chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was given second dose of Moderna during clinic. He was sitting in the electric cart waiting the 15 minutes for any adverse reactions, also waiting for his family members to receive their doses when he started to slump over onto his daughter. I was behind the screen preparing another dose when I heard his daughter saying "daddy are you ok?" I immediately got up to help. I asked my technician to call 911. I got the blood pressure monitor to check his blood pressure after he finally came to. His blood pressure was within normal range. I also checked his temperature which was 96.5. His daughter said that he had a habit of passing out at home. I called my coworker to come up front to help before the paramedics arrived. The paramedics finally arrived to check him out.
SEVERE DAILY PERSISTENT ARM PAIN FROM SHOULDER TO ELBOW "LIKE A TOOTHACHE" FOR APPROXIMATELY 3 MONTHS. NO PERSISTENT SWELLING/REDNESS.
Around midnight, I experienced severe pain in my arm that made it difficult to lift it without using my right arm.  It persisted for the remainder of the day, along with extreme weakness throughout my body that made it necessary to stay in bed, and a fever high enough to make my sheets felt like I had just ironed them. All of this occurred, despite taking Tylenol every 4 hours. However, I was fine the next day.
No appetite; Dizziness; Fall; Vomited; Whole body hurt; Light headache; Whole body was achy; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Whole body was achy), DECREASED APPETITE (No appetite), DIZZINESS (Dizziness), FALL (Fall) and PYREXIA (Fever) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN (Whole body was achy), PYREXIA (Fever), MYALGIA (Whole body hurt) and HEADACHE (Light headache). On 07-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VOMITING (Vomited). On an unknown date, the patient experienced DECREASED APPETITE (No appetite), DIZZINESS (Dizziness) and FALL (Fall). At the time of the report, PAIN (Whole body was achy), DECREASED APPETITE (No appetite), DIZZINESS (Dizziness), FALL (Fall), PYREXIA (Fever), VOMITING (Vomited), MYALGIA (Whole body hurt) and HEADACHE (Light headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.    Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: No new information reported
p/vax pt exp a red rash on lt trunk, front & back which did not cross the midline;seen by MD;pt also exp pruritus & over 100 lesions;pt exp discomfort from the itching;paint 3" on a scale form 0 to10;dx shingles;
This spontaneous report as received from a nurse (other health professional) refers to a patients of unknown age and gender. On unspecified date in October 2014 the patients were vaccinated with 2 unsupported, improperly stored doses of GARDASIL lot # K005083, exp. date: 04-NOV-2013; 0.5 ml, intramuscular. No adverse effect was reported. Additional information has been requested. This is one of several reports received from the same reporter.
Within a few hours after the injection, there was mild to moderate pain and tenderness that lasted about 24 hours.  On day 9 post injection, I noticed a reddened skin area about 3"x2.5" at the injection site with some mild swelling.
This spontaneous report as received from a physician refers to a patient of unknown age. On 15-AUG-2013 the patient was vaccinated with a dose of GARDASIL (lot#, expiration date not reported, 0.5 ml, intramuscularly. On 17-COT-2013 was vaccinated with two dose of  GARDASIL (lot#, expiration date not reported, 0.5 ml, intramuscularly). No adverse effect reported. Additional information has been requested.
felt sour cream taste in the mouth; Can´t eat; felt smells like nasty soap; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (felt sour cream taste in the mouth), EATING DISORDER (Can´t eat) and PAROSMIA (felt smells like nasty soap) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer (NOS).    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSGEUSIA (felt sour cream taste in the mouth), EATING DISORDER (Can´t eat) and PAROSMIA (felt smells like nasty soap). At the time of the report, DYSGEUSIA (felt sour cream taste in the mouth), EATING DISORDER (Can´t eat) and PAROSMIA (felt smells like nasty soap) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided   Reporter did not allow further contact
3 pts received a dose during the excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number 775YF, expiry date 22nd April 2023) for prophylaxis.   On an unknown date, the patient received Boostrix .5 ml. On an unknown date, unknown after receiving Boostrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 16-MAY-2022 Reporter's Comment: The reporter informed that their facility had a medication refrigerator excursion occur and patient received the Boostrix dose during excursion. The temperature range was from 35 degree F to 9.5 degree F and total duration was 11 hours. The reporter asked was this Boostrix vaccine was still viable. The vaccine was not a part of a prior temperature excursion. Additional Supportive Information: The patient received the Boostrix dose during excursion, which led to incorrect storage of drug. This was 1 of 3 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR081064:Same Reporter US-GLAXOSMITHKLINE-US2022AMR081065:Same Reporter
Beginning evening of day of vaccinations (Friday) 3/24. Child had mild red rash on face and trunk and cried around 2 hours before falling asleep. Saturday morning noted to have temp of 103 and worsening rash. Mother described rash on face as blotchy, red with some swelling between eyes and on cheeks. Six red small, red, scatches on trunk and  under neck. The rash seemed to bother her and she was scratching it. No sob, wheezing, hoarseness. Rash became worse on Sunday morning but fever was better. Rash became resolving Sunday evening. Mother seeked medical attention on Monday.
Had chills in middle of night. Woke up next morning with cough that developed into asthmatic episode. Couldn't get full breaths even after multiple attempts to use rescue inhaler Proair and stronger inhaler Flovent. Went to ER. Pulse Ox was 90 at admission. After course for Medrol and nebulizer, left hospital at 94.
CAN HEAR TIME SLOWING DOWN; SORE; WORST HEADACHE; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. 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, 1 total, start therapy date were not reported for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced can hear time slowing down, sore, and worst headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the worst headache, sore and can hear time slowing down was not reported. This report was non-serious.
Came to office 2 days after immunization, 3.5 x 3.14 red swollen deltoid site. C/o itching, discomfort warmth.
Pt reported developing slight bruising and a "bump" at the injection site, starting 3 days after receiving the vaccine (received vaccine on 3-11-21, developed symptoms on 3-14-21). Pt still had those symptoms on 3-27-21. Pt did not report any arm or injection site pain.
5/23/20 fever chills achy all over  took Tylenol and Benadryl 5/24/20 starting feeling better but still in pain and developed rash on one foot still taking Tylenol and benaryl 5/26/20 reported symptoms to pharmacist.  pharmacist told patient to contact family doctor for follow-up.  this was the 2nd and last shingrix shot in series
He states that this is day 8 for him (8 days after COVID started). 'He states he's had both Pfizer COVID vaccinations and one booster; He states that this is day 8 for him (8 days after COVID started). 'He states he's had both Pfizer COVID vaccinations and one booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), 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 "not recovered" and all described as "He states that this is day 8 for him (8 days after COVID started). 'He states he's had both Pfizer COVID vaccinations and one booster". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: I continue to get positive home test results; (23Aug2022) Positive, notes: tested positive for COVID today. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient came down with a mild case of COVID. His doctor put him on the 5-day Paxlovid treatment.  However, after taking it, he was continued to get positive home test results. Consumer clarified that he finished his course of Paxlovid yesterday and has tested positive for COVID today. He states that this was day 8 for him (8 days after COVID started). 'He states he had both Pfizer COVID vaccinations and one booster. He also stated: 'Friends have told him that they tested positive for 3-5 days and they were told that that was because they were vaccinated.' 'The primary efficacy endpoint was the proportion of subjects with COVID-19 related hospitalization or death from any cause through Day 28.' Viral RNA Rebound 'Post-treatment increases in SARS-CoV-2 RNA shedding levels (i.e., viral RNA rebound) in nasopharyngeal samples were observed on Day 10 and or Day 14 in a subset of PAXLOVID and placebo recipients, irrespective of COVID-19 symptoms.'  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
death Narrative:  88 yo male with PMH CAD, aortic valve stenosis, sensorineural hearing loss, impaired fasting glucose, thrombocytopenia, obesity, GERD, and mixed hyperlipidemia was found to have passed away when staff did an outreach on 3/8/2021 for patient to come back for his second vaccine dose. Per family member, patient passed away on 2/24/2021. Patient has no prior positive for COVID19, no recent hospitalization (none found within the facilities record). Patient received the vaccine on 2/8/2021 with no complications. We have no other records to review. Pt was not hospitalized prior to vaccination or post vaccination. Possible cause of death unknown, no death note found in chart.
After administration of Rotateq PO vaccine, baby was laid back down and baby appeared to be choking and looked limp. Eyes rolled and looked hazed. Baby subsequently had another similar episode in front of MDs. He was suctioned and had a oxygen saturation of 99%, HR 150. He gagged, and appeared to be choking and looked sleepy.   He was sent to the ER for further observation.
At 2am I woke up with chills and body aches. My muscles felt very tight so I took some baclofen and Tylenol and tried to sleep. I woke again several more times, but at 7am I experienced severe pain all over my body. It felt especially bad in my hands/forearms and feet/calves. I felt as if my nerves were being peeled back. I had severe spasticity and some weakness. I normally walk with crutches outside and no crutches inside. I could no longer walk and had my family get my old wheelchair out for me. I had problems dorsiflexing. I had noticeable weakness in my core, quads, and glutes. My hands were weak and clumsy and while I could move my fingers had trouble grasping things. I was unable to raise my arms overhead completely, even on the side I didn?t get the shot. I did take tizanidine for spasticity and Tylenol though the day. My mother is a Pt and she came by to mobilize my shoulder. Because it started to improve  over several hours I did not go to the ER. Strength in my ankles is retuning. I can walk better, although I still have quite a weak and spastic gait and am continuing to use my wheelchair so I don?t injure myself. The pain improved significantly. I am still having some weakness in my core, which I notice if I try to sit on a couch or roll over in bed.
Prevnar 20 vaccine administered, was later found that there was a temperature excursion in the fridge it was stored in between 10/24-10/25.  Patient was informed by provider it was recommended they return after two weeks to receive dose again.
Fever 102 ( 48 hrs)  Skin over sensitive to touch  Nerve Pain  Headache  Sneezing
Information was received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's medical history, concurrent conditions or concomitant medications. On or about 29-MAY-2008, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration unknown), as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 09-JUL-2014, the patient was treated by internal medicine associates for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster. The patient was prescribed hydrocodone for management of his painful and persistent symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
diarrhea after eating certain foods and drinking coffee; This case was reported by a nurse via call center representative and described the occurrence of diarrhea in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 25th September 2020, less than a day after receiving Shingrix, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was not recovered/not resolved.   It was unknown if the reporter considered the diarrhea to be related to Shingrix.  Additional details were reported as follows: The patient complained of diarrhea after eating certain foods and drinking coffee ever since she got her first Shingrix shot in left deltoid. The reporter did not consent to follow-up.
Pt became ill 2 days following inject; admitted to hosp because of dehydration; died 28SEP91; death certificate-ventricular fibrillation, hypoxia, aspiration, gastric contents;
Patient reported she had second dose of COVID vaccine (moderna) on 2/8. She states later that evening developed severe headache, and vomiting- which lasted 36 hours. Nausea and slight chills during that time.  Injection sight sore but no redness, swelling, rashes.  Today patient has been able to eat and drink fine, and feels much better.
Needlestick to palm of hand after giving vaccine to patient. There was no vaccine content in the syringe. Area washed with soap and water.
1st dose: fatigue; muscle soreness in neck and shoulders excluding site of injection which was also sore.; muscle soreness in neck and shoulders excluding site of injection which was also sore.; muscle soreness in neck and shoulders excluding site of injection which was also sore.; This is a spontaneous report from a contactable Other Health Professional reporting for herself   A 37 years old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1686) on 30Dec2020 at 19:00 at single dose intramuscular on right arm  for COVID-19 immunization. The patient didn't have medical history. Concomitant medications included ibuprofen MIDOL [IBUPROFEN] and ibuprofen. On an unspecified date after vaccination the patient experienced fatigue and muscle soreness in neck and shoulders excluding site of injection which was also sore. The patient didn't received treatment for the reported events. At the time of the reporting the patient was recovering from the events.
Information has been received from a physician concerning a 3 year old patient who on 10-OCT-2006 was vaccinated with a 0.5 mL dose of MMR II. Concomitant medication included unspecified "anti-seizure medication". On 10-OCT-2006 the patient experienced seizure after receiving the vaccine. Unspecified medical attention was sought. No further information was provided. There was no product quality complaint involved. Upon internal review, seizures were considered to be an other important medical event. Additional information has been requested.
she was felt like she was going to die and that she did not feel good; fever; sick; my arm is swollen big. It's really, really painful/her arm is swollen very big like something eating inside of her arm; my arm is swollen big. It's really, really painful/her left arm is very painful like someone has a knife in her arm slicing; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left, on 11Apr2021 as dose 1, single, then on 03May2021 as dose 2, single, both at the age of 57-years-old, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first Pfizer Covid vaccine 11Apr2021 and had swelling in arm and fever. Her swelling went down, and she decided to get her second Pfizer Covid shot on 03May2021. Her arm was swollen very big like something eating inside of her arm. Her arm was very painful like someone has a knife in her arm slicing. She had to miss a week of work. Clarified that the pain in her left arm lasted two days and no fever with the first dose. With the second one, she was sick. She felt like she was going to die and that she did not feel good. She cannot do something with left arm. If she does something heavy that it was painful in her hand. She explained she did not know what to do because had a lot of pain in her left arm. Clarified that second shot was on 03May2021. She had fever with the second dose. It was not getting better and was getting worse. It was hurting nonstop. She did not know what to do. Clarified that the arm involved both times was her left arm. The outcome of the events was not recovered.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Multiple episodes of vomiting.  Started at 6:30PM.  Vomited 9:15-30 x 2 hours.  Was pale, lethargic, not crying.  After 2nd episode of vomiting, vomiting was only bile-colored liquid.
Initially there was no reaction except soreness at the site. After about 6 weeks became lethargic which slowly increased over 6 months leading to numbness and tingling in hands, feet and slurring of speech.  went to several emergency rooms only to be sent home. In July 2022 finally admitted to local Health Services with unknown diagnosis. Went to alternate Clinic where it was diagnosed as autoimmune rhombencephilitis and hospice was recommended. Lifeflighted to 2nd. alternate facility for stem cell transplant. Currently in inpatient rehabilitation . Cannot walk, cannot use arms for eating dressing or grasping objects. Speech remains difficult.
Within 24 hours of my first dose, I experienced severe muscle pain. Since then, it has now evolved to become a constant tingling throughout my body that moves back and forth from each of my legs, my feet, my arms, and my hands. It often feels that my limbs are falling asleep so to speak. I also have weakness in my hands where I feel I cannot pick things up correctly and my fingers lock up. It is very distressing. I have received a Doppler which was negative but I am also currently seeing a rheumatologist and neurologist. It has deeply affected my quality of life.
Walking up and down steps was very painful; Lost effectiveness of ablation; Joint Pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GAIT DISTURBANCE (Walking up and down steps was very painful), SURGICAL FAILURE (Lost effectiveness of ablation) and ARTHRALGIA (Joint Pain) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 013620A) for COVID-19 vaccination.     The patient's past medical history included Back surgery (An ablation for back a month or so before the vaccination).   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced ARTHRALGIA (Joint Pain). On an unknown date, the patient experienced GAIT DISTURBANCE (Walking up and down steps was very painful) and SURGICAL FAILURE (Lost effectiveness of ablation). At the time of the report, GAIT DISTURBANCE (Walking up and down steps was very painful) and SURGICAL FAILURE (Lost effectiveness of ablation) outcome was unknown and ARTHRALGIA (Joint Pain) had resolved.            No concomitant medications were provided. Treatment medications were unknown. Action taken with mRNA-1273 in response to the events was not applicable.    Most recent FOLLOW-UP information incorporated above includes: On 06-Jun-2021: Follow-up information received on 06-JUN-2021 contains significant information: Added relevant medical history, new events ("walking up and down steps was very painful", "lost effectiveness of ablation"). The outcome of the event (Joint pain) changed from not resolved to resolved. On 07-Jun-2021: Follow-up information received on 07-JUN-2021 contains non-significant information.
5" red and swollen induration at site of DPT and IPV injection sites; tender at site of injection. Pt treated with Augmentin.
1 of 3 pts who exp an inject site react which included welts, redness & swelling; treated w/DPH;
pt recvd vax & exp local erythema & shoulder to elbow pain;MD stated a concern w/lot of vax involved in the report;pt exp swelling from shoulder to elbow & fever;
20-24 hours after DTaP #5, pt developed 2 inch firm, red, local reaction-then 6-8 hours later swelling and redness extended to elbow and encircled arm hot, itchy. After 72 hours of reaction, swelling began to regress.