chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain where they gave me the vaccine; headache; slight temperature; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced injection site pain (Verbatim: pain where they gave me the vaccine), headache (Verbatim: headache) and fever (Verbatim: slight temperature). The outcome of the injection site pain and fever were not reported and the outcome of the headache was resolved.   It was unknown if the reporter considered the injection site pain, headache and fever to be related to Shingles vaccine.     It was unknown if the company considered the injection site pain, headache and fever to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 24-JUL-2023 This case was reported by patient via interactive digital media. The patient states that he/she felt like that and when he/she received it 4 days ago they did not told he/she anything about that, just a slight temperature, a headache but only that day and pain where they gave me the vaccine.  Follow up was not possible, as no contact details were available.
10/10 - 12N lasting until 5pm 10/11. Weakness thighs and calves. Received Flu shot 10/6. No other symptoms or weakness. Felt weak when standing.
Information has been received from a medical biller in a physician's office concerning a female patient who was vaccinated with her first dose of Pneumovax 23. Subsequently, the patient "had a reaction". Her outcome was not reported. Additional information has been requested.
Patient was standing-gave immunization in left arm. Patient asked me a question...about 1 min later said "I'm feeling tingling in my arm. I don't feel right, seeing floating things." Immediately I had her sit down. She said her chest felt tight. I observed moderate red flushing around her neckline/chest.  said she felt light-headed. No noticeable flushing elsewhere that I noticed. Waited a moment to see if redness was spreading-no rash. No local reaction at injection site. Stayed with patient and continued to monitor. Patient did not have SOB. Offered patient glass of water. 15 min after initial reaction, patient reported no chest tightness, no tingling and redness had visibly decreased. Visual floaters still present. Told patient to please stay an additional 15 min for observation due to ADR. Moved her to seat in lobby (immunization room has a horrible fluorescent light and didn't know if that was complicating visual  issues).  Continued to check on patient every 5 mins until 1 pm offered to call a family member or help with ride arrangement-she refused but requested BP check before she left.  Took BP in right arm-reading 111/69; Pulse 70. Also offered to cal urgent care in town for follow up.  She refused-stated just a short drive home and would seek care if necessary, but was feeling better.
3-4 hours after administration, the patient developed fever up to 103 degrees axillary and was then given tylenol by the parents with only slight decrease in fever and continued fever until the next day approximately lasting 24 hours.  The parents did not notify me (the pediatrician) at that time, they only notified me of this just before his 4 month immunizations.
Headache for 2 days  Stiff neck for 4 days  Swollen legs from calves down, especially my left ankle. Skin was tight & itchy. Swelling lasted for 2 days in right leg & 2 weeks in left leg
I have been so sick; nervous; sweating; This is a spontaneous report from a contactable consumer or other non healthcare professional. A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced illness, nervousness and sweating causing hyperhidrosis on an unspecified date with outcome of unknown.    The lot number for the vaccine, [BNT162B2], was not provided and will be re-quested during follow up.
Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Shakiness-Medium
symptoms grew much worse again; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (symptoms grew much worse again) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Drug allergy (Sulfa drugs).   On 31-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 13-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (symptoms grew much worse again). At the time of the report, COVID-19 (symptoms grew much worse again) was resolving. Not Provided          No concomitant medications were reported  Patient did not taking any other medications or products within 2 weeks of starting COVID-19 treatment. Device date was reported as 18-May-2022  After a few days of improved symptoms after finishing the Paxlovid course, patient's symptoms grew much worse again about 9-10 days later. COMPANY COMMENT: This is an spontaneous case concerning an 39-years-old male patient with  medical history of PAXLOVID on 29-Apr-2022 who experienced the unexpected AESI event of COVID-19 180 days after  receiving the  3rd  dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: COMPANY COMMENT: This is an spontaneous case concerning an 39-years-old male patient with  medical history of PAXLOVID on 29-Apr-2022 who experienced the unexpected AESI event of COVID-19 180 days after  receiving the  3rd  dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
The patient received dose from vial beyond 30-day use by date; The patient received dose from vial beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received dose from vial beyond 30-day use by date) and PRODUCT STORAGE ERROR (The patient received dose from vial beyond 30-day use by date) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received dose from vial beyond 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The patient received dose from vial beyond 30-day use by date). On 09-Jun-2021, EXPIRED PRODUCT ADMINISTERED (The patient received dose from vial beyond 30-day use by date) had resolved. At the time of the report, PRODUCT STORAGE ERROR (The patient received dose from vial beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided.  Treatment information was not provided. Date of refrigeration was mentioned as 7 May 2021.
febrile seizure 48 hrs p/inject; temp to 105 @ 48 hrs p/inject;
This initial spontaneous report was received from a nurse referring to an unspecified number of patients of unknown ages and genders. Concurrent conditions and medical history were not provided. The nurse stated that on an unspecified dates, "about 250" patients received doses of improperly stored vaccine, within them ROTATEQ oral liquid (dose, lot number and expiration date not provided). There was no concomitant medication described. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number G9JA7, expiry date 15th April 2023) for prophylaxis. On 10th December 2021, the patient received Shingrix. On 10th December 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional details were reported as follows: The pharmacist reported that a patient, received only adjuvant component of Shingrix vaccine which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
This spontaneous report was received from a licensed practical nurse and refers to a 12 year old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. The nurse reported that the patient was vaccinated with GARDASIL 9 (dose, route of administration, lot# and expiration date were not reported) on 30-NOV-2016 and 10-MAY-2017. No adverse symptoms were reported. No product quality complaint (PQC) was involved.
Significant body aches starting 12 hours after injection lasting about 4 hours  Took Tylenol and went to sleep. Aches were gone by morning
C/o both hands itching below thumbs, area red. c/o throat feeling tight and dry.
I noticed while on vacation I started hurting and it got to the point that I could not walk. I ended up in a wheelchair and ended my vacation early. It felt like I had hot marbles going up and down left leg. I went to the emergency room where they did an MRI with and without contrast. I have had a gel shot in my left knee. I am scheduled to go in for my right knee so I can get the MRI with and without contrast and get the gel shot in it.
4/23/21 started to feel small inner thigh pain that slowly progressed until mid June when my right foot started to move involuntarily (IMM) 7/21/21 involuntary movement from my foot and started to affect my full right leg  7/28/21 involuntary movement starts to affect my upper right arm and into my neck - pressured speech starts to happen. 7/29/21 Went to Medical Center for a flair up of shingles on my lower back and talk about the pain and (IMM) on my right side.  Medication was prescribed for shingles, but Dr. unsure what the pain down the leg is (could be sciatic and shingles affect the nerves).  Referral to physical therapy.     Continue below Continuation of symptoms:  8/1/21  (IMM) is now very painful and continues on only the right side of my body mostly inner thigh, outer thigh, arch of my foot, lower back and back of neck.  We went to Lynden urgent care; attending Dr. told us to go to the ER at Hospital. CAT scan revealed nothing that would cause involuntary muscle movement.   8/5/21 - Pain continues to intensify (IMM) same areas all on the right side.  I was admitted to the hospital were I had an EEG, MRI, and Lumbar puncture.  No signs of lesions or anything else that would show why I was having (IMM).  Released on the Aug. 8th - and referred to my primary caregiver Dr. for results.  I met with his colleague around Aug 10 or so - results read to me by Dr. and referred back to Neurology.   9/14/21 - Neurologist- prescribes Carbidopa-Levodopa, (IMM stops in my leg, arm, neck but continues in my foot without pain) still intense pain in inner thigh out thigh lower back and foot.  refers me to Dr for Electromyography, and Neurology for a movement consultation.   10/4/21 - physical therapy 10/5/21 Electromyogpahy - reveal no results of "stiff person syndrome" or Dystonia 10/13 appointment with Neurology.  Not sure of results yet
On the first night of vaccine 2nd shot, extreme body aches started with shivering, nausea, and soon fever. This  situation stayed for 3-5 days along with loss of appetite. There was pain in the right shoulder to the extent I could not sleep on my right side.  After this felt weakness for 5-7 days.  Then life became normal. But pain and tenderness in the shoulder stayed. Thought it will go away on this own, and didn't cared much about it as it didn't restricted my daily activities. The pain and tenderness never went away. Instead it started progressing to my elbow and wrist.  When pain and tenderness reached my index finger and thumb, that alerted me. That the condition is progressing. 3 months have already passed by that time. Next I noticed I am unable to raise and bend my right arm. Then started using  OTC pain and heat patches. After 6 months I finally have to see my PCP and have to start physiotherapy and she had advised MRI as well.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose number unknown (booster), single (Lot number: GJ2524) at the age of 39 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications within 2 weeks. No known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Negative, notes: rebound covid on day 8 after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 with with Paxlovid (treatment start date: 30Jan2023 treatment stop date: 04Feb2023).  No follow-up attempts are possible. No further information is expected.
Patient had numbness/tingling shortly after (in arm) that resolved same day. Patient developed rash at margin of bandage which eventually looked like cut that was not healing. She saw doctor on 10/18 and was prescribed Bactrim DS. she did not complete 7 day course because of insomnia. The wound did scab over and was healing as of 10/25/2007.
Pain and severe itching in left upper arm with redness that spread to elbows. Seen in ER on 2/17/03 and treated with IV fluids. Dx'd with cellulitis and treated with Dicloxacillin tabs 250mg. Severe swelling and redness.
2-3 days after vaccine received student reported to parent of a facial rash that was itchy, the symptoms progressed cold and flu symptoms. Mother applied aloe, hyrdrocortisone, slightly improved as of 2 weeks after initial observation.
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not specified. On 01-APR-2016, the patient was vaccinated with improperly stored (Merck) VARIVAX lot # L029466, expiry date: 06-AUG-2017 (dose, strength, dose number, vaccination site, route not provided). Concomitant medications were not provided. No adverse effects were reported. Product quality complaint (PQC) was not reported. This is one of two reports from the same reporter. Additional information has been requested.
SOB and numbness. Epi administered. EMT's called Numbness in neck and arm. Advised to go to hospital. Declined to go to hospital.
Information has been received from a registered nurse concerning a 20 years old female with no medical history and no drug allergies who on 11-JUN-2009 was vaccinated with the first dose of GARDASIL. There was no concomitant medication. Subsequently, the patient experienced headache and nausea 4 hours after receiving the first dose of GARDASIL and symptoms lasted 5 hours. Unspecified medical attention was sought. At the time of the report, the patient recovered from headache and nausea. Additional information has been requested.
Patient had syncopal vasovagal response s\p dose #1 of Pfizer COVID vaccination. Spoke with patient's mother 11/15/2021- she stated patient has had non-resolving abdominal pain and dry heaves since receiving COVID vaccination.
It was reported that a pt (4 of 13) received a Fluzone SV '00-'01 vaccination on 17 Oct 2000. Reportedly sometime after the vaccination the pt developed a local reaction. No specifics were provided. Further information is requested.
This patient lost sight in his left eye. (Nothing else attached).     The follow up received on 7/3/01 states, "this is a 53 year old pt who was referred by Dr, to "try to help me." "I'm losing my vision; I basically lost my vision in my left eye." "I first noticed the loss of vision on January 5, I took the flu shot about 2:00 in the afternoon, and about 7:30 or 8:00, I went down to read a book and it was fuzzy." He checked the eyes individually and found that the fuzziness was only OS. When he awoke the next morning, it was still fuzzy. The same morning, Saturday, January 6, he was seen by Dr, an optometrist. "She basically said I needed to go see an ophthalmologist." It sounds like he was told that he had AION. On Monday, January 8, he was seen by Dr and "he basically told me I had the same problem but he wanted to go ahead and run various blood tests and an MRI." The MRI scan was done on January 9. "It was all good except he had sinusitis." "I didn't have any vision in the upper half." "This past Sunday (1/14), it started in the lower half, and since then it's just about to the point where it's all gone." "There is a mild swelling-like or puffy-like sensation." There has been no real pain; no pain on motility. "In driving down here yesterday, there was a lot of strain on it." "It just feels like your eye is weak, it's worn out, you just want to close it." "There has been no problem with vision OD. He has had some mild hypertension. "It's high when I first have it tested, but by the time I leave the office, it's down to around 140/90." Four days ago he was started on Norvasc. There is no history of diabetes, ASCVD, angina, MI, CVA, focal motor weakness, or cigarette consumption. He has been on Decadron for 2 years for "Meniere's disease." There was no prior MRI scan."
ADACEL given 5/4/12. Patient report rash/itching at injection site - onset 5/11/12. No trouble breathing/not widespread.
He had sharp chest pains  that would come and go in left side near ribs beginning around noon on 6/17/2021. They seemed to worsen throughout day & with laying down. Then, increasing pain along left side of body into hip and leg around 5:30pm. He experienced very "bad, cramp-like" pain in left calf area around 6:30pm. Sharp Chest pains intermittent at "10 pain level" & lower left leg at "8 pain level". Some nausea and vomited once at this point. We called the urgent care line for our doctor's office and spoke with  nurse who instructed us to go to the ER. They performed ECG and Chest XR. Labs were BMP, CBC, CK, D-dimer (quantitative), & Triponon-I.  They gave 800mg Motrin, IV fluids and keterolac in IV. They said they "did not identify a specific problem" but to rest, take ibuprofen, and follow-up with doctor and cardiologist. They said it was most likely related to the Covid-19 vaccination but could not give causation.  Patient seems fine so far today, but still has medication in system.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On 27-JUL-2016, the patient was vaccinated with improperly stored MMR II lot # L029266, therapy type, (dose, strength, route of administration and expiry date were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
AVA- dermatitis progressing to chronic urticaria, fatigue, arthralgias. Joint pain, multiple joints comment: 719.49, fatigue, malaise greater than 60 days comment: 780.79, urticaria, neuropathy, memory loss, short term comment: 780.93.
Three weeks after the vaccine date on February 12, I developed chills and a fever shortly after waking. By mid-day I had a fever of 101.4 degrees. I scheduled a COVID test for the next day (February 13) which was negative. By Tuesday February 16 I was feeling well enough to schedule and receive my second Pfizer COVID vaccine on thta day. By the next week I was still not feeling well (aches in neck and back) so I went to doctor (Feb 22), who diagnosed me with pneumonia (crackling in lungs) and ordered a chest x-ray. A 7-day course of antibiotics was prescribed. I was still not feeling well 10 days later so  visited doctor again (Mar 9). Still faint crackling in lungs  so CT scan of chest was ordered. Residual pain was diagnosed as residual swelling from bout of pneumonia and should relive as infection clears. On April 5 I still had some pain, was exercising back to "work out" pain when it suddenly was much worse. Called doctor on morning of April 6, who advised me to go to emergency room. At ER I was diagnosed with thoracic and cervical diskitis and was admitted. I spent approx 9 days in the hospital for tests and initiation of antibiotic treatment. Upon release I received twice daily IV antibiotics at home to clear the infection. On June 15 I received a screw fusion on vertebrae T4-T9    Infectious diseases doctor has stated that she does not understand how someone with my otherwise good health was sticken with this infection
FEVER; MUSCLE/BODY ACHE; DIZZINESS; BALANCE DISORDER; STIFF NECK; TIREDNESS; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported.  The patient's past medical history included miscarriage, and tetanus shot allergy, and concurrent conditions included ehler danlos type iv vascular, anemia, aneurysm, cavernoma, double jointed, hemorrhage, gluten intolerance, grain intolerance, seasonal allergies, and heavy menstrual flow. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced muscle/body ache. On APR-2021, the subject experienced dizziness. On APR-2021, the subject experienced balance disorder. On APR-2021, the subject experienced stiff neck. On APR-2021, the subject experienced tiredness. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced nausea. Laboratory data included: Blood test (NR: not provided) Low sodium and dehydration, and X-ray of nasal sinuses abnormal (NR: not provided) No abnormality found. On 07-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102.7 F.  Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and the outcome of tiredness, muscle/body ache, dizziness, balance disorder, nausea, stiff neck and fever was not reported. This report was non-serious.