chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient called Health Center on 7/18/15 at 9:00 am to report that her right arm was "swollen down to the elbow" after receiving a Pneumovax injection the previous day during the routine physical exam. The patient was advised to come to the Health Center ASAP for evaluation. Also c/o itchy eyes, facial swelling, and right arm pain. Upon examination, patient had erythema and urticaria to the right upper arm, increased warmth, tenderness, +1 non-pitting edema and induration. Affected area was 5.75 inches x 7.5 inches in diameter. Right upper arm circumference measured approx 1 inch larger than the left upper arm circumference. Patient was treated with OTC PO Benadryl and Prednisone 20mg PO BID x3 days.
diagnosed with Bell's Palsy 3 days after the vaccine was administered, when the caregiver noticed symptoms and rushed patient to a provider
4 hours after vaccine was administered patient noticed a stiff neck that gradually moved to her left shoulder.  Later that evening she had pain and stiffness, involving the entire neck and upper back.  She took Advile for relief.  The next 2 days the symptoms worsened, but by the 3rd day they gradually started to improve.  Week after vaccine give the patient still had slight stiffness and intermittent pain.  Has taken Advil and Flexeril.
headache, chills, and body aches begin on 4/12 chills and aches end after 48 hours  persistent symptoms: severe (tense, sometimes pounding) headache on right temple, sinus, back of head that worsens with activity, sometimes accompanied by nausea and loss of appetite sensitivity to light and sound and difficulty focusing vision fatigue and mind fog  taking ibuprofen with limited improvement
FELT SICK; This spontaneous report received from a consumer concerned a 65 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 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 patient experienced felt sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of felt sick was not reported. This report was non-serious. This case, from the same reporter is linked to 20211048011.
Information has been received from a registered nurse concerning an about 24 year old female patient who on 13-FEB-2011 was intramuscularly vaccinated with 0.5 mL of the first dose of GARDASIL (lot # and expiration not reported) and on 17-MAY-2011 2011 was intramuscularly vaccinated in the left arm with 0.5 mL of the second dose of GARDASIL (lot # and expiration not reported). Nurse reported that within one or two days after the second dose (on approximately 18-MAY-2011 or 19-MAY-2011) the patient developed pain in the shoulder and difficulty lifting the left arm. The patient was seen on 22-MAY-2011 or 23-MAY-2011 in the clinic and it was determined the vaccination was given about 1/2 inch higher than the deltoid, in the shoulder joint. The patient's condition as of today had not improved. There were no reports of adverse effects following the first dose of GARDASIL. No laboratories were performed. No treatment was given for this adverse event. At the time of reporting the patient had not recovered. The registered nurse considered pain in the shoulder and difficulty lifting the left arm to be disabling. Additional information has been requested.
I have a little of pain in my system; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "I have a little of pain in my system".  Additional Information: Consumer stated, I just want to know is that alright to take medicine when you have the time of Covid shot, I have a little of pain in my system from this shot is it okay to take medicine (Unspecified Medication), is it okay to have pain formula.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After 5 day course (Thursday evening to Tuesday morning) of Paxlovid, symptoms improved and home test was negative/Took another home test on Tuesday, 26Apr and it was positive.; After 5 day course (Thursday evening to Tuesday morning) of Paxlovid, symptoms improved and home test was negative/Took another home test on Tuesday, 26Apr and it was positive.; 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 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Nov2021 at 21:30 as dose 3 (booster), single (Lot number: 330308D) at the age of 63 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "migraines" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL], start date: 01Oct2021, stop date: 27Apr2022. Past drug history included: Erythromycin, reaction(s): "Known allergy:Erythromycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "unknown" and all described as "After 5 day course (Thursday evening to Tuesday morning) of Paxlovid, symptoms improved and home test was negative/Took another home test on Tuesday, 26Apr and it was positive.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Negative; (26Apr2022) Positive. Therapeutic measures were taken as a result of covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
one hour after shots were administered, patient cried continuously until taken to Hospital E.R. for 3-4 hours stay.
Pulsatile Tinnitus, trouble swallowing, headache, malaise, fast heartbeat, eyes tearing. Tinnitus persists (has not resolved to date), while the other symptoms have resolved.
11/4/09 child developed rash trunk, face. Tx "oatmeal bath", BENADRYL.
Gave HPV (GARDASIL). About 10 minutes later 1/2 to 1 in below injection site (L) deltoid - hive started - grew larger to about size of 4x4. 3 PM BENADRYL 25mg administered as directed by Dr. Checked 330 PM - hives subsiding and fading.
9/14 (day of vaccination) patient experienced dizziness and swelling of face - patient took BENADRYL. 9/15 patient experienced hives from head to toe.
First time patient ever received flu vaccine. Vaccine administered in left deltoid.  Patient was asked to remain in room for 10 minutes to observe for any adverse events.  Within 5 minutes patient reported numbness and tingling center of tongue and began traveling down into throat and esophagus.  On observation patient had no difficulty breathing or swallowing.  No edema of tongue or throat.  Within 10-15 minutes patient's symptoms resolved.
Pregnant and received the COVID-19 Vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received the COVID-19 Vaccine) in a 37-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (Has been under control and not treated for 10 years) and Nickel sensitivity. Concomitant products included ASA for Pre-eclampsia, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and DOCUSATE SODIUM (STOOL SOFTENER) for an unknown indication.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in May 2020 and the estimated date of delivery was 29-Jan-2021. On 29-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received the COVID-19 Vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 29-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received the COVID-19 Vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient had 2 previous pregnancies. The first pregnancy was full term birth in 2017 and second pregnancy was full term birth in 2019.   Reporter did not allow further contact; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 37-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Diarrhea; Dizziness; Joint aches; Serious fatigue; Generally headache; Low grade fever (highest I've had is 100); GI symptoms largely nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), HEADACHE (Generally headache), PYREXIA (Low grade fever (highest I've had is 100)) and NAUSEA (GI symptoms largely nausea) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced HEADACHE (Generally headache), PYREXIA (Low grade fever (highest I've had is 100)) and NAUSEA (GI symptoms largely nausea). On 18-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), ARTHRALGIA (Joint aches) and FATIGUE (Serious fatigue). At the time of the report, DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), HEADACHE (Generally headache), PYREXIA (Low grade fever (highest I've had is 100)), NAUSEA (GI symptoms largely nausea), ARTHRALGIA (Joint aches) and FATIGUE (Serious fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Mar-2021, Pyrexia: 100 (High) 100.
Patient is fully vaccinate. COVID + on admission to hospital 1/13/2022.  66-year-old gentleman with significant known history for small-cell lung cancer, who was recently admitted to our service and discharged on January 2 for new onset diabetes mellitus and diabetic ketoacidosis, presented due to complaint of shortness of breath, lightheadedness, and dizziness. Positive for leg edema. Elevated d dimer. Patient was maintained on steroids, multiple abx regimen, and had a long decline over the past few weeks desatting on 15L HF/NRB. Patient was attempted to put on AVAPs but kept pulling it off. Long discussion with family with palliative care before final decision to make DNR limited. Patient expired.
I experienced fatigued, headaches, chills with fever, muscle aches, dizziness, and joint pain that lasted for three days. I called my doctor/nurse said that side effects are to be expected after receiving the vaccine. I was advised to take Aleve to help with my symptoms. On the fourth day, I felt better.
Approximately 12 hours post vaccination of pneumovax 23, patient developed swelling left arm were pneumovax was given. Swelling extended into underarm and that night developed bloody discharge from left nipple which last a few days and seeking medical advice on 10/23.
He was sent to the hospital two weeks earlier for Pulmonary Edema, he was discharged and sent to hospice. When the caregiver takes her rounds, she finds the resident without vital signs, prior to that he had not manifested any symptoms. Certification of cardio-respiratory failure secondary to Alzheimer's disease
Suspected vaccination failure; shingles; break out; This case was reported by a physician and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and rash. On an unknown date, the outcome of the vaccination failure, shingles and rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. After receiving Shingles vaccine, the patient had shingles. The patient had a break out. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for herpes zoster were not provided. This case was linked with case US2020AMR183095, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR183095:original case US2020AMR183095
1/14 vaccination 1/15 3am, I woke up because I was wearing an apple watch when went to bed. HR was increasing to 170 BPM and wasn't going down. It went off 3 times in 30 minutes.  Admitted to hospital; liter of fluid, valium  *informed to take the next 3 days off of work.
Mild headache, mild nausea, injection site pain, and 1 bout of upset stomach
patient came in 1 week after vaccination to report that pain started after the vaccine was administered at the site of administration without any other symptom.  the pain spread down to her elbow then her hip and back over the next few days peaking approximately at day 5 or 6.  she contacted her chiropractor who referred her to primary care dr who then didn't return her call, and also reached out to her cardiologist and pharmacist who referred her to pcp or go to urgent care. she went to urgent care where she was given a muscle relaxer and a steroid.
Redness, rash looking, itchy, hives.  At 2:00 am rubbed Benadryl lotion over back, arms, stomach and chest.  Took Benadryl tablet at 9:00am and continue to put Benadryl gel lotion on body.
Felt very tired at two different intervals on day one; throat began swelling; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration, administered in left arm on 10Mar2021 08:00 as single dose for COVID-19 immunisation. Medical history included known allergies to acidic foods, and several antibiotics (neomycin, tetracycline, etc.). It was reported that the patient was in good health. Concomitant medications included colecalciferol, ubidecarenone (COQ10 + D3), dhea and vitamin/minerals, which were medications in two weeks. On 10Mar2021 13:00, the patient experienced felt very tired at two different intervals on day one and 5 hours after shot, throat began swelling; patient waited 15 minutes then took 10 mg Loratadine and she wasn't better and after another 15 minutes, she took another 10 mg Loratadine. On day 2, after 8 hours, she felt normal. Therapy for the events included antihistamine. The patient had no covid prior vaccination and was not covid tested post vaccination. The patient had no other vaccine in 4 weeks. Outcome of events was recovered on an unspecified date.   Information about lot/batch number has been requested.
Patient was admitted s/p right total hip arthroplasty with removal of hardware. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine
CHRONIC HYPOXEMIC RESPIRATORY FAILURE 3/28/2023 BILAT PNEUMONIA CHRONIC HYPOXEMIC RESPIRATORY FAILURE 3/28/2023 HYPONATREMIA
Approximately 10 min after receiving vaccine, pt experienced vasovagal episode.  Became faint, lightheaded, and complained of headache.
Redness increasing down arm distal from injection site into axillae, itching, warmth, pain. Injection was given at approx 0950am reaction started approx. 1055am. Associate had no s/s of anaphylaxis, benadryl 50mg given orally, ice was placed at injection site.
Narrative: Developed significant polyarthralgias after 2nd COVID-19 vaccination. Treated with NSAIDs.  September 2021 labs showed his inflammatory markers, ANA and RF were all elevated.
During administration her daughter continuously spat the medication out as it was getting administered.; No additional AE information reported; This spontaneous report was received from a pharmacist and refers to her daughter of unknown age. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally (dose number, dose, lot# and expiration date were not reported) for prophylaxis. During administration she continuously spat the medication out. The reporter was not sure how much was consumed. There was no additional adverse event reported.
Fever, headache, pain in arm; feeling better by 2/16/21, but still dizzy and fatigued. Now has a sore and itchy throat and pain has returned. Symptoms are "off and on."
Initial report received from a healthcare professional on 05 October 2012. A 54-year-old male patient, whose medical history was unknown and concomitant medications was not reported, had received intramuscular ADACEL vaccine (lot number U4384AA) in right deltoid and FLUZONE vaccine intramuscular in arm (batch number: UH7454AC) on 12 September 2012. 2-3 days after vaccination, the patient had headaches, neck pain and was not resting well. The symptoms were getting worse. Laboratory details and corrective treatment were not reported. The patient's outcome was not recovered. Document Held by Sender: None. Follow-up information received from a healthcare professional on 17 December 2012. The patient had not received any other vaccinations within 4 weeks of 12 September 2012. No laboratory investigations were done. The patient felt well around 30 days afterwards and had recovered from the events on an unspecified date.
06/01/2021 Elevated blood pressure.. 06/13/2021 SVT first episode. 6/24/2021 SVT second episode. 6/27/2021 third episode.  06/28/2021 Heart ablation.  Subsequent to ablation, debilitating fatigue/asthenia  in arms, legs and neck , flushing sensations throughout body, sensitive to cold, paresthesia in feet, rapid heart rate, high blood pressure, cough, anxiety
Swollen, itchy a few hours after administration. Hydrocortisone and cetirizine.
Spontaneous Dermatographia. Chronic hives as well that change locations every hour. Worsened skin irritation when scratched lightly.  First occurred on May 4th or 5th. Only instance of hives was 10 years ago and it was a 1 time event. Hives are not present at all times but come often.  OTC anti-histamines help slightly but do not eliminate the problem. No problems from first 2 Moderna vaccines except for slight fever the day after receiving the shot. No adverse reaction directly after the 3rd moderna shot until now.
Per husband at scene, patient was feeling ill after vaccine, then he called 911 in the evening.  Patient was in cardiac arrest.
My Arm Pit and my Breast on my right side of my body became so painful as if I had a major injury or surgery. Tylenol and Aspirin could not control the intense pain.  The pain was excruciating!!  I also had aches, fever, chills and tender lymph nodes in my neck.  The excruciating pain last 3-4 days.  7 days later I still have tenderness in my breast and arm pit.
Has receive Flu vaccine for 10 years with no problems. 24 hours after vaccination vision affected. Seeing sparks to the left, flashing lights, floaters on left eye. Saw eye doctor on 10/17 and diagnosed with post-vitreous detachment on left eye. Optic nerve fine at this point. On 2nd day after vaccination experiencing cold symptoms including stuffy nose, hoarseness, no scratchy throat yet. Took some cough drops.
March 1997 - High blood sugar, treated with Micronaise. April 1997 - Diagnosed with type I diabetes. Humalog and NPH injections for 4 days.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 14Oct2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 02Apr2022 at 15:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. The patient's 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 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid started on 27May2022 and stopped on 31May2022. Paxlovid rebound on 06Jun2022 at 05:00. No treatment received for symptoms and patient was not recovered from symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
hitting head; stomach going crazy or hurting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "hitting head"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "stomach going crazy or hurting".  Additional information: on Morning Radio Show started to tell story on 1/20 in AM regarding either her stomach going crazy or hurting the evening of 1/19 while she was watching TV. I switched channel before got all details. Do not know vaccination status - but she is likely vaccinated to some degree. Submitted another AE previously for hitting head. Believe she is in late 30s or in 40s.  The lot number for bnt162b2 was not provided and will be requested during follow up.