chrisvoncsefalvay/vaers-outcomes huggingface dataset:
He was down and out bedridden for 3 days; aches; fever; chills; nausea; tiredness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 02-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (He was down and out bedridden for 3 days), PAIN (aches), PYREXIA (fever), CHILLS (chills) and NAUSEA (nausea) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ATORVASTATIN CALCIUM (ASTATIN [ATORVASTATIN CALCIUM]) for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced BEDRIDDEN (He was down and out bedridden for 3 days), PAIN (aches), PYREXIA (fever), CHILLS (chills), NAUSEA (nausea) and FATIGUE (tiredness). On 27-Feb-2021, BEDRIDDEN (He was down and out bedridden for 3 days) had resolved. At the time of the report, PAIN (aches), PYREXIA (fever), CHILLS (chills), NAUSEA (nausea) and FATIGUE (tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication were reported.   Reporter did not allow further contact
She got her vaccine, had a sore arm immediately with severe pain.  The pain continued, was less severe to the point that when she raises her arm to get dressed it is hard to do and painful which continues.  She saw a doctor for this and ordered a CT scan and had to do PT.  She  saw her doctor yesterday who ordered the PT and has not gone there yet.  She diagnosed her with tendinitis from the vaccine.  She told her to take Ibuprofen for the pain.   She is scheduled to have a CT scan of her shoulder on 11/8/22.  The vaccine was given closer to the shoulder than in the arm itself.   She has not had any previous reactions to flu vaccines.  She did get her COVID vaccines and had no reactions to those either.
DIZZINESS; SLEEPINESS; BRUISE ON ARM AT SITE OF INJECTION; PAIN IN ARM; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, and legally blind, and other pre-existing medical conditions included she has diabetes and wanted to know if her sugar level would go up because she is on insulin. she wanted to know how long side effects would last because she needs to go to work tomorrow.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination on right arm. Concomitant medications included insulin for diabetes. On 24-MAR-2021, the subject experienced dizziness. On 24-MAR-2021, the subject experienced sleepiness. On 24-MAR-2021, the subject experienced bruise on arm at site of injection. On 24-MAR-2021, the subject experienced pain in arm. On 24-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, dizziness, sleepiness, pain in arm, and bruise on arm at site of injection. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. This report was non-serious.
Tingling in roof of mouth, tongue. Patient showed anxiety - emotional about death of cousin. BPs 155/95 (pulse 79), 136/90 (pulse 79). Given water and rested.
Numbness and tingling of lips and roof of mouth 5-10 minutes after vaccine administration, followed by globus sensation with swallowing 15 minutes after. Difficulty swallowing progressed with onset of full body tingling and rapid heartbeat 20 minutes after. BP and pulse elevated. Given 50mg Benadryl and recommended ER. Stayed in lobby and symptoms started to improve 10 minutes after Benadryl. I work in ENT on same campus with anaphylaxis cart in office, so permitted to return to work. Symptoms fully subsided within an hour or two.
Shortness of breath; difficulty breathing 10/04/16 - 5:00 p.m.- 11:00 p.m. Joint pain, body ache 10/4/16 5:00 p.m. - 10/7/16 noon. Fatigue, no energy 10/4/16 5:00 p.m. - 10/10/16 3:00 p.m.
Vasovagal reaction  ashen color bradycardia for approx 1-2 minutes decreased B/P 90/60 with full recovery with ingestion of orange juice and recumbency
1.  Two hour naps needed for 10 days after shot, now down to an hour. 2.   Extremely out of breath - from day of shot and continues.
The shot was given to me (Sat) in the upper (L) arm about 2 -1/2 inches down from top of shoulder.  It was a simple prick however I thought it seemed an odd location.  About 24 hours later (Sun) I felt first signs of tenderness at the site but didn't think much of it as that is what I had heard from others about the vaccine.  Later in the day it became achy.  On Monday morning I noticed my whole arm was achy in addition to the top of my shoulder and the left side of my neck and  upper shoulder blade.  At 9:30 am I felt very tired and laid down and awoke 4 hours later!  My aches were still all there as though I had slept wrong.  Again I was not too concerned except that my friends all said their discomfort was gone within 24 hrs.  Today is Tuesday and evening and as I sit here I have a very tender, sore, achy upper left arm and a small black and blue spot at the site.  It's strange because it doesn't hurt when I touch it, instead it is just an ache/pain that I feel and especially when I move the arm.  The tightness and ache in my neck and back and shoulder has lessened.  I am reporting as I was not expecting this type of reaction especially to last  3-1/2 days so far.  I feel this adverse reaction probably has more to do with the location that the technician chose to give me the vaccine.  I am thinking the muscles are reacting to injection.
Prior to March 21, 2021 patient was able to walk on her own (although pace was slow), get in and out of bed or chairs, able to dress herself, use the toilet and shower and communicate verbally (although voice was not very loud.  She received the second Pfizer/BioNTech COVID-19 vaccine 2:30 PM on March 18, 2021; on March 21, 2021 she had gotten up at 4:00 AM and was walking through the kitchen when she found herself on her back on the floor and was unable to get up.  She required help in getting up and has not been able to walk on her own ever since.  She requires help in getting in and out of bed, in and out of chairs, cannot use toilet and shower on her own, is unable to dress herself and her voice has become a whis
Erythematous Edematous and firm area on left upper arm from shoulder to lower 1/3 of humerus, warm to touch.
We were not the facility giving the vaccine. The vaccine was provided by the pediatrician. The patient was seen by us about 2 weeks after giving the vaccine and reported these events. I am unsure how the vaccines were given (combined MMR and Varicella or separate). The parents reported a high fever of 40C on 6/21-6/22. On 6/24-6/25, patient developed a generalized body rash consisting of diffuse red lesions (unclear if macular or papular). There were no remaining lesions at the time of the pulmonary visit. Patient also had a hyperpigmented lesion at the site of the vaccination.
37 y/o male, PMHx of partial small bowel obstruction, admitted for abdominal cramps, N/V/D on 1/17/22. Pt was diagnosed with Covid19 in the ER. CT/MRI of the abdomin shows multiple distended loops of small bowel. Pt underwent diagnostic laparoscopy on 1/17/22. On 1/18/22, pt left against medical advice.
Information has been received from a physician's assistant concerning a 15 year old female who on unspecified dates was vaccinated intramuscularly in the arm with the first and second dose of Gardasil. Within 24 hours of receiving the first and second dose of Gardasil the patient developed a localized rash on the forearm. It was reported that the patient went to a dermatologist for the rash. It was reported that the events disappeared after a day or so. At the time of this report, the patient had recovered from the event (date unknown). Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2007. Information has been received from a physician's assistant concerning a 14 year old female with acne vulgaris who on 26-OCT-2006 was vaccinated intramuscularly in the left arm with the first dose of GARDASIL (653978/0955F). Concomitant therapy included the influenza vaccine. On 15-NOV-2006 and the 16-NOV-2006, the patient was seen in the physician's office with a rash on the left forearm with red, raised, tender patches. The patient used NEOSPORIN and was referred to a dermatologist. On 17-NOV-2006, the patient was seen by a dermatologist. A punch biopsy of the left dorsal forearm was done which was consistent with an irritant contact dematitis. The patient subsequently recovered. On 27-DEC-2006, the patient was vaccinated with the second dose of GARDASIL (655165/1425F). On 30-DEC-2006, the patient developed the same type of rash on her right leg. The rash lasted two weeks and then resolved spontaneously. Additional information is not expected.
swelling from shoulder to fingers;raised circle 3-3 1/2" dark red @ inj site;had rash on arm also extremely itchy;can still see about 2" circle @ site looks like a scar;MD had them put cortisone cream on arm;
patients who stated they received the first dose 6 weeks ago or longer; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (patients who stated they received the first dose 6 weeks ago or longer) 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 24-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (patients who stated they received the first dose 6 weeks ago or longer). At the time of the report, PRODUCT DOSE OMISSION ISSUE (patients who stated they received the first dose 6 weeks ago or longer) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided.
Received the shot just before 11am. 14 hours later, at 1am, I woke up with horrific projectile vomiting, the kind that splashes back out of the toilet onto myself and the bathroom. This lasted for approximately 4 hours all while shivering/shaking/freezing and had a fever. I would throw up, shiver for about 10 minutes and then do it all over again non-stop for 4 hours. Finally fell asleep and woke up with a fever over 101 that lasted all day with body aches.
2/21/2020 Febrile seizure the same evening Tonic-clonic-lasted 1.5 minutes EMS was called Temp was 102 3/25/2020: Had another Febrile seizure 1 minute.
This spontaneous medically confirmed report (initial receipt-26-Nov-2014) concerns a 61 year-old female patient. On 25-Nov-2014, the patient received intramuscular AFLURIA (batch number-T51808) after it reached 32.5F for 6-7 hours on 22-Nov-2014. The vaccine did not freeze during this excursion. The pharmacist was not aware of any harm to the patient. No adverse events were reported. The outcome was not reported. Reporter comments: The reporter assessed the events as non-serious. It was reported that it was ok for flu vaccine to be at 32 degree F for up to 24 hours based on the bioCSL stability studies. Per the company it was okay for the pharmacy to continue using the vaccine.
Have experienced hearing loss after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (Have experienced hearing loss after vaccination) in a female patient of an unknown age 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 DEAFNESS (Have experienced hearing loss after vaccination) (seriousness criterion medically significant). At the time of the report, DEAFNESS (Have experienced hearing loss after vaccination) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  The patient is a part of a group of over 1000 patients (all vaccines, not just Moderna).  No treatment information was provided.  Company Comment : Very limited information regarding the events has been provided at this time. Additional information regarding date of onset, date of vaccination, medical history and concomitant medications are required for further evaluation.   This case was linked to US-MODERNATX, INC.-MOD-2021-091898, US-MODERNATX, INC.-MOD-2021-092733 (E2B Linked Report).; Sender's Comments: Very limited information regarding the events has been provided at this time. Additional information regarding date of onset, date of vaccination, medical history and concomitant medications are required for further evaluation. US-MODERNATX, INC.-MOD-2021-091898:Crosslinked (MOD21-082668) US-MODERNATX, INC.-MOD-2021-092733:Crosslinked (MOD21-082695)
broke out in hives; she was sick as well; This is a spontaneous report from a contactable consumer. This consumer (patient's mother) reported for a 15-year-old female patient (reporter's daughter) that: A 15-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation crisaborole (EUCRISA), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient medical history and concomitant medications were not reported. The reporter stated that her daughter got the vaccine, and she broke out in hives and she was sick as well and does not know if she broke out because she was sick or the vaccine. The outcome of the events was unknown at the time of reporting.  Information about batch/lot number has been requested.
Product storage error; Doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) and PRODUCT STORAGE ERROR (Product storage error) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) and PRODUCT STORAGE ERROR (Product storage error) outcome was unknown. Not Provided   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was placed in refrigerator on 12-Nov-2021. It was reported that the expired lots were administered due to the confusion with expiry date printed in the carton and the expiration date when the QR code was scanned. The vials did not undergo temperature excursion. The patient did not experience any adverse event.  No treatment medications were reported.
Fever ranging from 99.8 to 102 for 54 hours.  Fatigue (slept for 15 hours on first day); lower back ache, headache, muscle ache
On 5/15/17: mother reported that in the late afternoon of 3/13/17, infants feet swelled bilaterally. Later that evening, both feet became red and their was bleeding between her toes and she was crying. The parents contemplated taking her to the ED but did not. They did not call our clinic. The next morning, the infant awoke with symptoms resolved.
Development of mood swings, weakness, some sensory changes, orthostasis. Testing initially indicated ALS. Consultation after improvement in symptoms led to likely diagnosis of Guillian Barre. Pt continues to improve
Information has been received from a consumer via the internet concerning a 20 year old female who on an unspecified date was vaccinated with a dose of GARDASIL (lot #, dose and route not reported). Two hours after vaccination, the patient experienced vomiting and abdominal pain, which subsequently worsened. Subsequently, the patient was hospitalized and had an appendectomy. At the time of the report, the status of the patient was not reported. This is one of several reports from the same source. No further information is available.
pt states has swollen glands bilaterally to throat & axilla, generally achey, deep joint pain & fever of 100.3 of 18JUL94; pt reports that MD dx w/mumps; MD records requested; 21JUL no fever, still sl nauseated, vomited last noc; rash
Numbness / in her left hand; Tingling in her left hand; Continues to have mild discomfort; Decreased range of motion / unable to lift her left arm independently / has used physical therapy; unable to lift her left arm independently / has used physical therapy; Left side of her neck became sore / increasingly worse; Left arm soreness; This case was reported by a consumer and described the occurrence of pain in arm in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included osteoarthritis and rheumatoid arthritis. Concomitant products included methotrexate.   On 28th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 2nd November 2020, 5 days after receiving Shingrix, the patient experienced neck pain. On 4th November 2020, the patient experienced joint range of motion decreased and injected limb mobility decreased. On an unknown date, the patient experienced pain in arm, numbness in hand, tingling of extremity and discomfort. The patient was treated with prednisone and non-drug therapy (Physical Therapy). On an unknown date, the outcome of the pain in arm, joint range of motion decreased and injected limb mobility decreased were recovered/resolved and the outcome of the neck pain and discomfort were not recovered/not resolved and the outcome of the numbness in hand and tingling of extremity were unknown.   It was unknown if the reporter considered the pain in arm, neck pain, joint range of motion decreased, injected limb mobility decreased, numbness in hand, tingling of extremity and discomfort to be related to Shingrix.  Additional details were provided as follows: The patient received the dose of Shingrix in left arm. The patient had left arm soreness for approximately two days. On days three and four, she felt fine. On 2nd November 2020, the left side of her neck became sore and became increasingly worse. On 4th November 2020, she had a decreased range of motion. She was unable to lift her left arm independently. She also had numbness and tingling in her left hand. She had taken prednisone and had used physical therapy. The patient's range of motion was back to baseline, but she continued to have mild discomfort. The reporter consented to follow up.
Information has been received from two physicians referring to a 2 months old male infant. Information about concurrent condition, concomitant medication medical history, drug reactions or allergies was unknown. On 11-SEP-2018, the patient was vaccinated with ROTATEQ (lot# R007991, expiration date 18-OCT-2019) (strength, dose were not reported) orally for vaccination. On the same date, the patient vomited after administration the vaccine. It was also reported that the patient had been fed right before receiving the ROTATEQ and before the ROTATEQ was fully ingested, the patient vomited once. The patient also received other vaccinations after vomiting. The patient was fully recovered prior to leaving the office. One of the report physicians felt the vomiting was due to the feeding, and not the vaccine. Information about treatment given for the event and lab diagnostics/studies was unknown by the reporter. The patient had sought medical attention and seen by physician.
She is past the 42 day window between first and second shot / Has not received her second dose; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She is past the 42 day window between first and second shot / Has not received her second dose) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She is past the 42 day window between first and second shot / Has not received her second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She is past the 42 day window between first and second shot / Has not received her second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided. No treatment information mentioned. No patient history provided.    Reporter did not allow further contact
Less than 12 hours after getting the vaccine I had fatigue, muscle pain, fever, chills, and headache. They lasted for about 12 hours.  I had lingering effects but they were mild.  Then I was diagnosed with Covid on 09/11/2021.  They did not give me any medications or do any medical tests. We were taking really good care of ourselves but we still got Covid. I still have not recovered my smell and taste. I also developed some stomach issues and brain fog.
Received vaccination 9/18. On 9/20 patient noticed swollen arm below where vaccination was administered.
Patient had facial swelling the next day. Patient had no complaints post vaccine while under observation in the pharmacy
Flu shot was given in the left arm after it was given he leaned over to the left and started shaking. Felt dizzy, was seeing black spots and felt weak.
prolonged crying, inconsolable x several hrs on day of vax, & following day; APAP;
This spontaneous report as received from a pharmacist via publicist employee refers to a male patient of unknown age. Patient's concurrent conditions and relevant medical history was unknown. On an unknown date in 2014 the patient was vaccinated with PNEUMOVAX 23 (dose and route unspecified). The patient denied any prior vaccination with PNEUMOVAX 23 when asked by the pharmacist. After administering the PNEUMOVAX 23, the pharmacist received a call from unspecified physician stating that the patient received PNEUMOVAX 23 vaccine in 2013 (date unspecified). No adverse effects were reported. The outcome of the event was unknown. The causality of the events with PNEUMOVAX 23 was not reported. Additional information has been requested.
While I had POTS prior to the vaccine booster, I had a significant POTS flare after receiving the booster.  This prevented daily activities as well as being able to travel over the holidays.  While I didn't associate it at the time, I think I had a significant flare after my first two doses as I sought treatment for POTS from Dr.  as well as a cardiologist.