for stress test 5/31.  Negative discharged.  Returned 6/4 admitted second time in hospital.  Placed on iv antbiotics .  5/7 83 cc removed from cardiac sack and 6/6 6oocc removed from left lung sack.  Pain abated.  all lab tests negative no cause found for this strange event.  I am a daily workout person.  I do hike and yoga and taichi.
I was burned from the inside out third degree burned in the middle of my chest, arms, bikini line and legs.
sore arm; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of bnt162b2 (Pfizer Covid vaccine, Solution for injection, Batch/lot number: Unknown), via an unspecified route on an unknown date as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, patient experienced sore arm. The clinical outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Maculopapular rash onset about 3 days after receiving vaccine. Generalized over body. Self resolved after about 1 week (dried up per MOC). Also with angular cheilitis that self resolved at the same time.
1st day cranky x 5 days, chills, vomiting, fever of 104 R; 2nd day cranky, fever 103.0 R; 3rd day cranky, fever 103.0 R; days 4-6 cranky;
Myalgia chills Reported horrible body aches and chills that started the evening of the injection.
23AUG h/a 28AUG; 25AUG fever inc 103-28AUG-29AUG 99-100; 26AUG blurred vision; 26AUG stiff neck, unable to bend;
continuous ringing in my ears.  I will never hear quiet again.  This has altered my life
Arm very sore following the 1st vaccine injection.  As the vaccination was recent, the soreness has not yet cleared but the patient (reporter's niece) is expecting the AE to resolve without treatment within days.
I had dizziness and nausea. These lasted for 24 hours. I went to the doctor about this. They did no test. They said it was caused by the vaccine.
Patient presented in the office on 5/12 complaining of edema. The edema involves the left lower extremity. Onset was gradual 2 month(s) ago. Onset followed starting a new medication (around J and J vaccine). The symptoms occur intermittently. The patient describes this as unchanged. Symptoms are exacerbated by prolonged standing. Symptoms are relieved by leg elevation. Associated symptoms include calf pain (in upper thigh) and calf swelling, while associated symptoms do not include dyspnea, decreased urinary output, ascites, diarrhea, localized redness, localized warmth or fever. No chest pain
Ascending paresthesia & weakness arms & legs.  Presently with significant weakness (atypical Guillain-Barre).  IV immune globulin. 8/21/08-records received for DOS 5/31-6/9/08-DC DX: Atypical Guillain-Barré syndrome with autonomic dysfunction. Admitted with numbness, tingling, dysgeusia as well as unsteadiness, numbness and tingling with one episode of urinary incontinence. Orthostatic hypotension with reduced reflexes, form of peripheral nerve. Back pain, Bell's palsy.Transferred to rehabilitation facility.
covid; covid; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A 74-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 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), COVID-19 (medically significant), outcome "unknown" and all described as "covid". Clinical course: Patient received vaccine 8 days ago and now had covid. The caller wanted to know how long did the vaccine becomes effective once is administered and also wanted to know if there could be a drug interaction between the vaccine and an antiviral (molnupiravir) for the treatment of covid 19.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the known the information available the Causal relation between the events Drug ineffective, Covid 19 and suspect drug cannot be excluded completely
Deceased Narrative: Patient was a 79 yr old male with a PMH of metastatic rectal cancer with colostomy s/p chemo with RT in 2015-16 with recurrence in 2020, was on holiday from palliative chemo since 9/23/20 due to chemo-related toxicity. Patient was admitted back to Facility on 10/08 for RLE pain ins/o increased weakness and functional decline. Patient decided to transition to hospice care and was admitted to Facility 10/13 for end life care, where he continuously showed signs of functional decline.
Body/joint ache 18hrs post inj,  slight fever 99.2 ,  24 hrs later,  w/ chills,  dull headache, increased heart rate, pressure/heaviness around sternum, cough, tired. Feels like covid! Some dizziness when moving around
Breakthrough case after three vaccines Moderna 3/12/21 Lot# 040A21A  Moderna 4/9/21 Lot# 037A21B;  Moderna 12/23/21 Lot# 060H21A
vaccine was coming out of the syringe and needle; seems that patient did not have the full dose; vaccine came out of syringe running down the patients arm; A spontaneous report was received from a Pharmacist regarding a male patient who received first dose of Moderna Covid-19 vaccine and vaccine came out of syringe (device connection issue) running down the patients arm (exposure via skin contact). It seems that patient did not receive the full dose (underdose).  The patient's medical history was not provided. No concomitant medications were provided. No information on allergies.   On 13-FEB-2021, prior to the onset of events, the patient received first of two planned doses of Covid-19 vaccine for the prophylaxis of Covid-19 infection. According to Pharmacist, while administering the vaccine using 25G pharmacy needle, as soon as he pushed down the plunger, vaccine came out of syringe and needle running down the patients arm. Patient didn't seem to get the full dose and he is a lean guy, did not feel anything during administration. Pharmacist was enquiring with Medical information center at Moderna whether it is safe to give another dose. He was informed that in case of deviation from recommended dose, dose should not be repeated, and the patient should be closely followed for safety outcomes.  Action taken with the 2nd dose of vaccine was not reported.  The events, vaccine came out of syringe running down the patients arm and seems that patient did not receive the full dose, were resolved on 13 Feb 2021.; Reporter's Comments: This case concerns a 68-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot: unknown), reporting device connection issue, underdose and exposure via skin contact without any associated adverse events.
Suspected vaccination failure/Had shingrex 3 yrs ago, diagnosed shingles; shingles, lower side and stomach; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine  (received a dose of Shingles shot 7 years ago ).   On an unknown date, the patient received Shingrix. On 6th October 2022, more than 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     Additional Information: GSK receipt date: 8-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had a Shingrix shot 3 years ago and was just diagnosed Thursday with shingles.  The physician put him/her on a anti viral (Valtrex) to be taken for 7 days.  The patient had them on his/her lower left side and wraps around to the middle of his/her stomach and lower.  The patient stated that hopefully because of the vaccines and was asking that would have a milder case. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. As it was reported that the patient was diagnosed thurs with shingles, considering that onset date was captured as 6th October 2022.
After two weeks hives still have hem daily; This is a spontaneous report received from a contactable consumer(patient). A 75-old-year non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection; Lot number and Expiration date not provided) via unspecified route of administration in right arm on 05Apr2021 at 03:00 PM (at the age of 74-years-old) as single for covid-19 immunization. The patient medical history included Diabetic removal of gall bladder skin; the patient has yeast coruscation as known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included Diabetic meds insulin vitamins within 2 weeks. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12May2021 at 12:00, the patient experienced After two weeks hives still have hem daily. The patient did not receive any treatment. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.
1st dose 2006, 2nd 02Mar2023; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 69-year-old male patient who received HAV (Havrix 1440 adult) (batch number 3J9G4, expiry date 30th August 2025) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Havrix 1440 adult  (1st dose received in 2006).   On 2nd March 2023, the patient received the 2nd dose of Havrix 1440 adult and Havrix Pre-Filled Syringe Device. On 2nd March 2023, unknown after receiving Havrix 1440 adult and Havrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 02-MAR-2023 Reporter's comment: No further information about the first dose was available. The consent to follow up with healthcare professional was not asked. Additional supportive information: The patient received 2nd dose of Havrix in left arm later than the recommended interval, which led to lengthening of vaccination schedule.
BODY ACHES; FEVER; CHILLS; 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: Unknown) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. he batch number was not reported. The company is unable to perform follow up to request batch/lot number. No concomitant medications were reported. On 14-MAR-2021, the subject experienced body aches. On 14-MAR-2021, the subject experienced fever. On 14-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, fever, and chills on 15-MAR-2021. This report was non-serious.
Client states, "I developed a fever of 101 degrees the night of receiving vaccine along with general body aches. No respiratory problems". Lasted about 24 hrs. I called my PCP no treatment ordered.
Constant Ringing in left ear and many times feel like my head is extremely congested.  Started a few hours after dose and I still have the ringing in the same ear since 4/21/21 now it is 5/9/21
Tingling in arm and head fogginess approx 10 min post vaccination. Assessed by paramedics and refused transport AMA.
Patient received initial COVID vaccine on 2/11/2021 at Clinic. Direct observation for 15 minutes and no documentation noting an adverse reaction. On 2/14/2021 was diagnosed with Sepsis secondary to pneumonia, started on antibiotic therapy, cardiac arrested, and expired on 2/14/2021 while at Hospital.
Patient presented today (7/14/2018) with redness and itching at injection site. Patient indicated seemed to be improving. She was concerned about getting second dose.
Pain in hip; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Pain in hip) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and dose of ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced ARTHRALGIA (Pain in hip). At the time of the report, ARTHRALGIA (Pain in hip) was resolving. Not Provided. No Concomitant medication reported. Moderna Vaccine therapy started year reported 2022. No Treatment medication reported.
Temp 99 in the afternoon and then 102.5 by evening.  Thursday, temp still 100.2 and kept home from school.  Friday, went to school.  By Friday evening, hives on back, chest, upper arms.  No fever at that time.  Sunday evening, fever of 100 degrees.  Home from school again today.  Mom reports good appetite and fever down with medication.  Advised to stay home until fever free 24 hours without fever reducing medication.  No one else ill in household.
t105 tympanic-R equivalent several (>10) brief shivering episodes while temp 103-105; several (7) staring spells during which pt was non-responsive lasting 20seconds; limping;